Occupational Exposure to Beryllium and Beryllium Compounds

 
CONTENT

Federal Register, Volume 80 Issue 152 (Friday, August 7, 2015)

Federal Register Volume 80, Number 152 (Friday, August 7, 2015)

Proposed Rules

Pages 47565-47828

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2015-17596

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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

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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 (202) 693-2350 (OSHA's TTY number is (877) 889-5627). Deliveries (hand, express mail, messenger, or courier service) are accepted during the Docket Office's normal business hours, 8:15 a.m.-4:45 p.m., E.S.T.

Instructions: All submissions must include the Agency name and the docket number for this rulemaking (Docket No. OSHA-H005C-2006-0870). All comments, including any personal information you provide, are placed in the public docket without change and may be made available online at 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,

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OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-1999; email: meilinger.francis2@dol.gov . For technical inquiries, contact: William Perry or Maureen Ruskin, Directorate of Standards and Guidance, Room N-

3718, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1955 or fax (202) 693-1678; email: perry.bill@dol.gov.

SUPPLEMENTARY INFORMATION: The preamble to the proposed standard on occupational exposure to beryllium and beryllium compounds follows this outline:

Executive Summary

  1. Issues and Alternatives

  2. Pertinent Legal Authority

  3. Events Leading to the Proposed Standards

  4. Chemical Properties and Industrial Uses

  5. Health Effects

  6. Preliminary Risk Assessment

  7. Response to Peer Review

  8. Significance of Risk

  9. Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis

  10. OMB Review under the Paperwork Reduction Act of 1995

  11. Federalism

  12. State-Plan States

  13. Unfunded Mandates Reform Act

  14. Protecting Children from Environmental Health and Safety Risks

  15. Environmental Impacts

  16. Consultation and Coordination with Indian Tribal Governments

  17. Public Participation

  18. 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

  19. 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 (mug/m\3\) as an 8-

    hour time-weighted average. OSHA is proposing a new TWA PEL of 0.2 mug/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 mug/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 mug/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

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    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 mug/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.

  20. 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 mug/m\3\ and proposed STEL of 2 mug/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

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    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 mug/m\3\ if OSHA adopts a PEL of 0.2 mug/m\3\; it would be 0.5 mug/m\3\ if OSHA adopts a PEL of 0.1 mug/m\3\; and it would be 2.5 microg/m\3\ if OSHA adopts a PEL of 0.5 microg/m\3\ (see Regulatory Alternatives #4 and #5). Under Regulatory Alternative #4, the proposed PEL would be lowered from 0.2 mug/m\3\ to 0.1 mug/m\3\. Under Regulatory Alternative #5, the proposed PEL would be raised from 0.2 mug/m\3\ to 0.5 mug/m\3\. In addition, for informational purposes, OSHA examined a regulatory alternative that would maintain the TWA PEL at 2.0 mug/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

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    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 microg/

    m\3\ or the proposed STEL of 2 microg/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 mug/

    m\3\. However, the available evidence on feasibility suggests that 0.2 mug/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

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    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,

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    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 microg/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

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    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 microg/m\3\, which would be substantially reduced by the proposed TWA PEL of 0.2 microg/m\3\ and the alternative TWA PEL of 0.1 microg/

    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.

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    (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 (= 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 microg/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 microg/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 microg/

    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 microg/m\3\, as discussed in alternative #4, instead of the proposed PEL of 0.2 microg/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.

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    \2\ This would mean the prevailing beryllium exposures at DOE facilities are at or below 0.2 microg/m\3\.

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    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.

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    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 microg/m\3\ and action level of 0.1 microg/m\3\ in the final rule to adopting the PEL of 0.1 microg/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 microg/m\3\, 0.2 microg/m\3\, and 0.5 microg/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 microg/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 microg/m\3\ and action level of 0.1 microg/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 microg/m\3\ and an action level of 0.1 microg/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.

  21. 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 . . . The practical question is whether the standard threatens the competitive stability of an industry, . . . or whether any intra-industry or inter-industry discrimination in the standard might wreck such stability or lead to undue concentration. Id. (citing Indus. Union Dep't, AFL-CIO v. Hodgson, 499 F.2d 467 (D.C. Cir. 1974))

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

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

    Page 47578

  22. 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 microg/m\3\ as an 8-hour time-weighted average (TWA), and 25 microg/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 (ACGIHsupreg) also adopted a Threshold Limit Value (TLVsupreg) of 2 microg/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 microg/m\3\ as an 8-

    hour TWA; 5 microg/m\3\ as an acceptable ceiling concentration; and 25 microg/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 ACGIHsupreg's TLVsupregs.

    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 microg/m\3\ to 1 microg/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 microg/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 microg/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 mug/m\3\, and adopted OSHA's PEL of 2 mug/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 microg/m\3\ could lead to CBD. The RFI also cited studies describing the relationship between beryllium sensitization and CBD (67 FR at 70708). In addition, OSHA stated that beryllium had been identified as a carcinogen by organizations such as NIOSH, the International Agency for Research on Cancer (IARC), and the Environmental Protection Agency (EPA); and cancer had been evidenced in animal studies (67 FR at 70709).

    On November 15, 2007, OSHA convened a Small Business Advocacy Review Panel for a draft proposed standard for occupational exposure to beryllium. OSHA convened this panel under Section 609(b) of the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et seq.).

    The Panel included representatives from OSHA, the Solicitor's Office of the Department of Labor, the Office of Advocacy within the Small Business Administration, and the Office of Information and Regulatory Affairs of the Office of Management and Budget. Small Entity Representatives (SERs) made oral and written comments on the

    Page 47579

    draft rule and submitted them to the panel.

    The SBREFA Panel issued a report which included the SERs' comments on January 15, 2008. SERs expressed concerns about the impact of the ancillary requirements such as exposure monitoring and medical surveillance. Their comments addressed potential costs associated with compliance with the draft standard, and possible impacts of the standard on market conditions, among other issues. In addition, many SERs sought clarification of some of the ancillary requirements such as the meaning of ``routine'' contact or ``contaminated surfaces.''

    The SBREFA Panel issued a number of recommendations, which OSHA carefully considered. In section XVIII of this preamble, Summary and Explanation, OSHA has responded to the Panel's recommendations and clarified the requirements about which SERs expressed confusion. OSHA also examined the regulatory alternatives recommended by the SBREFA Panel. The regulatory alternatives examined by OSHA are listed in section I of this preamble, Issues and Alternatives. The alternatives are discussed in greater detail in section XVIII of this preamble, Summary and Explanation, and in the PEA (OSHA, 2014). In addition, the Agency intends to develop interpretive guidance documents following the publication of a final rule.

    In 2010, OSHA hired a contractor to oversee an independent scientific peer review of a draft preliminary beryllium health effects evaluation (OSHA, 2010a) and a draft preliminary beryllium risk assessment (OSHA, 2010b). The contractor identified experts familiar with beryllium health effects research and ensured that these experts had no conflict of interest or apparent bias in performing the review. The contractor selected five experts with expertise in such areas as pulmonary and occupational medicine, CBD, beryllium sensitization, the BeLPT, beryllium toxicity and carcinogenicity, and medical surveillance. Other areas of expertise included animal modeling, occupational epidemiology, biostatistics, risk and exposure assessment, exposure-response modeling, beryllium exposure assessment, industrial hygiene, and occupational/environmental health engineering.

    Regarding the health effects evaluation, the peer reviewers concluded that the health effect studies were described accurately and in sufficient detail, and OSHA's conclusions based on the studies were reasonable. The reviewers agreed that the OSHA document covered the significant health endpoints related to occupational beryllium exposure. Peer reviewers considered the preliminary conclusions regarding beryllium sensitization and CBD to be reasonable and well presented in the draft health evaluation section. All reviewers agreed that the scientific evidence supports sensitization as a necessary condition in the development of CBD. In response to reviewers' comments, OSHA made revisions to more clearly describe certain sections of the health effects evaluation. In addition, OSHA expanded its discussion regarding the BeLPT.

    Regarding the preliminary risk assessment, the peer reviewers were highly supportive of the Agency's approach and major conclusions. The peer reviewers stated that the key studies were appropriate and their selection clearly explained in the document. They regarded the preliminary analysis of these studies to be reasonable and scientifically sound. The reviewers supported OSHA's conclusion that substantial risk of sensitization and CBD were observed in facilities where the highest exposure generating processes had median full-shift exposures around 0.2 microg/m\3\ or higher, and that the greatest reduction in risk was achieved when exposures for all processes were lowered to 0.1 microg/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.

  23. 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 degC, boiling point of 2,970degC, and a density of 1.85 at 20 degC (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 (degC) Description Density (g/cm3) Solubility

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

    Beryllium metal............... 7440-41-7 Beryllium; 9.0122 1287............ Grey, close- 1.85 (20 degC) 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 degC). ethanol, diethyl

    yellow; ether and pyridine;

    orthorhombic, slightly soluble in

    deliquescent benzene, carbon

    crystal. disulfide and

    chloroform;

    insoluble in

    acetone, ammonia,

    and toluene.

    Page 47580

    Beryllium fluoride............ 7787-49-7 Beryllium 47.01 555............. Colorless or 1.986........... Soluble in water,

    (12323-05-6 difluoride. white, sulfuric acid,

    ) amorphous, mixture of ethanol

    hygroscopic and diethyl ether;

    solid. slightly soluble in

    ethanol; insoluble

    in hydrofluoric

    acid.

    Beryllium hydroxide........... 13327-32-7 Beryllium 43.3 138 (decomposes White, 1.92............ Soluble in hot

    (1304-49-0) dihydroxide. to beryllium amorphous, concentrated acids

    oxide). amphoteric and alkali; slightly

    powder. soluble in dilute

    alkali; insoluble in

    water.

    Beryllium sulfate............. 13510-49-1 Sulfuric acid, 105.07 550-600 degC 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 degC...... 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 degC Colorless to 3.01 (20 degC) Soluble in

    beryllium white, concentrated acids

    monoxide hexagonal and alkali;

    thermalox TM. crystal or insoluble in water.

    amorphous,

    amphoteric

    powder.

    Beryllium carbonate........... 1319-43-3 Carbonic acid, 112.05 No data......... White powder.... No data......... Soluble in acids and

    beryllium salt, alkali; insoluble in

    mixture with cold water;

    beryllium decomposes in hot

    hydroxide. water.

    Beryllium nitrate trihydrate.. 7787-55-5 Nitric acid, 187.97 60.............. White to faintly 1.56............ Very soluble in water

    beryllium salt, yellowish, and ethanol.

    trihydrate. deliquescent

    mass.

    Beryllium phosphate........... 13598-15-7 Phosphoric acid, 104.99 No data......... Not reported.... Not reported.... Slightly soluble in

    beryllium salt water.

    (1:1).

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

    ATSDR, 2002.

    The physical and chemical properties of beryllium were realized early in the 20th century, and it has since gained commercial importance in a wide range of industries. Beryllium is lightweight, hard, spark resistant, non-magnetic, and has a high melting point. It lends strength, electrical and thermal conductivity, and fatigue resistance to alloys (NTP, 2014). Beryllium also has a high affinity for oxygen in air and water, which can cause a thin surface film of beryllium oxide to form on the bare metal, making it extremely resistant to corrosion. These properties make beryllium alloys highly suitable for defense, nuclear, and aerospace applications (IARC, 1993).

    There are approximately 45 mineralized forms of beryllium. In the United States, the predominant mineral form mined commercially and refined into pure beryllium and beryllium alloys is bertrandite. Bertrandite, while containing less than 1% beryllium compared to 4% in beryl, is easily and efficiently processed into beryllium hydroxide (IARC, 1993). Imported beryl is also converted into beryllium hydroxide as the United States has very little beryl that can be economically mined (USGS, 2013a).

    Industrial Uses

    Materion Corporation, formerly called Brush Wellman, is the only producer of primary beryllium in the United States. Beryllium is used in a variety of industries, including aerospace, defense, telecommunications, automotive, electronic, and medical specialty industries. Pure beryllium metal is used in a range of products such as X-ray transmission windows, nuclear reactor neutron reflectors, nuclear weapons, precision instruments, rocket propellants, mirrors, and computers (NTP, 2014). Beryllium oxide is used in components such as ceramics, electrical insulators, microwave oven components, military vehicle armor, laser structural components, and automotive ignition systems (ATSDR, 2002). Beryllium oxide ceramics are used to produce sensitive electronic items such as lasers and satellite heat sinks.

    Beryllium alloys, typically beryllium/copper or beryllium/aluminum, are manufactured as high beryllium content or low beryllium content alloys. High content alloys contain greater than 30% beryllium. Low content alloys are typically less than 3% beryllium. Beryllium alloys are used in automotive electronics (e.g., electrical connectors and relays and audio components), computer components, home appliance parts, dental appliances (e.g., crowns), bicycle frames, golf clubs, and other articles (NTP, 2014; Ballance et al., 1978; Cunningham et al., 1998; Mroz, et al., 2001). Electrical components and conductors are stamped and formed from beryllium alloys. Beryllium-copper

    Page 47581

    alloys are used to make switches in automobiles (Ballance et al., 1978, 2002; Cunningham et al., 1998) and connectors, relays, and switches in computers, radar, satellite, and telecommunications equipment (Mroz et al., 2001). Beryllium-aluminum alloys are used in the construction of aircraft, high resolution medical and industrial X-ray equipment, and mirrors to measure weather patterns (Mroz et al., 2001). High content and low content beryllium alloys are precision machined for military and aerospace applications. Some welding consumables are also manufactured using beryllium.

    Beryllium is also found as a trace metal in materials such as aluminum ore, abrasive blasting grit, and coal fly ash. Abrasive blasting grits such as coal slag and copper slag contain varying concentrations of beryllium, usually less than 0.1% by weight. The burning of bituminous and sub-bituminous coal for power generation causes the naturally occurring beryllium in coal to accumulate in the coal fly ash byproduct. Scrap and waste metal for smelting and refining may also contain beryllium. A detailed discussion of the industries and job tasks using beryllium is included in the Preliminary Economic Analysis (OSHA, 2014).

    Occupational exposure to beryllium can occur from inhalation of dusts, fume, and mist. Beryllium dusts are created during operations where beryllium is cut, machined, crushed, ground, or otherwise mechanically sheared. Mists can also form during operations that use machining fluids. Beryllium fume can form while welding with or on beryllium components, and from hot processes such as those found in metal foundries.

    Occupational exposure to beryllium can also occur from skin, eye, and mucous membrane contact with beryllium particulate or solutions.

  24. 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 degC

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

    Beryllium Metal.................... Grey to White Powder.. Be.................... 9.0 Combustible; Finely None.

    dispersed particles--

    Explosive.

    Beryllium Oxide.................... White Crystals or BeO................... 25.0 Not combustible or Very sparingly

    Powder. explosive. soluble.

    Beryllium Carbonate................ White Powder.......... Be2CO3(OH)/Be2CO5H2... 181.07 Not combustible or None.

    explosive.

    Beryllium Sulfate.................. Colorless Crystals.... BeSO4................. 105.1 Not combustible or Slightly soluble.

    explosive.

    Beryllium Nitrate.................. White to Yellow Solid. BeN2O6/Be(NO3)2....... 133.0 Enhances combustion of Very soluble (1.66 x

    other substances. 10\6\ mg/L).

    Beryllium Hydroxide................ White amorphous powder Be(OH)2............... 43.0 Not reported............... Slightly soluble 0.8 x

    or crystalline solid. 10-4 mol/L

    (3.44 mg/L).

    Beryllium Chloride................. Colorless to Yellow BeCl2................. 79.9 Not combustible or Soluble.

    Crystals. explosive.

    Beryllium Fluoride................. Colorless Lumps....... BeF2.................. 47.0 Not combustible or Very soluble.

    explosive.

    Page 47582

    Beryllium Phosphate................ White solid........... Be3(PO4)2............. 271.0 Not reported............... Soluble.

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

    Source: International Chemical Safety Cards (except beryllium phosphate and hydroxide--HSDB).

    Beryllium shows a high affinity for oxygen in air and water, resulting in a thin surface film of beryllium oxide on the bare metal. If the surface film is disturbed, it may become airborne or dermal exposure may occur. The solubility, particle surface area, and particle size of some beryllium compounds are examined in more detail below. These properties have been evaluated in many toxicological studies. In particular, the properties related to the calcination (firing temperatures) and differences in crystal size and solubility are important aspects in their toxicological profile.

    2. Factors Affecting Potency and Effect of Beryllium Exposure

    The effect and potency of beryllium and its compounds, as for any toxicant, immunogen, or immunotoxicant, may be dependent upon the physical state in which they are presented to a host. For occupational airborne materials and surface contaminants, it is especially critical to understand those physical parameters in order to determine the extent of exposure to the respiratory tract and skin since these are generally the initial target organs for either route of exposure.

    For example, large particles may have less of an effect in the lung than smaller particles due to reduced potential to stay airborne to be inhaled or be deposited along the respiratory tract. In addition, once inhalation occurs particle size is critical in determining where the particle will deposit along the respiratory tract. Solubility also has an important part in determining the toxicity and bioavailability of airborne materials as well. Respiratory tract retention and skin penetration are directly influenced by the solubility and reactivity of airborne material.

    These factors may be responsible, at least in part, for the process by which beryllium sensitization progresses to CBD in exposed workers. Other factors influencing beryllium-induced toxicity include the surface area of beryllium particles and their persistence in the lung. With respect to dermal exposure, the physical characteristics of the particle are important as well since they can influence skin absorption and bioavailability. This section addresses certain physical characteristics (i.e., solubility, particle size, particle surface area) that are important in influencing the toxicity of beryllium materials in occupational settings.

    1. 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 degC, has an inverse relationship with calcination temperature. Although the solubility of the low-fired crystals can be as much as 10 times that of the high-

      fired crystals, low-fired beryllium oxide is still only sparingly soluble (Delic, 1992). In a study that measured the dissolution kinetics (rate to dissolve) of beryllium compounds calcined at different temperatures, Hoover et al., compared beryllium metal to beryllium oxide particles and found them to have similar solubilities. This was attributed to a fine layer of beryllium oxide that coats the metal particles (Hoover et al., 1989). A study conducted by Deubner et al., (2011) determined ore materials to be more soluble than beryllium oxide at pH 7.2 but similar in solubility at pH 4.5. Beryllium hydroxide was more soluble than beryllium oxide at both pHs (Deubner et al., 2011).

      Investigators have also attempted to determine how biological fluids can dissolve beryllium materials. In two studies, insoluble beryllium, taken up by activated phagocytes, was shown to be ionized by myeloperoxidases (Leonard and Lauwerys, 1987; Lansdown, 1995). The positive charge resulting from ionization enabled the beryllium to bind to receptors on the surface of cells such as lymphocytes or antigen-

      presenting cells which could make it more biologically active (NAS, 2008). In a study utilizing phagolysosomal-simulating fluid (PSF) with a pH of 4.5, both beryllium metal and beryllium oxide dissolved at a greater rate than that previously reported in water or SUF (simulant fluid) (Stefaniak et al., 2006), and the rate of dissolution of the multi-constituent (mixed) particles was greater than that of the single-constituent beryllium oxide powder. The authors speculated that copper in the particles rapidly dissolves, exposing the small inclusions of beryllium oxide, which have higher specific surface areas (SSA)

      Page 47583

      and therefore dissolve at a higher rate. A follow-up study by the same investigational team (Duling et al., 2012) confirmed dissolution of beryllium oxide by PSF and determined the release rate was biphasic (initial rapid diffusion followed by a latter slower surface reaction-

      driven release). During the latter phase, dissolution half-times were 1,400 to 2,000 days. The authors speculated this indicated bertrandite was persistent in the lung (Duling et al., 2012).

      In a recent study investigating the dissolution and release of beryllium ions for 17 beryllium-containing materials (ore, hydroxide, metal, oxide, alloys, and processing intermediates) using artificial human airway epithelial lining fluid, Stefaniak et al., (2011) found release of beryllium ions within 7 days (beryl ore melter dust). The authors calculated dissolution half-times ranging from 30 days (reduction furnace material) to 74,000 days (hydroxide). Stefaniak et al., (2011) speculated that despite the rapid mechanical clearance, billions of beryllium ions could be released in the respiratory tract via dissolution in airway lining fluid (ALF). Under this scenario beryllium-containing particles depositing in the respiratory tract dissolving in ALF could provide beryllium ions for absorption in the lung and interact with immune cells in the respiratory tract (Stefaniak et al., 2011).

      Huang et al., (2011) investigated the effect of simulated lung fluid (SLF) on dissolution and nanoparticle generation and beryllium-

      containing materials. Bertrandite-containing ore, beryl-containing ore, frit (a processing intermediate), beryllium hydroxide (a processing intermediate) and silica (used as a control), were equilibrated in SLF at two pH values (4.5 and 7.2) to reflect inter- and intra-cellular environments in the lung tissue. Concentrations of beryllium, aluminum, and silica ions increased linearly during the first 20 days in SLF, rose slowly thereafter, reaching equilibrium over time. The study also found nanoparticle formation (in the size range of 10-100 nm) for all materials (Huang et al., 2011).

      In an in vitro skin model, Sutton et al., (2003) demonstrated the dissolution of beryllium compounds (insoluble beryllium hydroxide, soluble beryllium phosphate) in a simulated sweat fluid. This model showed beryllium can be dissolved in biological fluids and be available for cellular uptake in the skin. Duling et al., (2012) confirmed dissolution and release of ions from bertrandite ore in an artificial sweat model (pH 5.3 and pH 6.5).

    2. Particle Size

      The toxicity of beryllium as exemplified by beryllium oxide also is dependent, in part, on the particle size, with smaller particles (-5 percent of the dose administered by intratracheal instillation in baboons and 3.1 x 10-5 percent in rats (Andre et al., 1987).

      4. Metabolism

      Beryllium and its compounds are not metabolized or biotransformed, but soluble beryllium salts may be converted to less soluble forms in the lung (Reeves and Vorwald, 1967). As stated earlier, solubility is an important factor for persistence of beryllium in the lung. Insoluble beryllium, engulfed by activated phagocytes, can be ionized by an acidic environment and by myeloperoxidases (Leonard and Lauwerys, 1987; Lansdown, 1995; WHO, 2001), and this positive charge could potentially make it more biologically reactive because it may allow the beryllium to bind to a peptide or protein and be presented to the T cell receptor or antigen-presenting cell (Fontenot, 2000).

      5. Preliminary Conclusion for Particle Characterization and Kinetics of Beryllium

      The forms and concentrations of beryllium across the workplace vary substantially based upon location, process, production and work task. Many factors influence the potency of beryllium including concentration, composition, structure, size and surface area of the particle.

      Studies have demonstrated that beryllium sensitization can occur via the skin or inhalation from soluble or poorly soluble beryllium particles. Beryllium must be presented to a cell in a soluble form for activation of the immune system (NAS, 2008), and this will be discussed in more detail in the section to follow. Poorly soluble beryllium can be solubilized via intracellular fluid, lung fluid and sweat (Sutton et al., 2003; Stefaniak et al., 2011). For beryllium to persist in the lung it needs to be insoluble. However, soluble beryllium has been shown to precipitate in the lung to form insoluble beryllium (Reeves and Vorwald, 1967).

      Some animal and epidemiological studies suggest that the form of beryllium may affect the rate of development of BeS and CBD. Beryllium in an inhalable form (either as soluble or insoluble particles or mist) can deposit in the respiratory tract and interact with immune cells located along the entire respiratory tract (Scheslinger, 1997). However, more study is needed to precisely determine the physiochemical characteristics of beryllium that influence toxicity and immunogenicity.

      C. Acute Beryllium Diseases

      Acute beryllium disease (ABD) is a relatively rapid onset inflammatory reaction resulting from breathing high airborne concentrations of beryllium. It was first reported in workers extracting beryllium oxide (Van Ordstrand et al., 1943). Since the Atomic Energy Commission's adoption of occupational exposure limits for beryllium beginning in 1949, cases of ABD have been rare. According to the World Health Organization (2001), ABD is generally associated with exposure to beryllium levels at or above 100 mug/m\3\ and may be fatal in 10 percent of cases. However, cases have been reported with beryllium exposures below 100 microg/m\3\ (Cummings et al., 2009). The disease involves an inflammatory reaction that may include the entire respiratory tract, involving the nasal passages, pharynx, bronchial airways and alveoli. Other tissues including skin and conjunctivae may be affected as well. The clinical features of

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      ABD include a nonproductive cough, chest pain, cyanosis, shortness of breath, low-grade fever and a sharp drop in functional parameters of the lungs. Pathological features of ABD include edematous distension, round cell infiltration of the septa, proteinaceous materials, and desquamated alveolar cells in the lung. Monocytes, lymphocytes and plasma cells within the alveoli are also characteristic of the acute disease process (Freiman and Hardy, 1970).

      Two types of acute beryllium disease have been characterized in the literature: a rapid and severe course of acute fulminating pneumonitis generally developing within 48 to 72 hours of a massive exposure, and a second form that takes several days to develop from exposure to lower concentrations of beryllium (still above the levels set by regulatory and guidance agencies) (Hall, 1950; DeNardi et al., 1953; Newman and Kreiss, 1992). Evidence of a dose-response relationship to the concentration of beryllium is limited (Eisenbud et al., 1948; Stokinger, 1950; Sterner and Eisenbud, 1951). Recovery from either type of ABD is generally complete after a period of several weeks or months (DeNardi et al., 1953). However, deaths have been reported in more severe cases (Freiman and Hardy, 1970). There have been documented cases of progression to CBD (ACCP, 1965; Hall, 1950) suggesting the possibility of an immune component to this disease (Cummings et al., 2009) as well. According to the BCR, in the United States, approximately 17 percent of ABD patients developed CBD (BCR, 2010). The majority of ABD cases occurred between 1932 and 1970 (Eisenbud, 1983; Middleton, 1998). ABD is extremely rare in the workplace today due to more stringent exposure controls implemented following occupational and environmental standards set in 1970-1972 (OSHA, 1971; ACGIH, 1971; ANSI, 1970) and 1974 (EPA, 1974).

      D. Chronic Beryllium Disease

      This section provides an overview of the immunology and pathogenesis of BeS and CBD, with particular attention to the role of skin sensitization, particle size, beryllium compound solubility, and genetic variability in individuals' susceptibility to beryllium sensitization and CBD.

      Chronic beryllium disease (CBD), formerly known as ``berylliosis'' or ``chronic berylliosis,'' is a granulomatous disorder primarily affecting the lungs. CBD was first described in the literature by Hardy and Tabershaw (1946) as a chronic granulomatous pneumonitis. It was proposed as early as 1951 that CBD could be a chronic disease resulting from an immune sensitization to beryllium (Sterner and Eisenbud, 1951; Curtis, 1959; Nishimura, 1966). However, for a time, there remained some controversy as to whether CBD was a delayed-onset hypersensitivity disease or a toxicant-induced disease (NAS, 2008). Wide acceptance of CBD as a hypersensitivity lung disease did not occur until bronchoscopy studies and bronchoalveolar lavage (BAL) studies were performed demonstrating that BAL cells from CBD patients responded to beryllium challenge (Epstein et al., 1982; Rossman et al., 1988; Saltini et al., 1989).

      CBD shares many clinical and histopathological features with pulmonary sarcoidosis, a granulomatous lung disease of unknown etiology. This includes such debilitating effects as airway obstruction, diminishment of physical capacity associated with reduced lung function, possible depression associated with decreased physical capacity, and decreased life expectancy. Without appropriate information, CBD may be difficult to distinguish from sarcoidosis. It is estimated that up to 6 percent of all patients diagnosed with sarcoidosis may actually have CBD (Fireman et al., 2003; Rossman and Kreiber, 2003). Among patients diagnosed with sarcoidosis in which beryllium exposure can be confirmed, as many as 40 percent may actually have CBD (Muller-Quernheim et al., 2006; Cherry et al., 2015).

      Clinical signs and symptoms of CBD may include, but are not limited to, a simple cough, shortness of breath or dypsnea, fever, weight loss or anorexia, skin lesions, clubbing of fingers, cyanosis, night sweats, cor pulmonale, tachycardia, edema, chest pain and arthralgia. Changes or loss of pulmonary function also occur with CBD such as decrease in vital capacity, reduced diffusing capacity, and restrictive breathing patterns. The signs and symptoms of CBD constitute a continuum of symptoms that are progressive in nature with no clear demarcation between any stages in the disease (Rossman, 1996; NAS, 2008). Besides these listed symptoms from CBD patients, there have been reported cases of CBD that remained asymptomatic (Muller-Querheim, 2005; NAS, 2008).

      Unlike ABD, CBD can result from inhalation exposure to beryllium at levels below the current OSHA PEL, can take months to years after initial beryllium exposure before signs and symptoms of CBD occur (Newman 1996, 2005 and 2007; Henneberger, 2001; Seidler et al., 2012; Schuler et al., 2012), and may continue to progress following removal from beryllium exposure (Newman, 2005; Sawyer et al., 2005; Seidler et al., 2012). Patients with CBD can progress to a chronic obstructive lung disorder resulting in loss of quality of life and the potential for decreased life expectancy (Rossman, et al., 1996; Newman et al., 2005). The NAS report (2008) noted the general lack of published studies on progression of CBD from an early asymptomatic stage to functionally significant lung disease (NAS, 2008). The report emphasized that risk factors and time course for clinical disease have not been fully delineated. However, for people now under surveillance, clinical progression from immunological sensitization and early pathological lesions (i.e., granulomatous inflammation) prior to onset of symptoms to symptomatic disease appears to be slow, although more follow-up is needed (NAS, 2008). A study by Newman (1996) emphasized the need for prospective studies to determine the natural history and time course from BeS and asymptomatic CBD to full-blown disease (Newman, 1996). Drawing from his own clinical experience, Newman was able to identify the sequence of events for those with symptomatic disease as follows: Initial determination of beryllium sensitization; gradual emergence of chronic inflammation of the lung; pathologic alterations with measurable physiologic changes (e.g., pulmonary function and gas exchange); progression to a more severe lung disease (with extrapulmonary effects such as clubbing and cor pulmonale in some cases); and finally death in some cases (reported between 5.8 to 38 percent) (NAS, 2008; Newman, 1996).

      In contrast to some occupationally related lung diseases, the early detection of chronic beryllium disease may be useful since treatment of this condition can lead not only to regression of the signs and symptoms, but also may prevent further progression of the disease in certain individuals (Marchand-Adam, 2008; NAS, 2008). The management of CBD is based on the hypothesis that suppression of the hypersensitivity reaction (i.e., granulomatous process) will prevent the development of fibrosis. However, once fibrosis has developed, therapy cannot reverse the damage.

      To date, there have been no controlled studies to determine the optimal treatment for CBD (Rossman, 1996; NAS 2008; Sood, 2009). Management of CBD is generally modeled after sarcoidosis treatment. Oral corticosteroid treatment can be initiated in patients with

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      evidence of disease (either by bronchoscopy or other diagnostic measures before progression of disease or after clinical signs of pulmonary deterioration occur). This includes treatment with other anti-inflammatory agents (NAS, 2008; Maier et al., 2012; Salvator et al., 2013) as well. It should be noted, however, that treatment with corticosteroids has side-effects of their own that need to be measured against the possibility of progression of disease (Gibson et al., 1996; Zaki et al., 1987). Alternative treatments such as azathiopurine and infliximab, while successful at treating symptoms of CBD, have been demonstrated to have side-effects as well (Pallavicino et al., 2013; Freeman, 2012).

      1. Development of Beryllium Sensitization

      Sensitization to beryllium is an essential step for worker development of CBD. Sensitization to beryllium can result from inhalation exposure to beryllium (Newman et al., 2005; NAS, 2008), as well as from skin exposure to beryllium (Curtis, 1951; Newman et al., 1996; Tinkle et al., 2003). Sensitization is currently detected using a laboratory blood test described in Appendix A. Although there may be no clinical symptoms associated with BeS, a sensitized worker's immune system has been activated to react to beryllium exposures such that subsequent exposure to beryllium can progress to serious lung disease (Kreiss et al., 1996; Kreiss et al., 1997; Kelleher et al., 2001; and Rossman, 2001). Since the pathogenesis of CBD involves a beryllium-

      specific, cell-mediated immune response, CBD cannot occur in the absence of sensitization (NAS, 2008). Various factors, including genetic susceptibility, have been shown to influence risk of developing sensitization and CBD (NAS 2008) and will be discussed later in this section.

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

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      Beryllium presentation to the immune system is believed to occur either by direct presentation or by antigen processing. It has been postulated that beryllium must be presented to the immune system in an ionic form for cell-mediated immune activation to occur (Kreiss et al., 2007). Some soluble forms of beryllium are readily presented, since the soluble beryllium form disassociates into its ionic components. However, for insoluble forms, dissolution may need to occur. A study by Harmsen et al. (1986) suggested that a sufficient rate of dissolution of small amounts of poorly soluble beryllium compounds might occur in the lungs to allow persistent low-level beryllium presentation to the immune system. Stefaniak et al. (2005 and 2012) reported that insoluble beryllium particles phagocytized by macrophages were dissolved in phagolysomal fluid (Stefaniak et al., 2005; Stefaniak et al., 2012) and that the dissolution rate stimulated by phagolysomal fluid was different for various forms of beryllium (Stefaniak et al., 2006; Duling et al., 2012). Several studies have demonstrated that macrophage uptake of beryllium can induce aberrant apoptotic processes leading to the continued release of beryllium ions which will continually stimulate T-cell activation (Sawyer et al., 2000; Sawyer et al., 2004; Kittle et al., 2002). Antigen processing can be mediated by antigen-

      presenting cells (APC). These may include macrophages, dendritic cells, or other antigen-presenting cells, although this has not been well defined in most studies (NAS, 2008).

      Because of their strong positive charge, beryllium ions have the ability to haptenate and alter the structure of peptides occupying the antigen-binding cleft of major histocompatibility complex (MHC) class II on antigen-presenting cells (APC). The MHC class II antigen-binding molecule for beryllium is the human leukocyte antigen (HLA) with specific alleles (e.g.,

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      HLA-DP, HLA-DR, HLA-DQ) associated with the progression to CBD (NAS, 2008; Yucesoy and Johnson, 2011). Several studies have also demonstrated that the electrostatic charge of HLA may be a factor in binding beryllium (Snyder et al., 2003; Bill et al., 2005; Dai et al., 2010). The strong positive ionic charge of the beryllium ion would have a strong attraction for the negatively charged patches of certain HLA alleles (Snyder et al., 2008; Dai et al., 2010). Alternatively, beryllium oxide has been demonstrated to bind to the MHC class II receptor in a neutral pH. The six carboxylates in the amino acid sequence of the binding pocket provide a stable bond with the Be-O-Be molecule when the pH of the substrate is neutral (Keizer et al., 2005). The direct binding of BeO may eliminate the biological requirement for antigen processing or dissolution of beryllium oxide to activate an immune response.

      Next in sequence is the beryllium-MHC-APC complex binding to a T-

      cell receptor (TCR) on a naiumlve T-cell which stimulates the proliferation and accumulation of beryllium-specific CD4\+\ (cluster of differentiation 4\+\) T-cells (Saltini et al., 1989 and 1990; Martin et al., 2011) as depicted in Figure 3. Fontenot et al. (1999) demonstrated that diversely different variants of TCR were expressed by CD4\+\ T-

      cells in peripheral blood cells of CBD patients. However, the CD4\+\ T-

      cells from the lung were more homologous in expression of TCR variants in CBD patients, suggesting clonal expansion of a subset of T-cells in the lung (Fontenot et al., 1999). This may also indicate a pathogenic potential for subsets of T-cell clones expressing this homologous TCR (NAS, 2008). Fontenot et al. (2006) reported beryllium self-

      presentation by HLA-DP expressing BAL CD4\+\ T-cells. Self-presentation by BAL T-cells in the lung granuloma may result in activation-induced cell death, which may then lead to oligoclonality of the T-cell population characteristic of CBD (NAS, 2008).

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      As CD4\+\ T-cells proliferate, clonal expansion of various subsets of the CD4\+\ beryllium specific T-cells occurs (Figure 3). In the peripheral blood, the beryllium-specific CD4\+\ T cells require co-

      stimulation with a co-stimulant CD28 (cluster of differentiation 28). During the proliferation and differentiation process CD4\+\ T-cells secrete pro-inflammatory cytokines that may influence this process (Sawyer et al., 2004; Kimber et al., 2011).

      2. Development of CBD

      The continued persistence of residual beryllium in the lung leads to a T-cell maturation process. A large portion of beryllium-specific CD4\+\ T cells were shown to cease expression of CD28 mRNA and protein, indicating these cells no longer required co-stimulation with the CD28 ligand (Fontenot et al., 2003). This change in phenotype correlated with lung inflammation (Fontenot et al., 2003). The CD4\+\ independent cells continued to secrete cytokines necessary for additional recruitment of inflammatory and immunological cells; however, they were less proliferative and less susceptible to cell death compared to the CD28 dependent cells (Fontenot et al., 2005; Mack et al., 2008). These beryllium-specific CD4\+\ independent cells are considered to be mature memory effector cells (Ndejembi et al., 2006; Bian et al., 2005). Repeat exposure to beryllium in the lung resulting in a mature population of T cell development independent of co-stimulation by CD28 and development of a population of T effector memory cells (Tem cells) may be one of the mechanisms that lead to the more severe reactions observed specifically in the lung (Fontenot et al., 2005).

      CD4\+\ T cells created in the sensitization process recognize the beryllium antigen, and respond by proliferating and secreting cytokines and inflammatory mediators, including IL-2, IFN-gamma, and TNF-

      alpha (Tinkle et al., 1997a and b; Fontenot et al., 2002) and MIP-

      1alpha and GRO-1 (Hong-Geller, 2006). This also results in the accumulation of various types of inflammatory cells including mononuclear cells (mostly CD4\+\ T cells) in the bronchoalveolar lavage fluid (BAL fluid) (Saltini et al., 1989, 1990).

      The development of granulomatous inflammation in the lung of CBD patients has been associated with the accumulation of beryllium responsive CD4\+\ Tem cells in BAL fluid (NAS, 2008). The subsequent release of pro-inflammatory cytokines, chemokines and reactive oxygen species by these cells may lead to migration of additional inflammatory/immune cells and the development of a microenvironment that contributes to the development of CBD (Sawyer et al., 2005; Tinkle et al., 1996; Hong-Geller et al., 2006; NAS, 2008).

      The cascade of events described above results in the formation of a noncaseating granulomatous lesion.

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      Release of cytokines by the accumulating T cells leads to the formation of granulomatous lesions that are characterized by an outer ring of histiocytes surrounding non-necrotic tissue with embedded multi-

      nucleated giant cells (Saltini et al., 1989, 1990).

      Over time, the granulomas spread and can lead to lung fibrosis and abnormal pulmonary function, with symptoms including a persistent dry cough and shortness of breath (Saber and Dweik, 2000). Fatigue, night sweats, chest and joint pain, clubbing of fingers (due to impaired oxygen exchange), loss of appetite or unexplained weight loss, and cor pulmonale have been experienced in certain patients as the disease progresses (Conradi et al., 1971; ACCP, 1965; Kriebel et al., 1988a and b). While CBD primarily affects the lungs, it can also involve other organs such as the liver, skin, spleen, and kidneys (ATSDR, 2002).

      As previously mentioned, the uptake of beryllium may lead to an aberrant apoptotic process with rerelease of beryllium ions and continual stimulation of beryllium-responsive CD4+ cells in the lung (Sawyer et al., 2000; Kittle et al., 2002; Sawyer et al., 2004). Several research studies suggest apoptosis may be one mechanism that enhances inflammatory cell recruitment, cytokine production and inflammation, thus creating a scenario for progressive granulomatous inflammation (Palmer et al., 2008; Rana, 2008). Macrophages and neutrophils can phagocytize beryllium particles in an attempt to remove the beryllium from the lung (Ding, et al., 2009). Multiple studies (Sawyer et al., 2004; Kittle et al., 2002) using BAL cells (mostly macrophages and neutrophils) from patients with CBD found that in vitro stimulation with beryllium sulfate induced the production of TNF-

      alpha (one of many cytokines produced in response to beryllium), and that production of TNF-alpha might induce apoptosis in CBD and sarcoidosis patients (Bost et al., 1994; Dai et al., 1999). The stimulation of CBD-derived macrophages by beryllium sulphate resulted in cells becoming apoptotic, as measured by propidium iodide. These results were confirmed in a mouse macrophage cell-line (p388D1) (Sawyer et al., 2000). However, other factors may influence the development of CBD and are outlined in the following section.

      3. Genetic and Other Susceptibility Factors

      Evidence from a variety of sources indicates genetic susceptibility may play an important role in the development of CBD in certain individuals, especially at levels low enough not to invoke a response in other individuals. Early occupational studies proposed that CBD was an immune reaction based on the high susceptibility of some individuals to become sensitized and progress to CBD and the lack of CBD in others who were exposed to levels several orders of magnitude higher (Sterner and Eisenbud, 1951). Additional in vitro human research has identified genes coding for specific protein molecules on the surface of their immune cells that place carriers at greater risk of becoming sensitized to beryllium and developing CBD (McCanlies et al., 2004). Recent studies have confirmed genetic susceptibility to CBD involves either HLA variants, T-cell receptor clonality, tumor necrosis factor (TNF-

      alpha) polymorphisms and/or transforming growth factor-beta (TGF-

      beta) polymorphisms (Fontenot et al., 2000; Amicosante et al., 2005; Tinkle et al., 1996; Gaede et al., 2005; Van Dyke et al., 2011; Silveira et al., 2012).

      Single Nucleotide Polymorphisms (SNPs) have been studied with regard to genetic variations associated with increased risk of developing CBD. SNPs are the most abundant type of human genetic variation. Polymorphisms in MHC class II and pro-inflammatory genes have been shown to contribute to variations in immune responses contributing to the susceptibility and resistance in many diseases including auto-immunity, and beryllium sensitization and CBD (McClesky et al., 2009). Specific SNPs have been evaluated as a factor in Glu69 variant from the HLA-DPB1 locus (Richeldi et al., 1993; Cai et al., 2000; Saltini et al., 2001; Silviera et al., 2012; Dai et al., 2013), HLA-DRPhebeta47 (Amicosante et al., 2005).

      HLA-DPB1 with a glutamic acid at amino position 69 (Glu 69) has been shown to confer increased risk of beryllium sensitization and CBD (Richeldi et al., 1993; Saltini et al., 2001; Amicosante et al., 2005; Van Dyke et al., 2011; Silveira et al., 2012). Fontenot et al. (2000) demonstrated that beryllium presentation by certain alleles of the class II human leukocyte antigen-DP (HLA-DP) to CD4+ T cells is the mechanism underlying the development of CBD. Richeldi et al. (1993) reported a strong association between the MHC class II allele HLA-DP 1 and the development of CBD in beryllium-exposed workers from a Tucson, AZ facility. This marker was found in 32 of the 33 workers who developed CBD, but in only 14 of 44 similarly exposed workers without CBD. The more common allele of the HLA-DP 1 variant is negatively charged at this site and could directly interact with the positively charged beryllium ion. The high percentage (~30 percent) of beryllium-

      exposed workers without CBD who had this allele indicates that other factors also contribute to the development of CBD (EPA, 1998). Additional studies by Amicosante et al. (2005) using blood lymphocytes derived from beryllium-exposed workers found a high frequency of this gene in those sensitized to beryllium. In a study of 82 CBD patients (beryllium-exposed workers), Stubbs et al. (1996) also found a relationship between the HLA-DP 1 allele and BeS. The glutamate-69 allele was present in 86 percent of sensitized subjects, but in only 48 percent of beryllium-exposed, non-sensitized subjects. Some variants of the HLA-DPB1 allele convey higher risk of BeS and CBD than others. For example, HLA-DPB1*0201 yielded an approximately 3-fold increase in disease outcome relative to controls; HLA-DPB1*1901 yielded an approximately 5-fold increase, and HLA-DPB1*1701 an approximately 10-

      fold increase (Weston et al., 2005; Snyder et al., 2008). By assigning odds ratios for specific alleles on the basis of previous studies discussed above, the researchers found a strong correlation (88 percent) between the reported risk of CBD and the predicted surface electrostatic potential and charge of the isotypes of the genes. They were able to conclude that the alleles associated with the most negatively charged proteins carry the greatest risk of developing beryllium sensitization and CBD. This confirms the importance of beryllium charge as a key factor in haptogenic potential.

      In contrast, the HLA-DRB1 allele, which lacks Glu 69, has also been shown to increase the risk of developing sensitization and CBD (Amicosante et al., 2005; Maier et al., 2003). Bill et al. (2005) found that HLA-DR has a glutamic acid at position 71 of the beta chain, functionally equivalent to the Glu 69 of HLA-DP (Bill et al., 2005). Associations with BeS and CBD have also been reported with the HLA-DQ markers (Amicosante et al., 2005; Maier et al., 2003). Stubbs et al. also found a biased distribution of the MHC class II HLA-DR gene between sensitized and non-sensitized subjects. Neither of these markers was completely specific for CBD, as each study found beryllium sensitization or CBD among individuals without the genetic risk factor. While there remains uncertainty as to which of the MHC class II genes interact directly with the beryllium ion, antibody inhibition data suggest that the HLA-DR gene product may be involved in the

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      presentation of beryllium to T lymphocytes (Amicosante et al., 2002). In addition, antibody blocking experiments revealed that anti-HLA-DP strongly reduced proliferation responses and cytokine secretion by BAL CD4 T cells (Chou et al., 2005). In the study by Chou (2005), anti-HLA-

      DR ligand antibodies mainly affected beryllium-induced proliferation responses with little impact on cytokines other than IL-2, thus implying that nonproliferating BAL CD4 T cells may still contribute to inflammation leading to the progression of CBD (Chou et al., 2005).

      TNF alpha (TNF-alpha) polymorphisms and TGF beta (TGF-beta) polymorphisms have also been shown to confer a genetic susceptibility for developing CBD in certain individuals. TNF-alpha is a pro-

      inflammatory cytokine associated with a more severe pulmonary disease in CBD (NAS, 2008). Beryllium exposure has been shown to upregulate transcription factors AP-1 and NF-kappaB (Sawyer et al., 2007) inducing an inflammatory response by stimulating production of pro-

      inflammatory cytokines such as TNF-alpha by inflammatory cells. Polymorphisms in the 308 position of the TNF-alpha gene have been demonstrated to increase production of the cytokine and increase severity of disease (Maier et al., 2001; Saltini et al., 2001; Dotti et al., 2004). While a study by McCanlies et al. (2007) found no relationship between TNF-alpha polymorphism and BeS or CBD, the inconsistency may be due to misclassification, exposure differences or statistical power (NAS, 2008).

      Other genetic variations have been shown to be associated with increased risk of beryllium sensitization and CBD (NAS, 2008). These include TGF-beta (Gaede et al., 2005), angiotensin-1 converting enzyme (ACE) (Newman et al., 1992; Maier et al., 1999) and an enzyme involved in glutathione synthesis (glutamate cysteine ligase) (Bekris et al., 2006). McCanlies et al. (2010) evaluated the association between polymorphisms in a select group of interleukin genes (IL-1A; IL-1B, IL-1RN, IL-2, IL-9, IL-9R) due to their role in immune and inflammatory processes. The study evaluated SNPs in three groups of workers from large beryllium manufacturing facilities in OH and AZ. The investigators found a significant association between variants IL-1A-

      1142, IL-1A-3769 and IL-1A-4697 and CBD but not with beryllium sensitization. However, these still require confirmation in larger studies (NAS, 2008).

      In addition to the genetic factors which may contribute to the susceptibility and severity of disease, other factors such as smoking and gender may play a role in the development of CBD (NAS, 2008). A recent longitudinal cohort study by Mroz et al. (2009) of 229 individuals identified with beryllium sensitization or CBD through workplace medical surveillance found that the prevalence of CBD among ever smokers was significantly lower than among never smokers (38.1 percent versus 49.4 percent, p=0.025). BeS subjects that never smoked were found to be more likely to develop CBD over the course of the study compared to current smokers (12.6 percent versus 6.4 percent, p=0.10). The authors suggested smoking may confer a protective effect against development of lung granulomas as has been demonstrated with hypersensitivity pneumonitis (Mroz et al., 2009).

      4. Beryllium Sensitization and CBD in the Workforce

      Sensitization to beryllium is currently detected in the workforce with the beryllium lymphocyte proliferation test (BeLPT), a laboratory blood test developed in the 1980s, also referred to as the LTT (Lymphocyte Transformation Test) or BeLT (Beryllium Lymphocyte Transformation Test). In this test, lymphocytes obtained from either bronchoalveolar lavage fluid (the BAL BeLPT) or from peripheral blood (the blood BeLPT) are cultured in vitro and exposed to beryllium sulfate to stimulate lymphocyte proliferation. The observation of beryllium-specific proliferation indicates beryllium sensitization. Hereafter, ``BeLPT'' generally refers to the blood BeLPT, which is typically used in screening for beryllium sensitization. This test is described in more detail in subsection D.5.b.

      CBD can be detected at an asymptomatic stage by a number of techniques including bronchoalveolar lavage and biopsy (Cordeiro et al., 2007; Maier, 2001). Bronchoalveolar lavage is a method of ``washing'' the lungs with fluid inserted via a flexible fiberoptic instrument known as a bronchoscope, removing the fluid and analyzing the content for the inclusion of immune cells reactive to beryllium exposure, as described earlier in this section. Fiberoptic bronchoscopy can be used to detect granulomatous lung inflammation prior to the onset of CBD symptoms as well, and has been used in combination with the BeLPT to diagnose pre-symptomatic CBD in a number of recent screening studies of beryllium-exposed workers, which are discussed in the following section detailing diagnostic procedures. Of workers who were found to be sensitized and underwent clinical evaluation, 31-49 percent of them were diagnosed with CBD (Kreiss et al., 1993; Newman et al., 1996, 2005, 2007; Mroz, 2009), however some estimate that with increased surveillance the percent could be much higher (Newman, 2005; Mroz, 2009). It has been estimated from ongoing surveillance studies of sensitized individuals with an average follow-up time of 4.5 years that 31 percent of beryllium-sensitized employees were estimated to progress to CBD (Newman et al., 2005). A study of nuclear weapons facility employees enrolled in an ongoing medical surveillance program found that only 20 percent of sensitized workers employed less than 5 years eventually were diagnosed with CBD, while 40 percent of sensitized workers employed 10 years or more developed CBD (Stange et al., 2001). One limitation for all these studies is lack of long-term follow-up. It may be necessary to continue to monitor these workers in order to determine whether all BeS workers will develop CBD (Newman et al., 2005).

      CBD has a clinical spectrum ranging from evidence of beryllium sensitization and granulomas in the lung with little symptomatology to loss of lung function and end stage disease which may result in the need for lung transplantation and decreased life expectancy. Unfortunately, there are very few published clinical studies describing the full range and progression of CBD from the beginning to the end stages and very few of the risk factors for progression of disease have been delineated (NAS, 2008). Clinical management of CBD is modeled after sarcoidosis where oral corticosteroid treatment is initiated in patients who have evidence of progressive lung disease, although progressive lung disease has not been well defined (NAS, 2008). In advanced cases of CBD, corticosteroids are the standard treatment (NAS, 2008). No comprehensive studies have been published measuring the overall effect of removal of workers from beryllium exposure on sensitization and CBD (NAS, 2008) although this has been suggested as part of an overall treatment regime for CBD (Mapel et al., 2002; Sood et al., 2004; Maier et al., 2006; Sood, 2009; Maier et al., 2012). Sood et al. reported that cessation of exposure can sometimes have beneficial effects on lung function (Sood et al., 2004). However, this was based on anecdotal evidence from six patients with CBD, so more research is needed to better determine the relationship between

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      exposure duration and disease progression

      5. Human Epidemiological Studies

      This section describes the human epidemiological data supporting the mechanistic overview of beryllium-induced disease in workers. It has been divided into reviews of epidemiological studies performed prior to development and implementation of the BeLPT in the late 1980s and after wide use of the BeLPT for screening purposes. Use of the BeLPT has allowed investigators to screen for beryllium sensitization and CBD prior to the onset of clinical symptoms, providing a more sensitive and thorough analysis of the worker population. The discussion of the studies has been further divided by manufacturing processes that may have similar exposure profiles. Table A.1 in the Appendix summarizes the prevalence of beryllium sensitization and CBD, range of exposure measurements, and other salient information from the key epidemiological studies.

      It has been well-established that beryllium exposure, either via inhalation or skin, may lead to beryllium sensitization, or, with inhalation exposure, may lead to the onset and progression of CBD. The available published epidemiological literature discussed below provides strong evidence of beryllium sensitization and CBD in workers exposed to airborne beryllium well below the current OSHA PEL of 2 mug/m\3\. Several studies demonstrate the prevalence of sensitization and CBD is related to the level of airborne exposure, including a cross-sectional survey of employees at a beryllium ceramics plant in Tucson, AZ (Henneberger et al., 2001), case-control studies of workers at the Rocky Flats nuclear weapons facility (Viet et al., 2000), and workers from a beryllium machining plant in Cullman, AL (Kelleher et al., 2001). The prevalence of beryllium sensitization also may be related to dermal exposure. An increased risk of CBD has been reported in workers with skin lesions, potentially increasing the uptake of beryllium (Curtis, 1951; Johnson et al., 2001; Schuler et al., 2005). Three studies describe comprehensive preventive programs, which included expanded respiratory protection, dermal protection, and improved control of beryllium dust migration, that substantially reduced the rate of beryllium sensitization among new hires (Cummings et al., 2007; Thomas et al., 2009; Bailey et al., 2010; Schuler et al., 2012).

      Some of the epidemiological studies presented in this review suffer from challenges common to many published epidemiological studies: Limitations in study design (particularly cross-sectional); small sample size; lack of personal and/or short-term exposure data, particularly those published before the late 1990s; and incomplete information regarding specific chemical form and/or particle characterization. Challenges that are specific to beryllium epidemiological studies include: uncertainty regarding the contribution of dermal exposure; use of various BeLPT protocols; a variety of case definitions for determining CBD; and use of various exposure sampling/

      assessment methods (e.g., daily weighted average (DWA), lapel sampling). Even with these limitations, the epidemiological evidence presented in this section clearly demonstrates that beryllium sensitization and CBD are continuing to occur from present-day exposures below OSHA's PEL. The available literature also indicates that the rate of BeS can be substantially lowered by reducing inhalation exposure and minimizing dermal contact.

    3. Studies Conducted Prior to the BeLPT

      First reports of CBD came from studies performed by Hardy and Tabershaw (1946). Cases were observed in industrial plants that were refining and manufacturing beryllium metal and beryllium alloys and in plants manufacturing fluorescent light bulbs (NAS, 2008). From the late 1940s through the 1960s, clusters of non-occupational CBD cases were identified around beryllium refineries in Ohio and Pennsylvania, and outbreaks in family members of beryllium factory workers were assumed to be from exposure to contaminated clothes (Hardy, 1980). It had been established that the risk of disease among beryllium workers was variable and generally rose with the levels of airborne concentrations (Machle et al., 1948). And while there was a relationship between air concentrations of beryllium and risk of developing disease both in and surrounding these plants, the disease rates outside the plants were higher than expected and not very different from the rate of CBD within the plants (Eisenbud et al., 1949; Lieben and Metzner, 1959). There remained considerable uncertainty regarding diagnosis due to lack of well-defined cohorts, modern diagnostic methods, or inadequate follow-

      up. In fact, many patients with CBD may have been misdiagnosed with sarcoidosis (NAS, 2008).

      The difficulties in distinguishing lung disease caused by beryllium from other lung diseases led to the establishment of the BCR in 1952 to identify and track cases of ABD and CBD. A uniform diagnostic criterion was introduced in 1959 as a way to delineate CBD from sarcoidosis. Patient entry into the BCR required either: documented past exposure to beryllium or the presence of beryllium in lung tissue as well as clinical evidence of beryllium disease (Hardy et al., 1967); or any three of the six criteria listed below (Hasan and Kazemi, 1974). Patients identified using the above criteria were registered and added to the BCR from 1952 through 1983 (Eisenbud and Lisson, 1983).

      The BCR listed the following criteria for diagnosing CBD (Eisenbud and Lisson, 1983):

      (1) Establishment of significant beryllium exposure based on sound epidemiologic history;

      (2) Objective evidence of lower respiratory tract disease and clinical course consistent with beryllium disease;

      (3) Chest X-ray films with radiologic evidence of interstitial fibronodular disease;

      (4) Evidence of restrictive or obstructive defect with diminished carbon monoxide diffusing capacity (DLCO) by physiologic studies of lung function;

      (5) Pathologic changes consistent with beryllium disease on examination of lung tissue; and

      (6) Presence of beryllium in lung tissue or thoracic lymph nodes.

      Prevalence of CBD in workers during the time period between the 1940s and 1950s was estimated to be between 1-10% (Eisenbud and Lisson, 1983). In a 1969 study, Stoeckle et al. presented 60 case histories with a selective literature review utilizing the above criteria except that urinary beryllium was substituted for lung beryllium to demonstrate beryllium exposure. Stoeckle et al. (1969) were able to demonstrate corticosteroids as a successful treatment option in one case of confirmed CBD. This study also presented a 28 percent mortality rate from complications of CBD at the time of publication. However, even with the improved methodology for determining CBD based on the BCR criteria, these studies suffered from lack of well-defined cohorts, modern diagnostic techniques or adequate follow-up.

    4. Criteria for Beryllium Sensitization and CBD Case Definition Following the Development of the BeLPT

      The criteria for diagnosis of CBD have evolved over time as more advanced

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      diagnostic technology, such as the (blood) BeLPT and BAL BeLPT, has become available. More recent diagnostic criteria have both higher specificity than earlier methods and higher sensitivity, identifying subclinical effects. Recent studies typically use the following criteria (Newman et al., 1989; Pappas and Newman, 1993; Maier et al., 1999):

      (1) History of beryllium exposure;

      (2) Histopathological evidence of noncaseating granulomas or mononuclear cell infiltrates in the absence of infection; and

      (3) Positive blood or BAL BeLPT (Newman et al., 1989).

      The availability of transbronchial lung biopsy facilitates the evaluation of the second criterion, by making histopathological confirmation possible in almost all cases.

      A significant component for the identification of CBD is the demonstration of a confirmed abnormal BeLPT result in a blood or BAL sample (Newman, 1996). Since the development of the BeLPT in the 1980s, it has been used to screen beryllium-exposed workers for sensitization in a number of studies to be discussed below. The BeLPT is a non-

      invasive in vitro blood test which measures the beryllium antigen-

      specific T-cell mediated immune response and is the most commonly available diagnostic tool for identifying beryllium sensitization. The BeLPT measures the degree to which beryllium stimulates lymphocyte proliferation under a specific set of conditions, and is interpreted based upon the number of stimulation indices that exceed the normal value. The `cut-off' is based on the mean value of the peak stimulation index among controls plus 2 or 3 standard deviations. This methodology was modeled into a statistical method known as the ``least absolute values'' or ``statistical-biological positive'' method and relies on natural log modeling of the median stimulation index values (DOE, 2001; Frome, 2003). In most applications, two or more stimulation indices that exceed the cut-off constitute an abnormal test.

      Early versions of the BeLPT test had high variability, but the use of tritiated thymidine to identify proliferating cells has led to a more reliable test (Mroz et al., 1991; Rossman et al., 2001). In recent years, the peripheral blood test has been found to be as sensitive as the BAL assay, although larger abnormal responses have been observed with the BAL assay (Kreiss et al., 1993; Pappas and Newman, 1993). False negative results have also been observed with the BAL BeLPT in cigarette smokers who have marked excess of alveolar macrophages in lavage fluid (Kreiss et al., 1993). The BeLPT has also been a useful tool in animal studies to identify those species with a beryllium-

      specific immune response (Haley et al., 1994).

      Screenings for beryllium sensitization have been conducted using the BeLPT in several occupational surveys and surveillance programs, including nuclear weapons facilities operated by the Department of Energy (Viet et al., 2000; Strange et al., 2001; DOE/HSS Report, 2006), a beryllium ceramics plant in Arizona (Kreiss et al., 1996; Henneberger et al., 2001; Cummings et al., 2007), a beryllium production plant in Ohio (Kreiss et al., 1997; Kent et al., 2001), a beryllium machining facility in Alabama (Kelleher et al., 2001; Madl et al., 2007), a beryllium alloy plant (Schuler et al., 2005, Thomas et al., 2009), and another beryllium processing plant (Rosenman et al., 2005) in Pennsylvania. In most of these studies, individuals with an abnormal BeLPT result were retested and were identified as sensitized (i.e., confirmed positive) if the abnormal result was repeated.

      There has been criticism regarding the reliability and specificity of the BeLPT as a screening tool (Borak et al., 2006). Stange et al. (2004) studied the reliability and laboratory variability of the BeLPT by splitting blood samples and sending samples to two laboratories simultaneously for BeLPT analysis. Stange et al. found the range of agreement on abnormal (positive BeLPT) results was 26.2--61.8 percent depending upon the labs tested (Stange et al., 2004). Borak et al. (2006) contended that the positive predictive value (PPV) (PPV is the portion of patients with positive test result correctly diagnosed) is not high enough to meet the criteria of a good screening tool. Middleton et al. (2008) used the data from the Stange et al. (2004) study to estimate the PPV and determined that the PPV of the BeLPT could be improved from 0.383 to 0.968 when an abnormal BeLPT result is confirmed with a second abnormal result (Middleton et al., 2008). However, an apparent false positive can occur in people not occupationally exposed to beryllium (NAS, 2008). An analysis of survey data from the general workforce and new employees at a beryllium manufacturer was performed to assess the reliability of the BeLPT (Donovan et al. 2007). Donovan et al. analyzed more than 10,000 test results from nearly 2400 participants over a 12-year period. Donovan et al. found that approximately 2 percent of new employees had at least one positive BeLPT at the time of hire and 1 percent of new hires with no known occupational exposure were confirmed positive at the time of hire with two BeLPTs. Since there are currently no alternatives to the BeLPT in a screening program many programs rely on a second test to confirm a positive result (NAS, 2008).

      The epidemiological studies presented in this section utilized the BeLPT as either a surveillance tool or a screening tool for determining sensitization status and/or sensitization/CBD prevalence in workers for inclusion in the published studies. Most epidemiological studies have reported rates of sensitization and disease based on a single screening of a working population (`cross-sectional' or 'population prevalence' rates). Studies of workers in a beryllium machining plant and a nuclear weapons facility have included follow-up of the population originally screened, resulting in the detection of additional cases of sensitization over several years (Newman et al., 2001, Stange et al., 2001). OSHA regards the BeLPT as a reliable medical surveillance tool. The BeLPT is discussed in more detail in Non-Mandatory Appendix A to the proposed standard, Immunological Testing for the Determination of Beryllium Sensitization.

    5. Beryllium Mining and Extraction

      Mining and extraction of beryllium usually involves the two major beryllium minerals, beryl (an aluminosilicate containing up to 4 percent beryllium) and bertrandite (a beryllium silicate hydrate containing generally less than 1 percent beryllium) (WHO, 2001). The United States is the world leader in beryllium extraction and also leads the world in production and use of beryllium and its alloys (WHO, 2001). Most exposures from mining and extraction come in the form of beryllium ore, beryllium salts, beryllium hydroxide (NAS 2008) or beryllium oxide (Stefaniak et al., 2008).

      Deubner et al. published a study of 75 workers employed at a beryllium mining and extraction facility in Delta, UT (Deubner et al., 2001b). Of the 75 workers surveyed for sensitization with the BeLPT, three were identified as sensitized by an abnormal BeLPT result. One of those found to be sensitized was diagnosed with CBD. Exposures at the facility included primarily beryllium ore and salts. General area (GA), breathing zone (BZ), and personal lapel (LP) exposure samples were collected from 1970 to 1999. Jobs involving beryllium hydrolysis and wet-grinding activities had the highest air concentrations, with an annual median GA concentration ranging from 0.1 to 0.4 mug/m\3\. Median BZ concentrations

      Page 47596

      were higher than either LP or GA. The average duration of exposure for beryllium sensitized workers was 21.3 years (27.7 years for the worker with CBD), compared to an average duration for all workers of 14.9 years. However, these exposures were less than either the Elmore, OH, or Tucson, AZ, facilities described below, which also had higher reported rates of BeS and CBD. A study by Stefaniak et al. (2008) demonstrated that beryllium was present at the mill in three forms: mineral, poorly crystalline oxide, and hydroxide.

      There was no sensitization or CBD among those who worked only at the mine where exposure to beryllium resulted solely from working with bertrandite ore. The authors concluded that the results of this study indicated that beryllium ore and salts may pose less of a hazard than beryllium metal and beryllium hydroxide. These results are consistent with the previously discussed animal studies examining solubility and particle size.

    6. Beryllium Metal Processing and Alloy Production

      Kreiss et al. (1997) conducted a study of workers at a beryllium production facility in Elmore, OH. The plant, which opened in 1953 and initially specialized in production of beryllium-copper alloy, later expanded its operations to include beryllium metal, beryllium oxide, and beryllium-aluminum alloy production; beryllium and beryllium alloy machining; and beryllium ceramics production, which was moved to a different factory in the early 1980s. Production operations included a wide variety of jobs and processes, such as work in arc furnaces and furnace rebuilding, alloy melting and casting, beryllium powder processing, and work in the pebble plant. Non-production work included jobs in the analytical laboratory, engineering research and development, maintenance, laundry, production-area management, and office-area administration. While the publication refers to the use of respiratory protection in some areas, such as the pebble plant, the extent of its use across all jobs or time periods was not reported. Use of dermal PPE was not reported.

      The authors characterized exposures at the plant using industrial hygiene (IH) samples collected between 1980 and 1993. The exposure samples and the plant's formulas for estimating workers' DWA exposures were used, together with study participants' work histories, to estimate their cumulative and average beryllium exposure levels. Exposure concentrations reflected the high exposures found historically in beryllium production and processing. Short-term BZ measurements had a median of 1.4, with 18.5 percent of samples exceeding OSHA's STEL of 5.0 mug/m\3\. Particularly high beryllium concentrations were reported in the areas of beryllium powder production, laundry, alloy arc furnace (approximately 40 percent of DWA estimates over 2.0 mug/

      m\3\) and furnace rebuild (28.6 percent of short-term BZ samples over the OSHA STEL of 5 mug/m\3\). LP samples (n = 179), which were available from 1990 to 1992, had a median value of 1 mug/m\3\.

      Of 655 workers employed at the time of the study, 627 underwent BeLPT screening. Blood samples were divided and split between two labs for analysis, with repeat testing for results that were abnormal or indeterminate. Thirty-one workers had an abnormal blood test upon initial testing and at least one of two subsequent tests was classified as sensitized. These workers, together with 19 workers who had an initial abnormal result and one subsequent indeterminate result, were offered clinical evaluation for CBD including the BAL-BeLPT and transbronchial lung biopsy. Nine with an initial abnormal test followed by two subsequent normal tests were not clinically evaluated, although four were found to be sensitized upon retesting in 1995. Of 47 workers who proceeded with evaluation for CBD (3 of the 50 initial workers with abnormal results declined to participate), 24 workers were diagnosed with CBD based on evidence of granulomas on lung biopsy (20 workers) or on other findings consistent with CBD (4 workers) (Kreiss et al., 1997). After including five workers who had been diagnosed prior to the study, a total of 29 (4.6 percent) current workers were found to have CBD. In addition, the plant medical department identified 24 former workers diagnosed with CBD before the study.

      Kreiss et al. reported that the highest prevalence of sensitization and CBD occurred among workers employed in beryllium metal production, even though the highest airborne total mass concentrations of beryllium were generally among employees operating the beryllium alloy furnaces in a different area of the plant (Kreiss et al., 1997). Preliminary follow-up investigations of particle size-specific sampling at five furnace sites within the plant determined that the highest respirable (e.g., particles 0.1). In the logistic regression analysis, only machinist work history was a significant predictor of case status in the final model. Quantitative exposure measures were not significant predictors of sensitization or disease risk.

      Citing an 11.5 percent prevalence of beryllium sensitization or CBD among machinists as compared with 2.9 percent prevalence among workers with no machinist work history, the authors concluded that the risk of sensitization and CBD is increased among workers who machine beryllium. Although differences between cases and controls in median cumulative exposure did not achieve conventional thresholds for statistical significance, the authors noted that cumulative exposures were consistently higher among cases than controls for all categories of exposure estimates and for all particle sizes, suggesting an effect of cumulative exposure on risk. The levels at which workers developed CBD and sensitization were predominantly below OSHA's current PEL of 2 mu g/m\3\, and no cases of sensitization or CBD were observed among workers with LTW exposure 0.20 mu g/m\3\.

      In 2007, Madl et al. published an additional study of 27 workers at the machining plant who were found to be sensitized or diagnosed with CBD between the start of medical surveillance in 1995 and 2005. As previously described, workers were offered a BeLPT in the initial 1995 screening (or within 3 months of their hire date if hired after 1995) and at 2-year intervals after their first screening. Workers with two positive BeLPTs were identified as sensitized and offered clinical evaluation for CBD, including bronchoscopy with BAL and transbronchial lung biopsy. The criteria for CBD in this study were somewhat stricter than those used in the Newman et al. study, requiring evidence of granulomas on lung biopsy or detection of X-ray or pulmonary function changes associated with CBD, in combination with two positive BeLPTs or one positive BAL-BeLPT.

      Based on the history of the plant's control efforts and their analysis of historical IH data, Madl et al. identified three ``exposure control eras'': A relatively uncontrolled period from 1980-1995; a transitional period from 1996 to 1999; and a relatively well-controlled ``modern'' period from 2000-2005. They found that the engineering and work practice controls instituted in the mid-1990s reduced workers' exposures substantially, with nearly a 15-fold difference in reported exposure levels between the pre-control and the modern period (Madl et al., 2007). Madl et al. estimated workers' exposures using LP samples collected between 1980 and 2005, including those collected by Kelleher et al., and work histories provided by the plant. As described more fully in the study, they used a variety of approaches to describe individual workers' exposures, including approaches designed to characterize the highest exposures workers were likely to have experienced. Their exposure-response analysis was based primarily on an exposure metric they derived by identifying the year and job of each worker's pre-diagnosis work history with the highest reported exposures. They used the upper 95th percentile of the LP samples collected in that job and year (in some cases supplemented with data from other years) to characterize the worker's upper-level exposures.

      Based on their estimates of workers' upper level exposures, Madl et al. concluded that workers with sensitization or CBD were likely to have been exposed to airborne beryllium levels greater than 0.2 mug/

      m\3\ as an 8-hour TWA at some point in their history of employment in the plant. They also concluded that most sensitization and CBD cases were likely to have been exposed to levels greater than 0.4 mug/m\3\ at some point in their work at the plant. Madl et al. did not reconstruct exposures for workers at the plant who did not have sensitization or CBD and therefore could not determine whether non-

      cases had upper-bound exposures lower than these levels. They found that upper-bound exposure estimates were generally higher for workers with CBD than for those who were sensitized but not diagnosed with CBD at the conclusion of the study (Madl et al., 2007). Because CBD is an immunological disease and beryllium sensitization has been shown to occur within a year of exposure for some workers, Madl et al. argued that their estimates of workers' short-term upper-bound exposures may better capture the exposure levels that led to sensitization and disease than estimates of long-term cumulative or average exposures such as the LTW exposure measure constructed by Kelleher et al. (Madl et al., 2007).

    7. Beryllium Oxide Ceramics

      Kreiss et al. (1993) conducted a screening of current and former workers at a plant that manufactured beryllium ceramics from beryllium oxide between 1958 and 1975, and then transitioned to metalizing circuitry onto beryllium ceramics produced elsewhere. Of the plant's 1,316 current and 350 retired workers, 505 participated who had not previously been diagnosed with CBD or sarcoidosis, including 377 current and 128 former workers. Although beryllium exposure was not estimated quantitatively in this survey, the authors conducted a questionnaire to assess study participants' exposures qualitatively. Results showed that 55 percent of participants reported working in jobs with exposure to beryllium dust. Close to 25 percent of participants did not know if they had exposure to beryllium, and just over 20 percent believed they had not been exposed.

      BeLPT tests were administered to all 505 participants in the 1989-

      1990 screening period and evaluated at a single lab. Seven workers had confirmed abnormal BeLPT results and were identified as sensitized; these workers were also diagnosed with CBD based on findings of granulomas upon clinical evaluation. Radiograph screening led to clinical evaluation and diagnosis of two additional CBD cases, who were among three participants with initially abnormal BeLPT results that could not be confirmed on repeat testing. In addition, nine workers had been previously diagnosed with CBD, and another five were diagnosed shortly after the screening period, in 1991-1992.

      Eight (3.7 percent of the screening population) of the nine CBD cases identified in the screening population were hired before the plant stopped producing beryllium ceramics in 1975, and were among the 216 participants who had reported having been near or

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      exposed to beryllium dust. Particularly high CBD rates of 11.1-15.8 percent were found among screening participants who had worked in process development/engineering, dry pressing, and ventilation maintenance jobs believed to have high or uncontrolled dust exposure. One case (0.6 percent) of CBD was diagnosed among the 171 study participants who had been hired after the plant stopped producing beryllium ceramics. Although this worker was hired eight years after the end of ceramics production, he had worked in an area later found to be contaminated with beryllium dust. The authors concluded that the study results suggested an exposure-response relationship between beryllium exposure and CBD, and recommended beryllium exposure control to reduce workers' risk of CBD.

      Kreiss et al. later published a study of workers at a second ceramics plant located in Tucson, AZ (Kreiss et al., 1996), which since 1980 had produced beryllium ceramics from beryllium oxide powder manufactured elsewhere. IH measurements collected between 1981 and 1992, primarily GA or short-term BZ samples and a few ( 0.1). Based on these results, together with the higher exposure levels reported for the rod and wire production area, Schuler et al. concluded that work in rod and wire was a key risk factor for CBD in this population. Schuler et al. also found a high prevalence (13 percent) of sensitization among workers who had been exposed to beryllium for less than a year at the time of the screening, a rate similar to that found by Henneberger et al. among beryllium ceramics workers exposed for one year or less (16 percent, Henneberger et al., 2001). All four workers who were sensitized without disease had been exposed 5 years or less; conversely, all six of the workers with CBD had first been exposed to beryllium at least five years prior to the screening (Schuler et al., Table 2).

      As has been seen in other studies, beryllium sensitization and CBD were found among workers who were typically exposed to low time-

      weighted average airborne concentrations of beryllium. While jobs in the rod and wire area had the highest exposure levels in the plant, the median personal sample value was only 0.12 mug/m\3\. However, workers may have occasionally been exposed to higher beryllium levels for short periods during specific tasks. A small fraction of personal samples recorded in rod and wire were above the OSHA PEL of 2.0 mug/m\3\, and half of workers with sensitization or CBD reported that they had experienced a ``high-exposure incident'' at some point in their work history (Schuler et al., 2005). The only group of workers with no cases of sensitization or CBD, a group of 26 office administration workers, was the group with the lowest recorded exposures (median personal sample 0.01 mug/m\3\, range 49 months, p = 5 years), with a statistically significant excess noted at = 25-year interval since the beginning of employment (p 9.3microg/m\3\-days, 22.8 3.4 microg/

      m\3\, and 32.4 13.8 microg/m\3\, respectively. The lung cancer mortality rate was 1.22 (95 percent CI = 1.03 - 1.43). Exposure estimates were lagged by 10 and 20 years in order to account for exposures that did not contribute to lung cancer because they occurred after the induction of cancer. In the 10- and 20-year lagged exposures the geometric mean tenures and cumulative exposures of the lung cancer mortality cases were higher than the controls. In addition, the geometric mean and maximum exposures of the workers were significantly higher than controls when the exposure estimates were lagged 10 and 20 years (p = 10 mug/m\3\ had higher rates of lung cancer, urinary tract cancer, COPD and the category containing cor pulmonale than workers with lower exposure. These studies showed strong associations for cumulative exposure (when short-term workers were excluded), maximum exposure or both. Significant positive trends with cumulative exposure were observed for nervous system cancers (p = 0.0006) and, when short-term workers were excluded, lung cancer (p = 0.01), urinary tract cancer (p = 0.003) and COPD (p 4-exposed animals, only 76 tumors are listed as histologically neoplastic. Only the new growths identified in single midcoronal sections of both lungs were recorded.

      Table 2--Neoplasm Analysis

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

      Neoplasm Number Metastases

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

      Adenoma.......................................... 18

      Squamous carcinoma............................... 5 1

      Acinous adenocarcinoma........................... 24 2

      Papillary adenocarcinoma......................... 11 1

      Alveolar-cell adenocarcinoma..................... 7

      Mucigenous tumor................................. 7 1

      Endothelioma..................................... 1

      Retesarcoma...................................... 3 3

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

      Total.......................................... 76 8

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

      Schepers (1962) reviewed 38 existing beryllium studies that evaluated seven beryllium compounds and seven mammalian species. Beryllium sulfate, beryllium fluoride, beryllium phosphate, beryllium alloy (BeZnMnSiO4), and beryllium oxide were proven to be carcinogenic and have remarkable pleomorphic neoplasiogenic proclivities. Ten varieties of tumors were observed, with adenocarcinoma being the most common variety.

      In another study, Vorwald and Reeves (1959) exposed Sherman albino rats via the inhalation route to aerosols of 0.006 mg beryllium/m\3\ as beryllium oxide and 0.0547 mg beryllium/m\3\ as beryllium sulfate for 6 hours/day, 5 days/week for an unspecified duration. Lung tumors (single or multifocal) were observed in the animals sacrificed following 9 months of daily inhalation exposure. The histologic pattern of the cancer was primarily adenomatous; however, epidermoid and squamous cell cancers were also observed. Infiltrative, vascular, and lymphogenous extensions often developed with secondary metastatic growth in the tracheobronchial lymph nodes, the mediastinal connective tissue, the parietal pleura, and the diaphragm.

      In the first of two articles, Reeves et al. (1967a) investigated the carcinogenic process in lungs resulting from chronic (up to 72 weeks) beryllium sulfate inhalation. One hundred fifty male and female Sprague Dawley C.D. strain rats were exposed to beryllium sulfate aerosol at a mean atmospheric concentration of 34.25 mug beryllium/

      m\3\ (with an average particle diameter of 0.12 microm). Prior to initial exposure and again during the 67-68 and 75-76 weeks of life, the animals received prophylactic treatments of tetracycline-HCl to combat recurrent pulmonary infections.

      The animals entered the exposure chamber at 6 weeks of age and were

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      exposed 7 hours per day/5 days per week for up to 2,400 hours of total exposure time. An equal number of unexposed controls were held in a separate chamber. Three male and three female rats were sacrificed monthly during the 72-week exposure period. Mortality due to respiratory or other infections did not appear until 55 weeks of age, and 87 percent of all animals survived until their scheduled sacrifices.

      Average lung weight towards the end of exposure was 4.25 times normal with progressively increasing differences between control and exposed animals. The increase in lung weight was accompanied by notable changes in tissue texture with two distinct pathological processes--

      inflammatory and proliferative. The inflammatory response was characterized by marked accumulation of histiocytic elements forming clusters of macrophages in the alveolar spaces. The proliferative response progressed from early epithelial hyperplasia of the alveolar surfaces, through metaplasia (after 20-22 weeks of exposure), anaplasia (cellular dedifferentiation) (after 32-40 weeks of exposure), and finally to lung tumors.

      Although the initial proliferative response occurred early in the exposure period, tumor development required considerable time. Tumors were first identified after nine months of beryllium sulfate exposure, with rapidly increasing rates of incidence until tumors were observed in 100 percent of exposed animals by 13 months. The 9-to-13-month interval is consistent with earlier studies. The tumors showed a high degree of local invasiveness. No tumors were observed in control rats. All 56 tumors studied appeared to be alveolar adenocarcinomas and 3 ``fast-growing'' tumors that reached a very large size comparatively early. About one-third of the tumors showed small foci where the histologic pattern differed. Most of the early tumor foci appeared to be alveolar rather than bronchiolar, which is consistent with the expected pathogenesis, since permanent deposition of beryllium was more likely on the alveolar epithelium rather than on the bronchiolar epithelium. Female rats appeared to have an increased susceptibility to beryllium exposure. Not only did they have a higher mortality (control males n = 8, exposed males n = 9 versus control females n = 4, exposed females n = 17) and body weight loss than male rats, but the three ``fast-growing'' tumors only occurred in females.

      In the second article, Reeves et al. (1967b) described the rate of accumulation and clearance of beryllium sulfate aerosol from the same experiment (Reeves et al., 1967a). At the time of the monthly sacrifice, beryllium assays were performed on the lungs, tracheobronchial lymph nodes, and blood of the exposed rats. The pulmonary beryllium levels of rats showed a rate of accumulation which decreased during continuing exposure and reached a plateau (defined as equilibrium between deposition and clearance) of about 13.5 mug beryllium for males and 9 mug beryllium for females in whole lungs after approximately 36 weeks. Females were notably less efficient than males in utilizing the lymphatic route as a method of clearance, resulting in slower removal of pulmonary beryllium deposits, lower accumulation of the inhaled material in the tracheobronchial lymph nodes, and higher morbidity and mortality.

      There was no apparent correlation between the extent and severity of pulmonary pathology and total lung load. However, when the beryllium content of the excised tumors was compared with that of surrounding nonmalignant pulmonary tissues, the former showed a notable decrease (0.50 0.35 mug beryllium/gram versus 1.50 0.55 mug beryllium/gram). This was believed to be largely a result of the dilution factor operating in the rapidly growing tumor tissue. However, other factors, such as lack of continued local deposition due to impaired respiratory function and enhanced clearance due to high vascularity of the tumor, may also have played a role. The portion of inhaled beryllium retained in the lungs for a longer duration, which is in the range of one-half of the original pulmonary load, may have significance for pulmonary carcinogenesis. This pulmonary beryllium burden becomes localized in the cell nuclei and may be an important factor in eliciting the carcinogenic response associated with beryllium inhalation.

      Groth et al. (1980) conducted a series of experiments to assess the carcinogenic effects of beryllium, beryllium hydroxide, and various beryllium alloys. For the beryllium metal/alloys experiment, 12 groups of 3-month-old female Wistar rats (35 rats/group) were used. All rats in each group received a single intratracheal injection of either 2.5 or 0.5 mg of one of the beryllium metals or beryllium alloys as described in Table 3 below. These materials were suspended in 0.4 cc of isotonic saline followed by 0.2 cc of saline. Forty control rats were injected with 0.6 cc of saline. The geometric mean particle sizes varied from 1 to 2 microm. Rats were sacrificed and autopsied at various intervals ranging from 1 to 18 months post-injection.

      Table 3--Summary of Beryllium Dose From Groth et al. (1980)

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

      Percent other Total No. rats Compound dose

      Form of Be Percent Be compounds autopsied (mg) Be dose (mg)

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

      Be metal..................... 100............. None........... 16 2.5 2.5

      21 0.5 0.5

      Passivated Be metal.......... 99.............. 0.26% Chromium. 26 2.5 2.5

      20 0.5 0.5

      BeAl alloy................... 62.............. 38% Aluminum... 24 2.5 1.55

      21 0.5 0.3

      BeCu alloy................... 4............... 96% Copper..... 28 2.5 0.1

      24 0.5 0.02

      BeCuCo alloy................. 2.4............. 0.4% Cobalt.... 33 2.5 0.06

      96% Copper..... 30 0.5 0.012

      BeNi alloy................... 2.2............. 97.8% Nickel... 28 2.5 0.056

      27 0.5 0.011

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

      Lung tumors were observed only in rats exposed to beryllium metal, passivated beryllium metal, and beryllium-aluminum alloy. Passivation refers to the process of removing iron contamination from the surface of

      Page 47613

      beryllium metal. As discussed, metal alloys may have a different toxicity than beryllium alone. Rats exposed to 100 percent beryllium exhibited relatively high mortality rates, especially in the groups where lung tumors were observed. Nodules varying from 1 to 10 mm in diameter were also observed in the lungs of rats exposed to beryllium metal, passivated beryllium metal, and beryllium-aluminum alloy. These nodules were suspected of being malignant.

      To test this hypothesis, transplantation experiments involving the suspicious nodules were conducted in nine rats. Seven of the nine suspected tumors grew upon transplantation. All transplanted tumor types metastasized to the lungs of their hosts. Lung tumors were observed in rats injected with both the high and low doses of beryllium metal, passivated beryllium metal, and beryllium-aluminum alloy. No lung tumors were observed in rats injected with the other compounds. From a total of 32 lung tumors detected, most were adenocarcinomas and adenomas; however, two epidermoid carcinomas and at least one poorly differentiated carcinoma were observed. Bronchiolar alveolar cell tumors were frequently observed in rats injected with beryllium metal, passivated beryllium metal, and beryllium-aluminum alloy. All stages of cuboidal, columnar, and squamous cell metaplasia were observed on the alveolar walls in the lungs of rats injected with beryllium metal, passivated beryllium metal, and beryllium-aluminum alloy. These lesions were generally reduced in size and number or absent from the lungs of animals injected with the other alloys (BeCu, BeCuCo, BeNi).

      The extent of alveolar metaplasia could be correlated with the incidence of lung cancer. The incidences of lung tumors in the rats that received 2.5 mg of beryllium metal, and 2.5 and 0.5 mg of passivated beryllium metal, were significantly different (p +/-) and wild-type (p53+/+) mice. Knockout mice can be valuable tools in determining the role of specific genes on the toxicity of a material of interest, in this case, beryllium. Equal numbers of approximately 10-week-old male and female mice were used for this study. Two exposure groups were used to provide dose-response information on lung carcinogenicity. The maximum initial lung burden (ILB) target of 60 mug beryllium was based on previous acute inhalation exposure studies in mice. The lower exposure target level of 15 mug was selected to provide a lung burden significantly less than the high-level group, but high enough to yield carcinogenic responses. Mice were exposed in groups to beryllium metal or to filtered air (controls) via nose-only inhalation. The specific exposure parameters are presented in Table 4 below. Mice were sacrificed 7 days post exposure for ILB analysis, and either at 6 months post exposure (n = 4-

      5 mice per group per gender) or when 10 percent or less of the original population remained (19 months post exposure for p53+/- knockout and 22.5 months post exposure for p53+/+ wild-type mice). The sacrifice time was extended in the study because a significant number of lung tumors were not observed at 6 months post exposure.

      Table 4--Summary of Animal Data From Finch Et Al., 1998 b

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

      Number of mice

      Mean exposure Target be lung Mean daily exposure with 1 or more

      Mouse strain concentration burden (mug) Number of mice duration (minutes) Mean ILB (mug) lung tumors/total

      (mug Be/L) number examined

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

      Knockout (p53+/-)............. 34 15 30 112 (single) NA 0/29

      36 60 30 139Dagger NA 4/28

      Wild-type (p53\+/+\) 34 15 6* 112 (single) 12 4 NA

      36 60 36dagger 139Dagger 54 6 0/28

      Knockout (p53+/-)............. NA (air) Control 30 60-180 (single) NA 0/30

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

      ILB = initial lung burden; NA = not applicable

      Median aerodynamic diameter of Be aerosol = 1.4 mum (sigmag = 1.8)

      * Wild-type mice in the low exposure group were not evaluated for carcinogenic effects; however ILB was analyzed in six wild-type mice.

      dagger Thirty wild-type mice were analyzed for carcinogenic effects; six wild-type mice were analyzed for ILB.

      Dagger Mice were exposed for 2.3 hours/day for three consecutive days.

      Lung burdens of beryllium measured in wild-type mice at 7 days post exposure were approximately 70-90 percent of target levels. No exposure-related effects on body weight were observed in mice; however, lung weights and lung-to-body-weight ratios were somewhat elevated in 60 mug target ILB p53+/- knockout mice compared to controls (0.05 +/- knockout mice and beryllium exposure tended to decrease survival time in both groups. The incidence of beryllium-induced lung tumors was marginally higher in the 60 mug target ILB p53+/- knockout mice compared to 60 mug target ILB p53+/+ wild-type mice (p = 0.056). The incidence of lung tumors in the 60 mug target ILB p53+/- knockout mice was also significantly higher than controls (p = 0.048). No tumors developed in the control mice, 15 mug target ILB p53+/- knockout mice, or 60 mug target ILB p53+/+ wild-type mice throughout the length of the study. Most lung tumors in beryllium-exposed mice were squamous cell carcinomas, three of four of which were poorly circumscribed and all were associated with at least some degree of granulomatous pneumonia. The study results suggest that having an inactivated p53 allele is associated with lung tumor progression in p53+/- knockout mice. This is based on the significant difference seen in the incidence of beryllium-induced lung neoplasms for the p53+/-knockout mice compared with the p53\+/+\ wild-type mice. The authors conclude that since there was a relatively late onset of tumors in the beryllium-exposed p53+/- knockout mice, a 6-month bioassay in this mouse strain might not be an appropriate model for lung carcinogenesis (Finch et al., 1998b).

      Page 47614

      Nickell-Brady et al. (1994) investigated the development of lung tumors in 12-week-old F344/N rats after a single nose-only inhalation exposure to beryllium aerosol, and evaluated whether beryllium lung tumor induction involves alterations in the K-ras, p53, and c-raf-1 genes. Four groups of rats (30 males and 30 females per group) were exposed to different mass concentrations of beryllium (Group 1: 500 mg/

      m\3\ for 8 min; Group 2: 410 mg/m\3\ for 30 min; Group 3: 830 mg/m\3\ for 48 min; Group 4: 980 mg/m\3\ for 39 min). The beryllium mass median aerodynamic diameter was 1.4 mum (sigmag = 1.9). The mean beryllium lung burdens for each exposure group were 40, 110, 360, and 430 mug, respectively.

      To examine genetic alterations, DNA isolation and sequencing techniques (PCR amplification and direct DNA sequence analysis) were performed on wild-type rat lung tissue (i.e., control samples) along with two mouse lung tumor cell lines containing known K-ras mutations, 12 carcinomas induced by beryllium (i.e., experimental samples), and 12 other formalin-fixed specimens. Tumors appeared in beryllium-exposed rats by 14 months, and 64 percent of exposed rats developed lung tumors during their lifetime. Lungs frequently contained multiple tumor sites, with some of the tumors greater than 1 cm. A total of 24 tumors were observed. Most of the tumors (n = 22) were adenocarcinomas exhibiting a papillary pattern characterized by cuboidal or columnar cells, although a few had a tubular or solid pattern. Fewer than 10 percent of the tumors were adenosquamous (n = 1) or squamous cell (n = 1) carcinomas.

      No transforming mutations of the K-ras gene (codons 12, 13, or 61) were detected by direct sequence analysis in any of the lung tumors induced by beryllium. However, using a more sensitive sequencing technique (PCR enrichment restriction fragment length polymorphism (RFLP) analysis) resulted in the detection of K-ras codon 12 GGT to GTT transversions in 2 of 12 beryllium-induced adenocarcinomas. No p53 and c-raf-1 alterations were observed in any of the tumors induced by beryllium exposure (i.e., no differences observed between beryllium-

      exposed and control rat tissues). The authors note that the results suggest that activation of the K-ras proto-oncogene is both a rare and late event, possibly caused by genomic instability during the progression of beryllium-induced rat pulmonary adenocarcinomas. It is unlikely that the K-ras gene plays a role in the carcinogenicity of beryllium. The results also indicate that p53 mutation is unlikely to play a role in tumor development in rats exposed to beryllium.

      Belinsky et al. (1997) reviewed the findings by Nickell-Brady et al. (1994) to further examine the role of the K-ras and p53 genes in lung tumors induced in the F344 rat by non-mutagenic (non-genotoxic) exposures to beryllium. Their findings are discussed along with the results of other genomic studies that look at carcinogenic agents that are either similarly non-mutagenic or, in other cases, mutagenic. The authors conclude that the identification of non-ras transforming genes in rat lung tumors induced by non-mutagenic exposures, such as beryllium, as well as mutagenic exposures will help define some of the mechanisms underlying cancer induction by different types of DNA damage.

      The inactivation of the p16INK4a (p16) gene is a contributing factor in disrupting control of the normal cell cycle and may be an important mechanism of action in beryllium-induced lung tumors. Swafford et al. (1997) investigated the aberrant methylation and subsequent inactivation of the p16 gene in primary lung tumors induced in F344/N rats exposed to known carcinogens via inhalation. The research involved a total of 18 primary lung tumors that developed after exposing rats to five agents, one of which was beryllium. In this study, only one of the 18 lung tumors was induced by beryllium exposure; the majority of the other tumors were induced by radiation (x-rays or plutonium-239 oxide). The authors hypothesized that if p16 inactivation plays a central role in development of non-small-cell lung cancer, then the frequency of gene inactivation in primary tumors should parallel that observed in the corresponding cell lines. To test the hypothesis, a rat model for lung cancer was used to determine the frequency and mechanism for inactivation of p16 in matched primary lung tumors and derived cell lines. The methylation-specific PCR (MSP) method was used to detect methylation of p16 alleles. The results showed that the presence of aberrant p16 methylation in cell lines was strongly correlated with absent or low expression of the gene. The findings also demonstrated that aberrant p16 CpG island methylation, an important mechanism in gene silencing leading to the loss of p16 expression, originates in primary tumors.

      Building on the rat model for lung cancer and associated findings from Swafford et al. (1997), Belinsky et al. (2002) conducted experiments in 12-week-old F344/N rats (male and female) to determine whether beryllium-induced lung tumors involve inactivation of the p16 gene and estrogen receptor alpha (ER) gene. Rats received a single nose-only inhalation exposure to beryllium aerosol at four different exposure levels. The mean lung burdens measured in each exposure group were 40, 110, 360, and 430 mug. The methylation status of the p16 and ER genes was determined by MSP. A total of 20 tumors detected in beryllium-exposed rats were available for analysis of gene-specific promoter methylation. Three tumors were classified as squamous cell carcinomas and the others were determined to be adenocarcinomas. Methylated p16 was present in 80 percent (16/20), and methylated ER was present in one-half (10/20), of the lung tumors induced by exposure to beryllium. Additionally, both genes were methylated in 40 percent of the tumors. The authors noted that four tumors from beryllium-exposed rats appeared to be partially methylated at the p16 locus. Bisulfite sequencing of exon 1 of the ER gene was conducted on normal lung DNA and DNA from three methylated, beryllium-induced tumors to determine the density of methylation within amplified regions of exon 1 (referred to as CpG sites). Two of the three methylated, beryllium-induced lung tumors showed extensive methylation, with more than 80 percent of all CpG sites methylated.

      The overall findings of this study suggest that inactivation of the p16 and ER genes by promoter hypermethylation are likely to contribute to the development of lung tumors in beryllium-exposed rats. The results showed a correlation between changes in p16 methylation and loss of gene transcription. The authors hypothesize that the mechanism of action for beryllium-induced p16 gene inactivation in lung tumors may be inflammatory mediators that result in oxidative stress. The oxidative stress damages DNA directly through free radicals or indirectly through the formation of 8-hydroxyguanosine DNA adducts, resulting primarily in a single-strand DNA break.

      Wagner et al. (1969) studied the development of pulmonary tumors after intermittent daily chronic inhalation exposure to beryllium ores in three groups of male squirrel monkeys. One group was exposed to bertrandite ore, a second to beryl ore, and the third served as unexposed controls. Each of these three exposure groups contained 12 monkeys. Monkeys from each group were sacrificed after 6, 12, or 23 months of exposure. The 12-month sacrificed

      Page 47615

      monkeys (n = 4 for bertrandite and control groups; n = 2 for beryl group) were replaced by a separate replacement group to maintain a total animal population approximating the original numbers and to provide a source of confirming data for biologic responses that might arise following the ore exposures. Animals were exposed to bertrandite and beryl ore concentrations of 15 mg/m\3\, corresponding to 210 mug beryllium/m\3\ and 620 mug beryllium/m\3\ in each exposure chamber, respectively. The parent ores were reduced to particles with geometric mean diameters of 0.27 mum ( 2.4) for bertrandite and 0.64 mum ( 2.5) for beryl. Animals were exposed for approximately 6 hours/day, 5 days/week. The histological changes in the lungs of monkeys exposed to bertrandite and beryl ore exhibited a similar pattern. The changes generally consisted of aggregates of dust-

      laden macrophages, lymphocytes, and plasma cells near respiratory bronchioles and small blood vessels. There were, however, no consistent or significant pulmonary lesions or tumors observed in monkeys exposed to either of the beryllium ores. This is in contrast to the findings in rats exposed to beryl ore and to a lesser extent bertrandite, where atypical cell proliferation and tumors were frequently observed in the lungs. The authors hypothesized that the rats' greater susceptibility may be attributed to the spontaneous lung disease characteristic of rats, which might have interfered with lung clearance.

      As previously described, Conradi et al. (1971) investigated changes in the lungs of monkeys and dogs two years after intermittent inhalation exposure to beryllium oxide calcined at 1,400 degC. Five adult male and female monkeys (Macaca irus) weighing between 3 and 5.75 kg were used in the study. The study included two control monkeys. Beryllium concentrations in the atmosphere of whole-body exposed monkeys varied between 3.30 and 4.38 mg/m\3\. Thirty-minute exposures occurred once a month for three months, with beryllium oxide concentrations increasing at each exposure interval. Lung tissue was investigated using electron microscopy and morphometric methods. Beryllium content in portions of the lungs of five monkeys was measured two years following exposure by emission spectrography. The reported concentrations in monkeys (82.5, 143.0, and 112.7 mug beryllium per 100 gm of wet tissue in the upper lobe, lower lobe, and combined lobes, respectively) were higher than those in dogs. No neoplastic or granulomatous lesions were observed in the lungs of any exposed animals and there was no evidence of chronic proliferative lung changes after two years.

      4. In vitro Studies

      The exact mechanism by which beryllium induces pulmonary neoplasms in animals remains unknown (NAS 2008). Keshava et al. (2001) performed studies to determine the carcinogenic potential of beryllium sulfate in cultured mammalian cells. Joseph et al. (2001) investigated differential gene expression to understand the possible mechanisms of beryllium-induced cell transformation and tumorigenesis. Both investigations used cell transformation assays to study the cellular/

      molecular mechanisms of beryllium carcinogenesis and assess carcinogenicity. Cell lines were derived from tumors developed in nude mice injected subcutaneously with non-transformed BALB/c-3T3 cells that were morphologically transformed in vitro with 50-200 mug beryllium sulfate/ml for 72 hours. The non-transformed cells were used as controls.

      Keshava et al. (2001) found that beryllium sulfate is capable of inducing morphological cell transformation in mammalian cells and that transformed cells are potentially tumorigenic. A dose-dependent increase (9-41 fold) in transformation frequency was noted. Using differential polymerase chain reaction (PCR), gene amplification was investigated in six proto-oncogenes (K-ras, c-myc, c-fos, c-jun, c-sis, erb-B2) and one tumor suppressor gene (p53). Gene amplification was found in c-jun and K-ras. None of the other genes tested showed amplification. Additionally, Western blot analysis showed no change in gene expression or protein level in any of the genes examined. Genomic instability in both the non-transformed and transformed cell lines was evaluated using random amplified polymorphic DNA fingerprinting (RAPD analysis). Using different primers, 5 of the 10 transformed cell lines showed genomic instability when compared to the non-transformed BALB/c-

      3T3 cells. The results indicate that beryllium sulfate-induced cell transformation might, in part, involve gene amplification of K-ras and c-jun and that some transformed cells possess neoplastic potential resulting from genomic instability.

      Using the Atlas mouse 1.2 cDNA expression microarrays, Joseph et al. (2001) studied the expression profiles of 1,176 genes belonging to several different functional categories. Compared to the control cells, expression of 18 genes belonging to two functional groups (nine cancer-

      related genes and nine DNA synthesis, repair, and recombination genes) was found to be consistently and reproducibly different (at least 2-

      fold) in the tumor cells. Differential gene expression profile was confirmed using reverse transcription-PCR with primers specific to the differentially expressed genes. Two of the differentially expressed genes (c-fos and c-jun) were used as model genes to demonstrate that the beryllium-induced transcriptional activation of these genes was dependent on pathways of protein kinase C and mitogen-activated protein kinase and independent of reactive oxygen species in the control cells. These results indicate that beryllium-induced cell transformation and tumorigenesis are associated with up-regulated expression of the cancer-related genes (such as c-fos, c-jun, c-myc, and R-ras) and down-

      regulated expression of genes involved in DNA synthesis, repair, and recombination (such as MCM4, MCM5, PMS2, Rad23, and DNA ligase I).

      5. Preliminary Lung Cancer Conclusions

      OSHA has preliminarily determined that the weight of evidence indicates that beryllium compounds should be regarded as potential occupational lung carcinogens. Other scientific organizations, including the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (ACGIH) have reached similar conclusions with respect to the carcinogenicity of beryllium.

      While some evidence exists for direct-acting genotoxicity as a possible mechanism for beryllium carcinogenesis, the weight of evidence suggests a possible indirect mechanism may be responsible for most tumorigenic activity of beryllium in animal models and possibly humans (EPA, 1998). Inflammation has been postulated to be a key contributor to many different forms of cancer (Jackson et al., 2006; Pikarsky et al., 2004; Greten et al., 2004; Leek, 2002). In fact, chronic inflammation may be a primary factor in the development of up to one-

      third of all cancers (Ames et al., 1990; NCI, 2010).

      In addition to a T-cell mediated response beryllium has been demonstrated to produce an inflammatory response in animal models similar to other particles (Reeves et al., 1967; Swafford et al., 1997; Wagner et al., 1969) possibly

      Page 47616

      contributing to its carcinogenic potential. Animal studies, as summarized above, have demonstrated a consistent scenario of beryllium exposure resulting in chronic pulmonary inflammation. Studies conducted in rats have demonstrated that chronic inhalation of materials similar in solubility to beryllium result in increased pulmonary inflammation, fibrosis, epithelial hyperplasia, and, in some cases, pulmonary adenomas and carcinomas (Heinrich et al., 1995; Nikula et al., 1995; NTP, 1993; Lee et al., 1985; Warheit et al., 1996). This response is generally referred to as an ``overload'' response or threshold effect. Substantial data indicate that tumor formation in the rat after exposure to some sparingly soluble particles at doses causing marked, chronic inflammation is due to a secondary mechanism unrelated to the genotoxicity (or lack thereof) of the particle itself.

      It has been hypothesized that the recruitment of neutrophils during the inflammatory response and subsequent release of oxidants from these cells have been demonstrated to play an important role in the pathogenesis of rat lung tumors (Borm et al., 2004; Carter and Driscoll, 2001; Carter et al., 2006; Johnston et al., 2000; Knaapen et al., 2004; Mossman, 2000). Inflammatory mediators, as characterized in many of the studies summarized above, have been shown to play a significant role in the recruitment of cells responsible for the release of reactive oxygen and hydrogen species. These species have been determined to be highly mutagenic themselves as well as mitogenic, inducing a proliferative response (Feriola and Nettesheim, 1994; Jetten et al., 1990; Moss et al., 1994; Coussens and Werb, 2002). The resultant effect is an environment rich for neoplastic transformations and the progression of fibrosis and tumor formation. This finding does not imply no risk at levels below an inflammatory response; rather, the overall weight of evidence is suggestive of a mechanism of an indirect carcinogen at levels where inflammation is seen. While tumorigenesis secondary to inflammation is one reasonable mode of action, other plausible modes of action independent of inflammation (e.g., epigenetic, mitogenic, reactive oxygen mediated, indirect genotoxicity, etc.) may also contribute to the lung cancer associated with beryllium exposure.

      Epidemiological studies indicate excess risk of lung cancer mortality from occupational beryllium exposure levels at or below the current OSHA PEL (Schubauer-Berigan et al., 2010; Table 4).

      F. Other Health Effects

      Past studies on other health effects have been thoroughly reviewed by several scientific organizations (NTP, 1999; EPA, 1998; ATSDR, 2002; WHO, 2001; HSDB, 2010). These studies include summaries of animal studies, in vitro studies, and human epidemiological studies associated with cardiovascular, hematological, hepatic, renal, endocrine, reproductive, ocular and mucosal, and developmental effects. High-dose exposures to beryllium have been shown to have an adverse effect upon a variety of organs and tissues in the body, particularly the liver. The adverse systemic effects from human exposures mostly occurred prior to the introduction of occupational and environmental standards set in 1970-1972 (OSHA, 1971; ACGIH, 1971; ANSI, 1970) and 1974 (EPA, 1974) and therefore are less relevant today than in the past. The available data is fairly limited. The hepatic, cardiovascular, renal, and ocular and mucosal effects are briefly summarized below. Health effects in other organ systems listed above were only observed in animal studies at very high exposure levels and are, therefore, not discussed here.

      1. Hepatic Effects

      Beryllium has been shown to accumulate in the liver and a correlation has been demonstrated between beryllium content and hepatic damage. Different compounds have been shown to distribute differently within the hepatic tissues. For example, beryllium phosphate had accumulated almost exclusively within sinusoidal (Kupffer) cells of the liver, while the beryllium derived from beryllium sulfate was found mainly in parenchymal cells. Conversely, beryllium sulphosalicylic acid complexes were rapidly excreted (Skillteter and Paine, 1979).

      According to a few autopsies, beryllium-laden liver had central necrosis, mild focal necrosis as well as congestion, and occasionally beryllium granuloma.

      Residents near a beryllium plant may have been exposed by inhaling trace amounts of beryllium powder, and different beryllium compounds may have induced different toxicant reactions (Yian and Yin, 1982).

      2. Cardiovascular Effects

      There is very limited evidence of cardiovascular effects of beryllium and its compounds in humans. Severe cases of chronic beryllium disease can result in cor pulmonale, which is hypertrophy of the right heart ventricle. In a case history study of 17 individuals exposed to beryllium in a plant that manufactured fluorescent lamps, autopsies revealed right atrial and ventricular hypertrophy (Hardy and Tabershaw, 1946). It is not likely that these cardiac effects were due to direct toxicity to the heart, but rather were a response to impaired lung function. However, an increase in deaths due to heart disease or ischemic heart disease was found in workers at a beryllium manufacturing facility (Ward et al., 1992).

      Animal studies performed in monkeys indicate heart enlargement after acute inhalation exposure to 13 mg beryllium/m\3\ as beryllium hydrogen phosphate, 0.184 mg beryllium/m\3\ as beryllium fluoride, or 0.198 mg beryllium/m\3\ as beryllium sulfate (Schepers 1964). Decreased arterial oxygen tension was observed in dogs exposed to 30 mg beryllium/m\3\ as beryllium oxide for 15 days (HSDB, 2010), 3.6 mg beryllium/m\3\ as beryllium oxide for 40 days (Hall et al., 1950), or 0.04 mg beryllium/m\3\ as beryllium sulfate for 100 days (Stokinger et al., 1950). These are expected to be indirect effects on the heart due to pulmonary fibrosis and toxicity which can increase arterial pressure and restrict blood flow.

      3. Renal Effects

      Renal calculi (stones) were unusually prevalent in severe cases that resulted from high levels of beryllium exposure. Renal stones containing beryllium occurred in about 10 percent of patients affected by high exposures (Barnett, et al., 1961). Kidney stones were observed in 10 percent of the CBD cases collected by the BCR up to 1959 (Hall et al., 1959). In addition, an excess of calcium in the blood and urine has been seen frequently in patients with chronic beryllium disease (ATSDR, 2002).

      4. Ocular and Mucosal Effects

      Both the soluble, sparingly soluble, and insoluble beryllium compounds have been shown to cause ocular irritation in humans (Van Orstrand et al., 1945; De Nardi et al., 1953; Nishimura, 1966; Epstein, 1990; NIOSH, 1994). In addition, beryllium compounds (soluble, sparingly soluble, or insoluble) have been demonstrated to induce acute conjunctivitis with corneal maculae and diffuse erythema (HSDB, 2010).

      The mucosa (mucosal membrane) is the moist lining of certain tissues/organs including the eyes, nose, mouth, lungs, and the urinary and digestive tracts. Soluble beryllium salts have been

      Page 47617

      shown to be directly irritating to mucous membranes (HSDB, 2010).

      G. Summary of Preliminary Conclusions Regarding Health Effects

      Through careful analysis of the current best available scientific information outlined in this Health Effects Section V, OSHA has preliminarily determined that beryllium and beryllium-containing compounds are able to cause sensitization, chronic beryllium disease (CBD) and lung cancer below the current OSHA PEL of 2 mug/m\3\. The Agency has preliminarily determined through the studies outlined in section V.A.2 of this health effects section that skin and inhalation exposure to beryllium can lead to sensitization; and inhalation exposure, or skin exposure coupled with inhalation, can cause onset and progression of CBD. In addition, the Agency has preliminarily determined through studies outlined in section V.E. of this health effects section that inhalation exposure to beryllium and beryllium containing materials causes lung cancer.

      1. Beryllium Causes Sensitization Below the Current PEL and Sensitization is a Precursor to CBD

      Through the biological and immunological processes outlined in section V.B. of the Health Effects, the Agency believes that the scientific evidence supports the following mechanism for the development of sensitization and CBD.

      Inhaled beryllium and beryllium-containing materials able to be retained and solubilized in the lungs initiate sensitization and facilitate CBD development (Section V.B.5).

      Beryllium compounds that dissolve in biological fluids, such as sweat, can penetrate intact skin and initiate sensitization (section V.A.2; V.B). Phagosomal fluid and lung fluid have been demonstrated to dissolve beryllium compounds in the lung (section V.A.2a).

      Sensitization occurs through a CD4+ T-cell mediated process with both soluble and insoluble beryllium and beryllium-

      containing compounds through direct antigen presentation or through further antigen processing (section V.D.1) in the skin or lung. T-cell mediated responses, such as sensitization, are generally regarded as long-lasting (e.g., not transient or readily reversible) immune conditions.

      Beryllium sensitization and CBD are adverse events along a pathological continuum in the disease process with sensitization being the necessary first step in the progression to CBD (section V.D).

      cir Animal studies have provided supporting evidence for T-cell proliferation in the development of granulomatous lung lesions after beryllium exposure (section V.D.2; V.D.6).

      cir Since the pathogenesis of CBD involves a beryllium-specific, cell-mediated immune response, CBD cannot occur in the absence of beryllium sensitization (V.D.1). While no clinical symptoms are associated with sensitization, a sensitized worker is at risk of developing CBD upon subsequent inhalation exposure to beryllium.

      cir Epidemiological evidence that covers a wide variety of different beryllium compounds and industrial processes demonstrates that sensitization and CBD are continuing to occur at present-day exposures below OSHA's PEL (section V.D.4; V.D.5).

      OSHA considers CBD to be a progressive illness with a continuous spectrum of symptoms ranging from its earliest asymptomatic stage following sensitization through to full-blown CBD and death (section V.D.7).

      Genetic variabilities may enhance risk for developing sensitization and CBD in some groups (section V.D.3).

      In addition, epidemiological studies outlined in section V.D.5 have demonstrated that efforts to reduce exposures have succeeded in reducing the frequency of sensitization and CBD.

      2. Evidence Indicates Beryllium is a Human Carcinogen

      OSHA has conducted an evaluation of the current available scientific information of the carcinogenic potential of beryllium and beryllium-containing compounds (section V.E). Based on weight of evidence and plausible mechanistic information obtained from in vitro and in vivo animal studies as well as clinical and epidemiological investigations, the Agency has preliminarily determined that beryllium and beryllium-containing materials should be regarded as human carcinogens. This information is in accordance with findings from IARC, NTP, EPA, NIOSH, and ACGIH (section V.E).

      Lung cancer is an irreversible and frequently fatal disease with an extremely poor 5-year survival rate (NCI, 2009).

      Epidemiological cohort studies have reported statistically significant excess lung cancer mortality among workers employed in U.S. beryllium production and processing plants during the 1930s to 1970s (Section V.E.2).

      Significant positive associations were found between lung cancer mortality and both average and cumulative beryllium exposures when appropriately adjusted for birth cohort and short-term work status (Section V.E.2).

      Studies in which large amounts of different beryllium compounds were inhaled or instilled in the respiratory tracts of experimental animals resulted in an increased incidence of lung tumors (Section V.E.3).

      Authoritative scientific organizations, such as the IARC, NTP, and EPA, have classified beryllium as a known or probable human carcinogen.

      While OSHA has preliminarily determined there is sufficient evidence of beryllium carcinogenicity, the exact tumorigenic mechanism for beryllium is unclear and a number of mechanisms are plausibly involved, including chronic inflammation, genotoxicity, mitogenicity oxidative stress, and epigenetic changes (section V.E.3).

      Studies of beryllium exposed animals have consistently demonstrated chronic pulmonary inflammation after exposure (section V.E.3).

      cir Substantial data indicate that tumor formation in certain animal models after inhalation exposure to sparingly soluble particles at doses causing marked, chronic inflammation is due to a secondary mechanism unrelated to the genotoxicty of the particle (section V.E.5).

      A review conducted by the NAS (2008) found that beryllium and beryllium-containing compounds tested positive for genotoxicity in nearly 50 percent of studies without exogenous metabolic activity, suggesting a possible direct-acting mechanism may exist (section V.E.1) as well as the potential for epigenetic changes (section V.E.4).

      Other health effects have been summarized in sections F of the Health Effects Section and include hepatic, cardiovascular, renal, ocular, and mucosal effects. The adverse systemic effects from human exposures mostly occurred prior to the introduction of occupational and environmental standards set in 1970-1972 (OSHA, 1971; ACGIH, 1971; ANSI, 1970) and 1974 (EPA, 1974) and therefore are less relevant today than in the past.

      Page 47618

      APPENDIX

      Table A.1--Summary of Beryllium Sensitization and Chronic Beryllium Disease Epidemiological Studies

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

      (%) Prevalence Range of Exposure-

      Reference Study type ------------------------------------ exposure response Study Additional

      Sensitization CBD measurements relationship limitations comments

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

      Studies Conducted Prior to BeLPT

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

      Hardy and Tabershaw, 1946.... Case-series..... N/A............. N/A............. N/A............. N/A............ Selection bias. Small sample

      size.

      Hardy, 1980.................. Case-series..... N/A............. N/A............. N/A............. N/A............ Selection bias. Small sample

      size.

      Machle et al., 1948.......... Case-series..... N/A............. N/A............. Semi- Yes............ Selection bias. Small sample

      quantitative. size;

      unreliable

      exposure data.

      Eisenbud et al., 1949........ Case-series..... N/A............. N/A............. Average ............... ............... Non-

      concentration: occupational;

      350-750 ft from ambient air

      plant--0.05-0.1 sampling.

      5 mug/m\3\;.

      2 Yes............ Small study Breathing zone

      survey of 151 mug/m\3\; population. sampling.

      workers. 2.4% samples >5

      mug/m\3\;.

      0.3% samples >25

      mug/m\3\.

      Cummings et al., 2007........ Longitudinal 0.7-5.6 (4 0.1--7.9 (3 Production...... Yes............ Small sample Personal

      study of 93 cases). cases). 1994-1999 size. sampling was

      workers. median--0.1mu effective in

      g/m\3\; 2000- reducing rates

      2003 median-- of new cases

      0.04mug/m\3\;. of

      Administrative sensitization.

      1994-1999

      median 0.1 mug/m\3\) is typically much greater, approaching 80-100% in several studies. The lower prevalence of CBD in this group of sensitized workers, who were believed to have primarily low exposure levels, suggests that controlling respiratory exposure to beryllium may reduce risk of CBD among sensitized workers as well as reducing risk of CBD via prevention of sensitization. However, it also demonstrates that some workers in low-exposure environments can become sensitized and go on to develop CBD. The next section discusses an additional source of information on low-level beryllium exposure and CBD: studies of community-acquired CBD in residential areas surrounding beryllium production facilities.

      C. Review of Community-Acquired CBD Literature

      The literature on community-acquired chronic beryllium disease (CA-

      CBD) documents cases of CBD among individuals exposed to airborne beryllium at concentrations below the proposed PEL. OSHA notes that these case studies do not provide information on how frequently individuals exposed to very low airborne levels develop CBD and that reconstructed exposure estimates for CA-CBD cases are less reliable than exposure estimates for working populations reviewed in the previous sections. In addition, the cumulative exposure that an occupationally exposed person would accrue at any given exposure concentration is far less than would typically accrue from long-term environmental exposure. The literature on CA-CBD thus has important limitations and is not used as a basis for quantitative risk assessment for CBD from low-level beryllium exposure. Nevertheless, these case reports and the broader CA-CBD literature indicate that individuals exposed to airborne beryllium below the proposed PEL can develop CBD.

      Cases of CA-CBD were first reported among residents of Lorain, OH, and Reading, PA, who lived in the vicinity of beryllium plants. More recently, BeLPT screening has been used to identify additional cases of CA-CBD in Reading.

      1. Lorain, OH

      In 1948, the State of Ohio Department of Public Health conducted an X-ray program surveying more than 6,000 people who lived within 1.5 miles of a Lorain beryllium plant (Eisenbud, 1949; Eisenbud, 1982; Eisenbud, 1998). This survey, together with a later review of all reported cases of CBD in the area, found 13 cases of CBD. All of the residents who developed CBD lived within 0.75 miles of the plant, and none had occupational exposure or lived with beryllium-exposed workers. Among the population of 500 people living within 0.25 miles of the plant, seven residents (1.4 percent) were diagnosed with CBD. Five cases were diagnosed among residents living between 0.25 and 0.5 miles from the plant, one case was diagnosed among residents living between 0.5 and 0.75 miles from the plant, and no cases were found among those living farther than 0.75 miles from the plant (total populations not reported) (Eisenbud, 1998).

      Beginning in January 1948, air sampling was conducted using a mobile sampling station to measure

      Page 47631

      atmospheric beryllium downwind from the plant. An approximate concentration of 0.2 mug/m\3\ was measured at 0.25 miles from the plant's exhaust stack, and concentrations decreased with greater distance from the plant, to 0.003 mug/m\3\ at a distance of 5 miles (Eisenbud, 1982). A 10-week sampling program was conducted using three fixed monitoring stations within 700 feet of the plant and one station 7,000 feet from the plant. Interpolating the measurements collected at these locations, Eisenbud and colleagues estimated an average airborne beryllium concentration of between 0.004 and 0.02 mug/m\3\ at a distance of 0.75 miles from the plant. Accounting for the possibility that previous exposures may have been higher due to production level fluctuations and greater use of rooftop emissions, they concluded that the lowest airborne beryllium level associated with CA-CBD in this community was somewhere between 0.01 mug/m\3\ and 0.1 mug/m\3\ (Eisenbud, 1982).

      2. Reading, PA

      Thirty-two cases of CA-CBD were reported in a series of papers published in 1959-1969 concerning a beryllium refinery in Reading (Lieben and Metzner, 1959; Metzner and Lieben, 1961; Dattoli et al., 1964; Lieben and Williams, 1969). The plant, which opened in 1935, manufactured beryllium oxide, alloys and metal, and beryllium tools and metal products (Maier et al., 2008; Sanderson et al., 2001b). In a follow-up study, Maier et al. presented eight additional cases of CA-

      CBD who had lived within 1.5 miles of the plant (Maier et al., 2008). Individuals with a history of occupational beryllium exposure and those who had resided with occupationally exposed workers were not classified as having CA-CBD.

      The Pennsylvania Department of Health conducted extensive environmental sampling in the area of the plant beginning in 1958. Based on samples collected in 1958, Maier et al. stated that most cases identified in their study would typically have been exposed to airborne beryllium at levels between 0.0155 and 0.028 mug/m\3\ on average, with the potential for some excursions over 0.35 mug/m\3\ (Maier et al 2008, p. 1015). To characterize exposures to cases identified in the earlier publications, Lieben and Williams cited a sampling program conducted by the Department of Health between January and July 1962, using nine sampling stations located between 0.2 and 4.8 miles from the plant. They reported that 72 percent of 24-hour samples collected were below 0.01 mug/m\3\. Of samples that exceeded 0.01 mug/m\3\, most were collected at close proximity to the plant (e.g., 0.2 miles from the plant).

      In the early series of publications, cases of CA-CBD were reported among people living both close to the plant (Maier et al., 2008; Dutra, 1948) and up to several miles away. Of new cases identified in the 1968 update, all lived between 3 and 7.5 miles from the plant. Lieben and Williams suggested that some cases of CA-CBD found among more distant residents might have resulted from working or visiting a graveyard closer to the plant (Lieben and Williams, 1969). For example, a milkman who developed CA-CBD had a route in the neighborhood of the plant. Another resident with CA-CBD had worked as a cleaning woman in the area of the plant, and a third worked within a half-mile of the plant.

      At the time of the final follow-up study (1968), 11 residents diagnosed with CA-CBD were alive and 21 were deceased. Among those who had died, berylliosis was listed as the cause of death for three, including a 10-year-old girl and two women in their sixties. Fibrosis, granuloma or granulomatosis, and chronic or fibrous pneumonitis were listed as the cause of death for eight more of those deceased. Histologic evidence of CBD was reported for nine of 12 deceased individuals who had been evaluated for it. In addition to showing radiologic abnormalities associated with CBD, all living cases were dyspneic.

      Following the 1969 publication by Liebman and Williams, no additional CA-CBD cases were reported in the Reading area until 1999, when a new case was diagnosed. The individual was a 72-year-old woman who had had abnormal chest x-rays for the previous six years (Maier et al., 2008). After the diagnosis of this case, Maier et al. reviewed medical records and/or performed medical evaluations, including BeLPT results for 16 community residents who were referred by family members or an attorney.

      Among those referred, eight cases of definite or probable CBD were identified between 1999 and 2002. All eight were women who lived between 0.1 and 1.05 miles from the plant, beginning between 1943-1953 and ending between 1956-2001. Five of the women were considered definite cases of CA-CBD, based on an abnormal blood or lavage cell BeLPT and granulomatous inflammation on lung biopsy. Three probable cases of CA-CBD were identified. One had an abnormal BeLPT and radiography consistent with CBD, but granulomatous disease was not pathologically proven. Two met Beryllium Case Registry epidemiologic criteria for CBD based on radiography, pathology and a clinical course consistent with CBD, but both died before they could be tested for beryllium sensitization. One of the probable cases, who could not be definitively diagnosed with CBD because she died before she could be tested, was the mother of both a definite case and the probable case who had an abnormal BeLPT but did not show granulomatous disease.

      The individuals with CA-CBD identified in this study suffered significant health impacts from the disease, including obstructive, restrictive, and gas exchange pulmonary defects in the majority of cases. All but two had abnormal pulmonary physiology. Those two were evaluated at early stages of disease following their mother's diagnosis. Six of the eight women required treatment with prednisone, a step typically reserved for severe cases due to the adverse side effects of steroid treatment. Despite treatment, three had died of respiratory impairment from CBD as of 2002 (Maier et al., 2008). The authors concluded that ``low levels of exposures with significant disease latency can result in significant morbidity and mortality'' (id., p. 1017).

      OSHA notes that compared with the occupational studies discussed in the previous section, there is comparatively sparse information on exposure levels of Lorain and Reading residents. There remains the possibility that some individuals with CA-CBD may have had higher exposures than were known and reported in these studies, or have had unreported exposure to beryllium dust via contact with beryllium-

      exposed workers. Nevertheless, the studies conducted in Lorain and Reading demonstrate that long-term exposure to the apparent low levels of airborne beryllium, with sufficient disease latency, can lead to serious or fatal CBD. Genetic susceptibility may play a role in cases of CBD among individuals with very low or infrequent exposures to beryllium. The role of genetic susceptibility in the CBD disease process is discussed in detail in section V.D.3.

      D. Exposure-Response Literature on Beryllium Sensitization and CBD

      To further examine the relationship between exposure level and risk of both sensitization and disease, we next review exposure-response studies in the CBD literature. Many publications have reported that exposure levels correlate with risk, including a small number of

      Page 47632

      exposure-response analyses. Most of these studies examined the association between job-specific beryllium air measurements and prevalence of sensitization and CBD. This section focuses on studies at three facilities that included a more rigorous historical reconstruction of individual worker exposures in their exposure-

      response analyses.

      1. Rocky Flats, CO, Facility

      In 2000, Viet et al. published a case-control study of participants in the Rocky Flats Beryllium Health Surveillance Program (BHSP), which was established in 1991 to screen workers at the Department of Energy's Rocky Flats, CO, nuclear weapons facility for beryllium sensitization and evaluate sensitized workers for CBD (Viet et al., 2000). The program, which at the time of publication had tested over 5,000 current and former Rocky Flats employees, had identified a total of 127 sensitized individuals as of 1994 when Viet et al. initiated their study.

      Workers were considered sensitized if two BeLPT results were positive, either from two blood draws or from a single blood draw analyzed by two different laboratories. All sensitized individuals were offered clinical evaluation, and 51 were diagnosed with CBD based on positive lung LPT and evidence of noncaseating granulomas upon lung biopsy. The number of sensitized individuals who declined clinical evaluation was not reported. Two cases, one with CBD and one who was sensitized but not diagnosed with CBD, were excluded from the case-

      control analysis due to reported or potential prior beryllium exposure at a ceramics plant. Another sensitized individual who had not been diagnosed with CBD was excluded because she could not be matched by the study's criteria to a non-sensitized control within the BHSP database. Viet et al. matched a total of 50 CBD cases to 50 controls who were negative on the BeLPT and had the same age ( 3 years), gender, race and smoking status, and were otherwise randomly selected from the database. Using the same matching criteria, 74 sensitized workers who were not diagnosed with CBD were age-, gender-, race-, and smoking status-matched to 74 control individuals who tested negative by the BeLPT from the BHSP database.

      Viet et al. developed exposure estimates for the cases and controls based on daily beryllium air samples collected in one of 36 buildings where beryllium was used at Rocky Flats, the Building 444 Beryllium Machine Shop. Over half of the approximately 500,000 industrial hygiene samples collected at Rocky Flats were taken from this building. Air monitoring in other buildings was reported to be limited and inconsistent and, thus, not utilized in the exposure assessment. The sampling data used to develop worker exposure estimates were exclusively Building 444 fixed airhead (FAH) area samples collected at permanent fixtures placed around beryllium work areas and machinery.

      Exposure estimates for jobs in Building 444 were constructed for the years 1960-1988 from this database. Viet et al. worked with Rocky Flats industrial hygienists and staff to assign a ``building area factor'' (BAF) to each of the other buildings, indicating the likely level of exposure in a building relative to exposures in Building 444. Industrial hygienists and staff similarly assigned a job factor (JF) to all jobs, representing the likely level of beryllium exposure relative to the levels experienced by beryllium machinists. A JF of 1 indicated the lowest exposures, and a JF of 10 indicated the highest exposures. For example, administrative work and vehicle operation were assigned a JF of 1, while machining, mill operation, and metallurgical operation were each assigned a JF of 10. Estimated FAH values for each combination of job, building and year in the study subjects' work histories were generated by multiplying together the job and building factors and the mean annual FAH exposure level. Using data collected by questionnaire from each BHSP participant, Viet et al. reconstructed work histories for each case and control, including job title and building location in each year of their employment at Rocky Flats. These work histories and the estimated FAH values were used to generate a cumulative exposure estimate (CEE) for each case and control in the study. A long-term mean exposure estimate (MEE) was generated by dividing each CEE by the individual's number of years employed at Rocky Flats.

      Viet et al.'s statistical analysis of the resulting data set included conditional logistic regression analysis, modeling the relationship between risk of each health outcome and log-transformed CEE and MEE. They found highly statistically significant relationships between log-CEE and risk of CBD (coef = 0.837, p = 0.0006) and between log-MEE (coef = 0.855, p = 0.0012) and risk of CBD, indicating that risk of CBD increases with exposure level. These coefficients correspond to odds ratios of 6.9 and 7.2 per 10-fold increase in exposure, respectively. Risk of sensitization without CBD did not show a statistically significant relationship with log-CEE (coef = 0.111, p = 0.32), but showed a nearly-significant relationship with log-MEE (coef = 0.230, p = 0.097).

      2. Cullman, AL, Facility

      The Cullman, AL, precision machining facility discussed previously was the subject of a case-control study published by Kelleher et al. in 2001. After the diagnosis of an index case of CBD at the plant in 1995, NJMRC researchers worked with the plant to conduct a medical surveillance program using the BeLPT to screen workers biennially for beryllium sensitization and CBD. Of 235 employees screened between 1995 and 1999, 22 (9.4 percent) were found to be sensitized, including 13 diagnosed with CBD (Newman et al., 2001). Concurrently, research was underway by Martyny et al. to characterize the particle size distribution of beryllium exposures generated by processes at this plant (Martyny et al., 2000). The exposure research showed that the machining operations during this time period generated respirable particles (10 mum or less) at the worker breathing zone that made up greater than 50 percent of the beryllium mass. Kelleher et al. used the dataset of 100 personal lapel samples collected by Martyny et al. and other NJMRC researchers in 1996, 1997, and 1999 to characterize exposures for each job in the plant. Following a statistical analysis comparing the samples collected by NJMRC with earlier samples collected at the plant, Kelleher et al. concluded that the 1996-1999 data could be used to represent job-specific exposures from earlier periods.

      Detailed work history information gathered from plant data and worker interviews was used in combination with job exposure estimates to characterize cumulative and LTW average beryllium exposures for workers in the surveillance program. In addition to cumulative and LTW exposure estimates based the total mass of beryllium reported in their exposure samples, Kelleher et al. calculated cumulative and LTW estimates based specifically on exposure to particles 0.5).

      Table VI-13--Proportional Hazards Model--Cumulative Exposure and CBD

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

      Variable Coefficient 95% Confidence interval P-value

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

      Cumulative Exposure (mug/m\3\-yrs).......... 0.03 .00 to 0.07..................... 0.09

      constant...................................... -3.77 -4.67 to -2.86.................. 20 mug/m\3\ for most jobs). The cumulative, average, and maximum beryllium exposure concentration estimates for the 142 known lung cancer cases were: 46.06 9.3mug/m\3\-days, 22.8 3.4 mug/m\3\, and 32.4 13.8 mug/m\3\, respectively. About two-thirds of cases and half of controls worked at the plant for less than a year. Thus, a risk assessment based on this exposure-response analysis would need to extrapolate from very high to very low exposures, based on a working population with extremely short tenure. While OSHA risk assessments must often make extrapolations to estimate risk within the range of exposures of interest, the Agency acknowledges that these issues of short tenure and extremely high exposures would create substantial uncertainty in a risk assessment based on this study population.

      In addition, the relatively high exposures of even the least-

      exposed workers in the NIOSH study may create methodological issues for the lung cancer case-control study design. Mortality risk is expressed as an odds ratio that compares higher exposure quartiles to the lowest quartile. It is preferable that excess risks attributable to occupational beryllium be determined relative to an unexposed or minimally exposed reference population. However, in the NIOSH study workers in the lowest quartile were exposed well above the OSHA PEL (average exposure 30 years) follow-up time for members of the cohort and the extensive exposure and work history data available for the development of exposure estimates for workers in the cohort. Among the weaknesses and uncertainties of the study are the limited information available on workers' smoking habits: smoking information was available only for workers employed in 1968, about 25 percent of the cohort. In addition, the JEMs used did not account for possible respirator use among workers in the cohort. The authors note that workers' exposures may therefore have been overestimated, and that overestimation may have been especially severe for workers with high estimated exposures. They suggest that overestimation of exposures for workers in highly exposed positions may have caused attenuation of the exposure-response curve in some models at higher exposures.

      The NIOSH publication did not discuss the reasons for basing risk estimates on mean exposure rather than cumulative exposure that is more commonly used for lung cancer risk analysis. OSHA believes the decision may involve the nonmonotonic relationship NIOSH observed between cancer risk and cumulative exposure level. As discussed previously, workers from the Reading plant frequently had very short tenures and high exposures yielding lower cumulative exposures compared to cohort workers from other plants with longer employment. Despite the low estimated cumulative exposures among the short-term Reading workers, they may be at high risk of lung cancer due to the tendency of beryllium to persist in the lung for long periods. This exposure misclassification could lead to the appearance of a nonmonotonic relationship between cumulative exposure and lung cancer risk. It is possible that a dose-rate effect may exist for beryllium, such that the risk from a cumulative exposure gained by long-term, low-level exposure is not equivalent to the risk from a cumulative exposure gained by very short-term, high-level exposure. In this case, mean exposure level may better correlate with the risk of lung cancer than cumulative exposure level. For these reasons OSHA considers the NIOSH choice of mean exposure metric to be appropriate and scientifically defensible for this particular dataset.

      H. Preliminary Conclusions

      As described above, OSHA's risk assessment for beryllium sensitization and CBD relied on two approaches: (1) review of the literature and (2) analysis of a dataset provided by NJRMC. First, the Agency reviewed the scientific literature to ascertain whether there is substantial risk to workers exposed at and below the current PEL and to characterize the expected impact of more stringent controls on workers' risk of sensitization and CBD. This review focused on facilities where exposures were primarily below the current PEL, and where several rounds of BeLPT and CBD screening had been conducted to evaluate the effectiveness of various exposure control measures. Second, OSHA investigated the exposure-response relationship for beryllium sensitization and CBD by analyzing a dataset that NJMRC provided on workers at a prominent, long-established beryllium machining facility. Although exposure-response studies have been published on sensitization and CBD, OSHA believes the nature and quality of their exposure data significantly limits their value for the Agency's risk assessment. Therefore, OSHA developed an independent exposure-response analysis using the NJMRC dataset, which was recently updated, includes workers exposed at low levels, and includes extensive exposure data collected in workers' breathing zones, as is preferred by OSHA.

      OSHA's review of the scientific literature found substantial risk of both sensitization and CBD in workplaces in compliance with OSHA's current PEL (e.g., Kreiss et al., 1992; Schuler et al., 2000; Madl et al., 2007). At these plants, including a copper-beryllium processing facility, a beryllia ceramics facility, and a beryllium machining facility, exposure reduction programs that primarily used engineering controls to reduce airborne exposures to median levels at or around 0.2 mug/m\3\ had only limited impact on workers' risk. Cases of sensitization continued to occur frequently among newly hired workers, and some of these workers developed CBD within the short follow-up time.

      In contrast, industrial hygiene programs that minimized both airborne and dermal exposure substantially lowered workers' risk of sensitization in the first years of employment. Programs that drastically reduced respiratory exposure via a combination of engineering controls and respiratory protection, minimized the potential for skin exposure via dermal PPE, and employed stringent housekeeping methods to keep work areas clean and prevent transfer of beryllium between areas sharply curtailed new cases of sensitization among newly-hired workers. For example, studies conducted at copper-

      beryllium processing, beryllium production, and beryllia ceramics facilities show that reduction of exposures to below 0.1 mug/m\3\ and protection from dermal exposure, in combination, achieved a substantial reduction in sensitization risk among newly-hired workers. However, even these stringent measures did not protect all workers from sensitization.

      Page 47646

      The most recent epidemiological literature on programs that have been successful in reducing workers' risk of sensitization have had very short follow-up time; therefore, they cannot address the question of how frequently workers sensitized in very low-exposure environments develop CBD. Clinical evaluation for CBD was not reported for workers at the copper-beryllium processing, beryllium production, and ceramics facilities. However, cases of CBD among workers exposed at low levels at a machining plant and cases of CA-CBD demonstrate that individuals exposed to low levels of airborne beryllium can develop CBD, and over time, can progress to severe disease. This conclusion is also supported by case reports within the literature of workers with CBD who may have been minimally exposed to beryllium, such as a worker employed only in administration at a beryllium ceramics facility (Kreiss et al., 1996).

      The Agency's analysis of the Cullman dataset provided by NJMRC showed strong exposure-response trends using multiple analytical approaches, including examination of sensitization and disease prevalence by exposure categories and a proportional hazards modeling approach. In the prevalence analysis, cases of sensitization and disease were evident at all levels of exposure. The lowest prevalence of sensitization (2.0 percent) and CBD (1.0 percent) was observed among workers with LTW average exposure levels below 0.1 mug/m\3\, while those with LTW average exposure between 0.1-0.2 mug/m\3\ showed a marked increase in overall prevalence of sensitization (9.8 percent) and CBD (7.3 percent). Prevalence of sensitization and CBD also increased with cumulative exposure.

      OSHA's proportional hazards analysis of the Cullman dataset found increasing risk of sensitization with both cumulative exposure and average exposure. OSHA also found a positive relationship between risk of CBD and cumulative exposure, but not between CBD and average exposure. The Agency used the cumulative exposure model results to estimate hazards ratios and risk of sensitization and CBD at the current PEL of 2 mug/m\3\ and each of the alternate PELs under consideration: 1 mug/m\3\, 0.5 mug/m\3\, 0.2 mug/m\3\, and 0.1 mug/m\3\. To estimate risk of CBD from a working lifetime of exposure, the Agency calculated the cumulative exposure associated with 45 years of exposure at each level, for total cumulative exposures of 90, 45, 22.5, 9, and 4.5 mug/m\3\-years. The risk estimates for sensitization and CBD ranged from 100-403 and 40-290 cases, respectively, per 1000 workers exposed at the current PEL of 2 mug/

      m\3\. The risks are projected to be substantially lower for both sensitization and CBD at 0.1 mug/m\3\ and range from 7.2-35 cases per 1000 and 3.1-26 cases per 1000, respectively. In these ways, the modeling results are similar to results observed from published studies of the Reading, Tucson, and Cullman plants and the OSHA analysis of sensitization and CBD prevalence within the Cullman plant.

      OSHA has a high level of confidence in the finding of substantial risk of sensitization and CBD at the current PEL, and the Agency believes that a standard requiring a combination of more stringent controls on beryllium exposure will reduce workers' risk of both sensitization and CBD. Programs that have reduced median levels to below 0.1 mug/m\3\, tightly controlled both respiratory and dermal exposure, and incorporated stringent housekeeping measures have substantially reduced risk of sensitization within the first years of exposure. These conclusions are supported by the results of several studies conducted in state-of-the-art facilities dealing with a variety of production activities and physical forms of beryllium. In addition, these conclusions are supported by OSHA's statistical analysis of a dataset with highly detailed exposure and work history information on several hundred beryllium workers. While there is uncertainty regarding the precision of model-derived risk estimates, they provide further evidence that there is substantial risk of sensitization and CBD associated with exposure at the current PEL, and that this risk can be substantially lessened by stringent measures to reduce workers' beryllium exposure levels.

      Furthermore, OSHA believes that beryllium-exposed workers' risk of lung cancer will be reduced by more stringent control of airborne beryllium exposures. The risk estimates from NIOSH's recent lung cancer study, described above, range from 33 to 140 excess lung cancers per 1000 workers exposed at the current PEL of 2 mug/m\3\. The NIOSH risk assessment's six best-fitting models each predict substantial reductions in risk with reduced exposure, ranging from 3 to 19 excess lung cancers per 1000 workers exposed at the proposed PEL of 0.1 mug/

      m\3\. The evidence of lung cancer risk from NIOSH's risk assessment provides additional support for OSHA's preliminary conclusions regarding the significance of risk to workers exposed to beryllium levels at and below the current PEL. However, the lung cancer risks require a sizable low dose extrapolation below beryllium exposure levels experienced by workers in the NIOSH study. As a result, there is a greater uncertainty in the lung cancer risk estimates and lesser confidence in their significance of risk below the current PEL than with beryllium sensitization and CBD. The preliminary conclusions with regard to significance of risk are presented and further discussed in section VIII of the preamble.

  25. Expert Peer Review of Health Effects and Preliminary Risk Assessment

    In 2010, Eastern Research Group, Inc. (ERG), under contract to the Occupational Safety and Health Administration (OSHA) ,\10\ conducted an independent, scientific peer review of (1) a draft Preliminary Beryllium Health Effects Evaluation (OSHA, 2010a), (2) a draft Preliminary Beryllium Risk Assessment (OSHA, 2010b), and (3) two NIOSH study manuscripts (Schubauer-Berigan et al., 2011 and 2011a). This section of the preamble describes the review process and summarizes peer reviewers' comments and OSHA's responses.

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    \10\ Task Order No. DOLQ59622303, Contract No. GS10F0125P, with a period of performance from May, 2010 through December, 2010.

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    ERG conducted a search for nationally recognized experts in the areas of occupational epidemiology, occupational medicine, toxicology, immunology, industrial hygiene/exposure assessment, and risk assessment/biostatistics as requested by OSHA. ERG sought experts familiar with beryllium health effects research and who had no conflict of interest (COI) or apparent bias in performing the review. Interested candidates submitted evidence of their qualifications and responded to detailed COI questions. ERG also searched the Internet to determine whether qualified candidates had made public statements or declared a particular bias regarding beryllium regulation.

    From the pool of qualified candidates, ERG selected five experts to conduct the review, based on:

    cir Their qualifications, including their degrees, years of relevant experience, number of related peer-reviewed publications, experience serving as a peer reviewer for OSHA or other government organizations, and committee and association memberships related to the review topic;

    cir Lack of any actual, potential, or perceived conflict of interest; and

    cir The need to ensure that the panel collectively was sufficiently broad and

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    diverse to fairly represent the relevant scientific and technical perspectives and fields of knowledge appropriate to the review.

    OSHA reviewed the qualifications of the candidates proposed by ERG to verify that they collectively represented the technical areas of interest. ERG then contracted the following experts to perform the review.

    (1) John Balmes, MD, Professor of Medicine, University of California-San Francisco

    Expertise: pulmonary and occupational medicine, CBD, occupational lung disease, epidemiology, occupational exposures, medical surveillance.

    (2) Patrick Breysse, Ph.D., Professor, Johns Hopkins University Bloomberg School of Public Health

    Expertise: industrial hygiene, occupational/environmental health engineering, exposure monitoring/analysis, biomarkers, beryllium exposure assessment

    (3) Terry Gordon, Ph.D., Professor, New York University School of Medicine.

    Expertise: inhalation toxicology, pulmonary disease, beryllium toxicity and carcinogenicity, CBD genetic susceptibility, mode of action, animal models.

    (4) Milton Rossman, MD, Professor of Medicine, Hospital of the University of Pennsylvania School of Medicine.

    Expertise: pulmonary and clinical medicine, immunology, beryllium sensitization, BeLPT, clinical diagnosis for CBD.

    (5) Kyle Steenland, Ph.D., Professor, Emory University, Rollins School of Public Health.

    Expertise: occupational epidemiology, biostatistics, risk and exposure assessment, lung cancer, CBD, exposure-response models.

    Reviewers were provided with the Technical Charge and Instructions (see ERG, 2010), a Request for Peer Review of NIOSH Manuscripts (see ERG, 2010), the draft Preliminary OSHA Health Effects Evaluation (OSHA, 2010a), the draft Preliminary Beryllium Risk Assessment (OSHA, 2010b), and access to relevant references. Each reviewer independently provided comments on the Health Effects, Risk Assessment, and NIOSH documents. A briefing call was held early in the review to ensure that reviewers understood the peer review process. ERG organized the call and OSHA representatives were available to respond to technical questions of clarification. Reviewers were invited to submit any subsequent questions of clarification.

    The written comments from each reviewer were received and organized by ERG by charge questions. The unedited individual and reorganized comments were submitted to OSHA and the reviewers in preparation for a follow-up conference call. The conference call, organized and facilitated by ERG, provided an opportunity for OSHA to clarify individual reviewer's comments. After the call, reviewers were given the opportunity to revise their written comments to include the clarifications or additional information provided on the call. ERG submitted the revised comments to OSHA organized by both individual reviewer and by charge question. A final peer review report is available in the docket (ERG, 2010). Section VII.A of this preamble summarizes the comments received on the draft health effects document and OSHA's responses to those comments. Section VII.B summarizes comments received on the draft Preliminary Risk Assessment and the OSHA response.

    A. Peer Review of Draft Health Effects Evaluation

    The Technical Charge to peer reviewers posed general questions on the draft health effects document as well as specific questions pertaining to particle/chemical properties, kinetics and metabolism, acute beryllium disease, development of beryllium sensitization and CBD, genetic susceptibility, epidemiological studies of sensitization and CBD, animal models of chronic beryllium disease, genotoxicity, lung cancer epidemiological studies, animal cancer studies, other health effects, and preliminary conclusions drawn by OSHA.

    OSHA asked the peer reviewers to generally comment on whether the draft health effects evaluation included the important studies, appropriately addressed their strengths and limitations, accurately described the results, and drew scientifically sound conclusions. Overall, the reviewers felt that the studies were described in sufficient detail, the interpretations accurate, and the conclusions reasonable. They agreed that the OSHA document covered the significant health endpoints related to occupational beryllium exposure. However, several reviewers requested that additional studies and other specific information be included in various sections of the document and these are discussed further below.

    The reviewers had similar suggestions to improve the section V.A of this preamble on physical/chemical properties and section V.B on kinetics/metabolism. Dr. Balmes requested that physical and chemical characteristics of beryllium more clearly relate to development of sensitization and progression to CBD. Dr. Gordon requested greater consistency in the terminology used to describe particle characteristics, sampling methodologies, and the particle deposition in the respiratory tract. Dr. Breysse agreed and requested that the respiratory deposition discussion be better related to the onset of sensitization and CBD. Dr. Rossman suggested that the discussion of particle/chemical characteristics might be better placed after section V.D on the immunobiology of sensitization and CBD.

    OSHA made a number of revisions to sections V.A and V.B to address the peer review comments above. Terminology used to describe particle characteristics in various studies was modified to be more consistent and better reflect the authors' intent in the published research articles. Section V.B.1 on respiratory kinetics of inhaled beryllium was modified to more clearly describe particle deposition in the different regions of the respiratory tract and their influence on CBD. At the recommendation of Dr. Gordon, a confusing figure was removed since it did not portray particle deposition in a clear manner. Rather than relocate the entire discussion of particle/chemical characteristics, a new section V.B.5 was added to specifically address the influence of beryllium particle characteristics and chemical form on the development of sensitization and CBD. Other section areas were shortened to remove information that was not necessarily relevant to the overall disease process. Statements were added on the effect of pre-existing diseases and smoking on beryllium clearance from the lung. It was made clear that the precise role of dermal exposure in beryllium sensitization is not completely understood. These smaller changes were made at the request of individual reviewers.

    There were a couple of comments from reviewers pertaining to acute beryllium disease (ABD). Dr. Rossman commented that ABD did not make the development of CBD more likely. He requested that the document include a reference to the Van Ordstrand et al. (1943) article that first reported ABD in the U.S. Dr. Balmes pointed out that pathologists, rather than clinicians, interpret ABD pathology from lung tissue biopsy. Dr. Gordon commented that ABD is of lesser importance than CBD to the risk assessment and suggested that discussion of ABD be moved later in the document.

    The Van Ordstrand reference was included in section V.C on acute beryllium diseases and statements were modified to address the peer review comments above. While OSHA agrees that ABD does not have a great impact on the Agency risk findings, the Agency believes the current organization does

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    not create confusion on this point and decided not to move the ABD section later in the document. A statement that ABD is only relevant at exposures higher than the current PEL has been added to section V.C. Other reviewers did not feel the ABD discussion needed to be moved to a later section.

    Most reviewers found the description of the development and pathogenesis of CBD in section V.D to be accurate and understandable. Dr. Breysse felt the section could better delineate the steps in disease development (e.g., development of beryllium sensitization, CBD progression) and recommended the 2008 National Academy of Sciences report as a model. He and Dr. Gordon felt the section overemphasized the role of apoptosis in CBD development. Dr. Breysse and Dr. Balmes recommended avoiding the phrase `subclinical' to describe sensitization and asymptomatic CBD, preferring the term `early stage' as a more appropriate description. Dr. Balmes requested clarification regarding accumulation of inflammatory cells in the bronchoalveolar lavage (BAL) fluid during CBD development. Dr. Rossman suggested some additional description of beryllium binding with the HLA-class II receptor and subsequent interaction with the naiumlve CD4\+\ T cells in the development of sensitization.

    OSHA extensively reorganized section V.D to clearly delineate the disease process in a more linear fashion starting with the formation of beryllium antigen complex, its interaction with naiumlve T-cells to trigger CD4\+\ T-cell proliferation, and development of beryllium sensitization. This is presented in section V.D.1. A figure has been added that schematically presents this process in its entirety and the steps at which dermal exposure and genetic factors are believed to influence disease development (Figure 2 in section V.D). Section V.D.2 describes how subsequent inhalation and the persistent residual presence of beryllium in the lung leads to CD4\+\ T cell differentiation, cytokine production, accumulation of inflammatory cells in the alveolar region, granuloma formation, and progression of CBD. The section was modified to present apoptosis as only one of the plausible mechanisms for development/progression of CBD. The `early stage' terminology was adopted and the role of inflammatory cells in BAL was clarified.

    While peer reviewers felt genetic susceptibility was adequately characterized, Dr. Rossman, Dr. Gordon, and Dr. Breysse suggested that additional study data be discussed to provide more depth on the subject, particularly the role genetic polymorphisms in providing a negatively charged HLA protein binding site for the positively charged beryllium ion. Section V.D.3 on genetic susceptibility now includes more information on the importance of gene-environment interaction in the development of CBD in low-exposed workers. The section expands on HLA-DPB1 alleles that influence beryllium-hapten binding and its impact on CBD risk.

    All reviewers found the definition of CBD to be clear and understandable. However, several reviewers commented on the document discussion of the BeLPT which operationally defines beryllium sensitization. Drs. Balmes and Rossman requested a more clear statement that two abnormal blood BeLPT results were generally necessary to confirm sensitization. Dr. Balmes and Dr. Breysse requested more discussion of historical changes in the BeLPT method that have led to improvement in test performance and reductions in interlaboratory variability. These comments were addressed in an expanded document section V.D.5.b on criteria for sensitization and CBD case definition following development of the BeLPT.

    Reviewers made suggestions to improve presentation of the many epidemiological studies of sensitization and CBD in the draft health effects document. Dr. Breysse and Dr. Gordon recommended that common weaknesses that apply to multiple studies be more rigorously discussed. Dr. Gordon requested that the discussion of the Beryllium Case Registry be modified to clarify the case inclusion criteria. Most reviewers called for the addition of tables to assist in summarizing the epidemiological study information.

    A paragraph has been added near the beginning of section V.D.5 that identifies the common challenges to interpreting the epidemiological evidence that supports the occurrence of sensitization and CBD at occupational beryllium exposures below the current PEL. These include studies with small numbers of subjects and CBD cases, potential exposure misclassification resulting from lack of personal and short-

    term exposure data prior to the late 1990s, and uncertain dermal contribution among other issues. Table A.1 summarizing the key sensitization and CBD epidemiological studies was added to this preamble in appendix A of section V. Subsection V.D.5.a on studies conducted prior to the BeLPT has been reorganized to more clearly present the need for the Registry prior to listing the inclusion criteria.

    Several reviewers requested that the draft health effects document discuss additional occupational studies on sensitization and CBD. Dr. Balmes suggested including Bailey et al. (2010) on reduction in sensitization at a beryllium production plant and Arjomandi et al. (2010) on CBD among workers in a nuclear weapons facility. Dr. Breysse recommended adding a brief discussion of Taiwo et al. (2008) on sensitization in aluminum smelter workers. Dr. Gordon and Dr. Rossman suggested mention of Curtis, (1951) on cutaneous hypersensitivity to beryllium as important for the role of dermal exposure. Dr. Rossman also provided a reference to a number of other sensitization and CBD articles of historical significance.

    The above studies have been incorporated in several subsections of V.D.5 on human epidemiological evidence. The 1951 Curtis study is mentioned in the introduction to section V.D.5 as evidence of sensitization from dermal exposure. The Bailey et al. (2010) study is discussed in subsection V.D.5.d on beryllium metal processing and alloy production. The Arjomandi et al. (2010) study is discussed subsection V.D.5.h on nuclear weapons facilities and cleanup of former facilities. The Taiwo et al. (2008) study is discussed in subsection V.D.5.i on aluminum smelting. The other historical studies of historical significance are referenced in subsection V.D.5.a on studies conducted prior to the BeLPT.

    Dr. Gordon suggested that the draft health effects document make clear that limitations in study design and lack of an appropriate model limited extrapolation of animal findings to the human immune-based respiratory disease. Dr. Rossman also remarked on the lack of a good animal model that consistently demonstrates a specific cell-mediated immune response to beryllium. Section V.D.6 was modified to include a statement that lack of a dependable animal model combined with studies that used single doses, few animals or abbreviated observation periods have limited the utility of the data. Table A.2 was added that summarizes important information on key animal studies of beryllium-

    induced immune response and lung inflammation.

    In general, peer reviewers considered the preliminary conclusions with regard to sensitization and CBD to be reasonable and well presented in the draft health effects evaluation. All reviewers agreed that the scientific evidence supports sensitization as a necessary condition and an early endpoint in the development of CBD.

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    The peer reviewers did not consider the presented evidence to convincingly show lung burden to be an important dose metric. Dr. Gordon explained that some animal studies in dogs have indicated that lung dose does influence granuloma formation but the importance of dose relative to genetic susceptibility, and physical/chemical form is unclear. He suggested the document indicate that many factors, including lung burden, affect the pulmonary tissue response to beryllium particles in the workplace.

    There were other suggested improvements to the preliminary conclusion section of the draft document. Dr. Breysse felt that presenting the range of observed prevalence from occupational studies would help support the Agency findings. He also recommended that the preliminary conclusions make clear that CBD is a very complex disease and certain steps involved in the onset and progression are not yet clearly understood. Dr. Rossman pointed out that a report from Mroz et al. (2009) updated information on the rate at which beryllium sensitized individuals progress to CBD.

    A statement has been added to section V.D.7 on the preliminary sensitization and CBD conclusions to indicate that all facets of development and progression of sensitization and CBD are not fully understood. Study references and prevalence ranges were provided to support the conclusion that epidemiological evidence demonstrates that sensitization and CBD occur from present-day exposures below OSHA's PEL. Statements were modified to indicate animal studies provide important insights into the roles of chemical form, genetic susceptibility, and residual lung burden in the development of beryllium lung disease. Updated information on rate of progression from sensitization to CBD was also included.

    Reviewers made suggestions to improve presentation of the epidemiological studies of lung cancer that were similar to their comments on the CBD studies. Dr. Steenland requested that a table summarizing the lung cancer studies be added. He also recommended that more emphasis be placed on the SMR results from the Ward et al. (1992) study. Dr. Balmes felt that more detail was presented on the animal cancer studies than necessary to convey the relevant message. All reviewers thought that the Schubauer-Berigan et al. (2010) cohort mortality study that addressed some of the shortcomings of earlier lung cancer mortality studies should be discussed in the health effects document.

    The recent Schubauer-Berigan et al. (2010) study conducted by the NIOSH Division of Surveillance, Hazard Evaluations, and Field Studies is now described and discussed in section V.E.2 on human epidemiology studies. Table A.3 summarizing the range of exposure measurements, study strengths and limitations, and other key lung cancer epidemiological study information was added to the health effects preamble. Section V.E.3 on the animal cancer studies already contained several tables that present study data so OSHA decided a summary table was not needed in this section.

    Reviewers were asked two questions regarding the OSHA preliminary conclusions on beryllium-induced lung cancer: was the inflammation mechanism presented in the lung cancer section reasonable; and were there other mechanisms or modes of action to be considered? All reviewers agreed that inflammation was a reasonable mechanistic presentation as outlined in the document. Dr. Gordon requested OSHA clarify that inflammation may not be the sole mechanism for carcinogenicity. OSHA inserted statements in section V.E.5 on the preliminary lung cancer conclusions clarifying that tumorigenesis secondary to inflammation is a reasonable mechanism of action but other plausible mechanisms independent of inflammation may also contribute to the lung cancer associated with beryllium exposure.

    There were a few comments from reviewers on health effects other than sensitization/CBD and lung cancer in the draft document. Dr. Balmes requested that the term ``beryllium poisoning'' not be used when referring to the hepatic effects of beryllium. He also offered language to clarify that the cardiovascular mortality among beryllium production workers in the Ward study cohort was probably due to ischemic heart disease and not the result of impaired lung function. Dr. Gordon requested removal of references to hepatic studies from in vitro and intravenous administration done at very high dose levels of little relevance to the occupational exposures of interest to OSHA. These changes were made to section V.F on other health effects.

    B. Peer Review of the Draft Preliminary Risk Assessment

    The Technical Charge to peer reviewers for review of the draft preliminary risk assessment was to ensure OSHA selected appropriate study data, assessed the data in a scientifically credible manner, and clearly explained its analysis. Specific charge questions were posed regarding choice of data sets, risk models, and exposure metrics; the role of dermal exposure and dermal protection; construction of the job exposure matrix; characterization of the risk estimates and their uncertainties; and whether a quantitative assessment of lung cancer risk, in addition to sensitization and CBD, was warranted.

    Overall, the peer reviewers were highly supportive of the Agency's approach and major conclusions. They offered valuable suggestions for revisions and additional analysis to improve the clarity and certain technical aspects of the risk assessment. These suggestions and the steps taken by OSHA to address them are summarized here. A final peer review report (ERG, 2010c) and a risk assessment background document (OSHA, 2014a) are available in the docket.

    OSHA asked peer reviewers a series of questions regarding its selection of surveys from a beryllium ceramics facility, a beryllium machining facility, and a beryllium alloy processing facility as the critical studies that form the basis of the preliminary risk assessment. Research showed that these workplaces had well characterized and relatively low beryllium exposures and underwent plant-wide screenings for sensitization and CBD before and after implementation of exposure controls. The reviewers were requested to comment on whether the study discussions were clearly presented, whether the role of dermal exposure and dermal protection were adequately addressed, and whether the preliminary conclusions regarding the observed exposure-related prevalence and reduction in risk were reasonable and scientifically credible. They were also asked to identify other studies that should be reviewed as part of the sensitization/CBD risk assessment.

    Every peer reviewer felt the key studies were appropriate and their selection clearly explained in the document. Every peer reviewer regarded the preliminary conclusions from the OSHA review of these studies to be reasonable and scientifically sound. This conclusion stated that substantial risk of sensitization and CBD were observed in facilities where the highest exposed processes had median full-shift beryllium exposures around 0.2 mug/m\3\ or higher and that the greatest reduction in risk was achieved when exposures for all processes were lowered to 0.1 mug/m\3\ or below.

    The reviewers suggested that three additional studies be added to the risk assessment review of the

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    epidemiological literature. Dr. Balmes felt the document would be strengthened by including the Bailey et al. (2010) investigation of sensitization in a population of workers at the beryllium metal, alloy, and oxide production plant in Elmore, OH and the Arjomandi et al. (2010) publication on a group of 50 sensitized workers from a nuclear plant. Dr. Breysse suggested the study by Taiwo et al. (2008) on sensitization among workers in four aluminum smelters be considered.

    A new subsection VI.A.3 was added to the preliminary risk assessment that describes the changes in beryllium exposure measurements, prevalence of sensitization and CBD, and implementation of exposure controls between 1992 and 2006 at the Elmore plant. This subsection includes a discussion of the Bailey et al. study. A summary of the Taiwo et al. (2008) study was added as subsection VI.A.5. A discussion of the Arjomandi et al. (2010) study was added in subsection VI.B as evidence that sensitized workers with primarily low beryllium exposure go on to develop CBD. However, the low rates of CBD among this group of sensitized workers also suggest that low beryllium exposure may reduce CBD risk when compared to worker populations with higher exposure levels.

    While the majority of reviewers stated that OSHA adequately addressed the role of dermal exposure in sensitization and the importance of dermal protection for workers, a few had additional suggestions for OSHA's discussion. Dr. Breysse and Dr. Gordon pointed out that because the beryllium exposure control programs featured steps to reduce both skin contact and inhalation, it was difficult to distinguish between the effects of reducing airborne and dermal exposure. A statement was added to subsection VI.B that concurrent implementation of respirator use, dermal protection and engineering changes made it difficult to attribute reduced risk to any single control measure. Since the Cullman plant did not require glove use, OSHA believes it to be the best data set available for evaluating the effects of airborne exposure control on risk of sensitization.

    Dr. Breysse requested additional discussion of the role of respiratory protection in achieving reduction in risk. Dr. Gordon suggested some additional clarification regarding mean and median exposure measures. Additional information on respiratory programs and exposure measures (e.g., median, arithmetic and geometric means), where available, were presented for each of the studies discussed in subsection VI.A.

    The peer reviewers generally agreed that it was reasonable to conclude that community-acquired CBD (CA-CBD) resulted from low beryllium exposures. Drs. Breysse, Balmes and others noted that higher short-term excursions could not be ruled out. Dr. Gordon suggested that genetic susceptibility may have a role in cases of CA-CBD. Dr. Rossman raised the possibility that some CA-CBD cases could occur from contact with beryllium workers. All these points were added to subsection VI.C.

    OSHA asked the peer reviewers to evaluate the choice of the National Jewish Medical and Research Center (NJMRC) data set on the Cullman, AL machinist population as a basis for exposure-response analysis and the reliance on cumulative exposure as the basis for the exposure-response analysis of sensitization and CBD. All peer reviewers indicated that the choice of the NJMRC data set for exposure-response analysis was clearly explained and reasonable and that they knew of no better data set for the analysis. Dr. Rossman commented that the NJMRC data set was an excellent source of exposures to different levels of beryllium and testing and evaluation of the workers. Dr. Steenland and Dr. Gordon suggested that the results from the OSHA analysis of the NJMRC data be compared with the available data from the studies of other beryllium facilities discussed in the epidemiological literature analysis. While a rigorous quantitative comparison (e.g., meta analysis) is difficult due to differences in the study designs and data types available for each study, subsection VI.E.4 compares the results of OSHA's prevalence analysis from the Cullman data with results from studies of the Tucson and Reading facilities.

    OSHA asked the peer reviewers to evaluate methods used to construct the job exposure matrix (JEM) and to estimate beryllium exposure for each worker in the NJMRC data set. The JEM procedure was briefly summarized in the review document and described in detail as part of a risk assessment technical background document made available to the reviewers (OSHA, 2014a). Dr. Balmes felt that a more thorough discussion of the JEM would strengthen the preamble document. Dr. Gordon requested information about values assigned exposures below the limit of detection. Dr. Steenland requested that both the preamble and technical background document contain additional information on aspects of the JEM construction such as the job categories, job-specific exposure values, how jobs were grouped, and how non-machining jobs were handled in the JEM. He suggested the entire JEM be included in the technical background document. OSHA greatly expanded subsection VI.E.2 on air sampling and JEM to include more detailed discussion of the JEM construction. Exposure values for machining and non-machining job titles were provided in Tables VI-4 and VI-5. The procedures and rationale for grouping job-specific measurements into four time periods was explained. Jobs were not grouped in the JEM; rather, individual exposure estimates were created for each job in the work history data set. The technical background document further clarifies the JEM construction and the full JEM is included as an appendix to the revised background document (OSHA, 2014a). Subsection VI.E.3 on worker exposure reconstruction contains further detail about the work histories.

    Peer reviewers fully supported OSHA's choice of the cumulative exposure metric to estimate risk of CBD from the NJMRC data set. As explained by Dr. Steenland, ``cumulative exposure is often the choice for many chronic diseases as opposed to average or highest exposure.'' He pointed out that the cumulative exposure metric also fit the CBD data better than other metrics. The reviewers generally felt that short-term peak exposure was probably the measure of airborne exposure most relevant to risk of beryllium sensitization. However, peer reviewers agreed that data required to capture workers' short-term peak exposures and to relate the peak exposure levels to sensitization were not available. Dr. Breysse explained that ``short-term (hrs to minutes) peak exposures may be important to sensitization risk, while long term averages are more important for CBD risk. Unfortunately data for short-

    term peak exposures may not exist.'' Dr. Steenland explained that of the available metrics ``cumulative exposure fits the sensitization data better than the two alternatives, and hence is the best metric.'' Statements were added to subsection VI.E.3 to indicate that while short-term exposures may be highly relevant to risk of sensitization, the individual peak exposures leading up to onset of sensitization was not able to be determined in the NJRMC Cullman study.

    Peer reviewers found the methods used in the statistical exposure-

    response analysis to be clearly described. With the exception of Dr. Steenland, reviewers believed that a detailed critique of the statistical approach was

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    beyond their level of expertise. Dr. Steenland supported OSHA's overall approach to the risk modeling and recommended additional analyses to explore the sensitivity of OSHA's results to alternate choices and to test the validity of aspects of the analysis. Dr. Steenland recommended that the logistic regression used by OSHA as a preliminary first analysis be dropped as an inappropriate model for a situation where it is important to account for changing exposures and case onset over time. Instead, he suggested a sensitivity analysis in which exposure-

    response coefficients generated using a traditional Cox proportionate hazards model be compared to the discrete time Cox model analog (i.e., complementary log-log Cox model) used by OSHA. The sensitivity analysis would facilitate examination of the proportional hazard assumption implied by the use of these models. Dr. Steenland advocated that OSHA include a table that displayed the mean number of BeLPT tests for the study population in order to address whether the number of sensitization tests introduced a potential bias. He inquired about the possibility of determining a sensitization incidence rate using cumulative or average exposure. Dr. Steenland suggested that the model control for additional potential confounders, such as age, smoking status, race and gender. He wanted a more complete explanation of the model constant for the year of diagnosis in Tables VI-9 through VI-12 to be included in the preamble as it was in the technical background document. Dr. Steenland recommended a sensitivity analysis that excludes the highest 5 to 10 percent of cumulative exposures which might address potential model uncertainty at the high end exposures. He requested that the results of statistical tests for non-linearity be included and confidence intervals for the risk estimates in Tables VI-

    17 and VI-18 be determined.

    Many of Dr. Steenland's comments were addressed in subsection VI.F on the statistical modeling. The logistic regression analysis was removed from the section. A sensitivity analysis using the standard Cox model that treats survival time as continuous rather than discrete was added to the risk assessment background document and results were described in subsection VI.F. The interaction between exposure and follow-up time was not significant in the models suggesting that the proportional hazard assumption should not be rejected. The model coefficients using the standard Cox model were similar to model coefficients for the discrete model. Given this, OSHA did not feel it necessary to further estimate risks using the continuous Cox model at specific exposure levels.

    A table of the mean number of BeLPT tests across the study population was added to the risk assessment background document. Subsection VI.F describes the table results and its impact on the statistical modeling. Smoking status and age were included in the discrete Cox proportional hazards model and not found to be significant predictors of beryllium sensitization. However, the available study population composition did not allow a confounder analysis of race and gender. OSHA chose not to include a detailed explanation of the model constant for the year of diagnosis in the preamble section. OSHA agrees with Dr. Steenland that the risk assessment background document adequately describes the model terms. For that reason, OSHA prefers that the risk assessment preamble focus on the results and major points of the analysis and refer the reader to the more technical background document for an explanation of model parameters. The linearity assumption was assessed using a fractional polynomial approach. The best fitting polynomials did not fit significantly better than the linear model. The details of the analysis were included in the risk assessment background document. Tables VI-17 and VI-18 now include the upper 95 percent confidence limits on the model-predicted cases of sensitization and CBD for the current and alternative PELs.

    Most peer reviewers felt the major uncertainties of the risk assessment were clearly and adequately discussed in the documents they reviewed. Dr. Breysse requested that the risk assessment cover potential underestimation of risk from exposure misclassification bias. He requested further discussion of the degree to which the risk estimates from the Cullman machining plant could be extrapolated to workplaces that use other physical (e.g., particle size) and chemical forms of beryllium. He went on to question the strength of evidence that insoluble forms of beryllium cause CBD. Dr. Breysse also suggested that the assumptions used in the risk modeling be consolidated and more clearly presented. Dr. Steenland felt that there was potential underestimation of CBD risk resulting from exclusion of former workers and case status of current workers after employment.

    Discussion of these uncertainties was added in the final paragraphs of section VI.F. The section was modified to more clearly identify assumptions with regard to the risk modeling such as an assumed linearity in exposure-response and cumulative dose equivalency when extrapolating risks over a 45-year working lifetime. Section VI.F recognizes the uncertainties in risk that can result from reconstructing individual exposures with very limited sampling data prior to 1994. The potential exposure misclassification can limit the strength of exposure-response relationships and result in the underestimation of risk. A more technical discussion of modeling assumptions and exposure measurement error are provided in the risk assessment background document. Section VI.F points out that the NJMRC data set does not capture CBD that occurred among workers who retired or left the Cullman plant. This and the short follow-up time is a source of uncertainty that likely leads to underestimation of risk. The section indicates that it is not unreasonable to expect the risk estimates to generally reflect onset of sensitization and CBD from exposure to beryllium forms that are relatively insoluble and enriched with respirable particles as encountered at the Cullman machining plant. Additional uncertainty is introduced when extrapolating the risk estimates to beryllium compounds of vastly different solubility and particle characteristics. OSHA does not agree with the comment suggesting that the association between CBD and insoluble forms of beryllium is weak. The principle sources of beryllium encountered at the Cullman machining plant, the Reading copper beryllium processing plant and the Tucson ceramics plant where excessive CBD was observed are insoluble forms of beryllium, such as beryllium metal, beryllium alloy, and beryllium oxide.

    Finally, OSHA asked the peer reviewers to evaluate its treatment of lung cancer in the earlier draft preliminary risk assessment (OSHA, 2010b). When that document was prepared, OSHA had elected not to conduct a lung cancer risk assessment. The Agency believed that the exposure-response data available to conduct a lung cancer risk assessment from a Sanderson et al. study of a Reading, PA beryllium plant by was highly problematic. The Sanderson study primarily involved workers with extremely high and short-term exposures above airborne exposure levels of interest to OSHA (2 mug/m\3\ and below).

    Just prior to arranging the peer review, a NIOSH study was published by Schubauer-Berigan et al. updating the Reading, PA cohort studied by Sanderson et al. and adding cohorts

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    from two additional plants in Elmore, OH and Hazleton, PA (Schubauer-

    Berigan, 2011). At OSHA's request, the peer reviewers reviewed this study to determine whether it could provide a better basis for lung cancer risk analysis than the Sanderson et al. study. The reviewers found that the NIOSH update addressed the major concerns OSHA had expressed about the Sanderson study. In particular, they pointed out that workers in the Elmore and Hazleton cohorts had longer tenure at the plants and experienced lower exposures than those at the Reading, PA plant. Dr. Steenland recommended that ``OSHA consider the new NIOSH data and develop risk estimates for lung cancer as well as sensitization and CBD.'' Dr. Breysse believed that the NIOSH data ``suggest that a risk assessment for lung cancer should be conducted by OSHA and the results be compared to the CBD/sensitization risk assessment before recommending an appropriate exposure concentration.'' While acknowledging the improvements in the quality of the data, other reviewers were more restrained in their support for quantitative estimates of lung cancer risk. Dr. Gordon stated that despite improvements, there was ``still uncertainty associated with the paucity of data below the current PEL of 2 mug/m\3\.'' Dr. Rossman noted that the NIOSH study ``did not address the problem of the uncertainty of the mechanism of beryllium carcinogenicity.'' He felt that the updated NIOSH lung cancer mortality data ``should not change the Agency's rationale for choosing to establish its risk findings for the proposed rule on its analysis for beryllium sensitization and CBD.'' Dr. Balmes agreed that ``the agency will be on firmer ground by focusing on sensitization and CBD.''

    The preliminary risk assessment preamble subsection VI.G on lung cancer includes a discussion of the quantitative lung cancer risk assessment published by NIOSH researchers in 2010 (Schubauer-Berigan, 2011). The discussion describes the lower exposure levels, longer tenure, fewer short-term workers and additional years of observation that make the data more suitable for risk assessment. NIOSH relied on several modeling approaches to show that lung cancer risk was significantly related to both mean and cumulative beryllium exposure. Subsection VI.G provides the excess lifetime lung cancer risks predicted from several best-fitting NIOSH models at beryllium exposures of interest to OSHA (Table VI-20). Using the piecewise log-linear proportional hazards model favored by NIOSH, there is a projected drop in excess lifetime lung cancer risks from approximately 61 cases per 1000 exposed workers at the current PEL of 2.0 mug/m\3\ to approximately 6 cases per 1000 at the proposed PEL of 0.2 mug/m\3\. Subsection VI.H on preliminary conclusions indicates that these projections support a reduced risk of lung cancer from more stringent control of beryllium exposures but that the lung cancer risk estimates are more uncertain than those for sensitization and CBD.

  26. Significance of Risk

    To promulgate a standard that regulates workplace exposure to toxic materials or harmful physical agents, OSHA must first determine that the standard reduces a ``significant risk'' of ``material impairment.'' The first part of this requirement, ``significant risk,'' refers to the likelihood of harm, whereas the second part, ``material impairment,'' refers to the severity of the consequences of exposure.

    The Agency's burden to establish significant risk is based on the requirements of the OSH Act (29 U.S.C. 651 et seq). Section 3(8) of the Act requires that workplace safety and health standards be ``reasonably necessary or appropriate to provide safe or healthful employment'' (29 U.S.C. 652(8)). The Supreme Court, in the Benzene decision, interpreted section 3(8) to mean that ``before promulgating any standard, the Secretary must make a finding that the workplaces in question are not safe'' (Industrial Union Department, AFL-CIO v. American Petroleum Institute, 448 U.S. 607, 642 (1980) (plurality opinion)). Examining section 3(8) more closely, the Court described OSHA's obligation to demonstrate significant risk:

    ``Safe'' is not the equivalent of ``risk-free.'' A workplace can hardly be considered ``unsafe'' unless it threatens the workers with a significant risk of harm. Therefore, before the Secretary can promulgate any permanent health or safety standard, he must make a threshold finding that the place of employment is unsafe in the sense that significant risks are present and can be eliminated or lessened by a change in practices (Id).

    As the Court made clear, the Agency has considerable latitude in defining significant risk and in determining the significance of any particular risk. The Court did not specify a means to distinguish significant from insignificant risks, but rather instructed OSHA to develop a reasonable approach to making a significant risk determination. The Court stated that ``it is the Agency's responsibility to determine in the first instance what it considers to be a 'significant' risk,'' (448 U.S. at 655) and it did not express ``any opinion on the . . . difficult question of what factual determinations would warrant a conclusion that significant risks are present which make promulgation of a new standard reasonably necessary or appropriate'' (448 U.S. at 659). The Court also stated that, while OSHA's significant risk determination must be supported by substantial evidence, the Agency ``is not required to support the finding that a significant risk exists with anything approaching scientific certainty'' (448 U.S. at 656). Furthermore:

    A reviewing court is to give OSHA some leeway where its findings must be made on the frontiers of scientific knowledge . . . . The Agency is free to use conservative assumptions in interpreting the data with respect to carcinogens, risking error on the side of overprotection rather than underprotection so long as such assumptions are based on a body of reputable scientific thought (448 U.S. at 656).

    Thus, to make the significance of risk determination for a new or proposed standard, OSHA uses the best available scientific evidence to identify material health impairments associated with potentially hazardous occupational exposures and to evaluate exposed workers' risk of these impairments.

    The OSH Act also requires that the Agency make a finding that the toxic material or harmful physical agent at issue causes material impairment to worker health. In that regard, the Act directs the Secretary of Labor to set standards based on the available evidence where no employee, over his/her working life time, will suffer from material impairment of health or functional capacity, even if such employee has regular exposure to the hazard, to the exent feasible (29 U.S.C. 655(b)(5)).

    As with significant risk, what constitutes material impairment in any given case is a policy determination for which OSHA is given substantial leeway. ``OSHA is not required to state with scientific certainty or precision the exact point at which each type of harm becomes a material impairment'' (AFL-CIO v. OSHA, 965 F.2d 962, 975 (11th Cir. 1992)). Courts have also noted that OSHA should consider all forms and degrees of material impairment--not just death or serious physical harm--and that OSHA may act with a ``pronounced bias towards worker safety'' (Id; Bldg & Constr. Trades Dep't v. Brock, 838 F.2d 1258, 1266 (D.C. Cir. 1988)). OSHA's long-standing policy is to consider 45 years as a ``working life,''

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    over which it must evaluate material impairment and risk.

    In formulating this proposed beryllium standard, OSHA has reviewed the best available evidence pertaining to the adverse health effects of occupational beryllium exposure, including lung cancer and chronic beryllium disease (CBD), and has evaluated the risk of these effects from exposures allowed under the current standard as well as the expected impact of the proposed standard on risk. Based on its review of extensive epidemiological and experimental research, OSHA has preliminarily determined that long-term exposure at the current Permissible Exposure Limit (PEL) would pose a significant risk of material impairment to workers' health, and that adoption of the new PEL and other provisions of the proposed rule will substantially reduce this risk.

    A. Material Impairment of Health

    In this preamble at section V, Health Effects, OSHA reviewed the scientific evidence linking occupational beryllium exposure to a variety of adverse health effects, including CBD and lung cancer. Based on this review, OSHA preliminarily concludes that beryllium exposure causes these effects. The Agency's preliminary conclusion was strongly supported by a panel of independent peer reviewers, as discussed in section VII.

    Here, OSHA discusses its preliminary conclusion that CBD and lung cancer constitute material impairments of health, and briefly reviews other adverse health effects that can result from beryllium exposure. Based on this preliminary conclusion and on the scientific evidence linking beryllium exposure to both CBD and lung cancer, OSHA concludes that occupational exposure to beryllium causes ``material impairment of health or functional capacity'' within the meaning of the OSH Act.

    1. Chronic Beryllium Disease

    CBD is a respiratory disease in which the body's immune system reacts to the presence of beryllium in the lung, causing a progression of pathological changes including chronic inflammation and tissue scarring. CBD can also impair other organs such as the liver, skin, spleen, and kidneys and cause adverse health effects such as granulomas of the skin and lymph nodes and cor pulmonale (i.e., enlargement of the heart) (Conradi et al., 1971; ACCP, 1965; Kriebel et al., 1988a and b). In early, asymptomatic stages of CBD, small granulomatous lesions and mild inflammation occur in the lungs. Early stage CBD among some workers has been observed to progress to more serious disease even after the worker is removed from exposure (Mroz, 2009), probably because common forms of beryllium have slow clearance rates and can remain in the lung for years after exposure. Sood et al. has reported that cessation of exposure can sometimes have beneficial effects on lung function (Sood et al., 2004). However, this was based on a small study of six patients with CBD, and more research is needed to better determine the relationship between exposure duration and disease progression. In general, progression of CBD from early to late stages is understood to vary widely, responding differently to exposure cessation and treatment for different individuals (Sood, 2009; Mroz, 2009).

    Over time, the granulomas can spread and lead to lung fibrosis (scarring) and moderate to severe loss of pulmonary function, with symptoms including a persistent dry cough and shortness of breath (Saber and Dweik, 2000). Fatigue, night sweats, chest and joint pain, clubbing of fingers (due to impaired oxygen exchange), loss of appetite, and unexplained weight loss may occur as the disease progresses. Corticosteroid therapy, in workers whose beryllium exposure has ceased, has been shown to control inflammation, ease symptoms (e.g., difficulty breathing, fever, cough, and weight loss) and in some cases prevent the development of fibrosis (Marchand-Adam et al., 2008). Thus early treatment can lead to CBD regression in some patients, although there is no cure (Sood, 2004). Other patients have shown short-term improvements from corticosteroid treatment, but then developed serious fibrotic lesions (Marchand-Adam et al., 2008). Once fibrosis has developed in the lungs, corticosteroid treatment cannot reverse the damage (Sood, 2009). Persons with late-stage CBD experience severe respiratory insufficiency and may require supplemental oxygen (Rossman, 1991). Historically, late-stage CBD often ended in death (NAS, 2008).

    While the use of steroid therapy has mitigated CBD mortality, treatment with corticosteroids has side effects that need to be measured against the possibility of progression of disease (Trikudanathan and McMahon, 2008; Lipworth, 1999; Gibson et al., 1996; Zaki et al., 1987). Adverse effects associated with long-term corticosteroid use include, but are not limited to, increased risk of opportunistic infections (Lionakis and Kontoyiannis, 2003; Trikudanathan and McMahon, 2008); accelerated bone loss or osteoporosis leading to increased risk of fractures or breaks (Hamida et al., 2011; Lehouck et al., 2011; Silva et al., 2011; Sweiss et al., 2011; Langhammer et al., 2009); psychiatric effects including depression, sleep disturbances, and psychosis (Warrington and Bostwick, 2006; Brown, 2009); adrenal suppression (Lipworth, 1999; Frauman, 1996); ocular effects including cataracts, ocular hypertension, and glaucoma (Ballonzolli and Bourchier, 2010; Trikudanathan and McMahon, 2008; Lipworth, 1999); an increase in glucose intolerance (Trikudanathan and McMahon, 2008); excessive weight gain (McDonough et al., 2008; Torres and Nowson, 2007; Dallman et al., 2007; Wolf, 2002; Cheskin et al., 1999); increased risk of atherosclerosis and other cardiovascular syndromes (Franchimont et al., 2002); skin fragility (Lipworth, 1999); and poor wound healing (de Silva and Fellows, 2010). Studies relating the long-term effect of corticosteroid use for the treatment of CBD need to be undertaken to evaluate the treatment's overall effectiveness against the risk of adverse side effects from continued usage.

    OSHA considers late-stage CBD to be a material impairment of health, as it involves permanent damage to the pulmonary system, causes additional serious adverse health effects, can have adverse occupational and social consequences, requires treatment associated with severe and lasting side effects, and may in some cases be life-

    threatening. Furthermore, OSHA believes that material impairment begins prior to the development of symptoms of the disease.

    Although there are no symptoms associated with early-stage CBD, during which small lesions and inflammation appear in the lungs, the Agency has preliminarily concluded that the earliest stage of CBD is material impairment of health. OSHA bases this conclusion on evidence showing that early-stage CBD is a measurable change in the state of health which, with and sometimes without continued exposure, can progress to symptomatic disease. Thus, prevention of the earliest stages of CBD will prevent development of more serious disease. The OSHA Lead Standard established the Agency's position that a `subclinical' health effect may be regarded as a material impairment of health. In the preamble to that standard, the Agency said:

    OSHA believes that while incapacitating illness and death represent one extreme of a spectrum of responses, other biological effects such as metabolic or physiological changes are precursors or sentinels of disease which should be prevented . . . Rather than revealing beginnings of illness the standard must be selected to prevent an earlier point

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    of measurable change in the state of health which is the first significant indicator of possibly more severe ill health in the future. The basis for this decision is twofold--first, pathophysiologic changes are early stages in the disease process which would grow worse with continued exposure and which may include early effects which even at early stages are irreversible, and therefore represent material impairment themselves. Secondly, prevention of pathophysiologic changes will prevent the onset of the more serious, irreversible and debilitating manifestations of disease.\11\ (43 FR 52952, 52954, November 14, 1978)

    \11\ Even if asymptomatic CBD were not itself a material impairment of health, the D.C. Circuit upheld OSHA's authority to regulate to prevent subclinical health effects as precursors to disease in United Steelworkers of America, AFL-CIO v. Marshall, 647 F.2d 1189, 1252 (D.C. Cir. 1980), which reviewed the Lead standard. Without deciding whether the early symptoms of disease were themselves a material impairment, the court concluded that OSHA may regulate subclinical effects if it can demonstrate on the basis of substantial evidence that preventing subclinical effects would help prevent the clinical phase of disease (Id.).

    Since the Lead rulemaking, OSHA has also found other non-

    symptomatic health conditions to be material impairments of health. In the Bloodborne Pathogens (BP) rulemaking, OSHA maintained that material impairment includes not only workers with clinically ``active'' hepatitis from the hepatitis B virus (HBV) but also includes asymptomatic HBV ``carriers'' who remain infectious and are able to put others at risk of serious disease through contact with body fluids (e.g., blood, sexual contact) (56 FR 64004, December 6, 1991). OSHA stated: ``Becoming a carrier of Hepatitis B is a material impairment of health even though the carrier may have no symptoms. This is because the carrier will remain infectious, probably for the rest of his or her life, and any person who is not immune to HBV who comes in contact with the carrier's blood or certain other body fluids will be at risk of becoming infected'' (56 FR 64004, 64036).

    OSHA preliminarily finds that early-stage CBD is the type of asymptomatic health effect the Agency determined to be a material impairment of health in the lead standard. Early stage CBD involves lung tissue inflammation without symptomatology that can worsen with--

    or without--continued exposure. The lung pathology progresses over time from a chronic inflammatory response to tissue scarring and fibrosis accompanied by moderate to severe loss in pulmonary function. Early stage CBD is clearly a precursor of advanced clinical disease, prevention of which will prevent symptomatic disease. OSHA argued in the Lead standard that such precursor effects should be considered material health impairments in their own right, and that the Agency should act to prevent them when it is feasible to do so. Therefore, OSHA preliminarily finds all stages of CBD to be material impairments of health.

    2. Lung Cancer

    OSHA considers lung cancer, a frequently fatal disease, to be a material impairment of health. OSHA's finding that inhaled beryllium causes lung cancer is based on the best available epidemiological data, reflects evidence from animal and mechanistic research, and is consistent with the conclusions of other government and public health organizations (see this preamble at section V, Health Effects). For example, the International Agency for Research on Cancer (IARC), National Toxicology Program (NTP), and American Conference of Governmental Industrial Hygienists (ACGIH) have all classified beryllium as a known human carcinogen (IARC, 2009).

    The Agency's epidemiological evidence comes from multiple studies of U.S. beryllium workers (Sanderson et al., 2001a; Ward et al., 1992; Wagoner et al., 1980; Mancuso et al., 1979). Most recently, a NIOSH cohort study found significantly increased lung cancer mortality among workers at seven beryllium processing facilities (Schubauer-Berigan et al., 2011). The cohort was exposed, on average, to lower levels of beryllium than those in most previous studies, had fewer short-term workers, and had sufficient follow-up time to observe lung cancer in the population. OSHA considers the Schubauer-Berigan study to be the best available epidemiological evidence regarding the risk of lung cancer from beryllium at exposure levels near the PEL.\12\

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    \12\ The scientific peer review panel for OSHA's Preliminary Risk Assessment agreed with the Agency that the Schubauer-Berigan analysis improves upon the previously available data for lung cancer risk assessment.

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    Supporting evidence of beryllium carcinogenicity comes from various animal studies as well as in vitro genotoxicity and other studies (EPA, 1998; ATSDR, 2002; Gordon and Bowser, 2003; NAS, 2008; Nickell-Brady et al., 1994; NTP, 1999 and 2005; IARC, 1993 and 2009). Multiple mechanisms may be involved in the carcinogenicity of beryllium, and factors such as epigenetics, mitogenicity, reactive oxygen-mediated indirect genotoxicity, and chronic inflammation may contribute to the lung cancer associated with beryllium exposure, although the results of studies testing the direct genotoxicity of beryllium are mixed (EPA summary, 1998). While there is uncertainty regarding the exact mechanism of carcinogenesis for beryllium, the overall weight of evidence for the carcinogenicity of beryllium is strong. Therefore, the Agency has preliminarily determined beryllium to be an occupational carcinogen.

    3. Other Impairments

    While OSHA has relied primarily on the relationship between occupational beryllium exposure and CBD and lung cancer to demonstrate the necessity of the standard, the Agency has also determined that several other adverse health effects can result from exposure to beryllium. Inhalation of high airborne concentrations of beryllium (well above the 2 mug/m\3\ OSHA PEL) can cause acute beryllium disease, a severe (sometimes fatal), rapid-onset inflammation of the lungs. Hepatic necrosis, damage to the heart and circulatory system, chronic renal disease, mucosal irritation and ulceration, and urinary tract cancer have also reportedly been associated with occupational exposures well above the current PEL (see this preamble at section V, Health Effects, subsection E, Epidemiological Studies, and subsection F, Other Health Effects). These adverse systemic effects and acute beryllium disease mostly occurred prior to the introduction of occupational and environmental standards set in 1970-1972 (OSHA, 1971; ACGIH, 1971; ANSI, 1970) and 1974 (EPA, 1974) and therefore are less relevant today than in the past. Because they occur only rarely in current-day occupational environments, they are not addressed in OSHA's risk analysis or significance of risk determination.

    The Agency has also determined that beryllium sensitization, a precursor which occurs before early stage CBD and is an essential step for worker development of the disease, can result from exposure to beryllium. The Agency takes no position at this time on whether sensitization constitutes a material impairment of health, because it was unnecessary to do so as part of this rulemaking. As discussed in Section V, Health Effects, only sensitized individuals can develop CBD (NAS, 2008). OSHA's risk assessment for sensitization informs the Agency's understanding of what exposure control measures have been successful in preventing sensitization, which in turn prevents development of CBD. Therefore sensitization is considered in the next section on significance of risk.

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    In AFL-CIO v. Marshall, 617 F.2d 636, 654 n.83 (D.C. Cir. 1979) (Cotton Dust), the D.C. Circuit upheld OSHA's authority to regulate to prevent precursors to a material impairment of health without deciding whether the precursors themselves constituted material impairment of health.

    B. Significance of Risk and Risk Reduction

    To evaluate the significance of the health risks that result from exposure to hazardous chemical agents, OSHA relies on the best available epidemiological, toxicological, and experimental evidence. The Agency uses both qualitative and quantitative methods to characterize the risk of disease resulting from workers' exposure to a given hazard over a working lifetime at levels of exposure reflecting compliance with current standards and compliance with the new standards being proposed.

    As discussed above, the Agency's characterization of risk is guided in part by the Benzene decision. In Benzene, the Court broadly describes the range of risks OSHA might determine to be significant:

    It is the Agency's responsibility to determine in the first instance what it considers to be a ``significant'' risk. Some risks are plainly acceptable and others are plainly unacceptable. If, for example, the odds are one in a billion that a person will die from cancer by taking a drink of chlorinated water, the risk clearly could not be considered significant. On the other hand, if the odds are one in a thousand that regular inhalation of gasoline vapors that are 2 percent benzene will be fatal, a reasonable person might well consider the risk significant and take the appropriate steps to decrease or eliminate it (Benzene, 448 U.S. at 655).

    The Court further stated, ``The requirement that a 'significant' risk be identified is not a mathematical straitjacket. . . . Although the Agency has no duty to calculate the exact probability of harm, it does have an obligation to find that a significant risk is present before it can characterize a place of employment as 'unsafe', ``and proceed to promulgate a regulation (Id.).

    In this preamble at section VI, Preliminary Risk Assessment, OSHA finds that the available epidemiological data are sufficient to evaluate risk for beryllium sensitization, CBD, and lung cancer among beryllium-exposed workers. The preliminary findings from this assessment are summarized below.

    1. Risk of Beryllium Sensitization and CBD

    OSHA's preliminary risk assessment for CBD and beryllium sensitization relies on studies conducted at a Tucson, AZ beryllium ceramics plant (Kreiss et al., 1996; Henneberger et al., 2001; Cummings et al., 2006); a Reading, PA alloy processing plant (Schuler et al., 2005; Thomas et al., 2009); a Cullman, AL beryllium machining plant (Kelleher et al., 2001; Madl et al., 2007); and an Elmore, OH metal, alloy, and oxide production plant (Kreiss et al., 1997; Bailey et al., 2010; Schuler et al., 2012). The Agency uses these studies to demonstrate the significance of risk at the current PEL and the significant reduction in risk expected with reduction of the PEL. In addition to the effects OSHA anticipates from reduction of airborne beryllium exposure, the Agency expects that dermal protection provisions in the proposed rule will further reduce risk. Studies conducted in the 1950s by Curtis et al. showed that soluble beryllium particles could penetrate the skin and cause beryllium sensitization (Curtis 1951, NAS 2008). Tinkle et al. established that 0.5- and 1.0-

    mum particles can penetrate intact human skin surface and reach the epidermis, where beryllium particles would encounter antigen-presenting cells and initiate sensitization (Tinkle et al., 2003). Tinkle et al. further demonstrated that beryllium oxide and beryllium sulfate, applied to the skin of mice, generate a beryllium-specific, cell-

    mediated immune response similar to human beryllium sensitization (Tinkle et al., 2003). In the epidemiological studies discussed below, the exposure control programs that most effectively reduced the risk of beryllium sensitization and CBD incorporated both respiratory and dermal protection. OSHA has preliminarily determined that an effective exposure control program should incorporate both airborne exposure reduction and dermal protection provisions.

    In the Tucson ceramics plant, 4,133 short-term breathing zone measurements collected between 1981 and 1992 had a median of 0.3 mug/

    m\3\. Kreiss et al. reported that eight (5.9 percent) of 136 workers tested for beryllium sensitization in 1992 were sensitized, six (4.4 percent) of whom were diagnosed with CBD. Exposure control programs were initiated in 1992 to reduce workers' airborne beryllium exposure, but the programs did not address dermal exposure. Full-shift personal samples collected between 1994 and 1999 showed a median beryllium exposure of 0.2 mug/m\3\ in production jobs and 0.1 mug/m\3\ in production support (Cummings et al., 2007). In 1998, a second screening found that 6, (9 percent) of 69 tested workers hired after the 1992 screening, were sensitized, of whom 1 was diagnosed with CBD. All of the sensitized workers had been employed at the plant for less than 2 years (Henneberger et al., 2001), too short a time period for most people to develop CBD following sensitization. Of the 77 Tucson workers hired prior to 1992 who were tested in 1998, 8 (10.4 percent) were sensitized and all but 1 of these (9.7 percent) were diagnosed with CBD (Henneberger et al., 2001).

    Kreiss et al., studied workers at a beryllium metal, alloy, and oxide production plant in Elmore, OH. Workers participated in a BeLPT survey in 1992 (Kreiss et al., 1997). Personal lapel samples collected during 1990-1992 had a median value of 1.0 mug/m\3\. Kreiss et al. reported that 43 (6.9 percent) of 627 workers tested in 1992 were sensitized, 6 of whom were diagnosed with CBD (4.4 percent).

    Newman et al. conducted a series of BeLPT screenings of workers at a Cullman, AL precision machining facility between 1995 and 1999 (Newman et al., 2001). Personal lapel samples collected at this plant in the early 1980s and in 1995 from all machining processes combined had a median of 0.33 mug/m\3\ (Madl et al., 2007). After a sentinel case of CBD was diagnosed at the plant in 1995, the company implemented engineering and administrative controls and PPE designed to reduce workers' beryllium exposures in machining operations. Personal lapel samples collected extensively between 1996 and 1999 in machining jobs have an overall median of 0.16 mug/m\3\, showing that the new controls reduced machinists' exposures during this period. However, the results of BeLPT screenings conducted in 1995-1999 showed that the exposure control program initiated in 1995 did not sufficiently protect workers from beryllium sensitization and CBD. In a group of 60 workers who had been employed at the plant for less than a year, and thus would not have been working there prior to 1995, 4 (6.7 percent) were found to be sensitized. Two of these workers (3.35 percent) were diagnosed with CBD. (Newman et al., 2001).

    Sensitization and CBD were studied in a population of workers at a Reading, PA copper beryllium plant, where alloys containing a low level of beryllium were processed (Schuler et al., 2005). Personal lapel samples were collected in production and production support jobs between 1995 and May 2000. These samples showed primarily very low airborne beryllium levels, with a median of 0.073 mug/m\3\. The wire

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    annealing and pickling process had the highest personal lapel sample values, with a median of 0.149 mug/m\3\. Despite these low exposure levels, a BeLPT screening conducted in 2000 showed that 5, (11.5 percent) workers of 43 hired after 1992 were sensitized (evaluation for CBD not reported). Two of the sensitized workers had been hired less than a year before the screening (Thomas et al., 2009).

    In summary, the epidemiological literature on beryllium sensitization and CBD that OSHA's risk assessment relied on show sensitization prevalences ranging from 6.5 percent to 11.5 percent and CBD prevalences ranging from 1.3 percent to 9.7 percent among workers who had full-shift exposures well below the current PEL and median full-shift exposures at or below the proposed PEL, and whose follow-up time was less than 45 years. As referenced earlier, OSHA is interested in the risk associated with a 45-year (i.e., working lifetime) exposure. Because CBD often develops over the course of years following sensitization, the risk of CBD that would result from 45 years' occupational exposure to airborne beryllium is likely to be higher than the prevalence of CBD observed among these workers.\13\ In either case, based on these studies, the risks to workers appear to be significant.

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    \13\ This point was emphasized by members of the scientific peer review panel for OSHA's Preliminary Risk Assessment (see this preamble at section VII).

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    The available epidemiological evidence shows that reducing workers' levels of airborne beryllium exposure can substantially reduce risk of beryllium sensitization and CBD. The best available evidence on effective exposure control programs comes partly from studies of programs introduced around 2000 at Reading, Tucson, and Elmore that used a combination of engineering controls, dermal and respiratory PPE, and stringent housekeeping measures to reduce workers' dermal exposures and airborne exposures to levels well below the proposed PEL of 0.2 mug/m\3\. These programs have substantially lowered the risk of sensitization among new workers. As discussed earlier, prevention of beryllium sensitization prevents subsequent development of CBD.

    In the Reading, PA copper beryllium plant, full-shift airborne exposures in all jobs were reduced to a median of 0.1 mug/m\3\ or below and dermal protection was required for production-area workers beginning in 2000-2001 (Thomas et al., 2009). After these adjustments were made, 2 (5.4 percent) of 37 newly hired workers became sensitized. Thereafter, in 2002, the process with the highest exposures (median 0.1 mug/m\3\) was enclosed and workers involved in that process were required to use respiratory protection. As a result, the remaining jobs had very low exposures (medians ~ 0.03 mug/m\3\). Among 45 workers hired after the enclosure was built and respiratory protection instituted, 1 was found to be sensitized (2.2 percent). This is a sharp reduction in sensitization from the 11.5 percent of 43 workers, discussed above, who were hired after 1992 and had been sensitized by the time of testing in 2000.

    In the Tucson beryllium ceramics plant, respiratory and skin protection was instituted for all workers in production areas in 2000. BeLPT testing done in 2000-2004 showed that only 1 (1 percent) worker had been sensitized out of 97 workers hired during that time period (Cummings et al., 2007; testing for CBD not reported). This contrasts with the prevalence of sensitization in the 1998 Tucson BeLPT screening, which found that 6 (9 percent) of 69 workers hired after 1992 were sensitized (Cummings et al., 2007).

    The modern Elmore facility provides further evidence that combined reductions in respiratory exposure (via respirator use) and dermal exposure are effective in reducing risk of beryllium sensitization. In Elmore, historical beryllium exposures were higher than in Tucson, Reading, and Cullman. Personal lapel samples collected at Elmore in 1990-1992 had a median of 1.0 microg/m\3\. In 1996-1999, the company took steps to reduce workers' beryllium exposures, including engineering and process controls (Bailey et al., 2010; exposure levels not reported). Skin protection was not included in the program until after 1999. Beginning in 1999 all new employees were required to wear loose-fitting powered air-purifying respirators (PAPR) in manufacturing buildings (Bailey et al., 2010). Skin protection became part of the protection program for new employees in 2000, and glove use was required in production areas and for handling work boots beginning in 2001. Bailey et al., (2010) compared the occurrence of beryllium sensitization and CBD in 2 groups of workers: 1) 258 employees who began work at the Elmore plant between January 15, 1993 and August 9, 1999 (the ``pre-program group'') and were tested in 1997 and 1999, and 2) 290 employees who were hired between February 21, 2000 and December 18, 2006 and underwent BeLPT testing in at least one of frequent rounds of testing conducted after 2000 (the ``program group''). They found that, as of 1999, 23 (8.9 percent) of the pre-program group were sensitized to beryllium. The prevalence of sensitization among the ``program group'' workers, who were hired after the respiratory protection and PPE measures were put in place, was around 2-3 percent. Respiratory protection and skin protection substantially reduced, but did not eliminate, risk of sensitization. Evaluation of sensitized workers for CBD was not reported.

    OSHA's preliminary risk assessment also includes analysis of a data set provided to OSHA by the National Jewish Research and Medical Center (NJMRC). The data set describes a population of 319 beryllium-exposed workers at a Cullman, AL machining facility. It includes exposure samples collected between 1980 and 2005, and has updated work history and screening information for over three hundred workers through 2003. Seven (2.2 percent) workers in the data set were reported as sensitized only. Sixteen (5.0 percent) workers were listed as sensitized and diagnosed with CBD upon initial clinical evaluation. Three (1.0 percent) workers, first shown to be sensitized only, were later diagnosed with CBD. The data set includes workers exposed at airborne beryllium levels near the proposed PEL, and extensive exposure data collected in workers' breathing zones, as is preferred by OSHA. Unlike the Tucson, Reading, and Elmore facilities, respirator use was not generally required for workers at the Cullman facility. Thus, analysis of this data set shows the risk associated with varying levels of airborne exposure, rather than the virtual elimination of airborne exposure via respiratory PPE. Also unlike the Tucson, Elmore, and Reading facilities, glove use was not reported to be mandatory in the Cullman facility. Thus, OSHA believes reductions in risk at the Cullman facility to be the result of airborne exposure control, rather than the combination of airborne and dermal exposure controls at the Tucson, Elmore, and Reading facilities.

    OSHA analyzed the prevalence of beryllium sensitization and CBD among workers at the Cullman facility who were exposed to airborne beryllium levels at and below the current PEL of 2 microg/m\3\. In addition, a statistical modeling analysis of the NJMRC Cullman data set was conducted under contract with Dr. Roslyn Stone of the University of Pittsburgh Graduate School of Public Heath, Department of Biostatistics. OSHA summarizes these analyses briefly below, and in more detail in this preamble at section VI, Preliminary Risk Assessment.

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    Tables 1 and 2 below present the prevalence of sensitization and CBD cases across several categories of lifetime-weighted (LTW) average and highest-exposed job (HEJ) exposure at the Cullman facility. The HEJ exposure is the exposure level associated with the highest-exposure job and time period experienced by each worker. The columns ``Total'' and ``Total percent'' refer to all sensitized workers in the dataset, including workers with and without a diagnosis of CBD.

    Table 1--Prevalence of Sensitization and CBD by Lifetime Weighted Average Exposure Quartile, Cullman, AL Machining Facility

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

    Sensitized

    LTW Average exposure (mug/m\3\) Group size only CBD Total Total % CBD %

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

    0.0-0.080............................................... 91 1 1 2 2.2 1.0

    0.081-0.18.............................................. 73 2 4 6 8.2 5.5

    0.19-0.51............................................... 77 0 6 6 7.8 7.8

    0.51-2.15............................................... 78 4 8 12 15.4 10.3

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

    Total............................................... 319 7 19 26 8.2 6.0

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

    Source: Section VI, Preliminary Risk Assessment.

    Table 2--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile, Cullman, AL Machining Facility

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

    Sensitized

    HEJ Exposure (mug/m\3\) Group size only CBD Total Total % CBD %

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

    0.0-0.086............................................... 86 1 0 1 1.2 0.0

    0.091-0.214............................................. 81 1 6 7 8.6 7.4

    0.387-0.691............................................. 76 2 9 11 14.5 11.8

    0.954-2.213............................................. 76 3 4 7 9.2 5.3

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

    Total............................................... 319 7 19 26 8.2 6.0

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

    Source: Section VI, Preliminary Risk Assessment.

    The current PEL of 2 mug/m\3\ is close to the upper bound of the highest quartile of LTW average (0.51-2.15 mug/m\3\) and HEJ (0.954-

    2.213) exposure levels. In the highest quartile of LTW average exposure, there were 12 cases of sensitization (15.4 percent), including 8 (10.3 percent) diagnosed with CBD. Notably, the Cullman workers had been exposed to beryllium dust for considerably less than 45 years at the time of testing. A high prevalence of sensitization (9.2 percent) and CBD (5.3 percent) is seen in the top quartile of HEJ exposure as well, with even higher prevalences in the third quartile (0.387-0.691 mug/m\3\).\14\

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

    \14\ This exposure-response pattern is sometimes attributed to a ``healthy worker effect'' or to exposure misclassification, as discussed in this preamble at section VI, Preliminary Risk Assessment.

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

    The proposed PEL of 0.2 mug/m\3\ is close to the upper bound of the second quartile of LTW average (0.81-0.18 mug/m\3\) and HEJ (0.091-0.214 mug/m\3\) exposure levels and to the lower bound of the third quartile of LTW average (0.19-0.50 mug/m\3\) exposures. The second quartile of LTW average exposure shows a high prevalence of beryllium-related health effects, with six workers sensitized (8.2 percent), of whom four (5.5 percent) were diagnosed with CBD. The second quartile of HEJ exposure also shows a high prevalence of beryllium-related health effects, with seven workers sensitized (8.6 percent), of whom 6 (7.4 percent) were diagnosed with CBD. Among six sensitized workers in the third quartile of LTW average exposures, all were diagnosed with CBD (7.8 percent). The prevalence of CBD among workers in these quartiles was approximately 5-8 percent, and overall sensitization (including workers with and without CBD) was about 8 percent. OSHA considers these rates as evidence that the risk of developing CBD is significant among workers exposed at and below the current PEL, even down to the proposed PEL. Much lower prevalences of sensitization and CBD were found among workers with exposure levels less than or equal to about 0.08 mug/m\3\. Two sensitized workers (2.2 percent), including 1 case of CBD (1.0 percent), were found among workers with LTW average exposure levels and HEJ exposure levels less than or equal to 0.08 mug/m\3\ and 0.086 mug/m\3\, respectively. Strict control of airborne exposure to levels below 0.1 mug/m\3\ can, therefore, significantly reduce risk of sensitization and CBD. Although OSHA recognizes that maintaining exposure levels below 0.1 mug/m\3\ may not be feasible in some operations (see this preamble at section IX, Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis), the Agency believes that workers in facilities that meet the proposed action level of 0.1 mug/m\3\ will be at less risk of sensitization and CBD than workers in facilities that cannot meet the action level.

    Table 3 below presents the prevalence of sensitization and CBD cases across cumulative exposure quartiles, based on the same Cullman data used to derive Tables 1 and 2. Cumulative exposure is the sum of a worker's exposure across the duration of his employment.

    Page 47658

    Table 3--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile Cullman, AL Machining Facility

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

    Sensitized

    Cumulative exposure (mug/m\3\ yrs) Group size only CBD Total Total % CBD %

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

    0.0-0.147............................................... 81 2 2 4 4.9 2.5

    0.148-1.467............................................. 79 0 2 2 2.5 2.5

    1.468-7.008............................................. 79 3 8 11 13.9 8.0

    7.009-61.86............................................. 80 2 7 9 11.3 8.8

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

    Total............................................... 319 7 19 26 8.2 6.0

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

    Source: Section VI, Preliminary Risk Assessment.

    A 45-year working lifetime of occupational exposure at the current PEL would result in 90 mug/m \3\-years, a value far higher than the cumulative exposures of workers in this data set, who worked for periods of time less than 45 years and whose exposure levels were mostly well below the PEL. Workers with 45 years of exposure to the proposed PEL would have a cumulative exposure (9 mug/m \3\-years) in the highest quartile for this worker population. As with the average and HEJ exposures, the greatest risk of sensitization and CBD appears at high exposure levels (> 1.468 mug/m \3\-years). The third cumulative quartile, at which a sharp increase in sensitization and CBD appears, is bounded by 1.468 and 7.008 mug/m \3\-years. This is equivalent to 0.73-3.50 years of exposure at the current PEL of 2 mug/m \3\, or 7.34-35.04 years of exposure at the proposed PEL of 0.2 mug/m \3\. Prevalence of both sensitization and CBD is substantially lower in the second cumulative quartile (0.148-1.467 mug/m \3\-

    years). This is equivalent to approximately 0.7 to 7 years at the proposed PEL of 0.2 mug/m \3\, or 1.5 to 15 years at the proposed action level of 0.1 mug/m \3\. This supports that maintaining exposure levels below the proposed PEL, where feasible, will help to protect long-term workers against risk of beryllium sensitization and early stage CBD.

    As discussed in the Health Effects section (V.D), CBD often worsens with increased time and level of exposure. In a longitudinal study, workers initially identified as beryllium sensitized through workplace surveillance developed early stage CBD defined by granulomatous inflammation but no apparent physiological abnormalities (Newman et al., 2005). A study of workers with this early stage CBD showed significant declines in breathing capacity and gas exchange over the 30 years from first exposure (Mroz et al., 2009). Many of the workers went on to develop more severe disease that required immunosuppressive therapy despite being removed from exposure. While precise beryllium exposure levels were not available on the individuals in these studies, most started work in the 1980s and 1990s and were likely exposed to average levels below the current 2 mug/m \3\ PEL. The evidence for time-dependent disease progression indicates that the CBD risk estimates for a 45-year lifetime exposure at the current PEL will include a higher proportion of individuals with advanced clinical CBD than found among the workers in the NJMRC data set.

    Studies of community-acquired (CA) CBD support the occurrence of advanced clinical CBD from long-term exposure to airborne beryllium (Eisenbud, 1998; Maier et al., 2008). A discussion of the study findings can be found in this preamble at section VI.C, Preliminary Risk Assessment. For example, one study evaluated 16 potential cases of CA-CBD in individuals that resided near a beryllium production facility in the years between 1943 and 2001 (Maier et al., 2008). Five cases of definite CBD and three cases of probable CBD were found. Two of the subjects with probable cases died before they could be confirmed with the BeLPT; the third had an abnormal BeLPT and radiography consistent with CBD, but granulomatous disease was not pathologically proven. The individuals with CA-CBD identified in this study suffered significant health impacts from the disease, including obstructive, restrictive, and gas exchange pulmonary defects. Six of the eight cases required treatment with prednisone, a step typically reserved for severe cases due to the adverse side effects of steroid treatment. Despite treatment, three had died of respiratory impairment as of 2002. There was insufficient information to estimate exposure to the individuals, but the limited amount of ambient air sampling in the 1950s suggested that average beryllium levels in the area where the cases resided were below 2 mug/m \3\. The authors concluded that ``low levels of exposures with significant disease latency can result in significant morbidity and mortality'' (Maier et al., 2008, p. 1017).

    OSHA believes that the literature review, prevalence analysis, and the evidence for time-dependent progression of CBD described above provide sufficient information to draw preliminary conclusions about significance of risk, and that further quantitative analysis of the NJMRC data set is not necessary to support the proposed rule. The studies OSHA used to support its preliminary conclusions regarding risk of beryllium sensitization and CBD were conducted at modern industrial facilities with exposure levels in the range of interest for this rulemaking, so a model is not needed to extrapolate risk estimates from high to low exposures, as has often been the case in previous rules. Nevertheless, the Agency felt further quantitative analysis might provide additional insight into the exposure-response relationship for sensitization and CBD.

    Using the NJMRC data set, Dr. Stone ran a complementary log-log proportional hazards model, an extension of logistic regression that allows for time-dependent exposures and differential time at risk. Relative risk of sensitization increased with cumulative exposure (p = 0.05). A positive, but not statistically significant association was observed with LTW average exposure (p = 0.09). There was little association with highest-exposed job (HEJ) exposure (p = 0.3). Similarly, the proportional hazards models for the CBD endpoint showed positive relationships with cumulative exposure (p = 0.09), but LTW average exposure and HEJ exposure were not closely related to relative risk of CBD (p-values > 0.5). Dr. Stone used the cumulative exposure models to generate risk estimates for sensitization and CBD.

    Tables 4 and 5 below present risk estimates from these models, assuming 5, 10, 20, and 45 years of beryllium exposure. The tables present sensitization and CBD risk estimates based on year-specific intercepts, as

    Page 47659

    explained in the section on Risk Assessment and the accompanying background document. Each estimate represents the number of sensitized workers the model predicts in a group of 1000 workers at risk during the given year with an exposure history at the specified level and duration. For example, in the exposure scenario for 1995, if 1000 workers were occupationally exposed to 2 mug/m \3\ for 10 years, the model predicts that about 56 (55.7) workers would be identified as sensitized. The model for CBD predicts that about 42 (41.9) workers would be diagnosed with CBD that year. The year 1995 shows the highest risk estimates generated by the model for both sensitization and CBD, while 1999 and 2002 show the lowest risk estimates generated by the model for sensitization and CBD, respectively. The corresponding 95 percent confidence intervals are based on the uncertainty in the exposure coefficient.

    Table 4a--Predicted Cases of Sensitization per 1000 Workers Exposed at Current and Alternate PELs Based on Proportional Hazards Model, Cumulative

    Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 1995 Baseline.

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

    1995 Exposure duration

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

    5 years 10 years 20 years 45 years

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

    Exposure level (mug/m\3\) Cumulative

    (mug/m\3\- cases/1000 mug/m\3\- cases/1000 mug/m\3\- cases/1000 mug/m\3\- cases/1000

    yrs) yrs yrs yrs

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

    2.0............................................. 10.0 41.1 20.0 55.7 40.0 101.0 90.0 394.4

    30.3-56.2 30.3-102.9 30.3-318.1 30.3-999.9

    1.0............................................. 5.0 35.3 10.0 41.1 20.0 55.7 45.0 116.9

    30.3-41.3 30.3-56.2 30.3-102.9 30.3-408.2

    0.5............................................. 2.5 32.7 5.0 35.3 10.0 41.1 22.5 60.0

    30.3-35.4 30.3-41.3 30.3-56.2 30.3-119.4

    0.2............................................. 1.0 31.3 2.0 32.2 4.0 34.3 9.0 39.9

    30.3-32.3 30.3-34.3 30.3-38.9 30.3-52.9

    0.1............................................. 0.5 30.8 1.0 31.3 2.0 32.2 4.5 34.8

    30.3-31.3 30.3-32.3 30.3-34.3 30.3-40.1

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

    Source: Section VI, Preliminary Risk Assessment.

    Table 4b--Predicted Cases of Sensitization per 1000 Workers Exposed at Current and Alternate PELs Based on Proportional Hazards Model, Cumulative

    Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 1999 Baseline.

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

    1999 Exposure duration

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

    5 years 10 years 20 years 45 years

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

    Exposure level (mug/m\3\) Cumulative

    (mug/m\3\- cases/1000 mug/m\3\- cases/1000 mug/m\3\- cases/1000 mug/m\3\- cases/1000

    yrs) yrs yrs yrs

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

    2.0............................................. 10.0 8.4 20.0 11.5 40.0 21.3 90.0 96.3

    6.2-11.6 6.2-21.7 6.2-74.4 6.2-835.4

    1.0............................................. 5.0 7.2 10.0 8.4 20.0 11.5 45.0 24.8

    6.2-8.5 6.2-11.6 6.2-21.7 6.2-100.5

    0.5............................................. 2.5 6.7 5.0 7.2 10.0 8.4 22.5 12.4

    6.2-7.3 6.2-8.5 6.2-11.6 6.2-25.3

    0.2............................................. 1.0 6.4 2.0 6.6 4.0 7.0 9.0 8.2

    6.2-6.6 6.2-7.0 6.2-8.0 6.2-10.9

    0.1............................................. 0.5 6.3 1.0 6.4 2.0 6.6 4.5 7.1

    6.2-6.4 6.2-6.6 6.2-7.0 6.2-8.2

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

    Source: Section VI, Preliminary Risk Assessment.

    Table 5a--Predicted Number of Cases of CBD per 1000 Workers Exposed at Current and Alternative PELs Based on Proportional Hazards Model, Cumulative

    Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 1995 Baseline.

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

    1995 Exposure duration

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

    5 years 10 years 20 years 45 years

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

    Exposure level (mug/m\3\) Cumulative Estimated Estimated Estimated Estimated

    (mug/m\3\- cases/1000 mug/m\3\- cases/1000 mug/m\3\- cases/1000 mug/m\3\- cases/1000

    yrs) (95% c.i.) yrs (95% c.i.) yrs (95% c.i.) yrs (95% c.i.)

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

    2.0............................................. 10.0 30.9 20.0 41.9 40.0 76.6 90.0 312.9

    22.8-44.0 22.8-84.3 22.8-285.5 22.8-999.9

    1.0............................................. 5.0 26.6 10.0 30.9 20.0 41.9 45.0 88.8

    22.8-31.7 22.8-44.0 22.8-84.3 22.8-375.0

    Page 47660

    0.5............................................. 2.5 24.6 5.0 26.6 10.0 30.9 22.5 45.2

    22.8-26.9 22.8-31.7 22.8-44.0 22.8-98.9

    0.2............................................. 1.0 23.5 2.0 24.2 4.0 25.8 9.0 30.0

    22.8-24.3 22.8-26.0 22.8-29.7 22.8-41.3

    0.1............................................. 0.5 23.1 1.0 23.5 2.0 24.2 4.5 26.2

    22.8-23.6 22.8-24.3 22.8-26.0 22.8-30.7

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

    Source: Section VI, Preliminary Risk Assessment.

    Table 5b--Predicted Number of Cases of CBD per 1000 Workers Exposed at Current and Alternative PELs Based on Proportional Hazards Model, Cumulative

    Exposure Metric, With Corresponding Interval Based on the Uncertainty in the Exposure Coefficient. 2002 Baseline.

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

    2002 Exposure duration

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

    5 years 10 years 20 years 45 years

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

    Exposure level (mug/m\3\) Cumulative Estimated Estimated Estimated Estimated

    (mug/m\3\- cases/1000 mug/m\3\- cases/1000 mug/m\3\- cases/1000 mug/m\3\- cases/1000

    yrs) (95% c.i.) yrs (95% c.i.) yrs (95% c.i.) yrs (95% c.i.)

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

    2.0............................................. 10.0 3.7 20.0 5.1 40.0 9.4 90.0 43.6

    2.7-5.3 2.7-10.4 2.7-39.2 2.7-679.8

    1.0............................................. 5.0 3.2 10.0 3.7 20.0 5.1 45.0 11.0

    2.7-3.8 2.7-5.3 2.7-10.4 2.7-54.3

    0.5............................................. 2.5 3.0 5.0 3.2 10.0 3.7 22.5 5.5

    2.7-3.2 2.7-3.8 2.7-5.3 2.7-12.3

    0.2............................................. 1.0 2.8 2.0 2.9 4.0 3.1 9.0 3.6

    2.7-2.9 2.7-3.1 2.7-3.6 2.7-5.0

    0.1............................................. 0.5 2.8 1.0 2.8 2.0 2.9 4.5 3.1

    2.7-2.8 2.7-2.9 2.7-3.1 2.7-3.7

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

    Source: Section VI, Preliminary Risk Assessment.

    As shown in Tables 4 and 5, the exposure-response models Dr. Stone developed based on the Cullman data set predict a high risk of both sensitization (about 96-394 cases per 1000 exposed workers) and CBD (about 44-313 cases per 1000) at the current PEL of 2 mug/m\3\ for an exposure duration of 45 years (90 mug/m\3\-yr). For a 45-year exposure at the proposed PEL of 0.2 mug/m\3\, risk estimates for sensitization (about 8-40 cases per 1000 exposed workers) and CBD (about 4-30 per 1000 exposed workers) are substantially reduced. Thus, the model predicts that the risk of sensitization and CBD at a PEL of 0.2 mug/m\3\ will be about 10 percent of the risk at the current PEL of 2 mug/m\3\.

    OSHA does not believe the risk estimates generated by these exposure-response models to be highly accurate. Limitations of the analysis include the size of the dataset, relatively sparse exposure data from the plant's early years, study size-related constraints on the statistical analysis of the dataset, and limited follow-up time on many workers. The Cullman study population is a relatively small group and can support only limited statistical analysis. For example, its size precludes inclusion of multiple covariates in the exposure-

    response models or a two-stage exposure-response analysis to model both sensitization and the subsequent development of CBD within the subpopulation of sensitized workers. The limited size of the Cullman dataset is characteristic of studies on beryllium-exposed workers in modern, low-exposure environments, which are typically small-scale processing plants (up to several hundred workers, up to 20-30 cases).

    Despite these issues with the statistical analysis, OSHA believes its main policy determinations are well supported by the best available evidence, including the literature review and careful examination of the prevalence of sensitization and CBD among workers with exposure levels comparable to the current and proposed PELs in the NJMRC data set. The previously described literature analysis and prevalence analysis demonstrate that workers with occupational exposure to airborne beryllium at the current PEL face a risk of becoming sensitized to beryllium and progressing to both early and advanced stages of CBD that far exceeds the value of 1 in 1000 used by OSHA as a benchmark of clearly significant risk. Furthermore, OSHA's preliminary risk assessment indicates that risk of beryllium sensitization and CBD can be significantly reduced by reduction of airborne exposure levels, along with respiratory and dermal protection measures, as demonstrated in facilities such as the Tucson ceramics plant, the Elmore beryllium production facility, and the Reading copper beryllium facility described in the literature review.

    Page 47661

    OSHA's preliminary risk assessment also indicates that despite the reduction in risk expected with the proposed PEL, the risk to workers with average exposure levels of 0.2 mug/m\3\ is still clearly significant (see this preamble at section VI). In the prevalence analysis, workers with LTW average or HEJ exposures close to 0.2 mug/

    m\3\ experienced high levels of sensitization and CBD. This finding is corroborated by the literature analysis, which showed that workers exposed to mean plant-wide airborne exposures between 0.1 and 0.5 mug/m\3\ had a similarly high prevalence of sensitization and CBD. Given the significant risk at these levels of exposure, the Agency believes that the proposed action level of 0.1 mug/m\3\, dermal protection requirements, and other ancillary provisions of the proposed rule are key to reducing the risk of beryllium sensitization and CBD among exposed workers. OSHA preliminarily concludes that the proposed standard, including the PEL of 0.2 mug/m\3\, the action level of 0.1 mug/m\3\, and provisions to limit dermal exposure to beryllium, together will significantly reduce workers' risk of beryllium sensitization and CBD from occupational beryllium exposure.

    2. Risk of Lung Cancer

    OSHA's review of epidemiological studies of lung cancer mortality among beryllium workers found that most did not characterize exposure levels sufficiently to characterize risk of lung cancer at the current and proposed PELs. However, as discussed in this preamble at section V, Health Effects and section VI, Preliminary Risk Assessment, NIOSH recently published a quantitative risk assessment based on beryllium exposure and lung cancer mortality among 5436 male workers employed at beryllium processing plants in Reading, PA; Elmore, OH; and Hazleton, PA, prior to 1970 (Schubauer-Berigan et al., 2010b). This new risk assessment addresses important sources of uncertainty for previous lung cancer analyses, including the sole prior exposure-response analysis for beryllium and lung cancer, conducted by Sanderson et al. (2001) on workers from the Reading plant alone. Workers from the Elmore and Hazleton plants who were added to the analysis by Schubauer-Berigan et al. were, in general, exposed to lower levels of beryllium than those at the Reading plant. The median worker from Hazleton had a mean exposure across his tenure of less than 2 mug/m\3\, while the median worker from Elmore had a mean exposure of less than 1 mug/m\3\. The Elmore and Hazleton worker populations also had fewer short-term workers than the Reading population. Finally, the updated cohorts followed the worker populations through 2005, increasing the length of follow-up time compared to the previous exposure-response analysis. For these reasons, OSHA based its preliminary risk assessment for lung cancer on the Schubauer-Berigan risk analysis.

    Schubauer-Berigan et al. (2011) analyzed the data set using a variety of exposure-response modeling approaches, described in this preamble at section VI, Preliminary Risk Assessment. The authors found that lung cancer mortality risk was strongly and significantly related to mean, cumulative, and maximum measures of workers' exposure to beryllium (all models reported in Schubauer-Berigan et al., 2011). They selected the best-fitting models to generate risk estimates for male workers with a mean exposure of 0.5 mug/m\3\ (the current NIOSH Recommended Exposure Limit for beryllium). In addition, they estimated the mean exposure that would be associated with an excess lung cancer mortality risk of one in one thousand. At OSHA's request, the authors also estimated excess risks for workers with mean exposures at each of the other alternate PELs under consideration: 1 mug/m\3\, 0.2 mug/

    m\3\, and 0.1 mug/m\3\. Table 6 presents the estimated excess risk of lung cancer mortality associated with various levels of beryllium exposure allowed under the current rule, based on the final models presented in Schubauer-Berigan et al's risk assessment.

    Table 6--Excess Risk of Lung Cancer Mortality per 1000 Male Workers at Alternate PELs (NIOSH Models)

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

    Mean exposure

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

    Exposure-response model 0.1 microg/ 0.2 microg/ 0.5 microg/ 1 microg/ 2 microg/

    m\3\ m\3\ m\3\ m\3\ m\3\

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

    Best monotonic PWL--all workers. 7.3 15 45 120 200

    Best monotonic PWL--excluding 3.1 6.4 17 39 61

    professional and asbestos

    workers........................

    Best categorical--all workers... 4.4 9 25 59 170

    Best categorical--excluding 1.4 2.7 7.1 15 33

    professional and asbestos

    workers........................

    Power model--all workers........ 12 19 30 40 52

    Power model--excluding 19 30 49 68 90

    professional and asbestos

    workers........................

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

    Source: Section VI, Preliminary Risk Assessment.

    The lowest estimate of excess lung cancer deaths from the six final models presented by Schubauer-Berigan et al. is 33 per 1000 workers exposed at a mean level of 2 mug/m\3\, the current PEL. Risk estimates as high as 200 lung cancer deaths per 1000 result from the other five models presented. Regardless of the model chosen, the excess risk of about 33 to 200 per 1000 workers is clearly significant, falling well above the level of risk the Supreme Court indicated a reasonable person might consider acceptable (See Benzene, 448 U.S. at 655). The proposed PEL of 0.2 mug/m\3\ is expected to reduce these risks significantly, to somewhere between 2.7-30 excess lung cancer deaths per 1000 workers. These risk estimates still fall above the threshold of 1 in 1000 that OSHA considers clearly significant. However, the Agency believes the lung cancer risks should be regarded with a greater degree of uncertainty than the risk estimates for CBD discussed previously. While the risk estimates for CBD at the proposed PEL were determined from exposure levels observed in occupational studies, the lung cancer risks are extrapolated from much higher exposure levels.

    C. Conclusions

    As discussed above, OSHA used the best available scientific evidence to identify adverse health effects of

    Page 47662

    occupational beryllium exposure, and to evaluate exposed workers' risk of these impairments. The Agency reviewed extensive epidemiological and experimental research pertaining to adverse health effects of occupational beryllium exposure, including lung cancer, immunological sensitization to beryllium, and CBD, and has evaluated the risk of these effects from exposures allowed under the current and proposed standards. The Agency has, additionally, reviewed previous policy determinations and case law regarding material impairment of health, and has preliminarily determined that CBD, in all stages, and lung cancer constitute material health impairments. Furthermore, OSHA has preliminarily determined that long-term exposure to beryllium at the current PEL would pose a risk of CBD and lung cancer greater than the risk of 1 per 1000 exposed workers the Agency considers clearly significant. OSHA's risk assessment for beryllium indicates that adoption of the new PEL, action level, and dermal protection provisions of the proposed rule will significantly reduce this risk. OSHA therefore believes it has met the statutory requirements pertaining to significance of risk, consistent with the OSH Act, Supreme Court precedent, and the Agency's previous policy decisions.

  27. Summary of the Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis

    A. Introduction and Summary

    OSHA's Preliminary Economic Analysis and Initial Regulatory Flexibility Analysis (PEA) addresses issues related to the costs, benefits, technological and economic feasibility, and the economic impacts (including impacts on small entities) of this proposed respirable beryllium rule and evaluates regulatory alternatives to the proposed rule. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, and public health and safety effects; distributive impacts; and equity), unless a statute requires another regulatory approach. Executive Order 13563 emphasized the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. The full PEA has been placed in OSHA rulemaking docket OSHA-H005C-2006-

    0870. This rule is an economically significant regulatory action under Sec. 3(f)(1) of Executive Order 12866 and has been reviewed by the Office of Information and Regulatory Affairs in the Office of Management and Budget, as required by executive order.

    The purpose of the PEA is to:

    Identify the establishments and industries potentially affected by the proposed rule;

    Estimate current exposures and the technologically feasible methods of controlling these exposures;

    Estimate the benefits resulting from employers coming into compliance with the proposed rule in terms of reductions in cases of lung cancer and chronic beryllium disease;

    Evaluate the costs and economic impacts that establishments in the regulated community will incur to achieve compliance with the proposed rule;

    Assess the economic feasibility of the proposed rule for affected industries; and

    Assess the impact of the proposed rule on small entities through an Initial Regulatory Flexibility Analysis (IRFA), to include an evaluation of significant regulatory alternatives to the proposed rule that OSHA has considered.

    The PEA contains the following chapters:

    Chapter I. Introduction

    Chapter II. Assessing the Need for Regulation

    Chapter III. Profile of Affected Industries

    Chapter IV. Technological Feasibility

    Chapter V. Costs of Compliance

    Chapter VI. Economic Feasibility Analysis and Regulatory Flexibility Determination

    Chapter VII. Benefits and Net Benefits

    Chapter VIII. Regulatory Alternatives

    Chapter IX. Initial Regulatory Flexibility Analysis

    The PEA includes all of the economic analyses OSHA is required to perform, including the findings of technological and economic feasibility and their supporting materials required by the OSH Act as interpreted by the courts (in Chapters III, IV, V, and VI); those required by EO 12866 and EO 13563 (primarily in Chapters III, V, and VII, though these depend on material in other chapters); and those required by the Regulatory Flexibility Act (in Chapters VI, VIII, and IX, though these depend, in part, on materials presented in other chapters).

    Key findings of these chapters are summarized below and in sections IX.B through IX.I of this PEA summary.

    Profile of Affected Industries

    This proposed rule would affect employers and employees in many different industries across the economy. As described in Section IX.C and reported in Table IX-2 of this preamble, OSHA estimates that a total of 35,051 employees in 4,088 establishments are potentially at risk from exposure to beryllium.

    Technological Feasibility

    As described in more detail in Section IX.D of this preamble and in Chapter IV of the PEA, OSHA assessed, for all affected sectors, the current exposures and the technological feasibility of the proposed PEL of 0.2 mug/m\3\.

    Tables IX-5 in section IX.D of this preamble summarizes all nine application groups (industry sectors and production processes) studied in the technological feasibility analysis. The technological feasibility analysis includes information on current exposures, descriptions of engineering controls and other measures to reduce exposures, and a preliminary assessment of the technological feasibility of compliance with the proposed PELs.

    The preliminary technological feasibility analysis shows that for the majority of the job groups evaluated, exposures are either already at or below the proposed PEL, or can be adequately controlled with additional engineering and work practice controls. Therefore, OSHA preliminarily concludes that the proposed PEL of 0.2 mug/m\3\ is technologically feasible for most operations most of the time.

    Based on the currently available evidence, it is more difficult to determine whether an alternative PEL of 0.1 mug/m\3\ would also be feasible in most operations. For some application groups, a PEL of 0.1 mug/m\3\ would almost certainly be feasible. In other application groups, a PEL of 0.1 mug/m\3\ appears feasible, except for establishments working with high beryllium content alloys. For application groups with the highest exposure, the exposure monitoring data necessary to more fully evaluate the effectiveness of exposure controls adopted after 2000 are not currently available to OSHA, which makes it difficult to determine the feasibility of achieving exposure levels at or below 0.1 mug/m\3\.

    OSHA also evaluated the feasibility of a STEL of 2.0 mug/m\3\. The majority of the available short-term measurements are below 2.0 mug/m\3\; therefore OSHA preliminarily concludes that the proposed STEL of 2.0 mug/m\3\ can be achieved for most operations most of the time. OSHA recognizes that for a small number of tasks, short-term exposures may exceed the proposed STEL, even after feasible control measures to reduce TWA exposure to below the proposed PEL have been implemented, and therefore assumes that the use of

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    respiratory protection will continue to be required for some short-term tasks. It is more difficult based on the currently available evidence to determine whether the alternative STEL of 1.0 mug/m\3\ would also be feasible in most operations based on lack of detail in the activities of the workers presented in the data. OSHA expects additional use of respiratory protection would be required for tasks in which peak exposures can be reduced to less than 2.0 mug/m\3\ but not less than 1.0 mug/m\3\. Due to limitations in the available sampling data and the higher detection limits for short term measurements, OSHA could not determine the percentage of the STEL measurements that are less than or equal to 0.5 mug/m\3\.

    Costs of Compliance

    As described in more detail in Section IX.E and reported, by application group and NAICS code, in Table IX-7 of this preamble, the total annualized cost of compliance with the proposed standard is estimated to be about $37.6 million. The major cost elements associated with the revisions to the standard are housekeeping ($12.6 million), engineering controls ($9.5 million), training ($5.8 million), and medical surveillance ($2.9 million).

    The compliance costs are expressed as annualized costs in order to evaluate economic impacts against annual revenue and annual profits, to be able to compare the economic impact of the rulemaking with other OSHA regulatory actions, and to be able to add and track Federal regulatory compliance costs and economic impacts in a consistent manner. Annualized costs also represent a better measure for assessing the longer-term potential impacts of the rulemaking. The annualized costs were calculated by annualizing the one-time costs over a period of 10 years and applying a discount rate of 3 percent (and an alternative discount rate of 7 percent).

    The estimated costs for the proposed beryllium standard represent the additional costs necessary for employers to achieve full compliance. They do not include costs associated with current compliance that has already been achieved with regard to the new requirements or costs necessary to achieve compliance with existing beryllium requirements, to the extent that some employers may currently not be fully complying with applicable regulatory requirements.

    Economic Impacts

    To assess the nature and magnitude of the economic impacts associated with compliance with the proposed rule, OSHA developed quantitative estimates of the potential economic impact of the new requirements on entities in each of the affected industry sectors. The estimated compliance costs were compared with industry revenues and profits to provide an assessment of the economic feasibility of complying with the revised standard and an evaluation of the potential economic impacts.

    As described in greater detail in Section IX.F of this preamble and in Chapter VI of the PEA, the costs of compliance with the proposed rulemaking are not large in relation to the corresponding annual financial flows associated with each of the affected industry sectors. The estimated annualized costs of compliance represent about 0.11 percent of annual revenues and about 1.52 percent of annual profits, on average, across all affected firms. Compliance costs do not represent more than 1 percent of revenues or more than 16.25 percent of profits in any affected industry.

    Based on its analysis of the relative inelasticity of demand for beryllium-containing inputs and products and of possible international trade effects, OSHA concluded that most or all costs arising from this proposed beryllium rule would be passed on in higher prices rather than absorbed in lost profits and that any price increases would result in minimal loss of business to foreign competition.

    Given the minimal potential impact on prices or profits in the affected industries, OSHA has preliminarily concluded that compliance with the requirements of the proposed rulemaking would be economically feasible in every affected industry sector.

    Benefits, Net Benefits, and Cost-Effectiveness

    As described in more detail in Section VIII.G of this preamble, OSHA estimated the benefits, net benefits, and incremental benefits of the proposed beryllium rule. That section also contains a sensitivity analysis to show how robust the estimates of net benefits are to changes in various cost and benefit parameters. A full explanation of the derivation of the estimates presented there is provided in Chapter VII of the PEA for the proposed rule.

    OSHA estimated the benefits associated with the proposed beryllium PEL of 0.2 mug/m\3\ and, for analytical purposes to comply with OMB Circular A-4, with alternative beryllium PELs of .1 mug/m\3\ and .5 mug/m\3\ by applying the dose-response relationship developed in the Agency's preliminary risk assessment--summarized in Section VI of this preamble--to current exposure levels. OSHA determined current exposure levels by first developing an exposure profile for industries with workers exposed to beryllium, using OSHA inspection and site-visit data, and then applying this exposure profile to the total current worker population. The industry-by-industry exposure profile is summarized in Table IX-3 in Section IX.C of this preamble.

    By applying the dose-response relationship to estimates of current exposure levels across industries, it is possible to project the number of cases of the following diseases expected to occur in the worker population given current exposure levels (the ``baseline''):

    fatal cases of lung cancer,

    fatal cases of chronic beryllium disease (CBD), and

    morbidity related to chronic beryllium disease.

    Table IX-1 provides a summary of OSHA's best estimate of the costs and benefits of the proposed rule. As shown, the proposed rule, once it is fully effective, is estimated to prevent 96 fatalities and 50 non-

    fatal beryllium-related illnesses annually, and the monetized annualized benefits of the proposed rule are estimated to be $575.8 million using a 3-percent discount rate and $255.3 million using a 7-

    percent discount rate. Also as shown in Table IX-1, the estimated annualized cost of the rule is $37.6 million using a 3-percent discount rate and $39.1 million using a 7-percent discount rate. The proposed rule is estimated to generate net benefits of $538.2 million annually using a 3-percent discount rate and $216.2 million annually using a 7-

    percent discount rate. The estimated costs and benefits of the proposed rule, disaggregated by industry sector, were previously presented in Table I-1 in this preamble.

    Table IX-1--Annualized Costs, Benefits and Net Benefits of OSHA's Proposed Beryllium Standard of 0.2 mug/m\3\

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

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

    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

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

    Source: OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis.

    Initial Regulatory Flexibility Analysis

    OSHA has prepared an Initial Regulatory Flexibility Analysis (IRFA) in accordance with the requirements of the Regulatory Flexibility Act, as amended in 1996. Among the contents of the IRFA are an analysis of the potential impact of the proposed rule on small entities and a description and discussion of significant alternatives to the proposed rule that OSHA has considered. The IRFA is presented in its entirety both in Chapter IX of the PEA and in Section IX.I of this preamble.

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

    B. The Need for Regulation

    C. Profile of Affected Industry

    D. Technological Feasibility Analysis

    E. Costs of Compliance

    F. Economic Feasibility Analysis and Regulatory Flexibility Determination

    G. Benefits and Net Benefits

    H. Regulatory Alternatives

  28. Initial Regulatory Flexibility Analysis.

    B. Need for Regulation

    Employees in work environments addressed by the proposed beryllium rule are exposed to a variety of significant hazards that can and do cause serious injury and death. As described in Chapter II of the PEA in support of the proposed rule, the risks to employees are excessively large due to the existence of various types of market failure, and existing and alternative methods of overcoming these negative consequences--such as workers' compensation systems, tort liability options, and information dissemination programs--have been shown to provide insufficient worker protection.

    After carefully weighing the various potential advantages and disadvantages of using a regulatory approach to improve upon the current situation, OSHA preliminarily concludes that, in the case of beryllium exposure, the proposed mandatory standards represent the best choice for reducing the risks to employees. In addition, rulemaking is necessary in this case in order to replace older existing standards with updated, clear, and consistent health standards.

    C. Profile of Affected Industries

    1. Introduction

    Chapter III of the PEA presents a profile of industries that use beryllium, beryllium oxide, and/or beryllium alloys. The discussion below summarizes the findings in that chapter. For each industry sector identified, the Agency describes the uses of beryllium and estimates the number of establishments and employees that may be affected by this proposed rulemaking. Employee exposure to beryllium can also occur as a result of certain processes such as welding that are found in many industries. OSHA uses the umbrella term ``application group'' to refer either to an industrial sector or a cross-industry group with a common process. These groups are all mutually exclusive and are analyzed in separate sections in Chapter III of the PEA. These sections briefly describe each application group and then explain how OSHA estimated the number of establishments working with beryllium and the number of employees exposed to beryllium. Beryllium is rarely used by all establishments in any particular application group because its unique properties and relatively high cost typically result in only very specific and limited usage within a portion of a group.

    The information in Chapter III of the PEA is based on reports prepared under task order by Eastern Research Group (ERG), an OSHA contractor; information collected during OSHA's Small Business Advocacy Review Panel (OSHA 2008b); and Agency research and analysis. Technological feasibility reports (summarized in Chapter IV of the PEA) for each beryllium-using application group provide a detailed presentation of processes and occupations with beryllium exposure, including available sampling exposure measurements and estimates of how many employees are affected in each specific occupation.

    OSHA has identified nine application groups that would be potentially affected by the proposed beryllium standard:

    1. Beryllium Production

    2. Beryllium Oxide Ceramics and Composites

    3. Nonferrous Foundries

    4. Secondary Smelting, Refining, and Alloying

    5. Precision Turned Products

    6. Copper Rolling, Drawing, and Extruding

    7. Fabrication of Beryllium Alloy Products

    8. Welding

    9. Dental Laboratories

    These application groups are broadly defined, and some include establishments in several North

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    American Industrial Classification System (NAICS) codes. For example, the Copper Rolling and Drawing, and Extruding application group is made up both of NAICS 331421 Copper Rolling, Drawing, and Extruding and NAICS 331422 Copper Wire Drawing. While an application group may contain numerous NAICS six-digit industry codes, in most cases only a fraction of the establishments in any individual six-digit NAICS industry use beryllium and would be affected by the proposed rule. For example, not all companies in the above application group work with copper that contains beryllium.

    One application group, welding, reflects industrial activities or processes that take place in various industry sectors. All of the industries in which a given activity or process may result in worker exposure to beryllium are identified in the sections on the application group. The section on each application group describes the production processes where occupational contact with beryllium can occur and contains estimates of the total number of firms, employees, affected establishments, and affected employees.

    Chapter III of the PEA presents formulas in the text, usually in parentheses, to help explain the derivation of estimates. Because the values used in the formulas shown in the text are sometimes rounded, while the actual spreadsheet formulas used to create final costs are not, the calculation using the presented formula will sometimes differ slightly from the total presented in the text--which is the actual total as shown in the tables.

    At the end of Chapter III in the PEA, OSHA discusses other industry sectors that have reportedly used beryllium in the past or for which there are anecdotal or informal reports of beryllium use. The Agency was unable to verify beryllium use in these sectors that would be affected by the proposed standard, and seeks further information in this rulemaking on these or other industries where there may be significant beryllium use and employee exposure.

    2. Summary of Affected Establishments and Employers

    As shown in Table IX-2, OSHA estimates that a total of 35,051 workers in 4,088 establishments will be affected by the proposed beryllium standard. Also shown are the estimated annual revenues for these entities.

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    3. Beryllium Exposure Profile of At-Risk Workers

    The technological feasibility analyses presented in Chapter IV of the PEA contain data and discussion of worker exposures to beryllium throughout industry. Exposure profiles, by job category, were developed from individual exposure measurements that were judged to be substantive and to contain sufficient accompanying description to allow interpretation of the circumstance of each measurement. The resulting exposure profiles show the job categories with current overexposures to beryllium and, thus, the workers for whom beryllium controls would be implemented under the proposed rule.

    Table IX-3 summarizes, from the exposure profiles, the number of workers at risk from beryllium exposure and the distribution of 8-hour TWA respirable beryllium exposures by affected job category and sector. Exposures are grouped into the following ranges: Less than 0.1 mug/

    m\3\; >= 0.1 mug/m\3\ and 0.2 mug/m\3\ and 0.5 mug/m\3\ and 1.0 mug/

    m\3\ and Section 3--Beryllium Production,

    Section 4--Beryllium Oxide Ceramics and Composites,

    Section 5--Nonferrous Foundries,

    Section 6--Secondary Smelting, Refining, and Alloying,

    Section 7--Precision Turned Products,

    Section 8--Copper Rolling, Drawing, and Extruding,

    Section 9--Fabrication of Beryllium Alloy Products,

    Section 10--Welding, and

    Section 11--Dental Laboratories.

    OSHA developed exposure profiles by job or group of jobs using exposure data at the application, operation or task level to the extent that such data were available. In those instances where there were insufficient exposure data to create a profile, OSHA used analogous operations to characterize the operations. The exposure profiles represent baseline conditions with existing controls for each operation with potential exposure. For job groups where exposures were above the proposed TWA PEL of 0.2 mug/m\3\, OSHA identified additional controls that could be implemented to reduce employee exposures to beryllium. These included engineering controls, such as process containment, local exhaust ventilation and wet methods for dust suppression, and work practices, such as improved housekeeping and the prohibition of compressed air for cleaning beryllium-contaminated surfaces.

    For the purposes of this technological feasibility assessment, these nine application groups can be divided into three general categories based on current exposure levels:

    (1) application groups in which current exposures for most jobs are already below the proposed PEL of 0.2 mug/m\3\;

    (2) application groups in which exposures for most jobs are below the current PEL, but exceed the proposed PEL of 0.2 mug/m\3\, and therefore additional controls would be required; and

    (3) application groups in which exposures in one or more jobs routinely exceed the current PEL, and therefore substantial reductions in exposure would be required to achieve the proposed PEL.

    The majority of exposure measurements taken in the application groups in the first category are already at or below the proposed PEL of 0.2 mug/m\3\, and most of the jobs with exposure to beryllium in these four application groups have median exposures below the alternative PEL of 0.1 mug/m\3\ (See Table IX-5). These four application groups include rolling, drawing, and extruding; fabrication of beryllium alloy products; welding; and dental laboratories.

    The two application groups in the second category include: precision turned products and secondary smelting. For these two groups, the median exposures in most jobs are below the current PEL, but the median exposure levels for some job groups currently exceed the proposed PEL. Additional exposure controls and work practices could be implemented that the Agency has preliminarily concluded would reduce exposures to or below the proposed PEL for most jobs most of the time. One exception is furnace operations in secondary smelting, in which the median exposure exceeds the current PEL. Furnace operations involve high temperatures that produce significant amounts of fumes and particulate that can be difficult to contain. Therefore, the proposed PEL may not be feasible for most furnace operations involved with secondary smelting, and in some cases, respiratory protection would be required to adequately protect furnace workers when exposures exceed 0.2 mug/m\3\ despite the implementation of all feasible controls.

    Exposures in the third category of application groups routinely exceed the current PEL for several jobs. The three application groups in this category include: Beryllium production, beryllium oxide ceramics production, and nonferrous foundries. The individual job groups for which exposures exceed the current PEL are discussed in the application group specific sections later in this summary, and described in greater detail in the PEA. For the jobs that routinely exceed the current PEL, OSHA identified additional exposure controls and work practices that the Agency preliminarily concludes would reduce exposures to or below the proposed PEL most of the time, with three exceptions: Furnace operations in primary beryllium production and nonferrous foundries, and shakeout operations at nonferrous foundries. For these jobs, OSHA recognizes that even after installation of feasible controls, respiratory protection may be needed to adequately protect workers.

    In conclusion, the preliminary technological feasibility analysis shows that for the majority of the job groups evaluated, exposures are either already at or below the proposed PEL, or can be adequately controlled with additional engineering and work practice controls. Therefore, OSHA preliminarily concludes that the proposed PEL of 0.2 mug/m\3\ is feasible for most operations most of the time. The preliminary feasibility determination for the proposed PEL is also supported by Materion Corporation, the sole primary beryllium production company in the U.S., and by the United Steelworkers, who jointly submitted a draft proposed standard that specified an exposure limit of 0.2 mug/m\3\ to OSHA (Materion and USW, 2012). The technological feasibility analysis conducted for each application group is briefly summarized below, and a more detailed discussion is presented in Sections 3 through 11 of Chapter IV of the PEA (OSHA, 2014).

    Based on the currently available evidence, it is more difficult to determine whether an alternative PEL of

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    0.1 mug/m\3\ would also be feasible in most operations. For some application groups, such as fabrication of beryllium alloy products, a PEL of 0.1 mug/m\3\ would almost certainly be feasible. In other application groups, such as precision turned products, a PEL of 0.1 mug/m\3\ appears feasible, except for establishments working with high beryllium content alloys. For application groups with the highest exposure, the exposure monitoring data necessary to more fully evaluate the effectiveness of exposure controls adopted after 2000 are not currently available to OSHA, which makes it difficult to determine the feasibility of achieving exposure levels at or below 0.1 mug/m\3\.

    OSHA also evaluated the feasibility of a STEL of 2.0 mug/m\3\, and alternative STELs of 0.5 and 1.0 mug/m\3\. An analysis of the available short-term exposure measurements indicates that elevated exposures can occur during short-term tasks such as those associated with the operation and maintenance of furnaces at primary beryllium production facilities, at nonferrous foundries, and at secondary smelting operations. Peak exposure can also occur during the transfer and handling of beryllium oxide powders. OSHA believes that in many cases, reducing short-term exposures will be necessary to reduce workers' TWA exposures to or below the proposed PEL. The majority of the available short-term measurements are below 2.0 mug/m\3\, therefore OSHA preliminarily concludes that the proposed STEL of 2.0 mug/m\3\ can be achieved for most operations most of the time. OSHA recognizes that for a small number of tasks, short-term exposures may exceed the proposed STEL, even after feasible control measures to reduce TWA exposure to below the proposed PEL have been implemented, and therefore assumes that the use of respiratory protection will continue to be required for some short-term tasks. It is more difficult based on the currently available evidence to determine whether the alternative STEL of 1.0 mug/m\3\ would also be feasible in most operations based on lack of detail in the activities of the workers presented in the data. OSHA expects additional use of respiratory protection would be required for tasks in which peak exposures can be reduced to less than 2.0 mug/m\3\ but not less than 1.0 mug/m\3\. Due to limitations in the available sampling data and the higher detection limits for short term measurements, OSHA could not determine the percentage of the STEL measurements that are less than or equal to 0.5 mug/m\3\. A detailed discussion of the STELs being considered by OSHA is presented in Section 12 of Chapter IV of the PEA (OSHA, 2014).

    OSHA requests available exposure monitoring data and comments regarding the effectiveness of currently implemented control measures and the feasibility of the PELs under consideration, particularly the proposed TWA PEL of 0.2 mug/m\3\, the alternative TWA PEL of 0.1 mug/m\3\, the proposed STEL of 2.0 mug/m\3\, and the alternative STEL of 1.0 mug/m\3\ to inform the Agency's final feasibility determinations.

    Application Group Summaries

    This section summarizes the technological feasibility analysis for each of the nine application groups affected by the proposed standard. Chapter IV of the PEA, Technological Feasibility Analysis, identifies specific jobs or job groups with potential exposure to beryllium, and presents exposure profiles for each of these job groups (OSHA, 2014). Control measures and work practices that OSHA believes can reduce exposures are described along with preliminary conclusions regarding the feasibility of the proposed PEL. Table IX-5, located at the end of this summary, presents summary statistics for the personal breathing zone samples taken to measure full-shift exposures to beryllium in each application group. For the five application groups in which the median exposure level for at least one job group exceeds the proposed PEL, the sampling results are presented by job group. Table IX-5 displays the number of measurements; the range, the mean and the median of the measurement results; and the percentage of measurements less than 0.1 mug/m\3\, less than or equal to the proposed PEL of 0.2 mug/m\3\, and less than or equal to the current PEL of 2.0 mug/m\3\. A more detailed discussion of exposure levels by job or job group for each application group is provided in Chapter IV of the PEA, sections 3 through 11, along with a description of the available exposure measurement data, existing controls, and additional controls that would be required to achieve the proposed PEL.

    Beryllium Production

    Only one primary beryllium production facility is currently in operation in the United States, a plant owned and operated by Materion Corporation,\15\ located in Elmore, Ohio. OSHA identified eight job groups at this facility in which workers are exposed to beryllium. These include: Chemical operations, powdering operations, production support, cold work, hot work, site support, furnace operations, and administrative work.

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

    \15\ Materion Corporation was previously named Brush Wellman. In 2011, subsequent to the collection of the information presented in this chapter, the name changed. ``Brush Wellman'' is used whenever the data being discussed pre-dated the name change.

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

    The Agency developed an exposure profile for each of these eight job groups to analyze the distribution of exposure levels associated with primary beryllium production. The job exposure profiles are based primarily on full-shift personal breathing zone (PBZ) (lapel-type) sample results from air monitoring conducted by Brush Wellman's primary production facility in 1999 (Brush Wellman, 2004). Starting in 2000, the company developed the Materion Worker Protection Program (MWPP), a multi-faceted beryllium exposure control program designed to reduce airborne exposures for the vast majority of workers to less than an internally established exposure limit of 0.2 mug/m\3\. According to information provided by Materion, a combination of engineering controls, work practices, and housekeeping were used together to reduce average exposure levels to below 0.2 mug/m\3\ for the majority of workers (Materion Information Meeting, 2012). Also, two operations with historically high exposures, the wet plant and pebble plants, were decommissioned in 2000, thereby reducing average exposure levels. Therefore, the samples taken prior to 2000 may overestimate current exposures.

    Additional exposure samples were taken by NIOSH at the Elmore facility from 2007 through 2008 (NIOSH, 2011). This dataset, which was made available to OSHA by Materion, contains fewer samples than the 1999 survey. OSHA did not incorporate these samples into the exposure profile due to the limited documentation associated with the sampling data. The lack of detailed information for individual samples has made it difficult for OSHA to correlate job classifications and identify the working conditions associated with the samples. Sampling data provided by Materion for 2007 and 2008 were not incorporated into the exposure profiles because the data lacked specific information on jobs and workplace conditions. In a meeting in May 2012 held between OSHA and Materion Corporation at the Elmore facility, the Agency was able to obtain some general information on the exposure control modifications that Materion Corporation made between 1999 and 2007, but has been unable to determine what specific

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    controls were in place at the time NIOSH conducted sampling (Materion Information Meeting, 2012).

    In five of the primary production job groups (i.e., hot work, cold work, production support, site support, and administrative work), the baseline exposure profile indicates that exposures are already lower than the proposed PEL of 0.2 mug/m\3\. Median exposure values for these job groups range from nondetectable to 0.08 mug/m\3\.

    For three of the job groups involved with primary beryllium production, (i.e., chemical operations, powdering, and furnace operations), the median exposure level exceeds the proposed PEL of 0.2 mug/m\3\. Median exposure values for these job groups are 0.47, 0.37, and 0.68 mug/m\3\ respectively, and only 17 percent to 29 percent of the available measurements are less than or equal to 0.2 mug/m\3\. Therefore, additional control measures for these job groups would be required to achieve compliance with the proposed PEL. OSHA has identified several engineering controls that the Agency preliminarily concludes can reduce exposures in chemical processes and powdering operations to less than or equal to 0.2 mug/m\3\. In chemical processes, these include fail-safe drum-handling systems, full enclosure of drum-handling systems, ventilated enclosures around existing drum positions, automated systems to prevent drum overflow, and automated systems for container cleaning and disposal such as those designed for hazardous powders in the pharmaceutical industry. Similar engineering controls would reduce exposures in powdering operations. In addition, installing remote viewing equipment (or other equally effective engineering controls) to eliminate the need for workers to enter the die-loading hood during die filling will reduce exposures associated with this powdering task and reduce powder spills. Based on the availability of control methods to reduce exposures for each of the major sources of exposure in chemical operations, OSHA preliminarily concludes that exposures at or below the proposed 0.2 mug/m\3\ PEL can be achieved in most chemical and powdering operations most of the time. OSHA believes furnace operators' exposures can be reduced using appropriate ventilation, including fume capture hoods, and other controls to reduce overall beryllium levels in foundries, but is not certain whether the exposures of furnace operators can be reduced to the proposed PEL with currently available technology. OSHA requests additional information on current exposure levels and the effectiveness of potential control measures for primary beryllium production operations to further refine this analysis.

    Beryllium Oxide Ceramics Production

    OSHA identified seven job groups involved with beryllium oxide ceramics production. These include: Material preparation operator, forming operator, machining operator, kiln operator, production support, metallization, and administrative work. Four of these jobs (material preparation, forming operator, machining operator and kiln operator) work directly with beryllium oxides, and therefore these jobs have a high potential for exposure. The other three job groups (production support work, metallization, and administrative work) have primarily indirect exposure that occurs only when workers in these jobs groups enter production areas and are exposed to the same sources to which the material preparation, forming, machining and kiln operators are directly exposed. However, some production support and metallization activities do require workers to handle beryllium directly, and workers performing these tasks may at times be directly exposed to beryllium.

    The Agency developed exposure profiles for these jobs based on air sampling data from four sources: (1) Samples taken between 1994 and 2003 at a large beryllium oxide ceramics facility, (2) air sampling data obtained during a site visit to a primary beryllium oxide ceramics producer, (3) a published report that provides information on beryllium oxide ceramics product manufacturing for a slightly earlier time period, and (4) exposure data from OSHA's Integrated Management Information System (OSHA, 2009). The exposure profile indicates that the three job groups with mostly indirect exposure (production support work, metallization, and administrative work) already achieve the proposed PEL of 0.2 mug/m\3\. Median exposure sample values for these job groups did not exceed 0.06 mug/m\3\.

    The four job groups with direct exposure had higher exposures. In forming operations and machining operations, the median exposure levels of 0.18 and 0.15 ug/m\3\, respectively, are below the proposed PEL, while the median exposure levels for material preparation and kiln operations of 0.41 mug/m\3\ and 0.25 mug/m\3\, respectively, exceed the proposed PEL.

    The profile for the directly exposed jobs may overestimate exposures due to the preponderance of data from the mid-1990s, a time period prior to the implementation of a variety of exposure control measures introduced after 2000. In forming operations, 44 percent of sample values in the exposure profile exceeded 0.2 ug/m\3\. However, the median exposure levels for some tasks, such as small-press and large-press operation, based on sampling conducted in 2003 were below 0.1 mug/m\3\. The exposure profile for kiln operation was based on three samples taken from a single facility in 1995, and are all above 0.2 ug/m\3\. Since then, exposures at the facility have declined due to changes in operations that reduced the amount of time kiln operators spend in the immediate vicinity of the kilns, as well as the discontinuation of a nearby high-exposure process. More recent information communicated to OSHA suggests that current exposures for kiln operators at the facility are currently below 0.1 ug/m\3\. Exposures in machining operations, most of which were already below 0.2 ug/m\3\ during the 1990s, may have been further reduced since then through improved work practices and exposure controls (PEA Chapter IV, Section 7). For forming, kiln, and machining operations, OSHA preliminarily concludes that the installation of additional controls such as machine interlocks (for forming) and improved enclosures and ventilation will reduce exposures to or below the proposed PEL most of the time. OSHA requests information on recent exposure levels and controls in beryllium oxide forming and kiln operations to help the Agency evaluate the effectiveness of available exposure controls for this application group.

    In the exposure profile for material preparation, 73 percent of sample values exceeded 0.2 ug/m\3\. As with other parts of the exposure profile, exposure values from the mid-1990s may overestimate airborne beryllium levels for current operations. During most material preparation tasks, such as material loading, transfer, and spray drying, OSHA preliminarily concludes that exposures can be reduced to or below 0.2 mug/m\3\ with process enclosures, ventilation hoods, and improved housekeeping procedures. However, OSHA acknowledges that peak exposures from some short-term tasks such as servicing of the spray chamber might continue to drive the TWA exposures above 0.2 mug/m\3\ on days when these material preparation tasks are performed. Respirators may be needed to protect workers from exposures above the proposed TWA PEL

    Page 47676

    during these tasks.\16\ OSHA notes that material preparation for production of beryllium oxide ceramics currently takes place at only two facilities in the United States.

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    \16\ One facility visited by ERG has reportedly modified this process to reduce worker exposures, but OSHA has no data to quantify the reduction.

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    Nonferrous Foundries

    OSHA identified eight job groups in aluminum and copper foundries with beryllium exposure: Molding, material handling, furnace operation, pouring, shakeout operation, abrasive blasting, grinding/finishing, and maintenance. The Agency developed exposure profiles based on an air monitoring survey conducted by NIOSH in 2007, a Health Hazard Evaluation (HHE) conducted by NIOSH in 1975, a site visit by ERG in 2003, a site visit report from 1999 by the California Cast Metals Association (CCMA); and two sets of data from air monitoring surveys obtained from Materion in 2004 and 2010.

    The exposure profile indicates that in foundries processing beryllium alloys, six of the eight job groups have median exposures that exceed the proposed PEL of 0.2 mug/m\3\ with baseline working conditions. One exception is grinding/finishing operations, where the median value is 0.12 mug/m\3\ and 73 percent of exposure samples are below 0.2 mug/m\3\. The other exception is abrasive blasting. The samples for abrasive blasting used in the exposure profile were obtained during blasting operations using enclosed cabinets, and all 5 samples were below 0.2 mug/m\3\. Exposures for other job groups ranged from just below to well above the proposed PEL, including molder (all samples above 0.2 mug/m\3\), material handler (1 sample total, above 0.2 mug/m\3\), furnace operator (81.8 percent of samples above 0.2 mug/m\3\), pouring operator (60 percent of samples above 0.2 mug/m\3\), shakeout operator (1 sample total, above 0.2 mug/m\3\), and maintenance worker (50 percent of samples above 0.2 mug/m\3\).

    In some of the foundries at which the air samples included in the exposure profile were collected, there are indications that the ventilation systems were not properly used or maintained, and dry sweeping or brushing and the use of compressed air systems for cleaning may have contributed to high dust levels. OSHA believes that exposures in foundries can be substantially reduced by improving and properly using and maintaining the ventilation systems; switching from dry brushing, sweeping and compressed air to wet methods and use of HEPA-

    filtered vacuums for cleaning molds and work areas; enclosing processes; automation of high-exposure tasks; and modification of processes (e.g., switching from sand-based to alternative casting methods). OSHA preliminarily concludes that these additional engineering controls and modified work practices can be implemented to achieve the proposed PEL most of the time for molding, material handling, maintenance, abrasive blasting, grinding/finishing, and pouring operations at foundries that produce aluminum and copper beryllium alloys.

    The Agency is less confident that exposure can be reliably reduced to the proposed PEL for furnace and shakeout operators. Beryllium concentrations in the proximity of the furnaces are typically higher than in other areas due to the fumes generated and the difficulty of controlling emissions during furnace operations. The exposure profile for furnace operations shows a median beryllium exposure level of 1.14 mug/m\3\. OSHA believes that furnace operators' exposures can be reduced using local exhaust ventilation and other controls to reduce overall beryllium levels in foundries, but it is not clear that they can be reduced to the proposed PEL with currently available technology. In foundries that use sand molds, the shakeout operation typically involves removing the freshly cast parts from the sand mold using a vibrating grate that shakes the sand from castings. The shakeout equipment generates substantial amounts of airborne dust that can be difficult to contain, and therefore shakeout operators are typically exposed to high dust levels. During casting of beryllium alloys, the dust may contain beryllium and beryllium oxide residues dislodged from the casting during the shakeout process. The exposure profile for the shakeout operations contains only one result of 1.3 mug/m\3\. This suggests that a substantial reduction would be necessary to achieve compliance with a proposed PEL of 0.2 mug/m\3\. OSHA requests additional information on recent employee exposure levels and the effectiveness of dust controls for shakeout operations for copper and aluminum alloy foundries.

    Secondary Smelting, Refining, and Alloying

    OSHA identified two job groups in this application group with exposure to beryllium: Mechanical process operators and furnace operations workers. Mechanical operators handle and treat source material, and furnace operators run heating processes for refining, melting, and casting metal alloy. OSHA developed exposure profiles for these jobs based on exposure data from ERG site visits to a precious/

    base metals recovery facility and a facility that melts and casts beryllium-containing alloys, both conducted in 2003. The available exposure data for this application group are limited, and therefore, the exposure profile is supplemented in part by summary data presented in secondary sources of information on beryllium exposures in this application group.

    The exposure profile for mechanical processing operators indicates low exposures (3 samples less than 0.2 mug/m\3\), even though these samples were collected at a facility where the ventilation system was allowing visible emissions to escape exhaust hoods. Summary data from studies and reports published in 2005-2009 showed that mechanical processing operator exposures averaged between 0.01 and 0.04 mug/m\3\ at facilities where mixed or electronic waste including beryllium alloy parts were refined. Based on these results, OSHA preliminarily concludes that the proposed PEL is already achieved for most mechanical processing operations most of the time, and exposures could be further reduced through improved ventilation system design and other measures, such as process enclosures.

    As with furnace operations examined in other application groups, the exposure profile indicates higher worker exposures for furnace operators in the secondary smelting, refining, and alloying application group (six samples with a median of 2.15 mug/m\3\, and 83.3 percent above 0.2 mug/m\3\). The two lowest samples in this job's exposure profile (0.03 and 0.5 mug/m\3\) were collected at a facility engaged in recycling and recovery of precious metals where work with beryllium-

    containing material is incidental. At this facility, the furnace is enclosed and fumes are ducted into a filtration system. The four higher samples, ranging from 1.92 to 14.08 mug/m\3\, were collected at a facility engaged primarily in beryllium alloying operations, where beryllium content is significantly higher than in recycling and precious metal recovery activities, the furnace is not enclosed, and workers are positioned directly in the path of the exhaust ventilation over the furnace. OSHA believes these exposures could be reduced by enclosing the furnace and repositioning the worker, but is not certain whether the reduction achieved would be enough to bring exposures down to the proposed PEL. Based on the limited number of samples in the exposure profile and surrogate data from furnace operations, the proposed PEL

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    may not be feasible for furnace work in beryllium recovery and alloying, and respirators may be necessary to protect employees performing these tasks.

    Precision Turned Products

    OSHA's preliminary feasibility analysis for precision turned products focuses on machinists who work with beryllium-containing alloys. The Agency also examined the available exposure data for non-

    machinists and has preliminarily concluded that, in most cases, controlling the sources of exposures for machinists will also reduce exposures for other job groups with indirect exposure when working in the vicinity of machining operations.

    OSHA developed exposure profiles based on exposure data from four NIOSH surveys conducted between 1976 and 2008; ERG site visits to precision machining facilities in 2002, 2003, and 2004; case study reports from six facilities machining copper-beryllium alloys; and exposure data collected between 1987 and 2001 by the U.S. Navy Environmental Health Center (NEHC). Analysis of the exposure data showed a substantial difference between the median exposure level for workers machining pure beryllium and/or high-beryllium alloys compared to workers machining low-beryllium alloys. Most establishments in the precision turned products application group work only with low-

    beryllium alloys, such as copper-beryllium. A relatively small number of establishments (estimated at 15) specialize in precision machining of pure beryllium and/or high-beryllium alloys.

    The exposure profile indicates that machinists working with low-

    beryllium alloys have mostly low exposure to airborne beryllium. Approximately 85 percent of the 80 exposure results are less than or equal to 0.2 mug/m\3\, and 74 percent are less than or equal to 0.1 mug/m\3\. Some of the results below 0.1 mug/m\3\ were collected at a facility where machining operations were enclosed, and metal cutting fluids were used to control the release of airborne contaminants. Higher results (0.1 mug/m\3\-1.07 mug/m\3\) were found at a facility where cutting and grinding operations were conducted in partially enclosed booths equipped with LEV, but some LEV was not functioning properly. A few very high results (0.77 mug/m\3\-24 mug/m\3\) were collected at a facility where exposure controls were reportedly inadequate and poor work practices were observed (e.g., improper use of downdraft tables, use of compressed air for cleaning). Based on these results, OSHA preliminarily concludes that exposures below 0.2 mug/m\3\ can be achieved most of the time for most machinists at facilities dealing primarily with low-beryllium alloys. OSHA recognizes that higher exposures may sometimes occur during some tasks where exposures are difficult to control with engineering methods, such as cleaning, and that respiratory protection may be needed at these times.

    Machinists working with high-beryllium alloys have higher exposure than those working with low-beryllium alloys. This difference is reflected in the exposure profile for this job, where the median of exposure is 0.31 mug/m\3\ and 75 percent of samples exceed the proposed PEL of 0.2 mug/m\3\. The exposure profile was based on two machining facilities at which LEV was used and machining operations were performed under a liquid coolant flood. Like most facilities where pure beryllium and high-beryllium alloys are machined, these facilities also used some combination of full or partial enclosures, as well as work practices to minimize exposure such as prohibiting the use of compressed air and dry sweeping and implementing dust migration control practices to prevent the spread of beryllium contamination outside production areas. At one facility machining high-beryllium alloys, where all machining operations were fully enclosed and ventilated, exposures were mostly below 0.1 mug/m\3\ (median 0.035 mug/m\3\, range 0.02-0.11 mug/m\3\). Exposures were initially higher at the second facility, where some machining operations were not enclosed, existing LEV system were in need of upgrades, and some exhaust systems were improperly positioned. Samples collected there in 2003 and 2004 were mostly below the proposed PEL in 2003 (median 0.1 mug/m\3\) but higher in 2004 (median 0.25 mug/m\3\), and high exposure means in both years (1.65 and 0.68 mug/m\3\ respectively) show the presence of high exposure spikes in the facility. However, the facility reported that measures to reduce exposure brought almost all machining exposures below 0.2 mug/m\3\ in 2006. With the use of fully enclosed machines and LEV and work practices that minimize worker exposures, OSHA preliminarily concludes that the proposed PEL is feasible for the vast majority of machinists working with pure beryllium and high-beryllium alloys. OSHA recognizes that higher exposures may sometimes occur during some tasks where exposures are difficult to control with engineering methods, such as machine cleaning and maintenance, and that respiratory protection may be needed at these times.

    Copper Rolling, Drawing, and Extruding

    OSHA's exposure profile for copper rolling, drawing, and extruding includes four job groups with beryllium exposure: strip metal production, rod and wire production, production support, and administrative work. Exposure profiles for these jobs are based on personal breathing zone lapel sampling conducted at the Brush Wellman Reading, Pennsylvania, rolling and drawing facility from 1977 to 2000.

    Prior to 2000, the Reading facility had limited engineering controls in place. Equipment in use included LEV in some operations, HEPA vacuums for general housekeeping, and wet methods to control loose dust in some rod and wire production operations. The exposure profile shows very low exposures for all four job groups. All had median exposure values below 0.1 mug/m\3\, and in strip metal production, production support, and administrative work, over 90 percent of samples were below 0.1 mug/m\3\. In rod and wire production, 70 percent of samples were below 0.1 mug/m\3\.

    To characterize exposures in extrusion, OSHA examined the results of an industrial hygiene survey of a copper-beryllium extruding process conducted in 2000 at another facility. The survey reported eight PBZ samples, which were not included in the exposure profile because of their short duration (2 hours). Samples for three of the four jobs involved with the extrusion process (press operator, material handler, and billet assembler) were below the limit of detection (LOD) (level not reported). The two samples for the press operator assistant, taken when the assistant was buffing, sanding, and cleaning extrusion tools, were very high (1.6 and 1.9 mug/m\3\). Investigators recommended a ventilated workstation to reduce exposure during these activities.

    In summary, exposures at or below 0.2 mug/m\3\ have already been achieved for most jobs in rolling, drawing, and extruding operations, and OSHA preliminarily concludes that the proposed PEL of 0.2 mug/

    m\3\ is feasible for this application group. For jobs or tasks with higher exposures, such as tool refinishing, use of exposure controls such as local exhaust ventilation can help reduce workers' exposures. The Agency recognizes the limitations of the available data, which were drawn from two facilities and did not include full-shift PBZ samples for extrusion. OSHA requests additional exposure data from other facilities in this application group, especially data from facilities where extrusion is performed.

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    Fabrication of Beryllium Alloy Products

    This application group includes the fabrication of beryllium alloy springs, stampings, and connectors for use in electronics. The exposure profile is based on a study conducted at four precision stamping companies; a NIOSH report on a spring and stamping company; an ERG site visit to a precision stamping, forming, and plating establishment; and exposure monitoring results from a stamping facility presented at the American Industrial Hygiene Conference and Exposition in 2007. The exposure profiles for this application group include three jobs: chemical processing operators, deburring operators, and assembly operators. Other jobs for which all samples results were below 0.1 mug/m\3\ are not shown in the profile.

    For the three jobs in the profile, the majority of exposure samples were below 0.1 mug/m\3\ (deburring operators, 79 percent; chemical processing operators, 81 percent; assembly operators, 93 percent). Based on these results, OSHA preliminarily concludes that the proposed PEL is feasible for this application group. The Agency notes that a few exposures above the proposed PEL were recorded for the chemical processing operator (in plating and bright cleaning) and for deburring (during corn cob deburring in an open tumbling mill). OSHA believes the use of LEV, improved housekeeping, and work practice modifications would reduce the frequency of excursions above the proposed PEL.

    Welding

    Most of the samples in OSHA's exposure profile for welders in general industry were collected between 1994 and 2001 at two of Brush Wellman's alloy strip distribution centers, and in 1999 at Brush Wellman's Elmore facility. At these facilities, tungsten inert gas (TIG) welding was conducted on beryllium alloy strip. Seven samples in the exposure profile came from a case study conducted at a precision stamping facility, where airborne beryllium levels were very low (see previous summary, Fabrication of Beryllium Alloy Products). At this facility, resistance welding was performed on copper-beryllium parts, and welding processes were automated and enclosed.

    Most of the sample results in the welding exposure profile were below 0.2 mug/m\3\. Of the 44 welding samples in the profile, 75 percent were below 0.2 mug/m\3\ and 64 percent were below 0.1 mug/

    m\3\, with most values between 0.01 and 0.05 mug/m\3\. All but one of the 16 exposure samples above 0.1 mug/m\3\ were collected in Brush Wellman's Elmore facility in 1999. According to company representatives, these higher exposure levels may have been due to beryllium oxide that can form on the surface of the material as a result of hot rolling. All seven samples from the precision stamping facility were below the limit of detection. Based on these results, OSHA preliminarily concludes that the proposed PEL of 0.2 mug/m\3\ is feasible for most welding operations in general industry.

    Dental Laboratories

    OSHA's exposure profile for dental technicians includes sampling results from a site visit conducted by ERG in 2003; a study of six dental laboratories published by Rom et al. in 1984; a data set of exposure samples collected between 1987 and 2001, on dental technicians working for the U.S. Navy; and a docket submission from CMP Industries including two samples from a large commercial dental laboratory using nickel-beryllium alloy. Information on exposure controls in these facilities suggests that controls in some cases may have been absent or improperly used.

    The exposure profile indicates that 52 percent of samples are less than or equal to 0.2 mug/m\3\. However, the treatment of nondetectable samples in the feasibility analysis may overestimate many of the sample values in the exposure profile. Twelve of the samples in the profile are nondetectable for beryllium. In the exposure profile, these were assigned the highest possible value, the limit of detection (LOD). For eight of the nondetectable samples, the LOD was reported as 0.2 mug/m\3\. For the other four nondetectable samples, the LOD was between 0.23 and 0.71 mug/m\3\. If the true values for these four nondetectable samples are actually less than or equal to the assigned value of 0.2 mug/m\3\, then the true percentage of profile sample values less than or equal to 0.2 mug/m\3\ is between 52 and 70 percent. Of the sample results with detectable beryllium above 0.2 mug/m\3\, some were collected in 1984 at facilities studied by Rom et al., who reported that they occurred during grinding with LEV that was improperly used or, in one case, not used at all. Others were collected at facilities where little contextual information was available to determine what control equipment or work practices might have reduced exposures.

    Based on this information, OSHA preliminarily concludes that beryllium exposures for most dental technicians are already below 0.2 mug/m\3\ most of the time. OSHA furthermore believes that exposure levels can be reduced to or below 0.1 mug/m\3\ most of the time via material substitution, engineering controls, and work practices. Beryllium-free alternatives for casting dental appliances are readily available from commercial sources, and some alloy suppliers have stopped carrying alloys that contain beryllium. For those dental laboratories that continue to use beryllium alloys, exposure control options include properly designed, installed, and maintained LEV systems (equipped with HEPA filters) and enclosures; work practices that optimize LEV system effectiveness; and housekeeping methods that minimize beryllium contamination in the workplace. In summary, OSHA preliminarily concludes that the proposed PEL is feasible for dental laboratories.

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    Table IX-5--Beryllium Full-Shift PBZ Samples by Application/Job Group (mug/m\3\)

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    Application/Job group N Range Mean Median % 2.0

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    Baseline................................ Dental labs............... 827 636 432 608 155 466 3,124

    Non-dental................ 5,912 631 738 287 112 214 7,893

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    Total.................. 6,739 1,267 1,171 895 267 679 11,017

    PEL = 0.2 mug/m\3\.................... Dental labs............... 679 0 0 0 0 0 679

    Non-dental................ 5,912 631 693 255 98 186 7,774

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    Total.................. 6,591 631 693 255 98 186 8,454

    Prevented by PEL reduction.............. Dental labs............... 148 636 432 608 155 466 2,444

    Non-dental................ 0 0 45 32 14 27 119

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    Total.................. 148 636 478 640 169 493 2,563

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    Page 47710

    In contrast to this PEL component of the benefits, both the ancillary program benefits calculation and the substitution benefits calculation are relatively simple. Both are percentages of the lifetime-risk-model CBD cases that still occur in the post-standard world. OSHA notes that in the context of existing CBD prevention programs, some ancillary-provision programs similar to those included in OSHA's proposal have eliminated a significant percentage of the remaining CBD cases (discussed later in this chapter). If the ancillary provisions reduce remaining CBD cases by 90 percent for example, and if the estimated baseline contains 120 cases of CBD, and post-standard compliance with a lower PEL reduces the total to 100 cases of CBD, then 90 of those remaining 100 cases of CBD would be averted due to the ancillary programs.

    OSHA assumed, based on the clinical experience discussed further below, that approximately 65 percent of CBD cases ultimately result in death. Later in this chapter, OSHA provides a sensitivity analysis of the effects of different values for assuming this percentage at 50 percent and 80 percent on the number of CBD deaths prevented. OSHA welcomes comment on this assumption. OSHA's exposure-response model for lung cancer is based on lung cancer mortality data. Thus, all of the estimated cases of lung cancer in the benefits analysis are cases of premature death from beryllium-related lung cancer.

    Finally, in recognition of the uncertainty in this aspect of these models, OSHA presents a ``high'' estimate, a ``low'' estimate, and uses the midpoint of these two as our ``primary'' estimate. The low estimate is simply those CBD fatalities prevented due to everything except the ancillary provisions, i.e., both the reduction in the PEL and the substitution by dental labs. The high estimate includes both of these factors plus all the ancillary benefits calculated at an effectiveness rate of 90 percent in preventing cases of CBD not averted by the reduction of the PEL. The midpoint is the combination of reductions attributed to adopting the proposed PEL, substitution by dental labs, and the ancillary provisions calculated at an effectiveness rate of only 45 percent.

    1. Chronic Beryllium Disease

      CBD is a respiratory disease in which the body's immune system reacts to the presence of beryllium in the lung, causing a progression of pathological changes including chronic inflammation and tissue scarring. Immunological sensitization to beryllium (BeS) is a precursor that occurs before early-stage CBD. Only sensitized individuals can go on to develop CBD. In early, asymptomatic stages of CBD, small granulomatous lesions and mild inflammation occur in the lungs. As CBD progresses, the capacity and function of the lungs decrease, which eventually affects other organs and bodily functions as well. Over time the spread of lung fibrosis (scarring) and loss of pulmonary function cause symptoms such as: A persistent dry cough, shortness of breath, fatigue, night sweats, chest and join pain, clubbing of fingers due to impaired oxygen exchange, and loss of appetite. In these later stages CBD can also impair the liver, spleen, and kidneys, and cause health effects such as granulomas of the skin and lymph nodes, and cor pulmonale (enlargement of the heart). The speed and extent of disease progression may be influenced by the level and duration of exposure, treatment with corticosteroids, and genetics, but these effects are not fully understood.

      Corticosteroid therapy, in workers whose beryllium exposure has ceased, has been shown to control inflammation, ease symptoms, and in some cases prevent the development of fibrosis. However, corticosteroid use can have adverse effects, including increased risk of infections; accelerated bone loss or osteoporosis; psychiatric effects such as depression, sleep disturbances, and psychosis; adrenal suppression; ocular effects; glucose intolerance; excessive weight gain; increased risk of cardiovascular disease; and poor wound healing. The effects of CBD, and of common treatments for CBD, are discussed in detail in this preamble at Section V, Health Effects, and Section VIII, Significance of Risk.

      OSHA's review of the literature on CBD suggests three broad types of CBD progression (see this preamble at Section V, Health Effects). In the first, individuals progress relatively directly toward death related to CBD. They suffer rapidly advancing disability and their death is significantly premature. Medical intervention is not applied, or if it is, does little to slow the progression of disease. In the second type, individuals live with CBD for an extended period of time. The progression of CBD in these individuals is naturally slow, or may be medically stabilized. They may suffer significant disability, in terms of loss of lung function--and quality of life--and require medical oversight their remaining years. They would be expected to lose some years of normal lifespan. As discussed previously, advanced CBD can involve organs and systems beyond the respiratory system; thus, CBD can contribute to premature death from other causes. Finally, individuals with the third type of CBD progression do not die prematurely from causes related to CBD. The disease is stabilized and may never progress to a debilitating state. These individuals nevertheless may experience some disability or loss of lung function, as well as side effects from medical treatment, and may be affected by the disease in many areas of their lives: Work, recreation, family, etc.\25\

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      \25\ As indicated in the Health Effects section of this preamble: ``It should be noted, however, that treatment with corticosteroids has side-effects of their own that need to be measured against the possibility of progression of disease (Gibson et al., 1996; Zaki et al., 1987). Alternative treatments such as azathiopurine and infliximab, while successful at treating symptoms of CBD, have been demonstrated to have side-effects as well (Pallavicino et al., 2013; Freeman, 2012)''.

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      In the analysis that follows, OSHA assumes, based on the clinical experience discussed below, that 35 percent of workers who develop CBD experience the third type of progression and do not die prematurely from CBD. The remaining 65 percent were estimated to die prematurely, whether from rapid disease progression (type 1) or slow (type 2). Although the proportion of CBD patients who die prematurely as a result of the disease is not well understood or documented at this time, OSHA believes this assumption is consistent with the information submitted in response to the RFI. Newman et al. (2003) presented a scenario for what they considered to be the ``typical'' CBD patient:

      We have included an example of a life care plan for a typical clinical case of CBD. In this example, the hypothetical case is diagnosed at age 40 and assumed to live an additional 33.7 years (approximately 5% reduced life expectancy in this model). In this hypothetical example, this individual would be considered to have moderate severity of chronic beryllium disease at the time of initial diagnosis. They require treatment with prednisone and treatment for early cor pulmonale secondary to CBD. They have experienced some, but not all, of the side effects of treatment and only the most common CBD-related health effects.

      In short, most workers diagnosed with CBD are expected to have shortened life expectancy, even if they do not progress rapidly and directly to death. It should be emphasized that this represents the Agency's best estimate of the mortality related to CBD based upon the current available evidence. As described in Section V, Health Effects, there is a substantial degree of uncertainty as to the prognosis for those contracting CBD, particularly as the relatively less severe

      Page 47711

      cases are likely not to be studied closely for the remainder of their lives.

      As mentioned previously, OSHA used the Cullman data set for empirical estimates of beryllium sensitization and CBD prevalence in its exposure response model, which translates beryllium exposure to risk of adverse health endpoints for the purpose of determining the benefits that could be achieved by preventing those adverse health endpoints.

      OSHA chose the cumulative exposure quartile data as the basis for this benefits analysis. The choice of cumulative quartiles was based in part on the need to use the cumulative exposure forecast developed in the model, and in part on the fact that in statistically fitted models for CBD, the cumulative exposure tended to fit the CBD data better than other exposure variables. OSHA also chose the quartile model because the outside expert who examined the logistic and proportional hazards models believed statistical modeling of the data set to be unreliable due to its small size. In addition, the proportional hazards model with its dummy variables by year of detection is difficult to interpret for purposes of this section. Of course regression analyses are often useful in empirical analysis. They can be a useful compact representation of a set of data, allow investigations of various variable interactions and possible causal relationships, have added flexibility due to covariate transformations, and under certain conditions can be shown to be statistically ``optimal.'' However, they are only useful when used in the proper setting. The possibility of misspecification of functional form, endogeneity, or incorrect distributional assumptions are just three reasons to be cautious about using regression analyses.

      On the other hand, the use of results produced by a quartile analysis as inputs in a benefits assessment implies that the analytic results are being interpreted as evidence of an exposure-response causal relationship. Regression analysis is a more sophisticated approach to estimating causal relationships (or even correlations) than quartile or other quantile analysis, and any data limitations that may apply to a particular regression-based exposure-response estimation also apply to exposure-response estimation conducted with a quartile analysis using the same data set. In this case, OSHA adopted the quartile analysis because the logistic regression analysis yielded extremely high prevalence rates for higher level of exposure over long time periods that some might not find credible. Use of the quartile analysis serves to show that there are significant benefits even without using an extremely high estimate of prevalence for long periods of exposure at high levels. As a check on the quartile model, the Agency performed the same benefits calculation using the logit model estimated by the Agency's outside expert, and these benefit results are presented in a separate OSHA background document (OSHA, 2015b). The difference in benefits between the two models is slight, and there is no qualitative change in final outcomes. The Agency solicits comment on these issues.

      (1) Number of CBD Cases Prevented by the Proposed PEL

      To examine the effect of simply changing the PEL, including the effect of the standard on some dental labs to discontinue their use of beryllium, OSHA compared the number of CBD-related deaths (mortality) and cases of non-fatal CBD (morbidity) that would occur if workers were exposed for a 45-year working life to PELs of 0.1, 0.2, or 0.5 mug/

      m\3\ to the number of cases that would occur at levels of exposure at or below the current PEL. The number of avoided cases over a hypothetical working life of exposure for the current population at a lower PEL is then equal to the difference between the number of cases at levels of exposure at or below the current PEL for that population minus the number of cases at the lower PEL. This approach represents a steady-state comparison based on what would hypothetically happen to workers who received a specific average level of occupational exposure to beryllium during an entire working life. (Chapter VII in the PEA modifies this approach by introducing a model that takes into account the timing of benefits before steady state is reached.)

      As indicated in Table IX-11, the Agency estimates that there would be 16,240 cases of beryllium sensitization, from which there would be 11,017, or about 70 percent, progressing to CBD. The Agency arrived at these estimates by using the CBD and BeS prevalence values from the Agency's preliminary risk analysis, the exposure profile at current exposure levels (under an assumption of full, or fixed, compliance with the existing beryllium PEL), and the model outlined in the previous methods of estimation section after a working lifetime of exposure. Applying the prior midpoint estimate, as explained above, that 65 percent of CBD cases cause or contribute to premature death, the Agency predicts a total of 7,161 cases of mortality and 3,856 cases of morbidity from exposure at current levels; this translates, annually, to 165 cases of mortality and 86 cases of morbidity. At the proposed PEL, OSHA's base model estimates that, due to the airborne factor only, a total of 2,563 CBD cases would be avoided from exposure at current levels, including 1,666 cases of mortality and 897 cases of morbidity--

      or an average of 37 cases of mortality and 20 cases of morbidity annually. OSHA has not estimated the quantitative benefits of sensitization cases avoided.

      OSHA requests comment on this analysis, including feedback on the data relied on and the approach and assumptions used. As discussed earlier, based on information submitted in response to the RFI, the Agency estimates that most of the workers with CBD will progress to an early death, even if it comes after retirement, and has quantified those cases prevented. However, given the evolving nature of science and medicine, the Agency invites public comment on the current state of CBD-related mortality.

      The proposed standard also includes provisions for medical surveillance and removal. The Agency believes that to the extent the proposal provides medical surveillance sooner and to more workers than would have been the case in the absence of the proposed standard, workers will be more likely to receive appropriate treatment and, where necessary, removal from beryllium exposure. These interventions may lessen the severity of beryllium-related illnesses, and possibly prevent premature death. The Agency requests public comment on this issue.

      (2) CBD Cases Prevented by the Ancillary Provisions of the Proposed Standard

      The nature of the chronic beryllium disease process should be emphasized. As discussed in this preamble at Section V, Heath Effects, the chronic beryllium disease process involves two steps. First, workers become sensitized to beryllium. In most epidemiological studies of CBD conducted to date, a large percentage of sensitized workers have progressed to CBD. A certain percentage of the population has an elevated risk of this occurring, even at very low exposure levels, and sensitization can occur from dermal as well as inhalation exposure to beryllium. For this reason, the threat of beryllium sensitization and CBD persist to a substantial degree, even at very low levels of airborne beryllium exposure. It is therefore desirable not only to significantly reduce airborne beryllium exposure, but to avoid nearly any source

      Page 47712

      of beryllium exposure, so as to prevent beryllium sensitization.

      The analysis presented above accounted only for CBD-prevention benefits associated with the proposed reduction of the PEL, from 2 ug/

      m\3\ to 0.2 ug/m\3\. However, the proposed standard also includes a variety of ancillary provisions--including requirements for respiratory protection, personal protective equipment (PPE), housekeeping procedures, hygiene areas, medical surveillance, medical removal, and training--that the Agency believes would further reduce workers' risk of disease from beryllium exposure. These provisions were described in Chapter I of the PEA and discussed extensively in Section XVIII of this preamble, Summary and Explanation of the Proposed Standard.

      The leading manufacturer of beryllium in the U.S., Materion Corporation (Materion), has implemented programs including these types of provisions in several of its plants and has worked with NIOSH to publish peer-reviewed studies of their effectiveness in reducing workers' risk of sensitization and CBD. The Agency used the results of these studies to estimate the health benefits associated with a comprehensive standard for beryllium.

      The best available evidence on comprehensive beryllium programs comes from studies of programs introduced at Materion plants in Reading, PA; Tucson, AZ; and Elmore, OH. These studies are discussed in detail in this preamble at Section VI, Preliminary Risk Assessment, and Section VIII, Significance of Risk. All three facilities were in compliance with the current PEL prior to instituting comprehensive programs, and had taken steps to reduce airborne levels of beryllium below the PEL, but their medical surveillance programs continued to identify cases of sensitization and CBD among their workers. Beginning around 2000, these facilities introduced comprehensive beryllium programs that used a combination of engineering controls, dermal and respiratory PPE, and stringent housekeeping measures to reduce workers' dermal exposures and airborne exposures. These comprehensive beryllium programs have substantially lowered the risk of sensitization among workers. At the times that studies of the programs were published, insufficient follow-up time had elapsed to report directly on the results for CBD. However, since only sensitized workers can develop CBD, reduction of sensitization risk necessarily reduces CBD risk as well.

      In the Reading, PA copper beryllium plant, full-shift airborne exposures in all jobs were reduced to a median of 0.1 ug/m\3\ or below, and dermal protection was required for production-area workers, beginning in 2000-2001 (Thomas et al., 2009). In 2002, the process with the highest exposures (with a median of 0.1 ug/m\3\) was enclosed, and workers involved in that process were required to use respiratory protection. Among 45 workers hired after the enclosure was built and respiratory protection instituted, one was found to be sensitized (2.2 percent). This is more than an 80 percent reduction in sensitization from a previous group of 43 workers hired after 1992, 11.5 percent of whom had been sensitized by the time of testing in 2000.

      In the Tucson beryllium ceramics plant, respiratory and skin protection was instituted for all workers in production areas in 2000 (Cummings et al., 2007). BeLPT testing in 2000-2004 showed that only 1 (1 percent) of 97 workers hired during that time period was sensitized to beryllium. This is a 90 percent reduction from the prevalence of sensitization in a 1998 BeLPT screening, which found that 6 (9 percent) of 69 workers hired after 1992 were sensitized.

      In the Elmore, OH beryllium production and processing facility, all new workers were required to wear loose-fitting powered air-purifying respirators (PAPRs) in manufacturing buildings, beginning in 1999 (Bailey et al., 2010). Skin protection became part of the protection program for new workers in 2000, and glove use was required in production areas and for handling work boots, beginning in 2001. Bailey et al. (2010) found that 23 (8.9 percent) of 258 workers hired between 1993 and 1999, before institution of respiratory and dermal protection, were sensitized to beryllium. The prevalence of sensitization among the 290 workers who were hired after the respiratory protection and PPE measures were put in place was about 2 percent, close to an 80 percent reduction in beryllium sensitization.

      In a response to OSHA's 2002 Request for Information (RFI), Lee Newman et al. from National Jewish Medical and Research Center (NJMRC) summarized results of beryllium program effectiveness from several sources. Said Dr. Newman (in response to Question #33):

      Q. 33. What are the potential impacts of reducing occupational exposures to beryllium in terms of costs of controls, costs for training, benefits from reduction in the number or severity of illnesses, effects on revenue and profit, changes in worker productivity, or any other impact measures than you can identify?

      A: From experience in the Tucson, AZ facility discussed above, one can infer that approximately 90 percent of beryllium sensitization can be eliminated. Furthermore, the preliminary data would suggest that potentially 100 percent of CBD can be eliminated with appropriate workplace control measures.

      In a study by Kelleher 2001, Martyny 2000, Newman, JOEM 2001) in a plant that previously had rates of sensitization as high as 9.7 percent, the data suggests that when lifetime weighted average exposures were below 0.02 mug per cu meter that the rate of sensitization fell to zero and the rate of CBD fell to zero as well.

      In an unpublished study, we have been conducting serial surveillance including testing new hires in a precision machining shop that handles beryllium and beryllium alloys in the Southeast United States. At the time of the first screening with the blood BeLPT of people tested within the first year of hire, we had a rate of 6.7 percent (4/60) sensitization and with 50 percent of these individuals showing CBD at the time of initial clinical evaluation. At that time, the median exposures in the machining areas of the plant was 0.47 mug per cu meter. Subsequently, efforts were made to reduce exposures, further educate the workforce, and increase monitoring of exposure in the plant. Ongoing testing of newly hired workers within the first year of hire demonstrated an incremental decline in the rate of sensitization and in the rate of CBD. For example, at the time of most recent testing when the median airborne exposures in the machining shop were 0.13 mug per cu meter, the percentage of newly hired workers found to have beryllium sensitization or CBD was now 0 percent (0/55). Notably, we also saw an incremental decline in the percentage of longer term workers being detected with sensitization and disease across this time period of exposure reduction and improved hygiene practices.

      Thus, in calculating the potential economic benefit, it's reasonable to work with the assumption that with appropriate efforts to control exposures in the work place, rates of sensitization can be reduced by over 90 percent. (NJMRC, RFI Ex. 6-20)

      OSHA has reviewed these papers and is in agreement with Dr. Newman's testimony. OSHA judges Dr. Newman's estimate to be an upper bound of the effectiveness of ancillary programs and examined the results of using Dr. Newman's estimate that beryllium ancillary programs can reduce BeS by 90 percent, and potentially eliminate CBD where sensitization is reduced, because CBD can only occur where there is sensitization. OSHA applied this 90 percent reduction factor to all cases of CBD remaining after application of the reductions due to lowering the PEL alone. OSHA applied this reduction broadly because the proposed standard would require housekeeping and PPE related to skin exposure (18,000 of

      Page 47713

      28,000 employees will need PPE because of possible skin exposure) to apply to all or most employees likely to come in contact with beryllium and not just those with exposure above the action level. Table IX-11 shows that there are 11,017 baseline cases of CBD and that the proposed PEL of 0.2 microg/m\3\ would prevent 2,563 cases through airborne prevention alone. The remaining number of cases of CBD is then 8,454 (11,017 minus 2,563). If OSHA applies the full ninety percent reduction factor to account for prevention of skin exposure (``non-airborne'' protections), then 7,609 (90 percent of 8,454 cases) additional cases of CBD would be prevented.

      The Agency recognizes that there are significant differences between the comprehensive programs discussed above and the proposed standard. While the proposed standard includes many of the same elements, it is generally less stringent. For example, the proposed standard's requirements for respiratory protection and PPE are narrower, and many provisions of the standard apply only to workers exposed above the proposed TWA PEL or STEL. However, many provisions, such as housekeeping and beryllium work areas, apply to all employers covered by the proposed standard. To account for these differences, OSHA has provided a range of benefits estimates (shown in Table IX-11), first, assuming that there are no ancillary provisions to the standard, and, second, assuming that the comprehensive standard achieves the full 90-percent reduction in risk documented in existing programs. The Agency is taking the midpoint of these two numbers as its main estimate of the benefits of avoided CBD due to the ancillary provisions of the proposed standard. The results in Table IX-11 suggest that approximately 60 percent of the beryllium sensitization cases and the CBD cases avoided would be attributable to the ancillary provisions of the standard. OSHA solicits comment on all aspects of this approach to analyzing ancillary provisions and solicits additional data that might serve to make more accurate estimates of the effects of ancillary provisions. OSHA is interested in the extent of the effects of ancillary provisions and whether these apply to all exposed employees or only those exposed above or below a given exposure level.

      (3) Morbidity Only Cases

      As previously indicated, the Agency does not believe that all CBD cases will ultimately result in premature death. While currently strong empirical data on this are lacking, the Agency estimates that approximately 35 percent of cases would not ultimately be fatal, but would result in some pain and suffering related to having CBD, and possible side effects from steroid treatment, as well as the dread of not knowing whether the disease will ultimately lead to premature death. These would be described as ``mild'' cases of CBD relative to the others. These are the residual cases of CBD after cases with premature mortality have been counted. As indicated in Table IX-11, the Agency estimates the standard will prevent 2,228 such cases (midpoint) over 45 years, or an estimated 50 cases annually.

    2. Lung Cancer

      In addition to the Agency's determinations with respect to the risk of chronic beryllium disease, the Agency has preliminarily determined that chronic beryllium exposure at the current PEL can lead to a significantly elevated risk of (fatal) lung cancer. OSHA used the estimation methodology outlined at the beginning of this section. However, unlike with chronic beryllium disease, the underlying data were based on incidence of lung cancer and thus there was no need to address the possible limitations of prevalence data. The Agency also used lifetime excess risk estimates of lung cancer mortality, presented in Table VI-20 in Section VI of this preamble, Preliminary Risk Assessment, to estimate the benefits of avoided lung cancer mortality. The lung cancer risk estimates are derived from one of the best-fitting models in a recent, high-quality NIOSH lung cancer study, and are based on average exposure levels. The estimates of excess lifetime risk of lung cancer were taken from the line in Table VI-20 in the risk assessment labeled PWL (piecewise log-linear) not including professional and asbestos workers. This model avoids possible confounding from asbestos exposure and reduces the potential for confounding due to smoking, as smoking rates and beryllium exposures can be correlated via professional worker status. Of the three estimates in the NIOSH study that excluded professional workers and those with asbestos exposure, this model was chosen because it was at the midpoint of risk results.

      Table IX-11 shows the number of avoided fatal lung cancers for PELs of 0.2 mug/m\3\, 0.1 mug/m\3\, and 0.5 mug/m\3\. At the proposed PEL of 0.2 mug/m\3\, an estimated 180 lung cancers would be prevented over the lifetime of the current worker population. This is the equivalent of 4.0 cases avoided annually, given a 45-year working life of exposure.

      Combining the two major fatal health endpoints--for lung cancer and CBD-related mortality--OSHA estimates that the proposed PEL would prevent between 1,846 and 6,791 premature fatalities over the lifetime of the current worker population, with a midpoint estimate of 4,318 fatalities prevented. This is the equivalent of between 41 and 151 premature fatalities avoided annually, with a midpoint estimate of 96 premature fatalities avoided annually, given a 45-year working life of exposure.

      Note that the Agency based its estimates of reductions in the number of beryllium-related diseases over a working life of constant exposure for workers who are employed in a beryllium-exposed occupation for their entire working lives, from ages 20 to 65. In other words, workers are assumed not to enter or exit jobs with beryllium exposure mid-career or to switch to other exposure groups during their working lives. While the Agency is legally obligated to examine the effect of exposures from a working lifetime of exposure and set its standard accordingly,\26\ in an alternative analysis purely for informational purposes, using the same underlying risk model for CBD, the Agency examined, in Chapter VII of the PEA, the effect of assuming that workers are exposed for a maximum of only 25 working years, as opposed to the 45 years assumed in the main analysis. While all workers are assumed to have less cumulative exposure under the 25-years-of-exposure assumption, the effective exposed population over time is proportionately increased.

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      \26\ Section (6)(b)(5) of the OSH Act states: ``The Secretary, in promulgating standards dealing with toxic materials or harmful physical agents under this subsection, shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.'' Given that it is necessary for OSHA to reach a determination of significant risk over a working life, it is a logical extension to estimate what this translates into in terms of estimated benefits for the affected population over the same period.

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      A comparison of exposures over a maximum of 25 working years versus over a potentially 45-year working life shows variations in the number of estimated prevented cases by health outcome. For chronic beryllium disease, there is a substantial increase in the number of estimated baseline and prevented cases if one assumes that the typical maximum exposure period is 25 years, as opposed to 45. This reflects the

      Page 47714

      relatively flat CBD risk function within the relevant exposure range, given varying levels of airborne beryllium exposure--shortening the average tenure and increasing the exposed population over time translates into larger total numbers of people sensitized to beryllium. This, in turn, results in larger populations of individuals contracting CBD. Since the lung cancer model itself is based on average, as opposed to cumulative, exposure, it is not adaptable to estimate exposures over a shorter period of time. As a practical matter, however, over 90 percent of illness and mortality attributable to beryllium exposure in this analysis comes from CBD.

      Overall, the 45-year-maximum-working-life assumption yields smaller estimates of the number of cases of avoided fatalities and illnesses than does the maximum-25-years-of-exposure assumption. For example, the midpoint estimates of the number of avoided fatalities and illnesses related to CBD under the proposed PEL of 0.2 mug/m\3\ increases from 92 and 50, respectively, under the maximum-45-year-working-life assumption to 145 and 78, respectively, under the maximum-25-year-

      working-life assumption--or approximately a 57 to 58 percent increase.\27\

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      \27\ Technically, this analysis assumes that workers receive 25 years' worth of beryllium exposure, but that they receive it over 45 working years, as is assumed by the risk models in the risk assessment. It also accounts for the turnover implied by 25, as opposed to 45, years of work. However, it is possible that an alternate analysis, which accounts for the larger number of post-

      exposure worker-years implied by workers departing their jobs before the end of their working lifetime, might find even larger health effects for workers receiving 25 years' worth of beryllium exposure.

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      Page 47715

      GRAPHIC TIFF OMITTED TP07AU15.022

      Page 47716

      Step 2--Estimating the Stream of Benefits Over Time

      Risk assessments in the occupational environment are generally designed to estimate the risk of an occupationally related illness over the course of an individual worker's lifetime. As demonstrated previously in this section, the current occupational exposure profile for a particular substance for the current cohort of workers can be matched up against the expected profile after the proposed standard takes effect, creating a ``steady state'' estimate of benefits. However, in order to annualize the benefits for the period of time after the beryllium rule takes effect, it is necessary to create a timeline of benefits for an entire active workforce over that period.

      While there are various approaches that could be taken for modeling the workforce, there seem to be two polar extremes. At one extreme, one could assume that none of the benefits occur until after the worker retires, or at least 45 years in the future. In the case of lung cancer, that period would effectively be at least 55 years, since the 45 years of exposure must be added to a 10-year latency period during which it is assumed that lung cancer does not develop.\28\ At the other extreme, one could assume that the benefits occur immediately, or at least immediately after a designated lag. However, based on the various risk models discussed in this preamble at Section VI, Risk Assessment, which reflect real-world experience with development of disease over an extended period of time, it appears that the actual pattern occurs at some point between these two extremes.

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      \28\ This assumption is consistent with the 10-year lag incorporated in the lung cancer risk models used in OSHA's preliminary risk assessment.

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      At first glance, the simplest intermediate approach would be to follow the pattern of the risk assessments, which are based in part on life tables, and observe that typically the risk of the illness grows gradually over the course of a working life and into retirement. Thus, the older the person exposed to beryllium, the higher the odds that that person will have developed the disease.

      However, while this is a good working model for an individual exposed over a working life, it is not very descriptive of the effect of lowering exposures for an entire working population. In the latter case, in order to estimate the benefits of the standard over time, one has to consider that workers currently being exposed to beryllium are going to vary considerably in age. Since the calculated health risks from beryllium exposure depend on a worker's cumulative exposure over a working lifetime, the overall benefits of the proposed standard will phase in over several decades, as the cumulative exposure gradually falls for all age groups, until those now entering the workforce reach retirement and the annual stream of beryllium-related illnesses reaches a new, significantly lowered ``steady state.'' \29\ That said, the near-term impact of the proposed rule estimated for those workers with similar current levels of cumulative exposure will be greater for workers who are now middle-aged or older. This conclusion follows in part from the structure of the relative risk model used for lung cancer in this analysis and the fact that the background mortality rates for lung cancer increase with age.

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      \29\ Technically, the RA lung cancer model is based on average exposure, Nonetheless, as noted in the RA, the underlying studies found lung cancer to be significantly related to cumulative exposure. Particularly since the large majority of the benefits are related to CBD, the Agency considers this fairly descriptive of the overall phase-in of benefits from the standard.

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      In order to characterize the magnitude of benefits before the steady state is reached, OSHA created a linear phase-in model to reflect the potential timing of benefits. Specifically, OSHA estimated that, for all non-cancer cases, while the number of cases of beryllium-

      related disease would gradually decline as a result of the proposed rule, they would not reach the steady-state level until 45 years had passed. The reduction in cases estimated to occur in any given year in the future was estimated to be equal to the steady-state reduction (the number of cases in the baseline minus the number of cases in the new steady state) times the ratio of the number of years since the standard was implemented and a working life of 45 years. Expressed mathematically:

      Nt = (C-S) x (t/45),

      Where Nt is the number of non-malignant beryllium-related diseases avoided in year t; C is the current annual number of non-

      malignant beryllium-related diseases; S is the steady-state annual number of non-malignant beryllium-related diseases; and t represents the number of years after the proposed standard takes effect, with t t = (Cm-Sm) x ((t-10)/45)),

      Where 10 t is the number of lung cancer cases avoided in year t as a result of the proposed rule; Cm is the current annual number of beryllium-related lung cancers; and Sm is the steady-state annual number of beryllium-related lung cancers.

      This model was extended to 60 years for all the health effects previously discussed in order to incorporate the 10-year lag, in the case of lung cancer, and a maximum-45-year working life, as well as to capture some occupationally-related disease that manifests itself after retirement.\30\ As a practical matter, however, there is no overriding reason for stopping the benefits analysis at 60 years. An internal analysis by OSHA indicated that, both in terms of cases prevented, and even with regard to monetized benefits, particularly when lower discount rates are used, the estimated benefits of the standard are larger on an annualized basis if the analysis extends further into the future. The Agency welcomes comment on the merit of extending the benefits analysis beyond the 60-years analyzed in the PEA.

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      \30\ The left-hand columns in the tables in Appendix VII-A of the PEA provide estimates using this model of the stream of prevented fatalities and illnesses due to the proposed beryllium rule.

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      In order to compare costs to benefits, OSHA assumes that economic conditions remain constant and that annualized costs--and the underlying costs--will repeat for the entire 60-year time horizon used for the benefits analysis (as discussed in Chapter V of the PEA). OSHA welcomes comments on the assumption for both the benefit and cost analysis that economic conditions remain constant for sixty years. OSHA is particularly interested in what assumptions and time horizon should be used instead and why.

      Separating the Timing of Mortality

      In previous sections, OSHA modeled the timing and incidence of morbidity. OSHA's benefit estimates are based on an underlying CBD-

      related mortality rate of 65 percent. However, this mortality is not simultaneous with the onset of morbidity. Although mortality from CBD has not been well studied, OSHA believes, based on discussions with experienced clinicians, that the average lag for a larger population has a range of 10 to 30 years between morbidity and mortality. The Agency's review of Workers Compensation data related to beryllium exposure from the Office of Worker Compensation Programs (OWCP) Division of Energy Employees Occupational Illness Compensation is consistent with this range. Hence, for the purposes of this

      Page 47717

      proposal, OSHA estimates that mortality occurs on average 20 years after the onset of CBD morbidity. Thus, for example, the prevented deaths that would have occurred in year 21 after the promulgation of the rule are associated with the CBD morbidity cases prevented in year one. OSHA requests comment on this estimate and range.

      The Agency invites comment on each of these elements of the analysis, particularly on the estimates of the expected life expectancy of a patient with CBD.

      Step 3--Monetizing the Benefits of the Proposed Rule

      To estimate the monetary value of the reductions in the number of beryllium-related fatalities, OSHA relied, as OMB recommends, on estimates developed from the willingness of affected individuals to pay to avoid a marginal increase in the risk of fatality. While a willingness-to-pay (WTP) approach clearly has theoretical merit, it should be noted that an individual's willingness to pay to reduce the risk of fatality would tend to underestimate the total willingness to pay, which would include the willingness of others--particularly the immediate family--to pay to reduce that individual's risk of fatality.

      For estimates using the willingness-to-pay concept, OSHA relied on existing studies of the imputed value of fatalities avoided based on the theory of compensating wage differentials in the labor market. These studies rely on certain critical assumptions for their accuracy, particularly that workers understand the risks to which they are exposed and that workers have legitimate choices between high- and low-

      risk jobs. These assumptions are far from obviously met in actual labor markets.\31\ A number of academic studies, as summarized in Viscusi & Aldy (2003), have shown a correlation between higher job risk and higher wages, suggesting that employees demand monetary compensation in return for a greater risk of injury or fatality. The estimated trade-

      off between lower wages and marginal reductions in fatal occupational risk--that is, workers' willingness to pay for marginal reductions in such risk--yields an imputed value of an avoided fatality: The willingness-to-pay amount for a reduction in risk divided by the reduction in risk.\32\

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      \31\ On the former assumption, see the discussion in Chapter II of the PEA on imperfect information. On the latter, see, for example, the discussion of wage compensation for risk for union versus nonunion workers in Dorman and Hagstrom (1998).

      \32\ For example, if workers are willing to pay $90 each for a 1/100,000 reduction in the probability of dying on the job, then the imputed value of an avoided fatality would be $90 divided by 1/

      100,000, or $9,000,000. Another way to consider this result would be to assume that 100,000 workers made this trade-off. On average, one life would be saved at a cost of $9,000,000.

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      OSHA has used this approach in many recent proposed and final rules. Although this approach has been criticized for yielding results that are less than statistically robust (see, for example, Hintermann, Alberini and Markandya, 2010), a more recent WTP analysis, by Kniesner et al. (2012), of the trade-off between fatal job risks and wages, using panel data, seems to address many of the earlier econometric criticisms by controlling for measurement error, endogeneity, and heterogeneity. In conclusion, the Agency views the WTP approach as the best available and will rely on it to monetize benefits.\33\ OSHA welcomes comments on the use of willingness-to-pay measures and estimates based on compensating wage differentials.

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      \33\ Note that, consistent with the economics literature, these estimates would be for reducing the risk of an acute (immediate) fatality. They do not include an individual's willingness to pay to avoid a higher risk of illness prior to fatality, which is separately estimated in the following section.

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      Viscusi & Aldy (2003) conducted a meta-analysis of studies in the economics literature that use a willingness-to-pay methodology to estimate the imputed value of life-saving programs and found that each fatality avoided was valued at approximately $7 million in 2000 dollars. Using the GDP Deflator (U.S. BEA, 2010), this $7 million base number in 2000 dollars yields an estimate of $8.7 million in 2010 dollars for each fatality avoided.\34\

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      \34\ An alternative approach to valuing an avoided fatality is to monetize, for each year that a life is extended, an estimate from the economics literature of the value of that statistical life-year (VSLY). See, for instance, Aldy and Viscusi (2007) for discussion of VSLY theory and FDA (2003), pp. 41488-9, for an application of VSLY in rulemaking. OSHA has not investigated this approach, but welcomes comment on the issue.

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      In addition to the benefits that are based on the implicit value of fatalities avoided, workers also place an implicit value on occupational injuries or illnesses avoided, which reflect their willingness to pay to avoid monetary costs (for medical expenses and lost wages) and quality-of-life losses as a result of occupational illness. Chronic beryllium disease and lung cancer can adversely affect individuals for years, or even decades, in non-fatal cases, or before ultimately proving fatal. Because measures of the benefits of avoiding these illnesses are rare and difficult to find, OSHA has included a range based on a variety of estimation methods.

      For both CBD and lung cancer, there is typically some permanent loss of lung function and disability, on-going medical treatments, side effects of medicines, and major impacts on one's ability to work, marry, enjoy family life, and quality of life.

      While diagnosis with CBD is evidence of material impairment of health, placing a precise monetary value on this condition is difficult, in part because the severity of symptoms may vary significantly among individuals. For that reason, for this preliminary analysis, the Agency employed a broad range of valuation, which should encompass the range of severity these individuals may encounter.

      Using the willingness-to-pay approach, discussed in the context of the imputed value of fatalities avoided, OSHA has estimated a range in valuations (updated and reported in 2010 dollars) that runs from approximately $62,000 per case--which reflects estimates developed by Viscusi and Aldy (2003), based on a series of studies primarily describing simple accidents--to upwards of $5 million per case--which reflects work developed by Magat, Viscusi, and Huber (1996) for non-

      fatal cancer. The latter number is based on an approach that places a willingness-to-pay value to avoid serious illness that is calibrated relative to the value of an avoided fatality. OSHA previously used this approach in the Preliminary Economic Analysis (PEA) supporting its respirable crystalline silica proposal (2013) and in the Final Economic Analysis (FEA) supporting its hexavalent chromium final rule (2006), and EPA (2003) used this approach in its Stage 2 Disinfection and Disinfection Byproducts Rule concerning regulation of primary drinking water. Based on Magat, Viscusi, and Huber (1996), EPA used studies on the willingness to pay to avoid nonfatal lymphoma and chronic bronchitis as a basis for valuing a case of nonfatal cancer at 58.3 percent of the value of a fatal cancer. OSHA's estimate of $5 million for an avoided case of non-fatal cancer is based on this 58.3 percent figure.

      The Agency believes this range of estimates, between $62,000 and $5 million, is descriptive of the value of preventing morbidity associated with moderate to severe CBD that ultimately results in premature death. \35\

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      \35\ There are several benchmarks for valuation of health impairment due to beryllium exposure, using a variety of techniques, which provide a number of mid-range estimates between OSHA's high and low estimates. For a fuller discussion of these benchmarks, see Chapter VII of the PEA.

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      Page 47718

      While the Agency has estimated that 65 percent of CBD cases will result in premature mortality, the Agency has also estimated that approximately 35 percent of CBD cases will not result in premature mortality. However, the Agency acknowledges that it is possible there have been new developments in medicine and industrial hygiene related to the benefits of early detection, medical intervention, and greater control of exposure achieved within the past decade. For that reason, as elsewhere, the Agency requests comment on these issues.

      Also not clear are the negative effects of the illness in terms of lost productivity, medical costs, and potential side-effects of a lifetime of immunosuppressive medication. Nonetheless, the Agency is assigning a valuation of $62,000 per case, to reflect the WTP value of a prevented injury not estimated to precede premature mortality. The Agency believes this is conservative, in part because, with any given case of CBD, the outcome is not known in advance, certainly not at the point of discovery; indeed much of the psychic value of preventing the cases may come from removing the threat of premature mortality. In addition, as previously noted, some of these cases could involve relatively severe forms of CBD where the worker died of other causes; however, in those cases, the duration of the disease would be shortened. While beryllium sensitization is a critical precursor of CBD, this preliminary analysis does not attempt to assign a separate value to sensitization itself.

      Particularly given the uncertainties in valuation on these questions, the Agency is interested in public input on the issue of valuing the cost to society of morbidity associated with CBD, both in cases preceding mortality, and those that may not result in premature mortality. The Agency is also interested in comments on whether it is appropriate to assign a separate valuation to prevented sensitization cases in their own right, and if so, how such cases should be valued.

    3. Summary of Monetized Benefits

      Table IX-12 presents the estimated annualized (over 60 years, using a 0 percent discount rate) benefits from each of these components of the valuation, and the range of estimates, based on uncertainty of the prevention factor (i.e., the estimated range of prevented cases, depending on how large an impact the rule has on cases beyond an airborne-only effect), and the range of uncertainty regarding valuation of morbidity. (Mid-point estimates of the undiscounted benefits for each of the first 60 years are provided in the middle columns of Table VII-A-1 in Appendix VII-A at the end of Chapter VII in the PEA. The estimates by year reach a peak of $3.5 billion in the 60th year. Note that, by using a 60-year time-period, OSHA is not including any monetized fatality benefits associated with reduced worker CBD cases originating after year 40 because the 20-year lag takes these CBD fatalities beyond the 60-year time horizon. To this extent, OSHA will have underestimated benefits.)

      As shown in Table IX-12, the full range of monetized benefits, undiscounted, for the proposed PEL of 0.2 microg/m\3\ runs from $291 million annually, in the case of the lowest estimate of prevented cases of CBD, and the lowest valuation for morbidity, up to $2.1 billion annually, for the highest of both. Note that the value of total benefits is more sensitive to the prevention factor used (ranging from $430 million to $1.6 billion, given estimates at the midpoint of the morbidity valuation) than to the valuation of morbidity (ranging from $666 million to $1.3 billion, given estimates at the midpoint of prevention factor).

      Also, the analysis illustrates that most of the morbidity benefits are related to CBD and lung cancer cases that are ultimately fatal. At the valuation and case frequency midpoint, $663 million in benefits are related to mortality, $226 million are related to morbidity preceding mortality, and $4.3 million are related to morbidity not preceding mortality.

      Page 47719

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    4. Adjustment of WTP Estimates to Reflect Rising Real Income Over Time

      OSHA's estimates of the monetized benefits of the proposed rule are based on the imputed value of each avoided fatality and each avoided beryllium-related disease. As previously discussed, these, in turn, are derived from a worker's willingness to pay to avoid a fatality (with an imputed value per fatality avoided of $8.7 million in 2010 dollars) and to avoid a beryllium-related disease (with an imputed value per disease avoided of between $62,000

      Page 47720

      and $5 million in 2010 dollars). To this point, these imputed values have been assumed to remain constant over time. However, two related factors suggest that these values will tend to increase over time.

      First, economic theory indicates that the value of reducing life-

      threatening and health-threatening risks--and correspondingly the willingness of individuals to pay to reduce these risks--will increase as real per capita income increases. With increased income, an individual's health and life becomes more valuable relative to other goods because, unlike other goods, they are without close substitutes and in relatively fixed or limited supply. Expressed differently, as income increases, consumption will increase but the marginal utility of consumption will decrease. In contrast, added years of life (in good health) is not subject to the same type of diminishing returns--

      implying that an effective way to increase lifetime utility is by extending one's life and maintaining one's good health (Hall and Jones, 2007).

      Second, real per capita income has broadly been increasing throughout U.S. history, including recent periods. For example, for the period 1950 through 2000, real per capita income grew at an average rate of 2.31 percent a year (Hall and Jones, 2007),\36\ although real per capita income for the recent 25-year period 1983 through 2008 grew at an average rate of only 1.3 percent a year (U.S. Census Bureau, 2010). More important is the fact that real U.S. per capita income is projected to grow significantly in future years. For example, the Annual Energy Outlook (AEO) projections, prepared by the Energy Information Administration (EIA) in the Department of Energy (DOE), show an average annual growth rate of per capita income in the United States of 2.7 percent for the period 2011-2035.\37\ The U.S. Environmental Protection Agency prepared its economic analysis of the Clean Air Act using the AEO projections. OSHA believes that it is reasonable to use the same AEO projections employed by DOE and EPA, and correspondingly projects that per capita income in the United States will increase by 2.7 percent a year.

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

      \36\ The results are similar if the historical period includes a major economic downturn (such as the United States has recently experienced). From 1929 through 2003, a period in U.S. history that includes the Great Depression, real per capita income still grew at an average rate of 2.22 percent a year (Gomme and Rupert, 2004).

      \37\ The EIA used DOE's National Energy Modeling System (NEMS) to produce the Annual Energy Outlook (AEO) projections (EIA, 2011). Future per capita GDP was calculated by dividing the projected real gross domestic product each year by the projected U.S. population for that year.

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

      On the basis of the predicted increase in real per capita income in the United States over time and the expected resulting increase in the value of avoided fatalities and diseases, OSHA has adjusted its estimates of the benefits of the proposed rule to reflect the anticipated increase in their value over time. This type of adjustment has been recognized by OMB (2003), supported by EPA's Science Advisory Board (EPA, 2000), and applied by EPA \38\. OSHA proposes to accomplish this adjustment by modifying benefits in year i from Bi to Bi * (1 + k)\i\, where ``k'' is the estimated annual increase in the magnitude of the benefits of the proposed rule.

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

      \38\ See, for example, EPA (2003, 2008).

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

      What remains is to estimate a value for ``k'' with which to increase benefits annually in response to annual increases in real per capita income, where ``k'' is equal to ``(1+g) * (eta)'', ``g'' is the expected annual percentage increase in real per capita income, and ``eta'' is the income elasticity of the value of a statistical life. Probably the most direct evidence of the value of ``k'' comes from the work of Costa and Kahn (2003, 2004). They estimate repeated labor market compensating wage differentials from cross-sectional hedonic regressions using census and fatality data from the Bureau of Labor Statistics for 1940, 1950, 1960, 1970, and 1980. In addition, with the imputed income elasticity of the value of life on per capita GNP of 1.7 derived from the 1940-1980 data, they then predict the value of an avoided fatality in 1900, 1920, and 2000. Given the change in the value of an avoided fatality over time, it is possible to estimate a value of ``k'' of 3.4 percent a year from 1900-2000; of 4.3 percent a year from 1940-1980; and of 2.5 percent a year from 1980-2000.

      Other, more indirect evidence comes from estimates in the economics literature of ``eta'', the income elasticity of the value of a statistical life. Viscusi and Aldy (2003) performed a meta-analysis on 0.2 wage-risk studies and concluded that the confidence interval upper bound on the income elasticity did not exceed 1.0 and that the point estimates across a variety of model specifications ranged between 0.5 and 0.6. Applied to a long-term increase in per capita income of about 2.7 percent a year, this would suggest a value of ``k'' of about 1.5 percent a year.

      More recently, Kniesner, Viscusi, and Ziliak (2010), using panel data quintile regressions, developed an estimate of the overall income elasticity of the value of a statistical life of 1.44. Applied to a long-term increase in per capita income of about 2.7 percent a year, this would suggest a value of ``k'' of about 3.9 percent a year.

      Based on the preceding discussion of these three approaches for estimating the annual increase in the value of the benefits of the proposed rule and the fact that the projected increase in real per capita income in the United States has flattened in recent years and could flatten in the long run, OSHA suggests a conservative value for ``k'' of approximately two percent a year. The Agency invites comment on this estimate and on estimates of the income elasticity of the value of a statistical life.

      The Agency believes that the rising value, over time, of health benefits is a real phenomenon that should be taken into account in estimating the annualized benefits of the proposed rule. Table IX-13, in the following section on discounting benefits, shows estimates of the monetized benefits of the proposed rule (under alternative discount rates) with this estimated increase in monetized benefits over time. The Agency invites comment on this adjustment to monetized benefits.

    5. The Discounting of Monetized Benefits

      As previously noted, the estimated stream of benefits arising from the proposed beryllium rule is not constant from year to year, both because of the 45-year delay after the rule takes effect until all active workers obtain reduced beryllium exposure over their entire working lives and because of, in the case of lung cancer, a 10-year latency period between reduced exposure and a reduction in the probability of disease. An appropriate discount rate \39\ is needed to reflect the timing of benefits over the 60-year period after the rule takes effect and to allow conversion to an equivalent steady stream of annualized benefits.

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

      \39\ Here and elsewhere throughout this section, unless otherwise noted, the term ``discount rate'' always refers to the real discount rate--that is, the discount rate net of any inflationary effects.

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

      1. Alternative Discount Rates for Annualizing Benefits

      Following OMB (2003) guidelines, OSHA has estimated the annualized benefits of the proposed rule using separate discount rates of 3 percent and 7 percent. Consistent with the Agency's own practices in recent rulemakings, OSHA has also estimated, for benchmarking purposes, undiscounted benefits--that is, benefits using a zero percent discount rate.

      Page 47721

      The question remains, what is the ``appropriate'' or ``preferred'' discount rate to use to monetize health benefits? The choice of discount rate is a controversial topic, one that has been the source of scholarly economic debate for several decades. However, in simplest terms, the basic choices involve a social opportunity cost of capital approach or social rate of time preference approach.

      The social opportunity cost of capital approach reflects the fact that private funds spent to comply with government regulations have an opportunity cost in terms of foregone private investments that could otherwise have been made. The relevant discount rate in this case is the pre-tax rate of return on the foregone investments (Lind, 1982, pp. 24-32).

      The rate of time preference approach is intended to measure the tradeoff between current consumption and future consumption, or in the context of the proposed rule, between current benefits and future benefits. The individual rate of time preference is influenced by uncertainty about the availability of the benefits at a future date and whether the individual will be alive to enjoy the delayed benefits. By comparison, the social rate of time preference takes a broader view over a longer time horizon--ignoring individual mortality and the riskiness of individual investments (which can be accounted for separately).

      The usual method for estimating the social rate of time preference is to calculate the post-tax real rate of return on long-term, risk-

      free assets, such as U.S. Treasury securities (OMB, 2003, p. 33). A variety of studies have estimated these rates of return over time and reported them to be in the range of approximately 1-4 percent.

      In accordance with OMB Circular A-4 (2003), OSHA presents benefits and net benefits estimates using discount rates of 3 percent (representing the social rate of time preference) and 7 percent (a rate estimated using the social cost of capital approach). The Agency is interested in any evidence, theoretical or applied, that would inform the application of discount rates to the costs and benefits of a regulation.

      2. Summary of Annualized Benefits under Alternative Discount Rates

      Table IX-13 presents OSHA's estimates of the sum of the annualized benefits of the proposed rule, using alternative discount rates of 0, 3, and 7 percent, with the suggested adjustment for increasing monetized benefits in response to annual increases in per capita income over time.

      Given that the stream of benefits extends out 60 years, the value of future benefits is sensitive to the choice of discount rate. The undiscounted benefits in Table IX-13 range from $291 million to $2.1 billion annually. Using a 7 percent discount rate, the annualized benefits range from $60 million to $591 million. As can be seen, going from undiscounted benefits to a 7 percent discount rate has the effect of cutting the annualized benefits of the proposed rule by about 74 percent.

      Taken as a whole, the Agency's best preliminary estimate of the total annualized benefits of the proposed rule--using a 3 percent discount rate with an adjustment for the increasing value of health benefits over time--is between $158 million and $1.2 billion, with a mid-point value of $576 million.

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      Step 4: Net Benefits of the Proposed Rule

      OSHA has estimated, in Table IX-14, the monetized and annualized net benefits of the proposed rule (with a PEL of 0.2 mug/m\3\), based on the benefits and costs previously presented. Table IX-14 also provides estimates of annualized net benefits for alternative PELs of 0.1 and 0.5 mug/m\3\. Both the proposed rule and the alternatives PEL options have the same ancillary provisions and an action level equal to half of the PEL in both cases.

      Table IX-14 is being provided for informational purposes only. As previously noted, the OSH Act requires the Agency to set standards based on eliminating significant risk to the extent feasible. An alternative criterion of maximizing net (monetized) benefits may result in very different regulatory outcomes. Thus, this analysis of net benefits has not been used by OSHA as the basis for its decision concerning the choice of a PEL or of other ancillary requirements for the proposed beryllium rule.

      Table IX-14 shows net benefits using alternative discount rates of 0, 3, and 7 percent for benefits and costs, having previously included an adjustment to monetized benefits to reflect increases in real per capita income over time. OSHA has relied on a uniform discount rate applied to both costs and benefits. The Agency is interested in any evidence, theoretical or applied, that would support or refute the application of differential discount rates to the costs and benefits of a regulation.

      As previously noted in this section, the choice of discount rate for annualizing benefits has a significant effect on annualized benefits. The same is true for net benefits. For example, the net benefits using a 7 percent discount rate for benefits are considerably smaller than the net benefits using a 3 percent discount rate, declining by over half under all scenarios. (Conversely, as noted in Chapter V of the PEA, the choice of discount rate for annualizing costs has a relatively minor effect on annualized costs.)

      Based on the results presented in Table IX-14, OSHA finds:

      While the net benefits of the proposed rule vary considerably--depending on the choice of discount rate used to annualize benefits and on whether the benefits being used are in the high, midpoint, or low range--benefits exceed costs for the proposed 0.2 mug/m\3\ PEL in all cases that OSHA considered.

      Page 47723

      The Agency's best estimate of the net annualized benefits of the proposed rule--using a uniform discount rate for both benefits and costs of 3 percent--is between $120 million and $1.2 billion, with a midpoint value of $538 million.

      The alternative of a 0.5 mug/m\3\ PEL has lower net benefits under all assumptions, whereas the effect on net benefits of the 0.1 mug/m\3\ PEL is mixed, relative to the proposed 0.2 mug/

      m\3\ PEL. However, for these alternative PELs, benefits were also found to exceed costs in all cases that OSHA considered.

      GRAPHIC TIFF OMITTED TP07AU15.025

      Incremental Benefits of the Proposed Rule

      Incremental costs and benefits are those that are associated with increasing the stringency of the standard. A comparison of incremental benefits and costs provides an indication of the relative efficiency of the proposed PEL and the alternative PELs. Again, OSHA has conducted these calculations for informational purposes only and has not used these results as the basis for selecting the PEL for the proposed rule.

      OSHA provides, in Table IX-15, estimates of the net benefits of the alternative 0.1 and 0.5 mug/m\3\ PELs. The incremental costs, benefits, and net benefits of meeting a 0.5mug/m\3\ PEL and then going to a 0.2 mug/m\3\ PEL (as well as meeting a 0.2 mug/m\3\ PEL and then going to a 0.1 mug/m\3\ PEL--which the Agency has not yet determined is feasible), for alternative discount rates of 3 and 7 percent, are presented in Table IX-15. Table IX-15 breaks out costs by provision and benefits by type of disease and by morbidity/mortality. As Table IX-15 shows, at a discount rate of 3 percent, a PEL of 0.2 mug/m\3\, relative to a PEL of 0.5 mug/m\3\, imposes additional costs of $4.4 million per year; additional benefits of $172.7 million per year; and additional net benefits of $168.2 million per year. The proposed PEL of 0.2 mug/m\3\ also has higher net benefits, relative to a PEL of 0.5 mug/m\3\, using a 7 percent discount rate.

      Table IX-15 demonstrates that, regardless of discount rate, there are net benefits to be achieved by lowering exposures from the current PEL of 2.0 mug/m\3\ to 0.5 mug/m\3\ and then, in turn, lowering them further to 0.2 mug/m\3\. However, the majority of the benefits and costs attributable to the proposed rule are from the initial effort to lower exposures to 0.5 mug/m\3\. Consistent with the previous analysis, net benefits decline across all increments as the discount rate for annualizing benefits increases. As also shown in Table IX-15, there is a slight positive net incremental benefit from going from a PEL of 0.2 mug/m\3\ to 0.1 mug/m\3\ for a discount rate of 3 percent, and a slight negative net increment for a discount rate of 7 percent. (Note that these results are for OSHA's midpoint estimate of benefits, although as indicated in Table IX-14, this is not universal across all estimation parameters.)

      In addition to examining alternative PELs, OSHA also examined alternatives to other provisions of the standard. These regulatory alternatives are discussed Section IX.H of this preamble.

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      Step 5: Sensitivity Analysis

      In this section, OSHA presents the results of two different types of sensitivity analysis to demonstrate how robust the estimates of net benefits are to changes in various cost and benefit parameters. In the first type of sensitivity analysis, OSHA made a series of isolated changes to individual cost and benefit input parameters in order to determine their effects on the Agency's estimates of annualized costs, annualized benefits, and annualized net benefits. In the second type of

      Page 47725

      sensitivity analysis--a so-called ``break-even'' analysis--OSHA also investigated isolated changes to individual cost and benefit input parameters, but with the objective of determining how much they would have to change for annualized costs to equal annualized benefits. For both types of sensitivity analyses, OSHA used the annualized costs and benefits obtained from a three-percent discount rate as the reference point.

      Again, the Agency has conducted these calculations for informational purposes only and has not used these results as the basis for selecting the PEL for the proposed rule.

    6. Analysis of Isolated Changes to Inputs

      The methodology and calculations underlying the estimation of the costs and benefits associated with this rulemaking are generally linear and additive in nature. Thus, the sensitivity of the results and conclusions of the analysis will generally be proportional to isolated variations in a particular input parameter. For example, if the estimated time that employees need to travel to (and from) medical screenings were doubled, the corresponding labor costs would double as well.

      OSHA evaluated a series of such changes in input parameters to test whether and to what extent the general conclusions of the economic analysis held up. OSHA first considered changes to input parameters that affected only costs and then changes to input parameters that affected only benefits. Each of the sensitivity tests on cost parameters had only a very minor effect on total costs or net costs. Much larger effects were observed when the benefits parameters were modified; however, in all cases, net benefits remained significantly positive. On the whole, OSHA found that the conclusions of the analysis are reasonably robust, as changes in any of the cost or benefit input parameters still show significant net benefits for the proposed rule. The results of the individual sensitivity tests are summarized in Table IX-16 and are described in more detail below.

      In the first of these sensitivity tests, where OSHA doubled the estimated portion of employees in need of protective clothing and equipment (PPE), essentially doubling the estimated baseline non-

      compliance rate (e.g., from 10 to 20 percent), and estimates of other input parameters remained unchanged, Table IX-16 shows that the estimated total costs of compliance would increase by $1.4 million annually, or by about 3.7 percent, while net benefits would also decline by $1.4 million annually, from $538.2 million to $536.8 million annually.

      In a second sensitivity test, OSHA increased the estimated unit cost of ventilation from $13.18 per cfm for most sectors to $25 per cfm for most sectors. As shown in Table IX-16, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $2.0 million annually, or by about 5.3 percent, while net benefits would also decline by $2.0 million annually, from $538.2 million to $536.2 million annually.

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      In a third sensitivity test, OSHA increased the estimated share of workers showing signs and symptoms of CBD from 15 to 25 percent, thereby adding these workers to the group eligible for medical surveillance and assuming that they would not be otherwise eligible for another reason (working in a regulated area, exposed during an emergency, etc.). As shown in Table IX-16, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $1.5 million annually, or by about 4.1 percent, while net benefits would also decline by $1.5 million annually, from $538.2 million to $536.7 million annually.

      In a fourth sensitivity test, OSHA increased its estimated incremental time per workers for housekeeping by 50

      Page 47727

      percent. As shown in Table IX-16, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $5.4 million annually, or by about 14.4 percent, while net benefits would also decline by $5.4 million annually, from $538.2 million to $532.8 million annually.

      In a fifth sensitivity test, OSHA increased the estimated number of establishments needing engineering controls. For this sensitivity test, if less than 50 percent of the establishments in an industry needed engineering controls, OSHA doubled the percentage of establishments needing engineering controls. If more than 50 percent of establishments in an industry needed engineering controls, then OSHA increased the percentage of establishment needing engineering control to 100 percent. The purpose of this sensitivity analysis was to check the importance of using a methodology that treated 50 percent of workers in a given occupation exposed above the PEL as equivalent to 50 percent of facilities lacking adequate exposure controls. As shown in Table IX-16, if OSHA's estimates of other input parameters remained unchanged, the total estimated costs of compliance would increase by $4.5 million, or by about 11.9 percent, while net benefits would also decline by $4.5 million, from $538.2 million to $533.7 million annually.

      The Agency also performed sensitivity tests on several input parameters used to estimate the benefits of the proposed rule. In the first two tests, in an extension of results previously presented in Table IX-12, the Agency examined the effect on annualized net benefits of employing the high-end estimate of the benefits, as well as the low-

      end estimate, specifically examining the effect on undiscounted benefits of varying the valuation of individual morbidity cases. Table IX-16 presents the effect on annualized net benefits of using the extreme values of these ranges: the high morbidity valuation case and the low morbidity valuation case. For the low estimate of valuation, the benefits decline by 37.7 percent, to $359 million annually, yielding net benefits of $321 million annually. As shown, using the high estimate of morbidity valuation, the benefits rise by 77.0 percent to $1.0 billion annually, yielding net benefits of $982 million annually.

      In a third sensitivity test of benefits, the Agency examined the effect of removing the component for the estimated rising value of health and safety over time. This would reduce the benefits by 54.6 percent, or $314 million annually, lowering the net benefits to $224 million annually.

      In Chapter VII of the PEA the Agency examined the effect of raising the discount rate for costs and benefits to 7 percent. Raising the discount rate to 7 percent would increase costs by $1.5 million annually and lower benefits by $320.5 million annually, yielding annualized net benefits of $216.2 million.

      Also in Chapter VII of the PEA the Agency performed a sensitivity analysis of dental lab substitution. In the PEA, OSHA estimates that 75 percent of the dental laboratory industry will react to a new standard on beryllium by substituting away from using beryllium to the use of other materials. Substitution is not costless, and Chapter V of the PEA estimates the increased cost due to the higher costs of using non-

      beryllium alloys. These costs are smaller than the avoided costs of the ancillary provisions and engineering controls. Thus, as indicated in Table VII-8 of the PEA, the benefits of the proposal would be lower and the costs higher if there were less substitution out of beryllium in dental labs. The lowest net benefits would occur if labs were unable to substitute out beryllium-containing materials at all, and had to use ventilation to control exposures. In this case, the proposal would yield only $420 million in net benefits. The highest net benefits, larger than assumed for OSHA's primary estimate, would be if all dental labs substituted out of beryllium-containing materials as a result of the proposal; as a result, the proposal would yield $573 million in net benefits. Another possibility is a scenario is which technology and the market move along rapidly away from using beryllium-containing materials, independently of an OSHA rule, and the proposal itself would therefore produce neither costs nor benefits in this sector. If dental labs are removed from the PEA, the net benefits for the proposal--for the remaining industry sectors--decline to $284 million. This analysis demonstrates, however, that regardless of any assumption regarding substitution in dental labs, the proposal would generate substantially more monetized benefits than costs.

      Finally, the Agency examined in Chapter VII of the PEA the effects of changes in two important inputs to the benefits analysis: the factor that transforms CBD prevalence rates into incidence rates, needed for the equilibrium lifetime risk model, and the percentage of CBD cases that eventually lead to a fatality.

      From the Cullman dataset, the Agency has estimated the prevalence of CBD cases at any point in time as a function of cumulative beryllium exposure. In order to utilize the lifetime risk model, which tracks workers over their working life in a job, OSHA has turned these prevalence rates into an incidence rate, which is the rate of contracting CBD at a point in time. OSHA's baseline estimate of the turnover rate in the model is 10 percent. In Table VII-10 in the PEA, OSHA also presented alternative turnover rates of 5 percent and 20 percent. A higher turnover rate translates into a higher incidence rate, and the table shows that, from a baseline midpoint estimate with 10 percent turnover the number of CBD cases prevented is 6,367, while raising the turnover rate to 20 percent causes this midpoint estimate to rise to 11,751. Conversely, a rate of 5 percent lowers the number of CBD cases prevented to 3,321. Translated into monetary benefits, the table shows that the baseline midpoint estimate of $575.8 million now ranges from $314.4 million to $1,038 million.

      Also in TableVII-10 of the PEA, the Agency looked at the effects of varying the percentage of CBD cases that eventuate in fatality. The Agency's baseline estimate of this outcome is 65 percent, with half of this occurring relatively soon, and the other half after an extended debilitating condition. The Agency judged that a reasonable range to investigate was a low of 50 percent and a high of 80 percent, while maintaining the shares of short-term and long-term endpoint fatality. At a baseline of 65 percent, the midpoint estimate of total CBD cases prevented is 4,139. At the low end of 50 percent mortality this estimate lowers to 3,183 while at the high end of 80 percent mortality this estimate rises to 5,094. Translated into monetary benefits, the table shows that the baseline midpoint estimate of $575.8 million now ranges from $500.1 million to $651.5 million.

    7. ``Break-Even'' Analysis

      OSHA also performed sensitivity tests on several other parameters used to estimate the net costs and benefits of the proposed rule. However, for these, the Agency performed a ``break-even'' analysis, asking how much the various cost and benefits inputs would have to vary in order for the costs to equal, or break even with, the benefits. The results are shown in Table IX-17.

      In one break-even test on cost estimates, OSHA examined how much total costs would have to increase in order for costs to equal benefits. As shown in Table IX-17, this point would

      Page 47728

      be reached if costs increased by $538.2 million, or by 1,431 percent.

      In a second test, looking specifically at the estimated engineering control costs, the Agency found that these costs would need to increase by $566.7 million, or 6,240 percent, for costs to equal benefits.

      In a third sensitivity test, on benefits, OSHA examined how much its estimated monetary valuation of an avoided illness or an avoided fatality would need to be reduced in order for the costs to equal the benefits. Since the total valuation of prevented mortality and morbidity are each estimated to exceed the estimated costs of $38 million, an independent break-even point for each is impossible. In other words, for example, if no value is attached to an avoided illness associated with the rule, but the estimated value of an avoided fatality is held constant, the rule still has substantial net benefits. Only through a reduction in the estimated net value of both components is a break-even point possible.

      The Agency, therefore, examined how large an across-the-board reduction in the monetized value of all avoided illnesses and fatalities would be necessary for the benefits to equal the costs. As shown in Table IX-17, a 94 percent reduction in the monetized value of all avoided illnesses and fatalities would be necessary for costs to equal benefits, reducing the estimated value to $733,303 per fatality prevented, and an equivalent percentage reduction to about $4,048 per illness prevented.

      In a fourth break-even sensitivity test, OSHA estimated how many fewer beryllium-related fatalities and illnesses would be required for benefits to equal costs. Paralleling the previous discussion, eliminating either the prevented mortality or morbidity cases alone would be insufficient to lower benefits to the break-even point. The Agency therefore examined them as a group. As shown in Table IX-17, a reduction of 96 percent, for both simultaneously, is required to reach the break-even point--90 fewer fatalities prevented annually, and 46 fewer beryllium-related illnesses-only cases prevented annually.

      Taking into account both types of sensitivity analysis the Agency performed on its point estimates of the annualized costs and annualized benefits of the proposed rule, the results demonstrate that net benefits would be positive in all plausible cases tested. In particular, this finding would hold even with relatively large variations in individual input parameters. Alternately, one would have to imagine extremely large changes in costs or benefits for the rule to fail to produce net benefits. OSHA concludes that its finding of significant net benefits resulting from the proposed rule is a robust one.

      OSHA welcomes input from the public regarding all aspects of this sensitivity analysis, including any data or information regarding the accuracy of the preliminary estimates of compliance costs and benefits and how the estimates of costs and benefits may be affected by varying assumptions and methodological approaches. OSHA also invites comment on the risk analysis and risk estimates from which the benefits estimates were derived.

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      H. Regulatory Alternatives

      This section discusses various regulatory alternatives to the proposed OSHA beryllium standard. Executive Order 12866 instructs agencies to ``select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity), unless a statute requires another regulatory approach.'' The OSH Act, as interpreted by the courts, requires health regulations to reduce significant risk to

      Page 47730

      the extent feasible. Nevertheless OSHA has examined possible regulatory alternatives that may not meet its statutory requirements.

      Each regulatory alternative presented here is described and analyzed relative to the proposed rule. Where appropriate, the Agency notes whether the regulatory alternative, to be a legitimate candidate for OSHA consideration, requires evidence contrary to the Agency's preliminary findings of significant risk and feasibility. To facilitate comment, OSHA has organized some two dozen specific regulatory alternatives into five categories: (1) Scope; (2) exposure limits; (3) methods of compliance; (4) ancillary provisions; and (5) timing.

      1. Scope Alternatives

      The first set of regulatory alternatives would alter scope of the proposed standard--that is, the groups of employees and employers covered by the proposed standard. The scope of the current beryllium proposal applies only to general industry work, and does not apply to employers when engaged in construction or maritime activities. In addition, the proposed rule provides an exemption for those working with materials that contain beryllium only as a trace contaminant (less than 0.1percent composition by weight).\40\

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      \40\ Employers engaged in general industry activities exempted from the proposed rule must still ensure that their employees are protected from beryllium exposure above the current PEL, as listed in 29 CFR 1910.1000 Table Z-2.

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      As discussed in the explanation of paragraph (a) in Section XVIII of this preamble, Summary and Explanation of the Proposed Standard, OSHA is considering alternatives to the proposed scope that would increase the range of employers and employees covered by the standard. OSHA's review of several industries indicates that employees in some construction and maritime industries, as well as some employees who deal with materials containing less than 0.1 percent beryllium, may be at significant risk of CBD and lung cancer as a result of their occupational exposures. Regulatory Alternatives #1a, #1b, #2a, and #2b would increase the scope of the proposed standard to provide additional protection to these workers.

      Regulatory Alternative #1a would expand the scope of the proposed standard to also include all operations in general industry where beryllium exists only as a trace contaminant; that is, where the materials used contain less than 0.1 percent beryllium by weight. Regulatory Alternative #1b is similar to Regulatory Alternative #1a, but exempts operations where beryllium exists only as a trace contaminant and the employer can show that employees' exposures will not meet or exceed the action level or exceed the STEL. Where the employer has objective data demonstrating that a material containing beryllium or a specific process, operation, or activity involving beryllium cannot release beryllium in concentrations at or above the proposed action level or above the proposed STEL under any expected conditions of use, that employer would be exempt from the proposed standard except for recordkeeping requirements pertaining to the objective data. Alternative #1a and Alternative #1b, like the proposed rule, would not cover employers or employees in construction or shipyards.

      OSHA has identified two industries with workers engaged in general industry work that would be excluded under the proposed rule but would fall within the scope of the standard under Regulatory Alternatives #1a and #1b: Primary aluminum production and coal-fired power generation. Beryllium exists as a trace contaminant in aluminum ore and may result in exposures above the proposed permissible exposure limits (PELs) during aluminum refining and production. Coal fly ash in coal-powered power plants is also known to contain trace amounts of beryllium, which may become airborne during furnace and baghouse operations and might also result in worker exposures. See Appendices VIII-A and VIII-B at the end of Chapter VIII in the PEA for a discussion of beryllium exposures and available controls in these two industries.

      As discussed in Appendix IV-B of the PEA, beryllium exposures from fly ash high enough to exceed the proposed PEL would usually be coupled with arsenic exposures exceeding the arsenic PEL. Employers would in that case be required to implement all feasible engineering controls, work practices, and necessary PPE (including respirators) to comply with the OSHA Inorganic Arsenic standard (29 CFR 1910.1018)--which would be sufficient to comply with those aspects of the proposed beryllium standard as well. The degree of overlap between the applicability of the two standards and, hence, the increment of costs attributable to this alternative are difficult to gauge. To account for this uncertainty, the Agency at this time is presenting a range of costs for Regulatory Alternative #1a: From no costs being taken for ancillary provisions under Regulatory Alternative #1a to all such costs being included. At the low end, the only additional costs under Regulatory Alternative #1a are due to the engineering control costs incurred by the aluminum smelters (see Appendix VIII-A).

      Similarly, the proposed beryllium standard would not result in additional benefits from a reduction in the beryllium PEL or from ancillary provisions similar to those already in place for the arsenic standard, but OSHA does anticipate some benefits will flow from ancillary provisions unique to the proposed beryllium standard. To account for significant uncertainty in the benefits that would result from the proposed beryllium standard for workers in primary aluminum production and coal-fired power generation, OSHA estimated a range of benefits for Regulatory Alternative #1a. The Agency estimated that the proposed ancillary provisions would avert between 0 and 45 percent \41\ of those baseline CBD cases not averted by the proposed PEL. Though the Agency is presenting a range for both costs and benefits for this alternative, the Agency judges the degree of overlap with the arsenic standard is likely to be substantial, so that the actual costs and benefits are more likely to be found at the low end of this range. The Agency invites comment on all these issues.

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      \41\ As discussed in Chapter VII of the PEA, OSHA used 45 percent to develop its best estimate.

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      Table IX-18 presents, for informational purposes, the estimated costs, benefits, and net benefits of Regulatory Alternative #1a using alternative discount rates of 3 percent and 7 percent. In addition, this table presents the incremental costs, incremental benefits, and incremental net benefits of this alternative relative to the proposed rule. Table IX-18 also breaks out costs by provision, and benefits by type of disease and by morbidity/mortality.

      As shown in Table IX-18, Regulatory Alternative #1a would increase the annualized cost of the rule from $37.6 million to between $39.6 and $56.0 million using a 3 percent discount rate and from $39.1 million to between $41.3 and $58.1 million using a 7 percent discount rate. OSHA estimates that regulatory Alternative #1a would prevent as few as an additional 0.3 (i.e., almost one fatality every 3 years) or as many as an additional 31.8 beryllium-related fatalities annually, relative to the proposed rule. OSHA also estimates that Regulatory Alternative #1a would prevent as few as an additional 0.002 or as many as an additional 9 beryllium-related non-fatal illnesses annually, relative to the proposed rule. As a result, annualized benefits in monetized

      Page 47731

      terms would increase from $575.8 million to between $578.0 and $765.2 million, using a 3 percent discount rate, and from $255.3 million to between $256.3 and $339.3 million using a 7 percent discount rate. Net benefits would increase from $538.2 million to between $538.4 and $709.2 million using a 3 percent discount rate and from $216.2 million to somewhere between $215.1 to $281.2 million using a 7 percent discount rate. As noted in Appendix VIII-B of Chapter VIII in the PEA, the Agency emphasizes that these estimates of benefits are subject to a significant degree of uncertainty, and the benefits associated with Regulatory Alternative #1a arguably could be a small fraction of OSHA's best estimate presented here.

      OSHA estimates that the costs and the benefits of Regulatory Alternative #1b will be somewhat lower than the costs of Regulatory Alternative #1a, because most--but not all--of the provisions of the proposed standard are triggered by exposures at the action level, 8-

      hour time-weighted average (TWA) PEL, or STEL. For example, where exposures exist but are below the action level and at or below the STEL, Alternative #1a would require employers to establish work areas; develop, maintain, and implement a written exposure control plan; provide medical surveillance to employees who show signs or symptoms of CBD; and provide PPE in some instances. Regulatory Alternative #1b would not require employers to take these measures in operations where they can produce objective data demonstrating that exposures are below the action level and at or below the STEL. OSHA only analyzed costs, not benefits, for this alternative, consistent with the Agency's treatment of Regulatory Alternatives in the past. Total costs for Regulatory Alternative #1b versus #1a, assuming full ancillary costs, drop from to $56.0 million to $49.9 million using a 3 percent discount rate, and from $58.1 million to $51.8 million using a 7 percent discount rate.

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      Regulatory Alternative #2a would expand the scope of the proposed standard to include employers in construction and maritime. For example, this alternative would cover abrasive blasters, pot tenders, and

      Page 47733

      cleanup staff working in construction and shipyards who have the potential for airborne beryllium exposure during blasting operations and during cleanup of spent media. Regulatory Alternative #2b would update 29 CFR 1910.1000 Tables Z-1 and Z-2, 1915.1000 Table Z, and 1926.55 Appendix A so that the proposed TWA PEL and STEL would apply to all employers and employees in general industry, shipyards, and construction, including occupations where beryllium exists only as a trace contaminant. For example, this alternative would cover abrasive blasters, pot tenders, and cleanup staff working in construction and shipyards who have the potential for significant airborne exposure during blasting operations and during cleanup of spent media. The changes to the Z tables would also apply to workers exposed to beryllium during aluminum refining and production, and workers engaged in maintenance operations at coal-powered utility facilities. All provisions of the standard other than the PELs, such as exposure monitoring, medical removal, and PPE, would be in effect only for employers and employees that fall within the scope of the proposed rule.\42\ Alternative #2b would not be as protective as Alternative #1a or Alternative #1b for employees in aluminum refining and production or coal-powered utility facilities because the other provisions of the proposed standard would not apply.

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      \42\ However, many of the occupations excluded from the scope of the proposed beryllium standard receive some ancillary provision protections from other rules, such as Personal Protective Equipment (29 CFR 1910 subpart I, 1915 subpart I, 1926.28, also 1926 subpart E), Ventilation (including abrasive blasting) (Sec. Sec. 1926.57 and 1915.34), Hazard Communication (Sec. 1910.1200), and specific provisions for welding (parts 1910 subpart Q, 1915 subpart D, and 1926 subpart J).

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      As discussed in the explanation of proposed paragraph (a) in this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, abrasive blasting is the primary application group in construction and maritime industries where workers may be exposed to beryllium. OSHA has judged that abrasive blasters and their helpers in construction and maritime industries have the potential for significant airborne exposure during blasting operations and during cleanup of spent media. Airborne concentrations of beryllium have been measured above the current TWA PEL of 2 mug/m\3\ when blast media containing beryllium are used as intended (see Appendix IV-C in the PEA for details).

      To address high concentrations of various hazardous chemicals in abrasive blasting material, employers must already be using engineering and work practice controls to limit workers' exposures and must be supplementing these controls with respiratory protection when necessary. For example, abrasive blasters in the construction industry fall under the protection of the Ventilation standard (29 CFR 1926.57). The Ventilation standard includes an abrasive blasting subsection (29 CFR 1926.57(f)), which requires that abrasive blasting respirators be worn by all abrasive blasting operators when working inside blast-

      cleaning rooms (29 CFR 1926.57(f)(5)(ii)(A)), or when using silica sand in manual blasting operations where the nozzle and blast are not physically separated from the operator in an exhaust-ventilated enclosure (29 CFR 1926.57(f)(5)(ii)(B)), or when needed to protect workers from exposures to hazardous substances in excess of the limits set in Sec. 1926.55 (29 CFR 1926.57(f)(5)(ii)(C); ACGIH, 1971). For maritime, standard 29 CFR 1915.34(c) covers similar requirements for respiratory protection needed in blasting operations. Due to these requirements, OSHA believes that abrasive blasters already have controls in place and wear respiratory protection during blasting operations. Thus, in estimating costs for Regulatory Alternatives #2a and #2b, OSHA judged that the reduction of the TWA PEL would not impose costs for additional engineering controls or respiratory protection in abrasive blasting (see Appendix VIII-C of Chapter VIII in the PEA for details). OSHA requests comment on this issue--in particular, whether abrasive blasters using blast material that may contain beryllium as a trace contaminant are already using all feasible engineering and work practice controls, respiratory protection, and PPE that would be required by Regulatory Alternatives #2a and #2b.

      In the estimation of benefits for Regulatory Alternative #2a, OSHA has estimated a range to account for significant uncertainty in the benefits to this population from some of the ancillary provisions of the proposed beryllium standard. It is unclear how many of the workers associated with abrasive blasting work would benefit from dermal protection, as comprehensive dermal protection may already be used by most blasting operators. It is also unclear whether the housekeeping requirements of the proposed standard would be feasible to implement in the context of abrasive blasting work, and to what extent they would benefit blasting helpers, who are themselves exposed while performing cleanup activities. OSHA estimated that the proposed ancillary provisions would avert between 0 and 45 percent of those baseline CBD cases not averted by the proposed PEL.

      These considerations also lead the Agency to present a range for the costs of this alternative: From no costs being estimated for ancillary provisions under Regulatory Alternative #2a to including all such costs. Based on the considerations discussed above, the Agency judges that costs and benefits at the low end of this range are more likely to be correct. The Agency invites comment on these issues.

      In addition, OSHA believes that a small number of welders in the maritime industry may be exposed to beryllium via arc and gas welding (and none through resistance welding). The number of maritime welders was estimated using the same methodology as was used to estimate the number of general industry welders. Brush Wellman's customer survey estimated 2,000 total welders on beryllium-containing products (Kolanz, 2001). Based on ERG's assumption of 4 welders per establishment, ERG estimated that a total of 500 establishments would be affected. These affected establishments were then distributed among the 26 NAICS industries with the highest number of IMIS samples for welders that were positive for beryllium. To do this, ERG first consulted the BLS OES survey to determine what share of establishments in each of the 26 NAICS employed welders and estimated the total number of establishments that perform welding regardless of beryllium exposure (BLS, 2010a). Then ERG distributed the 500 affected beryllium welding facilities among the 26 NAICS based on the relative share of the total number of establishments performing welding. Finally, to estimate the number of welders, ERG used the assumption of four welders per establishment. Based on the information from ERG, OSHA estimated that 30 welders would be covered in the maritime industry under this regulatory alternative. For these welders, OSHA used the same controls and exposure profile that were used to estimate costs for arc and gas welders in Chapter V of the PEA. ERG judged there to be no construction welders exposed to beryllium due to a lack of any evidence that the construction sector uses beryllium-containing products or electrodes in resistance welding. OSHA solicits comment and any relevant data on beryllium exposures for welders in construction and maritime employment.

      Estimated costs and benefits for Regulatory Alternative #2a are shown in Table IX-18a. Regulatory Alternative

      Page 47734

      Table IX-18b presents, for informational purposes, the estimated costs, benefits, and net benefits, of Regulatory Alternative #2b using alternative discount rates of 3 percent and 7 percent. In addition, this table presents the incremental costs, incremental benefits, and incremental net benefits of this alternative relative to the proposed rule. Table IX-18b also breaks out costs by provision and benefits by type of disease and by morbidity/mortality.

      As shown in Table IX-18b, this regulatory alternative would increase the annualized cost of the rule from $37.6 million to $39.6 million, using a 3 percent discount rate, and from $39.1 million to $41.1 million using a 7 percent discount rate. Regulatory Alternative #2b would prevent less than one additional beryllium-related fatalities and less than one beryllium-related illness annually relative to the proposed rule. As a result, annualized benefits would increase from $575.8 million to $578.1 million, using a 3 percent discount rate, and from $255.3 million to $256.3 million using a 7 percent discount rate. Net benefits would increase from $538.2 million to $538.5 million using a 3 percent discount rate and slightly decrease from $216.2 million to $215.2 million using a 7 percent discount rate.

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      2. Exposure Limit (TWA PEL, STEL, and ACTION LEVEL) Alternatives

      OSHA is proposing a new TWA PEL for beryllium of 0.2 mug/m\3\ and a STEL of 2.0 mug/m\3\ for all application groups covered by the rule. OSHA's proposal is based on the requirements of the Occupational Safety and Health Act (OSH Act) and court interpretations of

      Page 47737

      the Act. For health standards issued under section 6(b)(5) of the OSH Act, OSHA is required to promulgate a standard that reduces significant risk to the extent that it is technologically and economically feasible to do so. See Section II of this preamble, Pertinent Legal Authority, for a full discussion of OSHA legal requirements.

      Paragraph (c) of the proposed standard establishes two PELs for beryllium in all forms, compounds, and mixtures: An 8-hour TWA PEL of 0.2 mug/m\3\ (proposed paragraph (c)(1)), and a 15-minute short-term exposure limit (STEL) of 2.0 mug/m\3\ (proposed paragraph (c)(2)). OSHA has defined the action level for the proposed standard as an airborne concentration of beryllium of 0.1 mug/m\3\ calculated as an eight-hour TWA (proposed paragraph (b)). In this proposal, as in other standards, the action level has been set at one-half of the TWA PEL.

      As discussed in this preamble explanation of paragraph (c) in Section XVIII, Summary and Explanation of the Proposed Standard, OSHA is considering three regulatory alternatives that would modify the PELs for the proposed standard.

      Regulatory Alternative #3 would modify the proposed STEL to be five times the TWA PEL, as is typical for OSHA standards that have STELs. A STEL five times the TWA PEL has more practical effect because a STEL ten times the TWA PEL will rarely be exceeded without also driving exposures above the TWA PEL. For example, assuming a background exposure level of 0.1 mug/m\3\, a STEL ten times the TWA PEL could only be exceeded once in a work shift for 15 minutes without driving exposures above the TWA PEL, whereas a STEL five times the TWA PEL could be exceeded three times before driving exposures above the TWA PEL. OSHA's standards for methylene chloride (29 CFR 1910.1052), acrylonitrile (29 CFR 1910.1045), benzene (29 CFR 1910.1028), ethylene oxide (29 CFR 1910.1047), and 1,3-Butadiene (29 CFR 1910.1051) all set STELs at five times the TWA PEL. Thus, if OSHA promulgates the proposed TWA PEL of 0.2 mug/m\3\, the accompanying STEL under this regulatory alternative would be set at 1 mug/m\3\.

      As discussed in this preamble at Section V, Health Effects, immunological sensitization can be triggered by short-term exposures. OSHA believes a STEL for beryllium will help reduce the risk of sensitization and CBD in beryllium-exposed employees. For instance, without a STEL, workers' exposures could be as high as 6.4 mug/m\3\ (32 x 0.2 mug/m\3\) for 15 minutes under the proposed TWA PEL, if exposures during the remainder of the 8-hour work shift are non-

      detectable. A STEL serves to minimize high task-based exposures by requiring feasible controls in these situations, and has the added effect of further reducing the TWA exposure.

      OSHA requests comment on the range of short-term exposures in covered industries, the types of operations where these are occurring, and on the proposed and alternative STELs, including any data or information that may help OSHA choose between them.

      OSHA identified two job categories where workers would be expected to have short-term exposures in the range between the proposed STEL and the STEL under Regulatory Alternative #3 (that is, between 2.0 and 1.0 mug/m\3\): Furnace operators in nonferrous foundries and material preparation operators in the beryllium oxide ceramics application group. To estimate the costs for this alternative, OSHA judged, conservatively, that all workers in these job categories would need to wear respirators to meet a STEL of 1.0. OSHA also estimated costs for additional regulated areas and medical surveillance for workers in these two job categories. The costs for this alternative are presented in Table IX-19. Total costs rise from $37.6 million to $37.7 million using a 3 percent discount rate and from $39.1 million to $39.3 million using a 7 percent discount rate.

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      Under Regulatory Alternative #4, the TWA PEL would be 0.1 mug/

      m\3\ with an action level of 0.05 mug/m\3\. The Agency's preliminary risk assessment indicates that the risks remaining at the proposed TWA PEL of 0.2 mug/m\3\--while lower than risks at the current TWA PEL--

      are still significant (see this preamble at Section VIII, Significance of Risk). A

      Page 47738

      TWA PEL of 0.1 mug/m\3\ would reduce some of the remaining risks to workers at the proposed PEL. The OSH Act requires the Agency to set its standards to address significant risks of harm to the extent economically and technologically feasible, so OSHA would have very limited flexibility to adopt a higher PEL if a lower PEL is technologically and economically feasible.

      While OSHA's preliminary analysis indicates that the proposed TWA PEL of 0.2 mug/m\3\ is economically and technologically feasible, OSHA has less confidence in the feasibility of a TWA PEL of 0.1 mug/

      m\3\. In some industry sectors it is difficult to determine whether a TWA PEL of 0.1 mug/m\3\ could be achieved in most operations most of the time (see Section IX.D of this preamble, Technological Feasibility). OSHA believes that one way this uncertainty could be resolved would be with additional information on exposure control technologies and the exposure levels that are currently being achieved in these industry sectors. OSHA requests additional data and information to inform its final determinations on feasibility (see Section IX.D of this preamble, Technological Feasibility) and the alternative PELs under consideration.

      Regulatory Alternative #5, which would set a TWA PEL at 0.5 mug/

      m\3\ and an action level at 0.25 mug/m\3\, both higher than in the proposal, responds to an issue raised during the Small Business Advocacy Review (SBAR) process conducted in 2007 to consider a draft OSHA beryllium proposed rule that culminated in an SBAR Panel report (SBAR, 2008). That report included a recommendation that OSHA consider both the economic impact of a low TWA PEL and regulatory alternatives that would ease cost burden for small entities. OSHA has provided a full analysis of the economic impact of its proposed PELs (see Chapter VI of the PEA), and Regulatory Alternative #5 addresses the second half of that recommendation. However, the higher 0.5 mug/m\3\ TWA PEL does not appear to be consistent with the Agency's mandate under the OSH Act to promulgate a lower PEL if it is feasible and could prevent additional fatalities and non-fatal illnesses. The data presented in Table IX-20 below indicate that the lower TWA PEL would prevent additional fatalities and non-fatal illnesses, but nevertheless the Agency solicits comments on this alternative and OSHA's analysis of the costs and benefits associated with it.

      Table IX-20 below presents, for informational purposes, the estimated costs, benefits, and net benefits of the proposed rule under the proposed TWA PEL of 0.2 mug/m\3\ and for the regulatory alternatives of a TWA PEL of 0.1 mug/m\3\ and a TWA PEL of 0.5 mug/

      m\3\ (Regulatory Alternatives #4 and #5, respectively), using alternative discount rates of 3 percent and 7 percent. In addition, the table presents the incremental costs, the incremental benefits, and the incremental net benefits, of going from a TWA PEL of 0.5 mug/m\3\ to the proposed TWA PEL of 0.2 mug/m\3\ and then of going from the proposed TWA PEL of 0.2 mug/m\3\ to a TWA PEL of 0.1 mug/m\3\. Table IX-20 also breaks out costs by provision and benefits by type of disease and by morbidity/mortality.

      OSHA has not made a determination that a TWA PEL of 0.1 mug/m\3\ would be feasible for all application groups (that is, engineering and work practices would be sufficient to reduce and maintain beryllium exposures to a TWA PEL of 0.1 mug/m\3\ or below in most operations most of the time in the affected industries). For Regulatory Alternative #4, the Agency attempted to identify engineering controls and their costs for those affected application groups where the technology feasibility analysis in Chapter IV of the PEA indicated that a TWA PEL of 0.1 mug/m\3\ could be achieved. For those application groups, OSHA costed out the set of feasible controls necessary to meet this alternative PEL. For the rest of the affected application groups, OSHA assumed that all workers exposed between 0.2 mug/m\3\ and 0.1 mug/m\3\ would have to wear respirators to achieve compliance with the 0.1 mug/m\3\ TWA PEL and estimated the associated additional costs for respiratory protection. For all affected industries, OSHA also estimated the costs to satisfy the ancillary requirements specified in the proposed rule for all affected workers under the alternative TWA PEL of 0.1 mug/m\3\. For both controls and respirators, the unit costs were the same as presented in Chapter V of the PEA.

      The estimated benefits for Regulatory Alternative #4 were calculated based on the number of workers identified with exposures between 0.1 and 0.2 mug/m\3\, using the methods and unit benefit values developed in Chapter VII of the PEA.

      As Table IX-20 shows, going from a TWA PEL of 0.5 mug/m\3\ to a TWA PEL of 0.2 mug/m\3\ would prevent, annually, an additional 29 beryllium-related fatalities and an additional 15 non-fatal illnesses. This is consistent with OSHA's preliminary risk assessment, which indicates significant risk to workers exposed at a TWA PEL of 0.5 mug/m\3\; furthermore, OSHA's preliminary feasibility analysis indicates that a lower TWA PEL than 0.5 mug/m\3\ is feasible. Net benefits of this regulatory alternative versus the proposed TWA PEL of 0.2 mug/m\3\ would decrease from $538.2 million to $370.0 million using a 3 percent discount rate and from $216.2 million to $144.4 million using 7 percent discount rate.

      Table IX-20 also shows the costs and benefits of going from the proposed TWA PEL of 0.2 mug/m\3\ to a TWA PEL of 0.1 mug/m\3\. As shown there, going from a TWA PEL of 0.2 mug/m\3\ to a TWA PEL of 0.1 mug/m\3\ would prevent an additional 2 beryllium-related fatalities and 1 additional non-fatal illness. Net benefits of this regulatory alternative versus the proposed TWA PEL of 0.2 mug/m\3\ would increase from $538.2 million to $543.5 million using a 3 percent discount rate and decrease from $216.2 million to $214.9 million using a 7 percent discount rate.

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      Informational Alternative Featuring Unchanged PEL but Full Ancillary Provisions

      An Informational Analysis: This proposed regulation has the somewhat unusual feature for an OSHA substance-specific health standard that most of the quantified benefits would come from the ancillary provisions rather than from meeting the PEL with engineering controls. OSHA decided to analyze for informational purposes the effect of retaining the existing PEL but applying all of the ancillary provisions, including respiratory protection. Under this approach, the TWA PEL would remain at 2.0 micrograms per cubic meter, but all of the other proposed provisions (including respiratory protection, which OSHA does not consider an ancillary provision) would be required with their triggers remaining the same as in the proposed rule--either the presence of airborne beryllium at any level (e.g., initial monitoring, written exposure control plan), at certain kinds of dermal exposure (PPE), at the action level of 0.1 mug/m\3\ (e.g., periodic monitoring, medical removal), or at 0.2 mug/m\3\ (e.g., regulated areas, respiratory protection, medical surveillance).

      Given the record regarding beryllium exposures, this approach is not one OSHA could legally adopt because the absence of a more protective requirement for engineering controls would not be consistent with section 6(b)(5) of the OSH Act, which requires OSHA to ``set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.'' For that reason, this additional analysis is provided strictly for informational purposes. E.O. 12866 and E.O. 13563 direct agencies to identify approaches that maximize net benefits, and this analysis is purely for the purpose of exploring whether this approach would hold any real promise to maximize net benefits if it was permissible under the OSH Act. It does not appear to hold such promise because an ancillary-provisions-only approach would not be as protective and thus offers fewer benefits than one that includes a lower PEL and engineering controls, and OSHA estimates the costs would be about the same (or slightly lower, depending on certain assumptions) under that approach as under the traditional proposed approach.

      On an industry by industry basis, OSHA found that some industries would have lower costs if they could adopt the ancillary-provisions-

      only approach. Some employers would use engineering controls where they are cheaper, even if they are not mandatory. OSHA does not have sufficient information to do an analysis of the employer-by-employer situations in which there exist some employers for whom the ancillary-

      provisions-only approach might be cheaper. In the majority of affected industries, the Agency estimates there are no costs saving to the ancillary-provisions-only approach. However, OSHA estimates a total of $2,675,828 per year in costs saving for entire industries where the ancillary-provisions-only approach would be less expensive.

      The above discussion does not account for the possibility that the lack of engineering controls would result in higher beryllium exposures for workers in adjacent (non-production) work areas due to the increased level of beryllium in the air. Because of a lack of data, and because the issue did not arise in the other regulatory alternatives OSHA considered (all of which have a PEL of less than 2.0 mug/m\3\), OSHA did not carefully examine exposure levels in non-production areas for either cost or benefit purposes. To the extent such exposure levels would be above the action level, there would be additional costs for respiratory protection.

      The ancillary-provisions-only approach adds uncertainty to the benefits analysis such that the benefits of the rule as proposed may exceed, and perhaps greatly exceed, the benefits of this ancillary-

      provisions-only approach:

      (1) Most exposed individuals would be in respirators, which OSHA considers less effective than engineering controls in preventing employee exposure to beryllium. OSHA last did an extensive review of the evidence on effectiveness of respirators for its APFs rulemaking in 2006 (71 FR 50128-45, August 24, 2006). OSHA has not in the past tried to quantify the size of this effect, but it could partially negate the estimated benefits of 92 CBD deaths prevented per year and 4 lung cancer cases prevented per year by the proposed standard.

      (2) As noted above, in the proposal OSHA did not consider benefits caused by reductions in exposure in non-production areas. Unless employers act to reduce exposures in the production areas, the absence of a requirement for such controls would largely negate such benefits from reductions in exposure in the non-productions areas.

      (3) OSHA believes that there is a strong possibility that the benefits of the ancillary provisions (a midpoint estimate of eliminating 45 percent of all remaining cases of CBD) would be partially or wholly negated in the absence of engineering controls that would reduce both airborne and surface dust levels. The measured reduction in benefits from ancillary provision was in a facility with average exposure levels of less than 0.2 mug/m\3\.

      Based on these considerations, OSHA believes that the ancillary-

      provisions-only approach is not one that is likely to maximize net benefits. The costs saving, if any, are estimated to be small, and the difficult-to-measure declines in benefits could be substantial.

      3. A Method-of-Compliance Alternative

      Paragraph (f)(2) of the proposed rule contains requirements for the implementation of engineering and work practice controls to minimize beryllium exposures in beryllium work areas. For each operation in a beryllium work area, employers must ensure that at least one of the following engineering and work practice controls is in place to minimize employee exposure: Material and/or process substitution; ventilated enclosures; local exhaust ventilation; or process controls, such as wet methods and automation. Employers are exempt from using engineering and work practice controls only when they can show that such controls are not feasible or where exposures are below the action level based on two exposure samples taken seven days apart.

      These requirements, which are based on the stakeholders' recommended beryllium standard that beryllium industry and union stakeholders submitted to OSHA in 2012 (Materion and United Steelworkers, 2012), address a concern associated with the proposed TWA PEL. OSHA expects that day-to-day changes in workplace conditions, such as workers' positioning or patterns of airflow, may cause frequent exposures above the TWA PEL in workplaces where periodic sampling indicates exposures are between the action level and the TWA PEL. As a result, the default under the standard is that the controls are required until the employer can demonstrate that exposures have not exceeded the action level from at least two separate measurements taken seven days apart.

      OSHA believes that substitution or engineering controls such as those outlined in paragraph (f)(2)(i) provide the most reliable means to control variability in exposure levels. However, OSHA also recognizes that the requirements of paragraph (f)(2)(i) are

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      not typical of OSHA standards, which usually require engineering controls only where exposures exceed the TWA PEL or STEL. The Agency is therefore considering Regulatory Alternative #6, which would drop the provisions of (f)(2)(i) from the proposed standard and make conforming edits to paragraphs (f)(2)(ii) and (iii). This regulatory alternative does not eliminate the need for engineering controls to comply with the proposed TWA PEL and STEL, but does eliminate the requirement to use one or more of the specified engineering or work practice controls where exposures equal or exceed the action level. As shown in Table IX-

      21, Regulatory Alternative #6 would decrease the annualized cost of the proposed rule by about $457,000 using a discount rate of 3 percent and by about $480,000 using a discount rate of 7 percent. OSHA has not been able to estimate the change in benefits resulting from Regulatory Alternative #6 at this time and invites public comment on this issue.

      GRAPHIC TIFF OMITTED TP07AU15.034

      4. Regulatory Alternatives That Affect Ancillary Provisions

      The proposed standard contains several ancillary provisions (provisions other than the exposure limits), including requirements for exposure assessment, medical surveillance, medical removal, training, and regulated areas or access control. As reported in Chapter V of the PEA, these ancillary provisions account for $27.8 million (about 72 percent) of the total annualized costs of the rule ($37.6 million) using a 3 percent discount rate, or $28.6 million (about 73 percent) of the total annualized costs of the rule ($39.1 million) using a 7 percent discount rate. The most expensive of the ancillary provisions are the requirements for housekeeping and training, with annualized costs of $12.6 million and $5.8 million, respectively, at a 3 percent discount rate ($12.9 million and $5.8 million, respectively, at a 7 percent discount rate).

      OSHA's reasons for including each of the proposed ancillary provisions are explained in Section XVIII of this preamble, Summary and Explanation of the Standards.

      In particular, OSHA is proposing the requirements for exposure assessment to provide a basis for ensuring that appropriate measures are in place to limit worker exposures. Medical surveillance is especially important because workers exposed above the proposed TWA PEL, as well as many workers exposed below the proposed TWA PEL, are at significant risk of death and illness. Medical surveillance would allow for identification of beryllium-related adverse health effects at an early stage so that appropriate intervention measures can be taken. OSHA is proposing regulated areas and access control because they serve to limit exposure to beryllium to as few employees as possible. OSHA is proposing worker training to ensure that employers inform employees of the hazards to which they are exposed, along with associated protective measures, so that employees understand how they can minimize their exposure to beryllium. Worker training on beryllium-related work practices is particularly important in controlling beryllium exposures because engineering controls frequently require action on the part of workers to function effectively.

      OSHA has examined a variety of regulatory alternatives involving changes to one or more of the proposed ancillary provisions. The incremental cost of each of these regulatory alternatives and its impact on the total costs of the proposed rule is summarized in Table IX-22 at the end of this section. OSHA has preliminarily determined that several of these ancillary provisions will increase the benefits of the proposed rule, for example, by helping to ensure the TWA PEL is not exceeded or by lowering the risks to workers given the significant risk remaining at the proposed TWA PEL. However, except for Regulatory Alternative #7 (involving the elimination of all ancillary provisions), OSHA did not estimate changes in monetized benefits for the regulatory alternatives that affect ancillary provisions. Two regulatory alternatives that involve all ancillary provisions are presented below (#7 and #8), followed by regulatory alternatives for exposure monitoring (#9, #10, and #11), for regulated areas (#12), for personal

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      protective clothing and equipment (#13), for medical surveillance (#14 through #21), and for medical removal (#22).

    8. All Ancillary Provisions

      The SBAR Panel recommended that OSHA analyze a PEL-only standard as a regulatory alternative. The Panel also recommended that OSHA consider not applying ancillary provisions of the standard where exposure levels are low so as to minimize costs for small businesses (SBAR, 2008). In response to these recommendations, OSHA analyzed Regulatory Alternative #7, a PEL-only standard, and Regulatory Alternative #8, which would apply ancillary provisions of the beryllium standard only where exposures exceed the proposed TWA PEL of 0.2 mug/m\3\ or the proposed STEL of 2 mug/m\3\.

      Regulatory Alternative #7 would solely update 1910.1000 Tables Z-1 and Z-2, so that the proposed TWA PEL and STEL would apply to all workers in general industry. This alternative would eliminate all of the ancillary provisions of the proposed rule, including exposure assessment, medical surveillance, medical removal, PPE, housekeeping, training, and regulated areas or access control. Under this regulatory alternative, OSHA estimates that the costs for the proposed ancillary provisions of the rule (estimated at $27.8 million annually at a 3 percent discount rate) would be eliminated. In order to meet the PELs, employers would still commonly need to do monitoring, train workers on the use of controls, and set up some kind of regulated areas to indicate where respirator use would be required. It is also likely that, under this alternative, many employers would follow the recommendations of Materion and the United Steelworkers to provide medical surveillance, PPE, and other protective measures for their workers (Materion and USW, 2012). OSHA has not attempted to estimate the extent to which these ancillary-provision costs would be incurred if they were not formally required or whether any of these costs under Regulatory Alternative #7 would reasonably be attributable to the proposed rule. OSHA welcomes comment on the issue.

      OSHA has also estimated the effect of this regulatory alternative on the benefits of the rule. As a result of eliminating all of the ancillary provisions, annualized benefits are estimated to decrease 57 percent, relative to the proposed rule, from $575.8 million to $249.1 million, using a 3 percent discount rate, and from $255.3 million to $110.4 million using a 7 percent discount rate. This estimate follows from OSHA's analysis of benefits in Chapter VII of the PEA, which found that about 57 percent of the benefits of the proposed rule, evaluated at their mid-point value, were attributable to the combination of the ancillary provisions. As these estimates show, OSHA expects that the benefits estimated under the proposed rule will not be fully achieved if employers do not implement the ancillary provisions of the proposed rule.

      Both industry and worker groups have recognized that a comprehensive standard is needed to protect workers exposed to beryllium. The stakeholders' recommended standard that representatives of the primary beryllium manufacturing industry and the United Steelworkers union provided to OSHA confirms the importance of ancillary provisions in protecting workers from the harmful effects of beryllium exposure (Materion and USW, 2012). Ancillary provisions such as personal protective clothing and equipment, regulated areas, medical surveillance, hygiene areas, housekeeping requirements, and hazard communication all serve to reduce the risks to beryllium-exposed workers beyond that which the proposed TWA PEL alone could achieve.

      Moreover, where there is continuing significant risk at the TWA PEL, the decision in the Asbestos case (Bldg. and Constr. Trades Dep't, AFL-CIO v. Brock, 838 F.2d 1258, 1274 (D.C. Cir. 1988)) indicated that OSHA should use its legal authority to impose additional requirements on employers to further reduce risk when those requirements will result in a greater than de minimis incremental benefit to workers' health. Nevertheless, OSHA requests comment on this alternative.

      Under Regulatory Alternative #8, several ancillary provisions that the current proposal would require under a variety of exposure conditions (e.g., dermal contact, any airborne exposure, exposure at or above the action level) would instead only apply where exposure levels exceed the TWA PEL or STEL. Regulatory Alternative #8 affects the following provisions of the proposed standard:

      --Exposure monitoring: Whereas the proposed standard requires annual monitoring when exposure levels are at or above the action level and at or below the TWA PEL, Regulatory Alternative #8 would require annual exposure monitoring only where exposure levels exceed the TWA PEL or STEL;

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

      --Housekeeping: Whereas the proposed standard's housekeeping requirements apply across a wide variety of beryllium exposure conditions, Alternative #8 would limit housekeeping requirements to areas and employees with exposures above the TWA PEL or STEL;

      --PPE: Whereas the proposed standard requires PPE for employees under a variety of conditions, such as exposure to soluble beryllium or visible contamination with beryllium, Alternative #8 would require PPE only for employees exposed above the TWA PEL or STEL;

      --Medical Surveillance: Whereas the proposed standard's medical surveillance provisions require employers to offer medical surveillance to employees with signs or symptoms of beryllium-related health effects regardless of their exposure level, Alternative #8 would require surveillance only for those employees exposed above the TWA PEL or STEL.

      To estimate the cost savings for this alternative, OSHA re-

      estimated the group of workers that would fall under the above provisions and the changes to their scope. Combining these various adjustments along with associated unit costs, OSHA estimates that, under this regulatory alternative, the costs for the proposed rule would decline from $37.6 million to $18.9 million using a 3 percent discount rate and from $39.1 million to $20.0 million using a 7 percent discount rate.

      The Agency has not quantified the impact of this alternative on the benefits of the rule. However, ancillary provisions that offer protective measures to workers exposed below the proposed TWA PEL, such as personal protective clothing and equipment, beryllium work areas, hygiene areas, housekeeping requirements, and hazard communication, all serve to reduce the risks to beryllium-exposed workers beyond that which the proposed TWA PEL and STEL could achieve. OSHA's preliminary conclusion is that the requirements triggered by the action level and other exposures below the proposed PELs will result in very real and necessary, but difficult to quantify, further reduction in risk beyond that provided by the PELs alone.

      The remainder of this section discusses additional regulatory alternatives that apply to individual

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      ancillary provisions. At this time, OSHA is not able to quantify the effects of these regulatory alternatives on benefits. The Agency solicits comment on the effects of these regulatory alternatives on the benefits of the proposed rule.

    9. Exposure Monitoring

      Paragraph (d) of the proposed standard, Exposure Monitoring, requires annual monitoring where exposures are at or above the action level and at or below the TWA PEL. It does not require periodic monitoring where exposure levels have been determined to be below the action level, or above the TWA PEL. The rationale for this provision is provided in this preamble discussion of paragraph (a) in Section XVIII, Summary and Explanation of the Proposed Standard. Below is a brief summary, followed by a discussion of three alternatives.

      Because of the variable nature of employee exposures to airborne concentrations of beryllium, maintaining exposures below the action level provides reasonable assurance that employees will not be exposed to beryllium at levels above the TWA PEL on days when no exposure measurements are made. Even when all measurements on a given day fall at or below the TWA PEL, if those measurements are still at or above the action level, there is a smaller safety margin and a greater chance that on another day, when exposures are not measured, the employee's exposure may exceed the TWA PEL. When exposure measurements are at or above the action level, the employer cannot be reasonably confident that employees have not been exposed to beryllium concentrations in excess of the TWA PEL during at least some part of the work week. Therefore, requiring periodic exposure measurements when the action level is met or exceeded provides the employer with a reasonable degree of confidence in the results of the exposure monitoring. The proposed action level that would trigger the exposure monitoring is one-half of the TWA PEL, which reflects the Agency's typical approach to setting action levels (see, e.g., Inorganic arsenic (29 CFR 1910.1018), Ethylene oxide (29 CFR 1910.1047), Benzene (29 CFR 1910.1028), and Methylene Chloride (29 CFR 1910.1052)).

      Certain other aspects of the proposed periodic monitoring requirements, which the Agency based on the stakeholders' recommended standard submitted by Materion and the United Steelworkers (Materion and USW, 2012), depart significantly from OSHA's usual exposure monitoring requirements. The proposed standard only requires annual monitoring, and does not require periodic monitoring when exposures are recorded above the TWA PEL, whereas most OSHA standards require monitoring at least every 6 months when exposure levels exceed the action level, and every 3 months when exposures are above the TWA PEL. For example, the standards for vinyl chloride (29 CFR 1910.1017), inorganic arsenic (29 CFR 1910.1018), lead (29 CFR 1910.1025), cadmium (29 CFR 1910.1027), methylene chloride (29 CFR 1910.1052), acrylonitrile (29 CFR 1910.1045), ethylene oxide (29 CFR 1910.1047), and formaldehyde (29 CFR 1910.1048), all specify periodic monitoring at least every six months when exposures are at, or above, the action level. Monitoring is required every three months when exposures exceed the TWA PEL in the standards for methylene chloride, ethylene oxide, acrylonitrile, inorganic arsenic, lead, and vinyl chloride. In the standards for cadmium, 1,3-Butadiene, formaldehyde, benzene and asbestos (29 CFR 1910.1001), monitoring is required every six months when exposures exceed the TWA PEL. In these standards, monitoring workers exposed above the TWA PEL ensures that employers know workers' exposure levels in order to select appropriate respirators and other PPE, and that records of their exposures are available if needed for medical, legal, or epidemiological purposes.

      OSHA has examined three regulatory alternatives that would modify the requirements of paragraph (d) to be more similar to OSHA's typical periodic monitoring requirements. Under Regulatory Alternative #9, employers would be required to perform periodic exposure monitoring every 180 days when exposures are at or above the action level or above the STEL, but at or below the TWA PEL. As shown in Table IX-22, Regulatory Alternative #9 would increase the annualized cost of the proposed rule by about $773,000 using either a 3 percent or 7 percent discount rate.

      Under Regulatory Alternative #10, employers would be required to perform periodic exposure monitoring every 180 days when exposures are at or above the action level or above the STEL, including where exposures exceed the TWA PEL. As shown in Table IX-22, Regulatory Alternative #10 would increase the annualized cost of the proposed rule by about $929,000 using either a 3 percent or 7 percent discount rate.

      Under Regulatory Alternative #11, employers would be required to perform periodic exposure monitoring every 180 days when exposures are at or above the action level, and every 90 days where exposures exceed the TWA PEL or STEL. This alternative is similar to the periodic monitoring requirements in the draft proposed rule presented to the SERs during the 2007 OSHA beryllium SBAR Panel process. Of the exposure monitoring alternatives, it is also the most similar to the exposure monitoring provisions of most other 6(b)(5) standards. As shown in Table IX-22, Regulatory Alternative #11 would increase the annualized cost of the proposed rule by about $1.07 million using either a 3 percent or 7 percent discount rate.

    10. Regulated Areas

      Proposed paragraph (e) requires employers to establish and maintain beryllium work areas wherever employees are exposed to airborne beryllium, regardless of the level of exposure, and regulated areas wherever airborne concentrations of beryllium exceed the TWA PEL or STEL. Employers are required to demarcate beryllium work areas and regulated areas and limit access to regulated areas to authorized persons.

      The SBAR Panel report recommended that OSHA consider dropping or limiting the provision for regulated areas (SBAR, 2008). In response to this recommendation, OSHA examined Regulatory Alternative #12, which would eliminate the requirement that employers establish regulated areas. This alternative is meant only to eliminate the requirement to set up and demarcate specific physical areas: All ancillary provisions would be triggered by the same conditions as under the standard's definition of a ``regulated area.'' For example, under the current proposal, employees who work in regulated areas for at least 30 days annually are eligible for medical surveillance. If OSHA were to remove the requirement to establish regulated areas, the medical surveillance provisions would be altered so that employees who work more than 30 days annually in jobs or areas with exposures that exceed the TWA PEL or STEL are eligible for medical surveillance. This alternative would not eliminate the proposed requirement to establish beryllium work areas. As shown in Table IX-22, Regulatory Alternative #12 would decrease the annualized cost of the proposed rule by about $522,000 using a 3 percent discount rate, and by about $523,000 using a 7 percent discount rate.

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    11. Personal Protective Clothing and Equipment

      Regulatory Alternative #13 would modify the requirements for personal protective equipment (PPE) by requiring appropriate PPE whenever there is potential for skin contact with beryllium or beryllium-contaminated surfaces. This alternative would be broader, and thus more protective, than the PPE requirement in the proposed standard, which requires PPE to be used in three circumstances: (1) Where exposure exceeds the TWA PEL or STEL; (2) where employees' clothing or skin may become visibly contaminated with beryllium; and (3) where employees may have skin contact with soluble beryllium compounds. These PPE requirements were based on the stakeholders' recommended standard that Materion and the United Steelworkers submitted to the Agency (Materion and USW, 2012).

      The proposed rule's requirement to use PPE where work clothing or skin may become ``visibly contaminated'' with beryllium differs from prior standards, which do not require contamination to be visible in order for PPE to be required. While OSHA's language regarding PPE requirements varies somewhat from standard to standard, previous standards tend to emphasize potential for contact with a substance that can trigger health effects via dermal exposure, rather than ``visible contamination'' with the substance. For example, the standard for chromium (VI) requires the employer to provide appropriate PPE where a hazard is present or is likely to be present from skin or eye contact with chromium (VI) (29 CFR 1910.1026). The lead and cadmium standards require PPE where employees are exposed above the PEL or where there is potential for skin or eye irritation, regardless of airborne exposure level. Under the Methylenedianiline (MDA) standard (29 CFR 1910.1050), PPE must be provided where employees are subject to dermal exposure to MDA, where liquids containing MDA can be splashed into the eyes, or where airborne concentrations of MDA are in excess of the PEL.

      OSHA requests comment on the proposed PPE requirements in Regulatory Alternative #13, which would modify the proposed PPE requirements to be similar to the chromium (VI), lead, cadmium, and MDA standards. Because small beryllium particles can pass through intact or broken skin and cause sensitization, limiting the requirements for PPE based on surfaces that are ``visibly contaminated'' may not adequately protect workers from beryllium exposure. Submicron particles (less than 1 mug in diameter) are not visible to the naked eye and yet may pass through the skin and cause beryllium sensitization. Although solubility may play a role in the level of sensitization risk, the available evidence suggests that contact with insoluble, as well as soluble, beryllium can cause sensitization via dermal contact (see this preamble at Section V, Health Effects). Sensitized workers are at significant risk of developing CBD (see this preamble at Section V, Health Effects, and Section VIII, Significance of Risk).

      To estimate the cost of Regulatory Alternative #13, OSHA assumed that all at-risk workers, except administrative occupations, would require protective clothing and a pair of work gloves that would need to be replaced annually. The economic analysis of the proposed standard already contained costs for protective clothing for all employees whose clothing might be contaminated by beryllium (the analysis assumed that all clothing contamination would be visible, or the clothing is already provided even if not required by this standard) and gloves for many jobs where workers were expected to be exposed to visible contamination or soluble beryllium; thus OSHA estimated the cost of this alternative as the cost of providing gloves for the remainder of the jobs where workers have potential for skin exposure even in the absence of visible contamination. As shown in Table IX-22, Regulatory Alternative #13 would increase the annualized cost of the proposed rule by about $138,000 using either a 3 percent or 7 percent discount rate.

    12. Medical Surveillance

      The proposed requirements for medical surveillance include: (1) Medical examinations, including a test for beryllium sensitization, for employees who are exposed to beryllium in a regulated area (i.e., above the proposed TWA PEL or STEL) for 30 days or more per year, who are exposed to beryllium in an emergency, or who show signs or symptoms of CBD; and (2) CT scans for employees who were exposed above the proposed TWA PEL or STEL for more than 30 days in a 12-month period for 5 years or more. The proposed standard would require annual medical exams to be provided for employees exposed in a regulated area for 30 days or more per year and for employees showing signs or symptoms of CBD, while tests for beryllium sensitization and CT scans would be provided to eligible employees biennially.

      OSHA estimated in Chapter V of the PEA that the medical surveillance requirements would apply to 4,528 workers in general industry, of whom 387 already receive that surveillance.\43\ In Chapter V, OSHA estimated the costs of medical surveillance for the remaining 4,141 workers who would now have such protection due to the proposed standard. The Agency's preliminary analysis indicates that 4 workers with beryllium sensitization and 6 workers with CBD will be referred to pulmonary specialists annually as a result of this medical surveillance. Medical surveillance is particularly important for this rule because beryllium-exposed workers, including many workers exposed below the proposed PELs, are at significant risk of illness. OSHA did not estimate, and the benefits analysis does not include, monetized benefits resulting from early discovery of illness.

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      \43\ See current compliance rates for medical surveillance in Chapter V of the PEA, Table V-15.

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      OSHA has examined eight regulatory alternatives (#14 through #21) that would modify the proposed rule's requirements for employee eligibility, the tests that must be offered, and the frequency of periodic exams. Medical surveillance was a subject of special concern to SERs during the SBAR Panel process, and the SBAR Panel offered many comments and recommendations related to medical surveillance for OSHA's consideration. Some of the Panel's concerns have been partially addressed in this proposal, which was modified since the SBAR Panel was convened (see this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, for more detailed discussion). Several of the regulatory alternatives presented here (#16, #18, and #20) also respond to recommendations by the SBAR Panel to reduce burdens on small businesses by dropping or reducing the frequency of medical surveillance requirements. OSHA is also considering several additional regulatory alternatives that would increase the frequency of surveillance or the range of employees covered by medical surveillance (#14, #15, #17, #19, and #21).

      OSHA has preliminarily determined that a significant risk of beryllium sensitization, CBD, and lung cancer exists at exposure levels below the proposed TWA PEL and that there is evidence that beryllium sensitization can occur even from short-term exposures (see this preamble at Section V, Health Effects, and Section VIII,

      Page 47745

      Significance of Risk). The Agency therefore anticipates that more employees would develop adverse health effects without receiving the benefits of early intervention in the disease process because they are not eligible for medical surveillance (see this preamble at Section V, Health Effects).

      OSHA is considering three regulatory alternatives that would expand eligibility for medical surveillance to a broader group of employees than those eligible under the proposed standard. Under Regulatory Alternative #14, medical surveillance would be available to employees who are exposed to beryllium above the proposed TWA PEL or STEL, including employees exposed for fewer than 30 days per year. Regulatory Alternative #15 would expand eligibility for medical surveillance to employees who are exposed to beryllium above the proposed action level, including employees exposed for fewer than 30 days per year. Regulatory Alternative #21 would extend eligibility for medical surveillance as set forth in proposed paragraph (k) to all employees in shipyards, construction, and general industry who meet the criteria of proposed paragraph (k)(1). However, all other provisions of the standard would be in effect only for employers and employees that fall within the scope of the proposed rule. Each of these alternatives would provide surveillance to fewer workers (and cost less to employers) than the draft proposed rule presented to SERs during the SBAR Panel process, which included skin contact as a trigger and would therefore cover most beryllium-exposed workers in general industry, construction, and maritime. These alternatives would provide more surveillance (and cost more to employers) than the medical surveillance requirements in the current proposal.

      To estimate the cost of Regulatory Alternative #14, OSHA assumed that 1 person would enter regulated areas for less than 30 days a year for every 4 people working in regulated areas on a regular basis. Thus, this alternative includes costs for an incremental number of annual medical exams equal to 25 percent of the number of workers estimated to be working in regulated areas after the standard is promulgated. As shown in Table IX-22, Regulatory Alternative #14 would increase the annualized cost of the proposed rule by about $38,000 using either a 3 percent or 7 percent discount rate.

      To estimate the cost of Regulatory Alternative #15, OSHA assumed that all workers exposed above the action level before the standard would continue to be exposed after the standard is promulgated. OSHA also assumed that 1 person would enter areas exceeding the action level for fewer than 30 days a year for every 4 people working in an area exceeding the action level on a regular basis. Thus, this alternative includes costs for medical exams for the number of workers exposed between the action level and the TWA PEL as well as an incremental 25 percent of all workers exposed above the action level. As shown in Table IX-22, Regulatory Alternative #15 would increase the annualized cost of the proposed rule by about $3.9 million using a discount rate of 3 percent, and by about $4.0 million using a discount rate of 7 percent.

      For Alternative #21, OSHA is considering two different scenarios to estimate costs: One where the TWA PEL for the groups outside the scope of the proposed standard changes from 2 mug/m\3\ to 0.2 mug/m\3\, as in Regulatory Alternative #2; and one where the TWA PEL remains at the current level of 2.0 mug/m\3\. For costing purposes, these have been designated as Regulatory Alternative #21a and Regulatory Alternative #21b, respectively.

      For Regulatory Alternative #21a, medical surveillance above the proposed TWA PEL of 0.2, OSHA estimated the cost of extending medical surveillance to workers in aluminum production, abrasive blasting in construction, maritime abrasive blasting, maritime welding, and coal fired power plants, assuming that all feasible controls are in place to reduce exposures to the proposed TWA PEL of 0.2 mug/m\3\ or lower. OSHA did not include control costs to achieve compliance with a TWA PEL of 0.2 mug/m\3\, as these costs were addressed in Regulatory Alternative #2. (For a summary of the estimates of affected workers and the exposure profile, see the discussion accompanying Regulatory Alternative # 2.) As shown in Table IX-22, Regulatory Alternative #21a would increase the annualized cost of the proposed rule by about $4.4 million using a 3-percent discount rate and $4.5 million using a 7-

      percent discount rate.

      For Alternative #21b, medical surveillance above the current TWA PEL of 2.0 mug/m\3\, OSHA estimated that all abrasive blasters in construction and shipyards who are currently above the current TWA PEL of 2.0 mug/m\3\would be eligible for medical surveillance. As discussed under alternative #2, outside of abrasive blasting, OSHA has identified a small group of maritime welders who may be exposed to beryllium above the current TWA PEL in their work. Of these workers, 90 percent would be below the current TWA PEL if their employers instituted all feasible engineering and work practice controls to meet the existing standard. If they came into compliance with the current PELs, they would not be required to offer employees medical surveillance under Alternative #21b. OSHA estimated that the other 10 percent of these maritime welders, and 10 percent of workers in primary aluminum production and coal-fired power generation, with all feasible engineering controls and work practices in place, would still be exposed above the current TWA PEL and would be eligible for medical surveillance under Alternative #21b. OSHA's customary method in preparing an economic analysis of a new standard is to cost out the incremental cost of the new standard assuming full compliance with existing standards. Finally, OSHA estimated that 15 percent of the workers excluded from the scope of the proposed standard absent the alternative would show signs and symptoms of CBD or be exposed in emergencies, and so would be eligible for medical surveillance. As shown in Table IX-22, under these assumptions Regulatory Alternative #21b would increase the annualized cost of the proposed rule by about $3.0 million using a 3-percent discount rate and $3.1 million using a 7-percent discount rate. The Agency notes that, as abrasive blasters are the primary application group with beryllium exposure in construction and shipyards, it is unlikely that as many as 15 percent of other workers would show signs and symptoms of beryllium exposure or be exposed to beryllium in an emergency. Thus, OSHA believes the stated cost of about $3.0 million may overestimate the true costs for this alternative and invites comment on this issue.

      In response to concerns raised during the SBAR Panel process about testing requirements, OSHA is considering two regulatory alternatives that would provide greater flexibility in the program of tests provided as part of an employer's medical surveillance program. Under Regulatory Alternative #16, employers would not be required to offer employees testing for beryllium sensitization. As shown in Table IX-22, this alternative would decrease the annualized cost of the proposed rule by about $710,000 using a discount rate of 3 percent, and by about $724,000 using a discount rate of 7 percent.

      Regulatory Alternative #18 would eliminate the CT scan requirement from the proposed rule. This alternative would decrease the annualized cost of

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      the proposed rule by about $472,000 using a discount rate of 3 percent, and by about $481,000 using a discount rate of 7 percent.

      OSHA is considering several alternatives to the proposed frequency of sensitization testing, CT scans, and general medical examinations. The frequency of periodic medical surveillance is an important factor in the efficacy of the surveillance in protecting worker health. Regular, appropriately frequent medical surveillance promotes awareness of beryllium-related health effects and early intervention in disease processes among workers. In addition, the longer the time interval between when a worker becomes sensitized and when the worker's case is identified in the surveillance program, the more difficult it will be to identify and address the exposure conditions that led to sensitization. Therefore, reducing the frequency of sensitization testing would reduce the usefulness of the surveillance information in identifying problem areas and reducing risks to other workers. These concerns must be weighed against the costs and other burdens of surveillance.

      Regulatory alternative #17 would require employers to offer annual testing for beryllium sensitization to eligible employees, as in the draft proposal presented to the SBAR Panel. As shown in Table IX-22, this alternative would increase the annualized cost of the proposed rule by about $392,000 using a discount rate of 3 percent, and by about $381,000 using a discount rate of 7 percent.

      Regulatory Alternative #19 would similarly increase the frequency of periodic CT scans from biennial to annual scans, increasing the annualized cost of the proposed rule by about $459,000 using a discount rate of 3 percent, and by about $450,000 using a discount rate of 7 percent.

      Finally, under Regulatory Alternative #20, employers would only have to provide all periodic components of the medical surveillance exams biennially to eligible employees. This alternative would decrease the annualized cost of the proposed rule by about $446,000 using a discount rate of 3 percent and by about $433,000 using a discount rate of 7 percent.

    13. Medical Removal

      Under paragraph (l) of the proposed standard, Medical Removal, employees in jobs with exposure at or above the action level become eligible for medical removal when they are diagnosed with CBD or confirmed positive for beryllium sensitization. When an employee chooses removal, the employer is required to remove the employee to comparable work in an environment where beryllium exposure is below the action level if such work is available and the employee is either already qualified or can be trained within one month. If comparable work is not available, paragraph (l) would require the employer to place the employee on paid leave for six months or until comparable work becomes available (whichever comes first). Or, rather than choosing removal, an eligible employee could choose to remain in a job with exposure at or above the action level and wear a respirator. The proposed medical removal protection (MRP) requirements are based on the stakeholders' recommended beryllium standard that representatives of the beryllium production industry and the United Steelworkers union submitted to OSHA in 2012 (Materion and USW, 2012).

      The scientific information on effects of exposure cessation is limited at this time, but the available evidence suggests that removal from exposure can be beneficial for individuals who are sensitized or have early-stage CBD (see this preamble at Section VIII, Significance of Risk). As CBD progresses, symptoms become serious and debilitating. Steroid treatment is less effective at later stages, once fibrosis has developed (see this preamble at Section VIII, Significance of Risk). Given the progressive nature of the disease, OSHA believes it is reasonable to conclude that removal from exposure to beryllium will benefit sensitized employees and those with CBD. Physicians at National Jewish Health, one of the main CBD research and treatment sites in the US, ``consider it important and prudent for individuals with beryllium sensitization and CBD to minimize their exposure to airborne beryllium,'' and ``recommend individuals diagnosed with beryllium sensitization and CBD who continue to work in a beryllium industry to have exposure of no more than 0.01 micrograms per cubic meter of beryllium as an 8-hour time-weighted average'' (NJMRC, 2013). However, OSHA is aware that MRP may prove costly and burdensome for some employers and that the scientific literature on the effects of exposure cessation on the development of CBD among sensitized individuals and the progression from early-stage to late-stage CBD is limited.

      The SBAR Panel report included a recommendation that OSHA give careful consideration to the impacts that an MRP requirement could have on small businesses (SBAR, 2008). In response to this recommendation, OSHA analyzed Regulatory Alternative #22, which would remove the proposed requirement that employers offer MRP. As shown in Table IX-22, this alternative would decrease the annualized cost of the proposed rule by about $149,000 using a discount rate of 3 percent, and by about $166,000 using a discount rate of 7 percent.

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      5. Timing

      As proposed, the new standard would become effective 60 days following publication in the Federal Register. The majority of employer duties in the standard would become enforceable 90 days following the effective date. Change rooms, however, would not be required until one year after the effective date, and the deadline for engineering controls would be no later than two years after the effective date.

      OSHA invites suggestions for alternative phase-in schedules for engineering controls, medical surveillance, and other provisions of the standard. Although OSHA did not explicitly develop or quantitatively analyze any other regulatory alternatives involving longer-term or more complex phase-ins of the standard (possibly involving more delayed implementation dates for small businesses), some general outcomes are likely. For example, a longer phase-in time would have several advantages, such as reducing initial costs of the standard or allowing employers to coordinate their environmental and occupational safety and health control strategies to minimize potential costs. However, a longer phase-in would also postpone and reduce the benefits of the standard. Suggestions for alternatives may apply to specific industries (e.g., industries where first-year or annualized cost impacts are highest), specific size-classes of employers (e.g., employers with fewer than 20 employees), combinations of these factors, or all firms covered by the rule.

      OSHA requests comments on all these regulatory alternatives, including the Agency's regulatory alternatives presented above, the Agency's analysis of these alternatives, and whether there are other regulatory alternatives the Agency should consider.

  29. Initial Regulatory Flexibility Analysis

    The Regulatory Flexibility Act, as amended in 1996, requires the preparation of an Initial Regulatory Flexibility Analysis (IRFA) for proposed rules where there would be a significant economic impact on a substantial number of small entities. (5 U.S.C. 601-612). Under the provisions of the law, each such analysis shall contain:

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    1. A description of the impact of the proposed rule on small entities;

    2. A description of the reasons why action by the agency is being considered;

    3. A succinct statement of the objectives of, and legal basis for, the proposed rule;

    4. A description of and, where feasible, an estimate of the number of small entities to which the proposed rule will apply;

    5. A description of the projected reporting, recordkeeping, and other compliance requirements of the proposed rule, including an estimate of the classes of small entities which will be subject to the requirements and the type of professional skills necessary for preparation of the report or record;

    6. An identification, to the extent practicable, of all relevant Federal rules which may duplicate, overlap, or conflict with the proposed rule;

    7. A description and discussion of any significant alternatives to the proposed rule which accomplish the stated objectives of applicable statutes and which minimize any significant economic impact of the proposed rule on small entities, such as:

    (a) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities;

    (b) The clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities;

    (c) The use of performance rather than design standards; and

    (d) An exemption from coverage of the rule, or any part thereof, for such small entities.

    5 U.S.C. 603, 607. The Regulatory Flexibility Act further states that the required elements of the IRFA may be performed in conjunction with, or as part of, any other agenda or analysis required by any other law if such other analysis satisfies the provisions of the IRFA. 5 U.S.C. 605.

    While a full understanding of OSHA's analysis and conclusions with respect to costs and economic impacts on small entities requires a reading of the complete PEA and its supporting materials, the IRFA summarizes the key aspects of OSHA's analysis as they affect small entities.

    1. A Description of the Impact of the Proposed Rule on Small Entities

    Section IX.F of this preamble summarized the impacts of the proposed rule on small entities. Table IX-9 showed costs as a percentage of profits and revenues for small entities, classified as small by the Small Business Administration, and Tables IX-10 showed costs as a percentage of revenues and profits for business entities with fewer than 20 employees. (The costs in these tables were annualized using a discount rate of 3 percent.)

    2. A Description of the Reasons Why Action by the Agency Is Being Considered

    Chronic beryllium disease (CBD) is a hypersensitivity, or allergic reaction, to beryllium that leads to a chronic inflammatory disease of the lungs. It takes months to years after initial beryllium exposure before signs and symptoms of CBD occur. Removing an employee with CBD from the beryllium source does not always lead to recovery. In some cases CBD continues to progress following removal from beryllium exposure. CBD is not a chemical pneumonitis but an immune-mediated granulomatous lung disease. OSHA's preliminary risk assessment, presented in Section VI of this preamble, indicates that there is significant risk of beryllium sensitization and chronic beryllium disease from a 45-year (working life) exposure to beryllium at the current TWA PEL of 2 mug/m\3\. The risk assessment further indicates that there is significant risk of lung cancer to workers exposed to beryllium at the current TWA PEL of 2 mug/m\3\. The proposed standard, with a lower PEL of .2 mug/m\3\, will help to address these health concerns.

    For CBD to occur, an employee must first become sensitized (i.e., allergic) to beryllium. Once an employee is sensitized, inhaled beryllium that deposits and persists in the lung may trigger a cell-

    mediated immune response (i.e., hypersensitivity reaction) that results in the formation of a type of lung scarring known as a granuloma. The granuloma consists of a localized mass of immune and inflammatory cells that have formed around a beryllium particle lodged in the interstitium, which is tissue between the air sacs that can be affected by fibrosis or scarring. With time, the granulomas spread and can lead to chronic cough, shortness of breath (especially upon exertion), fatigue, abnormal pulmonary function, and lung fibrosis.

    While CBD primarily affects the lungs, it can also involve other organs such as the liver, skin, spleen, and kidneys. As discussed in more detail in this preamble, some studies demonstrate that sensitization and CBD cases have occurred in workplaces that use a wide range of beryllium compounds, including several beryllium salts, refined beryllium metal, beryllium oxide, and the beryllium alloys. While water-soluble and insoluble beryllium compounds have the potential to cause sensitization, it has been suggested that CBD is the result of occupational exposure to beryllium oxide and other water-

    insoluble berylliums rather than exposure to water-soluble beryllium or beryllium ores. However, there are inadequate data, at this time, on employees selectively exposed to specific beryllium compounds to eliminate a potential CBD concern for any particular form of this metal. Regardless of the type of beryllium compound, in order to cause respiratory disease the inhaled beryllium must contain particulates that are small enough to reach the bronchoalveolar region of the lung where the disease takes place (OSHA, 2007).

    Some research suggests that skin exposure to small beryllium particles or beryllium-containing solutions may also lead to sensitization (Tinkle et al., 2003). These additional risk factors may explain why some individuals with seemingly brief, low level exposure to airborne beryllium become sensitized while others with long-term high exposures do not. Other studies indicate that even though employees sensitized to beryllium do not exhibit clinical symptoms, their immune function is altered such that inhalation to previously safe levels of beryllium can now trigger serious lung disease (Kreiss et al., 1996; Kreiss et al., 1997; Kelleher et al., 2001 and Rossman, 2001).

    In the 1980s, the laboratory blood test known as the BeLPT was developed. The test substantially improved identification of beryllium-

    sensitized individuals and provides an opportunity to diagnose CBD at an early stage. The BeLPT measures the ability of immune cells (i.e., peripheral blood lymphocytes) to react with beryllium. It has been reported that the BeLPT can identify 70 to 90 percent of those sensitized with a high specificity (approximately 1 to 3 percent false positives) (Newman et al., 2001; Stange et al., 2004).

    An employee with an abnormal BeLPT (i.e., the individual is sensitized) can undergo fiber-optic bronchoscopy to obtain a lung biopsy sample from which granulomatous lung inflammation can be pathologically observed prior to the onset of symptoms. The combination of a confirmed abnormal BeLPT (that is, a second abnormal result from the BeLPT) and microscopic evidence of granuloma formation is considered diagnostic for CBD. The BeLPT assists in differentiating CBD from other granulomatous lung diseases (e.g., sarcoidosis) with similar lung

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    pathology. This pre-clinical diagnostic tool provides opportunities for early intervention that did not exist when diagnosis relied on clinical symptoms, chest x-rays, and abnormal pulmonary function (OSHA, 2007).

    The BeLPT/lung biopsy diagnostic approach has been utilized in several occupational surveys and surveillance programs over the last fifteen years. The findings have expanded scientific awareness of sensitization and CBD prevalence among beryllium employees and provided a better understanding of its work-related risk factors. Some of the more informative studies come from nuclear weapons facilities operated by the Department of Energy (Viet et al., 2000; Stange et al., 2001; DOE/HSS Report, 2006), a beryllium ceramics plant in Arizona (Kreiss et al., 1996; Henneberger et al., 2001; Cummings et al., 2007), a beryllium production plant in Ohio (Kreiss et al., 1997; Kent et al., 2001), a beryllium machining facility in Alabama (Kelleher et al., 2001; Madl et al., 2007), and a beryllium alloy plant (Shuler et al., 2005) and another beryllium processing plant (Rosenman et al., 2005), both in Pennsylvania. The prevalence of beryllium sensitization from these surveyed workforces generally ranged from 1 to 10 percent with a prevalence of CBD from 0.6 to 8 percent.

    In most of the surveys discussed above, 36-100 percent of those workers who initially tested positive with the BeLPT were diagnosed with CBD upon pathological evaluation. Most of these workers diagnosed with CBD had worked four to10 years on the job, although some were diagnosed within several months of employment. Surveys that found a high proportion (e.g., larger than 50 percent) of CBD among the sensitized employees were from facilities with a large number of employees who had been exposed to respirable beryllium for many years. It has been estimated from ongoing surveillance of sensitized individuals, with an average follow-up time of 4.5 years, that 37 percent of beryllium-exposed employees were estimated to progress to CBD (Newman et al, 2005). Another study of nuclear weapons facility employees enrolled in an ongoing medical surveillance program found that only about 20 percent of sensitized individuals employed less than five years eventually were diagnosed with CBD while 40 percent of sensitized employees employed ten years or more developed CBD (Stange et al., 2001). This observation, along with the study findings that CBD prevalence increases with cumulative exposure (described below), suggests that sensitized employees who acquire a higher lung burden of beryllium may be at greater risk of developing CBD than sensitized employees who have lesser amounts of beryllium in their lungs.

    The greatest prevalence of sensitization and CBD were reported for production processes that involve heating beryllium metal (e.g., furnace operations, hot wire pickling, and annealing) or generating and handling beryllium powder (e.g., machining, forming, firing). For example, nearly 15 percent of machinists at the Arizona beryllium ceramics plant were sensitized, compared to just 1 percent of workers who never worked in machining (Kreiss et al., 1996). A low prevalence of sensitization and CBD was reported among current employees at the Department of Energy (DOE) clean-up sites where beryllium was once used in the production of nuclear weapons (DOE/OSS, 2006). These sites have been subject to the DOE CBD-prevention programs since 1999. While the prevalence of sensitization and CBD in non-production jobs was less, cases of CBD were found among secretaries, office employees, and security guards. CBD cases have also been reported in downstream uses of beryllium such as dental laboratories and metal recycling (OSHA, 2007).

    The potential importance of respirable and ultrafine beryllium particulates in the onset of CBD is illustrated in studies of employees at a large beryllium metal, alloy, and oxide production plant in Ohio. An initial cross-sectional survey reported that the highest prevalence of sensitization and CBD occurred among workers employed in beryllium metal production, even though the highest airborne total mass concentrations of beryllium were generally among employees operating the beryllium alloy furnaces in a different area of the plant (Kreiss et al., 1997). Preliminary follow-up investigations of particle size-

    specific sampling at five furnace sites within the plant determined that the highest respirable (e.g., particles less than10 mum in diameter) and alveolar-deposited (e.g., particles less than1 mum in diameter) beryllium mass and particle number concentrations, as collected by a general area impactor device, were measured at the beryllium metal production furnaces rather than the beryllium alloy furnaces (Kent et al., 2001; McCawley et al., 2001). A statistically significant linear trend was reported between the above alveolar-

    deposited particle mass concentration and prevalence of CBD and sensitization in the furnace production areas. On the other hand, a linear trend was not found for CBD and sensitization prevalence and total beryllium mass concentration. The authors concluded that these findings suggest that alveolar-deposited particles may be a more relevant exposure metric for predicting the incidence of CBD or sensitization than the total mass concentration of airborne beryllium (OSHA, 2007).

    Several epidemiological cohort studies have reported excess lung cancer mortality among workers employed in U.S. beryllium production and processing plants during the 1930s to 1960s. The largest and most comprehensive study investigated the mortality experience of over 9,000 workers employed in seven different beryllium processing plants over a 30 year period (Ward et. al., 1992). The employees at the two oldest facilities (i.e., Lorain, OH and Reading, PA) were found to have significant excess lung cancer mortality relative to the U.S. population. These two plants were believed to have the highest exposure levels to beryllium. A different analysis of the lung cancer mortality in this cohort using various local reference populations and alternate adjustments for smoking generally found smaller, non-significant, excess mortality among the beryllium employees (Levy et al., 2002). All the cohort studies are limited by a lack of job history and air monitoring data that would allow investigation of mortality trends with beryllium exposure.

    The weight of evidence indicates that beryllium compounds should be regarded as potential occupational lung carcinogens, and OSHA has regulated it since 1974. Other organizations, such as the International Agency for Research on Cancer (IARC), the National Toxicology Program (NTP), the U.S. Environmental Protection Agency (EPA), the National Institute for Occupational Safety and Health (NIOSH), and the American Conference of Governmental Industrial Hygienists (ACGIH) have reached similar conclusions with respect to the carcinogenicity of beryllium.

    3. A Statement of the Objectives of, and Legal Basis for, the Proposed Rule

    The objective of the proposed beryllium standard is to reduce the number of fatalities and illnesses occurring among employees exposed to beryllium. This objective will be achieved by requiring employers to install engineering controls where appropriate and to provide employees with the equipment, respirators, training, medical surveillance, and other protective measures to perform their jobs safely. The legal basis for the rule is the responsibility given the U.S.

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    Department of Labor through the Occupational Safety and Health Act of 1970 (OSH Act). The OSH Act provides that, in promulgating health standards dealing with toxic materials or harmful physical agents, the Secretary ``shall set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.'' 29 U.S.C. 655(b)(5). See Section II of this preamble for a more detailed discussion.

    4. A Description of, and an Estimate of, the Number of Small Entities to Which the Proposed Rule Will Apply

    OSHA has completed a preliminary analysis of the impacts associated with this proposed rule, including an analysis of the type and number of small entities to which the proposed rule would apply. In order to determine the number of small entities potentially affected by this rulemaking, OSHA used the definitions of small entities developed by the Small Business Administration (SBA) for each industry.

    The proposed standard would impact occupational exposures to beryllium in all forms, compounds, and mixtures in general industry. Based on the definitions of small entities developed by SBA for each industry, the proposal is estimated to potentially affect a total of 3,741 small entities as shown in Table IX-1 in Chapter IX of the PEA.

    The Agency also estimated costs and conducted a screening analysis for very small employers (those with fewer than 20 employees). OSHA estimates that approximately 2,875 very small entities would be affected by the proposed standard, as shown in Table III-13 in Chapter III of the PEA.

    5. A Description of the Projected Reporting, Recordkeeping, and Other Compliance Requirements of the Proposed Rule

    Tables IX-23 and IX-24 show the average costs of the proposed standard by NAICS code and by compliance requirement (PEL/STEL or ancillary provisions) for, respectively, small entities (classified as small by SBA) and very small entities (those with fewer than 20 employees). Total costs are reported as N/A for NAICS codes with no affected entities in the relevant size classification. The weighted average cost per small entity for the proposed rule would be about $8,638 annually, with PEL/STEL compliance accounting for about 23 percent of the costs and ancillary provisions accounting for about 77 percent of the costs.

    The weighted average cost per very small entity for the proposed rule would be about $2,212 annually, with PEL/STEL compliance accounting for about 39 percent of the costs and ancillary provisions accounting for about 61 percent of the costs.

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

    Section 4(b)(1) of the OSH Act exempts the working conditions for certain Federal and non-Federal employees from the provisions of the OSH Act to the extent that other Federal agencies exercise statutory authority to prescribe and enforce occupational safety and health standards. The Department of Energy (DOE) issued a regulation in 1999 entitled Chronic Beryllium Disease Prevention Program (CBDPP) (10 CFR part 850, 64 FR 68854-68914, December 8, 1999). Additionally, DOE issued 10 CFR part

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    851, Worker Safety and Health Program (71 FR 6931-6948, February 9, 2006), which establishes requirements for worker safety and health for DOE contractors at DOE sites. The CBDPP establishes a beryllium program for DOE employees and DOE contractor employees. Therefore, under Section 4(b)(1) of the OSH Act, OSHA's beryllium standard would not apply to work subject to the CBDPP. DOE has included in its regulations a requirement for compliance with any more stringent PEL established by OSHA in rulemaking (10 CFR 850.22). OSHA requests comment on the potential overlap of DOE's rule with OSHA's proposed rule. (See I. Issues and Alternatives in this preamble).

    There is also a Federal statute addressing the compensation of some employees with beryllium related illnesses--The Energy Employees Occupational Illness Compensation Program Act (EEOICPA) of 2000 and its subsequent amendments. The EEOICPA creates a Federal employees' compensation program that covers beryllium-related health effects for DOE employees and its contractor employees, including many private companies that work away from DOE sites. Several of the private companies whose employees are covered by the OSH Act, either directly in amendments to the OSH Act or identified in subsequent Department of Labor regulations on that Act, would be covered by an OSHA occupational health standard for beryllium and EEOICPA.

    There would be no conflict or duplication, however, between an OSHA standard and the EEOICPA. In general, the OSHA standard would have requirements to protect employee health in the future, and the EEOICPA provides compensation for employees who have developed beryllium-

    related illness. There is some overlap between the two in that they may both require similar medical examinations, or require employers to provide some compensation to employees, but the proposed OSHA standard specifically contemplates and addresses that overlap to avoid conflict and duplication. The explanation for proposed paragraph (k) in Section XVIII of this preamble, Summary and Explanation, notes that employers may satisfy the both examination requirements with a single examination, and the proposed standard specifies that the amount of an employer's financial obligations will be reduced by the amount of EEOICPA payments received by that employee (see proposed paragraph (l)(4)).

    7. Alternatives to the Proposed Rule Which Accomplish the Stated Objectives of Applicable Statutes and Which Minimize Any Significant Economic Impact of the Proposed Rule on Small Entities

    This section first discusses several provisions in the proposed standard that OSHA has adopted or modified based on comments from small entity representatives (SERs) during the SBREFA process or on recommendations made by the SBAR Panel as potentially alleviating impacts on small entities. Then, the Agency presents various regulatory alternatives to the proposed OSHA beryllium standard.

    1. Elements of the Proposed Rule To Reduce Impacts on Small Entities

      During the SBAR Panel, SERs requested a clearer definition of the triggers for medical surveillance. This concern was rooted in the cost of BeLPTs and the trigger of potential skin contact. For the proposed rule, the Agency has removed skin contact as a trigger for medical surveillance along with providing four clearly defined trigger mechanisms. The newly defined medical surveillance provision reduces the number of employees requiring a BeLPT, particularly for small businesses with low exposures.

      Some of the SERs in low-exposure industries wanted to be ``shielded'' from ``expensive'' compliance with a standard they perceive to be unnecessary and suggested a PEL-only standard that triggered provisions on the PEL. The alternative of a PEL-only standard and ancillary provisions triggered only by the PEL are discussed in Chapter 8 of the PEA (and is repeated in the following section).

      Some SERs were already applying many of the protective controls and practices that would be required by the ancillary provisions of the standard. However, many SERs objected to the requirements regarding hygiene facilities. For this proposed rule, OSHA has preliminarily concluded that all affected employers currently have hand washing facilities. OSHA has also preliminarily concluded that no affected employers will be required to install showers. The Agency has determined that the long-term rental of modular units was representative of costs for a range of reasonable approaches to comply with the change room part of the provision. Alternatively, employers could renovate and rearrange their work areas in order to meet the requirements of this provision.

    2. Regulatory Alternatives

      For the convenience of those persons interested only in OSHA's regulatory flexibility analysis, this section repeats the discussion of the various regulatory alternatives to the proposed OSHA beryllium standard presented in Chapter VIII of the PEA, but only for the regulatory alternatives to the proposed OSHA beryllium standard that lower costs. OSHA believes that this presentation of specific regulatory alternatives explores the possibility of less costly ways (than the proposed rule) to provide an adequate level of worker protection from exposure to beryllium.

      Each regulatory alternative presented here is described and analyzed relative to the proposed rule. Where appropriate, the Agency notes whether the regulatory alternative, to be a legitimate candidate for OSHA consideration, requires evidence contrary to the Agency's preliminary findings of significant risk and feasibility. As noted above, for this chapter on the Initial Regulatory Flexibility Analysis, the Agency is only presenting regulatory alternatives that reduce costs for small entities. (See Chapter VIII for the full list of all alternatives analysed.) There are eight regulatory alternatives and an informational alternative that reduce costs for small entities (and for all businesses in total). Using the numbering scheme from Chapter VIII, these are Regulatory Alternatives #5, #6, #7, #8. #12, #16, #18, and #22. To facilitate comment, OSHA has organized these potentially less costly regulatory alternatives (and a general discussion of possible phase-ins of the rule) into four categories: (1) Exposure limits; (2) methods of compliance; (3) ancillary provisions; and (4) timing.

      (1) Exposure limit (TWA PEL, STEL, and ACTION LEVEL) alternatives

      Regulatory Alternative #5, which would set a TWA PEL at 0.5 mug/

      m\3\ and an action level at 0.25 mug/m\3\, both higher than in the proposal, responds to an issue raised during the Small Business Advocacy Review (SBAR) process conducted in 2007 to consider a draft OSHA beryllium proposed rule that culminated in an SBAR Panel report (SBAR, 2008). That report included a recommendation that OSHA consider both the economic impact of a low TWA PEL and regulatory alternatives that would ease cost burden for small entities. OSHA has provided a full analysis of the economic impact of its proposed PELs (see Chapter VI of the PEA), and Regulatory Alternative #5

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      addresses the second half of that recommendation. However, the higher 0.5 mug/m\3\ TWA PEL does not appear to be consistent with the Agency's mandate under the OSH Act to promulgate a lower PEL if it is feasible and could prevent additional fatalities and non-fatal illnesses. The data presented in Table IX-25 below indicate that the lower TWA PEL would prevent additional fatalities and non-fatal illnesses, but nevertheless the Agency solicits comments on this alternative and OSHA's analysis of the costs and benefits associated with it.

      Table IX-25 below presents, for informational purposes, the estimated costs, benefits, and net benefits of the proposed rule under the proposed TWA PEL of 0.2 mug/m\3\ and for the regulatory alternative of a TWA PEL of 0.5 mug/m\3\ (Regulatory Alternative #5), using alternative discount rates of 3 percent and 7 percent. Table IX-

      25 also breaks out costs by provision and benefits by type of disease and by morbidity/mortality. As Table IX-25 shows, going from a TWA PEL of 0.5 mug/m\3\ to a TWA PEL of 0.2 mug/m\3\ would prevent, annually, an additional 29 beryllium-related fatalities and an additional 15 non-fatal illnesses.

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      Informational Alternative Featuring Unchanged PEL but Full Ancillary Provisions

      An Informational Analysis: This proposed regulation has the somewhat unusual feature for an OSHA substance-specific health standard that most of the quantified benefits would come from the ancillary provisions rather than from meeting the PEL with engineering controls. OSHA decided to analyze for informational purposes the effect of retaining the existing PEL but applying all of the ancillary provisions, including respiratory protection. Under this approach, the TWA PEL would remain at 2.0 micrograms per cubic meter, but all of the other proposed provisions (including respiratory protection, which OSHA does not consider an ancillary provision) would be required with their triggers remaining the same as in the proposed rule--either the presence of airborne beryllium at any level (e.g., initial monitoring, written exposure control plan), at certain kinds of dermal exposure (PPE), at the action level of 0.1 mug/m\3\ (e.g., periodic monitoring, medical removal), or at 0.2 mug/m\3\ (e.g., regulated areas, respiratory protection, medical surveillance).

      Given the record regarding beryllium exposures, this approach is not one OSHA could legally adopt because the absence of a more protective requirement for engineering controls would not be consistent with section 6(b)(5) of the OSH Act, which requires OSHA to ``set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life.'' For that reason, this additional analysis is provided strictly for informational purposes. EO 12866 and EO 13563 direct agencies to identify approaches that maximize net benefits, and this analysis is purely for the purpose of exploring whether this approach would hold any real promise to maximize net benefits if it was permissible under the OSH Act. It does not appear to hold such promise because an ancillary-provisions-only approach would not be as protective and thus offers fewer benefits than one that includes a lower PEL and engineering controls, and OSHA estimates the costs would be about the same (or slightly lower, depending on certain assumptions) under that approach as under the traditional proposed approach.

      On an industry by industry basis, OSHA found that some industries would have lower costs if they could adopt the ancillary-provisions-

      only approach. Some employers would use engineering controls where they are cheaper, even if they are not mandatory. OSHA does not have sufficient information to do an analysis of the employer-by-employer situations in which there exist some employers for whom the ancillary-

      provisions-only approach might be cheaper. In the majority of affected industries, the Agency estimates there are no costs saving to the ancillary-provisions-only approach. However, OSHA estimates a total of $2,675,828 per year in costs saving for entire industries where the ancillary-provisions-only approach would be less expensive.

      The above discussion does not account for the possibility that the lack of engineering controls would result in higher beryllium exposures for workers in adjacent (non-production) work areas due to the increased level of beryllium in the air. Because of a lack of data, and because the issue did not arise in the other regulatory alternatives OSHA considered (all of which have a PEL of less than 2.0 mug/m\3\), OSHA did not carefully examine exposure levels in non-production areas for either cost or benefit purposes. To the extent such exposure levels would be above the action level, there would be additional costs for respiratory protection.

      The ancillary-provisions-only approach adds uncertainty to the benefits analysis such that the benefits of the rule as proposed may exceed, and perhaps greatly exceed, the benefits of this ancillary-

      provisions-only approach:

      (1) Most exposed individuals would be in respirators, which OSHA considers less effective than engineering controls in preventing employee exposure to beryllium. OSHA last did an extensive review of the evidence on effectiveness of respirators for its APFs rulemaking in 2006 (71 FR 50128-45 Aug 24, 2006). OSHA has not in the past tried to quantify the size of this effect, but it could partially negate the estimated benefits of 92 CBD deaths prevented per year and 4 lung cancer cases prevented per year by the proposed standard.

      (2) As noted above, in the proposal OSHA did not consider benefits caused by reductions in exposure in non-production areas. Unless employers act to reduce exposures in the production areas, the absence of a requirement for such controls would largely negate such benefits from reductions in exposure in the non-productions areas.

      (3) OSHA believes that there is a strong possibility that the benefits of the ancillary provisions (a midpoint estimate of eliminating 45 percent of all remaining cases of CBD) would be partially or wholly negated in the absence of engineering controls that would reduce both airborne and surface dust levels. The measured reduction in benefits from ancillary provision was in a facility with average exposure levels of less than 0.2 microg/m \3\.

      Based on these considerations, OSHA believes that the ancillary-

      provisions-only approach is not one that is likely to maximize net benefits. The costs saving, if any, are estimated to be small, and the difficult-to-measure declines in benefits could be substantial.

      (2) A Method-of-compliance Alternative

      Paragraph (f)(2) of the proposed rule contains requirements for the implementation of engineering and work practice controls to minimize beryllium exposures in beryllium work areas. For each operation in a beryllium work area, employers must ensure that at least one of the following engineering and work practice controls is in place to minimize employee exposure: Material and/or process substitution; ventilated enclosures; local exhaust ventilation; or process controls, such as wet methods and automation. Employers are exempt from using engineering and work practice controls only when they can show that such controls are not feasible or where exposures are below the action level based on two exposure samples taken seven days apart.

      These requirements, which are based on the stakeholders' recommended beryllium standard that beryllium industry and union stakeholders submitted to OSHA in 2012 (Materion and USW, 2012), address a concern associated with the proposed TWA PEL. OSHA expects that day-to-day changes in workplace conditions, such as workers' positioning or patterns of airflow, may cause frequent exposures above the TWA PEL in workplaces where periodic sampling indicates exposures are between the action level and the TWA PEL. As a result, the default under the standard is that the controls are required until the employer can demonstrate that exposures have not exceeded the action level from at least two separate measurements taken seven days apart.

      OSHA believes that substitution or engineering controls such as those outlined in paragraph (f)(2)(i) provide the most reliable means to control variability in exposure levels. However, OSHA also recognizes that the requirements of paragraph (f)(2)(i) are

      Page 47760

      not typical of OSHA standards, which usually require engineering controls only where exposures exceed the TWA PEL or STEL. The Agency is therefore considering Regulatory Alternative #6, which would drop the provisions of (f)(2)(i) from the proposed standard and make conforming edits to paragraphs (f)(2)(ii) and (iii). This regulatory alternative does not eliminate the need for engineering controls to comply with the proposed TWA PEL and STEL, but does eliminate the requirement to use one or more of the specified engineering or work practice controls where exposures equal or exceed the action level. As shown in Table IX-

      26, Regulatory Alternative #6 would decrease the annualized cost of the proposed rule by about $457,000 using a discount rate of 3 percent and by about $480,000 using a discount rate of 7 percent. OSHA has not been able to estimate the change in benefits resulting from Regulatory Alternative #6 at this time and invites public comment on this issue.

      GRAPHIC TIFF OMITTED TP07AU15.042

      (3) Regulatory Alternatives That Affect Ancillary Provisions

      The proposed standard contains several ancillary provisions (provisions other than the exposure limits), including requirements for exposure assessment, medical surveillance, medical removal, training, and regulated areas or access control. As reported in Chapter V of the PEA, these ancillary provisions account for $27.8 million (about 72 percent) of the total annualized costs of the rule ($37.6 million) using a 3 percent discount rate, or $28.6 million (about 73 percent) of the total annualized costs of the rule ($39.1 million) using a 7 percent discount rate. The most expensive of the ancillary provisions are the requirements for housekeeping and training, with annualized costs of $12.6 million and $5.8 million, respectively, at a 3 percent discount rate ($12.9 million and $5.8 million, respectively, at a 7 percent discount rate).

      OSHA's reasons for including each of the proposed ancillary provisions are explained in Section XVIII of this preamble, Summary and Explanation of the Standards. In particular, OSHA is proposing the requirements for exposure assessment to provide a basis for ensuring that appropriate measures are in place to limit worker exposures. Medical surveillance is especially important because workers exposed above the proposed TWA PEL, as well as many workers exposed below the proposed TWA PEL, are at significant risk of death and illness. Medical surveillance would allow for identification of beryllium-related adverse health effects at an early stage so that appropriate intervention measures can be taken. OSHA is proposing regulated areas and access control because they serve to limit exposure to beryllium to as few employees as possible. OSHA is proposing worker training to ensure that employers inform employees of the hazards to which they are exposed, along with associated protective measures, so that employees understand how they can minimize their exposure to beryllium. Worker training on beryllium-related work practices is particularly important in controlling beryllium exposures because engineering controls frequently require action on the part of workers to function effectively.

      OSHA has examined a variety of regulatory alternatives involving changes to one or more of the proposed ancillary provisions. The incremental cost of each of these regulatory alternatives and its impact on the total costs of the proposed rule is summarized in Table IX-27 at the end of this section. OSHA has preliminarily determined that several of these ancillary provisions will increase the benefits of the proposed rule, for example, by helping to ensure the TWA PEL is not exceeded or by lowering the risks to workers given the significant risk remaining at the proposed TWA PEL. However, except for Regulatory Alternative #7 (involving the elimination of all ancillary provisions), OSHA did not estimate changes in monetized benefits for the regulatory alternatives that affect ancillary provisions. Two regulatory alternatives that involve all ancillary provisions are presented below (#7 and #8), followed

      Page 47761

      by regulatory alternatives for regulated areas (#12), for medical surveillance (#16 and #18), and for medical removal (#22).

      (a) All Ancillary Provisions

      The SBAR Panel recommended that OSHA analyze a PEL-only standard as a regulatory alternative. The Panel also recommended that OSHA consider not applying ancillary provisions of the standard where exposure levels are low so as to minimize costs for small businesses (SBAR, 2008). In response to these recommendations, OSHA analyzed Regulatory Alternative #7, a PEL-only standard, and Regulatory Alternative #8, which would apply ancillary provisions of the beryllium standard only where exposures exceed the proposed TWA PEL of 0.2 mug/m\3\ or the proposed STEL of 2 mug/m\3\.

      Regulatory Alternative #7 would solely update 1910.1000 Tables Z-1 and Z-2, so that the proposed TWA PEL and STEL would apply to all workers in general industry. This alternative would eliminate all of the ancillary provisions of the proposed rule, including exposure assessment, medical surveillance, medical removal, PPE, housekeeping, training, and regulated areas or access control. Under this regulatory alternative, OSHA estimates that the costs for the proposed ancillary provisions of the rule (estimated at $27.8 million annually at a 3 percent discount rate) would be eliminated. In order to meet the PELs, employers would still commonly need to do monitoring, train workers on the use of controls, and set up some kind of regulated areas to indicate where respirator use would be required. It is also likely that, under this alternative, many employers would follow the recommendations of Materion and the United Steelworkers to provide medical surveillance, PPE, and other protective measures for their workers (Materion and USW, 2012). OSHA has not attempted to estimate the extent to which these ancillary-provision costs would be incurred if they were not formally required or whether any of these costs under Regulatory Alternative #7 would reasonably be attributable to the proposed rule. OSHA welcomes comment on the issue.

      OSHA has also estimated the effect of this regulatory alternative on the benefits of the rule. As a result of eliminating all of the ancillary provisions, annualized benefits are estimated to decrease 57 percent, relative to the proposed rule, from $575.8 million to $249.1 million, using a 3 percent discount rate, and from $255.3 million to $110.4 million using a 7 percent discount rate. This estimate follows from OSHA's analysis of benefits in Chapter VII of the PEA, which found that about 57 percent of the benefits of the proposed rule, evaluated at their mid-point value, were attributable to the combination of the ancillary provisions. As these estimates show, OSHA expects that the benefits estimated under the proposed rule will not be fully achieved if employers do not implement the ancillary provisions of the proposed rule.

      Both industry and worker groups have recognized that a comprehensive standard is needed to protect workers exposed to beryllium. The stakeholders' recommended standard that representatives of the primary beryllium manufacturing industry and the United Steelworkers union provided to OSHA confirms the importance of ancillary provisions in protecting workers from the harmful effects of beryllium exposure (Materion and USW, 2012). Ancillary provisions such as personal protective clothing and equipment, regulated areas, medical surveillance, hygiene areas, housekeeping requirements, and hazard communication all serve to reduce the risks to beryllium-exposed workers beyond that which the proposed TWA PEL alone could achieve.

      Moreover, where there is continuing significant risk at the TWA PEL, the decision in the Asbestos case (Bldg. and Constr. Trades Dep't, AFL-CIO v. Brock, 838 F.2d 1258, 1274 (D.C. Cir. 1988)) indicated that OSHA should use its legal authority to impose additional requirements on employers to further reduce risk when those requirements will result in a greater than de minimis incremental benefit to workers' health. Nevertheless, OSHA requests comment on this alternative.

      Under Regulatory Alternative #8, several ancillary provisions that the current proposal would require under a variety of exposure conditions (e.g., dermal contact, any airborne exposure, exposure at or above the action level) would instead only apply where exposure levels exceed the TWA PEL or STEL. Regulatory Alternative #8 affects the following provisions of the proposed standard:

      -- Exposure monitoring: Whereas the proposed standard requires annual monitoring when exposure levels are at or above the action level and at or below the TWA PEL, Regulatory Alternative #8 would require annual exposure monitoring only where exposure levels exceed the TWA PEL or STEL;

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

      -- Housekeeping: Whereas the proposed standard's housekeeping requirements apply across a wide variety of beryllium exposure conditions, Alternative #8 would limit housekeeping requirements to areas and employees with exposures above the TWA PEL or STEL;

      -- PPE: Whereas the proposed standard requires PPE for employees under a variety of conditions, such as exposure to soluble beryllium or visible contamination with beryllium, Alternative #8 would require PPE only for employees exposed above the TWA PEL or STEL;

      -- Medical Surveillance: Whereas the proposed standard's medical surveillance provisions require employers to offer medical surveillance to employees with signs or symptoms of beryllium-related health effects regardless of their exposure level, Alternative #8 would require surveillance only for those employees exposed above the TWA PEL or STEL.

      To estimate the cost savings for this alternative, OSHA re-

      estimated the group of workers that would fall under the above provisions and the changes to their scope. Combining these various adjustments along with associated unit costs, OSHA estimates that, under this regulatory alternative, the costs for the proposed rule would decline from $37.6 million to $18.9 million using a 3 percent discount rate and from $39.1 million to $20.0 million using a 7 percent discount rate.

      The Agency has not quantified the impact of this alternative on the benefits of the rule. However, ancillary provisions that offer protective measures to workers exposed below the proposed TWA PEL, such as personal protective clothing and equipment, beryllium work areas, hygiene areas, housekeeping requirements, and hazard communication, all serve to reduce the risks to beryllium-exposed workers beyond that which the proposed TWA PEL and STEL could achieve. OSHA's preliminary conclusion is that the requirements triggered by the action level and other exposures below the proposed PELs will result in very real and necessary, but difficult to quantify, further reduction in risk beyond that provided by the PELs alone.

      The remainder of this section discusses additional regulatory alternatives that apply to individual

      Page 47762

      ancillary provisions. At this time, OSHA is not able to quantify the effects of these regulatory alternatives on benefits. The Agency solicits comment on the effects of these regulatory alternatives on the benefits of the proposed rule.

      (b) Regulated Areas

      Proposed paragraph (e) requires employers to establish and maintain beryllium work areas wherever employees are exposed to airborne beryllium, regardless of the level of exposure, and regulated areas wherever airborne concentrations of beryllium exceed the TWA PEL or STEL. Employers are required to demarcate beryllium work areas and regulated areas and limit access to regulated areas to authorized persons.

      The SBAR Panel report recommended that OSHA consider dropping or limiting the provision for regulated areas (SBAR, 2008). In response to this recommendation, OSHA examined Regulatory Alternative #12, which would eliminate the requirement that employers establish regulated areas. This alternative is meant only to eliminate the requirement to set up and demarcate specific physical areas: All ancillary provisions would be triggered by the same conditions as under the standard's definition of a ``regulated area.'' For example, under the current proposal, employees who work in regulated areas for at least 30 days annually are eligible for medical surveillance. If OSHA were to remove the requirement to establish regulated areas, the medical surveillance provisions would be altered so that employees who work more than 30 days annually in jobs or areas with exposures that exceed the TWA PEL or STEL are eligible for medical surveillance. This alternative would not eliminate the proposed requirement to establish beryllium work areas. As shown in Table IX-27, Regulatory Alternative #12 would decrease the annualized cost of the proposed rule by about $522,000 using a 3 percent discount rate, and by about $523,000 using a 7 percent discount rate.

      (e) Medical Surveillance

      The proposed requirements for medical surveillance include: (1) Medical examinations, including a test for beryllium sensitization, for employees who are exposed to beryllium in a regulated area (i.e., above the proposed TWA PEL or STEL) for 30 days or more per year, who are exposed to beryllium in an emergency, or who show signs or symptoms of CBD; and (2) CT scans for employees who were exposed above the proposed TWA PEL or STEL for more than 30 days in a 12-month period for 5 years or more. The proposed standard would require annual medical exams to be provided for employees exposed in a regulated area for 30 days or more per year and for employees showing signs or symptoms of CBD, while tests for beryllium sensitization and CT scans would be provided to eligible employees biennially.

      OSHA estimated in Chapter V of the PEA that the medical surveillance requirements would apply to 4,528 workers in general industry, of whom 387 already receive that surveillance.\44\ In Chapter V, OSHA estimated the costs of medical surveillance for the remaining 4,141 workers who would now have such protection due to the proposed standard. The Agency's preliminary analysis indicates that four workers with beryllium sensitization and six workers with CBD will be referred to pulmonary specialists annually as a result of this medical surveillance. Medical surveillance is particularly important for this rule because beryllium-exposed workers, including many workers exposed below the proposed PELs, are at significant risk of illness. OSHA did not estimate, and the benefits analysis does not include, monetized benefits resulting from early discovery of illness.

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

      \44\ See current compliance rates for medical surveillance in Chapter V of the PEA, Table V-15.

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

      Medical surveillance was a subject of special concern to SERs during the SBAR Panel process, and the SBAR Panel offered many comments and recommendations related to medical surveillance for OSHA's consideration. Some of the Panel's concerns have been partially addressed in this proposal, which was modified since the SBAR Panel was convened (see this preamble at Section XVIII, Summary and Explanation of the Proposed Standard, for more detailed discussion). The regulatory alternatives presented in this sub-section (#16, #18, and #20) also respond to recommendations by the SBAR Panel to reduce burdens on small businesses by dropping or reducing the frequency of medical surveillance requirements. OSHA has preliminarily determined that a significant risk of beryllium sensitization, CBD, and lung cancer exists at exposure levels below the proposed TWA PEL and that there is evidence that beryllium sensitization can occur even from short-term exposures (see this preamble at Section V, Health Effects, and Section VIII, Significance of Risk). The Agency therefore anticipates that more employees would develop adverse health effects without receiving the benefits of early intervention in the disease process because they are not eligible for medical surveillance (see this preamble at Section V, Health Effects).

      In response to concerns raised during the SBAR Panel process about testing requirements, OSHA is considering two regulatory alternatives that would provide greater flexibility in the program of tests provided as part of an employer's medical surveillance program. Under Regulatory Alternative #16, employers would not be required to offer employees testing for beryllium sensitization. As shown in Table IX-27, this alternative would decrease the annualized cost of the proposed rule by about $710,000 using a discount rate of 3 percent, and by about $724,000 using a discount rate of 7 percent.

      Regulatory Alternative #18 would eliminate the CT scan requirement from the proposed rule. This alternative would decrease the annualized cost of the proposed rule by about $472,000 using a discount rate of 3 percent, and by about $481,000 using a discount rate of 7 percent.

      OSHA is considering several alternatives to the proposed frequency of sensitization testing, CT scans, and general medical examinations. The frequency of periodic medical surveillance is an important factor in the efficacy of the surveillance in protecting worker health. Regular, appropriately frequent medical surveillance promotes awareness of beryllium-related health effects and early intervention in disease processes among workers. In addition, the longer the time interval between when a worker becomes sensitized and when the worker's case is identified in the surveillance program, the more difficult it will be to identify and address the exposure conditions that led to sensitization. Therefore, reducing the frequency of sensitization testing would reduce the usefulness of the surveillance information in identifying problem areas and reducing risks to other workers. These concerns must be weighed against the costs and other burdens of surveillance.

      Finally, under Regulatory Alternative #20, employers would only have to provide all periodic components of the medical surveillance exams biennially to eligible employees. This alternative would decrease the annualized cost of the proposed rule by about $446,000 using a discount rate of 3 percent and by about $433,000 using a discount rate of 7 percent.

      Page 47763

      (d) Medical Removal

      Under paragraph (l) of the proposed standard, Medical Removal, employees in jobs with exposure at or above the action level become eligible for medical removal when they are diagnosed with CBD or confirmed positive for beryllium sensitization. When an employee chooses removal, the employer is required to remove the employee to comparable work in an environment where beryllium exposure is below the action level if such work is available and the employee is either already qualified or can be trained within one month. If comparable work is not available, paragraph (l) would require the employer to place the employee on paid leave for six months or until comparable work becomes available (whichever comes first). Or, rather than choosing removal, an eligible employee could choose to remain in a job with exposure at or above the action level and wear a respirator. The proposed medical removal protection (MRP) requirements are based on the stakeholders' recommended beryllium standard that representatives of the beryllium production industry and the United Steelworkers union submitted to OSHA in 2012 (Materion and USW, 2012).

      The scientific information on effects of exposure cessation is limited at this time, but the available evidence suggests that removal from exposure can be beneficial for individuals who are sensitized or have early-stage CBD (see this preamble at Section VIII, Significance of Risk). As CBD progresses, symptoms become serious and debilitating. Steroid treatment is less effective at later stages, once fibrosis has developed (see this preamble at Section VIII, Significance of Risk). Given the progressive nature of the disease, OSHA believes it is reasonable to conclude that removal from exposure to beryllium will benefit sensitized employees and those with CBD. Physicians at National Jewish Health, one of the main CBD research and treatment sites in the US, ``consider it important and prudent for individuals with beryllium sensitization and CBD to minimize their exposure to airborne beryllium,'' and ``recommend individuals diagnosed with beryllium sensitization and CBD who continue to work in a beryllium industry to have exposure of no more than 0.01 micrograms per cubic meter of beryllium as an 8-hour time-weighted average'' (NJMRC, 2013). However, OSHA is aware that MRP may prove costly and burdensome for some employers and that the scientific literature on the effects of exposure cessation on the development of CBD among sensitized individuals and the progression from early-stage to late-stage CBD is limited.

      The SBAR Panel report included a recommendation that OSHA give careful consideration to the impacts that an MRP requirement could have on small businesses (SBAR, 2008). In response to this recommendation, OSHA analyzed Regulatory Alternative #22, which would remove the proposed requirement that employers offer MRP. As shown in Table IX-27, this alternative would decrease the annualized cost of the proposed rule by about $149,000 using a discount rate of 3 percent, and by about $166,000 using a discount rate of 7 percent.

      Page 47764

      GRAPHIC TIFF OMITTED TP07AU15.043

      (5) Timing

      As proposed, the new standard would become effective 60 days following publication in the Federal Register. The majority of employer duties in the standard would become enforceable 90 days following the effective date. Change rooms, however, would not be required until one year after the effective date, and the deadline for engineering controls would be no later than two years after the effective date.

      OSHA invites suggestions for alternative phase-in schedules for engineering controls, medical surveillance, and other provisions of the standard. Although OSHA did not explicitly develop or quantitatively analyze any other regulatory alternatives involving longer-term or more complex phase-ins of the standard (possibly involving more delayed implementation dates for small businesses), some general outcomes are likely. For example, a longer phase-in time would have several advantages, such as reducing initial costs of the standard or allowing employers to coordinate their environmental and occupational safety and health control strategies to minimize potential costs. However, a longer phase-in would also postpone and reduce the benefits of the standard. Suggestions for alternatives may apply to specific industries (e.g., industries where first-year or annualized cost impacts are highest), specific size-classes of employers (e.g., employers with fewer than 20 employees), combinations of these factors, or all firms covered by the rule.

      OSHA requests comments on all these regulatory alternatives, including the Agency's regulatory alternatives presented above, the Agency's analysis of these alternatives, and whether there are other regulatory alternatives the Agency should consider.

      SBAR Panel

      Table IX-28 lists all of the SBAR Panel recommendations and OSHA's response to those recommendations.

      Page 47765

      Table IX-28--SBAR Panel Recommendations and OSHA Responses

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

      Panel recommendation OSHA response

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

      The Panel recommends that OSHA evaluate OSHA has reviewed its cost

      carefully the costs and technological estimates and the

      feasibility of engineering controls at technological feasibility of

      all PEL options, especially those at engineering controls at

      the lowest levels. various PEL levels. These

      issues are discussed in the

      Regulatory Alternatives

      Chapter of the PEA.

      The Panel recommends that OSHA consider OSHA has removed the initial

      alternatives that would alleviate the exposure monitoring

      need for monitoring in operations with requirement for workers likely

      exposures far below the PEL. The Panel to be exposed to beryllium by

      also recommends that OSHA consider skin or eye contact through

      explaining more clearly how employers routine handling of beryllium

      may use ``objective data'' to estimate powders or dusts or contact

      exposures. Although the draft proposal with contaminated surfaces.

      contains a provision allowing The periodic monitoring

      employers to initially estimate requirement presented in the

      exposures using ``objective data'' SBAR Panel report required

      (e.g., data showing that the action monitoring every 6 months for

      level is unlikely to be exceeded for airborne levels at or above

      the kinds of process or operations an the action level but below the

      employer has), the SERs did not appear PEL, and every 3 months for

      to have fully understood how this exposures at or above the PEL.

      alternative may be used. The proposed standard requires

      annual exposure monitoring for

      levels at or above the action

      level and at or below the PEL.

      By reducing the frequency of

      periodic monitoring from every

      6 months (version submitted to

      the SBAR panel) to annually

      where exposure levels are at

      or below the PEL (the proposed

      standard), the Agency has

      lessened the need for

      monitoring in small business

      operations with exposures at

      or below the PEL.

      In this preamble, OSHA has

      clarified the circumstances

      under which an employer may

      use historical and objective

      data in lieu of initial

      monitoring.

      OSHA is also considering

      whether to create a guidance

      product on the use of

      objective data. These issues

      are discussed in this preamble

      at Section XVIII, Summary and

      Explanation of the Proposed

      Standard, (d): Exposure

      Monitoring.

      The Panel recommends that OSHA consider In this preamble, OSHA has

      providing some type of guidance to clarified the circumstances

      describe how to use objective data to under which an employer may

      estimate exposures in lieu of use historical and objective

      conducting personal sampling. data in lieu of initial

      Using objective data could provide monitoring. OSHA is also

      significant regulatory relief to considering whether to create

      several industries where airborne a guidance product on the use

      exposures are currently reported by of objective data to satisfy

      SERs to be well below even the lowest the requirements of the

      PEL option. In particular, since proposed rule.

      several ancillary provisions, which These issues are discussed in

      may have significant costs for small this preamble at Section

      entities may be triggered by the PEL XVIII, Summary and Explanation

      or an action level, OSHA should of the Proposed Standard, (d):

      consider encouraging and simplifying Exposure Monitoring.

      the development of objective data from

      a variety of sources.

      The Panel recommends that OSHA revisit SERs with very low exposure

      its analysis of the costs of regulated levels or only occasional work

      areas if a very low PEL is proposed. with beryllium will not be

      Drop or limit the provision for required to have regulated

      regulated areas: SERs with very low areas unless exposures are

      exposure levels or only occasional above the proposed PEL of 0.2

      work with beryllium questioned the mug/m\3\.

      need for separating areas of work by The proposed standard requires

      exposure level. Segregating machines the employer to establish and

      or operations, SERs said, would affect maintain a regulated area

      productivity and flexibility. Until wherever employees are, or can

      the health risks of beryllium are be expected to be exposed to

      known in their industries, SERs airborne beryllium at levels

      challenged the need for regulated above a PEL of 0.2 mug/m\3\.

      areas.

      The Panel recommends that OSHA revisit The Agency has removed skin

      its cost model for hygiene areas to exposure as a trigger for the

      reflect SERs' comments that estimated hygiene provision. The

      costs are too low and more carefully requirement for washing

      consider the opportunity costs of facilities applies to each

      using space for hygiene areas where employee working in a

      SERs report they have no unused space beryllium work area. A

      in their physical plant for them. The beryllium work area means any

      Panel also recommends that OSHA work area where employees are,

      consider more clearly defining the or can reasonably be expected

      triggers (skin exposure and to be, exposed to airborne

      contaminated surfaces) for the hygiene beryllium. OSHA has

      areas provisions. In addition, the preliminarily concluded that

      Panel recommends that OSHA consider all affected employers

      alternative requirements for hygiene currently have hand-washing

      areas dependent on airborne exposure facilities.

      levels or types of processes. Such OSHA has also preliminarily

      alternatives might include, for concluded that no affected

      example, hand washing facilities in employers will be required to

      lieu of showers in particular cases or install showers.

      different hygiene area triggers where Change rooms have only been

      exposure levels are very low. costed for regulated areas or

      where employees are, or can

      reasonably be expected to be,

      exposed to airborne beryllium

      at levels above the PEL. The

      Agency has determined that the

      long-term rental of modular

      units was representative of

      costs for a range of

      reasonable approaches to

      comply with the change room

      part of the provision.

      Alternatively, employers could

      renovate and rearrange their

      work areas in order to meet

      the requirements of this

      provision.

      Page 47766

      The Panel recommends that OSHA consider In this preamble, OSHA has

      clearly explaining the purpose of the clarified the purpose of the

      housekeeping provision and describing housekeeping provision.

      what affected employers must do to However, due to the variety of

      achieve it. For example, OSHA should work settings in which

      consider explaining more specifically beryllium is used, OSHA has

      what surfaces need to be cleaned and preliminarily concluded that a

      how frequently they need to be highly specific directive on

      cleaned. The Panel recommends that the what surfaces need to be

      Agency consider providing guidance in cleaned, and how frequently,

      some form so that employers understand would not provide effective

      what they must do. The Panel also guidance to businesses.

      recommends that once the requirements Instead, at the suggestion of

      are clarified that the Agency re- industry and union

      analyzes its cost estimates. stakeholders (Materion and

      The Panel also recommends that OSHA USW, 2012), OSHA's proposed

      reconsider whether the risk and cost standard includes a more

      of all parts of the medical flexible requirement for

      surveillance provisions are employers to develop a written

      appropriate where exposure levels are exposure control plan specific

      very low. In that context, the Panel to their facilities. The

      recommends that OSHA should also written exposure control plan

      consider the special problems and must include documentation of

      costs to small businesses that up operations and jobs with

      until now may not have had to provide beryllium exposure and

      or manage the various parts of an housekeeping procedures,

      occupational health standard or including surface cleaning and

      program. beryllium migration control.

      OSHA requests suggestions for

      examples of specific guidance

      that could be helpful to

      employers preparing written

      exposure control plans.

      These issues are discussed in

      this preamble at Section

      XVIII, Summary and Explanation

      of the Proposed Standard, (f)

      Methods of Compliance and (j)

      Housekeeping.

      Regulatory Alternative #20

      would reduce the frequency of

      physical examinations from

      annual to biennial, matching

      the frequency of BeLPT testing

      in the proposed rule.

      These alternatives for medical

      surveillance are discussed in

      the Regulatory Alternatives

      Chapter and in this preamble

      at section XVIII, Summary and

      Explanation of the Proposed

      Standard, (k) Medical

      Surveillance.

      The Panel recommends that OSHA consider Under the proposed standard,

      that small entities may lack the employees are only eligible

      flexibility and resources to provide for medical removal if they

      alternative jobs to employees who test are sensitized or have been

      positive for the BeLPT, and whether diagnosed with CBD; skin

      MRP achieves its intended purpose exposure is not a trigger for

      given the course of beryllium disease. medical removal (unlike the

      The Panel also recommends that if MRP version submitted by the SBAR

      is implemented, that its effects on Panel). After becoming

      the viability of very small firms with eligible for medical removal

      a sensitized employee be considered an employee may choose to

      carefully. remain in a job with exposure

      at or above the action level,

      provided that the employee

      wears a respirator in

      accordance with the

      Respiratory Protection

      standard (29 CFR 1910.134). If

      the employee chooses removal,

      the employer is only required

      to place the employee in

      comparable work with exposure

      below the action level if such

      work is available; if such

      work is not available, the

      employer may place the

      employee on paid leave for six

      months or until such work

      becomes available.

      OSHA discusses the basis of the

      provision and requests

      comments on it in this

      preamble at Section XVIII,

      Summary and Explanation of the

      Proposed Standard, (l) Medical

      Removal Protection. OSHA

      provides an analysis of costs

      and economic impacts of the

      provision in the PEA in

      Chapter 5 and Chapter 6,

      respectively.

      The Panel recommends that OSHA consider As stated above, the triggers

      more clearly defining the trigger for medical surveillance in

      mechanisms for medical surveillance the proposed standard have

      and also consider additional or changed from those presented

      alternative triggers--such as limiting to the SBAR Panel. Whereas the

      the BeLPT to a narrower range of draft standard presented at

      exposure scenarios and reducing the the SBAR Panel required

      frequency of BeLPT tests and physical medical surveillance for

      exams. The Panel also recommends that employees with skin contact--

      OSHA reconsider whether the risk and potentially applying to

      cost of all parts of the medical employees with any level of

      surveillance provisions are airborne exposure--the

      appropriate where exposure levels are proposed standard ties medical

      very low. In that context, the Panel surveillance to exposures

      recommends that OSHA should also above the proposed PEL of 0.2

      consider the special problems and mug/m\3\ (or signs or

      costs to small businesses that up symptoms of beryllium-related

      until now may not have had to provide health effects, or emergency

      or manage the various parts of an exposure). Thus, small

      occupational health standard or businesses with exposures

      program. below the proposed PEL would

      not need to provide or manage

      medical surveillance for their

      employees unless employees

      develop signs or symptoms of

      beryllium-related health

      effects or are exposed in

      emergencies.

      These issues are discussed in

      this preamble at section

      XVIII, Summary and Explanation

      of the Proposed Standard, (k)

      Medical Surveillance.

      The Panel recommends that the Agency, OSHA has reviewed the possible

      in evaluating the economic feasibility effects of the proposed

      of a potential regulation, consider regulation on market demand

      not only the impacts of estimated and/or foreign production, in

      costs on affected establishments, but addition to the Agency's usual

      also the effects of the possible measures of economic impact

      outcomes cited by SERs: loss of market (costs as a fraction of

      demand, the loss of market to foreign revenues and profits). This

      competitors, and of U.S. production discussion can be found in

      being moved abroad by U.S. firms. The Chapter VI of the PEA

      Panel also recommends that OSHA (entitled Economic Feasibility

      consider the potential burdens on Analysis and Regulatory

      small businesses of dealing with Flexibility Determination).

      employees who have a positive test

      from the BeLPT. OSHA may wish to

      address this issue by examining the

      experience of small businesses that

      currently provide the BeLPT.

      Page 47767

      The Panel recommends that OSHA consider The provisions in the standard

      seeking ways of minimizing costs for presented in the SBAR panel

      small businesses where the exposure report applied to all

      levels may be very low. Clarifying the employees, whereas the

      use of objective data, in particular, proposed standard's ancillary

      may allow industries and provisions are only applied to

      establishments with very low exposures employees in work areas who

      to reduce their costs and involvement are, or can reasonably be

      with many provisions of a standard. expected to be, exposed to

      The Panel also recommends that the airborne beryllium.

      Agency consider tiering the In addition, the scope of the

      application of ancillary provisions of proposed standard includes

      the standard according to exposure several limitations. Whereas

      levels and consider a more limited or the standard presented in the

      narrowed scope of industries. SBAR panel report covered

      beryllium in all forms and

      compounds in general industry,

      construction, and maritime,

      the scope of the proposed

      standard (1) applies only to

      general industry; (2) does not

      apply to beryllium-containing

      articles that the employer

      does not process; and (3) does

      not apply to materials that

      contain less than 0.1 percent

      beryllium by weight.

      In this preamble, OSHA has

      clarified the circumstances

      under which an employer may

      use historical and objective

      data in lieu of initial

      monitoring (Section XVIII,

      Summary and Explanation of

      this Proposed Standard, (d)

      Exposure Monitoring). OSHA is

      also considering whether to

      create a guidance product on

      the use of objective data to

      comply with the requirements

      of this proposed standard.

      OSHA is considering two

      Regulatory Alternatives that

      would reduce the impact of

      ancillary alternatives on

      employers, including small

      businesses. Regulatory

      Alternative #7, a PEL-only

      standard, would drop all

      ancillary provisions from the

      standard. Regulatory

      Alternative #8 would limit the

      application of several

      ancillary provisions,

      including Exposure Monitoring,

      the written exposure control

      plan section of Method of

      Compliance, PPE, Housekeeping,

      and Medical Surveillance, to

      operations or employees with

      exposure levels exceeding the

      TWA PEL or STEL. These

      alternatives are discussed in

      the Regulatory Alternatives

      Chapter and in this preamble

      at Section I, Issues and

      Alternatives.

      The Panel recommends that OSHA provide The explanation and analysis

      an explanation and analysis for all for all health outcomes (and

      health outcomes (and their scientific their scientific basis) are

      basis) upon which it is regulating discussed in this preamble at

      employee exposure to beryllium. The Section V, Health Effects, and

      Panel also recommends that OSHA Section VI, Preliminary Risk

      consider to what extent a very low PEL Assessment. They are also

      (and lower action level) may result in reviewed in this preamble at

      increased costs of ancillary Section VIII, Significance of

      provisions to small entities (without Risk, and the Benefits Chapter

      affecting airborne employee of the PEA. OSHA requests

      exposures). Since in the draft comment on these health

      proposal the PEL and action level are outcomes.

      critical triggers, the Panel As discussed above, OSHA is

      recommends that OSHA consider considering Regulatory

      alternate action levels, including an Alternatives #7 and #8, which

      action level set at the PEL, if a very would eliminate or reduce the

      low PEL is proposed. impact of ancillary provisions

      on employers, respectively.

      These alternatives are

      discussed in the Regulatory

      Alternatives Chapter of the

      PEA and in this preamble at

      Section I, Issues and

      Alternatives. OSHA seeks

      comment on other ways to avoid

      costs of ancillary provisions

      when they are not necessary to

      protect employees from

      exposure to beryllium.

      The Panel recommends that OSHA consider OSHA has removed skin exposure

      more clearly and thoroughly defining as a trigger for several

      the triggers for ancillary provisions, ancillary provisions in this

      particularly the skin exposure proposed standard, including

      trigger. In addition, the Panel Exposure Monitoring, Hygiene

      recommends that OSHA clearly explain Areas and Practices, and

      the basis and need for small entities Medical Surveillance. In

      to comply with ancillary provisions. addition, the language of this

      The Panel also recommends that OSHA proposed standard regarding

      consider narrowing the trigger related skin exposure has changed: for

      to skin and contamination to capture some ancillary provisions,

      only those situations where surfaces including PPE and

      and surface dust may contain beryllium Housekeeping, the requirements

      in a concentration that is significant are triggered by visible

      enough to pose any risk--or limiting contamination with beryllium

      the application of the trigger for or dermal contact with soluble

      some ancillary provisions. beryllium compounds. These

      requirements are discussed in

      this preamble at Section

      XVIII, Summary and Explanation

      of this Proposed Standard. The

      Agency has also explained the

      basis and need for compliance

      with ancillary provisions in

      this preamble at Section

      XVIII, Summary and

      Explanation.

      Several SERs said that OSHA should In the Technological

      first assume the burden of describing Feasibility Analysis presented

      the exposure level in each industry in the PEA, OSHA has described

      rather than employers doing so. Others the exposure level in each

      said that the Agency should accept industry or application group.

      exposure determinations made on an In this preamble, OSHA has

      industry-wide basis, especially where clarified the circumstances

      exposures were far below the PEL under which an employer may

      options under consideration. use historical and objective

      As noted above, the Panel recommends data in lieu of initial

      that OSHA consider alternatives that monitoring (section XVIII,

      would alleviate the need for Summary and Explanation of

      monitoring in operations or processes this Proposed Standard, (d)

      with exposures far below the PEL. The Exposure Monitoring). Industry-

      use of objective data is a principal wide data may be used as

      method for industries with low objective data to support an

      exposures to satisfy compliance with a employer's case that exposures

      proposed standard. The Panel at its facilities are far

      recommends that OSHA consider below the PEL. OSHA is also

      providing some guidance to small considering whether to create

      entities in the use of objective data. a guidance product on the use

      of objective data to comply

      with requirements in the

      proposed standard.

      Page 47768

      The Panel recommends that OSHA consider OSHA has provided discussion of

      more fully evaluating whether the the BeLPT in Appendix A to the

      BeLPT is suitable as a test for regulatory text; in this

      beryllium sensitization in an OSHA preamble at section V, Health

      standard and respond to the points Effects; and in this preamble

      raised by the SERs about its efficacy. at section XVIII, Summary and

      In addition, the Agency should Explanation, (k) Medical

      consider the availability of other Surveillance. In the

      tests under development for detecting regulatory text, OSHA has

      beryllium sensitization and not limit clarified that a test for

      either employers' choices or new beryllium sensitization other

      science and technology in this area. than the BeLPT may be used in

      Finally, the Panel recommends that lieu of the BeLPT if a more

      OSHA re-consider the trigger for reliable and accurate

      medical surveillance where exposures diagnostic test is developed.

      are low and consider if there are In this preamble at Section I,

      appropriate alternatives. Issues and Alternatives, the

      Agency requests comments on

      the BeLPT and on the

      reliability and accuracy of

      alternate tests.

      As stated above, the triggers

      for medical surveillance in

      this proposed standard have

      changed from those presented

      to the SBAR Panel. Whereas the

      draft standard presented

      during the SBREFA process

      required medical surveillance

      for employees with skin

      contact--potentially applying

      to employees with any level of

      airborne exposure--this

      proposed standard ties medical

      surveillance to exposures

      above the proposed PEL of 0.2

      mug/m\3\ (or signs or

      symptoms of beryllium-related

      health effects, or emergency

      exposure). The triggers for

      medical surveillance are

      discussed in this preamble at

      section XVIII, Summary and

      Explanation, (k) Medical

      Surveillance.

      OSHA is considering Regulatory

      Alternative #16, which would

      eliminate BeLPT testing

      requirements from this

      proposed standard. This

      alternative is discussed in

      the Regulatory Alternatives

      Chapter and in in this

      preamble at Section XVIII,

      Summary and Explanation of the

      Proposed Standard, (k) Medical

      Surveillance.

      Seeking ways of minimizing costs to low The standard presented in the

      risk processes and operations: OSHA SBAR panel report had skin

      should consider alternatives for exposure as a trigger. The

      minimizing costs to industries, only skin exposure trigger in

      operations, or processes that have low this proposed standard is the

      exposures. Such alternatives may requirement for PPE when

      include, but not be limited to: employees' skin is potentially

      encouraging the use of objective data exposed to soluble beryllium

      by such mechanisms as providing compounds. OSHA uses an

      guidance for objective data; assuring exposure profile to determine

      that triggers for skin exposure and which workers will be affected

      surface contamination are clear and do by the standard. As a result,

      not pull in low risk operations; this proposed standard

      providing guidance on least-cost ways establishes regulated work

      for low risk facilities to determine areas and exposure monitoring

      what provisions of the standard they only with respect to employees

      need to comply with; and considering who are, or can reasonably be

      ways to limit the scope of 28 the expected to be, exposed to

      standard if it can be ascertained that airborne beryllium.

      certain processes do not represent a In addition, the scope of this

      significant risk. proposed standard includes

      several limitations. Whereas

      the standard presented in the

      SBAR panel report covered

      beryllium in all forms and

      compounds in general industry,

      construction, and maritime,

      the scope of this proposed

      standard (1) applies only to

      general industry; (2) does not

      apply to beryllium-containing

      articles that the employer

      does not process; and (3) does

      not apply to materials that

      contain less than 0.1 percent

      beryllium by weight. In this

      preamble, OSHA has clarified

      the circumstances under which

      an employer may use historical

      and objective data in lieu of

      initial monitoring (Section

      XVIII, Summary and Explanation

      of this Proposed Standard, (d)

      Exposure Monitoring). OSHA is

      also considering whether to

      create a guidance product on

      the use of objective data.

      PEL-only standard: One SER recommended OSHA is considering Regulatory

      a PEL-only standard. This would Alternative #7, a PEL-only

      protect employees from airborne standard. This alternative is

      exposure risks while relieving the discussed in the Regulatory

      beryllium industry of the cost of the Alternatives Chapter of the

      ancillary provisions. The Panel PEA and in this preamble at

      recommends that OSHA, consistent with Section I, Issues and

      its statutory obligations, analyze Alternatives.

      this alternative.

      Alternative triggers for ancillary OSHA has removed skin exposure

      provisions: The Panel recommends that as a trigger for several

      OSHA clarify and consider eliminating ancillary provisions in this

      or narrowing the triggers for proposed standard, including

      ancillary provisions associated with Exposure Monitoring, Hygiene

      skin exposure or contamination. In Areas and Practices, and

      addition, the Panel recommends that Medical Surveillance. In

      OSHA should consider trying ancillary addition, the language of this

      provisions dependent on exposure proposed standard regarding

      rather than have these provisions all skin exposure has changed: for

      take effect with the same trigger. If some ancillary provisions,

      OSHA does rely on a trigger related to including PPE and

      skin exposure, OSHA should thoroughly Housekeeping, the requirements

      explain and justify this approach are triggered by visible

      based on an analysis of the scientific contamination with beryllium

      or research literature that shows a or skin contact with soluble

      risk of sensitization via exposure to beryllium compounds. These

      skin. If OSHA adopts a relatively low requirements are discussed in

      PEL, OSHA should consider the effects this preamble at Section

      of alternative airborne action levels XVIII, Summary and

      in pulling in many low risk facilities Explanation. OSHA has

      that may be unlikely to exceed the explained the scientific basis

      PEL--and consider using only the PEL for minimizing skin exposure

      as a trigger at very low levels. to beryllium in this preamble

      at Section V, Health Effects,

      and explains the basis for

      specific ancillary provisions

      related to skin exposure in

      this preamble at Section

      XVIII, Summary and

      Explanation.

      Page 47769

      In this proposed standard, the

      application of ancillary

      provisions is dependent on

      exposure, and not all

      provisions take effect with

      the same trigger. A number of

      requirements are triggered by

      exposures (or a reasonable

      expectation of exposures)

      above the PEL or action level

      (AL). As discussed above, OSHA

      is considering Regulatory

      Alternatives #7 and #8, which

      would eliminate or reduce the

      impact of ancillary provisions

      on employers, respectively.

      These alternatives are

      discussed in the Regulatory

      Alternatives Chapter of the

      PEA and in this preamble at

      Section I, Issues and

      Alternatives.

      Revise the medical surveillance Responding to comments from

      provisions, including eliminating the SERs, OSHA has revised the

      BeLPT: The BeLPT was the most common medical surveillance provision

      complaint from SERs. The Panel and removed the skin exposure

      recommends that OSHA carefully examine trigger for medical

      the value of the BeLPT and consider surveillance. As a result,

      whether it should be a requirement of OSHA estimates that the number

      a medical surveillance program. The of small-business employees

      Panel recommends that OSHA present the requiring a BeLPT will be

      scientific evidence that supports the substantially reduced.

      use of the BeLPT as several SERs were OSHA has provided discussion of

      doubtful of its reliability. The Panel the BeLPT in Appendix A to the

      recommends that OSHA also consider regulatory text; in this

      reducing the frequency of physicals preamble at section V, Health

      and the BeLPT, if these provisions are Effects; and in this preamble

      included in a proposal. The Panel at section XVIII, Summary and

      recommends that OSHA also consider a Explanation, (k) Medical

      performance-based medical surveillance Surveillance. In the

      program, permitting employers in regulatory text, OSHA has

      consultation with physicians and clarified that a test for

      health experts to develop appropriate beryllium sensitization other

      tests and their frequency. than the BeLPT may be used in

      lieu of the BeLPT if a more

      reliable and accurate

      diagnostic test is developed.

      In this preamble at Section I,

      Issues and Alternatives, the

      Agency requests comments on

      the BeLPT and on the

      reliability and accuracy of

      alternate tests.

      The frequency of periodic BeLPT

      testing in this proposed

      standard is biennial, whereas

      annual testing was included in

      the draft standard presented

      to the SBAR Panel.

      Regulatory Alternative #20

      would reduce the frequency of

      physical examinations from

      annual to biennial, matching

      the frequency of BeLPT testing

      in this proposed rule.

      In response to the suggestion

      to allow performance-based

      medical surveillance, OSHA is

      considering two regulatory

      alternatives that would

      provide greater flexibility in

      the program of tests provided

      as part of an employer's

      medical surveillance program.

      Regulatory Alternative #16

      would eliminate BeLPT testing

      requirements from this

      proposed standard. Regulatory

      Alternative #18 would

      eliminate the CT scan

      requirement from this proposed

      standard. These alternatives

      are discussed in the

      Regulatory Alternatives

      Chapter and in this preamble

      at Section XVIII, Summary and

      Explanation, (k) Medical

      Surveillance.

      No medical removal protection (MRP): This proposed standard includes

      OSHA's draft proposed standard did not an MRP provision. OSHA

      include any provision for medical discusses the basis of the

      removal protection, but OSHA did ask provision and requests

      the SERs to comment on MRP as a comments on it in this

      possibility. Based on the SER preamble at Section XVIII,

      comments, the Panel recommends that if Summary and Explanation, (l)

      OSHA includes an MRP provision, the Medical Removal Protection.

      agency provide a thorough analysis of OSHA provides an analysis of

      why such a provision is needed, what costs and economic impacts of

      it might accomplish, and what its full the provision in the PEA in

      costs and economic impacts on those Chapter V and Chapter VI,

      small businesses that need to use it respectively.

      might be. The Agency is considering

      Alternative #22, which would

      eliminate the MRP requirement

      from the standard. This

      alternative is discussed in

      the Regulatory Alternatives

      Chapter and in in this

      preamble at section XVIII,

      Summary and Explanation, (l)

      Medical Removal Protection.

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

  30. OMB Review Under the Paperwork Reduction Act of 1995

    A. Overview

    The proposed general industry standard for occupational exposure to beryllium contains collection of information (paperwork) requirements that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA-95), 44 U.S.C. 3501 et seq., and OMB's regulations at 5 CFR part 1320. PRA-95 defines ``collection of information'' to mean, ``the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public, of facts or opinions by or for an agency, regardless of form or format'' (44 U.S.C. 3502(3)(A)).

    Under PRA-95, a Federal agency cannot conduct or sponsor a collection of information unless OMB approves it, and the agency displays a currently valid OMB control number. In addition, the public is not required to respond to a collection of information unless the collection of information displays a currently valid OMB control number. Also, notwithstanding any other provision of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number.

    B. Solicitation of Comments

    OSHA prepared and submitted an Information Collection Request (ICR) for the collection of information requirements identified in this NPRM to OMB for review in accordance with 44 U.S.C. 3507(d). The Agency solicits comments on the proposed collection of information requirements and the estimated burden hours and costs associated with these requirements, including comments on the following items:

    Whether the proposed collection of information requirements are necessary for the proper performance of the

    Page 47770

    Agency's functions, including whether the information is useful;

    The accuracy of OSHA's estimate of the burden (time and cost) of the information collection requirements, including the validity of the methodology and assumptions used;

    The quality, utility and clarity of the information collected; and

    Ways to minimize the compliance burden on employers, for example, by using automated or other technological techniques for collecting and transmitting information.

    C. Proposed Collection of Information Requirements

    As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(1), the following paragraphs provide information about this ICR.

    1. Title: Occupational Exposure to Beryllium

    2. Description of the ICR: The proposed Beryllium standard contains collection of information requirements which are essential components of the occupational safety and health standard that will assist both employers and their employees in identifying the exposures to beryllium and beryllium compounds, the medical effects of such exposures, and the means to reduce the risk of overexposures to beryllium and beryllium compounds.

    3. Brief Summary of the Collection of Information Requirements

    Below is a summary of the collection of information requirements identified in the Beryllium proposal. Specific details contained in the following collections of information requirements are discussed in Section XVIII: Summary and Explanation of the Proposed Standard.

    Sec. 1910.1024(d) Exposure Monitoring

    Under paragraph (d)(5)(i) of the proposed standard, within 15 working days after receiving the results of any exposure monitoring completed under this standard, employers must notify each employee whose exposure is characterized by the monitoring in writing. Employers must either notify each of these employees individually in writing, or post the exposure monitoring results in an appropriate location accessible to all of these employees. In this proposed standard, the following provisions require exposure monitoring: Sec. 1910.1024(d)(1), General; Sec. 1910.1024(d)(2), Initial Exposure Monitoring; Sec. 1910.1024(d)(3), Periodic Exposure Monitoring; Sec. 1910.1024(d)(4), Additional Monitoring.

    Proposed paragraph (d)(5)(ii) details additional information an employer would need to include in the written notification in (d)(5)(i), should beryllium exposure exceed the TWA PEL or STEL: a description of the suspected or known sources of exposure, and the corrective action(s) the employer has taken or will take to reduce the employee's exposure to or below the applicable PEL.

    Sec. 1910.1024(e)(2)(i) & (ii) Demarcation of Beryllium Work Areas

    Proposed paragraph (e)(2)(i) would require employers to identify each beryllium work area through signs or any other methods that adequately establish and inform each employee of the boundaries of each beryllium work area. Paragraph (e)(2)(ii) would require employers to identify each regulated area in accordance with paragraph (m)(2).

    Sec. 1910.1024(f)(1)(i), (ii), and (iii) Written Exposure Control Plan

    Proposed paragraph (f)(1)(i) would require employers to establish, implement, and maintain a written exposure control plan for beryllium work areas. The plan must contain: (A) An inventory of operations and job titles reasonably expected to have exposure; (B) an inventory of operations and job titles reasonably expected to have exposure at or above the action level; (C) an inventory of operations and job titles reasonably expected to have exposure above the TWA PEL or STEL; (D) procedures for minimizing cross-contamination, including but not limited to preventing the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas; (E) procedures for keeping surfaces in the beryllium work area as free as practicable of beryllium; (F) procedures for minimizing the migration of beryllium from beryllium work areas to other locations within or outside the workplace; (G) an inventory of engineering and work practice controls; and (H) procedures for removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators.

    Proposed paragraph (f)(1)(ii) would require employers to update their exposure control plans whenever any change in production processes, materials, equipment, personnel, work practices, or control methods results or can reasonably be expected to result in new or additional exposures to beryllium. Paragraph (f)(1)(ii) also requires employers to update their plans when an employee is confirmed positive for beryllium sensitization, is diagnosed with CBD, or shows other signs or symptoms related to beryllium exposure. In addition, this paragraph requires employers to update their plans if the employer has any reason to believe that new or additional exposures are occurring or will occur. Proposed paragraph (f)(1)(iii) would require employers to make a copy of the exposure control plan accessible to each employee who is or can reasonably be expected to be exposed to airborne beryllium in accordance with OSHA's Access to Employee Exposure and Medical Records (Records Access) standard (29 CFR 1910.1020(e)).

    Sec. 1910.1024(g) Respiratory Protection

    Proposed paragraph (g)(1) would require employers to provide at no cost and ensure that each employee uses respiratory protection during certain periods or operations. Where the proposed standard requires an employee to use respiratory protection, proposed paragraph (g)(2) requires such use to be in accordance with the Respiratory Protection Standard (29 CFR 1910.134).

    The Respiratory Protection Standard's collection of information requirements indicate that employers must: develop a written respirator program; obtain and maintain employee medical evaluation records; provide the physician or other licensed health care professional (PLHCP) with information about the employee's respirator and the conditions under which the employee will use the respirator; administer fit tests for employees who will use negative- or positive-pressure, tight-fitting facepieces; and establish and retain written information regarding medical evaluations, fit testing, and the respirator program.

    Sec. 1910.1024(h) Personal Protective Clothing and Equipment

    Sec. 1910.1024(h)(2)(v) Removal and Storage

    Proposed paragraph (h)(2)(v) would require employers to ensure that any protective clothing or equipment required by the standard which is removed from the workplace for laundering, cleaning, maintenance, or disposal is labeled in accordance with paragraph (m)(3) of the proposed standard and the Hazard Communication standard at 29 CFR 1910.1200.

    Sec. 1910.1024(h)(3)(iii) Cleaning and Replacement

    Proposed paragraph (h)(3)(iii) would require employers to inform in writing the persons or the business entities who launder, clean or repair the protective clothing or equipment required by this

    Page 47771

    standard of the potentially harmful effects of exposure to airborne beryllium and contact with soluble beryllium compounds and how the protective clothing and equipment must be handled in accordance with the standard.

    Sec. 1910.1024(j)(3) Housekeeping

    Proposed paragraph (j)(3)(i) requires waste, debris, and materials visibly contaminated with beryllium and consigned for disposal to be disposed of in sealed, impermeable enclosures. Proposed paragraph (j)(3)(ii) requires these enclosures to be labeled in accordance with proposed paragraph (m)(3) of the standard.

    Proposed paragraph (j)(3)(iii) requires materials designated for recycling that are visibly contaminated with beryllium to be cleaned to remove the visible particulate or placed in sealed, impermeable enclosures that are labeled in accordance with proposed paragraph (m)(3) of the standard.

    Sec. 1910.1024(k) Medical Surveillance

    Sec. 1910.1024(k)(1), (2), and (3) Employee Medical Surveillance

    Proposed paragraph (k)(1) details when and under what conditions an employer must make medical surveillance available to its employees. Paragraph (k)(2) of the proposed standard specifies the frequency of medical examinations that are to be offered to those employees covered by the medical surveillance program, and proposed paragraph (k)(3) details the content of the medical examinations.

    Sec. 1910.1024(k)(4) Information Provided to the PLHCP

    Proposed paragraph (k)(4) would require employers to provide a copy of this standard and its appendices to the examining PLHCP. In addition, the proposed paragraph would require employers to provide the following information, if known, to the PLHCP: (A) A description of the employee's former and current duties that relate to the employee's occupational exposure; (B) the employee's former and current levels of occupational exposure; (C) a description of any protective clothing and equipment, including respirators, used by the employee, including when and for how long the employee has used that protective clothing and equipment; and (D) information from records of employment-related medical examinations previously provided to the employee, currently within the control of the employer, after obtaining a medical release from the employee.

    Sec. 1910.1024(k)(5)(i), (ii), and (iii) Licensed Physician's Written Medical Opinion

    Under proposed paragraph (k)(5)(i), the employer must obtain a written medical opinion from the licensed physician within 30 days of the employee's medical examination. The written medical opinion must contain the following information: (A) The licensed physician's opinion as to whether the employee has any detected medical condition that would place the employee at increased risk of CBD from further exposure; (B) any recommended limitations on the employee's exposure, including the use and limitations of protective clothing or equipment, including respirators; and (C) a statement that the PLHCP has explained the results of the medical examination to the employee, including any tests conducted, any medical conditions related to exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment.

    Proposed paragraph (k)(5)(ii) would require the employer to ensure that neither the licensed physician nor any other PLHCP reveals to the employer findings or diagnoses which are unrelated to beryllium exposure.

    Proposed paragraph (k)(5)(iii) would require the employer to provide a copy of the licensed physician's written medical opinion to the employee within two weeks after receiving it.

    Sec. 1910.1024(k)(7) Beryllium Sensitization Test Results Research

    Proposed paragraph (k)(7) would require employers, upon request by OSHA, to convey employees' beryllium sensitization test results to OSHA for evaluation and analysis.

    Sec. 1910.1024(m) Communication of Hazards

    Proposed paragraph (m)(1)(i) would require chemical manufacturers, importers, distributors, and employers to comply with all applicable requirements of the Hazard Communication Standard (HCS) for beryllium (29 CFR 1910.1200). Proposed paragraph (m)(1)(ii) requires that when classifying the hazards of beryllium, the employer must address at least the following: cancer; lung effects (chronic beryllium disease and acute beryllium disease); beryllium sensitization; skin sensitization; and skin, eye, and respiratory tract irritation.

    Proposed paragraph (m)(1)(iii) would require employers to include beryllium in the hazard communication program established to comply with the HCS, and ensure that each employee has access to labels on containers and safety data sheets for beryllium.

    Proposed paragraph (m)(2)(i) would require employers to post warning signs at each approach to a regulated area so that each employee is able to read and understand the signs and take necessary protective steps before entering the area. Proposed paragraph (m)(2)(ii) would require these signs to be legible and readily visible, and contains language that would be required to appear on each warning sign.

    Proposed paragraph (m)(3) would require employers to label each bag and container of clothing, equipment, and materials visibly contaminated with beryllium consistent with the Hazard Communication standard at 29 CFR 1910.1200. Proposed paragraph (m)(3) also contains language that would be required to appear on every such label.

    Proposed paragraph (m)(4)(iv) would require employers to make copies of the standard and its appendices readily available at no cost to each employee and designated employee representative.

    Sec. 1910.1024(m)(4)(iv) Employee Information

    Paragraph (m)(4)(iv) requires that employers make copies of the standard and its appendices readily available at no cost to each employee and designated employee representative.

    Sec. 1910.1024(n) Recordkeeping

    Sec. 1910.1024(n)(1)(i), (ii), and (iii) Exposure Measurements.

    Proposed paragraph (n)(1)(i) would require employers to keep records of all measurements taken to monitor employee exposure to beryllium as required by paragraph (d) of the standard.

    Proposed paragraph (n)(1)(ii) would require employers to include at least the following information in the records: (A) The date of measurement for each sample taken; (B) the operation that is being monitored; (C) the sampling and analytical methods used and evidence of their accuracy; (D) the number, duration, and results of samples taken; (E) the type of personal protective clothing and equipment, including respirators, worn by monitored employees at the time of monitoring; and, (F) the name, social security number, and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.

    Proposed paragraph (n)(1)(iii) would require employers to maintain employee exposure monitoring records in

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    accordance with 29 CFR 1910.1020(d)(1)(ii).

    Sec. 1910.1024(n)(2)(i), (ii), and (iii) Historical Monitoring Data

    Proposed paragraph (n)(2)(i) would require employers to establish an accurate record of any historical monitoring data used to satisfy the initial monitoring requirements in paragraph (d)(2) of the proposed standard. Paragraph (n)(2)(ii) would require the employer to demonstrate that the data comply with the requirements of paragraph (d)(2) of the standard. Paragraph (n)(2)(iii) would require the employer to maintain historical monitoring data in accordance with 29 CFR 1910.1020.

    Sec. 1910.1024(n)(3)(i), (ii), and (iii) Objective Data

    Proposed paragraph (n)(3)(i) would require employers to establish accurate records of any objective data relied upon to satisfy the requirement for initial monitoring in proposed paragraph (d)(2). Proposed paragraph (n)(3)(ii) would require employers to have at least the following information in such records: (A) The data relied upon; (B) the beryllium-containing material in question; (C) the source of the objective data; (D) a description of the operation exempted from initial monitoring and how the data support the exemption; and (E) other information demonstrating that the data meet the requirements for objective data contained in paragraph (d)(2)(ii) of the proposed standard. Proposed paragraph (n)(3)(iii) would require employers to maintain objective data records in accordance with 29 CFR 1910.1020.

    Sec. 1910.1024(n)(4)(i), (ii), & (iii) Medical Surveillance

    Proposed paragraph (n)(4)(i) would require employers to establish accurate records for each employee covered by the medical surveillance requirements in proposed paragraph (k). Proposed paragraph (n)(4)(ii) would require employers to include in employee medical records the following information about the employee: (A) Name, social security number, and job classification; (B) a copy of all licensed physicians' written opinions; and (C) a copy of the information provided to the PLHCP as required by paragraph (k)(4) of the proposed standard. Proposed paragraph (n)(4)(iii) would require employers to maintain medical records in accordance with 29 CFR 1910.1020.

    Sec. Sec. 1910.1024(n)(5)(i) & (ii) Training

    Proposed paragraph (n)(5)(i) would require employers to prepare an employee training record at the completion of any training required by the proposed standard. The training record must contain the following information: The name, social security number, and job classification of each employee trained; the date the training was completed; and the topic of the training. Proposed paragraph (n)(5)(ii) would require employers to maintain employee training records for three years after the completion of training. This record maintenance requirement would also apply to records of annual retraining or additional training as described in paragraph (m)(4) of the proposed standard.

    Sec. 1910.1024(n)(6) Access to Records

    Under proposed paragraph (n)(6), employers must make all records maintained as a requirement of the standard available for examination and copying to the Assistant Secretary, the Director of NIOSH, each employee, and each employee's designated representative(s) in accordance with the Access to employee exposure and medical records standard (29 CFR 1910.1020).

    Sec. 1910.1024(n)(7) Transfer of Records

    Paragraph (n)(7) of the proposed standard would require employers to comply with the transfer requirements contained in the Access to employee exposure and medical records standard (29 CFR 1910.1020(h)). That existing standard requires employers either to transfer records to successor employers or, if there is no successor employer, to inform employees of their access rights at least three months before the cessation of the employer's business.

    4. Affected Public: Business or other for-profit. This standard applies to employers in general industry who have employees that may have occupational exposures to any form of beryllium, including compounds and mixtures, except those articles and materials exempted by paragraphs (a)(2) and (a)(3) of the proposed standard. This standard does not apply to articles, as defined in the Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), that contain beryllium and that the employer does not process. Also, this standard does not apply to materials containing less than 0.1% beryllium by weight.

    5. Number of respondents: Employers in general industry that have employees working in jobs affected by beryllium exposure (4,088 employers).

    6. Frequency of responses: Frequency of response varies depending on the specific collection of information.

    7. Number of responses:155,818.

    8. Average time per response: Varies from 5 minutes (.08 hours) for a clerical worker to generate and maintain an employee medical record, to 8 hours for a human resource manager to develop and implement a written exposure control plan.

    9. Estimated total burden hours: 80,776.

    10. Estimated cost (capital-operation and maintenance): $10,900,579.

    D. Submitting Comments

    Members of the public who wish to comment on the paperwork requirements in this proposal must send their written comments to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the Department of Labor, OSHA (RIN-1218-AB76), Office of Management and Budget, Room 10235, Washington, DC 20503, Fax: 202-395-5806 (this is not a toll-free numbers), email: OIRA_submission@omb.eop.gov. The Agency encourages commenters also to submit their comments on these paperwork requirements to the rulemaking docket (Docket Number OSHA-

    H005C-2006-0870), along with their comments on other parts of the proposed rule. For instructions on submitting these comments to the rulemaking docket, see the sections of this Federal Register notice titled DATES and ADDRESSES.

    E. Docket and Inquiries

    To access the docket to read or download comments and other materials related to this paperwork determination, including the complete Information Collection Request (ICR) (containing the Supporting Statement with attachments describing the paperwork determinations in detail) use the procedures described under the section of this notice titled ADDRESSES. You also may obtain an electronic copy of the complete ICR by visiting the Web page at http://www.reginfo.gov/public/do/PRAMain, scroll under ``Currently Under Review'' to ``Department of Labor (DOL)'' to view all of the DOL's ICRs, including those ICRs submitted for proposed rulemakings. To make inquiries, or to request other information, contact Mr. Todd Owen, Directorate of Standards and Guidance, OSHA, Room N-3609, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2222.

  31. Federalism

    The Agency reviewed the proposed beryllium rule according to the Executive Order (E.O.) on Federalism (E.O. 13132, 64 FR 43255, Aug. 10, 1999), which requires that Federal

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    agencies, to the extent possible, refrain from limiting State policy options, consult with States before taking actions that would restrict States' policy options and take such actions only when clear constitutional authority exists and the problem is of national scope. The E.O. allows Federal agencies to preempt State law only with the expressed consent of Congress; in such cases, Federal agencies must limit preemption of State law to the extent possible.

    Under Section 18 of the Occupational Safety and Health Act (the ``Act'' or ``OSH Act,'' 29 U.S.C. 667), Congress expressly provides that States may adopt, with Federal approval, a plan for the development and enforcement of occupational safety and health standards; States that obtain Federal approval for such a plan are referred to as ``State-Plan States.'' (29 U.S.C. 667). Occupational safety and health standards developed by State-Plan States must be at least as effective in providing safe and healthful employment and places of employment as the Federal standards.

    While OSHA drafted this proposed rule to protect employees in every State, Section 18(c)(2) of the OSHA Act permits State-Plan States to develop and enforce their own standards, provided the requirements in these standards are at least as safe and healthful as the requirements specified in this proposed rule if it is promulgated.

    In summary, this proposed rule complies with E.O. 13132. In States without OSHA-approved State plans, Congress expressly provides for OSHA standards to preempt State occupational safety and health standards in areas addressed by the Federal standards; in these States, this rule limits State policy options in the same manner as every standard promulgated by the Agency. In States with OSHA-approved State plans, this rulemaking does not significantly limit State policy options.

  32. State-Plan States

    When Federal OSHA promulgates a new standard or a more stringent amendment to an existing standard, the 27 State and U.S. territories with their own OSHA-approved occupational safety and health plans (``State-Plan States'') must revise their standards to reflect the new standard or amendment. The State standard must be at least as effective as the Federal standard or amendment, and must be promulgated within six months of the publication date of the final Federal rule. 29 CFR 1953.5(a).

    The State may demonstrate that a standard change is not necessary because, for example, the State standard is already the same as or at least as effective as the Federal standard change. In order to avoid delays in worker protection, the effective date of the State standard and any of its delayed provisions must be the date of State promulgation or the Federal effective date, whichever is later. The Assistant Secretary may permit a longer time period if the State makes a timely demonstration that good cause exists for extending the time limitation. 29 CFR 1953.5(a).

    Of the 27 States and territories with OSHA-approved State plans, 22 cover public and private-sector employees: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. The five states and territories whose OSHA-approved State plans cover only public-sector employees are: Connecticut, Illinois, New Jersey, New York, and the Virgin Islands.

    This proposed beryllium rule applies to general industry. If adopted as proposed, all State Plan States would be required to revise their general industry standard appropriately within six months of Federal promulgation.

  33. Unfunded Mandates Reform Act

    Under Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1532, an agency must prepare a written ``qualitative and quantitative assessment'' of any regulation creating a mandate that ``may result in the expenditure by the State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more'' in any one year before issuing a notice of proposed rulemaking. OSHA's proposal does not place a mandate on State or local governments, for purposes of the UMRA, because OSHA cannot enforce its regulations or standards on State or local governments (see 29 U.S.C. 652(5)). Under voluntary agreement with OSHA, some States enforce compliance with their State standards on public sector entities, and these agreements specify that these State standards must be equivalent to OSHA standards. The OSH Act also does not cover tribal governments in the performance of traditional governmental functions, though it does when tribal governments engage in commercial activity. However, the proposal would not require tribal governments to expend, in the aggregate, $100,000,000 or more in any one year for their commercial activities. Thus, although OSHA may include compliance costs for affected governmental entities in its analysis of the expected impacts associated with a proposal, the proposal does not trigger the requirements of UMRA based on its impact on State, local, or tribal governments.

    Based on the analysis presented in the Preliminary Economic Analysis (see Section IX above), OSHA concludes that the proposal would impose a Federal mandate on the private sector in excess of $100 million in expenditures in any one year. The Preliminary Economic Analysis constitutes the written statement containing a qualitative and quantitative assessment of the anticipated costs and benefits required under Section 202(a) of the UMRA (2 U.S.C. 1532).

  34. Protecting Children From Environmental Health and Safety Risks

    E.O.13045 (66 FR 19931 (Apr. 23, 2003)) requires that Federal agencies submitting covered regulatory actions to OMB's Office of Information and Regulatory Affairs (OIRA) for review pursuant to E.O. 12866 (58 FR 51735 (Oct. 4, 1993)) must provide OIRA with (1) an evaluation of the environmental health or safety effects that the planned regulation may have on children, and (2) an explanation of why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency. E.O.13045 defines ``covered regulatory actions'' as rules that may (1) be economically significant under E.O. 12866 (i.e., a rulemaking that has an annual effect on the economy of $100 million or more, or would adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities), and (2) concern an environmental health risk or safety risk that an agency has reason to believe may disproportionately affect children. In this context, the term ``environmental health risks and safety risks'' means risks to health or safety that are attributable to products or substances that children are likely to come in contact with or ingest (e.g., through air, food, water, soil, product use).

    The proposed beryllium rule is economically significant under E.O. 12866 (see Section IX of this preamble). However, after reviewing the proposed beryllium rule, OSHA has determined that the rule would not impose environmental health or safety risks to children as set forth in E.O. 13045. The proposed rule would require employers to limit employee exposure to beryllium and take other precautions to protect employees from adverse health effects

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    associated with exposure to beryllium. OSHA is not aware of any studies showing that exposure to beryllium disproportionately affects children or that employees under 18 years of age who may be exposed to beryllium are disproportionately affected by such exposure. Based on this preliminary determination, OSHA believes that the proposed beryllium rule does not constitute a covered regulatory action as defined by E.O. 13045. However, if such conditions exist, children who are exposed to beryllium in the workplace would be better protected from exposure to beryllium under the proposed rule than they are currently.

  35. Environmental Impacts

    OSHA has reviewed the beryllium proposal according to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321 et seq.), the regulations of the Council on Environmental Quality (40 CFR part 1500), and the Department of Labor's NEPA procedures (29 CFR part 11). Based on that review, OSHA does not expect that the proposed rule, in and of itself, would create additional environmental issues. OSHA has made a preliminary determination that the proposed standard will have no impact on air, water, or soil quality; plant or animal life; the use of land or aspects of the external environment. Therefore, OSHA concludes that the proposed beryllium standard would have no significant environmental impacts.

  36. Consultation and Coordination With Indian Tribal Governments

    OSHA reviewed this proposed rule in accordance with E.O. 13175 on Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), and determined that it does not have ``tribal implications'' as defined in that order. The rule, if promulgated, would not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

  37. Public Participation

    OSHA encourages members of the public to participate in this rulemaking by submitting comments on the proposal.

    Written Comments. OSHA invites interested persons to submit written data, views, and arguments concerning this proposal. In particular, OSHA encourages interested persons to comment on the issues raised at the end of each section. When submitting comments, persons must follow the procedures specified above in the sections titled DATES and ADDRESSES.

    Informal public hearings. The Agency will schedule an informal public hearing on the proposed rule if requested during the comment period.

  38. Summary and Explanation

    Introduction

    This section of the preamble explains the requirements that OSHA proposes to control occupational exposure to beryllium, including the purpose of these requirements and how they will protect workers from hazardous beryllium exposures.

    OSHA believes, based on currently available information, that the proposed requirements are necessary and appropriate to protect workers exposed to beryllium. In developing this proposed rule, OSHA has considered many sources of data and information, including responses to the Request for Information (RFI) for ``Occupational Exposure to Beryllium'' (OSHA, 2002); the responses from Small Entity Representatives (SERs) who participated in the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et seq.) process (OSHA, 2007a); recommendations of the Small Business Advocacy Review (SBAR) Panel (OSHA, 2008b); the Department of Energy (DOE) Chronic Beryllium Disease Prevention Program rule (DOE, 1999); and numerous scientific studies, professional journal articles, and other data obtained by the Agency.

    The provisions in the proposed standard are generally consistent with other recent OSHA health standards, such as chromium (VI)(29 CFR 1910.1026) and cadmium (29 CFR 1910.1027). Using a similar approach across health standards, when possible, makes them more understandable and easier for employers to follow, and helps to facilitate uniformity of interpretation. This approach is also consistent with section 6(b)(5) of the OSH Act, which states that health standards shall consider ``experience gained under this and other health and safety laws'' (29 U.S.C. 655(b)(5)). However, to the extent that protecting workers from occupational exposure to beryllium requires different or unique approaches, the Agency has formulated proposed requirements to address the specific hazards and working conditions associated with beryllium exposure.

    Also pursuant to section 6(b)(5), OSHA has expressed the proposed requirements in performance-based language, where possible, to provide employers with greater flexibility in determining the most effective strategies for controlling beryllium hazards in their workplaces. OSHA believes this approach allows employers to incorporate changes and advancements in control strategy, technology, and industry practice, thereby reducing the need to revise the rule when those changes occur.

    (a) Scope and Application

    In paragraph (a)(1), OSHA proposes to apply this standard to occupational exposure to beryllium in all forms, compounds, and mixtures in general industry.

    For the purpose of the proposed rule, OSHA is treating beryllium generally, instead of individually addressing specific compounds, forms, and mixtures. Based on a review of scientific studies, OSHA has preliminarily determined that the toxicological effects of beryllium exposure on the human body are similar regardless of the form of beryllium (see the Health Effects section of this preamble at V.B.5; V.G). OSHA is not aware of any information that would lead the Agency to conclude that exposure to different forms of beryllium necessitates different regulatory approaches or requirements.

    OSHA has preliminarily decided to limit the scope of the rulemaking to general industry. This proposal is modeled on a suggested rule that was crafted by two major stakeholders in general industry, Materion Brush and the United Steelworkers Union (Materion and USW, 2012). In the course of developing this proposal, they provided OSHA with data on exposure and control measures and information on their experiences with handling beryllium in general industry settings. At this time, the information available to OSHA on beryllium exposures outside of general industry is limited, but suggests that most operations in other sectors are unlikely to involve beryllium exposure. The Agency hopes to expedite the rulemaking process by limiting the scope of this proposal to general industry and relying on already existing standards to protect workers in those operations outside of general industry where beryllium exposure may exist.

    The proposed rule would not apply to marine terminals, longshoring, or agriculture. OSHA has not found evidence indicating that beryllium is used or handled in these sectors in a way that might result in beryllium exposure. The proposed rule also excludes the construction and shipyard sectors. OSHA believes that occupational exposures to beryllium in

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    the construction and shipyard sectors occur primarily in abrasive blasting operations.

    Abrasive blasters and ancillary abrasive blasting workers are exposed to beryllium from coal slag and other abrasive blast material that may contain beryllium as a trace contaminant. Airborne concentrations of beryllium have been measured above the current TWA PEL of 2 mug/m\3\ when blast material containing beryllium is used as intended (see Appendix IV-C in the PEA, OSHA 2014). Abrasive blasters, pot tenders, and cleanup workers have the potential for significant airborne exposure during blasting operations and during cleanup of spent material that may contain beryllium as a trace contaminant.

    To address high concentrations of various hazardous chemicals in abrasive blasting material, employers must already be using engineering and work practice controls to limit workers' exposures and must be supplementing these controls with respiratory protection when necessary. For example, abrasive blasters in the construction industry fall under the protection of the Ventilation standard (29 CFR 1926.57). The Ventilation standard includes an abrasive blasting subsection (29 CFR 1926.57(f)), which requires that abrasive blasting respirators be worn by all abrasive blasting operators when working inside blast-

    cleaning rooms (29 CFR 1926.57(f)(5)(ii)(A)), or when using silica sand in manual blasting operations where the nozzle and blast are not physically separated from the operator in an exhaust-ventilated enclosure (29 CFR 1926.57(f)(5)(ii)(B)), or when needed to protect workers from exposures to hazardous substances in excess of the limits set in Sec. 1926.55 (29 CFR 1926.57(f)(5)(ii)(C); ACGIH, 1971)). For maritime, standard 29 CFR 1915.34(c) covers similar requirements for respiratory protection needed in blasting operations. Due to these requirements, OSHA believes that abrasive blasters already have controls in place and wear respiratory protection during blasting operations. Thus, in estimating costs for Regulatory Alternatives #2a and #2b, OSHA judged that the reduction of the TWA PEL would not impose costs for additional engineering controls or respiratory protection in abrasive blasting (see Appendix VIII-C in this chapter for details). OSHA requests comment on this issue--in particular, whether abrasive blasters using blast material that may contain beryllium as a trace contaminant are already using all feasible engineering and work practice controls, respiratory protection, and PPE that would be required by Regulatory Alternatives #2a and #2b.

    OSHA requests comment on the limitation of the scope to general industry, as well as information on beryllium exposures in all industry sectors. The Agency requests information on whether employees in the construction, maritime, longshoring, shipyard, and agricultural sectors are exposed to beryllium in any form and, if so, their levels of exposure and what types of exposure controls are currently in place. In particular, OSHA requests comment on whether abrasive blasters using blast material that may contain beryllium as a trace contaminant are already using all feasible engineering and work practice controls, respiratory protection, and PPE. OSHA also requests comment on Regulatory Alternatives #2a and #2b, presented at the end of this section, that would provide protection to workers in sectors outside of general industry. Regulatory Alternative #2a would expand the scope of the proposed standard to include employers in construction and maritime. Regulatory #2b would change the Z tables in 29 CFR 1910.1000 and 29 CFR 1915.1000, and Appendix A of 29 CFR 1926.55, to lower the permissible exposure limits for beryllium for workers in all beryllium-

    exposed occupations. Another regulatory alternative that would impact the scope of affected industries, extending eligibility for medical surveillance to employees in shipyards, construction, and parts of general industry excluded from the scope of the proposed standard, is discussed along with other medical surveillance alternatives (see this preamble at Section XVIII, paragraph (k), Regulatory Alternative #21). Depending on the nature of the data and comments provided, OSHA envisions possible expansions of its regulation of beryllium either as part of this rulemaking or at a later time.

    Paragraph (a)(2) specifies that the proposed rule would not apply to articles, as defined in the Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), that contain beryllium and that the employer does not process. The HCS defines an article as ``a manufactured item other than a fluid or particle: (i) Which is formed to a specific shape or design during manufacture; (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (iii) which under normal conditions of use does not release more than very small quantities e.g., minute or trace amounts of a hazardous chemical (as determined under paragraph (d) of this section), and does not pose a physical hazard or health risk to employees.'' For example, items or parts containing beryllium that employers assemble where the physical integrity of the item is not compromised are unlikely to release more than a very small quantity of beryllium that would not pose a physical or health hazard for workers. These items would be considered articles that are exempt from the scope of the proposed standard. Similarly, finished or processed items or parts containing beryllium that employers are simply packing in containers or affixing with shipping tags or labels are unlikely to release more than a minute or trace amount of beryllium. These items would also come within the proposed exemption. By contrast, if an employer performs operations such as machining, grinding, blasting, sanding, or other processes that physically alter an item, these operations would not fall within the exemption in proposed paragraph (a)(2) because they involve processing of the item and could result in significant exposure to beryllium-

    containing material.

    Paragraph (a)(3) specifies that the proposed rule would not apply to materials containing less than 0.1% beryllium by weight. A similar exemption is included in several previously promulgated standards, including Benzene (29 CFR 1910.1028), Methylenedianiline (MDA) (29 CFR 1910.1050), and 1,3-Butadiene (BD) (29 CFR 1910.1051). These exemptions were established to limit the regulatory burden on employers who do not use materials containing 0.1 percent or more of the substance in question, on the premise that workers in exempted industries are not exposed at levels of concern. In the preamble to the MDA standard, OSHA states that the Agency relied on data showing that worker exposure to mixtures or materials of MDA containing less than 0.1 percent MDA did not create any hazards other than those expected from worker exposure beneath the action level (57 FR 35630, 35645-46, August 10, 1992). The exemption in the BD standard does not apply where airborne concentrations generated by such mixtures can exceed the action level or STEL. The exemption in the Benzene standard was based on indications that exposures resulting from substances containing trace amounts of benzene would generally be below the exposure limit, and on OSHA's belief that the exemption would encourage employers to reduce the concentration of benzene in certain

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    substances (43 FR 27962, 27968, June 27, 1978).

    OSHA is aware of two industries in the general industry sector that would be exempted from the proposed standard under proposed paragraph (a)(3): Coal-fired electric power generation and primary aluminum production. As discussed in the PEA, Chapter IV, Appendices A and B, most employees' TWA exposures in these industries do not exceed the proposed action level of 0.1 mug/m\3\. However, exposures above the proposed PEL of 0.2 mug/m\3\ have been found in some jobs and in facilities with poor housekeeping and work practices. In coal-fired electric power generation, these higher exposures are associated with intermittent exposure to fly ash during maintenance work in and around baghouses and boilers. Fly ash contains less than 0.01% beryllium; however, exposures between 0.1 and 0.4 mug/m\3\ were observed among workers maintaining boilers. Exposures for baghouse cleaning frequently exceeded the current PEL, reaching as high as 13 mug/m\3\. In aluminum production, the bauxite ore used as a raw material contains naturally occurring beryllium in the part per million range (i.e. The configuration of the beryllium work area or regulated area;

    Whether the beryllium work area or regulated area is permanent or temporary;

    The airborne concentrations of beryllium in the beryllium work area or regulated area;

    The number of employees working in areas adjacent to any beryllium work area or regulated area; and

    The period of time the beryllium work area or regulated area is expected to have hazardous exposures.

    OSHA requests comment on the proposed requirement to demarcate beryllium work areas and regulated areas. OSHA also requests comment on whether the standard should allow the performance-based approach indicated in the proposal or whether the rule should specify what types of demarcation employers must use.

    Proposed paragraph (e)(3) requires employers to limit access to regulated areas. Because of the potentially serious health effects of exposure to beryllium and the need for persons entering the regulated area to be properly protected, OSHA believes that the number of persons allowed to access regulated areas should be limited to those individuals listed in proposed paragraph (e)(3). Specifically, this provision would require employers to limit access to regulated areas to: (i) persons the employer authorizes or requires to be in a regulated area to perform work duties; (ii) persons entering a regulated area as designated representatives of employees for the purposes of exercising the right to observe exposure monitoring procedures under paragraph (d)(6) of this standard; and (iii) persons authorized by law to be in a regulated area.

    The first group, persons the employer authorizes or requires to be in a regulated area to perform work duties, may include workers and other persons whose jobs involve operating machinery, equipment, and processes located in regulated areas; performing maintenance and repair operations on machinery, equipment, and processes in those areas; conducting inspections or quality control tasks; and supervising those who work in regulated areas.

    The second group is made up of persons entering a regulated area as designated representatives of employees for the purpose of exercising the right to observe exposure monitoring under paragraph (d)(6). As explained in this section of the preamble regarding paragraph (d), providing employees and their representatives with the opportunity to observe monitoring is consistent with the OSH Act and OSHA's other substance-specific health standards, such as those for cadmium (29 CFR 1910.1027) and methylene chloride (29 CFR 1910.1052).

    The third consists of persons authorized by law to be in a regulated area. This category includes persons authorized to enter regulated areas by the OSH Act, OSHA regulations, or any other applicable law. OSHA compliance officers would fall into this group.

    Proposed paragraph (e)(4) requires employers to provide and ensure that each employee entering a regulated area uses personal protective clothing and equipment, including respirators, in accordance with paragraphs (g) and (h) of this standard.

    In general, commenters did not oppose the concept of regulated areas. Stakeholders responding to the RFI supported the need for regulated areas

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    (ASAS, 2002; AFL-CIO, 2003; Honeywell, 2003). For example, the Department of Defense thought the use of regulated areas was a good way to limit the number of workers potentially exposed to beryllium (DOD, 2003).

    Most small entity representatives (SERs) who participated in the SBREFA process were not concerned about the impact of tying the regulated area requirements to one of the PEL options presented in the SBREFA draft proposed standard (OSHA, 2007b). Only one of the SERs indicated that it may have a process where typical or average exposures are above the lowest PEL option of 0.1 mug/m\3\ (OSHA, 2007a), which is one half the currently proposed TWA PEL.

    SERs were divided on the issue of whether it was possible to isolate or segregate operations to meet the conditions of a regulated area. Most of the SERs did not currently isolate or segregate their beryllium processes, and several expressed concern about the difficulty and costs associated with isolating or segregating their beryllium processes (OSHA, 2008b). Some SERs said they have large, open plant floors making it difficult to isolated specific beryllium operations (OSHA, 2008b). Other SERs said the proposed requirement for a regulated area would be difficult and costly because they move machinery and equipment for production purposes. They said that segregating or restricting processes or machines and equipment to certain areas would affect productivity to some extent (OSHA, 2008b). SERs who use beryllium-containing materials only occasionally, frequently as part of a larger order, said that it would be impractical to isolate specific areas or machines for beryllium work (OSHA, 2008b). SERs in the precision metal products industry indicated their beryllium operations already were well controlled with machine enclosures (e.g., lathes and forming machines) and therefore would not need to segregate these operations (OSHA, 2008b). The Panel recommended that OSHA revisit the cost analysis of regulated areas if the lowest PEL option (0.1 mug/

    m\3\) is proposed (OSHA, 2008b). The Panel also recommended that OSHA consider dropping or limiting the provision for regulated areas (OSHA, 2008b). In response to this recommendation, OSHA analyzed Regulatory Alternative #12, which would not require employers to establish regulated areas.

    The proposed rule presented during the SBREFA process did not contain any requirements for beryllium work areas. These requirements were added by OSHA after the SBREFA process in response to a proposal OSHA received from a stakeholder group (Materion and USW, 2012). However, because the proposal presented during the SBREFA process included a range of proposed TWA PELs down to 0.1 mug/m\3\, SERs had the opportunity to comment on the requirements for regulated areas at very low exposure levels. OSHA believes that SER comments about regulated areas should reflect SER concerns about beryllium work areas as well. OSHA has also made the establishment and demarcation requirements for beryllium work areas flexible and performance-based to address SER concerns. OSHA invites comment on the proposed requirements for beryllium work areas and regulated areas, and on Regulatory Alternative 12 below. OSHA also requests comments and information on work settings where establishing regulated areas could be problematic or infeasible and what other approaches might be used to warn employees in such work settings of high risk areas.

    Regulatory Alternative 12

    This alternative would eliminate the requirement to establish and demarcate regulated areas within facilities where there is beryllium exposure. It does not eliminate the proposal's requirement to establish and demarcate beryllium work areas.

    OSHA is aware that eliminating the requirement for regulated areas may ease the costs and burdens of compliance for some employers. However, this potential benefit of Alternative #12 must be considered in light of the reasons regulated areas were included in the proposal, and are a feature of most OSHA health regulations. As discussed previously, the proposed requirements for regulated areas serve to ensure that access to areas where beryllium exposures exceed the TWA PEL or STEL is restricted, reducing the number of people exposed to beryllium at levels that create a high risk of adverse health effects. Second, the requirement for warning signs ensures that persons who enter areas where exposures exceed the TWA PEL or STEL will be aware of the hazards present and take appropriate precautions such as the proper use of personal protective equipment.

    OSHA believes the proposed requirements for beryllium work areas and regulated areas balance commenters' concerns with the need to reduce the number of employees exposed to beryllium and notify those exposed of the risks involved. The proposed standard does not require employers to establish and demarcate beryllium work areas or regulated areas by permanently segregating and isolating processes generating airborne beryllium. Instead, the standard allows employers to use temporary or flexible methods to demarcate beryllium work areas and regulated areas.

    OSHA believes that these flexible, performance-based requirements could accommodate open work spaces, changeable plant layouts, and sporadic or occasional beryllium use without imposing undue costs or burdens. For example, the standard does not prohibit employers from moving machinery or equipment for production purposes as occurs in the beryllium-copper alloy industry (OSHA, 2008b). Where employers need to move machinery and equipment, the proposed rule allows employers to use methods such as temporary designations and flexible demarcations. OSHA also notes that some employers have enclosed machines (e.g., lathes) to prevent the release of airborne beryllium into the workplace, thereby potentially eliminating the need for the machine to be in a regulated area (OSHA, 2008b).

    (f) Methods of Compliance

    Paragraph (f) of the proposed rule establishes methods for reducing employee exposure to beryllium through the use of a written exposure control plan and engineering and work practice controls.

    Under proposed paragraph (f)(1)(i), employers must establish, implement, and maintain a written exposure control plan for beryllium work areas. OSHA believes that adherence to the written exposure control plan will help reduce skin contact with beryllium, which can lead to beryllium sensitization, and airborne exposure, which can lead to beryllium sensitization, CBD, and lung cancer. Because skin contact and airborne exposure can occur in any workplace within the scope of the standard, OSHA has made the preliminary determination to require a written exposure control plan for all employers within the scope of the standard. In addition, requiring employers to establish and maintain a written exposure control plan is consistent with other OSHA health standards, including 1,3 butadiene (29 CFR 1910.1051) and bloodborne pathogens (29 CFR 1910.1030).

    OSHA's proposal to require a written exposure control plan is based in part on the recommendation of two stakeholders, Materion Corporation and the Steelworkers Union. Materion and the Steelworkers submitted a joint proposal for a standard to the Agency (Materion and Steelworkers, 2012) that includes a requirement for a written

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    exposure control plan. In the stakeholders' joint proposal, the written exposure control plan included requiring documentation of operations and jobs likely to have exposure to beryllium at various levels; procedures for minimizing the migration of beryllium; procedures for keeping work surfaces clean; and documentation of engineering and work practice controls. OSHA's proposed requirements for maintaining and implementing a written exposure control plan follow the example of the stakeholders' proposal in most respects.

    Under proposed paragraphs (f)(1)(i)(A), (B), and (C), the written exposure control plan must contain inventories of operations and job titles reasonably expected to have any exposure to airborne beryllium, exposure at or above the action level, and exposure above the TWA PEL or STEL. And, under proposed paragraph (f)(1)(i)(G), the plan must include an inventory of engineering and work practice controls required by paragraph (f)(2) of this standard.

    A record of which operations and job titles are likely to have exposures at certain levels and which engineering and work practice controls the company has selected to control exposures will make it easier for employers to implement monitoring, hygiene practices, housekeeping, engineering and work practice controls, and other measures. These inventories will also help to assure employees' awareness of the exposures associated with their jobs, their eligibility for medical surveillance, and the controls that should be in use throughout the workplace. This will enable employees to work together with employers to ensure that the appropriate engineering controls and work practices are in use and functioning and that provisions such as medical surveillance, housekeeping, and PPE are properly implemented. In addition, these inventories, like all of the items required to be included in the written exposure control plan, will help safety and health personnel, including OSHA Compliance Officers, carry out their duties. A written plan provides detailed information to interested parties including employees, employee representatives, supervisors, and safety consultants of the employer's determination of the jobs and operations that may place employees at risk of exposure and the measures the employer has selected to control exposure.

    Under proposed paragraph (f)(1)(D) through (F) and (H), the exposure control plan must contain procedures for: minimizing cross-

    contamination, including preventing the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas; keeping surfaces in the beryllium work area as free as practicable of beryllium; minimizing the migration of beryllium from beryllium work areas to other locations within or outside the workplace; and removal, laundering, storage, cleaning, repairing, and disposal of beryllium-contaminated personal protective clothing and equipment, including respirators. Each of these procedures serves to minimize the spread of beryllium throughout and outside the workplace. They also work to reduce the likelihood of skin contact and re-

    entrainment of beryllium particulate into the workplace atmosphere. Additional discussion of some of these requirements may be found in this section of the preamble, Summary and Explanation, at paragraph (h), Personal Protective Clothing and Equipment; paragraph (i), Hygiene Areas and Practices; and paragraph (j), Housekeeping.

    The requirement to document these procedures in writing, as part of the exposure control plan, will help to ensure that employees are advised of their responsibilities and can easily review the procedures if they have questions. Because employees play an important part in exposure control through compliance with the rules regarding hygiene practices, housekeeping, and other measures, employees should have easy access to documentation detailing the procedures in place in their workplace. A review of the written exposure control plan should be part of the hazard communication training for employees as required by 1910.1200 and proposed paragraph (m). Additionally, the documentation of the procedures will help OSHA Compliance Officers assess employers' procedures.

    Proposed paragraph (f)(1)(ii) requires that employers update their exposure control plans whenever any change in production processes, materials, equipment, personnel, work practices, or control methods results or can reasonably be expected to result in new or additional exposures to beryllium. Paragraph (f)(1)(ii) also requires employers to update their plans when an employee is confirmed positive for beryllium sensitization, is diagnosed with CBD, or shows other signs and symptoms related to beryllium exposure. In addition, the paragraph requires employers to update their plans if the employer has any reason to believe that new or additional exposures are occurring or will occur.

    The requirements to update the exposure control plan if changes in the workplace result in or can be expected to result in new or additional exposures, or where the employer has any reason to believe that such exposures are occurring or will occur, ensure that an employer's plan reflects the current conditions in the workplace. If an employee becomes sensitized or develops CBD, the employer should investigate the source(s) of exposure responsible, and must make any necessary changes to address the source(s) of exposure, and update the written exposure control plan as necessary to reflect any new information or corrective action resulting from the employer's investigation. For example, the employer may find that housekeeping procedures in the employee's area need improvement, or that more appropriate PPE could be used. In some cases, the employer may find that additional engineering or work practice controls are appropriate to the processes in use. When the employer discovers new sources of exposure or makes changes in its control strategy, the employer must update its written exposure control plan to reflect current conditions in the workplace. Employers such as Materion and Axsys Technologies, who have worked to identify and document the exposure sources associated with cases of sensitization and CBD in their facilities, have used this information to develop and update beryllium exposure control plans (Bailey et al., 2010; Schuler et al., 2012; Madl et al., 2007). OSHA believes this proposed process, whereby an employer uses employee health outcome data to check and improve the effectiveness of the employer's exposure control plan, is consistent with other performance-oriented aspects of this proposed standard.

    Proposed paragraph (f)(1)(iii) requires employers to make a copy of the exposure control plan accessible to each employee who is or can reasonably be expected to be exposed to airborne beryllium in accordance with OSHA's Access to Employee Exposure and Medical Records Standard (29 CFR 1910.1020). As mentioned above, access to the exposure control plan will enable employees to partner with their employers in keeping the workplace safe.

    Paragraph (f)(2) of the proposed rule contains requirements for the implementation of engineering and work practice controls to minimize beryllium exposures in beryllium work areas. The proposed rule relies on engineering and work practice controls as the primary means to reduce

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    exposures. Where, after the implementation of feasible engineering and work practice controls, exposures exceed or can reasonably be expected to exceed the TWA PEL or STEL, employers are required to supplement these controls with respiratory protection, according to the requirements of paragraph (g) of the proposed rule. OSHA proposes to require primary reliance on engineering and work practice controls because reliance on these methods is consistent with good industrial hygiene practice, with the Agency's experience in ensuring that workers have a healthy workplace, and with OSHA's traditional adherence to a hierarchy of controls.

    OSHA requires adherence to this hierarchy of controls in a number of standards, including the Air Contaminants (29 CFR 1910.1000) and Respiratory Protection (29 CFR 1910.134) standards, as well as other substance-specific standards. The Agency's adherence to the hierarchy of controls has been successfully upheld by the courts (see AFL-CIO v. Marshall, 617 F.2d 636 (D.C. Cir. 1979) (cotton dust standard); United Steelworkers v. Marshall, 647 F.2d 1189 (D.C. Cir. 1980), cert. denied, 453 U.S. 913 (1981) (lead standard); ASARCO v. OSHA, 746 F.2d 483 (9th Cir. 1984) (arsenic standard); Am. Iron & Steel v. OSHA, 182 F.3d 1261 (11th Cir. 1999) (respiratory protection standard); Pub. Citizen v. U.S. Dep't of Labor, 557 F.3d 165 (3rd Cir. 2009) (hexavalent chromium standard)).

    The Agency understands that engineering controls are reliable, provide consistent levels of protection to a large number of workers, can be monitored continually and inexpensively, allow for predictable performance levels, and can efficiently remove toxic substances from the workplace. Once removed, the toxic substances no longer pose a threat to employees. The effectiveness of engineering controls does not generally depend to any substantial degree on human behavior, and the operation of control equipment is not as vulnerable to human error as is personal protective equipment. For these reasons, engineering controls are preferred by OSHA and the safety and health professional community in general.

    The provisions related to engineering and work practice controls begin in paragraph (f)(2)(i)(A). For each operation in a beryllium work area, employers must ensure that at least one of the following engineering and work practice controls is in place to minimize employee exposure:

    (1) Material and/or process substitution;

    (2) Ventilated partial or full enclosures;

    (3) Local exhaust ventilation at the points of operation, material handling, and transfer; or

    (4) Process control, such as wet methods and automation. OSHA has included a non-mandatory appendix presenting a non-exhaustive list of engineering controls employers may use to comply with paragraph (f)(2)(i) (Appendix B).

    Proposed paragraph (f)(2)(i)(B) offers two exemptions from the engineering and work practice controls requirements. First, under paragraph (f)(2)(i)(B)(1), an employer is exempt from using engineering and work practice controls where the employer can establish that the controls are not feasible.

    Second, under paragraph (f)(2)(i)(B)(2), an employer is exempt from using the controls where the employer can demonstrate that exposures are below the action level, using no fewer than two representative personal breathing zone samples taken 7 days apart, for each affected operation.

    The engineering work practice control requirement in paragraph (f)(2)(i)(A), like the written exposure control plan requirement, was proposed by the United Steelworkers and Materion as part of their joint submission to OSHA (Materion and United Steelworkers, 2012). The inclusion of the engineering work practice control provision in paragraph (f)(2)(i)(A) addresses a concern regarding the proposed PEL. OSHA expects that day-to-day changes in workplace conditions may cause frequent excursions above the PEL in workplaces where periodic sampling indicates exposures are between the action level and the PEL. Normal variability in the workplace and work processes, such as workers' positioning or patterns of airflow, can lead to excursions above the PEL. OSHA believes that substitution or engineering controls such as those outlined in paragraph (f)(2)(i)(A) provide the most reliable means to control variability in exposure levels. OSHA therefore included this requirement in the proposal. The Agency included the exemption in paragraph (f)(2)(i)(B)(2) to reduce the cost burden to employers with operations where measured exposures are below the action level, and therefore less likely to exceed the PEL in the course of typical exposure fluctuations. This exemption is similar to a provision in 1,3 Butadiene (29 CFR 1910.1051), which requires an exposure goal program where exposures exceed the action level.

    OSHA recognizes that the requirements of paragraph (f)(2)(i) are not typical of OSHA standards, which usually require engineering controls only where exposures exceed the PEL(s). The Agency is therefore considering Regulatory Alternative #6, which would drop the provisions of paragraph (f)(2)(i) from the proposed standard. OSHA requests comments on the potential benefits of including such a provision in the beryllium standard, the potential costs and burdens associated with it, and whether OSHA should include or exclude this provision in the final standard.

    Proposed paragraph (f)(2)(ii) applies when exposures exceed the TWA PEL or STEL after employers have implemented the control(s) required by paragraph (f)(2)(i). It requires employers to implement additional or enhanced engineering and work practice controls to reduce exposures to or below the PELs. For example, an enhanced engineering control may entail a redesigned hood on a local ventilation system to more effectively capture airborne beryllium at the source.

    However, under proposed paragraph (f)(2)(iii), wherever the employer demonstrates that it is not feasible to reduce exposures to or below the PELs by the engineering and work practice controls required by paragraphs (f)(2)(i) and (f)(2)(ii), the employer shall implement and maintain engineering and work practice controls to reduce exposures to the lowest levels feasible and supplement these controls by using respiratory protection in accordance with paragraph (g) of this standard.

    Paragraph (f)(3) of the proposed rule would prohibit the employer from rotating workers to different jobs to achieve compliance with the PELs. Worker rotation can potentially reduce exposures to individual employees, but increases the number of employees exposed. Because OSHA has made a preliminary determination that exposure to beryllium can result in sensitization, CBD, and cancer, the Agency considers it inappropriate to place more workers at risk. Since no absolute threshold has been established for sensitization or resulting CBD or the carcinogenic effects of beryllium, it is prudent to limit the number of workers exposed at any concentration.

    This provision is not a general prohibition of worker rotation wherever workers are exposed to beryllium. It is only intended to restrict its use as a compliance method for the proposed PEL; worker rotation may be used as deemed appropriate by the employer in

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    activities such as to provide cross-training or to allow workers to alternate physically demanding tasks with less strenuous activities. This same provision was used for the asbestos (29 CFR 1910.1001 and 29 CFR 1926.1101), chromium (VI) (29 CFR 1910.1026), 1,3 butadiene (29 CFR 1910.1051), methylene chloride (29 CFR 1910.1052), cadmium (29 CFR 1910.1027 and 29 CFR 1926.1127), and methylenedianiline (29 CFR 1926.60) OSHA standards.

    The SERs who participated in the SBREFA process did not voice opposition to a requirement for a written exposure control program or challenge the utility of a written program in helping to control exposures (OSHA, 2008b). Several indicated that they already had a beryllium exposure control program in place. Some SERs suggested that OSHA should tie the written exposure control program requirement to exposures exceeding a revised PEL (OSHA, 2008b). The SERs' request to tie the written exposure control program requirement to the PEL appears to emerge from their belief that employees exposed below the proposed PEL are not at risk from beryllium exposure (OSHA, 2008b).

    As stated earlier, OSHA's proposed standard would require a written exposure control plan for all beryllium work areas; i.e., wherever airborne beryllium is found in the workplace. OSHA believes a written exposure control plan is needed to reduce employees' risks in low-

    exposure areas, where the proposed standard does not require employers to install engineering controls, as well as in high-risk areas. The Agency's preliminary risk assessment shows that adverse health effects from beryllium exposure occur at levels below the proposed PEL, and even below the proposed action level (see this preamble at Section VIII, Significance of Risk). In addition, dermal contact with beryllium can occur in jobs where exposures are below the PEL or the action level. Dermal exposure to beryllium can cause beryllium sensitization, a necessary first step in the development of CBD (see this preamble at Section V, Health Effects, and Section VIII, Significance of Risk). However, in response to the SERs' comments on the written exposure control plan and other requirements that may affect workplaces with exposure levels below the proposed PEL, OSHA is considering Regulatory Alternative #8 (see chapter VIII of the PEA). Where the proposed standard requires written exposure control plans to be maintained in any facility covered by the standard, Regulatory Alternative #8 would require only facilities with exposures above the TWA PEL or STEL to maintain a plan. OSHA requests comment on the proposed written exposure control plan requirement and on Regulatory Alternative #8.

    Several SERs expressed doubt that material substitution could be an effective means of reducing beryllium exposures in their facilities. One SER stated that substitutes for beryllium alloys are not presently viable for industrial uses that require certain high-performance electrical characteristics, or wear resistance (OSHA, 2007a). Another SER commented that substitutes for beryllium alloys in the dental appliance industry have also been associated with occupational disease (OSHA, 2007a).

    OSHA recognizes that the use of substitutes for beryllium may not be feasible or appropriate for some employers. The Agency's intent is to offer material substitution as one possible means of compliance with the proposed standard. Employers must determine whether material substitution is an effective and appropriate means of exposure control for their facilities. In addition, it is employers' responsibility to check the toxicity of any material they may use in their facilities, including potential substitutes for beryllium.

    OSHA anticipates that most small businesses will be able to comply with the proposed standard regardless of whether they choose to substitute other materials for beryllium in their facilities.

    (g) Respiratory Protection

    Paragraph (g) of the proposed standard lays out the situations in which employers are required to protect employees' health through the use of respiratory protection. Specifically, this paragraph would require that employers provide respiratory protection at no cost and ensure that employees utilize the protection during the situations listed in paragraph (g)(1). As detailed in proposed paragraph (g)(2), the required respiratory protection must comply with the Respiratory Protection standard (29 CFR 1910.134).

    Proposed paragraph (g)(1) requires employers to ensure that each employee required to use a respirator does so. Accordingly, simply providing respirators to employees will not satisfy an employer's obligations under proposed paragraph (g)(1) unless the employer also ensures that its employees wear the respirators when required. Proposed paragraph (g)(1) would also require employers to provide required respirators at no cost to employees. This requirement is consistent with OSHA's Respiratory Protection standard, which also requires employers to provide required respiratory protection to employees at no cost (29 CFR 1910.134(c)(4)).

    Paragraph (g)(1) requires appropriate respiratory protection during certain enumerated situations. Proposed paragraph (g)(1)(i) requires respiratory protection during the installation and implementation of engineering and/or work practice controls where exposures exceed or can reasonably be expected to exceed the TWA PEL or STEL. The Agency realizes that changing workplace conditions may require employers to install new engineering controls, modify existing controls, or make other workplace changes to reduce employee exposure to beryllium to at or below the TWA PEL and STEL. In these cases, the proposed standard recognizes that installing appropriate engineering controls and implementing proper work practices may take time. During this time, employers must demonstrate that they are making prompt, good faith efforts to purchase and install appropriate engineering controls and implement effective work practices, and to evaluate their effectiveness for reducing exposure to beryllium to at or below the TWA PEL and STEL.

    Proposed paragraph (g)(1)(ii) requires the provision of respiratory protection during any operations, including maintenance and repair operations and other non-routine tasks, when engineering and work practice controls are not feasible and exposures exceed or can reasonably be expected to exceed the TWA PEL or STEL. OSHA included this provision because the Agency realizes that certain operations may take place when engineering and work practice controls are not operational or capable of controlling exposures to at or below the TWA PEL and STEL. For example, during maintenance and repair operations, engineering controls may lose their full effectiveness or require partial or total breach, bypass, or shutdown. Under these circumstances, if exposures exceed or can reasonably be expected to exceed the TWA PEL or STEL, the employer must provide and ensure the use of respiratory protection.

    Proposed paragraph (g)(1)(iii) requires the provision of respiratory protection where beryllium exposures exceed the TWA PEL or STEL even after the employer has installed and implemented all feasible engineering and work practice controls. OSHA anticipates that there will be very few situations where feasible engineering and work practice controls are incapable of lowering employee exposure to beryllium to at or below the TWA PEL

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    or STEL (see this preamble at section IX.D, Technological Feasibility). In such cases, the proposed standard requires that employers install and implement all feasible engineering and work practice controls and supplement those controls by providing respiratory protection (proposed paragraph (f)(2)(iii)). OSHA reiterates that paragraph (f)(2)(iii) would also require employers to demonstrate that engineering and work practice controls are not feasible or sufficient to reduce exposure to levels at or below the TWA PEL and STEL. OSHA requests comment about the proposed situations during which employers should be required to provide and ensure the use of respiratory protection.

    Proposed paragraph (g)(1)(iv) requires the provision of respiratory protection in emergencies. At such times, engineering controls may not be functioning fully or may be overwhelmed or rendered inoperable. Also, emergencies may occur in areas where there are no engineering controls. The proposed standard recognizes that the provision of respiratory protection is critical in emergencies, as beryllium exposures may be very high and engineering controls may not be adequate to control an unexpected release of beryllium.

    The situations in which respiratory protection is required are generally consistent with the requirements in other OSHA health standards, such as those for chromium (VI)(29 CFR 1910.1026), butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052). Those standards and this proposed standard also reflect the Agency's traditional adherence to a hierarchy of controls in which engineering and work practice controls are preferred to respiratory protection (see the discussion of proposed paragraph (f) earlier in this section of the preamble).

    Whenever respirators are used to comply with the requirements of this proposed standard, paragraph (g)(2) requires that the employer implement a comprehensive written respiratory protection program in accordance with OSHA's Respiratory Protection standard (29 CFR 1910.134). The Respiratory Protection standard is designed to ensure that employers properly select and use respiratory protection in a manner that effectively protects exposed workers. Under 29 CFR 1910.134(c)(1), the employer's respiratory protection program must include:

    Procedures for selecting appropriate respirators for use in the workplace;

    Medical evaluations of employees required to use respirators;

    Respirator fit testing procedures;

    Procedures for proper use of respirators in routine and reasonably foreseeable emergency situations;

    Procedures and schedules for maintaining respirators;

    Procedures to ensure adequate quality, quantity, and flow of breathing air for atmosphere-supplying respirators;

    Training of employees in the respiratory hazards to which they are potentially exposed during routine and emergency situations, and in the proper use of respirators; and

    Procedures for evaluating the effectiveness of the program.

    In accordance with the Agency's policy to avoid duplication and to establish regulatory consistency, proposed paragraph (g)(2) incorporates by reference the requirements of 29 CFR 1910.134 rather than reprinting those requirements in this proposed standard. OSHA notes that the respirator selection provisions in 1910.134 include requirements for Assigned Protection Factors (APFs) and Maximum Use Concentrations (MUCs) that OSHA adopted in 2006 (71 FR 50122-50192, August 24, 2006). The APFs and MUCs provide employers with critical information for the selection of respirators to protect workers from exposure to atmospheric workplace contaminants.

    OSHA believes that the proposed respiratory protection requirements are feasible even for small employers. Although none of the SERs who participated in the SBREFA process made specific recommendations about respiratory protection, some said that they currently have existing respiratory protection programs in place as supplemental support to engineering and work practice controls (OSHA, 2008b).

    OSHA requests comment on the proposed requirement to establish and maintain a respiratory protection program that complies with 29 CFR 1910.134. OSHA would like to hear from companies of all sizes regarding whether they have respiratory protection programs to protect employees from beryllium exposures. If so, please explain the parameters of your program including types of respirators used, when and where respirators are required, program evaluation, and annual costs.

    (h) Personal Protective Clothing and Equipment

    Paragraph (h) of the proposed standard requires employers to provide employees with personal protective clothing and equipment (PPE) where employee exposure exceeds or can reasonably be expected to exceed the TWA PEL or STEL; where work clothing or skin may become visibly contaminated with beryllium, including during maintenance and repair activities or during non-routine tasks; and where employees are exposed to soluble beryllium compounds. These PPE requirements are intended to prevent adverse health effects associated with dermal exposure to beryllium, and accumulation of beryllium on clothing, shoes, and equipment that can result in additional inhalation exposure. The requirements also protect employees in other work areas from exposures that could occur if contaminated clothing carried beryllium to those areas, as well as employees and other individuals outside the workplace. The proposed standard requires the employer to provide PPE at no cost to employees, and to ensure that employees use the provided PPE in accordance with the written exposure control plan as described in paragraph (f)(1) of this proposed standard and OSHA'S Personal Protective Equipment standards (29 CFR part 1910 subpart I).

    Proposed paragraph (h)(1)(i) requires the provision and use of PPE for employees exposed to airborne beryllium in any form exceeding the TWA PEL or STEL because such exposure would likely result in skin contact by means of deposits on employees' skin or clothes or on surfaces touched by employees. And, OSHA believes that regardless of the level of exposure, the use of PPE further reduces exposure where employees' clothing or skin could become visibly contaminated with beryllium (paragraph (h)(1)(ii)).

    The term ``visibly contaminated with beryllium'' means visibly contaminated with any material that contains beryllium. The proposed standard does not specify criteria for determining whether work clothing or skin may become visibly contaminated with beryllium. When evaluating whether this definition is satisfied, OSHA expects that the employer will assess the workplace in a manner consistent with the Agency's general requirements for the use of personal protective equipment in general industry (29 CFR part 1910 subpart I). These standards require the employer to assess the workplace to determine if hazards associated with dermal or inhalation exposure to a substance such as beryllium are, or are likely to be, present.

    The proposed standard also requires the provision and use of PPE where employees are exposed to soluble

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    beryllium compounds, regardless of the level of airborne exposure (paragraph (h)(1)(iii)). Solubility is a concern because dermal absorption may occur at a greater rate for soluble beryllium than for insoluble beryllium. Once absorbed through the skin, beryllium can induce a sensitization response that is a necessary first step toward CBD (See the Health Effects section of this preamble, section V.A.2). However, there is also evidence that beryllium in other forms can be absorbed through the skin and cause sensitization (see this preamble at section V.B.2, Health Effects). OSHA requests comment on this provision, and whether employers should also be required to provide PPE to limit dermal contact with insoluble forms of beryllium as specified in Regulatory Alternative #13 below.

    Requiring PPE is consistent with section 6(b)(7) of the OSH Act which states that, where appropriate, standards shall prescribe suitable protective equipment to be used in connection with hazards. The proposed requirements for PPE are based upon widely accepted principles and conventional practices of industrial hygiene, and in some respects are similar to other OSHA health standards such as those for chromium (VI) (29 CFR 1910.1026), lead (29 CFR 1910.1025), cadmium (29 CFR 1910.1027), and methylenedianiline (MDA; 29 CFR 1910.1050). However, the requirement to use PPE where work clothing or skin may become ``visibly contaminated'' with beryllium differs from prior health standards, which do not require contamination to be visible in order for PPE to be required. For example, the standard for chromium (VI) requires the employer to provide appropriate PPE where a hazard is present or is likely to be present from skin or eye contact with chromium (VI) (29 CFR 1910.1026). The lead (29 CFR 1910.1025) and cadmium (29 CFR 1910.127) standards require PPE where employees are exposed above the PEL or where there is potential for skin or eye irritation, regardless of airborne exposure level. In the case of MDA, PPE must be provided where employees are subject to dermal exposure to MDA, where liquids containing MDA can be splashed into the eyes, or where airborne concentrations of MDA are in excess of the PEL (29 CFR 1910.1050). While OSHA's language regarding PPE requirements varies somewhat from standard to standard, previous standards tend to emphasize potential for contact with a substance that can trigger health effects via dermal exposure, rather than ``visible contamination'' with the substance.

    The employer must exercise reasonable judgment in selecting appropriate PPE. This requirement is consistent with OSHA's current standards for provision of personal protective equipment for general industry (29 CFR part 1910 subpart I). As described in the non-

    mandatory appendix providing guidance on conducting a hazard assessment for OSHA general industry standards (29 CFR 1910 subpart I appendix B), the employer should ``exercise common sense and appropriate expertise'' in assessing hazards. By ``appropriate expertise,'' OSHA expects individuals conducting hazard assessments to be familiar the employer's work processes, materials, and work environment. A thorough hazard assessment should include a walk-through survey to identify sources of hazards to employees, wipe sampling to detect beryllium contamination on surfaces, review of injury and illness data, and employee input on the hazards to which they are exposed. Information obtained in this manner provides a basis for the identification and evaluation of potential hazards. OSHA believes that the implementation of a comprehensive and thorough program to determine areas of potential exposure, consistent with the employer's written exposure control plan, is a sound safety and health practice and a necessary element of ensuring overall worker protection.

    Based on the hazard assessment results, the employer must determine what PPE is necessary to protect employees. The proposed requirement is performance-oriented, and is designed to allow the employer flexibility in selecting the PPE most suitable for each particular workplace. The type of PPE needed will depend on the potential for exposure, the physical properties of the beryllium-containing material used, and the conditions of use in the workplace. For example, shipping and receiving activities may necessitate only work uniforms and gloves. In other situations such as when a worker is performing facility maintenance, gloves, work uniforms, coveralls, and respiratory protection may be appropriate. Beryllium compounds can exist in acidic or alkaline form, and these characteristics may influence the choice of PPE. Face shields may be appropriate in situations where there is a danger of being splashed in the face with soluble beryllium or a liquid containing beryllium. Coveralls with a head covering may be appropriate when a sudden release of airborne beryllium could result in beryllium contamination of clothing, hair, or skin. Respirators are addressed separately in the explanation of proposed paragraph (g) earlier in this section of the preamble.

    Note that paragraph (i)(2) of this proposed standard requires change rooms only where employees are required to remove their personal clothing. Although some personal protective clothing may be worn over street clothing, it is not appropriate for workers to wear protective clothing over street clothing if doing so could reasonably result in contamination of the workers' street clothes. In situations in which it is not appropriate for workers to wear protective clothing over their street clothes, the employer must select and ensure the use of protective clothing that is worn in lieu of (rather than over) street clothing.

    Paragraph (h)(2) contains proposed requirements for removal and storage of PPE. This provision is intended to reduce beryllium contamination in the workplace and limit beryllium exposure outside the workplace. Wearing contaminated clothing outside the beryllium work area could lengthen the duration of exposure and carry beryllium from beryllium work areas to other areas of the workplace. In addition, contamination of personal clothing could result in beryllium being carried to employees' cars and homes, increasing employees' exposure as well as exposing others to beryllium hazards. A National Jewish Medical and Research Center collaborative study with NIOSH documented inadvertent transfer of beryllium from the workplace to workers' automobiles, and stressed the need for separating clean and contaminated (``dirty'') PPE (Sanderson, 1999). Toxic metals brought by workers into the home via contaminated clothing and vehicles continue to result in exposure to children and other household members. A recent study of battery recycling workers found that lead surface contamination above the Environmental Protection Agency level of concern ( 40 mug/ft\2\) was common in the workers' homes and vehicles (Centers for Disease Control and Prevention, 2012).

    Under proposed paragraph (h)(2)(i)(A), beryllium-contaminated PPE must be removed at the end of the work shift or at the completion of tasks involving beryllium exposure, whichever comes first. This language is intended to convey that PPE contaminated with beryllium should not be worn when tasks involving beryllium exposure have been completed for the day. For example, if employees perform work tasks involving beryllium exposure for the first two hours of a

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    work shift, and then perform tasks that do not involve exposure, they should remove their PPE after the exposure period to avoid the possibility of increasing the duration of exposure and contamination of the work area from beryllium residues on the PPE (i.e., re-entrainment of beryllium particulate). If, however, employees are performing tasks involving exposure intermittently throughout the day, or if employees are exposed to other contaminants where PPE is needed, this provision is not intended to prevent them from wearing the PPE until the completion of their shift, unless it has become visibly contaminated with beryllium (paragraph (h)(2)(i)(B)).

    Paragraph (h)(2)(i)(B) would require employers to ensure that employees remove PPE that has become visibly contaminated with beryllium. This language is intended to convey that PPE that is visibly contaminated with beryllium should be changed at the earliest reasonable opportunity, for example, at the end of the task during which it became visibly contaminated. This language is intended to protect employees working with beryllium and their co-workers from exposure due to accumulation of beryllium on PPE, and reduces the likelihood of cross-contamination from beryllium-contaminated PPE.

    Proposed paragraph (h)(2)(ii) requires employees to remove PPE consistent with the written exposure control plan required by proposed paragraph (f)(1). Paragraph (f)(1) specifies that the employer's written exposure control plan must contain procedures for minimizing cross-contamination, and procedures for the storage of beryllium-

    contaminated PPE, among other provisions (see (f)(1)(i)(D) & (H)). Paragraph (h)(2)(iii) would require employers to ensure that protective clothing is stored separately from employees' street clothing. OSHA believes these provisions are necessary to prevent the spread of beryllium throughout and outside the workplace.

    To further limit exposures outside the workplace, OSHA proposes in paragraph (h)(2)(iv) that the employer ensure that beryllium-

    contaminated PPE is only removed by employees who are authorized to do so for the purpose of laundering, cleaning, maintaining, or disposing of such PPE. These items must be brought to an appropriate location away from the workplace. To be an appropriate location for purposes of paragraph (h)(2)(iv), the facility must be equipped to handle beryllium-contaminated items in accordance with this proposed standard. The standard would further require in paragraph (h)(2)(v) that PPE removed from the workplace for laundering, cleaning, maintenance, or discarding be placed in closed, impermeable bags or containers. These requirements are intended to minimize cross-contamination and migration of beryllium, and to protect employees or other individuals who later handle beryllium-contaminated items. Required warning labels would alert those handling the contaminated PPE of the potential hazards of exposure to beryllium. Such labels must conform with the HCS (29 CFR 1910.1200) and paragraph (m)(3) of this proposed standard. These warning requirements are meant to reduce confusion and ambiguity regarding critical information communicated in the workplace by requiring that this information be presented in a clear and uniform manner.

    Proposed paragraph (h)(3)(i) would require the employer to ensure that reusable PPE is cleaned, laundered, repaired, and replaced as needed to maintain its effectiveness. These requirements must be completed at a frequency, and in a manner, necessary to ensure that PPE continues to serve its intended purpose of protecting workers from beryllium exposure.

    In keeping with the performance-orientation of the proposed standard, OSHA does not specify how often PPE should be cleaned, repaired or replaced. The Agency believes that appropriate time intervals may vary widely based on the types of PPE used, the nature of the beryllium exposures, and other circumstances in the workplace. However, even in the absence of a mandated schedule, the employer is still obligated to keep the PPE in the condition necessary to perform its protective function. A number of Small Entity Representatives (SERS) from OSHA's SBREFA panel noted they now use low maintenance Tyvek disposable protective suits for some high exposure areas to address potential contamination situations (OSHA, 2007a).

    Under paragraph (h)(3)(ii), removal of beryllium from PPE by blowing, shaking, or any other means which disperses beryllium in the air would be prohibited as this practice could result in unnecessary exposure to airborne beryllium.

    Paragraph (h)(3)(iii) would require the employer to inform in writing any person or business entity who launders, cleans, or repairs PPE required by this standard of the potentially harmful effects of exposure to airborne beryllium and dermal contact with soluble beryllium compounds, and of the need to handle the PPE in accordance with this standard. This provision is intended to limit dermal or inhalation exposure to beryllium, and to emphasize the need for hazard awareness and protective measures consistent with the proposed standard among persons who clean, launder, or repair beryllium-contaminated items.

    Comments from SERs indicate that a number of beryllium-related businesses already have comprehensive protocols in place for the use and maintenance of PPE (OSHA, 2007a). One commenter indicated that it has effectively reduced sensitization and CBD through the use of respirators, other PPE, and engineering controls (OSHA, 2007a). Another commenter stated that it utilizes PPE to reduce skin exposure (OSHA, 2007a). These existing PPE programs achieve many of the Agency's goals and incorporate many of the requirements of this proposed standard.

    The primary objections from SERs came from companies that raised concerns regarding the ``trigger'' (e.g., exposure level or surface contamination) for PPE in the draft standard, and particularly the use of such terms as ``anticipated,'' ``routine,'' and ``contaminated surface area'' in connection with the requirements to protect against dermal exposure to beryllium (OSHA, 2007a). They also contend that for certain processes such as stamping, change rooms, PPE, and other hygiene practices are not necessary (OSHA, 2007a). Much of this criticism was based on early pre-proposal drafts in circulation to the SBREFA Panel (OSHA, 2007b). Since that time, OSHA has endeavored to refine the regulatory text to reflect the concerns and comments submitted on this topic. ``Contaminated surface area'' is no longer a trigger for PPE; however, employers must provide PPE if a contaminated surface presents the potential for workers' skin or clothing to become visibly contaminated with beryllium (paragraph (h)(1)(ii)). The term ``routine'' has been removed as a trigger, and paragraph (h)(1)(ii) makes clear that protections are required where skin or clothing may become visibly contaminated whether during routine or non-routine tasks. OSHA clarified that dermal protections are required only where the skin may become visibly contaminated with beryllium. OSHA believes that this proposed standard addresses commenters' objections with textual changes and this explanation of the text, which together provide further guidance to those who would be covered by the standard.

    However, OSHA is concerned that the requirement to use PPE where work clothing or skin may become ``visibly contaminated'' with beryllium or where

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    soluble forms of beryllium are used may not be sufficiently protective of beryllium-exposed workers. OSHA has preliminarily concluded that sensitization can occur through dermal exposure. And although solubility may play a role in the level of sensitization risk, the available evidence suggests that contact with insoluble as well as soluble beryllium can cause sensitization via dermal contact (see this preamble at section V, Health Effects). Furthermore, at exposure levels below the current or proposed PEL, beryllium surface contamination is unlikely to be visible yet may still cause sensitization. The specification of ``visible contamination'' is a departure from most OSHA standards, which do not specify that contamination must be visible in order for PPE to be required. OSHA is therefore considering Regulatory Alternative #13, which would require appropriate PPE wherever there is potential for skin contact with beryllium or beryllium-contaminated surfaces. Please provide comments on this alternative, including the benefits and drawbacks of a comprehensive PPE requirement, and any relevant data or studies the Agency should consider.

    (i) Hygiene Areas and Practices

    Paragraph (i) of the proposed standard requires that, when certain conditions are met, employers must provide employees with readily accessible washing facilities, change rooms, and showers. Proposed paragraph (i) also requires employers to take certain steps to minimize exposure in eating and drinking areas, and prohibits certain practices that may contribute to beryllium exposure. OSHA believes that strict compliance with these provisions would substantially reduce employee exposure to beryllium.

    The proposed standard requires certain hygiene facilities and procedures in beryllium work areas, and additional hygiene facilities and procedures when airborne exposures exceed the TWA PEL or STEL. OSHA believes that skin contact with beryllium can occur even at low airborne exposures. Skin wipe sample analysis of dental laboratory technicians performing grinding operations demonstrated that beryllium was present on the hands of workers even when airborne exposures were well below the PEL (ERG, 2006).

    As discussed in the Health Effects section of this preamble, section V, respiratory tract, skin, eye, or mucosal contact with beryllium can result in sensitization, which is a necessary first step toward the development of CBD. Also, beryllium can contaminate employees' clothing, shoes, skin, and hair, prolonging workers' beryllium exposure and exposing others such as family members if proper hygiene practices are not observed. A study by the National Jewish Medical and Research Center of Denver, Colorado, measured the levels of beryllium on workers' skin and vehicle surfaces at a machining plant where many workers did not change out of their clothes and shoes at the end of their shifts. The study showed elevated surface levels of beryllium were present on workers' skin and in their vehicles, demonstrating that workers carried residual beryllium on their hands and shoes when leaving work (Sanderson et al., 1999). Paragraph (i) of the proposed standard would reduce employees' skin contact with beryllium, the possibility of accidental ingestion and inhalation of beryllium, and the spread of beryllium within and outside the workplace.

    Paragraph (i)(1) would require the employer to provide readily accessible washing facilities capable of removing beryllium from the hands, face, and neck, and to ensure that employees working in beryllium work areas use these facilities when necessary. This requirement is performance-oriented, and does not specify any particular frequency. At a minimum, employees working in a beryllium work area must wash their hands, faces, and necks at the end of the shift to remove any residual beryllium. Likewise, washing prior to eating, drinking, smoking, chewing tobacco or gum, applying cosmetics, or using the toilet would also protect employees against beryllium ingestion and inhalation.

    Typically, washing facilities would consist of one or more sinks, soap or another cleaning agent, and a means for employees to dry themselves after washing. OSHA does not intend to require the use of any particular soap or cleaning agent. Employers can provide whatever washing materials and equipment they choose, as long as those materials and equipment are effective in removing beryllium from the skin and do not themselves cause skin or eye problems.

    Washing reduces exposure by limiting the period of time that beryllium is in contact with the skin, and helps prevent accidental ingestion. Although engineering and work practice controls and protective clothing and equipment are designed to prevent hazardous skin and eye contact, OSHA realizes that in some circumstances exposure will nevertheless occur. For example, an employee who wears gloves to protect against hand contact with beryllium may inadvertently touch his or her face with the contaminated glove during the course of the day. The purpose of requiring washing facilities is to mitigate adverse health effects when skin or eye contact with beryllium occurs.

    Under proposed paragraph (i)(2), where employees are required to remove their personal clothing in order to use personal protective clothing, the employer must provide designated change rooms with separate storage facilities for street and work clothing to prevent cross contamination. Change rooms must be in accordance with the Sanitation standard (29 CFR 1910.141). OSHA intends the change rooms requirement to apply to all covered workplaces where employees must change their clothing (i.e., take off their street clothes) to use protective clothing. In situations where removal of street clothes is not necessary (e.g., in a workplace where only gloves are used as protective clothing), change rooms are not required. Note that paragraph (h) of this proposed standard requires employers to provide ``appropriate'' personal protective clothing. It is not appropriate for employees to wear protective clothing over street clothing if doing so results in contamination of the employee's street clothes. In such situations, the employer must ensure that employees wear protective clothing in lieu of (rather than over) street clothing, and provide change rooms.

    Change rooms must be designed in accordance with the written exposure control plan required by paragraph (f)(1) of this proposed standard, and with the Sanitation standard (29 CFR 1910.141). These provisions require change rooms to be equipped with storage facilities (e.g., lockers) for protective clothing, and separate storage facilities for street clothes, to prevent cross-contamination. Minimizing contamination of employees' personal clothes will also reduce the likelihood that beryllium will contaminate employees' cars and homes, and other areas outside the workplace.

    Because of the risk of beryllium sensitization via the skin as described in section V of this preamble, Health Effects, OSHA has determined that employers must provide showers if their employees could reasonably be expected to be exposed above the TWA PEL or STEL (paragraph (i)(3)(i)(A)), and if employees' hair or body parts other than hands, face, and neck could reasonably be expected to be contaminated with beryllium (paragraph (i)(3)(i)(B)). Employers are only required to provide showers if paragraphs (i)(3)(i)(A) and (B) both apply. Other OSHA health standards, such as the standards for cadmium (29 CFR

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    1910.1027) and lead (29 CFR 1910.1025), also require showers when exposures exceed the PEL. OSHA's standard for coke oven emissions (29 CFR 1910.1029) requires employers to provide showers and ensure that employees working in a regulated area shower at the end of the work shift. The standard for methylenedianiline (MDA) (29 CFR 1910.1050) requires employers to ensure that employees who may potentially be exposed to MDA above the action level shower at the end of the work shift.

    Paragraph (i)(3)(ii) requires employers to ensure that employees use the showers at the end of the work activity or shift involving beryllium if the employees reasonably could have been exposed above the TWA PEL or STEL, and if beryllium could reasonably have contaminated the employees' body parts other than hands, face, and neck. This language is intended to convey that showers are required for employees who satisfy both paragraphs (i)(3)(ii)(A) and (B) when work activities involving beryllium exposure have been completed for the day. For example, if employees perform work activities involving beryllium exposure for the first two hours of a work shift, and then perform activities that do not involve exposure, they should shower after the exposure period to avoid increasing the duration of exposure, potential of accidental ingestion, and contamination of the work area from beryllium residue on their hair and body parts other than hands, face, and neck. If, however, employees are performing tasks involving exposure intermittently throughout the day, this provision is not intended to require them to shower before the completion of the last task involving exposure.

    To minimize the possibility of food contamination and the likelihood of additional exposure to beryllium through inhalation or ingestion, paragraph (i)(4) would require that employers provide employees with a place to eat and drink where beryllium exposure is below the action level, and where the surfaces are maintained as free as practicable of beryllium. Eating and drinking areas must further comply with the Sanitation standard (29 CFR 1910.141(g)), which prohibits consuming food or beverages in a toilet area or in any area with exposures above an OSHA PEL.

    The requirement to maintain surfaces as free as practicable of beryllium is included in other OSHA health standards such as those for lead in general industry (29 CFR 1910.1025), lead in construction (29 CFR 1926.62), chromium (IV) (29 CFR 1910.1026), and asbestos (29 CFR 1910.1001). As OSHA explained in a January 13, 2003, letter of interpretation concerning the meaning of ``as free as practicable'' in OSHA's Lead in Construction standard (29 CFR 1926.62), OSHA evaluates whether a surface is ``as free as practicable'' of a contaminant by the rigor of the employer's program to keep surfaces clean (OSHA, 2003). A sufficient housekeeping program may be indicated by a routine cleaning schedule and the use of effective cleaning methods to minimize the possibility of exposure from accumulation of beryllium on surfaces. OSHA's compliance directive on Inspection Procedures for Chromium (IV) Standards provides additional detail on how OSHA interprets ``as free as practicable'' for enforcement purposes (OSHA, 2008a). As explained in the directive, if a wipe sample reveals a toxic substance on a surface, and the employer has not taken practicable measures to keep the surface clean, the employer has not kept the surface as free as practicable of the toxic substance.

    The proposed standard does not require the employer to provide separate eating and drinking areas to employees at the worksite. Employees may consume food or beverages offsite. However, where the employer chooses to allow employees to consume food or beverages at a worksite where beryllium is present, the employer would be required to maintain the area in accordance with paragraph (i)(4) of this proposed standard.

    Paragraph (i)(5)(i) would prohibit eating, drinking, smoking, chewing tobacco or gum, or applying cosmetics in regulated areas. Where exposures can reasonably be expected at levels above the proposed TWA PEL or STEL, there is a greater risk of beryllium contaminating the food, drink, tobacco, gum, or cosmetics. Prohibiting these activities would reduce the potential for this manner of exposure.

    Under paragraph (i)(5)(ii), employers would also be required to ensure that employees do not enter eating or drinking areas wearing contaminated protective clothing or equipment. This is to further minimize the likelihood that employees will be exposed to beryllium in eating and drinking areas through inhalation, dermal contact, and ingestion.

    The draft regulatory text presented during the SBREFA process would have required handwashing facilities and certain other hygiene provisions when exposures exceeded the TWA PEL, or when there was ``anticipated skin exposure.'' Small Entity Representatives (SERs) from OSHA's SBREFA panel expressed concern that the phrase ``anticipated skin exposure'' was vague and lacked definition (OSHA, 2007a). Commenters suggested that this could require employers at workplaces with low exposures to make significant modifications to the workplace, such as installing showers and change rooms. OSHA has evaluated the hygiene triggers and clarified that change rooms are only required when employees must remove their street clothes in order to wear protective clothing. Showers are only required when exposures exceed the TWA PEL or STEL, and beryllium could reasonably contaminate employees' hair or body parts other than hands, face, and neck. OSHA has removed the phrase ``anticipated skin exposure'' from the proposed standard. OSHA believes these changes address the commenters' concerns.

    (j) Housekeeping

    Paragraph (j) of the proposed standard requires employers to maintain surfaces in beryllium work areas as free as practicable of accumulations of beryllium; promptly clean spills and emergency releases; use appropriate cleaning methods; and properly dispose of beryllium-contaminated waste, debris, and materials. These provisions are especially important because they minimize additional sources of exposure that engineering controls are not designed to address. Good housekeeping measures are a cost-effective way to control employee exposures by removing settled beryllium that could otherwise become re-

    entrained into the surrounding atmosphere by physical disturbances or air currents and could enter an employee's breathing zone. Contact with contaminated surfaces may also result in dermal exposure to beryllium. As discussed in this preamble at section V, Health Effects, researchers have identified skin exposure to beryllium as a pathway to sensitization. The proposed provisions in this paragraph are consistent with housekeeping requirements in other OSHA standards for toxic metals including cadmium (29 CFR 1910.1027), chromium (VI)(29 CFR 1910.1026), and lead (29 CFR 1910.1025).

    Paragraph (j)(1) requires the employer to ensure that all surfaces in beryllium work areas are maintained as free as practicable of accumulations of beryllium, and that spills and emergency releases are cleaned up promptly. Employers must follow the procedures that they have listed under their exposure control plan required by paragraph (f)(1) to clean beryllium-

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    contaminated surfaces, and use the cleaning methods required by paragraph (j)(2). Good housekeeping practices are essential in controlling beryllium exposure. Beryllium-containing material deposited on ledges, equipment, floors, and other surfaces must be promptly removed to prevent these deposits from becoming airborne and to minimize the likelihood of skin contact with beryllium.

    Paragraph (j)(1) directs the employer to maintain surfaces where beryllium may accumulate ``as free as practicable'' of beryllium. In this context, the phrase ``as free as practicable'' sets forth the baseline goal in the development of an employer's housekeeping program to keep work areas free from surface contamination. For a detailed discussion of the meaning of the phrase ``as free as practicable,'' see the discussion of proposed paragraph (i) earlier in this section of the preamble.

    Employers must regularly clean surfaces in beryllium work areas to minimize re-entrainment of dust into the work environment, and to ensure that accumulations of beryllium do not become sources of exposure. Although OSHA does not define ``surface'' in the proposed standard, the term would include surfaces workers come into contact with such as working surfaces, floors, and storage facilities, as well as surfaces workers do not directly contact such as rafters. Because all surfaces in beryllium work areas could potentially accumulate beryllium that workers could later inhale, touch, or ingest, all surfaces in beryllium works areas must be kept as free as practicable of beryllium.

    OSHA has preliminarily decided not to require employers to measure beryllium contamination on surfaces, because the Agency does not have the necessary data to understand the relationship between surface level of beryllium and risk of absorption through the skin. The use of wipe samples, however, remains a useful qualitative tool to detect the presence of beryllium on surfaces.

    As mentioned above, when beryllium is released into the workplace as a result of a spill or emergency release, paragraph (j)(1)(ii) would require the employer to ensure prompt and proper cleanup in accordance with the written exposure control plan required by paragraph (f)(1) and to use the cleaning methods required by paragraph (j)(2) of this proposed standard. Spills or emergency releases not attended to promptly are likely to result in additional employee exposure or skin contact.

    Paragraph (j)(2) provides that clean-up procedures for beryllium-

    containing material must minimize employee exposure. OSHA recognizes that each work environment is unique, so OSHA has established performance-oriented requirements for housekeeping to allow employers to determine how best to clean beryllium work areas while minimizing employee exposure. Paragraph (j)(2)(i) of the proposed standard would require that surfaces contaminated with beryllium be cleaned by high efficiency particulate air filter (HEPA) vacuuming or other methods that minimize the likelihood of beryllium exposure. OSHA believes HEPA vacuuming is a highly effective method of cleaning beryllium-

    contaminated surfaces. However, other cleaning methods equally effective at minimizing the likelihood of beryllium exposure may be used.

    Paragraph (j)(2)(ii) would permit dry sweeping or brushing in certain cases only. The employer must demonstrate that it has tried cleaning with a HEPA-filter vacuum or another method that minimizes the likelihood of exposure, and that those methods were not effective under the particular circumstances found in the workplace. OSHA has included this provision in an attempt to provide employers flexibility when exposure-minimizing cleaning methods would not be effective, but OSHA is not aware of any circumstances in which dry sweeping or brushing would be necessary. OSHA requests comment on whether dry sweeping or brushing would ever be necessary, and if so, under what circumstances (see section I of this preamble, Issues and Alternatives).

    Paragraph (j)(2)(iii) would prohibit the use of compressed air in cleaning beryllium-contaminated surfaces unless it is used in conjunction with a ventilation system designed to capture any resulting airborne beryllium. This provision is also intended to prevent the dispersal of beryllium into the air.

    Proposed paragraph (j)(2)(iv) details further protections for those employees who are using certain cleaning methods. Under this provision, where employees use dry sweeping, brushing, or compressed air to clean beryllium-contaminated surfaces, the employer must provide respiratory protection and protective clothing and equipment and ensure that each employee uses this protection in accordance with paragraphs (g) and (h) of this standard. The failure to provide proper and adequate protection to those employees performing cleanup activities would defeat the purpose of the housekeeping practices required to control beryllium exposure.

    Paragraph (j)(2)(v) would require employers to ensure that equipment used to clean beryllium from surfaces is handled in a manner that minimizes employee exposure and the re-entrainment of beryllium into the workplace environment. For example, cleaning and maintenance of HEPA-filtered vacuum equipment must be done carefully to avoid exposure to beryllium. Similarly, filter changes and bag and waste disposal must be performed in a manner that minimizes the risk of employee exposure to airborne beryllium. This provision is consistent with the requirement in proposed paragraph (f)(1)(i)(F) for the written exposure control plan, under which employers must establish and implement procedures for minimizing the migration of beryllium. And of course, employees handling and maintaining cleaning equipment must be protected in accordance with the other paragraphs of this proposed standard as well, including the requirements for respiratory protection and PPE in paragraphs (g) and (h).

    Proposed paragraph (j)(3)(i) would require that items visibly contaminated with beryllium and consigned for disposal be disposed of in sealed, impermeable bags or other closed impermeable containers. Proposed paragraph (j)(3)(ii) requires these containers to be marked with warning labels to inform individuals who handle these items of the potential hazards associated with beryllium exposure, and the labels must contain specific language in accordance with paragraph (m)(3) of the proposed standard. Alerting employers and employees who are involved in disposal to the potential hazards of beryllium exposure will better enable them to implement protective measures.

    Proposed paragraph (j)(3)(iii) gives employers two options for materials designated for recycling that are visibly contaminated with beryllium: Sealing them in impermeable enclosures and labeling them in accordance with proposed paragraph (m)(3), or cleaning them to remove visible particulate. Proposed paragraph (j)(3)(iii) allows employers this flexibility to facilitate the recycling process, and ensures that employees handling these items for recycling purposes will not be exposed to visible particulate if the items are not sealed in impermeable enclosures and labeled with warnings about the dangers of beryllium exposure.

    OSHA believes that the concept and importance of housekeeping programs in protecting workers from beryllium

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    exposure are generally well understood and acknowledged by the affected employer community. Small Entity Representatives (SERs) on the SBREFA Advisory Panel indicated that most of the responding small business entities engaged in regular and routine housekeeping activities in areas where beryllium-containing material has been used or processed (OSHA, 2008b). Housekeeping activities included wet mopping, vacuuming, and sweeping in and around machinery and other surfaces. In performing these tasks, respirator and PPE usage varied. In some cases, employers provided the protection, but did not require its usage. In other instances, no protection was available to workers performing housekeeping duties. (OSHA, 2007a).

    Those companies that did have comprehensive housekeeping policies provided the Agency with a number of useful practices and examples in response to the RFI as well as during the SBREFA process. One company offered its 8-step housekeeping and control strategy into the record as a comprehensive model (Brush Wellman, 2003). Another company presented its facility housekeeping program specifying a number of containment measures such as tack mats, absorbent carpet, and damp disposable towels to collect any contamination from beryllium operations. Certain practices were expressly prohibited such as dry sweeping, brushing, wiping, and the use of compressed air systems to clean machinery (Honeywell, 2003). Researchers with the National Jewish Hospital and Research Center found that most of the beryllium facilities that they visited prohibited the use of compressed air in beryllium areas (NJMRC, 2003).

    Several commenters also questioned the vagueness of the term ``contaminated surfaces'' (OSHA, 2008b). The proposed standard no longer uses this term. Rather, proposed paragraph (j) would require employers to maintain surfaces in beryllium work areas ``as free as practicable of accumulations of beryllium,'' which is explained earlier in this section.

    (k) Medical Surveillance

    Under paragraph (k)(1) of the proposed standard, OSHA would require employers to make medical surveillance available at no cost, and at a reasonable time and place, for all employees who have worked in a regulated area for more than 30 days in the past 12 months; show signs and symptoms of CBD; are exposed to beryllium during an emergency; or were exposed to beryllium in concentrations above 0.2 mug/m\3\ for more than 30 days in a 12-month period for 5 years or more.

    Under paragraph (k)(1)(ii), the required medical surveillance must be performed by or under the direction of a licensed physician. OSHA chose to require licensed physicians, as opposed to PLHCPs, to oversee medical surveillance in this standard, and to provide certain services required by this standard (see, e.g., paragraphs (k)(1)(ii) and (k)(5)). OSHA has in the past allowed a PLHCP to perform all aspects of medical surveillance, regardless of whether the PLHCP is a licensed physician (see OSHA's standards regulating chromium (VI) (29 CFR 1910.1026) and methylene chloride (29 CFR 1910.1052)). OSHA has proposed that a licensed physician perform some of the requirements of paragraph (k) in response to a multi-stakeholder coalition proposal to this effect. OSHA believes this requirement strikes an appropriate balance between ensuring that a licensed physician supervises the overall care of the employee, while giving the employer the flexibility to retain the services of a variety of qualified licensed health care professionals to perform certain other services required by paragraph (k). However, OSHA also believes it may be appropriate to allow a PLHCP who is not a licensed physician to perform all of the services required by proposed paragraph (k) (see also section I of this preamble, Issues and Alternatives). OSHA requests comment on this proposed requirement.

    The purpose of medical surveillance for beryllium is, where reasonably possible, to identify beryllium-related adverse health effects so that appropriate intervention measures can be taken, and to determine the employee's fitness to use personal protective equipment such as respirators. The proposed standard is consistent with Section 6(b)(7) of the OSH Act (29 U.S.C. 655(b)(7)), which requires that, where appropriate, medical surveillance programs be included in OSHA health standards to aid in determining whether the health of employees is adversely affected by exposure to toxic substances. Other OSHA health standards, such as Chromium (VI) (29 CFR 1910.1026), Methylene Chloride (29 CFR 1910.1052), and Cadmium (29 CFR 1910.1027), also include medical surveillance requirements.

    The proposed standard is intended to encourage participation in medical surveillance by requiring at paragraph (k)(1)(i) that the employer provide medical examinations without cost to employees (also required by section 6(b)(7) of the Act (29 U.S.C. 655(b)(7)), and at a reasonable time and place. If participation requires travel away from the worksite, the employer would be required to bear all travel costs. Employees must be paid for time away from work spent attending medical examinations, including travel time.

    Paragraph (k)(1)(i)(A) proposes to require employers to make medical surveillance available to all employees who worked in a regulated area for more than 30 days in the past 12 months. This requirement attempts to ensure that those employees who are at most risk for developing beryllium-related adverse health effects have access to medical services so that such adverse health effects can be detected early.

    In addition, paragraph (k)(1)(i)(B) would require that employers provide medical surveillance to any employee who shows signs or symptoms of CBD. It is expected that employees experiencing signs and symptoms of exposure will report them to their employers. If an employer becomes aware that an employee shows signs and symptoms of CBD either through employee self-reporting or from observation of the employee, the employer is required to provide medical surveillance to the employee. However, this provision is not intended to force employers to survey their workforce, make diagnoses, or determine causality.

    Proposed paragraph (k)(1)(i)(B) recognizes that some employees may exhibit signs and symptoms of the adverse health effects associated with beryllium exposure even when not exposed above the TWA PEL or the STEL for more than 30 days per year. OSHA's preliminary risk assessment concludes that there is significant risk of adverse health effects from beryllium exposure below the proposed PEL (see this preamble at section VI, Preliminary Risk Assessment). In addition, beryllium sensitization and CBD could develop in employees who are especially sensitive to beryllium, may have been unknowingly exposed, or may have been exposed to greater amounts than the exposure assessment suggests.

    Self-reporting by employees will be supported by the training required under proposed paragraph (m)(4)(ii) on the health hazards of beryllium exposure and the signs and symptoms of CBD, and the medical surveillance and medical removal requirements of the proposed standard in paragraphs (k) and (l). Employees have a right under section 11(c) of the OSH Act to report suspected work-related health effects to their employers without retaliation. Any employer program or practice that

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    discourages employees from reporting or penalizes workers who report work-related health effects would violate section 11(c). See Memorandum from Richard E. Fairfax to Regional Administrators (March 12, 2012), available at http://www.osha.gov/as/opa/whistleblowermemo.html.

    As discussed in this preamble at section V, Health Effects, CBD causes fatigue, weakness, difficulty breathing, and a persistent dry cough, among other symptoms. In more advanced cases, CBD may also result in anorexia and weight loss, as well as right side heart enlargement (cor pulmonale) and heart disease. By requiring covered employers to make a medical exam available when an employee exhibits these types of symptoms, the proposed standard would protect all employees who may have developed CBD, whether or not these employees have been exposed to beryllium in an emergency or for more than 30 days in a regulated area.

    Paragraph (k)(1)(i)(C) would require that appropriate surveillance also be made available for employees exposed to beryllium during an emergency, regardless of the airborne concentrations of beryllium to which these employees are routinely exposed in the workplace. Emergency situations involve uncontrolled releases of airborne beryllium, and the significant exposures that can occur in these situations justify a requirement for medical surveillance. The proposed requirement for medical examinations after exposure in an emergency is consistent with several other OSHA health standards, including the standards for chromium (VI) (29 CFR 1910.1026), methylenedianiline (29 CFR 1910.1050), butadiene (29 CFR 1910.1051), and methylene chloride (29 CFR 1910.1052).

    Paragraph (k)(1)(i)(D) would require medical surveillance to be provided to employees who have been exposed to beryllium above 0.2 mug/m\3\ for more than 30 days in a 12-month period for 5 years or more. The five-years of exposure would not need to be consecutive to satisfy this provision. OSHA included this provision to ensure that these employees receive the low-dose helical tomography (CT scan, low-

    dose computed tomography (LDCT), or CT screening) required by paragraph (k)(3)(ii)(F) of the proposed standard, even if these employees have not been exposed above 0.2 mug/m\3\ in the previous 12-month period, are not exhibiting signs and symptoms of CBD, and have not been exposed in an emergency. The CT scan is a method of detecting tumors, and is commonly used to diagnose lung cancer.

    Paragraph (k)(2) of the proposed standard specifies how frequently medical examinations are to be offered to those employees covered by the medical surveillance program. Under paragraph (k)(2)(i)(A), employers would be required to provide each employee with a medical examination within 30 days after the employee has worked in a regulated area for more than 30 days in the past 12 months, unless the employee has received a medical examination provided in accordance with this standard within the previous 12 months. Paragraph (k)(2)(i)(B) requires employers to provide medical examinations to employees exposed to beryllium during an emergency, and to those who are showing signs or symptoms of CBD, within 30 days of the employer becoming aware that these employees meet the criteria of paragraph (k)(1)(i)(B) or (C). Paragraph (k)(2)(i)(B) requires an examination without regard to whether these employees received an exam in the previous 12 months.

    Paragraph (k)(2)(ii) of the proposed standard requires that employers provide an examination annually (after the first examination is made available) to employees who continue to meet the criteria of paragraph (k)(1)(i)(A) or (B). This includes employees who have worked in a regulated area for more than 30 days in the past 12 months and employees who continue to exhibit signs and symptoms of CBD. The requirement for annual examinations in paragraph (k)(2)(ii) means that an examination must be made available at least once every 12 months.

    Employees exposed in an emergency, who are covered by paragraph (k)(1)(i)(C), are not included in the annual examination requirement unless they also meet the criteria of paragraph (k)(1)(i)(A) or (B), because OSHA expects that most effects of exposure will be detected during the medical examination provided within 30 days of the emergency, pursuant to paragraph (k)(2)(i)(A). An exception to this is beryllium sensitization, which OSHA believes may result from exposure in an emergency, but may not be detected within 30 days of the emergency. Thus, proposed paragraph (k)(3)(ii)(E) requires biennial testing for beryllium sensitization for employees exposed in emergencies. This paragraph is discussed in more detail later in this section of the preamble. Employees covered by paragraph (k)(1)(i)(D) are also not required to receive exams annually unless they also meet the criteria of paragraph (k)(1)(i)(A) or (B).

    OSHA believes that the annual provision of medical surveillance, and the biennial provision of beryllium sensitization testing and CT scans for certain employees, are appropriate frequencies for screening employees for beryllium-related diseases. The main goals of medical surveillance for employees are to detect beryllium sensitization before employees develop CBD, and to detect CBD, lung cancer, and other adverse health effects at an early stage. The proposed requirement for annual examinations is consistent with other OSHA health standards, including those for chromium (VI) (29 CFR 1910.1026) and formaldehyde (29 CFR 1910.1048). Based on the Agency's experience, OSHA believes that annual surveillance and biennial tests for beryllium sensitization and CT scans would strike a reasonable balance between the need to diagnose health effects at an early stage, while being sufficiently affordable for employers.

    Finally, proposed paragraph (k)(2)(iii) would require the employer to offer a medical examination at the termination of employment, if the departing employee meets the criteria of paragraph (k)(1)(i)(A), (B), or (C) at the time the employee's employment is terminated. This would apply to employees who worked in a regulated area for more than 30 days during the previous 12 months, employees showing signs or symptoms of CBD, and employees who were exposed to beryllium in an emergency at any time during their employment. This proposed requirement is waived if the employer provided the departing employee with an exam during the six months prior to the date of termination. The provision of an exam at termination is intended to ensure that no employee terminates employment while carrying a detectable, but undiagnosed, health condition related to beryllium exposure.

    Proposed paragraph (k)(3) details the contents of the examination. Paragraph (k)(3)(i) would require the employer to ensure that the PLHCP advises the employee of the risks and benefits of participating in the medical surveillance program and the employee's right to opt out of any or all parts of the medical examination. Benefits of participating in medical surveillance may include early detection of adverse health effects, and aiding intervention efforts to prevent or treat disease. However, there may also be risks associated with medical testing for some conditions, which the PLHCP should communicate to the employee.

    Paragraph (k)(3)(ii) then specifies that the medical examination must consist of a medical and work history; a physical examination with emphasis on the respiratory tract, skin breaks, and wounds; and pulmonary function tests.

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    Special emphasis is placed on the portions of the medical and work history focusing on beryllium exposure, health effects associated with beryllium exposure, and smoking.

    The physical exam focuses on organs and systems known to be susceptible to beryllium toxicity. For example, proposed paragraph (k)(3)(ii)(C) focuses on the skin, and paragraph (k)(3)(ii)(D) focuses on the lungs. The information obtained will allow the PLHCP and supervising physician to assess the employee's health status, identify adverse health effects related to beryllium exposure, and determine if limitations should be placed on the employee's exposure to beryllium. The proposed standard does not include a comprehensive list of specific tests that must be part of the medical examination. OSHA does not believe that any particular test--beyond those listed in paragraph (k)(3)(ii)(D)-(F)--is necessarily applicable to all employees covered by the medical surveillance requirements. The Agency proposes to give the PLCHP the flexibility to determine any other appropriate tests to be selected for a given employee, as provided in paragraph (k)(3)(ii)(G).

    Under paragraph (k)(3)(ii)(E), an employee must be offered a BeLPT (or a more reliable and accurate test for identifying beryllium sensitization) at the employee's first examination, and then every two years after the first examination unless the employee is confirmed positive. The requirement to test for beryllium sensitization applies whether or not an employee is otherwise entitled to a medical examination in a given year. For example, for an employee exposed during an emergency who would normally be entitled to 1 exam within 30 days of the emergency but not annual exams thereafter, the employer must still provide this employee with a test for beryllium sensitization every 2 years. This biennial requirement applies until the employee is confirmed positive. OSHA believes that the biennial testing required under paragraph (k)(3)(ii)(E) is adequate to monitor employees that have the potential to develop sensitization while being sufficiently affordable for employers.

    OSHA considers the BeLPT to be a reliable medical surveillance tool for the purposes of a medical surveillance program. However, OSHA considers two abnormal test results necessary to confirm a finding of beryllium sensitization when using the BeLPT (``confirmed positive''). Therefore, a BeLPT must also be offered within one month of an employee receiving a single abnormal result. However, this requirement is waived if a more reliable and accurate test becomes available that could confirm beryllium sensitization based on one test result. OSHA requests comment on how to determine whether a test is more reliable and accurate than the BeLPT for identifying beryllium sensitization. OSHA has included a non-mandatory appendix that describes the BeLPT, discusses several studies of the BeLPT's validity and reliability, and states criteria OSHA believes are important to judge a new test's validity and reliability (Appendix A).

    Under paragraph (k)(3)(ii)(F), a CT scan must be offered to employees who have been exposed to beryllium at concentrations above 0.2 mug/m\3\ for more than 30 days in a 12-month period for 5 years or more. The five years of exposure do not need to be consecutive. As with the requirement for sensitization testing explained above, the CT scan must be offered to an employee who meets the criteria of paragraph (k)(1)(i)(D) without regard to whether the employee is otherwise required to receive a medical exam in a given year. The CT scan must be offered to employees who meet the criteria of paragraph (k)(1)(i)(D) for the first time beginning on the start-up date of this standard, or 15 years after the employee's first exposure to beryllium above 0.2 mug/m\3\ for more than 30 days in a 12-month period, whichever is later. OSHA proposed the requirement for CT screening based in part on the Agency's consideration of the draft recommended standard submitted by industry and union stakeholders (Materion and USW, 2012).

    The CT scan requirement may be triggered by exposures that occurred before or after the effective date of this standard, or a combination of exposures before and after the effective date. This requirement may also be triggered by exposures that occurred when the employee was working for a different employer. An employer is required to offer a CT scan to employees who meet the criteria of paragraph (k)(1)(i)(D) if the employer has exposure records demonstrating that the employee meets the criteria, regardless of whether the exposure records were generated by the employer or given to the employer by the employee or a third party.

    In a recent systematic review of CT screening trials for lung cancer, Bach et al. found a significant (20 percent) mortality reduction in the population studied (26,309 men and women between ages 55 and 74, with at least 30 pack-years of smoking history) (National Lung Screening Trial, 2011). The benefits of screening for other populations are less clear at this time. CT screening was not shown to offer significant reduction in mortality in two other, smaller trial populations with at least 20 pack-years of smoking history (DANTE, 2009; DLCST, 2012). In addition, there is yet to be agreement on how to properly compute and set the radiation dose for LDCT. Clarification on such procedural issues will help inform analyses of LDCT-associated radiation exposure and its risks as part of a screening protocol for employees exposed to occupational carcinogens (Christensen, 2014).

    OSHA seeks comment on the proposed requirement and whether it is likely to benefit the beryllium-exposed employee population. As appropriate, please submit information, studies and data to support your comments.

    OSHA notes that another form of CT scanning, High Resolution Computed Tomography (HRCT), is available and may be useful in screening for CBD. In patients with CBD, HRCT scanning of the chest is more sensitive than plain chest radiography in identifying abnormalities (NAS, 2008). However, HRCT scans showing no signs consistent with CBD have been reported in 25 percent of patients with biopsy-proven noncaseating granulomas (Newman et al., 1994). OSHA seeks comment on whether HRCT should be included in the list of diagnostic procedures a CBD Diagnostic Center should be able to provide (see this Preamble at Section XVIII, paragraph (b), Definitions).

    Other types of tests and examinations not mentioned in this standard, including X-ray, arterial blood gas, diffusing capacity, and oxygen desaturation during exercise, may also be useful in evaluating the effects of beryllium exposure. In addition, medical examinations that include more invasive testing, such as bronchoscopy, alveolar lavage, and transbronchial biopsy, have been demonstrated to provide additional valuable medical information. OSHA believes that the PLHCP is in the best position to decide which medical tests are necessary for each individual examined. Where specific tests are deemed appropriate by the PLHCP, the proposed standard, at paragraph (k)(3)(ii)(G), would require that they be provided.

    Proposed paragraph (k)(4) details which information must be provided to the PHLCP. Specifically, the proposed standard would require the employer to ensure the examining PLHCP has a copy of the standard and all the appendices, and to provide to the examining PLHCP the following information, if known or reasonably available to the employer: a

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    description of the employee's former and current duties as they relate to beryllium exposure ((k)(4)(i)); the employee's former and current exposure levels ((k)(4)(ii)); a description of any personal protective clothing and equipment, including respirators, used or to be used by the employee, including when and for how long the employee has used that clothing and equipment ((k)(4)(iii)); and information the employer has obtained from previous medical examinations provided to the employee, that is currently within the employer's control ((k)(4)(iv)). OSHA believes making this information available to the PLHCP will aid in the PLHCP's evaluation of the employee's health as it relates to the employee's assigned duties and fitness to use personal protective equipment, including respirators, when necessary. In order to protect the employee's privacy, employee medical information may only be provided to the PLHCP by the employer after the employee has signed a medical release.

    Providing the PLHCP with exposure monitoring results, as required under paragraph (k)(4)(ii), will assist the physician completing the written medical opinion in determining if an employee is likely to be at risk of adverse effects from beryllium exposure at work. A well-

    documented exposure history would also assist the PLCHP in determining if a condition (e.g., dermatitis, decrease in diffusing capacity, or gradual changes in arterial blood gases) may be related to beryllium exposure. See this preamble at section V, Health Effects, for a more detailed discussion of the health effects associated with beryllium exposure.

    Proposed paragraph (k)(5) would require employers to obtain a written medical opinion from the licensed physician who performed or directed the exam within 30 days of the examination. The purpose of requiring the physician to supply a written opinion to the employer is to provide the employer with a documented medical basis for the employee's eligibility for medical removal, and to assess the employee's ability to use protective clothing and equipment, including respirators. In addition, provision of the written opinion to the employer may alert the employer to sources of beryllium exposure or problems with exposure controls at its worksite. OSHA believes the 30-

    day period will allow the licensed physician sufficient time to receive and consider the results of any tests included in the examination, and allow the employer to take any necessary protective measures in a timely manner. The proposed requirement that the opinion be in written form is intended to ensure that employers and employees have the benefit of the same information and that no information gets lost in oral communications. OSHA requests comment on the relative merits of the proposed standard's requirement that employers obtain the PLHCP's written opinion or an alternative that would provide employees with greater discretion over the information that goes to employers (see this preamble at Section 1, Issues and Alternatives, Issue #26).

    Paragraphs (k)(5)(i)(A)-(C) of the proposed standard specify what must be included in the licensed physician's written opinion. The first item for inclusion is the licensed physician's opinion as to whether the employee has any detected medical condition that would place the employee at increased risk of CBD from further exposure. The standard also proposes that the medical opinion include any recommended limitations on the employee's exposure, including recommended use of, and limitations on the use of, personal protective clothing or equipment such as respirators.

    The licensed physician would also need to state in the written opinion that the PLHCP has explained the results of the medical examination to the employee, including the results of any tests conducted, any medical conditions related to exposure that require further evaluation or treatment, and any special provisions for use of protective clothing or equipment, including respirators. Under proposed paragraph (k)(5)(i)(C), OSHA anticipates that the employee will be informed directly by the PLCHP of all results of his or her medical examination, including conditions of non-occupational origin. Direct consultation between the PLHCP and employee ensures that the employee will receive all information about the employee's health status, including non-occupationally related conditions that are not communicated to the employer.

    Proposed paragraph (k)(5)(ii) would require the employer to ensure that neither the licensed physician nor any other PLHCP reveals to the employer findings or diagnoses which are unrelated to beryllium exposure. OSHA has proposed this provision to reassure employees participating in medical surveillance that they will not be penalized or embarrassed as a result of the employer obtaining information about them not directly pertinent to beryllium exposure. Paragraph (k)(5)(iii) would also require the employer to provide a copy of the licensed physician's written opinion to the employee within two weeks after receiving it to ensure that the employee has been informed of the results of the examination in a timely manner.

    Proposed paragraph (k)(6)(i) provides for the referral to a CBD diagnostic center of any employee who is confirmed positive for beryllium sensitization. Within 30 days after the employer learns of the confirmed positive result, the employer must ensure that a licensed physician designated by the employer consults with the employee about referral to a CBD diagnostic center for further testing, to determine whether a sensitized employee has CBD. If the employee chooses to obtain a clinical evaluation at a CBD diagnostic center, the diagnostic center must be agreed upon by the employer and the employee. The employer and employee must make a good faith effort to agree on a CBD diagnostic center that is acceptable to them both. Under paragraph (k)(6)(ii), the employer is responsible for all costs associated with testing performed at the center. The term CBD diagnostic center is defined in proposed paragraph (b), and discussed in this section of the preamble regarding proposed paragraph (b).

    Finally, under paragraph (k)(7), the employer would be required to convey the results of the medical tests to OSHA for evaluation and analysis at the request of the Assistant Secretary. The results of the tests may be used to evaluate the nature, variability, reliability, and relevance of the beryllium sensitization test results, to evaluate the effectiveness of the beryllium standard in reducing beryllium-related occupational disease, or for other scientific purposes. Results conveyed to OSHA must first be stripped of employees' names, social security numbers, and other identifying information.

    Employees of beryllium vendors who qualify for benefits under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) (42 U.S.C. 7384-7385s-15) and its implementing regulations (20 CFR part 30) may also qualify for medical surveillance benefits under this proposed standard. Covered medical surveillance provided to eligible persons under the EEOICPA program is paid for by the federal government.

    Employees covered by both the EEOICPA program and this proposed standard would not be required to attend separate medical examinations for the separate programs. Rather, these dual-coverage employees could attend consolidated medical examinations at which they would receive the services

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    required under both programs. These examinations would be paid for by the federal government under the EEOICPA program to the extent that the services provided are covered under the EEOICPA program. If this proposed standard requires services that are not covered by the EEOICPA program, the employer would be required to pay for these additional services.

    As stated in the SBREFA Report, the medical surveillance section ``was the most controversial part of the draft standard for most SERs and received the most comment'' (OSHA, 2008b). SERs generally were concerned about the cost of medical surveillance, commenting that surveillance is unnecessary for employees with low beryllium exposures (OSHA, 2008b). The requirement of dermal triggers for medical surveillance was confusing for SERs and led to a number of comments (OSHA, 2008b). One SER suggested that the medical surveillance requirements should be performance-based, which would allow employers to determine which tests were appropriate for their employees (OSHA, 2008b). Use of the BeLPT was also controversial, given SERs' concerns about its accuracy and costs (OSHA, 2008b). OSHA requests comment on the proposed requirements for beryllium sensitization testing, including issues raised in this preamble at section I, Issues and Alternatives, and on the regulatory alternatives presented later in this section.

    In response to these concerns, OSHA notes several changes made to the regulatory text since the SBREFA panel was convened. In the proposed standard, medical surveillance is limited to those employees who have worked in a regulated area for more than 30 days per year in the previous 12-month period, employees showing signs and symptoms of CBD, employees exposed during emergencies, and employees who have been exposed above 0.2 mug/m\3\ for more than 30 days in a 12-month period for five years or more. Requiring medical surveillance for employees with exposures in a regulated area (i.e., with exposures above the TWA PEL or STEL for more than 30 days in a year) should alleviate some SERs' concerns that surveillance is not necessary for employees with low exposures. Employees with exposures at or above the action level but below the PEL are no longer included in medical surveillance, unless they show signs or symptoms of CBD or were exposed during an emergency. Since the SBREFA panel was held, OSHA has also removed the requirement for medical surveillance based only on dermal exposure to beryllium, eliminating the confusion caused by the dermal exposure provision.

    These changes will result in fewer employees being eligible for medical surveillance than were covered in the draft standard presented to the SBREFA panel. The changes will thereby reduce costs to employers. However, OSHA has preliminarily determined that a significant risk of beryllium sensitization, CBD, and lung cancer exist at exposure levels below the proposed PEL, and there is evidence that beryllium sensitization can occur from short-term exposures (see this preamble at Section V, Health Effects, and Section VIII, Significance of Risk). The Agency therefore anticipates that some employees will develop adverse health effects and may not receive the benefits of early intervention in the disease process because they are not eligible for medical surveillance (see this preamble at Section V, Health Effects). Thus, OSHA is considering three regulatory alternatives that would expand eligibility for medical surveillance to a broader group of employees than those eligible in the proposed standard. Under Regulatory Alternative #14, medical surveillance would be available to employees who are exposed to beryllium above the proposed PEL, including employees exposed for fewer than 30 days per year. Regulatory Alternative #15 would expand eligibility for medical surveillance to employees who are exposed to beryllium above the proposed action level, including employees exposed for fewer than 30 days per year. Regulatory Alternative #21 would extend eligibility for medical surveillance as set forth in proposed paragraph (k) to all employees in shipyards, construction, and general industry who meet the criteria of proposed paragraph (k)(1). However, all other provisions of the standard would be in effect only for employers and employees that fall within the scope of the proposed rule. Most of these alternatives would provide surveillance to fewer employees (and cost less to employers) than the draft regulation presented to the SBREFA Panel, but would provide more surveillance (and cost more to employers) than the medical surveillance requirements in the current proposal.

    The SER who suggested allowing performance-based surveillance stated that this would permit employers ``to design and determine what tests were appropriate'' (OSHA, 2008b). OSHA is considering two regulatory alternatives that would provide greater flexibility in the program of tests provided as part of an employer's medical surveillance program. Under Regulatory Alternative #16, employers would not be required to offer employees testing for beryllium sensitization. Regulatory Alternative #18 would eliminate the CT scan requirement from the proposed rule.

    OSHA is evaluating these alternatives and has also included some performance-based elements in its medical surveillance requirements (e.g., (k)(3)(G)). However, the Agency has preliminarily determined that the testing required by the proposed standard is necessary and appropriate for the employees who must be offered medical surveillance. OSHA believes it is important to detect cases of sensitization, CBD and other beryllium-related health effects early so that employees can quickly be removed from exposure, be provided appropriate protective clothing and equipment, benefit from medical removal, and receive treatment, as applicable. As discussed in this preamble at section VIII, Significance of Risk, early intervention in the disease process may slow or prevent progression to more advanced disease. Further, this surveillance is particularly necessary in a standard such as this one, where OSHA has preliminarily found a significant risk of material impairment of health at the proposed PEL. OSHA requests comments on the proposed requirements for sensitization testing, CT scans, and medical examinations, and on Regulatory Alternatives #14 and #15 discussed above.

    Finally, at least one SER commented that providing annual BeLPTs would result in high costs with no added benefit to employees (OSHA, 2008b). As discussed previously, OSHA would also allow substitution of a more accurate and reliable test for the BeLPT should such a test become available. When this occurs, employers can choose to use whichever test is less expensive. OSHA has also, in its proposed standard, reduced the frequency of required BeLPTs (or other test substituted for the BeLPT) to every two years, with follow-up tests for employees who receive abnormal test results. This change would significantly reduce the cost of testing, but would also delay early detection of beryllium-related health effects and intervention to prevent disease progression among employees in medical surveillance. In addition, the longer the time interval between when an employee becomes sensitized and when the employee's case is identified in the surveillance program, the more difficult it will be to identify and address the exposure conditions that led to the employee's sensitization. Therefore, lengthening the time between

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    sensitization tests will diminish the usefulness of the surveillance information in identifying and correcting problem areas and reducing risks to other employees.

    The benefits of regular medical surveillance for beryllium-related health effects and the costs of surveillance to employers are important and complex factors in the proposed standard, and OSHA requests feedback from the regulated and medical communities to help determine the most appropriate schedule for periodic testing. In particular, the Agency requests comments on several alternatives to the proposed frequency of sensitization testing, CT scans, and general medical examinations. Regulatory alternative #17 would require employers to offer annual testing for beryllium sensitization to eligible employees, as in the draft proposal presented to the SBREFA panel. Regulatory Alternative #19 would similarly increase the frequency of periodic CT scans from biennial to annual scans. Finally, under Regulatory Alternative #20, all periodic components of the medical surveillance exams would be available biennially to eligible employees. Instead of requiring employers to offer eligible employees a medical examination every year, employers would be required to offer eligible employees a medical examination every other year. The frequency of testing for beryllium sensitization and CT scans would also be biennial for eligible employees, as in the proposed standard. For all comments on the medical surveillance provisions of the proposed standard, please provide an explanation of your position, and supporting data or studies as appropriate.

    (l) Medical Removal Protection

    Paragraph (l) of the proposed rule contains the provisions related to medical removal protection (MRP). Proposed paragraph (l)(1) explains that employees in jobs with exposure at or above the action level become eligible for medical removal when they are diagnosed with CBD or confirmed positive for beryllium sensitization. These medical findings may be made pursuant to the surveillance requirements of proposed paragraph (k). The terms ``CBD'' and ``confirmed positive'' are defined in proposed paragraph (b).

    Proposed paragraph (l)(1) is in keeping with OSHA's provisions for MRP in past standards, where the Agency has specified objective removal criteria. For example, the Lead standard (29 CFR 1910.1025) requires that an employee be removed from exposure at or above the action level when an employee's blood lead concentration exceeds a certain value. Similarly, the Cadmium standard (29 CFR 1910.1027) includes objective biological monitoring criteria that trigger removal.

    Paragraph (l)(2) lays out the options for employees who are eligible for MRP. Specifically, paragraph (l)(2)(i) would permit eligible employees to choose removal as described under proposed paragraph (l)(3), and proposed paragraph (l)(2)(ii) would permit them to remain in a job with exposure at or above the action level and wear a respirator in accordance with the Respiratory Protection standard (29 CFR 1910.134). Eligible employees must choose one of these two options. OSHA requests comment on whether the standard should establish a timeframe in which eligible employees must choose one of the options in paragraph (l)(3) (such as within 7 days, 14 days, or 30 days), and whether the standard should require the employee to wear a respirator if the employee fails to choose one of the options within the specified timeframe.

    Proposed paragraph (l)(3) describes eligible employees' removal options. When an employee chooses removal, the employer is required to remove the employee to comparable work if such work is available. Comparable work is a position for which the employee is already qualified or can be trained within one month, in an environment where beryllium exposure is below the action level. Comparable work would not require the employee to use a respirator, although the employee may choose to use a respirator to minimize beryllium exposure. An employer is not required to place an employee on paid leave if the employee refuses comparable work offered under paragraph (l)(3)(i). An employee must be transferred to comparable work, trained for comparable work, or placed on paid leave immediately after choosing removal.

    If comparable work is not immediately available, paragraph (l)(3)(ii) would require the employer to place the employee on paid leave for six months or until comparable work becomes available, whichever occurs first. If comparable work becomes available before the end of the six month paid leave period, the employer is obligated to offer the open position to the employee. Should the employee decline, the employer has no further obligation to continue the paid leave.

    Proposed paragraph (l)(3)(iii) would continue a removed employee's rights and benefits for six months, regardless of whether the employee is removed to comparable work or placed on paid leave. The six month period would begin when the employee is removed, which means either the day the employer transfers the employee to comparable work, or the day the employer places the employee on paid leave. For this period, the provision would require the employer to maintain the employee's base earnings, seniority, and other rights and benefits of employment as they existed at the time of removal. This provision is typical of medical removal provisions in other OSHA standards, such as Cadmium (29 CFR 1910.1027) and Benzene (29 CFR 1910.1028).

    Paragraph (l)(4) would reduce an employer's obligation to provide MRP benefits to a removed employee if, and to the extent that, the employee receives compensation from a publicly or employer-funded compensation program for earnings lost during the removal period, or receives income from another employer made possible by virtue of the employee's removal. Benefits received under the Energy Employees Occupational Illness Compensation Program Act (EEOICPA) do not constitute wage replacement, and therefore would not offset the employee's medical removal benefits under this proposed standard.

    By protecting an employee's rights and benefits during the first six months of removal, and by reducing in certain circumstances an employer's obligation to compensate employees for earnings lost, OSHA emphasizes that MRP is not intended to serve as a workers' compensation system. The primary reason MRP has been included in this standard is to provide eligible employees a six-month period to adjust to the comparable work arrangement or seek alternative employment, without any further exposure at or above the action level.

    The prospect of a medical removal provision concerned some SERS. Some stated that there is no evidence that removing sensitized employees will change their health outcomes (OSHA 2008b). Others commented that they did not believe medical removal was appropriate because neither sensitization nor CBD is reversible (OSHA 2008b).

    OSHA believes that medical removal is an important means of protecting employees who have become sensitized or developed CBD, and is an appropriate means to enable them to avoid further exposure. The scientific information on effects of exposure cessation is limited at this time, but the available evidence suggests that removal from exposure can be beneficial for individuals who are

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    sensitized or have early-stage CBD (see this preamble at section VIII, Significance of Risk). As discussed in the Health Effects section of this preamble, section V, only those who are sensitized can develop CBD. As CBD progresses, symptoms become serious and debilitating. Steroid treatment is less effective at later stages, once fibrosis has developed (see this preamble at section VIII, Significance of Risk). Given the progressive nature of the disease, OSHA believes it is reasonable to conclude that removal from exposure to beryllium will benefit sensitized employees and those with CBD.

    There is widespread support for removal of individuals with sensitization or CBD from further beryllium exposure in the medical community and among other experts in beryllium disease prevention and treatment. Physicians at National Jewish, one of the main CBD research and treatment sites in the US, ``consider it important and prudent for individuals with beryllium sensitization and CBD to minimize their exposure to airborne beryllium,'' and ``recommend individuals diagnosed with beryllium sensitization and CBD who continue to work in a beryllium industry to have exposure of no more than 0.01 micrograms per cubic meter of beryllium as an 8-hour time-weighted average'' (National Jewish site on Chronic Beryllium Disease: Work Environment Management, accessed May 2013). The Department of Energy included MRP in its Chronic Beryllium Disease Prevention Program (10 CFR part 850), stating that without MRP, employers would be ``free to maintain high-risk workers in their current jobs, which would not be sufficiently protective of their health'' (64 FR 68894, December 8, 1999). MRP is included in the recommended beryllium standard that beryllium industry and union stakeholders submitted to OSHA in 2012 (Materion and United Steelworkers, 2012).

    OSHA believes that MRP also improves the medical surveillance program described in proposed paragraph (k). Paragraph (k)(1)(i)(B) requires medical examinations for employees showing signs or symptoms of CBD. The success of that program will depend in part on employees' willingness to report their symptoms, submit to examinations, respond to questions, and comply with instructions. Guaranteeing paid leave or comparable work can help allay an employee's fear that a CBD diagnosis will negatively affect earnings or career prospects. MRP encourages employees to report their symptoms and seek treatment, as OSHA has previously recognized when including medical removal in regulations governing the exposure to lead (43 FR 52973, November 14, 1978), benzene (52 FR 34557, September 11, 1987), and cadmium (57 FR 42367-68, September 14, 1992). This reasoning was also cited by the Department of Energy in support of the medical removal provisions of its Chronic Beryllium Disease Prevention Program, stating that the availability of medical removal benefits encourages worker participation and cooperation in medical surveillance (64 FR 68893, December 8, 1999).

    MRP also provides an incentive for employers to keep employee exposures low. The risk of developing CBD or beryllium sensitization decreases at lower exposures (see this preamble at section VI, Preliminary Risk Assessment), meaning that employers can improve their chances of avoiding MRP costs by lowering employee exposure levels. OSHA previously noted this incentive when describing MRP provisions in the Lead standard (43 FR 52973, November 14, 1978) and the Cadmium standard (57 FR 42368, September 14, 1992).

    Finally, OSHA's preliminary risk assessment indicates that significant risk remains at the proposed TWA PEL (see this preamble at section VI, Preliminary Risk Assessment). MRP offers additional protection for situations in which workers develop CBD or beryllium sensitization despite exposures at or below the PEL. As discussed above regarding the definition of ``action level'' in paragraph (b), if OSHA finds a continuing exposure risk at the PEL, it has the authority to impose additional feasible requirements on employers to further reduce risk when those requirements will result in a greater than minimal incremental benefit to workers' health (Asbestos II, 838 F.2d at 1274).

    During the SBREFA process, SERs commented that small entities may lack the flexibility and resources to provide comparable positions for MRP-eligible employees (OSHA 2008b). The SBREFA Panel recommended that OSHA give careful consideration to the impacts that an MRP requirement could have on small businesses (OSHA, 2008b). In response to this recommendation, the Agency has provided flexibility in how employers may comply with MRP requirements. Where employers have no comparable positions in environments with exposures below the action level, the proposed standard permits an employer to place eligible employees on paid leave for six months, or until comparable work becomes available. Under proposed paragraph (l)(4), if an employee is placed on paid leave and receives government or employer-provided compensation, or such paid leave allows the employee to secure other work, the original employer's compensation obligations would be offset. Also in response to the Panel's recommendations, OSHA analyzed Regulatory Alternative #22, which would eliminate the proposed requirement to offer MRP to employees with beryllium sensitization or CBD.

    Finally, OSHA notes that there is considerable scientific uncertainty about the effects of exposure cessation on the development of CBD among sensitized individuals and the progression from early-

    stage to late-stage CBD. Members of the medical community support removal from beryllium exposure as a prudent step in the management of beryllium sensitization and disease. For example, physicians at National Jewish Medical Center, a leading organization in CBD research and treatment, recommend individuals diagnosed with beryllium sensitization and CBD who continue to work in a beryllium industry to have exposure of no more than 0.01 micrograms per cubic meter of beryllium as an 8-hour TWA (http://www.nationaljewish.org/healthinfo/conditions/beryllium-disease/environment-management/). However, the scientific literature on the effects of exposure cessation is limited. It suggests that removal from exposure can have beneficial effects for some individuals, but provides no conclusive evidence on whether exposure cessation will prevent CBD or CBD progression for most people (see this preamble at Section V, Health Effects, and Section VIII, Significance of Risk).

    OSHA proposes to include MRP in the beryllium standard, providing workers with sensitization or CBD the opportunity and means to minimize their further exposure to beryllium via MRP in keeping with the recommendation of beryllium specialists in the medical community and with the draft recommended standard provided by union and industry stakeholders (Materion and Steelworkers, 2012).

    OSHA solicits comments on the health effects of MRP and the proposed provisions for MRP. Is MRP an appropriate means of intervention in the disease process for workers with beryllium sensitization or CBD? Do the proposed MRP provisions appropriately balance SBREFA commenters' concerns with the need to reduce beryllium exposure for employees with

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    sensitization or CBD? Please comment on whether MRP should be included in the standard (Regulatory Alternative #22). Please explain your positions on these issues and provide any relevant data or studies.

    (m) Communication of Hazards to Employees

    Paragraph (m) of this proposal sets forth the employer's obligations to comply with OSHA's Hazard Communication standard (HCS)(29 CFR 1910.1200), and to take additional steps to warn and train employees about the hazards of beryllium.

    Paragraph (m)(1)(i) of this proposal requires chemical manufacturers, importers, distributors, and employers to comply with all applicable requirements of the HCS for beryllium. As described in this preamble at section V, Health Effects, and section VI, Preliminary Beryllium Risk Assessment, OSHA considers beryllium a hazardous chemical.

    In classifying the hazards of beryllium, the employer must address at least the following: Cancer; lung effects (chronic beryllium disease and acute beryllium disease); beryllium sensitization; skin sensitization; and skin, eye, and respiratory tract irritation (paragraph (m)(1)(ii)). According to the HCS, employers must classify hazards if they do not rely on the classifications of chemical manufacturers, importers, and distributors (see 29 CFR 1910.1200(d)(1)).

    Paragraph (m)(1)(iii) requires that employers include beryllium in the hazard communication program established to comply with the HCS, and ensure that each employee has access to labels on containers and safety data sheets for beryllium and is trained in accordance with the HCS and paragraph (m)(4) of this proposal.

    According to paragraph (e)(1)(ii) of this proposal, employers must establish and maintain regulated areas wherever employees are or can reasonably be expected to be exposed to beryllium at levels above the TWA PEL or STEL, and each employee entering a regulated area must wear a respirator and protective clothing and equipment in accordance with paragraphs (g) and (h) of this standard. Under paragraph (m)(2) of this proposal, employers must provide and display warning signs at each approach to a regulated area so that each employee is able to read and understand the signs and take necessary protective steps before entering the area. Employers must ensure that warning signs required by paragraph (m)(2) are legible and readily visible, and that they bear the following legend:

    Danger; Beryllium; May Cause Cancer; Causes Damage to Lungs; Authorized Personnel Only; Wear respiratory protection and protective clothing and equipment in this area.

    Some SERs objected to having cancer warnings displayed on the legends for warning signs and labels. They expressed the opinion that cancer warnings would unnecessarily scare customers and employees. Further, they alleged evidence for beryllium causation of cancer was not sufficient (OSHA, 2008b). OSHA disagrees with these comments. OSHA has thoroughly reviewed the literature for beryllium carcinogenicity, and has preliminarily concluded that beryllium is carcinogenic. OSHA's finding that inhaled beryllium causes lung cancer is based on the best available epidemiological data, reflects evidence from animal and mechanistic research, and is consistent with the conclusions of other government and public health organizations (see this preamble at section V, Health Effects). For example, the International Agency for Research on Cancer (IARC), National Toxicology Program (NTP), and American Conference of Governmental Industrial Hygienists (ACGIH) have all classified beryllium as a known human carcinogen (IARC, 2009). OSHA believes that the weight of evidence is sufficient to support the requirement for cancer warnings on signs and labels.

    The signs required by paragraph (m)(2) of this proposal are intended to serve as a warning to employees and others who may not be aware that they are entering a regulated area, and to remind them of the hazards of beryllium so that they take necessary protective steps before entering the area. These signs are also intended to supplement the training that employees must receive regarding the hazards of beryllium, since even trained employees need to be reminded of the locations of regulated areas and of the precautions necessary before entering these dangerous areas (see paragraph (m)(4) of this proposal and 29 CFR 1910.1200(h) for training requirements).

    The use of warning signs is important to make employees who are regularly scheduled to work at these sites aware of beryllium hazards, to alert employees who have limited access to these sites of beryllium hazards, and to warn those who do not have access to regulated areas to avoid the area. Access must be limited to authorized personnel to ensure that those entering the area are adequately trained and equipped, and to limit exposure to those whose presence is absolutely necessary. By limiting access to authorized persons, employers can minimize employee exposure to beryllium in regulated areas and thereby minimize the number of employees that may require medical surveillance or be subject to the other requirements in this proposal associated with working in a regulated area.

    Paragraph (m)(2) specifies the wording of the warning signs for regulated areas in order to ensure that the proper warning is consistently given to employees, and to notify employees that respirators and personal protective clothing and equipment are required in the regulated area. OSHA believes that the use of the word ``Danger'' is appropriate, based on the evidence of the toxicity of beryllium. ``Danger'' is used to attract the attention of employees to alert them to the fact that they are entering an area where the TWA PEL or STEL may be exceeded, and to emphasize the importance of the message that follows. The use of the word ``Danger'' is also consistent with other OSHA health standards dealing with toxins such as cadmium (29 CFR 1910.1027), methylenedianiline (29 CFR 1910.1050), asbestos (29 CFR 1910.1001), and benzene (29 CFR 1910.1028). In addition, use of the word ``Danger'' for this chemical is consistent with the Globally Harmonized System of Classification and Labeling of Chemical guidelines (GHS) (77 FR 17740-48, March 26, 2012). In the Federal Register notice for the revised HCS, which incorporates the GHS, OSHA explains that for substance-specific standards, warning signs must be as consistent as possible with label information for that substance (Id.).

    Paragraph (m)(3) requires that labels be affixed to all bags and containers of clothing, equipment, and materials visibly contaminated with beryllium. The term ``materials'' includes waste, scrap, debris, and any other items visibly contaminated with beryllium that are consigned for disposal or recycling (see paragraphs (h)(2)(iv) and (v) and (j)(3)(i) through (iii)). The labels must state:

    Danger; Contains Beryllium; May Cause Cancer; Causes Damage to Lungs; Avoid Creating Dust; Do Not Get on Skin.

    The purpose of this labeling requirement is to ensure that all affected employees, not only the employees of a particular employer, are apprised of the presence of beryllium-containing materials and the hazardous nature of beryllium exposure. With this knowledge, employees can take steps to protect themselves through proper work practices established by their employers. Employees are also better able to alert their employers if they

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    believe exposures or skin contamination can occur.

    As discussed previously, these labeling requirements are consistent with the HCS, which requires classification of hazardous chemicals and labeling appropriate for the classification (see 77 FR 17740-48, March 26, 2012). In addition, these requirements for labeling are consistent with the mandate of section (6)(b)(7) of the OSH Act, which requires that OSHA health standards prescribe the use of labels or other appropriate forms of warning to apprise employees of the hazards to which they are exposed.

    Paragraph (m)(4) contains requirements for employee information and training, and applies to all employees who are or can reasonably be expected to be exposed to airborne beryllium. Employers must ensure that employees receive information and training in accordance with the requirements of the HCS (29 CFR 1910.1200(h)), including specific information on beryllium as well as any other hazards addressed in the workplace hazard communication program. Under the HCS, employers must provide their employees with information such as the location and availability of the written hazard communication program, including lists of hazardous chemicals and safety data sheets, and the location of operations in their work areas where hazardous chemicals are present. The HCS also requires employers to train their employees on ways to detect the presence or release of hazardous chemicals in the work area such as any monitoring conducted, the physical and health hazards of the chemicals in the work area, measures employees can take to protect themselves, and the details of the employer's hazard communication program (29 CFR 1910.1200(h)(3)).

    Under paragraph (m)(4)(i)(B), training must be provided to each employee by the time of initial assignment, which means before the employee's first day of work in a job that could reasonably be expected to involve exposure to airborne beryllium. This training must be repeated at least annually thereafter ((m)(4)(i)(C)). OSHA believes that annual retraining is necessary due to the hazards of beryllium exposure, and for reinforcement of employees' knowledge of those hazards. The annual training requirement is consistent with other OSHA standards such as those for lead (29 CFR 1910.1025), cadmium (29 CFR 1910.1027), benzene (29 CFR 1910.1028), coke oven emissions (29 CFR 1910.1029), cotton dust (29 CFR 1910.1043), and butadiene (29 CFR 1910.1051).

    Paragraph (m)(4)(ii) requires the employer to ensure that each employee who is or can reasonably be expected to be exposed to airborne beryllium can demonstrate knowledge of nine enumerated categories of information (see paragraph (m)(4)(ii)(A)--(I)). Providing information and training on these topics is essential to informing employees of current hazards and explaining how to minimize potential health hazards associated with beryllium exposure. As part of an overall hazard communication program, training serves to explain and reinforce the information presented on labels and safety data sheets. These written forms of communication will be most effective when employees understand the information presented and are aware of how to avoid or minimize exposures, thereby reducing the possibility of experiencing adverse health effects. Training should lead to better work practices and hazard avoidance.

    The training requirements in paragraph (m)(4)(ii) are performance-

    oriented. This paragraph lists the topics that training must address, but does not prescribe specific training methods. OSHA believes that the employer is in the best position to determine how to conduct training that imparts knowledge and promotes retention. Appropriate training may include video, DVD or slide presentations; classroom instruction; hands-on training; informal discussions during safety meetings; written materials; or a combination of these methods. This performance-oriented approach is intended to encourage employers to tailor training to the needs of their workplaces, thereby resulting in the most effective training program in each individual workplace.

    For training to be effective, the employer must ensure that it is provided in a manner that each employee is able to understand. OSHA recognizes that employees have varying education levels, literacy levels, and language skills, and is requiring that they receive training in a language and at a level of complexity that accounts for these differences. This may require, for example, providing materials, instruction, or assistance in Spanish rather than English if the employees being trained are Spanish-speaking and do not understand English well. The employer would not be required to provide training in the employee's preferred language if the employee understands both languages; as long as the employee is able to understand the language used, the intent of the proposed standard would be met.

    To ensure that employees comprehend the material presented during training, it is critical that trainees have the opportunity to ask questions and receive answers if they do not fully understand the material that is presented to them. When video presentations or computer-based programs are used, employers may meet this requirement by having a qualified trainer available to address questions after the presentation, or providing a telephone hotline so that trainees will have direct access to a qualified trainer.

    In addition to being performance-oriented, these training requirements are also results-oriented. Paragraph (m)(4)(ii) requires employers to ensure that affected employees can demonstrate knowledge of the nine topics enumerated in paragraph (m)(4)(ii)(A) through (I). Accordingly, employers must ensure that employees participate in and comprehend the training, and are able to demonstrate knowledge of the specified topics. Some examples of methods to ensure knowledge are discussions of the required training subjects, written tests, or oral quizzes. Although the standard only requires annual retraining, employers must ensure that employees can demonstrate up-to-date knowledge of the listed topics at all times.

    Paragraph (m)(4)(iii) requires employers to provide additional training, even if a year has not passed since the previous training, when workplace changes (such as modification of equipment, tasks, or procedures) result in new or increased employee exposure that exceeds or can reasonably be expected to exceed either the TWA PEL or the STEL. Some examples of changes in work conditions triggering the requirement for additional training include changes in work production operations or personnel that affect the way employees operate equipment. Additional training would also be required if employers introduce new production or personal protective equipment where employees do not yet know how to properly use the new equipment. Misuse of either the new production equipment or PPE could result in new exposures above the TWA PEL or STEL. As another example, employers must provide additional training before employees repair or upgrade engineering controls if exposures during these activities will exceed or can reasonably be expected to exceed either the TWA PEL or the STEL. OSHA believes the additional training requirement in this proposal is essential because it ensures that employees are able to actively participate in protecting themselves under the conditions found in the workplace, even if those conditions change.

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    Paragraph (m)(5) requires that employers make copies of the standard and its appendices readily available at no cost to each employee and designated employee representative. This requirement ensures that employees and their representatives have direct access to regulations affecting them, and knowledge of the protective measures employers must take on employees' behalf.

    Commenters to both the RFI and SBREFA recognized the importance of educating and training their employees about the hazards of beryllium exposure. In commenting on an earlier OSHA draft standard for beryllium during the SBREFA process, several companies (e.g., Morgan Bronze Products, Precision Stamping, and Mid Atlantic Coatings) supported training that was understandable to the employee. They agreed that employees should be able to demonstrate knowledge of health hazards associated with beryllium exposure, and the medical surveillance program as described in paragraph (k) of this section. They also supported additional training when exposures exceed the PEL (OSHA 2008b). Most SERs reported already training their employees about beryllium risks and how employees can protect themselves (OSHA, 2008b). OSHA agrees with comments supporting the necessity of training, and in order to assist in the development of training programs, intends to develop outreach materials and other guidance materials.

    (n) Recordkeeping

    Paragraph (n) of the proposed standard requires employers to maintain records of exposure measurements, historical monitoring data, objective data, medical surveillance, and training. The recordkeeping requirements are proposed in accordance with section 8(c) of the OSH Act (29 U.S.C. 657(c)), which authorizes OSHA to require employers to keep and make available records as necessary or appropriate for the enforcement of the Act or for developing information regarding the causes and prevention of occupational injuries and illnesses. The proposed recordkeeping provisions are also consistent with OSHA's standard addressing access to employee exposure and medical records (29 CFR 1910.1020).

    Proposed paragraph (n)(1)(i) requires employers to keep records of all measurements taken to monitor employee exposure to beryllium as required by paragraph (d) of this standard. Paragraph (n)(1)(ii) would require that such records include the following information: The date of measurement for each sample taken; the operation involving exposure to beryllium that was monitored; the sampling and analytical methods used and evidence of their accuracy; the number, duration, and results of samples taken; the types of respiratory protection and other personal protective equipment used; and the name, social security number, and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.

    These requirements are consistent with those found in other OSHA standards, such as those for methylene chloride (29 CFR 1910.1052) and chromium (VI) (29 CFR 1910.1026). These standards, like most of OSHA's substance-specific standards, require that exposure monitoring and medical surveillance records include the employee's social security number. OSHA has included this requirement in the past because social security numbers are particularly useful in identifying employees, since each number is unique to an individual for a lifetime and does not change when an employee changes employers. When employees have identical or similar names, identifying employees solely by name makes it difficult to determine to which employee a particular record pertains. However, based on privacy concerns, OSHA examined alternatives to requiring social security numbers for employee identification as part of its Standards Improvement Project-Phase II (``SIPs'') Final Rule. The Agency analyzed public comment on the necessity, usefulness, and effectiveness of social security numbers as a means of identifying employee records. OSHA also analyzed comments regarding privacy concerns raised by this requirement, as well as the availability of other effective methods of identifying employees for OSHA recordkeeping purposes. Comments were divided regarding whether social security information should be retained for exposure and medical records. The Agency examined the comments and decided not to take any action in the SIPs final rule regarding the use of social security numbers because the conflicting comments all raised significant concerns, and OSHA wished to study the issue further. (See 70 FR 1112, 1126-27, March 7, 2005).

    In this rulemaking, OSHA proposes to continue to require the use of social security numbers. OSHA emphatically recommends against distributing or posting employees' social security numbers with monitoring results. OSHA welcomes comment on this issue.

    Proposed paragraph (n)(2) addresses historical monitoring data. Paragraph (n)(2)(i) would require employers to establish and maintain an accurate record of any historical monitoring data used to satisfy the initial monitoring requirements in paragraph (d)(2) of this standard. As explained earlier in this preamble, paragraph (d)(2) permits employers to substitute beryllium monitoring results obtained at an earlier time for the initial monitoring requirements, as long as employers abide by the criteria specified. Paragraph (n)(2)(ii) requires the employer to establish and maintain records or documents showing that the criteria discussed in paragraph (d)(2) are met. This would mean documenting the workplace conditions present when the historical data were collected, for purposes of showing that those conditions closely resemble the conditions present in the employer's current operations. Employers should also document the dates of reliance on the historical data as well as the dates on which the historical data were collected.

    Proposed paragraph (n)(3) addresses objective data. Proposed paragraph (n)(3)(i) requires employers to establish and maintain accurate records of the objective data relied upon to satisfy the requirement for initial monitoring in proposed paragraph (d)(2). Under proposed paragraph (n)(3)(ii), the record must contain the following information: The data relied upon; the beryllium-containing material in question; the source of the data; a description of the operation exempted from initial monitoring and how the data support the exemption; and other information demonstrating that the data meet the requirements for objective data in accordance with paragraph (d)(2). Such other information may include reports of engineering controls, work area layout and dimensions, and natural air movements pertaining to the data and current conditions.

    Since historical and objective data may be used to exempt the employer from certain types of monitoring, as specified in paragraph (d), it is critical that the use of these types of data be carefully documented. Historical and objective data are intended to provide the same degree of assurance that employee exposures have been correctly characterized as would exposure monitoring. The records must demonstrate a reasonable basis for conclusions drawn from the data.

    Under proposed paragraph (n)(4)(i) employers must establish and maintain accurate medical surveillance records for each employee covered by the

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    medical surveillance requirements of the standard in paragraph (k). Paragraph (n)(4)(ii) lists the categories of information that an employer would be required to record: the employee's name, social security number, and job classification; a copy of all physicians' written opinions; and a copy of the information provided to the PLHCP as required by paragraph (k)(4) of this standard.

    OSHA believes that medical records, like exposure records, are necessary and appropriate. Medical records document the results of medical surveillance and the screening of employees. Employers can use the information contained in the records to identify and adjust hazardous workplace conditions and mitigate exposures. Employees can use these records to make informed decisions regarding medical surveillance and medical removal. PLHCPs would have the records to use in any further employee consultations or in making recommendations at a later time. In sum, medical records play an important part in properly evaluating the effects of beryllium exposure on employees' health.

    Paragraph (n)(5)(i) would require that employers prepare and maintain records of any training required by this standard. At the completion of training, the employer would be required to prepare a record that indicates the name, social security number, and job classification of each employee trained; the date the training was completed; and the topic of the training. This record maintenance requirement would also apply to records of annual retraining or additional training as described in paragraph (m)(4).

    Proposed paragraphs (n)(1) through (4) require employers to maintain exposure measurements, historical monitoring data, and medical surveillance records, respectively, in accordance with OSHA's Records Access standard (29 CFR 1910.1020). That standard, specifically 29 CFR 1910.1020(d), requires employers to ensure the preservation and retention of exposure and medical records. Exposure measurements and historical monitoring data are considered employee exposure records that must be maintained for at least 30 years in accordance with 29 CFR 1910.1020(d)(1)(ii). Medical surveillance records must be maintained for at least the duration of employment plus 30 years in accordance with 29 CFR 1910.1020(d)(1)(i).

    Proposed paragraph (n)(5)(ii) requires employers to retain training records, including records of annual retraining or additional training required under this standard, for a period of three years after the completion of the training. OSHA believes that the retention period for training records is reasonable for documentation purposes. The three year period for the maintenance of training records is consistent with the Bloodborne Pathogens standard (29 CFR 1910.1030). Other OSHA standards require training records to be kept for one year beyond the last date of employment (e.g., Asbestos (29 CFR 1910.1001), Methylenedianiline in construction (29 CFR 1926.60), and Asbestos in construction (29 CFR 1926.1101)).

    These maintenance provisions, as well as the access requirements discussed below, ensure that records are available to employees so that they may examine the employer's exposure measurements, historical monitoring data, and objective data, as well as medical surveillance and training records, and evaluate whether employees are being adequately protected. Moreover, compliance with the requirement to maintain records of exposure data will enable the employer to show, at least for the duration of the retention-of-records period, that the requirements of this standard were carried out appropriately. For example, maintenance of these types of data could protect employers from allegations of violating paragraph (d)(2). The lengthy record retention period is necessitated by the long latency period commonly associated with diseases such as chronic beryllium disease and cancer (see this preamble at section V, Health Effects).

    Paragraph (n)(6) requires that all records mandated by this standard must be made available for examination and copying to the Assistant Secretary, the Director of NIOSH, each employee, and each employee's designated representative as stipulated by OSHA's Records Access standard (29 CFR 1910.1020).

    Paragraph (n)(7) requires that employers comply with the Records Access standard regarding the transfer of records. Specifically, the requirements for the transfer of records are explained in 29 CFR 1910.1020(h), which instructs employers either to transfer records to successor employers or, if there is no successor employer, to inform employees of their access rights at least three months before the cessation of the employer's business.

    Commenters to the RFI fully endorsed the need for the collection and maintenance of health-related records dealing with beryllium exposure, as well as those for employee hazard training (Brush Wellman, 2003). No comments were received in opposition to the need for such recordkeeping. However, one commenter suggested that most dental labs will not have any incentive to comply with the recordkeeping requirements because they have fewer than ten employees and therefore would not be subject to OSHA audits of their records. The commenter noted that OSHA will have difficulty measuring the effectiveness of the standard if small businesses do not keep accurate records (OSHA, 2007a). OSHA does not intend to exempt small businesses from the recordkeeping requirements in this proposal because the Agency believes the severity of disease resulting from beryllium exposure is great enough to justify requiring small businesses to maintain employee health records in accordance with this proposal. Also, recordkeeping for fewer employees should be less resource-intensive than for a larger organization. OSHA requests comment on the appropriateness of the proposed recordkeeping requirements.

    (o) Dates

    According to paragraph (o), this standard will become effective 60 days after the publication of the final rule in the Federal Register. OSHA intends for this period to allow affected employers the opportunity to familiarize themselves with the standard and to make preparations in order to be in compliance by the start-up dates. Under paragraph (o)(2), employer obligations to comply with most requirements of the final rule would begin 90 days after the effective date (150 days after publication of the final rule). This additional time period is designed to allow employers to complete initial exposure assessments or otherwise make exposure determinations by use of historical or objective data, to establish regulated areas, to obtain appropriate work clothing and equipment, and to comply with other provisions of the rule.

    There are two exceptions to the normal start-up intervals--

    establishing change rooms and implementing engineering controls--that provide additional time for employers to comply. Change rooms are required no later than one year after the effective date of the standard, and engineering controls need to be in place within two years after the effective date. The delayed start-up dates allow affected employers sufficient time to design and construct change rooms where necessary, and to design, obtain, and install any required control equipment. In addition, the longer intervals for change rooms and engineering controls are consistent with other OSHA

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    substance-specific standards such as those for chromium (VI) (29 CFR 1910.1026) and cadmium (29 CFR 1910.1027). OSHA solicits comment on the appropriateness of these proposed start-up dates.

  39. References

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    List of Subjects in 29 CFR Part 1910

    Cancer, Chemicals, Hazardous substances, Health, Occupational safety and health, Reporting and recordkeeping requirements.

    Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, directed the preparation of this notice. OSHA is issuing this notice under Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); section 41 of the Longshore and Harbor Worker's Compensation Act (33 U.S.C. 941); section 107 of the Contract Work Hours and Safety Standards Act (Construction Safety Act) (40 U.S.C. 3704); Secretary of Labor's Order 1-2012 (77 FR 3912, January 25, 2012); and 29 CFR part 1911.

    Signed at Washington, DC, on July 14, 2015.

    David Michaels,

    Assistant Secretary of Labor for Occupational Safety and Health.

    Proposed Standard

    Chapter XVII of Title 29 of the Code of Federal Regulations is proposed to be amended as follows:

    PART 1910--OCCUPATIONAL SAFETY AND HEALTH STANDARDS

    Subpart Z--Toxic and Hazardous Substances

    0

    1. The authority citation for subpart Z of part 1910 is revised to read as follows:

    Authority: Sections 4, 6, 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), 6-96 (62 FR 111), 3-2000 (65 FR 50017), 5-2002 (67 FR 65008), 5-2007 (72 FR 31159), 4-2010 (75 FR 55355), or 1-2012 (77 FR 3912), as applicable; and 29 CFR part 1911.

    All of subpart Z issued under section 6(b) of the Occupational Safety and Health Act of 1970, except those substances that have exposure limits listed in Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000. The latter were issued under section 6(a) (29 U.S.C. 655(a)).

    Section 1910.1000, Tables Z-1, Z-2 and Z-3 also issued under 5 U.S.C. 553, but not under 29 CFR part 1911 except for the arsenic (organic compounds), benzene, cotton dust, and chromium (VI) listings.

    Section 1910.1001 also issued under section 107 of the Contract Work Hours and Safety Standards Act (40 U.S.C. 3704) and 5 U.S.C. 553.

    Section 1910.1002 also issued under 5 U.S.C. 553, but not under 29 U.S.C. 655 or 29 CFR part 1911.

    Sections 1910.1018, 1910.1029, and 1910.1200 also issued under 29 U.S.C. 653. Section 1910.1030 also issued under Pub. L. 106-430, 114 Stat. 1901.

    Page 47820

    Sec. 1910.1000 Amended

    0

    2. In Sec. 1910.1000:

    0

    1. Table Z-1 is amended by revising the entry for ``Beryllium and beryllium compounds (as Be)''; and by adding footnote ``W''; and

      0

    2. Table Z-2 is amended by adding footnote ``Y''.

      The revisions and additions read as follows:

      Table Z-1--Limits for Air Contaminants

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

      ppm (a) mg/m\3\ (b) Skin

      Substance CAS No. (c) \1\ \1\ designation

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

      * * * * * * *

      Beryllium and beryllium compounds (as Be); see

      1910.1024 \W\........................................

      * * * * * * *

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

      \1\ The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit. They are to be

      determined from breathing-zone air samples.

    3. Parts of vapor or gas per million parts of contaminated air by volume at 25 degC and 760 torr.

    4. Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when

      listed with a ppm entry, it is approximate.

    5. The CAS number is for information only. Enforcement is based on the substance name. For an entry covering

      more than one metal compound, measured as the metal, the CAS number for the metal is given--not CAS numbers

      for the individual compounds.

    6. The final benzene standard in Sec. 1910.1028 applies to all occupational exposures to benzene except in

      some circumstances the distribution and sale of fuels, sealed containers and pipelines, coke production, oil

      and gas drilling and production, natural gas processing, and the percentage exclusion for liquid mixtures; for

      the excepted subsegments, the benzene limits in Table Z-2 apply. See Sec. 1910.1028 for specific

      circumstances.

    7. This 8-hour TWA applies to respirable dust as measured by a vertical elutriator cotton dust sampler or

      equivalent instrument. The time-weighted average applies to the cottom waste processing operations of waste

      recycling (sorting, blending, cleaning and willowing) and garnetting. See also Sec. 1910.1043 for cotton

      dust limits applicable to other sectors.

    8. All inert or nuisance dusts, whether mineral, inorganic, or organic, not listed specifically by substance

      name are covered by the Particulates Not Otherwise Regulated (PNOR) limit which is the same as the inert or

      nuisance dust limit of Table Z-3.

      * * * * * * *

      \W\ See Table Z-2 for the exposure limits for any operations or sectors for which the exposure limits in Sec.

      1910.1024 are not in effect.

      Table Z-2

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

      Acceptable maximum peak above the

      8-hour time Acceptable acceptable ceiling average concentration

      Substance weighted ceiling for an 8-hr shift

      average concentration ------------------------------------------

      Concentration Maximum duration

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

      * * * * * * *

      Beryllium and beryllium compounds (as 2 mug/m\3\ 5 mug/m\3\ 25mug/m\3\ 30 minutes

      Be) \Y\.

      * * * * * * *

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

      * * * * * *

      \Y\ This standard applies to any operations or sectors for which the Beryllium standard, 1910.1024, is not in

      effect.

      0

      3. Section 1910.1024 is added to subpart Z to read as follows:

      Sec. 1910.1024 Beryllium

      (a) Scope and application. (1) This section applies to occupational exposures to beryllium in all forms, compounds, and mixtures in general industry, except those articles and materials exempted by paragraphs (a)(2) and (3) of this section.

      (2) This section does not apply to articles, as defined in the Hazard Communication standard (HCS) (29 CFR 1910.1200(c)), that contain beryllium and that the employer does not process.

      (3) This section does not apply to materials containing less than 0.1% beryllium by weight.

      (b) Definitions.

      Action level means a concentration of airborne beryllium of 0.1 micrograms per cubic meter of air (mug/m\3\) calculated as an 8-hour time-weighted average (TWA).

      Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and Health, United States Department of Labor, or designee.

      Beryllium lymphocyte proliferation test (BeLPT) means the measurement of blood lymphocyte proliferation in a laboratory test when lymphocytes are challenged with a soluble beryllium salt. A confirmed positive test result indicates the person has beryllium sensitization.

      Beryllium work area means any work area where employees are, or can reasonably be expected to be, exposed to airborne beryllium, regardless of the level of exposure.

      CBD Diagnostic Center means a medical diagnostic center that has on-site facilities to perform a clinical evaluation for the presence of chronic beryllium disease (CBD) that includes bronchoalveolar lavage, transbronchial biopsy and interpretation of the biopsy pathology, and the beryllium bronchoalveolar lavage lymphocyte proliferation test (BeBALLPT).

      Chronic beryllium disease (CBD) means a chronic lung disease associated with exposure to airborne beryllium.

      Confirmed Positive means two abnormal test results from either consecutive BeLPTs or a second abnormal BeLPT result within a 2-year period of the first abnormal test result. It also means the result of a more reliable and accurate test indicating a

      Page 47821

      person has been identified as having beryllium sensitization.

      Director means the Director of the National Institute for Occupational Safety and Health (NIOSH), U.S. Department of Health and Human Services, or designee.

      Emergency means any uncontrolled release of airborne beryllium.

      Exposure and exposure to beryllium mean the exposure to airborne beryllium that would occur if the employee were not using a respirator.

      High-efficiency particulate air (HEPA) filter means a filter that is at least 99.97 percent efficient in removing particles 0.3 micrometers in diameter.

      Physician or other licensed health care professional (PLHCP) means an individual whose legally permitted scope of practice (i.e., license, registration, or certification) allows the individual to independently provide or be delegated the responsibility to provide some or all of the health care services required by paragraph (k) of this standard.

      Regulated area means an area that the employer must demarcate, including temporary work areas where maintenance or non-routine tasks are performed, where an employee's exposure exceeds, or can reasonably be expected to exceed, either of the permissible exposure limits (PELs).

      This standard means this beryllium standard, 29 CFR 1910.1024.

      (c) Permissible Exposure Limits (PELs). (1) Time-weighted average (TWA) PEL. The employer shall ensure that each employee's exposure does not exceed 0.2 mug/m\3\ calculated as an 8-hour TWA.

      (2) Short-term exposure limit (STEL). The employer shall ensure that each employee's exposure does not exceed 2.0 mug/m\3\ as determined over a sampling period of 15 minutes.

      (d) Exposure monitoring--(1) General. (i) These exposure monitoring requirements apply when employees are, or may reasonably be expected to be, exposed to airborne beryllium.

      (ii) Except as provided in paragraphs (d)(2)(i) and (ii) of this section, the employer shall determine the 8-hour TWA exposure for each employee based on one or more breathing zone samples that reflect the exposure of employees on each work shift, for each job classification, in each beryllium work area.

      (iii) Except as provided in paragraph (d)(2)(i) and (ii) of this section, the employer shall determine short-term exposure from 15-

      minute breathing zone samples measured in operations that are likely to produce exposures above the STEL for each work shift, for each job classification, and in each beryllium work area.

      (iv) The employer may perform representative sampling to characterize exposure, provided that the employer:

      (A) Performs representative sampling where several employees perform the same job tasks, in the same job classification, on the same work shift, and in the same work area, and have similar duration and frequency of exposure;

      (B) Takes sufficient personal breathing zone air samples to accurately characterize exposure on each work shift, for each job classification, in each work area; and

      (C) Samples those employee(s) who are expected to have the highest exposure.

      (v) Accuracy of measurement. The employer shall use a method of exposure monitoring and analysis that can measure beryllium to an accuracy of plus or minus 25 percent within a statistical confidence level of 95 percent for airborne concentrations at or above the action level.

      (2) Initial exposure monitoring. The employer shall conduct initial exposure monitoring to determine the 8-hour TWA exposure and 15-minute short-term exposure for each employee. The employer does not have to conduct initial exposure monitoring in the following situations:

      (i) Whe