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




  Vol. 82

  Monday,

  No. 5

  January 9, 2017

  Part II





  Department of Labor





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  Occupational Safety and Health Administration





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  29 CFR Parts 1910, 1915, and 1926





  Occupational Exposure to Beryllium; Final Rule

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



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  DEPARTMENT OF LABOR

  Occupational Safety and Health Administration

  29 CFR Parts 1910, 1915, and 1926

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


  Occupational Exposure to Beryllium

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

  ACTION: Final rule.

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  SUMMARY: The Occupational Safety and Health Administration (OSHA) is
  amending its existing standards for occupational exposure to beryllium
  and beryllium compounds. OSHA has determined that employees exposed to
  beryllium at the previous permissible exposure limits face a
  significant risk of material impairment to their health. The evidence
  in the record for this rulemaking indicates that workers exposed to
  beryllium are at increased risk of developing chronic beryllium disease
  and lung cancer. This final rule establishes new permissible exposure
  limits of 0.2 micrograms of beryllium per cubic meter of air (0.2
  μg/m3\) as an 8-hour time-weighted average and 2.0 μg/m3\ as a
  short-term exposure limit determined over a sampling period of 15
  minutes. It also includes other provisions to protect employees, such
  as requirements for exposure assessment, methods for controlling
  exposure, respiratory protection, personal protective clothing and
  equipment, housekeeping, medical surveillance, hazard communication,
  and recordkeeping.
      OSHA is issuing three separate standards--for general industry, for
  shipyards, and for construction--in order to tailor requirements to the
  circumstances found in these sectors.

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

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

  FOR FURTHER INFORMATION CONTACT: For general information and press
  inquiries, contact Frank Meilinger, Director, Office of Communications,
  Room N-3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue
  NW., Washington, DC 20210; telephone (202) 693-1999; email
  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) 693-1950.

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

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

  Citation Method

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

  I. Executive Summary

      This final rule establishes new permissible exposure limits (PELs)
  for beryllium of 0.2 micrograms of beryllium per cubic meter of air
  (0.2 μg/m3\) as an 8-hour time-weighted average (TWA) and 2.0
  μg/m3\ as a short-term exposure limit (STEL) determined over a
  sampling period of 15 minutes. In addition to the PELs, the rule
  includes provisions to protect employees such as requirements for
  exposure assessment, methods for controlling exposure, respiratory
  protection, personal protective clothing and equipment, housekeeping,
  medical surveillance, hazard communication, and recordkeeping. OSHA is
  issuing three separate standards--for general


  industry, for shipyards, and for construction--in order to tailor
  requirements to the circumstances found in these sectors. There are,
  however, numerous common elements in the three standards.
      The final rule is based on the requirements of the Occupational
  Safety and Health Act (OSH Act) and court interpretations of the Act.
  For health standards issued under section 6(b)(5) of the OSH Act, OSHA
  is required to promulgate a standard that reduces significant risk to
  the extent that it is technologically and economically feasible to do
  so. See Section II, Pertinent Legal Authority, for a full discussion of
  OSH Act legal requirements.
      OSHA has conducted an extensive review of the literature on adverse
  health effects associated with exposure to beryllium. OSHA has also
  developed estimates of the risk of beryllium-related diseases, assuming
  exposure over a working lifetime, at the preceding PELs as well as at
  the revised PELs and action level. Comments received on OSHA's
  preliminary analysis, and the Agency's final findings, are discussed in
  Section V, Health Effects, Section VI, Risk Assessment, and Section
  VII, Significance of Risk. OSHA finds that employees exposed to
  beryllium at the preceding PELs are at an increased risk of developing
  chronic beryllium disease (CBD) and lung cancer. As discussed in
  Section VII, OSHA concludes that exposure to beryllium constitutes a
  significant risk of material impairment to health and that the final
  rule will substantially lower that risk. The Agency considers the level
  of risk remaining at the new TWA PEL to still be significant. However,
  OSHA did not adopt a lower TWA PEL because the Agency could not
  demonstrate technological feasibility of a lower TWA PEL. The Agency
  has adopted the STEL and ancillary provisions of the rule to further
  reduce the remaining significant risk.
      OSHA's examination of the technological and economic feasibility of
  the rule is presented in the Final Economic Analysis and Regulatory
  Flexibility Analysis (FEA), and is summarized in Section VIII of this
  preamble. OSHA concludes that the final PELs are technologically
  feasible for all affected industries and application groups. Thus, OSHA
  concludes that engineering and work practice controls will be
  sufficient to reduce and maintain beryllium exposures to the new PELs
  or below in most operations most of the time in the affected
  industries. For those few operations within an industry or application
  group where compliance with the PELs cannot be achieved even when
  employers implement all feasible engineering and work practice
  controls, use of respirators will be required.
      OSHA developed quantitative estimates of the compliance costs of
  the rule for each of the affected industry sectors. The estimated
  compliance costs were compared with industry revenues and profits to
  provide a screening analysis of the economic feasibility of complying
  with the rule and an evaluation of the economic impacts. Industries
  with unusually high costs as a percentage of revenues or profits were
  further analyzed for possible economic feasibility issues. After
  performing these analyses, OSHA finds that compliance with the
  requirements of the rule is economically feasible in every affected
  industry sector.
      The final rule includes several major changes from the proposed
  rule as a result of OSHA's analysis of comments and evidence received
  during the comment periods and public hearings. The major changes are
  summarized below and are fully discussed in Section XVI, Summary and
  Explanation of the Standards. OSHA also presented a number of
  regulatory alternatives in the Notice of Proposed Rulemaking (80 FR
  47566, 47729-47748 (8/7/2015). Where the Agency received substantive
  comments on a regulatory alternative, those comments are also discussed
  in Section XVI. A full discussion of all regulatory alternatives can be
  found in Chapter VIII of the Final Economic Analysis (FEA).
      Scope. OSHA proposed to cover occupational exposures to beryllium
  in general industry, with an exemption for articles and an exemption
  for materials containing less than 0.1% beryllium by weight. OSHA has
  made a final determination to cover exposures to beryllium in general
  industry, shipyards, and construction under the final rule, and to
  issue separate standards for each sector. The final rule also provides
  an exemption for materials containing less than 0.1% beryllium by
  weight only where the employer has objective data demonstrating that
  employee exposure to beryllium will remain below the action level of
  0.1 μg/m3\ as an 8-hour TWA under any foreseeable conditions.
      Exposure Assessment. The proposed rule would have required periodic
  exposure monitoring annually where employee exposures are at or above
  the action level but at or below the TWA PEL; no periodic monitoring
  would have been required where employee exposures exceeded the TWA PEL.
  The final rule specifies that exposure monitoring must be repeated
  within six months where employee exposures are at or above the action
  level but at or below the TWA PEL, and within three months where
  employee exposures are above the TWA PEL or STEL. The final rule also
  includes provisions allowing the employer to discontinue exposure
  monitoring where employee exposures fall below the action level and
  STEL. In addition, the final rule includes a new provision that allows
  employers to assess employee exposures using any combination of air
  monitoring data and objective data sufficient to accurately
  characterize airborne exposure to beryllium (i.e., the "performance
  option").
      Beryllium Work Areas. The proposed rule would have required the
  employer to establish and maintain a beryllium work area wherever
  employees are, or can reasonably be expected to be, exposed to airborne
  beryllium, regardless of the level of exposure. As discussed in the
  Summary and Explanation section of this preamble, OSHA has narrowed the
  definition of beryllium work area in the final rule from the proposal.
  The final rule now limits the requirement to work areas containing a
  process or operation that can release beryllium where employees are, or
  can reasonably be expected to be, exposed to airborne beryllium at any
  level. The final rule expands the exposure requirement to include work
  areas containing a process or operation where there is potential dermal
  contact with beryllium based on comments from public health experts
  that relying solely on airborne exposure omits the potential
  contribution of dermal exposure to total exposure. See the Summary and
  Explanation section of this preamble for a full discussion of the
  relevant comments and reasons for changes from the proposed standard.
  Beryllium work areas are not required under the standards for shipyards
  and construction.
      Respiratory Protection. OSHA has added a provision in the final
  rule requiring the employer to provide a powered air-purifying
  respirator (PAPR) instead of a negative pressure respirator where
  respiratory protection is required by the rule and the employee
  requests a PAPR, provided that the PAPR provides adequate protection.
      Personal Protective Clothing and Equipment. The proposed rule would
  have required use of protective clothing and equipment where employee
  exposure exceeds, or can reasonably be expected to exceed the TWA PEL
  or STEL; where employees' clothing or skin may become visibly
  contaminated with beryllium; and where employees'


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

   Table I-1--Annualized Benefits, Costs and Net Benefits of OSHA's Final
                             Beryllium Standard
                   [3 Percent discount rate, 2015 dollars]
  ------------------------------------------------------------------------

  ------------------------------------------------------------------------
  Annualized Costs:
    Control Costs.........................................     $12,269,190
    Rule Familiarization..................................         180,158
    Exposure Assessment...................................      13,748,676
    Regulated Areas.......................................         884,106



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

  II. Pertinent Legal Authority

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

  Material Impairment of Health

      Subject to the limitations discussed below, when setting standards
  regulating exposure to toxic materials or harmful physical agents, the
  Secretary is required to set health standards that ensure that "no
  employee will suffer material impairment of health or functional
  capacity. . ." (29 U.S.C. 655(b)(5)). "OSHA is not required to state
  with scientific certainty or precision the exact point at which each
  type of [harm] becomes a material impairment" (AFL-CIO v. OSHA, 965
  F.2d 962, 975 (11th Cir. 1992)). Courts have also noted that OSHA
  should consider all forms and degrees of material impairment--not just
  death or serious physical harm (AFL-CIO, 965 F.2d at 975). Thus the
  Agency has taken the position that "subclinical" health effects,
  which may be precursors to more serious disease, can be material
  impairments of health that OSHA should address when feasible (43 FR
  52952, 52954 (11/14/78) (Lead Preamble)).

  Significant Risk

      Section 3(8) of the Act requires that workplace safety and health
  standards be "reasonably necessary or appropriate to provide safe or
  healthful employment" (29 U.S.C. 652(8)). The Supreme Court, in its
  decision on OSHA's benzene standard, interpreted section 3(8) to mean
  that before promulgating any standard, the Secretary must evaluate
  whether "significant risk[ ]" exists under current conditions and to
  then determine whether that risk can be "eliminated or lessened"
  through regulation (Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst.,
  448 U.S. 607, 642 (1980) (plurality opinion) ("Benzene")). The
  Court's holding is consistent with evidence in the legislative record,
  with regard to section 6(b)(5) of the Act (29 U.S.C. 655(b)(5)), that
  Congress intended the Agency to regulate unacceptably severe
  occupational hazards, and not "to establish a utopia free from any
  hazards" or to address risks comparable to those that exist in
  virtually any occupation or workplace (116 Cong. Rec. 37614 (1970),
  Leg. Hist. 480-82). It is also consistent with Section 6(g) of the OSH
  Act, which states that, in determining regulatory priorities, "the
  Secretary shall give due regard to the urgency of the need for
  mandatory safety and health standards for particular industries,
  trades, crafts, occupations, businesses, workplaces or work
  environments" (29 U.S.C. 655(g)).
      The Supreme Court in Benzene clarified that "[i]t is the Agency's
  responsibility to determine, in the first instance, what it considers
  to be a `significant' risk" (Benzene, 448 U.S. at 655), and that it
  was not the Court's responsibility to "express any opinion on the . .
  . difficult question of what factual determinations would warrant a
  conclusion that significant risks are present which make promulgation
  of a new standard reasonably necessary or appropriate" (Benzene, 448
  U.S. at 659). The Court stated, however, that the section 6(f) (29
  U.S.C. 655(b)(f)) substantial evidence standard applicable to OSHA's
  significant risk determination does not require the Agency "to support
  its finding that a significant risk exists with anything approaching
  scientific certainty" (Benzene, 448 U.S. at 656). Rather, OSHA may
  rely on "a body of reputable scientific thought" to which
  "conservative assumptions in interpreting the data . . . " may be
  applied, "risking error on the side of


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

      If . . . the odds are one in a billion that a person will die
  from cancer by taking a drink of chlorinated water, the risk clearly
  could not be considered significant. On the other hand, if the odds
  are one in a thousand that regular inhalation of gasoline vapors
  that are 2% benzene will be fatal, a reasonable person might well
  consider the risk significant . . . (Benzene, 448 U.S. at 655).

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

  Working Life Assumption

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

  Best Available Evidence

      Section 6(b)(5) of the Act requires OSHA to set standards "on the
  basis of the best available evidence" and to consider the "latest
  available scientific data in the field" (29 U.S.C. 655(b)(5)). As
  noted above, the Supreme Court, in its Benzene decision, explained that
  OSHA must look to "a body of reputable scientific thought" in making
  its material harm and significant risk determinations, while noting
  that a reviewing court must "give OSHA some leeway where its findings
  must be made on the frontiers of scientific knowledge" (Benzene, 448
  U.S. at 656).
      The courts of appeals have afforded OSHA similar latitude to issue
  health standards in the face of scientific uncertainty. The Second
  Circuit, in upholding the vinyl chloride standard, stated: "[T]he
  ultimate facts here in dispute are `on the frontiers of scientific
  knowledge', and, though the factual finger points, it does not
  conclude. Under the command of OSHA, it remains the duty of the
  Secretary to act to protect the workingman, and to act even in
  circumstances where existing methodology or research is deficient"
  (Society of the Plastics Industry, Inc. v. OSHA, 509 F.2d 1301, 1308
  (2d Cir. 1975) (quoting Indus. Union Dep't, AFL-CIO v. Hodgson, 499
  F.2d 467, 474 (D.C. Cir. 1974) ("Asbestos I"))). The D.C. Circuit, in
  upholding the cotton dust standard, stated: "OSHA's mandate
  necessarily requires it to act even if information is incomplete when
  the best available evidence indicates a serious threat to the health of
  workers" (Am. Fed'n of Labor & Cong. of Indus. Orgs. v. Marshall, 617
  F.2d 636, 651 (D.C. Cir. 1979), aff'd in part and vacated in part on
  other grounds, American Textile Mfrs. Inst., Inc. v. Donovan, 452 U.S.
  490 (1981)). When there is disputed scientific evidence in the record,
  OSHA must review the evidence on both sides and "reasonably resolve"
  the dispute (Pub. Citizen Health Research Grp. v. Tyson, 796 F.2d 1479,
  1500 (D.C. Cir. 1986)). The Court in Public Citizen further noted that,
  where "OSHA has the expertise we lack and it has exercised that
  expertise by carefully reviewing the scientific data," a dispute
  within the scientific community is not occasion for the reviewing court
  to take sides about which view is correct (Pub. Citizen Health Research
  Grp., 796 F.2d


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

  Feasibility

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

  Technological Feasibility

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

      [W]ithin the limits of the best available evidence . . . OSHA
  must prove a reasonable possibility that the typical firm will be
  able to develop and install engineering and work practice controls
  that can meet the PEL in most of its operations . . . The effect of
  such proof is to establish a presumption that industry can meet the
  PEL without relying on respirators . . . Insufficient proof of
  technological feasibility for a few isolated operations within an
  industry, or even OSHA's concession that respirators will be
  necessary in a few such operations, will not undermine this general
  presumption in favor of feasibility. Rather, in such operations
  firms will remain responsible for installing engineering and work
  practice controls to the extent feasible, and for using them to
  reduce . . . exposure as far as these controls can do so (Lead I,
  647 F.2d at 1272).

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


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

  Economic Feasibility

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

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

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

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

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

  Structure of OSHA Health Standards

      OSHA's health standards traditionally incorporate a comprehensive
  approach to reducing occupational disease. OSHA substance-specific
  health standards generally include the "hierarchy of controls,"
  which, as a matter of OSHA's preferred policy, mandates that employers
  install and implement all feasible engineering and work practice
  controls before respirators may be used. The Agency's adherence to the
  hierarchy of controls has been upheld by the courts (ASARCO, Inc. v.
  OSHA, 746 F.2d 483, 496-498 (9th Cir. 1984); Am. Iron & Steel Inst. v.
  OSHA, 182 F.3d 1261, 1271 (11th Cir. 1999)). In fact, courts view the
  legal standard for proving technological feasibility as incorporating
  the hierarchy: "OSHA must prove a reasonable possibility that the
  typical firm will be able to develop and install engineering and work
  practice controls that can meet the PEL in most of its operations. . .
  . The effect of such proof is to establish a presumption that industry
  can meet the PEL without relying on respirators" (Lead I, 647 F.2d at
  1272).
      The reasons supporting OSHA's continued reliance on the hierarchy
  of controls, as well as its reasons for limiting the use of
  respirators, are numerous and grounded in good industrial hygiene
  principles (see discussion in Section XVI. Summary and Explanation of
  the Standards, Methods of Compliance). The hierarchy of controls
  focuses on removing harmful airborne materials at their source "to
  prevent atmospheric contamination" to which the employee would be
  exposed, rather than relying on the proper functioning of a respirator
  as the primary means of protecting the employee (see 29 CFR 1910.134,
  1910.1000(e), 1926.55(b)).
      In health standards such as this one, the hierarchy of controls is
  augmented by ancillary provisions. These provisions work with the
  hierarchy of controls and personal protective equipment requirements to
  provide comprehensive protection to employees in affected workplaces.
  Such provisions typically include exposure assessment, medical
  surveillance, hazard communication, and recordkeeping.
      The OSH Act compels OSHA to require all feasible measures for
  reducing significant health risks (29 U.S.C. 655(b)(5); Pub. Citizen
  Health Research Grp., 796 F.2d at 1505 ("if in fact a STEL [short-term
  exposure limit] would further reduce a significant health risk and is
  feasible to implement, then the OSH Act compels the agency to adopt it
  (barring alternative avenues to the same result)"). When there is
  significant risk below the PEL, the D.C. Circuit indicated that OSHA
  should use its regulatory authority to impose additional requirements
  on employers when those requirements will result in


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

  III. Events Leading to the Final Standards

      The first occupational exposure limit for beryllium was set in 1949
  by the Atomic Energy Commission (AEC), which required that beryllium
  exposure in the workplaces under its jurisdiction be limited to 2
  µg/m3\ as an 8-hour time-weighted average (TWA), and 25
  µg/m3\ as a peak exposure never to be exceeded (Document ID
  1323). These exposure limits were adopted by all AEC installations
  handling beryllium, and were binding on all AEC contractors involved in
  the handling of beryllium.
      In 1956, the American Industrial Hygiene Association (AIHA)
  published a Hygienic Guide which supported the AEC exposure limits. In
  1959, the American Conference of Governmental Industrial Hygienists
  (ACGIH[supreg]) also adopted a Threshold Limit Value (TLV[supreg]) of 2
  µg/m3\ as an 8-hour TWA (Borak, 2006). In 1970, ANSI issued a
  national consensus standard for beryllium and beryllium compounds (ANSI
  Z37.29-1970). The standard set a permissible exposure limit (PEL) for
  beryllium and beryllium compounds at 2 µg/m3\ as an 8-hour TWA;
  5 µg/m3\ as an acceptable ceiling concentration; and 25
  µg/m3\ as an acceptable maximum peak above the acceptable
  ceiling concentration for a maximum duration of 30 minutes in an 8-hour
  shift (Document ID 1303).
      In 1971, OSHA adopted, under Section 6(a) of the Occupational
  Safety and Health Act of 1970, and made applicable to general industry,
  the ANSI standard (Document ID 1303). Section 6(a) provided that in the
  first two years after the effective date of the Act, OSHA was to
  promulgate "start-up" standards, on an expedited basis and without
  public hearing or comment, based on national consensus or established
  Federal standards that improved employee safety or health. Pursuant to
  that authority, in 1971, OSHA promulgated approximately 425 PELs for
  air contaminants, including beryllium, derived principally from Federal
  standards applicable to government contractors under the Walsh-Healey
  Public Contracts Act, 41 U.S.C. 35, and the Contract Work Hours and
  Safety Standards Act (commonly known as the Construction Safety Act),
  40 U.S.C. 333. The Walsh-Healey Act and Construction Safety Act
  standards, in turn, had been adopted primarily from ACGIH[supreg]'s
  TLV[supreg]s as well as several from United States of America Standards
  Institute (USASI) [later the American National Standards Institute
  (ANSI)].
      The National Institute for Occupational Safety and Health (NIOSH)
  issued a document entitled Criteria for a Recommended Standard:
  Occupational Exposure to Beryllium (Criteria Document) in June 1972
  with Recommended Exposure Limits (RELs) of 2 µg/m3\ as an 8-hour
  TWA and 25 µg/m3\ as an acceptable maximum peak above the
  acceptable ceiling concentration for a maximum duration of 30 minutes
  in an 8-hour shift. OSHA reviewed the findings and recommendations
  contained in the Criteria Document along with the AEC control
  requirements for beryllium exposure. OSHA also considered existing data
  from animal and epidemiological studies, and studies of industrial
  processes of beryllium extraction, refinement, fabrication, and
  machining. In 1975, OSHA asked NIOSH to update the evaluation of the
  existing data pertaining to the carcinogenic potential of beryllium. In
  response to OSHA's request, the Director of NIOSH stated that, based on
  animal data and through all possible routes of exposure including
  inhalation, "beryllium in all likelihood represents a carcinogenic
  risk to man."
      In October 1975, OSHA proposed a new beryllium standard for all
  industries based on information from studies finding that beryllium
  caused cancer in animals (40 FR 48814 (10/17/75)). Adoption of this
  proposal would have lowered the 8-hour TWA exposure limit from 2
  µg/m3\ to 1 µg/m3\. 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 µg/m3\
  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
  µg/m3\ over an 8-hour TWA based on evidence of CBD and
  sensitization in exposed workers. Then in 2009, ACGIH adopted a revised
  TLV for beryllium that lowered the TWA to 0.05 μg/m3\ (inhalable)
  (see Document ID 1755, Tr. 136).
      In 1999, the Department of Energy (DOE) issued a Chronic Beryllium
  Disease Prevention Program (CBDPP) Final Rule for employees exposed to
  beryllium in its facilities (Document ID 1323). The DOE rule set an
  action level of 0.2 μg/m3\, and adopted OSHA's PEL of 2 μg/m3\
  or any more stringent PEL OSHA might adopt in the future (10 CFR
  850.22; 64 FR 68873 and 68906, Dec. 8, 1999).
      Also in 1999, OSHA was petitioned by the Paper, Allied-Industrial,
  Chemical and Energy Workers International Union (PACE) (Document ID
  0069) and by Dr. Lee Newman and Ms. Margaret Mroz, from the National
  Jewish Health (NJH) (Document ID 0069), to promulgate an Emergency
  Temporary Standard (ETS) for beryllium in the workplace. In 2001, OSHA
  was petitioned for an ETS by Public Citizen Health Research Group and
  again by PACE (Document ID 0069). In order to promulgate an ETS, the
  Secretary of Labor must prove (1) that employees are exposed to grave
  danger from exposure to a hazard, and (2) that such an emergency
  standard is necessary to protect employees from such danger (29 U.S.C.
  655(c) [6(c)]). The burden of proof is on the Department and because of
  the difficulty of meeting this burden, the Department usually proceeds
  when appropriate with ordinary notice and comment [section 6(b)]
  rulemaking rather than a 6(c) ETS. Thus, instead of granting the ETS
  requests, OSHA instructed staff to further collect and analyze research
  regarding the harmful effects of beryllium in preparation for possible
  section 6(b) rulemaking.
      On November 26, 2002, OSHA published a Request for Information
  (RFI) for "Occupational Exposure to Beryllium" (Document ID 1242).
  The RFI contained questions on employee exposure, health effects, risk
  assessment, exposure assessment and monitoring methods, control
  measures and technological feasibility, training, medical surveillance,
  and impact on small business entities. In the RFI, OSHA expressed
  concerns about health effects such as chronic beryllium disease (CBD),
  lung cancer, and beryllium sensitization. OSHA pointed to studies
  indicating that even short-term exposures below OSHA's PEL of 2
  µg/m3\ could lead to CBD. The RFI also cited studies describing
  the relationship between beryllium sensitization and CBD (67 FR at
  70708). In addition,


  OSHA stated that beryllium had been identified as a carcinogen by
  organizations such as NIOSH, the International Agency for Research on
  Cancer (IARC), and the Environmental Protection Agency (EPA); and
  cancer had been evidenced in animal studies (67 FR at 70709).
      On November 15, 2007, OSHA convened a Small Business Advocacy
  Review Panel for a draft proposed standard for occupational exposure to
  beryllium. OSHA convened this panel under Section 609(b) of the
  Regulatory Flexibility Act (RFA), as amended by the Small Business
  Regulatory Enforcement Fairness Act of 1996 (SBREFA) (5 U.S.C. 601 et
  seq.).
      The Panel included representatives from OSHA, the Solicitor's
  Office of the Department of Labor, the Office of Advocacy within the
  Small Business Administration, and the Office of Information and
  Regulatory Affairs of the Office of Management and Budget. Small Entity
  Representatives (SERs) made oral and written comments on the draft rule
  and submitted them to the panel.
      The SBREFA Panel issued a report on January 15, 2008 which included
  the SERs' comments. SERs expressed concerns about the impact of the
  ancillary requirements such as exposure monitoring and medical
  surveillance. Their comments addressed potential costs associated with
  compliance with the draft standard, and possible impacts of the
  standard on market conditions, among other issues. In addition, many
  SERs sought clarification of some of the ancillary requirements such as
  the meaning of "routine" contact or "contaminated surfaces."
      OSHA then developed a draft preliminary beryllium health effects
  evaluation (Document ID 1271) and a draft preliminary beryllium risk
  assessment (Document ID 1272), and in 2010, OSHA hired a contractor to
  oversee an independent scientific peer review of these documents. The
  contractor identified experts familiar with beryllium health effects
  research and ensured that these experts had no conflict of interest or
  apparent bias in performing the review. The contractor selected five
  experts with expertise in such areas as pulmonary and occupational
  medicine, CBD, beryllium sensitization, the Beryllium Lymphocyte
  Proliferation Test (BeLPT), beryllium toxicity and carcinogenicity, and
  medical surveillance. Other areas of expertise included animal
  modeling, occupational epidemiology, biostatistics, risk and exposure
  assessment, exposure-response modeling, beryllium exposure assessment,
  industrial hygiene, and occupational/environmental health engineering.
      Regarding the preliminary health effects evaluation, the peer
  reviewers concluded that the health effect studies were described
  accurately and in sufficient detail, and OSHA's conclusions based on
  the studies were reasonable (Document ID 1210). The reviewers agreed
  that the OSHA document covered the significant health endpoints related
  to occupational beryllium exposure. Peer reviewers considered the
  preliminary conclusions regarding beryllium sensitization and CBD to be
  reasonable and well presented in the draft health evaluation section.
  All reviewers agreed that the scientific evidence supports
  sensitization as a necessary condition in the development of CBD. In
  response to reviewers' comments, OSHA made revisions to more clearly
  describe certain sections of the health effects evaluation. In
  addition, OSHA expanded its discussion regarding the BeLPT.
      Regarding the preliminary risk assessment, the peer reviewers were
  highly supportive of the Agency's approach and major conclusions
  (Document ID 1210). The peer reviewers stated that the key studies were
  appropriate and their selection clearly explained in the document. They
  regarded the preliminary analysis of these studies to be reasonable and
  scientifically sound. The reviewers supported OSHA's conclusion that
  substantial risk of sensitization and CBD were observed in facilities
  where the highest exposure generating processes had median full-shift
  exposures around 0.2 µg/m3\ or higher, and that the greatest
  reduction in risk was achieved when exposures for all processes were
  lowered to 0.1 µg/m3\ or below.
      In February 2012, the Agency received for consideration a draft
  recommended standard for beryllium (Materion and USW, 2012, Document ID
  0754). This draft standard was the product of a joint effort between
  two stakeholders: Materion Corporation, a leading producer of beryllium
  and beryllium products in the United States, and the United
  Steelworkers, an international labor union representing workers who
  manufacture beryllium alloys and beryllium-containing products in a
  number of industries. They sought to craft an OSHA-like model beryllium
  standard that would have support from both labor and industry. OSHA has
  considered this proposal along with other information submitted during
  the development of the Notice of Proposed Rulemaking (NPRM) for
  beryllium. As described in greater detail in the Introduction to the
  Summary and Explanation of the final rule, there was substantial
  agreement between the submitted joint standard and the OSHA proposed
  standard.
      On August 7, 2015, OSHA published its NPRM in the Federal Register
  (80 FR 47565 (8/7/15)). In the NPRM, the Agency made a preliminary
  determination that employees exposed to beryllium and beryllium
  compounds at the preceding PEL face a significant risk to their health
  and that promulgating the proposed standard would substantially reduce
  that risk. The NPRM (Section XVIII) also responded to the SBREFA Panel
  recommendations, which OSHA carefully considered, and clarified the
  requirements about which SERs expressed confusion. OSHA also discussed
  the regulatory alternatives recommended by the SBREFA Panel in NPRM,
  Section XVIII, and in the PEA (Document ID 0426).
      The NPRM invited interested stakeholders to submit comments on a
  variety of issues and indicated that OSHA would schedule a public
  hearing upon request. Commenters submitted information and suggestions
  on a variety of topics. In addition, in response to a request from the
  Non-Ferrous Founders' Society, OSHA scheduled an informal public
  hearing on the proposed rule. The Agency invited interested persons to
  participate by providing oral testimony and documentary evidence at the
  hearing. OSHA also welcomed presentation of data and documentary
  evidence that would provide the Agency with the best available evidence
  to use in determining whether to develop a final rule.
      The public hearing was held in Washington, DC on March 21 and 22,
  2016. Administrative Law Judge William Colwell presided over the
  hearing. The Agency heard testimony from several organizations, such as
  public health groups, the Non-Ferrous Founders' Society, other industry
  representatives, and labor unions. Following the hearing, participants
  who had filed notices of intent to appear were allowed 30 days--until
  April 21, 2016--to submit additional evidence and data, and an
  additional 15 days--until May 6, 2016--to submit final briefs,
  arguments, and summations (Document ID 1756, Tr. 326).
      In 2016, in an action parallel to OSHA's rulemaking, DOE proposed
  to update its action level to 0.05 μg/m3\ (81 FR 36704-36759, June
  7, 2016). 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 (Document ID 1323; 10 CFR 850.23(b)). Unlike OSHA's
  PEL, however, DOE's selection of an action level is not required to
  meet statutory requirements of technological and economic feasibility.
      In all, the OSHA rulemaking record contains over 1,900 documents,
  including all the studies OSHA relied on in its preliminary health
  effects and risk assessment analyses, the hearing transcript and
  submitted testimonies, the joint Materion-USW draft proposed standard,
  and the pre- and post-hearing comments and briefs. The final rule on
  occupational exposure to beryllium and beryllium compounds is thus
  based on consideration of the entire record of this rulemaking
  proceeding, including materials discussed or relied upon in the
  proposal, the record of the hearing, and all written comments and
  exhibits timely received. Based on this comprehensive record, OSHA
  concludes that employees exposed to beryllium and beryllium compounds
  are at significant risk of material impairment of health, including
  chronic beryllium disease and lung cancer. The Agency concludes that
  the PEL of 0.2 μg/m3\ reduces the significant risks of material
  impairments of health posed to workers by occupational exposure to
  beryllium and beryllium compounds to the maximum extent that is
  technologically and economically feasible. OSHA's substantive
  determinations with regard to the comments, testimony, and other
  information in the record, the legal standards governing the decision-
  making process, and the Agency's analysis of the data resulting in its
  assessments of risks, benefits, technological and economic feasibility,
  and compliance costs are discussed elsewhere in this preamble. More
  technical or complex issues are discussed in greater detail in the
  background documents referenced in this preamble.

  IV. Chemical Properties and Industrial Uses

  Chemical and Physical Properties

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

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



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

  Industrial Uses

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

  V. Health Effects

  Overview of Findings and Supportive Comments

      As discussed in detail throughout this section (section V, Final
  Health Effects) and in Section VI, Final Quantitative Risk Assessment
  and Significance of Risk, OSHA finds, based upon the best available
  evidence in the record, that exposure to soluble and poorly soluble
  forms of beryllium are associated with several adverse health outcomes
  including sensitization, chronic beryllium disease, acute beryllium
  disease and lung cancer.
      The findings and conclusions in this section are consistent with
  those of the National Academies of Sciences (NAS), the World Health
  Organization's International Agency for Research on Cancer (IARC), the
  U.S. Department of Health and Human Services' (HHS) National Toxicology
  Program (NTP), the National Institute for Occupational Safety and
  Health (NIOSH), the Agency for Toxic Substance and Disease Registry
  (ATSDR), the European Commission on Health, Safety and Hygiene at Work,
  and many other organizations and individuals, as evidenced in the
  rulemaking record and further discussed below. Other scientific
  organizations and governments have recognized the strong body of
  scientific evidence pointing to the health risks of exposure to
  beryllium and have deemed it necessary to take action to reduce those
  risks. In 1999, the Department of Energy (DOE) updated its airborne
  beryllium concentration action level to 0.2 μg/m3\ (Document ID
  1323). In 2009, the American Conference of Governmental Industrial
  Hygienists (ACGIH), a professional society that has been recommending
  workplace exposure limits for six decades, revised its Threshold Limit
  Value (TLV) for beryllium and beryllium-containing compounds to 0.05
  μg/m3\ (Document ID 1304).
      In finalizing this Health Effects preamble section for the final
  rule, OSHA updated the preliminary Health Effects section published in
  the NPRM based on the stakeholder response received by the Agency
  during the public comment period and public hearing. OSHA also
  corrected several non-substantive errors that were published in the
  NPRM as well as those identified by NIOSH and Materion including
  several minor organizational changes made to sections V.D.3 and V.E.2.b
  (Document ID 1671, pp. 10-11; 1662, pp. 3-5). A section titled "Dermal
  Effects" was added to V.F.5 based on comments received by the American
  Thoracic Society (ATS), National Jewish Health, and the National
  Supplemental Screening Program (Document ID 1688, p. 2; 1664, p. 5;
  1677, p. 3). Additionally, the Agency responded to relevant stakeholder
  comments contained in specific sections.
      In developing its review of the preliminary health effects from
  beryllium exposure and assessment of risk for the NPRM, OSHA prepared a


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

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

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

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

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

  . . . the ATS supports the inclusion of beryllium sensitization,
  CBD, and skin disease as the major adverse health effects associated
  with exposure to beryllium at or below 0.1 μg/m3\ and acute
  beryllium disease at higher exposures based on the currently
  available epidemiologic and experimental studies. (Document ID 1688,
  p. 2)

  In addition, OSHA received supporting comments from labor organizations
  representing workers exposed to beryllium. The AFL-CIO, NABTU, and USW
  submitted comments supporting the inclusion of beryllium sensitization,
  CBD and lung cancer as health effects from beryllium exposure (Document
  ID 1689, pp. 1, 3; 1679, p. 6; 1681, p. 19). AFL-CIO commented that
  "[t]he proposal is based on extensive scientific and medical evidence
  . . ." and "[b]eryllium exposure causes immunological sensitivity,
  CBD and lung cancer. These health effects are debilitating, progressive
  and irreversible. Workers are exposed to beryllium through respiratory,
  dermal and gastrointestinal routes." (Document ID 1689, pp. 1, 3).
  Comments submitted by USW state that "OSHA has correctly identified,
  and comprehensively documented the material impairments of health
  resulting from beryllium exposure." (Document ID 1681, p. 19).
      Dr. Lisa Maier and Ms. Margaret Mroz of National Jewish Health
  testified about the health effects of beryllium in support of the
  beryllium standard:

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

  American Association for Justice noted that:

      Unlike many toxins, there is no threshold below which no worker
  will become sensitized to beryllium. Worker sensitization to
  beryllium is a precursor to CBD, but not cancer. The symptoms of
  chronic beryllium disease (CBD) are part of a continuum of disease
  that is progressive in nature. Early recognition of and treatment
  for CBD may lead to a lessening of symptoms and may prevent the
  disease from progressing further. Symptoms of CBD may occur at
  exposure levels well below the proposed permissible exposure limit
  of .2 µg/m3\ and even below the action level of .1 µg/
  m3\. OSHA has clear authority to regulate health effects across the
  entire continuum of disease to protect workers. We applaud OSHA for
  proposing to do so. (Document ID 1683, pp. 1-2).

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


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

  Introduction

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

                                  Table 1--Beryllium Characteristics and Properties
  ----------------------------------------------------------------------------------------------------------------
                                                                                                    Solubility in
          Compound name                 Chemical formula          Molecular      Acute physical      water at 20
                                                                     mass           hazards             [deg]C
  ----------------------------------------------------------------------------------------------------------------
  Beryllium Metal..............  Be............................          9.0  Combustible; Finely  None.
                                                                               dispersed
                                                                               particles--Explosi
                                                                               ve.
  Beryllium Oxide..............  BeO...........................         25.0  Not combustible or   Very sparingly
                                                                               explosive.           soluble.
  Beryllium Carbonate..........  Be2CO3(OH)/Be2CO5 H2..........       181.07  Not combustible or   None.
                                                                               explosive.
  Beryllium Sulfate............  BeSO4.........................        105.1  Not combustible or   Slightly
                                                                               explosive.           soluble.
  Beryllium Nitrate............  BeN2O6/Be(NO3)2...............        133.0  Enhances combustion  Very soluble
                                                                               of other             (1.66 x 106
                                                                               substances.          mg/L).
  Beryllium Hydroxide..........  Be(OH)2.......................         43.0  Not reported.......  Slightly
                                                                                                    soluble 0.8 x
                                                                                                    10\-4\ mol/L
                                                                                                    (3.44 mg/L).
  Beryllium Chloride...........  BeCl2.........................         79.9  Not combustible or   Soluble.
                                                                               explosive.
  Beryllium Fluoride...........  BeF2..........................         47.0  Not combustible or   Very soluble.
                                                                               explosive.
  Beryllium Phosphate..........  Be3(PO4)2.....................        271.0  Not reported.......  Soluble.
  ----------------------------------------------------------------------------------------------------------------



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

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

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


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


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


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

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


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


  2. Dermal Exposure
      Beryllium compounds have been shown to cause skin irritation and
  sensitization in humans and certain animal models (Van Ordstrand et
  al., 1945, Document ID 1383; de Nardi et al., 1953 (1545); Nishimura,
  1966 (1435); Epstein, 1991 (0526); Belman, 1969 (1562); Tinkle et al.,
  2003 (1483); Delic, 1992 (1547)). The Agency for Toxic Substances and
  Disease Registry (ATSDR) estimated that less than 0.1 percent of
  beryllium compounds are absorbed through the skin (ATSDR, 2002,
  Document ID 1371). However, even minute contact and absorption across
  the skin may directly elicit an immunological response resulting in
  sensitization (Deubner et al., 2001, Document ID 1543; Toledo et al.,
  2011 (0522)). Studies by Tinkle et al. (2003) showed that penetration
  of beryllium oxide particles was possible ex vivo for human intact skin
  at particle sizes of less than or equal to 1μm in diameter, as
  confirmed by scanning electron microscopy (Document ID 1483). Using
  confocal microscopy, Tinkle et al. demonstrated that surrogate
  fluorescent particles up to 1 μm in size could penetrate the mouse
  epidermis and dermis layers in a model designed to mimic the flexing
  and stretching of human skin in motion. Other poorly soluble particles,
  such as titanium dioxide, have been shown to penetrate normal human
  skin (Tan et al., 1996, Document ID 1391) suggesting the flexing and
  stretching motion as a plausible mechanism for dermal penetration of
  beryllium as well. As earlier summarized, poorly soluble forms of
  beryllium can be solubilized in biological fluids (e.g., sweat) making
  them available for absorption through intact skin (Sutton et al., 2003,
  Document ID 1393; Stefaniak et al., 2011 (0537) and 2014 (0517); Duling
  et al., 2012 (0539)).
      Although its precise role remains to be elucidated, there is
  evidence that dermal exposure can contribute to beryllium
  sensitization. As early as the 1940s it was recognized that dermatitis
  experienced by workers in primary beryllium production facilities was
  linked to exposures to the soluble beryllium salts. Except in cases of
  wound contamination, dermatitis was rare in workers whose exposures
  were restricted to exposure to poorly soluble beryllium-containing
  particles (Van Ordstrand et al., 1945, Document ID 1383). Further
  investigation by McCord in 1951 (Document ID 1448) indicated that
  direct skin contact with soluble beryllium compounds, but not beryllium
  hydroxide or beryllium metal, caused dermal lesions (reddened,
  elevated, or fluid-filled lesions on exposed body surfaces) in
  susceptible persons. Curtis, in 1951, demonstrated skin sensitization
  to beryllium with patch testing using soluble and poorly soluble forms
  of beryllium in beryllium-na[iuml]ve subjects. These subjects later
  developed granulomatous skin lesions with the classical delayed-type
  contact dermatitis following repeat challenge (Curtis, 1951, Document
  ID 1273). These lesions appeared after a latent period of 1-2 weeks,
  suggesting a delayed allergic reaction. The dermal reaction occurred
  more rapidly and in response to smaller amounts of beryllium in those
  individuals previously sensitized (Van Ordstrand et al., 1945, Document
  ID 1383). Contamination of cuts and scrapes with beryllium can result
  in the beryllium becoming embedded within the skin causing an
  ulcerating granuloma to develop in the skin (Epstein, 1991, Document ID
  0526). Soluble and poorly soluble beryllium-compounds that penetrate
  the skin as a result of abrasions or cuts have been shown to result in
  chronic ulcerations and skin granulomas (Van Ordstrand et al., 1945,
  Document ID 1383; Lederer and Savage, 1954 (1467)). Beryllium
  absorption through bruises and cuts has been demonstrated as well
  (Rossman et al., 1991, Document ID 1332).
      In a study by Ivannikov et al. (1982) (as cited in Deubner et al.,
  2001, Document ID 0023), beryllium chloride was applied directly to
  three different types of wounded skin: abrasions (superficial skin
  trauma), cuts (skin and superficial muscle trauma), and penetration
  wounds (deep muscle trauma). According to Deubner et al. (2001) the
  percentage of the applied dose systemically absorbed during a 24-hour
  exposure was significant, ranging from 7.8 percent to 11.4 percent for
  abrasions, from 18.3 percent to 22.9 percent for cuts, and from 34
  percent to 38.8 percent for penetration wounds (Deubner et al., 2001,
  Document ID 0023).
      A study by Deubner et al. (2001) concluded that exposure across
  damaged skin can contribute as much systemic loading of beryllium as
  inhalation (Deubner et al., 2001, Document ID 1543). Deubner et al.
  (2001) estimated dermal loading (amount of particles penetrating into
  the skin) in workers as compared to inhalation exposure. Deubner's
  calculations assumed a dermal loading rate for beryllium on skin of
  0.43 μg/cm2, based on the studies of loading on skin after workers
  cleaned up (Sanderson et al.., 1999, Document ID 0474), multiplied by a
  factor of 10 to approximate the workplace concentrations and the very
  low absorption rate of beryllium into skin of 0.001 percent (taken from
  EPA estimates). As cited by Deubner et al. (2001), the EPA noted that
  these calculations did not take into account absorption of soluble
  beryllium salts that might occur across nasal mucus membranes, which
  may result from contact between contaminated skin and the nose (Deubner
  et al., 2001, Document ID 1543).
      A study conducted by Day et al. (2007) evaluated the effectiveness
  of a dermal protection program implemented in a beryllium alloy
  facility in 2002 (Document ID 1548). The investigators evaluated levels
  of beryllium in air, on workplace surfaces, on cotton gloves worn over
  nitrile gloves, and on the necks and faces of workers over a six day
  period. The investigators found a strong correlation between air
  concentrations determined from sampling data and work surface
  contamination at this facility. The investigators also found measurable
  levels of beryllium on the skin of workers as a result of work
  processes even from workplace areas promoted as "visually clean" by
  the company housekeeping policy. Importantly, the investigators found
  that the beryllium contamination could be transferred from body region
  to body region (e.g., hand to face, neck to face) demonstrating the
  importance of dermal protection measures since sensitization can occur
  via dermal exposure as well as respiratory exposure. The investigators
  demonstrated multiple pathways of exposure which could lead to
  sensitization, increasing risk for developing CBD (Day et al., 2007,
  Document ID 1548).
      The same group of investigators extended their work on
  investigating multiple exposure pathways contributing to sensitization
  and CBD (Armstrong et al., 2014, Document ID 0502). The investigators
  evaluated four different beryllium manufacturing and processing
  facilities to assess the contribution of various exposure pathways on
  worker exposure. Airborne, work surface and cotton glove beryllium
  concentrations were evaluated. The investigators found strong
  correlations between air and surface concentrations; glove and surface
  concentrations; and air and glove concentrations at this facility. This
  work supports findings from Day et al. (2007) (Document ID 1548)
  demonstrating the importance of airborne beryllium concentrations to
  surface contamination and dermal exposure even at exposures below the


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

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

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


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

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


  poorly soluble beryllium compounds were distributed systemically
  through the lymphatics and stored in the skeleton for potential later
  release (Furchner et al., 1973, Document ID 1523). Therefore, while
  intravenous administration can lead to uptake, OSHA does not consider
  oral and gastrointestinal exposure to be a major route for the uptake
  of beryllium because poorly soluble beryllium is not readily absorbed
  in the gastrointestinal tract.
  4. Metabolism
      Beryllium and its compounds may not be metabolized or
  biotransformed, but soluble beryllium salts may be converted to less
  soluble forms in the lung (Reeves and Vorwald, 1967, Document ID 1309).
  As stated earlier, solubility is an important factor for persistence of
  beryllium in the lung. Poorly soluble phagocytized beryllium particles
  can be dissolved into an ionic form by an acidic cellular environment
  and by myeloperoxidases or macrophage phagolysomal fluids (Leonard and
  Lauwerys, 1987, Document ID 1293; Lansdown, 1995 (1469); WHO, 2001
  (1282); Stefaniak et al., 2006 (1398)). The positive charge of the
  beryllium ion could potentially make it more biologically reactive
  because it may allow the beryllium to bind to a peptide or protein and
  be presented to the T cell receptor or antigen-presenting cell
  (Fontenot, 2000, Document ID 1531).
  5. Conclusion For Particle Characterization and Kinetics and Metabolism
  of Beryllium
      The forms and concentrations of beryllium across the workplace vary
  substantially based upon location, process, production and work task.
  Many factors may influence the potency of beryllium including
  concentration, composition, structure, size, solubility and surface
  area of the particle.
      Studies have demonstrated that beryllium sensitization can occur
  via the skin or inhalation from soluble or poorly soluble beryllium
  particles. Beryllium must be presented to a cell in a soluble form for
  activation of the immune system (NAS, 2008, Document ID 1355), and this
  will be discussed in more detail in the section to follow. Poorly
  soluble beryllium can be solubilized via intracellular fluid, lung
  fluid and sweat to release beryllium ions (Sutton et al., 2003,
  Document ID 1393; Stefaniak et al., 2011(0537) and 2014(0517)). For
  beryllium to persist in the lung it needs to be poorly soluble.
  However, soluble beryllium has been shown to precipitate in the lung to
  form poorly soluble beryllium (Reeves and Vorwald, 1967, Document ID
  1309).
      Some animal and epidemiological studies suggest that the form of
  beryllium may affect the rate of development of BeS and CBD. Beryllium
  in an inhalable form (either as soluble or poorly soluble particles or
  mist) can deposit in the respiratory tract and interact with immune
  cells located along the entire respiratory tract (Scheslinger, 1997,
  Document ID 1290). Interaction and presentation of beryllium (either in
  ionic or particulate form) is discussed further in Section V.D.1.
  C. Acute Beryllium Diseases
      Acute beryllium disease (ABD) is a relatively rapid onset
  inflammatory reaction resulting from breathing high airborne
  concentrations of beryllium. It was first reported in workers
  extracting beryllium oxide (Van Ordstrand et al., 1943, Document ID
  1383) and later reported by Eisenbud (1948) and Aub (1949) (as cited in
  Document ID 1662, p. 2). Since the Atomic Energy Commission's adoption
  of a maximum permissible peak occupational exposure limit of 25 μg/
  m3\ for beryllium beginning in 1949, cases of ABD have been much
  rarer. According to the World Health Organization (2001), ABD is
  generally associated with exposure to beryllium levels at or above 100
  μg/m3\ and may be fatal in 10 percent of cases (Document ID 1282).
  However, cases of ABD have been reported with beryllium exposures below
  100 µg/m3\ (Cummings et al., 2009, Document ID 1550). The
  Cummings et al. (2009) study examined two cases of workers exposed to
  soluble and poorly soluble beryllium below 100 µg/m3\ using data
  obtained from company records. Cummings et al. (2009) also examined the
  possibility that an immune-mediated mechanism may exist for ABD as well
  as CBD and that ABD and CBD are on a pathological continuum since some
  patients would later develop CBD after recovering from ABD (ACCP, 1965,
  Document ID 1286; Hall, 1950 (1494); Cummings et al., 2009 (1550)).
      ABD involves an inflammatory or immune-mediated reaction that may
  include the entire respiratory tract, involving the nasal passages,
  pharynx, bronchial airways and alveoli. Other tissues including skin
  and conjunctivae may be affected as well. The clinical features of ABD
  include a nonproductive cough, chest pain, cyanosis, shortness of
  breath, low-grade fever and a sharp drop in functional parameters of
  the lungs. Pathological features of ABD include edematous distension,
  round cell infiltration of the septa, proteinaceous materials, and
  desquamated alveolar cells in the lung. Monocytes, lymphocytes and
  plasma cells within the alveoli are also characteristic of the acute
  disease process (Freiman and Hardy, 1970, Document ID 1527).
      Two types of acute beryllium disease have been characterized in the
  literature: A rapid and severe course of acute fulminating pneumonitis
  generally developing within 48 to 72 hours of a massive exposure, and a
  second form that takes several days to develop from exposure to lower
  concentrations of beryllium (still above the levels set by regulatory
  and guidance agencies) (Hall, 1950, Document ID 1494; DeNardi et al.,
  1953 (1545); Newman and Kreiss, 1992 (1440)). Evidence of a dose-
  response relationship to the concentration of beryllium is limited
  (Eisenbud et al., 1948, Document ID 0490; Stokinger, 1950 (1484);
  Sterner and Eisenbud, 1951 (1396)). Recovery from either type of ABD is
  generally complete after a period of several weeks or months (DeNardi
  et al., 1953, Document ID 1545). However, deaths have been reported in
  more severe cases (Freiman and Hardy, 1970, Document ID 1527).
  According to the BCR, in the United States, approximately 17 percent of
  ABD patients developed CBD (BCR, 2010). The majority of ABD cases
  occurred between 1932 and 1970 (Eisenbud, 1982, Document ID 1254;
  Middleton, 1998 (1445)). ABD is extremely rare in the workplace today
  due to more stringent exposure controls implemented following
  occupational and environmental standards set in 1970-1971 (ACGIH, 1971,
  Document ID 0543; ANSI, 1970 (1303); OSHA, 1971, see 39 FR 23513; EPA,
  1973 (38 FR 8820)).
      Materion submitted post-hearing comments regarding ABD (Document ID
  1662, p. 2; Attachment A, p. 1). Materion contended that only soluble
  forms of beryllium have been demonstrated to produce ABD at exposures
  above 100 µg/m3\ because cases of ABD were only found in workers
  exposed to beryllium during beryllium extraction processes which always
  contain soluble beryllium (Document ID 1662, pp. 2, 3). Citing
  communications between Marc Kolanz (Materion) and Dr. Eisenbud,
  Materion noted that when Mr. Kolanz asked Dr. Eisenbud if he ever
  "observed an acute reaction to beryllium that did not involve the
  beryllium extraction process and exposure to soluble salts of
  beryllium," Dr. Eisenbud responded that "he did not know of a case
  that was not either directly associated with


  exposure to soluble compounds or where the work task or operation would
  have been free from exposure to soluble beryllium compounds from
  adjacent operations." (Document ID 1662, p. 3). OSHA acknowledges that
  workers with ABD may have been exposed to a combination of soluble and
  poorly soluble beryllium. This alone, however, cannot completely
  exclude poorly soluble beryllium as a causative or contributing agent
  of ABD. The WHO (2001) has concluded that both ABD and CBD results from
  exposure to both soluble and insoluble forms of beryllium. In addition,
  the European Commission has classified poorly soluble beryllium and
  beryllium oxide as acute toxicity categories 2 and 3 (Document ID 1669,
  p. 2).
      Additional comments from Materion regarding ABD criticized the
  study by Cummings et al. (2009), stating that it "incompletely
  explained the source of the workers exposures, which resulted in the
  use of a misleading statement that, `None of the measured air samples
  exceeded 100 μg/m3\ and most were less than 10 μg/m3\.' "
  (Document ID 1662, p. 3). Materion argues that the Cummings et al.
  study is not valid because workers in that study "had been involved
  with high exposures to soluble beryllium salts caused by upsets during
  the chemical extraction of beryllium." (Document ID 1662, pp. 3-4). In
  response, NIOSH written testimony explained that the measurements in
  the study "were collected in areas most likely to be sources of high
  beryllium exposures in processes, but were not personal breathing zone
  measurements in the usual sense." (Document ID 1725, p. 3). "Cummings
  et al. (2009) made every effort to overestimate (rather than
  underestimate) exposure," including "select[ing] the highest time
  weighted average (TWA) value from the work areas or activities
  associated with a worker's job and tenure" and not adjusting for
  "potential protective effects of respirators, which were reportedly
  used for some tasks and during workplace events potentially associated
  with uncontrolled higher exposures." Even so, "the available TWA data
  did not exceed 100 μg/m3\ even on days with evacuations."
  (Document ID 1725, p. 3). Furthermore, OSHA notes that, the discussion
  in Cummings et al. (2009) stated, "we cannot rule out the possibility
  of unusually elevated airborne concentrations of beryllium that went
  unmeasured." (Document ID 1550, p. 5).
      In response to Materion's contention that OSHA should eliminate the
  section on ABD because this disease is no longer a concern today
  (Document ID 1661, p. 2), OSHA notes that the discussion on ABD is
  included for thoroughness in review of the health effects caused by
  exposure to beryllium. As indicated above, the Agency acknowledges that
  ABD is extremely rare, but not non-existent, in workplaces today due to
  the more stringent exposure controls implemented since OSHA's inception
  (OSHA, 1971, see 39 FR 23513).
  D. Beryllium Sensitization and Chronic Beryllium Disease
      This section provides an overview of the immunology and
  pathogenesis of BeS and CBD, with particular attention to the role of
  skin sensitization, particle size, beryllium compound solubility, and
  genetic variability in individuals' susceptibility to beryllium
  sensitization and CBD.
      Chronic beryllium disease (CBD), formerly known as "berylliosis"
  or "chronic berylliosis," is a granulomatous disorder primarily
  affecting the lungs. CBD was first described in the literature by Hardy
  and Tabershaw (1946) as a chronic granulomatous pneumonitis (Document
  ID 1516). It was proposed as early as 1951 that CBD could be a chronic
  disease resulting from sensitization to beryllium (Sterner and
  Eisenbud, 1951, Document ID 1396; Curtis, 1959 (1273); Nishimura, 1966
  (1435)). However, for a time, there remained some controversy as to
  whether CBD was a delayed-onset hypersensitivity disease or a toxicant-
  induced disease (NAS, 2008, Document ID 1355). Wide acceptance of CBD
  as a hypersensitivity lung disease did not occur until bronchoscopy
  studies and bronchoalveolar lavage (BAL) studies were performed
  demonstrating that BAL cells from CBD patients responded to beryllium
  challenge (Epstein et al., 1982, Document ID 0436; Rossman et al., 1988
  (0476); Saltini et al., 1989 (1351)).
      CBD shares many clinical and histopathological features with
  pulmonary sarcoidosis, a granulomatous lung disease of unknown
  etiology. These similarities include such debilitating effects as
  airway obstruction, diminishment of physical capacity associated with
  reduced lung function, possible depression associated with decreased
  physical capacity, and decreased life expectancy. Without appropriate
  information, CBD may be difficult to distinguish from sarcoidosis. It
  is estimated that up to 6 percent of all patients diagnosed with
  sarcoidosis may actually have CBD (Fireman et al., 2003, Document ID
  1533; Rossman and Kreider, 2003 (1423)). Among patients diagnosed with
  sarcoidosis in which beryllium exposure can be confirmed, as many as 40
  percent may actually have CBD (Muller-Quernheim et al., 2005, Document
  ID 1262; Cherry et al., 2015 (0463)).
      Clinical signs and symptoms of CBD may include, but are not limited
  to, a simple cough, shortness of breath or dypsnea, fever, weight loss
  or anorexia, skin lesions, clubbing of fingers, cyanosis, night sweats,
  cor pulmonale, tachycardia, edema, chest pain and arthralgia. Changes
  or loss of pulmonary function also occur with CBD such as decrease in
  vital capacity, reduced diffusing capacity, and restrictive breathing
  patterns. The signs and symptoms of CBD constitute a continuum of
  symptoms that are progressive in nature with no clear demarcation
  between any stages in the disease (Pappas and Newman, 1993, Document ID
  1433; Rossman, 1996 (1283); NAS, 2008 (1355)). These symptoms are
  consistent with the CBD symptoms described during the public hearing by
  Dr. Kristin Cummings of NIOSH and Dr. Lisa Maier of National Jewish
  Health (Document ID 1755, Tr. 70-71; 1756, Tr. 105-107).
      Besides these listed symptoms from CBD patients, there have been
  reported cases of CBD that remained asymptomatic (Pappas and Newman,
  1993, Document ID 1433; Muller-Querheim, 2005 (1262); NAS, 2008 (1355);
  NIOSH, 2011 (0544)). Asymptomatic CBD refers to those patients that
  have physiological changes upon clinical evaluation yet exhibit no
  outward signs or symptoms (also referred to as subclinical CBD).
      Unlike ABD, CBD can result from inhalation exposure to beryllium at
  levels below the preceding OSHA PEL, can take months to years after
  initial beryllium exposure before signs and symptoms of CBD occur
  (Newman 1996, Document ID 1283, 2005 (1437) and 2007 (1335);
  Henneberger, 2001 (1313); Seidler et al., 2012 (0457); Schuler et al.,
  2012 (0473)), and may continue to progress following removal from
  beryllium exposure (Newman, 2005, Document ID 1437; Sawyer et al., 2005
  (1415); Seidler et al., 2012 (0457)). Patients with CBD can progress to
  a chronic obstructive lung disorder resulting in loss of quality of
  life and the potential for decreased life expectancy (Rossman, et al.,
  1996, Document ID 1425; Newman et al., 2005 (1437)). The National
  Academy of Sciences (NAS) report (2008) noted the general lack of
  published studies on progression of CBD from an early asymptomatic
  stage to functionally significant lung disease (NAS, 2008, Document ID
  1355). The report emphasized that risk factors and


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

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

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


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

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


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


  [GRAPHIC] [TIFF OMITTED] TR09JA17.002

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


  pulmonary function, with symptoms including a persistent dry cough and
  shortness of breath (Saber and Dweik, 2000, Document ID 1421). Fatigue,
  night sweats, chest and joint pain, clubbing of fingers (due to
  impaired oxygen exchange), loss of appetite or unexplained weight loss,
  and cor pulmonale have been experienced in certain patients as the
  disease progresses (Conradi et al., 1971, Document ID 1319; ACCP, 1965
  (1286); Kriebel et al., 1988, Document ID 1292; Kriebel et al., 1988
  (1473)). While CBD primarily affects the lungs, it can also involve
  other organs such as the liver, skin, spleen, and kidneys (ATSDR, 2002,
  Document ID 1371).
      As previously mentioned, the uptake of beryllium may lead to an
  aberrant apoptotic process with rerelease of beryllium ions and
  continual stimulation of beryllium-responsive CD4+ cells in the lung
  (Sawyer et al., 2000, Document ID 1417; Kittle et al., 2002 (0485);
  Sawyer et al., 2004 (1416)). Several research studies suggest apoptosis
  may be one mechanism that enhances inflammatory cell recruitment,
  cytokine production and inflammation, thus creating a scenario for
  progressive granulomatous inflammation (Palmer et al., 2008, Document
  ID 0478; Rana, 2008 (0477)). Macrophages and neutrophils can
  phagocytize beryllium particles in an attempt to remove the beryllium
  from the lung (Ding, et al., 2009, Document ID 0492)). Multiple studies
  (Sawyer et al., 2004, Document ID 1416; Kittle et al., 2002 (0485))
  using BAL cells (mostly macrophages and neutrophils) from patients with
  CBD found that in vitro stimulation with beryllium sulfate induced the
  production of TNF-α (one of many cytokines produced in response
  to beryllium), and that production of TNF-α might induce
  apoptosis in CBD and sarcoidosis patients (Bost et al., 1994, Document
  ID 1299; Dai et al., 1999 (0495)). The stimulation of CBD-derived
  macrophages by beryllium sulfate resulted in cells becoming apoptotic,
  as measured by propidium iodide. These results were confirmed in a
  mouse macrophage cell-line (p388D1) (Sawyer et al., 2000, Document ID
  1417). However, other factors, such as genetic factors and duration or
  level of exposure leading to a continued presence of beryllium in the
  lung, may influence the development of CBD and are outlined in the
  following sections V.D.3 and V.D.4.
      In summary, the persistent presence of beryllium in the lung of a
  sensitized individual creates a progressive inflammatory response that
  can culminate in the granulomatous lung disease, CBD.
  3. Genetic and Other Susceptibility Factors
      Evidence from a variety of sources indicates genetic susceptibility
  may play an important role in the development of CBD in certain
  individuals, especially at levels low enough not to invoke a response
  in other individuals. Early occupational studies proposed that CBD was
  an immune reaction based on the high susceptibility of some individuals
  to become sensitized and progress to CBD and the lack of CBD in others
  who were exposed to levels several orders of magnitude higher (Sterner
  and Eisenbud, 1951, Document ID 1396). Recent studies have confirmed
  genetic susceptibility to CBD involves either, HLA variants, T-cell
  receptor clonality, tumor necrosis factor (TNF-α) polymorphisms
  and/or transforming growth factor-beta (TGF-β) polymorphisms
  (Fontenot et al., 2000, Document ID 1531; Amicosante et al., 2005
  (1564); Tinkle et al., 1996 (0468); Gaede et al., 2005 (0486); Van Dyke
  et al., 2011 (1696); Silveira et al., 2012 (0472)).
      Potential sources of variation associated with genetic
  susceptibility have been investigated. Single Nucleotide Polymorphisms
  (SNPs) have been studied with regard to genetic variations associated
  with increased risk of developing CBD. SNPs are the most abundant type
  of human genetic variation. Polymorphisms in MHC class II and pro-
  inflammatory genes have been shown to contribute to variations in
  immune responses contributing to the susceptibility and resistance in
  many diseases including auto-immunity, beryllium sensitization, and CBD
  (McClesky et al., 2009, as cited in Document ID 1808, p. 3). Specific
  SNPs have been evaluated as a factor in the Glu69 variant from the HLA-
  DPB1 locus (Richeldi et al., 1993, Document ID 1353; Cai et al., 2000
  (0445); Saltini et al., 2001 (0448); Silviera et al., 2012 (0472); Dai
  et al., 2013 (0493)). Other SNPs lacking the Glu69 variant, such as
  HLA-DRPheβ47, have also been evaluated for an association with CBD
  (Amicosante et al., 2005, Document ID 1564).
      HLA-DPB1 (one of 2 subtypes of HLA-DP) with a glutamic acid at
  amino position 69 (Glu69) has been shown to confer increased risk of
  beryllium sensitization and CBD (Richeldi et al., 1993, Document ID
  1353; Saltini et al., 2001 (0448); Amicosante et al., 2005 (1564); Van
  Dyke et al., 2011 (1696); Silveira et al., 2012 (0472)). In vitro human
  research has identified genes coding for specific protein molecules on
  the surface of the immune cells of sensitized individuals from a cohort
  of beryllium workers (McCanlies et al., 2004, Document ID 1449). The
  research identified the HLA-DPB1 (Glu69) allele that place carriers at
  greater risk of becoming sensitized to beryllium and developing CBD
  than those not carrying this allele (McCanlies et al., 2004, Document
  ID 1449). Fontenot et al. (2000) demonstrated that beryllium
  presentation by certain alleles of the class II human leukocyte
  antigen-DP (HLA-DP 3) to CD4+ T cells is the mechanism underlying
  the development of CBD (Document ID 1531). Richeldi et al. (1993)
  reported a strong association between the MHC class II allele HLA-DPB 1
  and the development of CBD in beryllium-exposed workers from a Tucson,
  AZ facility (Document ID 1353). This marker was found in 32 of the 33
  workers who developed CBD, but in only 14 of 44 similarly exposed
  workers without CBD. The more common alleles of the HLA-DPB 1
  containing a variant of Glu69 are negatively charged at this site and
  could directly interact with the positively charged beryllium ion.
  Additional studies by Amicosante et al. (2005) (Document ID 1564) using
  blood lymphocytes derived from beryllium-exposed workers found a high
  frequency of this gene in those sensitized to beryllium. In a study of
  82 CBD patients (beryllium-exposed workers), Stubbs et al. (1996)
  (Document ID 1394) also found a relationship between the HLA-DP 1
  allele and beryllium sensitization. The glutamate-69 allele was present
  in 86 percent of sensitized subjects, but in only 48 percent of
  beryllium-exposed, non-sensitized subjects. Some variants of the HLA-
  DPB1 allele convey higher risk of sensitization and CBD than others.
  For example, HLA-DPB1*0201 yielded an approximately 3-fold increase in
  disease outcome relative to controls; HLA-DPB1*1901 yielded an
  approximately 5-fold increase, and HLA-DPB1*1701 yielded an
  approximately 10-fold increase (Weston et al., 2005, Document ID 1345;
  Snyder et al., 2008 (0471)). Specifically, Snyder et al. (2008) found
  that variants of the Glu69 allele with the greatest negative charge may
  confer greater risk for developing CBD (Document ID 0471). The study by
  Weston et al. (2005) assigned odds ratios for specific alleles on the
  basis of previous studies discussed above (Document ID 1345). The
  researchers found a strong


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

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

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


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

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

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

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

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


  of developing CBD. As such, sensitization is a necessary step along a
  continuum to clinical lung disease.
  5. Human Epidemiological Studies
      This section describes the human epidemiological data supporting
  the mechanistic overview of beryllium-induced disease in workers. It
  has been divided into reviews of epidemiological studies performed
  prior to development and implementation of the BeLPT in the late 1980s
  and after wide use of the BeLPT for screening purposes. Use of the
  BeLPT has allowed investigators to screen for beryllium sensitization
  and CBD prior to the onset of clinical symptoms, providing a more
  sensitive and thorough analysis of the worker population. The
  discussion of the studies has been further divided by manufacturing
  processes that may have similar exposure profiles. Table A.1 in the
  Supplemental Information for the Beryllium Health Effects Section
  summarizes the prevalence of beryllium sensitization and CBD, range of
  exposure measurements, and other salient information from the key
  epidemiological studies (Document ID 1965).
      It has been well-established that beryllium exposure, either via
  inhalation or skin, may lead to beryllium sensitization, or, with
  inhalation exposure, may lead to the onset and progression of CBD. The
  available published epidemiological literature discussed below provides
  strong evidence of beryllium sensitization and CBD in workers exposed
  to airborne beryllium well below the preceding OSHA PEL of 2 μg/
  m3\. Several studies demonstrate the prevalence of sensitization and
  CBD is related to the level of airborne exposure, including a cross-
  sectional survey of employees at a beryllium ceramics plant in Tucson,
  AZ (Henneberger et al., 2001, Document ID 1313), case-control studies
  of workers at the Rocky Flats nuclear weapons facility (Viet et al.,
  2000, Document ID 1344), and workers from a beryllium machining plant
  in Cullman, AL (Kelleher et al., 2001, Document ID 1363). The
  prevalence of beryllium sensitization also may be related to dermal
  exposure. An increased risk of CBD has been reported in workers with
  skin lesions, potentially increasing the uptake of beryllium (Curtis,
  1951, Document ID 1368; Johnson et al., 2001 (1505); Schuler et al.,
  2005 (0919)). Three studies describe comprehensive preventive programs,
  which included expanded respiratory protection, dermal protection, and
  improved control of beryllium dust migration, that substantially
  reduced the rate of beryllium sensitization among new hires (Cummings
  et al., 2007; Thomas et al., 2009 (0590); Bailey et al., 2010 (0676);
  Schuler et al., 2012(0473)).
      Some of the epidemiological studies presented in this section
  suffer from challenges common to many published epidemiological
  studies: Limitations in study design (particularly cross-sectional);
  small sample size; lack of personal and/or short-term exposure data,
  particularly those published before the late 1990s; and incomplete
  information regarding specific chemical form and/or particle
  characterization. Challenges that are specific to beryllium
  epidemiological studies include: uncertainty regarding the contribution
  of dermal exposure; use of various BeLPT protocols; a variety of case
  definitions for determining CBD; and use of various exposure sampling/
  assessment methods (e.g., daily weighted average (DWA), lapel
  sampling). Even with these limitations, the epidemiological evidence
  presented in this section clearly demonstrates that beryllium
  sensitization and CBD are continuing to occur from present-day
  exposures below OSHA's preceding PEL of 2 μg/m3\. The available
  literature also indicates that the rate of beryllium sensitization can
  be substantially lowered by reducing inhalation exposure and minimizing
  dermal contact.
  a. Studies Conducted Prior to the BeLPT
      First reports of CBD came from studies performed by Hardy and
  Tabershaw (1946) (Document ID 1516). Cases were observed in industrial
  plants that were refining and manufacturing beryllium metal and
  beryllium alloys and in plants manufacturing fluorescent light bulbs
  (NAS, 2008, Document ID 1355). From the late 1940s through the 1960s,
  clusters of non-occupational CBD cases were identified around beryllium
  refineries in Ohio and Pennsylvania, and outbreaks in family members of
  beryllium factory workers were assumed to be from exposure to
  contaminated clothes (Hardy, 1980, Document ID 1514). It had been
  established that the risk of disease among beryllium workers was
  variable and generally rose with the levels of airborne concentrations
  (Machle et al., 1948, Document ID 1461). And while there was a
  relationship between air concentrations of beryllium and risk of
  developing disease both in and surrounding these plants, the disease
  rates outside the plants were higher than expected and not very
  different from the rate of CBD within the plants (Eisenbud et al.,
  1949, Document ID 1284; Lieben and Metzner, 1959 (1343)). There
  remained considerable uncertainty regarding diagnosis due to lack of
  well-defined cohorts, modern diagnostic methods, or inadequate follow-
  up. In fact, many patients with CBD may have been misdiagnosed with
  sarcoidosis (NAS, 2008, Document ID 1355).
      The difficulties in distinguishing lung disease caused by beryllium
  from other lung diseases led to the establishment of the BCR in 1952 to
  identify and track cases of ABD and CBD. A uniform diagnostic criterion
  was introduced in 1959 as a way to delineate CBD from sarcoidosis.
  Patient entry into the BCR required either: Documented past exposure to
  beryllium or the presence of beryllium in lung tissue as well as
  clinical evidence of beryllium disease (Hardy et al., 1967, Document ID
  1515); or any three of the six criteria listed below (Hasan and Kazemi,
  1974, Document ID 0451). Patients identified using the above criteria
  were registered and added to the BCR from 1952 through 1983 (Eisenbud
  and Lisson, 1983, Document ID 1296).
      The BCR listed the following criteria for diagnosing CBD (Eisenbud
  and Lisson, 1983, Document ID 1296):
      (1) Establishment of significant beryllium exposure based on sound
  epidemiologic history;
      (2) Objective evidence of lower respiratory tract disease and
  clinical course consistent with beryllium disease;
      (3) Chest X-ray films with radiologic evidence of interstitial
  fibronodular disease;
      (4) Evidence of restrictive or obstructive defect with diminished
  carbon monoxide diffusing capacity (DL CO) by physiologic
  studies of lung function;
      (5) Pathologic changes consistent with beryllium disease on
  examination of lung tissue; and
      (6) Presence of beryllium in lung tissue or thoracic lymph nodes.
      Prevalence of CBD in workers during the time period between the
  1940s and 1950s was estimated to be between 1-10% (Eisenbud and Lisson,
  1983, Document ID 1296). In a 1969 study, Stoeckle et al. presented 60
  case histories with a selective literature review utilizing the above
  criteria except that urinary beryllium was substituted for lung
  beryllium to demonstrate beryllium exposure. Stoeckle et al. (1969)
  were able to demonstrate corticosteroids as a successful treatment
  option in one case of confirmed CBD (Document ID 0447). This study also
  presented a 28 percent mortality rate from complications of CBD at the
  time of publication. However, even with the improved


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

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

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



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

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

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

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


  the BeLPT as a reliable medical surveillance tool.
  c. Beryllium Mining and Extraction
      Mining and extraction of beryllium usually involves the two major
  beryllium minerals, beryl (an aluminosilicate containing up to 4
  percent beryllium) and bertrandite (a beryllium silicate hydrate
  containing generally less than 1 percent beryllium) (WHO, 2001,
  Document ID 1282). The United States is the world leader in beryllium
  extraction and also leads the world in production and use of beryllium
  and its alloys (WHO, 2001, Document ID 1282). Most exposures from
  mining and extraction come in the form of beryllium ore, beryllium
  salts, beryllium hydroxide (NAS, 2008, Document ID 1355) or beryllium
  oxide (Stefaniak et al., 2008, Document ID 1397).
      Deubner et al. published a study of 75 workers employed at a
  beryllium mining and extraction facility in Delta, UT (Deubner et al.,
  2001b, Document ID 1543). Of the 75 workers surveyed for sensitization
  with the BeLPT, three were identified as sensitized by an abnormal
  BeLPT result. One of those found to be sensitized was diagnosed with
  CBD. Exposures at the facility included primarily beryllium ore and
  salts. General area (GA), breathing zone (BZ), and personal lapel (LP)
  exposure samples were collected from 1970 to 1999. Jobs involving
  beryllium hydrolysis and wet-grinding activities had the highest air
  concentrations, with an annual median GA concentration ranging from 0.1
  to 0.4 μg/m3\. Median BZ concentrations were higher than either LP
  or GA concentrations. The average duration of exposure for beryllium
  sensitized workers was 21.3 years (27.7 years for the worker with CBD),
  compared to an average duration for all workers of 14.9 years. However,
  these exposures were less than either the Elmore, OH, or Tucson, AZ,
  facilities described below, which also had higher reported rates of BeS
  and CBD. A study by Stefaniak et al. (2008) demonstrated that beryllium
  was present at the mill in three forms: Mineral, poorly crystalline
  oxide, and hydroxide (Document ID 1397).
      There was no sensitization or CBD among those who worked only at
  the mine where exposure to beryllium resulted solely from working with
  bertrandite ore. The authors concluded that the results of this study
  indicated that beryllium ore and salts may pose less of a hazard than
  beryllium metal and beryllium hydroxide. These results are consistent
  with the previously discussed animal studies examining solubility and
  particle size.
  d. Beryllium Metal Processing and Alloy Production
      Kreiss et al. (1997) conducted a study of workers at a beryllium
  production facility in Elmore, OH (Document ID 1360). The plant, which
  opened in 1953 and initially specialized in production of beryllium-
  copper alloy, later expanded its operations to include beryllium metal,
  beryllium oxide, and beryllium-aluminum alloy production; beryllium and
  beryllium alloy machining; and beryllium ceramics production, which was
  moved to a different factory in the early 1980s. Production operations
  included a wide variety of jobs and processes, such as work in arc
  furnaces and furnace rebuilding, alloy melting and casting, beryllium
  powder processing, and work in the pebble plant. Non-production work
  included jobs in the analytical laboratory, engineering research and
  development, maintenance, laundry, production-area management, and
  office-area administration. While the publication refers to the use of
  respiratory protection in some areas, such as the pebble plant, the
  extent of its use across all jobs or time periods was not reported. Use
  of dermal PPE was not reported.
      The authors characterized exposures at the plant using industrial
  hygiene (IH) samples collected between 1980 and 1993. The exposure
  samples and the plant's formulas for estimating workers' DWA exposures
  were used, together with study participants' work histories, to
  estimate their cumulative and average beryllium exposure levels.
  Exposure concentrations reflected the high exposures found historically
  in beryllium production and processing. Short-term BZ measurements had
  a median of 1.4 μg/m3\, with 18.5 percent of samples exceeding
  OSHA's preceding permissible ceiling concentration of 5.0 μg/m3\.
  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 μg/m3\) and
  furnace rebuild (28.6 percent of short-term BZ samples over the
  preceding OSHA permissible ceiling concentration of 5 μg/m3\). LP
  samples (n = 179), which were available from 1990 to 1992, had a median
  value of 1 μg/m3\.
      Of 655 workers employed at the time of the study, 627 underwent
  BeLPT screening. Blood samples were divided and split between two labs
  for analysis, with repeat testing for results that were abnormal or
  indeterminate. Thirty-one workers had an abnormal blood test result
  upon initial testing and at least one of two subsequent test results
  for each of those workers confirmed the worker as sensitized. These
  workers, together with 19 workers who had an initial abnormal result
  and one subsequent indeterminate result, were offered clinical
  evaluation for CBD including the BAL-BeLPT and transbronchial lung
  biopsy. Nine workers with an initial abnormal test followed by two
  subsequent normal tests were not clinically evaluated, although four
  were found to be sensitized upon retesting in 1995. Of 47 workers who
  proceeded with evaluation for CBD (3 of the 50 initial workers with
  abnormal results declined to participate), 24 workers were diagnosed
  with CBD based on evidence of granulomas on lung biopsy (20 workers) or
  on other findings consistent with CBD (4 workers) (Kreiss et al., 1997,
  Document ID 1360). After including five workers who had been diagnosed
  prior to the study, a total of 29 (4.6 percent of the 627 workers who
  underwent BeLPT screening) workers still employed at the time of the
  study were found to have CBD. In addition, the plant medical department
  identified 24 former workers diagnosed with CBD before the study.
      Kreiss et al. reported that the highest prevalence of sensitization
  and CBD occurred among workers employed in beryllium metal production,
  even though the highest airborne total mass concentrations of beryllium
  were generally among employees operating the beryllium alloy furnaces
  in a different area of the plant (Kreiss et al., 1997, Document ID
  1360). Preliminary follow-up investigations of particle size-specific
  sampling at five furnace sites within the plant determined that the
  highest respirable (i.e., particles <10 μm in diameter as defined by
  the authors) and alveolar-deposited (i.e., particles <1 μm in
  diameter as defined by the authors) beryllium mass and particle number
  concentrations, as collected by a general area impactor device, were
  measured at the beryllium metal production furnaces rather than the
  beryllium alloy furnaces (Kent et al., 2001, Document ID 1361; McCawley
  et al., 2001 (1357)). A statistically significant linear trend was
  reported between the above alveolar-deposited particle mass
  concentration and prevalence of CBD and sensitization in the furnace
  production areas. The authors concluded that alveolar-deposited
  particles may be a more relevant exposure metric for predicting the
  incidence of CBD or sensitization


  than the total mass concentration of airborne beryllium.
      Bailey et al. (2010) (Document ID 0610) evaluated the effectiveness
  of a workplace preventive program in lowering incidences of
  sensitization at the beryllium metal, oxide, and alloy production plant
  studied by Kreiss et al. (1997) (Document ID 1360). The preventive
  program included use of administrative and PPE controls (e.g., improved
  training, skin protection and other PPE, half-mask or air-purified
  respirators, medical surveillance, improved housekeeping standards,
  clean uniforms) as well as engineering and administrative controls
  (e.g., migration controls, physical separation of administrative
  offices from production facilities) implemented over the course of five
  years.
      In a cross-sectional/longitudinal hybrid study, Bailey et al.
  compared rates of sensitization in pre-program workers to those hired
  after the preventive program began. Pre-program workers were surveyed
  cross-sectionally in 1993-1994, and again in 1999 using the BeLPT to
  determine sensitization and CBD prevalence rates. The 1999 cross-
  sectional survey was conducted to determine if improvements in
  engineering and administrative controls were successful. However,
  results indicated no improvement in reducing rates of sensitization or
  CBD.
      An enhanced preventive program including particle migration
  control, respiratory and dermal protection, and process enclosure was
  implemented in 2000, with continuing improvements made to the program
  in 2001, 2002-2004, and 2005. Workers hired during this period were
  longitudinally surveyed for sensitization using the BeLPT. Both the
  pre-program and program survey of worker sensitization status utilized
  split-sample testing to verify positive test results using the BeLPT.
  Of the total 660 workers employed at the production plant, 258 workers
  participated from the pre-program group while 290 participated from the
  program group (206 partial program, 84 full program). Prevalence
  comparisons of the pre-program and program groups (partial and full)
  were performed by calculating prevalence ratios. A 95 percent
  confidence interval (95 percent CI) was derived using a cohort study
  method that accounted for the variance in survey techniques (cross-
  sectional versus longitudinal) (Bailey et al., 2010). The sensitization
  prevalence of the pre-program group was 3.8 times higher (95 percent
  CI, 1.5-9.3) than the program group, 4.0 times higher (95 percent CI,
  1.4-11.6) than the partial program subgroup, and 3.3 times higher (95
  percent CI, 0.8-13.7) than the full program subgroup indicating that a
  comprehensive preventive program can reduce, but not eliminate,
  occurrence of sensitization among non-sensitized workers (Bailey et
  al., 2010, Document ID 0610).
      Rosenman et al. (2005) studied a group of several hundred workers
  who had been employed at a beryllium production and processing facility
  that operated in eastern Pennsylvania between 1957 and 1978 (Document
  ID 1352). Of 715 former workers located, 577 were screened for
  beryllium sensitization with the BLPT and 544 underwent chest
  radiography to identify cases of beryllium sensitization and CBD.
  Workers were reported to have exposure to beryllium dust and fume in a
  variety of chemical forms including beryl ore, beryllium metal,
  beryllium fluoride, beryllium hydroxide, and beryllium oxide.
      Rosenman et al. used the plant's DWA formulas to assess workers'
  full-shift exposure levels, based on IH data collected between 1957-
  1962 and 1971-1976, to calculate exposure metrics including cumulative,
  average, and peak for each worker in the study (Document ID 1352). The
  DWA was calculated based on air monitoring that consisted of GA and
  short-term task-based BZ samples. Workers' exposures to specific
  chemical and physical forms of beryllium were assessed, including
  poorly soluble beryllium (metal and oxide), soluble beryllium (fluoride
  and hydroxide), mixed soluble and poorly soluble beryllium, beryllium
  dust (metal, hydroxide, or oxide), fume (fluoride), and mixed dust and
  fume. Use of respiratory or dermal protection by workers was not
  reported. Exposures in the plant were high overall. Representative
  task-based IH samples ranged from 0.9 μg/m3\ to 84 μg/m3\ in
  the 1960s, falling to a range of 0.5-16.7 μg/m3\ in the 1970s. A
  large number of workers' mean DWA estimates (25 percent) were above the
  preceding OSHA PEL of 2.0 μg/m3\, while most workers had mean DWA
  exposures between 0.2 and 2.0 μg/m3\ (74 percent) or below 0.02
  μg/m3\ (1 percent) (Rosenman et al., Table 11; revised erratum
  April, 2006, Document ID 1352).
      Blood samples for the BeLPT were collected from the former workers
  between 1996 and 2001 and were evaluated at a single laboratory.
  Individuals with an abnormal test result were offered repeat testing,
  and were classified as sensitized if the second test was also abnormal.
  Sixty workers with two positive BeLPTs and 50 additional workers with
  chest radiography suggestive of disease were offered clinical
  evaluation, including bronchoscopy with bronchial biopsy and BAL-BeLPT.
  Seven workers met both criteria. Only 56 (51 percent) of these workers
  proceeded with clinical evaluation, including 57 percent of those
  referred on the basis of confirmed abnormal BeLPT and 47 percent of
  those with abnormal radiographs (Document ID 1352).
      Of the 577 workers who were evaluated for CBD, 32 (5.5 percent)
  with evidence of granulomas were classified as "definite" CBD cases
  (as identified by bronchoscopy). Twelve (2.1 percent) additional
  workers with positive BAL-BeLPT or confirmed positive BeLPT and
  radiographic evidence of upper lobe fibrosis were classified as
  "probable" CBD cases. Forty workers (6.9 percent) without upper lobe
  fibrosis who had confirmed abnormal BeLPT, but who were not biopsied or
  who underwent biopsy with no evidence of granuloma, were classified as
  sensitized without disease. It is not clear how many of those 40
  workers underwent biopsy. Another 12 (2.1 percent) workers with upper
  lobe fibrosis and negative or unconfirmed positive BeLPT were
  classified as "possible" CBD cases. Nine additional workers who were
  diagnosed with CBD before the screening were included in some parts of
  the authors' analysis (Document ID 1352).
      The authors reported a total prevalence of 14.5 percent for CBD
  (definite and probable) and sensitization. This rate, considerably
  higher than the overall prevalence of sensitization and disease in
  several other worker cohorts as described earlier in this section,
  reflects in part the very high exposures experienced by many workers
  during the plant's operation in the 1950s, 1960s and 1970s. A total of
  115 workers had mean DWAs above the preceding OSHA PEL of 2 μg/m3\.
  Of those, seven (6.0 percent) had definite or probable CBD and another
  13 (11 percent) were classified as sensitized without disease. The true
  prevalence of CBD in the group may be higher than reported, due to the
  low rate of clinical evaluation among sensitized workers (Document ID
  1352).
      Although most of the workers in this study had high exposures,
  sensitization and CBD also were observed within the small subgroup of
  participants believed to have relatively low beryllium exposures.
  Thirty-three cases of CBD and 24 additional cases of sensitization
  occurred among 339 workers with mean DWA exposures below OSHA's PEL of
  2.0 μg/m3\ (Rosenman et al., Table 11, erratum 2006, Document ID
  1352). Ten cases of sensitization and five cases of


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


  on BeLPT testing above), and was considered borderline if one of the
  indices exceeded the normal range. A repeat BeLPT was conducted for
  workers with abnormal or borderline initial results. Workers were
  identified as beryllium sensitized and referred for a clinical
  evaluation, including BAL and transbronchial lung biopsy, if the repeat
  test was abnormal. CBD was diagnosed upon evidence of sensitization
  with granulomas or mononuclear cell infiltrates in the lung tissue
  (Newman et al., 2001, Document ID 1354). Following the initial plant-
  wide screening, plant employees were offered BeLPT testing at two-year
  intervals. Workers hired after the initial screening were offered a
  BeLPT within 3 months of their hire date, and at 2-year intervals
  thereafter (Madl et al., 2007, Document ID 1056).
      Kelleher et al. performed a nested case-control study of the 235
  workers evaluated in Newman et al. (2001) to evaluate the relationship
  between beryllium exposure levels and risk of sensitization and CBD
  (Kelleher et al., 2001, Document ID 1363). The authors evaluated
  exposures at the plant using IH samples they had collected between 1996
  and 1999, using personal cascade impactors designed to measure the mass
  of beryllium particles less than 6 μm in diameter, particles less
  than 1 μm in diameter, and total mass. The great majority of
  workers' exposures were below the preceding OSHA PEL of 2 μg/m3\.
  However, a few higher exposure levels were observed in machining jobs
  including deburring, lathing, lapping, and grinding. Based on a
  statistical comparison between their samples and historical data
  provided by the plant, the authors concluded that worker beryllium
  exposures across all time periods included in the study parameters
  (1981 to 1984, 1995 to 1997, and 1998 to 1999) could be approximated
  using the 1996-1999 data. They estimated workers' cumulative and
  "lifetime weighted" (LTW) beryllium exposure based on the exposure
  samples they collected for each job in 1996-1999 and company records of
  each worker's job history.
      Twenty workers with beryllium sensitization or CBD (cases) were
  compared to 206 workers (controls) for the case-control analysis from
  the study evaluating workers originally conducted by Newman et al. Of
  the 20 workers composing the case group, thirteen workers were
  diagnosed with CBD based on lung biopsy evidence of granulomas and/or
  mononuclear cell infiltrates (11) or positive BAL results with evidence
  of lymphocytosis (2). The other seven were evaluated for CBD and found
  to be sensitized only. Nine of the remaining 215 workers first
  identified in original study (Newman et al., 2001, Document ID 1354)
  were excluded due to incomplete job history information, leaving 206
  workers in the control group.
      Kelleher et al.'s analysis included comparisons of the case and
  control groups' median exposure levels; calculation of odds ratios for
  workers in high, medium, and low exposure groups; and logistic
  regression testing of the association of sensitization or CBD with
  exposure level and other variables. Median cumulative exposures for
  total mass, particles less than 6 μm in diameter, and particles less
  than 1 μm in diameter were approximately three times higher among
  the cases than controls, although the relationships observed were not
  statistically significant (p values ~ 0.2). No clear difference between
  cases and controls was observed for the median LTW exposures. Odds
  ratios with sensitization and CBD as outcomes were elevated in high
  (upper third) and intermediate exposure groups relative to low (lowest
  third) exposure groups for both cumulative and LTW exposure, though the
  results were not statistically significant (p >0.1). In the logistic
  regression analysis, only machinist work history was a significant
  predictor of case status in the final model. Quantitative exposure
  measures were not significant predictors of sensitization or disease
  risk.
      Citing an 11.5 percent prevalence of beryllium sensitization or CBD
  among machinists as compared with 2.9 percent prevalence among workers
  with no machinist work history, the authors concluded that the risk of
  sensitization and CBD is increased among workers who machine beryllium.
  Although differences between cases and controls in median cumulative
  exposure did not achieve conventional thresholds for statistical
  significance, the authors noted that cumulative exposures were
  consistently higher among cases than controls for all categories of
  exposure estimates and for all particle sizes, suggesting an effect of
  cumulative exposure on risk. The levels at which workers developed CBD
  and sensitization were predominantly below OSHA's preceding PEL of 2
  μg/m3\, and no cases of sensitization or CBD were observed among
  workers with LTW exposure less than 0.02 μg/m3\. Twelve (60
  percent) of the 20 sensitized workers had LTW exposures >0.20 μg/
  m3\.
      In 2007, Madl et al. published an additional study of 27 workers at
  the machining plant who were found to be sensitized or diagnosed with
  CBD between the start of medical surveillance in 1995 and 2005 (Madl et
  al., 2007, Document ID 1056). As previously described, workers were
  offered a BeLPT in the initial 1995 screening (or within 3 months of
  their hire date if hired after 1995) and at 2-year intervals after
  their first screening. Workers with two positive BeLPTs were identified
  as sensitized and offered clinical evaluation for CBD, including
  bronchoscopy with BAL and transbronchial lung biopsy. The criteria for
  CBD in this study were somewhat stricter than those used in the Newman
  et al. study, requiring evidence of granulomas on lung biopsy or
  detection of X-ray or pulmonary function changes associated with CBD,
  in combination with two positive BeLPTs or one positive BAL-BeLPT.
      Based on the history of the plant's control efforts and their
  analysis of historical IH data, Madl et al. identified three "exposure
  control eras": A relatively uncontrolled period from 1980-1995; a
  transitional period from 1996 to 1999; and a relatively well-controlled
  "modern" period from 2000-2005. They found that the engineering and
  work practice controls instituted in the mid-1990s reduced workers'
  exposures substantially, with nearly a 15-fold difference in reported
  exposure levels between the pre-control and the modern period (Madl et
  al., 2007, Document ID 1056). Madl et al. estimated workers' exposures
  using LP samples collected between 1980 and 2005, including those
  collected by Kelleher et al., and work histories provided by the plant.
  As described more fully in the study, they used a variety of approaches
  to describe individual workers' exposures, including approaches
  designed to characterize the highest exposures workers were likely to
  have experienced. Their exposure-response analysis was based primarily
  on an exposure metric they derived by identifying the year and job of
  each worker's pre-diagnosis work history with the highest reported
  exposures. They used the upper 95th percentile of the LP samples
  collected in that job and year (in some cases supplemented with data
  from other years) to characterize the worker's upper-level exposures.
      Based on their estimates of workers' upper level exposures, Madl et
  al. concluded that sensitized workers or workers with CBD were likely
  to have been exposed to airborne beryllium levels greater than 0.2
  μg/m3\ as an 8-hour TWA at some point in their history of
  employment in the plant. Madl et al. also concluded that most
  sensitization and CBD cases were likely to have been exposed to levels
  greater than 0.4 μg/m3\


  at some point in their work at the plant. Madl et al. did not
  reconstruct exposures for workers at the plant who were not sensitized
  and did not develop CBD and therefore could not determine whether non-
  cases had upper-bound exposures lower than these levels. They found
  that upper-bound exposure estimates were generally higher for workers
  with CBD than for those who were sensitized but not diagnosed with CBD
  at the conclusion of the study (Madl et al., 2007, Document ID 1056).
  Because CBD is an immunological disease and beryllium sensitization has
  been shown to occur within a year of exposure for some workers, Madl et
  al. argued that their estimates of workers' short-term upper-bound
  exposures may better capture the exposure levels that led to
  sensitization and disease than estimates of long-term cumulative or
  average exposures such as the LTW exposure measure constructed by
  Kelleher et al. (Madl et al., 2007, Document ID 1056).
  f. Beryllium Oxide Ceramics
      Kreiss et al. (1993) conducted a screening of current and former
  workers at a plant that manufactured beryllium ceramics from beryllium
  oxide between 1958 and 1975, and then transitioned to metalizing
  circuitry onto beryllium ceramics produced elsewhere (Document ID
  1478). Of the plant's 1,316 current and 350 retired workers, 505
  participated who had not previously been diagnosed with CBD or
  sarcoidosis, including 377 current and 128 former workers. Although
  beryllium exposure was not estimated quantitatively in this survey, the
  authors conducted a questionnaire to assess study participants'
  exposures qualitatively. Results showed that 55 percent of participants
  reported working in jobs with exposure to beryllium dust. Close to 25
  percent of participants did not know if they had exposure to beryllium,
  and just over 20 percent believed they had not been exposed.
      BeLPT tests were administered to all 505 participants in the 1989-
  1990 screening period and evaluated at a single lab. Seven workers had
  confirmed abnormal BeLPT results and were identified as sensitized;
  these workers were also diagnosed with CBD based on findings of
  granulomas upon clinical evaluation. Radiograph screening led to
  clinical evaluation and diagnosis of two additional CBD cases, who were
  among three participants with initially abnormal BeLPT results that
  could not be confirmed on repeat testing. In addition, nine workers had
  been previously diagnosed with CBD, and another five were diagnosed
  shortly after the screening period, in 1991-1992.
      Eight of the 9 CBD cases identified in the screening population
  were hired before the plant stopped producing beryllium ceramics in
  1975, and were among the 216 participants who had reported having been
  near or exposed to beryllium dust. Particularly high CBD rates of 11.1
  to 15.8 percent were found among screening participants who had worked
  in process development/engineering, dry pressing, and ventilation
  maintenance jobs believed to have high or uncontrolled dust exposure.
  One case (0.6 percent) of CBD was diagnosed among the 171 study
  participants who had been hired after the plant stopped producing
  beryllium ceramics. Although this worker was hired eight years after
  the end of ceramics production, he had worked in an area later found to
  be contaminated with beryllium dust. The authors concluded that the
  study results suggested an exposure-response relationship between
  beryllium exposure and CBD, and recommended beryllium exposure control
  to reduce workers' risk of CBD.
      Kreiss et al. later published a study of workers at a second
  ceramics plant located in Tucson, AZ (Kreiss et al., 1996, Document ID
  1477), which since 1980 had produced beryllium ceramics from beryllium
  oxide powder manufactured elsewhere. IH measurements collected between
  1981 and 1992, primarily GA or short-term BZ samples and a few (<100)
  LP samples, were available from the plant. Airborne beryllium exposures
  were generally low. The majority of area samples were below the
  analytical detection limit of 0.1 μg/m3\, while LP and short-term
  BZ samples had medians of 0.3 μg/m3\. However, 3.6 percent of
  short-term BZ samples and 0.7 percent of GA samples exceeded 5.0 μg/
  m3\, while LP samples ranged from 0.1 to 1.8 μg/m3\. Machining
  jobs had the highest beryllium exposure levels among job tasks, with
  short-term BZ samples significantly higher for machining jobs than for
  non-machining jobs (median 0.6 μg/m3\ vs. 0.3 μg/m3\, p =
  0.0001). The authors used DWA formulas provided by the plant to
  estimate workers' full-shift exposure levels, and to calculate
  cumulative and average beryllium exposures for each worker in the
  study. The median cumulative exposure was 591.7 mg-days/m3\ and the
  median average exposure was 0.35 μg/m3\ as a DWA.
      One hundred thirty-six of the 139 workers employed at the plant at
  the time of the Kreiss et al. (1996) study underwent BeLPT screening
  and chest radiographs in 1992 (Document ID 1477). Blood samples were
  split between two laboratories. If one or both test results were
  abnormal, an additional sample was collected and split between the
  labs. Seven workers with an abnormal result on two draws were initially
  identified as sensitized. Those with confirmed abnormal BeLPTs or
  abnormal chest X-rays were offered clinical evaluation for CBD,
  including transbronchial lung biopsy and BAL BeLPT. CBD was diagnosed
  based on observation of granulomas on lung biopsy, in five of the six
  sensitized workers who accepted evaluation. An eighth case of
  sensitization and sixth case of CBD were diagnosed in one worker hired
  in October 1991 whose initial BeLPT was normal, but who was confirmed
  as sensitized and found to have lung granulomas less than two years
  later, after sustaining a beryllium-contaminated skin wound. The plant
  medical department reported 11 additional cases of CBD among former
  workers (Kreiss et al., 1996, Document ID 1477). The overall prevalence
  of sensitization in the plant was 5.9 percent, with a 4.4 percent
  prevalence of CBD.
      Kreiss et al. (1996) (Document ID 1477) reported that six (75
  percent) of the eight sensitized workers were exposed as machinists
  during or before the period October 1985-March 1988, when measurements
  were first available for machining jobs. The authors reported that 14.3
  percent of machinists were sensitized, compared to 1.2 percent of
  workers who had never been machinists (p <0.01). Workers' estimated
  cumulative and average beryllium exposures did not differ significantly
  for machinists and non-machinists, or for cases and non-cases. As in
  the previous study of the same ceramics plant published by Kreiss et
  al. in 1993 (Document ID 1478), one case of CBD was diagnosed in a
  worker who had never been employed in a production job. This worker was
  employed in office administration, a job with a median DWA of 0.1
  μg/m3\ (range 0.1-0.3 μg/m3\).
      In 1998, Henneberger et al. conducted a follow-up cross-sectional
  survey of 151 employees employed at the beryllium ceramics plant
  studied by Kreiss et al. (1996) (Henneberger et al., 2001, Document ID
  1313). All current plant employees were eligible for the study unless
  they had previously been diagnosed with CBD. The study tracked two sets
  of workers in presenting prevalence outcomes and exposure
  characterization. "Short-term workers" were those hired since the
  last plant survey in 1992. "Long-term workers"


  were those hired before 1992 and had a longer history of beryllium
  exposures. There were 74 short-term and 77 long-term workers in the
  survey (Henneberger et al., 2001, Document ID 1313).
      The authors estimated workers' cumulative, average, and peak
  beryllium exposures based on the plant's formulas for estimating job-
  specific DWA exposures, participants' work histories, and area and
  short-term task-specific BZ samples collected from the start of full
  production at the plant in 1981 to 1998. The long-term workers, who
  were hired before the 1992 study was conducted, had generally higher
  estimated exposures (median--0.39 μg/m3\; mean--14.9 μg/m3\)
  than the short-term workers, who were hired after 1992 (median--0.28
  μg/m3\, mean--6.1 μg/m3\).
      Fifteen cases of sensitization were found in the 151 study
  participants (15/151; 9.9%), including seven among short-term (7/74;
  9.5%) and eight among long-term workers (8/77; 10.4%). There were eight
  cases of CBD (8/151; 5.3%) identified in the study. One sensitized
  short-term worker developed CBD (1/74; 1.4%). Seven of the eight
  sensitized long-term workers developed CBD (7/77; 9.1%). The other
  sensitized long-term worker declined to participate in the clinical
  evaluation.
      Henneberger et al. (2001) reported a higher prevalence of
  sensitization among long-term workers with "high" (greater than
  median) peak exposures compared to long-term workers with "low"
  exposures; however, this relationship was not statistically significant
  (Document ID 1313). No association was observed for average or
  cumulative exposures. The authors reported higher (but not
  statistically significant) prevalence of sensitization among short-term
  workers with "high" (greater than median) average, cumulative, and
  peak exposures compared to short-term workers with "low" exposures of
  each type.
      The cumulative incidence of sensitization and CBD was investigated
  in a cohort of 136 workers at the beryllium ceramics plant previously
  studied by the Kreiss and Henneberger groups (Schuler et al., 2008.
  Document ID 1291). The study cohort consisted of those who participated
  in the plant-wide BeLPT screening in 1992. Both current and former
  workers from this group were invited to participate in follow-up BeLPT
  screenings in 1998, 2000, and 2002-2003. A total of 106 of the 128 non-
  sensitized individuals in 1992 participated in the 11-year follow-up.
  Sensitization was defined as a confirmed abnormal BeLPT based on the
  split blood sample-dual laboratory protocol described earlier. CBD was
  diagnosed in sensitized individuals based on pathological findings from
  transbronchial biopsy and BAL fluid analysis. The 11-year crude
  cumulative incidence of sensitization and CBD was 13 percent (14 of
  106) and 8 percent (9 of 106) respectively. The cumulative prevalence
  was about triple the point prevalences determined in the initial 1992
  cross-sectional survey. The corrected cumulative prevalences for those
  that ever worked in machining were nearly twice that for non-
  machinists. The data illustrate the value of longitudinal medical
  screening over time to obtain a more accurate estimate of the
  occurrence of sensitization and CBD among an exposed working
  population.
      Following the 1998 survey, the company continued efforts to reduce
  exposures and risk of sensitization and CBD by implementing additional
  engineering, administrative, and PPE measures (Cummings et al., 2007,
  Document ID 1369). Respirator use was required in production areas
  beginning in 1999, and latex gloves were required beginning in 2000.
  The lapping area was enclosed in 2000, and enclosures were installed
  for all mechanical presses in 2001. Between 2000 and 2003, water-
  resistant or water-proof garments, shoe covers, and taped gloves were
  incorporated to keep beryllium-containing fluids from wet machining
  processes off the skin. The new engineering measures did not appear to
  substantially reduce airborne beryllium levels in the plant. LP samples
  collected between 2000 and 2003 had a median of 0.18 μg/m3\ in
  production, similar to the 1994-1999 samples. However, respiratory
  protection requirements to control workers' airborne beryllium
  exposures were instituted prior to the 2000 sample collections, so
  actual exposure to the production workers may have been lower than the
  airborne beryllium levels indicate.
      To test the efficacy of the new measures instituted after 1998, in
  January 2000 the company began screening new workers for sensitization
  at the time of hire and at 3, 6, 12, 24, and 48 months of employment.
  These more stringent measures appear to have substantially reduced the
  risk of sensitization among new employees. Of 126 workers hired between
  2000 and 2004, 93 completed BeLPT testing at hire and at least one
  additional test at 3 months of employment. One case of sensitization
  was identified at 24 months of employment (1 percent of 126 workers).
  This worker had experienced a rash after an incident of dermal exposure
  to lapping fluid through a gap between his glove and uniform sleeve,
  indicating that he may have become sensitized via the skin. He was
  tested again at 48 months of employment, with an abnormal result.
      A second worker in the 2000-2004 group had two abnormal BeLPT tests
  at the time of hire, and a third had one abnormal test at hire and a
  second abnormal test at 3 months. Both had normal BeLPTs at 6 months,
  and were not tested thereafter. A fourth worker had one abnormal BeLPT
  result at the time of hire, a normal result at 3 months, an abnormal
  result at 6 months, and a normal result at 12 months. Four additional
  workers had one abnormal result during surveillance, which could not be
  confirmed upon repeat testing.
      Cummings et al. (2007) calculated two sensitization rates based on
  these screening results: (1) A rate using only the sensitized worker
  identified at 24 months, and (2) a rate including all four workers who
  had repeated abnormal results (Document ID 1369). They reported a
  sensitization incidence rate (IR) of 0.7 per 1,000 person-months to 2.7
  per 1,000 person-months for the workers hired between 2000 and 2004,
  using the sum of sensitization-free months of employment among all 93
  workers as the denominator.
      The authors also estimated an incidence rate (IR) of 5.6 per 1,000
  person-months for workers hired between 1993 and the 1998 survey. This
  estimated IR was based on one BeLPT screening, rather than BeLPTs
  conducted throughout the workers' employment. The denominator in this
  case was the total months of employment until the 1998 screening.
  Because sensitized workers may have been sensitized prior to the
  screening, the denominator may overestimate sensitization-free time in
  the legacy group, and the actual sensitization IR for legacy workers
  may be somewhat higher than 5.6 per 1,000 person-months. Based on
  comparison of the IRs, the authors concluded that the addition of
  respirator use, dermal protection, and particle migration control
  (housekeeping) improvements appeared to have reduced the risk of
  sensitization among workers at the plant, even though airborne
  beryllium levels in some areas of the plant had not changed
  significantly since the 1998 survey.
  g. Copper-Beryllium Alloy Processing and Distribution
      Schuler et al. (2005) studied a group of 152 workers at a facility
  who processed copper-beryllium alloys and small quantities of nickel-
  beryllium alloys and converted semi-finished alloy


  strip and wire into finished strip, wire, and rod. Production
  activities included annealing, drawing, straightening, point and
  chamfer, rod and wire packing, die grinding, pickling, slitting, and
  degreasing. Periodically in the plant's history, it also performed salt
  baths, cadmium plating, welding and deburring. Since the late 1980s,
  rod and wire production processes have been physically segregated from
  strip metal production. Production support jobs included mechanical
  maintenance, quality assurance, shipping and receiving, inspection, and
  wastewater treatment. Administration was divided into staff primarily
  working within the plant and personnel who mostly worked in office
  areas (Schuler, et al., 2005, Document ID 0919). Workers' respirator
  use was limited, mostly to occasional tasks where high exposures were
  anticipated.
      Following the 1999 diagnosis of a worker with CBD, the company
  surveyed the workforce, offering all current employees BeLPT testing in
  2000 and offering sensitized workers clinical evaluation for CBD,
  including BAL and transbronchial biopsy. Of the facility's 185
  employees, 152 participated in the BeLPT screening. Samples were split
  between two laboratories, with additional draws and testing for
  confirmation if conflicting tests resulted in the initial draw. Ten
  participants (7 percent) had at least two abnormal BeLPT results. The
  results of nine workers who had abnormal BeLPT results from only one
  laboratory were not included because the authors believed the
  laboratory was experiencing technical problems with the test (Schuler
  et al., 2005, Document ID 0919). CBD was diagnosed in six workers (4
  percent) on evidence of pathogenic abnormalities (e.g., granulomas) or
  evidence of clinical abnormalities consistent with CBD based on
  pulmonary function testing, pulmonary exercise testing, and/or chest
  radiography. One worker diagnosed with CBD had been exposed to
  beryllium during previous work at another copper-beryllium processing
  facility.
      Schuler et al. (2005) evaluated airborne beryllium levels at the
  plant using IH samples collected between 1969 and 2000, including 4,524
  GA samples, 650 LP samples and 815 short-duration (3-5 min) high volume
  (SD-HV) BZ task-specific samples (Document ID 0919). Occupational
  exposures to airborne beryllium were generally low. Ninety-nine percent
  of all LP measurements were below the preceding OSHA PEL of 2.0 μg/
  m3\ (8-hr TWA); 93 percent were below the new final OSHA PEL of 0.2
  μg/m3\ and the median value was 0.02 μg/m3\. The SD-HV BZ
  samples had a median value of 0.44 μg/m3\, with 90 percent below
  the preceding OSHA ceiling limit of 5.0 μg/m3\. The highest levels
  of beryllium exposure were found in rod and wire production,
  particularly in wire annealing and pickling, the only production job
  with a median personal sample measurement greater than 0.1 μg/m3\
  (median 0.12 μg/m3\; range 0.01-7.8 μg/m3\) (Schuler et al.,
  Table 4). These concentrations were significantly higher than the
  exposure levels in the strip metal area (median 0.02 μg/m3\, range
  0.01-0.72 μg/m3\), in production support jobs (median 0.02 μg/
  m3\, range <0.01-0.33 μg/m3\), plant administration (median 0.02
  μg/m3\, range <0.01-0.11 μg/m3\), and office administration
  jobs (median 0.01 μg/m3\, range <0.01-0.06 μg/m3\).
      The authors reported that eight of the ten sensitized employees,
  including all six CBD cases, had worked in both major production areas
  during their tenure with the plant. The 7 percent prevalence (6 of 81
  workers) of CBD among employees who had ever worked in rod and wire was
  statistically significantly elevated compared with employees who had
  never worked in rod and wire (p <0.05), while the 6 percent prevalence
  (6 of 94 workers) among those who had worked in strip metal was not
  significantly elevated compared to workers who had never worked in
  strip metal (p > 0.1). Based on these results, together with the higher
  exposure levels reported for the rod and wire production area, Schuler
  et al. (2005) concluded that work in rod and wire was a key risk factor
  for CBD in this population. Schuler et al. also found a high prevalence
  (13 percent) of sensitization among workers who had been exposed to
  beryllium for less than a year at the time of the screening, a rate
  similar to that found by Henneberger et al. (2001) among beryllium
  ceramics workers exposed for one year or less (16 percent) (Henneberger
  et al., 2001, Document ID 1313). All four workers who were sensitized
  without disease had been exposed for 5 years or less; conversely, all
  six of the workers with CBD had first been exposed to beryllium at
  least five years prior to the screening (Schuler et al., 2005, Table 2,
  Document ID 0919).
      As has been seen in other studies, beryllium sensitization and CBD
  were found among workers who were typically exposed to low time-
  weighted average airborne concentrations of beryllium. While jobs in
  the rod and wire area had the highest exposure levels in the plant, the
  median personal sample value was only 0.12 μg/m3\ as a DWA.
  However, workers may have occasionally been exposed to higher beryllium
  levels for short periods during specific tasks. A small fraction of
  personal samples recorded in rod and wire were above the preceding OSHA
  PEL of 2.0 μg/m3\, and half of workers with sensitization or CBD
  reported that they had experienced a "high-exposure incident" at some
  point in their work history (Schuler et al., 2005, Document ID 0919).
  The only group of workers with no cases of sensitization or CBD, a
  group of 26 office administration workers, was the group with the
  lowest recorded exposures (median personal sample 0.01 μg/m3\,
  range <0.01-0.06 μg/m3\).
      After the BeLPT screening was conducted in 2000, the company began
  implementing new measures to further reduce workers' exposure to
  beryllium (Thomas et al., 2009, Document ID 1061). Measures designed to
  minimize dermal contact with beryllium, including long-sleeve facility
  uniforms and polymer gloves, were instituted in production areas in
  2000. In 2001, the company installed LEV in die grinding and polishing.
  LP samples collected between June 2000 and December 2001 show reduced
  exposures plant-wide. Of 2,211 exposure samples collected, 98 percent
  were below 0.2 μg/m3\, and 59 percent below the limit of detection
  (LOD), which was either 0.02 µg/m3\ or 0.2 µg/m3\
  depending on the method of sample analysis (Thomas et al., 2009).
  Median values below 0.03 μg/m3\ were reported for all processes
  except the wire annealing and pickling process. Samples for this
  process remained somewhat elevated, with a median of 0.1 μg/m3\. In
  January 2002, the plant enclosed the wire annealing and pickling
  process in a restricted access zone (RAZ), requiring respiratory
  protection in the RAZ and implementing stringent measures to minimize
  the potential for skin contact and beryllium transfer out of the zone.
  While exposure samples collected by the facility were sparse following
  the enclosure, they suggest exposure levels comparable to the 2000-2001
  samples in areas other than the RAZ. Within the RAZ, required use of
  powered air-purifying respirators indicates that actual respiratory
  exposure was negligible (Thomas et al., 2009, Document ID 1061).
      To test the efficacy of the new measures in preventing
  sensitization and CBD, in June 2000 the facility began an intensive
  BeLPT screening program for all new workers. The company screened
  workers at the time of hire; at intervals of 3, 6, 12, 24, and 48
  months;


  and at 3-year intervals thereafter. Among 82 workers hired after 1999,
  three (3.7 percent) cases of sensitization were found. Two (5.4
  percent) of 37 workers hired prior to enclosure of the wire annealing
  and pickling process were found to be sensitized within 6 months of
  beginning work at the plant. One (2.2 percent) of 45 workers hired
  after the enclosure was confirmed as sensitized (Thomas et al., 2009,
  Document ID 1061).
      Thomas et al. (2009) calculated a sensitization IR of 1.9 per 1,000
  person-months for the workers hired after the exposure control program
  was initiated in 2000 ("program workers"), using the sum of
  sensitization-free months of employment among all 82 workers as the
  denominator (Thomas et al., 2009, Document ID 1061). They calculated an
  estimated IR of 3.8 per 1,000 person-months for 43 workers hired
  between 1993 and 2000 who had participated in the 2000 BeLPT screening
  ("legacy workers"). This estimated IR was based on one BeLPT
  screening, rather than BeLPTs conducted throughout the legacy workers'
  employment. The denominator in this case is the total months of
  employment until the 2000 screening. Because sensitized workers may
  have been sensitized prior to the screening, the denominator may
  overestimate sensitization-free time in the legacy group, and the
  actual sensitization IR for legacy workers may be somewhat higher than
  3.8 per 1,000 person-months. Based on comparison of the IRs and the
  prevalence rates discussed previously, the authors concluded that the
  combination of dermal protection, respiratory protection, housekeeping
  improvements and engineering controls implemented beginning in 2000
  appeared to have reduced the risk of sensitization among workers at the
  plant. However, they noted that the small size of the study population
  and the short follow-up time for the program workers suggested that
  further research is needed to confirm the program's efficacy (Thomas et
  al., 2009, Document ID 1061).
      Stanton et al. (2006) (Document ID 1070) conducted a study of
  workers in three different copper-beryllium alloy distribution centers
  in the United States. The distribution centers, consisting of one bulk
  products center established in 1963 and strip metal centers established
  in 1968 and 1972, sell products received from beryllium production and
  finishing facilities and small quantities of copper-beryllium,
  aluminum-beryllium, and nickel-beryllium alloy materials. Work at
  distribution centers does not require large-scale heat treatment or
  manipulation of material typical of beryllium processing and machining
  plants, but involves final processing steps that can generate airborne
  beryllium. Slitting, the main production activity at the two strip
  product distribution centers, generates low levels of airborne
  beryllium particles, while operations such as tensioning and welding
  used more frequently at the bulk products center can generate somewhat
  higher levels. Non-production jobs at all three centers included
  shipping and receiving, palletizing and wrapping, production-area
  administrative work, and office-area administrative work.
      Stanton et al. (2006) estimated workers' beryllium exposures using
  IH data from company records and job history information collected
  through interviews conducted by a company occupational health nurse
  (Document ID 1090). Stanton et al. evaluated airborne beryllium levels
  in various jobs based on 393 full-shift LP samples collected from 1996
  to 2004. Airborne beryllium levels at the plant were generally very
  low, with 54 percent of all samples at or below the LOD, which ranged
  from 0.02 to 0.1 μg/m3\. The authors reported a median of 0.03
  μg/m3\ and an arithmetic mean of 0.05 μg/m3\ for the 393 full-
  shift LP samples, where samples below the LOD were assigned a value of
  half the applicable LOD. Median values for specific jobs ranged from
  0.01-0.07 µg/m3\ while geometric mean values for specific jobs
  ranged from 0.02-0.07 µg/m3\. All measurements were below the
  preceding OSHA PEL of 2.0 μg/m3\ and 97 percent were below the new
  final OSHA PEL of 0.2 μg/m3\. The study does not report use of
  respiratory or skin protection.
      Eighty-eight of the 100 workers (88 percent) employed at the three
  centers at the time of the study participated in screening for
  beryllium sensitization. Blood samples were collected between November
  2000 and March 2001 by the company's medical staff. Samples collected
  from employees of the strip metal centers were split and evaluated at
  two laboratories, while samples from the bulk product center workers
  were evaluated at a single laboratory. Participants were considered to
  be "sensitized" to beryllium if two or more BeLPT results, from two
  laboratories or from repeat testing at the same laboratory, were found
  to be abnormal. One individual was found to be sensitized and was
  offered clinical evaluation, including BAL and fiberoptic bronchoscopy.
  He was found to have lung granulomas and was diagnosed with CBD.
      The worker diagnosed with CBD had been employed at a strip metal
  distribution center from 1978 to 2000 as a shipper and receiver,
  loading and unloading trucks delivering materials from a beryllium
  production facility and to the distribution center's customers.
  Although the LP samples collected for his job between 1996 and 2000
  were generally low (n = 35, median 0.01 µg/m3\, range <0.02-0.13
  µg/m3\), it is not clear whether these samples adequately
  characterize his exposure conditions over the course of his work
  history. He reported that early in his work history, containers of
  beryllium oxide powder were transported on the trucks he entered. While
  he did not recall seeing any breaks or leaks in the beryllium oxide
  containers, some containers were known to have been punctured by
  forklifts on trailers used by the company during the period of his
  employment, and could have contaminated trucks he entered. With 22
  years of employment at the facility, this worker had begun beryllium-
  related work earlier and performed it longer than about 90 percent of
  the study population (Stanton et al., 2006, Document ID 1090).
  h. Nuclear Weapons Production Facilities and Cleanup of Former
  Facilities
      Primary exposure from nuclear weapons production facilities comes
  from beryllium metal and beryllium alloys. A study conducted by Kreiss
  et al. (1989) (Document ID 1480) documented sensitization and CBD among
  beryllium-exposed workers in the nuclear industry. A company medical
  department identified 58 workers with beryllium exposure among a work
  force of 500, of whom 51 (88 percent) participated in the study.
  Twenty-four workers were involved in research and development (R&D),
  while the remaining 27 were production workers. The R&D workers had a
  longer tenure with a mean time from first exposure of 21.2 years,
  compared to a mean time since first exposure of 5 years among the
  production workers. Six workers had abnormal BeLPT readings, and four
  were diagnosed with CBD. This study classified workers as sensitized
  after one abnormal BeLPT reading, so this resulted in an estimated 11.8
  percent prevalence of sensitization.
      Kreiss et al. (1993) expanded the work of Kreiss et al. (1989)
  (Document ID 1480) by performing a cross-sectional study of 895 current
  and former beryllium workers in the same nuclear weapons plant
  (Document ID 1479). Participants were placed in qualitative exposure
  groups ("no exposure," "minimal exposure," "intermittent


  exposure," and "consistent exposure") based on questionnaire
  responses. Eighteen workers had abnormal BeLPT test results, with 12
  being diagnosed with CBD. Three additional sensitized workers (those
  with abnormal BeLPT results) developed CBD over the next 2 years.
  Sensitization occurred in all of the qualitatively defined exposure
  groups. Individuals who had worked as machinists were statistically
  overrepresented among beryllium-sensitized cases, compared with non-
  cases. Cases were more likely than non-cases to report having had a
  measured overexposure to beryllium (p = 0.009), a factor which proved
  to be a significant predictor of sensitization in logistic regression
  analyses, as was exposure to beryllium prior to 1970. Beryllium
  sensitized cases were also significantly more likely to report having
  had cuts that were delayed in healing (p = 0.02). The authors concluded
  that both individual susceptibility to sensitization and exposure
  circumstance affect the development of beryllium sensitization and CBD.
      In 1991, the Beryllium Health Surveillance Program (BHSP) was
  established at the Rocky Flats Nuclear Weapons Facility to offer BeLPT
  screening to current and former employees who may have been exposed to
  beryllium (Stange et al., 1996, Document ID 0206). Participants
  received an initial BeLPT and follow-ups at one and three years. Based
  on histologic evidence of pulmonary granulomas and a positive BAL-
  BeLPT, Stange et al. published a study of 4,397 BHSP participants
  tested from June 1991 to March 1995, including current employees (42.8
  percent) and former employees (57.2 percent). Twenty-nine cases of CBD
  and 76 cases of sensitization were identified. The sensitization rate
  for the population was 2.43 percent. Available exposure data included
  fixed airhead exposure samples collected between 1970 and 1988 (mean
  concentration 0.016 µg/m3\) and personal samples collected
  between 1984 and 1987 (mean concentration 1.04 µg/m3\). Cases of
  CBD and sensitization were noted in individuals in all jobs
  classifications, including those believed to involve minimal exposure
  to beryllium. The authors recommended ongoing surveillance for workers
  in all jobs with potential for beryllium exposure.
      Stange et al. (2001) extended the previous study, evaluating 5,173
  participants in the Rocky Flats BHSP who were tested between June 1991
  and December 1997 (Document ID 1403). Three-year serial testing was
  offered to employees who had not been tested for three years or more
  and did not show beryllium sensitization during the previous study.
  This resulted in 2,891 employees being tested. Of the 5,173 workers
  participating in the study, 172 were found to have abnormal BeLPT test
  results. Ninety-eight (3.33 percent) of the workers were found to be
  sensitized (confirmed abnormal BeLPT results) in the initial screening,
  conducted in 1991. Of these workers 74 were diagnosed with CBD, based
  on a history of beryllium exposure, evidence of non-caseating
  granulomas or mononuclear cell infiltrates on lung biopsy, and a
  positive BeLPT or BAL-BeLPT. A follow-up survey of 2,891 workers three
  years later identified an additional 56 sensitized workers and an
  additional seven cases of CBD. Sensitization and CBD rates were
  analyzed with respect to gender, building work locations, and length of
  employment. Historical employee data included hire date, termination
  date, leave of absences, and job title changes. Exposure to beryllium
  was determined by job categories and building or work area codes. In
  order to determine beryllium exposure for all participants in the
  study, personal beryllium air monitoring results were used, when
  available, from employees with the same job title or similar job.
  However, no quantitative exposure information was presented in the
  study. The authors conclude that for some individuals, exposure to
  beryllium at levels below the preceding OSHA PEL appears to cause
  sensitization and CBD.
      Viet et al. (2000) conducted a case-control study of the Rocky
  Flats worker population studied by Stange et al. (1996 and 2001,
  Document ID 0206 and 1403) to examine the relationship between
  estimated beryllium exposure level and risk of sensitization or CBD.
  The worker population included 74 beryllium-sensitized workers and 50
  workers diagnosed with CBD. Beryllium exposure levels were estimated
  based on fixed airhead samples from Building 444, the beryllium machine
  shop, where machine operators were considered to have the highest
  exposures at the Rocky Flats facility. These fixed air samples were
  collected away from the breathing zone of the machine operator and
  likely underestimated exposure. To estimate levels in other locations,
  these air sample concentrations were used to construct a job exposure
  matrix that included the determination of the Building 444 exposure
  estimates for a 30-year period; each subject's work history by job
  location, task, and time period; and assignment of exposure estimates
  to each combination of job location, task, and time period as compared
  to Building 444 machinists. The authors adjusted the levels observed in
  the machine shop by factors based on interviews with former workers.
  Workers' estimated mean exposure concentrations ranged from 0.083
  µg/m3\ to 0.622 µg/m3\. Estimated maximum air
  concentrations ranged from 0.54 µg/m3\ to 36.8 µg/m3\.
  Cases were matched to controls of the same age, race, gender, and
  smoking status (Viet et al., 2000, Document ID 1344).
      Estimated mean and cumulative exposure levels and duration of
  employment were found to be significantly higher for CBD cases than for
  controls. Estimated mean exposure levels were significantly higher for
  sensitization cases than for controls but no significant difference was
  observed for estimated cumulative exposure or duration of exposure.
  Similar results were found using logistic regression analysis, which
  identified statistically significant relationships between CBD and both
  cumulative and mean estimated exposure, but did not find significant
  relationships between estimated exposure levels and sensitization
  without CBD. Comparing CBD with sensitization cases, Viet et al. found
  that workers with CBD had significantly higher estimated cumulative and
  mean beryllium exposure levels than workers who were sensitized but did
  not have CBD.
      Johnson et al. (2001) conducted a review of personal sampling
  records and medical surveillance reports at an atomic weapons
  establishment in Cardiff, United Kingdom (Document ID 1505). The study
  evaluated airborne samples collected over the 36-year period of
  operation for the plant. Data included 367,757 area samples and 217,681
  personal lapel samples from 194 workers from 1981-1997. The authors
  estimated that over the 17 years of measurement data analyzed, airborne
  beryllium concentrations did exceed 2.0 µg/m3\, but due to the
  limitations with regard to collection times, it is difficult to assess
  the full reliability of this estimate. The authors noted that in the
  entire plant's history, only one case of CBD had been diagnosed. It was
  also noted that BeLPT had not been routinely conducted among any of the
  workers at this facility.
      Arjomandi et al. (2010) (Document ID 1275) conducted a cross-
  sectional study of workers at a nuclear weapons research and
  development (R&D) facility to determine the risk of developing CBD in
  sensitized workers at facilities with exposures much lower than
  production plants (Document ID 1275). Of the 1,875 current or former
  workers at the R&D facility, 59 were determined to be


  sensitized based on at least two positive BeLPTs (i.e., samples drawn
  on two separate occasions or on split samples tested in two separate
  DOE-approved laboratories) for a sensitization rate of 3.1 percent.
  Workers found to have positive BeLPTs were further evaluated in an
  Occupational Medicine Clinic between 1999 and 2005. Arjomandi et al.
  (2010) evaluated 50 of the sensitized workers who also had medical and
  occupational histories, physical examination, chest imaging with high-
  resolution computed tomography (HRCT) (N = 49), and pulmonary function
  testing (nine of the 59 workers refused physical examinations so were
  not included in this study). Forty of the 50 workers chosen for this
  study underwent bronchoscopy for bronchoalveolar lavage and
  transbronchial biopsies in additional to the other testing. Five of the
  49 workers had CBD at the time of evaluation (based on histology or
  high-resolution computed tomography); three others had evidence of
  probable CBD; however, none of these cases were classified as severe at
  the time of evaluation. The rate of CBD at the time of study among
  sensitized individuals was 12.5 percent (5/40) for those using
  pathologic review of lung tissue, and 10.2 percent (5/49) for those
  using HRCT as a criteria for diagnosis. The rate of CBD among the
  entire population (5/1875) was 0.3 percent.
      The mean duration of employment at the facility was 18 years, and
  the mean latency period (from first possible exposure) to time of
  evaluation and diagnosis was 32 years. There was no available exposure
  monitoring in the breathing zone of workers at the facility, but the
  authors believed beryllium levels were relatively low (possibly less
  than 0.1 μg/m3\ for most jobs). There was not an apparent exposure-
  response relationship for sensitization or CBD. The sensitization
  prevalence was similar across exposure categories and the CBD
  prevalence higher among workers with the lower-exposure jobs. The
  authors concluded that these sensitized workers, who were subjected to
  an extended duration of low potential beryllium exposures over a long
  latency period, had a low prevalence of CBD (Arjomandi et al., 2010,
  Document ID 1275).
  i. Aluminum Smelting
      Bauxite ore, the primary source of aluminum, contains naturally
  occurring beryllium. Worker exposure to beryllium can occur at aluminum
  smelting facilities where aluminum extraction occurs via electrolytic
  reduction of aluminum oxide into aluminum metal. Characterization of
  beryllium exposures and sensitization prevalence rates were examined by
  Taiwo et al. (2010) in a study of nine aluminum smelting facilities
  from four different companies in the U.S., Canada, Italy, and Norway
  (Document ID 0621).
      Of the 3,185 workers determined to be potentially exposed to
  beryllium, 1,932 (60 percent) agreed to participate in a medical
  surveillance program between 2000 and 2006. The medical surveillance
  program included BeLPT analysis, confirmation of an abnormal BeLPT with
  a second BeLPT, and follow-up of all confirmed positive BeLPT results
  by a pulmonary physician to evaluate for progression to CBD.
      Eight-hour TWA exposures were assessed utilizing 1,345 personal
  samples collected from the 9 smelters. The personal beryllium samples
  obtained showed a range of 0.01-13.00 μg/m3\ TWA with an arithmetic
  mean of 0.25 μg/m3\ and geometric mean of 0.06 μg/m3\. Based on
  a survey of published studies, the investigators concluded that
  exposure levels to beryllium observed in aluminum smelters were similar
  to those seen in other industries that utilize beryllium. Of the 1,932
  workers surveyed by BeLPT, nine workers were diagnosed with
  sensitization (prevalence rate of 0.47 percent, 95% confidence interval
  = 0.21-0.88 percent) with 2 of these workers diagnosed with probable
  CBD after additional medical evaluations.
      The authors concluded that compared with beryllium-exposed workers
  in other industries, the rate of sensitization among aluminum smelter
  workers appears lower. The authors speculated that this lower observed
  rate could be related to a more soluble form of beryllium found in the
  aluminum smelting work environment as well as the consistent use of
  respiratory protection. However, the authors also speculated that the
  low participation rate of 60 percent may have underestimated the
  sensitization rate in this worker population.
      A study by Nilsen et al. (2010) also found a low rate of
  sensitization among aluminum workers in Norway. Three-hundred sixty-two
  workers and thirty-one control individuals were tested for beryllium
  sensitization based on the BeLPT. The results found that one (0.28%) of
  the smelter workers had been sensitized. No borderline results were
  reported. The exposures estimated in this plant were 0.1 µg/m3\
  to 0.31 µg/m3\ (Nilsen et al., 2010, Document ID 0460).
  6. Animal Models of CBD
      This section reviews the relevant animal studies supporting the
  biological mechanisms outlined above. In order for an animal model to
  be useful for investigating the mechanisms underlying the development
  of CBD, the model should include: The demonstration of a beryllium-
  specific immune response; the formation of immune granulomas following
  inhalation exposure to beryllium; and progression of disease as
  observed in human disease. While exposure to beryllium has been shown
  to cause chronic granulomatous inflammation of the lung in animal
  studies using a variety of species, most of the granulomatous lesions
  were not immune-induced reactions (which would predominantly consist of
  T-cells or lymphocytes), but were foreign-body-induced reactions, which
  predominantly consist of macrophages and monocytes, with only a small
  numbers of lymphocytes. Although no single model has completely
  mimicked the disease process as it progresses in humans, animal studies
  have been useful in providing biological plausibility for the role of
  immunological alterations and lung inflammation and in clarifying
  certain specific mechanistic aspects of beryllium disease, such as
  sensitization and CBD. However, there is no dependable animal model
  that mimics all facets of the human response, and studies thus far have
  been limited by single dose experiments, too few animals, or
  abbreviated observation periods. Therefore, the utility of this data is
  limited. The following is a discussion of the most relevant animal
  studies regarding the mechanisms of sensitization and CBD development
  in humans. Table A.2 in the Supplemental Information for the Beryllium
  Health Effects Section summarizes species, route, chemical form of
  beryllium, dose levels, and pathological findings of the key studies
  (Document ID 1965).
      Harmsen et al. performed a study to assess whether the beagle dog
  could provide an adequate model for the study of beryllium-induced lung
  diseases (Harmsen et al., 1986, Document ID 1257). One group of dogs
  served as an air inhalation control group and four other groups
  received high (approximately 50 μg/kg) and low (approximately 20
  μg/kg) doses of beryllium oxide calcined at 500 [deg]C or 1,000
  [deg]C, administered as aerosols in a single exposure.6
  ---------------------------------------------------------------------------

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

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


      BAL content was collected at 30, 60, 90, 180, and 210 days after
  exposure, and lavage fluid and cellular content was evaluated for
  neutrophilic and lymphocytic infiltration. In addition, BAL cells were
  evaluated at the 210 day period to determine activation potential by
  phytohemagglutinin (PHA) or beryllium sulfate as mitogen. BAL
  neutrophils were significantly elevated only at 30 days with exposure
  to either dose of 500 [deg]C beryllium oxide. BAL lymphocytes were
  significantly elevated at all time points of the high dose of beryllium
  oxide. No significant effect of 1,000 [deg]C beryllium oxide exposure
  on mitogenic response of any lymphocytes was seen. In contrast,
  peripheral blood lymphocytes from the 500 [deg]C beryllium oxide
  exposed groups were significantly stimulated by beryllium sulfate
  compared with the phytohemagglutinin exposed cells. Only the BAL
  lymphocytes from animals exposed to the 500 [deg]C beryllium oxide
  responded to stimulation by either PHA or beryllium sulfate.
      In a series of studies, Haley et al. also found that the beagle dog
  models certain aspects of human CBD (Haley et al., 1989, 1991 and 1992;
  Document ID 1366, 1315, 1365. Briefly, dogs were exposed by inhalation
  to a single exposure to beryllium aerosol generated from beryllium
  oxide calcined at 500 [deg]C or 1,000 [deg]C for initial lung burdens
  of 17 or 50 μg beryllium/kg body weight (Haley et al., 1989,
  Document ID 1366; 1991 (1315)). The dogs were monitored for lung
  pathologic effects, particle clearance, and immune sensitization of
  peripheral blood leukocytes. Lung retention was higher in the 1,000
  [deg]C treated beryllium oxide group (Haley et al., 1989, Document ID
  1366).
      Haley et al. (1989) described the bronchoalveolar lavage (BAL) and
  histopathological changes in dogs exposed as described above. One group
  of dogs underwent BAL for lung lymphocyte analysis at 3, 6, 7, 11, 15,
  18, and 22 months post exposure. The investigators found an increase in
  the percentage and numbers of lymphocytes in BAL fluid at 3 months
  post-exposure in dogs exposed to either dose of beryllium oxide
  calcined at 500 [deg]C and 1,000 [deg]C. Positive BeLPT results were
  observed with BAL lymphocytes only in the group with a high initial
  lung burden of the material calcined at 500 [deg]C at 3 and 6 month
  post exposure. Another group underwent histopathological examination at
  days 8, 32, 64, 180, and 365 (Haley et al., 1989, Document ID 1366;
  1991 (1315)). Histopathologic examination revealed peribronchiolar and
  perivascular lymphocytic histiocytic inflammation, peaking at 64 days
  after beryllium oxide exposure. Lymphocytes were initially well
  differentiated, but progressed to lymphoblastic cells and aggregated in
  lymphofollicular nodules or microgranulomas over time. Although there
  was considerable inter-animal variation, lesions were generally more
  severe in the dogs exposed to material calcined at 500 [deg]C. The
  investigators observed granulomatous lesions and lung lymphocyte
  responses consistent with those observed in humans with CBD, including
  perivascular and peribronchiolar infiltrates of lymphocytes and
  macrophages, progressing to microgranulomas with areas of granulomatous
  pneumonia and interstitial fibrosis. However, lesions declined in
  severity after 64 days post-exposure. The lesions found in dog lungs
  closely resembled those found in humans with CBD: Severe granulomas,
  lymphoblast transformation, increased pulmonary lymphocyte
  concentrations and variation in beryllium sensitivity. It was concluded
  that the canine model for CBD may provide insight into this disease.
      In a follow-up experiment, control dogs and those exposed to
  beryllium oxide calcined at 500 [deg]C were allowed to rest for 2.5
  years, and then re-exposed to filtered air (controls) or beryllium
  oxide calcined at 500 [deg]C (cases) for an initial lung burden target
  of 50 μg beryllium oxide/kg body weight (Haley et al., 1992,
  Document ID 1365). Immune responses of blood and BAL lymphocytes, as
  well as lung lesions in dogs sacrificed 210 days post-exposure, were
  compared with results following the initial exposure. The severity of
  lung lesions was comparable under both conditions, suggesting that a
  2.5-year interval was sufficient to prevent cumulative pathologic
  effects in beagle dogs.
      In a comparison study of dogs and monkeys, Conradi et al. (1971)
  exposed animals via inhalation to an average aerosol to either 0, 3,300
  or 4,380 μg/m3\ of beryllium as beryllium oxide calcined at 1,400
  [deg]C for 30 minutes, once per month for 3 months (Document ID 1319).
  Conradi et al. found no changes in the histological or ultrastructure
  of the lung of animals exposed to beryllium versus control animals.
  This was in contrast to previous findings reported in other studies
  cited by Conradi et al. The investigators speculated that the
  differences may be due in part to calcination temperature or follow-up
  time after initial exposure. The findings from Haley et al. (1989,
  Document ID 1366; 1991 (1915); and 1992 (1365)) as well as Harmsen et
  al. (1986, Document ID 1257) suggest that the beagle model for
  sensitization of CBD is more closely related to the human response that
  other species such as the monkey (and those reviewed in Table A2 of the
  Supplemental Information for the Beryllium Health Effects Section).
      A 1994 study by Haley et al. comparing the potential toxicity of
  beryllium oxide versus beryllium metal showed that instillation of both
  beryllium oxide and beryllium metal induced an immune response in
  monkeys. Briefly, male cynomolgus monkeys were exposed to either
  beryllium metal or beryllium oxide calcined at 500 [deg]C via
  intrabronchiolar instillation as a saline suspension. Lymphocyte counts
  in BAL fluid were observed through bronchoalveolar lavage at 14, 30,
  60, 90, and 120 days post exposure, and were found to be significantly
  increased in monkeys exposed to beryllium metal on post-exposure days
  14, 30, 60, and 90, and in monkeys exposed to beryllium oxide on post-
  exposure day 30 and 60. Histological examination of lung tissue
  revealed that monkeys exposed to beryllium metal developed interstitial
  fibrosis, Type II cell hyperplasia with increased lymphocytes
  infiltration, and lymphocytic mantles accumulating around alveolar
  macrophages. Similar but much less severe lesions were observed in
  beryllium-oxide-exposed monkeys. Only monkeys exposed to beryllium
  metal had positive BAL BeLPT results (Haley et al., 1994, Document ID
  1364).
      As discussed earlier in this Health Effects section, at the
  cellular level, beryllium dissolution may be necessary in order for
  either a dendritic cell or a macrophage to present beryllium as an
  antigen to induce the cell-mediated CBD immune reactions (NAS, 2008,
  Document ID 1355). Several studies have shown that low-fired beryllium
  oxide, which is predominantly made up of poorly crystallized small
  particles, is more immunologically reactive than beryllium oxide
  calcined at higher firing temperatures that result in less reactivity
  due to increasing crystal size (Stefaniak et al., 2006, Document ID
  1398). As discussed previously, Haley et al. (1989, Document ID 1366)
  found more severe lung lesions and a stronger immune response in beagle
  dogs receiving a single inhalation exposure to beryllium oxide calcined
  at 500 [deg]C than in dogs receiving an equivalent initial lung burden
  of beryllium oxide calcined at 1,000 [deg]C. Haley et al. found that
  beryllium oxide calcined at 1,000 [deg]C


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


  sensitization to CBD could be much higher. Mroz et al. (2009) (Document
  ID 1356) conducted a longitudinal study between 1982 and 2002 in which
  they followed 171 cases of CBD and 229 cases of sensitization initially
  evaluated through workforce medical surveillance by National Jewish
  Health. All study subjects had abnormal BeLPTs upon study entry and
  were then clinically evaluated and treated for CBD. Over the 20-year
  study period, 22 sensitized individuals went on to develop CBD which
  was an incidence of 8.8 percent (i.e., 22 cases out of 251 sensitized,
  calculated by adding those 22 cases to the 229 initially classified as
  sensitized). The findings from this study indicated that the average
  span of time from initial beryllium exposure to CBD diagnosis for those
  22 workers was 24 years (Mroz et al., 2009, Document ID 1356).
      A study of sensitized workers believed to have been exposed to low
  levels of airborne beryllium metal (e.g., 0.01 µg/m3\ or less)
  at a nuclear weapons research and development facility were clinically
  evaluated between 1999 and 2005 (Arjomandi et al., 2010, Document ID
  1275). Five of 49 sensitized workers (10.2 percent incidence) were
  found to have pathology consistent with CBD. The CBD was asymptomatic
  and had not progressed to clinical disease. The mean duration of
  employment among workers in the study was 18 years with mean latency of
  32 years to time of CBD diagnosis (Arjomandi et al., 2010, Document ID
  1275). This suggests that some sensitized individuals can develop CBD
  even from low levels of beryllium exposure. Another study of nuclear
  weapons facility employees enrolled in an ongoing medical surveillance
  program found that sensitization rate among exposed workers was highest
  over the first 10 years of beryllium exposure while onset of CBD
  pathology was greatest following 15 to 30 years of exposure (Stange et
  al., 2001, Document ID 1403). This indicates length of exposure may
  play a role in further development of the disease. OSHA concludes from
  the study evidence that the persistent presence of beryllium in the
  lungs of sensitized workers can lead to a progression of CBD over time
  from an asymptomatic stage to serious clinical disease.
  E. Beryllium Lung Cancer Section
      Beryllium exposure is associated with a variety of adverse health
  effects, including lung cancer. The potential for beryllium and its
  compounds to cause cancer has been previously assessed by various other
  agencies (EPA, ATSDR, NAS, NIEHS, and NIOSH), with each agency
  identifying beryllium as a potential carcinogen. In addition, IARC did
  an extensive evaluation in 1993 (Document ID 1342) and reevaluation in
  April 2009 (IARC, 2012, Document ID 0650). In brief, IARC determined
  beryllium and its compounds to be carcinogenic to humans (Group 1
  category), while EPA considers beryllium to be a probable human
  carcinogen (EPA, 1998, Document ID 0661), and the National Toxicology
  Program (NTP) classifies beryllium and its compounds as known
  carcinogens (NTP, 2014, Document ID 0389). OSHA has conducted an
  independent evaluation of the carcinogenic potential of beryllium and
  these compounds. The following is a summary of the studies used to
  support the Agency's finding that beryllium and its compounds are human
  carcinogens.
  1. Genotoxicity Studies
      Genotoxicity can be an important indicator for screening the
  potential of a material to induce cancer and an important mechanism
  leading to tumor formation and carcinogenesis. In a review conducted by
  the National Academy of Science, beryllium and its compounds have
  tested positively in nearly 50 percent of the genotoxicity studies
  conducted without exogenous metabolic activity. However, they were
  found to be non-genotoxic in most bacterial assays (NAS, 2008, Document
  ID 1355).
      Non-mammalian test systems (generally bacterial assays) are often
  used to identify genotoxicity of a compound. In bacteria studies
  evaluating beryllium sulfate for mutagenicity, all studies performed
  utilizing the Ames assay (Simmon, 1979, Document ID 0434; Dunkel et
  al., 1981 (0432); Arlauskas et al., 1985 (0454); Ashby et al., 1990
  (0437)) and other bacterial assays (E. coli pol A (Rosenkranz and
  Poirer, 1979, Document ID 1426); E. coli WP2 uvrA (Dunkel et al., 1981,
  Document ID 0432), as well as those utilizing Saccharomyces cerevisiae
  (Simmon, 1979, Document ID 0434)) were reported as negative, with the
  exception of results reported for Bacillus subtilis rec assay (Kada et
  al., 1980, Document ID 0433; Kanematsu et al., 1980 (1503)). Beryllium
  nitrate was also reported as negative in the Ames assay (Tso and Fung,
  1981, Document ID 0446; Kuroda et al., 1991 (1471)) but positive in a
  Bacillus subtilis rec assay (Kuroda et al., 1991, Document ID 1471). In
  addition, beryllium chloride was reported as negative using the Ames
  assay (Ogawa et al., 1987, as cited in Document ID 1341, p. 112; Kuroda
  et al., 1991 (1471)) and other bacterial assays (E. coli WP2 uvrA
  (Rossman et al., 1984, Document ID 0431), as well as the Bacillus
  subtilis rec assay (Nishioka, 1975, Document ID 0449)) and failed to
  induce SOS DNA repair in E. coli (Rossman et al., 1984, Document ID
  0431). Positive results for beryllium chloride were reported for
  Bacillus subtilis rec assay using spores (Kuroda et al., 1991, Document
  ID 1471) as well as increased mutations in the lacI gene of E. coli
  KMBL 3835 (Zakour and Glickman, 1984, Document ID 1373). Beryllium
  oxide was reported to be negative in the Ames assay and Bacillus
  subtilis rec assays (Kuroda et al., 1991, Document ID 1471; EPA, 1998
  (0661)).
      Mutations using in vitro mammalian systems were also evaluated.
  Beryllium chloride induced mutations in V79 and CHO cultured cells
  (Miyaki et al., 1979, Document ID 0450; Hsie et al., 1978 (0427);
  Vegni-Talluri and Guiggiani, 1967 (1382)), and beryllium sulfate
  induced clastogenic alterations, producing breakage or disrupting
  chromosomes in mammalian cells (Brooks et al., 1989, Document ID 0233;
  Larramendy et al., 1981 (1468); Gordon and Bowser, 2003 (1520)).
  However, beryllium sulfate did not induce unscheduled DNA synthesis in
  primary rat hepatocytes and was not mutagenic when injected
  intraperitoneally in adult mice in a host-mediated assay using
  Salmonella typhimurium (Williams et al., 1982). Positive results were
  found for beryllium chloride when evaluating the hprt gene in Chinese
  hamster lung V79 cells (Miyaki et al., 1979, Document ID 0450).
      Data from in vivo genotoxicity testing of beryllium are limited.
  Beryllium metal was found to induce methylation of the p16 gene in the
  lung tumors of rats exposed to beryllium metal (Swafford et al., 1997,
  Document ID 1392) (described in more detail in section V.E.3). A study
  by Nickell-Brady et al., (1994) found that beryllium sulfate (1.4 and
  2.3 g/kg, 50 percent and 80 percent of median lethal dose) administered
  by gavage did not induce micronuclei in the bone marrow of CBA mice.
  However, a marked depression of red blood cell production was
  suggestive of bone marrow toxicity, which was evident 24 hours after
  dosing. No mutations were seen in p53 or c-raf-1 and only weak
  mutations were detected in K-ras in lung carcinomas from F344/N rats
  given a single nose-only exposure to beryllium metal (described in more
  detail in section V. E. 3) (Nickell-Brady et al., 1994, Document ID
  1312). On the other hand, beryllium chloride evaluated in a mouse model
  indicated increased DNA strand breaks and the formation of micronuclei


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


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


  Levy et al. (2002) (Document ID 1463) to conclude that there was little
  evidence of statistically significant elevated SMRs in those plants.
  This study was not included in the synthesis of epidemiological studies
  assessed by IARC due to several methodological limitations (IARC, 2012,
  Document ID 0650).
      The EPA Integrated Risk Information System (IRIS), IARC, and
  California EPA Office of Environmental Health Hazard Assessment (OEHHA)
  all based their cancer assessments on the Ward et al. 1992 study, with
  supporting data concerning exposure concentrations from Eisenbud and
  Lisson (1983) (Document ID 1296) and NIOSH (1972) (Document ID 0560),
  who estimated that the lower-bound estimate of the median exposure
  concentration exceeded 100 µg/m3\ and found that concentrations
  in excess of 1,000 µg/m3\ were common. The IRIS cancer risk
  assessment recalculated expected lung cancers based on U.S. white male
  lung cancer rates (including the period 1968-1975) and used an
  alternative adjustment for smoking. In addition, one individual with
  lung cancer, who had not worked at the plant, was removed from the
  cohort. After these adjustments were made, an elevated rate of lung
  cancer was still observed in the overall cohort (46 cases vs. 41.9
  expected cases). However, based on duration of employment or interval
  since beginning of employment, neither the total cohort nor any of the
  subgroups had a statistically significant increase in lung cancer
  deaths (EPA, 1987, Document ID 1295). Based on its evaluation of this
  and other epidemiological studies, the EPA characterized the human
  carcinogenicity data then available as "limited" but "suggestive of
  a causal relationship between beryllium exposure and an increased risk
  of lung cancer" (EPA, 1998, Document ID 0237). The EPA report includes
  quantitative estimates of risk that were derived using the information
  presented in Wagoner et al. (1980), the expected lung cancers
  recalculated by the EPA, and bounds on presumed exposure levels.
      Sanderson et al. (2001) (Document ID 1419) estimated the
  cumulative, average, and maximum beryllium exposure concentration for
  the 142 known lung cancer cases to be 46.06  9.3µg/
  m3\-days, 22.8  3.4 µg/m3\, and 32.4
  13.8 µg/m3\, respectively. The lung cancer mortality rate was
  1.22 (95 percent CI = 1.03 - 1.43). Exposure estimates were lagged by
  10 and 20 years in order to account for exposures that did not
  contribute to lung cancer because they occurred after the induction of
  cancer. In the 10- and 20-year lagged exposures the geometric mean
  tenures and cumulative exposures of the lung cancer mortality cases
  were higher than the controls. In addition, the geometric mean and
  maximum exposures of the workers were significantly higher than
  controls when the exposure estimates were lagged 10 and 20 years (p
  <0.01).
      Results of a conditional logistic regression analysis indicated
  that there was an increased risk of lung cancer in workers with higher
  exposures when dose estimates were lagged by 10 and 20 years (Sanderson
  et al., 2001, Document ID 1419). There was also a lack of evidence that
  confounding factors such as smoking affected the results of the
  regression analysis. The authors noted that there was considerable
  uncertainty in the estimation of exposure in the 1940s and 1950s and
  the shape of the dose-response curve for lung cancer (Sanderson et al.,
  2001, Document ID 1419). Another analysis of the study data using a
  different statistical method did not find a significantly greater
  relative risk of lung cancer with increasing beryllium exposures (Levy
  et al., 2007). The average beryllium air levels for the lung cancer
  cases were estimated to be an order of magnitude above the preceding 8-
  hour OSHA TWA PEL (2 μg/m3\) and roughly two orders of magnitude
  higher than the typical air levels in workplaces where beryllium
  sensitization and pathological evidence of CBD have been observed. IARC
  evaluated this reanalysis in 2012 and found the study introduced a
  downward bias into risk estimates (IARC, 2012, Document ID 0650). NIOSH
  comments in the rulemaking docket support IARC's finding (citing
  Schubauer-Berigan et al., 2007; Hein et al., 2009, 2011; Langholz and
  Richardson 2009; Wacholder 2009) (Document ID 1671, Attachment 1, p.
  10).
      Schubauer-Berigan et al. (2008) (Document ID 1350) reanalyzed data
  from the Sanderson et al. (2001) nested case-control study of 142 lung
  cancer cases in the Reading, PA, beryllium processing plant. This
  dataset was reanalyzed using conditional (stratified by case age)
  logistic regression. Independent adjustments were made for potential
  confounders of birth year and hire age. Average and cumulative
  exposures were analyzed using the values reported in the original
  study. The objective of the reanalysis was to correct for the known
  differences in smoking rates by birth year. In addition, the authors
  evaluated the effects of age at hire to determine differences observed
  by Sanderson et al. in 2001 (Document ID 1419). The effect of birth
  cohort adjustment on lung cancer rates in beryllium-exposed workers was
  evaluated by adjusting in a multivariable model for indicator variables
  for the birth cohort quartiles.
      Unadjusted analyses showed little evidence of lung cancer risk
  associated with beryllium occupational exposure using cumulative
  exposure until a 20-year lag was used. Adjusting for either birth
  cohort or hire age attenuated the risk for lung cancer associated with
  cumulative exposure. Using a 10- or 20-year lag in workers born after
  1900 also showed little evidence of lung cancer risk, while those born
  prior to 1900 did show a slight elevation in risk. Unlagged and lagged
  analysis for average exposure showed an increase in lung cancer risk
  associated with occupational exposure to beryllium. The finding was
  consistent for either workers adjusted or unadjusted for birth cohort
  or hire age. Using a 10-year lag for average exposure showed a
  significant effect by birth cohort.
      Schubauer-Berigan et al. stated that the reanalysis indicated that
  differences in the hire ages among cases and controls, first noted by
  Deubner et al. (2001) (Document ID 0109) and Levy et al. (2007)
  (Document ID 1462), were primarily due to the fact that birth years
  were earlier among controls than among cases, resulting from much lower
  baseline risk of lung cancer for men born prior to 1900 (Schubauer-
  Berigan et al., 2008, Document ID 1350). The authors went on to state
  that the reanalysis of the previous NIOSH case-control study suggested
  the relationship observed previously between cumulative beryllium
  exposure and lung cancer was greatly attenuated by birth cohort
  adjustment.
      Hollins et al. (2009) (Document ID 1512) re-examined the weight of
  evidence of beryllium as a lung carcinogen in a recent publication.
  Citing more than 50 relevant papers, the authors noted the
  methodological shortcomings examined above, including lack of well-
  characterized historical occupational exposures and inadequacy of the
  availability of smoking history for workers. They concluded that the
  increase in potential risk of lung cancer was observed among those
  exposed to very high levels of beryllium and that beryllium's
  carcinogenic potential in humans at these very high exposure levels was
  not relevant to today's industrial settings. IARC performed a similar
  re-evaluation in 2009 (IARC, 2012, Document ID 0650) and found that the
  weight of evidence for beryllium lung carcinogenicity, including the
  animal studies described below, still warranted a Group I
  classification, and that


  beryllium should be considered carcinogenic to humans.
      Schubauer-Berigan et al. (2011) (Document ID 1266) extended their
  analysis from a previous study estimating associations between
  mortality risk and beryllium exposure to include workers at 7 beryllium
  processing plants. The study followed the mortality incidences of 9,199
  workers from 1940 through 2005 at the 7 beryllium plants. JEMs were
  developed for three plants in the cohort: The Reading plant, the
  Hazleton plant, and the Elmore plant. The last is described in Couch et
  al. 2010. Including these JEMs substantially improved the evidence base
  for evaluating the carcinogenicity of beryllium, and this change
  represents more than an update of the beryllium cohort. Standardized
  mortality ratios (SMRs) were estimated based on U.S. population
  comparisons for lung, nervous system and urinary tract cancers, chronic
  obstructive pulmonary disease (COPD), chronic kidney disease, and
  categories containing chronic beryllium disease (CBD) and cor
  pulmonale. Associations with maximum and cumulative exposure were
  calculated for a subset of the workers.
      Overall mortality in the cohort compared with the U.S. population
  was elevated for lung cancer (SMR 1.17; 95% CI 1.08 to 1.28), COPD (SMR
  1.23; 95% CI 1.13 to 1.32), and the categories containing CBD (SMR
  7.80; 95% CI 6.26 to 9.60) and cor pulmonale (SMR 1.17; 95% CI 1.08 to
  1.26) (Schubauer-Berigan et al., 2011, Document ID 1266). Mortality
  rates for most diseases of interest increased with time since hire. For
  the category including CBD, rates were substantially elevated compared
  to the U.S. population across all exposure groups. Workers whose
  maximum beryllium exposure was >=10 μg/m3\ had higher rates of lung
  cancer, urinary tract cancer, COPD and the category containing cor
  pulmonale than workers with lower exposure. These studies showed strong
  associations for cumulative exposure (when short-term workers were
  excluded), maximum exposure, or both. Significant positive trends with
  cumulative exposure were observed for nervous system cancers (p =
  0.0006) and, when short-term workers were excluded, lung cancer (p =
  0.01), urinary tract cancer (p = 0.003), and COPD (p <0.0001).
      The authors concluded that the findings from this reanalysis
  reaffirmed that lung cancer and CBD are related to beryllium exposure.
  The authors went on to suggest that beryllium exposures may be
  associated with nervous system and urinary tract cancers and that
  cigarette smoking and other lung carcinogens were unlikely to explain
  the increased incidences in these cancers. The study corrected an error
  that was discovered in the indirect smoking adjustment initially
  conducted by Ward et al., concluding that cigarette smoking rates did
  not differ between the cohort and the general U.S. population. No
  association was found between cigarette smoking and either cumulative
  or maximum beryllium exposure, making it very unlikely that smoking was
  a substantial confounder in this study (Schubauer-Berigan et al., 2011,
  Document ID 1266).
      A study by Boffetta et al. (2014, Document ID 0403) and an abstract
  by Boffetta et al., (2015, Document ID 1661, Attachment 1) were
  submitted by Materion for Agency consideration (Document ID 1661, p.
  3). Briefly, Boffetta et al. investigated lung cancer and other
  diseases in a cohort of 4,950 workers in four beryllium manufacturing
  facilities. Based on available process information from the facilities,
  the cohort of workers included only those working with poorly soluble
  beryllium. Workers having potential for soluble beryllium exposure were
  excluded from the study. Boffetta et al. reported a slight increase in
  lung cancer rates among workers hired prior to 1960, but the increase
  was reported as not statistically significant. Bofetta et al. (2014)
  indicated that "[t]his study confirmed the lack of an increase in
  mortality from lung cancer and nonmalignant respiratory diseases
  related to [poorly] soluble beryllium compounds" (Document ID 0403, p.
  587). OSHA disagrees, and a more detailed analysis of the Boffetta et
  al. (2014, Document ID 0403) study is provided in the Risk Assessment
  section (VI) of this preamble. The Boffetta et al. (2015, Document ID
  1661, Attachment 1) study cited by Materion was an abstract to the 48th
  annual Society of Epidemiological Research conference and does not
  provide sufficient information for OSHA to consider.
      To summarize, most of the epidemiological studies reviewed in this
  section show an elevated lung cancer rate in beryllium-exposed workers
  compared to control groups. While exposure data was incomplete in many
  studies inferences can be made based on industry profiles.
  Specifically, studies reviewing excess lung cancer in workers
  registered in the BCR found an elevated lung cancer rate in those
  patients identified as having acute beryllium disease (ABD). ABD
  patients are most closely associated with exposure to soluble forms of
  beryllium (Infante et al., 1980, Document ID 1507; Steenland and Ward,
  1991 (1348)). Industry profiles in processing and extraction indicate
  that most exposures would be due to poorly soluble forms of beryllium.
  Excess lung cancer rates were observed in workers in industries
  associated with extraction and processing (Schubauer-Berigan et al.,
  2008, Document ID 1350; Schubauer-Berigan et al. 2011 (1266, 1815
  Attachment 105); Ward et al., 1992 (1378); Hollins et al., 2009 (1512);
  Sanderson et al., 2001 (1419); Mancuso et al., 1980 (1452); Wagoner et
  al., 1980 (1379)). During the public comment period NIOSH noted that:

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

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


  osteosarcomas have been produced in mice and rabbits exposed to various
  beryllium salts by intravenous injection or implantation into the bone
  (NTP, 1999, Document ID 1341: IARC, 2012 (0650)). While not completely
  understood, experimental studies in animals (in vitro and in vivo) have
  found that a number of mechanisms are likely involved in beryllium-
  induced carcinogenicity, including chronic inflammation, genotoxicity,
  mitogenicity, oxidative stress, and epigenetic changes.
      In an inhalation study assessing the potential tumorigenicity of
  beryllium, Schepers et al. (1957) (Document ID 0458) exposed 115 albino
  Sherman and Wistar rats (male and female) via inhalation to 0.0357 mg
  beryllium/m3\ (1 [gamma] beryllium/ft3) 7 as an aqueous aerosol of
  beryllium sulfate for 44 hours/week for 6 months, and observed the rats
  for 18 months after exposure. Three to four control rats were killed
  every two months for comparison purposes. Seventy-six lung
  neoplasms,8 including adenomas, squamous-cell carcinomas, acinous
  adenocarcinomas, papillary adenocarcinomas, and alveolar-cell
  adenocarcinomas, were observed in 52 of the rats exposed to the
  beryllium sulfate aerosol. Adenocarcinomas were the most numerous.
  Pulmonary metastases tended to localize in areas with foam cell
  clustering and granulomatosis. No neoplasia was observed in any of the
  control rats. The incidence of lung tumors in exposed rats is presented
  in the following Table 3:
  ---------------------------------------------------------------------------

      7 Schepers et al. (1957) reported concentrations in [gamma]
  Be/ft3; however, [gamma]/ft3 is no longer a common unit.
  Therefore, the concentration was converted to mg/m3\.
      8 While a total of 89 tumors were observed or palpated at the
  time of autopsy in the BeSO4-exposed animals, only 76
  tumors are listed as histologically neoplastic. Only the new growths
  identified in single midcoronal sections of both lungs were
  recorded.

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

      Schepers (1962) (Document ID 1414) reviewed 38 existing beryllium
  studies that evaluated seven beryllium compounds and seven mammalian
  species. Beryllium sulfate, beryllium fluoride, beryllium phosphate,
  beryllium alloy (BeZnMnSiO4), and beryllium oxide were
  proven to be carcinogenic. Ten varieties of tumors were observed, with
  adenocarcinoma being the most common variety.
      In another study, Vorwald and Reeves (1959) (Document ID 1482)
  exposed Sherman albino rats via the inhalation route to aerosols of
  0.006 mg beryllium/m3\ as beryllium oxide and 0.0547 mg beryllium/m3\
  as beryllium sulfate for 6 hours/day, 5 days/week for an unspecified
  duration. Lung tumors (single or multifocal) were observed in the
  animals sacrificed following 9 months of daily inhalation exposure. The
  histologic pattern of the cancer was primarily adenomatous; however,
  epidermoid and squamous cell cancers were also observed. Infiltrative,
  vascular, and lymphogenous extensions often developed with secondary
  metastatic growth in the tracheobronchial lymph nodes, the mediastinal
  connective tissue, the parietal pleura, and the diaphragm.
      In the first of two articles, Reeves et al. (1967) investigated the
  carcinogenic process in lungs resulting from chronic (up to 72 weeks)
  beryllium sulfate inhalation (Document ID 1310). One hundred fifty male
  and female Sprague Dawley C.D. strain rats were exposed to beryllium
  sulfate aerosol at a mean atmospheric concentration of 34.25 μg
  beryllium/m3\ (with an average particle diameter of 0.12 µm).
  Prior to initial exposure and again during the 67-68 and 75-76 weeks of
  life, the animals received prophylactic treatments of tetracycline-HCl
  to combat recurrent pulmonary infections.
      The animals entered the exposure chamber at 6 weeks of age and were
  exposed 7 hours per day/5 days per week for up to 2,400 hours of total
  exposure time. An equal number of unexposed controls were held in a
  separate chamber. Three male and three female rats were sacrificed
  monthly during the 72-week exposure period. Mortality due to
  respiratory or other infections did not appear until 55 weeks of age,
  and 87 percent of all animals survived until their scheduled
  sacrifices.
      Average lung weight towards the end of exposure was 4.25 times
  normal with progressively increasing differences between control and
  exposed animals. The increase in lung weight was accompanied by notable
  changes in tissue texture with two distinct pathological processes--
  inflammatory and proliferative. The inflammatory response was
  characterized by marked accumulation of histiocytic elements forming
  clusters of macrophages in the alveolar spaces. The proliferative
  response progressed from early epithelial hyperplasia of the alveolar
  surfaces, through metaplasia (after 20-22 weeks of exposure), anaplasia
  (cellular dedifferentiation) (after 32-40 weeks of exposure), and
  finally to lung tumors.
      Although the initial proliferative response occurred early in the
  exposure period, tumor development required considerable time. Tumors
  were first identified after nine months of beryllium sulfate exposure,
  with rapidly increasing rates of incidence until tumors were observed
  in 100 percent of exposed animals by 13 months. The 9-to-13-month
  interval is consistent with earlier studies. The tumors showed a high
  degree of local invasiveness. No tumors were observed in control rats.
  All 56 tumors studied appeared to be alveolar adenocarcinomas and 3
  were "fast-growing" tumors that reached a very large size
  comparatively early. About one-third of the tumors showed small foci
  where the histologic pattern differed. Most of the early tumor foci
  appeared to be alveolar rather than bronchiolar, which is consistent
  with the expected pathogenesis, since permanent deposition of beryllium
  was more likely on the alveolar epithelium rather than on the
  bronchiolar epithelium. Female rats appeared to have an increased
  susceptibility to beryllium exposure. Not only did they have a higher
  mortality (control males [n = 8], exposed males [n = 9] versus control
  females [n = 4], exposed females [n = 17]) and body weight loss than
  male rats, but the three "fast-growing" tumors occurred in females.
      In the second article, Reeves et al. (1967) (Document ID 1309)
  described the rate of accumulation and clearance of beryllium sulfate
  aerosol from the same experiment (Reeves et al., 1967) (Document ID
  1310). At the time of the monthly sacrifice, beryllium assays were
  performed on the lungs, tracheobronchial lymph nodes, and blood of the
  exposed rats. The pulmonary beryllium levels of rats showed a rate of
  accumulation which


  decreased during continuing exposure and reached a plateau (defined as
  equilibrium between deposition and clearance) of about 13.5 μg
  beryllium for males and 9 μg 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 μg beryllium/gram versus 1.50
  0.55 μg beryllium/gram). This was believed to be largely a result of
  the dilution factor operating in the rapidly growing tumor tissue.
  However, other factors, such as lack of continued local deposition due
  to impaired respiratory function and enhanced clearance due to high
  vascularity of the tumor, may also have played a role. The portion of
  inhaled beryllium retained in the lungs for a longer duration, which is
  in the range of one-half of the original pulmonary load, may have
  significance for pulmonary carcinogenesis. This pulmonary beryllium
  burden becomes localized in the cell nuclei and may be an important
  factor in eliciting the carcinogenic response associated with beryllium
  inhalation.
      Groth et al. (1980) (Document ID 1316) conducted a series of
  experiments to assess the carcinogenic effects of beryllium, beryllium
  hydroxide, and various beryllium alloys. For the beryllium metal/alloys
  experiment, 12 groups of 3-month-old female Wistar rats (35 rats/group)
  were used. All rats in each group received a single intratracheal
  injection of either 2.5 or 0.5 mg of one of the beryllium metals or
  beryllium alloys as described in Table 3 below. These materials were
  suspended in 0.4 cc of isotonic saline followed by 0.2 cc of saline.
  Forty control rats were injected with 0.6 cc of saline. The geometric
  mean particle sizes varied from 1 to 2 µm. Rats were sacrificed
  and autopsied at various intervals ranging from 1 to 18 months post-
  injection.

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

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


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

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

      Lung burdens of beryllium measured in wild-type mice at 7 days post
  exposure were approximately 70-90 percent of target levels. No
  exposure-related effects on body weight were observed in mice; however,
  lung weights and lung-to-body-weight ratios were somewhat elevated in
  60 μg 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 μg
  target ILB p53 +/- knockout mice compared to 60 μg target
  ILB p53+/+ wild-type mice (p= 0.056). The incidence of lung tumors in
  the 60 μg target ILB p53 +/- knockout mice was also
  significantly higher than controls (p = 0.048). No tumors developed in
  the control mice, 15 μg target ILB p53 +/- knockout mice,
  or 60 μg target ILB p53+/+ wild-type mice throughout the length of
  the study. Most lung tumors in beryllium-exposed mice were squamous
  cell carcinomas, three of four of which were poorly circumscribed and
  all of which were associated with at least some degree of granulomatous
  pneumonia. The study results suggest that having an inactivated p53
  allele is associated with lung tumor progression in p53 +/-
  knockout mice. This is based on the significant difference seen in the
  incidence of beryllium-induced lung neoplasms for the p53
  +/- knockout mice compared with the p53 \+/+\ wild-type
  mice. The authors conclude that since there was a relatively late onset
  of tumors in the beryllium-exposed p53 +/- knockout mice, a
  6-month bioassay in this mouse strain might not be an appropriate model
  for lung carcinogenesis (Finch et al., 1998, Document ID 1367).
      During the public comment period Materion submitted correspondence
  from Dr. Finch speculating on the reason for the less-robust lung
  cancer response observed in mice (versus that observed in rats)
  (Document ID 1807, Attachment 11, p. 1). Materion contended that this
  was support for their assertion of evidence that "directly contradicts
  the claims that beryllium metal causes cancer in animals" (Document ID
  1807, p. 6). OSHA reviewed this correspondence and disagrees with
  Materion's assertion. While Dr. Finch did suggest that the mouse lung
  cancer response was less robust, it was still present. Dr. Finch went
  on to suggest that while the rat has a more profound neutrophilic
  response (typical of a "foreign body response), the mouse has a lung
  response more typical of humans (neutrophilic and lymphocytic)
  (Document ID 1807, Attachment 11, p. 1).
      Nickell-Brady et al. (1994) investigated the development of lung
  tumors in 12-week-old F344/N rats after a single nose-only inhalation
  exposure to beryllium aerosol, and evaluated whether beryllium lung
  tumor induction involves alterations in the K-ras, p53, and c-raf-1
  genes (Document ID 1312). Four groups of rats (30 males and 30 females
  per group) were exposed to different mass concentrations of beryllium
  (Group 1: 500 mg/m3\ for 8 min; Group 2: 410 mg/m3\ for 30 min; Group
  3: 830 mg/m3\ for 48 min; Group 4: 980 mg/m3\ for 39 min). The
  beryllium mass median aerodynamic diameter was 1.4 μm
  ([sigma]g= 1.9). The mean beryllium lung burdens for each
  exposure group were 40, 110, 360, and 430 μg, respectively.
      To examine genetic alterations, DNA isolation and sequencing
  techniques (PCR amplification and direct DNA sequence analysis) were
  performed on wild-type rat lung tissue (i.e., control samples) along
  with two mouse lung tumor cell lines containing known K-ras mutations,
  12 carcinomas induced by beryllium (i.e., experimental samples), and 12
  other formalin-fixed specimens. Tumors appeared in beryllium-exposed
  rats by 14 months, and 64 percent of exposed rats developed lung tumors
  during their lifetime. Lungs frequently contained multiple tumor sites,
  with some of the tumors greater than 1 cm. A total of 24 tumors were
  observed. Most of the tumors (n = 22) were adenocarcinomas exhibiting a
  papillary pattern characterized by cuboidal or columnar cells, although
  a few had a tubular or solid pattern. Fewer than 10 percent of the
  tumors were adenosquamous (n = 1) or squamous cell (n = 1) carcinomas.
      No transforming mutations of the K-ras gene (codons 12, 13, or 61)
  were detected by direct sequence analysis in any of the lung tumors
  induced by beryllium. However, using a more sensitive sequencing
  technique (PCR enrichment restriction fragment length polymorphism
  (RFLP) analysis) resulted in the detection of K-ras codon 12 GGT to GTT
  transversions in 2 of 12 beryllium-induced adenocarcinomas. No p53 or
  c-raf-1 alterations were observed in any of the tumors induced by
  beryllium exposure (i.e., no differences observed between beryllium-
  exposed and control rat tissues). The authors note that the results
  suggest that


  activation of the K-ras proto-oncogene is both a rare and late event,
  possibly caused by genomic instability during the progression of
  beryllium-induced rat pulmonary adenocarcinomas. It is unlikely that
  the K-ras gene plays a role in the carcinogenicity of beryllium. The
  results also indicate that p53 mutation is unlikely to play a role in
  tumor development in rats exposed to beryllium.
      Belinsky et al. (1997) reviewed the findings by Nickell-Brady et
  al. (1994) (Document ID 1312) to further examine the role of the K-ras
  and p53 genes in lung tumors induced in the F344 rat by non-mutagenic
  (non-genotoxic) exposures to beryllium. Their findings are discussed
  along with the results of other genomic studies that look at
  carcinogenic agents that are either similarly non-mutagenic or, in
  other cases, mutagenic. The authors concluded that the identification
  of non-ras transforming genes in rat lung tumors induced by non-
  mutagenic exposures, such as beryllium, as well as mutagenic exposures
  will help define some of the mechanisms underlying cancer induction by
  different types of DNA damage.
      The inactivation of the p16 INK4a(p16) gene is a contributing
  factor in disrupting control of the normal cell cycle and may be an
  important mechanism of action in beryllium-induced lung tumors.
  Swafford et al. (1997) investigated the aberrant methylation and
  subsequent inactivation of the p16 gene in primary lung tumors induced
  in F344/N rats exposed to known carcinogens via inhalation (Document ID
  1392). The research involved a total of 18 primary lung tumors that
  developed after exposing rats to five agents, one of which was
  beryllium. In this study, only one of the 18 lung tumors was induced by
  beryllium exposure; the majority of the other tumors were induced by
  radiation (x-rays or plutonium-239 oxide). The authors hypothesized
  that if p16 inactivation plays a central role in development of non-
  small-cell lung cancer, then the frequency of gene inactivation in
  primary tumors should parallel that observed in the corresponding cell
  lines. To test the hypothesis, a rat model for lung cancer was used to
  determine the frequency and mechanism for inactivation of p16 in
  matched primary lung tumors and derived cell lines. The methylation-
  specific PCR (MSP) method was used to detect methylation of p16
  alleles. The results showed that the presence of aberrant p16
  methylation in cell lines was strongly correlated with absent or low
  expression of the gene. The findings also demonstrated that aberrant
  p16 CpG island methylation, an important mechanism in gene silencing
  leading to the loss of p16 expression, originates in primary tumors.
      Building on the rat model for lung cancer and associated findings
  from Swafford et al. (1997) (Document ID 1392), Belinsky et al. (2002)
  (Document ID 1300) conducted experiments in 12-week-old F344/N rats
  (male and female) to determine whether beryllium-induced lung tumors
  involve inactivation of the p16 gene and estrogen receptor α (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 μg. The
  methylation status of the p16 and ER genes was determined by MSP. A
  total of 20 tumors detected in beryllium-exposed rats were available
  for analysis of gene-specific promoter methylation. Three tumors were
  classified as squamous cell carcinomas and the others were determined
  to be adenocarcinomas. Methylated p16 was present in 80 percent (16/
  20), and methylated ER was present in one-half (10/20), of the lung
  tumors induced by exposure to beryllium. Additionally, both genes were
  methylated in 40 percent of the tumors. The authors noted that four
  tumors from beryllium-exposed rats appeared to be partially methylated
  at the p16 locus. Bisulfite sequencing of exon 1 of the ER gene was
  conducted on normal lung DNA and DNA from three methylated, beryllium-
  induced tumors to determine the density of methylation within amplified
  regions of exon 1 (referred to as CpG sites). Two of the three
  methylated, beryllium-induced lung tumors showed extensive methylation,
  with more than 80 percent of all CpG sites methylated.
      The overall findings of this study suggest that inactivation of the
  p16 and ER genes by promoter hypermethylation are likely to contribute
  to the development of lung tumors in beryllium-exposed rats. The
  results showed a correlation between changes in p16 methylation and
  loss of gene transcription. The authors hypothesize that the mechanism
  of action for beryllium-induced p16 gene inactivation in lung tumors
  may be inflammatory mediators that result in oxidative stress. The
  oxidative stress damages DNA directly through free radicals or
  indirectly through the formation of 8-hydroxyguanosine DNA adducts,
  resulting primarily in a single-strand DNA break.
      Wagner et al. (1969) (Document ID 1481) studied the development of
  pulmonary tumors after intermittent daily chronic inhalation exposure
  to beryllium ores in three groups of male squirrel monkeys. One group
  was exposed to bertrandite ore, a second to beryl ore, and the third
  served as unexposed controls. Each of these three exposure groups
  contained 12 monkeys. Monkeys from each group were sacrificed after 6,
  12, or 23 months of exposure. The 12-month sacrificed monkeys (n = 4
  for bertrandite and control groups; n = 2 for beryl group) were
  replaced by a separate replacement group to maintain a total animal
  population approximating the original numbers and to provide a source
  of confirming data for biologic responses that might arise following
  the ore exposures. Animals were exposed to bertrandite and beryl ore
  concentrations of 15 mg/m3\, corresponding to 210 μg beryllium/m3\
  and 620 μg beryllium/m3\ in each exposure chamber, respectively.
  The parent ores were reduced to particles with geometric mean diameters
  of 0.27 μm ( 2.4) for bertrandite and 0.64 μm ( 2.5) for beryl. Animals were exposed for approximately 6 hours/
  day, 5 days/week. The histological changes in the lungs of monkeys
  exposed to bertrandite and beryl ore exhibited a similar pattern. The
  changes generally consisted of aggregates of dust-laden macrophages,
  lymphocytes, and plasma cells near respiratory bronchioles and small
  blood vessels. There were, however, no consistent or significant
  pulmonary lesions or tumors observed in monkeys exposed to either of
  the beryllium ores. This is in contrast to the findings in rats exposed
  to beryl ore and to a lesser extent bertrandite, where atypical cell
  proliferation and tumors were frequently observed in the lungs. The
  authors hypothesized that the rats' greater susceptibility may be
  attributed to the spontaneous lung disease characteristic of rats,
  which might have interfered with lung clearance.
      As previously described, Conradi et al. (1971) investigated changes
  in the lungs of monkeys and dogs two years after intermittent
  inhalation exposure to beryllium oxide calcined at 1,400 [deg]C
  (Document ID 1319). Five adult male and female monkeys (Macaca irus)
  weighing between 3 and 5.75 kg were used in the study. The study
  included two control monkeys. Beryllium concentrations in the
  atmosphere of whole-body exposed monkeys varied between 3.30 and 4.38
  mg/m3\. 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 μg beryllium per 100 gm of wet tissue in the upper lobe, lower
  lobe, and combined lobes, respectively) were higher than those in dogs.
  No neoplastic or granulomatous lesions were observed in the lungs of
  any exposed animals and there was no evidence of chronic proliferative
  lung changes after two years.
      To summarize, animal studies show that multiple forms of beryllium,
  when inhaled or instilled in the respiratory tract of rats, mice, and
  monkeys, lead to increased incidence of lung tumors. Animal studies
  have demonstrated a consistent scenario of beryllium exposure resulting
  in chronic pulmonary inflammation and tumor formation at levels below
  overload conditions (Groth et al., 1980, Document ID 1316; Finch et
  al., 1998 (1367); Nickel-Brady et al., 1994 (1312)). The animal studies
  support the human epidemiological evidence and contributed to the
  findings of the NTP, IARC, and others that beryllium and beryllium-
  containing material should be regarded as known human carcinogens. The
  beryllium compounds found to be carcinogenic in animals include both
  soluble beryllium compounds, such as beryllium sulfate and beryllium
  hydroxide, as well as poorly soluble beryllium compounds, such as
  beryllium oxide and beryllium metal. The doses that produce tumors in
  experimental animal are fairly large and also lead to chronic pulmonary
  inflammation. The exact tumorigenic mechanism for beryllium is unclear
  and a number of mechanisms are likely involved, including chronic
  inflammation, genotoxicity, mitogenicity, oxidative stress, and
  epigenetic changes.
  4. In Vitro Studies
      The exact mechanism by which beryllium induces pulmonary neoplasms
  in animals remains unknown (NAS 2008, Document ID 1355). Keshava et al.
  (2001) performed studies to determine the carcinogenic potential of
  beryllium sulfate in cultured mammalian cells (Document ID 1362).
  Joseph et al. (2001) investigated differential gene expression to
  understand the possible mechanisms of beryllium-induced cell
  transformation and tumorigenesis (Document ID 1490). Both
  investigations used cell transformation assays to study the cellular/
  molecular mechanisms of beryllium carcinogenesis and assess
  carcinogenicity. Cell lines were derived from tumors developed in nude
  mice injected subcutaneously with non-transformed BALB/c-3T3 cells that
  were morphologically transformed in vitro with 50-200 μg beryllium
  sulfate/ml for 72 hours. The non-transformed cells were used as
  controls.
      Keshava et al. (2001) found that beryllium sulfate is capable of
  inducing morphological cell transformation in mammalian cells and that
  transformed cells are potentially tumorigenic (Document ID 1362). A
  dose-dependent increase (9-41 fold) in transformation frequency was
  noted. Using differential polymerase chain reaction (PCR), gene
  amplification was investigated in six proto-oncogenes (K-ras, c-myc, c-
  fos, c-jun, c-sis, erb-B2) and one tumor suppressor gene (p53). Gene
  amplification was found in c-jun and K-ras. None of the other genes
  tested showed amplification. Additionally, Western blot analysis showed
  no change in gene expression or protein level in any of the genes
  examined. Genomic instability in both the non-transformed and
  transformed cell lines was evaluated using random amplified polymorphic
  DNA fingerprinting (RAPD analysis). Using different primers, 5 of the
  10 transformed cell lines showed genomic instability when compared to
  the non-transformed BALB/c-3T3 cells. The results indicate that
  beryllium sulfate-induced cell transformation might, in part, involve
  gene amplification of K-ras and c-jun and that some transformed cells
  possess neoplastic potential resulting from genomic instability.
      Using the Atlas mouse 1.2 cDNA expression microarrays, Joseph et
  al. (2001) studied the expression profiles of 1,176 genes belonging to
  several different functional categories after beryllium sulfate
  exposure in a mouse cell line (Document ID 1490). Compared to the
  control cells, expression of 18 genes belonging to two functional
  groups (nine cancer-related genes and nine DNA synthesis, repair, and
  recombination genes) was found to be consistently and reproducibly
  different (at least 2-fold) in the tumor cells. Differential gene
  expression profile was confirmed using reverse transcription-PCR with
  primers specific to the differentially expressed genes. Two of the
  differentially expressed genes (c-fos and c-jun) were used as model
  genes to demonstrate that the beryllium-induced transcriptional
  activation of these genes was dependent on pathways of protein kinase C
  and mitogen-activated protein kinase and independent of reactive oxygen
  species in the control cells. These results indicate that beryllium-
  induced cell transformation and tumorigenesis are associated with up-
  regulated expression of the cancer-related genes (such as c-fos, c-jun,
  c-myc, and R-ras) and down-regulated expression of genes involved in
  DNA synthesis, repair, and recombination (such as MCM4, MCM5, PMS2,
  Rad23, and DNA ligase I).
      In summary, in vitro studies have been used to evaluate the
  neoplastic potential of beryllium compounds and the possible underlying
  mechanisms. Both Keshava et al. (2001) (Document ID 1362) and Joseph et
  al. (2001) (Document ID 1490) have found that beryllium sulfate induced
  a number of onco-genes (c-fos, c-jun, c-myc, and R-ras) and down-
  regulated genes responses for normal cellular function and repair
  (including those involved in DNA synthesis, repair, and recombination).
  5. Lung Cancer Conclusions
      OSHA has determined that substantial evidence in the record
  indicates that beryllium compounds should be regarded as occupational
  lung carcinogens. Many well-respected scientific organizations,
  including IARC, NTP, EPA, NIOSH, and ACGIH, have reached similar
  conclusions with respect to the carcinogenicity of beryllium.
      While some evidence exists for direct-acting genotoxicity as a
  possible mechanism for beryllium carcinogenesis, the weight of evidence
  suggests that an indirect mechanism, such as inflammation or other
  epigenetic changes, may be responsible for most tumorigenic activity of
  beryllium in animals and humans (IARC, 2012, Document ID 0650).
  Inflammation has been postulated to be a key contributor to many
  different forms of cancer (Jackson et al., 2006; Pikarsky et al., 2004;
  Greten et al., 2004; Leek, 2002). In fact, chronic inflammation may be
  a primary factor in the development of up to one-third of all cancers
  (Ames et al., 1990; NCI, 2010).
      In addition to a T-cell-mediated immunological response, beryllium
  has been demonstrated to produce an inflammatory response in animal
  models similar to the response produced by other particles (Reeves et
  al., 1967, Document ID 1309; Swafford et al., 1997 (1392); Wagner et
  al., 1969 (1481)), possibly contributing to its carcinogenic potential.
  Studies conducted in rats have demonstrated that chronic inhalation of
  materials similar in solubility to beryllium results in increased
  pulmonary inflammation,


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


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

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

  As further noted by NIOSH:

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

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

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

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

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

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


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

  F. Other Health Effects

      Past studies on other health effects have been thoroughly reviewed
  by several scientific organizations (NTP, 1999, Document ID 1341; EPA,
  1998 (0661); ATSDR, 2002 (1371); WHO, 2001 (1282); HSDB, 2010 (0533)).
  These studies include summaries of animal studies, in vitro studies,
  and human epidemiological studies associated with cardiovascular,
  hematological, hepatic, renal, endocrine, reproductive, ocular and
  mucosal, and developmental effects. High-dose exposures to beryllium
  have been shown to have an adverse effect upon a variety of organs and
  tissues in the body, particularly the liver. The adverse systemic
  effects on humans mostly occurred prior to the introduction of
  occupational and environmental standards set in 1970-1972 OSHA, 1971,
  see 39 FR 23513; EPA, 1973 (38 FR 8820)). (OSHA, 1971, see 39 FR 23513;
  ACGIH, 1971 (0543); ANSI, 1970 (1303)) and EPA, 1973 (38 FR 8820) and
  therefore are less relevant today than in the past. The available data
  is fairly limited. The hepatic, cardiovascular, renal, and ocular and
  mucosal effects are briefly summarized below. Health effects in other
  organ systems listed above were only observed in animal studies at very
  high exposure levels and are, therefore, not discussed here. During the
  public comment period OSHA received comments suggesting that OSHA add
  dermal effects to this section. Therefore, dermal effects have been
  added, below, and are also discussed in the section on kinetics and
  metabolism (section V.B.2).
  1. Hepatic Effects
      Beryllium has been shown to accumulate in the liver and a
  correlation has been demonstrated between beryllium content and hepatic
  damage. Different compounds have been shown to distribute differently
  within the hepatic tissues. For example, in one study, beryllium
  phosphate accumulated almost exclusively within sinusoidal (Kupffer)
  cells of the liver, while beryllium sulfate was found mainly in
  parenchymal cells. Conversely, beryllium sulphosalicylic acid complexes
  were rapidly excreted (Skilleter and Paine, 1979, Document ID 1410).
      According to a few autopsies, beryllium-laden livers had central
  necrosis, mild focal necrosis and inflammation, as well as,
  occasionally, beryllium granuloma (Sprince et al., 1975, Document ID
  1405).
  2. Cardiovascular Effects
      Severe cases of CBD can result in cor pulmonale, which is
  hypertrophy of the right heart ventricle. In a case history study of 17
  individuals exposed to beryllium in a plant that manufactured
  fluorescent lamps, autopsies revealed right atrial and ventricular
  hypertrophy (Hardy and Tabershaw, 1946, Document ID 1516). It is not
  likely that these cardiac effects were due to direct toxicity to the
  heart, but rather were a response to impaired lung function. However,
  an increase in deaths due to heart disease or ischemic heart disease
  was found in workers at a beryllium manufacturing facility (Ward et
  al., 1992, Document ID 1378). Additionally, a study by Schubauer-
  Berigan et al. (2011) found an increase in mortality due to cor
  pulmonale in a follow-up study of workers at seven beryllium processing
  plants who were exposed to beryllium levels near the preceding OSHA PEL
  of 2.0 μg/m3\ (Schubauer-Berigan et al., 2011, Document ID 1266).
      Animal studies performed in monkeys indicate heart enlargement
  after acute inhalation exposure to 13 mg beryllium/m3\ as beryllium
  hydrogen phosphate, 0.184 mg beryllium/m3\ as beryllium fluoride, or
  0.198 mg beryllium/m3\ as beryllium sulfate (Schepers, 1957, Document
  ID 0458). Decreased arterial oxygen tension was observed in dogs
  exposed to 30 mg beryllium/m3\ as beryllium oxide for 15 days (HSDB,
  2010, Document ID 0533), 3.6 mg beryllium/m3\ as beryllium oxide for
  40 days (Hall et al., 1950, Document ID 1494), and 0.04 mg beryllium/
  m3\ as beryllium sulfate for 100 days (Stokinger et al., 1950,
  Document ID 1484). These are thought to be indirect effects on the
  heart due to pulmonary fibrosis and toxicity, which can increase
  arterial pressure and restrict blood flow.
  3. Renal Effects
      Renal or kidney stones have been found in severe cases of CBD that
  resulted from high levels of beryllium exposure. Renal stones
  containing beryllium occurred in about 10 percent of patients affected
  by high exposures (Barnett et al., 1961, Document ID 0453). The ATSDR
  reported that 10 percent of the CBD cases found in the BCR reported
  kidney stones. In addition, an excess of calcium in the blood and urine
  was frequently found in patients with CBD (ATSDR, 2002, Document ID
  1371).
  4. Ocular and Mucosal Effects
      Soluble and poorly soluble beryllium compounds have been shown to
  cause ocular irritation in humans (VanOrdstrand et al., 1945, Document
  ID 1383; De Nardi et al., 1953 (1545); Nishimura, 1966 (1435); Epstein,
  1991 (0526); NIOSH, 1994 (1261). In addition, soluble and poorly
  soluble beryllium has been shown to induce acute conjunctivitis with
  corneal maculae and diffuse erythema (HSDB, 2010, Document ID 0533).
      The mucosa (mucosal membrane) is the moist lining of certain
  tissues/organs including the eyes, nose, mouth, lungs, and the urinary
  and digestive tracts. Soluble beryllium salts have been shown to be
  directly irritating to mucous membranes (HSDB, 2010, Document ID 0533).
  5. Dermal Effects
      Several commenters suggested OSHA add dermal effects to this Health
  Effects section. National Jewish Health noted that rash and
  granulomatous reactions of the skin still occur in occupational
  settings (Document ID 1664, p. 5). The National Supplemental Screening
  Program also recommended including skin conditions such as dermatitis
  and nodules (Document ID 1677, p. 3). The American Thoracic Society
  also recommended including "beryllium sensitization, CBD, and skin
  disease as the major adverse health effects


  associated with exposure to beryllium at or below 0.1 μg/m3\ and
  acute beryllium disease at higher exposures based on the currently
  available epidemiologic and experimental studies" (Document ID 1688,
  p. 2). OSHA agrees and has included dermal effects in this section of
  the final preamble.
      As summarized in Epstein (1991), skin exposure to soluble beryllium
  compounds (mainly beryllium fluoride but also beryllium metal which may
  contain beryllium fluoride) resulted in irritant dermatitis with
  inflammation, and local edema. Beryllium oxide, beryllium alloys and
  nearly pure beryllium metal did not produce such responses in the skin
  of workers (Epstein, 1991, Document ID 0526). Skin lacerations or
  abrasions contaminated with soluble beryllium can lead to skin
  ulcerations (Epstein, 1991, Document ID 0526). Soluble and poorly
  soluble beryllium-compounds that penetrate the skin as a result of
  abrasions or cuts have been shown to result in chronic ulcerations and
  skin granulomas (VanOrdstrand et al., 1945, Document ID 1383; Lederer
  and Savage, 1954 (1467)). However, ulcerating granulomatous formation
  of the skin is generally associated with poorly soluble forms of
  beryllium (Epstein, 1991, Document ID 0526). Beryllium, beryllium oxide
  and other soluble and poorly soluble forms of beryllium have been
  classified as a skin irritant (category 2) in accordance with the EU
  Classification, Labelling and Packaging Regulation (Document ID 1669,
  p. 2). Contact dermatitis (skin hypersensitivity) was observed in some
  individuals exposed via skin to soluble forms of beryllium, especially
  individuals with a dermal irritant response (Epstein, 1991, Document ID
  0526). Contact allergy has been observed in workers exposed to
  beryllium chloride (Document ID 0522).
  G. Summary of Conclusions Regarding Health Effects
      Through careful analysis of the best available scientific
  information outlined in this section, OSHA has determined that
  beryllium and beryllium-containing compounds can cause sensitization,
  CBD, and lung cancer. The Agency has determined through its review and
  evaluation of the studies outlined in section V.A.2 of this health
  effects section that skin and inhalation exposure to beryllium can lead
  to sensitization; and inhalation exposure, or skin exposure coupled
  with inhalation, can cause onset and progression of CBD. In addition,
  the Agency's review and evaluation of the studies outlined in section
  V.E. of this health effects section led to a finding that inhalation
  exposure to beryllium and beryllium-containing materials can cause lung
  cancer.
  1. OSHA's Evaluation of the Evidence Finds That Beryllium Causes
  Sensitization Below the Preceding PEL and Sensitization is a Precursor
  to CBD
      Through the biological and immunological processes outlined in
  section V.B. of the Health Effects, the Agency has concluded that the
  scientific evidence supports the following mechanisms for the
  development of sensitization and CBD.
       Inhaled beryllium and beryllium-containing materials able
  to be retained and solubilized in the lungs have the ability to
  initiate sensitization and facilitate CBD development (section V.B.5).
  Genetic susceptibility may play a role in the development of
  sensitization and progression to CBD in certain individuals.
       Beryllium compounds that dissolve in biological fluids,
  such as sweat, can penetrate intact skin and initiate sensitization
  (section V.A.2; V.B). Phagosomal fluid and lung fluid have the capacity
  to dissolve beryllium compounds in the lung (section V.A.2a).
       Sensitization occurs through a T-cell mediated process
  with both soluble and poorly soluble beryllium and beryllium-containing
  compounds through direct antigen presentation or through further
  antigen processing in the skin or lung. T-cell mediated responses, such
  as sensitization, are generally regarded as long-lasting (e.g., not
  transient or readily reversible) immune conditions (section V.D.1).
       Beryllium sensitization and CBD are adverse events along a
  pathological continuum in the disease process with sensitization being
  the necessary first step in the progression to CBD (section V.D).
       Particle characteristics such as size, solubility, surface
  area, and other properties may play a role in the rate of development
  of beryllium sensitization and CBD. However, there is currently not
  sufficient information to delineate the biological role these
  characteristics may play.
       Animal studies have provided supporting evidence for T-
  cell proliferation in the development of granulomatous lung lesions
  after beryllium exposure (sections V.D.2; V.D.6).
       Since the pathogenesis of CBD involves a beryllium-
  specific, cell-mediated immune response, CBD cannot occur in the
  absence of beryllium sensitization (section V.D.1). While no clinical
  symptoms are associated with sensitization, a sensitized worker is at
  risk of developing CBD when inhalation exposure to beryllium has
  occurred. Epidemiological evidence that covers a wide variety of
  beryllium compounds and industrial processes demonstrates that
  sensitization and CBD are continuing to occur at present-day exposures
  below OSHA's preceding PEL (sections V.D.4; V.D.5 and section VI of
  this preamble).
       OSHA considers CBD to be a progressive illness with a
  continuous spectrum of symptoms ranging from its earliest asymptomatic
  stage following sensitization through to full-blown CBD and death
  (section V.D.7).
       Genetic variabilities appear to enhance risk for
  developing sensitization and CBD in some groups (section V.D.3).
      In addition, epidemiological studies outlined in section V.D.5 have
  demonstrated that efforts to reduce exposures have succeeded in
  reducing the frequency of sensitization and CBD.
  2. OSHA's Evaluation of the Evidence Has Determined Beryllium To Be a
  Human Carcinogen
      OSHA conducted an evaluation of the available scientific
  information regarding the carcinogenic potential of beryllium and
  beryllium-containing compounds (section V.E). Based on the weight of
  evidence and plausible mechanistic information obtained from in vitro
  and in vivo animal studies as well as clinical and epidemiological
  investigations, the Agency has determined that beryllium and beryllium-
  containing materials are properly regarded as human carcinogens. This
  information is in accordance with findings from IARC, NTP, EPA, NIOSH,
  and ACGIH (section V.E). Key points from this analysis are summarized
  briefly here.
       Epidemiological cohort studies have reported statistically
  significant excess lung cancer mortality among workers employed in U.S.
  beryllium production and processing plants during the 1930s to 1970s
  (section V.E.2).
       Significant positive associations were found between lung
  cancer mortality and both average and cumulative beryllium exposures
  when appropriately adjusted for birth cohort and short-term work status
  (section V.E.2).
       Studies in which large amounts of different beryllium
  compounds were inhaled or instilled in the respiratory tracts in
  multiple species of laboratory animals resulted in an increased


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

  VI. Risk Assessment

      To promulgate a standard that regulates workplace exposure to toxic
  materials or harmful physical agents, OSHA must first determine that
  the standard reduces a "significant risk" of "material impairment."
  Section 6(b)(5) of the OSH Act, 29 U.S.C. 655(b). The first part of
  this requirement, "significant risk," refers to the likelihood of
  harm, whereas the second part, "material impairment," refers to the
  severity of the consequences of exposure. Section II, Pertinent Legal
  Authority, of this preamble addresses the statutory bases for these
  requirements and how they have been construed by the Supreme Court and
  federal courts of appeals.
      It is OSHA's practice to evaluate risk to workers and determine the
  significance of that risk based on the best available evidence. Using
  that evidence, OSHA identifies material health impairments associated
  with potentially hazardous occupational exposures, assesses whether
  exposed workers' risks are significant, and determines whether a new or
  revised rule will substantially reduce these risks. As discussed in
  Section II, Pertinent Legal Authority, when determining whether a
  significant risk exists OSHA considers whether there is a risk of at
  least one-in-a-thousand of developing amaterial health impairment from
  a working lifetime of exposure at the prevailing OSHA standard
  (referred to as the "preceding standard" or "preceding TWA PEL" in
  this preamble). For this purpose, OSHA generally assumes that a term of
  45 years constitutes a working life. The Supreme Court has found that
  OSHA is not required to support its finding of significant risk with
  scientific certainty, but may instead rely on a body of reputable
  scientific thought and may make conservative assumptions (i.e., err on
  the side of protecting the worker) in its interpretation of the
  evidence (see Section II, Pertinent Legal Authority).
      For single-substance standards governed by section 6(b)(5) of the
  OSH Act, 29 U.S.C. 655(b)(5), OSHA sets a permissible exposure limit
  (PEL) based on its risk assessment as well as feasibility
  considerations. These health and risk determinations are made in the
  context of a rulemaking record in which the body of evidence used to
  establish material impairment, assess risks, and identify affected
  worker population, as well as the Agency's preliminary risk assessment,
  are placed in a public rulemaking record and subject to public comment.
  Final determinations regarding the standard, including final
  determinations of material impairment and risk, are thus based on
  consideration of the entire rulemaking record.
      OSHA's approach for the risk assessment for beryllium incorporates
  both: (1) A review of the literature on populations of workers exposed
  to beryllium at and below the preceding time-weighted average
  permissible exposure limit (TWA PEL) of 2 μg/m3\; and (2) OSHA's
  own analysis of a data set of beryllium-exposed machinists. The
  Preliminary Risk Assessment included in the NPRM evaluated risk at
  several alternate TWA PELs that the Agency was considering (1 μg/
  m3\, 0.5 μg/m3\, 0.2 μg/m3\, and 0.1 μg/m3\), as well as
  OSHA's preceding TWA PEL of 2 μg/m3\. OSHA's risk assessment relied
  on available epidemiological studies to evaluate the risk of
  sensitization and CBD for workers exposed to beryllium at and below the
  preceding TWA PEL and the effectiveness of exposure control programs in
  reducing risk. OSHA also conducted a statistical analysis of the
  exposure-response relationship for sensitization and CBD at the
  preceding PEL and alternate PELs the Agency was considering. For this
  analysis, OSHA used data provided by National Jewish Health (NJH), a
  leading medical center specializing in the research and treatment of
  CBD, on a population of workers employed at a beryllium machining plant
  in Cullman, AL. The review of the epidemiological studies and OSHA's
  own analysis both show significant risk of sensitization and CBD among
  workers exposed at and below the preceding TWA PEL of 2 μg/m3\.
  They also show substantial reduction in risk where employers
  implemented a combination of controls, including stringent control of
  airborne beryllium levels and additional measures, such as respirators
  and dermal personal protective equipment (PPE) to further protect
  workers against dermal contact and airborne beryllium exposure.
      To evaluate lung cancer risk, OSHA relied on a quantitative risk
  assessment published in 2011 by Schubauer-Berigan et al. (Document ID
  1265). Schubauer-Berigan et al. found that lung cancer risk was
  strongly and significantly related to mean, cumulative, and maximum
  measures of workers' exposure; the authors predicted significant risk
  of lung cancer at the preceding TWA PEL, and substantial reductions in
  risk at the alternate PELs OSHA considered in the proposed rule,
  including the final TWA PEL of 0.2 μg/m3\ (Schubauer-Berigan et
  al., 2011).
      OSHA requested input on the preliminary risk assessment presented
  in the NPRM, and received comments from a variety of public health
  experts and organizations, unions, industrial organizations, individual
  employers, and private citizens. While many comments supported OSHA's
  general approach to the risk assessment and the conclusions of the risk
  assessment, some commenters raised specific concerns with OSHA's
  analytical methods or recommended additional studies for OSHA's
  consideration. Comments about the risk assessment as a whole are
  reviewed here, while comments on specific aspects of the risk
  assessment are addressed in the relevant sections throughout the
  remainder of


  this chapter and in the background document, Risk Analysis of the NJH
  Data Set from the Beryllium Machining Facility in Cullman, Alabama--CBD
  and Sensitization (OSHA, 2016), which can be found in the rulemaking
  docket (docket number OSHA-H005C-2006-0870) at www.regulations.gov.
  Following OSHA's review of all the comments submitted on the
  preliminary risk assessment, and its incorporation of suggested changes
  to the risk assessment, where appropriate, the Agency reaffirms its
  conclusion that workers' risk of material impairment of health from
  beryllium exposure at the preceding PEL of 2 μg/m3\ is significant,
  and is substantially reduced but still significant at the new PEL of
  0.2 μg/m3\ (see this preamble at Section VII, Significance of
  Risk).
      The comments OSHA received on its preliminary risk analysis
  generally supported OSHA's overall approach and conclusions. NIOSH
  indicated that OSHA relied on the best available evidence in its risk
  assessment and concurred with "OSHA's careful review of the available
  literature on [beryllium sensitization] and CBD, OSHA's recognition of
  dermal exposure as a potential pathway for sensitization, and OSHA's
  careful approach to assessing risk for [beryllium sensitization] and
  CBD" (Document ID 1725, p. 3). NIOSH agreed with OSHA's approach to
  the preliminary lung cancer risk assessment (Document ID 1725, p. 7)
  and the selection of a 2011 analysis (Schubauer-Berigan et al., 2011,
  Document ID 1265) as the basis of that risk assessment (Document ID
  1725, p. 7). NIOSH further supported OSHA's preliminary conclusions
  regarding the significance of risk of material health impairment at the
  preceding TWA PEL of 2 μg/m3\, and the substantial reduction of
  such risk at the new TWA PEL of 0.2 μg/m3\ (Document ID 1725, p.
  3). Finally, NIOSH agreed with OSHA's preliminary conclusion that
  compliance with the new PEL would lessen but not eliminate risk to
  exposed workers, noting that OSHA likely underestimated the risks of
  beryllium sensitization and CBD (Document ID 1725, pp. 3-4).
      Other commenters also agreed with the general approach and
  conclusions of OSHA's preliminary risk assessment. NJH, for example,
  determined that "OSHA performed a thorough assessment of risk for
  [beryllium sensitization], CBD and lung cancer using all available
  studies and literature" (Document ID 1664, p. 5). Dr. Kenny Crump and
  Ms. Deborah Proctor commented, on behalf of beryllium producer
  Materion, that they "agree with OSHA's conclusion that there is a
  significant risk (>1/1000 risk of CBD) at the [then] current PEL, and
  that risk is reduced at the proposed PEL (0.2 μg/m3\) in
  combination with stringent measures (ancillary provisions) to reduce
  worker's exposures" (Document ID 1660, p. 2). They further stated that
  OSHA's "finding is evident based on the available literature . . . and
  the prevalence data [OSHA] presented for the Cullman facility"
  (Document ID 1660, p. 2).
      OSHA also received comments objecting to OSHA's conclusions
  regarding risk of lung cancer from beryllium exposure and suggesting
  additional published analyses for OSHA's consideration (e.g., Document
  ID 1659; 1661, pp. 1-3). One comment critiqued the statistical
  exposure-response model OSHA presented as one part of its preliminary
  risk analysis for sensitization and CBD (Document ID 1660). These
  comments are discussed and addressed in the remainder of this chapter.

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

      As discussed in the Health Effects section, studies of beryllium-
  exposed workers conducted using the beryllium lymphocyte proliferation
  test (BeLPT) have found high rates of beryllium sensitization and CBD
  among workers in many industries, including at some facilities where
  exposures were primarily below OSHA's preceding PEL of 2 μg/m3\
  (e.g., Kreiss et al., 1993, Document ID 1478; Henneberger et al., 2001
  (1313); Schuler et al., 2005 (0919); Schuler et al., 2012 (0473)). In
  the mid-1990s, some facilities using beryllium began to aggressively
  monitor and reduce workplace exposures. In the NPRM, OSHA reviewed
  studies of workers at four plants where several rounds of BeLPT
  screening were conducted before and after implementation of new
  exposure control methods. These studies provide the best available
  evidence on the effectiveness of various exposure control measures in
  reducing the risk of sensitization and CBD. The experiences of these
  plants--a copper-beryllium processing facility in Reading, PA, a
  ceramics facility in Tucson, AZ, a beryllium processing facility in
  Elmore, OH, and a machining facility in Cullman, AL--show that
  comprehensive exposure control programs that used engineering controls
  to reduce airborne exposure to beryllium, required the use of
  respiratory protection, controlled dermal contact with beryllium using
  PPE, and employed stringent housekeeping methods to keep work areas
  clean and prevent transfer of beryllium between work areas, sharply
  curtailed new cases of sensitization among newly-hired workers. In
  contrast, efforts to prevent sensitization and CBD by using engineering
  controls to reduce workers' beryllium exposures to median levels around
  0.2 μg/m3\, with no corresponding emphasis on PPE, were less
  effective than comprehensive exposure control programs implemented more
  recently. OSHA also reviewed additional, but more limited, information
  on the occurrence of sensitization and CBD among workers with low-level
  beryllium exposures at nuclear facilities and aluminum smelting plants.
  A summary discussion of the experiences at all of these facilities is
  provided in this section. Additional discussion of studies on these
  facilities and several other studies of sensitization and CBD among
  beryllium-exposed workers is provided in Section V, Health Effects.
      The Health Effects section also discusses OSHA's findings and the
  supporting evidence concerning the role of particle characteristics and
  beryllium compound solubility in the development of sensitization and
  CBD among beryllium-exposed workers. First, it finds that respirable
  particles small enough to reach the deep lung are responsible for CBD.
  However, larger inhalable particles that deposit in the upper
  respiratory tract may lead to sensitization. Second, it finds that both
  soluble and poorly soluble forms of beryllium are able to induce
  sensitization and CBD. Poorly soluble forms of beryllium that persist
  in the lung for longer periods may pose greater risk of CBD while
  soluble forms may more easily trigger immune sensitization. Although
  particle size and solubility may influence the toxicity of beryllium,
  the available data are too limited to reliably account for these
  factors in the Agency's estimates of risk.
  1. Reading, PA, Plant
      Schuler et al. (2005, Document ID 0919) and Thomas et al. (2009,
  Document ID 0590) conducted studies of workers at a copper-beryllium
  processing facility in Reading, PA. Exposures at this plant were
  believed to be low throughout its history due to both the low
  percentage of beryllium in the metal alloys used and the relatively low
  exposures found in general area samples collected starting in 1969
  (sample median <=0.1 μg/m3\, 97% < 0.5 μg/m3\) (Schuler et al.,
  2005). Ninety-nine percent of personal lapel sample measurements were
  below the preceding OSHA TWA PEL of 2 μg/m3\; 93 percent were below
  the new TWA


  PEL of 0.2 μg/m3\ (Schuler et al., 2005). Schuler et al. (2005)
  screened 152 workers at the facility with the BeLPT in 2000. The
  reported prevalences of sensitization (6.5 percent) and CBD (3.9
  percent) showed substantial risk at this facility, even though airborne
  exposures were primarily below both the preceding and final TWA
  PELs.\11\ The only group of workers with no cases of sensitization or
  CBD, a group of 26 office administration workers, was the group with
  the lowest recorded exposures (median personal sample 0.01 μg/m3\,
  range <0.01-0.06 μg/m3\ (Schuler et al., 2005).
  ---------------------------------------------------------------------------

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

      After the initial BeLPT screening was conducted in 2000, the
  company began implementing new measures to further reduce workers'
  exposure to beryllium (Thomas et al. 2009, Document ID 0590).
  Requirements designed to minimize dermal contact with beryllium,
  including long-sleeve facility uniforms and polymer gloves, were
  instituted in production areas in 2000-2002. In 2001, the company
  installed local exhaust ventilation (LEV) in die grinding and polishing
  operations (Thomas et al., 2009, Figure 1). Personal lapel samples
  collected between June 2000 and December 2001, showed reduced exposures
  plant-wide (98 percent were below 0.2 μg/m3\). Median, arithmetic
  mean, and geometric mean values less than or equal to 0.03 μg/m3\
  were reported in this period for all processes except one, a wire
  annealing and pickling process. Samples for this process remained
  elevated, with a median of 0.1 μg/m3\ (arithmetic mean of 0.127
  μg/m3\, geometric mean of 0.083 μg/m3\) (Thomas et al., 2009,
  Table 3). In January 2002, the company enclosed the wire annealing and
  pickling process in a restricted access zone (RAZ). Beginning in 2002,
  the company required use of powered air-purifying respirators (PAPRs)
  in the RAZ, and implemented stringent measures to minimize the
  potential for skin contact and beryllium transfer out of the zone, such
  as requiring RAZ workers to shower before leaving the zone (Thomas et
  al., 2009, Figure 1). While exposure samples collected by the facility
  were sparse following the enclosure, they suggest exposure levels
  comparable to the 2000-2001 samples in areas other than the RAZ (Thomas
  et al., 2009, Table 3). The authors reported that outside the RAZ,
  "the vast majority of employees do not wear any form of respiratory
  protection due to very low airborne beryllium concentrations" (Thomas
  et al., 2009, p. 122).
      To test the efficacy of the new measures in preventing
  sensitization and CBD, in June 2000 the facility began an intensive
  BeLPT screening program for all new workers (Thomas et al., 2009,
  Document ID 0590). Among 82 workers hired after 1999, three cases of
  sensitization were found (3.7 percent). Two (5.4 percent) of 37 workers
  hired prior to enclosure of the wire annealing and pickling process,
  which had been releasing beryllium into the surrounding area, were
  found to be sensitized within 3 and 6 months of beginning work at the
  plant. One (2.2 percent) of 45 workers hired after the enclosure was
  built was confirmed as sensitized. From these early results comparing
  the screening conducted on workers hired before 2000 and those hired in
  2000 and later, especially following the enclosure of the RAZ, it
  appears that the greatest reduction in sensitization risk (to one
  sensitized worker, or 2.2 percent) was achieved after workers'
  exposures were reduced to below 0.1 μg/m3\ and PPE to prevent
  dermal contact was instituted (Thomas et al., 2009).
  2. Tucson, AZ, Plant
      Kreiss et al. (1996, Document ID 1477), Cummings et al. (2007,
  Document ID 1369), and Henneberger et al. (2001, Document ID 1313)
  conducted studies of workers at a beryllia ceramics plant in Tucson,
  Arizona. Kreiss et al. (1996) screened 136 workers at this plant with
  the BeLPT in 1992. Full-shift area samples collected between 1983 and
  1992 showed primarily low airborne beryllium levels at this facility
  (76 percent of area samples were at or below 0.1 μg/m3\ and less
  than 1 percent exceeded 2 μg/m3\). 4,133 short-term breathing zone
  measurements collected between 1981 and 1992 had a median of 0.3 μg/
  m3\. A small set (75) of personal lapel samples collected at the plant
  beginning in 1991 had a median of 0.2 μg/m3\ and ranged from 0.1 to
  1.8 μg/m3\ (arithmetic and geometric mean values not reported)
  (Kreiss et al., 1996).
      Kreiss et al. reported that eight (5.9 percent) of the 136 workers
  tested in 1992 were sensitized, six (4.4 percent) of whom were
  diagnosed with CBD. One sensitized worker was one of 13 administrative
  workers screened, and was among those diagnosed with CBD. Exposures of
  administrative workers were not well characterized, but were believed
  to be among the lowest in the plant. Personal lapel samples taken on
  administrative workers during the 1990s were below the detection limit
  at the time, 0.2 μg/m3\ (Cummings et al., 2007, Document ID 1369).
      Following the 1992 screening, the facility reduced exposures in
  machining areas (for example, by enclosing additional machines and
  installing additional exhaust ventilation), resulting in median
  exposures of 0.2 μg/m3\ in production jobs and 0.1 μg/m3\ in
  production support jobs (Cummings et al., 2007). In 1998, a second
  screening found that 7 out of 74 tested workers hired after the 1992
  screening (9.5 percent) were sensitized, one of whom was diagnosed with
  CBD. All seven of these sensitized workers had been employed at the
  plant for less than two years (Henneberger et al., 2001, Document ID
  1313, Table 3). Of 77 Tucson workers hired prior to 1992 who were
  tested in 1998, 8 (10.4 percent) were sensitized and 7 of these (9.7
  percent) were diagnosed with CBD (Henneberger et al., 2001).
      Following the 1998 screening, the company continued efforts to
  reduce exposures, along with risk of sensitization and CBD, by
  implementing additional engineering and administrative controls and a
  comprehensive PPE program which included the use of respiratory
  protection (1999) and latex gloves (2000) (Cummings et al., 2007,
  Document ID 1369). Enclosures were installed for various beryllium-
  releasing processes by 2001. Between 2000 and 2003, water-resistant or
  water-proof garments, shoe covers, and taped gloves were incorporated
  to keep beryllium-containing fluids from wet machining processes off
  the skin. To test the efficacy of the new measures instituted after
  1998, in January 2000 the company began screening new workers for
  sensitization at the time of hire and at 3, 6, 12, 24, and 48 months of
  employment. These more stringent measures appear to have substantially
  reduced the risk of sensitization among new employees. Of 97 workers
  hired between 2000 and 2004, one case of sensitization was identified
  (1 percent) (Cummings et al., 2007).
  3. Elmore, OH, Plant
      Kreiss et al. (1997, Document ID 1360), Bailey et al. (2010,
  Document ID 0676), and Schuler et al. (2012, Document ID 0473)
  conducted studies of workers at a beryllium metal, alloy, and oxide
  production plant in Elmore, Ohio. Workers participated in several
  plant-wide BeLPT surveys beginning in 1993-1994 (Kreiss et al., 1997;
  Schuler et al., 2012) and in a series of screenings


  for workers hired in 2000 and later, conducted beginning in 2000
  (Bailey et al., 2010).
      Exposure levels at the plant between 1984 and 1993 were
  characterized using a mixture of general area, short-term breathing
  zone, and personal lapel samples (Kreiss et al., 1997, Document ID
  1360). Kreiss et al. reported that the median area samples for various
  work areas ranged from 0.1 to 0.7 µg/m3\, with the highest
  values in the alloy arc furnace and alloy melting-casting areas.
  Personal lapel samples were available from 1990-1992, and showed high
  exposures overall (median value of 1.0 µg/m3\), with very high
  exposures for some processes. Kreiss et al. reported median sample
  values from the personal lapel samples of 3.8 µg/m3\ for
  beryllium oxide production, 1.75 µg/m3\ for alloy melting and
  casting, and 1.75 µg/m3\ for the arc furnace. The authors
  reported that 43 (6.9 percent) of 627 workers tested in 1993-1994 were
  sensitized. 29 workers (including 5 previously identified) were
  diagnosed with CBD (29/632, or 4.6 percent) (Kreiss et al., 1997).
      In 1996-1999, the company took further steps to reduce workers'
  beryllium exposures, including enclosure of some beryllium-releasing
  processes, establishment of restricted-access zones, and installation
  or updating of certain engineering controls (Bailey et al., 2010,
  Document ID 0676, Tables 1-2). Beginning in 1999, all new employees
  were required to wear loose-fitting PAPRs in manufacturing buildings.
  Skin protection became part of the protection program for new employees
  in 2000, and glove use was required in production areas and for
  handling work boots beginning in 2001. By 2001, either half-mask
  respirators or PAPRs were required throughout the production facility
  (type determined by airborne beryllium levels) and respiratory
  protection was required for roof work and during removal of work boots
  (Bailey et al., 2010).
      Beginning in 2000, newly hired workers were offered periodic BeLPT
  testing to evaluate the effectiveness of the new exposure control
  program implemented by the company (Bailey et al., 2010). Bailey et al.
  compared the occurrence of beryllium sensitization and disease among
  258 employees who began work at the Elmore plant between January 15,
  1993 and August 9, 1999 (the "pre-program group") with that of 290
  employees who were hired between February 21, 2000 and December 18,
  2006, and were tested at least once after hire (the "program group").
  They found that, as of 1999, 23 (8.9 percent) of the pre-program group
  were sensitized to beryllium. Six (2.1 percent) of the program group
  had confirmed abnormal results on their final round of BeLPTs, which
  occurred in different years for different employees. This four-fold
  reduction in sensitization suggests that beryllium-exposed workers'
  risk of sensitization (and therefore of CBD, which develops only
  following sensitization) can be much reduced by the combination of
  process controls, respiratory protection requirements, and PPE
  requirements applied in this facility. Because most of the workers in
  the study had been employed at the facility for less than two years,
  and CBD typically develops over a longer period of time (see section V,
  Health Effects), Bailey et al. did not report the incidence of CBD
  among the sensitized workers (Bailey et al., 2010). Schuler et al.
  (2012, Document ID 0473) published a study examining beryllium
  sensitization and CBD among short-term workers at the Elmore, OH plant,
  using exposure estimates created by Virji et al. (2012, Document ID
  0466). The study population included 264 workers employed in 1999 with
  up to 6 years tenure at the plant (91 percent of the 291 eligible
  workers). By including only short-term workers, Virji et al. were able
  to construct participants' exposures with more precision than was
  possible in studies involving workers exposed for longer durations and
  in time periods with less exposure sampling. A set of 1999 exposure
  surveys and employee work histories was used to estimate employees'
  long-term lifetime weighted (LTW) average, cumulative, and highest-job-
  worked exposures for total, respirable, and submicron beryllium mass
  concentrations (Schuler et al., 2012; Virji et al., 2012).
      As reported by Schuler et al. (2012), the overall prevalence of
  sensitization was 9.8 percent (26/264). Sensitized workers were offered
  further evaluation for CBD. Twenty-two sensitized workers consented to
  clinical testing for CBD via transbronchial biopsy. Although follow-up
  time was too short (at most 6 years) to fully evaluate CBD in this
  group, 6 of those sensitized were diagnosed with CBD (2.3 percent, 6/
  264). Schuler et al. (2012) found 17 cases of sensitization (8.6%)
  within the first 3 quartiles of LTW average exposure (198 workers with
  LTW average total mass exposures lower than 1.1 µg/m3\) and 4
  cases of CBD (2.2%) within those first 3 quartiles (183 workers with
  LTW average total mass exposures lower than 1.07 µg/m3\)\12\ The
  authors found 3 cases (4.6%) of sensitization among 66 workers with
  total mass LTW average exposures below 0.1 µg/m3\, and no cases
  of sensitization among workers with total mass LTW average exposures
  below 0.09 µg/m3\, suggesting that beryllium-exposed workers'
  risk can be much reduced or eliminated by reducing airborne exposures
  to average levels below 0.1 µg/m3\.
  ---------------------------------------------------------------------------

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

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

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

      Materion submitted comments supporting OSHA's use of the Schuler et
  al. (2012) study as a basis for the final TWA PEL of 0.2 µg/m3\.
  Materion stated that "the best available evidence to establish a risk-
  based OEL [occupational exposure limit] is the study conducted by NIOSH
  and presented in Schuler 2012. The exposure assessment in


  Schuler et al. was based on a highly robust workplace monitoring
  dataset and the study provides improved data for determining OELs"
  (Document ID 1661, pp. 9-10). Materion also submitted an unpublished
  manuscript documenting an analysis it commissioned, entitled "Derived
  No-Effect Levels for Occupational Beryllium Exposure Using Cluster
  Analysis and Benchmark Dose Modeling" (Proctor et al., Document ID
  1661, Attachment 5). In this document, Proctor et al. used data from
  Schuler et al. 2012 to develop a Derived No-Effect Level (DNEL) for
  beryllium measured as respirable beryllium, total mass of beryllium,
  and inhalable beryllium.\14\ OSHA's beryllium standard measures
  beryllium as total mass; thus, the results for total mass are most
  relevant to OSHA's risk analysis for the beryllium standard. The
  assessment reported a DNEL of 0.14 µg/m3\ for total mass
  beryllium (Document ID 1661, Attachment 5, p. 16). Materion commented
  that this finding "add[s] to the body of evidence that supports the
  fact that OSHA is justified in lowering the existing PEL to 0.2
  µg/m3\" (Document ID 1661, p. 11).
  ---------------------------------------------------------------------------

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

      Proctor et al. characterized the DNEL of 0.14 µg/m3\ as
  "inherently conservative because average exposure metrics were used to
  determine DNELs, which are limits not [to] be exceeded on a daily
  basis" (Document ID 1661, Attachment 5, p. 22). Materion referred to
  the DNELs derived by Proctor et al. as providing an "additional margin
  of safety" for similar reasons (Document ID 1661, p. 11).
      Consistent with NIOSH comments discussed in the next paragraph,
  OSHA disagrees with this characterization of the DNEL as representing a
  "no effect level" for CBD or as providing a margin of safety for
  several reasons. The DNEL from Proctor et al. is based on CBD findings
  among a short-term worker population and thus cannot represent the risk
  presented to workers who are exposed over a working lifetime. Proctor
  et al. noted that it is "important to consider that these data are
  from relatively short-term exposures [median tenure 20.9 months] and
  are being used to support DNELs for lifetime occupational exposures,"
  but considered the duration of exposure to be sufficient because "CBD
  can develop with latency as short as 3 months of exposure, and . . .
  the risk of CBD declines over time" (Document ID 1661, Attachment 5,
  p. 19). In stating this, Procter et al. cite studies by Newman et al.
  (2001, Document ID 1354) and Harber et al. (2009, as cited in Document
  ID 1661). Newman et al. (2001) studied a group of workers in a
  machining plant with job tenures averaging 11.7 years, considerably
  longer than the worker cohort from the study used by Procter et al.,
  and identified new cases of CBD from health screenings conducted up to
  4 years after an initial screening. Harber et al., (2009) developed an
  analytic model of disease progression from beryllium exposure and found
  that, although the rate at which new cases of CBD declined over time,
  the overall proportion of individuals with CBD increased over time from
  initial exposure (see Figure 2 of Haber et al., 2009). Furthermore, the
  study used by Proctor et al. to derive the DNEL, Schuler et al. (2012),
  did report finding that the risk of CBD increased with cumulative
  exposure to beryllium, as summarized above. Therefore, OSHA is not
  convinced that a "no effect level" for beryllium that is based on the
  health experience of workers with a median job tenure of 20.9 months
  can represent a "no-effect level" for workers exposed to beryllium
  for as long as 45 years.
      NIOSH commented on the results of Proctor et al.'s analysis and the
  underlying data set, noting several features of the dataset that are
  common to the beryllium literature, such as uncertain date of
  sensitization or onset of CBD and no "background" rate of beryllium
  sensitization or CBD, that make statistical analyses of the data
  difficult and add uncertainty to the derivation of a DNEL (Document ID
  1725, p. 5). NIOSH also noted that risk of CBD may be underestimated in
  the underlying data set if workers with CBD were leaving employment
  due, in part, to adverse health effects ("unmeasured survivor bias")
  and estimated that as much as 30 percent of the cohort could have been
  lost over the 6-year testing period (Document ID 1725, p. 5). NIOSH
  concluded that Proctor et al.'s analysis "does not contribute to the
  risk assessment for beryllium workers" (Document ID 1725, p. 5). OSHA
  agrees with NIOSH that the DNEL identified by Proctor et al. cannot be
  considered a reliable estimate of a no-effect level for beryllium.
  4. Cullman, AL, Plant
      Newman et al. (2001, Document ID 1354), Kelleher et al. (2001,
  Document ID 1363), and Madl et al. (2007, Document ID 1056) studied
  beryllium workers at a precision machining facility in Cullman,
  Alabama. After a case of CBD was diagnosed at the plant in 1995, the
  company began BeLPT screenings to identify workers at risk of CBD and
  implemented engineering and administrative controls designed to reduce
  workers' beryllium exposures in machining operations. Newman et al.
  (2001) conducted a series of BeLPT screenings of workers at the
  facility between 1995 and 1999. The authors reported 22 (9.4 percent)
  sensitized workers among 235 tested, 13 of whom were diagnosed with CBD
  within the study period. Personal lapel samples collected between 1980
  and 1999 indicate that median exposures were generally well below the
  preceding PEL (<=0.35 µg/m3\ in all job titles except
  maintenance (median 3.1 µg/m3\ during 1980-1995) and gas
  bearings (1.05 µg/m3\ during 1980-1995)).
      Between 1995 and 1999, the company built enclosures around several
  beryllium-releasing operations; installed or updated LEV for several
  machining departments; replaced pressurized air hoses and dry sweeping
  with wet methods and vacuum systems for cleaning; changed the layout of
  the plant to keep beryllium-releasing processes close together; limited
  access to the production area of the plant; and required the use of
  company uniforms. Madl et al. (2007, Document ID 1056) reported that
  engineering and work process controls, rather than personal protective
  equipment, were used to limit workers' exposure to beryllium. In
  contrast to the Reading and Tucson plants, gloves were not required at
  this plant. Personal lapel samples collected extensively between 1996
  and 1999 in machining and non-machining jobs had medians of 0.16
  µg/m3\ and 0.08 µg/m3\, respectively (Madl et al., 2007,
  Table IV). At the time that Newman et al. reviewed the results of BeLPT
  screenings conducted in 1995-1999, a subset of 60 workers had been
  employed at the plant for less than a year and had therefore benefitted
  to some extent from the controls described above. Four (6.7 percent) of
  these workers were found to be sensitized, of whom two were diagnosed
  with CBD and one with probable CBD (Newman et al., 2001, Document ID
  1354). The later study by Madl. et al. reported seven sensitized
  workers who had been hired between 1995 and 1999, of whom four had
  developed CBD as of 2005 (2007, Table II) (total number of workers
  hired between 1995 and 1999 not reported).
      Beginning in 2000 (after the implementation of controls between
  1997 and 1999), exposures in all jobs at the machining facility were
  reduced to


  extremely low levels (Madl et al., 2007, Document ID 1056). Personal
  lapel samples collected between 2000 and 2005 had a median of 0.12
  µg/m3\ or less in all machining and non-machining processes
  (Madl. et al., 2007, Table IV). Only one worker hired after 1999 became
  sensitized (Madl et al. 2007, Table II). The worker had been employed
  for 2.7 years in chemical finishing, which had the highest median
  exposure of 0.12 µg/m3\ (medians for other processes ranged from
  0.02 to 0.11 µg/m3\); Madl et al. 2007, Table II). This result
  from Madl et al. (2007) suggests that beryllium-exposed workers' risk
  of sensitization can be much reduced by steps taken to reduce workers'
  airborne exposures in this facility, including enclosure of beryllium-
  releasing processes, LEV, wet methods and vacuum systems for cleaning,
  and limiting worker access to production areas.
      The Cullman, AL facility was also the subject of a case-control
  study published by Kelleher et al. in 2001 (Document ID 1363). After
  the diagnosis of a case of CBD at the plant in 1995, NJH researchers,
  including Kelleher, worked with the plant to conduct the medical
  surveillance program mentioned above, using the BeLPT to screen workers
  biennially for beryllium sensitization and offering sensitized workers
  further evaluation for CBD (Kelleher et al., 2001). Concurrently,
  research was underway by Martyny et al. to characterize the particle
  size distribution of beryllium exposures generated by processes at this
  plant (Martyny et al., 2000, Document ID 1358). Kelleher et al. used
  the dataset of 100 personal lapel samples collected by Martyny et al.
  and other NJH researchers to characterize exposures for each job in the
  plant. Detailed work history information gathered from plant data and
  worker interviews was used in combination with job exposure estimates
  to characterize cumulative and LTW average beryllium exposures for
  workers in the surveillance program. In addition to cumulative and LTW
  average exposure estimates based on the total mass of beryllium
  reported in their exposure samples, Kelleher et al. calculated
  cumulative and LTW average estimates based specifically on exposure to
  particles <6 μm and particles <1 μm in diameter. To analyze the
  relationship between exposure level and risk of sensitization and CBD,
  Kelleher et al. performed a case-control analysis using measures of
  both total beryllium exposure and particle size-fractionated exposure.
  The results, however, were inconclusive, probably due to the relatively
  small size of the dataset (Kelleher et al., 2001).
  5. Aluminum Smelting Plants
      Taiwo et al. (2008, Document ID 0621; 2010 (0583) and Nilsen et al.
  (2010, Document ID 0460) studied the relationship between beryllium
  exposure and adverse health effects among workers at aluminum smelting
  plants. Taiwo et al. (2008) studied a population of 734 employees at 4
  aluminum smelters located in Canada (2), Italy (1), and the United
  States (1). In 2000, a company-wide beryllium exposure limit of 0.2
  μg/m3\ and an action level of 0.1 μg/m3\, expressed as 8-hour
  TWAs, and a short-term exposure limit (STEL) of 1.0 μg/m3\ (15-
  minute sample) were instituted at these plants. Sampling to determine
  compliance with the exposure limit began at all four smelters in 2000.
  Table VI-1 below, adapted from Taiwo et al. (2008), shows summary
  information on samples collected from the start of sampling through
  2005.

                               Table VI-1--Exposure Sampling Data By Plant--2000-2005
  ----------------------------------------------------------------------------------------------------------------
                                                                                      Arithmetic
                       Smelter                      Number samples  Median (μg/   mean (μg/   Geometric mean
                                                                         m3\)           m3\)       (μg/m3\)
  ----------------------------------------------------------------------------------------------------------------
  Canadian smelter 1..............................             246            0.03            0.09            0.03
  Canadian smelter 2..............................             329            0.11            0.29            0.08
  Italian smelter.................................              44            0.12            0.14            0.10
  US smelter......................................             346            0.03            0.26            0.04
  ----------------------------------------------------------------------------------------------------------------
  Adapted from Taiwo et al., 2008, Document ID 0621, Table 1.

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

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

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


  criteria to determine "significant" exposure, and the criteria
  appeared to vary considerably (Taiwo et al., 2010); thus, it is
  difficult to compare rates of sensitization across companies in this
  study. 1932 workers, about 60 percent of invited workers, participated
  in the program between 2000 and 2006, of whom 9 were determined to be
  sensitized (.4 percent). The authors stated that all nine workers were
  referred to a respiratory physician for further evaluation for CBD. Two
  were diagnosed with CBD (.1 percent), as described above (see Taiwo et
  al., 2008).
      In general, there appeared to be a low level of sensitization and
  CBD among employees at the aluminum smelters studied by Taiwo et al.
  (2008; 2010). This is striking in light of the fact that many of the
  employees tested had worked at the smelters long before the institution
  of exposure limits for beryllium at some smelters in 2000. However, the
  authors noted that respiratory and dermal protection had been used at
  these plants to protect workers from other hazards (Taiwo et al.,
  2008).
      A study by Nilsen et al. (2010, Document ID 0460) of aluminum
  workers in Norway also found a low rate of sensitization. In the study,
  362 workers and 31 control individuals received BeLPT testing for
  beryllium sensitization. The authors found one sensitized worker (0.28
  percent). No borderline results were reported. The authors reported
  that exposure measurements in this plant ranged from 0.1 μg/m3\ to
  0.31 μg/m3\ (Nilsen et al., 2010) and that respiratory protection
  was in use, as was the case in the smelters studied by Taiwo et al.
  (2008; 2010).
  6. Nuclear Weapons Facilities
      Viet et al. (2000, Document ID 1344) and Arjomandi et al. (2010,
  Document ID 1275) evaluated beryllium-exposed nuclear weapons workers.
  In 2000, Viet et al. published a case-control study of participants in
  the Rocky Flats Beryllium Health Surveillance Program (BHSP), which was
  established in 1991 to screen workers at the Department of Energy's
  Rocky Flats, CO, nuclear weapons facility for beryllium sensitization
  and evaluate sensitized workers for CBD. The program, which the authors
  reported had tested over 5,000 current and former Rocky Flats employees
  for sensitization, had identified a total of 127 sensitized individuals
  as of 1994 when Viet et al. initiated their study; 51 of these
  sensitized individuals had been diagnosed with CBD.
      Using subjects from the BHSP, Viet et al. (2000) matched a total of
  50 CBD cases to 50 controls who tested negative for beryllium
  sensitization and had the same age ( 3 years), gender, race
  and smoking status, and were otherwise randomly selected from the
  database. Using the same matching criteria, 74 sensitized workers who
  were not diagnosed with CBD were matched to 74 control individuals from
  the BHSP database who tested negative for beryllium sensitization.
      Viet et al. (2000) developed exposure estimates for the cases and
  controls based on daily fixed airhead (FAH) beryllium air samples
  collected in one of 36 buildings at Rocky Flats where beryllium was
  used, the Building 444 Beryllium Machine Shop. Annual mean FAH samples
  in Building 444 collected between 1960 and 1988 ranged from a low of
  0.096 μg/m3\ (1988) to a high of 0.622 μg/m3\ (1964) (Viet et
  al., 2000, Table II). Because exposures in this shop were better
  characterized than in other buildings, the authors developed estimates
  of exposures for all workers based on samples from Building 444. The
  authors' statistical analysis of the resulting data set included
  conditional logistic regression analysis, modeling the relationship
  between risk of each health outcome and individuals' log-transformed
  cumulative exposure estimate (CEE) and mean exposure estimate (MEE).
  These coefficients corresponded to odds ratios of 6.9 and 7.2 per 10-
  fold increase in exposure, respectively. Risk of sensitization without
  CBD did not show a statistically significant relationship with log-CEE
  (coef = 0.111, p = 0.32), but showed a nearly-significant relationship
  with log-MEE (coef = 0.230, p = 0.097). Viet et al. found highly
  statistically significant relationships between log-CEE and risk of CBD
  (coef = 0.837, p = 0.0006) and between log-MEE (coef = 0.855, p =
  0.0012) and risk of CBD, indicating that risk of CBD increases with
  exposure level.
      Arjomandi et al. (2010) published a study of 50 sensitized workers
  from a nuclear weapons research and development facility who were
  evaluated for CBD. Quantitative exposure estimates for the workers were
  not presented; however, the authors characterized their likely
  exposures as low (possibly below 0.1 μg/m3\ for most jobs). In
  contrast to the studies of low-exposure populations discussed
  previously, this group had much longer follow-up time (mean time since
  first exposure = 32 years) and length of employment at the facility
  (mean of 18 years).
      Five of the 50 evaluated workers (10 percent) were diagnosed with
  CBD based on histology or high-resolution computed tomography. An
  additional three (who had not undergone full clinical evaluation for
  CBD) were identified as probable CBD cases, bringing the total
  prevalence of CBD and probable CBD in this group to 16 percent. OSHA
  notes that this prevalence of CBD among sensitized workers is lower
  than the prevalence of CBD that has been observed in some other worker
  groups known to have exposures exceeding the action level of 0.1 μg/
  m3\. For example, as discussed above, Newman et al. (2001, Document ID
  1354) reported 22 sensitized workers, 13 of whom (59 percent) were
  diagnosed with CBD within the study period. Comparison of these results
  suggests that controlling respiratory exposure to beryllium may reduce
  risk of CBD among already-sensitized workers as well as reducing risk
  of CBD via prevention of sensitization. However, it also demonstrates
  that some workers in low-exposure environments can become sensitized
  and then develop CBD.
  7. Conclusions
      The published literature on beryllium sensitization and CBD
  discussed above shows that risk of both health effects can be
  significant in workplaces in compliance with OSHA's preceding PEL
  (e.g., Kreiss et al., 1996, Document ID 1477; Henneberger et al., 2001
  (1313); Newman et al., 2001 (1354); Schuler et al., 2005 (0919), 2012
  (0473); Madl et al., 2007 (1056)). For example, in the Tucson beryllia
  ceramics plant discussed above, Kreiss et al. (1996) reported that 8
  (5.9 percent) of the 136 workers tested in 1992 were sensitized, 6 (4.4
  percent) of whom were diagnosed with CBD. In addition, of 77 Tucson
  workers hired prior to 1992 who were tested in 1998, 8 (10.4 percent)
  were sensitized and 7 of these (9.7 percent) were diagnosed with CBD
  (Henneberger et al., 2001, Document ID 1313). Full-shift area samples
  showed airborne beryllium levels below the preceding PEL (76 percent of
  area samples collected between 1983 and 1992 were at or below 0.1
  μg/m3\ and less than 1 percent exceeded 2 μg/m3\; short-term
  breathing zone measurements collected between 1981 and 1992 had a
  median of 0.3 μg/m3\; personal lapel samples collected at the plant
  beginning in 1991 had a median of 0.2 μg/m3\) (Kreiss et al.,
  1996).
      Results from the Elmore, OH beryllium metal, alloy, and oxide
  production plant and Cullman, AL machining facility also showed
  significant risk of sensitization and CBD


  among workers with exposures below the preceding TWA PEL. Schuler et
  al. (2012, Document ID 0473) found 17 cases of sensitization (8.6%)
  among Elmore, OH workers within the first three quartiles of LTW
  average exposure (198 workers with LTW average total mass exposures
  lower than 1.1 μg/m3\) and 4 cases of CBD (2.2%) within the first
  three quartiles of LTW average exposure (183 workers with LTW average
  total mass exposures lower than 1.07 μg/m3\; note that follow-up
  time of up to 6 years for all study participants was very short for
  development of CBD). At the Cullman, AL machining facility, Newman et
  al. (2001, Document ID 1354) reported 22 (9.4 percent) sensitized
  workers among 235 tested in 1995-1999, 13 of whom were diagnosed with
  CBD. Personal lapel samples collected between 1980 and 1999 indicate
  that median exposures were generally well below the preceding PEL
  (<=0.35 μg/m3\ in all job titles except maintenance (median 3.1
  μg/m3\ during 1980-1995) and gas bearings (1.05 μg/m3\ during
  1980-1995)).
      There is evidence in the literature that although risk will be
  reduced by compliance with the new TWA PEL, significant risk of
  sensitization and CBD will remain in workplaces in compliance with
  OSHA's new TWA PEL of 0.2 μg/m3\ and could extend down to the new
  action level of 0.1 μg/m3\, although there is less information and
  therefore greater uncertainty with respect to significant risk from
  airborne beryllium exposures at and below the action level. For
  example, Schuler et al. (2005, Document ID 0919) reported substantial
  prevalences of sensitization (6.5 percent) and CBD (3.9 percent) among
  152 workers at the Reading, PA facility who had BeLPT screening in
  2000. These results showed significant risk at this facility, even
  though airborne exposures were primarily below both the preceding and
  final TWA PELs due to the low percentage of beryllium in the metal
  alloys used (median general area samples <=0.1 μg/m3\, 97% <=0.5
  μg/m3\); 93% of personal lapel samples were below the new TWA PEL
  of 0.2 μg/m3\). The only group of workers with no cases of
  sensitization or CBD, a group of 26 office administration workers, was
  the group with exposures below the new action level of 0.1 μg/m3\
  (median personal sample 0.01 μg/m3\, range <0.01-0.06 μg/m3\
  (Schuler et al., 2005). The Schuler et al. (2012, Document ID 0473)
  study of short-term workers in the Elmore, OH facility found 3 cases
  (4.6%) of sensitization among 66 workers with total mass LTW average
  exposures below 0.1 μg/m3\; 3 of these workers had LTW average
  exposures of approximately 0.09 μg/m3\.
      Furthermore, cases of sensitization and CBD continued to arise in
  the Cullman, AL machining plant after control measures implemented
  beginning in 1995 brought median airborne exposures below 0.2 μg/
  m3\ (personal lapel samples between 1996 and 1999 in machining jobs
  had a median of 0.16 μg/m3\ and 0.08 μg/m3\ in non-machining
  jobs) (Madl et al., 2007, Document ID 1056, Table IV). At the time that
  Newman et al. (2001, Document ID 1354) reviewed the results of BeLPT
  screenings conducted in 1995-1999, a subset of 60 workers had been
  employed at the plant for less than a year and had therefore benefitted
  to some extent from the exposure reductions. Four (6.7 percent) of
  these workers were found to be sensitized, two of whom were diagnosed
  with CBD and one with probable CBD (Newman et al., 2001). A later study
  by Madl. et al. (2007, Document ID 1056) reported seven sensitized
  workers who had been hired between 1995 and 1999, of whom four had
  developed CBD as of 2005 (Table II; total number of workers hired
  between 1995 and 1999 not reported).
      The experiences of several facilities in developing effective
  industrial hygiene programs have shown the importance of minimizing
  both airborne exposure and dermal contact to effectively reduce risk of
  sensitization and CBD. Exposure control programs that have used a
  combination of engineering controls and PPE to reduce workers' airborne
  exposure and dermal contact have substantially lowered risk of
  sensitization among newly hired workers.\15\ Of 97 workers hired
  between 2000 and 2004 in the Tucson, AZ plant after the introduction of
  mandatory respirator use in production areas beginning in 1999 and
  mandatory use of latex gloves beginning in 2000, one case of
  sensitization was identified (1 percent) (Cummings et al., 2007,
  Document ID 1369). In Elmore, OH, where all workers were required to
  wear respirators and skin PPE in production areas beginning in 2000-
  2001, the estimated prevalence of sensitization among workers hired
  after these measures were put in place was around 2 percent (Bailey et
  al., 2010, Document ID 0676). In the Reading, PA facility, only one
  (2.2 percent) of 45 workers hired after workers' exposures were reduced
  to below 0.1 μg/m3\ and PPE to prevent dermal contact was
  instituted was sensitized (Thomas et al., 2009, Document ID 0590). And,
  in the aluminum smelters discussed by Taiwo et al. (2008, Document ID
  0621), where available exposure samples from four plants indicated
  median beryllium levels of about 0.1 μg/m3\ or below (measured as
  an 8-hour TWA) and workers used respiratory and dermal protection,
  confirmed cases of sensitization were rare (zero or one case per
  location).
  ---------------------------------------------------------------------------

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

      OSHA recognizes that the studies on recent programs to reduce
  workers' risk of sensitization and CBD were conducted on populations
  with very short exposure and follow-up time. Therefore, they could not
  adequately address the question of how frequently workers who become
  sensitized in environments with extremely low airborne exposures
  (median <0.1 μg/m3\) develop CBD. Clinical evaluation for CBD was
  not reported for sensitized workers identified in the studies examining
  the post-2000, very low-exposed worker cohorts in Tucson, Reading, and
  Elmore (Cummings et al. 2007, Document ID 1369; Thomas et al. 2009
  (0590); Bailey et al. 2010 (0676)). In Cullman, however, two of the
  workers with CBD had been employed for less than a year and worked in
  jobs with very low exposures (median 8-hour personal sample values of
  0.03-0.09 μg/m3\) (Madl et al., 2007, Document ID 1056, Table III).
  The body of scientific literature on occupational beryllium disease
  also includes case reports of workers with CBD who are known or
  believed to have experienced minimal beryllium exposure, such as a
  worker employed only in shipping at a copper-beryllium distribution
  center (Stanton et al., 2006, Document ID 1070), and workers employed
  only in administration at a beryllium ceramics facility (Kreiss et al.,
  1996, Document ID 1477). Therefore, there is some evidence that cases
  of CBD can occur in work environments where beryllium exposures are
  quite low.
  8. Community-Acquired CBD
      In the NPRM, OSHA discussed an additional source of information on
  low-level beryllium exposure and CBD: Studies of community-acquired
  chronic beryllium disease (CA-CBD) in residential areas surrounding
  beryllium


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

  B. OSHA's Prevalence Analysis for Sensitization and CBD

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

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

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

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

                              Table VI-3--Prevalence of Sensitization and CBD by LTW Average Exposure Quartile in NJH Data Set
  --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Sensitized                         Total
             LTW average exposure  (μg/m3\)               Group size         only             CBD         sensitized      Total  (%)       CBD  (%)
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  0.0-0.080...............................................              91               1               1               2             2.2             1.0
  0.081-0.18..............................................              73               2               4               6             8.2             5.5
  0.19-0.51...............................................              77               0               6               6             7.8             7.8
  0.51-2.15...............................................              78               4               8              12            15.4            10.3
                                                           =================


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


                               Table VI-4--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile in NJH Data Set
  --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Sensitized                         Total
           Cumulative  exposure  (μg/m3\-yrs)             Group size         only             CBD         sensitized      Total  (%)       CBD  (%)
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  0.0-0.147...............................................              81               2               2               4             4.9             2.5
  0.148-1.467.............................................              79               0               2               2             2.5             2.5
  1.468-7.008.............................................              79               3               8              11            13.9             8.0
  7.009-61.86.............................................              80               2               7               9            11.3             8.8
                                                           -----------------------------------------------------------------------------------------------
      Total...............................................             319               7              19              26            8.2%            6.0%
  --------------------------------------------------------------------------------------------------------------------------------------------------------


                          Table VI-5--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile in NJH Data Set
  --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Sensitized                         Total
                 HEJ exposure  (μg/m3\)                   Group size         only             CBD         sensitized      Total  (%)       CBD  (%)
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  0.0-0.086...............................................              86               1               0               1             1.2             0.0
  0.091-0.214.............................................              81               1               6               7             8.6             7.4
  0.387-0.691.............................................              76               2               9              11            14.5            11.8
  0.954-2.213.............................................              76               3               4               7             9.2             5.3
                                                           -----------------------------------------------------------------------------------------------
      Total...............................................             319               7              19              26             8.2             6.0
  --------------------------------------------------------------------------------------------------------------------------------------------------------

      Table VI-3 shows increasing prevalence of total sensitization and
  CBD with increasing LTW average exposure. The lowest prevalence of
  sensitization and CBD was observed among workers with average exposure
  levels less than or equal to 0.08 μg/m3\, where two sensitized
  workers (2.2 percent), including one case of CBD (1.0 percent), were
  found. The sensitized worker in this category without CBD had worked at
  the facility as an inspector since 1972, one of the lowest-exposed jobs
  at the plant. Because the job was believed to have very low exposures,
  it was not sampled prior to 1998. Thus, estimates of exposures in this
  job are based on data from 1998-2003 only. It is possible that
  exposures earlier in this worker's employment history were somewhat
  higher than reflected in his estimated average exposure. The worker
  diagnosed with CBD in this group had been hired in 1996 in production
  control, and had an estimated average exposure of 0.08 μg/m3\. This
  worker was diagnosed with CBD in 1997.
      The second quartile of LTW average exposure (0.081-0.18 μg/m3\)
  shows a marked rise in overall prevalence of beryllium-related health
  effects, with 6 workers sensitized (8.2 percent), of whom 4 (5.5
  percent) were diagnosed with CBD. Among 6 sensitized workers in the
  third quartile (0.19-0.51 μg/m3\), all were diagnosed with CBD (7.8
  percent). Another increase in prevalence is seen from the third to the
  fourth quartile, with 12 cases of sensitization (15.4 percent),
  including eight (10.3 percent) diagnosed with CBD.
      The quartile analysis of cumulative exposure also shows generally
  increasing prevalence of sensitization and CBD with increasing
  exposure. As shown in Table VI-4, the lowest prevalences of CBD and
  sensitization are in the first two quartiles of cumulative exposure
  (0.0-0.147 μg/m3\-yrs, 0.148-1.467 μg/m3\-yrs). The upper bound
  on this cumulative exposure range, 1.467 μg/m3\-yrs, is the
  cumulative exposure that a worker would have if exposed to beryllium at
  a level of 0.03 μg/m3\ for a working lifetime of 45 years; 0.15
  μg/m3\ for ten years; or 0.3 μg/m3\ for five years. These
  exposure levels are in the range of those OSHA was interested in
  evaluating for purposes of this rulemaking.
      A sharp increase in prevalence of sensitization and CBD occurs in
  the third quartile (1.468-7.008 μg/m3\-yrs), with roughly similar
  levels of both in the highest group (7.009-61.86 μg/m3\-yrs).
  Cumulative exposures in the third quartile would be experienced by a
  worker exposed for 45 years to levels between 0.03 and 0.16 μg/m3\,
  for 10 years to levels between 0.15 and 0.7 μg/m3\, or for 5 years
  to levels between 0.3 and 1.4 μg/m3\.
      When workers' exposures from their highest-exposed job are
  considered, the exposure-response pattern is similar to that for LTW
  average exposure in the lower quartiles. In Table VI-5, the lowest
  prevalence is observed in the first quartile (0.0-0.086 μg/m3\),
  with sharply rising prevalence from first to second and second to third
  exposure quartiles. The prevalence of sensitization and CBD in the top
  quartile (0.954-2.213 μg/m3\) decreases relative to the third, with
  levels similar to the overall prevalence in the dataset. Many workers
  in the highest exposure quartiles are long-time employees, who were
  hired during the early years of the shop when exposures were highest.
  One possible explanation for the drop in prevalence in the highest
  exposure quartiles is that other highly-exposed workers from early
  periods may have developed CBD and left the plant before sensitization
  testing began in 1995 (i.e., the healthy worker survivor effect).
      The results of this prevalence analysis support OSHA's conclusion
  that maintaining exposure levels below the new TWA PEL will help to
  reduce risk


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

  C. OSHA's Statistical Modeling for Sensitization and CBD

  1. OSHA's Preliminary Analysis of the NJH Data Set
      In the course of OSHA's development of the proposed rule, OSHA's
  contractor (ERG) also developed a statistical analysis using the NJH
  data set and a discrete time proportional hazards analysis (DTPHA).
  This preliminary analysis predicted significant risks of both
  sensitization (96-394 cases per 1,000, or 9.6-39.4 percent) and CBD
  (44-313 cases per 1,000, or 4.4-31.3 percent) at the preceding TWA PEL
  of 2 μg/m3\ for an exposure duration of 45 years (90 μg/m3\-
  yr). The predicted risks of 8.2-39.9 cases of sensitization per 1,000
  (0.8-3.9 percent) and 3.6 to 30.0 cases of CBD per 1,000 (0.4-3
  percent) were approximately 10-fold less, but still significant, for a
  45-year exposure at the new TWA PEL of 0.2 μg/m3\ (9 μg/m3\-
  yr).
      In interpreting the risk estimates, OSHA took into consideration
  limitations in the preliminary statistical analysis, primarily study
  size-related constraints. Consequently, as discussed in the NPRM, OSHA
  did not rely on the preliminary statistical analysis for its
  significance of risk determination or to develop its benefits analysis.
  The Agency relied primarily on the previously-presented analysis of the
  epidemiological literature and the prevalence analysis of the Cullman
  data for its preliminary significance of risk determination, and on the
  prevalence analysis for its preliminary estimate of benefits. Although
  OSHA did not rely on the results of the preliminary statistical
  analysis for its findings, the Agency presented the DTPHA in order to
  inform the public of its results, explain its limitations, and solicit
  public comment on the Agency's approach.
      Dr. Kenny Crump and Ms. Deborah Proctor submitted comments on
  OSHA's preliminary risk assessment (Document ID 1660). Crump and
  Proctor agreed with OSHA's review of the epidemiological literature and
  the prevalence analysis presented previously in this section. They
  stated, "we agree with OSHA's conclusion that there is a significant
  risk (>1/1000 risk of CBD) at the [then] current PEL, and that risk is
  reduced at the [then] proposed PEL (0.2 μg/m3\) in combination with
  stringent measures (ancillary provisions) to reduce worker's exposures.
  This finding is evident based on the available literature, as described
  by OSHA, and the prevalence data presented for the Cullman facility"
  (Document ID 1660, p. 2). They also presented a detailed evaluation of
  the statistical analysis of the Cullman data presented in the NPRM,
  including a critique of OSHA's modeling approach and interpretation and
  suggestions for alternate analyses. However, they emphasized that the
  new beryllium rule should not be altered or delayed due to their
  comments regarding the statistical model (Document ID 1660, p. 2).
      After considering comments on this preliminary model, OSHA
  instructed its contractor to change the statistical analysis to address
  technical concerns and to incorporate suggestions from Crump and
  Proctor, as well as NIOSH (Document ID 1660; 1725). OSHA reviews and
  addresses these comments on the preliminary statistical analysis and
  provides a presentation of the final statistical analysis in the
  background document (Risk Analysis of the NJH Data Set from the
  Beryllium Machining Facility in Cullman, Alabama--CBD and
  Sensitization, OSHA, 2016). The results of the final statistical
  analysis are summarized here.
  2. OSHA's Final Statistical Analysis of the NJH Data Set
      As noted above, Dr. Roslyn Stone of University of Pittsburgh School
  of Public Health reanalyzed for OSHA the Cullman data set in order to
  address concerns raised by Crump and Proctor (Document ID 1660). The
  reanalysis uses a Cox proportional hazards model instead of the DTPHA.
  The Cox model, a regression method for survival data, provides an
  estimate of the hazard ratio (HR) and its confidence interval.\17\ Like
  the DTPHA, the Cox model can accommodate time-dependent data; however,
  the Cox model has an advantage over the DTPHA for OSHA's purpose of
  estimating risk to beryllium-exposed workers in that it does not
  estimate different "baseline" rates of sensitization and CBD for
  different years. Time-specific risk sets were constructed to
  accommodate the time-dependent exposures. P-values were based on
  likelihood ratio tests (LRTs), with p-values <0.05 considered to be
  statistically significant.
  ---------------------------------------------------------------------------

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

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

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

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


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

  Table VI-6--Predicted Cases of Sensitization per 1,000 Workers Exposed at the Preceding and Alternate PELs Based
      on Cox Proportional Hazards Model, LTW Average Exposure Metric, With Corresponding Interval Based on the
                                      Uncertainty in the Exposure Coefficient.
                                        [1 Percent and 0.5 percent baselines]
  ----------------------------------------------------------------------------------------------------------------
                                                       Estimated                       Estimated
            Exposure level  (μg/m3\)              cases/1000,       95% CI        cases/1000,       95% CI
                                                     .5% baseline                     1% baseline
  ----------------------------------------------------------------------------------------------------------------
  2.0.............................................           42.75     11.4-160.34           85.49    22.79-320.69
  1.0.............................................           14.62      7.55-28.31           29.24     15.10-56.63
  0.5.............................................            8.55      6.14-11.90           17.10     12.29-23.80
  0.2.............................................            6.20       5.43-7.07           12.39     10.86-14.15
  0.1.............................................            5.57       5.21-5.95           11.13     10.42-11.89
  ----------------------------------------------------------------------------------------------------------------


   Table VI-7--Predicted Cases of CBD per 1,000 Workers Exposed at the Preceding and Alternative PELs Based on Cox Proportional Hazards Model, Cumulative
                              Exposure Metric, with Corresponding Interval Based on the Uncertainty in the Exposure Coefficient
                                                                   [0.5 percent baseline]
  --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Exposure Duration
                                                ----------------------------------------------------------------------------------------------------------
                                                          5 years                    10 years                   20 years                  45 years
           Exposure level (μg/m3\)          ----------------------------------------------------------------------------------------------------------
                                                  Cumulative    Estimated                  Estimated                  Estimated                 Estimated
                                                 (μg/m3\-  cases/1000   μg/m3\-   cases/1000   μg/m3\-   cases/1000   μg/m3\-   cases/1000
                                                     yrs)        95% CI         yrs         95% CI         yrs         95% CI         yrs         95% CI
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  2.0..........................................         10.0         7.55          20.0        11.39          40.0        25.97          90.0       203.60
                                                               5.34-10.67                 5.70-22.78                 6.5-103.76                9.02-4595.6
                                                                                                                                                         7
  1.0..........................................          5.0         6.14          10.0         7.55          20.0        11.39          45.0        31.91
                                                                5.17-7.30                 5.34-10.67                 5.70-22.78                6.72-151.59
  0.5..........................................          2.5         5.54           5.0         6.14          10.0         7.55          22.5        12.63
                                                                5.08-6.04                  5.17-7.30                 5.34-10.67                 5.79-27.53
  0.2..........................................          1.0         5.21           2.0         5.43           4.0          5.9           9.0         7.24
                                                                5.03-5.39                  5.07-5.82                  5.13-6.77                  5.30-9.89
  0.1..........................................          0.5          5.1           1.0         5.21           2.0         5.43           4.5         6.02
                                                                5.02-5.19                  5.03-5.39                  5.07-5.82                  5.15-7.03
  --------------------------------------------------------------------------------------------------------------------------------------------------------

      The Cox proportional hazards model, used with the fixed
  "baseline" rates of 0.5 percent and 1 percent, predicted risks of
  sensitization totaling 43 and 86 cases per 1,000 workers, respectively,
  or 4.3 and 8.6 percent, at the preceding PEL of 2 μg/m3\. The
  predicted risk of CBD is 203 cases per 1,000 workers, or 20.3 percent,
  at the preceding PEL of 2 μg/m3\, assuming 45 years of exposure
  (cumulative exposure of 90 μg/m3\-yr).\20\ The predicted risks of
  sensitization at the new PEL of 0.2 μg/m3\ are substantially lower,
  at 6 and 12 cases per 1,000 for the baselines of 0.5% and 1.0%,
  respectively. The predicted risk of CBD is also much lower at the new
  TWA PEL of 0.2 μg/m3\ (9 μg/m3\-year), at 7 cases per 1,000
  assuming 45 years of exposure.
  ---------------------------------------------------------------------------

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

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


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

  D. Lung Cancer

      As discussed more fully in the Health Effects section of the
  preamble, OSHA has determined beryllium to be a carcinogen based on an
  extensive review of the scientific literature regarding beryllium and
  cancer (see Section V.E). This review included an evaluation of the
  human epidemiological, animal cancer, and mechanistic studies described
  in the Health Effects section of this preamble. OSHA's conclusion is
  supported by the findings of public health organizations such as the
  International Agency for Research on Cancer (IARC), which has
  determined beryllium and its compounds to be carcinogenic to humans
  (Group 1 category) (IARC 2012, Document ID 0650); the National
  Toxicology Program (NTP), which classifies beryllium and its compounds
  as known carcinogens (NTP 2014, Document ID 0389); and the
  Environmental Protection Agency (EPA), which considers beryllium to be
  a probable human carcinogen (EPA 1998, Document ID 0661).
      The Sanderson et al. study previously discussed in Health Effects
  evaluated the association between beryllium exposure and lung cancer
  mortality based on data from a beryllium processing plant in Reading,
  PA (Sanderson et al., 2001, Document ID 1419). Specifically, this case-
  control study evaluated lung cancer mortality in a cohort of 3,569 male
  workers employed at the plant from 1940 to 1969 and followed through
  1992. For each lung cancer victim, 5 age- and race-matched controls
  were selected by incidence density sampling, for a total of 142
  identified lung cancer cases and 710 controls.
      A conditional logistic regression analysis showed an increased risk
  of death from lung cancer in workers with higher exposures when dose
  estimates were lagged by 10 and 20 years (Sanderson et al., 2001,
  Document ID 1419). This lag was incorporated in order to account for
  exposures that did not contribute to lung cancer because they occurred
  after the induction of cancer. The authors noted that there was
  considerable uncertainty in the estimation of exposure levels for the
  1940s and 1950s and in the shape of the dose-response curve for lung
  cancer. In a 2008 study, Schubauer-Berigan et al. reanalyzed the data,
  adjusting for potential confounders of hire age and birth year
  (Schubauer-Berigan et al., 2008, Document ID 1350). The study reported
  a significant increasing trend (p < 0.05) in lung cancer mortality when
  average (log transformed) exposure was lagged by 10 years. However, it
  did not find a significant trend when cumulative (log transformed)
  exposure was lagged by 0, 10, or 20 years (Schubauer-Berigan et al.,
  2008, Table 3).
      In formulating the final rule, OSHA was particularly interested in
  lung cancer risk estimates from a 45-year (i.e., working lifetime)
  exposure to beryllium levels between 0.1 μg/m3\ and 2 μg/m3\.
  The majority of case and control workers in the Sanderson et al. (2001,
  Document ID 1419) case-control analysis were first hired during the
  1940s and 50s when exposures were extremely high (estimated daily
  weighted averages (DWAs) >20 μg/m3\ for most jobs) in comparison to
  the exposure range of interest to OSHA (Sanderson et al. 2001, Document
  ID 1419, Table II). About two-thirds of cases and half of controls
  worked at the plant for less than a year. Thus, a risk assessment based
  on this exposure-response analysis would have needed to extrapolate
  from very high to low exposures, based on a working population with
  extremely short tenure. While OSHA risk assessments must often make
  extrapolations to estimate risk within the range of exposures of
  interest, the Agency acknowledges that these issues of short tenure and
  high exposures would have created substantial uncertainty in a risk
  assessment based on this particular study population.
      In addition, the relatively high exposures of the least-exposed
  workers in the study population might have created methodological
  issues for the lung cancer case-control study design. Mortality risk is
  expressed as an odds ratio that compares higher exposure quartiles to
  the lowest quartile. It is preferable that excess risks attributable to
  occupational beryllium be determined relative to an unexposed or
  minimally exposed reference population. However, in this study
  population, workers in the lowest quartile were exposed well above the
  preceding OSHA TWA PEL (average exposure <11.2 μg/m3\) and may have
  had a significant lung cancer risk. This issue would have introduced
  further uncertainty into the lung cancer risks.
      In 2011, Schubauer-Berigan et al. published a quantitative risk
  assessment that addressed several of OSHA's concerns regarding the
  Sanderson et al. analysis. This new risk assessment was based on an
  update of the Reading cohort analyzed by Sanderson et al., as well as
  workers from two smaller plants (Schubauer-Berigan et al. 2011,
  Document ID 1265). This study population was exposed, on average, to
  lower levels of beryllium and had fewer short-term workers than the
  previous cohort analyzed by Sanderson et al. (2001, Document ID 1250)
  and Schubauer-Berigan et al. (2008, Document ID 1350). Schubauer-
  Berigan et al. (2011) followed the study population through 2005 where
  possible, increasing the length of follow-up time overall by an
  additional 17 years of observation compared to the previous analyses.
  For these reasons, OSHA considered the Schubauer-Berigan (2011)
  analysis more appropriate than Sanderson et al. (2001) and Schubauer-
  Berigan (2008) for its risk assessment. OSHA therefore based its
  preliminary QRA for lung cancer on the results from Schubauer-Berigan
  et al. (2011).
      OSHA received several comments about its choice of Schubauer-
  Berigan et al. (2011) as the basis for its preliminary QRA for lung
  cancer. NIOSH commented that OSHA's choice of Schubauer-Berigan et al.
  for its preliminary analysis was appropriate because "[n]o other study
  is available that presents quantitative dose-response information for
  lung cancer, across a range of beryllium processing facilities"
  (Document ID 1725, p. 7). In supporting OSHA's use of this study, NIOSH
  emphasized in particular the study's inclusion of relatively low-
  exposed workers from two facilities that began operations in the 1950s
  (after employer awareness of acute beryllium disease (ABD) and CBD led
  to efforts to minimize worker exposures to beryllium), as well as the
  presence of both soluble and poorly soluble forms of beryllium in the
  facilities studied (Document ID 1725, p. 7).
      According to Dr. Paolo Boffetta, who submitted comments on this
  study,


  Schubauer-Berigan et al. (2011) is not the most relevant study
  available to OSHA for its lung cancer risk analysis. Dr. Boffetta
  argued that the most informative study of lung cancer risk in the
  beryllium industry after 1965 is one that he developed in 2015
  (Boffetta et al., 2015), which he described as a pooled analysis of 11
  plants and 4 distribution centers (Document ID 1659, p. 1). However,
  Dr. Boffetta did not provide OSHA with the manuscript of his study,
  which he stated was under review for publication. Instead, he reported
  some results of the study and directed OSHA to an abstract of the study
  in the 2015 Annual Conference of the Society for Epidemiologic Research
  (Document ID 1659; Document ID 1661, Attachment 1).
      Because only an abstract of Boffetta et al.'s 2015 study was
  available to OSHA (see Document ID 1661, Attachment 1), OSHA could not
  properly evaluate it or use it as the basis of a quantitative risk
  assessment for lung cancer. Nevertheless, OSHA has addressed comments
  Dr. Boffetta submitted based on his analyses in the relevant sections
  of the final QRA for lung cancer below. Because it was not possible to
  use this study for its lung cancer QRA and OSHA is not aware of other
  studies appropriate for use in its lung cancer QRA (nor did commenters
  besides Dr. Boffetta suggest that OSHA use any additional studies for
  this purpose), OSHA finds that the body of available evidence has not
  changed since the Agency conducted its preliminary QRA based on
  Schubauer-Berigan et al. (2011, Document ID 1265). Therefore, OSHA
  concludes that Schubauer-Berigan et al. (2011) is the most appropriate
  study for its final lung cancer QRA, presented below.
  1. QRA for Lung Cancer Based on Schubauer-Berigan et al. (2011)
      The cohort studied by Schubauer-Berigan et al. (2011, Document ID
  1265) included 5,436 male workers who had worked for at least 2 days at
  the Reading facility or at the beryllium processing plants in Hazleton,
  PA and Elmore, OH prior to 1970. The authors developed job-exposure
  matrices (JEMs) for the three plants based on extensive historical
  exposure data, primarily short-term general area and personal breathing
  zone samples, collected on a quarterly basis from a wide variety of
  operations. These samples were used to create DWA estimates of workers'
  full-shift exposures, using records of the nature and duration of tasks
  performed by workers during a shift. Details on the JEM and DWA
  construction can be found in Sanderson et al. (2001, Document ID 1250),
  Chen et al. (2001, Document ID 1593), and Couch et al. (2010, Document
  ID 0880).
      Workers' cumulative exposures (μg/m3\-days) were estimated by
  summing daily average exposures (assuming five workdays per week)
  (Schubauer-Berigan et al., 2011). To estimate mean exposure (μg/
  m3\), cumulative exposure was divided by exposure time (in days),
  accounting where appropriate for lag time. Maximum exposure (μg/
  m3\) was calculated as the highest annual DWA on record for a worker
  from the first exposure until the study cutoff date of December 31,
  2005, again accounting where appropriate for lag time. Exposure
  estimates were lagged by 5, 10, 15, and 20 years in order to account
  for exposures that may not have contributed to lung cancer because of
  the long latency required for manifestation of the disease. The authors
  also fit models with no lag time.
      As shown in Table VI-8 below, estimated exposure levels for workers
  from the Hazleton and Elmore plants were on average far lower than
  those for workers from the Reading plant (Schubauer-Berigan et al.,
  2011). Whereas the median worker from Hazleton had a mean exposure
  across his tenure of less than 1.5 μg/m3\ and the median worker
  from Elmore had a mean exposure of less than 1 μg/m3\, the median
  worker from Reading had a mean exposure of 25 μg/m3\. The Elmore
  and Hazleton worker populations also had fewer short-term workers than
  the Reading population. This was particularly evident at Hazleton,
  where the median value for cumulative exposure among cases was higher
  than at Reading despite the much lower mean and maximum exposure
  levels.

                                         Table VI-8--Cohort Description and Distribution of Cases by Exposure Level
  --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                              All plants     Reading plant  Hazleton plant   Elmore plant
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  Number of cases................................  .......................................             293             218              30              45
  Number of non-cases............................  .......................................            5143            3337             583            1223
  Median value for mean exposure.................  No lag.................................           15.42              25           1.443           0.885
  (μg/m3\) among cases.......................  10-year lag............................           15.15              25           1.443           0.972
  Median value for cumulative exposure...........  No lag.................................            2843            2895            3968            1654
  (μg/m3\-days) among cases..................  10-year lag............................            2583            2832            3648            1449
  Median value for maximum exposure..............  No lag.................................              25            25.1            3.15            2.17
  (μg/m3\) among cases.......................  10-year lag............................              25              25            3.15            2.17
  Number of cases with potential asbestos          .......................................       100 (34%)        68 (31%)        16 (53%)        16 (36%)
   exposure.
  Number of cases who were professional workers..  .......................................         26 (9%)        21 (10%)         3 (10%)          2 (4%)
  --------------------------------------------------------------------------------------------------------------------------------------------------------
   Table adapted from Schubauer-Berigan et al., 2011, Document ID 1265, Table 1.

      Schubauer-Berigan et al. analyzed the data set using a variety of
  exposure-response modeling approaches, including categorical analyses,
  continuous-variable piecewise log-linear models, and power models
  (2011, Document ID 1265). All models adjusted for birth cohort and
  plant. Because exposure values were log-transformed for the power model
  analyses, the authors added small values to exposures of 0 in lagged
  analyses (0.05 μg/m3\ for mean and maximum exposure, 0.05 μg/
  m3\-days for cumulative exposure). The authors used restricted cubic
  spline models to assess the shape of the exposure-response curves and
  suggest appropriate parametric model forms. The Akaike Information
  Criterion (AIC) value was used to evaluate the fit of different model
  forms and lag times.
      Because smoking information was available for only about 25 percent
  of the cohort (those employed in 1968), smoking could not be controlled
  for directly in the models. Schubauer-Berigan et al. reported that
  within the subset with smoking information, there was little difference
  in smoking by cumulative or maximum exposure category, suggesting that
  smoking was unlikely to act as a confounder in the cohort. In addition
  to models based on the full cohort, Schubauer-Berigan et al. also
  prepared risk estimates based on models excluding professional workers
  (ten percent of cases) and workers believed to have asbestos exposure
  (one-third of cases). These models were


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

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

      The authors found that lung cancer risk was strongly and
  significantly related to mean, cumulative, and maximum measures of
  workers' exposure (all models reported in Schubauer-Berigan et al.,
  2011, Document ID 1265). They selected the best-fitting categorical,
  power, and monotonic piecewise log-linear (PWL) models with a 10-year
  lag to generate HRs for male workers with a mean exposure of 0.5 μg/
  m3\ (the current NIOSH Recommended Exposure Limit for beryllium).\22\
  In addition, they estimated the daily weighted average exposure that
  would be associated with an excess lung cancer mortality risk of one in
  one thousand (.005 μg/m3\ to .07 μg/m3\ depending on model
  choice). To estimate excess risk of cancer, they multiplied these
  hazard ratios by the 2004 to 2006 background lifetime lung cancer rate
  among U.S. males who had survived, cancer-free, to age 30. At OSHA's
  request, Dr. Schubauer-Berigan also estimated excess lung cancer risks
  for workers with mean exposures at the preceding PEL of 2 μg/m3\
  and at each of the other alternate PELs that were under consideration:
  1 μg/m3\, 0.2 μg/m3\, and 0.1 μg/m3\ (Document ID 0521).
  The resulting risk estimates are presented in Table VI-9 below.
  ---------------------------------------------------------------------------

      \22\ Here, "monotonic PWL model" means a model producing a
  monotonic exposure-response curve in the 0 to 2 μg/m3\ range.

     Table VI-9--Excess Lung Cancer Risk per 1,000 [95% Confidence Interval] For Male Workers at Alternate PELs
                                      [Based on Schubauer-Berigan et al., 2011]
  ----------------------------------------------------------------------------------------------------------------
                                                                     Mean exposure
       Exposure-response model     -------------------------------------------------------------------------------
                                    0.1 μg/m3\  0.2 μg/m3\  0.5 μg/m3\   1 μg/m3\    2 μg/m3\
  ----------------------------------------------------------------------------------------------------------------
  Best monotonic PWL--all workers.    7.3 [2.0-13]     15 [3.3-29]       45 [9-98]    120 [20-340]    140 [29-370]
  Best monotonic PWL--excluding        3.1 [<0-11]     6.4 [<0-23]      17 [<0-74]     39 [39-230]     61 [<0-280]
   professional and asbestos
   workers........................
  Best categorical--all workers...     4.4 [1.3-8]      9 [2.7-17]       25 [6-48]     59 [13-130]    170 [29-530]
  Best categorical--excluding         1.4 [<0-6.0]     2.7 [<0-12]     7.1 [<0-35]      15 [<0-87]     33 [<0-290]
   professional and asbestos
   workers........................
  Power model--all workers........       12 [6-19]     19 [9.3-29]      30 [15-48]      40 [19-66]      52 [23-88]
  Power model--excluding               19 [8.6-31]      30 [13-50]      49 [21-87]     68 [27-130]     90 [34-180]
   professional and asbestos
   workers........................
  ----------------------------------------------------------------------------------------------------------------
  Source: Schubauer-Berigan, Document ID 0521, pp. 6-10.

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


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


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

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

      Finally, the approach of Boffetta et al. (2014), which relies on
  SMR analyses, does not account for the healthy worker effect. SMRs are
  calculated by comparing disease levels in the study population to
  disease levels in the general population, using regional or national
  reported disease rates. However, because working populations tend to
  have lower disease rates than the overall population, SMRs can
  underestimate excess risk of disease in those populations. The SMR in
  Boffetta et al. (2014) for overall mortality in the study population
  was statistically significantly reduced (94.7, 95 percent CI 89.9-
  99.7), suggesting a possible healthy worker effect. The SMR for overall
  mortality was even further reduced in the category of workers with at
  least 20 years of employment (87.7, 95 percent CI 74.3-102.7), in which
  an elevated SMR for lung cancer was observed. NIOSH commented that
  "[i]n a modern industrial population, the expected SMR for lung cancer
  would be approximately 0.93 [Park et al. (1991)]" (Document ID 1725,
  p. 8). This is lower than the SMR for lung cancer (96) observed in
  Boffetta et al. (2014) and much lower than the SMR for lung cancer in
  the category of workers employed for at least 20 years (112.7), which
  is the group most likely to have had sufficient exposure and latency to
  show excess lung cancer (Boffetta et al., 2014, Document ID 0403,
  Tables 2 and 3). Thus, it appears that the healthy worker effect is
  another factor (in addition to low cumulative exposures) that may
  account for the findings of Boffetta et al.'s 2014 study.
      Taken together, OSHA finds that the animal toxicology evidence on
  the carcinogenicity of poorly soluble beryllium forms, the long
  residence of poorly soluble beryllium in the lung, the likelihood that
  most workers in Schubauer-Berigan et al. (2011) were exposed to a
  mixture of soluble and poorly soluble beryllium forms, and the points
  raised above regarding Boffetta et al. (2014) rebut Boffetta's claim
  that low solubility of beryllium compounds is the most likely
  explanation for the lack of statistically significantly elevated SMR
  results.
      Dr. Boffetta's comment also raised technical questions regarding
  the Schubauer-Berigan et al. (2011, Document ID 1265) risk analysis. He
  noted that risk estimates at low exposures are dependent on choice of
  model in their analysis; the authors' choice of a single "best" model
  was based on purely statistical criteria, and the results of the
  statistics used (AIC) were similar between the models" (Document ID
  1659, p. 2). Therefore, according to Dr. Boffetta, "there is ample
  uncertainty about the shape of the dose-response function in the low-
  dose range" (Document ID 1659, p. 3).
      OSHA agrees that it is difficult to distinguish a single "best"
  model from the set of models presented by Schubauer-Berigan et al.
  (2011), and that risk estimates at low exposure levels vary depending
  on choice of model. That is one reason OSHA presented results from all
  of the models (see Table VI-9). OSHA further agrees that there is
  uncertainty in the lung cancer risk estimates, the estimation of which
  (unlike for CBD) required extrapolation below beryllium exposure levels
  experienced by workers in the Schubauer-Berigan et al. (2011) study.
  However, the Schubauer-Berigan risk assessment's six best-fitting
  models all support OSHA's significant risk determination, as they all
  predict a significant risk of lung cancer at the preceding TWA PEL of 2
  μg/m3\ (estimates ranging from 33 to 170 excess lung cancers per
  1,000 workers) and a substantially reduced, though still significant,
  risk of lung cancer at the new TWA PEL of 0.2 μg/m3\ (estimates
  ranging from 3 to 30 excess lung cancers per 1,000 workers) (see Table
  VI-9).
      Dr. Boffetta also noted that the risk estimates provided by
  Schubauer-Berigan et al. (2011, Document ID 1265) for OSHA's lung
  cancer risk assessment depend on the background lung cancer rate used
  in excess risk calculations, and that industrial workers may have a
  different background lung cancer risk than the U.S. population as a
  whole (Document ID 1659, p. 2). OSHA agrees that choice of background
  risk could influence the number of excess lung cancers predicted by the
  models the Agency relied on for its lung cancer risk estimates.
  However, choice of background risk did not influence OSHA's finding
  that excess lung cancer risks would be substantially reduced by a
  decrease in exposure from the preceding TWA PEL to the final TWA PEL,
  because the same background risk was factored into estimates of risk at
  both levels. Furthermore, the Schubauer-Berigan et al. (2011) estimates
  of excess lung cancer from exposure at the preceding PEL of 2 μg/
  m3\ (ranging from 33 to 170 excess lung cancers per 1,000 workers,
  depending on the model) are much higher than the level of 1 per 1,000
  that OSHA finds to be clearly significant. Even at the final TWA PEL of
  0.2 μg/m3\, the models demonstrate a range of risks of excess lung
  cancers of 3 to 30 per 1,000 workers, estimates well above the
  threshold for significant risk (see Section II, Pertinent Legal
  Authority). Small variations in background risk across different
  populations are highly unlikely to influence excess lung cancer risk
  estimates sufficiently to influence OSHA's finding of significant risk
  at the preceding TWA PEL, which is the finding OSHA relies on to
  support the need for a new standard.
      Finally, Dr. Boffetta noted that the models that exclude
  professional and asbestos workers (the groups that Schubauer-Berigan et
  al. believed could be affected by confounding from tobacco and asbestos
  exposure) showed non-significant increases in lung cancer with
  increasing beryllium exposure. According to Dr. Boffetta, this suggests
  that confounding may contribute to the results of the models based on
  the full population. He speculates that if more precise information on
  confounding exposures were available, excess risk estimates might be
  further reduced (Document ID 1659, p. 2).
      OSHA agrees with Dr. Boffetta that there is uncertainty in the
  Schubauer-Berigan et al. (2011) lung cancer risk estimates, including
  uncertainty due to limited information on possible confounding from
  associations between beryllium exposure level and workers' smoking
  habits or occupational co-exposures. However, in the absence of
  detailed smoking and co-exposure information, the models excluding
  professional and asbestos workers are a reasonable approach to
  addressing the possible effects of unmeasured confounding. OSHA's
  decision to include these models in its preliminary and final QRAs
  therefore represents the Agency's best available means of dealing with
  this uncertainty.

  E. Risk Assessment Conclusions

      As described above, OSHA's risk assessment for beryllium
  sensitization and CBD relied on two approaches: (1) Review of the
  literature, and (2) analysis of a data set provided by NJH. OSHA has a
  high level of confidence in its finding that the risks of sensitization
  and CBD are above the benchmark of 1 in 1,000 at the preceding PEL, and
  the Agency believes that a comprehensive standard requiring a
  combination of more stringent controls on beryllium exposure will
  reduce workers' risk of both sensitization and CBD. Programs that have
  reduced median levels to below 0.1 μg/m3\ and tightly controlled
  both respiratory exposure and dermal contact have substantially reduced
  risk of sensitization within the first years of exposure. These
  conclusions are supported by the results of several studies conducted
  in facilities dealing


  with a variety of production activities and physical forms of beryllium
  that have reduced workers' exposures substantially by implementing
  stringent exposure controls and PPE requirements since approximately
  2000. In addition, these conclusions are supported by OSHA's analyses
  of the NJH data set, which contains highly-detailed exposure and work
  history information on several hundred beryllium workers.
      Furthermore, OSHA believes that more stringent control of airborne
  beryllium exposures will reduce beryllium-exposed workers' significant
  risk of lung cancer. The risk estimates from the lung cancer study by
  Schubauer-Berigan et al. (2011, Document ID 1265; 0521), described
  above, range from 33 to 170 excess lung cancers per 1,000 workers
  exposed at the preceding PEL of 2 μg/m3\, based on the study's six
  best-fitting models. These models each predict substantial reductions
  in risk with reduced exposure, ranging from 3 to 30 excess lung cancers
  per 1,000 workers exposed at the final PEL of 0.2 μg/m3\. The
  evidence of lung cancer risk from the Schubauer-Berigan et al. (2011)
  risk assessment provides additional support for OSHA's conclusions
  regarding the significance of risk of adverse health effects for
  workers exposed to beryllium levels at and below the preceding PEL.
  However, the lung cancer risks required a sizable low dose
  extrapolation below beryllium exposure levels experienced by workers in
  the Schubauer-Berigan et al. (2011) study. As a result, there is
  greater uncertainty regarding the lung cancer risk estimates than there
  is for the risk estimates for beryllium sensitization and CBD. The
  conclusions with regard to significance of risk are presented and
  further discussed in section VII of the preamble.

  VII. Significance of Risk

      In this section, OSHA discusses its findings that workers exposed
  to beryllium at and below the preceding TWA PEL face a significant risk
  of material impairment of health or functional capacity within the
  meaning of the OSH Act, and that the new standards will substantially
  reduce this risk. To make the significance of risk determination for a
  new final or proposed standard, OSHA uses the best available scientific
  evidence to identify material health impairments associated with
  potentially hazardous occupational exposures and to evaluate exposed
  workers' risk of these impairments assuming exposure over a working
  lifetime. As discussed in section II, Pertinent Legal Authority, courts
  have stated that OSHA should consider all forms and degrees of material
  impairment--not just death or serious physical harm. To evaluate the
  significance of the health risks that result from exposure to hazardous
  chemical agents, OSHA relies on epidemiological, toxicological, and
  experimental evidence. The Agency uses both qualitative and
  quantitative methods to characterize the risk of disease resulting from
  workers' exposure to a given hazard over a working lifetime (generally
  45 years) at levels of exposure reflecting compliance with the
  preceding standard and compliance with the new standards (see Section
  II, Pertinent Legal Authority). When determining whether a significant
  risk exists OSHA considers whether there is a risk of at least one-in-
  a-thousand of developing a material health impairment from a working
  lifetime of exposure. The Supreme Court has found that OSHA is not
  required to support its finding of significant risk with scientific
  certainty, but may instead rely on a body of reputable scientific
  thought and may make conservative assumptions (i.e., err on the side of
  protecting the worker) in its interpretation of the evidence (Section
  II, Pertinent Legal Authority).
      OSHA's findings in this section follow in part from the conclusions
  of the preceding sections V, Health Effects, and VI, Risk Assessment.
  In this preamble at section V, Health Effects, OSHA reviewed the
  scientific evidence linking occupational beryllium exposure to a
  variety of adverse health effects and determined that beryllium
  exposure causes sensitization, CBD, and lung cancer, and is associated
  with various other adverse health effects (see section V.D, V.E, and
  V.F). In this preamble at section VI, Risk Assessment, OSHA found that
  the available epidemiological data are sufficient to evaluate risk for
  beryllium sensitization, CBD, and lung cancer among beryllium-exposed
  workers. OSHA evaluated the risk of sensitization, CBD, and lung cancer
  from levels of airborne beryllium exposure that were allowed under the
  previous standard, as well as the expected impact of the new standards
  on risk of these conditions. In this section of the preamble, OSHA
  explains its determination that the risk of material impairments of
  health, particularly CBD and lung cancer, from occupational exposures
  allowable under the preceding TWA PEL of 2 μg/m3\ is significant,
  and is substantially reduced but still significant at the new TWA PEL
  of 0.2 μg/m3\. Furthermore, evidence reviewed in section VI, Risk
  Assessment, shows that significant risk of CBD and lung cancer could
  remain in workplaces with exposures as low as the new action level of
  0.1 μg/m3\. OSHA also explains here that the new standards will
  reduce the occurrence of sensitization.
      In the NPRM, OSHA preliminarily determined that both CBD and lung
  cancer are material impairments of health. OSHA also preliminarily
  determined that a working lifetime (45 years) of exposure to airborne
  beryllium at the preceding time-weighted average permissible exposure
  limit (TWA PEL) of 2 μg/m3\ would pose a significant risk of both
  CBD and lung cancer, and that this risk is substantially reduced but
  still significant at the new TWA PEL of 0.2 μg/m3\. OSHA did not
  make a preliminary determination as to whether beryllium sensitization
  is a material impairment of health because, as the Agency explained in
  the NPRM, it was not necessary to make such a determination. The
  Agency's preliminary findings on CBD and lung cancer were sufficient to
  support the promulgation of new beryllium standards.
      Upon consideration of the entire rulemaking record, including the
  comments and information submitted to the record in response to the
  preliminary Health Effects, Risk Assessment, and Significance of Risk
  analyses (NPRM Sections V, VI, and VIII), OSHA reaffirms its
  preliminary findings that long-term exposure at the preceding TWA PEL
  of 2 μg/m3\ poses a significant risk of material impairment of
  workers' health, and that adoption of the new TWA PEL of 0.2 μg/m3\
  and other provisions of the final standards will substantially reduce
  this risk.

  Material Impairment of Health

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


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

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

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

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

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


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


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

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


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

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

  Risk Assessment

      As discussed in Section VI, Risk Assessment, the risk assessment
  for beryllium sensitization and CBD relied on two approaches: (1)
  OSHA's review of epidemiological studies of sensitization and CBD that
  contain information on exposures in the range of interest to OSHA (2
  μg/m3\ and below), and (2) OSHA's analysis of a NJH data set on
  sensitization and CBD in a group of beryllium-exposed machinists in
  Cullman, AL.
      OSHA's review of the literature includes studies of beryllium-
  exposed workers at a Tucson, AZ ceramics plant (Kreiss et al., 1996,
  Document ID 1477; Henneberger et al., 2001 (1313); Cummings et al.,
  2007 (1369)); a Reading, PA copper-beryllium processing plant (Schuler
  et al., 2005, Document ID 0919; Thomas et al., 2009 (0590)); a Cullman,
  AL beryllium machining plant (Newman et al., 2001, Document ID 1354;
  Kelleher et al., 2001 (1363); Madl et al., 2007 (1056)); an Elmore, OH
  metal, alloy, and oxide production plant (Kreiss et al., 1993 Document
  ID 1478; Bailey et al., 2010 (0676); Schuler et al., 2012 (0473));
  aluminum smelting facilities (Taiwo et al. 2008, Document ID 0621; 2010
  (0583); Nilsen et al., 2010 (0460)); and nuclear facilities (Viet et
  al., 2000, Document ID 1344; Arjomandi et al., 2010 (1275)).
      The published literature on beryllium sensitization and CBD
  discussed in section VI shows that the risk of both can be significant
  in workplaces where exposures are at or below OSHA's preceding PEL of 2
  μg/m3\ (e.g., Kreiss et al., 1996, Document ID 1477; Henneberger et
  al., 2001 (1313); Newman et al., 2001 (1354); Schuler et al., 2005
  (0919), 2012 (0473); Madl et al., 2007 (1056)). For example, in the
  Tucson ceramics plant mentioned above, Kreiss et al. (1996) reported
  that eight (5.9 percent) \26\ of the 136 workers tested in 1992 were
  sensitized, six (4.4 percent) of whom were diagnosed with CBD. In
  addition, of 77 Tucson workers hired prior to 1992 who were tested in
  1998, eight (10.4 percent) were sensitized and seven of these (9.7
  percent) were diagnosed with CBD (Henneberger et al., 2001, Document ID
  1313). Full-shift area samples showed most airborne beryllium levels
  below the preceding PEL: 76 percent of area samples collected between
  1983 and 1992 were at or below 0.1 μg/m3\ and less than 1 percent
  exceeded 2 μg/m3\; short-term breathing zone measurements collected
  between 1981 and 1992 had a median of 0.3 μg/m3\; and personal
  lapel samples collected at the plant beginning in 1991 had a median of
  0.2 μg/m3\ (Kreiss et al., 1996).
  ---------------------------------------------------------------------------

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

      Results from the Elmore, OH beryllium metal, alloy, and oxide
  production plant and the Cullman, AL machining facility also showed
  significant risk of sensitization and CBD among workers with exposures
  below the preceding TWA PEL. Schuler et al. (2012, Document ID 0473)
  found 17 cases of sensitization (8.6 percent) among Elmore, OH workers
  within the first three quartiles of LTW average exposure (198 workers
  with LTW average total mass exposures lower than 1.1 μg/m3\) and 4
  cases of CBD (2.2 percent) within those quartiles of LTW average
  exposure (183 workers with LTW average total mass exposures lower than
  1.07 μg/m3\; note that follow-up time of up to 6 years for all
  study participants was very short for development of CBD). At the
  Cullman, AL machining facility, Newman et al. (2001, Document ID 1354)
  reported 22 (9.4 percent) sensitized workers among 235 tested in 1995-
  1999, 13 of whom were diagnosed with CBD within the study period.
  Personal lapel samples collected between 1980 and 1999 indicate that
  median exposures were generally well below the preceding PEL (<=0.35
  μg/m3\ in all job titles except maintenance (median 3.1 μg/m3\
  during 1980-1995) and gas bearings (1.05 μg/m3\ during 1980-1995)).
      Although risk will be reduced by compliance with the new TWA PEL,
  evidence in the epidemiological studies reviewed in section VI, Risk
  Assessment, shows that significant risk of sensitization and CBD could
  remain in workplaces with exposures as low as the new action level of
  0.1 μg/m3\. For example, Schuler et al. (2005, Document ID 0919)
  reported substantial prevalences of sensitization (6.5 percent) and CBD
  (3.9 percent) among 152 workers at the Reading, PA facility screened
  with the BeLPT in 2000. These results showed significant risk at this
  facility, even though airborne exposures were primarily below both the
  preceding and final TWA PELs due to the low percentage of beryllium in
  the metal alloys used (median general area samples <=0.1 μg/m3\,
  97% < 0.5 μg/m3\; 93% of personal lapel samples below the new TWA
  PEL of 0.2 μg/m3\). The only group of workers with no cases of
  sensitization or CBD, a group of 26 office administration workers, was
  the group with exposures below the new action level of 0.1 μg/m3\
  (median personal sample 0.01 μg/m3\, range <0.01-0.06 μg/m3\)
  (Schuler et al., 2005). The Schuler et al. (2012, Document ID 0473)
  study of short-term workers in the Elmore, OH facility found three
  cases (4.6%) of sensitization among 66 workers with total mass LTW
  average exposures below 0.1 μg/m3\. All three of these sensitized
  workers had LTW average exposures of approximately 0.09 μg/m3\.
      Furthermore, cases of sensitization and CBD continued to arise in
  the Cullman, AL machining plant after control measures implemented
  beginning in 1995 brought median airborne exposures below 0.2 μg/
  m3\ (personal lapel samples between 1996 and 1999 in machining jobs
  had a median of 0.16 μg/m3\ and the median was 0.08 μg/m3\ in
  non-machining jobs)


  (Madl et al., 2007, Document ID 1056, Table IV). At the time that
  Newman et al. (2001, Document ID 1354) reviewed the results of BeLPT
  screenings conducted in 1995-1999, a subset of 60 workers had been
  employed at the plant for less than a year and had therefore benefitted
  to some extent from the exposure reductions. Four (6.7 percent) of
  these workers were found to be sensitized, of whom two were diagnosed
  with CBD and one with probable CBD (Newman et al., 2001). A later study
  by Madl. et al. (2007, Document ID 1056) reported seven sensitized
  workers who had been hired between 1995 and 1999, of whom four had
  developed CBD as of 2005 (Table II; total number of workers hired
  between 1995 and 1999 not reported).
      The enhanced industrial hygiene programs that have proven effective
  in several facilities demonstrate the importance of minimizing both
  airborne exposure and dermal contact to effectively reduce risk of
  sensitization and CBD. Exposure control programs that have used a
  combination of engineering controls, PPE, and stringent housekeeping
  measures to reduce workers' airborne exposure and dermal contact have
  substantially lowered risk of sensitization among newly-hired
  workers.\27\ Of 97 workers hired between 2000 and 2004 in the Tucson,
  AZ plant after the introduction of a comprehensive program which
  included the use of respiratory protection (1999) and latex gloves
  (2000), one case of sensitization was identified (1 percent) (Cummings
  et al., 2007, Document ID 1369). In Elmore, OH, where all workers were
  required to wear respirators and skin PPE in production areas beginning
  in 2000-2001, the estimated prevalence of sensitization among workers
  hired after these measures were put in place was around 2 percent
  (Bailey et al., 2010, Document ID 0676). In the Reading, PA facility,
  after workers' exposures were reduced to below 0.1 μg/m3\ and PPE
  to prevent dermal contact was instituted, only one (2.2 percent) of 45
  workers hired was sensitized (Thomas et al. 2009, Document ID 0590).
  And, in the aluminum smelters discussed by Taiwo et al. (2008, Document
  ID 0621), where available exposure samples from four plants indicated
  median beryllium levels of about 0.1 μg/m3\ or below (measured as
  an 8-hour TWA) and workers used respiratory and dermal protection,
  confirmed cases of sensitization were rare (zero or one case per
  location).
  ---------------------------------------------------------------------------

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

      OSHA notes that the studies on recent programs to reduce workers'
  risk of sensitization and CBD were conducted on populations with very
  short exposure and follow-up time. Therefore, they could not adequately
  address the question of how frequently workers who become sensitized in
  environments with extremely low airborne exposures (median <0.1 μg/
  m3\) develop CBD. Clinical evaluation for CBD was not reported for
  sensitized workers identified in the studies examining the post-2000
  worker cohorts with very low exposures in Tucson, Reading, and Elmore
  (Cummings et al. 2007, Document ID 1369; Thomas et al. 2009, (0590);
  Bailey et al. 2010, (0676)). In Cullman, however, two of the workers
  with CBD had been employed for less than a year and worked in jobs with
  very low exposures (median 8-hour personal sample values of 0.03-0.09
  μg/m3\) (Madl et al., 2007, Document ID 1056, Table III). The body
  of scientific literature on occupational beryllium disease also
  includes case reports of workers with CBD who are known or believed to
  have experienced minimal beryllium exposure, such as a worker employed
  only in shipping at a copper-beryllium distribution center (Stanton et
  al., 2006, Document ID 1070), and workers employed only in
  administration at a beryllium ceramics facility (Kreiss et al., 1996,
  Document ID 1477). Therefore, there is some evidence that cases of CBD
  can occur in work environments where beryllium exposures are quite low.
      In summary, the epidemiological literature on beryllium
  sensitization and CBD that OSHA's risk assessment relied on show
  sufficient occurrence of sensitization and CBD to be considered
  significant within the meaning of the OSH Act. These demonstrated risks
  are far in excess of 1 in 1,000 among workers who had full-shift
  exposures well below the preceding TWA PEL of 2 μg/m3\ and workers
  who had median full-shift exposures down to the new action level of 0.1
  μg/m3\. These health effects occurred among populations of workers
  whose follow-up time was much less than 45 years. As stated earlier,
  OSHA is interested in the risk associated with a 45-year (i.e., working
  lifetime) exposure. Because CBD often develops over the course of years
  following sensitization, the risk of CBD that would result from 45
  years of occupational exposure to airborne beryllium is likely to be
  higher than the prevalence of CBD observed among these workers.\28\ In
  either case, based on these studies, the risks to workers from long-
  term exposure at the preceding TWA PEL and below are clearly
  significant. OSHA's review of epidemiological studies further showed
  that worker protection programs that effectively reduced the risk of
  beryllium sensitization and CBD incorporated engineering controls, work
  practice controls, and personal protective equipment (PPE) that reduce
  workers' airborne beryllium exposure and dermal contact with beryllium.
  OSHA has therefore determined that an effective worker protection
  program should incorporate both airborne exposure reduction and dermal
  protection provisions.
  ---------------------------------------------------------------------------

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

      OSHA's conclusions on significance of risk at the final PEL and
  action level are further supported by its analysis of the data set
  provided to OSHA by NJH from which OSHA derived additional information
  on sensitization and CBD at exposure levels of interest. The data set
  describes a population of 319 beryllium-exposed workers at a Cullman,
  AL machining facility. It includes exposure samples collected between
  1980 and 2005, and has updated work history and screening information
  through 2003. Seven (2.2 percent) workers in the data set were reported
  as sensitized only. Sixteen (5.0 percent) workers were listed as
  sensitized and diagnosed with CBD upon initial clinical evaluation.
  Three (0.9 percent) workers, first shown to be sensitized only, were
  later diagnosed with CBD. The data set includes workers exposed at
  airborne beryllium levels near the new TWA PEL of 0.2 μg/m3\, and
  extensive exposure data collected in workers' breathing zones, as is
  preferred by OSHA. Unlike the Tucson, Reading, and Elmore facilities
  after 2000, respirator use was not generally required for workers at
  the Cullman facility. Thus, analysis of this data set shows the risk
  associated with varying levels of airborne exposure rather than
  estimating exposure accounting for respirators. Also unlike the Tucson,
  Elmore, and Reading facilities, glove use was not reported to be
  mandatory in the Cullman facility. Therefore, OSHA believes reductions
  in risk at the Cullman facility to be the result of airborne exposure
  control, rather than the combination of airborne and dermal exposure
  controls used at other facilities.
      OSHA analyzed the prevalence of beryllium sensitization and CBD
  among


  workers at the Cullman facility who were exposed to airborne beryllium
  levels at and below the preceding TWA PEL of 2 μg/m3\. In addition,
  a statistical modeling analysis of the NJH Cullman data set was
  conducted under contract with Dr. Roslyn Stone of the University of
  Pittsburgh Graduate School of Public Heath, Department of
  Biostatistics. OSHA summarizes these analyses briefly below, and in
  more detail in section VI, Risk Assessment and in the background
  document (Risk Analysis of the NJH Data Set from the Beryllium
  Machining Facility in Cullman, Alabama--CBD and Sensitization, OSHA,
  2016).
      Tables VII-1 and VII-2 below present the prevalence of
  sensitization and CBD cases across several categories of lifetime-
  weighted (LTW) average and highest-exposed job (HEJ) exposure at the
  Cullman facility. The HEJ exposure is the exposure level associated
  with the highest-exposure job and time period experienced by each
  worker. The columns "Total" and "Total percent" refer to all
  sensitized workers in the data set, including workers with and without
  a diagnosis of CBD.

                              Table VII-1--Prevalence of Sensitization and CBD by LTW Average Exposure Quartile in NJH Data Set
  --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Sensitized
              LTW average exposure (μg/m3\)               Group size         only             CBD            Total        Total  (%)       CBD  (%)
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  0.0-0.080...............................................              91               1               1               2             2.2             1.0
  0.081-0.18..............................................              73               2               4               6             8.2             5.5
  0.19-0.51...............................................              77               0               6               6             7.8             7.8
  0.51-2.15...............................................              78               4               8              12            15.4            10.3
                                                           -----------------------------------------------------------------------------------------------
      Total...............................................             319               7              19              26             8.2             6.0
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  Source: Section VI, Risk Assessment.


                          Table VII-2--Prevalence of Sensitization and CBD by Highest-Exposed Job Exposure Quartile in NJH Data Set
  --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Sensitized
                  HEJ exposure (μg/m3\)                   Group size         only             CBD            Total         Total (%)        CBD (%)
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  0.0-0.086...............................................              86               1               0               1             1.2             0.0
  0.091-0.214.............................................              81               1               6               7             8.6             7.4
  0.387-0.691.............................................              76               2               9              11            14.5            11.8
  0.954-2.213.............................................              76               3               4               7             9.2             5.3
                                                           -----------------------------------------------------------------------------------------------
      Total...............................................             319               7              19              26             8.2             6.0
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  Source: Section VI, Risk Assessment.

      The preceding PEL of 2 μg/m3\ is close to the upper bound of
  the highest quartile of LTW average (0.51-2.15 μg/m3\) and HEJ
  (0.954-2.213 μg/m3\) exposure levels. In the highest quartile of
  LTW average exposure, there were 12 cases of sensitization (15.4
  percent), including eight (10.3 percent) diagnosed with CBD. Notably,
  the Cullman workers had been exposed to beryllium dust for considerably
  less than 45 years at the time of testing. A high prevalence of
  sensitization (9.2 percent) and CBD (5.3 percent) is seen in the top
  quartile of HEJ exposure as well, with even higher prevalences in the
  third quartile (0.387-0.691 μg/m3\).\29\
  ---------------------------------------------------------------------------

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

      The new TWA PEL of 0.2 μg/m3\ is close to the upper bound of
  the second quartile of LTW average (0.81-0.18 μg/m3\) and HEJ
  (0.091-0.214 μg/m3\) exposure levels and to the lower bound of the
  third quartile of LTW average (0.19-0.50 μg/m3\) exposures. The
  second quartile of LTW average exposure shows a high prevalence of
  beryllium-related health effects, with six workers sensitized (8.2
  percent), of whom four (5.5 percent) were diagnosed with CBD. The
  second quartile of HEJ exposure also shows a high prevalence of
  beryllium-related health effects, with seven workers sensitized (8.6
  percent), of whom six (7.4 percent) were diagnosed with CBD. Among six
  sensitized workers in the third quartile of LTW average exposures, all
  were diagnosed with CBD (7.8 percent). The prevalence of CBD among
  workers in these quartiles was approximately 5-8 percent, and overall
  sensitization (including workers with and without CBD) was about 8-9
  percent. OSHA considers these rates to be evidence that the risks of
  developing sensitization and CBD are significant among workers exposed
  at and below the preceding TWA PEL, and even below the new TWA PEL.
  These risks are much higher than the benchmark for significant risk of
  1 in 1,000. Much lower prevalences of sensitization and CBD were found
  among workers with exposure levels less than or equal to about 0.08
  μg/m3\, although these risks are still significant. Two sensitized
  workers (2.2 percent), including one case of CBD (1.0 percent), were
  found among workers with LTW average exposure levels less than or equal
  to 0.08 μg/m3\. One case of sensitization (1.2 percent) and no
  cases of CBD were found among workers with HEJ exposures of at most
  0.086 μg/m3\. Strict control of airborne exposure to levels below
  0.1 μg/m3\ using engineering and work practice controls can,
  therefore, substantially reduce risk of sensitization and CBD. Although
  OSHA recognizes that maintaining exposure levels below 0.1 μg/m3\
  may not be feasible in some operations (see this preamble at section
  VIII, Summary of the Economic Analysis and Regulatory Flexibility
  Analysis), the Agency finds that workers in facilities that meet the
  action level of 0.1 μg/m3\ will face lower risks of sensitization
  and CBD than workers in facilities that cannot meet the action level.
      Table VII-3 below presents the prevalence of sensitization and CBD
  cases across cumulative exposure quartiles, based on the same Cullman
  data used to derive Tables 1 and 2. Cumulative exposure is the sum of a
  worker's exposure across the duration of his or her employment.




                              Table VII-3--Prevalence of Sensitization and CBD by Cumulative Exposure Quartile in NJH Data Set
  --------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                              Sensitized
            Cumulative exposure (μg/m3\-yrs)              Group size         only             CBD            Total          Total %          CBD %
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  0.0-0.147...............................................              81               2               2               4             4.9             2.5
  0.148-1.467.............................................              79               0               2               2             2.5             2.5
  1.468-7.008.............................................              79               3               8              11            13.9             8.0
  7.009-61.86.............................................              80               2               7               9            11.3             8.8
                                                           -----------------------------------------------------------------------------------------------
      Total...............................................             319               7              19              26             8.2             6.0
  --------------------------------------------------------------------------------------------------------------------------------------------------------
  Source: Section VI, Risk Assessment.

      A 45-year working lifetime of occupational exposure at the
  preceding PEL would result in 90 μg/m3\-years of exposure, a value
  far higher than the cumulative exposures of workers in this data set,
  who worked for periods of time less than 45 years and whose exposure
  levels were mostly well below the previous PEL. Workers with 45 years
  of exposure to the new TWA PEL of 0.2 μg/m3\ would have a
  cumulative exposure (9 μg/m3\-years) in the highest quartile for
  this worker population. As with the average and HEJ exposures, the
  greatest risk of sensitization and CBD appears at the higher exposure
  levels (<1.467 μg/m3\-years). The third cumulative quartile, at
  which a sharp increase in sensitization and CBD appears, is bounded by
  1.468 and 7.008 μg/m3\-years. This is equivalent to 0.73-3.50 years
  of exposure at the preceding PEL of 2 μg/m3\, or 7.34-35.04 years
  of exposure at the new TWA PEL of 0.2 μg/m3\. Prevalence of both
  sensitization and CBD is substantially lower in the second cumulative
  quartile (0.148-1.467 μg/m3\-years). This is equivalent to
  approximately 0.7 to 7 years at the new TWA PEL of 0.2 μg/m3\, or
  1.5 to 15 years at the action level of 0.1 μg/m3\. Risks at all
  levels of cumulative exposure presented in Table 3 are significant.
  These findings support OSHA's determination that maintaining exposure
  levels below the new TWA PEL will help to protect workers against risk
  of beryllium sensitization and CBD. Moreover, while OSHA finds that
  significant risk remains at the PEL, OSHA's analysis shows that further
  reductions of risk will ensue if employers are able to reduce exposure
  to the action level or even below.

  Lung Cancer

      Lung cancer, a frequently fatal disease, is a well-recognized
  material impairment of health. OSHA has determined that beryllium
  causes lung cancer based on an extensive review of the scientific
  literature regarding beryllium and cancer. This review included an
  evaluation of the human epidemiological, animal cancer, and mechanistic
  studies described in section V, Health Effects. OSHA's conclusion that
  beryllium is carcinogenic is supported by the findings of expert public
  health and governmental organizations such as the International Agency
  for Research on Cancer (IARC), which has determined beryllium and its
  compounds to be carcinogenic to humans (Group 1 category) (IARC, 2012,
  Document ID 0650); the National Toxicology Program (NTP), which
  classifies beryllium and its compounds as known carcinogens (NTP, 2014,
  Document ID 0389); and the Environmental Protection Agency (EPA), which
  considers beryllium to be a probable human carcinogen (EPA, 1998,
  Document ID 0661).
      OSHA's review of epidemiological studies of lung cancer mortality
  among beryllium workers found that most of them did not characterize
  exposure levels sufficiently to evaluate the risk of lung cancer at the
  preceding and new TWA PELs. However, as discussed in this preamble at
  section V, Health Effects and section VI, Risk Assessment, Schubauer-
  Berigan et al. published a quantitative risk assessment based on
  beryllium exposure and lung cancer mortality among 5,436 male workers
  first employed at beryllium processing plants in Reading, PA, Elmore,
  OH, and Hazleton, PA, prior to 1970 (Schubauer-Berigan et al., 2011,
  Document ID 1265). This risk assessment addresses important sources of
  uncertainty for previous lung cancer analyses, including the sole prior
  exposure-response analysis for beryllium and lung cancer, conducted by
  Sanderson et al. (2001) on workers from the Reading plant alone.
  Workers from the Elmore and Hazleton plants who were added to the
  analysis by Schubauer-Berigan et al. were, in general, exposed to lower
  levels of beryllium than those at the Reading plant. The median worker
  from Hazleton had a LTW average exposure of less than 1.5 μg/m3\,
  while the median worker from Elmore had a LTW average exposure of less
  than 1 μg/m3\. The Elmore and Hazleton worker populations also had
  fewer short-term workers than the Reading population. Finally, the
  updated cohorts followed the worker populations through 2005,
  increasing the length of follow-up time compared to the previous
  exposure-response analysis. For these reasons, OSHA based the
  preliminary risk assessment for lung cancer on the Schubauer-Berigan
  risk analysis.
      Schubauer-Berigan et al. (2011, Document ID 1265) analyzed the data
  set using a variety of exposure-response modeling approaches, described
  in this preamble at section VI, Risk Assessment. The authors found that
  lung cancer mortality risk was strongly and significantly correlated
  with mean, cumulative, and maximum measures of workers' exposure to
  beryllium (all of the models reported in the study). They selected the
  best-fitting models to generate risk estimates for male workers with a
  mean exposure of 0.5 μg/m3\ (the current NIOSH Recommended Exposure
  Limit for beryllium). In addition, they estimated the daily weighted
  average exposure that would be associated with an excess lung cancer
  mortality risk of one in one thousand (.005 μg/m3\ to .07 μg/
  m3\ depending on model choice). At OSHA's request, the authors also
  estimated excess lifetime risks for workers with mean exposures at the
  preceding TWA PEL of 2 μg/m3\ as well as at each of the alternate
  TWA PELs that were under consideration: 1 μg/m3\, 0.2 μg/m3\,
  and 0.1 μg/m3\. Table VII-4 presents the estimated excess risk of
  lung cancer mortality associated with various levels of beryllium
  exposure, based on the final models presented in Schubauer-Berigan et
  al's risk assessment.\30\
  ---------------------------------------------------------------------------

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




   Table VII-4--Excess Risk of Lung Cancer Mortality per 1,000 Male Workers at Alternate PELs (based on Schubauer-
                                                Berigan et al., 2011)
  ----------------------------------------------------------------------------------------------------------------
                                                                     Mean exposure
       Exposure-response model     -------------------------------------------------------------------------------
                                    0.1 μg/m3\  0.2 μg/m3\  0.5 μg/m3\   1 μg/m3\    2 μg/m3\
  ----------------------------------------------------------------------------------------------------------------
  Best monotonic PWL-all workers..             7.3              15              45             120             140
  Best monotonic PWL--excluding                3.1             6.4              17              39              61
   professional and asbestos
   workers........................
  Best categorical--all workers...             4.4               9              25              59             170
  Best categorical--excluding                  1.4             2.7             7.1              15              33
   professional and asbestos
   workers........................
  Power model--all workers........              12              19              30              40              52
  Power model--excluding                        19              30              49              68              90
   professional and asbestos
   workers........................
  ----------------------------------------------------------------------------------------------------------------
  Source: Schubauer-Berigan, Document ID 0521, pp. 6-10.

      The lowest estimate of excess lung cancer deaths from the six final
  models presented by Schubauer-Berigan et al. is 33 per 1,000 workers
  exposed at a mean level of 2 μg/m3\, the preceding TWA PEL. Risk
  estimates as high as 170 lung cancer deaths per 1,000 result from the
  other five models presented. Regardless of the model chosen, the excess
  risk of about 33 to 170 per 1,000 workers is clearly significant,
  falling well above the level of risk the Supreme Court indicated a
  reasonable person might consider acceptable (see Benzene, 448 U.S. at
  655). The new PEL of 0.2 μg/m3\ is expected to reduce these risks
  significantly, to somewhere between 2.7 and 30 excess lung cancer
  deaths per 1,000 workers. At the new action level of 0.1 μg/m3\,
  risk falls within the range of 1.4 to 19 excess lung cancer deaths.
  These risk estimates still fall above the threshold of 1 in 1,000 that
  OSHA considers clearly significant. However, the Agency believes the
  lung cancer risks should be regarded as less certain than the risk
  estimates for CBD and sensitization discussed previously. While the
  risk estimates for CBD and sensitization at the preceding and new TWA
  PELs were determined from exposure levels observed in occupational
  studies, the lung cancer risks were extrapolated from much higher
  exposure levels.

  Conclusions

      As discussed throughout this section, OSHA used the best available
  scientific evidence to identify adverse health effects of occupational
  beryllium exposure, and to evaluate exposed workers' risk of these
  impairments. The Agency reviewed extensive epidemiological and
  experimental research pertaining to adverse health effects of
  occupational beryllium exposure, including lung cancer, CBD, and
  beryllium sensitization, and has evaluated the risk of these effects
  from exposures allowed under the preceding and new TWA PELs. The Agency
  has, additionally, reviewed the medical literature, as well as previous
  policy determinations and case law regarding material impairment of
  health, and has determined that CBD, at all stages, and lung cancer
  constitute material health impairments.
      OSHA has determined that long-term exposure to beryllium at the
  preceding TWA PEL would pose a risk of CBD and lung cancer greater than
  the risk of 1 per 1,000 exposed workers the Agency considers clearly
  significant, and that adoption of the new TWA PEL, action level, and
  dermal protection requirements of the final standards will
  substantially reduce this risk. OSHA believes substantial evidence
  supports its determinations, including its choices of the best
  available published studies on which to base its risk assessment, its
  examination of the prevalence of sensitization and CBD among workers
  with exposure levels comparable to the preceding TWA PEL and new TWA
  PEL in the NJH data set, and its selection of the Schubauer-Berigan QRA
  to form the basis for its lung cancer risk estimates. The previously-
  described analyses demonstrate that workers with occupational exposure
  to airborne beryllium at the preceding PEL face risks of developing CBD
  and dying from lung cancer that far exceed the value of 1 in 1,000 used
  by OSHA as a benchmark of clearly significant risk. Furthermore, OSHA's
  risk assessment indicates that risk of CBD and lung cancer can be
  significantly reduced by reduction of airborne exposure levels, and
  that dermal protection measures will additionally help reduce risk of
  sensitization and, therefore, of CBD.
      OSHA's risk assessment also indicates that, despite the reduction
  in risk expected with the new PEL, the risks of CBD and lung cancer to
  workers with average exposure levels of 0.2 μg/m3\ are still
  significant and could extend down to 0.1 μg/m3\, although there is
  greater uncertainty in this finding for 0.1 μg/m3\ since there is
  less information available on populations exposed at and below this
  level. Although significant risk remains at the new TWA PEL, OSHA is
  also required to consider the technological and economic feasibility of
  the standard in determining exposure limits. As explained in Section
  VIII, Summary of the Final Economic Analysis and Final Regulatory
  Flexibility Analysis, OSHA determined that the new TWA PEL of 0.2
  μg/m3\ is both technologically and economically feasible in the
  general industry, construction, and shipyard sectors. OSHA was unable
  to demonstrate, however, that a lower TWA PEL of 0.1 μg/m3\ would
  be technologically feasible. Therefore, OSHA concludes that, in setting
  a TWA PEL of 0.2 μg/m3\, the Agency is reducing the risk to the
  extent feasible, as required by the OSH Act (see section II, Pertinent
  Legal Authority). In this context, the Agency finds that the action
  level of 0.1 μg/m3\, dermal protection requirements, and other
  ancillary provisions of the final rule are critically important in
  reducing the risk of sensitization, CBD, and lung cancer among workers
  exposed to beryllium. Together, these provisions, along with the new
  TWA PEL of 0.2 μg/m3\, will substantially reduce workers' risk of
  material impairment of health from occupational beryllium exposure.

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

  A. Introduction

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


  12866 direct agencies to assess all costs and benefits of available
  regulatory alternatives and, if regulation is necessary, to select
  regulatory approaches that maximize net benefits (including potential
  economic, environmental, and public health and safety effects;
  distributive impacts; and equity). Executive Order 13563 emphasized the
  importance of quantifying both costs and benefits, of reducing costs,
  of harmonizing rules, and of promoting flexibility. The full FEA has
  been placed in OSHA rulemaking docket OSHA-H005C-2006-0870. This rule
  is an economically significant regulatory action under Sec. 3(f)(1) of
  Executive Order 12866 and has been reviewed by the Office of
  Information and Regulatory Affairs in the Office of Management and
  Budget, as required by executive order.
      The purpose of the FEA is to:
       Identify the establishments and industries potentially
  affected by the final rule;
       Estimate current exposures and the technologically
  feasible methods of controlling these exposures;
       Estimate the benefits resulting from employers coming into
  compliance with the final rule in terms of reductions in cases of lung
  cancer, chronic beryllium disease;
       Evaluate the costs and economic impacts that
  establishments in the regulated community will incur to achieve
  compliance with the final rule;
       Assess the economic feasibility of the final rule for
  affected industries; and
       Assess the impact of the final rule on small entities
  through a Final Regulatory Flexibility Analysis (FRFA), to include an
  evaluation of significant regulatory alternatives to the final rule
  that OSHA has considered.
  Significant Changes to the FEA Between the Proposed Standards and the
  Final Standards
      OSHA made changes to the Preliminary Economic Analysis (PEA) for
  several reasons:
       Changes to the rule, summarized in Section I of the
  preamble and discussed in detail in the Summary and Explanation;
       Comments on the PEA;
       Updates of economic data; and
       Recognition of errors in the PEA.
      OSHA revised its technological and economic analysis in response to
  these changes and to comments received on the NPRM. The FEA contains
  some costs that were not included in the PEA and updates data to use
  more recent data sources and, in some cases, revised methodologies.
  Detailed discussions of these changes are included in the relevant
  sections throughout the FEA.
      The Final Economic Analysis contains the following chapters:

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

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

     Table VIII-1--Annualized Benefits, Costs and Net Benefits of OSHA's
                          Final Beryllium Standard
                   [3 Percent Discount Rate, 2015 dollars]
  ------------------------------------------------------------------------

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

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

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

  B. Market Failure and the Need for Regulation

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

  C. Profile of Affected Industries

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

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


   Abrasive Blasting

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


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

      The OSH Act requires OSHA to demonstrate that a proposed health
  standard is technologically feasible (29 U.S.C. 655(b)(5)). As
  described in the preamble to the final rule (see Section II, Pertinent
  Legal Authority), technological feasibility has been interpreted
  broadly to mean "capable of being done" (Am. Textile Mfrs. Inst. v.
  Donovan, 452 U.S. 490, 509-510 (1981) ("Cotton Dust")). A standard is
  technologically feasible if the protective measures it requires already
  exist, can be brought into existence with available technology, or can
  be created with technology that can reasonably be expected to be
  developed, i.e., technology that "looms on today's horizon" (United
  Steelworkers of Am., AFL-CIO-CLC v. Marshall, 647 F.2d 1189, 1272 (D.C.
  Cir. 1980) ("Lead I"); Amer. Iron & Steel Inst. v. OSHA, 939 F.2d
  975, 980 (D.C. Cir. 1991) ("Lead II"); AFL-CIO v. Brennan, 530 F.2
  109, 121 (3rd Cir. 1975)). Courts have also interpreted technological
  feasibility to mean that, for health standards, a typical firm in each
  affected industry will reasonably be able to implement engineering and
  work practice controls that can reduce workers' exposures to meet the
  permissible exposure limit in most operations most of the time, without
  reliance on respiratory protection (see Lead I, 647 F.2d at 1272; Lead
  II, 939 F.2d at 990).
      OSHA's technological feasibility analysis is presented in Chapter
  IV of the FEA. The technological feasibility analysis identifies the
  affected industries and application groups in which employees can
  reasonably be expected to be exposed to beryllium, summarizes the
  available air sampling data used to develop employee exposure profiles,
  and provides descriptions of engineering controls and other measures
  employers can take to reduce their employees' exposures to beryllium.
  For each affected industry sector or application group, OSHA provides
  an assessment of the technological feasibility of compliance with the
  final permissible exposure limit (PEL) of 0.2 μg/m3\ as an 8-hour
  TWA and a 15-minute short-term exposure limit (STEL) of 2.0 μg/m3\.
      The technological feasibility analysis covers twelve application
  groups that correspond to specific industries or production processes
  that involve the potential for occupational exposures to materials
  containing beryllium and that OSHA has determined fall within the scope
  of this final beryllium standard. Within each of these application
  groups, exposure profiles have been developed to characterize the
  distribution of the available exposure measurements by job title or
  group of jobs. Each section includes descriptions of existing, or
  baseline, engineering controls for operations that generate beryllium
  exposure. For those job groups in which current exposures were found to
  exceed the final PEL, OSHA identifies and describes additional
  engineering and work practice controls that can be implemented to
  reduce exposure and achieve compliance with the final PEL. For each
  application group or industry, a final determination is made regarding
  the technological feasibility of achieving the proposed permissible
  exposure limits based on the use of engineering and work practice
  controls and without reliance on the use of respiratory protection. The
  determination is made based on the legal standard of whether the PEL
  can be achieved for most operations most of the time using such
  controls. In a separate chapter on short-term exposures, OSHA also
  analyzes the feasibility of achieving compliance with the Short-Term
  Exposure Limit (STEL).
      The analysis is based on the best evidence currently available to
  OSHA, including a comprehensive review of the industrial hygiene
  literature, National Institute for Occupational Safety and Health
  (NIOSH) Health Hazard Evaluations and case studies of beryllium
  exposure, site visits conducted by an OSHA contractor (Eastern Research
  Group (ERG)), and inspection data from OSHA's Integrated Management
  Information System (IMIS) and OSHA's Information System (OIS). OSHA
  also obtained information on beryllium production processes, worker
  exposures, and the effectiveness of existing control measures from
  Materion Corporation, the primary beryllium producer in the United
  States, interviews with industry experts, and comments submitted to the
  rulemaking docket in response to the Notice of Proposed Rulemaking and
  informal public hearings. All of this evidence is in the rulemaking
  record.
      The twelve application groups are:
       Primary Beryllium Production,
       Beryllium Oxide Ceramics and Composites,
       Nonferrous Foundries,
       Secondary Smelting, Refining, and Alloying, Including
  Handling of Scrap and Recycled Materials,
       Precision Turned Products,
       Copper Rolling, Drawing, and Extruding,
       Fabrication of Beryllium Alloy Products,
       Welding,
       Dental Laboratories,
       Abrasive Blasting,
       Coal-Fired Electric Power Generation,
       Aluminum Production
      For discussion purposes, the twelve application groups are divided
  into four general categories based on the distribution of exposures in
  the exposure profiles: (1) Application groups in which baseline
  exposures for most jobs are already at or below the final PEL of 0.2
  μg/m3\; (2) application groups in which baseline exposures for one
  or more jobs exceed the final PEL of 0.2 μg/m3\, but additional
  controls have been identified that could achieve exposures at or below
  the final PEL for most of the operations most of the time; (3)
  application groups in which exposures in one or more jobs routinely
  exceed the preceding PEL of 2.0 μg/m3\, and therefore substantial
  reductions in exposure would be required to achieve the final PEL; and
  (4) application groups in which exposure to beryllium occurs due to
  trace levels of beryllium found in dust or fumes that nonetheless can
  result in exposures that exceed 0.1 μg/m3\ as an 8-hour TWA under
  foreseeable conditions.
      The application groups in category 1, where exposures for most jobs
  are already at or below the final PEL of 0.2 μg/m3\, typically
  handle beryllium alloys containing a low percentage of beryllium (<2
  percent) using processes that do not result in significant airborne
  exposures. These four application groups are (1) copper rolling,
  drawing, and extruding; (2) fabrication of beryllium alloy products;
  (3) welding; and (4) aluminum production. The handling of beryllium
  alloys in solid form is not expected to result in exposures of concern.
  For example, beryllium alloys used in copper rolling, drawing, and
  extruding typically contain 2 percent beryllium by weight or less
  (Document ID 0081, Attachment 1). One facility noted that the copper-
  beryllium alloys it used contained as little as 0.1 percent beryllium
  (Document ID 0081, Attachment 1). These processes, such as rolling
  operations that consist of passing beryllium alloys through a rolling
  press to conform to a desired thickness, tend to produce less
  particulate and fume than high energy processes. Exposures can be
  controlled using containment, exhaust ventilation, and work practices
  that include rigorous housekeeping. In addition, the heating of metal
  during welding operations results in the release of fume, but the
  beryllium in the welding fume accounts for a relatively small
  percentage of the beryllium exposure. Worker exposure to beryllium


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


  primary beryllium production company in the U.S., and USW, jointly
  submitted a draft proposed rule that included an exposure limit of 0.2
  μg/m3\ (Document ID 0754, p. 4). In its written comments, Materion
  explained that it is feasible to control exposure to levels below 0.2
  μg/m3\ through the use of engineering controls and work practices
  in most, but not all, operations:

      Based on many years' experience in controlling beryllium
  exposures, its vigorous product stewardship program in affected
  operations, and the judgment of its professional industrial hygiene
  staff, Materion Brush believes that the 0.2 μg/m3\ PEL for
  beryllium, based on median exposures, can be achieved in most
  operations, most of the time. Materion Brush does recognize that it
  is not feasible to reduce exposures to below the PEL in some
  operations, and in particular, certain beryllium production
  operations, solely through the use of engineering and work practice
  controls (Document ID 1052).

      On the other hand, the Nonferrous Founders' Society (NFFS) asserted
  that OSHA had not demonstrated that the final PEL of 0.2 µg/m3\
  was feasible for the nonferrous foundry industry (Document ID 1678, pp.
  2-3). NFFS asserted that "OSHA has failed to meet its burden of proof
  that a ten-fold reduction to the current two micrograms per cubic meter
  limit is technologically or economically feasible in the non-ferrous
  foundry industry" (Document ID 1678, pp. 2-3; 1756, Tr. 18). In
  written testimony submitted as a hearing exhibit, NFFS claimed that
  OSHA's supporting documentation in the PEA had no "concrete assurance
  on technologic feasibility either by demonstration or technical
  documentation" (Document ID 1732, Appendix A, p. 4).
      However, contrary to the NFFS comments, which are addressed at
  greater length in Section IV-5 of the FEA, OSHA's exposure profile is
  based on the best available evidence for nonferrous foundries; the
  exposure data are taken from NIOSH surveys, an ERG site visit, and the
  California Cast Metals Association (Document ID 1217; 1185; 0341,
  Attachment 6; 0899). Materion also submitted substantial amounts of
  monitoring data, process descriptions and information of engineering
  controls that have been implemented in its facilities to control
  beryllium exposure effectively, including operations that involve the
  production of beryllium alloys using the same types of furnace and
  casting operations as those conducted at nonferrous foundries producing
  beryllium alloys (Document ID 0719; 0720; 0723). Furthermore, Materion
  submitted the above-referenced letter to the docket stating that, based
  on its many years of experience controlling beryllium exposures, a PEL
  of 0.2 μg/m3\ can be achieved in most operations, most of the time
  (Document ID 1052). Materion's letter is consistent with the monitoring
  data Materion submitted, and OSHA considers its statement regarding
  feasibility at the final PEL relevant to nonferrous foundries because
  Materion has similar operations in its facilities, such as beryllium
  alloy production. As stated in Section IV-5 of the FEA, the size and
  configuration of nonferrous foundries may vary, but they all use
  similar processes; they melt and pour molten metal into the prepared
  molds to produce a casting, and remove excess metal and blemishes from
  the castings (NIOSH 85-116, 1985). While the design may vary, the basic
  operations and worker job tasks are similar regardless of whether the
  casting metal contains beryllium.
      In the NPRM, OSHA requested that affected industries submit to the
  record any available exposure monitoring data and comments regarding
  the effectiveness of currently implemented control measures to inform
  the Agency's final feasibility determinations. During the informal
  public hearings, OSHA asked the NFFS panel to provide information on
  current engineering controls or the personal protective equipment used
  in foundries claiming to have difficulty complying with the preceding
  PEL, but no additional information was provided (Document ID 1756; Tr.
  24-25; 1785, p. 1). Thus, the NFFS did not provide any sampling data or
  other evidence regarding current exposure levels or existing control
  measures to support its assertion that a PEL of 0.2 μg/m3\ is not
  feasible, and did not show that the data in the record are insufficient
  to demonstrate technological feasibility for nonferrous foundry
  industry.
      In sum, while OSHA agrees that two of the operations in the
  nonferrous foundry industry, furnace and shakeout operations, employing
  a relatively small percentage of workers in the industry, may not be
  able to achieve the final PEL of 0.2 μg/m3\ most of the time,
  evidence in the record indicates that the final PEL is achievable in
  the other six job categories in this industry. Therefore, in the FEA,
  OSHA finds the PEL of 0.2 μg/m3\ is technologically feasible for
  the nonferrous foundry industry.
      OSHA also recognizes that engineering and work practice controls
  may not be able to consistently reduce and maintain exposures to the
  final PEL of 0.2 μg/m3\ in some job categories in other application
  groups, due to the processing of materials containing high
  concentrations of beryllium, which can result in the generation of
  substantial amounts of fumes and particulate. For example, the final
  PEL of 0.2 μg/m3\ cannot be achieved most of the time for furnace
  operations in primary beryllium production and for some furnace
  operation activities in secondary smelting, refining, and alloying
  facilities engaged in beryllium recovery and alloying. Workers may need
  supplementary respiratory protection during these high exposure
  activities where exposures exceed the final PEL of 0.2 μg/m3\ or
  STEL of 2.0 μg/m3\ with engineering and work practice controls. In
  addition, OSHA has determined that workers who perform open-air
  abrasive blasting using mineral grit (i.e., coal slag) will routinely
  be exposed to levels above the final PEL (even after the installation
  of feasible engineering and work practice controls), and therefore,
  these workers will also be required to wear respiratory protection.
      Overall, however, based on the information discussed above and the
  other evidence in the record and described in Chapter IV of the FEA,
  OSHA has determined that for the majority of the job groups evaluated
  exposures are either already at or below the final PEL, or can be
  adequately controlled to levels below the final PEL through the
  implementation of additional engineering and work practice controls for
  most operations most of the time. Therefore, OSHA concludes that the
  final PEL of 0.2 μg/m3\ is technologically feasible.
      In contrast, the record evidence does not show that it is feasible
  for most operations in all affected industries and application groups
  to achieve the alternative PEL of 0.1 μg/m3\ most of the time. As
  discussed below, although a number of operations can achieve this
  level, they may be interspersed with operations that cannot, and OSHA
  sees value in having a uniform PEL that can be enforced consistently
  for all operations, rather than enforcing different PELs for the same
  contaminant in different operations.
      Several commenters supported a PEL of 0.1 μg/m3\. Specifically,
  Public Citizen; the American Federation of Labor and Congress of
  Industrial Organizations (AFL-CIO); the International Union, United
  Automobile, Aerospace, and Agriculture Implement Workers of America
  (UAW); North America's Building Trades Unions (NABTU); and the American
  College of Occupational and Environmental Medicine contended that OSHA
  should adopt this lower level because of the residual risk at 0.2
  μg/m3\


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


  experienced during operation. The level of physical work effort
  required, the use of protective clothing, and environmental factors
  such as temperature extremes and high humidity can interact with
  respirator use to increase the physiological strain on employees.
  Inability to cope with this strain as a result of medical conditions
  such as cardiovascular and respiratory diseases, reduced pulmonary
  function, neurological or musculoskeletal disorders, impaired sensory
  function, or psychological conditions can place employees at increased
  risk of illness, injury, and even death. The widespread, routine use of
  respirators for extended periods of time that may be required by a PEL
  of 0.1 μg/m3\ creates more significant concerns than the less
  frequent respirator usage that is required by a PEL of 0.2 μg/m3\.
      Furthermore, OSHA concludes that it would complicate both
  compliance and enforcement of the rule if it were to set a PEL of 0.1
  μg/m3\ for some industries or operations and a PEL of 0.2 μg/
  m3\ for the remaining industries and operations where technological
  feasibility at the lower PEL is either unattainable or unknown. OSHA
  may exercise discretion to issue a uniform PEL if it determines that
  the PEL is technologically feasible for all affected industries (if not
  for all affected operations) and that a uniform PEL would constitute
  better public policy. See Pertinent Legal Authority (discussing the
  Chromium decision). In declining to lower the PEL to 0.1 μg/m3\ for
  any segment of the affected industries, OSHA has made that
  determination here. Therefore, OSHA has determined that the proposed
  alternative PEL of 0.1 μg/m3\ is not appropriate.
      OSHA also evaluated the technological feasibility of the final STEL
  of 2.0 μg/m3\ and the alternative STEL of 1.0 μg/m3\. An
  analysis of the available short-term exposure measurements presented in
  Chapter IV, Section 15 of the FEA indicates that elevated exposures can
  occur during short-term tasks such as those associated with the
  operation and maintenance of furnaces at primary beryllium production
  facilities, at nonferrous foundries, and at secondary smelting
  operations. Peak exposures can also occur during the transfer and
  handling of beryllium oxide powders. OSHA finds that in many cases, the
  control of peak short-term exposures associated with these intermittent
  tasks will be necessary to reduce workers' TWA exposures to or below
  the final PEL. The short-term exposure data presented in the FEA show
  that the majority (79%) of these exposures are already below 2.0 μg/
  m3\.
      A number of stakeholders submitted comments related to the proposed
  and alternative STELs. Some of these stakeholders supported a STEL of
  2.0 μg/m3\. Materion stated that a STEL of 2.0 μg/m3\ for
  controlling the upper range of worker short term exposures is
  sufficient to prevent CBD (Document ID 1661, p. 3). Other commenters
  recommended a STEL of 1.0 μg/m3\ (Document ID 1661, p. 19; 1681, p.
  7). However, no additional engineering controls capable of reducing
  short term exposures to at or below 1.0 μg/m3\ were identified by
  these commenters. OSHA provides a full discussion of the public
  comments in the Summary and Explanation section of this preamble. OSHA
  has determined that the implementation of engineering and work practice
  controls required to maintain full shift exposures at or below a PEL of
  0.2 μg/m3\ will reduce short term exposures to 2.0 μg/m3\ or
  below, and that a STEL of 1.0 μg/m3\ would require additional
  respirator use. Furthermore, OSHA notes that the combination of a PEL
  of 0.2 μg/m3\ and a STEL of 2.0 μg/m3\ would, in most cases,
  keep workers from being exposed to 15 minute intervals of 1.0 μg/
  m3\. See Table IV.78 of Chapter IV of the FEA.
      Therefore, OSHA concludes that the STEL of 2.0 μg/m3\ can be
  achieved for most operations most of the time, given that most short-
  term exposures are already below 2.0 μg/m3\. OSHA recognizes that
  for a small number of tasks, short-term exposures may exceed the final
  STEL, even after feasible control measures to reduce TWA exposure to or
  below the final PEL have been implemented, and therefore, some limited
  use of respiratory protection will continue to be required for short-
  term tasks in which peak exposures cannot be reduced to less than 2.0
  μg/m3\ through use of engineering controls.
      After careful consideration of the record, including all available
  data and stakeholder comments in the record, OSHA has determined that a
  STEL of 2.0 μg/m3\ is technologically feasible. Thus, as explained
  in the Summary and Explanation for paragraph (c), OSHA has retained the
  proposed value of 2.0 μg/m3\ as the final STEL.

  E. Costs of Compliance

      In Chapter V, Costs of Compliance, OSHA assesses the costs to
  general industry, maritime, and construction establishments in all
  affected application groups of reducing worker exposures to beryllium
  to an eight-hour time-weighted average (TWA) permissible exposure limit
  (PEL) of 0.2 μg/m3\ and to the final short-term exposure limit
  (STEL) of 2.0 μg/m3\, as well as of complying with the final
  standard's ancillary provisions. These ancillary provisions encompass
  the following requirements: Exposure monitoring, regulated areas (and
  competent person in construction), a written exposure control plan,
  protective work clothing, hygiene areas and practices, housekeeping,
  medical surveillance, medical removal, familiarization, and worker
  training. This final cost assessment is based in part on OSHA's
  technological feasibility analysis presented in Chapter IV of the FEA;
  analyses of the costs of the final standard conducted by OSHA's
  contractor, Eastern Research Group (ERG); and the comments submitted to
  the docket in response to the request for information (RFI) as part of
  the Small Business Regulatory Enforcement Fairness Act (SBREFA)
  process, comments submitted to the docket in response to the PEA,
  comments during the hearings conducted in March 2016, and comments
  submitted to the docket after the hearings concluded.
      Table VIII-4 presents summary of the annualized costs. All costs in
  this chapter are expressed in 2015 dollars and were annualized using a
  discount rate of 3 percent. (Costs at other discount rates are
  presented in the chapter itself). Annualization periods for
  expenditures on equipment are based on equipment life, and one-time
  costs are annualized over a 10-year period. Chapter V provides detailed
  explanation of the basis for these cost estimates.


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  F. Economic Feasibility and Regulatory Flexibility Determination

      In Chapter VI, OSHA investigates the economic impacts of its final
  beryllium rule on affected employers. This impact investigation has two
  overriding objectives: (1) To establish whether the final rule is
  economically feasible for all affected application groups/
  industries,\31\ and (2) to determine if the Agency can certify that the
  final rule will not have a significant economic impact on a substantial
  number of small entities.
  ---------------------------------------------------------------------------

      \31\ As noted in the FEA, OSHA uses the umbrella term
  "application group" to refer either to an industrial sector or to
  a cross-industry group with a common process. In the industrial
  profile chapter, because some of the discussion being presented has
  historically been framed in the context of the economic feasibility
  for an "industry," the Agency uses the term "application group"
  and "industry" interchangeably.
  ---------------------------------------------------------------------------

      Table VIII-5 presents OSHA's screening analysis, which shows costs
  as percentage of revenues and as a percentage of profits. The chapter
  explains why these screening analysis


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


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

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


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


  [GRAPHIC] [TIFF OMITTED] TR09JA17.043

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

  H. Regulatory Alternatives

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

  I. Final Regulatory Flexibility Analysis

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


  compliance requirements of the rule, including an estimate of the
  classes of small entities which will be subject to the requirement and
  the type of professional skills necessary for preparation of the report
  or record;
      6. a description of the steps the agency has taken to minimize the
  significant economic impact on small entities consistent with the
  stated objectives of applicable statutes, including a statement of the
  factual, policy, and legal reasons for selecting the alternative
  adopted in the final rule and why each one of the other significant
  alternatives to the rule considered by the agency which affect the
  impact on small entities was rejected; and for a covered agency, as
  defined in section 609(d)(2), a description of the steps the agency has
  taken to minimize any additional cost of credit for small entities.
      The Regulatory Flexibility Act further states that the required
  elements of the FRFA may be performed in conjunction with or as part of
  any other agenda or analysis required by any other law if such other
  analysis satisfies the provisions of the FRFA. 5 U.S.C. 605(a).
      In addition to these elements, OSHA also includes in this section
  the recommendations from the Small Business Advocacy Review (SBAR)
  Panel and OSHA's responses to those recommendations.
      While a full understanding of OSHA's analysis and conclusions with
  respect to costs and economic impacts on small entities requires a
  reading of the complete FEA and its supporting materials, this FRFA
  will summarize the key aspects of OSHA's analysis as they affect small
  entities.
   The Need for, and Objective of, the Rule
      The objective of the final beryllium standard is to reduce the
  number of fatalities and illnesses occurring among employees exposed to
  beryllium. This objective will be achieved by requiring employers to
  install engineering controls where appropriate and to provide employees
  with the equipment, respirators, training, medical surveillance, and
  other protective measures necessary to perform their jobs safely. The
  legal basis for the rule is the responsibility given the U.S.
  Department of Labor through the Occupational Safety and Health Act of
  1970 (OSH Act). The OSH Act provides that, in promulgating health
  standards dealing with toxic materials or harmful physical agents, the
  Secretary "shall set the standard which most adequately assures, to
  the extent feasible, on the basis of the best available evidence, that
  no employee will suffer material impairment of health or functional
  capacity even if such employee has regular exposure to the hazard dealt
  with by such standard for the period of his working life." 29 U.S.C.
  655(b)(5). See Section II of the preamble for a more detailed
  discussion.
      Chronic beryllium disease (CBD) is a hypersensitivity, or allergic
  reaction, to beryllium that leads to a chronic inflammatory disease of
  the lungs. It takes months to years after final beryllium exposure
  before signs and symptoms of CBD occur. Removing an employee with CBD
  from the beryllium source does not always lead to recovery. In some
  cases CBD continues to progress following removal from beryllium
  exposure. CBD is not a chemical pneumonitis but an immune-mediated
  granulomatous lung disease. OSHA's final risk assessment, presented in
  Section VI of the preamble, indicates that there is significant risk of
  beryllium sensitization and chronic beryllium disease from a 45-year
  (working life) exposure to beryllium at the current TWA PEL of 2 μg/
  m3\. 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 μg/m3\. The final standard, with a lower PEL of 0.2 μg/
  m3\, will help to address these health concerns. See the Health
  Effects and Risk Assessment sections of the preamble for further
  discussion.
   Summary of Significant Issues Raised by Comments on the
  Initial Regulatory Flexibility Analysis (IRFA) and OSHA's Assessment
  of, and Response to, Those Issues
      This section of the FRFA focuses only on public comments concerning
  significant issues raised on the Initial Regulatory Flexibility
  Analysis (IRFA). OSHA received only one such comment.
      The Non-Ferrous Founders' Society claimed that the costs of the
  rule will disproportionately affect small employers and result in job
  losses to foreign competition (Document ID 1678, p. 3). This comment is
  addressed in the FEA in the section on International Trade Effects in
  Chapter VI: Economic Feasibility Analysis and Regulatory Flexibility
  Determination. The summary of OSHA's response is that, in general,
  metalcasters in the U.S. have shortened lead times, improved
  productivity through computer design and logistics management, expanded
  design and development services to customers, and provided a higher
  quality product than foundries in China and other nations where labor
  costs are low (Document ID 1780, p. 3-12). All of these measures,
  particularly the higher quality of many U.S. metalcasting products and
  the ability of domestic foundries to fulfill orders quickly, are
  substantial advantages for U.S. metalcasters that may outweigh the very
  modest price increases that might occur due to the final rule. For a
  more detailed response please see the section on International Trade
  Effects in Chapter VI of the FEA.
  Response to Comments by the Chief Counsel for Advocacy of the Small
  Business Administration and OSHA'S Response to Those Comments
      The Chief Counsel for Advocacy of the Small Business Administration
  ("Advocacy") did not provide OSHA with comments on this rule.
   A Description of, and an Estimate of, the Number of Small
  Entities To Which the Rule Will Apply
      OSHA has analyzed the impacts associated with this final rule,
  including the type and number of small entities to which the standard
  will apply. In order to determine the number of small entities
  potentially affected by this rulemaking, OSHA used the definitions of
  small entities developed by the Small Business Administration (SBA) for
  each industry.
      OSHA estimates that approximately 6.600 small business entities
  would be affected by the beryllium standard. Within these small
  entities, 33,800 workers are exposed to beryllium and would be
  protected by this final standard. A breakdown, by industry, of the
  number of affected small entities is provided in Table III-14 in
  Chapter III of the FEA.
      OSHA estimates that approximately 5,280 very small entities--those
  with fewer than 20 employees--would be affected by the beryllium
  standard. Within these very small entities, 11,800 workers are exposed
  to beryllium and would be protected by the standard. A breakdown, by
  industry, of the number of affected very small entities is provided in
  Table III-15 in Chapter III of the FEA.
  A Description of the Projected Reporting, Recordkeeping, and Other
  Compliance Requirements of the Rule
      Tables VIII-9 and VIII-10 show the average costs of the beryllium
  standard and the costs of compliance as a percentage of profits and
  revenues by NAICS code for, respectively, small entities (classified as
  small by SBA) and very small entities (those with fewer than 20
  employees). The full derivation of these costs is presented in Chapter
  V. The cost for SBA-defined small entities ranges from a low of $832
  per entity for


  entities in NAICS 339116a: Dental Laboratories, to a high of about
  $599,836 for NAICS 331313: Alumina Refining and Primary Aluminum
  Production.
      The annualized cost for very small entities ranges from a low of
  $542 for entities in NAICS 339116a: Dental Laboratories, to a high of
  about $34,222 for entities in NAICS 331529b: Other Nonferrous Metal
  Foundries (except Die-Casting).\32\
  ---------------------------------------------------------------------------

      \32\ The cost of $542 for NAICS 339116a is the sum of a $524
  cost to substitute for a non-hazard material and $19 for cost of
  ancillary provisions. The total cost of $34,222 for NAICS 331529b is
  the sum of $22,601 for engineering controls, $186 for respirator
  costs, and $11,435 for ancillary provisions.

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


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

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

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

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

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


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


  [GRAPHIC] [TIFF OMITTED] TR09JA17.052

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


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


  [GRAPHIC] [TIFF OMITTED] TR09JA17.053




  [GRAPHIC] [TIFF OMITTED] TR09JA17.054




  (2) Exposure Limit (TWA PEL, STEL, and Action Level) Alternatives
      Paragraph (c) of the three final standards establishes two PELs for
  beryllium in all forms, compounds, and mixtures: An 8-hour TWA PEL of
  0.2 μg/m3\ (paragraph (c)(1)), and a 15-minute short-term exposure
  limit (STEL) of 2.0 μg/m3\ (paragraph (c)(2)). OSHA has defined the
  action level for the final standard as an airborne concentration of
  beryllium of 0.1 μg/m3\ calculated as an eight-hour TWA (paragraph
  (b)). In this final rule, as in other standards, the action level has
  been set at one half of the TWA PEL.
      Regulatory Alternative #5 would set a higher TWA PEL at 0.5
  µg/m3\ and an action level at 0.25 µg/m3\. This
  alternative responds to an issue raised during the Small Business
  Advocacy Review (SBAR) process conducted in 2007 to consider a draft
  OSHA beryllium proposed rule that culminated in an SBAR Panel report
  (SBAR, 2008). That report included a recommendation that OSHA consider
  both the economic impact of a low TWA PEL and regulatory alternatives
  that would ease cost burden for small entities. OSHA has provided a
  full analysis of the economic impact of its final PELs (see Chapter VI
  of the FEA), and Regulatory Alternative #5 was considered in response
  to the second half of that recommendation. However, the higher 0.5
  µg/m3\ TWA PEL is not consistent with the Agency's mandate under
  the OSH Act to promulgate a lower PEL if it is feasible and could
  prevent additional fatalities and non-fatal illnesses. The data
  presented in Table VIII-14 below indicate that the final TWA PEL would
  prevent additional fatalities and non-fatal illnesses relative to
  Regulatory Alternative #5.
      Table VIII-14 below presents, for informational purposes, the
  estimated costs, benefits, and net benefits of the final rule under the
  final TWA PEL of 0.2 μg/m3\ and for the regulatory alternative TWA
  PEL of 0.5 μg/m3\ (Regulatory Alternative #5), using alternative
  discount rates of 3 percent and 7 percent. In addition, the table
  presents the incremental costs, the incremental benefits, and the
  incremental net benefits of going from a TWA PEL of 0.5 μg/m3\ to
  the final TWA PEL of 0.2 μg/m3\. Table VIII-14 also breaks out
  costs by provision and benefits by type of disease and by morbidity/
  mortality.
      As Table VIII-14 shows, going from a TWA PEL of 0.5 μg/m3\ to a
  TWA PEL of 0.2 μg/m3\ would prevent, annually, an additional 30
  beryllium-related fatalities and an additional 16 non-fatal illnesses.
  This is consistent with OSHA's final risk assessment, which indicates
  significant risk to workers exposed at a TWA PEL of 0.5 μg/m3\;
  furthermore, OSHA's final feasibility analysis indicates that a lower
  TWA PEL than 0.5 μg/m3\ is feasible. Net benefits of this
  regulatory alternative versus the final TWA PEL of 0.2 μg/m3\ would
  decrease from $487.0 million to $376.5 million using a 3 percent
  discount rate and from $172.4 million to $167.2 million using 7 percent
  discount rate.


  [GRAPHIC] [TIFF OMITTED] TR09JA17.055




  Regulatory Alternative With Unchanged PEL But Full Ancillary Provisions
      An Informational Analysis: This final regulation has the somewhat
  unusual feature for an OSHA substance-specific health standard that
  most of the quantified benefits that OSHA estimated would come from the
  ancillary provisions rather than from meeting the PEL solely with
  engineering controls (see Chapter VII of the FEA for a more detailed
  discussion). OSHA decided to analyze for informational purposes the
  effect of retaining the preceding PEL but applying all of the ancillary
  provisions, including respiratory protection. Under this approach, the
  TWA PEL would remain at 2.0 micrograms per cubic meter, but all of the
  other final provisions (including respiratory protection) would be
  required with their triggers remaining the same as in the final rule--
  either the presence of airborne beryllium at any level (e.g., initial
  monitoring, written exposure control plan), at certain kinds of dermal
  exposure (PPE), at the action level of 0.1 µg/m3\ (e.g.,
  periodic monitoring, medical removal), or at 0.2 µg/m3\ (e.g.,
  regulated areas, respiratory protection, medical surveillance).
      Given the record regarding beryllium exposures, this approach is
  not one OSHA could legally adopt. The absence of engineering controls
  would not be consistent with OSHA's application of the hierarchy of
  controls, in which engineering controls are applied to eliminate or
  control hazards, before administrative controls and personal protective
  equipment are applied to address remaining exposures. Section 6(b)(5)
  of the OSH Act requires OSHA to "set the standard which most
  adequately assures, to the extent feasible, on the basis of the best
  available evidence, that no employee will suffer material impairment of
  health or functional capacity even if such employee has regular
  exposure to the hazard dealt with by such standard for the period of
  his working life." For that reason, this additional analysis is
  provided strictly for informational purposes. E.O. 12866 and E.O. 13563
  direct agencies to identify approaches that maximize net benefits, and
  this analysis is purely for the purpose of exploring whether this
  approach would hold any real promise to maximize net benefits if it was
  permissible under the OSH Act. It does not appear to hold such promise
  because an ancillary-provisions-only approach would not be as
  protective and thus offers fewer benefits than one that includes a
  lower PEL and engineering controls. Also, OSHA estimates the costs
  would be about the same (or slightly lower, depending on certain
  assumptions) under that approach as under the traditional final
  approach.
      When examined on an industry-by-industry basis, OSHA found that
  some industries would have lower costs if they could adopt the
  ancillary-provision-only approach. Some employers would use engineering
  controls where they are cheaper, even if they are not mandatory. OSHA
  does not have sufficient information to do an analysis employer-by-
  employer of when the ancillary-provisions-only approach might be
  cheaper. In the majority of affected industries, the Agency estimates
  there are no cost savings to the ancillary-provisions-only approach.
  However, OSHA estimates an annualized total cost saving of $2.7 million
  per year for entire industries where the ancillary-provisions-only
  approach would be less expensive.
      The above discussion does not account for the possibility that the
  lack of engineering controls would result in higher beryllium exposures
  for workers in adjacent (non-production) work areas due to the
  increased level of beryllium in the air. Because of a lack of data, and
  because the issue did not arise in the other regulatory alternatives
  OSHA considered (all of which have a PEL of less than 2.0 µg/
  m3\), OSHA did not examine exposure levels in non-production areas for
  either cost or benefit purposes. To the extent such exposure levels
  would be above the action level, there would be additional costs for
  respiratory protection and medical surveillance.
      If respirators were as effective as engineering controls, the
  ancillary-provisions-only approach would have benefits comparable to
  the benefits of the final rule. However, in this alternative most
  exposed individuals would be required to use respirators, which OSHA
  considers less effective than engineering controls in preventing
  employee exposure to beryllium. OSHA also examined what the benefits
  would be if respirators were not required, were not worn, or were
  ineffective. OSHA found that, if all of the other aspects of the
  benefits analysis remained the same, the annualized benefits would be
  reduced by from $33.2 million using a discount rate of 3 percent, and
  $22.4 using a discount rate of 7 percent, largely as a result of
  failing to reduce deaths from lung cancer, which are unaffected by the
  ancillary provisions. However, there are also other reasons to believe
  that benefits may be even lower:
      (1) As noted above, in the final rule OSHA did not consider
  benefits caused by reductions in exposure in non-production areas.
  Unless employers act to reduce exposures in the production areas, the
  absence of a requirement for such controls would largely negate such
  benefits from reductions in exposure in the non-productions areas.
      (2) OSHA judges that the benefits of the ancillary provisions (a
  midpoint estimate of eliminating 45 percent of all remaining cases of
  CBD for all sectors except for abrasive blasting and coal-fired power
  plants, and an estimate of 11.25 percent, or one fourth of the
  percentage for other sectors, for abrasive blasting and coal-fired
  power plants) would be partially or wholly negated in the absence of
  engineering controls that would reduce both airborne and surface dust
  levels. The Agency's high estimate (90 percent for all sectors except
  abrasive blasting and coal fired power plants, 22.5 percent for
  abrasive blasting and coal-fired power plants) of the proportion of
  remaining CBD cases eliminable by ancillary provisions is based on data
  from a facility with average exposure levels of less than 0.2 µg/
  m3\.
      Based on these considerations, OSHA finds that the ancillary-
  provisions-only approach is not one that is likely to maximize net
  benefits. The cost savings, if any, are estimated to be small, and the
  difficult-to-measure declines in benefits could be substantial.
  (2) A Method-of-Compliance Alternative
      Paragraph (f)(2)(i) of the final standards contains requirements
  for the implementation of engineering and work practice controls to
  minimize beryllium exposures in general industry, maritime, and
  construction. For each operation in a beryllium work area in general
  industry or where exposures are or can reasonably be expected to be
  above the action level in shipyards or construction, employers must
  ensure that one or more of the following are in place to minimize
  employee exposure: Material and/or process substitution; isolation,
  such as ventilated partial or full enclosures; local exhaust
  ventilation; or process controls, such as wet methods and automation.
  Employers are exempt from using these methods only when they can show
  that such methods are not feasible or where exposures are below the
  action level based on two exposure samples taken at least seven days
  apart.
      OSHA believes that the methods outlined in paragraph (f)(2)(i)
  provide the most reliable means to control variability in exposure
  levels. However, OSHA also recognizes that the requirements of
  paragraph (f)(2)(i) are not typical of OSHA standards, which usually
  require engineering controls


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

  (4) Regulatory Alternatives That Affect Ancillary Provisions
      The final standard contains several ancillary provisions
  (provisions other than the exposure limits), including requirements for
  exposure assessment, medical surveillance, medical removal, training,
  competent person, and regulated areas or access control. As reported in
  Chapter V of the FEA, these ancillary provisions account for $61.3
  million (about 83 percent) of the total annualized costs of the rule
  ($73.4 million) using a 3 percent discount rate. The most expensive of
  the ancillary provisions are the requirements for housekeeping and
  exposure monitoring, with annualized costs of $22.8 million and $13.7
  million, respectively, at a 3 percent discount rate.
      OSHA's reasons for including each of the final ancillary provisions
  are explained in Section XVI of the preamble, Summary and Explanation
  of the Standards.
      OSHA has examined a variety of regulatory alternatives involving
  changes to one or more of the final ancillary provisions. The
  incremental cost of each of these regulatory alternatives and its
  impact on the total costs of the final rule are summarized in Table
  VIII-16 at the end of this section. OSHA has determined that several of
  these ancillary provisions will increase the benefits of the final
  rule, for example, by helping to ensure the TWA PEL is not exceeded or
  by lowering the risks to workers given the significant risk remaining
  at the final TWA PEL. However, except for Regulatory Alternative #7
  (involving the elimination of all ancillary provisions), OSHA did not
  estimate changes in monetized benefits for the regulatory alternatives
  that affect ancillary provisions. Two regulatory alternatives that
  involve all ancillary provisions are presented below (#7 and #8),
  followed by regulatory alternatives for exposure monitoring (#9, #10,
  and #11), for regulated areas (#12), for personal protective clothing
  and equipment (#13), for medical surveillance (#14 through #20), and
  for medical removal protection (#22).
  All Ancillary Provisions
      The SBAR Panel recommended that OSHA analyze a PEL-only standard as
  a regulatory alternative. The Panel also recommended that OSHA consider
  not applying ancillary provisions of the standard where exposure levels
  are low so as to minimize costs for small businesses (SBAR, 2008). In
  response to these recommendations, OSHA analyzed Regulatory Alternative
  #7, a PEL-only standard, and Regulatory Alternative #8, which would
  apply ancillary provisions of the beryllium standard only where
  exposures exceed the final TWA PEL of 0.2 μg/m3\ or the final STEL
  of 2.0 μg/m3\.
      Regulatory Alternative #7 would only update 1910.1000 Tables Z-1
  and Z-2, so that the final TWA PEL and STEL would apply to all workers
  in general industry, construction, and maritime. This alternative would
  eliminate all of the ancillary provisions of the final rule, including
  exposure assessment, medical surveillance, medical removal protection,
  PPE, housekeeping, training, competent person, and regulated areas or
  access control. Under this regulatory alternative, OSHA estimates that
  the costs for the final ancillary provisions of the rule (estimated at
  $61.4 million annually at a 3 percent discount rate) would be
  eliminated. In order to meet the PELs, employers would still commonly
  need to do monitoring, train workers on the use of controls, and set up
  some kind of regulated areas to indicate where respirator use would be
  required. It is also likely that, under this alternative, many
  employers would follow the recommendations of Materion and the United
  Steelworkers to provide medical surveillance, PPE, and other protective
  measures for their workers (Materion and United Steelworkers, 2012).
  OSHA has not attempted to estimate the extent to which these ancillary
  provision costs would be incurred if they were not formally required or
  whether any of


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

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

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

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

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


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

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

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


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


  [GRAPHIC] [TIFF OMITTED] TR09JA17.057




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

  ------------------------------------------------------------------------
            Panel recommendation                    OSHA response
  ------------------------------------------------------------------------
  The Panel recommends that OSHA evaluate  OSHA has reviewed its cost
   carefully the costs and technological    estimates and the
   feasibility of engineering controls at   technological feasibility of
   all PEL options, especially those at     engineering controls at
   the lowest levels.                       various PEL levels. These
                                            issues are discussed in the
                                            Regulatory Alternatives
                                            Chapter.
  The Panel recommends that OSHA consider  OSHA has removed the initial
   alternatives that would alleviate the    exposure monitoring
   need for monitoring in operations with   requirement for workers likely
   exposures far below the PEL. The Panel   to be exposed to beryllium by
   also recommends that OSHA consider       skin or eye contact through
   explaining more clearly how employers    routine handling of beryllium
   may use "objective data" to estimate   powders or dusts or contact
   exposures. Although the draft proposal   with contaminated surfaces.
   contains a provision allowing           The periodic monitoring
   employers to initially estimate          requirement presented in the
   exposures using "objective data"       SBAR Panel report required
   (e.g., data showing that the action      monitoring every 6 months for
   level is unlikely to be exceeded for     airborne levels at or above
   the kinds of process or operations an    the action level but below the
   employer has), the SERs did not appear   PEL, and every 3 months for
   to have fully understood how this        exposures at or above the PEL.
   alternative may be used.                 The final standard, in line
                                            with OSHA's normal practice,
                                            requires exposure monitoring
                                            every three months for levels
                                            above the PEL or STEL and
                                            every six months for exposures
                                            between the action level and
                                            the PEL. In the preamble to
                                            the final standard, OSHA
                                            provides further explanation
                                            on the use of objective data,
                                            which would exempt employers
                                            from the requirements of the
                                            final rule.
                                           These issues are discussed in
                                            the preamble at Section XVI,
                                            Summary and Explanation of the
                                            Standards, (d): Exposure
                                            Monitoring.
  The Panel recommends that OSHA consider  In the preamble to the final
   providing some type of guidance to       standards, OSHA discusses the
   describe how to use objective data to    issue of objective data. While
   estimate exposures in lieu of            OSHA recognizes that some
   conducting personal sampling.            establishments will have
  Using objective data could provide        objective data, for purposes
   significant regulatory relief to         of estimating the cost of this
   several industries where airborne        rule, the Agency is assuming
   exposures are currently reported by      that no establishments will
   SERs to be well below even the lowest    use objective data. The Agency
   PEL option. In particular, since         recognizes that this will
   several ancillary provisions, which      overestimate costs.
   may have significant costs for small    The use of objective data is
   entities may be triggered by the PEL     discussed in the preamble at
   or an action level, OSHA should          Section XVI, Summary and
   consider encouraging and simplifying     Explanation of the Standards,
   the development of objective data from   (d): Exposure Monitoring.
   a variety of sources.
  The Panel recommends that OSHA revisit   SERs with very low exposure
   its analysis of the costs of regulated   levels or only occasional work
   areas if a very low PEL is proposed.     with beryllium will not be
   Drop or limit the provision for          required to have regulated
   regulated areas: SERs with very low      areas unless exposures are
   exposure levels or only occasional       above the final PEL of 0.2
   work with beryllium questioned the       μg/m3\.
   need for separating areas of work by    The final standards for general
   exposure level. Segregating machines     industry and maritime require
   or operations, SERs said, would affect   the employer to establish and
   productivity and flexibility. Until      maintain a regulated area
   the health risks of beryllium are        wherever employees are, or can
   known in their industries, SERs          be expected to be, exposed to
   challenged the need for regulated        airborne beryllium at levels
   areas.                                   above the PEL of 0.2 μg/
                                            m3\. There is no regulated
                                            area requirement in
                                            Construction.
  The Panel recommends that OSHA revisit   In General industry employers
   its cost model for hygiene areas to      must ensure that employees who
   reflect SERs' comments that estimated    have dermal contact with
   costs are too low and more carefully     beryllium wash any exposed
   consider the opportunity costs of        skin at the end of the
   using space for hygiene areas where      activity, process, or work
   SERs report they have no unused space    shift and prior to eating,
   in their physical plant for them. The    drinking, smoking, chewing
   Panel also recommends that OSHA          tobacco or gum, applying
   consider more clearly defining the       cosmetics, or using the
   triggers (skin exposure and              toilet. In General Industry,
   contaminated surfaces) for the hygiene   although there is a shower
   areas provisions. In addition, the       requirement, OSHA has
   Panel recommends that OSHA consider      determined that establishments
   alternative requirements for hygiene     required to have showers will
   areas dependent on airborne exposure     already have them, and
   levels or types of processes. Such       employers will not have to
   alternatives might include, for          install showers to comply with
   example, hand washing facilities in      the beryllium standard (Please
   lieu of showers in particular cases or   see the Hygiene Areas and
   different hygiene area triggers where    Practices section in Chapter V
   exposure levels are very low.            of the FEA). In Construction
                                            and Maritime, for each
                                            employee required to use
                                            personal protective clothing
                                            or equipment, the employer
                                            must ensure that employees who
                                            have dermal contact with
                                            beryllium wash any exposed
                                            skin at the end of the
                                            activity, process, or work
                                            shift and prior to eating,
                                            drinking, smoking, chewing
                                            tobacco or gum, applying
                                            cosmetics, or using the
                                            toilet. For Construction and
                                            Maritime, language involving
                                            showers has been removed but
                                            employers are still required
                                            to provide change rooms. Where
                                            personal protective clothing
                                            or equipment must be used, the
                                            employer must provide washing
                                            facilities. The standards do
                                            not require that eating and
                                            drinking areas be provided,
                                            but impose requirements when
                                            the employer chooses to have
                                            eating and drinking areas.
                                           Change rooms have been costed
                                            in general industry for
                                            employees who work in a
                                            beryllium work area and in
                                            construction and maritime for
                                            employees who required to use
                                            personal protective clothing
                                            or equipment. The Agency has
                                            determined that the long-term
                                            rental of modular units is
                                            representative of costs for a
                                            range of reasonable approaches
                                            to comply with the change room
                                            part of the provision.
                                            Alternatively, employers could
                                            renovate and rearrange their
                                            work areas in order to meet
                                            the requirements of this
                                            provision.



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



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



  Several SERs said that OSHA should       In the Technological
   first assume the burden of describing    Feasibility Analysis presented
   the exposure level in each industry      in the FEA, OSHA has described
   rather than employers doing so. Others   the baseline exposure levels
   said that the Agency should accept       in each industry or
   exposure determinations made on an       application group.
   industry-wide basis, especially where   In the preamble to the final
   exposures were far below the PEL         standards, OSHA discusses the
   options under consideration.             issue of objective data. While
  As noted above, the Panel recommends      OSHA recognizes that some
   that OSHA consider alternatives that     establishments will have
   would alleviate the need for             objective data, for purposes
   monitoring in operations or processes    of the economic analysis, the
   with exposures far below the PEL. The    Agency is choosing to assume
   use of objective data is a principal     that no establishments will
   method for industries with low           use objective data. The Agency
   exposures to satisfy compliance with a   recognizes that this will
   proposed standard. The Panel             overestimate costs.
   recommends that OSHA consider
   providing some guidance to small
   entities in the use of objective data.
  The Panel recommends that OSHA consider  OSHA has provided discussion of
   more fully evaluating whether the        the BeLPT in the preamble to
   BeLPT is suitable as a test for          the final rule at section V,
   beryllium sensitization in an OSHA       Health Effects; and in the
   standard and respond to the points       preamble at section XVI,
   raised by the SERs about its efficacy.   Summary and Explanation of the
   In addition, the Agency should           Standards, (b) Definitions and
   consider the availability of other       (k) Medical Surveillance. In
   tests under development for detecting    the regulatory text, OSHA has
   beryllium sensitization and not limit    clarified that a test for
   either employers' choices or new         beryllium sensitization other
   science and technology in this area.     than the BeLPT may be used in
   Finally, the Panel recommends that       lieu of the BeLPT if a more
   OSHA re-consider the trigger for         reliable and accurate
   medical surveillance where exposures     diagnostic test is developed.
   are low and consider if there are       As stated above, the triggers
   appropriate alternatives.                for medical surveillance in
                                            the final standard have
                                            changed from those presented
                                            to the SBAR Panel. Whereas the
                                            draft standard presented
                                            during the SBREFA process
                                            required medical surveillance
                                            for employees with skin
                                            contact--potentially applying
                                            to employees with any level of
                                            airborne exposure--the final
                                            standard ties medical
                                            surveillance to exposures
                                            above the final action level
                                            of 0.1 μg/m3\ (or signs or
                                            symptoms of beryllium-related
                                            health effects, emergency
                                            exposure, or a medical opinion
                                            recommending medical
                                            surveillance on the basis of a
                                            CBD or sensitization
                                            diagnosis). The triggers for
                                            medical surveillance are
                                            discussed in the preamble at
                                            section XVI, Summary and
                                            Explanation of the Standards,
                                            (k) Medical Surveillance.
                                           OSHA has considered Regulatory
                                            Alternative #16, where
                                            employers would not be
                                            required to offer employees a
                                            BeLPT that tests for beryllium
                                            sensitization. from the final
                                            standard. This alternative is
                                            discussed in the Regulatory
                                            Alternatives Chapter and in in
                                            the preamble at Section XVI,
                                            Summary and Explanation of the
                                            Final Standard, (k) Medical
                                            Surveillance.
  Seeking ways of minimizing costs to low- The standard presented in the
   risk processes and operations: OSHA      SBAR panel report had skin
   should consider alternatives for         exposure as a trigger. The
   minimizing costs to industries,          final standards require PPE
   operations, or processes that have low   when there is a reasonable
   exposures. Such alternatives may         expectation of dermal contact
   include, but not be limited to:          with beryllium. The employer
   Encouraging the use of objective data    must ensure that employees who
   by such mechanisms as providing          have dermal contact with
   guidance for objective data; assuring    beryllium wash any exposed
   that triggers for skin exposure and      skin at the end of the
   surface contamination are clear and do   activity, process, or work
   not pull in low-risk operations;         shift and prior to eating,
   providing guidance on least-cost ways    drinking, smoking, chewing
   for low risk facilities to determine     tobacco or gum, applying
   what provisions of the standard they     cosmetics, or using the
   need to comply with; and considering     toilet. OSHA uses an exposure
   ways to limit the scope of the           profile to determine which
   standard if it can be ascertained that   workers will be affected by
   certain processes do not represent a     the standards. As a result, in
   significant risk.                        General Industry and Maritime,
                                            the final standards require
                                            regulated areas where
                                            exposures can exceed the PEL
                                            or STEL. In General Industry,
                                            beryllium work areas must be
                                            established in areas that
                                            contain a process or operation
                                            that can release beryllium
                                            where employees are, or can
                                            reasonably be expected to be,
                                            exposed to airborne beryllium
                                            at any level or where there is
                                            the potential for dermal
                                            contact with beryllium.
                                           In Construction, the written
                                            exposure control plan must
                                            contain procedures used to
                                            restrict access to work areas
                                            when airborne exposures are,
                                            or can reasonably be expected
                                            to be, above the TWA PEL or
                                            STEL, and the competent person
                                            must implement the plan.
                                           In addition, the scope of the
                                            final standards includes
                                            several limitations. Whereas
                                            the standard presented in the
                                            SBAR panel report covered
                                            beryllium in all forms and
                                            compounds in general industry,
                                            construction, and maritime,
                                            the scope of the final
                                            standard (1) does not apply to
                                            beryllium-containing articles
                                            that the employer does not
                                            process; and (2) does not
                                            apply to materials that
                                            contain less than 0.1%
                                            beryllium by weight where the
                                            employer has objective data
                                            demonstrating that employee
                                            exposure to beryllium will
                                            remain below the action level
                                            as an 8-hour TWA under any
                                            foreseeable conditions. In the
                                            preamble to the final
                                            standards, OSHA discusses the
                                            issue of objective data. While
                                            OSHA recognizes that some
                                            establishments will have
                                            objective data, for purposes
                                            of this rule, the Agency is
                                            choosing to assume that no
                                            establishments will use
                                            objective data. The Agency
                                            recognizes that this will
                                            overestimate costs.



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



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

  IX. OMB Review Under the Paperwork Reduction Act of 1995

  Introduction

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

  Summary of Information Collection Requirements

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


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

  Discussion of Significant Changes in the Collections of Information
  Requirements

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

  Exposure Assessment

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

  Methods of Compliance

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


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

  Respiratory Protection

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

  Personal Protective Equipment

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

  Housekeeping

      Paragraph (j)(3) requires warning labels in accordance with the
  requirements in paragraph (m) when employer transfer materials
  containing beryllium. Medical Surveillance Final paragraph (k) sets
  forth requirements for the medical surveillance provisions. The
  paragraph specifies which employees must be offered medical
  surveillance, as well as the frequency and content of medical
  examinations. It also sets forth the information that the licensed
  physician and CBD diagnostic center is to provide to the employee and
  employer.
      In paragraphs (k)(1)(i)(A)-(D) of the proposal, OSHA specified that
  employers must make medical surveillance required by this paragraph
  available for each employee: (1) Who has worked in a regulated area for
  more than 30 days in the last 12 months; (2) showing symptoms or signs
  of CBD, such as shortness of breath after a short walk or climbing
  stairs, persistent dry cough, chest pain, or fatigue; or (3) exposed to
  beryllium during an emergency; and (4) who was exposed to airborne
  beryllium above .2 μg/m3\ for more than 30 days in a 12-month
  period for 5 years or more, limited to the procedures described in
  paragraph (k)(3)(ii)(F) of this section unless the employee also
  qualifies for an examination under paragraph (k)(1)(i)(A), (B), or (C)
  of this section. OSHA revised the first proposed medical surveillance
  trigger to require the offering of medical surveillance based on
  exposures at or above the action level, rather than the PEL. In
  addition, OSHA revised the proposed trigger to require employers to
  make medical surveillance available to each employee who is or is
  reasonably expected to be exposed at or above the action level for more
  than 30 days a year, rather than waiting for the 30th day of exposure
  to occur.
      Paragraph (k)(1)(i)(B) has been revised to include signs or
  symptoms of other beryllium-related health effects.
      Proposed paragraph (k)(1)(i)(C) required employers to offer medical
  surveillance to employees exposed during an emergency. No revisions
  were made to this paragraph.
      OSHA added final paragraph (k)(1)(i)(D), which requires that
  medical surveillance be made available when the most recent written
  medical opinion to the employer recommends continued medical
  surveillance. Under final paragraphs (k)(6) and (k)(7), the written
  opinion must contain a recommendation for continued periodic medical
  surveillance if the employee is confirmed positive or diagnosed with
  CBD, and the employee provides written authorization.
      Frequency: Proposed paragraph (k)(2) specified when and how
  frequently medical examinations were to be offered to those employees
  covered by the medical surveillance program. Under proposed paragraph
  (k)(2)(i)(A), employers would have been required to provide each
  employee with a medical examination within 30 days after making a
  determination that the employee had worked in a regulated area for more
  than 30 days in the past 12 months, unless the employee had received a
  medical examination provided in accordance with this standard within
  the previous 12 months. OSHA made several changes to this requirement.
  First, OSHA revised the medical surveillance trigger of employees
  working in a regulated area to a determination that employee is or is
  reasonably expected to be exposed at or above the action level for more
  than 30 days of year; or who shows signs or symptoms of CBD or other
  beryllium-related health effects. Second, the Agency changed the
  extended the length of time from within the last 12 months to within
  the last two years.
      Proposed paragraph (k)(2)(ii) required employers to provide an
  examination annually (after the first examination is made available) to
  employees who continue to meet the criteria of proposed paragraph
  (k)(1)(i)(A) or (B). OSHA revised the paragraph to specify that medical
  examinations were to be made available "at least" every two years and
  to include employees who continue to meet the criteria of final
  paragraph (k)(1)(i)(D), i.e., each employee whose most recent written
  medical opinion required by paragraph (k)(6) or (k)(7) recommends
  periodic medical surveillance. Under the final standards, employees
  exposed in an


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

  Information Provided to the PLHCP

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

  Licensed Physician's Written Medical Opinion

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

  Licensed Physician's Written Medical Report for the Employee

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


  Licensed Physician's Written Medical Opinion for the Employer

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

  Beryllium Sensitization Test Results Research (Removed)

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

  Referral to a Diagnostic Center

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

  Communication of Hazards

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

  Recordkeeping

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


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

  X. Federalism

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

  XI. State-Plan States

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


  States") must revise their standards to reflect the new standard or
  amendment. The State standard must be at least as effective as the
  Federal standard or amendment, and must be promulgated within six
  months of the publication date of the final Federal rule. 29 CFR
  1953.5(a). Currently, there are 28 State-Plan States.
      A State-Plan State may demonstrate that a standard change is not
  necessary because the State standard is already the same as or at least
  as effective as the new or amended Federal standard. In order to avoid
  delays in worker protection, the effective date of the State standard
  and any of its delayed provisions must be the date of State
  promulgation or the Federal effective date, whichever is later. The
  Assistant Secretary may permit a longer time period if the State makes
  a timely demonstration that good cause exists for extending the time
  limitation. 29 CFR 1953.5(a).
      Of the 28 States and territories with OSHA-approved State plans, 22
  cover public and private-sector employees: Alaska, Arizona, California,
  Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada,
  New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina,
  Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. The
  remaining six states and territories cover only public-sector
  employees: Connecticut, Illinois, New Jersey, Maine, New York, and the
  Virgin Islands.
      This beryllium rule applies to general industry, construction, and
  shipyards. This rule requires that all State-Plan States revise their
  standards appropriately within six months of the date of this notice.

  XII. Unfunded Mandates Reform Act

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

  XIII. Protecting Children From Environmental Health and Safety Risks

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

  XIV. Environmental Impacts

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


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

  XV. Consultation and Coordination With Indian Tribal Governments

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

  XVI. Summary and Explanation of the Standards

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


  proposed rule that were based on the evidence provided in the record.
  Any changes made to the provisions in the final standards are described
  in detail in their specific summary and explanation sections.
      Although details of the final standards for general industry,
  construction, and shipyards differ slightly, most of the requirements
  are the same or similar in all three standards. Therefore, the summary
  and explanation is organized according to the main requirements of the
  standards, but includes paragraph references to the standards for
  general industry, construction, and shipyards. The summary and
  explanation uses the term "standards" or "final standards" when
  referring to all three standards. Generally, when the summary and
  explanation refers to the term "standards," it is referring to the
  final standards. To avoid confusion, the term "final rule" is
  sometimes used when making a comparison to or clarifying a change from
  the proposed rule.
      The proposed rule applied to occupational exposure to beryllium in
  all forms, compounds, and mixtures in general industry, except those
  articles and materials exempted by proposed paragraphs (a)(2) and
  (a)(3) of the proposed standard. The final standards are identical in
  their application to occupational exposures to beryllium. In the
  summary and explanation sections, OSHA has changed "beryllium and
  beryllium compounds" or anything specifying soluble beryllium to just
  "beryllium." OSHA intends the term "beryllium" to cover all forms
  of beryllium, including compounds and mixtures, both soluble and poorly
  soluble, throughout the summary and explanation sections. Other global
  changes in the regulatory text include changing "shall" to "must"
  to make it clear when a provision is a requirement and adding
  "personal" to "protective clothing or equipment" and "protective
  clothing and equipment" consistently. OSHA has changed "exposure" to
  "airborne exposure" to make it clear when referring to just airborne
  exposure, and specifically noting when OSHA intends to cover dermal
  contact.
      As noted above, OSHA's proposed rule was based, in part, upon a
  draft occupational health standard submitted to the Agency by Materion,
  the leading producer of beryllium and beryllium products in the United
  States, and USW, an international labor union representing workers who
  manufacture beryllium alloys and beryllium-containing products in a
  number of industries (Document ID 0754). Materion and USW worked
  together to craft a model beryllium standard that OSHA could adopt and
  that would have support from both labor and industry. They submitted
  their joint draft standard to OSHA in February 2012.
      Like the proposal, many of the provisions in the final rules are
  identical or substantively similar to those contained in Materion and
  USW's draft standard. For example, the final rule for general industry
  and the Materion/USW draft standard both include an exclusion for
  materials containing less than 0.1 percent beryllium; both contain many
  similar definitions; both contain a time weighted average (TWA) PEL of
  0.2 μg/m3\; both include exposure monitoring provisions, including
  provisions for scheduled monitoring, employee notification of results,
  methods of sample analysis, and observation of monitoring; both contain
  similar requirements for beryllium work areas and regulated areas; both
  mandate a written exposure control plan and engineering and work
  practice controls that follow OSHA's traditional hierarchy of controls;
  and both include similar provisions related to respiratory protection,
  protective clothing and equipment, hygiene areas and practices,
  housekeeping, medical surveillance, medical removal protection,
  training and communication of hazards, recordkeeping, and compliance
  dates.

  (a) Scope and Application

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

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

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


  protections to beryllium exposed workers by extending the scope of the
  proposed standard to workers in the construction and maritime
  industries. National COSH explained: "In the proposed preamble, OSHA
  recognizes that these workers are exposed to beryllium during abrasive
  blasting and clean-up of spent material. The risks that construction
  and maritime workers face when exposed to beryllium particulate is the
  same as the risk faced at similar exposures by general industry
  workers" (Document ID 1690, p. 2). The American Federation of Labor
  and Congress of Industrial Organizations (AFL-CIO) agreed, adding that
  "[a]vailable data in the construction and maritime sector shows that
  there is a significant risk of sensitization and CBD among these
  workers" (Document ID 1689, p. 6). Similarly, the American Industrial
  Hygiene Association (AIHA) warned that the "[p]otential for exposure,
  especially in the construction industry, is very high" (Document ID
  1686, p. 2).
      OSHA also heard testimony during the public hearing from Dr. Lee
  Newman of the American College of Occupational and Environmental
  Medicine (ACOEM), Peggy Mroz of National Jewish Health (NJH), Emily
  Gardner of Public Citizen, Mary Kathryn Fletcher of AFL-CIO, and Mike
  Wright of the USW that supported covering workers in the construction
  and maritime industries (Document ID 1756, Tr. 81; 1756, Tr. 97-98;
  1756, Tr. 172-175; 1756, Tr. 198-199; 1755, Tr. 181). Peggy Mroz of NJH
  testified that "[b]ased on the data presented, [NJH] support[s]
  expanding the scope of the proposed standard to include . . . employers
  in construction and maritime" (Document ID 1756, Tr. 98). Emily
  Gardner of Public Citizen argued that "the updated standard cannot
  leave construction and shipyard workers vulnerable to the devastating
  effects of beryllium" (Document ID 1756, Tr. 175). She added that
  "Public Citizen urges OSHA to revise the proposed rule to cover these
  workers" (Document ID 1756, Tr. 175).
      Several commenters specifically supported Regulatory Alternative
  #2a. For example, the International Union, United Automobile,
  Aerospace, and Agriculture Implement Workers of America (UAW) indicated
  its support for this alternative (Document ID 1693, p. 3 (pdf)). UAW
  added that Alternative #2a would cover abrasive blasters, pot tenders,
  and cleanup staff working in construction and shipyards who have the
  potential for airborne beryllium exposure during blasting operations
  and during cleanup of spent media (Document ID 1693, p. 3 (pdf)).
  Kimberly-Clark Professional (KCP) similarly indicated that it favored
  the adoption of this alternative (Document ID 1676, p. 1). KCP
  explained that "[h]azardous exposures are equally dangerous to workers
  regardless of whether the worker is in a factory or on a construction
  site, and the worker protection provided by OSHA regulations should
  also be equal" (Document ID 1676, p. 1). In addition, 3M Company also
  observed that Regulatory Alternative #2a is a more protective
  alternative (Document ID 1625, p. 3 (pdf)).
      However, other commenters argued in favor of keeping the proposed
  scope unchanged (e.g., Document ID 1583; 1661, Attachment 2, pp. 6-7;
  1673, pp. 12-23). Some of these stakeholders contended that adding
  construction and maritime was not necessary (e.g., Document ID 1673,
  pp. 20-22). For example, Materion opined that "the requirements of [29
  CFR] 1910.94 provide sufficient protections for the construction and
  maritime industries and accordingly, [Materion and USW] did not include
  construction and maritime within [their] assessment of technological
  feasibility or the scope of the standard" (Document ID 1661,
  Attachment 2, p. 7). Materion added that "it is [its] understanding
  that in the absence of a specific maritime standard, OSHA applies
  general industry standards to the maritime industries" (Document ID
  1661, Attachment 2, p. 7). While this may be the general practice of
  the industry, OSHA does not enforce general industry standards where
  the shipyard standards apply unless they are specifically cross
  referenced in the shipyard standards.
      Some of these commenters offered specific concerns with covering
  the construction and maritime industries, or with covering abrasive
  blasting in general. For instance, Jack Allen, Inc. argued against
  extending the proposed rule to cover the use of coal slag in the
  sandblasting industry because the industry already has processes and
  controls in place to prevent exposures to all dusts during operations
  (Document ID 1582). The Abrasive Blasting Manufacturers Alliance (ABMA)
  presented a number of arguments against the coverage of abrasive
  blasting. ABMA argued that regulating the trace amounts of beryllium in
  abrasive blasting will increase the use of silica-based blasting agents
  "despite OSHA's longstanding recommendation of substitution for
  silica-based materials" (Document ID 1673, p. 14). ABMA added that
  scoping in abrasive blasting would increase the amount of coal slag
  materials "going to landfills rather than being used for beneficial
  purpose" (Document ID 1673, p. 14). ABMA also cited to technological
  feasibility issues in sampling and analysis, noted that the proposed
  standard was not appropriately tailored to construction and maritime
  worksites, and argued that it is not appropriate to regulate abrasive
  blasting on a chemical-by-chemical basis (Document ID 1673, pp. 8, 21-
  23).
      After careful consideration of these comments and those relating to
  Regulatory #2b discussed below, OSHA has decided to adopt Regulatory
  Alternative #2a to expand the proposal's scope to cover construction
  and shipyards. As noted by commenters like the AFL-CIO, record evidence
  shows that exposures above the new action level and PEL, primarily from
  abrasive blasting operations, occur in both the construction and
  shipyard industries (see Chapter IV of the Final Economic Analysis and
  Regulatory Flexibility Analysis (FEA)). As discussed in Section V,
  Health Effects, and Section VII, Significance of Risk, employees
  exposed to airborne beryllium at these levels are at significant risk
  of developing adverse health effects, primarily chronic beryllium
  disease (CBD) and lung cancer. And under the OSH Act, and specifically
  section 6(b)(5), the Agency is required to set health standards which
  most adequately assure, to the extent feasible, that no employee will
  suffer material impairment of health or functional capacity even if
  such employee has regular exposure to the hazard dealt with by such
  standards for the period of his working life. Therefore, OSHA finds it
  would be inappropriate to exclude construction and shipyard employers
  from coverage under this rule.
      OSHA disagrees with Materion's assertion that existing standards
  render it unnecessary to have this standard cover construction and
  shipyard employers whose employees are exposed to beryllium during
  abrasive blasting operations. The OSHA Ventilation standard referenced
  by Materion (29 CFR 1910.94) applies only to general industry and does
  not cover construction and shipyard workers. The OSHA Ventilation
  standard in construction (1926.57) and Mechanical paint removers
  standard in shipyards (1915.34) provide some general protections for
  abrasive blasting workers but do not provide the level of protection
  provided by the ancillary provisions contained in the final standards
  such as medical surveillance, personal protective clothing and
  equipment, and beryllium-specific training.


      OSHA also disagreed with Jack Allen, Inc.'s assertion that the
  employers conducting abrasive blasting already have sufficient
  processes and controls in place to prevent exposures to all dusts
  during operations. OSHA's examination of the record identifies data on
  beryllium exposure in the abrasive blasting industry showing beryllium
  exposure above the action level and TWA PEL when beryllium-containing
  slags are used (e,g., Document ID 1166; 1815, Attachment 35; 1880). And
  even in abrasive blasting operations where all available controls and
  work processes to reduce beryllium exposure are used, additional
  ancillary provisions are still as necessary to protect workers from the
  harmful effects of exposure to beryllium as in general industry. OSHA
  also finds unsubstantiated ABMA's assertion that regulating the trace
  amounts of beryllium in abrasive blasting will increase the use of
  silica-based blasting agents and result in an increase in the amount of
  coal slag materials going to landfills. OSHA has identified several
  controls for abrasive blasting in its technological feasibility
  analysis (see Chapter IV of the FEA). OSHA also noted that substitution
  is not always feasible and employers should be cautious to not
  introduce additional hazards when switching to an alternate media. The
  Agency is certainly not encouraging employers to increase the use of
  silica sand as a blasting media. However, workers using silica-based
  blasting materials are protected under a new comprehensive silica
  standard (29 CFR 1910.1053, 29 CFR 1926.1153). Employers are in the
  best position to determine which blasting material to use and how to
  weigh the costs of compliance with the two rules. A 1998 NIOSH-funded
  study on substitute materials for silica sand in abrasive blasting
  provides comprehensive information on alternative media and can be used
  by employers seeking to identify appropriate abrasive blasting media
  alternatives (Document ID 1815, Attachment 85-87). In fact, exploring
  the use of alternative media for safer abrasive blasting media is
  already underway (Document ID 1741, p. 2). OSHA anticipates that the
  amount of slag material being deposited in landfills will remain
  constant regardless of its use prior to disposal, as the spent slag
  material used in abrasive blasting will still need to be disposed of.
  OSHA is also not persuaded by ABMA's technological feasibility argument
  that regulating trace amounts of beryllium would require testing below
  the limit of detection and that it is not technologically feasible to
  measure beryllium exposures in abrasive blasting. As explained in
  sections 2 and 12 of Chapter IV of the Final Economic Analysis, there
  are a number of available sampling and analytical methods that are
  capable of detecting beryllium at air concentrations below the action
  level of 0.1 μg/m3\, as well as existing exposure data for
  beryllium in abrasive blasting operations. And finally, OSHA disagrees
  with ABMA's assertion that regulating abrasive blasting on a chemical-
  by-chemical basis is inappropriate. The beryllium rule is typical of
  OSHA substance-specific health standards that have been promulgated for
  the construction and shipyard industries and include abrasive blasting
  operations, such as the Lead standard for construction (1926.62) and
  the Lead standard for general industry (1910.1025), which applies to
  the shipyard industry.
      However, OSHA does agree with ABMA's observation that many of the
  conditions in the construction and shipyard industries are distinct
  from those in general industry, and agrees that the standard as
  proposed was not tailored to construction and shipyard worksites. The
  Agency has long recognized a distinction between the construction and
  general industry sectors and has issued standards specifically
  applicable to construction and shipyard work under 29 CFR part 1926 and
  29 CFR part 1915, respectively. OSHA's understanding of the differences
  between these industries is why OSHA specifically asked stakeholders
  with experience and knowledge of the construction or shipyard
  industries to opine on whether coverage of those industries is
  appropriate and, if so, how the proposal should be revised to best
  protect workers in those industries. As discussed throughout the rest
  of this Summary and Explanation section, many stakeholders responded to
  OSHA's request.
      After careful consideration of the record, OSHA finds that the
  unique needs of, conditions in, and challenges posed by the
  construction and maritime sectors, particularly concerning abrasive
  blasting operations at construction sites and shipyards, warrant
  different requirements from general industry. Therefore, OSHA is
  issuing three separate standards--one for each of these sectors. OSHA
  judges that the primary source of beryllium exposure at construction
  worksites and in shipyards is from abrasive blasting operations when
  using abrasives that contain trace amounts beryllium.
      Abrasive blasters and their helpers are exposed to beryllium from
  coal slag and other abrasive blasting material like copper slag that
  may contain beryllium as a trace contaminant. The most commonly used
  abrasives in the construction industry include coal slag and steel
  grit, which are used to remove old coatings and etch the surfaces of
  outdoor structures, such as bridges, prior to painting (Document ID
  1815, Attachment 93, p. 80). Shipyards are large users of mineral slag
  abrasives. In a recent survey conducted for the Navy, the use of coal
  slag abrasives accounted for 68 percent and copper slag accounted for
  20 percent of abrasive media usage as reported by 26 U.S. shipyards and
  boatyards (Document ID 0767). The use of coal and copper slag abrasives
  has increased in recent years as industries have sought substitutes for
  silica sand blasting abrasives to avoid health risks associated with
  respirable crystalline silica (Document ID 1671, Attachment 3; 1681,
  Attachment 1, pp. 1-2).
      OSHA's exposure profile for abrasive blasters, pot tenders/helpers,
  and abrasive material cleanup workers is found in Section 12 of Chapter
  IV in the FEA. The exposure profile for abrasive blasters shows a
  median of 0.2 μg/m3\, a mean of 2.18 μg/m3\, and a range from
  0.004 μg/m3\ to 66.5 μg/m3\. The mean level of 2.18 µg/
  m3\ is above the preceding PEL for beryllium. For pot tenders/helpers,
  the exposure profile shows a median of 0.09 μg/m3\, a mean of 0.10
  μg/m3\, and a range from 0.04 to 0.20 μg/m3\. Beryllium
  exposure for workers engaged in abrasive material cleanup shows a
  median of 0.18 μg/m3\, a mean of 1.76 μg/m3\, and a range from
  0.04 μg/m3\ to 7.4 μg/m3\ (see Section 12 of Chapter IV in the
  FEA). OSHA concludes that abrasive blasters, pot tenders/helpers, and
  cleanup workers have the potential for significant airborne beryllium
  exposure during abrasive blasting operations and during cleanup of
  spent abrasive material. Accordingly, these workers require protection
  under the beryllium standards. To address high concentrations of
  various hazardous chemicals in abrasive blasting, employers are already
  required to use engineering and work practice controls to limit
  workers' exposures and supplement these controls with respiratory
  protection when necessary. For example, abrasive blasters in the
  construction industry fall under the protection of the Ventilation
  standard (29 CFR 1926.57). The Ventilation standard includes an
  abrasive blasting subsection (29 CFR 1926.57(f)), which requires that
  abrasive blasting respirators be worn by all abrasive


  blasting operators when working inside blast-cleaning rooms (29 CFR
  1926.57(f)(5)(ii)(A)), when using silica sand in manual blasting
  operations where the nozzle and blast are not physically separated from
  the operator in an exhaust-ventilated enclosure (29 CFR
  1926.57(f)(5)(ii)(B)), or when needed to protect workers from exposures
  to hazardous substances in excess of the limits set in Sec.  1926.55
  (29 CFR 1926.57(f)(5)(ii)(C)). For the shipyard industry, paragraph (c)
  of the Mechanical paint removers standard (29 CFR 1915.34) also has
  respiratory protection requirements for abrasive blasting operations.
  Because of these requirements, OSHA believes that employers already
  have those controls in place and provide respiratory protection during
  abrasive blasting operations. Nonetheless, the construction and
  shipyard standards' new ancillary provisions such as medical
  surveillance, personal protective clothing and equipment, housekeeping,
  and beryllium-specific training will provide increased protections to
  workers in these industries.
      OSHA also received comment and heard testimony on potential
  beryllium exposure from other sources. NIOSH commented that
  construction workers may be exposed to beryllium when demolishing
  buildings or building equipment, based on a study of workers
  demolishing oil-fired boilers (Document ID 1671, Attachment 1, pp. 5,
  15; 1671, Attachment 21). Peggy Mroz of NJH testified that "[n]umerous
  studies have documented beryllium exposure sensitization and chronic
  beryllium disease in construction industries, demolition and
  decommissioning, and among workers who use non-sparking tools"
  (Document ID 1756, Tr. 98). Many such cases were discovered among trade
  workers at Department of Energy sites from the National Supplemental
  Screening Program (Document ID 1756, Tr. 81-82). Ashlee Fitch from the
  USW testified that in addition to abrasive blasting using beryllium-
  contaminated slags, workers in the maritime industry use non-sparking
  tools that are composed of beryllium alloys. Ms. Fitch stated that
  these tools can create beryllium particulate when they are dressed
  (e.g., sharpening, grinding, straightening). She also noted that
  shipyards may use beryllium for other tasks in the future. Ms. Fitch
  alluded to a 2000 Navy survey of potential exposure to beryllium in
  shipyards which identified potential beryllium sources in welding,
  abrasive blasting, and metal machining (Document ID 1756, Tr. 242-243).
  Mr. Wright of the USW testified that shipyard management told a USW
  representative "that most of the beryllium that they're aware of comes
  in in the form of articles . . . . That is to say, it might be part of
  some assembly . . . [a]nd it comes in and it's sealed and closed"
  (Document ID 1756, Tr. 270). However, Mr. Wright stated that beryllium
  is a high-tech material and that "there is nothing more high-tech than
  an aircraft carrier or a nuclear submarine" so exposure from
  beryllium-containing alloys cannot be ruled out in these operations
  (Document ID 1756, Tr. 270).
      Despite requesting information both in the NPRM and during the
  public hearing, OSHA does not have sufficient data on beryllium
  exposures in the construction and shipyard industries to characterize
  exposures of workers in application groups other than abrasive blasting
  with beryllium-containing slags. OSHA could not develop exposure
  profiles for construction and shipyard workers engaged in activities
  involving non-sparking tools, demolition of beryllium-contaminated
  buildings or equipment, and working with beryllium-containing alloys.
  However, OSHA acknowledges the USW's concerns about future beryllium
  use and recognizes that there is potential for exposure to beryllium in
  construction and shipyard operations other than abrasive blasting. As
  such, workers engaged in such operations are exposed to the same hazard
  of developing CBD and other beryllium-related disease, and therefore
  deserve the same level of protection as do workers who are engaged in
  abrasive blasting or covered in the general industry final rule.
  Therefore, although at this time OSHA cannot specifically quantify
  exposures in construction or shipyard operations outside of abrasive
  blasting, OSHA has determined that it is necessary for the final
  standards for construction and maritime to cover all occupational
  exposures to beryllium in those industries in order to ensure that the
  standard is broadly effective and addresses all potential harmful
  exposures.
      Three commenters representing the maritime industry supported
  Regulatory Alternative #2b--adopting the new PELs for construction and
  maritime by updating the existing Z tables to incorporate them, but not
  applying the other ancillary provisions of this standard to
  construction and maritime (Document ID 1595, p. 2; 1618, p. 2; 1657. p.
  1). The Shipbuilders Council of America (SCA) supported lowering the
  PEL for beryllium from 2.0 μ/m3\ to 0.2 μ/m3\ in 29 CFR
  1915.1000 Table Z, but argued that a new beryllium standard would prove
  to be redundant. SCA contended that many shipyards maintain a
  comprehensive industrial hygiene program focused on exposure
  assessments and protective measures for a variety of metals in shipyard
  tasks, and that shipyards encounter beryllium only at trace contaminant
  levels in materials involved in the welding and abrasive blasting
  processes. SCA stated that the potential hazards inherent in and unique
  to abrasive blasting in shipyards are already effectively controlled
  through existing regulations (Document ID 1618, pp. 2-4). General
  Dynamics' Bath Iron Works expressed similar views in their comments on
  this issue, as did Newport News Shipbuilding (Document 1595, p. 2;
  1657, p. 1).
      In addition to the commenters representing the maritime industry,
  Ameren, an electric and natural gas public utility, also supported
  applying the proposed TWA PEL and STEL to all employers in general
  industry, construction, and maritime even where beryllium exists only
  as a trace contaminant (Document ID 1675, p. 3). However, not all
  commenters endorsed Alternative #2b. The Department of Energy's
  National Supplemental Screening Program (NSSP) did not support this
  alternative because the other provisions of the standard would only
  cover employers and employees within the scope of the proposed general
  industry rule (Document ID 1677, p. 2). Furthermore, many commenters
  supported extending the full protections of the standard to the
  construction and maritime industries as set forth in Regulatory
  Alternative #2a, discussed earlier, which implicitly rejects Regulatory
  Alternative #2b (see, e.g., Document ID 1756, Tr. 81; 1756, Tr. 97-98;
  1756, Tr. 172-175; 1756, Tr. 198-199; 1755, Tr. 181).
      OSHA is not persuaded by the maritime industry commenters'
  assertions that the ancillary provisions of the beryllium standard
  would be redundant. While OSHA acknowledges that shipyards encounter
  beryllium only at trace levels in materials involved in the welding and
  abrasive blasting processes, OSHA disagrees with their contention that
  updating the PEL and STEL will provide adequate protection to shipyard
  workers. OSHA agrees with NSSP and all the commenters supporting
  Regulatory Alternative #2a that a comprehensive standard specific to
  beryllium will provide the important protection of ancillary
  provisions, such as medical surveillance and medical removal
  protection. OSHA intends to


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

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

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

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

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


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

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

  Whether a particular item is an "article" under the HCS depends on
  the physical properties and intended use of that item. However,
  employers may use and process beryllium-containing items in ways not
  necessarily intended by the manufacturer. Therefore, OSHA has decided
  not to link the processing limitation to the definition of an
  "article" and is retaining the language of proposed (a)(2) to comport
  with the intention of the exemption.
      In response to the ADA's request for clarification that employers
  who use but do not process articles are fully exempt from all
  requirements of the rule, OSHA notes that paragraph (a)(2) of the final
  standards states that the "standard does not apply" to those
  articles. Furthermore, the recordkeeping requirement for objective data
  in paragraph (n)(2) of the standards states that it applies to
  objective data used to satisfy exposure assessment requirements, but
  does not mention any data used to determine coverage under paragraph
  (a). Therefore, OSHA has determined that no further clarification in
  the regulatory text is necessary.
      In response to the comment from Public Citizen, OSHA did not
  receive any evidence on the issue of beryllium exposure through dermal
  contact with unprocessed articles. Therefore, OSHA cannot find that
  such contact poses a risk.
      Paragraph (a)(2) of the final standards therefore remains unchanged
  from the proposed standard. The final standards do not apply to
  articles, as defined in the Hazard Communication standard (HCS) (29 CFR
  1910.1200(c)), that contain beryllium and that the employer does not
  process.
      Paragraph (a)(3). Proposed paragraph (a)(3) exempted from coverage
  materials containing less than 0.1 percent beryllium by weight.
  Requesting comment on this exemption (80 FR 47776), OSHA presented
  Regulatory Alternative #1a, which would have eliminated the proposal's
  exemption for materials containing less than 0.1 percent beryllium by
  weight, and #1b, which would have exempted operations where the
  employer can show that employees' exposures will not meet or exceed the
  action level or exceed the STEL. The Agency asked whether it is
  appropriate to include an exemption for operations where beryllium
  exists only as a trace contaminant, but some workers can nevertheless
  be significantly exposed. And the Agency asked whether it should
  consider dropping the exemption, or limiting it to operations where
  exposures are below the proposed action level and STEL. In addition,
  OSHA requested additional data describing the levels of airborne
  beryllium in workplaces that fall under this exemption. Some
  stakeholders supported keeping the 0.1 percent exemption as proposed
  (Document ID 1661, p. 6; 1666, p. 2; 1668, p. 2; 1673, p. 8; 1674, p.
  3; 1687, Attachment 2, p. 8; 1691, Attachment 1, p. 3; 1756, Tr. 35-36,
  63). For example, the Edison Electric Institute (EEI) strongly
  supported the exemption and asserted "that abandoning the exemption
  would result in no additional benefits from a reduction in the
  beryllium permissible exposure limit (PEL) or from ancillary provisions
  similar to those already in place for the arsenic and other standards"
  (Document ID 1674, p. 3). Mr. Weaver of NFFS also opposed eliminating
  the exemption, testifying that without the 0.1 percent exemption, 900
  to 1,100 foundries would come under the scope of the rule (Document ID
  1756, Tr. 55-56).
      ABMA also supported the proposed 0.1 percent exemption, suggesting
  that there is a lack of evidence of significant risk from working with
  material containing beryllium in trace amounts and that OSHA needs
  substantial evidence that it is "at least more likely than not" that
  exposure to beryllium in trace amounts presents significant risk of
  harm, under court decisions concerning the Benzene rule (Document ID
  1673, pp. 8-9). ABMA further argued that significant risk does not
  exist even below the previous PEL of 2.0 μg/m3\ (Document ID 1673,
  pp. 8-9, 11). ABMA added that its members collectively have over 200
  years of experience producing coal and/or copper slag abrasive material
  and have employed thousands of employees in this production process.
  ABMA explained:

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

      OSHA is not persuaded by these arguments. The lack of anecdotal
  evidence of sensitization or beryllium-related illness does not mean
  these workers are not at risk. As noted by Representative Robert C.
  "Bobby" Scott, Ranking Member of the U.S. House of Representatives
  Committee on Education and the Workforce the U.S. House of
  Representatives, "medical surveillance has not been required for
  beryllium-exposed workers outside of the U.S. Department of Energy. The
  absence of evidence is not evidence of absence" (Document ID 1672). As
  discussed in Section II of this preamble, Pertinent Legal Authority,
  courts have not required OSHA "to support its finding that a
  significant risk exists with anything approaching scientific
  certainty" (Benzene, 448 U.S. 607, 656 (1980)). Rather, OSHA may rely
  on "a body of reputable scientific thought" to which "conservative
  assumptions in interpreting the data . . ." may be applied, "risking
  error on the side of overprotection" (Benzene, 448 U.S. at 656). OSHA
  may thus act with a "pronounced bias towards worker safety" in making
  its risk determinations (Bldg & Constr. Trades Dep't v. Brock, 838 F.2d
  1258, 1266 (D.C. Cir. 1988). Where, as here, the Agency has evidence
  indicating that a certain operation can result in exposure levels that
  the Agency knows can pose a significant risk--such as evidence that
  workers that have been exposed to beryllium at the final PEL of 0.2
  μg/m3\ in primary beryllium production and beryllium machining
  operations have developed CBD (see this preamble at section V, Risk
  assessment)--OSHA need not wait until it has specific evidence that
  employees in that


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


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

  where the employer has objective data demonstrating that a material
  containing beryllium or a specific process, operation, or activity
  involving beryllium cannot release dusts, fumes, or mists of
  beryllium in concentrations at or above 0.02 μg/m3\ as an 8-hour
  time-weighted average (TWA) or at or above 0.2 μg/m3\ as
  determined over a sampling period of 15 minutes under any expected
  conditions of use (Document ID 1667, p. 12).

  Other commenters, like ABMA, criticized Regulatory Alternative #1b,
  insisting that the rulemaking record contained no evidence to support
  expanding the scope, but that if the scope was expanded to cover trace
  beryllium, a significant exemption would be needed. ABMA argued that
  such an exemption would need to go considerably beyond that of using
  the action level or STEL because of the substantial costs, particularly
  on small businesses, that would be incurred where there is no evidence
  of benefit. However, ABMA did not specify what such an exemption would
  look like (Document ID 1673, p. 11). Similarly, the National Rural
  Electric Cooperative Association (NRECA) objected to Regulatory
  Alternative #1b as being unnecessary to protect employees from CBD in
  coal fired power plants (Document ID 1687, p. 2).
      Ameren did not agree with the objective data requirement in
  Regulatory Alternative #1b because it would be difficult to perform
  sampling in a timely manner for the many different maintenance
  operations that occur infrequently. This would include in the scope of
  the rule activities for which exposures are difficult to measure, but
  are less likely to cause exposure than other operations (Document ID
  1675, p. 2). The NSSP also does not support Regulatory Alternative #1b
  because without first expanding the scope of the rule to cover the
  construction and maritime sectors, employers in construction and
  maritime would still be excluded (Document ID 1677, p. 1).
      OSHA agrees with the many commenters and testimony expressing
  concern that materials containing trace amounts of beryllium (less than
  0.1 percent by weight) can result in hazardous exposures to beryllium.
  We disagree, however, with those who supported completely eliminating
  the exemption because this could have unintended consequences of
  expanding the scope to cover minute amounts of naturally occurring
  beryllium (Ex 1756 Tr. 55). Instead, we believe that alternative #1b--
  essentially as proposed by Materion and USW and acknowledging that
  workers can have significant beryllium exposures even with materials
  containing less than 0.1%--is the most appropriate approach. Therefore,
  in the final standard, it is exempting from the standard's application
  materials containing less than 0.1% beryllium by weight only where the
  employer has objective data demonstrating that employee exposure to
  beryllium will remain below the action level as an 8-hour TWA under any
  foreseeable conditions.
      As noted by NIOSH, NABTU, and the AFL-CIO, and discussed in Chapter
  IV of the FEA, workers in abrasive blasting operations using materials
  that contain less than 0.1 percent beryllium still have the potential
  for significant airborne beryllium exposure during abrasive blasting
  operations and during cleanup of spent abrasive material. NIOSH and the
  AFL-CIO also identified coal-fired electric power generation and
  primary aluminum production as industries that could fall under the 0.1
  percent exemption but still have significant worker exposure to
  beryllium. Furthermore, OSHA agrees with NIOSH that the Agency should
  regulate based on the potential for employee exposures and not the
  concentration of beryllium in the material being handled. However, OSHA
  acknowledges the concerns expressed by ABMA and EEI that processing
  materials with trace amounts of beryllium may not necessarily cause
  significant exposures to beryllium. OSHA does not have evidence that
  all materials containing less than 0.1 percent beryllium by weight can
  result in significant exposure to beryllium, but the record contains
  ample evidence that there are significant exposures in operations using
  materials with trace amounts of beryllium, such as abrasive blasting,
  coal-fired power generation, and primary aluminum production. As
  discussed in Section VII of this preamble, Significance of Risk,
  preventing airborne exposures at or above the action level reduces the
  risk of beryllium-related health effects to workers. OSHA is also not
  persuaded by comments that claim obtaining this exposure data is too
  difficult for infrequent or short-term tasks because employers must be
  able to establish their eligibility for the exemption before being able
  to take advantage of it. If an employer cannot establish by objective
  data, including actual monitoring data, that exposures will not exceed
  the action level, then the beryllium standards apply to protect that
  employer's workers.
      As pointed out by commenters such as the USW, similar exemptions
  are included in other OSHA standards, including Benzene (29 CFR
  1910.1028), Methylenedianiline (MDA) (29 CFR 1910.1050), and 1,3-
  Butadiene (BD) (29 CFR 1910.1051). These exemptions were established
  because workers in the exempted industries or workplaces were not
  exposed to the subject chemical substances at levels of significant
  risk. In the preamble to the MDA standard, OSHA states that the Agency
  relied on data showing that worker exposure to mixtures or materials of
  MDA containing less than 0.1 percent MDA did not create any hazards
  other than those expected from worker exposure beneath the action level
  (57 FR 35630, 35645-46). The exemption in the BD standard does not
  apply where airborne concentrations generated by mixtures containing
  less than 0.1 percent BD by volume can exceed the action level or STEL
  (29 CFR 1910.1051(a)(2)(ii)). The exemption in the Benzene standard was
  based on indications that exposures resulting from substances
  containing trace amounts of benzene would generally be below the
  exposure limit and on OSHA's determination that the exemption would
  encourage employers to reduce the concentration of benzene in certain
  substances (43 FR 27962, 27968).
      OSHA's decision to maintain the 0.1 percent exemption and require
  employers to demonstrate, using objective data, that the materials,
  when processed or handled, cannot release beryllium in concentrations
  at or above the action level as an 8-hour TWA under any foreseeable
  conditions, is a change from proposed paragraph (a)(3) that specified
  only that the standard did not apply to materials containing less than
  0.1 percent beryllium by weight. This is also a change from Regulatory
  Alternative #1b in another respect, insofar as it proposed requiring
  objective data demonstrating that employee exposure to beryllium will
  remain below both the proposed action level and STEL. OSHA removed the
  STEL requirement as largely redundant because if exposures exceed the
  STEL of 2.0 µg/m3\ for more than one 15-minute period per 8-hour
  shift, even if exposures are non-detectable for the remainder of the
  shift, the 8-hour TWA would exceed the action level of 0.1 μg/m3\.
      Further, OSHA added the phrase "under any foreseeable conditions"
  to paragraph (a)(3) of the final standards to make clear that limited
  sampling results indicating exposures are below the


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

  (b) Definitions

      Paragraph (b) includes definitions of key terms used in the
  standard. To the extent possible, OSHA uses the same terms and
  definitions in the standard as the Agency has used in other OSHA health
  standards. Using similar terms across health standards, when possible,
  makes them more understandable and easier for employers to follow. In
  addition, using similar terms and definitions helps to facilitate
  uniformity of interpretation and enforcement.
      Action level means a concentration of airborne beryllium of 0.1
  micrograms per cubic meter of air (μg/m3\) calculated as an 8-hour
  time-weighted average (TWA). Exposures at or above the action level
  trigger requirements for periodic exposure monitoring when the employer
  is following the scheduled monitoring option (see paragraph (d)(3)). In
  addition, paragraph (f)(1)(i)(B) requires employers to list as part of
  their written exposure control plan the operations and job titles
  reasonably expected to have exposure at or above the action level.
  Paragraph (f)(2) requires employers to ensure that at least one of the
  controls listed in paragraph (f)(2)(i) is in place unless employers can
  demonstrate for each operation or process either that such controls are
  not feasible, or that employee exposures are below the action level
  based on at least two representative personal breathing zone samples
  taken at least seven days apart. In addition, under paragraph
  (k)(1)(i)(A), employee exposure at or above the action level for more
  than 30 days per year triggers requirements for medical surveillance.
  The medical surveillance provision triggered by the action level allows
  employees to receive exams at least every two years at no cost to the
  employee. The action level is also relevant to the medical removal
  requirements. Employees eligible for removal can choose to remain in
  environments with exposures at or above the action level, provided they
  wear respirators (paragraph (l)(2)(ii)). These employees may also
  choose to be transferred to comparable work in environments with
  exposures below the action level (if comparable work is not available,
  the employer must maintain the employee's earnings and benefits for six
  months or until comparable work becomes available (paragraph (l)(3)).
      OSHA's risk assessment indicates that significant risk remains at
  and below the TWA PEL (see this preamble at section VII, Significance
  of Risk). When there is significant risk remaining at the PEL, the
  courts have ruled that OSHA has the legal authority to impose
  additional requirements, such as action levels, on employers to further
  reduce risk when those requirements will result in a greater than
  minimal incremental benefit to workers' health (Asbestos II, 838 F.2d
  at 1274). OSHA concludes that an action level for beryllium exposure
  will result in a further reduction in risk beyond that provided by the
  PEL alone.
      Another important reason to set an action level involves the
  variable nature of employee exposures to beryllium. Because of this
  fact, OSHA concludes that maintaining exposures below the action level
  provides reasonable assurance that employees will not be exposed to
  beryllium above the TWA PEL on days when no exposure measurements are
  made. This consideration is discussed later in this section of the
  preamble regarding paragraph (d)(3).
      The United Steelworkers (USW) commented in support of the action
  level, noting that it is typical in OSHA standards to have an action
  level at one half of the PEL (Document ID 1681, p. 11). The USW also
  commented that the "action level will further reduce exposure to
  beryllium by workers and will incentivize employers to implement best
  practice controls keeping exposures at a minimum as well as reducing
  costs of monitoring and assessments" (Document ID 1681, p. 11).
  National Jewish Health (NJH) also supported OSHA's proposal for a more
  comprehensive standard and noted that the action level in the
  Department of Energy's beryllium standard has been "very effective at
  reducing exposures and rates of beryllium sensitization and chronic
  beryllium disease in those facilities" (Document ID 1756, p. 90).
      As noted by the commenters, OSHA's decision to set an action level
  of one-half of the TWA PEL is consistent with previous standards,
  including those for inorganic arsenic (29 CFR 1910.1018), chromium (VI)
  (29 CFR 1910.1026), benzene (29 CFR 1910.1028), ethylene oxide (29 CFR
  1910.1047), methylene chloride (29 CFR 1910.1052), and respirable
  crystalline silica (29 CFR 1910.1053).
      The definition of "action level" is therefore unchanged from the
  proposal. Some of the ancillary provisions triggered by the action
  level have changed since the proposal. Those changes are discussed in
  more detail in the Summary and Explanation sections for those
  provisions.
      Airborne exposure and airborne exposure to beryllium mean the
  exposure to airborne beryllium that would occur if the employee were
  not using a respirator.
      OSHA included a definition for the terms "exposure" and
  "exposure to beryllium" in the proposed rule, and defined the terms
  to mean "the exposure to airborne beryllium that would occur if the
  employee were not using a respirator." In the final rule, the word
  "airborne" is added to the terms to make clear that they refer only
  to airborne beryllium, and not to dermal contact with beryllium. The
  modified terms replace "exposure" and "exposure to beryllium" in
  the rule, and the terms "exposure" and "exposure to beryllium" are
  no longer defined.
      Assistant Secretary means the Assistant Secretary of Labor for
  Occupational Safety and Health, United States Department of Labor, or
  designee. OSHA received no comments on this definition, and it is
  unchanged from the proposal.
      Beryllium lymphocyte proliferation test (BeLPT) means the
  measurement of blood lymphocyte proliferation in a


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


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

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

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


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


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

  (c) Permissible Exposure Limits (PELs)

      Paragraph (c) of the standards establishes two permissible exposure
  limits (PELs) for beryllium in all forms, compounds, and mixtures: An
  8-hour time-weighted average (TWA) PEL of 0.2 μg/m3\ (paragraph
  (c)(1)), and a 15-minute short-term exposure limit (STEL) of 2.0 μg/
  m3\ (paragraph (c)(2)). The TWA PEL section of the standards requires
  employers to ensure that no employee's exposure to beryllium, averaged
  over the course of an 8-hour work shift, exceeds 0.2 μg/m3\. The
  STEL section of the standards requires employers to ensure that no
  employee's exposure, sampled over any 15-minute period during the work
  shift, exceeds 2.0 μg/m3\. While the proposed rule contained
  slightly different language in paragraph (c), i.e. requiring that
  "each employee's airborne exposure does not exceed" the TWA PEL and
  STEL, the final language was chosen by OSHA to remain consistent with
  prior OSHA health standards and to clarify that OSHA did not intend a
  different interpretation of the PELs in this standard. The same PELs
  apply to general industry, construction, and shipyards.
      TWA PEL. OSHA proposed a new TWA PEL of 0.2 μg/m3\ of
  beryllium--one-tenth the preceding TWA PEL of 2 μg/m3\--because
  OSHA preliminarily found that occupational exposure to beryllium at and
  below the preceding TWA PEL of 2 μg/m3\ poses a significant risk of
  material impairment of health to exposed workers. As with several other
  provisions of these standards, OSHA's proposed TWA PEL followed the
  draft recommended standard submitted to the Agency by Materion
  Corporation (Materion) and the United Steelworkers (USW) (see this
  preamble at section III, Events Leading to the Standards).
      After evaluating the record, including published studies and more
  recent exposure data from industrial facilities involved in beryllium
  work, OSHA is adopting the proposed TWA PEL of 0.2 μg/m3\. OSHA has
  made a final determination that occupational exposure to a variety of
  beryllium compounds at levels below the preceding PELs poses a
  significant risk to workers (see this preamble at section VII,
  Significance of Risk). OSHA's risk assessment, presented in section VI
  of this preamble, indicates that there is significant risk of beryllium
  sensitization,\38\ CBD, and lung cancer from a 45-year (working life)
  exposure to beryllium at the preceding TWA PEL of 2 μg/m3\. The
  risk assessment further indicates that, although the risk is much
  reduced, significant risk remains at the new TWA PEL of 0.2 μg/m3\.
  ---------------------------------------------------------------------------

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

      OSHA has determined that the new TWA PEL is feasible across all
  affected industry sectors (see section VIII.D of this preamble,
  Technological Feasibility) and that compliance with the new PEL will
  substantially reduce employees' risks of beryllium sensitization,
  Chronic Beryllium Disease (CBD), and lung cancer (see section VI of
  this preamble, Risk Assessment). OSHA's conclusion about feasibility is
  supported both by the results of the Agency's feasibility analysis and
  by the recommendation of the PEL of 0.2 μg/m3\ by Materion and the
  USW.
       Materion is the sole beryllium producer in the U.S., and its
  facilities include some of the processes where OSHA expects it will be
  most challenging to control beryllium exposures. Although OSHA also
  found that there is significant risk at the proposed alternative TWA
  PEL of 0.1 μg/m3\, OSHA did not adopt that alternative because the
  Agency could not demonstrate technological feasibility at that level
  (see section VIII.D of this preamble, Technological Feasibility).
      The TWA PEL was the subject of numerous comments in the rulemaking
  record. Comments from stakeholders in labor and industry, public health
  experts, and the general public supported OSHA's selection of 0.2
  μg/m3\ as the final PEL (NIOSH, Document ID 1671, Attachment 1, p.
  2; National Safety Council, 1612, p. 3; The Sampling and Analysis
  Subcommittee Task Group of the Beryllium Health and Safety Committee of
  the Department of Energy's National Nuclear Security Administration
  Lawrence Livermore National Lab (BHSC Task Group), 1655, p. 2; Newport
  News Shipbuilding, 1657, p. 1; National Jewish Health (NJH),1664, p. 2;
  The Aluminum Association, 1666, p. 1; The Boeing Company (Boeing),
  1667, p. 1; American Industrial Hygiene Association (AIHA), 1686, p. 2;
  United Steelworkers (USW), 1681, p. 7; Andrew Brown, 1636, p. 6;
  Department of Defense, 1684, p. 1). Materion stated that the record
  does not support the feasibility of any limit lower than 0.2 μg/m3\
  (Document ID 1808, p. 2). OSHA also received comments supporting
  selection of a lower TWA PEL of 0.1 μg/m3\ from Public Citizen, the
  AFL-CIO, the United Automobile, Aerospace & Agricultural Implement
  Workers of America (UAW), North America's Building Trades Unions
  (NABTU), and the American College of Occupational and Environmental
  Medicine (ACOEM) (Document ID 1689, p. 7; 1693, p. 3; 1670, p. 1; 1679,
  pp. 6-7; 1685, p. 1; 1756, Tr. 167). These commenters based their
  recommendations on the significant risk of material health impairment
  from exposure at the TWA PEL of 0.2 μg/m3\ and below, which OSHA
  acknowledges.
      In addition to their concerns about risk, Public Citizen and the
  American Federation of Labor and Congress of Industrial Organizations
  (AFL-CIO) argued that a TWA PEL of 0.1 μg/m3\ is feasible (Document
  ID 1756, Tr. 168-169, 197-198). As discussed further below, however,
  OSHA's selection of the TWA PEL in this case was limited by the
  findings of its technological feasibility analysis. No commenter
  provided information that would permit OSHA to show the feasibility of
  a TWA PEL of 0.1 μg/m3\ in industries where OSHA did not have
  sufficient information to make this determination at the proposal
  stage. Public Citizen instead argued that insufficient evidence that
  engineering and work practice controls can maintain exposures at or
  below a TWA PEL of 0.1


  μg/m3\ should not preclude OSHA from establishing such a PEL; and
  that workplaces unable to achieve a TWA PEL of 0.1 μg/m3\ should be
  required to reduce airborne exposures as much as possible using
  engineering and work practice controls, supplemented with a respiratory
  protection program (Document ID 1670, p. 5).
      OSHA has determined that Public Citizen's claim that the Agency
  should find a PEL of 0.1 μg/m3\ technologically feasible is
  inconsistent with the test for feasibility as described by the courts
  as well as the evidence in the rulemaking record. OSHA bears the
  evidentiary burden of establishing feasibility in a rulemaking
  challenge. The D.C. Circuit, in its decision on OSHA's Lead standard
  (United Steelworkers of America v. Marshall, 647 F.2d 1189 (D.C. Cir.
  1981) ("Lead")), explained that in order to establish that a standard
  is technologically feasible, "OSHA must prove a reasonable possibility
  that the typical firm will be able to develop and install engineering
  and work practice controls that can meet the PEL in most of its
  operations" (Lead, 647 F.2d at 1272). "The effect of such proof,"
  the court continued, "is to establish a presumption that industry can
  meet the PEL without relying on respirators" (Lead, 647 F.2d at 1272).
  The court's definition of technological feasibility thus recognizes
  that, for a standard based on a hierarchy of controls prioritizing
  engineering and work practice controls over respirators, a particular
  PEL is not technologically feasible simply because it can be achieved
  through the widespread use of respirators (see Lead, 647 F.2d at 1272).
  OSHA's long-held policy of avoiding requirements that will result in
  extensive respirator use is consistent with this legal standard.
      In considering an alternative TWA PEL of 0.1 μg/m3\ that would
  reduce risks to workers further than would the TWA PEL of 0.2 μg/
  m3\, OSHA was unable to determine that this level was technologically
  feasible. For some work operations, the evidence is insufficient for
  OSHA to demonstrate that a TWA PEL of 0.1 μg/m3\ could be achieved
  most of the time. In other operations, a TWA PEL of 0.1 μg/m3\
  appears to be impossible to achieve without resort to respirators (see
  section VIII.D of this preamble, Technological Feasibility, for a
  detailed discussion of OSHA's feasibility findings). Thus, OSHA was
  unable to meet its legal burden to demonstrate the technological
  feasibility of the alternative TWA PEL of 0.1 μg/m3\ (see Lead, 647
  F.2d at 1272; Amer. Iron & Steel Inst. v. OSHA, 939 F.2d 975, 990 (D.C.
  Cir. 1991)) and has adopted the proposed PEL of 0.2 μg/m3\, for
  which there is substantial evidence demonstrating technological
  feasibility.
      OSHA also invited comment on and considered an alternative TWA PEL
  of 0.5 μg/m3\--two-and-a-half times greater than the proposed PEL
  that it is adopting. As noted above, OSHA determined that significant
  risk to worker health exists at the preceding PEL of 2.0 μg/m3\ as
  well as at the new TWA PEL of 0.2 μg/m3\. Because OSHA found that a
  TWA PEL of 0.2 μg/m3\ is technologically and economically feasible,
  the Agency concludes that setting the TWA PEL at 0.5 μg/m3\--a
  level that would leave workers exposed to even greater health risks
  than they will face at the new PEL of 0.2 μg/m3\--would be contrary
  to the OSH Act, which requires OSHA to eliminate the risk of material
  health impairment "to the extent feasible" (29 U.S.C. 655(b)(5)).
  Thus, the Agency is not adopting the proposed alternative TWA PEL of
  0.5 μg/m3\.
      Because significant risks of sensitization, CBD, and lung cancer
  remain at the new TWA PEL of 0.2 μg/m3\, the final standards
  include a variety of ancillary provisions to further reduce risk to
  workers. These ancillary provisions include implementation of feasible
  engineering controls in beryllium work areas, respiratory protection,
  personal protective clothing and equipment, exposure monitoring,
  regulated areas, medical surveillance, medical removal, hygiene areas,
  housekeeping requirements, and hazard communication. The Agency has
  determined that these provisions will reduce the risk beyond that which
  the TWA PEL alone could achieve. These provisions are discussed later
  in this Summary and Explanation section of the preamble.
      STEL. OSHA is also promulgating a STEL of 2.0 μg/m3\, as
  determined over a sampling period of 15 minutes. The new STEL of 2
  μg/m3\ was suggested by the joint Materion-USW proposed rule and
  proposed in the NPRM. As discussed in section VII of this preamble,
  significant risks of sensitization, CBD, and lung cancer remain at the
  TWA PEL of 0.2 μg/m3\. Where a significant risk of material
  impairment of health remains at the TWA PEL, OSHA must impose a STEL if
  doing so would further reduce risk and is feasible to implement (Pub.
  Citizen Health Research Grp. v. Tyson, 796 F.2d 1479, 1505 (D.C. Cir.
  1986) ("Ethylene Oxide"); see also Building and Construction Trades
  Department, AFL-CIO v. Brock, 838 F.2d 1258, 1271 (D.C. Cir. 1988)). In
  this case, the evidence in the record demonstrates that the STEL is
  feasible and that it will further reduce the risk remaining at the TWA
  PEL. The goal of a STEL is to protect employees from the risk of harm
  that can occur as a result of brief exposures that exceed the TWA PEL.
  Without a STEL, the only protection workers would have from high short-
  duration exposures is that, when those exposures are factored in, they
  cannot exceed the cumulative 8-hour exposure at the proposed 0.2 μg/
  m3\ TWA PEL (i.e., 1.6 μg/m3\). Since there are 32 15-minute
  periods in an 8-hour work shift, a worker's 15-minute exposure in the
  absence of a STEL could be as high as 6.4 μg/m3\ (32 x 0.2 μg/
  m3\) if that worker's exposures during the remainder of the 8-hour
  work shift are non-detectable. A STEL serves to minimize high, task-
  based exposures by requiring feasible controls in these situations, and
  has the added effect of further reducing the 8-hour TWA exposure.
      OSHA believes a STEL for beryllium will help reduce the risk of
  sensitization and CBD in beryllium-exposed employees. As discussed in
  this preamble at section V, Health Effects, beryllium sensitization is
  the initial step in the development of CBD. Sensitization has been
  observed in some workers who were only exposed to beryllium for a few
  months (see section V.D.1 of this preamble), and tends to be more
  strongly associated with 'peak' and highest-job-worked exposure metrics
  than cumulative exposure (see section V.D.5 of this preamble). Short-
  term exposures to beryllium have also been shown to contribute to the
  development of lung disease in laboratory animals (see this preamble at
  section V, Health Effects). These study findings indicate that adverse
  effects to the lung may occur from beryllium exposures of relatively
  short duration. Thus OSHA expects a STEL to add further protection from
  the demonstrated significant risk of harm than that afforded by the new
  0.2 μg/m3\ TWA PEL alone.
      STEL exposures are typically associated with, and need to be
  measured by the employer during, the highest-exposure operations that
  an employee performs (see paragraph (d)(3)(ii)). OSHA has determined
  that the STEL of 2.0 μg/m3\ can be measured for this brief period
  of time using OSHA's available sampling and analytical methodology, and
  that feasible means exist to maintain 15-minute short-term exposures at
  or below the proposed STEL (see section VIII.D of this preamble,
  Technological Feasibility). Comments on the STEL were generally
  supportive of OSHA's


  decision to include a beryllium STEL, but differed on the appropriate
  level. NIOSH recommended a STEL of at most 1 μg/m3\, noting that
  available exposure assessment methods are sensitive enough to support a
  STEL of 1 μg/m3\ and that it is likely to be more protective than
  the proposed STEL of 2 μg/m3\ (Document ID 1960, Attachment 2, p.
  4; 1725, p. 35; 1755, Tr. 22). NJH's comments also supported a STEL of
  1 μg/m3\ as the best option (Document ID 1664, p. 3). Public
  Citizen and the AFL-CIO advocated for a STEL of 1 μg/m3\, stating
  that it would be more protective than the proposed STEL of 2 μg/m3\
  (Document ID 1670, p. 6; 1689, p. 7-8). The AFL-CIO and Public Citizen
  both stated that a STEL of 1 μg/m3\ is supported in the record,
  including by exposure data from OSHA workplace inspections (Document ID
  1670, p. 6; 1756, Tr. 171). However, no additional engineering controls
  capable of reducing short term exposures to or below 1.0 μg/m3\
  were identified by commenters. Public commenters did not provide any
  empirical data to suggest that those exposed to working conditions
  associated with a STEL of 2.0 μg/m3\ would be more likely to be
  sensitized than those exposed to working conditions associated with a
  STEL of 1.0 μg/m3\. However, OSHA notes that the available
  epidemiological literature on beryllium-related disease does not
  address the question of whether those exposed to working conditions
  associated with a STEL of 2.0 μg/m3\ would be more likely to be
  sensitized than those exposed to working conditions associated with a
  STEL of 1.0 μg/m3\. Detailed documentation of workers' short-term
  exposures is typically not available to researchers. Therefore, OSHA
  cannot exclusively rely on evidence relating health effects to specific
  short-term exposure levels to set a STEL. In setting a STEL, OSHA also
  examines the likelihood that a given STEL will help to reduce
  excursions above the TWA PEL and the feasibility of meeting a given
  STEL using engineering controls. The UAW emphasized that "OSHA must
  include the STEL in the standard to ensure that peak exposures are
  characterized and controlled" (Document ID 1693, p. 3). The UAW
  argued, specifically, for a STEL of five times the PEL (recommending a
  STEL of 0.5 μg/m3\ based on a TWA PEL of 0.1 μg/m3\), noting
  that single short-term, high-level beryllium exposures can lead to
  sensitization, and that UAW members in industries such as nonferrous
  foundries and scrap metal reclamation may experience such exposures
  even when not exposed above the 8 hour TWA PEL (Document ID 1693, p.
  3). Ameren Services Company, a public utility that includes electric
  power generation companies, expressed support for the proposed PEL and
  STEL, but also expressed support for selecting a STEL of five times the
  PEL in order to maintain consistency with OSHA's typical approach to
  setting STELs (Document ID 1675, p. 3).
      In contrast, NGK Metals Corporation (NGK) supported the proposed
  STEL of 2 μg/m3\, and specifically argued against a STEL of 0.5
  μg/m3\ on the basis that a reduced STEL would not be feasible or
  offer significantly more protection than the proposed STEL (Document ID
  1663, p. 4). Materion emphasized the need for "proactive operational
  control" of tasks that could generate high, short-term beryllium
  exposures, and supported the STEL of 2 μg/m3\ contained in OSHA's
  proposed rule (Document ID 1661, pp. 3, 5). Materion indicated in its
  comments that the proposed STEL of 2.0 μg/m3\ was based on
  controlling the upper range of worker short term exposures (Document ID
  1661). Materion used data provided in the Johnson study of the United
  Kingdom Atomic Weapons Establishment (AWE) in Cardiff, Wales, as
  supporting evidence for the proposed STEL (Document ID 1505). However,
  Dr. Christine Schuler from NIOSH commented that the AWE study was not
  an appropriate basis for an OSHA STEL because the AWE study was based
  on workers showing physical signs of CBD ("If somebody became really
  apparently ill, then they would have identified them.") (Document ID
  1755, Tr. 35). Dr. Schuler additionally commented that the studies
  performed in the United States are more appropriate since they are
  based on identified cases of CBD at an earlier stage where there are
  generally very few symptoms (called asymptomatic or subclinical)
  (Document ID 1755, Tr. 34-35). OSHA agrees with Dr. Schuler's
  assessment and that the AWE study should not be used as scientific
  evidence to support a STEL of 2.0 μg/m3\.
      After careful consideration of the record, including all available
  data and stakeholder comments, OSHA has reaffirmed its preliminary
  determinations that a STEL of 2.0 μg/m3\ (ten times the final PEL
  of 0.2 μg/m3\) is technologically feasible and will help reduce the
  risk of beryllium-related health effects in exposed employees. As
  discussed in section VIII.D of this preamble, Technological
  Feasibility, OSHA has determined that the implementation of engineering
  and work practice controls required to maintain full shift exposures at
  or below a PEL of 0.2 μg/m3\ will reduce short term exposures to
  2.0 μg/m3\ or below. However, adopting a STEL of 1.0 μg/m3\ or
  lower would likely require additional respirator use in some
  situations. Thus, OSHA has retained the proposed value of 2.0 μg/
  m3\ as the final STEL.
      OSHA also received a comment from Paul Wambach, (an independent
  commenter) stating that a STEL should not be included in the final
  rule, arguing that the diseases associated with beryllium exposure are
  chronic in nature and therefore are not affected by brief excursions
  above the TWA PEL (Document ID 1591, p. 1). However, as discussed
  above, OSHA has determined that there is sufficient evidence that
  brief, high-level exposures to beryllium contribute to the development
  of beryllium sensitization and CBD to support inclusion of a STEL in
  the final rule (see this preamble at section V, Health Effects). This
  comment also discussed the statistical relationship between a 15-minute
  STEL and 8-hour TWA PEL and issues of sampling strategy, discussed in
  section VIII.D of this preamble, Technological Feasibility.
      CFR Entries. OSHA's preceding PELs for "beryllium and beryllium
  compounds," were contained in 29 CFR 1910.1000 Table Z-2 for general
  industry. Table Z-2 contained two PELs: (1) A 2 μg/m3\ TWA PEL, and
  (2) a ceiling concentration of 5 μg/m3\ that employers must ensure
  is not exceeded during the 8-hour work shift, except for a maximum peak
  of 25 μg/m3\ over a 30-minute period in an 8-hour work shift. The
  preceding PELs for beryllium and beryllium compounds in shipyards (29
  CFR 1915.1000 Table Z) and construction (29 CFR 1926.55 Appendix A)
  were also 2 μg/m3\, but did not include ceiling or peak exposure
  limits. OSHA adopted the preceding PELs in 1972 pursuant to section
  6(a) of the OSH Act (29 U.S.C. 655(a)). The 1972 PELs were based on the
  1970 American National Standards Institute (ANSI) Beryllium and
  Beryllium Compounds standard (Document ID 1303), which in turn was
  based on a 1949 U.S. Atomic Energy Commission adoption of a threshold
  limit for beryllium of 2.0 μ/m3\ and was included in the 1971
  American Conference of Governmental Industrial Hygienists Documentation
  of the Threshold Limit Values for Substances in Workroom Air (Document
  ID 0543).
      OSHA is revising the entry for beryllium and beryllium compounds in
  29 CFR 1910.1000 Table Z-1 to cross-reference the new general industry
  standard, 1910.1024. A comparable revision to 29 CFR 1915.1000 Table Z


  cross-references the shipyard standard, 1915.1024, and 29 CFR 1926.55
  Appendix A is revised to cross-reference the construction standard,
  1926.1124. A footnote is added to 29 CFR 1910.1000 Table Z-1, which
  refers to 29 CFR 1910.1000 Table Z-2 for situations when the new
  exposure limits in 1910.1024 are stayed or otherwise not in effect. The
  preceding PELs for beryllium are retained in 29 CFR 1910.1000 Table Z-
  2, 29 CFR 1915.1000 Table Z, and 29 CFR 1926.55 Appendix A. Footnotes
  are added to these tables to make clear that the preceding PELs apply
  to any sectors or operations where the new TWA PEL of 0.2 μg/m3\
  and STEL of 2.0 μg/m3\ are not in effect. The preceding PELs are
  also applicable during the time between publication of the beryllium
  rule and the dates established for compliance with the rule, as well as
  in the event of regulatory delay, a stay, or partial or full
  invalidation by the Court.

  (d) Exposure Assessment

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


  frequency schedule for periodic monitoring and a requirement to perform
  periodic exposure monitoring when exposures are above the PEL in the
  scheduled monitoring option in paragraph (d)(3)(vi) and when exposures
  are above the STEL in the scheduled monitoring option in paragraph
  (d)(3)(viii).
      Proposed paragraphs (d)(1)(ii)-(v) have been moved to different
  paragraphs in the final standards and will be discussed in the
  appropriate sections below.
      The performance option. Proposed paragraph (d)(2) set forth initial
  exposure monitoring requirements and the circumstances under which
  employers do not need to conduct initial exposure monitoring. In the
  proposal, employers did not have