2470 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations

DEPARTMENT OF LABOR Register announcing the Office of (m) Communication of Hazards Management and Budget has approved (n) Recordkeeping Occupational Safety and Health them under the Paperwork Reduction (o) Dates Administration Act. (p) Appendix A (General Industry) Authority and Signature ADDRESSES: In accordance with 28 29 CFR Parts 1910, 1915, and 1926 Amendments to Standards U.S.C. 2112(a), the Agency designates Citation Method [Docket No. OSHA–H005C–2006–0870] Ann Rosenthal, Associate Solicitor of In the docket for the beryllium RIN 1218–AB76 Labor for Occupational Safety and Health, Office of the Solicitor of Labor, rulemaking, found at http:// Occupational Exposure to Beryllium Room S–4004, U.S. Department of www.regulations.gov, every submission Labor, 200 Constitution Avenue NW., was assigned a document identification AGENCY: Occupational Safety and Health Washington, DC 20210, to receive (ID) number that consists of the docket Administration (OSHA), Department of petitions for review of the final rule. number (OSHA–H005C–2006–0870) Labor. FOR FURTHER INFORMATION CONTACT: For followed by an additional four-digit ACTION: Final rule. general information and press inquiries, number. For example, the document ID contact Frank Meilinger, Director, Office number for OSHA’s Preliminary SUMMARY: The Occupational Safety and of Communications, Room N–3647, Economic Analysis and Initial Health Administration (OSHA) is OSHA, U.S. Department of Labor, 200 Regulatory Flexibility Analysis is amending its existing standards for Constitution Avenue NW., Washington, OSHA–H005C–2006–0870–0426. Some occupational exposure to beryllium and DC 20210; telephone (202) 693–1999; document ID numbers include one or beryllium compounds. OSHA has email [email protected]. more attachments, such as the National determined that employees exposed to For technical inquiries, contact Institute for Occupational Safety and beryllium at the previous permissible William Perry or Maureen Ruskin, Health (NIOSH) prehearing submission exposure limits face a significant risk of Directorate of Standards and Guidance, (see Document ID OSHA–H005C–2006– material impairment to their health. The Room N–3718, OSHA, U.S. Department 0870–1671). evidence in the record for this of Labor, 200 Constitution Avenue NW., When citing exhibits in the docket, rulemaking indicates that workers Washington, DC 20210; telephone (202) OSHA includes the term ‘‘Document exposed to beryllium are at increased 693–1950. ID’’ followed by the last four digits of risk of developing chronic beryllium the document ID number, the disease and lung cancer. This final rule SUPPLEMENTARY INFORMATION: The preamble to the rule on occupational attachment number or other attachment establishes new permissible exposure identifier, if applicable, page numbers limits of 0.2 micrograms of beryllium exposure to beryllium follows this outline: (designated ‘‘p.’’ or ‘‘Tr.’’ for pages from per cubic meter of air (0.2 mg/m3) as an a hearing transcript). In a citation that 8-hour time-weighted average and 2.0 I. Executive Summary contains two or more document ID mg/m3 as a short-term exposure limit II. Pertinent Legal Authority numbers, the document ID numbers are determined over a sampling period of 15 III. Events Leading to the Final Standards IV. Chemical Properties and Industrial Uses separated by semi-colons. In some minutes. It also includes other sections, such as Section V, Health provisions to protect employees, such as V. Health Effects VI. Risk Assessment Effects, author names and year of study requirements for exposure assessment, VII. Significance of Risk publication are included before the methods for controlling exposure, VIII. Summary of the Final Economic document ID number in a citation, for respiratory protection, personal Analysis and Final Regulatory Flexibility example: (Deubner et al., 2011, protective clothing and equipment, Analysis Document ID 0527). Where multiple housekeeping, medical surveillance, IX. OMB Review Under the Paperwork exhibits are listed with author names hazard communication, and Reduction Act of 1995 and year of study publication, document recordkeeping. X. Federalism XI. State-Plan States ID numbers after the first are in OSHA is issuing three separate parentheses, for example: (Elder et al., standards—for general industry, for XII. Unfunded Mandates Reform Act XIII. Protecting Children From 2005, Document ID 1537; Carter et al., shipyards, and for construction—in Environmental Health and Safety Risks 2006 (1556); Refsnes et al., 2006 (1428)). order to tailor requirements to the XIV. Environmental Impacts circumstances found in these sectors. XV. Consultation and Coordination With I. Executive Summary DATES: Effective date: The final rule Indian Tribal Governments This final rule establishes new becomes effective on March 10, 2017. XVI. Summary and Explanation of the permissible exposure limits (PELs) for Compliance dates: Compliance dates Standards beryllium of 0.2 micrograms of for specific provisions are set in Introduction beryllium per cubic meter of air (0.2 mg/ (a) Scope and Application 3 § 1910.1024(o) for general industry, (b) Definitions m ) as an 8-hour time-weighted average 3 § 1915.1024(o) for shipyards, and (c) Permissible Exposure Limits (PELs) (TWA) and 2.0 mg/m as a short-term § 1926.1124(o) for construction. There (d) Exposure Assessment exposure limit (STEL) determined over are a number of collections of (e) Beryllium Work Areas and Regulated a sampling period of 15 minutes. In information contained in this final rule Areas (General Industry); Regulated addition to the PELs, the rule includes (see Section IX, OMB Review under the Areas (Maritime); and Competent Person provisions to protect employees such as Paperwork Reduction Act of 1995). (Construction) requirements for exposure assessment, Notwithstanding the general date of (f) Methods of Compliance methods for controlling exposure, applicability that applies to all other (g) Respiratory Protection respiratory protection, personal (h) Personal Protective Clothing and requirements contained in the final rule, Equipment protective clothing and equipment, affected parties do not have to comply (i) Hygiene Areas and Practices housekeeping, medical surveillance, with the collections of information until (j) Housekeeping hazard communication, and the Department of Labor publishes a (k) Medical Surveillance recordkeeping. OSHA is issuing three separate document in the Federal (l) Medical Removal separate standards—for general

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

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skin can reasonably be expected to be employee’s exposure to beryllium, change rooms and showers commences exposed to soluble beryllium referral to a CBD diagnostic center, a two years after the effective date; and compounds. The final rule requires use recommendation for continued periodic the obligation for engineering controls of protective clothing and equipment medical surveillance, or a commences three years after the where employee exposure exceeds, or recommendation for medical removal if effective date.1 can reasonably be expected to exceed the employee provides written Under the OSH Act’s legal standard the TWA PEL or STEL; or where there authorization. The final rule requires a directing OSHA to set health standards is a reasonable expectation of dermal separate written medical report based on findings of significant risk of contact with beryllium. provided to the employee to include material impairment and technological Medical Surveillance. The exposure this additional information, as well as and economic feasibility, OSHA does trigger for medical examinations has detailed information related to the not use cost-benefit analysis to been revised from the proposal. The employee’s health. determine the PEL or other aspects of proposed rule would have required that The proposed rule would have the rule. It does, however, determine medical examinations be offered to each required that the licensed physician and analyze costs and benefits for its employee who has worked in a provide the employer with a written own informational purposes and to meet regulated area (i.e., an area where an medical opinion within 30 days of the certain Executive Order requirements, employee’s exposure exceeds, or can examination. The final rule requires that as discussed in Section VIII, Summary reasonably be expected to exceed, the the licensed physician provide the of the Final Economic Analysis and TWA PEL or STEL) for more than 30 employee with a written medical report Final Regulatory Flexibility Analysis days in the last 12 months. The final and the employer with a written and in the FEA. Table I–1—which is rule requires that medical examinations medical opinion within 45 days of the derived from material presented in be offered to each employee who is or examination, including any follow-up Section VIII of this preamble—provides is reasonably expected to be exposed at beryllium lymphocyte proliferation test a summary of OSHA’s best estimate of or above the action level for more than (BeLPTs). the costs and benefits of the rule using 30 days per year. A trigger to offer The final rule also adds requirements a discount rate of 3 percent. As shown, periodic medical surveillance when for the employer to provide the CBD the rule is estimated to prevent 90 recommended by the most recent diagnostic center with the same fatalities and 46 new cases of CBD written medical opinion was also added information provided to the physician annually once the full effects are the final rule. Under the final rule, the or other licensed health care realized, and the estimated cost of the licensed physician recommends professional who administers the rule is $73.9 million annually. Also as continued periodic medical surveillance medical examination, and for the CBD shown in Table I–1, the discounted for employees who are confirmed diagnostic center to provide the monetized benefits of the rule are positive for sensitization or diagnosed employee with a written medical report estimated to be $560.9 annually, and the with CBD. The proposed rule also and the employer with a written rule is estimated to generate net benefits would have required that medical medical opinion. Under the final of approximately $487 annually; examinations be offered annually; the standard, employees referred to a CBD however, there is a great deal of final rule requires that medical diagnostic center can choose to have uncertainty in those benefits due to examinations be offered at least every future evaluations performed there. A assumptions made about dental two years. requirement that laboratories workers’ exposures and reductions; see The final medical surveillance performing BeLPTs be certified was also Section VIII of this preamble. As that provisions have been revised to provide added to the final rule. section shows, benefits significantly enhanced privacy for employees. The The proposed rule would have exceed costs regardless of how dental rule requires the employer to obtain a required that employers provide low workers’ exposures are treated. written medical opinion from a licensed dose computed tomography (LDCT) physician for medical examinations scans to employees who met certain TABLE I–1—ANNUALIZED BENEFITS, provided under the rule but limits the exposure criteria. The final rule requires information provided to the employer to LDCT scans when recommended by the COSTS AND NET BENEFITS OF the date of the examination, a statement physician or other licensed healthcare OSHA’S FINAL BERYLLIUM STAND- that the examination has met the professional administering the medical ARD requirements of the standard, any exam, after considering the employee’s [3 Percent discount rate, 2015 dollars] recommended limitations on the history of exposure to beryllium along employee’s use of respirators, protective with other risk factors. Annualized Costs: Control Costs ...... $12,269,190 clothing, and equipment, and a Dates. OSHA proposed an effective Rule Familiarization ...... 180,158 statement that the results of the exam date 60 days after publication of the Exposure Assessment ...... 13,748,676 have been explained to the employee. rule; a date for compliance with all Regulated Areas ...... 884,106 The proposed rule would have required provisions except change rooms and that such opinions contain additional engineering controls of 90 days after the 1 Note that the main analysis of costs and benefits information, without requiring effective date; a date for compliance presented in this FEA does not take into account the lag in effective dates but, instead, assumes that employee authorization, such as the with change room requirements, which the rule takes effect in Year 1. To account for the physician’s opinion as to whether the was one year after the effective date; and lag in effective dates, OSHA has provided in the employee has any detected medical a date for compliance with engineering sensitivity analysis in Chapter VII of the FEA an condition that would place the control requirements of two years after estimate of its separate effects on costs and benefits relative to the main analysis. This analysis, which employee at increased risk of CBD from the effective date. appears in Table VII–16 of the FEA, indicates that further exposure, and any recommended OSHA has revised the proposed if employers delayed implementation of all limitations upon the employee’s compliance dates. The final rule is provisions until legally required, and no benefits exposure to beryllium. In the final rule, effective 60 days after publication. All occurred until all provisions went into effect, this would decrease the estimated costs by 3.9 percent; the written opinion provided to the obligations for compliance commence the estimated benefits by 8.5 percent, and the employer will only include one year after the effective date, with estimated net benefits of the standard by 9.2 percent recommended limitations on the two exceptions: The obligation for (to $442 million).

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TABLE I–1—ANNUALIZED BENEFITS, standard which most adequately should address when feasible (43 FR COSTS AND NET BENEFITS OF assures, to the extent feasible, on the 52952, 52954 (11/14/78) (Lead OSHA’S FINAL BERYLLIUM STAND- basis of the best available evidence, that Preamble)). no employee will suffer material ARD—Continued Significant Risk impairment of health or functional [3 Percent discount rate, 2015 dollars] capacity even if such employee has Section 3(8) of the Act requires that Beryllium Work Areas ...... 129,648 regular exposure to the hazard dealt workplace safety and health standards Medical Surveillance ...... 7,390,958 with by such standard for the period of be ‘‘reasonably necessary or appropriate Medical Removal ...... 1,151,058 to provide safe or healthful Written Exposure Control Plan .... 2,339,058 his working life’’ (29 U.S.C. 655(b)(5)). Protective Work Clothing & Thus, ‘‘[w]hen Congress passed the employment’’ (29 U.S.C. 652(8)). The Equipment ...... 1,985,782 Occupational Safety and Health Act in Supreme Court, in its decision on Hygiene Areas and Practices ...... 2,420,584 1970, it chose to place pre-eminent OSHA’s benzene standard, interpreted Housekeeping ...... 22,763,595 section 3(8) to mean that before Training ...... 8,284,531 value on assuring employees a safe and Respirators ...... 320,885 healthful working environment, limited promulgating any standard, the only by the feasibility of achieving such Secretary must evaluate whether Total Annualized Costs an environment’’ (American Textile ‘‘significant risk[ ]’’ exists under current (Point Estimate) ...... $73,868,230 conditions and to then determine Annual Benefits: Number of Cases Mfrs. Institute, Inc. v. Donovan, 452 US Prevented: 490, 541 (1981) (‘‘Cotton Dust’’)). whether that risk can be ‘‘eliminated or Fatal Lung Cancers (Midpoint Es- OSHA proposed this new standard for lessened’’ through regulation (Indus. timate) ...... 4 beryllium and beryllium compounds Union Dep’t, AFL–CIO v. Am. Petroleum Fatal Chronic Beryllium Disease 86 and conducted its rulemaking pursuant Inst., 448 U.S. 607, 642 (1980) (plurality Beryllium-Related Mortality ...... 90 Beryllium Morbidity ...... 46 to section 6(b)(5) of the Act ((29 U.S.C. opinion) (‘‘Benzene’’)). The Court’s Monetized Annual Benefits (Mid- 655(b)(5)). The preceding beryllium holding is consistent with evidence in point Estimate) ...... $560,873,424 standard, however, was adopted under the legislative record, with regard to Net Benefits: the Secretary’s authority in section 6(a) section 6(b)(5) of the Act (29 U.S.C. Net Benefits ...... $487,005,194 of the OSH Act (29 U.S.C. 655(a)), to 655(b)(5)), that Congress intended the Sources: US DOL, OSHA, Directorate of adopt national consensus and Agency to regulate unacceptably severe Standards and Guidance, Office of Regulatory established Federal standards within occupational hazards, and not ‘‘to Analysis. two years of the Act’s enactment (see 29 establish a utopia free from any II. Pertinent Legal Authority CFR 1910.1000 Table Z–1). Any rule hazards’’ or to address risks comparable that ‘‘differs substantially from an to those that exist in virtually any The purpose of the Occupational existing national consensus standard’’ occupation or workplace (116 Cong. Safety and Health Act (29 U.S.C. 651 et must ‘‘better effectuate the purposes of Rec. 37614 (1970), Leg. Hist. 480–82). It seq.) (‘‘the Act’’ or ‘‘the OSH Act’’), is this Act than the national consensus is also consistent with Section 6(g) of ‘‘to assure so far as possible every standard’’ (29 U.S.C. 655(b)(8)). Several the OSH Act, which states that, in working man and woman in the Nation additional legal requirements arise from determining regulatory priorities, ‘‘the safe and healthful working conditions the statutory language in sections 3(8) Secretary shall give due regard to the and to preserve our human resources’’ and 6(b)(5) of the Act (29 U.S.C. 652(8), urgency of the need for mandatory (29 U.S.C. 651(b)). To achieve this goal 655(b)(5)). The remainder of this section safety and health standards for Congress authorized the Secretary of discusses these requirements, which particular industries, trades, crafts, Labor (‘‘the Secretary’’) ‘‘to set OSHA must consider and meet before it occupations, businesses, workplaces or mandatory occupational safety and may promulgate this occupational work environments’’ (29 U.S.C. 655(g)). health standards applicable to health standard regulating exposure to The Supreme Court in Benzene businesses affecting interstate beryllium and beryllium compounds. clarified that ‘‘[i]t is the Agency’s commerce’’ (29 U.S.C. 651(b)(3); see 29 responsibility to determine, in the first U.S.C. 654(a) (requiring employers to Material Impairment of Health instance, what it considers to be a comply with OSHA standards), 655(a) Subject to the limitations discussed ‘significant’ risk’’ (Benzene, 448 U.S. at (authorizing summary adoption of below, when setting standards 655), and that it was not the Court’s existing consensus and federal regulating exposure to toxic materials or responsibility to ‘‘express any opinion standards within two years of the Act’s harmful physical agents, the Secretary is on the . . . difficult question of what enactment), and 655(b) (authorizing required to set health standards that factual determinations would warrant a promulgation, modification or ensure that ‘‘no employee will suffer conclusion that significant risks are revocation of standards pursuant to material impairment of health or present which make promulgation of a notice and comment)). The primary functional capacity. . .’’ (29 U.S.C. new standard reasonably necessary or statutory provision relied upon by the 655(b)(5)). ‘‘OSHA is not required to appropriate’’ (Benzene, 448 U.S. at 659). Agency in promulgating health state with scientific certainty or The Court stated, however, that the standards is section 6(b)(5) of the Act; precision the exact point at which each section 6(f) (29 U.S.C. 655(b)(f)) other sections of the OSH Act, however, type of [harm] becomes a material substantial evidence standard authorize the Occupational Safety and impairment’’ (AFL–CIO v. OSHA, 965 applicable to OSHA’s significant risk Health Administration (‘‘OSHA’’) to F.2d 962, 975 (11th Cir. 1992)). Courts determination does not require the require labeling and other appropriate have also noted that OSHA should Agency ‘‘to support its finding that a forms of warning, exposure assessment, consider all forms and degrees of significant risk exists with anything medical examinations, and material impairment—not just death or approaching scientific certainty’’ recordkeeping in its standards (29 serious physical harm (AFL–CIO, 965 (Benzene, 448 U.S. at 656). Rather, U.S.C. 655(b)(5), 655(b)(7), 657(c)). F.2d at 975). Thus the Agency has taken OSHA may rely on ‘‘a body of reputable The Act provides that in promulgating the position that ‘‘subclinical’’ health scientific thought’’ to which standards dealing with toxic materials effects, which may be precursors to ‘‘conservative assumptions in or harmful physical agents, such as more serious disease, can be material interpreting the data . . . ’’ may be beryllium, the Secretary ‘‘shall set the impairments of health that OSHA applied, ‘‘risking error on the side of

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overprotection’’ (Benzene, 448 U.S. at the OSH Act as requiring OSHA to set (Asbestos II, 838 F.2d at 1264–1265). 656; see also United Steelworkers of the standard that eliminates or reduces OSHA might calculate the health risks Am., AFL–CIO–CLC v. Marshall, 647 risk to the lowest feasible level; as of exposure, and the related benefits of F.2d 1189, 1248 (D.C. Cir. 1980) (‘‘Lead discussed below, the limits of lowering the exposure limit, based on I’’) (noting the Benzene court’s technological and economic feasibility an assumption of a shorter working life, application of this principle to usually determine where the new such as 25 years, but such estimates are carcinogens and applying it to the lead standard is set (see UAW v. Pendergrass, for informational purposes only. standard, which was not based on 878 F.2d 389, 390 (D.C. Cir. 1989)). In Best Available Evidence carcinogenic effects)). OSHA may thus choosing among regulatory alternatives, act with a ‘‘pronounced bias towards however, ‘‘[t]he determination that [one Section 6(b)(5) of the Act requires worker safety’’ in making its risk standard] is appropriate, as opposed to OSHA to set standards ‘‘on the basis of determinations (Bldg & Constr. Trades a marginally [more or less protective] the best available evidence’’ and to Dep’t v. Brock, 838 F.2d 1258, 1266 standard, is a technical decision consider the ‘‘latest available scientific (D.C. Cir. 1988) (‘‘Asbestos II’’). entrusted to the expertise of the agency data in the field’’ (29 U.S.C. 655(b)(5)). The Supreme Court further . . . ’’ (Nat’l Mining Ass’n v. Mine As noted above, the Supreme Court, in recognized that what constitutes Safety and Health Admin., 116 F.3d its Benzene decision, explained that ‘‘significant risk’’ is ‘‘not a mathematical 520, 528 (D.C. Cir. 1997)) (analyzing a OSHA must look to ‘‘a body of reputable straitjacket’’ (Benzene, 448 U.S. at 655) Mine Safety and Health Administration scientific thought’’ in making its and will be ‘‘based largely on policy standard under the Benzene significant material harm and significant risk considerations’’ (Benzene, 448 U.S. at risk standard). In making its choice, determinations, while noting that a 655 n. 62). The Court gave the following OSHA may incorporate a margin of reviewing court must ‘‘give OSHA some example: safety even if it theoretically regulates leeway where its findings must be made If . . . the odds are one in a billion that below the lower limit of significant risk on the frontiers of scientific knowledge’’ a person will die from cancer by taking a (Nat’l Mining Ass’n, 116 F.3d at 528 (Benzene, 448 U.S. at 656). drink of chlorinated water, the risk clearly (citing American Petroleum Inst. v. The courts of appeals have afforded could not be considered significant. On the Costle, 665 F.2d 1176, 1186 (D.C. Cir. OSHA similar latitude to issue health other hand, if the odds are one in a thousand 1982))). standards in the face of scientific that regular inhalation of gasoline vapors that uncertainty. The Second Circuit, in are 2% benzene will be fatal, a reasonable Working Life Assumption upholding the vinyl chloride standard, person might well consider the risk The OSH Act requires OSHA to set stated: ‘‘[T]he ultimate facts here in significant . . . (Benzene, 448 U.S. at 655). the standard that most adequately dispute are ‘on the frontiers of scientific Following Benzene, OSHA has, in many protects employees against harmful knowledge’, and, though the factual of its health standards, considered the workplace exposures for the period of finger points, it does not conclude. one-in-a-thousand metric when their ‘‘working life’’ (29 U.S.C. Under the command of OSHA, it determining whether a significant risk 655(b)(5)). OSHA’s longstanding policy remains the duty of the Secretary to act exists. Moreover, as ‘‘a prerequisite to is to define ‘‘working life’’ as to protect the workingman, and to act more stringent regulation’’ in all constituting 45 years; thus, it assumes even in circumstances where existing subsequent health standards, OSHA has, 45 years of exposure when evaluating methodology or research is deficient’’ consistent with the Benzene plurality the risk of material impairment to health (Society of the Plastics Industry, Inc. v. decision, based each standard on a caused by a toxic or hazardous OSHA, 509 F.2d 1301, 1308 (2d Cir. finding of significant risk at the ‘‘then substance. This policy is not based on 1975) (quoting Indus. Union Dep’t, AFL– prevailing standard’’ of exposure to the empirical data that most employees are CIO v. Hodgson, 499 F.2d 467, 474 (D.C. relevant hazardous substance (Asbestos exposed to a particular hazard for 45 Cir. 1974) (‘‘Asbestos I’’))). The D.C. II, 838 F.2d at 1263). The Agency’s final years. Instead, OSHA has adopted the Circuit, in upholding the cotton dust risk assessment is derived from existing practice to be consistent with the standard, stated: ‘‘OSHA’s mandate scientific and enforcement data and its statutory directive that ‘‘no employee’’ necessarily requires it to act even if final conclusions are made only after suffer material impairment of health information is incomplete when the best considering all evidence in the ‘‘even if’’ such employee is exposed to available evidence indicates a serious rulemaking record. Courts reviewing the the hazard for the period of his or her threat to the health of workers’’ (Am. validity of these standards have working life (see 74 FR 44796 (8/31/ Fed’n of Labor & Cong. of Indus. Orgs. uniformly held the Secretary to the 09)). OSHA’s policy was given judicial v. Marshall, 617 F.2d 636, 651 (D.C. Cir. significant risk standard first articulated approval in a challenge to an OSHA 1979), aff’d in part and vacated in part by the Benzene plurality and have standard that lowered the permissible on other grounds, American Textile generally upheld the Secretary’s exposure limit (PEL) for asbestos Mfrs. Inst., Inc. v. Donovan, 452 U.S. significant risk determinations as (Asbestos II, 838 F.2d at 1264–1265). In 490 (1981)). When there is disputed supported by substantial evidence and that case, the petitioners claimed that scientific evidence in the record, OSHA ‘‘a reasoned explanation for his policy the median duration of employment in must review the evidence on both sides assumptions and conclusions’’ the affected industry sectors was only and ‘‘reasonably resolve’’ the dispute (Asbestos II, 838 F.2d at 1266). five years. Therefore, according to (Pub. Citizen Health Research Grp. v. Once OSHA makes its significant risk petitioners, OSHA erred in assuming a Tyson, 796 F.2d 1479, 1500 (D.C. Cir. finding, the ‘‘more stringent regulation’’ 45-year working life in calculating the 1986)). The Court in Public Citizen (Asbestos II, 838 F.2d at 1263) it risk of health effects caused by asbestos further noted that, where ‘‘OSHA has promulgates must be ‘‘reasonably exposure. The D.C. Circuit disagreed, the expertise we lack and it has necessary or appropriate’’ to reduce or stating ‘‘[e]ven if it is only the rare exercised that expertise by carefully eliminate that risk, within the meaning worker who stays with asbestos-related reviewing the scientific data,’’ a dispute of section 3(8) of the Act (29 U.S.C. tasks for 45 years, that worker would within the scientific community is not 652(8)) and Benzene (448 U.S. at 642) face a 64/1000 excess risk of contracting occasion for the reviewing court to take (see Asbestos II, 838 F.2d at 1269). The cancer; Congress clearly authorized sides about which view is correct (Pub. courts have interpreted section 6(b)(5) of OSHA to protect such a worker’’ Citizen Health Research Grp., 796 F.2d

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at 1500) or for OSHA or the courts to operations could reasonably be expected employers to decrease exposures to the ‘‘ ‘be paralyzed by debate surrounding to meet a lower PEL. OSHA health PEL, provisions such as exposure diverse medical opinions’ ’’ (Pub. standards generally set a single PEL for measurement requirements must also be Citizen Health Research Grp., 796 F.2d all affected employers; OSHA exercised technologically feasible (see Forging at 1497 (quoting H.R. Rep. No. 91–1291, this discretion most recently in its final Indus. Ass’n v. Sec’y of Labor, 773 F.2d 91st Cong., 2d Sess. 18 (1970), reprinted rules on occupational exposure to 1436, 1453 (4th Cir. 1985)). in Legislative History of the Chromium (VI) (71 FR 10100, 10337– In its Lead decisions, the D.C. Circuit Occupational Safety and Health Act of 10338 (2/28/2006) and Respirable described OSHA’s obligation to 1970 at 848 (1971))). Provided the Crystalline Silica (81 FR 16285, 16576– demonstrate the technological feasibility Agency gave adequate notice in the 16575 (3/25/2016); see also 62 FR 1494, of reducing occupational exposure to a proposal’s preamble discussion of 1575 (1/10/97) (methylene chloride)). In hazardous substance. potential regulatory alternatives that the its decision upholding the chromium [W]ithin the limits of the best available Secretary would be considering one or (VI) standard, including the uniform evidence . . . OSHA must prove a reasonable more stated options for regulation, PEL, the Court of Appeals for the Third possibility that the typical firm will be able OSHA is not required to prefer the Circuit addressed this issue as one of to develop and install engineering and work option in the text of the proposal over deference, stating ‘‘OSHA’s decision to practice controls that can meet the PEL in a given regulatory alternative that was select a uniform exposure limit is a most of its operations . . . The effect of such addressed in the rulemaking if legislative policy decision that we will proof is to establish a presumption that industry can meet the PEL without relying on substantial evidence in the record uphold as long as it was reasonably respirators . . . Insufficient proof of supports inclusion of the alternative in drawn from the record’’ (Chromium technological feasibility for a few isolated the final standard. See Owner-Operator (VI), 557 F.3d at 183 (3d Cir. 2009)); see operations within an industry, or even Independent Drivers Ass’n, Inc. v. also Am. Iron & Steel Inst. v. OSHA, 577 OSHA’s concession that respirators will be Federal Motor Carrier Safety Admin., F.2d 825, 833 (3d Cir. 1978)). OSHA’s necessary in a few such operations, will not 494 F.3d 188, 209 (D.C. Cir. 2007) reasons for choosing one chromium (VI) undermine this general presumption in favor (notice by agency concerning PEL, rather than imposing different of feasibility. Rather, in such operations firms modification of sleeper-berth PELs on different application groups or will remain responsible for installing requirements for truck drivers was industries, included: Multiple PELs engineering and work practice controls to the extent feasible, and for using them to reduce sufficient because proposal listed would create enforcement and . . . exposure as far as these controls can do several options and asked a question compliance problems because many so (Lead I, 647 F.2d at 1272). regarding the details of the one option workplaces, and even workers, were that ultimately appeared in final rule); affected by multiple categories of Additionally, the D.C. Circuit explained Kooritzky v. Reich, 17 F.3d 1509, 1513 chromium (VI) exposure; discerning that ‘‘[f]easibility of compliance turns (D.C. Cir. 1994) (noting that a final rule individual PELs for different groups of on whether exposure levels at or below need not match a proposed rule, as long establishments would impose a huge [the PEL] can be met in most operations as ‘‘the agency has alerted interested evidentiary burden on the Agency and most of the time . . .’’ (Lead II, 939 F.2d parties to the possibility of the agency’s unnecessarily delay implementation of at 990). adopting a rule different than the one the standard; and a uniform PEL would, Courts have given OSHA significant proposed’’ and holding that agency by eliminating confusion and deference in reviewing its technological failed to comply with notice and simplifying compliance, enhance feasibility findings. ‘‘So long as we comment requirements when ‘‘preamble worker protection (Chromium (VI), 557 require OSHA to show that any required in July offered no clues of what was to F.3d at 173, 183–184). The Court held means of compliance, even if it carries come in October’’). that OSHA’s rationale for choosing a no guarantee of meeting the PEL, will uniform PEL, despite evidence that substantially lower . . . exposure, we Feasibility some application groups or industries can uphold OSHA’s determination that The OSH Act requires that, in setting could meet a lower PEL, was reasonably every firm must exploit all possible a standard, OSHA must eliminate the drawn from the record and that the means to meet the standard’’ (Lead I, risk of material health impairment ‘‘to Agency’s decision was within its 647 F.2d at 1273). Even in the face of the extent feasible’’ (29 U.S.C. discretion and supported by past significant uncertainty about 655(b)(5)). The statutory mandate to practice (Chromium (VI), 557 F.3d at technological feasibility in a given consider the feasibility of the standard 183–184). industry, OSHA has been granted broad encompasses both technological and discretion in making its findings (Lead economic feasibility; these analyses Technological Feasibility I, 647 F.2d at 1285). ‘‘OSHA cannot let have been done primarily on an A standard is technologically feasible workers suffer while it awaits . . . industry-by-industry basis (Lead I, 647 if the protective measures it requires scientific certainty. It can and must F.2d at 1264, 1301). The Agency has already exist, can be brought into make reasonable [technological also used application groups, defined by existence with available technology, or feasibility] predictions on the basis of common tasks, as the structure for its can be created with technology that can ‘credible sources of information,’ feasibility analyses (Pub. Citizen Health reasonably be expected to be developed whether data from existing plants or Research Grp. v. OSHA, 557 F.3d 165, (Lead I, 647 F.2d at 1272; Amer. Iron & expert testimony’’ (Lead I, 647 F.2d at 177–179 (3d Cir. 2009)). The Supreme Steel Inst. v. OSHA, 939 F.2d 975, 980 1266 (quoting Am. Fed’n of Labor & Court has broadly defined feasible as (D.C. Cir. 1991) (‘‘Lead II’’)). OSHA’s Cong. of Indus. Orgs., 617 F.2d at 658)). ‘‘capable of being done’’ (Cotton Dust, standards may be ‘‘technology forcing,’’ For example, in Lead I, the D.C. Circuit 452 U.S. at 509–510). i.e., where the Agency gives an industry allowed OSHA to use, as best available Although OSHA must set the most a reasonable amount of time to develop evidence, information about new and protective PEL that the Agency finds to new technologies, OSHA is not bound expensive industrial smelting processes be technologically and economically by the ‘‘technological status quo’’ (Lead that had not yet been adopted in the feasible, it retains discretion to set a I, 647 F.2d at 1264). While the test for U.S. and would require the rebuilding of uniform PEL even when the evidence technological feasibility is normally plants (Lead I, 647 F.2d at 1283–1284). demonstrates that certain industries or articulated in terms of the ability of Even under circumstances where

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OSHA’s feasibility findings were less 29 & n. 54) as long as they are generally include the ‘‘hierarchy of certain and the Agency was relying on adequately explained. Thus, as the D.C. controls,’’ which, as a matter of OSHA’s its ‘‘legitimate policy of technology Circuit further explained: preferred policy, mandates that forcing,’’ the D.C. Circuit approved of Standards may be economically feasible employers install and implement all OSHA’s feasibility findings when the even though, from the standpoint of feasible engineering and work practice Agency granted lengthy phase-in employers, they are financially burdensome controls before respirators may be used. periods to allow particular industries and affect profit margins adversely. Nor does The Agency’s adherence to the time to comply (Lead I, 647 F.2d at the concept of economic feasibility hierarchy of controls has been upheld 1279–1281, 1285). necessarily guarantee the continued by the courts (ASARCO, Inc. v. OSHA, OSHA is permitted to adopt a existence of individual employers. It would 746 F.2d 483, 496–498 (9th Cir. 1984); standard that some employers will not appear to be consistent with the purposes of Am. Iron & Steel Inst. v. OSHA, 182 be able to meet some of the time, with the Act to envisage the economic demise of F.3d 1261, 1271 (11th Cir. 1999)). In an employer who has lagged behind the rest employers limited to challenging of the industry in protecting the health and fact, courts view the legal standard for feasibility at the enforcement stage safety of employees and is consequently proving technological feasibility as (Lead I, 647 F.2d at 1273 & n. 125; financially unable to comply with new incorporating the hierarchy: ‘‘OSHA Asbestos II, 838 F.2d at 1268). Even standards as quickly as other employers. As must prove a reasonable possibility that when the Agency recognized that it the effect becomes more widespread within the typical firm will be able to develop might have to balance its general an industry, the problem of economic and install engineering and work feasibility findings with flexible feasibility becomes more pressing (Asbestos practice controls that can meet the PEL enforcement of the standard in I, 499 F.2d. at 478). in most of its operations.... The individual cases, the courts of appeals OSHA standards therefore satisfy the effect of such proof is to establish a have generally upheld OSHA’s economic feasibility criterion even if presumption that industry can meet the technological feasibility findings (Lead they impose significant costs on PEL without relying on respirators’’ II, 939 F.2d at 980; see Lead I, 647 F.2d regulated industries so long as they do (Lead I, 647 F.2d at 1272). at 1266–1273; Asbestos II, 838 F.2d at not cause massive economic The reasons supporting OSHA’s 1268). Flexible enforcement policies dislocations within a particular industry continued reliance on the hierarchy of have been approved where there is or imperil the very existence of the controls, as well as its reasons for variability in measurement of the industry (Lead II, 939 F.2d at 980; Lead limiting the use of respirators, are regulated hazardous substance or where I, 647 F.2d at 1272; Asbestos I, 499 F.2d. numerous and grounded in good exposures can fluctuate uncontrollably at 478). As with its other legal findings, industrial hygiene principles (see (Asbestos II, 838 F.2d at 1267–1268; OSHA ‘‘is not required to prove discussion in Section XVI. Summary Lead II, 939 F.2d at 991). A common economic feasibility with certainty, but and Explanation of the Standards, means of dealing with the measurement is required to use the best available Methods of Compliance). The hierarchy variability inherent in sampling and evidence and to support its conclusions of controls focuses on removing harmful analysis is for the Agency to add the with substantial evidence’’ ((Lead II, 939 airborne materials at their source ‘‘to standard sampling error to its exposure F.2d at 980–981) (citing Lead I, 647 F.2d prevent atmospheric contamination’’ to measurements before determining at 1267)). which the employee would be exposed, whether to issue a citation (e.g., 51 FR Because section 6(b)(5) of the Act rather than relying on the proper 22612, 22654 (06/20/86) (Asbestos explicitly imposes the ‘‘to the extent functioning of a respirator as the Preamble)). feasible’’ limitation on the setting of primary means of protecting the employee (see 29 CFR 1910.134, Economic Feasibility health standards, OSHA is not permitted to use cost-benefit analysis to 1910.1000(e), 1926.55(b)). In addition to technological make its standards-setting decisions (29 In health standards such as this one, feasibility, OSHA is required to U.S.C. 655(b)(5)). the hierarchy of controls is augmented demonstrate that its standards are by ancillary provisions. These economically feasible. A reviewing Congress itself defined the basic provisions work with the hierarchy of court will examine the cost of relationship between costs and benefits, by controls and personal protective compliance with an OSHA standard ‘‘in placing the ‘‘benefit’’ of worker health above all other considerations save those making equipment requirements to provide relation to the financial health and attainment of this ‘‘benefit’’ unachievable. comprehensive protection to employees profitability of the industry and the Any standard based on a balancing of costs in affected workplaces. Such provisions likely effect of such costs on unit and benefits by the Secretary that strikes a typically include exposure assessment, consumer prices . . .’’ (Lead I, 647 F.2d different balance than that struck by Congress medical surveillance, hazard at 1265 (omitting citation)). As would be inconsistent with the command set communication, and recordkeeping. articulated by the D.C. Circuit in Lead forth in § 6(b)(5) (Cotton Dust, 452 U.S. at The OSH Act compels OSHA to I, ‘‘OSHA must construct a reasonable 509). require all feasible measures for estimate of compliance costs and Thus, while OSHA estimates the costs reducing significant health risks (29 demonstrate a reasonable likelihood that and benefits of its proposed and final U.S.C. 655(b)(5); Pub. Citizen Health these costs will not threaten the rules, these calculations do not form the Research Grp., 796 F.2d at 1505 (‘‘if in existence or competitive structure of an basis for the Agency’s regulatory fact a STEL [short-term exposure limit] industry, even if it does portend disaster decisions; rather, they are performed to would further reduce a significant for some marginal firms’’ (Lead I, 647 ensure compliance with requirements health risk and is feasible to implement, F.2d at 1272). A reasonable estimate such as those in Executive Orders 12866 then the OSH Act compels the agency entails assessing ‘‘the likely range of and 13563. to adopt it (barring alternative avenues costs and the likely effects of those costs to the same result)’’). When there is on the industry’’ (Lead I, 647 F.2d at Structure of OSHA Health Standards significant risk below the PEL, the D.C. 1266). As with OSHA’s consideration of OSHA’s health standards traditionally Circuit indicated that OSHA should use scientific data and control technology, incorporate a comprehensive approach its regulatory authority to impose however, the estimates need not be to reducing occupational disease. OSHA additional requirements on employers precise (Cotton Dust, 452 U.S. at 528– substance-specific health standards when those requirements will result in

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a greater than de minimis incremental beryllium, derived principally from TWA based on evidence of CBD and benefit to workers’ health (Asbestos II, Federal standards applicable to sensitization in exposed workers. Then 838 F.2d at 1274). The Supreme Court government contractors under the in 2009, ACGIH adopted a revised TLV alluded to a similar issue in Benzene, Walsh-Healey Public Contracts Act, 41 for beryllium that lowered the TWA to pointing out that ‘‘in setting a U.S.C. 35, and the Contract Work Hours 0.05 mg/m3 (inhalable) (see Document ID permissible exposure level in reliance and Safety Standards Act (commonly 1755, Tr. 136). on less-than-perfect methods, OSHA known as the Construction Safety Act), In 1999, the Department of Energy would have the benefit of a backstop in 40 U.S.C. 333. The Walsh-Healey Act (DOE) issued a Chronic Beryllium the form of monitoring and medical and Construction Safety Act standards, Disease Prevention Program (CBDPP) testing’’ (Benzene, 448 U.S. at 657). in turn, had been adopted primarily Final Rule for employees exposed to OSHA concludes that the ancillary from ACGIH®’s TLV®s as well as several beryllium in its facilities (Document ID provisions in this final standard provide from United States of America 1323). The DOE rule set an action level significant benefits to worker health by Standards Institute (USASI) [later the of 0.2 mg/m3, and adopted OSHA’s PEL providing additional layers and types of American National Standards Institute of 2 mg/m3 or any more stringent PEL protection to employees exposed to (ANSI)]. OSHA might adopt in the future (10 beryllium and beryllium compounds. The National Institute for CFR 850.22; 64 FR 68873 and 68906, Occupational Safety and Health Dec. 8, 1999). III. Events Leading to the Final (NIOSH) issued a document entitled Also in 1999, OSHA was petitioned Standards Criteria for a Recommended Standard: by the Paper, Allied-Industrial, The first occupational exposure limit Occupational Exposure to Beryllium Chemical and Energy Workers for beryllium was set in 1949 by the (Criteria Document) in June 1972 with International Union (PACE) (Document Atomic Energy Commission (AEC), Recommended Exposure Limits (RELs) ID 0069) and by Dr. Lee Newman and which required that beryllium exposure of 2 mg/m3 as an 8-hour TWA and 25 mg/ Ms. Margaret Mroz, from the National in the workplaces under its jurisdiction m3 as an acceptable maximum peak Jewish Health (NJH) (Document ID be limited to 2 mg/m3 as an 8-hour time- above the acceptable ceiling 0069), to promulgate an Emergency weighted average (TWA), and 25 mg/m3 concentration for a maximum duration Temporary Standard (ETS) for beryllium as a peak exposure never to be exceeded of 30 minutes in an 8-hour shift. OSHA in the workplace. In 2001, OSHA was (Document ID 1323). These exposure reviewed the findings and petitioned for an ETS by Public Citizen limits were adopted by all AEC recommendations contained in the Health Research Group and again by installations handling beryllium, and Criteria Document along with the AEC PACE (Document ID 0069). In order to were binding on all AEC contractors control requirements for beryllium promulgate an ETS, the Secretary of involved in the handling of beryllium. exposure. OSHA also considered Labor must prove (1) that employees are In 1956, the American Industrial existing data from animal and exposed to grave danger from exposure Hygiene Association (AIHA) published epidemiological studies, and studies of to a hazard, and (2) that such an a Hygienic Guide which supported the industrial processes of beryllium emergency standard is necessary to AEC exposure limits. In 1959, the extraction, refinement, fabrication, and protect employees from such danger (29 American Conference of Governmental machining. In 1975, OSHA asked U.S.C. 655(c) [6(c)]). The burden of ® Industrial Hygienists (ACGIH ) also NIOSH to update the evaluation of the proof is on the Department and because adopted a Threshold Limit Value existing data pertaining to the of the difficulty of meeting this burden, ® (TLV ) of 2 mg/m3 as an 8-hour TWA carcinogenic potential of beryllium. In the Department usually proceeds when (Borak, 2006). In 1970, ANSI issued a response to OSHA’s request, the appropriate with ordinary notice and national consensus standard for Director of NIOSH stated that, based on comment [section 6(b)] rulemaking beryllium and beryllium compounds animal data and through all possible rather than a 6(c) ETS. Thus, instead of (ANSI Z37.29–1970). The standard set a routes of exposure including inhalation, granting the ETS requests, OSHA permissible exposure limit (PEL) for ‘‘beryllium in all likelihood represents a instructed staff to further collect and beryllium and beryllium compounds at carcinogenic risk to man.’’ analyze research regarding the harmful 2 mg/m3 as an 8-hour TWA; 5 mg/m3 as In October 1975, OSHA proposed a effects of beryllium in preparation for an acceptable ceiling concentration; and new beryllium standard for all possible section 6(b) rulemaking. 25 mg/m3 as an acceptable maximum industries based on information from On November 26, 2002, OSHA peak above the acceptable ceiling studies finding that beryllium caused published a Request for Information concentration for a maximum duration cancer in animals (40 FR 48814 (10/17/ (RFI) for ‘‘Occupational Exposure to of 30 minutes in an 8-hour shift 75)). Adoption of this proposal would Beryllium’’ (Document ID 1242). The (Document ID 1303). have lowered the 8-hour TWA exposure RFI contained questions on employee In 1971, OSHA adopted, under limit from 2 mg/m3 to 1 mg/m3. In exposure, health effects, risk Section 6(a) of the Occupational Safety addition, the proposal included assessment, exposure assessment and and Health Act of 1970, and made ancillary provisions for such topics as monitoring methods, control measures applicable to general industry, the ANSI exposure monitoring, hygiene facilities, and technological feasibility, training, standard (Document ID 1303). Section medical surveillance, and training medical surveillance, and impact on 6(a) provided that in the first two years related to the health hazards from small business entities. In the RFI, after the effective date of the Act, OSHA beryllium exposure. The rulemaking OSHA expressed concerns about health was to promulgate ‘‘start-up’’ standards, was never completed. effects such as chronic beryllium on an expedited basis and without In 1977, NIOSH recommended an disease (CBD), lung cancer, and public hearing or comment, based on exposure limit of 0.5 mg/m3 and beryllium sensitization. OSHA pointed national consensus or established identified beryllium as a potential to studies indicating that even short- Federal standards that improved occupational carcinogen. In December term exposures below OSHA’s PEL of 2 employee safety or health. Pursuant to 1998, ACGIH published a Notice of mg/m3 could lead to CBD. The RFI also that authority, in 1971, OSHA Intended Change for its beryllium cited studies describing the relationship promulgated approximately 425 PELs exposure limit. The notice proposed a between beryllium sensitization and for air contaminants, including lower TLV of 0.2 mg/m3 over an 8-hour CBD (67 FR at 70708). In addition,

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OSHA stated that beryllium had been assessment, industrial hygiene, and (NPRM) for beryllium. As described in identified as a carcinogen by occupational/environmental health greater detail in the Introduction to the organizations such as NIOSH, the engineering. Summary and Explanation of the final International Agency for Research on Regarding the preliminary health rule, there was substantial agreement Cancer (IARC), and the Environmental effects evaluation, the peer reviewers between the submitted joint standard Protection Agency (EPA); and cancer concluded that the health effect studies and the OSHA proposed standard. had been evidenced in animal studies were described accurately and in On August 7, 2015, OSHA published (67 FR at 70709). sufficient detail, and OSHA’s its NPRM in the Federal Register (80 FR On November 15, 2007, OSHA conclusions based on the studies were 47565 (8/7/15)). In the NPRM, the convened a Small Business Advocacy reasonable (Document ID 1210). The Agency made a preliminary Review Panel for a draft proposed reviewers agreed that the OSHA determination that employees exposed standard for occupational exposure to document covered the significant health to beryllium and beryllium compounds beryllium. OSHA convened this panel endpoints related to occupational at the preceding PEL face a significant under Section 609(b) of the Regulatory beryllium exposure. Peer reviewers risk to their health and that Flexibility Act (RFA), as amended by considered the preliminary conclusions promulgating the proposed standard the Small Business Regulatory regarding beryllium sensitization and would substantially reduce that risk. Enforcement Fairness Act of 1996 CBD to be reasonable and well The NPRM (Section XVIII) also (SBREFA) (5 U.S.C. 601 et seq.). presented in the draft health evaluation responded to the SBREFA Panel The Panel included representatives section. All reviewers agreed that the recommendations, which OSHA from OSHA, the Solicitor’s Office of the scientific evidence supports carefully considered, and clarified the Department of Labor, the Office of sensitization as a necessary condition in requirements about which SERs Advocacy within the Small Business the development of CBD. In response to expressed confusion. OSHA also Administration, and the Office of reviewers’ comments, OSHA made discussed the regulatory alternatives Information and Regulatory Affairs of revisions to more clearly describe recommended by the SBREFA Panel in the Office of Management and Budget. certain sections of the health effects NPRM, Section XVIII, and in the PEA Small Entity Representatives (SERs) evaluation. In addition, OSHA (Document ID 0426). made oral and written comments on the expanded its discussion regarding the The NPRM invited interested draft rule and submitted them to the BeLPT. stakeholders to submit comments on a panel. Regarding the preliminary risk variety of issues and indicated that The SBREFA Panel issued a report on assessment, the peer reviewers were OSHA would schedule a public hearing January 15, 2008 which included the highly supportive of the Agency’s upon request. Commenters submitted SERs’ comments. SERs expressed approach and major conclusions information and suggestions on a variety concerns about the impact of the (Document ID 1210). The peer reviewers of topics. In addition, in response to a ancillary requirements such as exposure stated that the key studies were request from the Non-Ferrous Founders’ monitoring and medical surveillance. appropriate and their selection clearly Society, OSHA scheduled an informal Their comments addressed potential explained in the document. They public hearing on the proposed rule. costs associated with compliance with regarded the preliminary analysis of The Agency invited interested persons the draft standard, and possible impacts these studies to be reasonable and to participate by providing oral of the standard on market conditions, scientifically sound. The reviewers testimony and documentary evidence at among other issues. In addition, many supported OSHA’s conclusion that the hearing. OSHA also welcomed SERs sought clarification of some of the substantial risk of sensitization and CBD presentation of data and documentary ancillary requirements such as the were observed in facilities where the evidence that would provide the Agency meaning of ‘‘routine’’ contact or highest exposure generating processes with the best available evidence to use ‘‘contaminated surfaces.’’ had median full-shift exposures around in determining whether to develop a OSHA then developed a draft 0.2 mg/m3 or higher, and that the final rule. preliminary beryllium health effects greatest reduction in risk was achieved The public hearing was held in evaluation (Document ID 1271) and a when exposures for all processes were Washington, DC on March 21 and 22, draft preliminary beryllium risk lowered to 0.1 mg/m3 or below. 2016. Administrative Law Judge assessment (Document ID 1272), and in In February 2012, the Agency William Colwell presided over the 2010, OSHA hired a contractor to received for consideration a draft hearing. The Agency heard testimony oversee an independent scientific peer recommended standard for beryllium from several organizations, such as review of these documents. The (Materion and USW, 2012, Document ID public health groups, the Non-Ferrous contractor identified experts familiar 0754). This draft standard was the Founders’ Society, other industry with beryllium health effects research product of a joint effort between two representatives, and labor unions. and ensured that these experts had no stakeholders: Materion Corporation, a Following the hearing, participants who conflict of interest or apparent bias in leading producer of beryllium and had filed notices of intent to appear performing the review. The contractor beryllium products in the United States, were allowed 30 days—until April 21, selected five experts with expertise in and the United Steelworkers, an 2016—to submit additional evidence such areas as pulmonary and international labor union representing and data, and an additional 15 days— occupational medicine, CBD, beryllium workers who manufacture beryllium until May 6, 2016—to submit final sensitization, the Beryllium alloys and beryllium-containing briefs, arguments, and summations Lymphocyte Proliferation Test (BeLPT), products in a number of industries. (Document ID 1756, Tr. 326). beryllium toxicity and carcinogenicity, They sought to craft an OSHA-like In 2016, in an action parallel to and medical surveillance. Other areas of model beryllium standard that would OSHA’s rulemaking, DOE proposed to expertise included animal modeling, have support from both labor and update its action level to 0.05 mg/m3 (81 occupational epidemiology, industry. OSHA has considered this FR 36704–36759, June 7, 2016). The biostatistics, risk and exposure proposal along with other information DOE action level triggers workplace assessment, exposure-response submitted during the development of precautions and control measures such modeling, beryllium exposure the Notice of Proposed Rulemaking as periodic monitoring, exposure

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reduction or minimization, regulated timely received. Based on this discussed in greater detail in the areas, hygiene facilities and practices, comprehensive record, OSHA concludes background documents referenced in respiratory protection, protective that employees exposed to beryllium this preamble. clothing and equipment, and warning and beryllium compounds are at IV. Chemical Properties and Industrial signs (Document ID 1323; 10 CFR significant risk of material impairment Uses 850.23(b)). Unlike OSHA’s PEL, of health, including chronic beryllium however, DOE’s selection of an action disease and lung cancer. The Agency Chemical and Physical Properties level is not required to meet statutory concludes that the PEL of 0.2 mg/m3 Beryllium (Be; CAS Number 7440– requirements of technological and reduces the significant risks of material 41–7) is a silver-grey to greyish-white, economic feasibility. impairments of health posed to workers In all, the OSHA rulemaking record strong, lightweight, and brittle metal. It by occupational exposure to beryllium contains over 1,900 documents, is a Group IIA element with an atomic and beryllium compounds to the including all the studies OSHA relied weight of 9.01, atomic number of 4, on in its preliminary health effects and maximum extent that is technologically melting point of 1,287 °C, boiling point risk assessment analyses, the hearing and economically feasible. OSHA’s of 2,970 °C, and a density of 1.85 at 20 transcript and submitted testimonies, substantive determinations with regard °C (Document ID 0389, p. 1). It occurs the joint Materion-USW draft proposed to the comments, testimony, and other naturally in rocks, soil, coal, and standard, and the pre- and post-hearing information in the record, the legal volcanic dust (Document ID 1567, p. 1). comments and briefs. The final rule on standards governing the decision- Beryllium is insoluble in water and occupational exposure to beryllium and making process, and the Agency’s soluble in acids and alkalis. It has two beryllium compounds is thus based on analysis of the data resulting in its common oxidation states, Be(0) and consideration of the entire record of this assessments of risks, benefits, Be(+2). There are several beryllium rulemaking proceeding, including technological and economic feasibility, compounds with unique CAS numbers materials discussed or relied upon in and compliance costs are discussed and chemical and physical properties. the proposal, the record of the hearing, elsewhere in this preamble. More Table IV–1 describes the most common and all written comments and exhibits technical or complex issues are beryllium compounds. TABLE IV–1—PROPERTIES OF BERYLLIUM AND BERYLLIUM COMPOUNDS

Synonyms Molecular Melting point Density Chemical name CAS No. and trade ° Description Solubility names weight ( C) (g/cm3)

Beryllium metal 7440–41–7 Beryllium; beryllium-9, 9.0122 1287 ...... Grey, close-packed, 1.85 (20 °C) Soluble in most dilute acids beryllium element; hexagonal, brittle and alkali; decomposes in beryllium metallic. metal. hot water; insoluble in mercury and cold water. Beryllium chlo- 7787–47–5 Beryllium dichloride .... 79.92 399.2 ...... Colorless to slightly 1.899 (25 Soluble in water, ethanol, ride. yellow; °C). diethyl ether and pyridine; orthorhombic, slightly soluble in ben- deliques-cent crystal. zene, carbon disulfide and chloroform; insoluble in acetone, ammonia, and toluene. Beryllium fluo- 7787–49–7 Beryllium difluoride ..... 47.01 555 ...... Colorless or white, 1.986 ...... Soluble in water, sulfuric ride. (12323–05–6) amorphous, hygro- acid, mixture of ethanol scopic solid. and diethyl ether; slightly soluble in ethanol; insol- uble in hydrofluoric acid. Beryllium hy- 13327–32–7 Beryllium dihydroxide 43.3 138 (decomposes White, amorphous, 1.92 ...... Soluble in hot concentrated droxide. (1304–49–0) to beryllium amphoteric powder. acids and alkali; slightly oxide). soluble in dilute alkali; in- soluble in water. Beryllium sulfate 13510–49–1 Sulfuric acid, beryllium 105.07 550–600 °C (de- Colorless crystal ...... 2.443 ...... Forms soluble tetrahydrate salt (1:1). composes to be- in hot water; insoluble in ryllium oxide). cold water. Beryllium sulfate 7787–56–6 Sulfuric acid; beryllium 177.14 100 °C ...... Colorless, tetragonal 1.713 ...... Soluble in water; slightly tetrhydrate. salt (1:1), tetra- crystal. soluble in concentrated hydrate. sulfuric acid; insoluble in ethanol. Beryllium Oxide 1304–56–9 Beryllia; beryllium 25.01 2508–2547 °C ...... Colorless to white, 3.01 (20 °C) Soluble in concentrated monoxide thermalox hexagonal crystal or acids and alkali; insoluble TM. amorphous, ampho- in water. teric powder. Beryllium car- 1319–43–3 Carbonic acid, beryl- 112.05 No data ...... White powder ...... No data ...... Soluble in acids and alkali; bonate. lium salt, mixture insoluble in cold water; with beryllium hy- decomposes in hot water. droxide. Beryllium nitrate 7787–55–5 Nitric acid, beryllium 187.97 60 ...... White to faintly yel- 1.56 ...... Very soluble in water and trihydrate. salt, trihydrate. lowish, deliquescent ethanol. mass. Beryllium phos- 13598–15–7 Phosphoric acid, beryl- 104.99 No data ...... Not reported ...... Not reported Slightly soluble in water. phate. lium salt (1:1). ATSDR, 2002.

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The physical and chemical properties and relays and audio components), exposure to soluble and poorly soluble of beryllium were realized early in the computer components, home appliance forms of beryllium are associated with 20th century, and it has since gained parts, dental appliances (e.g., crowns), several adverse health outcomes commercial importance in a wide range bicycle frames, golf clubs, and other including sensitization, chronic of industries. Beryllium is lightweight, articles (Document ID 0389, p. 2; 1278, beryllium disease, acute beryllium hard, spark resistant, non-magnetic, and p. 182; 1280, pp. 1–2; 1281, pp. 816, disease and lung cancer. has a high melting point. It lends 818). Electrical components and The findings and conclusions in this strength, electrical and thermal conductors are stamped and formed section are consistent with those of the conductivity, and fatigue resistance to from beryllium alloys. Beryllium-copper National Academies of Sciences (NAS), alloys (Document ID 0389, p. 1). alloys are used to make switches in the World Health Organization’s Beryllium also has a high affinity for automobiles (Document ID 1280, p. 2; International Agency for Research on oxygen in air and water, which can 1281, p. 818) and connectors, relays, Cancer (IARC), the U.S. Department of cause a thin surface film of beryllium and switches in computers, radar, Health and Human Services’ (HHS) oxide to form on the bare metal, making satellite, and telecommunications National Toxicology Program (NTP), the it extremely resistant to corrosion. equipment (Document ID 1278, p. 183). National Institute for Occupational These properties make beryllium alloys Beryllium-aluminum alloys are used in Safety and Health (NIOSH), the Agency highly suitable for defense, nuclear, and the construction of aircraft, high for Toxic Substance and Disease aerospace applications (Document ID resolution medical and industrial X-ray Registry (ATSDR), the European 1342, pp. 45, 48). equipment, and mirrors to measure Commission on Health, Safety and There are approximately 45 weather patterns (Document ID 1278, p. Hygiene at Work, and many other mineralized forms of beryllium. In the 183). High content and low content organizations and individuals, as United States, the predominant mineral beryllium alloys are precision machined evidenced in the rulemaking record and form mined commercially and refined for military and aerospace applications. further discussed below. Other scientific into pure beryllium and beryllium Some welding consumables are also organizations and governments have alloys is bertrandite. Bertrandite, while manufactured using beryllium. recognized the strong body of scientific containing less than 1% beryllium Beryllium is also found as a trace evidence pointing to the health risks of compared to 4% in beryl, is easily and metal in materials such as aluminum exposure to beryllium and have deemed efficiently processed into beryllium ore, abrasive blasting grit, and coal fly it necessary to take action to reduce hydroxide (Document ID 1342, p. 48). ash. Abrasive blasting grits such as coal those risks. In 1999, the Department of Imported beryl is also converted into slag and copper slag contain varying Energy (DOE) updated its airborne beryllium hydroxide as the United concentrations of beryllium, usually less beryllium concentration action level to 3 States has very little beryl that can be than 0.1% by weight. The burning of 0.2 mg/m (Document ID 1323). In 2009, economically mined (Document ID bituminous and sub-bituminous coal for the American Conference of 0616, p. 28). power generation causes the naturally Governmental Industrial Hygienists (ACGIH), a professional society that has Industrial Uses occurring beryllium in coal to accumulate in the coal fly ash been recommending workplace Materion Corporation (Materion), byproduct. Scrap and waste metal for exposure limits for six decades, revised formerly called Brush Wellman, is the its Threshold Limit Value (TLV) for only producer of primary beryllium in smelting and refining may also contain beryllium. A detailed discussion of the beryllium and beryllium-containing the United States. Beryllium is used in compounds to 0.05 mg/m3 (Document ID a variety of industries, including industries and job tasks using beryllium is included in the Preliminary Economic 1304). aerospace, defense, In finalizing this Health Effects Analysis (Document ID 0385, 0426). telecommunications, automotive, preamble section for the final rule, Occupational exposure to beryllium electronic, and medical specialty OSHA updated the preliminary Health can occur from inhalation of dusts, industries. Pure beryllium metal is used Effects section published in the NPRM fume, and mist. Beryllium dusts are in a range of products such as X-ray based on the stakeholder response created during operations where transmission windows, nuclear reactor received by the Agency during the beryllium is cut, machined, crushed, neutron reflectors, nuclear weapons, public comment period and public ground, or otherwise mechanically precision instruments, rocket hearing. OSHA also corrected several sheared. Mists can also form during propellants, mirrors, and computers non-substantive errors that were operations that use machining fluids. (Document ID 0389, p. 1). Beryllium published in the NPRM as well as those Beryllium fume can form while welding oxide is used in components such as identified by NIOSH and Materion ceramics, electrical insulators, with or on beryllium components, and including several minor organizational microwave oven components, military from hot processes such as those found changes made to sections V.D.3 and vehicle armor, laser structural in metal foundries. V.E.2.b (Document ID 1671, pp. 10–11; Occupational exposure to beryllium components, and automotive ignition 1662, pp. 3–5). A section titled ‘‘Dermal can also occur from skin, eye, and systems (Document ID 1567, p. 147). Effects’’ was added to V.F.5 based on Beryllium oxide ceramics are used to mucous membrane contact with comments received by the American produce sensitive electronic items such beryllium particulate or solutions. Thoracic Society (ATS), National Jewish as lasers and satellite heat sinks. V. Health Effects Health, and the National Supplemental Beryllium alloys, typically beryllium/ Screening Program (Document ID 1688, copper or beryllium/aluminum, are Overview of Findings and Supportive p. 2; 1664, p. 5; 1677, p. 3). manufactured as high beryllium content Comments Additionally, the Agency responded to or low beryllium content alloys. High As discussed in detail throughout this relevant stakeholder comments content alloys contain greater than 30% section (section V, Final Health Effects) contained in specific sections. beryllium. Low content alloys are and in Section VI, Final Quantitative In developing its review of the typically less than 3% beryllium. Risk Assessment and Significance of preliminary health effects from Beryllium alloys are used in automotive Risk, OSHA finds, based upon the best beryllium exposure and assessment of electronics (e.g., electrical connectors available evidence in the record, that risk for the NPRM, OSHA prepared a

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pair of draft documents, entitled Workforce, the U.S. House of the inclusion of beryllium sensitization, ‘‘Occupation Exposure to Beryllium: Representatives, national labor CBD and lung cancer as health effects Preliminary Health Effects Evaluation’’ organizations (American Federation of from beryllium exposure (Document ID (OSHA, 2010, Document ID 1271) and Labor—Congress of Industrial 1689, pp. 1, 3; 1679, p. 6; 1681, p. 19). ‘‘Preliminary Beryllium Risk Organizations (AFL–CIO), North AFL–CIO commented that ‘‘[t]he Assessment’’ (OSHA, 2010, Document American Building Trades Unions proposal is based on extensive scientific ID 1272), that underwent independent (NABTU), United Steelworkers (USW), and medical evidence . . .’’ and scientific peer review in accordance Public Citizen, ORCHSE, experts from ‘‘[b]eryllium exposure causes with the Office of Management and National Jewish Health (Lisa Maier, MD immunological sensitivity, CBD and Budget’s (OMB) Information Quality and Margaret Mroz, MSPH), the lung cancer. These health effects are Bulletin for Peer Review. Eastern American Association for Justice, and debilitating, progressive and Research Group, Inc. (ERG), under the National Council for Occupational irreversible. Workers are exposed to contract with OSHA, selected five Safety and Health. beryllium through respiratory, dermal highly qualified experts with collective For example, NIOSH commented in and gastrointestinal routes.’’ (Document expertise in occupational epidemiology, its prepared written hearing testimony: ID 1689, pp. 1, 3). Comments submitted occupational medicine, toxicology, OSHA has appropriately identified and by USW state that ‘‘OSHA has correctly immunology, industrial hygiene, and documented all critical health effects identified, and comprehensively risk assessment methodology.2 The peer associated with occupational exposure to documented the material impairments reviewers responded to 27 questions beryllium and has appropriately focused its of health resulting from beryllium that covered the accuracy, greatest attention on beryllium sensitization exposure.’’ (Document ID 1681, p. 19). completeness, and understandability of (BeS), chronic beryllium disease (CBD) and Dr. Lisa Maier and Ms. Margaret Mroz lung cancer . . . key studies and adverse health of National Jewish Health testified about endpoints as well as questions regarding NIOSH went on to say that sensitization the health effects of beryllium in the adequacy, clarity and was more than a test result with little support of the beryllium standard: reasonableness of the risk analysis (ERG, meaning. It relates to a condition in which the immune system is able to We know that chronic beryllium disease 2010; Document ID 1270). often will not manifest clinically until Overall, the peer reviewers found that recognize and adversely react to irreversible lung scarring has occurred, often the OSHA draft health effects evaluation beryllium in a way that increases the years after exposure, with a latency of 20 to described the studies in sufficient risk of developing CBD. NIOSH agrees 30 years as discussed yesterday. Much too detail, appropriately addressed their with OSHA that sensitization is a late to make changes in the work place. We strengths and limitations, and drew functional change that is necessary in need to look for early markers of health scientifically sound conclusions. The order to proceed along the pathogenesis effects, cast the net widely to identify cases peer reviewers were also supportive of to serious lung disease. of sensitization and disease, and use the Agency’s preliminary risk The National Safety Council, a screening results in concert with exposure sampling to identify areas of increased risk assessment approach and the major congressionally chartered nonprofit safety organization, also stated that that can be modified in the work place. conclusions. OSHA provided detailed (Document ID 1756, Tr. 102; 1806). responses to reviewer comments in its ‘‘beryllium represents a serious health publication of the NPRM (80 FR 47646– threat resulting from acute or chronic American Association for Justice noted 47652, 8/7/2015). Revisions to the draft exposures.’’ (Document ID 1612, p. 5). that: health effects evaluation and Representative Robert C. ‘‘Bobby’’ Scott, Unlike many toxins, there is no threshold preliminary risk assessment in response Ranking Member of Committee on below which no worker will become to the peer review comments were Education and the Workforce, the U.S. sensitized to beryllium. Worker sensitization reflected in sections V and VI of the House of Representatives, submitted a to beryllium is a precursor to CBD, but not cancer. The symptoms of chronic beryllium same publication (80 FR 47581–47646, statement recognizing that the evidence strongly supports the conclusion that disease (CBD) are part of a continuum of 8/7/2015). OSHA received public disease that is progressive in nature. Early comment and testimony on the Health sensitization can occur from exposure to recognition of and treatment for CBD may Effects and Preliminary Risk soluble and poorly soluble forms of lead to a lessening of symptoms and may Assessment sections published in the beryllium (Document ID 1672, p. 3). prevent the disease from progressing further. NPRM, which are discussed in this OSHA also received supporting Symptoms of CBD may occur at exposure preamble. statements from ATS and ORCHSE on levels well below the proposed permissible The Agency received a wide variety of the inclusion of beryllium sensitization, exposure limit of .2 mg/m3 and even below 3 stakeholder comments and testimony CBD, skin disease, and lung cancer as the action level of .1 mg/m . OSHA has clear for this rulemaking on issues related to major adverse health effects associated authority to regulate health effects across the entire continuum of disease to protect the health effects and risk of beryllium with beryllium exposure (Document ID 1688, p. 7; 1691, p. 14). ATS specifically workers. We applaud OSHA for proposing to exposure. Statements supportive of do so. (Document ID 1683, pp. 1–2). OSHA’s Health Effects section include stated: National Committee for Occupational comments from NIOSH, the National . . . the ATS supports the inclusion of Safety and Health support OSHA Safety Council, the American Thoracic beryllium sensitization, CBD, and skin Society (ATS), Representative Robert C. disease as the major adverse health effects findings of health effects due to ‘‘Bobby’’ Scott, Ranking Member of associated with exposure to beryllium at or beryllium exposure (1690, p. 1). 3 Committee on Education and the below 0.1 mg/m and acute beryllium disease Comments from Public Citizen also at higher exposures based on the currently support OSHA findings: ‘‘Beryllium is available epidemiologic and experimental toxic at extremely low levels and 2 The five selected peer reviewers were John studies. (Document ID 1688, p. 2) Balmes, MD, University of California-San Francisco; exposure can result in BeS, an immune Patrick Breysse, Ph.D., Johns Hopkins University, In addition, OSHA received supporting response that eventually can lead to an Bloomberg School of Public Health; Terry Gordon, comments from labor organizations autoimmune granulomatous lung Ph.D., New York University School of Medicine; Milton Rossman, MD, University of Pennsylvania representing workers exposed to disease known as CBD. BeS is a School of Medicine; Kyle Steenland, Ph.D., Emory beryllium. The AFL–CIO, NABTU, and necessary prerequisite to the University, Rollins School of Public Health. USW submitted comments supporting development of CBD, with OSHA’s

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NPRM citing studies showing that 31– life-altering conditions including Beryllium has a high charge-to-radius 49 percent of all sensitized workers pneumonitis, loss of lung capacity ratio, forming various types of ionic were diagnosed with CBD after clinical (reduction in pulmonary function bonds. In addition, beryllium has a evaluations. Beryllium also is a leading to pulmonary dysfunction), loss strong tendency for covalent bond recognized carcinogen that can cause of physical capacity associated with formation (e.g., it can form lung cancer.’’ (Document ID 1670, p.2). reduced lung capacity, systemic effects organometallic compounds such as In addition to the comments above related to pulmonary dysfunction, and Be(CH3)2 and many other complexes) and those noted throughout this Health decreased life expectancy (NIOSH, (ATSDR, 2002, Document ID 1371; Effects section, Materion submitted their 1972, Document ID 1324, 1325, 1326, Greene et al., 1998 (1519)). However, it correspondence to the National 1327, 1328; NIOSH, 2011 (0544)). appears that few, if any, toxicity studies Academies (NAS) regarding the This Health Effects section presents exist for the organometallic compounds. company’s assessment of the NAS information on beryllium and its Additional physical/chemical beryllium studies and their compounds, the fate of beryllium in the properties, such as solubility, for correspondence to NIOSH regarding the body, research that relates to its toxic beryllium compounds that may be Cummings 2009 study (Document 1662, mechanisms of action, and the scientific important in their biological response Attachments) to OSHA. For the NAS literature on the adverse health effects are summarized in Table 1 below. study, Materion included a series of associated with beryllium exposure, Solubility (as discussed in biological comments regarding studies included in including ABD, sensitization, CBD, and fluids in Section V.A.2.A below) is an the NAS report. OSHA has reviewed lung cancer. OSHA considers CBD to be important factor in evaluating the these comments and found that the a progressive illness with a continuous biological response to beryllium. For comments submitted to the NAS spectrum of symptoms ranging from no comparative purposes, water solubility critiquing their review of the health symptomatology at its earliest stage is used in Table 1. The International effects of beryllium were considered following sensitization to mild Chemical Safety Cards lists water and incorporated where appropriate. symptoms such as a slight almost solubility as a way to standardize For the NIOSH study Materion included imperceptible shortness of breath, to solubility values among particles and comments regarding 2 cases of acute loss of pulmonary function, debilitating fibers. The information contained beryllium disease evaluated in a study lung disease, and, in many cases, death. within Table 1 was obtained from the published by Cummings et al., 2009. This section also discusses the nature of International Chemical Safety Cards NIOSH also dealt with the comments these illnesses, the scientific evidence (ICSC) for beryllium metal (ICSC 0226, from Materion as they found that they are causally associated with Document ID 0438), beryllium oxide appropriate. However, none of the occupational exposure to beryllium, and (ICSC 1325, Document ID 0444), changes recommended by Materion to the probable mechanisms of action with beryllium sulfate (ICSC 1351, Document the NAS or NIOSH altered the overall a more thorough review of the ID 0443), beryllium nitrate (ICSC 1352, findings or conclusions from either supporting studies. Document ID 0442), beryllium carbonate study. OSHA has taken the Materion A. Beryllium and Beryllium (ICSC 1353, Document ID 0441), comments into account in the review of Compounds—Particle Characterization beryllium chloride (ICSC 1354, these documents. OSHA found them not Document ID 0440), beryllium fluoride to be sufficient to discount either the 1. Particle Physical/Chemical Properties (ICSC 1355, Document ID 0439) and findings of the NAS or NIOSH. Beryllium has two oxidative states: from the hazardous substance data bank Be(0) and Be(2+) (Agency for Toxic (HSDB) for beryllium hydroxide Introduction Substance and Disease Registry (CASRN: 13327–32–7), and beryllium Beryllium-associated health effects, (ATSDR) 2002, Document ID 1371). It is phosphate (CASRN: 13598–15–7, including acute beryllium disease likely that the Be(2+) state is the most Document ID 0533). Additional (ABD), beryllium sensitization (also biologically reactive and able to form a information on chemical and physical referred to in this preamble as bond with peptides leading to it properties as well as industrial uses for ‘‘sensitization’’), chronic beryllium becoming antigenic (Snyder et al., 2003) beryllium can be found in this preamble disease (CBD), and lung cancer, can lead as discussed in more detail in the at Section IV, Chemical Properties and to a number of highly debilitating and Beryllium Sensitization section below. Industrial Uses.

TABLE 1—BERYLLIUM CHARACTERISTICS AND PROPERTIES

Molecular ° Compound name Chemical formula mass Acute physical hazards Solubility in water at 20 C

Beryllium Metal ...... Be ...... 9.0 Combustible; Finely dispersed particles—Ex- None. plosive. Beryllium Oxide ...... BeO ...... 25.0 Not combustible or explosive ...... Very sparingly soluble. Beryllium Carbonate ..... Be2CO3(OH)/Be2CO5 H2 181.07 Not combustible or explosive ...... None. Beryllium Sulfate ...... BeSO4 ...... 105.1 Not combustible or explosive ...... Slightly soluble. 6 Beryllium Nitrate ...... BeN2O6/Be(NO3)2 ...... 133.0 Enhances combustion of other substances ..... Very soluble (1.66 × 10 mg/L). Beryllium Hydroxide ...... Be(OH)2 ...... 43.0 Not reported ...... Slightly soluble 0.8 × 10 minus;4 mol/L (3.44 mg/L). Beryllium Chloride ...... BeCl2 ...... 79.9 Not combustible or explosive ...... Soluble. Beryllium Fluoride ...... BeF2 ...... 47.0 Not combustible or explosive ...... Very soluble. Beryllium Phosphate ..... Be3(PO4)2 ...... 271.0 Not reported...... Soluble.

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Beryllium shows a high affinity for a. Solubility an important factor in the development oxygen in air and water, resulting in a Solubility has been shown to be an of CBD since lower-soluble forms of thin surface film of beryllium oxide on important determinant of the toxicity of beryllium have been shown to persist in the bare metal. If the surface film is airborne materials, influencing the the lung for longer periods of time and disturbed, it may become airborne and deposition and persistence of inhaled persistence in the lung may be needed cause respiratory tract exposure or particles in the respiratory tract, their in order for this disease to occur (NAS, dermal exposure (also referred to as bioavailability, and the likelihood of 2008, Document ID 1355). Beryllium oxide (BeO), hydroxide dermal contact). The physical properties presentation to the immune system. A (Be(OH) ), carbonate (Be CO (OH) ), of solubility, particle surface area, and number of chemical agents, including 2 2 3 2 and sulfate (anhydrous) (BeSO ) are particle size of some beryllium metals that contact and penetrate the 4 compounds are examined in more detail either insoluble, slightly soluble, or skin, are able to induce an immune considered to be sparingly or poorly below. These properties have been response, such as sensitization soluble (almost insoluble or having an evaluated in many toxicological studies. (Boeniger, 2003, Document ID 1560; extremely slow rate of dissolution and In particular, the properties related to Mandervelt et al., 1997 (1451)). Similar most often referred to as poorly soluble the calcination (firing temperatures) and to inhaled agents, the ability of in more recent literature). The solubility differences in crystal size and solubility materials to penetrate the skin is also of beryllium oxide, which is prepared are important aspects in their influenced by solubility because dermal from beryllium hydroxide by calcining toxicological profile. absorption may occur at a greater rate (heating to a high temperature without for soluble materials than poorly soluble fusing in order to drive off volatile 2. Factors Affecting Potency and Effect materials (Kimber et al., 2011, of Beryllium Exposure chemicals) at temperatures between 500 Document ID 0534). In post-hearing and 1,750 °C, has an inverse The effect and potency of beryllium comments, NIOSH explained: relationship with calcination and its compounds, as for any toxicant, In biological systems, solubility is used to temperature. Although the solubility of immunogen, or immunotoxicant, may describe the rate at which a material will the low-fired crystals can be as much as be dependent upon the physical state in undergo chemical clearance and dissolve in 10 times that of the high-fired crystals, which they are presented to a host. For a fluid (airway lining, inside phagolysomes) low-fired beryllium oxide is still only relative to the rate of mechanical clearance. occupational airborne materials and sparingly soluble (Delic, 1992, For example, in the lung a ‘‘poorly soluble’’ Document 1547). In a study that surface contaminants, it is especially material is one that dissolves at a rate slower critical to understand those physical than the rate of mechanical removal via the measured the dissolution kinetics (rate parameters in order to determine the mucociliary escalator. Examples of poorly to dissolve) of beryllium compounds extent of exposure to the respiratory soluble forms of beryllium are beryllium calcined at different temperatures, tract and skin since these are generally silicates, beryllium oxide, and beryllium Hoover et al., compared beryllium metal the initial target organs for either route metal and alloys (Deubner et al. 2011; Huang to beryllium oxide particles and found of exposure. et al. 2011; Duling et al. 2012; Stefaniak et them to have similar solubilities. This al. 2006, 201la, 2012). A highly soluble was attributed to a fine layer of For example, solubility has an material is one that dissolves at a rate faster beryllium oxide that coats the metal important part in determining the than mechanical clearance. Examples of particles (Hoover et al., 1989, Document toxicity and bioavailability of airborne highly soluble forms of beryllium are ID 1510). A study conducted by beryllium fluoride, beryllium sulfate, and materials as well. Respiratory tract Deubner et al. (2011) determined ore retention and skin penetration are beryllium chloride. (Document ID 1660–A2, p. 9). materials to be more soluble than directly influenced by the solubility and beryllium oxide at pH 7.2 but similar in reactivity of airborne material. Large This section reviews the relevant solubility at pH 4.5. Beryllium particles may have less of an effect in information regarding solubility, its hydroxide was more soluble than the lung than smaller particles due to importance in a biological matrix and its beryllium oxide at both pHs (Deubner et reduced potential to stay airborne, to be relevance to sensitization and beryllium al., 2011, Document ID 0527). inhaled, or be deposited along the lung disease. The weight of evidence Investigators have also attempted to respiratory tract. In addition, once presented below suggests that both determine how biological fluids can inhalation occurs particle size is critical soluble and poorly soluble forms of dissolve beryllium materials. In two in determining where the particle will beryllium can induce a sensitization studies, poorly soluble beryllium, taken deposit along the respiratory tract. response and result in progression of up by activated phagocytes, was shown lung disease. to be ionized by myeloperoxidases These factors may be responsible, at Beryllium salts, including the (Leonard and Lauwerys, 1987, least in part, for the process by which chloride (BeCl2), fluoride (BeF2), nitrate Document ID 1293; Lansdown, 1995 beryllium sensitization progresses to (Be(NO3)2), phosphate (Be3 (PO4)2), and (1469)). The positive charge resulting CBD in exposed workers. Other factors sulfate (tetrahydrate) (BeSO4 · 4H2O) from ionization enabled the beryllium to influencing beryllium-induced toxicity salts, are all water soluble. However, bind to receptors on the surface of cells include the surface area of beryllium soluble beryllium salts can be converted such as lymphocytes or antigen- particles and their persistence in the to less soluble forms in the lung (Reeves presenting cells which could make it lung. With respect to dermal contact or and Vorwald, 1967, Document ID 1309). more biologically active (NAS, 2008, exposure, the physical characteristics of According to an EPA report, aqueous Document ID 1355). In a study utilizing the particle are also important since solutions of the soluble beryllium salts phagolysosomal-simulating fluid (PSF) they can influence skin absorption and are acidic as a result of the formation of with a pH of 4.5, both beryllium metal + bioavailability. This section addresses Be(OH2)4 2 , the tetrahydrate, which and beryllium oxide dissolved at a certain physical characteristics (i.e., will react to form poorly soluble greater rate than that previously solubility, particle size, particle surface hydroxides or hydrated complexes reported in water or SUF (simulant area) that influence the toxicity of within the general physiological range fluid) (Stefaniak et al., 2006, Document beryllium materials in occupational of pH values (between 5 and 8) (EPA, ID 1398), and the rate of dissolution of settings. 1998, Document ID 1322). This may be the multi-constituent (mixed) particles

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

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

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

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

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

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

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preceding OSHA PEL (Armstrong et al., effectiveness of PPE in facilities working in the urine (Crowley et al., 1949, 2014, Document ID 0502). with beryllium (with special emphasis Document ID 1551; Furchner et al., 1973 OSHA received comments regarding on skin protection) have demonstrated a (1523); LeFevre and Joel, 1986 (1464)). the potential for dermal penetration of reduced rate of beryllium sensitization Research using soluble beryllium sulfate poorly soluble particles. Materion after implementation of this type of has shown that as the compound passes contended there is no supporting control (Day et al., 2007, Document ID into the intestine, which has a higher evidence to suggest that insoluble or 1548; Armstrong et al., 2014 (0502)). Dr. pH than the stomach (approximate pH poorly soluble particles penetrate skin Stefaniak confirmed these findings: of 6 to 8 for the intestine, pH of 1 or 2 and stated: for the stomach), the beryllium is [T]he particles can actually dissolve when precipitated as the poorly soluble . . . we were aware that, a hypothesis has they’re in contact with liquids on the skin, been put forth which suggests that being phosphate and is not absorbed (Reeves, like sweat. So we’ve actually done a series of 1965, Document ID 1430; WHO, 2001 sensitized to beryllium either through a skin studies, using a simulant of sweat, but it had wound or via penetration of small beryllium characteristics that very closely matched (1282)). particles through intact skin could result in human sweat. We see in those studies that, Further studies suggested that sensitization to beryllium which upon in fact, beryllium particles, beryllium oxide, beryllium absorbed into the bloodstream receiving a subsequent inhalation dose of beryllium metal, beryllium alloys, all these is primarily excreted via urine (Crowley airborne beryllium could result in CBD. sort of what we call insoluble forms actually et al., 1949, Document ID 1551; However, there are no studies that skin do in fact dissolve very readily in analog of Furchner et al., 1973 (1523); Scott et al., absorption of insoluble beryllium results in human sweat. And once beryllium is in an 1950 (1413); Stiefel et al., 1980 (1288)). a systemic effect. The study by Curtis, the ionic form on the skin, it’s actually very easy Unabsorbed beryllium is primarily only human study looking for evidence of a for it to cross the skin barrier. And that’s excreted via the fecal route (Finch et al., beryllium sensitization reaction occurring been shown many, many times in studies through intact human skin, found no 1990, Document ID 1318; Hart et al., that beryllium ions can cross the skin and 1980 (1493)). Parenteral administration sensitization reaction using insoluble forms induce sensitization. (Document ID 1755, Tr. of beryllium. (Document ID 1661, p. 12). 36–37). in a variety of animal species demonstrated that beryllium was OSHA disagrees with the assertion that Based on information from various eliminated at much higher percentages no studies are available indicating skin studies demonstrating that poorly in the urine than in the feces (Crowley absorption of poorly soluble (insoluble) soluble particles have the potential to et al., 1949, Document ID 1551; beryllium. In addition to the study cited penetrate skin, that skin as a barrier is Furchner et al., 1973 (1523); Scott et al., by Materion (Curtis, 1951, Document ID rarely intact (especially in industrial 1950 (1413)). A study using 1273), OSHA reviewed numerous settings), and that beryllium particles percutaneous administration of soluble studies on the effects of beryllium can readily dissolve in sweat and other beryllium nitrate in rats demonstrated solubility and dermal penetration (see biological fluids, OSHA finds that that more than 90 percent of the section V. B. 2) including the Tinkle et dermal exposure to poorly soluble beryllium in the bloodstream was al. (2003) (Document ID 1483) study beryllium can cause sensitization eliminated via urine (WHO, 2001, which demonstrated the potential for (Rossman, et al., 1991, Document ID Document ID 1282). Greater than 99 poorly soluble beryllium particles to 1332; Deubner et al., 2001 (1542); percent of ingested beryllium chloride penetration skin using an ex vivo Tinkle et al., 2003 (1483); Sutton et al., was excreted in the feces (Mullen et al., human skin model. While OSHA 2003 (1393); Stefaniak et al., 2011 1972, Document ID 1442). A study of believes that these studies demonstrate (0537) and 2014 (0517); Duling et al., mice, rats, monkeys, and dogs given poorly soluble beryllium can in fact 2012 (0539); Document ID 1755, Tr. 36– intravenously dosed with beryllium penetrate intact skin, penetration 37). chloride determined elimination half- through intact skin is not the only 3. Oral and Gastrointestinal Exposure times to be between 890 to 1,770 days means for a person to become sensitized (2.4 to 4.8 years) (Furchner et al., 1973, through skin contact with poorly According to the WHO Report (2001), Document ID 1523). In a comparison soluble beryllium. During the informal gastrointestinal absorption of beryllium study, baboons and rats were instilled hearing proceedings, NIOSH was asked can occur by both the inhalation and intratracheally with beryllium metal. about the role of poorly soluble oral routes of exposure (Document ID Mean daily excretion rates were beryllium in sensitizing workers to 1282). In the case of inhalation, a calculated as 4.6 × 10¥5 percent of the beryllium. Aleks Stefaniak, Ph.D., portion of the inhaled material is dose administered in baboons and 3.1 × NIOSH, stated that ‘‘intact skin transported to the gastrointestinal tract 10¥5 percent in rats (Andre et al., 1987, naturally has a barrier that prevents by the mucociliary escalator or by the Document ID 0351). moisture from seeping out of the body swallowing of the poorly soluble In summary, animal studies and things from getting into the body. material deposited in the upper evaluating the absorption, distribution Very few people actually have fully respiratory tract (Schlesinger, 1997, and excretion of beryllium compounds intact skin, especially in an industrial Document ID 1290). Animal studies found that, in general, poorly soluble environment. So the skin barrier is often have shown oral administration of beryllium compounds were not readily compromised, which would make beryllium compounds to result in very absorbed in the gastrointestinal tract penetration of particles much easier.’’ limited absorption and storage (as and was mostly excreted via feces (Hart (Document ID 1755, Tr. 36). reviewed by U.S. EPA, 1998, Document et al., 1980, Document ID 1493; Finch et As summarized above, poorly soluble ID 0661). Oral studies utilizing radio- al., 1990 (1318); Mullen et al., 1972 beryllium particles have been shown to labeled beryllium chloride in rats, mice, (1442)). Soluble beryllium compounds solubilize in biological fluids (e.g., dogs, and monkeys, found the majority orally administered were partially sweat) releasing beryllium ions and of the beryllium was unabsorbed by the cleared via urine; however, some making them available for absorption gastrointestinal tract and was eliminated soluble forms are precipitated in the through intact skin (Sutton et al., 2003, in the feces. In most studies, less than gastrointestinal tract due to different pH Document ID 1393; Stefaniak et al. 2014 1 percent of the administered values between the intestine and the (0517); Duling et al., 2012 (0539)). radioactivity was absorbed into the stomach (Reeves, 1965, Document ID Epidemiological studies evaluating the bloodstream and subsequently excreted 1430). Intravenous administration of

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

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

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time course for clinical disease have not to exercise; (2) abnormal pulmonary beryllium (Curtis, 1951, Document ID been fully delineated. However, for function test during exercise; (3) 1273; Newman et al., 1996 (1439); people now under surveillance, clinical abnormal arterial blood gases during Tinkle et al., 2003 (1483); Rossman, et progression from sensitization and early exercise. Of the patients identified as al., 1991, (1332); Deubner et al., 2001 pathological lesions (i.e., granulomatous ‘‘surveillance identified,’’ 52 percent (1542); Tinkle et al., 2003 (1483); Sutton inflammation) prior to onset of had abnormal exercise physiologies et al., 2003 (1393); Stefaniak et al., 2011 symptoms to symptomatic disease while 87 percent of the ‘‘clinically (0537) and 2014 (0517); Duling et al., appears to be slow, although more identified’’ patients had abnormal 2012 (0539); Document ID 1755, Tr. 36– follow-up is needed (NAS, 2008, physiologies (Pappas and Newman, 37). Representative Robert C. ‘‘Bobby’’ Document ID 1355). A study by 1993, Document ID 1433). During the Scott, Ranking Member of Committee on Newman (1996) emphasized the need public hearing, Dr. Newman noted that: Education and the Workforce, the U.S. for prospective studies to determine the . . . one of the sometimes overlooked points House of Representatives, provided natural history and time course from is that in that study . . . the majority of comments to the record stating that beryllium sensitization and people who were found to have early stage ‘‘studies have demonstrated that asymptomatic CBD to full-blown disease disease already had physiologic impairment. beryllium sensitization, an indicator of (Newman, 1996, Document ID 1283). So before the x-ray or the CAT scan could immune response to beryllium, can Drawing from his own clinical find it the BeLPT had picked it up, we had occur from both soluble and poorly experience, Dr. Newman was able to made a diagnosis of pathology in those people, and their lung function tests—their soluble beryllium particles.’’ (Document identify the sequence of events for those measures of gas exchange, were already ID 1672, p. 3). with symptomatic disease as follows: abnormal. Which put them on our watch list Sensitization is currently detected Initial determination of beryllium for early and more frequent monitoring so using the BeLPT (a laboratory blood sensitization; gradual emergence of that we could observe their worsening and test) described in section V.D.5. chronic inflammation of the lung; then jump in with treatment at the earliest Although there may be no clinical pathologic alterations with measurable appropriate time. So there is advantage of having that early diagnosis in terms of the symptoms associated with beryllium physiologic changes (e.g., pulmonary sensitization, a sensitized worker’s function and gas exchange); progression appropriate tracking and appropriate timing of treatment. (Document ID 1756, p. 112). immune system has been activated to to a more severe lung disease (with react to beryllium exposures such that extrapulmonary effects such as clubbing OSHA was unable to find any subsequent exposure to beryllium can and cor pulmonale in some cases); and controlled studies to determine the progress to serious lung disease (Kreiss finally death in some cases (reported optimal treatment for CBD (see et al., 1996, Document ID 1477; between 5.8 to 38 percent) (NAS, 2008, Rossman, 1996, Document ID 1425; Newman et al., 1996 (1439); Kreiss et Document ID 1355; Newman, 1996 NAS 2008 (1355); Sood, 2009 (0456)), al., 1997 (1360); Kelleher et al., 2001 (1283)). and none were added to the record In contrast to some occupationally during the public comment period. (1363); Rossman, 2001 (1424); Newman related lung diseases, the early detection Management of CBD is generally et al., 2005 (1437)). Since the of chronic beryllium disease may be modeled after sarcoidosis treatment. pathogenesis of CBD involves a useful since treatment of this condition Oral corticosteroid treatment can be beryllium-specific, cell-mediated can lead not only to regression of the initiated in patients with evidence of immune response, CBD cannot occur in signs and symptoms, but also may disease (either by bronchoscopy or other the absence of sensitization (NAS, 2008, prevent further progression of the diagnostic measures before progression Document ID 1355). The expert peer disease in certain individuals of disease or after clinical signs of reviewers agreed that the scientific (Marchand-Adam et al., 2008, pulmonary deterioration occur). This evidence supported sensitization as a Document ID 0370; NAS, 2008 (1355)). includes treatment with other anti- necessary condition and an early The management of CBD is based on the inflammatory agents (NAS, 2008. endpoint in the development of CBD hypothesis that suppression of the Document ID 1355; Maier et al., 2012 (ERG, 2010, Document ID 1270, pp. 19– hypersensitivity reaction (i.e., (0461); Salvator et al., 2013 (0459)) as 21). Dr. John Balmes remarked that the granulomatous process) will prevent the well. It should be noted, however, that ‘‘scientific evidence reviewed in the development of fibrosis. However, once treatment with corticosteroids has side- [Health Effects] document supports fibrosis has developed, therapy cannot effects of their own that need to be consideration of beryllium sensitization reverse the damage. measured against the possibility of as an early endpoint and as a necessary A study by Pappas and Newman progression of disease (Gibson et al., condition in the development of CBD.’’ (1993) observed that patients with 1996, Document ID 1521; Zaki et al., Dr. Patrick Breysee stated that ‘‘there is known prior beryllium exposure and 1987 (1374)). Alternative treatments strong scientific consensus that identified as confirmed positive for such as azathioprine and infliximab, sensitization is a key first step in the beryllium sensitization through the while successful at treating symptoms of progression of CBD.’’ Dr. Terry Gordon beryllium lymphocyte proliferation test CBD, have been demonstrated to have stated that ‘‘[a]s discussed in the draft (BeLPT) screening were evaluated for side effects as well (Pallavicino et al., [Health Effects] document, beryllium physiological changes in the lung. 2013, Document ID 0630; Freeman, 2012 sensitization should be considered as an Pappas and Newman categorized the (0655)). early endpoint in the development of patients as being either ‘‘clinically CBD.’’ Finally, Dr. Milton Rossman identified,’’ meaning they had known 1. Development of Beryllium agreed ‘‘that sensitization is necessary physiological abnormalities (e.g., Sensitization for someone to develop CBD and should abnormal chest radiogram, respiratory Sensitization to beryllium is an be considered a condition/risk factor for symptoms) or ‘‘surveillance-identified,’’ essential step for worker development of the development of CBD.’’ Various meaning they had BeLPT positive CBD. Sensitization to beryllium can factors, including genetic susceptibility, results with no reported symptoms, to result from inhalation exposure to have been shown to influence risk of differentiate state of disease progression. beryllium (Newman et al., 2005, developing sensitization and CBD (NAS Physiological changes were identified Document ID 1437; NAS, 2008 (1355)), 2008, Document ID 1355) and will be by three factors: (1) Reduced tolerance as well as from skin exposure to discussed later in this section.

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

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

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

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

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pulmonary function, with symptoms 3. Genetic and Other Susceptibility the surface of the immune cells of including a persistent dry cough and Factors sensitized individuals from a cohort of shortness of breath (Saber and Dweik, Evidence from a variety of sources beryllium workers (McCanlies et al., 2000, Document ID 1421). Fatigue, night indicates genetic susceptibility may 2004, Document ID 1449). The research sweats, chest and joint pain, clubbing of play an important role in the identified the HLA–DPB1 (Glu69) allele fingers (due to impaired oxygen development of CBD in certain that place carriers at greater risk of exchange), loss of appetite or individuals, especially at levels low becoming sensitized to beryllium and unexplained weight loss, and cor enough not to invoke a response in developing CBD than those not carrying pulmonale have been experienced in other individuals. Early occupational this allele (McCanlies et al., 2004, certain patients as the disease studies proposed that CBD was an Document ID 1449). Fontenot et al. progresses (Conradi et al., 1971, immune reaction based on the high (2000) demonstrated that beryllium Document ID 1319; ACCP, 1965 (1286); susceptibility of some individuals to presentation by certain alleles of the class II human leukocyte antigen-DP Kriebel et al., 1988, Document ID 1292; become sensitized and progress to CBD Kriebel et al., 1988 (1473)). While CBD (HLA–DP 3) to CD4+ T cells is the and the lack of CBD in others who were primarily affects the lungs, it can also mechanism underlying the development exposed to levels several orders of involve other organs such as the liver, of CBD (Document ID 1531). Richeldi et magnitude higher (Sterner and skin, spleen, and kidneys (ATSDR, al. (1993) reported a strong association Eisenbud, 1951, Document ID 1396). 2002, Document ID 1371). between the MHC class II allele HLA– Recent studies have confirmed genetic As previously mentioned, the uptake DPB 1 and the development of CBD in susceptibility to CBD involves either, of beryllium may lead to an aberrant beryllium-exposed workers from a HLA variants, T-cell receptor clonality, apoptotic process with rerelease of Tucson, AZ facility (Document ID 1353). tumor necrosis factor (TNF-a) beryllium ions and continual This marker was found in 32 of the 33 polymorphisms and/or transforming stimulation of beryllium-responsive workers who developed CBD, but in b CD4+ cells in the lung (Sawyer et al., growth factor-beta (TGF- ) only 14 of 44 similarly exposed workers 2000, Document ID 1417; Kittle et al., polymorphisms (Fontenot et al., 2000, without CBD. The more common alleles 2002 (0485); Sawyer et al., 2004 (1416)). Document ID 1531; Amicosante et al., of the HLA–DPB 1 containing a variant Several research studies suggest 2005 (1564); Tinkle et al., 1996 (0468); of Glu69 are negatively charged at this apoptosis may be one mechanism that Gaede et al., 2005 (0486); Van Dyke et site and could directly interact with the enhances inflammatory cell recruitment, al., 2011 (1696); Silveira et al., 2012 positively charged beryllium ion. cytokine production and inflammation, (0472)). Additional studies by Amicosante et al. thus creating a scenario for progressive Potential sources of variation (2005) (Document ID 1564) using blood granulomatous inflammation (Palmer et associated with genetic susceptibility lymphocytes derived from beryllium- al., 2008, Document ID 0478; Rana, 2008 have been investigated. Single exposed workers found a high frequency (0477)). Macrophages and neutrophils Nucleotide Polymorphisms (SNPs) have of this gene in those sensitized to can phagocytize beryllium particles in been studied with regard to genetic beryllium. In a study of 82 CBD patients an attempt to remove the beryllium from variations associated with increased risk (beryllium-exposed workers), Stubbs et the lung (Ding, et al., 2009, Document of developing CBD. SNPs are the most al. (1996) (Document ID 1394) also ID 0492)). Multiple studies (Sawyer et abundant type of human genetic found a relationship between the HLA– al., 2004, Document ID 1416; Kittle et variation. Polymorphisms in MHC class DP 1 allele and beryllium sensitization. al., 2002 (0485)) using BAL cells (mostly II and pro-inflammatory genes have The glutamate-69 allele was present in macrophages and neutrophils) from been shown to contribute to variations 86 percent of sensitized subjects, but in patients with CBD found that in vitro in immune responses contributing to the only 48 percent of beryllium-exposed, stimulation with beryllium sulfate susceptibility and resistance in many non-sensitized subjects. Some variants induced the production of TNF-a (one diseases including auto-immunity, of the HLA–DPB1 allele convey higher of many cytokines produced in response beryllium sensitization, and CBD risk of sensitization and CBD than to beryllium), and that production of (McClesky et al., 2009, as cited in others. For example, HLA–DPB1*0201 TNF-a might induce apoptosis in CBD Document ID 1808, p. 3). Specific SNPs yielded an approximately 3-fold and sarcoidosis patients (Bost et al., have been evaluated as a factor in the increase in disease outcome relative to 1994, Document ID 1299; Dai et al., Glu69 variant from the HLA–DPB1 controls; HLA–DPB1*1901 yielded an 1999 (0495)). The stimulation of CBD- locus (Richeldi et al., 1993, Document approximately 5-fold increase, and derived macrophages by beryllium ID 1353; Cai et al., 2000 (0445); Saltini HLA–DPB1*1701 yielded an sulfate resulted in cells becoming et al., 2001 (0448); Silviera et al., 2012 approximately 10-fold increase (Weston apoptotic, as measured by propidium (0472); Dai et al., 2013 (0493)). Other et al., 2005, Document ID 1345; Snyder iodide. These results were confirmed in SNPs lacking the Glu69 variant, such as et al., 2008 (0471)). Specifically, Snyder a mouse macrophage cell-line (p388D1) HLA–DRPheb47, have also been et al. (2008) found that variants of the (Sawyer et al., 2000, Document ID evaluated for an association with CBD Glu69 allele with the greatest negative 1417). However, other factors, such as (Amicosante et al., 2005, Document ID charge may confer greater risk for genetic factors and duration or level of 1564). developing CBD (Document ID 0471). exposure leading to a continued HLA–DPB1 (one of 2 subtypes of The study by Weston et al. (2005) presence of beryllium in the lung, may HLA–DP) with a glutamic acid at amino assigned odds ratios for specific alleles influence the development of CBD and position 69 (Glu69) has been shown to on the basis of previous studies are outlined in the following sections confer increased risk of beryllium discussed above (Document ID 1345). V.D.3 and V.D.4. sensitization and CBD (Richeldi et al., The researchers found a strong In summary, the persistent presence 1993, Document ID 1353; Saltini et al., of beryllium in the lung of a sensitized 2001 (0448); Amicosante et al., 2005 3 HLA–DP and HLA DPB1 alleles have been individual creates a progressive (1564); Van Dyke et al., 2011 (1696); associated with genetic susceptibility for inflammatory response that can Silveira et al., 2012 (0472)). In vitro developing CBD. HLA–DP has 2 subtypes, HLA– DPA and HLA–DPB. HLA–DBP1 is involved with culminate in the granulomatous lung human research has identified genes the Glu69 allele most associated with genetic disease, CBD. coding for specific protein molecules on susceptibility.

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correlation (88 percent) between the Document ID 1355) inducing an the study compared to current smokers reported risk of CBD and the predicted inflammatory response by stimulating (12.6 percent versus 6.4 percent, p = surface electrostatic potential and production of pro-inflammatory 0.10). The authors suggested smoking charge of the isotypes of the genes. They cytokines such as TNF-a by may confer a protective effect against were able to conclude that the alleles inflammatory cells. Polymorphisms in development of lung granulomas as has associated with the most negatively the 308 position of the TNF-a gene have been demonstrated with charged proteins carry the greatest risk been demonstrated to increase hypersensitivity pneumonitis (Mroz et of developing beryllium sensitization production of the cytokine and increase al., 2009, Document ID 1356). and CBD (Weston et al., 2005, severity of disease (Maier et al., 2001, 4. Beryllium Sensitization and CBD in Document ID 1345). This confirms the Document ID 1456; Saltini et al., 2001 the Workforce importance of beryllium charge as a key (0448); Dotti et al., 2004 (1540)). While factor in its ability to induce an immune a study by McCanlies et al. (2007) Sensitization to beryllium is currently response. (Document ID 0482) of 886 beryllium detected in the workforce with the In contrast, the HLA–DRB1 allele, workers (including 64 sensitized for beryllium lymphocyte proliferation test which lacks Glu69, has also been shown beryllium and 92 with CBD) found no (BeLPT), a laboratory blood test to increase the risk of developing relationship between TNF-a developed in the 1980s, also referred to sensitization and CBD (Amicosante et polymorphism and sensitization or as the LTT (Lymphocyte Transformation al., 2005, Document ID 1564; Maier et CBD, the National Academies of Test) or BeLTT (Beryllium Lymphocyte al., 2003 (0484)). Bill et al. (2005) found Sciences noted that ‘‘discrepancies Transformation Test). In this test, that HLA–DR has a glutamic acid at between past studies showing lymphocytes obtained from either position 71 of the b chain, functionally associations and the more recent studies bronchoalveolar lavage fluid (the BAL equivalent to the Glu69 of HLA–DP (Bill may be due to misclassification, BeLPT) or from peripheral blood (the et al., 2005, Document ID 0499). exposure differences, linkage blood BeLPT) are cultured in vitro and Associations with BeS and CBD have disequilibrium between HLA–DRB1 and exposed to beryllium sulfate to also been reported with the HLA–DQ TNF-a genes, or statistical power.’’ stimulate lymphocyte proliferation. The markers (Amicosante et al., 2005, (NAS, 2008, Document ID 1355). observation of beryllium-specific Document ID 1564; Maier et al., 2003 Other genetic variations have been proliferation indicates beryllium (0484)). Stubbs et al. also found a biased shown to be associated with increased sensitization. Hereafter, ‘‘BeLPT’’ distribution of the MHC class II HLA– risk of beryllium sensitization and CBD generally refers to the blood BeLPT, DR gene between sensitized and non- (NAS, 2008, Document ID 1355). These which is typically used in screening for sensitized subjects. Neither of these include TGF-b (Gaede et al., 2005, beryllium sensitization. This test is markers was completely specific for Document ID 0486), angiotensin-1 described in more detail in subsection CBD, as each study found beryllium converting enzyme (ACE) (Newman et D.5.b. sensitization or CBD among individuals al., 1992, Document ID 1440; Maier et CBD can be detected at an without the genetic risk factor. While al., 1999 (1458)) and an enzyme asymptomatic stage by a number of there remains uncertainty as to which of involved in glutathione synthesis techniques including bronchoalveolar the MHC class II genes interact directly (glutamate cysteine ligase) (Bekris et al., lavage and biopsy (Cordeiro et al., 2007, with the beryllium ion, antibody 2006, as cited in Document ID 1355). Document ID 1552; Maier, 2001 (1456)). inhibition data suggest that the HLA–DR McCanlies et al. (2010) evaluated the Bronchoalveolar lavage is a method of gene product may be involved in the association between polymorphisms in ‘‘washing’’ the lungs with fluid inserted presentation of beryllium to T a select group of interleukin genes (IL– via a flexible fiberoptic instrument lymphocytes (Amicosante et al., 2002, 1A; IL–1B, IL–1RN, IL–2, IL–9, IL–9R) known as a bronchoscope, removing the Document ID 1370). In addition, due to their role in immune and fluid and analyzing the content for the antibody blocking experiments revealed inflammatory processes (Document ID inclusion of immune cells reactive to that anti-HLA–DP strongly reduced 0481). The study evaluated SNPs in beryllium exposure, as described earlier proliferation responses and cytokine three groups of workers from large in this section. Fiberoptic bronchoscopy secretion by BAL CD4 T cells (Chou et beryllium manufacturing facilities in can be used to detect granulomatous al., 2005, Document ID 0497). In the OH and AZ. The investigators found a lung inflammation prior to the onset of study by Chou (2005), anti-HLA–DR significant association between variants CBD symptoms as well, and has been ligand antibodies mainly affected IL–1A–1142, IL–1A–3769 and IL–1A– used in combination with the BeLPT to beryllium-induced proliferation 4697 and CBD but not between those diagnose pre-symptomatic CBD in a responses with little impact on variants and beryllium sensitization. number of recent screening studies of cytokines other than IL–2, thus In addition to the genetic factors beryllium-exposed workers, which are implying that non-proliferating BAL which may contribute to the discussed in the following section CD4 T cells may still contribute to susceptibility and severity of disease, detailing diagnostic procedures. Of inflammation leading to the progression other factors such as smoking and sex workers who were found to be of CBD (Chou et al., 2005, Document ID may play a role in the development of sensitized and underwent clinical 0497). CBD (NAS, 2008, Document ID 1355). A evaluation, 31 to 49 percent of them TNF alpha (TNF-a) polymorphisms recent longitudinal cohort study by were diagnosed with CBD (Kreiss et al., and TGF beta (TGF-b) polymorphisms Mroz et al. (2009) of 229 individuals 1993, Document ID 1479; Newman et have also been shown to confer a identified with beryllium sensitization al., 1996 (1283), 2005 (1437), 2007 genetic susceptibility for developing or CBD through workplace medical (1335); Mroz, 2009 (1356)), although CBD in certain individuals. TNF-a is a surveillance found that the prevalence some estimate that with increased pro-inflammatory cytokine that may be of CBD among ever smokers was surveillance that percentage could be associated with a more progressive form significantly lower than among never much higher (Newman, 2005, Document of CBD (NAS, 2008). Beryllium smokers (38.1 percent versus 49.4 ID 1437; Mroz, 2009 (1356)). It has been exposure has been shown to upregulate percent, p = 0.025). BeS subjects that estimated from ongoing surveillance transcription factors AP–1 and NF-kB never smoked were found to be more studies of sensitized individuals with an (Sawyer et al., 2007, as cited in likely to develop CBD over the course of average follow-up time of 4.5 years that

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31 percent of beryllium-sensitized the beginning to the end stages and very which CD4+ T cells recognize a complex employees were estimated to progress to few of the risk factors for progression of composed of beryllium ion, self-peptide, and CBD (Newman et al., 2005, Document disease have been delineated (NAS, major histocompatibility complex (MHC) 2008, Document ID 1355). OSHA Class II molecule on an antigen-presenting ID 1437). The study by Newman et al. cell [Falta et al. (2013); Fontenot et al. (2005) was the first longitudinal study requested additional information in the (2016)]. BeS necessarily precedes CBD. to assess the progression from beryllium NPRM, but no additional studies were Pathogenesis depends on the immune sensitization to CBD in individuals added during the public comment system’s recognition of and reaction to undergoing clinical evaluation at period. Clinical management of CBD is beryllium in the lung, resulting in National Jewish Medical and Research modeled after sarcoidosis where oral granulomatous lung disease. BeS can be Center from 1988 through 1998. corticosteroid treatment is initiated in detected with tests that assess the immune Approximately 50 percent of sensitized patients who have evidence of response, such as the beryllium lymphocyte proliferation test (BeLPT), which measures T individuals (as identified by BeLPT) had progressive lung disease, although cell activity in the presence of beryllium salts CBD at their initial clinical evaluation. progressive lung disease has not been [Balmes et al. (2014)]. Furthermore, after the The remaining 50 percent, or 76 well defined (NAS, 2008, Document ID presence of BeS has been confirmed, periodic individuals, without evidence of CBD 1355). In advanced cases of CBD, medical evaluation at 1–3 year intervals were monitored at approximately two corticosteroids are the standard thereafter is required to assess whether BeS year intervals for indication of disease treatment (NAS, 2008, Document ID has progressed to CBD [Balmes et al. (2014)]. progression by pulmonary function 1355). No comprehensive studies have Thus, BeS is not just a test result, but an been published measuring the overall adverse health effect that poses risk of the testing, chest radiography (with irreversible lung disease CBD. (Document ID International Labour Organization B effect of removal of workers from 1725, p. 2) reading), fiberoptic bronchoscopy with beryllium exposure on sensitization and bronchoalveolar lavage, and CBD (NAS, 2008, Document ID 1355) The American College of transbronchial lung biopsy. Fifty-five of although this has been suggested as part Occupational and Environmental the 76 individuals were monitored with of an overall treatment regime for CBD Medicine (ACOEM) also commented a range of two to five clinical (Mapel et al., 2002, as cited in that the term pathological ‘‘continuum’’ evaluations each. The Newman et al. Document ID 1850; Sood et al., 2004 should only refer to signs and symptoms (2005) study found that CBD developed (1331); Sood, 2009 (0456); Maier et al., associated with CBD because some in 31 percent of individuals (17 of the 2012 (0461)). Expert testimony from Dr. sensitized workers never develop CBD 55) in a period ranging from 1.0 to 9.5 Lee Newman and Dr. Lisa Maier agreed (Document ID 1685, p. 6). However, Dr. years (average 3.8 years). After an that while no studies exist on the Newman, testifying on behalf of average of 4.8 years (range 1.7 to 11.6 efficacy of removal from beryllium ACOEM, clarified that not all members years) the remaining individuals exposure, it is medically prudent to of the ACOEM task force agreed: showed no signs of progression to CBD. reduce beryllium exposure once So I hope I’m reflecting to you the range A study of nuclear weapons facility someone is sensitized (Document ID and variety of outcomes relating to this. My employees enrolled in an ongoing 1756, Tr. 142). Sood et al. reported that own view is that it’s on a continuum. I do cessation of exposure can sometimes want to reflect back that the divided opinion medical surveillance program found among people on the ACOEM task force was that the sensitization rate in exposed have beneficial effects on lung function that we should call it a spectrum because not workers increased rapidly over the first (Sood et al., 2004, Document ID 1331). everybody is necessarily lock step into a 10 years of beryllium exposure and then However, this was based on anecdotal continuum that goes from sensitization to more gradually in succeeding years. On evidence from six patients with CBD, fatality. (Document ID 1756, Tr. 133). the other hand, the rate of CBD while this indicates a benefit of removal Lisa Maier, MD of National Jewish pathology increased slowly over the first of patients from exposure, more Health agreed with Dr. Newman 15 years of exposure and then climbed research is needed to better determine (Document ID 1756, Tr. 133–134). more steeply following 15 to 30 years of the relationship between exposure Additionally, Dr. Weissman of NIOSH beryllium exposure (Stange et al., 2001, duration and disease progression. testified that sensitization is ‘‘a Document ID 1403). The findings from Materion commented that biological change in people exposed to these longitudinal studies of sensitized sensitization should be defined as a test beryllium that is associated with workers provide evidence of CBD result indicating an immunological increased risk for developing CBD’’ and progression over time from sensitivity to beryllium without should be considered an adverse health asymptomatic to symptomatic disease. identifiable adverse health effects or effect (Document ID 1755, Tr. 13). One limitation for all these studies is other signs of illness or disability. It OSHA agrees that not every sensitized lack of long-term follow-up. Newman went on to say that, for these reasons, worker develops CBD, and that other suggested that it may be necessary to sensitization is not on a pathological factors such as extent of exposure, continue to monitor these workers in continuum with CBD (Document ID particulate characteristics, and genetic order to determine whether all 1661, pp. 4–7). Other commenters susceptibility influence the sensitized workers will develop CBD disagreed. NIOSH addressed whether development and progression of disease. (Newman et al., 2005, Document ID sensitization should be considered an The mechanisms by which beryllium 1437). adverse health effect and said the sensitization leads to CBD are described CBD has a clinical spectrum ranging following in their written hearing in earlier sections and are supported by from evidence of beryllium sensitization testimony: numerous studies (Newman et al., and granulomas in the lung with little Some have questioned whether BeS should 1996a, Document ID 1439; Newman et symptomatology to loss of lung function be considered an adverse health effect. al., 2005 (1437); Saltini et al., 1989 and end stage disease, which may result NIOSH views it as such, since it is a (1351); Amicosante et al., 2005a (1564); in the need for lung transplantation and biological change in people exposed to Amicosante et al., 2006 (1465); Fontenot beryllium that is associated with increased decreased life expectancy. risk for developing CBD. BeS refers to the et al., 1999 (0489); Fontenot et al., 2005 Unfortunately, there are very few immune system’s ability to recognize and (1528)). OSHA concludes that published clinical studies describing the react to beryllium. BeS is an antigen-specific sensitization is an immunological full range and progression of CBD from cell mediated immunity to beryllium, in condition that increases one’s likelihood

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

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

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%

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

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TABLE 2—CHARACTERISTICS OF BELPT ALGORITHMS (ADAPTED FROM MIDDLETON et al., (2008)—Continued [Adapted from Middleton et al., 2008, Document ID 0480]

Criterion B Criterion A (1 abnormal + Criterion C (1 abnormal) 1 borderline) (2 abnormal)

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

The Middleton et al. (2008) study another study to evaluate borderline or a similar test if validated in the demonstrated that confirmation of results from BeLPT testing (Document future, as it detects early and late BeLPT results, whether as one abnormal ID 0399). Utilizing the common clinical beryllium health effects. It has been and one borderline abnormal or as two algorithm with a criterion that accepted validated in many population-based abnormals, enhances the test’s PPV and one abnormal result and one borderline studies.’’ (Document ID 1756, Tr. 103). protects the persons tested from result as establishing beryllium Since there are currently no unnecessary and invasive medical sensitization resulted in a PPV of 94.4 alternatives to the BeLPT in a beryllium procedures. In populations with a high percent. This study also found that three sensitization screening program, many prevalence of beryllium sensitization borderline results resulted in a PPV of programs rely on a second test to (i.e., 10 percent or more), however, a 91 percent. Both of these PPVs were confirm a positive result (NAS, 2008). single test may be adequate to predict based on a population prevalence of 2 Various expert organizations support sensitization (Middleton et al., 2008, percent. This study further the use of the BeLPT (with a second Document ID 0480). demonstrates the value of borderline confirmational test) as a screening tool Still, there has been criticism results in predicting beryllium for beryllium sensitization and CBD. regarding the reliability and specificity sensitization using the BeLPT. OSHA The American Thoracic Society (ATS), of the BeLPT as a screening tool and finds that multiple, consistent based on a systematic review of the that the BeLPT has not been validated borderline BeLPT results (as found with literature, noted that ‘‘the BeLPT is the appropriately (Cher et al., 2006, as cited three borderline results) recognize a cornerstone of medical surveillance’’ in Document ID 1678; Borak et al., 2006 change in a person’s immune system to (Balmes et al., 2014; Document ID 0364, (0498); Donovan et al., 2007 (0491); beryllium exposure. In addition, a study pp. 1–2). The use of the BeLPT in Document ID 1678, Attachment 1, p. 6). by Harber et al. (2014) reexamined the medical surveillance has been endorsed Even when a confirmational second test algorithms to determine sensitization by the National Academies in their is performed, an apparent false positive and CBD data using the BioBank data.5 review of beryllium-related diseases and can occur in people not occupationally The study suggested that changing the disease prevention programs for the U. exposed to beryllium (NAS, 2008, algorithm could potentially help S. Air Force (NAS, 2008, Document ID Document ID 1355). An analysis of distinguish sensitization from 1355). In 2011, NIOSH issued an alert survey data from the general workforce progression to CBD (Harber et al., 2014, ‘‘Preventing Sensitization and Disease and new employees at a beryllium Document ID 0363). from Beryllium Exposure’’ where the manufacturer was performed to assess Materion further contended that BeLPT is recommended as part of a the reliability of the BeLPT (Donovan et ‘‘[w]hile some refer to BeLPT testing as medical screening and surveillance al. 2007, Document ID 0491). Donovan a ‘gold’ standard for BeS, it is hardly program (NIOSH, 2011, Document ID et al. analyzed more than 10,000 test ‘golden,’ as numerous commentators 0544). OSHA finds that the BeLPT is a results from nearly 2400 participants have noted.’’ (Document ID 1808, p. 4). useful and reliable test method that has over a 12-year period. Donovan et al. NIOSH submitted testimony to OSHA been utilized in numerous studies and found that approximately 2 percent of comparing the use of the BeLPT for validated and improved through new employees had at least one positive determining beryllium sensitization to multiple studies. BeLPT at the time of hire and 1 percent other common medical screening tools The epidemiological studies of new hires with no known such as mammography for breast cancer, presented in this section utilized the occupational exposure were confirmed tuberculin skin test for latent BeLPT as either a surveillance tool or a positive at the time of hire with two tuberculosis infection, prostate-specific screening tool for determining BeLPTs. However, this should not be antigen (PSA) for prostate cancer, and sensitization status and/or sensitization/ considered unusual because there have fecal occult blood testing for colon CBD prevalence in workers for inclusion been reported incidences of non- cancer. NIOSH stated that ‘‘[a]lthough in the published studies. Most occupational and community-based there is no gold standard test to identify epidemiological studies have reported beryllium sensitization (Eisenbud et al., beryllium sensitization, BeLPT has been rates of sensitization and disease based 1949, Document ID 1284; Leiben and estimated to have a sensitivity of 66– on a single screening of a working Metzner, 1959 (1343); Newman and 86% and a specificity of >99% for population (‘‘cross-sectional’’ or Kreiss, 1992 (1440); Maier and Rossman, sensitization [Middleton et al. (2006)]. ‘‘population prevalence’’ rates). Studies of workers in a beryllium machining 2008 (0598); NAS, 2008 (1355); Harber These values are comparable or superior plant and a nuclear weapons facility et al., 2014 (0415), Harber et al., 2014 to those of other common medical have included follow-up of the (0421)). screening tests.’’ (Document ID 1725, population originally screened, Materion objected to OSHA treating pp. 32–33). In addition, Dr. Maier of resulting in the detection of additional ‘‘two or three uninterpretable or National Jewish Health stated during the cases of sensitization over several years borderline abnormal BeLPT test results public hearing that ‘‘medical (Newman et al., 2001, Document ID as confirmation of BeS for the purposes surveillance should rely on the BeLPT of the standard’’ (Document ID 1808, p. 1354; Stange et al., 2001 (1403)). Based 4). In order to address some criticism 5 BioBank is a repository of biological specimens on the studies above, as well as regarding the PPV of the BeLPT, and clinical data collected from beryllium-exposed comments from NIOSH, ATS, and Middleton et al. (2011) conducted Department of Energy workers and contractors. National Jewish Health, OSHA regards

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the BeLPT as a reliable medical discussed animal studies examining workers had an abnormal blood test surveillance tool. solubility and particle size. result upon initial testing and at least one of two subsequent test results for c. Beryllium Mining and Extraction d. Beryllium Metal Processing and Alloy each of those workers confirmed the Production Mining and extraction of beryllium worker as sensitized. These workers, usually involves the two major Kreiss et al. (1997) conducted a study together with 19 workers who had an beryllium minerals, beryl (an of workers at a beryllium production initial abnormal result and one aluminosilicate containing up to 4 facility in Elmore, OH (Document ID subsequent indeterminate result, were percent beryllium) and bertrandite (a 1360). The plant, which opened in 1953 offered clinical evaluation for CBD beryllium silicate hydrate containing and initially specialized in production including the BAL-BeLPT and generally less than 1 percent beryllium) of beryllium-copper alloy, later transbronchial lung biopsy. Nine (WHO, 2001, Document ID 1282). The expanded its operations to include workers with an initial abnormal test United States is the world leader in beryllium metal, beryllium oxide, and followed by two subsequent normal beryllium extraction and also leads the beryllium-aluminum alloy production; tests were not clinically evaluated, world in production and use of beryllium and beryllium alloy although four were found to be beryllium and its alloys (WHO, 2001, machining; and beryllium ceramics sensitized upon retesting in 1995. Of 47 Document ID 1282). Most exposures production, which was moved to a workers who proceeded with evaluation from mining and extraction come in the different factory in the early 1980s. for CBD (3 of the 50 initial workers with form of beryllium ore, beryllium salts, Production operations included a wide abnormal results declined to beryllium hydroxide (NAS, 2008, variety of jobs and processes, such as participate), 24 workers were diagnosed Document ID 1355) or beryllium oxide work in arc furnaces and furnace with CBD based on evidence of (Stefaniak et al., 2008, Document ID rebuilding, alloy melting and casting, granulomas on lung biopsy (20 workers) 1397). beryllium powder processing, and work or on other findings consistent with in the pebble plant. Non-production Deubner et al. published a study of 75 CBD (4 workers) (Kreiss et al., 1997, work included jobs in the analytical workers employed at a beryllium Document ID 1360). After including five laboratory, engineering research and mining and extraction facility in Delta, workers who had been diagnosed prior development, maintenance, laundry, UT (Deubner et al., 2001b, Document ID to the study, a total of 29 (4.6 percent production-area management, and 1543). Of the 75 workers surveyed for of the 627 workers who underwent office-area administration. While the BeLPT screening) workers still sensitization with the BeLPT, three were publication refers to the use of employed at the time of the study were identified as sensitized by an abnormal respiratory protection in some areas, found to have CBD. In addition, the BeLPT result. One of those found to be such as the pebble plant, the extent of plant medical department identified 24 sensitized was diagnosed with CBD. its use across all jobs or time periods former workers diagnosed with CBD Exposures at the facility included was not reported. Use of dermal PPE before the study. primarily beryllium ore and salts. was not reported. General area (GA), breathing zone (BZ), The authors characterized exposures Kreiss et al. reported that the highest and personal lapel (LP) exposure at the plant using industrial hygiene prevalence of sensitization and CBD samples were collected from 1970 to (IH) samples collected between 1980 occurred among workers employed in 1999. Jobs involving beryllium and 1993. The exposure samples and beryllium metal production, even hydrolysis and wet-grinding activities the plant’s formulas for estimating though the highest airborne total mass had the highest air concentrations, with workers’ DWA exposures were used, concentrations of beryllium were an annual median GA concentration together with study participants’ work generally among employees operating ranging from 0.1 to 0.4 mg/m3. Median histories, to estimate their cumulative the beryllium alloy furnaces in a BZ concentrations were higher than and average beryllium exposure levels. different area of the plant (Kreiss et al., either LP or GA concentrations. The Exposure concentrations reflected the 1997, Document ID 1360). Preliminary average duration of exposure for high exposures found historically in follow-up investigations of particle size- beryllium sensitized workers was 21.3 beryllium production and processing. specific sampling at five furnace sites years (27.7 years for the worker with Short-term BZ measurements had a within the plant determined that the CBD), compared to an average duration median of 1.4 mg/m3, with 18.5 percent highest respirable (i.e., particles <10 mm for all workers of 14.9 years. However, of samples exceeding OSHA’s preceding in diameter as defined by the authors) these exposures were less than either permissible ceiling concentration of 5.0 and alveolar-deposited (i.e., particles <1 the Elmore, OH, or Tucson, AZ, mg/m3. Particularly high beryllium mm in diameter as defined by the facilities described below, which also concentrations were reported in the authors) beryllium mass and particle had higher reported rates of BeS and areas of beryllium powder production, number concentrations, as collected by CBD. A study by Stefaniak et al. (2008) laundry, alloy arc furnace a general area impactor device, were demonstrated that beryllium was (approximately 40 percent of DWA measured at the beryllium metal present at the mill in three forms: estimates over 2.0 mg/m3) and furnace production furnaces rather than the Mineral, poorly crystalline oxide, and rebuild (28.6 percent of short-term BZ beryllium alloy furnaces (Kent et al., hydroxide (Document ID 1397). samples over the preceding OSHA 2001, Document ID 1361; McCawley et There was no sensitization or CBD permissible ceiling concentration of 5 al., 2001 (1357)). A statistically among those who worked only at the mg/m3). LP samples (n = 179), which significant linear trend was reported mine where exposure to beryllium were available from 1990 to 1992, had between the above alveolar-deposited resulted solely from working with a median value of 1 mg/m3. particle mass concentration and bertrandite ore. The authors concluded Of 655 workers employed at the time prevalence of CBD and sensitization in that the results of this study indicated of the study, 627 underwent BeLPT the furnace production areas. The that beryllium ore and salts may pose screening. Blood samples were divided authors concluded that alveolar- less of a hazard than beryllium metal and split between two labs for analysis, deposited particles may be a more and beryllium hydroxide. These results with repeat testing for results that were relevant exposure metric for predicting are consistent with the previously abnormal or indeterminate. Thirty-one the incidence of CBD or sensitization

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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beryllium should be considered cigarette smoking and other lung and Ward, 1991 (1348)). Industry carcinogenic to humans. carcinogens were unlikely to explain the profiles in processing and extraction Schubauer-Berigan et al. (2011) increased incidences in these cancers. indicate that most exposures would be (Document ID 1266) extended their The study corrected an error that was due to poorly soluble forms of analysis from a previous study discovered in the indirect smoking beryllium. Excess lung cancer rates were estimating associations between adjustment initially conducted by Ward observed in workers in industries mortality risk and beryllium exposure to et al., concluding that cigarette smoking associated with extraction and include workers at 7 beryllium rates did not differ between the cohort processing (Schubauer-Berigan et al., processing plants. The study followed and the general U.S. population. No 2008, Document ID 1350; Schubauer- the mortality incidences of 9,199 association was found between cigarette Berigan et al. 2011 (1266, 1815 workers from 1940 through 2005 at the smoking and either cumulative or Attachment 105); Ward et al., 1992 7 beryllium plants. JEMs were maximum beryllium exposure, making (1378); Hollins et al., 2009 (1512); developed for three plants in the cohort: it very unlikely that smoking was a Sanderson et al., 2001 (1419); Mancuso The Reading plant, the Hazleton plant, substantial confounder in this study et al., 1980 (1452); Wagoner et al., 1980 and the Elmore plant. The last is (Schubauer-Berigan et al., 2011, (1379)). During the public comment described in Couch et al. 2010. Document ID 1266). period NIOSH noted that: Including these JEMs substantially A study by Boffetta et al. (2014, . . . in Table 1 of Ward et al. (1992), all three improved the evidence base for Document ID 0403) and an abstract by of these beryllium plants were engaged in evaluating the carcinogenicity of Boffetta et al., (2015, Document ID 1661, operations associated with both soluble and beryllium, and this change represents Attachment 1) were submitted by [poorly soluble] forms of beryllium. more than an update of the beryllium Materion for Agency consideration Industrial hygienists from NIOSH [Sanderson cohort. Standardized mortality ratios (Document ID 1661, p. 3). Briefly, et al. (2001); Couch et al. (2011)] and (SMRs) were estimated based on U.S. Boffetta et al. investigated lung cancer elsewhere [Chen (2001); Rosenman et al. population comparisons for lung, and other diseases in a cohort of 4,950 (2005)] created job-exposure matrices (JEMs), nervous system and urinary tract workers in four beryllium which estimated the form of beryllium cancers, chronic obstructive pulmonary manufacturing facilities. Based on exposure (soluble, consisting of beryllium salts; [poorly soluble], consisting of disease (COPD), chronic kidney disease, available process information from the beryllium metal, alloys, or beryllium oxide; and categories containing chronic facilities, the cohort of workers included and mixed forms) associated with each job, beryllium disease (CBD) and cor only those working with poorly soluble department and year combination at each pulmonale. Associations with maximum beryllium. Workers having potential for plant. Unpublished evaluations of these JEM and cumulative exposure were soluble beryllium exposure were estimates linked to the employee work calculated for a subset of the workers. excluded from the study. Boffetta et al. histories in the NIOSH risk assessment study Overall mortality in the cohort reported a slight increase in lung cancer [Schubauer-Berigan et al., 2011b, Document compared with the U.S. population was rates among workers hired prior to 1960, ID 0521] show that the vast majority of elevated for lung cancer (SMR 1.17; but the increase was reported as not beryllium work-time at all three of these 95% CI 1.08 to 1.28), COPD (SMR 1.23; statistically significant. Bofetta et al. facilities was due to either [poorly] soluble or 95% CI 1.13 to 1.32), and the categories mixed chemical forms. In fact, [poorly] (2014) indicated that ‘‘[t]his study soluble beryllium was the largest single containing CBD (SMR 7.80; 95% CI 6.26 confirmed the lack of an increase in contributor to work-time (for beryllium to 9.60) and cor pulmonale (SMR 1.17; mortality from lung cancer and exposure of known solubility class) at the 95% CI 1.08 to 1.26) (Schubauer-Berigan nonmalignant respiratory diseases three facilities across most time periods et al., 2011, Document ID 1266). related to [poorly] soluble beryllium .... Therefore, the strong and consistent Mortality rates for most diseases of compounds’’ (Document ID 0403, p. exposure-response pattern that was observed interest increased with time since hire. 587). OSHA disagrees, and a more in the published NIOSH studies was very For the category including CBD, rates detailed analysis of the Boffetta et al. likely associated with exposure to [poorly] were substantially elevated compared to (2014, Document ID 0403) study is soluble as well as soluble forms of beryllium. the U.S. population across all exposure provided in the Risk Assessment section (Document ID 1725, p. 9) groups. Workers whose maximum (VI) of this preamble. The Boffetta et al. Taken collectively, the Agency finds beryllium exposure was ≥10 mg/m3 had (2015, Document ID 1661, Attachment that the epidemiological data presented higher rates of lung cancer, urinary tract 1) study cited by Materion was an in the reviewed studies provides cancer, COPD and the category abstract to the 48th annual Society of sufficient evidence to demonstrate containing cor pulmonale than workers Epidemiological Research conference carcinogenicity in humans of both with lower exposure. These studies and does not provide sufficient soluble and poorly soluble forms of showed strong associations for information for OSHA to consider. beryllium. cumulative exposure (when short-term To summarize, most of the workers were excluded), maximum epidemiological studies reviewed in this 3. Animal Cancer Studies exposure, or both. Significant positive section show an elevated lung cancer This section reviews the animal trends with cumulative exposure were rate in beryllium-exposed workers literature used to support the findings observed for nervous system cancers (p compared to control groups. While for beryllium-induced lung cancer. = 0.0006) and, when short-term workers exposure data was incomplete in many Early animal studies revealed that some were excluded, lung cancer (p = 0.01), studies inferences can be made based on beryllium compounds are carcinogenic urinary tract cancer (p = 0.003), and industry profiles. Specifically, studies when inhaled (ATSDR, 2002, Document COPD (p <0.0001). reviewing excess lung cancer in workers ID 1371). Lung tumors have been The authors concluded that the registered in the BCR found an elevated induced via inhalation and intratracheal findings from this reanalysis reaffirmed lung cancer rate in those patients administration of beryllium to rats and that lung cancer and CBD are related to identified as having acute beryllium monkeys, and osteosarcomas have been beryllium exposure. The authors went disease (ABD). ABD patients are most induced via intravenous and on to suggest that beryllium exposures closely associated with exposure to intramedullary (inside the bone) may be associated with nervous system soluble forms of beryllium (Infante et injection of beryllium in rabbits and and urinary tract cancers and that al., 1980, Document ID 1507; Steenland mice. In addition to lung cancer,

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osteosarcomas have been produced in TABLE 3—NEOPLASM ANALYSIS, survived until their scheduled mice and rabbits exposed to various BASED ON SCHEPERS ET AL. sacrifices. beryllium salts by intravenous injection (1957)—Continued Average lung weight towards the end or implantation into the bone (NTP, of exposure was 4.25 times normal with 1999, Document ID 1341: IARC, 2012 Neoplasm Number Metastases progressively increasing differences (0650)). While not completely between control and exposed animals. understood, experimental studies in Total ...... 76 8 The increase in lung weight was animals (in vitro and in vivo) have accompanied by notable changes in found that a number of mechanisms are Schepers (1962) (Document ID 1414) tissue texture with two distinct likely involved in beryllium-induced reviewed 38 existing beryllium studies pathological processes—inflammatory carcinogenicity, including chronic that evaluated seven beryllium and proliferative. The inflammatory inflammation, genotoxicity, compounds and seven mammalian response was characterized by marked mitogenicity, oxidative stress, and species. Beryllium sulfate, beryllium accumulation of histiocytic elements epigenetic changes. fluoride, beryllium phosphate, forming clusters of macrophages in the In an inhalation study assessing the beryllium alloy (BeZnMnSiO4), and alveolar spaces. The proliferative potential tumorigenicity of beryllium, beryllium oxide were proven to be response progressed from early Schepers et al. (1957) (Document ID carcinogenic. Ten varieties of tumors epithelial hyperplasia of the alveolar 0458) exposed 115 albino Sherman and were observed, with adenocarcinoma surfaces, through metaplasia (after 20– Wistar rats (male and female) via being the most common variety. 22 weeks of exposure), anaplasia inhalation to 0.0357 mg beryllium/m3 (1 In another study, Vorwald and Reeves (cellular dedifferentiation) (after 32–40 g beryllium/ft3) 7 as an aqueous aerosol (1959) (Document ID 1482) exposed weeks of exposure), and finally to lung of beryllium sulfate for 44 hours/week Sherman albino rats via the inhalation tumors. for 6 months, and observed the rats for route to aerosols of 0.006 mg beryllium/ Although the initial proliferative 18 months after exposure. Three to four m3 as beryllium oxide and 0.0547 mg response occurred early in the exposure control rats were killed every two beryllium/m3 as beryllium sulfate for 6 period, tumor development required months for comparison purposes. hours/day, 5 days/week for an considerable time. Tumors were first Seventy-six lung neoplasms,8 including unspecified duration. Lung tumors identified after nine months of adenomas, squamous-cell carcinomas, (single or multifocal) were observed in beryllium sulfate exposure, with rapidly acinous adenocarcinomas, papillary the animals sacrificed following 9 increasing rates of incidence until tumors were observed in 100 percent of adenocarcinomas, and alveolar-cell months of daily inhalation exposure. exposed animals by 13 months. The 9- adenocarcinomas, were observed in 52 The histologic pattern of the cancer was to-13-month interval is consistent with of the rats exposed to the beryllium primarily adenomatous; however, earlier studies. The tumors showed a sulfate aerosol. Adenocarcinomas were epidermoid and squamous cell cancers high degree of local invasiveness. No the most numerous. Pulmonary were also observed. Infiltrative, tumors were observed in control rats. metastases tended to localize in areas vascular, and lymphogenous extensions All 56 tumors studied appeared to be with foam cell clustering and often developed with secondary alveolar adenocarcinomas and 3 were granulomatosis. No neoplasia was metastatic growth in the ‘‘fast-growing’’ tumors that reached a observed in any of the control rats. The tracheobronchial lymph nodes, the incidence of lung tumors in exposed very large size comparatively early. mediastinal connective tissue, the About one-third of the tumors showed rats is presented in the following Table parietal pleura, and the diaphragm. 3: small foci where the histologic pattern In the first of two articles, Reeves et differed. Most of the early tumor foci al. (1967) investigated the carcinogenic appeared to be alveolar rather than TABLE 3—NEOPLASM ANALYSIS, process in lungs resulting from chronic BASED ON SCHEPERS ET AL. (1957) bronchiolar, which is consistent with (up to 72 weeks) beryllium sulfate the expected pathogenesis, since inhalation (Document ID 1310). One Neoplasm Number Metastases permanent deposition of beryllium was hundred fifty male and female Sprague more likely on the alveolar epithelium Adenoma ...... 18 0 Dawley C.D. strain rats were exposed to rather than on the bronchiolar Squamous car- beryllium sulfate aerosol at a mean epithelium. Female rats appeared to cinoma ...... 5 1 atmospheric concentration of 34.25 mg have an increased susceptibility to Acinous adeno- beryllium/m3 (with an average particle beryllium exposure. Not only did they carcinoma ...... 24 2 diameter of 0.12 mm). Prior to initial have a higher mortality (control males Papillary adeno- exposure and again during the 67–68 [n = 8], exposed males [n = 9] versus carcinoma ...... 11 1 and 75–76 weeks of life, the animals Alveolar-cell ade- control females [n = 4], exposed females nocarcinoma .... 7 0 received prophylactic treatments of [n = 17]) and body weight loss than male Mucigenous tetracycline-HCl to combat recurrent rats, but the three ‘‘fast-growing’’ tumors tumor ...... 7 1 pulmonary infections. occurred in females. Endothelioma ...... 1 0 The animals entered the exposure In the second article, Reeves et al. Retesarcoma ...... 3 3 chamber at 6 weeks of age and were (1967) (Document ID 1309) described exposed 7 hours per day/5 days per the rate of accumulation and clearance week for up to 2,400 hours of total of beryllium sulfate aerosol from the 7 Schepers et al. (1957) reported concentrations in exposure time. An equal number of same experiment (Reeves et al., 1967) g Be/ft3; however, g/ft3 is no longer a common unit. Therefore, the concentration was converted to mg/ unexposed controls were held in a (Document ID 1310). At the time of the m3. separate chamber. Three male and three monthly sacrifice, beryllium assays 8 While a total of 89 tumors were observed or female rats were sacrificed monthly were performed on the lungs, palpated at the time of autopsy in the BeSO4- during the 72-week exposure period. tracheobronchial lymph nodes, and exposed animals, only 76 tumors are listed as Mortality due to respiratory or other histologically neoplastic. Only the new growths blood of the exposed rats. The identified in single midcoronal sections of both infections did not appear until 55 weeks pulmonary beryllium levels of rats lungs were recorded. of age, and 87 percent of all animals showed a rate of accumulation which

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

TABLE 4—SUMMARY OF BERYLLIUM DOSE, BASED ON GROTH ET AL. (1980) [Document ID 1316]

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

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

TABLE 5—SUMMARY OF ANIMAL DATA, BASED ON FINCH ET AL. (1998) [Document ID 1367]

Mean exposure Target beryllium Mean daily expo- Number of mice Mouse strain concentration lung burden Number of mice sure duration Mean ILB with 1 or more μ μ (μg) lung tumors/total ( g Be/L) ( g) (minutes) number examined

Knockout (p53 34 15 30 112 (single) NA 0/29 ∂/¥) 36 60 30 139 NA 4/28 Wild-type (p53 +⁄+) 34 15 6 112 (single) 12 ± 4 NA 36 60 36 139 54 ± 6 0/28 Knockout (p53 NA (air) Control 30 60–180 (single) NA 0/30 ∂/¥)

Lung burdens of beryllium measured in this mouse strain might not be an lung burdens for each exposure group in wild-type mice at 7 days post appropriate model for lung were 40, 110, 360, and 430 mg, exposure were approximately 70–90 carcinogenesis (Finch et al., 1998, respectively. percent of target levels. No exposure- Document ID 1367). To examine genetic alterations, DNA related effects on body weight were During the public comment period isolation and sequencing techniques observed in mice; however, lung Materion submitted correspondence (PCR amplification and direct DNA weights and lung-to-body-weight ratios from Dr. Finch speculating on the sequence analysis) were performed on were somewhat elevated in 60 mg target reason for the less-robust lung cancer wild-type rat lung tissue (i.e., control ILB p53 ∂/¥ knockout mice compared response observed in mice (versus that samples) along with two mouse lung to controls (0.05

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activation of the K-ras proto-oncogene is also demonstrated that aberrant p16 pulmonary tumors after intermittent both a rare and late event, possibly CpG island methylation, an important daily chronic inhalation exposure to caused by genomic instability during mechanism in gene silencing leading to beryllium ores in three groups of male the progression of beryllium-induced rat the loss of p16 expression, originates in squirrel monkeys. One group was pulmonary adenocarcinomas. It is primary tumors. exposed to bertrandite ore, a second to unlikely that the K-ras gene plays a role Building on the rat model for lung beryl ore, and the third served as in the carcinogenicity of beryllium. The cancer and associated findings from unexposed controls. Each of these three results also indicate that p53 mutation Swafford et al. (1997) (Document ID exposure groups contained 12 monkeys. is unlikely to play a role in tumor 1392), Belinsky et al. (2002) (Document Monkeys from each group were development in rats exposed to ID 1300) conducted experiments in 12- sacrificed after 6, 12, or 23 months of beryllium. week-old F344/N rats (male and female) exposure. The 12-month sacrificed Belinsky et al. (1997) reviewed the to determine whether beryllium- monkeys (n = 4 for bertrandite and findings by Nickell-Brady et al. (1994) induced lung tumors involve control groups; n = 2 for beryl group) (Document ID 1312) to further examine inactivation of the p16 gene and were replaced by a separate replacement the role of the K-ras and p53 genes in estrogen receptor a (ER) gene. Rats group to maintain a total animal lung tumors induced in the F344 rat by received a single nose-only inhalation population approximating the original non-mutagenic (non-genotoxic) exposure to beryllium aerosol at four numbers and to provide a source of exposures to beryllium. Their findings different exposure levels. The mean confirming data for biologic responses are discussed along with the results of lung burdens measured in each that might arise following the ore other genomic studies that look at exposure group were 40, 110, 360, and exposures. Animals were exposed to carcinogenic agents that are either 430 mg. The methylation status of the bertrandite and beryl ore concentrations similarly non-mutagenic or, in other p16 and ER genes was determined by of 15 mg/m3, corresponding to 210 mg cases, mutagenic. The authors MSP. A total of 20 tumors detected in beryllium/m3 and 620 mg beryllium/m3 concluded that the identification of non- beryllium-exposed rats were available in each exposure chamber, respectively. ras transforming genes in rat lung for analysis of gene-specific promoter The parent ores were reduced to tumors induced by non-mutagenic methylation. Three tumors were particles with geometric mean diameters exposures, such as beryllium, as well as classified as squamous cell carcinomas of 0.27 mm (± 2.4) for bertrandite and mutagenic exposures will help define and the others were determined to be 0.64 mm (± 2.5) for beryl. Animals were some of the mechanisms underlying adenocarcinomas. Methylated p16 was exposed for approximately 6 hours/day, cancer induction by different types of present in 80 percent (16/20), and 5 days/week. The histological changes DNA damage. methylated ER was present in one-half in the lungs of monkeys exposed to The inactivation of the p16 (10/20), of the lung tumors induced by bertrandite and beryl ore exhibited a INK4a(p16) gene is a contributing factor exposure to beryllium. Additionally, similar pattern. The changes generally in disrupting control of the normal cell both genes were methylated in 40 consisted of aggregates of dust-laden cycle and may be an important percent of the tumors. The authors macrophages, lymphocytes, and plasma mechanism of action in beryllium- noted that four tumors from beryllium- cells near respiratory bronchioles and induced lung tumors. Swafford et al. exposed rats appeared to be partially small blood vessels. There were, (1997) investigated the aberrant methylated at the p16 locus. Bisulfite however, no consistent or significant methylation and subsequent sequencing of exon 1 of the ER gene was pulmonary lesions or tumors observed inactivation of the p16 gene in primary conducted on normal lung DNA and in monkeys exposed to either of the lung tumors induced in F344/N rats DNA from three methylated, beryllium- beryllium ores. This is in contrast to the exposed to known carcinogens via induced tumors to determine the findings in rats exposed to beryl ore and inhalation (Document ID 1392). The density of methylation within amplified to a lesser extent bertrandite, where research involved a total of 18 primary regions of exon 1 (referred to as CpG atypical cell proliferation and tumors lung tumors that developed after sites). Two of the three methylated, were frequently observed in the lungs. exposing rats to five agents, one of beryllium-induced lung tumors showed The authors hypothesized that the rats’ which was beryllium. In this study, only extensive methylation, with more than greater susceptibility may be attributed one of the 18 lung tumors was induced 80 percent of all CpG sites methylated. by beryllium exposure; the majority of The overall findings of this study to the spontaneous lung disease the other tumors were induced by suggest that inactivation of the p16 and characteristic of rats, which might have radiation (x-rays or plutonium-239 ER genes by promoter hypermethylation interfered with lung clearance. oxide). The authors hypothesized that if are likely to contribute to the As previously described, Conradi et p16 inactivation plays a central role in development of lung tumors in al. (1971) investigated changes in the development of non-small-cell lung beryllium-exposed rats. The results lungs of monkeys and dogs two years cancer, then the frequency of gene showed a correlation between changes after intermittent inhalation exposure to inactivation in primary tumors should in p16 methylation and loss of gene beryllium oxide calcined at 1,400 °C parallel that observed in the transcription. The authors hypothesize (Document ID 1319). Five adult male corresponding cell lines. To test the that the mechanism of action for and female monkeys (Macaca irus) hypothesis, a rat model for lung cancer beryllium-induced p16 gene weighing between 3 and 5.75 kg were was used to determine the frequency inactivation in lung tumors may be used in the study. The study included and mechanism for inactivation of p16 inflammatory mediators that result in two control monkeys. Beryllium in matched primary lung tumors and oxidative stress. The oxidative stress concentrations in the atmosphere of derived cell lines. The methylation- damages DNA directly through free whole-body exposed monkeys varied specific PCR (MSP) method was used to radicals or indirectly through the between 3.30 and 4.38 mg/m3. Thirty- detect methylation of p16 alleles. The formation of 8-hydroxyguanosine DNA minute exposures occurred once a results showed that the presence of adducts, resulting primarily in a single- month for three months, with beryllium aberrant p16 methylation in cell lines strand DNA break. oxide concentrations increasing at each was strongly correlated with absent or Wagner et al. (1969) (Document ID exposure interval. Lung tissue was low expression of the gene. The findings 1481) studied the development of investigated using electron microscopy

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

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

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Annex VI of Directive 67/548/EEC (2009) (as cited in Document ID 1960, Globally Harmonized System of which establishes criteria for Attachment 2, Appendix, p. 20) found Classification and Labelling of classification and labelling of hazardous that Levy et al.’s method of eliminating Chemicals (citing ILSI (2000) as substances under the UN Globally controls from the study had the effect of supporting evidence for poorly soluble Harmonized System of Classification ‘‘always produc[ing] downwardly particles), Snipes (1996), the Health and Labelling of Chemicals (GHS). biased effect estimates and for many Risk Assessment Guidance for Metals, OSHA reviewed the Strupp and Furnes scenarios the bias was substantial.’’ ICMM (2007), and ECETOC (2013)— (2010) ‘‘expert statement’’ submitted by (Document ID 1960, Attachment 2, discuss the inhalation of high exposure NFFS and found it to be unpersuasive. Appendix, p. 20). NIOSH went on to levels of poorly soluble particles in rats Its review of the epidemiological cite numerous errors in the studies cited and the relevance of these studies to the evidence mischaracterized the findings by Strupp (2011) (Document ID 1794, human carcinogenic response from the NIOSH cohort and the nested 1795).9 OSHA finds NIOSH’s criticisms (Document ID 1807, Attachment 10, pp. case-control studies (Ward et al., 1992; of the Strupp (2011) studies as well as 1–3 (pdf pp. 85–87)). Using particles Sanderson et al., 2001; Schubauer- their criticism of studies by Levy et al., such as titanium dioxide, carbon black, Berigan et al., 2008) and misunderstood 2007 and Deubner et al., 2007 to be non-asbestiform talc, coal dust, and the methods commonly used to analyze reliable and credible. diesel soot as models, ILSI (2000) and occupational cohort studies (Document The Strupp and Furnes (2010) ECETOC (2013) describe studies that ID 1725, pp. 27–28). statement provided insufficient have demonstrated that chronic The Strupp and Furnes statement also information on the extraction of inhalation of poorly soluble particles did not include the more recent studies beryllium metal for OSHA to fully can result in pulmonary inflammation, by Schubauer-Berigan et al. (2011, evaluate the merit of the studies fibrosis, epithelial cell hyperplasia, and Document ID 1815, Attachment 105, regarding potential genotoxicity of adenomas and carcinomas in rats at 2011 (0626)), which demonstrated poorly soluble beryllium (Document ID exposure levels that exceed lung elevated rates for lung cancer (SMR 1678, Attachment 1, pp. 18–20). In clearance mechanisms (the ‘‘overload’’ 1.17; 95% CI 1.08 to 1.28) in a study of addition, Strupp and Furnes did not phenomenon) (ILSI (2000) 10, p. 2, as 7 beryllium processing plants. In consider the peer-reviewed published cited in Document ID 1807, Attachment addition, Strupp and Furnes did not studies evaluating the genotoxicity of 10, pp. 1–3 (pdf pp. 85–87)). consider expert criticism from IARC on beryllium metal (see section V.E.1 and However, these expert reports the studies by Levy et al. (2007) and V.E.2). indicate that the ‘‘overload’’ Deubner et al., (2007), which formed the In coming to the conclusion that the phenomenon caused by biologically basis of their findings. NIOSH submitted evidence is insufficient for classification inert particles (poorly soluble particles comments that stated: under GHS, Strupp and Furnes failed to of low cytotoxicity for which there is no consider the full weight of evidence in evidence of genotoxicity) is relevant The Strupp (2011b) review of the only to the rat species. (Document ID epidemiological evidence for lung their evaluation using the criteria set carcinogenicity of beryllium contained forth under Annex VI of Directive 67/ 1807, Attachment 10, pp. 1–3 (pdf pp. fundamental mischaracterizations of the 548/EEC which establishes criteria for 85–87)). OSHA finds that this model is findings of the NIOSH cohort and nested classification and labelling of hazardous not in keeping with the data presented case-control studies (Ward et al. 1992; substances under the UN Globally for beryllium for several reasons. First, Sanderson et al. 2001; Schubauer-Berigan et Harmonized System of Classification beryllium has been shown to be a al. 2008), as well as an apparent and Labelling of Chemicals (GHS) ‘‘biologically active’’ particle due to its misunderstanding of the methods commonly (Document ID 1678, attachment 1, pp. ability to induce an immune response in used to analyze occupational cohort studies multiple species including humans, has (Document ID 1960, Attachment 2, p. 10). 21–23). Thus, the Agency concludes that the Strupp and Furnes statement been shown to be genotoxic in certain As further noted by NIOSH: does not constitute the best available mammalian test systems, and induces Strupp’s epidemiology summary mentions scientific evidence for the evaluation of epigenetic changes (e.g. DNA two papers that were critical of the whether poorly soluble forms of methylation) (as described in detail in Sanderson et al. (2001) nested case-control beryllium cause cancer. sections V. D. 6, V.E.1, V.E.3 and V.E.4). study. The first of these, Levy et al. (2007a), Materion also submitted comments Second, beryllium has been shown to was a re-analysis that incorporated a produce lung tumors after inhalation or nonstandard method of selecting control indicating there is an ongoing scientific subjects and the second, Deubner et al. debate regarding the relevance of the rat instillation in several animal species, (2007), was a simulation study designed to lung tumor response to humans with including rats, mice, and monkeys evaluate Sanderson’s study design. Both of respect to poorly soluble beryllium (Finch et al., 1998, Document ID 1367; these papers have themselves been criticized compounds (Document ID 1807, Schepers et al., 1957 (0458) and 1962 for using faulty methods (Schubauer-Berigan Attachment 10, pp. 1–3 (pdf pp. 85– (1414); Wagner et al., 1969 (1481); et al. 2007; Kriebel, 2008; Langholz and 87)), Materion contended that the Belinsky et al., 2002 (1300); Groth et al., Richardson, 2008); however, Strupp’s coverage of this is incomplete. (Document ID increased lung cancer risk in beryllium- exposed animals is due to a particle 10 It is important to note that the ILSI report states 1960, Attachment 2, Appendix, p. 19). that in interpreting data from rat studies alone, ‘‘in overload phenomenon, in which lung NIOSH went on to state that while the the absence of mechanistic data to the contrary it clearance of beryllium particles initiates must be assumed that the rat model can identify Sanderson et al. (2001) used standard a non-specific neutrophilic response potential hazards to humans’’ (ILSI, 2000, p. 2, as accepted methods for selecting the that results in intrapulmonary lung cited in Document ID 1807, Attachment 10, p. 1 (pdf p. 85)). The report by Oberdorster has similar control group, the Deubner et al. (2007) tumors. The materials cited by Materion study limited control group eligibility language to the ILSI report (see Document ID 1807, as supportive of its argument— Attachment 10, pp. 1, 3 (pdf pp. 85, 87). It should and failed to adequately match control Obedorster (1995), a 2009 working also be noted that the working paper to the UN and case groups (Document ID 1960, paper to the UN Subcommittee on the Subcommittee on the Globally Harmonized System Attachment 2, Appendix, pp. 19–20). of Classification and Labelling of Chemicals, which NIOSH noted that an independent cited ILSI (2000), was not adopted and has not been 9 Strupp and Furnes was the background included in any revision to the GHS (http:// analysis published by Langholz and information for the Strupp (2011) publications www.unece.org/fileadmin/DAM/trans/doc/2009/ Richardson (2009) and Hein et al., (Document ID, Attachment 2, Appendix, p. 20). ac10c4/ST-SG-AC10-C4-34e.pdf).

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1980 (1316); Vorwald and Reeves, 1957 mucosal effects are briefly summarized beryllium sulfate (Schepers, 1957, (1482); Nickell-Brady et al., 1994 (1312); below. Health effects in other organ Document ID 0458). Decreased arterial Swafford et al., 1997 (1392); IARC, 2012 systems listed above were only observed oxygen tension was observed in dogs (1355)). In addition, poorly soluble in animal studies at very high exposure exposed to 30 mg beryllium/m3 as beryllium has been demonstrated to levels and are, therefore, not discussed beryllium oxide for 15 days (HSDB, produce chronic inflammation at levels here. During the public comment period 2010, Document ID 0533), 3.6 mg below overload (Groth et al., 1980, OSHA received comments suggesting beryllium/m3 as beryllium oxide for 40 Document ID 1316; Nickell-Brady et al., that OSHA add dermal effects to this days (Hall et al., 1950, Document ID 1994 (1312); Finch et al., 1998 (1367); section. Therefore, dermal effects have 1494), and 0.04 mg beryllium/m3 as Finch et al., 2000 (as cited in Document been added, below, and are also beryllium sulfate for 100 days ID 1960, p. 11)). discussed in the section on kinetics and (Stokinger et al., 1950, Document ID In addition, IARC and NAS performed metabolism (section V.B.2). 1484). These are thought to be indirect an extensive review of the available effects on the heart due to pulmonary 1. Hepatic Effects animal studies and their findings were fibrosis and toxicity, which can increase supportive of the OSHA findings of Beryllium has been shown to arterial pressure and restrict blood flow. carcinogenicity (IARC, 2012, Document accumulate in the liver and a correlation ID 0650; NAS, 2008 (1355)). OSHA has been demonstrated between 3. Renal Effects performed an independent evaluation as beryllium content and hepatic damage. Renal or kidney stones have been outlined in section V.E.3 and found Different compounds have been shown found in severe cases of CBD that sufficient evidence of tumor formation to distribute differently within the resulted from high levels of beryllium in multiple species (rats, mice, and hepatic tissues. For example, in one exposure. Renal stones containing monkeys) after inhalation at levels study, beryllium phosphate beryllium occurred in about 10 percent below overload conditions. The Agency accumulated almost exclusively within of patients affected by high exposures has found evidence supporting the sinusoidal (Kupffer) cells of the liver, (Barnett et al., 1961, Document ID hypothesis that multiple mechanisms while beryllium sulfate was found 0453). The ATSDR reported that 10 may be at work in the development of mainly in parenchymal cells. percent of the CBD cases found in the cancer in experimental animals and Conversely, beryllium sulphosalicylic BCR reported kidney stones. In humans and cannot dismiss the roles of acid complexes were rapidly excreted addition, an excess of calcium in the inflammation (neutrophilic and T-cell (Skilleter and Paine, 1979, Document ID blood and urine was frequently found in mediated), genotoxicity, and epigenetic 1410). patients with CBD (ATSDR, 2002, factors (see section V.E.1, V.E. 3, V.E.4). According to a few autopsies, Document ID 1371). After evaluating the best scientific beryllium-laden livers had central 4. Ocular and Mucosal Effects evidence available from epidemiological necrosis, mild focal necrosis and and animal studies (see section V.E) inflammation, as well as, occasionally, Soluble and poorly soluble beryllium OSHA concludes the weight of evidence beryllium granuloma (Sprince et al., compounds have been shown to cause supports a mechanistic finding that both 1975, Document ID 1405). ocular irritation in humans (VanOrdstrand et al., 1945, Document soluble and poorly soluble forms of 2. Cardiovascular Effects beryllium and beryllium-containing ID 1383; De Nardi et al., 1953 (1545); compounds are carcinogenic. Severe cases of CBD can result in cor Nishimura, 1966 (1435); Epstein, 1991 pulmonale, which is hypertrophy of the (0526); NIOSH, 1994 (1261). In addition, F. Other Health Effects right heart ventricle. In a case history soluble and poorly soluble beryllium Past studies on other health effects study of 17 individuals exposed to has been shown to induce acute have been thoroughly reviewed by beryllium in a plant that manufactured conjunctivitis with corneal maculae and several scientific organizations (NTP, fluorescent lamps, autopsies revealed diffuse erythema (HSDB, 2010, 1999, Document ID 1341; EPA, 1998 right atrial and ventricular hypertrophy Document ID 0533). (0661); ATSDR, 2002 (1371); WHO, (Hardy and Tabershaw, 1946, Document The mucosa (mucosal membrane) is 2001 (1282); HSDB, 2010 (0533)). These ID 1516). It is not likely that these the moist lining of certain tissues/organs studies include summaries of animal cardiac effects were due to direct including the eyes, nose, mouth, lungs, studies, in vitro studies, and human toxicity to the heart, but rather were a and the urinary and digestive tracts. epidemiological studies associated with response to impaired lung function. Soluble beryllium salts have been cardiovascular, hematological, hepatic, However, an increase in deaths due to shown to be directly irritating to renal, endocrine, reproductive, ocular heart disease or ischemic heart disease mucous membranes (HSDB, 2010, and mucosal, and developmental was found in workers at a beryllium Document ID 0533). effects. High-dose exposures to manufacturing facility (Ward et al., beryllium have been shown to have an 1992, Document ID 1378). Additionally, 5. Dermal Effects adverse effect upon a variety of organs a study by Schubauer-Berigan et al. Several commenters suggested OSHA and tissues in the body, particularly the (2011) found an increase in mortality add dermal effects to this Health Effects liver. The adverse systemic effects on due to cor pulmonale in a follow-up section. National Jewish Health noted humans mostly occurred prior to the study of workers at seven beryllium that rash and granulomatous reactions introduction of occupational and processing plants who were exposed to of the skin still occur in occupational environmental standards set in 1970– beryllium levels near the preceding settings (Document ID 1664, p. 5). The 1972 OSHA, 1971, see 39 FR 23513; OSHA PEL of 2.0 mg/m3 (Schubauer- National Supplemental Screening EPA, 1973 (38 FR 8820)). (OSHA, 1971, Berigan et al., 2011, Document ID 1266). Program also recommended including see 39 FR 23513; ACGIH, 1971 (0543); Animal studies performed in monkeys skin conditions such as dermatitis and ANSI, 1970 (1303)) and EPA, 1973 (38 indicate heart enlargement after acute nodules (Document ID 1677, p. 3). The FR 8820) and therefore are less relevant inhalation exposure to 13 mg beryllium/ American Thoracic Society also today than in the past. The available m3 as beryllium hydrogen phosphate, recommended including ‘‘beryllium data is fairly limited. The hepatic, 0.184 mg beryllium/m3 as beryllium sensitization, CBD, and skin disease as cardiovascular, renal, and ocular and fluoride, or 0.198 mg beryllium/m3 as the major adverse health effects

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

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incidence of lung tumors (section requirements and how they have been mg/m3, 0.2 mg/m3, and 0.1 mg/m3), as V.E.3). construed by the Supreme Court and well as OSHA’s preceding TWA PEL of • Authoritative scientific federal courts of appeals. 2 mg/m3. OSHA’s risk assessment relied organizations, such as the IARC, NTP, It is OSHA’s practice to evaluate risk on available epidemiological studies to and EPA, have classified beryllium as a to workers and determine the evaluate the risk of sensitization and known or probable human carcinogen significance of that risk based on the CBD for workers exposed to beryllium at (section V.E). best available evidence. Using that and below the preceding TWA PEL and While OSHA has determined there is evidence, OSHA identifies material the effectiveness of exposure control sufficient evidence of beryllium health impairments associated with programs in reducing risk. OSHA also carcinogenicity, the Agency potentially hazardous occupational conducted a statistical analysis of the acknowledges that the exact exposures, assesses whether exposed exposure-response relationship for tumorigenic mechanism for beryllium workers’ risks are significant, and sensitization and CBD at the preceding has yet to be determined. A number of determines whether a new or revised PEL and alternate PELs the Agency was mechanisms are likely involved, rule will substantially reduce these considering. For this analysis, OSHA including chronic inflammation, risks. As discussed in Section II, used data provided by National Jewish genotoxicity, mitogenicity, oxidative Pertinent Legal Authority, when Health (NJH), a leading medical center stress, and epigenetic changes (section determining whether a significant risk specializing in the research and V.E.3). exists OSHA considers whether there is treatment of CBD, on a population of • Studies of beryllium-exposed a risk of at least one-in-a-thousand of workers employed at a beryllium animals have consistently demonstrated developing amaterial health impairment machining plant in Cullman, AL. The chronic pulmonary inflammation after from a working lifetime of exposure at review of the epidemiological studies exposure (section V.E.3). Substantial the prevailing OSHA standard (referred and OSHA’s own analysis both show data indicate that tumor formation in to as the ‘‘preceding standard’’ or significant risk of sensitization and CBD certain animals after inhalation ‘‘preceding TWA PEL’’ in this among workers exposed at and below exposure to poorly soluble particles at preamble). For this purpose, OSHA the preceding TWA PEL of 2 mg/m3. doses causing marked, chronic generally assumes that a term of 45 They also show substantial reduction in inflammation is due to a secondary years constitutes a working life. The risk where employers implemented a mechanism unrelated to the Supreme Court has found that OSHA is combination of controls, including genotoxicity of the particles (section not required to support its finding of stringent control of airborne beryllium V.E.5). significant risk with scientific certainty, levels and additional measures, such as • A review conducted by the NAS but may instead rely on a body of respirators and dermal personal (2008) (Document ID 1355) found that reputable scientific thought and may protective equipment (PPE) to further beryllium and beryllium-containing make conservative assumptions (i.e., err protect workers against dermal contact compounds tested positive for on the side of protecting the worker) in and airborne beryllium exposure. genotoxicity in nearly 50 percent of its interpretation of the evidence (see To evaluate lung cancer risk, OSHA studies without exogenous metabolic Section II, Pertinent Legal Authority). relied on a quantitative risk assessment activity, suggesting a possible direct- For single-substance standards published in 2011 by Schubauer- acting mechanism may exist (section governed by section 6(b)(5) of the OSH Berigan et al. (Document ID 1265). V.E.1) as well as the potential for Act, 29 U.S.C. 655(b)(5), OSHA sets a Schubauer-Berigan et al. found that lung epigenetic changes (section V.E.4). permissible exposure limit (PEL) based cancer risk was strongly and Other health effects are discussed in on its risk assessment as well as significantly related to mean, sections F of the Health Effects Section feasibility considerations. These health cumulative, and maximum measures of and include hepatic, cardiovascular, and risk determinations are made in the workers’ exposure; the authors renal, ocular, and mucosal effects. The context of a rulemaking record in which predicted significant risk of lung cancer adverse systemic effects from human the body of evidence used to establish at the preceding TWA PEL, and exposures mostly occurred prior to the material impairment, assess risks, and substantial reductions in risk at the introduction of occupational and identify affected worker population, as alternate PELs OSHA considered in the environmental standards set in 1970– well as the Agency’s preliminary risk proposed rule, including the final TWA 1973 (ACGIH, 1971, Document ID 0543; assessment, are placed in a public PEL of 0.2 mg/m3 (Schubauer-Berigan et ANSI, 1970 (1303); OSHA, 1971, see 39 rulemaking record and subject to public al., 2011). FR 23513; EPA, 1973 (38 FR 8820)) and comment. Final determinations OSHA requested input on the therefore are less relevant. regarding the standard, including final preliminary risk assessment presented determinations of material impairment in the NPRM, and received comments VI. Risk Assessment and risk, are thus based on from a variety of public health experts To promulgate a standard that consideration of the entire rulemaking and organizations, unions, industrial regulates workplace exposure to toxic record. organizations, individual employers, materials or harmful physical agents, OSHA’s approach for the risk and private citizens. While many OSHA must first determine that the assessment for beryllium incorporates comments supported OSHA’s general standard reduces a ‘‘significant risk’’ of both: (1) A review of the literature on approach to the risk assessment and the ‘‘material impairment.’’ Section 6(b)(5) populations of workers exposed to conclusions of the risk assessment, of the OSH Act, 29 U.S.C. 655(b). The beryllium at and below the preceding some commenters raised specific first part of this requirement, time-weighted average permissible concerns with OSHA’s analytical ‘‘significant risk,’’ refers to the exposure limit (TWA PEL) of 2 mg/m3; methods or recommended additional likelihood of harm, whereas the second and (2) OSHA’s own analysis of a data studies for OSHA’s consideration. part, ‘‘material impairment,’’ refers to set of beryllium-exposed machinists. Comments about the risk assessment as the severity of the consequences of The Preliminary Risk Assessment a whole are reviewed here, while exposure. Section II, Pertinent Legal included in the NPRM evaluated risk at comments on specific aspects of the risk Authority, of this preamble addresses several alternate TWA PELs that the assessment are addressed in the relevant the statutory bases for these Agency was considering (1 mg/m3, 0.5 sections throughout the remainder of

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this chapter and in the background significant risk (>1/1000 risk of CBD) at areas clean and prevent transfer of document, Risk Analysis of the NJH the [then] current PEL, and that risk is beryllium between work areas, sharply Data Set from the Beryllium Machining reduced at the proposed PEL (0.2 mg/m3) curtailed new cases of sensitization Facility in Cullman, Alabama—CBD and in combination with stringent measures among newly-hired workers. In contrast, Sensitization (OSHA, 2016), which can (ancillary provisions) to reduce worker’s efforts to prevent sensitization and CBD be found in the rulemaking docket exposures’’ (Document ID 1660, p. 2). by using engineering controls to reduce (docket number OSHA–H005C–2006– They further stated that OSHA’s workers’ beryllium exposures to median 0870) at www.regulations.gov. ‘‘finding is evident based on the levels around 0.2 mg/m3, with no Following OSHA’s review of all the available literature . . . and the corresponding emphasis on PPE, were comments submitted on the preliminary prevalence data [OSHA] presented for less effective than comprehensive risk assessment, and its incorporation of the Cullman facility’’ (Document ID exposure control programs implemented suggested changes to the risk 1660, p. 2). more recently. OSHA also reviewed assessment, where appropriate, the OSHA also received comments additional, but more limited, Agency reaffirms its conclusion that objecting to OSHA’s conclusions information on the occurrence of workers’ risk of material impairment of regarding risk of lung cancer from sensitization and CBD among workers health from beryllium exposure at the beryllium exposure and suggesting with low-level beryllium exposures at preceding PEL of 2 mg/m3 is significant, additional published analyses for nuclear facilities and aluminum and is substantially reduced but still OSHA’s consideration (e.g., Document smelting plants. A summary discussion significant at the new PEL of 0.2 mg/m3 ID 1659; 1661, pp. 1–3). One comment of the experiences at all of these (see this preamble at Section VII, critiqued the statistical exposure- facilities is provided in this section. Significance of Risk). response model OSHA presented as one Additional discussion of studies on The comments OSHA received on its part of its preliminary risk analysis for these facilities and several other studies preliminary risk analysis generally sensitization and CBD (Document ID of sensitization and CBD among supported OSHA’s overall approach and 1660). These comments are discussed beryllium-exposed workers is provided conclusions. NIOSH indicated that and addressed in the remainder of this in Section V, Health Effects. OSHA relied on the best available chapter. The Health Effects section also evidence in its risk assessment and discusses OSHA’s findings and the A. Review of Epidemiological Literature concurred with ‘‘OSHA’s careful review supporting evidence concerning the role on Sensitization and Chronic Beryllium of the available literature on [beryllium of particle characteristics and beryllium Disease sensitization] and CBD, OSHA’s compound solubility in the recognition of dermal exposure as a As discussed in the Health Effects development of sensitization and CBD potential pathway for sensitization, and section, studies of beryllium-exposed among beryllium-exposed workers. OSHA’s careful approach to assessing workers conducted using the beryllium First, it finds that respirable particles risk for [beryllium sensitization] and lymphocyte proliferation test (BeLPT) small enough to reach the deep lung are CBD’’ (Document ID 1725, p. 3). NIOSH have found high rates of beryllium responsible for CBD. However, larger agreed with OSHA’s approach to the sensitization and CBD among workers in inhalable particles that deposit in the preliminary lung cancer risk assessment many industries, including at some upper respiratory tract may lead to (Document ID 1725, p. 7) and the facilities where exposures were sensitization. Second, it finds that both selection of a 2011 analysis (Schubauer- primarily below OSHA’s preceding PEL soluble and poorly soluble forms of Berigan et al., 2011, Document ID 1265) of 2 mg/m3 (e.g., Kreiss et al., 1993, beryllium are able to induce as the basis of that risk assessment Document ID 1478; Henneberger et al., sensitization and CBD. Poorly soluble (Document ID 1725, p. 7). NIOSH 2001 (1313); Schuler et al., 2005 (0919); forms of beryllium that persist in the further supported OSHA’s preliminary Schuler et al., 2012 (0473)). In the mid- lung for longer periods may pose greater conclusions regarding the significance 1990s, some facilities using beryllium risk of CBD while soluble forms may of risk of material health impairment at began to aggressively monitor and more easily trigger immune the preceding TWA PEL of 2 mg/m3, and reduce workplace exposures. In the sensitization. Although particle size and the substantial reduction of such risk at NPRM, OSHA reviewed studies of solubility may influence the toxicity of the new TWA PEL of 0.2 mg/m3 workers at four plants where several beryllium, the available data are too (Document ID 1725, p. 3). Finally, rounds of BeLPT screening were limited to reliably account for these NIOSH agreed with OSHA’s preliminary conducted before and after factors in the Agency’s estimates of risk. conclusion that compliance with the implementation of new exposure 1. Reading, PA, Plant new PEL would lessen but not eliminate control methods. These studies provide risk to exposed workers, noting that the best available evidence on the Schuler et al. (2005, Document ID OSHA likely underestimated the risks of effectiveness of various exposure 0919) and Thomas et al. (2009, beryllium sensitization and CBD control measures in reducing the risk of Document ID 0590) conducted studies (Document ID 1725, pp. 3–4). sensitization and CBD. The experiences of workers at a copper-beryllium Other commenters also agreed with of these plants—a copper-beryllium processing facility in Reading, PA. the general approach and conclusions of processing facility in Reading, PA, a Exposures at this plant were believed to OSHA’s preliminary risk assessment. ceramics facility in Tucson, AZ, a be low throughout its history due to NJH, for example, determined that beryllium processing facility in Elmore, both the low percentage of beryllium in ‘‘OSHA performed a thorough OH, and a machining facility in the metal alloys used and the relatively assessment of risk for [beryllium Cullman, AL—show that comprehensive low exposures found in general area sensitization], CBD and lung cancer exposure control programs that used samples collected starting in 1969 using all available studies and engineering controls to reduce airborne (sample median ≤0.1 mg/m3, 97% < 0.5 literature’’ (Document ID 1664, p. 5). Dr. exposure to beryllium, required the use mg/m3) (Schuler et al., 2005). Ninety- Kenny Crump and Ms. Deborah Proctor of respiratory protection, controlled nine percent of personal lapel sample commented, on behalf of beryllium dermal contact with beryllium using measurements were below the producer Materion, that they ‘‘agree PPE, and employed stringent preceding OSHA TWA PEL of 2 mg/m3; with OSHA’s conclusion that there is a housekeeping methods to keep work 93 percent were below the new TWA

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PEL of 0.2 mg/m3 (Schuler et al., 2005). than the RAZ (Thomas et al., 2009, plant. Personal lapel samples taken on Schuler et al. (2005) screened 152 Table 3). The authors reported that administrative workers during the 1990s workers at the facility with the BeLPT outside the RAZ, ‘‘the vast majority of were below the detection limit at the in 2000. The reported prevalences of employees do not wear any form of time, 0.2 mg/m3 (Cummings et al., 2007, sensitization (6.5 percent) and CBD (3.9 respiratory protection due to very low Document ID 1369). percent) showed substantial risk at this airborne beryllium concentrations’’ Following the 1992 screening, the facility, even though airborne exposures (Thomas et al., 2009, p. 122). facility reduced exposures in machining were primarily below both the To test the efficacy of the new areas (for example, by enclosing preceding and final TWA PELs.11 The measures in preventing sensitization additional machines and installing only group of workers with no cases of and CBD, in June 2000 the facility began additional exhaust ventilation), sensitization or CBD, a group of 26 an intensive BeLPT screening program resulting in median exposures of 0.2 mg/ office administration workers, was the for all new workers (Thomas et al., m3 in production jobs and 0.1 mg/m3 in group with the lowest recorded 2009, Document ID 0590). Among 82 production support jobs (Cummings et exposures (median personal sample 0.01 workers hired after 1999, three cases of al., 2007). In 1998, a second screening mg/m3, range <0.01–0.06 mg/m3 (Schuler sensitization were found (3.7 percent). found that 7 out of 74 tested workers et al., 2005). Two (5.4 percent) of 37 workers hired hired after the 1992 screening (9.5 After the initial BeLPT screening was prior to enclosure of the wire annealing percent) were sensitized, one of whom conducted in 2000, the company began and pickling process, which had been was diagnosed with CBD. All seven of implementing new measures to further releasing beryllium into the surrounding these sensitized workers had been reduce workers’ exposure to beryllium area, were found to be sensitized within employed at the plant for less than two (Thomas et al. 2009, Document ID 3 and 6 months of beginning work at the years (Henneberger et al., 2001, 0590). Requirements designed to plant. One (2.2 percent) of 45 workers Document ID 1313, Table 3). Of 77 minimize dermal contact with hired after the enclosure was built was Tucson workers hired prior to 1992 who beryllium, including long-sleeve facility confirmed as sensitized. From these were tested in 1998, 8 (10.4 percent) uniforms and polymer gloves, were early results comparing the screening were sensitized and 7 of these (9.7 instituted in production areas in 2000– conducted on workers hired before 2000 percent) were diagnosed with CBD 2002. In 2001, the company installed and those hired in 2000 and later, (Henneberger et al., 2001). local exhaust ventilation (LEV) in die especially following the enclosure of the Following the 1998 screening, the grinding and polishing operations RAZ, it appears that the greatest company continued efforts to reduce (Thomas et al., 2009, Figure 1). Personal reduction in sensitization risk (to one exposures, along with risk of lapel samples collected between June sensitized worker, or 2.2 percent) was sensitization and CBD, by implementing 2000 and December 2001, showed achieved after workers’ exposures were additional engineering and 3 administrative controls and a reduced exposures plant-wide (98 reduced to below 0.1 mg/m and PPE to comprehensive PPE program which percent were below 0.2 mg/m3). Median, prevent dermal contact was instituted included the use of respiratory arithmetic mean, and geometric mean (Thomas et al., 2009). protection (1999) and latex gloves values less than or equal to 0.03 mg/m3 2. Tucson, AZ, Plant (2000) (Cummings et al., 2007, were reported in this period for all Kreiss et al. (1996, Document ID Document ID 1369). Enclosures were processes except one, a wire annealing 1477), Cummings et al. (2007, installed for various beryllium-releasing and pickling process. Samples for this Document ID 1369), and Henneberger et processes by 2001. Between 2000 and process remained elevated, with a al. (2001, Document ID 1313) conducted 2003, water-resistant or water-proof median of 0.1 mg/m3 (arithmetic mean of studies of workers at a beryllia ceramics garments, shoe covers, and taped gloves m 3 0.127 g/m , geometric mean of 0.083 plant in Tucson, Arizona. Kreiss et al. were incorporated to keep beryllium- m 3 g/m ) (Thomas et al., 2009, Table 3). In (1996) screened 136 workers at this containing fluids from wet machining January 2002, the company enclosed the plant with the BeLPT in 1992. Full-shift processes off the skin. To test the wire annealing and pickling process in area samples collected between 1983 efficacy of the new measures instituted a restricted access zone (RAZ). and 1992 showed primarily low after 1998, in January 2000 the company Beginning in 2002, the company airborne beryllium levels at this facility began screening new workers for required use of powered air-purifying (76 percent of area samples were at or sensitization at the time of hire and at respirators (PAPRs) in the RAZ, and below 0.1 mg/m3 and less than 1 percent 3, 6, 12, 24, and 48 months of implemented stringent measures to exceeded 2 mg/m3). 4,133 short-term employment. These more stringent minimize the potential for skin contact breathing zone measurements collected measures appear to have substantially and beryllium transfer out of the zone, between 1981 and 1992 had a median of reduced the risk of sensitization among such as requiring RAZ workers to 0.3 mg/m3. A small set (75) of personal new employees. Of 97 workers hired shower before leaving the zone (Thomas lapel samples collected at the plant between 2000 and 2004, one case of et al., 2009, Figure 1). While exposure beginning in 1991 had a median of 0.2 sensitization was identified (1 percent) samples collected by the facility were mg/m3 and ranged from 0.1 to 1.8 mg/m3 (Cummings et al., 2007). sparse following the enclosure, they (arithmetic and geometric mean values suggest exposure levels comparable to not reported) (Kreiss et al., 1996). 3. Elmore, OH, Plant the 2000–2001 samples in areas other Kreiss et al. reported that eight (5.9 Kreiss et al. (1997, Document ID percent) of the 136 workers tested in 1360), Bailey et al. (2010, Document ID 11 Although OSHA reports percentages to indicate 1992 were sensitized, six (4.4 percent) 0676), and Schuler et al. (2012, the risks of sensitization and CBD in this section, the benchmark OSHA typically uses to demonstrate of whom were diagnosed with CBD. One Document ID 0473) conducted studies significant risk, as discussed in Pertinent Legal sensitized worker was one of 13 of workers at a beryllium metal, alloy, Authority, is greater than or equal to 1 in 1,000 administrative workers screened, and and oxide production plant in Elmore, workers. One in 1,000 workers is equivalent to 0.1 was among those diagnosed with CBD. Ohio. Workers participated in several percent. Therefore, any value of 0.1 percent or higher when reporting occurrence of a health effect Exposures of administrative workers plant-wide BeLPT surveys beginning in is considered by OSHA to indicate a significant were not well characterized, but were 1993–1994 (Kreiss et al., 1997; Schuler risk. believed to be among the lowest in the et al., 2012) and in a series of screenings

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for workers hired in 2000 and later, beryllium. Six (2.1 percent) of the of sensitization among 66 workers with conducted beginning in 2000 (Bailey et program group had confirmed abnormal total mass LTW average exposures al., 2010). results on their final round of BeLPTs, below 0.1 mg/m3, and no cases of Exposure levels at the plant between which occurred in different years for sensitization among workers with total 1984 and 1993 were characterized using different employees. This four-fold mass LTW average exposures below a mixture of general area, short-term reduction in sensitization suggests that 0.09 mg/m3, suggesting that beryllium- breathing zone, and personal lapel beryllium-exposed workers’ risk of exposed workers’ risk can be much samples (Kreiss et al., 1997, Document sensitization (and therefore of CBD, reduced or eliminated by reducing ID 1360). Kreiss et al. reported that the which develops only following airborne exposures to average levels median area samples for various work sensitization) can be much reduced by below 0.1 mg/m3. areas ranged from 0.1 to 0.7 mg/m3, with the combination of process controls, Schuler et al. (2012, Document ID the highest values in the alloy arc respiratory protection requirements, and 0473) then used logistic regression to furnace and alloy melting-casting areas. PPE requirements applied in this explore the relationship between Personal lapel samples were available facility. Because most of the workers in estimated beryllium exposure and from 1990–1992, and showed high the study had been employed at the sensitization and CBD. For beryllium exposures overall (median value of 1.0 facility for less than two years, and CBD sensitization, the logistic models by mg/m3), with very high exposures for typically develops over a longer period Schuler et al. showed elevated odds some processes. Kreiss et al. reported of time (see section V, Health Effects), ratios (OR) for LTW average (OR 1.48) median sample values from the personal Bailey et al. did not report the incidence and highest job (OR 1.37) exposure for lapel samples of 3.8 mg/m3 for beryllium of CBD among the sensitized workers total mass exposure; the OR for oxide production, 1.75 mg/m3 for alloy (Bailey et al., 2010). Schuler et al. (2012, cumulative exposure was smaller (OR melting and casting, and 1.75 mg/m3 for Document ID 0473) published a study 1.23) and borderline statistically the arc furnace. The authors reported examining beryllium sensitization and significant (95 percent CI barely that 43 (6.9 percent) of 627 workers CBD among short-term workers at the included unity).13 Relationships tested in 1993–1994 were sensitized. 29 Elmore, OH plant, using exposure between sensitization and respirable workers (including 5 previously estimates created by Virji et al. (2012, exposure estimates were similarly identified) were diagnosed with CBD Document ID 0466). The study elevated for LTW average (OR 1.37) and (29/632, or 4.6 percent) (Kreiss et al., population included 264 workers highest job (OR 1.32) exposures. Among 1997). employed in 1999 with up to 6 years the submicron exposure estimates, only In 1996–1999, the company took tenure at the plant (91 percent of the highest job (OR 1.24) had a 95 percent further steps to reduce workers’ 291 eligible workers). By including only CI that just included unity for beryllium exposures, including short-term workers, Virji et al. were able sensitization. For CBD, elevated odds enclosure of some beryllium-releasing to construct participants’ exposures ratios were observed only for the processes, establishment of restricted- with more precision than was possible cumulative exposure estimates and were access zones, and installation or in studies involving workers exposed similar for total mass and respirable updating of certain engineering controls for longer durations and in time periods exposure (total mass OR 1.66, respirable (Bailey et al., 2010, Document ID 0676, with less exposure sampling. A set of OR 1.68). Cumulative submicron Tables 1–2). Beginning in 1999, all new 1999 exposure surveys and employee exposure showed an elevated, employees were required to wear loose- work histories was used to estimate borderline significant odds ratio (OR fitting PAPRs in manufacturing employees’ long-term lifetime weighted 1.58). The odds ratios for average buildings. Skin protection became part (LTW) average, cumulative, and highest- exposure and highest-exposed job were of the protection program for new job-worked exposures for total, not statistically significantly elevated. employees in 2000, and glove use was respirable, and submicron beryllium Schuler et al. concluded that both total required in production areas and for mass concentrations (Schuler et al., and respirable mass concentrations of handling work boots beginning in 2001. 2012; Virji et al., 2012). beryllium exposure were relevant By 2001, either half-mask respirators or As reported by Schuler et al. (2012), predictors of risk for beryllium PAPRs were required throughout the the overall prevalence of sensitization sensitization and CBD. Average and production facility (type determined by was 9.8 percent (26/264). Sensitized highest job exposures were predictive of airborne beryllium levels) and workers were offered further evaluation risk for sensitization, while cumulative respiratory protection was required for for CBD. Twenty-two sensitized workers exposure was predictive of risk for CBD roof work and during removal of work consented to clinical testing for CBD via (Schuler et al., 2012). boots (Bailey et al., 2010). transbronchial biopsy. Although follow- Materion submitted comments Beginning in 2000, newly hired up time was too short (at most 6 years) supporting OSHA’s use of the Schuler et workers were offered periodic BeLPT to fully evaluate CBD in this group, 6 of al. (2012) study as a basis for the final testing to evaluate the effectiveness of those sensitized were diagnosed with TWA PEL of 0.2 mg/m3. Materion stated the new exposure control program CBD (2.3 percent, 6/264). Schuler et al. that ‘‘the best available evidence to implemented by the company (Bailey et (2012) found 17 cases of sensitization establish a risk-based OEL [occupational al., 2010). Bailey et al. compared the (8.6%) within the first 3 quartiles of exposure limit] is the study conducted occurrence of beryllium sensitization LTW average exposure (198 workers by NIOSH and presented in Schuler and disease among 258 employees who with LTW average total mass exposures 2012. The exposure assessment in began work at the Elmore plant between lower than 1.1 mg/m3) and 4 cases of January 15, 1993 and August 9, 1999 CBD (2.2%) within those first 3 quartiles workers reported in their table of LTW average (the ‘‘pre-program group’’) with that of (183 workers with LTW average total quartiles for CBD. The table for CBD appeared to 290 employees who were hired between mass exposures lower than 1.07 mg/ exclude 20 workers with sensitization and no CBD. February 21, 2000 and December 18, 13 An odds ratio (OR) is a measure of association m3)12 The authors found 3 cases (4.6%) 2006, and were tested at least once after between an exposure and an outcome. The OR represents the odds that an outcome will occur hire (the ‘‘program group’’). They found 12 The total number of workers Schuler et al. given a particular exposure, compared to the odds that, as of 1999, 23 (8.9 percent) of the reported in their table of LTW average quartiles for of the outcome occurring in the absence of that pre-program group were sensitized to sensitization differs from the total number of exposure.

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Schuler et al. was based on a highly with latency as short as 3 months of workers at a precision machining robust workplace monitoring dataset exposure, and . . . the risk of CBD facility in Cullman, Alabama. After a and the study provides improved data declines over time’’ (Document ID 1661, case of CBD was diagnosed at the plant for determining OELs’’ (Document ID Attachment 5, p. 19). In stating this, in 1995, the company began BeLPT 1661, pp. 9–10). Materion also Procter et al. cite studies by Newman et screenings to identify workers at risk of submitted an unpublished manuscript al. (2001, Document ID 1354) and CBD and implemented engineering and documenting an analysis it Harber et al. (2009, as cited in administrative controls designed to commissioned, entitled ‘‘Derived No- Document ID 1661). Newman et al. reduce workers’ beryllium exposures in Effect Levels for Occupational (2001) studied a group of workers in a machining operations. Newman et al. Beryllium Exposure Using Cluster machining plant with job tenures (2001) conducted a series of BeLPT Analysis and Benchmark Dose averaging 11.7 years, considerably screenings of workers at the facility Modeling’’ (Proctor et al., Document ID longer than the worker cohort from the between 1995 and 1999. The authors 1661, Attachment 5). In this document, study used by Procter et al., and reported 22 (9.4 percent) sensitized Proctor et al. used data from Schuler et identified new cases of CBD from health workers among 235 tested, 13 of whom al. 2012 to develop a Derived No-Effect screenings conducted up to 4 years after were diagnosed with CBD within the Level (DNEL) for beryllium measured as an initial screening. Harber et al., (2009) study period. Personal lapel samples respirable beryllium, total mass of developed an analytic model of disease collected between 1980 and 1999 beryllium, and inhalable beryllium.14 progression from beryllium exposure indicate that median exposures were OSHA’s beryllium standard measures and found that, although the rate at generally well below the preceding PEL beryllium as total mass; thus, the results which new cases of CBD declined over (≤0.35 mg/m3 in all job titles except for total mass are most relevant to time, the overall proportion of maintenance (median 3.1 mg/m3 during OSHA’s risk analysis for the beryllium individuals with CBD increased over 1980–1995) and gas bearings (1.05 mg/ standard. The assessment reported a time from initial exposure (see Figure 2 m3 during 1980–1995)). DNEL of 0.14 mg/m3 for total mass of Haber et al., 2009). Furthermore, the Between 1995 and 1999, the company beryllium (Document ID 1661, study used by Proctor et al. to derive the built enclosures around several Attachment 5, p. 16). Materion DNEL, Schuler et al. (2012), did report beryllium-releasing operations; installed commented that this finding ‘‘add[s] to finding that the risk of CBD increased or updated LEV for several machining the body of evidence that supports the with cumulative exposure to beryllium, departments; replaced pressurized air fact that OSHA is justified in lowering as summarized above. Therefore, OSHA hoses and dry sweeping with wet the existing PEL to 0.2 mg/m3’’ is not convinced that a ‘‘no effect level’’ methods and vacuum systems for (Document ID 1661, p. 11). for beryllium that is based on the health cleaning; changed the layout of the Proctor et al. characterized the DNEL experience of workers with a median job plant to keep beryllium-releasing of 0.14 mg/m3 as ‘‘inherently tenure of 20.9 months can represent a processes close together; limited access conservative because average exposure ‘‘no-effect level’’ for workers exposed to to the production area of the plant; and metrics were used to determine DNELs, beryllium for as long as 45 years. required the use of company uniforms. which are limits not [to] be exceeded on NIOSH commented on the results of Madl et al. (2007, Document ID 1056) a daily basis’’ (Document ID 1661, Proctor et al.’s analysis and the reported that engineering and work Attachment 5, p. 22). Materion referred underlying data set, noting several process controls, rather than personal to the DNELs derived by Proctor et al. features of the dataset that are common protective equipment, were used to as providing an ‘‘additional margin of to the beryllium literature, such as limit workers’ exposure to beryllium. In safety’’ for similar reasons (Document ID uncertain date of sensitization or onset contrast to the Reading and Tucson 1661, p. 11). of CBD and no ‘‘background’’ rate of plants, gloves were not required at this Consistent with NIOSH comments beryllium sensitization or CBD, that plant. Personal lapel samples collected discussed in the next paragraph, OSHA make statistical analyses of the data extensively between 1996 and 1999 in disagrees with this characterization of difficult and add uncertainty to the machining and non-machining jobs had the DNEL as representing a ‘‘no effect derivation of a DNEL (Document ID medians of 0.16 mg/m3 and 0.08 mg/m3, level’’ for CBD or as providing a margin 1725, p. 5). NIOSH also noted that risk respectively (Madl et al., 2007, Table of safety for several reasons. The DNEL of CBD may be underestimated in the IV). At the time that Newman et al. from Proctor et al. is based on CBD underlying data set if workers with CBD reviewed the results of BeLPT findings among a short-term worker were leaving employment due, in part, screenings conducted in 1995–1999, a population and thus cannot represent to adverse health effects (‘‘unmeasured subset of 60 workers had been employed the risk presented to workers who are survivor bias’’) and estimated that as at the plant for less than a year and had exposed over a working lifetime. Proctor much as 30 percent of the cohort could therefore benefitted to some extent from et al. noted that it is ‘‘important to have been lost over the 6-year testing the controls described above. Four (6.7 consider that these data are from period (Document ID 1725, p. 5). NIOSH percent) of these workers were found to relatively short-term exposures [median concluded that Proctor et al.’s analysis be sensitized, of whom two were tenure 20.9 months] and are being used ‘‘does not contribute to the risk diagnosed with CBD and one with to support DNELs for lifetime assessment for beryllium workers’’ probable CBD (Newman et al., 2001, occupational exposures,’’ but (Document ID 1725, p. 5). OSHA agrees Document ID 1354). The later study by considered the duration of exposure to with NIOSH that the DNEL identified by Madl. et al. reported seven sensitized be sufficient because ‘‘CBD can develop Proctor et al. cannot be considered a workers who had been hired between reliable estimate of a no-effect level for 1995 and 1999, of whom four had 14 Derived No-Effect Level (DNEL) is used in beryllium. developed CBD as of 2005 (2007, Table REACH quantitative risk characterizations to mean II) (total number of workers hired the level of exposure above which humans should 4. Cullman, AL, Plant between 1995 and 1999 not reported). not be exposed. It is intended to represent a safe Newman et al. (2001, Document ID Beginning in 2000 (after the level of exposure for humans., REACH is the European Union’s regulation on Registration, 1354), Kelleher et al. (2001, Document implementation of controls between Evaluation, Authorization and Restriction of ID 1363), and Madl et al. (2007, 1997 and 1999), exposures in all jobs at Chemicals. Document ID 1056) studied beryllium the machining facility were reduced to

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

TABLE VI–1—EXPOSURE SAMPLING DATA BY PLANT—2000–2005

Arithmetic Smelter Number Median mean Geometric samples (μg/m3) mean (μg/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 more times per year, were offered shows test results for each facility beryllium levels at or above the action medical surveillance, including the between 2001 and 2005. level for at least 12 days per year, or BeLPT (Taiwo et al., 2008). Table VI–2 exposed at or above the STEL 12 or below, adapted from Taiwo et al. (2008),

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

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

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among workers with exposures below workers had LTW average exposures of estimated prevalence of sensitization the preceding TWA PEL. Schuler et al. approximately 0.09 mg/m3. among workers hired after these (2012, Document ID 0473) found 17 Furthermore, cases of sensitization measures were put in place was around cases of sensitization (8.6%) among and CBD continued to arise in the 2 percent (Bailey et al., 2010, Document Elmore, OH workers within the first Cullman, AL machining plant after ID 0676). In the Reading, PA facility, three quartiles of LTW average exposure control measures implemented only one (2.2 percent) of 45 workers (198 workers with LTW average total beginning in 1995 brought median hired after workers’ exposures were mass exposures lower than 1.1 mg/m3) airborne exposures below 0.2 mg/m3 reduced to below 0.1 mg/m3 and PPE to and 4 cases of CBD (2.2%) within the (personal lapel samples between 1996 prevent dermal contact was instituted first three quartiles of LTW average and 1999 in machining jobs had a was sensitized (Thomas et al., 2009, exposure (183 workers with LTW median of 0.16 mg/m3 and 0.08 mg/m3 in Document ID 0590). And, in the average total mass exposures lower than non-machining jobs) (Madl et al., 2007, aluminum smelters discussed by Taiwo 1.07 mg/m3; note that follow-up time of Document ID 1056, Table IV). At the et al. (2008, Document ID 0621), where up to 6 years for all study participants time that Newman et al. (2001, available exposure samples from four was very short for development of CBD). Document ID 1354) reviewed the results plants indicated median beryllium At the Cullman, AL machining facility, of BeLPT screenings conducted in levels of about 0.1 mg/m3 or below Newman et al. (2001, Document ID 1995–1999, a subset of 60 workers had (measured as an 8-hour TWA) and 1354) reported 22 (9.4 percent) been employed at the plant for less than workers used respiratory and dermal sensitized workers among 235 tested in a year and had therefore benefitted to protection, confirmed cases of 1995–1999, 13 of whom were diagnosed some extent from the exposure sensitization were rare (zero or one case with CBD. Personal lapel samples reductions. Four (6.7 percent) of these per location). collected between 1980 and 1999 workers were found to be sensitized, OSHA recognizes that the studies on indicate that median exposures were two of whom were diagnosed with CBD recent programs to reduce workers’ risk generally well below the preceding PEL and one with probable CBD (Newman et of sensitization and CBD were (≤0.35 mg/m3 in all job titles except al., 2001). A later study by Madl. et al. conducted on populations with very maintenance (median 3.1 mg/m3 during (2007, Document ID 1056) reported short exposure and follow-up time. 1980–1995) and gas bearings (1.05 mg/ seven sensitized workers who had been Therefore, they could not adequately m3 during 1980–1995)). hired between 1995 and 1999, of whom address the question of how frequently four had developed CBD as of 2005 workers who become sensitized in There is evidence in the literature that (Table II; total number of workers hired environments with extremely low although risk will be reduced by between 1995 and 1999 not reported). airborne exposures (median <0.1 mg/m3) compliance with the new TWA PEL, The experiences of several facilities in develop CBD. Clinical evaluation for significant risk of sensitization and CBD developing effective industrial hygiene CBD was not reported for sensitized will remain in workplaces in programs have shown the importance of workers identified in the studies compliance with OSHA’s new TWA minimizing both airborne exposure and examining the post-2000, very low- 3 PEL of 0.2 mg/m and could extend dermal contact to effectively reduce risk exposed worker cohorts in Tucson, down to the new action level of 0.1 mg/ of sensitization and CBD. Exposure Reading, and Elmore (Cummings et al. 3 m , although there is less information control programs that have used a 2007, Document ID 1369; Thomas et al. and therefore greater uncertainty with combination of engineering controls and 2009 (0590); Bailey et al. 2010 (0676)). respect to significant risk from airborne PPE to reduce workers’ airborne In Cullman, however, two of the beryllium exposures at and below the exposure and dermal contact have workers with CBD had been employed action level. For example, Schuler et al. substantially lowered risk of for less than a year and worked in jobs (2005, Document ID 0919) reported sensitization among newly hired with very low exposures (median 8-hour substantial prevalences of sensitization workers.15 Of 97 workers hired between personal sample values of 0.03–0.09 mg/ (6.5 percent) and CBD (3.9 percent) 2000 and 2004 in the Tucson, AZ plant m3) (Madl et al., 2007, Document ID among 152 workers at the Reading, PA after the introduction of mandatory 1056, Table III). The body of scientific facility who had BeLPT screening in respirator use in production areas literature on occupational beryllium 2000. These results showed significant beginning in 1999 and mandatory use of disease also includes case reports of risk at this facility, even though airborne latex gloves beginning in 2000, one case workers with CBD who are known or exposures were primarily below both of sensitization was identified (1 believed to have experienced minimal the preceding and final TWA PELs due percent) (Cummings et al., 2007, beryllium exposure, such as a worker to the low percentage of beryllium in Document ID 1369). In Elmore, OH, employed only in shipping at a copper- the metal alloys used (median general where all workers were required to wear beryllium distribution center (Stanton et area samples ≤0.1 mg/m3, 97% ≤0.5 mg/ respirators and skin PPE in production al., 2006, Document ID 1070), and m3); 93% of personal lapel samples areas beginning in 2000–2001, the workers employed only in were below the new TWA PEL of 0.2 mg/ administration at a beryllium ceramics m3). The only group of workers with no 15 As discussed in Section V, Health Effects, facility (Kreiss et al., 1996, Document ID cases of sensitization or CBD, a group of beryllium sensitization can occur from dermal 1477). Therefore, there is some evidence 26 office administration workers, was contact with beryllium. Studies conducted in the 1950s by Curtis et al. showed that soluble beryllium that cases of CBD can occur in work the group with exposures below the new particles could cause beryllium hypersensitivity environments where beryllium action level of 0.1 mg/m3 (median (Curtis, 1951, Document ID 1273; NAS, 2008, exposures are quite low. personal sample 0.01 mg/m3, range Document ID 1355). Tinkle et al. established that m 3 0.5- and 1.0-mm particles can penetrate intact 8. Community-Acquired CBD <0.01–0.06 g/m (Schuler et al., 2005). human skin surface and reach the epidermis, where The Schuler et al. (2012, Document ID beryllium particles would encounter antigen- In the NPRM, OSHA discussed an 0473) study of short-term workers in the presenting cells and initiate sensitization (Tinkle et additional source of information on low- Elmore, OH facility found 3 cases al., 2003, Document ID 1483). Tinkle et al. further level beryllium exposure and CBD: demonstrated that beryllium oxide and beryllium (4.6%) of sensitization among 66 sulfate, applied to the skin of mice, generate a Studies of community-acquired chronic workers with total mass LTW average beryllium-specific, cell-mediated immune response beryllium disease (CA–CBD) in exposures below 0.1 mg/m3; 3 of these similar to human beryllium sensitization. residential areas surrounding beryllium

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production facilities. The literature on Set from the Beryllium Machining when workers became sensitized or CA–CBD, including the Eisenbud (1949, Facility in Cullman, Alabama—CBD and what their ‘‘true’’ peak exposures Document ID 1284), Leiben and Metzner Sensitization, OSHA, 2016). leading up to sensitization were. Only a (1959, Document ID 1343), and Maier et NJH researchers, with consent and rough approximation of the upper levels al. (2008, Document ID 0598) studies, information provided by the Cullman of exposure a worker experienced is documents cases of CBD among facility, compiled a dataset containing possible. ERG attempted to represent individuals exposed to airborne employee work histories, medical workers’ highest exposures by beryllium at concentrations below the diagnoses, and air sampling results and constructing a third type of exposure new PEL. OSHA included a review of provided it to OSHA for analysis. estimate reflecting the exposure level these studies in the NPRM as a OSHA’s contractors from Eastern associated with the highest-exposure job secondary source of information on risk Research Group (ERG) gathered (HEJ) and time period experienced by of CBD from low-level beryllium additional information about work each worker. This exposure estimate exposure. However, the available operations and conditions at the plant, (HEJ), the cumulative exposure estimate, studies of CA–CBD have important developed exposure estimates for and the average exposure were used in limitations. These case studies do not individual workers in the dataset, and the quartile analysis and statistical provide information on how frequently helped to conduct quantitative analyses analyses presented below. individuals exposed to very low of the data to inform OSHA’s risk 2. Prevalence of Sensitization and CBD airborne levels develop CBD. In assessment (Document ID tbd). addition, the reconstructed exposure In the database provided to OSHA, 7 1. Worker Exposure Reconstruction estimates for CA–CBD cases are less workers were reported as sensitized reliable than the exposure estimates for The work history database contains only (that is, sensitized with no known working populations reviewed in the job history records for 348 workers. ERG development of CBD). Sixteen workers previous sections. The literature on CA– calculated cumulative and average were listed as sensitized and diagnosed CBD therefore was not used by OSHA as exposure estimates for each worker in with CBD upon initial clinical a basis for its quantitative risk the database. Cumulative exposure was evaluation. Three workers, first shown assessment for CBD, and the Agency did calculated as, to be sensitized only, were later not receive any comments or testimony diagnosed with CBD. Tables VI–3, VI–4, on this literature. Nevertheless, these and VI–5 below present the prevalence case reports and the broader CA–CBD of sensitization and CBD cases across literature indicate that individuals where e(i) is the exposure level for job several categories of LTW average, exposed to airborne beryllium below the (i), and t(i) is the time spent in job (i). cumulative, and HEJ exposure. final TWA PEL can develop CBD (e.g., Cumulative exposure was divided by Exposure values were grouped by Leiben and Metzner, 1959; Maier et al., total exposure time to estimate each quartile. For this analysis, OSHA 2008). worker’s long-term average exposure. excluded 8 workers with no job title These exposures were computed in a listed in the data set (because their B. OSHA’s Prevalence Analysis for time-dependent manner for the exposures could not be estimated); 7 Sensitization and CBD statistical modeling.16 For workers with workers whose date of hire was before OSHA evaluated exposure and health beryllium sensitization or CBD, 1969 (because this indicates they outcome data on a population of exposure estimates excluded exposures worked in the company’s previous workers employed at the Cullman following diagnosis. plant, for which no exposure machining facility as one part of the Workers who were employed for long measurements were available); and 14 Agency’s Preliminary Risk Analysis time periods in jobs with low-level workers who had zero exposure time in presented in the NPRM. A summary of exposures tend to have low average and the data set, perhaps indicating that OSHA’s preliminary analyses of these cumulative exposures due to the way they had been hired but had not come data, a discussion of comments received these measures are constructed, to work at Cullman. After these on the analyses and OSHA’s responses incorporating the worker’s entire work exclusions, a total of 319 workers to these comments, as well as a history. As discussed in the Health remained. None of the excluded workers summary OSHA’s final quantitative Effects chapter, higher-level exposures were identified as having beryllium analyses, are presented in the remainder or short-term peak exposures such as sensitization or CBD. of this section. A more detailed those encountered in machining jobs Note that all workers with CBD are discussion of the data, background may be highly relevant to risk of also sensitized. Thus, the columns information on the facility, and OSHA’s sensitization. However, individuals’ ‘‘Total Sensitized’’ and ‘‘Total %’’ refer analyses appears in the background beryllium exposure levels and to all sensitized workers in the dataset, document OSHA has placed in the sensitization status are not continuously including workers with and without a record (Risk Analysis of the NJH Data monitored, so it is not known exactly diagnosis of CBD.

TABLE VI–3—PREVALENCE OF SENSITIZATION AND CBD BY LTW AVERAGE EXPOSURE QUARTILE IN NJH DATA SET

LTW average exposure Group size Sensitized CBD Total Total CBD (μg/m3) only sensitized (%) (%)

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

16 Each worker’s exposure was calculated at each time that BeLPT testing was conducted.

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TABLE VI–3—PREVALENCE OF SENSITIZATION AND CBD BY LTW AVERAGE EXPOSURE QUARTILE IN NJH DATA SET— Continued

LTW average exposure Group size Sensitized CBD Total Total CBD (μg/m3) only sensitized (%) (%)

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

TABLE VI–4—PREVALENCE OF SENSITIZATION AND CBD BY CUMULATIVE EXPOSURE QUARTILE IN NJH DATA SET

Cumulative Sensitized Total Total CBD exposure Group size only CBD sensitized (%) (%) (μg/m3-yrs)

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

HEJ exposure Group size Sensitized CBD Total Total CBD (μg/m3) only sensitized (%) (%)

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

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of beryllium sensitization and CBD, and that risk is reduced at the [then] As in the preliminary statistical that maintaining exposure levels below proposed PEL (0.2 mg/m3) in analysis, Dr. Stone used fractional the action level can further reduce risk combination with stringent measures polynomials 18 to check for possible of beryllium sensitization and CBD. (ancillary provisions) to reduce worker’s nonlinearities in the exposure-response However, risk of both sensitization and exposures. This finding is evident based models, and checked the effects of age CBD remains even among the workers on the available literature, as described and smoking habits using data on birth with the lowest airborne exposures in by OSHA, and the prevalence data year and smoking (current, former, this data set. presented for the Cullman facility’’ never) provided in the Cullman data set. (Document ID 1660, p. 2). They also Data on workers’ estimated exposures C. OSHA’s Statistical Modeling for presented a detailed evaluation of the and health outcomes through 2005 were Sensitization and CBD statistical analysis of the Cullman data included in the reanalysis.19 The 1995 1. OSHA’s Preliminary Analysis of the presented in the NPRM, including a risk set (e.g., analysis of cases of NJH Data Set critique of OSHA’s modeling approach sensitization and CBD identified in 1995) was excluded from all models in In the course of OSHA’s development and interpretation and suggestions for the reanalysis so as not to analyze long- of the proposed rule, OSHA’s contractor alternate analyses. However, they standing (prevalent) cases of (ERG) also developed a statistical emphasized that the new beryllium rule sensitization and CBD together with analysis using the NJH data set and a should not be altered or delayed due to newly arising (incident) cases of discrete time proportional hazards their comments regarding the statistical sensitization and CBD. Finally, Dr. analysis (DTPHA). This preliminary model (Document ID 1660, p. 2). Stone used the testing protocols analysis predicted significant risks of After considering comments on this provided in the literature on the both sensitization (96–394 cases per preliminary model, OSHA instructed its Cullman study population to determine 1,000, or 9.6–39.4 percent) and CBD contractor to change the statistical the years in which each employee was analysis to address technical concerns (44–313 cases per 1,000, or 4.4–31.3 scheduled to be tested, and excluded and to incorporate suggestions from percent) at the preceding TWA PEL of employees from the analysis for years in 2 mg/m3 for an exposure duration of 45 Crump and Proctor, as well as NIOSH 3 which they were not scheduled to be years (90 mg/m -yr). The predicted risks (Document ID 1660; 1725). OSHA tested (Newman et al., 2001, Document of 8.2–39.9 cases of sensitization per reviews and addresses these comments ID 1354). 1,000 (0.8–3.9 percent) and 3.6 to 30.0 on the preliminary statistical analysis In the reanalysis of the NJH data set, cases of CBD per 1,000 (0.4–3 percent) and provides a presentation of the final the HR for sensitization increased were approximately 10-fold less, but statistical analysis in the background significantly with increasing LTW still significant, for a 45-year exposure document (Risk Analysis of the NJH average exposure (HR = 2.92, 95% CI = at the new TWA PEL of 0.2 mg/m3 (9 mg/ Data Set from the Beryllium Machining 1.51–5.66, p = 0.001; note that HRs are m3-yr). Facility in Cullman, Alabama—CBD and rounded to the second decimal place). In interpreting the risk estimates, Sensitization, OSHA, 2016). The results Cumulative exposure was also a OSHA took into consideration of the final statistical analysis are statistically significant predictor for limitations in the preliminary statistical summarized here. beryllium sensitization, although it was analysis, primarily study size-related 2. OSHA’s Final Statistical Analysis of not as strongly related to sensitization as constraints. Consequently, as discussed the NJH Data Set LTW average exposure (HR = 1.04, 95% in the NPRM, OSHA did not rely on the CI 1.00–1.07, p = 0.03). The HR for CBD preliminary statistical analysis for its As noted above, Dr. Roslyn Stone of increased significantly with increasing significance of risk determination or to University of Pittsburgh School of cumulative exposure (HR = 1.04, 95% develop its benefits analysis. The Public Health reanalyzed for OSHA the CI = 1.01–1.08, p = 0.02). The HR for Agency relied primarily on the Cullman data set in order to address CBD increased somewhat with previously-presented analysis of the concerns raised by Crump and Proctor increasing LTW average exposure, but epidemiological literature and the (Document ID 1660). The reanalysis this increase was not significant at the prevalence analysis of the Cullman data uses a Cox proportional hazards model 0.05 level (HR = 2.25, 95% CI = 0.94– for its preliminary significance of risk instead of the DTPHA. The Cox model, 5.35, p = 0.07). determination, and on the prevalence a regression method for survival data, None of the analyses Dr. Stone analysis for its preliminary estimate of provides an estimate of the hazard ratio performed to check for nonlinearities in benefits. Although OSHA did not rely (HR) and its confidence interval.17 Like exposure-response or the effects of on the results of the preliminary the DTPHA, the Cox model can smoking or age substantially impacted statistical analysis for its findings, the accommodate time-dependent data; the results of the analyses for beryllium Agency presented the DTPHA in order however, the Cox model has an sensitization or CBD. The sensitivity to inform the public of its results, advantage over the DTPHA for OSHA’s analysis recommended by Crump and explain its limitations, and solicit purpose of estimating risk to beryllium- Proctor, excluding workers hired prior public comment on the Agency’s exposed workers in that it does not to 1980 (see Document ID 1660, p. 11), approach. estimate different ‘‘baseline’’ rates of did not substantially impact the results Dr. Kenny Crump and Ms. Deborah sensitization and CBD for different Proctor submitted comments on OSHA’s years. Time-specific risk sets were 18 Fractional polynomials are linear combinations preliminary risk assessment (Document constructed to accommodate the time- of polynomials that provide flexible shapes of ID 1660). Crump and Proctor agreed exposure response. dependent exposures. P-values were 19 Data from 2003 to 2005 were excluded in some with OSHA’s review of the based on likelihood ratio tests (LRTs), previous analyses due to uncertainty in some epidemiological literature and the with p-values <0.05 considered to be employees’ work histories. OSHA accepted prevalence analysis presented statistically significant. the.Crump and Proctor recommendation that these previously in this section. They stated, data should be included, so as to treat uncertain exposure estimates consistently in the reanalysis ‘‘we agree with OSHA’s conclusion that 17 The hazard ratio is an estimate of the ratio of (data prior to the start of sampling in 1980 were there is a significant risk (>1/1000 risk the hazard rate in the exposed group to that of the included in the previous analysis and most models of CBD) at the [then] current PEL, and control group. in the reanalysis).

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

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]

Exposure level Estimated Estimated μ 3 cases/1000, 95% CI cases/1000, 95% CI ( g/m ) .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 cases/1000 μg/m3-yrs cases/1000 μg/m3-yrs cases/1000 μg/m3-yrs cases/1000 (μg/m3-yrs) 95% CI 95% CI 95% CI 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– 4595.67 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, (cumulative exposure of 90 mg/m3-yr).20 1.0%, respectively. The predicted risk of used with the fixed ‘‘baseline’’ rates of The predicted risks of sensitization at CBD is also much lower at the new 0.5 percent and 1 percent, predicted the new PEL of 0.2 mg/m3 are TWA PEL of 0.2 mg/m3 (9 mg/m3-year), risks of sensitization totaling 43 and 86 substantially lower, at 6 and 12 cases at 7 cases per 1,000 assuming 45 years cases per 1,000 workers, respectively, or per 1,000 for the baselines of 0.5% and of exposure. 4.3 and 8.6 percent, at the preceding Due to limitations in the Cox analysis, PEL of 2 mg/m3. The predicted risk of 20 The predictions for each model represent the including the small size of the dataset, estimated probability of being sensitized or having CBD is 203 cases per 1,000 workers, or relatively limited exposure data from CBD at one point in time, rather than the the plant’s early years, study size- 20.3 percent, at the preceding PEL of 2 cumulative risk over a lifetime of exposure, which mg/m3, assuming 45 years of exposure would be higher. Lifetime risks are presented in the related constraints on the statistical FEA, Benefits Analysis. analysis of the dataset, limited follow-

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up time on many workers, and A conditional logistic regression preferable that excess risks attributable sensitivity of the results to the analysis showed an increased risk of to occupational beryllium be ‘‘baseline’’ values assumed for death from lung cancer in workers with determined relative to an unexposed or sensitization and CBD, OSHA must higher exposures when dose estimates minimally exposed reference interpret the model-based risk estimates were lagged by 10 and 20 years population. However, in this study presented in Tables VI–6 and VI–7 with (Sanderson et al., 2001, Document ID population, workers in the lowest caution. Uncertainties in these risk 1419). This lag was incorporated in quartile were exposed well above the estimates are discussed in the order to account for exposures that did preceding OSHA TWA PEL (average background document (Risk Analysis of not contribute to lung cancer because exposure <11.2 mg/m3) and may have the NJH Data Set from the Beryllium they occurred after the induction of had a significant lung cancer risk. This Machining Facility in Cullman, cancer. The authors noted that there was issue would have introduced further Alabama—CBD and Sensitization, considerable uncertainty in the uncertainty into the lung cancer risks. OSHA, 2016). However, these estimation of exposure levels for the In 2011, Schubauer-Berigan et al. uncertainties do not alter OSHA’s 1940s and 1950s and in the shape of the published a quantitative risk assessment conclusions with regard to the dose-response curve for lung cancer. In that addressed several of OSHA’s significance of risk at the preceding PEL a 2008 study, Schubauer-Berigan et al. concerns regarding the Sanderson et al. and alternate PELs that OSHA reanalyzed the data, adjusting for analysis. This new risk assessment was considered, which are based primarily potential confounders of hire age and based on an update of the Reading on the Agency’s review of the literature birth year (Schubauer-Berigan et al., cohort analyzed by Sanderson et al., as and the prevalence analysis presented 2008, Document ID 1350). The study well as workers from two smaller plants earlier in this section (also see Section reported a significant increasing trend (Schubauer-Berigan et al. 2011, VII, Significance of Risk). (p < 0.05) in lung cancer mortality when Document ID 1265). This study average (log transformed) exposure was population was exposed, on average, to D. Lung Cancer lagged by 10 years. However, it did not lower levels of beryllium and had fewer As discussed more fully in the Health find a significant trend when short-term workers than the previous Effects section of the preamble, OSHA cumulative (log transformed) exposure cohort analyzed by Sanderson et al. has determined beryllium to be a was lagged by 0, 10, or 20 years (2001, Document ID 1250) and carcinogen based on an extensive (Schubauer-Berigan et al., 2008, Table Schubauer-Berigan et al. (2008, review of the scientific literature 3). Document ID 1350). Schubauer-Berigan regarding beryllium and cancer (see In formulating the final rule, OSHA et al. (2011) followed the study Section V.E). This review included an was particularly interested in lung population through 2005 where evaluation of the human cancer risk estimates from a 45-year possible, increasing the length of follow- epidemiological, animal cancer, and (i.e., working lifetime) exposure to up time overall by an additional 17 beryllium levels between 0.1 mg/m3 mechanistic studies described in the and years of observation compared to the 2 mg/m3. The majority of case and previous analyses. For these reasons, Health Effects section of this preamble. control workers in the Sanderson et al. OSHA considered the Schubauer- OSHA’s conclusion is supported by the (2001, Document ID 1419) case-control Berigan (2011) analysis more findings of public health organizations analysis were first hired during the appropriate than Sanderson et al. (2001) such as the International Agency for 1940s and 50s when exposures were and Schubauer-Berigan (2008) for its Research on Cancer (IARC), which has extremely high (estimated daily risk assessment. OSHA therefore based determined beryllium and its weighted averages (DWAs) >20 mg/m3 its preliminary QRA for lung cancer on compounds to be carcinogenic to for most jobs) in comparison to the the results from Schubauer-Berigan et humans (Group 1 category) (IARC 2012, exposure range of interest to OSHA al. (2011). Document ID 0650); the National (Sanderson et al. 2001, Document ID OSHA received several comments Toxicology Program (NTP), which 1419, Table II). About two-thirds of about its choice of Schubauer-Berigan et classifies beryllium and its compounds cases and half of controls worked at the al. (2011) as the basis for its preliminary as known carcinogens (NTP 2014, plant for less than a year. Thus, a risk QRA for lung cancer. NIOSH Document ID 0389); and the assessment based on this exposure- commented that OSHA’s choice of Environmental Protection Agency response analysis would have needed to Schubauer-Berigan et al. for its (EPA), which considers beryllium to be extrapolate from very high to low preliminary analysis was appropriate a probable human carcinogen (EPA exposures, based on a working because ‘‘[n]o other study is available 1998, Document ID 0661). population with extremely short tenure. that presents quantitative dose-response The Sanderson et al. study previously While OSHA risk assessments must information for lung cancer, across a discussed in Health Effects evaluated often make extrapolations to estimate range of beryllium processing facilities’’ the association between beryllium risk within the range of exposures of (Document ID 1725, p. 7). In supporting exposure and lung cancer mortality interest, the Agency acknowledges that OSHA’s use of this study, NIOSH based on data from a beryllium these issues of short tenure and high emphasized in particular the study’s processing plant in Reading, PA exposures would have created inclusion of relatively low-exposed (Sanderson et al., 2001, Document ID substantial uncertainty in a risk workers from two facilities that began 1419). Specifically, this case-control assessment based on this particular operations in the 1950s (after employer study evaluated lung cancer mortality in study population. awareness of acute beryllium disease a cohort of 3,569 male workers In addition, the relatively high (ABD) and CBD led to efforts to employed at the plant from 1940 to 1969 exposures of the least-exposed workers minimize worker exposures to and followed through 1992. For each in the study population might have beryllium), as well as the presence of lung cancer victim, 5 age- and race- created methodological issues for the both soluble and poorly soluble forms of matched controls were selected by lung cancer case-control study design. beryllium in the facilities studied incidence density sampling, for a total Mortality risk is expressed as an odds (Document ID 1725, p. 7). of 142 identified lung cancer cases and ratio that compares higher exposure According to Dr. Paolo Boffetta, who 710 controls. quartiles to the lowest quartile. It is submitted comments on this study,

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Schubauer-Berigan et al. (2011) is not evidence has not changed since the et al., 2011). To estimate mean exposure the most relevant study available to Agency conducted its preliminary QRA (mg/m3), cumulative exposure was OSHA for its lung cancer risk analysis. based on Schubauer-Berigan et al. divided by exposure time (in days), Dr. Boffetta argued that the most (2011, Document ID 1265). Therefore, accounting where appropriate for lag informative study of lung cancer risk in OSHA concludes that Schubauer- time. Maximum exposure (mg/m3) was the beryllium industry after 1965 is one Berigan et al. (2011) is the most calculated as the highest annual DWA that he developed in 2015 (Boffetta et appropriate study for its final lung on record for a worker from the first al., 2015), which he described as a cancer QRA, presented below. exposure until the study cutoff date of pooled analysis of 11 plants and 4 December 31, 2005, again accounting 1. QRA for Lung Cancer Based on distribution centers (Document ID 1659, where appropriate for lag time. Schubauer-Berigan et al. (2011) p. 1). However, Dr. Boffetta did not Exposure estimates were lagged by 5, provide OSHA with the manuscript of The cohort studied by Schubauer- 10, 15, and 20 years in order to account his study, which he stated was under Berigan et al. (2011, Document ID 1265) for exposures that may not have review for publication. Instead, he included 5,436 male workers who had contributed to lung cancer because of reported some results of the study and worked for at least 2 days at the Reading the long latency required for directed OSHA to an abstract of the facility or at the beryllium processing manifestation of the disease. The study in the 2015 Annual Conference of plants in Hazleton, PA and Elmore, OH authors also fit models with no lag time. the Society for Epidemiologic Research prior to 1970. The authors developed As shown in Table VI–8 below, (Document ID 1659; Document ID 1661, job-exposure matrices (JEMs) for the estimated exposure levels for workers Attachment 1). three plants based on extensive from the Hazleton and Elmore plants Because only an abstract of Boffetta et historical exposure data, primarily were on average far lower than those for al.’s 2015 study was available to OSHA short-term general area and personal workers from the Reading plant (see Document ID 1661, Attachment 1), breathing zone samples, collected on a (Schubauer-Berigan et al., 2011). OSHA could not properly evaluate it or quarterly basis from a wide variety of Whereas the median worker from use it as the basis of a quantitative risk operations. These samples were used to Hazleton had a mean exposure across assessment for lung cancer. create DWA estimates of workers’ full- his tenure of less than 1.5 mg/m3 and the Nevertheless, OSHA has addressed shift exposures, using records of the median worker from Elmore had a mean comments Dr. Boffetta submitted based nature and duration of tasks performed exposure of less than 1 mg/m3, the on his analyses in the relevant sections by workers during a shift. Details on the median worker from Reading had a of the final QRA for lung cancer below. JEM and DWA construction can be mean exposure of 25 mg/m3. The Elmore Because it was not possible to use this found in Sanderson et al. (2001, and Hazleton worker populations also study for its lung cancer QRA and Document ID 1250), Chen et al. (2001, had fewer short-term workers than the OSHA is not aware of other studies Document ID 1593), and Couch et al. Reading population. This was appropriate for use in its lung cancer (2010, Document ID 0880). particularly evident at Hazleton, where QRA (nor did commenters besides Dr. Workers’ cumulative exposures (mg/ the median value for cumulative Boffetta suggest that OSHA use any m3-days) were estimated by summing exposure among cases was higher than additional studies for this purpose), daily average exposures (assuming five at Reading despite the much lower OSHA finds that the body of available workdays per week) (Schubauer-Berigan 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 exposure ...... 100 (34%) 68 (31%) 16 (53%) 16 (36%) 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 m3-days for cumulative exposure). The Berigan et al. reported that within the data set using a variety of exposure- authors used restricted cubic spline subset with smoking information, there response modeling approaches, models to assess the shape of the was little difference in smoking by including categorical analyses, exposure-response curves and suggest cumulative or maximum exposure continuous-variable piecewise log-linear appropriate parametric model forms. category, suggesting that smoking was models, and power models (2011, The Akaike Information Criterion (AIC) unlikely to act as a confounder in the Document ID 1265). All models adjusted value was used to evaluate the fit of cohort. In addition to models based on for birth cohort and plant. Because different model forms and lag times. the full cohort, Schubauer-Berigan et al. exposure values were log-transformed Because smoking information was also prepared risk estimates based on for the power model analyses, the available for only about 25 percent of models excluding professional workers authors added small values to exposures the cohort (those employed in 1968), (ten percent of cases) and workers of 0 in lagged analyses (0.05 mg/m3 for smoking could not be controlled for believed to have asbestos exposure (one- mean and maximum exposure, 0.05 mg/ directly in the models. Schubauer- third of cases). These models were

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intended to mitigate the potential models with a 10-year lag to generate 2004 to 2006 background lifetime lung impact of smoking and asbestos as HRs for male workers with a mean cancer rate among U.S. males who had confounders.21 exposure of 0.5 mg/m3 (the current survived, cancer-free, to age 30. At The authors found that lung cancer NIOSH Recommended Exposure Limit OSHA’s request, Dr. Schubauer-Berigan risk was strongly and significantly for beryllium).22 In addition, they also estimated excess lung cancer risks related to mean, cumulative, and estimated the daily weighted average for workers with mean exposures at the maximum measures of workers’ exposure that would be associated with preceding PEL of 2 mg/m3 and at each exposure (all models reported in an excess lung cancer mortality risk of of the other alternate PELs that were Schubauer-Berigan et al., 2011, one in one thousand (.005 mg/m3 to .07 under consideration: 1 mg/m3, 0.2 mg/ Document ID 1265). They selected the mg/m3 depending on model choice). To m3, and 0.1 mg/m3 (Document ID 0521). best-fitting categorical, power, and estimate excess risk of cancer, they The resulting risk estimates are monotonic piecewise log-linear (PWL) multiplied these hazard ratios by the presented in Table VI–9 below.

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 professional and asbes- tos workers ...... 3.1 [<0–11] 6.4 [<0–23] 17 [<0–74] 39 [39–230] 61 [<0–280] 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 professional and asbestos workers ...... 1.4 [<0–6.0] 2.7 [<0–12] 7.1 [<0–35] 15 [<0–87] 33 [<0–290] Power model—all workers ...... 12 [6–19] 19 [9.3–29] 30 [15–48] 40 [19–66] 52 [23–88] Power model—excluding professional and asbestos work- ers ...... 19 [8.6–31] 30 [13–50] 49 [21–87] 68 [27–130] 90 [34–180]

SOURCE: Schubauer-Berigan, Document ID 0521, pp. 6–10.

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

21 The authors appeared to reason that if workers. However, smoking was unlikely to be 22 Here, ‘‘monotonic PWL model’’ means a model professional workers had both lower beryllium correlated with beryllium exposure among producing a monotonic exposure-response curve in exposures and lower smoking rates than production production workers, and would therefore probably the 0 to 2 mg/m3 range. workers, smoking could be a confounder in the not act as a confounder in a cohort excluding cohort comprising both production and professional professional workers.

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limited information available to the showing that the solubility of the exposure of known solubility class) at Agency. OSHA also responds to Dr. beryllium to which the workers in the the three facilities across most time Boffetta’s comments on Schubauer- studies he cited were exposed accounts periods’’ (Document ID 1725, p. 9). Berigan et al. (2011, Document ID 1265) for the lack of statistically significantly NIOSH also provided figures showing and Boffetta et al. (2014, Document ID elevated risk in the Boffetta et al. (2014) the contribution of insoluble beryllium 0403), which Dr. Boffetta asserts cohort or the Schubauer-Berigan et al. to exposure over time in the Schubauer- provides evidence that poorly soluble (2011) subcohort. While it is true that Berigan et al. (2011) study, as well as beryllium compounds are not associated the SMR for lung cancer was not the relatively small proportion of work with lung cancer (Document ID 1659, p. statistically significantly elevated in the years during which workers in the study 1). Schubauer-Berigan et al. (2011) study were exposed exclusively to either Boffetta argued that the most when workers hired before 1955 in the soluble or poorly soluble forms informative study in the modern (post- Reading and Lorain plants were (Document ID 1725, pp. 10–11). 1965) beryllium industry is Boffetta et excluded from the study population, or Boffetta et al. (2014, Document ID al. (2015, Document ID 1661, in the study of four facilities published 0403) examined a population of workers Attachment 1). According to Boffetta’s by Boffetta et al. in 2014, there are allegedly exposed exclusively to poorly comment, the study found an SMR of various possible reasons for these soluble beryllium compounds, in which 1.02 (95% CI 0.94–1.10, based on 672 results that Dr. Boffetta did not consider overall SMR for lung cancer was not deaths) for the overall cohort and an in his comment. As discussed below, statistically significantly elevated (SMR SMR for lung cancer among workers OSHA finds that the type of beryllium 96.0, 95% CI 80.0–114.3). Boffetta et al. exposed only to insoluble beryllium of compounds to which these workers concluded, ‘‘[a]lthough a small risk for 0.93 (95% CI 0.79–1.08, based on 157 were exposed is not likely to explain Dr. lung cancer is compatible with our deaths). Boffetta noted that his study Boffetta’s observations. results, we can confidently exclude an was based on 23 percent more overall As discussed in Section V, Health excess greater than 20%’’ in the study deaths than the Schubauer-Berigan et al. Effects and in comments submitted by population (Boffetta et al., 2014, p. 592). cohort (Document ID 1659, pp. 1–2). As NIOSH, animal toxicology evidence Limitations of the study include a lack stated earlier, this study is unpublished shows that poorly soluble beryllium of information on many workers’ job and was not provided to OSHA. The compounds can cause cancer. IARC titles, a lack of any beryllium exposure abstract provided by Materion determined that poorly soluble forms of measurements, and the very short-term (Document ID 1661, Attachment 1) beryllium are carcinogenic to humans in employment of most cohort members at included very little information beyond its 2012 review of Group I carcinogens the study facilities (less than 5 years for the SMRs reported; for example, it (see section V.E.5 of this preamble; 72 percent of the workers) (Boffetta et provided no information about the Document ID 1725, p. 9; IARC, 2012, al., 2014). manufacturing plants and distribution Document ID 0650). NIOSH noted that OSHA reviewed this study, and finds centers included, workers’ beryllium poorly soluble forms of beryllium that it does not contradict the findings exposure levels, how the cohorts were remain in the lung for longer time of the Schubauer-Berigan et al. (2011) defined, or how the authors determined periods than soluble forms, and can lung cancer risk analysis for several the solubility of the beryllium to which therefore create prolonged exposure of reasons. First, as shown in Table VI–9 workers were exposed. OSHA is lung tissue to beryllium (Document ID above, none of the predictions of excess therefore unable to evaluate the quality 1725, p. 9). This prolonged exposure risk in the risk analysis exceed 20 or conclusions of this study. may lead to the sustained tissue percent (200 per 1,000 workers); most Dr. Boffetta also commented that there inflammation that causes many forms of are well below this level, and thus are is a lack of evidence of increased lung cancer and is believed to be one well within the range that Boffetta et al. cancer risk among workers exposed only pathway for carcinogenesis due to (2014) state they cannot confidently to poorly soluble beryllium compounds beryllium exposure (see Section V, exclude. Thus, the statement by Boffetta (Document ID 1659, p. 1). To support Health Effects). et al. that the risk of excess lung cancer this statement, he cited a study he The comments from NIOSH also is no higher than 20 percent is actually published in 2014 of workers at four demonstrate that the available consistent with the risk findings from ‘‘insoluble facilities’’ (Boffetta et al., information cannot distinguish between Schubauer-Berigan et al. (2011) 2014) and Schubauer-Berigan et al.’s the effects of soluble and poorly soluble presented above. Second, the fact that 2011 study, arguing that increased beryllium. NIOSH submitted most workers in the cohort were cancer risk in beryllium-exposed information on the solubility of employed for less than five years workers in those two studies was only beryllium in the Schubauer-Berigan et suggests that most workers’ cumulative observed in workers employed in al. (2011) cohort, stating that operations exposures to beryllium were likely to be Reading and Lorain prior to 1955. typically involving both soluble and quite low, which would explain the Workers employed at the other plants poorly soluble beryllium were non-elevated SMR for lung cancer in the and workers who were first employed in performed at all three of the beryllium study population regardless of the type Reading and Lorain after 1955, plants included in the study (Document of beryllium to which workers were according to Dr. Boffetta, were exposed ID 1725, p. 9; Ward et al., 1992, exposed. The SMR for workers primarily to poorly soluble forms of Document ID 1378). Based on employed in the study facilities for at beryllium and did not experience an evaluations of the JEMs and work least 20 years was elevated (112.7, CI increased risk of lung cancer. Dr. histories of employees in the cohort 66.8–178.1) (Boffetta et al., 2014, Boffetta further stated that his (which were not published in the 2011 Document ID 0403, Table 3),23 unpublished paper (Boffetta et al., 2015) Schubauer-Berigan et al. paper), NIOSH supporting OSHA’s observation that the shows a similar result (Document ID stated that ‘‘the vast majority of lack of elevated SMR in the cohort 1659, p. 1). beryllium work-time at all three of these overall may be due to short-term OSHA carefully considered Dr. facilities was due to either insoluble or Boffetta’s argument regarding the status mixed chemical forms. In fact, insoluble 23 This SMR was not statistically significantly of poorly soluble beryllium compounds, beryllium was the largest single elevated, probably due to the small size of this and did not find persuasive evidence contributor to work-time (for beryllium subcohort (153 total deaths, 18 lung cancer deaths).

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employment and low cumulative were similar between the models’’ threshold for significant risk (see exposures. (Document ID 1659, p. 2). Therefore, Section II, Pertinent Legal Authority). Finally, the approach of Boffetta et al. according to Dr. Boffetta, ‘‘there is Small variations in background risk (2014), which relies on SMR analyses, ample uncertainty about the shape of across different populations are highly does not account for the healthy worker the dose-response function in the low- unlikely to influence excess lung cancer effect. SMRs are calculated by dose range’’ (Document ID 1659, p. 3). risk estimates sufficiently to influence comparing disease levels in the study OSHA agrees that it is difficult to OSHA’s finding of significant risk at the population to disease levels in the distinguish a single ‘‘best’’ model from preceding TWA PEL, which is the general population, using regional or the set of models presented by finding OSHA relies on to support the national reported disease rates. Schubauer-Berigan et al. (2011), and need for a new standard. However, because working populations that risk estimates at low exposure Finally, Dr. Boffetta noted that the tend to have lower disease rates than the levels vary depending on choice of models that exclude professional and overall population, SMRs can model. That is one reason OSHA asbestos workers (the groups that underestimate excess risk of disease in presented results from all of the models Schubauer-Berigan et al. believed could those populations. The SMR in Boffetta (see Table VI–9). OSHA further agrees be affected by confounding from tobacco et al. (2014) for overall mortality in the that there is uncertainty in the lung and asbestos exposure) showed non- study population was statistically cancer risk estimates, the estimation of significant increases in lung cancer with significantly reduced (94.7, 95 percent which (unlike for CBD) required increasing beryllium exposure. CI 89.9–99.7), suggesting a possible extrapolation below beryllium exposure According to Dr. Boffetta, this suggests healthy worker effect. The SMR for levels experienced by workers in the that confounding may contribute to the overall mortality was even further Schubauer-Berigan et al. (2011) study. results of the models based on the full reduced in the category of workers with However, the Schubauer-Berigan risk population. He speculates that if more at least 20 years of employment (87.7, assessment’s six best-fitting models all precise information on confounding 95 percent CI 74.3–102.7), in which an support OSHA’s significant risk exposures were available, excess risk elevated SMR for lung cancer was determination, as they all predict a estimates might be further reduced observed. NIOSH commented that ‘‘[i]n significant risk of lung cancer at the (Document ID 1659, p. 2). a modern industrial population, the preceding TWA PEL of 2 mg/m3 OSHA agrees with Dr. Boffetta that expected SMR for lung cancer would be (estimates ranging from 33 to 170 excess there is uncertainty in the Schubauer- approximately 0.93 [Park et al. (1991)]’’ lung cancers per 1,000 workers) and a Berigan et al. (2011) lung cancer risk (Document ID 1725, p. 8). This is lower substantially reduced, though still estimates, including uncertainty due to than the SMR for lung cancer (96) significant, risk of lung cancer at the limited information on possible observed in Boffetta et al. (2014) and new TWA PEL of 0.2 mg/m3 (estimates confounding from associations between much lower than the SMR for lung ranging from 3 to 30 excess lung cancers beryllium exposure level and workers’ cancer in the category of workers per 1,000 workers) (see Table VI–9). smoking habits or occupational co- employed for at least 20 years (112.7), Dr. Boffetta also noted that the risk exposures. However, in the absence of which is the group most likely to have estimates provided by Schubauer- detailed smoking and co-exposure had sufficient exposure and latency to Berigan et al. (2011, Document ID 1265) information, the models excluding show excess lung cancer (Boffetta et al., for OSHA’s lung cancer risk assessment professional and asbestos workers are a 2014, Document ID 0403, Tables 2 and depend on the background lung cancer reasonable approach to addressing the 3). Thus, it appears that the healthy rate used in excess risk calculations, possible effects of unmeasured worker effect is another factor (in and that industrial workers may have a confounding. OSHA’s decision to addition to low cumulative exposures) different background lung cancer risk include these models in its preliminary that may account for the findings of than the U.S. population as a whole and final QRAs therefore represents the Boffetta et al.’s 2014 study. (Document ID 1659, p. 2). OSHA agrees Agency’s best available means of Taken together, OSHA finds that the that choice of background risk could dealing with this uncertainty. animal toxicology evidence on the influence the number of excess lung E. Risk Assessment Conclusions carcinogenicity of poorly soluble cancers predicted by the models the beryllium forms, the long residence of Agency relied on for its lung cancer risk As described above, OSHA’s risk poorly soluble beryllium in the lung, the estimates. However, choice of assessment for beryllium sensitization likelihood that most workers in background risk did not influence and CBD relied on two approaches: (1) Schubauer-Berigan et al. (2011) were OSHA’s finding that excess lung cancer Review of the literature, and (2) analysis exposed to a mixture of soluble and risks would be substantially reduced by of a data set provided by NJH. OSHA poorly soluble beryllium forms, and the a decrease in exposure from the has a high level of confidence in its points raised above regarding Boffetta et preceding TWA PEL to the final TWA finding that the risks of sensitization al. (2014) rebut Boffetta’s claim that low PEL, because the same background risk and CBD are above the benchmark of 1 solubility of beryllium compounds is was factored into estimates of risk at in 1,000 at the preceding PEL, and the the most likely explanation for the lack both levels. Furthermore, the Agency believes that a comprehensive of statistically significantly elevated Schubauer-Berigan et al. (2011) standard requiring a combination of SMR results. estimates of excess lung cancer from more stringent controls on beryllium Dr. Boffetta’s comment also raised exposure at the preceding PEL of 2 mg/ exposure will reduce workers’ risk of technical questions regarding the m3 (ranging from 33 to 170 excess lung both sensitization and CBD. Programs Schubauer-Berigan et al. (2011, cancers per 1,000 workers, depending that have reduced median levels to Document ID 1265) risk analysis. He on the model) are much higher than the below 0.1 mg/m3 and tightly controlled noted that risk estimates at low level of 1 per 1,000 that OSHA finds to both respiratory exposure and dermal exposures are dependent on choice of be clearly significant. Even at the final contact have substantially reduced risk model in their analysis; the authors’ TWA PEL of 0.2 mg/m3, the models of sensitization within the first years of choice of a single ‘‘best’’ model was demonstrate a range of risks of excess exposure. These conclusions are based on purely statistical criteria, and lung cancers of 3 to 30 per 1,000 supported by the results of several the results of the statistics used (AIC) workers, estimates well above the studies conducted in facilities dealing

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with a variety of production activities forms and degrees of material Assessment, shows that significant risk and physical forms of beryllium that impairment—not just death or serious of CBD and lung cancer could remain in have reduced workers’ exposures physical harm. To evaluate the workplaces with exposures as low as the substantially by implementing stringent significance of the health risks that new action level of 0.1 mg/m3. OSHA exposure controls and PPE requirements result from exposure to hazardous also explains here that the new since approximately 2000. In addition, chemical agents, OSHA relies on standards will reduce the occurrence of these conclusions are supported by epidemiological, toxicological, and sensitization. OSHA’s analyses of the NJH data set, experimental evidence. The Agency In the NPRM, OSHA preliminarily which contains highly-detailed uses both qualitative and quantitative determined that both CBD and lung exposure and work history information methods to characterize the risk of cancer are material impairments of on several hundred beryllium workers. disease resulting from workers’ health. OSHA also preliminarily Furthermore, OSHA believes that exposure to a given hazard over a determined that a working lifetime (45 more stringent control of airborne working lifetime (generally 45 years) at years) of exposure to airborne beryllium beryllium exposures will reduce levels of exposure reflecting compliance at the preceding time-weighted average beryllium-exposed workers’ significant with the preceding standard and permissible exposure limit (TWA PEL) risk of lung cancer. The risk estimates compliance with the new standards (see of 2 mg/m3 would pose a significant risk from the lung cancer study by Section II, Pertinent Legal Authority). of both CBD and lung cancer, and that Schubauer-Berigan et al. (2011, When determining whether a significant this risk is substantially reduced but Document ID 1265; 0521), described risk exists OSHA considers whether still significant at the new TWA PEL of above, range from 33 to 170 excess lung there is a risk of at least one-in-a- 0.2 mg/m3. OSHA did not make a cancers per 1,000 workers exposed at thousand of developing a material preliminary determination as to whether the preceding PEL of 2 mg/m3, based on health impairment from a working beryllium sensitization is a material the study’s six best-fitting models. lifetime of exposure. The Supreme impairment of health because, as the These models each predict substantial Court has found that OSHA is not Agency explained in the NPRM, it was reductions in risk with reduced required to support its finding of not necessary to make such a exposure, ranging from 3 to 30 excess significant risk with scientific certainty, determination. The Agency’s lung cancers per 1,000 workers exposed but may instead rely on a body of preliminary findings on CBD and lung 3 at the final PEL of 0.2 mg/m . The reputable scientific thought and may cancer were sufficient to support the evidence of lung cancer risk from the make conservative assumptions (i.e., err promulgation of new beryllium Schubauer-Berigan et al. (2011) risk on the side of protecting the worker) in standards. assessment provides additional support its interpretation of the evidence Upon consideration of the entire for OSHA’s conclusions regarding the (Section II, Pertinent Legal Authority). rulemaking record, including the significance of risk of adverse health comments and information submitted to effects for workers exposed to beryllium OSHA’s findings in this section the record in response to the levels at and below the preceding PEL. follow in part from the conclusions of preliminary Health Effects, Risk However, the lung cancer risks required the preceding sections V, Health Effects, Assessment, and Significance of Risk a sizable low dose extrapolation below and VI, Risk Assessment. In this analyses (NPRM Sections V, VI, and beryllium exposure levels experienced preamble at section V, Health Effects, VIII), OSHA reaffirms its preliminary by workers in the Schubauer-Berigan et OSHA reviewed the scientific evidence findings that long-term exposure at the al. (2011) study. As a result, there is linking occupational beryllium preceding TWA PEL of 2 mg/m3 poses a greater uncertainty regarding the lung exposure to a variety of adverse health significant risk of material impairment cancer risk estimates than there is for effects and determined that beryllium of workers’ health, and that adoption of the risk estimates for beryllium exposure causes sensitization, CBD, and the new TWA PEL of 0.2 mg/m3 and sensitization and CBD. The conclusions lung cancer, and is associated with other provisions of the final standards with regard to significance of risk are various other adverse health effects (see will substantially reduce this risk. presented and further discussed in section V.D, V.E, and V.F). In this Material Impairment of Health section VII of the preamble. preamble at section VI, Risk Assessment, OSHA found that the As discussed in Section V, Health VII. Significance of Risk available epidemiological data are Effects, CBD is a respiratory disease In this section, OSHA discusses its sufficient to evaluate risk for beryllium caused by exposure to beryllium. CBD findings that workers exposed to sensitization, CBD, and lung cancer develops when the body’s immune beryllium at and below the preceding among beryllium-exposed workers. system reacts to the presence of TWA PEL face a significant risk of OSHA evaluated the risk of beryllium in the lung, causing a material impairment of health or sensitization, CBD, and lung cancer progression of pathological changes functional capacity within the meaning from levels of airborne beryllium including chronic inflammation and of the OSH Act, and that the new exposure that were allowed under the tissue scarring. CBD can also impair standards will substantially reduce this previous standard, as well as the other organs such as the liver, skin, risk. To make the significance of risk expected impact of the new standards spleen, and kidneys and cause adverse determination for a new final or on risk of these conditions. In this health effects such as granulomas of the proposed standard, OSHA uses the best section of the preamble, OSHA explains skin and lymph nodes and cor available scientific evidence to identify its determination that the risk of pulmonale (i.e., enlargement of the material health impairments associated material impairments of health, heart) (Conradi et al., 1971 (Document with potentially hazardous occupational particularly CBD and lung cancer, from ID 1319); ACCP, 1965 (1286); Kriebel et exposures and to evaluate exposed occupational exposures allowable under al., 1988a (1292) and b (1473)). workers’ risk of these impairments the preceding TWA PEL of 2 mg/m3 is In early, asymptomatic stages of CBD, assuming exposure over a working significant, and is substantially reduced small granulomatous lesions and mild lifetime. As discussed in section II, but still significant at the new TWA PEL inflammation occur in the lungs. Over Pertinent Legal Authority, courts have of 0.2 mg/m3. Furthermore, evidence time, the granulomas can spread and stated that OSHA should consider all reviewed in section VI, Risk lead to lung fibrosis (scarring) and

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moderate to severe loss of pulmonary CBD had developed from beryllium Treatment of CBD using inhaled and function, with symptoms including a exposure in his job melting an systemic steroid therapy has been persistent dry cough and shortness of aluminum alloy in a foundry casting shown to ease symptoms and slow or breath (Saber and Dweik, 2000, airplane parts (Document ID 1756, Tr. prevent some aspects of disease Document ID 1421). Fatigue, night 105–106). She described how her progression. As explained below, these sweats, chest and joint pain, clubbing of patient could no longer work because of treatments can be most effectively fingers (due to impaired oxygen his condition. ‘‘He requires oxygen and applied when CBD is diagnosed prior to exchange), loss of appetite, and systemic therapy . . . despite aggressive development of symptoms. In addition, unexplained weight loss may occur as treatment [his] test findings continue to the forms of treatment that can be used the disease progresses (Conradi et al., demonstrate worsening of his disease to manage early-stage CBD have 1971, Document ID 1319; ACCP, 1965 and increased needs for oxygen and relatively minor side effects on patients, (1286); Kriebel et al., 1988 (1292); medications as well as severe side while systemic steroid treatments Kriebel et al., 1988 (1473)). effects from medications. This patient required to treat later-stage CBD often Dr. Lee Newman, speaking at the may well need a lung transplant if this cause severe side effects. public hearing on behalf of the disease continues to progress . . . ’’ In the public hearing, Dr. Newman American College of Occupational and (Document ID 1756, Tr. 106–107). and Dr. Maier testified about their Environmental Medicine (ACOEM), The likelihood, speed, and severity of experiences treating patients with CBD testified on his experiences treating individuals’ transition from at various stages of the disease. Dr. patients with CBD: ‘‘as a physician who asymptomatic to symptomatic CBD is Newman stated that patients’ outcomes has spent most of my [practicing] career understood to vary widely, with some depend greatly on how early they are seeing patients with exposure to individuals responding differently to diagnosed. ‘‘So there are those people beryllium, with beryllium sensitization, exposure cessation and treatment than who are diagnosed very late in the and with chronic beryllium disease others (Sood, 2009, Document ID 0456; course of disease where there’s little including those who have gone on to Mroz et al., 2009 (1443)). In the public that we can do to intervene and they are require treatment and to die hearing, Dr. Newman testified that the going to die prematurely. There are prematurely of this disease . . . [I’ve great majority of individuals with very those people who may be detected with seen] hundreds and hundreds, probably early stage CBD in a cross-sectional milder disease where there are over a thousand individuals during my study he published (Pappas and opportunities to intervene’’ (Document career who have suffered from this Newman, 1993) had physiologic ID 1756, Tr. 132). Both Dr. Maier and condition’’ (Document ID 1756, Tr. 79). impairment. Thus, even before x-rays or Dr. Newman emphasized the Dr. Newman further testified about his CAT scans found evidence of CBD, the importance of early detection and 30 years of experience treating CBD in lung functions of those individuals were diagnosis, stating that removing the patients at various stages of the disease: abnormal (Document ID 1756, Tr. 112). patient from exposure and providing Materion commented that the best treatment early in the course of the . . . some of them will go from being available evidence on the transition sensitized to developing subclinical disease, disease can slow or even halt meaning that they have no symptoms. As I from asymptomatic to more severe CBD progression of the disease (Document ID mentioned earlier, most of those will, if we is a recent longitudinal study by Mroz 1756, Tr. 111, 132). actually do the tests of their lung function et al. (2009, Document ID 1443), which Dr. Maier testified that inhaled and their oxygen levels in their blood, those found that 19.3 percent of individuals steroids can be used to treat relatively people are already demonstrating physiologic with CBD developed clinical mild symptoms that may occur in early abnormality. They already have disease abnormalities requiring oral stages of the disease, such as a cough affecting their health. They go on to develop immunosuppressive therapy (Document symptomatic disease and progress to the during exercise (Document ID 1756, Tr. ID 1661, pp. 5–6). The authors’ overall 139). Inhaled steroids, she stated, are point where they require treatment. And conclusions in that study include a sometimes to the extent of even requiring a commonly used to treat other health [lung] transplant (Document ID 1756, Tr. finding that adverse physiological conditions and have fewer and milder 131). changes among initially asymptomatic side effects than forms of steroid CBD patients progress over time, Dr. Newman described one example treatment that are used to treat more requiring many individuals to be treated severe forms of CBD (Document ID of a patient who developed CBD from with corticosteroids, and that the his occupational beryllium exposure 1756, Tr. 140). Early detection of CBD patients’ levels of beryllium exposure helps physicians to properly treat early- and ‘‘who went on to die prematurely may affect progression (Mroz et al., with a great deal of suffering along the onset symptoms, since appropriate 2009). Dr. Maier, a co-author of the forms of treatment for early stage CBD way due to the condition chronic study, testified that studies ‘‘indicate beryllium disease’’ (Document ID 1756, can differ from treatments for conditions that higher levels of exposure not only it is commonly mistaken for, such as Tr. 80). are risk factors for [developing CBD in During her testimony at the public chronic obstructive pulmonary disease general] but also for more severe [CBD] hearing, Dr. Lisa Maier of National (Document ID 1756, Tr. 111).24 Jewish Health (NJH) provided an lung biopsies. Of 171 CBD cases, 33 (19.3%) developed clinical abnormalities requiring oral example from her experience with 24 The study by Mroz et al. (2009, Document ID immunosuppressive therapy, at an average of 1.4 treating CBD patients. ‘‘This gentleman 1443) included all individuals who were clinically years after the initial diagnosis of CBD. To examine started to have a cough, a dry cough in evaluated at NJH between 1982 and 2002 and were the effect of beryllium exposure level on the 2011 . . . His symptoms progressed and found to have CBD on baseline clinical evaluation. progression of CBD, Mroz et al. compared clinical All cohort members were identified by abnormal manifestations of CBD among machinists (the group he developed shortness of breath, BeLPTs before identification of symptoms, of patients likely to have had the highest beryllium wheezing, chills, night sweats, and physiologic abnormalities, or radiographic changes. exposures) to non- machinists, including only CBD fatigue. These were so severe that he All members were offered evaluation for clinical patients who had never smoked. Longitudinal was eventually hospitalized’’ abnormalities every 2 years through 2002, including analyses showed significant declines in some pulmonary function testing, exercise testing, chest clinical indicators over time since first exposure for (Document ID 1756, Tr. 105). Dr. Maier radiograph with International Labor Organization machinists (p <0.01) as well as faster development noted that this patient had no beryllium (ILO) B-reading, fiberoptic bronchoscopy with of illness (p < 0.05), compared to a control group exposure prior to 2006, and that his bronchoalveolar lavage (BAL), and transbronchial of non-machinists.

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(COPD) and asthma (Document ID 1756, glaucoma (Ballonzoli and Bourcier, debilitating manifestations of disease (43 FR Tr. 140–141). 2010, Document ID 0391; 52952, 52954). CBD in later stages is often managed Trikudanathan and McMahon, 2008 Since the Lead rulemaking, OSHA has using systemic steroid treatments such (0366); Lipworth, 1999 (0371)); an also found other non-symptomatic (or as corticosteroids. In workers with CBD increase in glucose intolerance sub-clinical) health conditions to be whose beryllium exposure has ceased, (Trikudanathan and McMahon, 2008, material impairments of health. In the corticosteroid therapy has been shown Document ID 0366); excessive weight Bloodborne Pathogens rulemaking, to control inflammation, ease symptoms gain (McDonough et al., 2008, OSHA maintained that material (e.g., difficulty breathing, fever, cough, Document ID 0369; Torres and Nowson, impairment includes not only workers and weight loss), and in some cases 2007 (0387); Dallman et al., 2007 (0357); with clinically ‘‘active’’ hepatitis from prevent the development of fibrosis Wolf, 2002 (0354); Cheskin et al., 1999 the hepatitis B virus (HBV) but also (Marchand-Adam et al., 2008, (0358)); increased risk of atherosclerosis includes asymptomatic HBV ‘‘carriers’’ Document ID 0370). Thus, although and other cardiovascular syndromes who remain infectious and are able to there is no cure for CBD, properly-timed (Franchimont et al., 2002, Document ID put others at risk of serious disease treatment can lead to CBD regression in 0376); skin fragility (Lipworth, 1999, through contact with body fluids (e.g., some patients (Sood, 2004, Document ID Document ID 0371); and poor wound blood, sexual contact) (56 FR 64004). 1331). Other patients have shown short- healing (de Silva and Fellows, 2010, OSHA stated: ‘‘Becoming a carrier [of term improvements from corticosteroid Document ID 0390). HBV] is a material impairment of health treatment, but then developed serious Based on the above, OSHA considers even though the carrier may have no fibrotic lesions (Marchand-Adam et al., late-stage CBD to be a material symptoms. This is because the carrier 2008). Ms. Peggy Mroz, of NJH, impairment of health, as it involves will remain infectious, probably for the discussed the results of the Marchand- permanent damage to the pulmonary rest of his or her life, and any person Adam et al. study in the hearing, stating system, causes additional serious who is not immune to HBV who comes that treatment of CBD using steroids has adverse health effects, can have adverse in contact with the carrier’s blood or been most successful when treatment occupational and social consequences, certain other body fluids will be at risk begins prior to the development of lung requires treatment that can cause severe of becoming infected’’ (56 FR 64004, fibrosis (Document ID 1756, Tr. 113). and lasting side effects, and may in 64036). Once fibrosis has developed in the some cases cause premature death. OSHA finds that early-stage CBD is lungs, corticosteroid treatment cannot Furthermore, OSHA has determined the type of asymptomatic health effect reverse the damage (Sood, 2009, that early-stage CBD, an asymptomatic Document ID 0456). Persons with late- the Agency determined to be a material period during which small lesions and impairment of health in the Lead and stage CBD experience severe respiratory inflammation appear in the lungs, is insufficiency and may require Bloodborne Pathogens standards. Early also a material impairment of health. stage CBD involves lung tissue supplemental oxygen (Rossman, 1991, OSHA bases this conclusion on Document 1332). Historically, late-stage inflammation without symptoms that evidence and expert testimony that can worsen with—or without— CBD often ended in death (NAS, 2008, early-stage CBD is a measurable change Document ID 1355). While the use of continued exposure. The lung pathology in an individual’s state of health that, progresses over time from a chronic steroid treatments can help to reduce with and sometimes without continued the effects of CBD, OSHA is not aware inflammatory response to tissue scarring exposure, can progress to symptomatic and fibrosis accompanied by moderate of any studies showing the effect of disease (e.g., Mroz et al., 2009 (1443); these treatments on the frequency of to severe loss in pulmonary function. 1756, Tr. 131). Thus, prevention of the Early stage CBD is clearly a precursor of premature death among patients with earliest stages of CBD will prevent CBD. advanced clinical disease, prevention of development of more serious disease. In which will prevent symptomatic Treatment with corticosteroids has OSHA’s Lead standard, promulgated in severe side effects (Trikudanathan and disease. OSHA determined in the Lead 1978, the Agency stated its position that standard that such precursor effects McMahon, 2008, Document ID 0366; a ‘‘subclinical’’ health effect may be Lipworth, 1999 (0371); Gibson et al., should be considered material health regarded as a material impairment of impairments in their own right, and that 1996 (1521); Zaki et al., 1987 (1374)). health. In the preamble to that standard, Adverse effects associated with long- the Agency should act to prevent them the Agency said: term corticosteroid use include, but are when it is feasible to do so. Therefore, not limited to: increased risk of OSHA believes that while incapacitating OSHA finds all stages of CBD to be opportunistic infections (Lionakis and illness and death represent one extreme of a material impairments of health within Kontoyiannis, 2003, Document ID 0372; spectrum of responses, other biological the meaning of section 6(b)(5) of the Trikudanathan and McMahon, 2008 effects such as metabolic or physiological OSH Act (29 U.S.C. 655(b)(5)). (0366)); accelerated bone loss or changes are precursors or sentinels of disease In reviewing OSHA’s Lead standard osteoporosis leading to increased risk of which should be prevented.... Rather than in United Steelworkers of America, revealing the beginnings of illness the AFL–CIO v. Marshall, 647 F.2d 1189, fractures or breaks (Hamida et al., 2011, standard must be selected to prevent an Document ID 0374; Lehouck et al., 2011 earlier point of measurable change in the 1252 (D.C. Cir. 1980) (Lead I), the D.C. (0355); Silva et al., 2011 (0388); Sweiss state of health which is the first significant Circuit affirmed that the OSH Act et al., 2011 (0367); Langhammer et al., indicator of possibly more severe ill health in ‘‘empowers OSHA to set a PEL that 2009 (0373)); psychiatric effects the future. The basis for this decision is prevents the subclinical effects of lead including depression, sleep twofold—first, pathophysiologic changes are that lie on a continuum shared with disturbances, and psychosis early stages in the disease process which overt lead disease.’’ See also AFL–CIO v. (Warrington and Bostwick, 2006, would grow worse with continued exposure Marshall, 617 F.2d 636, 654 n.83 (D.C. and which may include early effects which Cir. 1979) (upholding OSHA’s authority Document ID 0365; Brown, 2009 even at early stages are irreversible, and (0377)); adrenal suppression (Lipworth, therefore represent material impairment to prevent early symptoms of a disease, 1999, Document ID 0371; Frauman, themselves. Secondly, prevention of even if the effects of the disease are, at 1996 (0356)); ocular effects including pathophysiologic changes will prevent the that point, reversible). According to the cataracts, ocular hypertension, and onset of the more serious, irreversible and Court, OSHA only had to demonstrate,

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on the basis of substantial evidence, that (1363); Madl et al., 2007 (1056)); an percent) within those quartiles of LTW preventing the subclinical effects would Elmore, OH metal, alloy, and oxide average exposure (183 workers with help prevent the clinical phase of production plant (Kreiss et al., 1993 LTW average total mass exposures lower disease (United Steelworkers of Document ID 1478; Bailey et al., 2010 than 1.07 mg/m3; note that follow-up America, AFL–CIO, 647 F.2d at 1252). (0676); Schuler et al., 2012 (0473)); time of up to 6 years for all study Thus, OSHA has the authority to aluminum smelting facilities (Taiwo et participants was very short for regulate to prevent asymptomatic CBD al. 2008, Document ID 0621; 2010 development of CBD). At the Cullman, whether or not it is properly labeled as (0583); Nilsen et al., 2010 (0460)); and AL machining facility, Newman et al. a material impairment of health. nuclear facilities (Viet et al., 2000, (2001, Document ID 1354) reported 22 OSHA has also determined that Document ID 1344; Arjomandi et al., (9.4 percent) sensitized workers among exposure to beryllium can cause 2010 (1275)). 235 tested in 1995–1999, 13 of whom beryllium sensitization. Sensitization is The published literature on beryllium were diagnosed with CBD within the a precursor to development of CBD and sensitization and CBD discussed in study period. Personal lapel samples an essential step for development of the section VI shows that the risk of both collected between 1980 and 1999 disease. As discussed in Section V, can be significant in workplaces where indicate that median exposures were Health Effects, only sensitized exposures are at or below OSHA’s generally well below the preceding PEL individuals can develop CBD (NAS, preceding PEL of 2 mg/m3 (e.g., Kreiss et (≤0.35 mg/m3 in all job titles except 2008, Document ID 1355).25 As al., 1996, Document ID 1477; maintenance (median 3.1 mg/m3 during explained above, OSHA has the Henneberger et al., 2001 (1313); 1980–1995) and gas bearings (1.05 mg/ authority to promulgate regulations Newman et al., 2001 (1354); Schuler et m3 during 1980–1995)). designed to prevent precursors to al., 2005 (0919), 2012 (0473); Madl et Although risk will be reduced by material impairments of health. al., 2007 (1056)). For example, in the compliance with the new TWA PEL, Therefore, OSHA’s new beryllium Tucson ceramics plant mentioned evidence in the epidemiological studies standards aim to prevent sensitization above, Kreiss et al. (1996) reported that reviewed in section VI, Risk as well as the development of CBD and eight (5.9 percent) 26 of the 136 workers Assessment, shows that significant risk lung cancer. OSHA’s risk assessment for tested in 1992 were sensitized, six (4.4 of sensitization and CBD could remain sensitization, presented in section VI, percent) of whom were diagnosed with in workplaces with exposures as low as informs the Agency’s understanding of CBD. In addition, of 77 Tucson workers the new action level of 0.1 mg/m3. For what exposure control measures have hired prior to 1992 who were tested in example, Schuler et al. (2005, Document been successful in preventing 1998, eight (10.4 percent) were ID 0919) reported substantial sensitization, which in turn prevents sensitized and seven of these (9.7 prevalences of sensitization (6.5 development of CBD. Therefore, OSHA percent) were diagnosed with CBD percent) and CBD (3.9 percent) among addresses sensitization in this section (Henneberger et al., 2001, Document ID 152 workers at the Reading, PA facility on significance of risk. 1313). Full-shift area samples showed screened with the BeLPT in 2000. These results showed significant risk at this Risk Assessment most airborne beryllium levels below the preceding PEL: 76 percent of area facility, even though airborne exposures As discussed in Section VI, Risk samples collected between 1983 and were primarily below both the Assessment, the risk assessment for 1992 were at or below 0.1 mg/m3 and preceding and final TWA PELs due to beryllium sensitization and CBD relied less than 1 percent exceeded 2 mg/m3 the low percentage of beryllium in the on two approaches: (1) OSHA’s review ; short-term breathing zone metal alloys used (median general area of epidemiological studies of samples ≤0.1 mg/m3, 97% < 0.5 mg/m3; sensitization and CBD that contain measurements collected between 1981 and 1992 had a median of 0.3 mg/m3; 93% of personal lapel samples below information on exposures in the range of 3 and personal lapel samples collected at the new TWA PEL of 0.2 mg/m ). The interest to OSHA (2 mg/m3 and below), only group of workers with no cases of and (2) OSHA’s analysis of a NJH data the plant beginning in 1991 had a median of 0.2 mg/m3 (Kreiss et al., sensitization or CBD, a group of 26 set on sensitization and CBD in a group office administration workers, was the of beryllium-exposed machinists in 1996). Results from the Elmore, OH group with exposures below the new Cullman, AL. 3 beryllium metal, alloy, and oxide action level of 0.1 mg/m (median OSHA’s review of the literature 3 production plant and the Cullman, AL personal sample 0.01 mg/m , range includes studies of beryllium-exposed 3 machining facility also showed <0.01–0.06 mg/m ) (Schuler et al., 2005). workers at a Tucson, AZ ceramics plant The Schuler et al. (2012, Document ID (Kreiss et al., 1996, Document ID 1477; significant risk of sensitization and CBD among workers with exposures below 0473) study of short-term workers in the Henneberger et al., 2001 (1313); Elmore, OH facility found three cases Cummings et al., 2007 (1369)); a the preceding TWA PEL. Schuler et al. (2012, Document ID 0473) found 17 (4.6%) of sensitization among 66 Reading, PA copper-beryllium workers with total mass LTW average cases of sensitization (8.6 percent) processing plant (Schuler et al., 2005, exposures below 0.1 mg/m3. All three of among Elmore, OH workers within the Document ID 0919; Thomas et al., 2009 these sensitized workers had LTW first three quartiles of LTW average (0590)); a Cullman, AL beryllium average exposures of approximately 0.09 exposure (198 workers with LTW machining plant (Newman et al., 2001, mg/m3. Document ID 1354; Kelleher et al., 2001 average total mass exposures lower than 3 Furthermore, cases of sensitization 1.1 mg/m ) and 4 cases of CBD (2.2 and CBD continued to arise in the 25 In the NPRM, OSHA took no position on Cullman, AL machining plant after whether beryllium sensitization by itself is a 26 Although OSHA reports percentages to indicate material impairment of health, stating it was the risks of sensitization and CBD in this section, control measures implemented unnecessary to do so as part of this rulemaking. The the benchmark OSHA typically uses to demonstrate beginning in 1995 brought median only comment on this issue came from Materion, significant risk, as discussed earlier, is greater than airborne exposures below 0.2 mg/m3 which argued that ‘‘BeS does not constitute a or equal to 1 in 1,000 workers. One in 1,000 (personal lapel samples between 1996 material impairment of health or functional workers is equivalent to 0.1 percent. Therefore, any capacity’’ (document ID 1958). Because BeS is also value of 0.1 percent or higher when reporting and 1999 in machining jobs had a 3 a precursor to CBD, OSHA finds it unnecessary to occurrence of a health effect is considered by OSHA median of 0.16 mg/m and the median resolve this issue here. to indicate a significant risk. was 0.08 mg/m3 in non-machining jobs)

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(Madl et al., 2007, Document ID 1056, sensitization were rare (zero or one case these workers.28 In either case, based on Table IV). At the time that Newman et per location). these studies, the risks to workers from al. (2001, Document ID 1354) reviewed OSHA notes that the studies on recent long-term exposure at the preceding the results of BeLPT screenings programs to reduce workers’ risk of TWA PEL and below are clearly conducted in 1995–1999, a subset of 60 sensitization and CBD were conducted significant. OSHA’s review of workers had been employed at the plant on populations with very short exposure epidemiological studies further showed for less than a year and had therefore and follow-up time. Therefore, they that worker protection programs that benefitted to some extent from the could not adequately address the effectively reduced the risk of beryllium exposure reductions. Four (6.7 percent) question of how frequently workers who sensitization and CBD incorporated of these workers were found to be become sensitized in environments with engineering controls, work practice sensitized, of whom two were diagnosed extremely low airborne exposures controls, and personal protective with CBD and one with probable CBD (median <0.1 mg/m3) develop CBD. equipment (PPE) that reduce workers’ (Newman et al., 2001). A later study by Clinical evaluation for CBD was not airborne beryllium exposure and dermal Madl. et al. (2007, Document ID 1056) reported for sensitized workers contact with beryllium. OSHA has therefore determined that an effective reported seven sensitized workers who identified in the studies examining the worker protection program should had been hired between 1995 and 1999, post-2000 worker cohorts with very low incorporate both airborne exposure of whom four had developed CBD as of exposures in Tucson, Reading, and reduction and dermal protection 2005 (Table II; total number of workers Elmore (Cummings et al. 2007, provisions. hired between 1995 and 1999 not Document ID 1369; Thomas et al. 2009, reported). OSHA’s conclusions on significance (0590); Bailey et al. 2010, (0676)). In of risk at the final PEL and action level The enhanced industrial hygiene Cullman, however, two of the workers are further supported by its analysis of programs that have proven effective in with CBD had been employed for less the data set provided to OSHA by NJH several facilities demonstrate the than a year and worked in jobs with from which OSHA derived additional importance of minimizing both airborne very low exposures (median 8-hour information on sensitization and CBD at exposure and dermal contact to personal sample values of 0.03–0.09 mg/ exposure levels of interest. The data set 3 effectively reduce risk of sensitization m ) (Madl et al., 2007, Document ID describes a population of 319 beryllium- and CBD. Exposure control programs 1056, Table III). The body of scientific exposed workers at a Cullman, AL that have used a combination of literature on occupational beryllium machining facility. It includes exposure engineering controls, PPE, and stringent disease also includes case reports of samples collected between 1980 and housekeeping measures to reduce workers with CBD who are known or 2005, and has updated work history and workers’ airborne exposure and dermal believed to have experienced minimal screening information through 2003. contact have substantially lowered risk beryllium exposure, such as a worker Seven (2.2 percent) workers in the data of sensitization among newly-hired employed only in shipping at a copper- 27 set were reported as sensitized only. workers. Of 97 workers hired between beryllium distribution center (Stanton et Sixteen (5.0 percent) workers were 2000 and 2004 in the Tucson, AZ plant al., 2006, Document ID 1070), and listed as sensitized and diagnosed with after the introduction of a workers employed only in CBD upon initial clinical evaluation. comprehensive program which included administration at a beryllium ceramics Three (0.9 percent) workers, first shown the use of respiratory protection (1999) facility (Kreiss et al., 1996, Document ID to be sensitized only, were later and latex gloves (2000), one case of 1477). Therefore, there is some evidence diagnosed with CBD. The data set sensitization was identified (1 percent) that cases of CBD can occur in work includes workers exposed at airborne (Cummings et al., 2007, Document ID environments where beryllium beryllium levels near the new TWA PEL 1369). In Elmore, OH, where all workers exposures are quite low. of 0.2 mg/m3, and extensive exposure were required to wear respirators and In summary, the epidemiological data collected in workers’ breathing skin PPE in production areas beginning literature on beryllium sensitization and zones, as is preferred by OSHA. Unlike in 2000–2001, the estimated prevalence CBD that OSHA’s risk assessment relied the Tucson, Reading, and Elmore of sensitization among workers hired on show sufficient occurrence of facilities after 2000, respirator use was after these measures were put in place sensitization and CBD to be considered not generally required for workers at the was around 2 percent (Bailey et al., significant within the meaning of the Cullman facility. Thus, analysis of this 2010, Document ID 0676). In the OSH Act. These demonstrated risks are data set shows the risk associated with Reading, PA facility, after workers’ far in excess of 1 in 1,000 among varying levels of airborne exposure exposures were reduced to below 0.1 workers who had full-shift exposures rather than estimating exposure mg/m3 and PPE to prevent dermal well below the preceding TWA PEL of accounting for respirators. Also unlike contact was instituted, only one (2.2 2 mg/m3 and workers who had median the Tucson, Elmore, and Reading percent) of 45 workers hired was full-shift exposures down to the new facilities, glove use was not reported to sensitized (Thomas et al. 2009, action level of 0.1 mg/m3. These health be mandatory in the Cullman facility. Document ID 0590). And, in the effects occurred among populations of Therefore, OSHA believes reductions in aluminum smelters discussed by Taiwo workers whose follow-up time was risk at the Cullman facility to be the et al. (2008, Document ID 0621), where much less than 45 years. As stated result of airborne exposure control, available exposure samples from four earlier, OSHA is interested in the risk rather than the combination of airborne plants indicated median beryllium associated with a 45-year (i.e., working and dermal exposure controls used at levels of about 0.1 mg/m3 or below lifetime) exposure. Because CBD often other facilities. (measured as an 8-hour TWA) and develops over the course of years OSHA analyzed the prevalence of workers used respiratory and dermal following sensitization, the risk of CBD beryllium sensitization and CBD among protection, confirmed cases of that would result from 45 years of occupational exposure to airborne 28 This point was emphasized by members of the 27 As discussed in Section V, Health Effects, scientific peer review panel for OSHA’s Preliminary beryllium sensitization can occur from dermal beryllium is likely to be higher than the Risk Assessment (see the NPRM preamble at section contact with beryllium. prevalence of CBD observed among VII).

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

TABLE VII–1—PREVALENCE OF SENSITIZATION AND CBD BY LTW AVERAGE EXPOSURE QUARTILE IN NJH DATA SET

μ 3 Sensitized Total CBD LTW average exposure ( g/m ) Group size only CBD Total (%) (%)

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

μ 3 Sensitized Total CBD HEJ exposure ( g/m ) Group size only CBD Total (%) (%)

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 mg/m3 is close exposure shows a high prevalence of including one case of CBD (1.0 percent), to the upper bound of the highest beryllium-related health effects, with six were found among workers with LTW quartile of LTW average (0.51–2.15 mg/ workers sensitized (8.2 percent), of average exposure levels less than or m3) and HEJ (0.954–2.213 mg/m3) whom four (5.5 percent) were diagnosed equal to 0.08 mg/m3. One case of exposure levels. In the highest quartile with CBD. The second quartile of HEJ sensitization (1.2 percent) and no cases of LTW average exposure, there were 12 exposure also shows a high prevalence of CBD were found among workers with cases of sensitization (15.4 percent), of beryllium-related health effects, with HEJ exposures of at most 0.086 mg/m3. including eight (10.3 percent) diagnosed seven workers sensitized (8.6 percent), Strict control of airborne exposure to with CBD. Notably, the Cullman of whom six (7.4 percent) were levels below 0.1 mg/m3 using workers had been exposed to beryllium diagnosed with CBD. Among six engineering and work practice controls dust for considerably less than 45 years sensitized workers in the third quartile can, therefore, substantially reduce risk at the time of testing. A high prevalence of LTW average exposures, all were of sensitization and CBD. Although of sensitization (9.2 percent) and CBD diagnosed with CBD (7.8 percent). The OSHA recognizes that maintaining (5.3 percent) is seen in the top quartile prevalence of CBD among workers in exposure levels below 0.1 mg/m3 may of HEJ exposure as well, with even these quartiles was approximately 5–8 not be feasible in some operations (see higher prevalences in the third quartile percent, and overall sensitization this preamble at section VIII, Summary (0.387–0.691 mg/m3).29 (including workers with and without of the Economic Analysis and The new TWA PEL of 0.2 mg/m3 is CBD) was about 8–9 percent. OSHA Regulatory Flexibility Analysis), the close to the upper bound of the second considers these rates to be evidence that Agency finds that workers in facilities quartile of LTW average (0.81–0.18 mg/ the risks of developing sensitization and that meet the action level of 0.1 mg/m3 m3) and HEJ (0.091–0.214 mg/m3) CBD are significant among workers will face lower risks of sensitization and exposure levels and to the lower bound exposed at and below the preceding CBD than workers in facilities that of the third quartile of LTW average TWA PEL, and even below the new cannot meet the action level. (0.19–0.50 mg/m3) exposures. The TWA PEL. These risks are much higher Table VII–3 below presents the second quartile of LTW average than the benchmark for significant risk prevalence of sensitization and CBD of 1 in 1,000. Much lower prevalences cases across cumulative exposure 29 This exposure-response pattern, wherein of sensitization and CBD were found quartiles, based on the same Cullman higher rates of response are seen in workers with among workers with exposure levels data used to derive Tables 1 and 2. lower exposures, is sometimes attributed to a m 3 ‘‘healthy worker effect’’ or to exposure less than or equal to about 0.08 g/m , Cumulative exposure is the sum of a misclassification, as discussed in this preamble at although these risks are still significant. worker’s exposure across the duration of section VI, Risk Assessment. Two sensitized workers (2.2 percent), his or her employment.

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TABLE VII–3—PREVALENCE OF SENSITIZATION AND CBD BY CUMULATIVE EXPOSURE QUARTILE IN NJH DATA SET

μ 3 Sensitized Cumulative exposure ( g/m -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 the scientific literature regarding of beryllium than those at the Reading occupational exposure at the preceding beryllium and cancer. This review plant. The median worker from PEL would result in 90 mg/m3-years of included an evaluation of the human Hazleton had a LTW average exposure exposure, a value far higher than the epidemiological, animal cancer, and of less than 1.5 mg/m3, while the median cumulative exposures of workers in this mechanistic studies described in section worker from Elmore had a LTW average data set, who worked for periods of time V, Health Effects. OSHA’s conclusion exposure of less than 1 mg/m3. The less than 45 years and whose exposure that beryllium is carcinogenic is Elmore and Hazleton worker levels were mostly well below the supported by the findings of expert populations also had fewer short-term previous PEL. Workers with 45 years of public health and governmental workers than the Reading population. exposure to the new TWA PEL of 0.2 mg/ organizations such as the International Finally, the updated cohorts followed m3 would have a cumulative exposure Agency for Research on Cancer (IARC), the worker populations through 2005, (9 mg/m3-years) in the highest quartile which has determined beryllium and its increasing the length of follow-up time for this worker population. As with the compounds to be carcinogenic to compared to the previous exposure- average and HEJ exposures, the greatest humans (Group 1 category) (IARC, 2012, response analysis. For these reasons, risk of sensitization and CBD appears at Document ID 0650); the National OSHA based the preliminary risk the higher exposure levels (<1.467 mg/ Toxicology Program (NTP), which assessment for lung cancer on the m3-years). The third cumulative classifies beryllium and its compounds Schubauer-Berigan risk analysis. quartile, at which a sharp increase in as known carcinogens (NTP, 2014, Schubauer-Berigan et al. (2011, sensitization and CBD appears, is Document ID 0389); and the Document ID 1265) analyzed the data bounded by 1.468 and 7.008 mg/m3- Environmental Protection Agency set using a variety of exposure-response years. This is equivalent to 0.73–3.50 (EPA), which considers beryllium to be modeling approaches, described in this years of exposure at the preceding PEL a probable human carcinogen (EPA, preamble at section VI, Risk of 2 mg/m3, or 7.34–35.04 years of 1998, Document ID 0661). Assessment. The authors found that exposure at the new TWA PEL of 0.2 mg/ OSHA’s review of epidemiological lung cancer mortality risk was strongly m3. Prevalence of both sensitization and studies of lung cancer mortality among and significantly correlated with mean, CBD is substantially lower in the second beryllium workers found that most of cumulative, and maximum measures of cumulative quartile (0.148–1.467 mg/m3- them did not characterize exposure workers’ exposure to beryllium (all of years). This is equivalent to levels sufficiently to evaluate the risk of the models reported in the study). They approximately 0.7 to 7 years at the new lung cancer at the preceding and new selected the best-fitting models to TWA PEL of 0.2 mg/m3, or 1.5 to 15 TWA PELs. However, as discussed in generate risk estimates for male workers years at the action level of 0.1 mg/m3. this preamble at section V, Health with a mean exposure of 0.5 mg/m3 (the Risks at all levels of cumulative Effects and section VI, Risk Assessment, current NIOSH Recommended Exposure exposure presented in Table 3 are Schubauer-Berigan et al. published a Limit for beryllium). In addition, they significant. These findings support quantitative risk assessment based on estimated the daily weighted average OSHA’s determination that maintaining beryllium exposure and lung cancer exposure that would be associated with exposure levels below the new TWA mortality among 5,436 male workers an excess lung cancer mortality risk of PEL will help to protect workers against first employed at beryllium processing one in one thousand (.005 mg/m3 to .07 risk of beryllium sensitization and CBD. plants in Reading, PA, Elmore, OH, and mg/m3 depending on model choice). At Moreover, while OSHA finds that Hazleton, PA, prior to 1970 (Schubauer- OSHA’s request, the authors also significant risk remains at the PEL, Berigan et al., 2011, Document ID 1265). estimated excess lifetime risks for OSHA’s analysis shows that further This risk assessment addresses workers with mean exposures at the reductions of risk will ensue if important sources of uncertainty for preceding TWA PEL of 2 mg/m3 as well employers are able to reduce exposure previous lung cancer analyses, as at each of the alternate TWA PELs to the action level or even below. including the sole prior exposure- that were under consideration: 1 mg/m3, response analysis for beryllium and 0.2 mg/m3, and 0.1 mg/m3. Table VII–4 Lung Cancer lung cancer, conducted by Sanderson et presents the estimated excess risk of Lung cancer, a frequently fatal al. (2001) on workers from the Reading lung cancer mortality associated with disease, is a well-recognized material plant alone. Workers from the Elmore various levels of beryllium exposure, impairment of health. OSHA has and Hazleton plants who were added to based on the final models presented in determined that beryllium causes lung the analysis by Schubauer-Berigan et al. Schubauer-Berigan et al’s risk cancer based on an extensive review of were, in general, exposed to lower levels assessment.30

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

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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 professional and asbes- tos workers ...... 3.1 6.4 17 39 61 Best categorical—all workers ...... 4.4 9 25 59 170 Best categorical—excluding professional and asbestos workers ...... 1.4 2.7 7.1 15 33 Power model—all workers ...... 12 19 30 40 52 Power model—excluding professional and asbestos work- ers ...... 19 30 49 68 90 Source: Schubauer-Berigan, Document ID 0521, pp. 6–10.

The lowest estimate of excess lung and new TWA PELs. The Agency has, uncertainty in this finding for 0.1 mg/m3 cancer deaths from the six final models additionally, reviewed the medical since there is less information available presented by Schubauer-Berigan et al. is literature, as well as previous policy on populations exposed at and below 33 per 1,000 workers exposed at a mean determinations and case law regarding this level. Although significant risk level of 2 mg/m3, the preceding TWA material impairment of health, and has remains at the new TWA PEL, OSHA is PEL. Risk estimates as high as 170 lung determined that CBD, at all stages, and also required to consider the cancer deaths per 1,000 result from the lung cancer constitute material health technological and economic feasibility other five models presented. Regardless impairments. of the standard in determining exposure of the model chosen, the excess risk of OSHA has determined that long-term limits. As explained in Section VIII, about 33 to 170 per 1,000 workers is exposure to beryllium at the preceding Summary of the Final Economic clearly significant, falling well above the TWA PEL would pose a risk of CBD and Analysis and Final Regulatory level of risk the Supreme Court lung cancer greater than the risk of 1 per Flexibility Analysis, OSHA determined indicated a reasonable person might 1,000 exposed workers the Agency that the new TWA PEL of 0.2 mg/m3 is consider acceptable (see Benzene, 448 considers clearly significant, and that both technologically and economically U.S. at 655). The new PEL of 0.2 mg/m3 adoption of the new TWA PEL, action feasible in the general industry, is expected to reduce these risks level, and dermal protection construction, and shipyard sectors. significantly, to somewhere between 2.7 requirements of the final standards will OSHA was unable to demonstrate, and 30 excess lung cancer deaths per substantially reduce this risk. OSHA however, that a lower TWA PEL of 0.1 1,000 workers. At the new action level believes substantial evidence supports mg/m3 would be technologically of 0.1 mg/m3, risk falls within the range its determinations, including its choices feasible. Therefore, OSHA concludes of 1.4 to 19 excess lung cancer deaths. of the best available published studies that, in setting a TWA PEL of 0.2 mg/m3, These risk estimates still fall above the on which to base its risk assessment, its the Agency is reducing the risk to the threshold of 1 in 1,000 that OSHA examination of the prevalence of extent feasible, as required by the OSH considers clearly significant. However, sensitization and CBD among workers Act (see section II, Pertinent Legal the Agency believes the lung cancer with exposure levels comparable to the Authority). In this context, the Agency risks should be regarded as less certain preceding TWA PEL and new TWA PEL finds that the action level of 0.1 mg/m3, than the risk estimates for CBD and in the NJH data set, and its selection of dermal protection requirements, and sensitization discussed previously. the Schubauer-Berigan QRA to form the other ancillary provisions of the final While the risk estimates for CBD and basis for its lung cancer risk estimates. rule are critically important in reducing sensitization at the preceding and new The previously-described analyses the risk of sensitization, CBD, and lung TWA PELs were determined from demonstrate that workers with cancer among workers exposed to exposure levels observed in occupational exposure to airborne beryllium. Together, these provisions, occupational studies, the lung cancer beryllium at the preceding PEL face along with the new TWA PEL of 0.2 mg/ risks were extrapolated from much risks of developing CBD and dying from m3, will substantially reduce workers’ higher exposure levels. lung cancer that far exceed the value of risk of material impairment of health 1 in 1,000 used by OSHA as a from occupational beryllium exposure. Conclusions benchmark of clearly significant risk. As discussed throughout this section, Furthermore, OSHA’s risk assessment VIII. Summary of the Final Economic OSHA used the best available scientific indicates that risk of CBD and lung Analysis and Final Regulatory evidence to identify adverse health cancer can be significantly reduced by Flexibility Analysis effects of occupational beryllium reduction of airborne exposure levels, A. Introduction exposure, and to evaluate exposed and that dermal protection measures workers’ risk of these impairments. The will additionally help reduce risk of OSHA’s Final Economic Analysis and Agency reviewed extensive sensitization and, therefore, of CBD. Final Regulatory Flexibility Analysis epidemiological and experimental OSHA’s risk assessment also indicates (FEA) addresses issues related to the research pertaining to adverse health that, despite the reduction in risk costs, benefits, technological and effects of occupational beryllium expected with the new PEL, the risks of economic feasibility, and the economic exposure, including lung cancer, CBD, CBD and lung cancer to workers with impacts (including impacts on small and beryllium sensitization, and has average exposure levels of 0.2 mg/m3 are entities) of this final beryllium rule and evaluated the risk of these effects from still significant and could extend down evaluates regulatory alternatives to the exposures allowed under the preceding to 0.1 mg/m3, although there is greater final rule. Executive Orders 13563 and

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12866 direct agencies to assess all costs these changes are included in the The remainder of this section (Section and benefits of available regulatory relevant sections throughout the FEA. VIII) of the preamble is organized as alternatives and, if regulation is The Final Economic Analysis follows: necessary, to select regulatory contains the following chapters: B. Market Failure and the Need for approaches that maximize net benefits Regulation Chapter I. Introduction (including potential economic, C. Profile of Affected Industries Chapter II. Market Failure and the Need for environmental, and public health and D. Technological Feasibility safety effects; distributive impacts; and Regulation E. Costs of Compliance Chapter III. Profile of Affected Industries equity). Executive Order 13563 F. Economic Feasibility Analysis and Chapter IV. Technological Feasibility Regulatory Flexibility Determination emphasized the importance of Chapter V. Costs of Compliance quantifying both costs and benefits, of G. Benefits and Net Benefits Chapter VI. Economic Feasibility Analysis H. Regulatory Alternatives reducing costs, of harmonizing rules, and Regulatory Flexibility Determination I. Final Regulatory Flexibility Analysis. and of promoting flexibility. The full Chapter VII. Benefits and Net Benefits FEA has been placed in OSHA Chapter VIII. Regulatory Alternatives B. Market Failure and the Need for rulemaking docket OSHA–H005C– Chapter IX. Final Regulatory Flexibility Regulation 2006–0870. This rule is an economically Analysis Employees in work environments significant regulatory action under Sec. addressed by the final beryllium rule are 3(f)(1) of Executive Order 12866 and has Table VIII–1 provides a summary of OSHA’s best estimate of the costs and exposed to a variety of significant been reviewed by the Office of hazards that can and do cause serious Information and Regulatory Affairs in benefits of the final rule using a discount rate of 3 percent. As shown, injury and death. As described in the Office of Management and Budget, Chapter II of the FEA in support of the as required by executive order. the final rule is estimated to prevent 90 fatalities and 46 beryllium-related final rule, OSHA concludes there is a The purpose of the FEA is to: demonstrable failure of private markets • Identify the establishments and illnesses annually once it is fully effective, and the estimated cost of the to protect workers from exposure to industries potentially affected by the unnecessarily high levels beryllium and final rule; rule is $74 million annually. Also as shown in Table VIII–1, the discounted that private markets, as well as • Estimate current exposures and the information dissemination programs, technologically feasible methods of monetized benefits of the final rule are estimated to be $561 million annually, workers’ compensation systems, and controlling these exposures; tort liability options, each may fail to • Estimate the benefits resulting from and the final rule is estimated to generate net benefits of $487 million protect workers from beryllium employers coming into compliance with exposure, resulting in the need for a the final rule in terms of reductions in annually. Table VIII–1 also presents the estimated costs and benefits of the final more protective OSHA beryllium rule. cases of lung cancer, chronic beryllium After carefully weighing the various rule using a discount rate of 7 percent. disease; potential advantages and disadvantages • Evaluate the costs and economic of using a regulatory approach to TABLE VIII–1—ANNUALIZED BENEFITS, impacts that establishments in the improve upon the current situation, regulated community will incur to COSTS AND NET BENEFITS OF OSHA concludes that, in the case of achieve compliance with the final rule; OSHA’S FINAL BERYLLIUM STAND- beryllium exposure, the final mandatory • Assess the economic feasibility of ARD standards represent the best choice for the final rule for affected industries; and [3 Percent Discount Rate, 2015 dollars] reducing the risks to employees. • Assess the impact of the final rule on small entities through a Final Annualized Costs: C. Profile of Affected Industries Control Costs ...... $12,269,190 Chapter III of the FEA presents profile Regulatory Flexibility Analysis (FRFA), Rule Familiarization ...... 180,158 to include an evaluation of significant Exposure Assessment ...... 13,748,676 data for industries potentially affected regulatory alternatives to the final rule Regulated Areas ...... 884,106 by the final beryllium rule. This Chapter that OSHA has considered. Beryllium Work Areas ...... 129,648 provides the background data used Medical Surveillance ...... 7,390,958 throughout the remainder of the FEA Significant Changes to the FEA Between Medical Removal ...... 1,151,058 including estimates of what industries the Proposed Standards and the Final Written Exposure Control Plan .... 2,339,058 are affected, and their economic and Standards Protective Work Clothing & Equipment ...... 1,985,782 beryllium exposure characteristics. OSHA made changes to the Hygiene Areas and Practices ...... 2,420,584 OSHA identified the following Preliminary Economic Analysis (PEA) Housekeeping ...... 22,763,595 application groups as affected by the for several reasons: Training ...... 8,284,531 standard: Respirators ...... 320,885 • Changes to the rule, summarized in • Beryllium Production Section I of the preamble and discussed Total Annualized Costs • Beryllium Oxide Ceramics and in detail in the Summary and (Point Estimate) ...... 73,868,230 Composites Explanation; Annual Benefits: Number of Cases • Nonferrous Foundries • Prevented: • Comments on the PEA; Fatal Lung Cancers (Midpoint Es- Secondary Smelting, Refining, and • Updates of economic data; and timate) ...... 4 Alloying • Recognition of errors in the PEA. Fatal Chronic Beryllium Disease 86 • Precision Turned Products OSHA revised its technological and Beryllium-Related Mortality ...... 90 • Copper Rolling, Drawing, and economic analysis in response to these Beryllium Morbidity ...... 46 Monetized Annual Benefits (Mid- Extruding changes and to comments received on point Estimate) ...... $560,873,424 • Fabrication of Beryllium Alloy the NPRM. The FEA contains some Net Benefits: Products costs that were not included in the PEA Net Benefits ...... $487,005,194 • Welding • and updates data to use more recent Sources: US DOL, OSHA, Directorate of Dental Laboratories data sources and, in some cases, revised Standards and Guidance, Office of Regulatory • Aluminum Production methodologies. Detailed discussions of Analysis • Coal-Fired Electric Power Generation

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

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00086 Fmt 4701 Sfmt 4700 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2555 Establishment $9,161,081 $35,031,183 $3,395,911 $6,359,128 $85,233,010 ,500 Entity Revenues/ Revenues/ $38,871 $10,184,393 $97,259,754 Revenues ,OOO)[a] $29,075,882 $2,224,322 $3,497,362 $3,829,332 $15,853,340 $2,944,276 $6,414,545 ($1 Total Entities 120 144 Employees 616 83 60 [b] Affected [b] Beryllium-All Establish- 10 12 ments 2 for 11 1 1 Entities 9 5 5 [b] Affected Affected 2 Standard Final 13,096 19,796 10,773 Employees 66,833 8,767 Total OSHA's [a] [a] by 186 Establish- 830 ments 418 Total Affected Entities 163 636 655 376 748 [a] 459 463 Total Industries and Coil, and of and (except Other Wireless Equipment Composites Inductor Industry ns Manufacturing Broadcasting Nonferrous Metal Pottery, Manufacturing Plumbing Fixture Manufacturing Manufacturing Refining Radicand Equipment Resistor, and and Smelting Communicatio Ceramics, Capacitor, Audio Aluminum) Video Television Transformer, and Ceramics Characteristics NAICS 331410a 327110a 334310 334220 334416 Production Oxide Vlll-2: Oxide- Oxide- Oxide- Oxide- Be Beryllium Beryllium Beryllium Be Be Be Primary Production Secondary Secondary Secondary Group Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00087 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.004 2556 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations Establishment $31,469,837 $38,912,791 $3,395,911 $9,332,309 $18,843,147 $7,274,311 ,328 Entity Revenues/ Revenues/ $34,525,161 $20,651 Revenues ,336,550 ,OOO)[a] $21 $29,145,680 $43,242,849 $2,224,322 $3,497,362 $11,749,377 $10,111,340 $8,177,926 $2,953,370 $7,711,149 ($1 Total 120 108 168 120 Employees 360 822 [b] Affected (continued) 14 10 Establish 30 50 [b] -ments Affected Entities 14 Entities 8 9 9 7 7 [b] Affected 45 28 Beryllium-All for 13,096 15,446 Employees 64,271 50,017 31,010 54,693 Total Standard [a] [a] Final Establish- 749 ments 434 406 Total OSHA's by Entities 1,162 1,259 674 618 678 636 655 396 383 [a] Total Affected and and Die- Vehicle Die- Apparatus Industries and of Industry utic (except Plumbing Manufacturing Nonferrous Metal Manufacturing Pottery, Manufacturing Motor Equipment Electrotherape Electronic Manufacturing Electronic Electrical Fixture Electrometrica Foundries Foundries I casting Other Ceramics, casting) Component Aluminum NAICS 327110b 331523 334510 336320a 334419 331524 Characteristics Foundries Vlll-2: Sand Sand Oxide- Oxide- Oxide- Oxide- Be Be Be Be Nonferrous Non Non Foundries Foundries Secondary Secondary Secondary Secondary Group Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00088 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.005 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2557 Establishment $58,175,989 $8,391,582 $97,872,075 $8,391,582 $51,464,153 1 Entity Revenues/ Revenues/ $136,146,07 $63,770,798 Revenues ,OOO)[a] $15,183,933 $66,596,198 $24,370,147 $2,517,475 $8,592,063 $2,517,475 $8,592,063 $5,866,913 ($1 Total Employees 36 304 9 [b] 430 270 Affected (continued) Establish 30 [b] -ments Affected Entities 18 18 1 1 Entities 3 4 [b] Affected 26 22 23 Beryllium-All for 10,913 [a] Employees 21,408 9,522 9,522 5,415 Total Standard [a] Final 114 Establish- 300 300 ments Total 249 261 OSHA's by Entities 179 92 [a] Total 293 228 293 Affected and and and of of and Alloying (except Industries and of Industry (except Die- (except Die- Nonferrous Metal Drawing, Metal Nonferrous Rolling, Refining, Metal Foundries Nonferrous Extruding, Foundries Secondary Smelting, Other Copper Copper Casting) Other Secondary Smelting Casting) Aluminum Alloying Alloying Aluminum) Alloying Refining, NAICS 331529a 331492 331420b 331529b 331314 Characteristics Smelting, Vlll-2: Sand Alloys Alloys Be Non Precious Foundries Be Foundries Smelting- Smelting- Sand Secondary Group Smelting- metals Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00089 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.006 2558 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations Establishment $5,102,561 $5,102,561 $97,872,075 $9.569.611 $97,872,075 1 ,400 .231 1 1 Entity Revenues/ Revenues/ $11 $5,225,839 $5,225,839 $136,146,07 $136,146,07 1 Revenues ,OOO)[a] $18,818,245 $18,818,245 $24,370,147 $3.751.288 $24,370,147 ($1 Total 1 1,086 Employees 3,597 [b] 4,607 289 Affected 12,166 (continued) 11 Establish 347 [b] 45 22 -ments Affected 1296 Entities Entities 339 8 32 [b] Affected 21 1252 Beryllium-All for 103,546 103,546 Employees 21,408 21,408 Total 114,829 Standard [a] [a] Final Establish- 3,688 3,688 ments Total 249 249 1392 OSHA's by Entities 179 179 3,601 3,601 334 [a] Total I Affected and and product product Manufacturing beryllium beryllium Industries Extruding of Industry (low (high manufacturing manufacturing Precision Precision Drawing, Manufacturing Rolling, Drawing, Extruding, Rolling, Extruding, content) content) Spring Copper Copper Alloying Alloying turned turned I and Connector and Drawing NAICS 332721b 332721a 331420c 331420a 1332613 Characteristics Spring, Machining Rolling, Vlll-2: Machining Machining Precision Rolling Drawing Copper Springs Stamping, (low) (high) Group Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00090 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.007 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2559 Establishment $8,224,939 $31,469,837 $25,385,715 $704,996 $704,996 Entity Revenues/ Revenues/ $8,700,906 $34,525,161 $873,199 $821,007 $30,462,858 $735,751 $735,751 Revenues ,336,550 ,OOO)[a] $21 $12,329,183 $81,961,314 $5,940,257 $1,201,666 $3,604,997 ($1 Total 1,037 1,985 Employees 508 328 851 5,954 [b] Affected (continued) 183 148 Establish 72 [b] 47 426 -ments Affected Entities 172 135 1,225 1,278 Entities 68 39 [b] Affected 408 Beryllium-All for 11,024 Employees 21,132 654,879 50,017 53,018 33,073 Total Standard [a] [a] Final Establish- 5,114 ments Total 234 OSHA's by Entities 1,417 1,499 195 1,633 1,705 618 678 93,863 99,830 [a] 4,900 Total Affected and and of Metal Vehicle Crown, Industries of Industry (except Metal Laboratories Manufacturing Dentists Electronic Manufacturing Motor Dental Dental Laboratories Equipment Electrical Electronic Stamping Closure, Other Connector Offices Automotive) NAICS 621210a 332119 334417 336320c 339116b 339116a Characteristics Non- Laboratories Vlll-2: Dental Dental Dental Dental Labs- Labs- Labs- ** * * Stamping Stamping Substituting Stamping Substituting Substituting Group Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00091 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.008 2560 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations Establishment $821,007 $8,983,399 $15,876,625 $210,206,160 $37,430,907 $22,756,739 ,673,076 Entity Revenues/ Revenues/ $41 $7,532,692 $6,959,553 $873,199 $9,861,691 $17,451,166 $285,352,32 $24,398,978 3 Revenues ,OOO)[a] $7,043,067 $27,320,438 $118,135,862 $6,250,961 $27,839,554 $7,461,246 $6,161,227 $5,992,968 $2,111,591 $4,733,402 ($1 Total 13 Employees 6 87 3 5 [b] 284 24 216 Affected (continued) Establish 61 54 [b] 22 -ments Affected Entities 1 1 1 2 1 1 Entities 57 3 3 5 6 [b] Affected 49 21 Beryllium-All for 105,309 18,236 Employees 218,293 27,852 87,722 8,160 34,225 7,836 Total Standard [a] [a] Final 167 133 1,245 1,012 Establish- 3,099 562 ments Total 208 OSHA's by Entities 121 150 1,211 194 31,288 33,277 935 [a] 414 Total 2,823 Affected Steel of Steel Work and Blade and Handtool Industries of Investment) Iron Industry (except Manufacturing Dentists Metal Manufacturing Plate Powder Metallurgy Part Manufacturing Fabricated Manufacturing Mills Manufacturing Manufacturing Rolled Ferroalloy Foundries and Structural Shape Saw Steel Offices NAICS 621210b 332312 331221 332313 331513 332117 332216 331110a Welding Characteristics Gas Non- Vlll-2: and Dental Labs- ** Substituting Group WeldingGI WeldingGI WeldingGI WeldingGI WeldingGI WeldingGI WeldingGI Table Arc Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00092 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.009 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2561 Establishment $4,338,602 $20,834,244 $11,230,472 $37,433,440 ,434 Entity Revenues/ Revenues/ $4,425,798 $22,601 $13,039,407 $12,552,603 $11,728,174 $5,455,021 $5,097,031 Revenues ,OOO)[a] $15,415,053 $5,062,721 $42,075,186 $40,148,079 $3,885,743 $6,058,633 $2,785,578 $2,736,510 $5,535,698 $20,892,732 ($1 Total 153 12 154 18 Employees 82 [b] 24 286 Affected (continued) Establish 3 39 71 [b] 20 -ments Affected Entities 19 Entities 3 38 38 5 6 38 67 [b] Affected 4 4 Beryllium-All for 14,260 11,749 17,959 Employees 65,302 29,694 70,118 98,201 Total Standard [a] [a] Final 1,124 Establish- 3,553 346 ments 4,099 472 Total OSHA's by Entities 1,048 3,483 3,830 [a] 224 243 441 298 2,175 2,214 Total Affected Warm Metal Metal Metal and Product Work Fitting Furnaces) Other Industries of Industry (except Manufacturing Machinery Metal Pipe Farm Miscellaneous Manufacturing Manufacturing Manufacturing Fabricated Equipment Heating Equipment Metal Manufacturing Manufacturing Manufacturing and Other and Container Other Sheet Ornamental All Valve Architectural Air Work NAICS 333111a 332919 332999 333414a 332439 332323 332322 Characteristics Vlll-2: Group WeldingGI WeldingGI WeldingGI WeldingGI WeldingGI WeldingGI WeldingGI Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00093 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.010 2562 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations Establishment $32,702,145 $15,889,234 $11,196,135 $29,505,027 $15,903,842 $40,204,361 ,699 Entity Revenues/ Revenues/ $34,625,801 $36,061 $11,911,734 $9,890,897 $9,508,178 $46,565,420 Revenues ,OOO)[a] $11,772,772 $15,903,209 $11,773,922 $17,948,052 $8,945,712 $15,726,526 $10,544,247 $18,466,282 $60,628,177 ($1 Total 18 Employees 60 84 54 [b] 41 27 25 Affected (continued) 10 Establish 7 [b] 21 -ments Affected Entities 10 12 13 13 15 Entities 6 5 6 [b] Affected 4 5 20 Beryllium-All for 122,041 Employees 22,389 51,495 31,725 39,267 33,772 40,544 Total Standard [a] [a] Final 1,654 1,508 Establish- 663 360 539 799 741 ments Total OSHA's by Entities 1,590 1,302 656 340 571 751 [a] 441 Total Affected and Parts and Trailer Tractor, and Motor Vehicle Camper Other Industries of Industrial Industry Pumping Machinery Manufacturing Miscellaneous Pump Body Manufacturing Manufacturing Manufacturing Purpose Machinery Manufacturing Motor Equipment Equipment Manufacturing Manufacturing and Stacker Conveyor General Conveying Other All Vehicle Travel Truck, Trailer, NAICS 333911 333999 336214 333924 333922 336211 336390a Characteristics Vlll-2: Group WeldingGI WeldlngGI WeldingGI WeldingGI WeldingGI WeldingGI WeldingGI Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00094 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.011 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2563 Establishment $19,473,827 $76,685,188 1 Entity Revenues/ Revenues/ $6,535,062 $6,207,415 $19,977,027 $1,756,220 $1,617,512 $109,416,67 Revenues ,OOO)[a] $6,809,534 $7,731,109 $34,529,038 $17,944,334 ($1 Total 10 12 13 Employees 589 [b] Affected (continued) 147 Establish 3 [b] -ments Affected Entities 136 Entities 3 [b] Affected 2 2 2 3 Beryllium-All for 193,427 13,327 Employees 29,173 33,437 Total Standard [a] [a] Final 1,097 Establish- ments 21,347 234 Total OSHA's by Entities 19,661 1,042 164 387 397 [a] Total Affected and Stock and Industrial Other Industries of Industry (except Locker Manufacturing Machinery Equipment Maintenance Manufacturing Partition, Equipment Rolling Manufacturing Electronic) Repair Railroad and and and Shelving, Commercial Showcase, Automotive All Transportation NAICS 811310 337215 336510a 336999 Characteristics Welding Vlll-2: Resistance Group WeldingGI WeldingGI WeldingGI WeldingGI Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00095 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.012 2564 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations Establishment $12,787,881 $47,696,913 $36,278,855 $28,035,564 Entity Revenues/ Revenues/ $15,166,303 $49,203,131 $29,920,308 Revenues ,OOO)[a] $6,278,849 $4,674,297 $31,852,834 $43,693,874 $3,560,517 ($1 Total 107 138 Employees 766 [b] 428 Affected (continued) Establish 35 5 [b] 20 -ments Affected Entities 17 Entities 6 6 5 [b] Affected 29 Beryllium-All for 10,408 Employees 24,138 84,823 8,216 Total Standard [a] [a] Final 127 Establish- 878 ments 491 Total OSHA's by Entities 119 729 95 98 [a] 414 Total Affected Air Air and and and Industrial Warm Industries of Industrial Industry Blower Purification Manufacturing Manufacturing Fan Equipment Heating Equipment Manufacturing Manufacturing Refrigeration Equipment Electrical Household and and and Commercial Conditioning Small Commercial Cooking Air- Appliance Appliance NAICS 333413 333415 335221 335210 Characteristics Vlll-2: Resistance Resistance Resistance Resistance Group Welding Welding Welding Welding Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00096 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.013 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2565 4,888 05,730,833 Establishment $1 $31,469,837 $50,164,329 $130,842,293 $122,87 $39,146,993 1 Entity Revenues/ Revenues/ $160,271,59 $157,010,75 $34,525,161 $118,947,18 7 4 Revenues ,336,550 ,OOO)[a] $21 $12,290,261 $58,525,051 $4,710,323 $3,686,247 $951,577 $33,235,797 $42,177,407 ($1 Total 10 Employees 39 33 739 925 [b] 267 Affected (continued) 12 Establish 34 0 [b] 42 -ments Affected Entities 11 1 2 Entities 31 0 39 [b] Affected 2 2 Beryllium-All for 1,994 Employees 28,663 9,059 9,374 52,752 50,017 Total Standard [a] [a] Final Establish- 36 30 849 ments Total 245 OSHA's by Entities 30 618 678 8 9 788 [a] Total 23 210 Affected and and Parts and Major Vehicle Vehicle Vehicle Home Industries of Industry (except Manufacturing Manufacturing Manufacturing Motor Household Refrigerator Household Manufacturing Motor Equipment Laundry Equipment Manufacturing Engine Household Freezer Manufacturing Motor Engine Electrical Electronic and Spring) Suspension Steering Other Components Gasoline Appliance NAICS 335222 335228 336330 336310 335224 336320b Characteristics Vlll-2: Resistance Resistance Resistance Resistance Resistance Resistance Group Welding Welding Welding Welding Welding Welding Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00097 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.014 2566 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations Establishment $53,679,036 $40,204,361 $46,339,915 $71,157,690 $59,375,247 $42,434,722 Entity Revenues/ Revenues/ $123,573,10 $12,552,603 $11,728,174 $50,855,876 7 Revenues ,OOO)[a] $10,467,412 $67,098,794 $60,628,177 $46,565,420 $370,719 $35,792,318 $84,415,844 $5,535,698 $23,631,348 $78,249,498 $32,802,040 ($1 Total 1,644 Employees 859 548 843 [b] 412 434 213 Affected (continued) 10 Establish 6 75 [b] 25 20 -ments Affected Entities 18 19 15 Entities 8 65 32 39 [b] Affected 2 21 Beryllium-All for 17,959 122,041 Employees 21,859 58,248 5,433 81,018 47,010 Total Standard [a] [a] Final 195 Establish- 503 398 773 ments 472 Total OSHA's by Entities 156 1,302 1,508 3 8 302 645 [a] 424 441 Total Affected and and Parts Warm Trim System Motor Vehicle Vehicle Vehicle Vehicle Parts Power Furnaces) Industries of Industry Interior (except Brake Manufacturing Motor Motor Primary Manufacturing Production Manufacturing Motor Refining Manufacturing Manufacturing Motor Metal Heating Equipment and Seating Stamping Other Alumina Aluminum Air Vehicle Transmission Train NAICS 336350 336340 331313 336360 336390b 336370 333414b Characteristics Utilities Production Vlll-2: Fired Resistance Resistance Production Resistance Resistance Resistance Resistance Coal Group Welding Welding Welding Welding Welding Welding Table Aluminum Aluminum Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00098 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.015 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2567 ,019 Establishment $61,664,772 $167,834,268 $84,140,910 $216,003,795 $155,553,993 $25,182,374 $204,681,680 $160,905,142 $33,991 $30,633,533 $162,928,496 ,478,25 08,662,51 1 Entity Revenues/ Revenues/ $1 $367,284,03 $415,965,99 $321 $189,300,16 7 5 $28,037,353 $35,482,914 7 $362,276,40 $207,363,54 $45,025,125 7 $361,158,34 0 4 2 Revenues ,OOO)[a] $167,481,521 $29,706,665 $97,687,597 $45,144,793 $4,822,174 $12,894,946 $3,218,103 $9,644,849 $29,912,097 $6,708,744 ($1 Total $6,842,997 10,534 113 Employees 310 395 677 338 56 56 [b] 451 28 28 Affected (continued) 11 14 12 16 Establish [b] 418 4 24 -ments Affected Entities 1 1 1 1 Entities 6 70 3 7 7 [b] 7 Affected 20 2 2 2 2 Beryllium-All for 142,164 17,101 13,423 Employees 69,352 27,740 6,687 5,790 35,545 8,678 60,053 4,398 Total Standard [a] [a] Final 1,161 177 Establish- 63 31 383 880 ments 2,716 Total 42 20 219 209 OSHA's by Entities 15 17 149 125 31 899 344 843 82 [a] 456 Total 33 Affected and Power (except Fuel Product and Sugar Mills Com Industries of Industry Fossil Electric Manufacturing Mills Plastics Material Mills Newsprint Manufacturing Breweries Beet Resin Manufacturing Milling Mills Extract Paperboard Reconstituted Manufacturing Pulp Paper Newsprint) Generation Spice Wet Wood NAICS 311313 311221 325211 322122 311942 312120 322130 321219 322110 322121 221112 Characteristics Vlll-2: Fired Fired Fired Fired Fired Fired Fired Fired Fired Fired Fired Utilities Utilities Utilities Utilities Utilities Utilities Utilities Utilities Utilities Utilities Utilities Coal Coal Coal Coal Coal Coal Coal Group Coal Coal Coal Coal Table Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00099 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.016 2568 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations Establishment $42,728,192 $624,531 $26,026,757 $53,711,531 $37,433,440 $76,685,188 ,85 ,891 ,200,178 01 1 Entity Revenues/ Revenues/ $51 $1 $625,707 $1,371,067 $1,355,127 $40,148,079 $109,416,67 7 Revenues ,OOO)[a] $28,371,519 $46,132,552 $19,595,278 $39,396,242 $6,246,422 $232,517,218 $42,075,186 $17,944,334 ($1 Total Employees 56 [b] 4,360 4,040 28 254 28 28 Affected (continued) 1,090 1,010 1 Establish [b] -ments Affected Entities 1 1 2 1,088 1 1 1 1 Entities 998 5 9 [b] Affected Beryllium-All for 12,617 163,073 193,631 1,805,199 Employees 23,229 29,173 65,302 Total Standard [a] [a] Final 1,124 Establish- ments 4,329 240 Total 29,072 234 OSHA's by Entities 122 1,048 164 615 664 31,317 31,376 [a] Total 28,734 2,282 Affected and Stock and Covering Other Industries of Industry Detergent Manufacturing Professional Painting Manufacturing Machinery Farm Manufacturing Equipment Railroad Rolling Manufacturing Universities, and and Soap Other Cement Schools Specialty Contractors Contractors Colleges, All Wall Trade Construction Shipyards*- NAICS 325611 327310 611310 333111b 336510b 238320 238990 Characteristics Blasting- Blasting Vlll-2: Fired Fired Fired Fired Fired Blasting- Blasting- Utilities Utilities Utilities Utilities Utilities Coal Coal Constructio Constructio Coal Coal Coal Group n n Table Abrasive Abrasive Abrasive Abrasive Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00100 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.017 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2569 final and the the by to alloys affected Establishment $37,933,508 $37,933,508 $37,933,508 of required and ,832 ,832 ,832 beryllium-free number ships. provisions entities the establishments Entity Revenues/ Revenues/ $43,271 $43,271 $982,357 $975,905 $9,334,778 $8,540,786 $43,271 $7,617,412 $7,093,593 and between 7 ancillary boats of the Affected industry, differential affected of ,519 Revenues of cost price ,OOO)[a] the blasting. the the surfaces $26,136,187 $26,136,187 $2,042,890,84 $1,931,626,954 ($1 Total $58,991 $52,272,373 NAICS to incur etch number due to abrasive and each the costs and establishments. of alloys incur abrasives Employees 3,825 61,747 8,400 50,261 3,086 [b] Within 26 Affected and welding ratio and slag berylium Analysis. both the alloys. use do (continued) entities mineral to beryllium and Establish 689 696 7,333 [b] 4,538 -ments Affected may use for employees. that Entities continue Regulatory beryllium-free material of that employers industry the associated blasters Entities 604 6 7 610 6,565 3,869 [b] Affected 2,086 2,100 PEL affected these cast that of and the to of Office Beryllium-All for abrasive beryllium-free how below for Some number 108,311 108,311 Employees 216,622 6,450,760 5,877,434 356,704 Total beryllium entities employing substitute Guidance, the technicians to exposures Standard of shipyards. that 2012. to in [a] [a] with and dental Final shipyards 226,165 287,991 60,448 are welders equal Establish- 689 689 ments Total number teach exposed to or OSHA's establishments total employ estabishments by to Standards Businesses: Shipyards than of training are of Entities 1,208 1,378 604 604 [a] Total 206,928 268,187 60,051 US applies potentially less of Affected Shipyards Blasting- in additional be product of to Building Building the Substituting Repairing Repairing cost Directorate Non-Substituting Abrasive Welding Industries - Statistics as the employees of Industry and Ship and Ship Labs- group group Labs of plus OSHA, Dental Dental establishments. constrained Bureau, Subtotal beryllium application application calculated NAICS 336611a 336611b DOL, group group in in total Subtotal Characteristics estimates Shipyards**** US of was Industries contain Subtotal in In Industry Census Vlll-2: All that Application Employers Employers US OSHA Application Blasting- Maritime number [a] [b] alloys ** *** *** entities Shipyards Shipyards establishments Source: Construction General Group Welding Welding Table Total standard. Total, Abrasive Application

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00101 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.018 2570 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 60 83 120 144 108 360 Total 1 1 1 1 2 4 >2.0 1 1 3 5 2 2 ::S2.0 (~gfm3) >1.0to Range 3 5 7 7 5 to 16 :S1.0 >0.5 Exposure 6 to 11 13 10 32 34 and (1Jgfm3) ::S0.5 >0.25 Level Industry 1 6 3 7 2 2 :S0.25 Exposure >0.2to Affected by 8 15 16 19 14 47 :S0.2 to Beryllium >0.1 to 9 to 50 37 41 21 124 :S0.1 >0.05 Exposed 9 50 37 41 21 124 Workers :S0.0.5 to of 0 and and Number and Video Fixture Coil, and and Electronic Inductor Industry Vlll-3: Manufacturing Plumbing Pottery, Broadcasting Resistor, Manufacturing Equipment Manufacturing Manufacturing Manufacturing Manufacturing Equipment Radio Electromedical Electrotherapeutic Capacitor, Other Other Communications Ceramics, Component and Audio Apparatus Wireless Transformer, Television Table Primary Secondary - - Group/ Oxide Oxide NAICS 334416 334310 334220 334419 334510 327110a Application Beryllium Beryllium

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VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00112 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.029 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2581 26 Total 3,060 3,086 8,400 4,360 4,040 61,747 50,261 1 333 253 252 692 >2.0 1,798 2,742 and final the alloys by 0 87 87 123 359 114 736 (continued) 238 :!1:2.0 required ) 1,060 3 to beryllium-free >1.0 ships. provisions (1Jg/m and between 3 58 82 76 61 159 :!1:1.0 ancillary boats 2,665 >0.5to Range of the differential of price cost surfaces 4 blasting. to the the the 155 152 216 200 (1Jg/m3) 416 to :!1:0.5 Exposure 3,413 2,842 2,445 incur etch due >0.25 abrasive to and Level and costs and alloys 1 to incur 30 31 83 43 40 abrasives 683 568 welding and :!1:0.25 slag >0.2 Industry Exposure berylium both do alloys. use mineral to beryllium Feasibility. may 4 for use Affected :!1:0.2 1,013 1,443 1,337 1,017 7,428 that 2,781 continue 11,225 to by beryllium-free material employers that the >0.1 blasters PEL these cast of the to 7 ofTechnological abrasive 970 734 742 beryllium-free Beryllium :!1:0.1 how Some 1,046 2,016 below to to Office substitute employing >0.05 technicians shipyards. exposures that in with 7 Exposed Guidance, dental shipyards 970 742 734 1,046 2,016 welders are and :!1:0.0.5 17,222 17,222 19,979 19,979 teach to to establishments 0 employ to estabishments Workers Shipyards training are of rounding. Standards applies and and Wall to of Shipyards in Blasting- Trade additional and due of Number Building Building Substituting Welding cost Non-Substituting other Abrasive totals Directorate the Industry Painting Repairing Repairing Specialty Ship Ship Covering Contractors Contractors All to Labs- group group Labs- Vlll-3: plus sum Shipyards*** OSHA, Dental Dental Subtotal not Table application beryllium application Group/ DOL Subtotal group in group in may Shipyards**** US Industries Blasting Subtotal in Industry contain NAICS 238320 238990 336611a 336611b All Data that Employers Application Employers Application Application Maritime Note: alloys •••• •• Sources: General Construction ... Welding Total Total, standard. Abrasive

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

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

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primary beryllium production company referenced letter to the docket stating processing of materials containing high in the U.S., and USW, jointly submitted that, based on its many years of concentrations of beryllium, which can a draft proposed rule that included an experience controlling beryllium result in the generation of substantial exposure limit of 0.2 mg/m3 (Document exposures, a PEL of 0.2 mg/m3 can be amounts of fumes and particulate. For ID 0754, p. 4). In its written comments, achieved in most operations, most of the example, the final PEL of 0.2 mg/m3 Materion explained that it is feasible to time (Document ID 1052). Materion’s cannot be achieved most of the time for control exposure to levels below 0.2 mg/ letter is consistent with the monitoring furnace operations in primary beryllium m3 through the use of engineering data Materion submitted, and OSHA production and for some furnace controls and work practices in most, but considers its statement regarding operation activities in secondary not all, operations: feasibility at the final PEL relevant to smelting, refining, and alloying facilities Based on many years’ experience in nonferrous foundries because Materion engaged in beryllium recovery and controlling beryllium exposures, its vigorous has similar operations in its facilities, alloying. Workers may need product stewardship program in affected such as beryllium alloy production. As supplementary respiratory protection operations, and the judgment of its stated in Section IV–5 of the FEA, the during these high exposure activities professional industrial hygiene staff, size and configuration of nonferrous where exposures exceed the final PEL of Materion Brush believes that the 0.2 mg/m3 foundries may vary, but they all use 0.2 mg/m3 or STEL of 2.0 mg/m3 with PEL for beryllium, based on median similar processes; they melt and pour engineering and work practice controls. exposures, can be achieved in most molten metal into the prepared molds to In addition, OSHA has determined that operations, most of the time. Materion Brush produce a casting, and remove excess workers who perform open-air abrasive does recognize that it is not feasible to reduce metal and blemishes from the castings blasting using mineral grit (i.e., coal exposures to below the PEL in some operations, and in particular, certain (NIOSH 85–116, 1985). While the design slag) will routinely be exposed to levels beryllium production operations, solely may vary, the basic operations and above the final PEL (even after the through the use of engineering and work worker job tasks are similar regardless of installation of feasible engineering and practice controls (Document ID 1052). whether the casting metal contains work practice controls), and therefore, beryllium. these workers will also be required to On the other hand, the Nonferrous In the NPRM, OSHA requested that wear respiratory protection. Founders’ Society (NFFS) asserted that affected industries submit to the record Overall, however, based on the OSHA had not demonstrated that the 3 any available exposure monitoring data information discussed above and the final PEL of 0.2 mg/m was feasible for and comments regarding the other evidence in the record and the nonferrous foundry industry effectiveness of currently implemented described in Chapter IV of the FEA, (Document ID 1678, pp. 2–3). NFFS control measures to inform the Agency’s OSHA has determined that for the asserted that ‘‘OSHA has failed to meet final feasibility determinations. During majority of the job groups evaluated its burden of proof that a ten-fold the informal public hearings, OSHA exposures are either already at or below reduction to the current two micrograms asked the NFFS panel to provide the final PEL, or can be adequately per cubic meter limit is technologically information on current engineering controlled to levels below the final PEL or economically feasible in the non- controls or the personal protective through the implementation of ferrous foundry industry’’ (Document ID equipment used in foundries claiming additional engineering and work 1678, pp. 2–3; 1756, Tr. 18). In written to have difficulty complying with the practice controls for most operations testimony submitted as a hearing preceding PEL, but no additional most of the time. Therefore, OSHA exhibit, NFFS claimed that OSHA’s information was provided (Document ID concludes that the final PEL of 0.2 mg/ supporting documentation in the PEA 1756; Tr. 24–25; 1785, p. 1). Thus, the m3 is technologically feasible. had no ‘‘concrete assurance on NFFS did not provide any sampling In contrast, the record evidence does technologic feasibility either by data or other evidence regarding current not show that it is feasible for most demonstration or technical exposure levels or existing control operations in all affected industries and documentation’’ (Document ID 1732, measures to support its assertion that a application groups to achieve the Appendix A, p. 4). PEL of 0.2 mg/m3 is not feasible, and did alternative PEL of 0.1 mg/m3 most of the However, contrary to the NFFS not show that the data in the record are time. As discussed below, although a comments, which are addressed at insufficient to demonstrate number of operations can achieve this greater length in Section IV–5 of the technological feasibility for nonferrous level, they may be interspersed with FEA, OSHA’s exposure profile is based foundry industry. operations that cannot, and OSHA sees on the best available evidence for In sum, while OSHA agrees that two value in having a uniform PEL that can nonferrous foundries; the exposure data of the operations in the nonferrous be enforced consistently for all are taken from NIOSH surveys, an ERG foundry industry, furnace and shakeout operations, rather than enforcing site visit, and the California Cast Metals operations, employing a relatively small different PELs for the same contaminant Association (Document ID 1217; 1185; percentage of workers in the industry, in different operations. 0341, Attachment 6; 0899). Materion may not be able to achieve the final PEL Several commenters supported a PEL also submitted substantial amounts of of 0.2 mg/m3 most of the time, evidence of 0.1 mg/m3. Specifically, Public monitoring data, process descriptions in the record indicates that the final PEL Citizen; the American Federation of and information of engineering controls is achievable in the other six job Labor and Congress of Industrial that have been implemented in its categories in this industry. Therefore, in Organizations (AFL–CIO); the facilities to control beryllium exposure the FEA, OSHA finds the PEL of 0.2 mg/ International Union, United effectively, including operations that m3 is technologically feasible for the Automobile, Aerospace, and Agriculture involve the production of beryllium nonferrous foundry industry. Implement Workers of America (UAW); alloys using the same types of furnace OSHA also recognizes that North America’s Building Trades and casting operations as those engineering and work practice controls Unions (NABTU); and the American conducted at nonferrous foundries may not be able to consistently reduce College of Occupational and producing beryllium alloys (Document and maintain exposures to the final PEL Environmental Medicine contended that ID 0719; 0720; 0723). Furthermore, of 0.2 mg/m3 in some job categories in OSHA should adopt this lower level Materion submitted the above- other application groups, due to the because of the residual risk at 0.2 mg/m3

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

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experienced during operation. The level also occur during the transfer and stakeholder comments in the record, of physical work effort required, the use handling of beryllium oxide powders. OSHA has determined that a STEL of of protective clothing, and OSHA finds that in many cases, the 2.0 mg/m3 is technologically feasible. environmental factors such as control of peak short-term exposures Thus, as explained in the Summary and temperature extremes and high associated with these intermittent tasks Explanation for paragraph (c), OSHA humidity can interact with respirator will be necessary to reduce workers’ has retained the proposed value of 2.0 use to increase the physiological strain TWA exposures to or below the final mg/m3 as the final STEL. on employees. Inability to cope with PEL. The short-term exposure data this strain as a result of medical presented in the FEA show that the E. Costs of Compliance conditions such as cardiovascular and majority (79%) of these exposures are In Chapter V, Costs of Compliance, respiratory diseases, reduced pulmonary already below 2.0 mg/m3. OSHA assesses the costs to general function, neurological or A number of stakeholders submitted musculoskeletal disorders, impaired comments related to the proposed and industry, maritime, and construction sensory function, or psychological alternative STELs. Some of these establishments in all affected conditions can place employees at stakeholders supported a STEL of 2.0 application groups of reducing worker increased risk of illness, injury, and mg/m3. Materion stated that a STEL of exposures to beryllium to an eight-hour even death. The widespread, routine use 2.0 mg/m3 for controlling the upper time-weighted average (TWA) of respirators for extended periods of range of worker short term exposures is permissible exposure limit (PEL) of 0.2 time that may be required by a PEL of sufficient to prevent CBD (Document ID mg/m3 and to the final short-term 0.1 mg/m3 creates more significant 1661, p. 3). Other commenters exposure limit (STEL) of 2.0 mg/m3, as concerns than the less frequent recommended a STEL of 1.0 mg/m3 well as of complying with the final respirator usage that is required by a (Document ID 1661, p. 19; 1681, p. 7). standard’s ancillary provisions. These PEL of 0.2 mg/m3. However, no additional engineering ancillary provisions encompass the Furthermore, OSHA concludes that it controls capable of reducing short term following requirements: Exposure would complicate both compliance and exposures to at or below 1.0 mg/m3 were monitoring, regulated areas (and enforcement of the rule if it were to set identified by these commenters. OSHA competent person in construction), a a PEL of 0.1 mg/m3 for some industries provides a full discussion of the public written exposure control plan, or operations and a PEL of 0.2 mg/m3 for comments in the Summary and protective work clothing, hygiene areas the remaining industries and operations Explanation section of this preamble. and practices, housekeeping, medical where technological feasibility at the OSHA has determined that the surveillance, medical removal, lower PEL is either unattainable or implementation of engineering and familiarization, and worker training. unknown. OSHA may exercise work practice controls required to This final cost assessment is based in discretion to issue a uniform PEL if it maintain full shift exposures at or below part on OSHA’s technological feasibility determines that the PEL is a PEL of 0.2 mg/m3 will reduce short analysis presented in Chapter IV of the technologically feasible for all affected term exposures to 2.0 mg/m3 or below, FEA; analyses of the costs of the final industries (if not for all affected and that a STEL of 1.0 mg/m3 would standard conducted by OSHA’s operations) and that a uniform PEL require additional respirator use. contractor, Eastern Research Group would constitute better public policy. Furthermore, OSHA notes that the (ERG); and the comments submitted to See Pertinent Legal Authority combination of a PEL of 0.2 mg/m3 and the docket in response to the request for (discussing the Chromium decision). In a STEL of 2.0 mg/m3 would, in most information (RFI) as part of the Small declining to lower the PEL to 0.1 mg/m3 cases, keep workers from being exposed Business Regulatory Enforcement for any segment of the affected to 15 minute intervals of 1.0 mg/m3. See Fairness Act (SBREFA) process, industries, OSHA has made that Table IV.78 of Chapter IV of the FEA. comments submitted to the docket in determination here. Therefore, OSHA Therefore, OSHA concludes that the 3 response to the PEA, comments during has determined that the proposed STEL of 2.0 mg/m can be achieved for the hearings conducted in March 2016, 3 alternative PEL of 0.1 mg/m is not most operations most of the time, given and comments submitted to the docket that most short-term exposures are appropriate. after the hearings concluded. OSHA also evaluated the already below 2.0 mg/m3. OSHA technological feasibility of the final recognizes that for a small number of Table VIII–4 presents summary of the STEL of 2.0 mg/m3 and the alternative tasks, short-term exposures may exceed annualized costs. All costs in this STEL of 1.0 mg/m3. An analysis of the the final STEL, even after feasible chapter are expressed in 2015 dollars available short-term exposure control measures to reduce TWA and were annualized using a discount measurements presented in Chapter IV, exposure to or below the final PEL have rate of 3 percent. (Costs at other Section 15 of the FEA indicates that been implemented, and therefore, some discount rates are presented in the elevated exposures can occur during limited use of respiratory protection chapter itself). Annualization periods short-term tasks such as those will continue to be required for short- for expenditures on equipment are associated with the operation and term tasks in which peak exposures based on equipment life, and one-time maintenance of furnaces at primary cannot be reduced to less than 2.0 mg/ costs are annualized over a 10-year beryllium production facilities, at m3 through use of engineering controls. period. Chapter V provides detailed nonferrous foundries, and at secondary After careful consideration of the explanation of the basis for these cost smelting operations. Peak exposures can record, including all available data and estimates.

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Table Vlll-4 Total Annualized Costs, by Sector and Six-Digit NAICS Industry, for Entities Affected by the Final Beryllium Standard; Results Shown by Size Category (3 Percent Discount Rate, 2015 Dollars)

Application Small Entities Very Small Entities Industry All Establishments Group/ NAICS (SBA-defined) (<20 Employees)

Beryllium Oxide - Primary

327110a Pottery, Ceramics, and Plumbing Fixture Manufacturing $315,959 $117,793 - Beryllium Oxide - Secondary

Radio and Television Broadcasting and Wireless 334220 $232,556 $105,595 - Communications Equipment Manufacturing

334310 Audio and Video Equipment Manufacturing $118,084 $99,209 -

Capacitor, Resistor, Coil, Transformer, and Other Inductor 334416 $278,998 $199,642 - Manufacturing

334419 Other Electronic Component Manufacturing $697,514 $482,652 -

Electromedical and Electrotherapeutic Apparatus 334510 $209,703 $35,369 - Manufacturing

327110b Pottery, Ceramics, and Plumbing Fixture Manufacturing $325,494 $218,758 -

Motor Vehicle Electrical and Electronic Equipment 336320a $232,562 $140,444 - Manufacturing Beryllium Production

331410a Nonferrous Metal (except Aluminum) Smelting and Refining $2,013,397 - - Dental Labs - Substituting*

339116a Dental Laboratories $1,253,495 $1,017,075 $631,145

621210a Offices of Dentists $178,968 $168,032 $144,738 Dental Labs - Non-Substituting**

339116b Dental Laboratories $2,167,822 $1,757,907 $1,090,462

621210b Offices of Dentists $309,649 $290,706 $250,457 Drawing

331420c Copper Rolling, Drawing, Extruding, and Alloying $4,426,834 $2,252,945 $109,260 Machining - High

332721a Precision Turned Product Manufacturing $729,198 $640,150 $137,756 Machining - Low

332721b Precision Turned Product Manufacturing $8,049,765 $7,072,180 $1,542,921 Non Sand Foundries

331523 Nonferrous Metal Die-Casting Foundries $3,576,462 $2,153,997 $534,414

331524 Aluminum Foundries (except Die-Casting) $521,441 $419,706 $106,565

331529a Other Nonferrous Metal Foundries (except Die-Casting) $1,323,804 $955,352 $336,613 Rolling

331420a Copper Rolling, Drawing, Extruding, and Alloying $1,177,254 $599,439 $29,407 Sand Foundries

331529b Other Nonferrous Metal Foundries (except Die-Casting) $1,802,392 $1,307,125 $468,335

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Smelting - Beryllium Alloys

331314 Secondary Smelting and Alloying of Aluminum $41,736 $34,100 $26,479 1 1 1 331420b I Copper Rolling, Drawing, Extruding, and Alloying $114,295 $67,494 $14,331

Table Vlll-4 Total Annualized Costs, by Sector and Six-Digit NAICS Industry, for Entities Affected by the Final Beryllium Standard; Results Shown by Size Category (3 Percent Discount Rate, 2015 Dollars) (continued)

Application Small Entities Very Small Entities Group/ Industry All Establishments (SBA-defined) (<20 Employees) NAICS Smelting - Precious Metals

Secondary Smelting, Refining, and Alloying of Nonferrous Metal 331492 $805,282 $527,762 $184,943 (except Copper and Aluminum) Springs

332613 Spring Manufacturing $3,702,257 $2,602,479 $666,079 Stamping

Metal Crown, Closure, and Other Metal Stamping (except 332119 $904,241 $736,071 $177,472 Automotive)

334417 Electronic Connector Manufacturing $584,177 $277,415 $74,764

Motor Vehicle Electrical and Electronic Equipment 336320c $1,846,653 $1,070,556 $325,146 Manufacturing Welding - Arc and Gas

331110a Iron and Steel Mills and Ferroalloy Manufacturing $67,570 $17,445 $6,384

331221 Rolled Steel Shape Manufacturing $19,960 $16,860 $5,201

331513 Steel Foundries (except Investment) $16,788 $9,628 $5,852

332117 Powder Metallurgy Part Manufacturing $12,314 $8,617 $6,564

332216 Saw Blade and Handtool Manufacturing $38,399 $26,832 $8,395

332312 Fabricated Structural Metal Manufacturing $581,440 $394,214 $100,387

332313 Plate Work Manufacturing $233,595 $206,246 $41,748

332322 Sheet Metal Work Manufacturing $769,001 $629,529 $153,221

332323 Ornamental and Architectural Metal Work Manufacturing $415,257 $342,102 $133,212

332439 Other Metal Container Manufacturing $66,574 $38,415 $10,537

332919 Other Metal Valve and Pipe Fitting Manufacturing $35,290 $19,690 $4,906

All Other Miscellaneous Fabricated Metal Product 332999 $412,635 $359,345 $92,112 Manufacturing

333111a Farm Machinery and Equipment Manufacturing $219,739 $119,863 $37,334

333414a Heating Equipment (except Warm Air Furnaces) Manufacturing $50,310 $34,014 $9,120

333911 Pump and Pumping Equipment Manufacturing $75,055 $29,195 $10,276

333922 Conveyor and Conveying Equipment Manufacturing $109,339 $83,855 $14,647

Industrial Truck, Tractor, Trailer, and Stacker Machinery 333924 $51,556 $24,921 $8,516 Manufacturing

All Other Miscellaneous General Purpose Machinery 333999 $226,282 $138,069 $39,972 Manufacturing

336211 Motor Vehicle Body Manufacturing $162,264 $104,321 $22,757

336214 Travel Trailer and Camper Manufacturing $145,158 $61,005 $23,374

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Table Vlll-4 Total Annualized Costs, by Sector and Six-Digit NAICS Industry, for Entities Affected by the Final Beryllium Standard; Results Shown by Size Category (3 Percent Discount Rate, 2015 Dollars) (continued)

Application Small Entities Very Small Entities Group/ Industry All Establishments (SBA-defined) (<20 Employees) NAICS

336390a Other Motor Vehicle Parts Manufacturing $68,384 $33,840 $10,605

336510a Railroad Rolling Stock Manufacturing $36,795 $12,111 $4,009

336999 All Other Transportation Equipment Manufacturing $35,556 $16,540 $9,603

337215 Showcase, Partition, Shelving, and Locker Manufacturing $28,978 $21,921 $6,522

Commercial and Industrial Machinery and Equipment (except 811310 $1,584,633 $932,053 $611,277 Automotive and Electronic) Repair and Maintenance Welding - Resistance Welding

Industrial and Commercial Fan and Blower and Air Purification 333413 $526,305 $256,015 $33,706 Equipment Manufacturing

Air-Conditioning and Warm Air Heating Equipment and

333415 Commercial and Industrial Refrigeration Equipment $941,303 $328,435 $32,255

Manufacturing

335210 Small Electrical Appliance Manufacturing $170,175 $125,024 $8,227

335221 Household Cooking Appliance Manufacturing $131,328 $60,983 $4,126

335222 Household Refrigerator and Home Freezer Manufacturing $40,241 $7,346 $1,310

335224 Household Laundry Equipment Manufacturing $12,166 $1,369 $1,310

335228 Other Major Household Appliance Manufacturing $48,304 $7,091 $1,310

Motor Vehicle Gasoline Engine and Engine Parts 336310 $1,137,535 $398,286 $57,392 Manufacturing

Motor Vehicle Electrical and Electronic Equipment 336320b $908,472 $455,773 $39,843 Manufacturing

Motor Vehicle Steering and Suspension Components (except 336330 $328,342 $107,290 $8,454 Spring) Manufacturing

336340 Motor Vehicle Brake System Manufacturing $261,342 $112,290 $5,042

Motor Vehicle Transmission and Power Train Parts 336350 $674,120 $241,333 $16,175 Manufacturing

336360 Motor Vehicle Seating and Interior Trim Manufacturing $533,438 $189,394 $12,131

336370 Motor Vehicle Metal Stamping $1,036,026 $617,330 $25,234

333414b Heating Equipment (except Warm Air Furnaces) Manufacturing $505,883 $332,174 $46,775

336390b Other Motor Vehicle Parts Manufacturing $2,020,751 $953,614 $75,178 Aluminum Production

331313 Alumina Refining and Primary Aluminum Production $1,448,385 $1,448,385 -

Coal Fired Utilities

221112 Fossil Fuel Electric Power Generation $6,174,423 $989,185 $27,884

311221 Wet Corn Milling $198,450 $32,970 -

311313 Beet Sugar Manufacturing $231,570 $42,324 -

311942 Spice and Extract Manufacturing $33,064 $19,954 -

312120 Breweries $33,089 $18,534 -

321219 Reconstituted Wood Product Manufacturing $16,530 $7,274 -

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Table Vlll-4 Total Annualized Costs, by Sector and Six-Digit NAICS Industry, for Entities Affected by the Final Beryllium Standard; Results Shown by Size Category (3 Percent Discount Rate, 2015 Dollars) (continued)

Application Small Entities Very Small Entities Group/ Industry All Establishments (SBA-defined) (<20 Employees) NAICS

322110 Pulp Mills $16,553 $2,995 -

322121 Paper (except Newsprint) Mills $182,256 $39,535 -

322122 Newsprint Mills $397,171 $173,886 -

322130 Paperboard Mills $264,737 $37,754 -

325211 Plastics Material and Resin Manufacturing $66,132 $33,457 -

325611 Soap and Other Detergent Manufacturing $16,537 $7,446 -

327310 Cement Manufacturing $33,060 $10,073 -

333111b Farm Machinery and Equipment Manufacturing $16,538 $8,747 -

336510b Railroad Rolling Stock Manufacturing $16,542 $4,748 -

611310 Colleges, Universities, and Professional Schools $149,175 $11,694 - Abrasive Blasting - Construction

238320 Painting and Wall Covering Contractors $4,416,714 $3,719,871 $2,605,987

238990 All Other Specialty Trade Contractors $4,092,952 $3,147,411 $2,149,166 Abrasive Blasting - Shipyards***

336611a Ship Building and Repairing $3,316,687 $1,063,477 $557,570 Welding in Shipyards••••

336611b Ship Building and Repairing $69,071 $20,244 $11,326 Total General Industry Subtotal $61,972,805 $36,113,291 $8,624,173 Construction Subtotal $8,509,666 $6,867,282 $4,755,152 Maritime Subtotal $3,385,759 $1,083,721 $568,896 Total, All Industries $73,868,230 $44,064,294 $13,948,222

Notes:

Figures in rows may not add to totals due to rounding.

"-" denotes industries where OSHA has preliminarily determined that there are no affected small or very small establishments.

Application group Dental Labs- Substituting applies to establishments that substitute beryllium-free material for beryllium and incur costs due

to the price differential between beryllium-free alloys and alloys that contain beryllium plus the cost of additional training to teach dental technicians

how to cast the beryllium-free alloys.

•• Application group Dental Labs - Non-Substituting are estabishments with exposures below the PEL that continue to use berylium alloys and

incur the cost of the ancillary provisions required by the final standard.

••• Employers in application group Abrasive Blasting- Shipyards are shipyards employing abrasive blasters that use mineral slag abrasives to etch

the surfaces of boats and ships.

•••• Employers in application group Welding in Shipyards employ welders in shipyards. Some of these employers may do both welding and

abrasive blasting.

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

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

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results can reasonably be viewed as shows similar results for small and very economically feasible. Section VIII.j small entities. Percent Profits a of As 1.65% 1.90% 13.87% 1.26% -155.58% 9.84% 6.43% 6.32% 8.56% 9.27% -- -- 4.88% 43.52% 4.89% Percent a Revenues of As 0.72% 0.62% 0.10% 0.12% 0.07% 0.25% 0.25% 0.37% 0.68% 0.07% 0.14% 0.66% 0.06% -- -- Costs Per Establishment $5,087 $5,087 $99,439 $980 $23,256 $23,250 $23,250 $23,617 $23,256 $157,979 $2,013,397 $981 $33,512 $23,300 Compliance Rate Discount Per Establishment $51,693 $59,424 $51,693 $2,037,366 $59,424 $250,797 $361,417 $53,418 $23,250 -$15,180 $368,172 $475,965 $241,533 $1,842,824 -- -- Percent a 3 a Rate 1.57% 1.51% Profits -0.24% 2.08% 0.72% 3.95% 3.95% -- -- 7.33% 7.24% 7.33% 7.24% 4.73% 4.74% Using '183 Per Calculated Establishment -- $704,996 $35,031 $6,359,128 $9,161,081 $9,332,309 $3,395,911 $821,007 $704,996 $97,872,075 $5,102,561 $821,007 $38,912,791 -- Costs With Total ($1,000) Revenues $2,224,322 $1,201,666 $29,075,882 $2,944,276 $3,829,332 $11,749,377 $2,224,322 $21,336,550 $31,469,837 $27,320,438 $3,604,997 $15,853,340 $24,370,147 $18,818,245 $81,961,314 $29,145,680 Standard TableVIII-5 Beryllium Affected Final Total Establishments 14 10 12 10 1,278 1 183 5 2 22 61 30 9 426 45 the by Total Affected Establishments 1,259 186 1,705 678 655 655 5,114 99,830 33,277 3,688 749 418 463 249 830 Establishments for Refining Inductor Manufacturing and Analysis Other Manufacturing Manufacturing Alloying Wireless Equipment Manufacturing and Apparatus Smelting and and Screening Fixture Fixture Manufacturing Industry Manufacturing Electronic Manufacturing Aluminum) Extruding, Transformer, and Plumbing Plumbing Broadcasting Coil, Electrotherapeutic and and (except Product Equipment Equipment Manufacturing Component Drawing, and Electrical Metal Resistor, Television Video Dentists Dentists Turned Ceramics, Ceramics, Rolling, of of Laboratories Laboratories Primary Secondary and and Electronic Vehicle - Substituting* Non-Substituting** High - - Motor Nonferrous Manufacturing Pottery, Radio Dental Dental Precision Pottery, Electromedical Offices Other Offices Communications Copper Capacitor, Audio - Production Oxide- Oxide Labs Labs Code NAICS 621210b 621210a 334310 336320a 327110a 334220 331410a 339116a 339116b 331420c 332721a 334419 334416 334510 327110b Machining Beryllium Beryllium Beryllium Dental Dental Drawing

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00123 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.035 2592 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations Percent Profits a of As 18.53% 1.42% 1.21% 2.24% 21.42% 20.17% 2.67% 2.54% 9.51% 8.25% 3.35% 3.69% 4.87% Costs Percent a Revenues of As 1.01% 0.05% 0.45% 0.39% 0.08% 0.10% 0.88% 0.95% 0.03% 0.13% 0.15% 0.05% 0.04% Compliance Per Establishment $22,015 $70,398 $40,853 $25,959 $95,071 $70,535 $70,394 $76,605 $27,690 $11,590 $11,597 $11,591 $11,596 Rate Per Discount Establishment $1,217,849 $231,495 $853,009 $1,160,700 $1,952,698 $329,300 $379,878 $379,878 $1,952,698 $314,432 $434,159 $959,882 $456,185 Profits Percent a 3 a Rate 1.51% 2.47% 2.08% 2.08% 2.08% 3.99% 3.95% 4.73% 4.72% 4.72% 4.72% 4.72% 4.73% Using Per Calculated Establishment $4,890,512 $49,325,439 $18,060,076 $93,804,771 $6,972,010 $8,042,850 $8,042,850 $93,804,771 $9,171,923 $7,883,132 $24,330,752 $30,162,034 Costs Revenues With ,000) ($1 Standard Total continued $18,036,209 $14,552,929 $55,758,349 $7,838,073 $23,357,388 $2,412,855 $2,412,855 $3,595,394 $20,449,859 $5,623,100 $23,357,388 $2,830,636 $11,816,815 $5,693,396 Vlll-5, Beryllium Table Affected Final the Total Establishments 11 1 18 148 23 296 347 50 30 7 72 4 47 by Affected Total Establishments 114 1,499 3,688 300 678 300 434 261 249 249 234 392 406 Establishments for (except Nonferrous Analysis of Die-Casting) Die-Casting) Alloying Alloying Stamping Equipment and and Aluminum Alloying (except (except Screening of Metal and Foundries Die-Casting) Eleclronic Industry Other Aluminum) Manufacturing Extruding, Extruding, Alloying Foundries Foundries and and and Manufacturing Refining, (except and Metal Metal Die-Casting Product Drawing, Drawing, Electrical Copper Closure, Metal Smelting Smelting, Foundries Connector Turned Alloys Metals Rolling, Rolling, Manufacturing Vehicle Nonferrous Nonferrous Crown, (except Low Precision Nonferrous Metal Metal Motor Manufacturing Electronic Copper Other Secondary Copper Secondary Spring Other Aluminum Automotive) Foundries Precious Beryllium - - Foundries Code NAICS 332721b 331523 331420a 331529b 331314 331420b 331492 332613 332119 331524 334417 331529a 336320c Rolling Non-Sand Machining- Sand Smelting Smelting Springs Stamping

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00124 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.036 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2593 Percent Profits a of As 1.69% 1.30% 1.96% 14.45% 6.60% 2.84% 0.42% 3.98% 2.41% 0.86% 3.23% 0.93% 0.49% 3.00% 0.93% 7.76% 4.40% 4.48% 4.08% Costs Percent a Revenues of As 0.01% 0.12% 0.17% 0.04% 0.06% 0.08% 0.18% 0.03% 0.07% 0.21% 0.39% 0.10% 0.06% 0.25% 0.03% 0.11% 0.04% 0.10% 0.10% Compliance Per Establishment $10,496 $10,768 $11,630 $12,618 $13,345 $11,887 $10,769 $11,272 $10,773 $10,768 $10,765 $11,043 $11,767 $10,766 $10,772 $10,769 $10,961 $10,771 $11,294 Rate Per Discount Establishment $2,500,783 $244,507 $292,270 $746,804 $1,030,173 $606,949 $163,115 $1,304,162 $240,317 $138,729 $74,481 $341,463 $1,268,082 $264,070 $2,193,945 $379,186 $1,176,661 $446,502 $376,991 Profits Percent a 3 a Rate 1.24% 1.51% 2.72% 2.08% 2.72% 2.72% 2.72% 6.09% 6.09% 3.99% 3.99% 3.04% 5.86% 3.99% 3.99% 3.99% 3.21% 4.20% 4.72% Using Per Calculated Establishment $201,470,548 $6,959,553 $8,983,399 $5,992,968 $35,875,377 $21,811,029 $15,216,835 $32,702,145 $5,097,031 $2,736,510 $11,230,472 $20,834,244 $4,338,602 $37,433,440 $9,508,178 $29,505,027 $11,196,135 $11,728,174 Costs Revenues With ,000) '188 ($1 Standard Total continued $113,226,448 $7,043,067 $7,461,246 $5,991 $4,536,694 $2,023,839 $11,772,772 $6,058,633 $42,075,186 $15,903,209 $5,535,698 $27,839,554 $11,773,922 $15,889,234 $20,892,732 $3,885,743 $5,062,721 $15,415,053 $15,726,526 $8,945,712 Vlll-5, Beryllium Table Affected Final the Total Establishments 1 1 15 10 22 2 21 6 20 3 54 6 71 5 39 3 38 7 4 by Affected Total Establishments 1,245 167 1,012 133 1,124 1,654 539 360 3,553 4,099 472 208 2,214 243 562 3,099 346 741 799 Establishments for Machinery Analysis Manufacturing Machinery Product Furnaces) Manufacturing Stacker Work Metal Manufacturing Manufacturing Screening Air Purpose Manufacturing and Manufacturing Metal Fitting Manufacturing Warm Industry Equipment Manufacturing Trailer, Investment) Fabricated General Ferroalloy Manufacturing Pipe Manufacturing Metal Equipment Equipment Manufacturing Manufacturing (except and Part and Manufacturing and Architectural Tractor, (except Handtool Mills Conveying Body Shape Work and Container Valve Manufacturing and Structural Pumping and Truck, Miscellaneous Steel Equipment Metallurgy Steel Gas Metal and Metal Vehicle Metal Machinery Foundries Work Blade and Other Miscellaneous Other and Plate Powder Rolled Manufacturing Pump Manufacturing Fabricated Manufacturing Manufacturing Motor Farm Heating Iron Industrial Steel Saw Sheet Ornamental Other Other Conveyor All All Arc - Code NAICS 331221 332313 332312 332117 332322 331513 332216 331110a 333911 333999 332323 332999 333111a 333414a 336211 332439 332919 333922 333924 Welding

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00125 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.037 2594 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations Percent Profits a of As 1.81% 1.39% 1.01% 1.31% 2.30% 23.71% 2.23% 6.52% 6.71% 5.63% 3.53% 3.30% 0.51% 0.27% 0.48% 4.48% 4.53% Costs Percent a Revenues of As 0.05% 0.03% 0.06% 0.07% 0.02% 0.09% 0.07% 0.06% 0.05% 0.21% 0.20% 0.67% 0.10% 0.02% 0.01% 0.02% 0.07% Compliance Per Establishment $26,803 $11,028 $10,771 $11,708 $11,749 $26,799 $26,802 $26,802 $26,804 $26,798 $12,129 $10,763 $26,799 $12,166 $26,827 $26,836 $26,797 Rate 148 Per Discount '166, Establishment $758,710 $1 $608,070 $240,538 $1,159,824 $848,139 $475,965 $811,868 $2,042,354 $411,054 $180,835 $45,395 $1,200,467 $4,527,333 $5,261,431 $5,602,591 $592,078 Profits Percent a 3 a Rate 1.51% 1.51% 1.51% 1.51% 1.51% 1.51% 1.51% 2.91% 2.81% 3.21% 3.21% 4.36% 4.28% 4.28% 4.28% 4.28% 4.28% Using Per Calculated ,469,837 Establishment $50,164,329 $40,204,361 $19,473,827 $53,679,036 $47,696,913 $31 $12,787,881 $36,278,855 $6,207,415 $28,035,564 $122,874,888 $105,730,833 $1,617,512 $130,842,293 Costs Revenues With ,000) ($1 ,852,834 Standard Total continued $12,290,261 $10,544,247 $15,903,842 $4,674,297 $31 $6,278,849 $3,560,517 $3,686,247 $34,529,038 $33,235,797 $39,146,993 $21,336,550 $60,628,177 $17,944,334 $7,731,109 $76,685,188 $10,467,412 $951,577 $6,809,534 $4,710,323 Vlll-5, Beryllium Table Affected Final the Total Establishments 12 13 10 1 147 20 6 2 2 2 3 3 6 5 35 34 42 by Affected Total Establishments 1,508 1,097 195 127 663 98 678 491 245 234 21,347 397 30 878 9 36 849 Establishments for (except (except Purification and Air Analysis Parts Manufacturing and Manufacturing Equipment Equipment Components Equipment Maintenance Equipment and Manufacturing Engine Blower Locker Freezer and Screening Manufacturing Manufacturing and and Heating and Manufacturing Manufacturing Electronic Home Suspension Air Repair Industry Manufacturing Fan Machinery Refrigeration Manufacturing Manufacturing Equipment and Engine Appliance and and Manufacturing Shelving, Warm System Parts Appliance Equipment Camper Industrial Industrial and Stock Electronic) Appliance Steering Gasoline Brake Electrical Commercial and and and Household Vehicle and Partition, Manufacturing Refrigerator Cooking Laundry Welding and Transportation Rolling Manufacturing Trailer Electrical Vehicle Vehicle Vehicle Motor Major Vehicle Other Motor Manufacturing Motor Railroad Manufacturing Equipment Household Motor Motor Manufacturing Household Household Industrial Other Showcase, Commercial Spring) Commercial Small Other All Air-Conditioning Automotive Travel Resistance - Code NAICS 336390a 336510a 336999 337215 336330 333415 336214 333413 336340 335222 335210 335224 335228 335221 336320b 336310 Welding 811310

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00126 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.038 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2595 Percent Profits a of As 19.66% 1.43% 2.49% 2.98% 5.34% 0.17% 0.13% 0.54% 0.72% 0.69% 0.33% 0.31% 0.75% 0.45% 3.93% 0.71% 7.11% 4.18% 4.32% 4.41% Costs Percent a Revenues of As 0.02% 0.01% 0.01% 0.01% 0.04% 0.49% 0.07% 0.01% 0.01% 0.02% 0.04% 0.04% 0.05% 0.06% 0.23% 0.05% 0.05% 0.01% 0.06% 0.07% Compliance Per Establishment $29,543 $16,537 $16,541 $16,569 $26,804 $224,939 $16,532 $16,533 $16,549 $16,546 $16,537 $16,538 $26,806 $26,805 $26,795 $16,544 $16,530 $16,553 $16,530 $26,800 Rate Per Discount Establishment $553,734 $9,466,006 $12,796,838 $3,086,804 $1,076,224 $1,144,136 $1,159,747 $4,998,379 $2,299,416 $2,398,437 $5,274,306 $2,193,945 $898,020 $641,804 $376,991 $3,665,509 $420,171 $2,328,331 $382,683 $608,070 Profits Percent a 3 a Rate 1.51% 1.43% 1.51% 1.43% 1.43% 12.34% 1.51% 10.78% 1.37% 1.43% 1.47% 1.51% 2.47% 0.90% 8.23% 5.94% 5.86% 3.21% 4.62% 4.61% Using Per Calculated Establishment $123,329,544 $204,681,680 $155,553,993 $216,003,795 $46,339,915 $25,182,374 $84,140,910 $160,905,142 $167,834,268 $37,433,440 $42,434,722 $11,728,174 $30,633,533 $162,928,496 $26,026,757 $40,204,361 Costs Revenues With ,000) ($1 Standard Total continued $12,894,946 $4,822,174 $35,792,318 $71,157,690 $28,371,519 $42,728,192 $23,631,348 $32,802,040 $59,375,247 $5,535,698 $29,912,097 $6,708,744 $33,991,019 $6,842,997 $167,481,521 $45,144,793 $370,719 $9,644,849 $97,687,597 $3,218,103 $29,706,665 $42,075,186 $6,246,422 $60,628,177 Vlll-5, Beryllium Table Affected Final the Total Establishments 11 12 14 16 1 1 1 1 19 25 2 24 20 2 2 6 39 75 418 4 by Affected Total Establishments 1,161 177 1,124 1,508 503 773 42 472 2,716 20 63 31 240 219 209 664 383 398 8 880 Establishments for Parts Analysis Production Manufacturing Train Furnaces) Trim Screening Air Power Manufacturing Aluminum Manufacturing and Manufacturing Warm Industry Manufacturing Interior Manufacturing Generation Mills and Primary Resin Equipment Product Parts Stamping (except Power Manufacturing and and and Detergent Newsprint) Seating Metal Wood Transmission Vehicle Mills Manufacturing Electric Mills Extract Other Milling Refining Manufacturing Material Equipment (except Fuel Vehicle Vehicle Vehicle Motor and Machinery and Sugar Mills Corn Motor Newsprint Manufacturing Motor Paperboard Plastics Fossil Pulp Paper Manufacturing Motor Reconstituted Heating Farm Spice Soap Cement Other Beet Breweries Alumina Wet Utilities Production Fired Code NAICS 311313 311221 336350 331313 311942 322122 336360 312120 322130 325211 325611 327310 321219 322121 336390b 336370 333414b 322110 333111b Aluminum 221112 Coal

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In Chapter VII, OSHA estimates the beryllium rule. The methodology for as in the PEA. OSHA did not receive benefits and net benefits of the final these estimates largely remains the same many comments challenging any aspect

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

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

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

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In the fifth step, OSHA provides a percentage of dental laboratories were to promulgated, have a significant sensitivity analysis to explore the substitute materials that do not contain economic impact on a substantial robustness of the estimates of net beryllium for beryllium-containing number of small entities. As discussed benefits with respect to many of the materials. OSHA also estimates net in Chapter VI of the FEA, OSHA was assumptions made in developing and benefits with a variety of scenarios in unable to so certify for the final applying the underlying models. This is which dental laboratories are not beryllium rule. done because the models underlying included. All of these results are For OSHA rulemakings, as required each step inevitably need to make a presented in Chapter VII of the FEA. by 5 U.S.C. 604(a), the FRFA must contain: variety of assumptions based on limited H. Regulatory Alternatives data. OSHA invited comments on each 1. A statement of the need for, and aspect of the data and methods used in Chapter VIII presents the costs, objectives of, the rule; this chapter, and received none benefits and net benefits of a variety of 2. a statement of the significant issues raised by the public comments in specifically on the sensitivity analysis. regulatory alternatives. response to the initial regulatory Because dental laboratories constituted I. Final Regulatory Flexibility Analysis flexibility analysis, a statement of the a significant source of both costs and The Regulatory Flexibility Act, (RFA), assessment of the agency of such issues, benefits to the proposal, the PEA Public Law 96–354, 94 Stat. 1164 and a statement of any changes made in indicated that OSHA was particularly (codified at 5 U.S.C. 601), requires the proposed rule as a result of such interested in comments regarding the Federal agencies to consider the comments; appropriateness of the model, economic impact that a final rulemaking 3. the response of the agency to any assumptions, and data for estimating the will have on small entities. The RFA comments filed by the Chief Counsel for benefits to workers in that industry. states that whenever an agency Advocacy of the Small Business Although the Agency did not receive promulgates a final rule that is required Administration (SBA) in response to the any comments on this question directly, to conform to the notice-and-comment proposed rule, and a detailed statement the American Dental Association’s rulemaking requirements of section 553 of any change made to the proposed rule comments relevant to the underlying of the Administrative Procedure Act in the final rule as a result of the use of beryllium alloys in dental labs are (APA), the agency shall prepare a final comments; addressed in Chapter III of the FEA. The regulatory flexibility analysis (FRFA). 5 4. a description of and an estimate of Agency has not altered its main U.S.C. 604(a). the number of small entities to which estimates of the exposure profile for However, 5 U.S.C. 605(b) of the RFA the rule will apply or an explanation of dental laboratory workers, but provides states that Section 604 shall not apply why no such estimate is available; sensitivity analyses in the FEA to to any final rule if the head of the 5. a description of the projected examine the outcome if a lower agency certifies that the rule will not, if reporting, recordkeeping and other

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

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

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Table Vlll-9: Average Costs and Impacts for SBA-Defined Small Entities Affected by the Final Beryllium Standard With Costs Calculated Using a 3 Percent Discount Rate Application Cost Per Cost to Cost to Industry Group/ NAICS Entity Revenue Profit Beryllium Oxide - Primary

327110a Pottery, Ceramics, and Plumbing Fixture Manufacturing $118,743 -- -- Beryllium Oxide - Secondary

Radio and Television Broadcasting and Wireless Communications Equipment 334220 $12,538 0.1% 18.1% Manufacturing

334310 Audio and Video Equipment Manufacturing $20,325 0.4% -173.4%

334416 Capacitor, Resistor, Coil, Transformer, and Other Inductor Manufacturing $19,317 0.3% 8.3%

334419 Other Electronic Component Manufacturing $18,331 0.3% 7.8%

334510 Electromedical and Electrotherapeutic Apparatus Manufacturing $7,414 0.5% 10.3%

327110b Pottery, Ceramics, and Plumbing Fixture Manufacturing $16,508 1.0% 63.6%

336320a Motor Vehicle Electrical and Electronic Equipment Manufacturing $16,333 0.1% 7.1% Beryllium Production

331410a Nonferrous Metal (except Aluminum) Smelting and Refining $0 -- -- Dental Labs Substituting*

339116a Dental Laboratories $832 0.2% 2.1%

621210a Offices of Dentists $981 0.1% 1.7% Dental Labs - Non-Substituting**

339116b Dental Laboratories $4,315 0.8% 11.0%

621210b Offices of Dentists $5,090 0.6% 8.6% Drawing

331420c Copper Rolling, Drawing, Extruding, and Alloying $79,253 0.1% 6.9% Machining - High

332721a Precision Turned Product Manufacturing $30,658 0.7% 14.5% Machining - Low

332721b Precision Turned Product Manufacturing $21,237 0.5% 10.0% Non-Sand Foundries

331523 Nonferrous Metal Die-Casting Foundries $52,387 0.6% 12.1%

331524 Aluminum Foundries (except Die-Casting) $63,675 1.3% 27.1%

331529a Other Nonferrous Metal Foundries (except Die-Casting) $56,187 1.0% 21.8%

Rolling

331420a Copper Rolling, Drawing, Extruding, and Alloying $82,941 0.1% 7.2% Sand Foundries

331529b Other Nonferrous Metal Foundries (except Die-Casting) $61,501 1.1% 23.8% Smelting - Beryllium Alloys

331314 Secondary Smelting and Alloying of Aluminum $36,757 0.1% 5.0%

331420b Copper Rolling, Drawing, Extruding, and Alloying $26,425 0.0% 2.3% Smelting - Precious Metals

Secondary Smelting, Refining, and Alloying of Nonferrous Metal (except Copper and 331492 $22,398 0.0% 2.2% Aluminum)

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Table Vlll-9: Average Costs and Impacts for SBA-Defined Small Entities Affected by the Final Beryllium Standard With Costs Calculated Using a 3 Percent Discount Rate, Continued Application Cost Per Cost to Cost to Industry Group/ NAICS Entity Revenue Profit Springs

332613 Spring Manufacturing $10,777 0.2% 3.4% Stamping

332119 Metal Crown, Closure, and Other Metal Stamping (except Automotive) $11,131 0.2% 4.4%

334417 Electronic Connector Manufacturing $7,926 0.1% 1.5%

336320c Motor Vehicle Electrical and Electronic Equipment Manufacturing $8,419 0.1% 3.7% Welding - Arc and Gas

331110a Iron and Steel Mills and Ferroalloy Manufacturing $4,380 0.0% 0.6%

331221 Rolled Steel Shape Manufacturing $13,662 0.0% 1.8%

331513 Steel Foundries (except Investment) $9,473 0.1% 1.9%

332117 Powder Metallurgy Part Manufacturing $8,783 0.1% 2.4%

332216 Saw Blade and Handtool Manufacturing $9,018 0.2% 5.5%

332312 Fabricated Structural Metal Manufacturing $8,243 0.1% 5.1%

332313 Plate Work Manufacturing $9,998 0.2% 7.1%

332322 Sheet Metal Work Manufacturing $9,650 0.2% 8.9%

332323 Ornamental and Architectural Metal Work Manufacturing $9,132 0.4% 15.7%

332439 Other Metal Container Manufacturing $7,874 0.1% 4.5%

332919 Other Metal Valve and Pipe Fitting Manufacturing $8,224 0.1% 1.1%

332999 All Other Miscellaneous Fabricated Metal Product Manufacturing $9,726 0.3% 4.4%

333111a Farm Machinery and Equipment Manufacturing $6,431 0.1% 1.1%

333414a Heating Equipment (except Warm Air Furnaces) Manufacturing $8,622 0.1% 3.4%

333911 Pump and Pumping Equipment Manufacturing $5,759 0.1% 1.3%

333922 Conveyor and Conveying Equipment Manufacturing $9,180 0.1% 2.7%

333924 Industrial Truck, Tractor, Trailer, and Stacker Machinery Manufacturing $6,208 0.1% 1.5%

333999 All Other Miscellaneous General Purpose Machinery Manufacturing $7,212 0.1% 3.6%

336211 Motor Vehicle Body Manufacturing $8,159 0.1% 5.1%

336214 Travel Trailer and Camper Manufacturing $5,388 0.1% 5.7%

336390a Other Motor Vehicle Parts Manufacturing $6,784 0.0% 2.3%

336510a Railroad Rolling Stock Manufacturing $6,219 0.0% 1.9%

336999 All Other Transportation Equipment Manufacturing $5,817 0.1% 3.1%

337215 Showcase, Partition, Shelving, and Locker Manufacturing $9,887 0.2% 7.4%

Commercial and Industrial Machinery and Equipment (except Automotive and 811310 $7,050 0.7% 25.1% Electronic) Repair and Maintenance Welding - Resistance Welding

Industrial and Commercial Fan and Blower and Air Purification Equipment 333413 $16,755 0.2% 7.2% Manufacturing

Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial 333415 $11,917 0.1% 2.9% Refrigeration Equipment Manufacturing

335210 Small Electrical Appliance Manufacturing $21,934 0.1% 2.9%

335221 Household Cooking Appliance Manufacturing $13,257 0.1% 1.5%

335222 Household Refrigerator and Home Freezer Manufacturing $7,733 0.0% 0.5%

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Table Vlll-9: Average Costs and Impacts for SBA-Defined Small Entities Affected by the Final Beryllium Standard With Costs Calculated Using a 3 Percent Discount Rate, Continued Application Cost Per Cost to Cost to Industry Group/ NAICS Entity Revenue Profit

335224 Household Laundry Equipment Manufacturing $1,369 0.0% 0.6%

335228 Other Major Household Appliance Manufacturing $6,753 0.0% 0.7%

336310 Motor Vehicle Gasoline Engine and Engine Parts Manufacturing $10,707 0.1% 8.5%

336320b Motor Vehicle Electrical and Electronic Equipment Manufacturing $15,635 0.1% 6.8%

336330 Motor Vehicle Steering and Suspension Components (except Spring) Manufacturing $11,414 0.1% 3.4%

336340 Motor Vehicle Brake System Manufacturing $16,760 0.1% 4.5%

336350 Motor Vehicle Transmission and Power Train Parts Manufacturing $12,376 0.1% 3.6%

336360 Motor Vehicle Seating and Interior Trim Manufacturing $13,577 0.1% 4.3%

336370 Motor Vehicle Metal Stamping $20,274 0.1% 5.4%

333414b Heating Equipment (except Warm Air Furnaces) Manufacturing $19,867 0.2% 7.7%

336390b Other Motor Vehicle Parts Manufacturing $15,723 0.1% 5.3% Aluminum Production

331313 Alumina Refining and Primary Aluminum Production $599,836 0.5% 19.7% Coal Fired Utilities

221112 Fossil Fuel Electric Power Generation $41,467 0.0% 3.8%

311221 Wet Corn Milling $6,657 0.0% 0.3%

311313 Beet Sugar Manufacturing $10,413 0.0% 0.1%

311942 Spice and Extract Manufacturing $12,092 0.1% 1.9%

312120 Breweries $9,720 0.2% 1.5%

321219 Reconstituted Wood Product Manufacturing $8,314 0.0% 3.4%

322110 Pulp Mills $3,137 0.0% 0.5%

322121 Paper (except Newsprint) Mills $7,437 0.0% 0.8%

322122 Newsprint Mills $11,147 0.0% 0.7%

322130 Paperboard Mills $7,201 0.0% 1.0%

325211 Plastics Material and Resin Manufacturing $11,843 0.0% 0.6%

325611 Soap and Other Detergent Manufacturing $7,622 0.1% 0.9%

327310 Cement Manufacturing $11,512 0.1% 4.9%

333111b Farm Machinery and Equipment Manufacturing $9,096 0.1% 1.5%

336510b Railroad Rolling Stock Manufacturing $5,305 0.0% 1.6%

611310 Colleges, Universities, and Professional Schools $3,773 0.0% 0.6% Abrasive Blasting - Construction

238320 Painting and Wall Covering Contractors $3,430 0.6% 18.7%

238990 All Other Specialty Trade Contractors $3,175 0.3% 8.8% Abrasive Blasting Shipyards***

336611a Ship Building and Repairing $1,818 0.0% 0.3% Welding Shipyards****

336611b Ship Building and Repairing $3,613 0.0% 0.6% Total General Industry Subtotal $9,651 0.3% 8.1% Construction Subtotal $3,308 0.4% 12.3% Maritime Subtotal $1,835 0.0% 0.3% Weighted Average, All Industries $6,876 0.0% 0.9%

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Table Vlll-9: Average Costs and Impacts for SBA-Defined Small Entities Affected by the Final Beryllium Standard With Costs Calculated Using a 3 Percent Discount Rate, Continued Application Cost Per Cost to Cost to Industry Group/ NAICS Entity Revenue Profit

Notes:

Figures in rows may not add to totals due to rounding.

"--" indicates areas where data are not available. (While the average revenues and implied profits for the Beryllium Production (NAICS 32711 Oa)

and Beryllium Oxide (NAICS 331410a) industries can be calculated, they would in no way reflect the actual revenues and profits of the affected

facilities.

Application group Dental Labs- Substituting applies to establishments that substitute beryllium-free material for beryllium and incur costs due

to the price differential between beryllium-free alloys and alloys that contain beryllium plus the cost of additional training to teach dental technicians

how to cast the beryllium-free alloys.

•• Application group Dental Labs - Non-Substituting are estabishments with exposures below the PEL that continue to use berylium alloys and

incur the cost of the ancillary provisions required by the final standard.

••• Employers in application group Abrasive Blasting -Shipyards are shipyards employing abrasive blasters that use mineral slag abrasives to etch

the surfaces of boats and ships.

•••• Employers in application group Welding in Shipyards employ welders in shipyards. Some of these employers may do both welding and

abrasive blasting.

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

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Table Vlll-10: Average Costs and Impacts for Very Small Entities (with Fewer than 20 Employees) Affected by the Final Beryllium Standard With Costs Calculated Using a 3 Percent Discount Rate

Application Cost Per Cost to Cost to Industry Group/ NAICS Entity Revenue Profit Beryllium Oxide - Primary

327110a Pottery, Ceramics, and Plumbing Fixture Manufacturing $0 -- -- Beryllium Oxide - Secondary

Radio and Television Broadcasting and Wireless Communications Equipment 334220 $0 0.00% 0.00% Manufacturing

334310 Audio and Video Equipment Manufacturing $0 0.00% 0.00%

334416 Capacitor, Resistor, Coil, Transformer, and Other Inductor Manufacturing $0 0.00% 0.00%

334419 Other Electronic Component Manufacturing $0 0.00% 0.00%

334510 Electromedical and Electrotherapeutic Apparatus Manufacturing $0 0.00% 0.00%

327110b Pottery, Ceramics, and Plumbing Fixture Manufacturing $0 0.00% 0.00%

336320a Motor Vehicle Electrical and Electronic Equipment Manufacturing $0 0.00% 0.00% Beryllium Production

331410a Nonferrous Metal (except Aluminum) Smelting and Refining $0 -- -- Dental Labs Substituting•

339116a Dental Laboratories $542 0.18% 2.42%

621210a Offices of Dentists $872 0.12% 1.67% Dental Labs - Non-Substituting••

339116b Dental Laboratories $2,812 0.92% 12.54%

621210b Offices of Dentists $4,526 0.63% 8.67% Drawing

331420c Copper Rolling, Drawing, Extruding, and Alloying $9,121 0.26% 12.66% Machining - High

332721a Precision Turned Product Manufacturing $10,396 0.83% 17.64% Machining - Low

332721b Precision Turned Product Manufacturing $7,300 0.59% 12.39% Non-Sand Foundries

331523 Nonferrous Metal Die-Casting Foundries $23,395 1.85% 39.11%

331524 Aluminum Foundries (except Die-Casting) $26,897 3.36% 71.13%

331529a Other Nonferrous Metal Foundries (except Die-Casting) $30,747 2.47% 52.38% Rolling

331420a Copper Rolling, Drawing, Extruding, and Alloying $9,656 0.28% 13.41% Sand Foundries

331529b Other Nonferrous Metal Foundries (except Die-Casting) $34,222 2.75% 58.30% Smelting - Beryllium Alloys

331314 Secondary Smelting and Alloying of Aluminum $26,479 0.69% 28.12%

331420b Copper Rolling, Drawing, Extruding, and Alloying $13,315 0.38% 18.48% Smelting - Precious Metals

Secondary Smelting, Refining, and Alloying of Nonferrous Metal (except Copper 331492 $13,081 0.27% 13.12% and Aluminum)

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Table Vlll-10: Average Costs and Impacts for Very Small Entities (with Fewer than 20 Employees) Affected by the Final Beryllium Standard With Costs Calculated Using a 3 Percent Discount Rate, Continued Application Cost Per Cost to Cost to Industry Group/ NAICS Entity Revenue Profit Springs

332613 Spring Manufacturing $4,458 0.37% 7.84% Stamping

332119 Metal Crown, Closure, and Other Metal Stamping (except Automotive) $4,587 0.33% 8.19%

334417 Electronic Connector Manufacturing $3,854 0.34% 8.72%

336320c Motor Vehicle Electrical and Electronic Equipment Manufacturing $3,882 0.33% 21.75% Welding - Arc and Gas

331110a Iron and Steel Mills and Ferroalloy Manufacturing $3,277 0.12% 9.87%

331221 Rolled Steel Shape Manufacturing $5,201 0.13% 6.14%

331513 Steel Foundries (except Investment) $5,852 0.48% 10.10%

332117 Powder Metallurgy Part Manufacturing $6,564 0.31% 7.82%

332216 Saw Blade and Handtool Manufacturing $3,829 0.51% 12.17%

332312 Fabricated Structural Metal Manufacturing $3,039 0.21% 7.67%

332313 Plate Work Manufacturing $3,212 0.28% 10.14%

332322 Sheet Metal Work Manufacturing $3,372 0.30% 11.06%

332323 Ornamental and Architectural Metal Work Manufacturing $4,217 0.59% 21.53%

332439 Other Metal Container Manufacturing $3,287 0.28% 9.33%

332919 Other Metal Valve and Pipe Fitting Manufacturing $3,936 0.16% 2.70%

332999 All Other Miscellaneous Fabricated Metal Product Manufacturing $3,249 0.38% 6.26%

333111a Farm Machinery and Equipment Manufacturing $3,043 0.25% 4.19%

333414a Heating Equipment (except Warm Air Furnaces) Manufacturing $3,514 0.23% 7.22%

333911 Pump and Pumping Equipment Manufacturing $3,210 0.12% 3.09%

333922 Conveyor and Conveying Equipment Manufacturing $3,034 0.18% 4.57%

333924 Industrial Truck, Tractor, Trailer, and Stacker Machinery Manufacturing $3,491 0.26% 6.50%

333999 All Other Miscellaneous General Purpose Machinery Manufacturing $3,040 0.22% 5.49%

336211 Motor Vehicle Body Manufacturing $3,034 0.20% 13.43%

336214 Travel Trailer and Camper Manufacturing $3,034 0.25% 16.59%

336390a Other Motor Vehicle Parts Manufacturing $3,269 0.19% 12.35%

336510a Railroad Rolling Stock Manufacturing $3,877 0.17% 11.02%

336999 All Other Transportation Equipment Manufacturing $3,924 0.28% 6.47%

337215 Showcase, Partition, Shelving, and Locker Manufacturing $4,266 0.52% 17.84%

Commercial and Industrial Machinery and Equipment (except Automotive and 811310 $4,938 0.76% 27.08% Electronic) Repair and Maintenance Welding - Resistance Welding

Industrial and Commercial Fan and Blower and Air Purification Equipment 333413 $3,830 0.25% 7.90% Manufacturing

Air-Conditioning and Warm Air Heating Equipment and Commercial and Industrial 333415 $1,952 0.10% 3.25% Refrigeration Equipment Manufacturing

335210 Small Electrical Appliance Manufacturing $2,165 0.12% 2.70%

335221 Household Cooking Appliance Manufacturing $1,310 0.11% 2.68%

335222 Household Refrigerator and Home Freezer Manufacturing $1,310 0.08% 1.82%

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Table Vlll-10: Average Costs and Impacts for Very Small Entities (with Fewer than 20 Employees) Affected by the Final Beryllium Standard With Costs Calculated Using a 3 Percent Discount Rate, Continued Application Cost Per Cost to Cost to Industry Group/ NAICS Entity Revenue Profit

335224 Household Laundry Equipment Manufacturing $1,310 0.09% 2.08%

335228 Other Major Household Appliance Manufacturing $1,310 0.06% 1.41%

336310 Motor Vehicle Gasoline Engine and Engine Parts Manufacturing $1,923 0.20% 13.52%

336320b Motor Vehicle Electrical and Electronic Equipment Manufacturing $2,075 0.18% 11.63%

Motor Vehicle Steering and Suspension Components (except Spring) 336330 $1,470 0.07% 4.62% Manufacturing

336340 Motor Vehicle Brake System Manufacturing $1,310 0.11% 7.60%

336350 Motor Vehicle Transmission and Power Train Parts Manufacturing $1,315 0.08% 4.98%

336360 Motor Vehicle Seating and Interior Trim Manufacturing $1,488 0.09% 6.26%

336370 Motor Vehicle Metal Stamping $2,214 0.10% 6.85%

333414b Heating Equipment (except Warm Air Furnaces) Manufacturing $4,252 0.28% 8.73%

336390b Other Motor Vehicle Parts Manufacturing $1,906 0.11% 7.20% Aluminum Production

331313 Alumina Refining and Primary Aluminum Production $0 0.00% 0.00% Coal Fired Utilities

221112 Fossil Fuel Electric Power Generation $2,626 0.01% 2.39%

311221 Wet Corn Milling $0 0.00% 0.00%

311313 Beet Sugar Manufacturing $0 0.00% 0.00%

311942 Spice and Extract Manufacturing $0 0.00% 0.00%

312120 Breweries $0 0.00% 0.00%

321219 Reconstituted Wood Product Manufacturing $0 0.00% 0.00%

322110 Pulp Mills $0 0.00% 0.00%

322121 Paper (except Newsprint) Mills $0 0.00% 0.00%

322122 Newsprint Mills $0 0.00% 0.00%

322130 Paperboard Mills $0 0.00% 0.00%

325211 Plastics Material and Resin Manufacturing $0 0.00% 0.00%

325611 Soap and Other Detergent Manufacturing $0 0.00% 0.00%

327310 Cement Manufacturing $0 0.00% 0.00%

333111b Farm Machinery and Equipment Manufacturing $0 0.00% 0.00%

336510b Railroad Rolling Stock Manufacturing $0 0.00% 0.00%

611310 Colleges, Universities, and Professional Schools $0 0.00% 0.00% Abrasive Blasting - Construction

238320 Painting and Wall Covering Contractors $2,504 0.71% 20.34%

238990 All Other Specialty Trade Contractors $2,289 0.32% 9.28% Abrasive Blasting Shipyards***

336611a Ship Building and Repairing $1,467 0.10% 1.66% Welding Shipyards****

336611b Ship Building and Repairing $3,112 0.22% 3.52% Total General Industry Subtotal $2,956 0.34% 6.06% Construction Subtotal $2,402 0.46% 13.22% Maritime Subtotal $1,483 0.10% 1.68%

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Description of the Steps OSHA Has ancillary provisions of the standard. construction work may not have been Taken To Minimize the Significant However, many SERs objected to the expressly addressed in the PEA, OSHA Economic Impact on Small Entities requirements regarding hygiene notes that their employers are typically Consistent With the Stated Objectives of facilities. For this final rule, OSHA has already required to provide readily Applicable Statutes and Statement of concluded that all affected employers accessible washing facilities to comply the Reasons For Selecting the currently have hand washing facilities. with other OSHA standards such as its Alternative Adopted in the Final Rule OSHA has also concluded that no sanitation standard at 29 CFR 34 OSHA has made a number of changes affected employers will be required to 1926.51(f)(1). In the absence of in the final beryllium rule that will install showers. OSHA noted in the PEA additional comment, OSHA is not serve to minimize significant impacts on that some facilities already have including any costs for washing small entities consistent with the showers. There were no comments facilities in the FEA. objectives of the OSH Act. These challenging the Agency’s preliminary OSHA’s shipyard standard at 29 CFR changes are explained in more detail in determinations regarding the existing 1915.58(e) requires handwashing Section XVI: Summary and Explanation availability of shower facilities or the facilities ‘‘at or adjacent to each toilet in this preamble. means of preventing contamination, so facility’’ and ‘‘equipped with . . . During the SBAR Panel, SERs the Agency concludes that all employers running water and soap, or with requested a clearer definition of the have showers where needed. Therefore, waterless skin-cleansing agents that are triggers for medical surveillance. This employers will not need to provide any capable of . . . neutralizing the concern was rooted in the cost of new shower facilities to comply with contaminants to which the employee 33 BeLPTs and the trigger of potential skin the standard. may be exposed.’’ OSHA’s construction contact. For the final rule, the Agency Similarly, in the PEA the Agency standard at 29 CFR 1926.51(f)(1) has removed skin contact as a trigger for included no additional costs for readily requires ‘‘adequate washing facilities for medical surveillance. OSHA has also accessible washing facilities, under the employees engaged in . . . operations expectation that employers already have where contaminants may be harmful to reduced the frequency of medical such facilities in place (PEA p. IX–19). the employees. Such facilities shall be surveillance from annually (in the Although the abrasive blasters exposed in near proximity to the worksite and proposed rule) to biennially in the final to beryllium in maritime and shall be so equipped as to enable rule. In the final rule, OSHA has added a employees to remove such substances.’’ 33 performance option, as an alternative to OSHA reached the same conclusion in the PEA (p. V–118). For information purposes, OSHA 34 OSHA’s shipyard standard at 29 CFR scheduled monitoring, to allow estimated the initial cost of installing portable 1915.58(e) requires handwashing facilities ‘‘at or employers to comply with exposure showers at $39,687, with an annualized cost of adjacent to each toilet facility’’ and ‘‘equipped with assessment requirements. This $4,653 per facility (Id.) and did not receive any . . . running water and soap, or with waterless performance option should allow comments suggesting that shower costs should be skin-cleansing agents that are capable of . . . included or regarding the cost of installing them. neutralizing the contaminants to which the employers more flexibility, and often The annual cost per employee for shower supplies, employee may be exposed.’’ OSHA’s construction lower cost, in complying with the towels, and time required for showering was standard at 29 CFR 1926.51(f)(1) requires ‘‘adequate exposure assessment requirements. estimated to be $1,519. However, as indicated above washing facilities for employees engaged in . . . Some SERs were already applying in the text, the Agency believed that employers operations where contaminants may be harmful to would be able to comply with the standard by less the employees. Such facilities shall be in near many of the protective controls and costly means than the installation of shower proximity to the worksite and shall be so equipped practices that would be required by the facilities. as to enable employees to remove such substances.’’

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

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

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

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00144 Fmt 4701 Sfmt 4700 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations 2613 $0.0 $0.0 $0.0 $0.0 -$0.3 -$0.2 -$1.6 -$0.1 -$5.4 -$0.2 -$0.8 -$0.1 -$0.6 -$12.2 7% Dollars) Million $0.0 $0.0 $0.0 -$0.3 -$1.4 -$1.5 -$0.2 -$1.5 -$0.1 -$5.3 -$1.6 -$1.7 -$0.2 -$0.8 -$0.1 -$0.5 -$27.4 -$11.9 -$12.3 -$27.6 -$12.3 -$15.7 Costs/Benefrts 3% (2015 #2a) 0 -4 -4 -2 Incremental cases Alternative $0.9 $0.6 $6.2 $2.2 $8.9 $0.3 $0.1 $0.2 $0.7 $1.5 $21.6 $64.4 $236.8 $172.5 (Regulatory Sectors) 7% 2a $6.0 $0.9 $0.6 $2.1 $8.5 $0.3 $0.1 $0.1 $0.7 $1.8 $1.8 $7.5 $7.6 $2.7 Construction Construction $21.1 $62.0 $12.2 $13.2 $530.6 $235.3 $533.3 $471.3 3% and and Alternative 4 81 44 85 Maritime Maritime Cases (Remove Excluding ) 3 $0.3 $2.0 $0.9 $0.2 $0.2 $1.3 Scope $76.6 $249.1 $172.4 $247.5 7% IJg/m 0 0.1 Alternative = of $0.3 $0.2 $0.1 $1.2 $2.0 $8.3 $8.3 $0.9 $7.4 $2.3 $7.7 $2.4 $2.4 $2.4 $2.9 $1.6 AL $12.3 $13.3 $13.7 $14.4 $22.8 $23.2 $73.9 , $558.0 $560.9 $487.0 3 3% Rule Standard 11g1ID 4 0.2 90 86 46 = Analysis Beryllium Cases (PEL Final Regulatory of OSHA's of Office Benefits Guidance, and Incremental rounding. and to Standards due Estimate) of Prevented Benefits totals Estimate) to Cases (Midpoint Costs, Directorate of add Disease Equipment not (Midpoint Practices and Benefits Estimate) Mortality Plan OSHA, Number may Areas and Annualized Beryllium DOL, (Point Costs Cancers Annual Areas Clothing rows Control Assessment Morbidity Work Areas US Removal Surveillance in Costs Benefits: Vlll-12 Lung Costs Chronic Familiarization Benefrts Benefits Table Medical Medical Protective Monetized Net Notes: Respirators Rule Exposure Regulated Exposure Hygiene Housekeeping Fatal Fatal Figures Source: Control Beryllium Beryllium-Related Beryllium Net Training Total Annualized Annual

VerDate Sep<11>2014 21:46 Jan 06, 2017 Jkt 241001 PO 00000 Frm 00145 Fmt 4701 Sfmt 4725 E:\FR\FM\09JAR2.SGM 09JAR2 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ER09JA17.053 2614 Federal Register / Vol. 82, No. 5 / Monday, January 9, 2017 / Rules and Regulations $0.0 $0.0 $0.0 -$0.3 -$2.6 -$0.5 -$0.1 -$0.8 -$0.4 -$1.8 -$0.2 -$8.7 -$8.9 -$29.8 -$30.0 -$21.1 7% Contaminan1s $0.0 $0.0 $0.0 -$4.4 -$4.5 -$8.3 -$0.3 -$2.4 -$0.5 -$1.6 -$1.6 -$0.1 -$0.7 -$0.4 -$1.8 -$0.4 -$67.2 -$47.2 -$67.5 -$20.4 Trace Cos1s/Benefi1s 3% with 0 -6 -11 -11 Incremental Industries Cases for Costs $0.1 $0.6 $5.1 $1.9 $0.9 $0.3 $0.2 $0.5 $1.6 $6.6 $1.4 $5.7 $13.3 $18.7 $55.6 $163.5 $219.1 $217.7 Control Control 7% Require and Requiring and 1926.55 Contamlnan1s) $0.6 $5.0 $1.9 $0.9 $0.3 $0.2 $0.5 $1.6 $6.5 $2.5 $0.1 $5.4 $53.5 $12.3 $18.3 $490.8 $439.8 $493.3 2b and 1926.55 Trace and 3% with Alternative 1915.1000, 1915.1000, Industries for 4 Dollars) 75 79 40 1910.1000, Cos1s Million 1910.1000, Tables Z Cases (2015 Tables Z #2b) (Update Updating $2.0 $0.2 $0.9 $0.3 $0.2 $1.3 of $76.6 Alternative $172.4 $249.1 $247.5 7% ~glm') Standard 0.1 = (Regula1ory $0.3 $0.2 $0.1 $1.2 $2.0 $8.3 $8.3 $0.9 $7.4 $2.3 $7.7 $2.4 $2.4 $2.4 $2.9 $1.6 AL $12.3 $13.3 $13.7 $14.4 $22.8 $23.2 $73.9 Analysis $558.0 $560.9 $487.0 3% Rule Beryllium ~g/m', Final 0.2 4 90 86 46 Regulatory of (PEL= OSHA's Cases of Office Benefits Guidance, and Incremental rounding. to and Standards due Estimate) of Prevented Benefi1s totals Estimate) to Cases (Midpoint Costs, Directorate of add Disease Equipment not (Midpoint Practices and Benefits Estimate) Mortality Plan OSHA, Number may Areas and Beryllium Annualized DOL, (Point Cos1s Cancers Annual Areas Clothing rows Control Assessment Morbidity Work Areas US Removal Surveillance in Costs Benefi1s: Vlll-13 Lung Chronic Costs Familiarization Benefits Benefi1s Table Medical Medical Protective Monetized Net Notes: Respirators Rule Exposure Regulated Exposure Hygiene Housekeeping Fatal Fatal Figures Control Source: Beryllium Beryllium-Related Beryllium Nat Training Total Annualized Annual

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

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

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

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

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these costs under Regulatory Alternative and every three months when Exposure Monitoring #7 would reasonably be attributable to exposure levels exceed the TWA Paragraph (d) of the final standard, the final rule. The total costs for this PEL, Regulatory Alternative #8 Exposure Assessment, allows employers alternative are $12.5 million at a 3% would require annual exposure to choose either the performance option discount rate and $13.5 million at a 7% monitoring where exposure levels or scheduled monitoring. The scheduled discount rate. exceed the TWA PEL or STEL; monitoring option requires semi-annual OSHA has also estimated the effect of monitoring for those workers exposed at Æ this regulatory alternative on the Written exposure control plan: or above the action level but at or below benefits of the rule, presented in Table Whereas the final standards require the PEL and quarterly exposure VIII–16. As a result of eliminating all of written exposure control plans to be monitoring for those workers exposed the ancillary provisions, annualized maintained in any facility covered by above the PEL. The rationale for this benefits are estimated to decrease 71 the standard, Regulatory Alternative #8 provision is provided in the preamble percent, relative to the final rule, from would require only facilities with discussion of paragraph (a) in Section $560.9 million to $211.9 million, using exposures above the TWA PEL or STEL XVI, Summary and Explanation of the a 3 percent discount rate, and from to maintain a plan; Standards. $249.1 million to $94.0 million using a OSHA has examined three regulatory Æ 7 percent discount rate. This estimate PPE: Whereas the final standards alternatives that would modify the follows from OSHA’s analysis of require PPE when airborne exposure to requirements of periodic monitoring in benefits in Chapter VII of the FEA, beryllium exceeds, or can reasonably be the final rule. Under Regulatory which found that about 68 percent of expected to exceed, the PEL or STEL, Alternative #9, employers would be the benefits of the final rule, evaluated and where there is a reasonable required to perform periodic exposure at their mid-point value, were expectation of dermal contact with monitoring annually when exposures attributable to the combination of the beryllium, Alternative #8 would require are at or above the action level or above ancillary provisions. As these estimates PPE only for employees exposed above the STEL, but at or below the TWA PEL. show, OSHA expects that the benefits the TWA PEL or STEL; As shown in Table VIII–16, Regulatory estimated under the final rule will not Alternative #9 would decrease the be fully achieved if employers do not Æ Medical Surveillance: Whereas the annualized cost of the final rule by implement the ancillary provisions of final standard’s medical surveillance about $4.3 million using either a 3 the final rule. provisions require employers to offer percent or 7 percent discount rate. Both industry and worker groups have medical surveillance to employees Under Regulatory Alternative #10, recognized that a comprehensive exposed above the action level for 30 employers would be required to perform standard is needed to protect workers days per year, showing signs or periodic exposure monitoring annually exposed to beryllium. The stakeholders’ symptoms of CBD, exposed to beryllium when exposures are at or above the recommended standard—that in an emergency, or when action level. As shown in Table VIII–16, representatives of Materion, the primary recommended by a medical opinion, Regulatory Alternative #10 would beryllium producer, and the United Alternative #8 would require decrease the annualized cost of the final Steelworkers union provided to surveillance only for those employees rule by about $4.9 million using either OSHA—confirms the importance of exposed above the TWA PEL or STEL. a 3 percent or 7 percent discount rate. ancillary provisions in protecting To estimate the cost savings for this Under Regulatory Alternative #11, workers from the harmful effects of alternative, OSHA re-estimated the employers would be required to perform beryllium exposure (Materion and group of workers that would fall under annual exposure monitoring where United Steelworkers, 2012). Ancillary the above provisions, with results exposures are at or above the action provisions such as personal protective presented in Table VIII–16. Combining level but at or below the TWA PEL and clothing and equipment, regulated these various adjustments along with STEL. When exposures are above the areas, medical surveillance, hygiene associated unit costs, OSHA estimates TWA PEL, no periodic monitoring areas, housekeeping requirements, and that, under this regulatory alternative, would be required. As shown in Table hazard communication all serve to the costs for the final rule would decline VIII–16, Regulatory Alternative #11 reduce the risks to beryllium-exposed from $73.9 million to $35.8 million, would decrease the annualized cost of workers beyond that which the final using a 3 percent discount rate, and the final rule by about $5.0 million TWA PEL alone could achieve. from $76.6 million to $37.9 million, using either a 3 percent or 7 percent Under Regulatory Alternative #8, using a 7 percent discount rate. discount rate. OSHA is unable to several ancillary provisions that the The Agency has not quantified the quantify the effect of this change on current final rule would require under impact of this alternative on the benefits benefits but has judged the alternative a variety of exposure conditions (e.g., of the rule. However, ancillary adopted necessary and protective. dermal contact, any airborne exposure, provisions that offer protective exposure at or above the action level) measures to workers exposed below the Regulated Areas would instead only apply where final TWA PEL, such as personal Final paragraph (e) for General exposure levels exceed the TWA PEL or protective clothing and equipment, Industry requires employers to establish STEL. beryllium work areas, hygiene areas, and maintain beryllium work areas in Regulatory Alternative #8 affects the housekeeping requirements, and hazard any work area containing a process or following provisions of the final communication, all serve to reduce the operation that can release beryllium standard: risks to beryllium-exposed workers where employees are, or can reasonably —Exposure monitoring: Whereas the beyond that which the final TWA PEL be expected to be, exposed to airborne scheduled monitoring option of the and STEL could achieve. beryllium at any level or where there is final standards requires monitoring The remainder of this chapter the potential for dermal contact with every six months when exposure discusses additional regulatory beryllium, and regulated areas wherever levels are at or above the action alternatives that apply to individual airborne concentrations of beryllium level and at or below the TWA PEL ancillary provisions. exceed, or can reasonably be expected to

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exceed, the TWA PEL or STEL. The action level for more than 30 days per exists at exposure levels below the final Shipyards standard also requires year, who show signs or symptoms of TWA PEL and that there is evidence regulated areas. The Construction CBD or other beryllium-related health that beryllium sensitization can occur standard has a comparable competent effects, are exposed to beryllium in an even from short-term exposures (see the person requirement. Employers in emergency, or whose more recent preamble at Section V, Health Effects, General Industry and Shipyards are written medical opinion required by and Section VII, Significance of Risk). required to demarcate regulated areas paragraph (k)(6) or (k)(7) recommends The Agency therefore anticipates that and limit access to regulated areas to such surveillance, and (2) low dose CT more employees would develop adverse authorized persons. scans for employees when health effects without receiving the The SBAR Panel report recommended recommended by the PLCHP. The final benefits of early intervention in the that OSHA consider dropping or standards require biennial medical disease process because they are not limiting the provision for regulated exams to be provided for eligible eligible for medical surveillance (see areas (SBAR, 2008). In response to this employees. The standards also require section XVI of this preamble, the recommendation, OSHA examined tests for beryllium sensitization to be Summary and Explanation for Regulatory Alternative #12, which provided to eligible employees paragraph (k)). would eliminate the requirement that biennially. Regulatory Alternative #15 would employers establish regulated areas in OSHA estimated in Chapter V of the decrease eligibility for medical the General Industry and Maritime FEA that the medical surveillance surveillance to employees who are standards, and eliminate the competent requirements would apply to 4,528 exposed to beryllium above the final person requirement in the Construction workers in general industry, of whom PEL standard. This alternative would not 387 already receive medical To estimate the cost of Regulatory eliminate the final requirement to surveillance.35 In Chapter V of the FEA, Alternative #15, OSHA assumed that all establish beryllium work areas, where OSHA estimated the costs of medical workers exposed above the PEL before required. As shown in Table VIII–16, surveillance for the remaining 4,141 the final rule would continue to be Regulatory Alternative #12 would workers who would now have such exposed after the standard is decrease the annualized cost of the final protection due to the final standard. The promulgated. Thus, this alternative rule by about $1.0 million using either Agency’s final analysis indicates that 4 eliminates costs for medical exams for a 3 or 7 percent discount rate. workers with beryllium sensitization the number of workers exposed between and 6 workers with CBD will be referred the action level and the TWA PEL. As Personal Protective Clothing and shown in Table VIII–16, Regulatory Equipment to a CBD diagnostic center annually as a result of this medical surveillance. Alternative #15 would decrease the Regulatory Alternative #13 would Medical surveillance is particularly annualized cost of the final rule by modify the requirements for personal important for this rule because about $4.5 million using a discount rate protective equipment (PPE) by beryllium-exposed workers, including of 3 percent, and by about $4.8 million eliminating the requirement for many workers exposed below the final using a discount rate of 7 percent. appropriate PPE whenever there is In response to concerns raised during PELs, are at significant risk of illness.36 potential for skin contact with beryllium the SBAR Panel process about testing OSHA has examined four regulatory or beryllium-contaminated surfaces. requirements, OSHA considered two alternatives (#15, #16, #18, and #22) that This alternative would be narrower, and regulatory alternatives that would would modify the final rule’s thus less protective, than the PPE provide greater flexibility in the requirements for employee eligibility, requirement in the final standards, program of tests provided as part of an the tests that must be offered, and the which require PPE to be used where employer’s medical surveillance frequency of periodic exams. Medical airborne exposure exceeds, or can program. Under Regulatory Alternative surveillance was a subject of special reasonably be expected to exceed, the #16, employers would not be required to concern to SERs during the SBAR Panel TWA PEL or STEL, or where there is a offer employees testing for beryllium process, and the SBAR Panel offered reasonable expectation of dermal sensitization. As shown in Table VIII– many comments and recommendations contact with beryllium. 16, this alternative would decrease the related to medical surveillance for The economic analysis for the final annualized cost of the final rule by OSHA’s consideration. Some of the standard already contains costs for about $2.4 million using either a 3 Panel’s concerns have been partially protective clothing, namely gloves, for percent or 7 percent discount rate. all employees who can reasonably be addressed in this final rule, which was Regulatory Alternative #18 would expected to be have dermal contact with modified since the SBAR Panel was eliminate the CT scan requirement from beryllium; thus OSHA estimated the convened (see the preamble at Section the final rule. This alternative would cost of this alternative as the cost XVI, Summary and Explanation of the decrease the annualized cost of the final reduction from not providing gloves Standards, for more detailed rule by about $613,000 using a discount under these circumstances. As shown in discussion). Regulatory Alternative #16 rate of 3 percent, and by about $643,000 Table VIII–16, Regulatory Alternative also responds to recommendations by using a discount rate of 7 percent. #13 would decrease the annualized cost the SBAR Panel to reduce burdens on • Medical Removal of the final rule by about $481,000 using small businesses by dropping or either a 3 percent or 7 percent discount reducing the frequency of medical Under paragraph (l) of the final rate. surveillance requirements. standard, Medical Removal, employees OSHA has determined that a in jobs with exposure at or above the • Medical Surveillance significant risk of beryllium action level become eligible for medical The final requirements for medical sensitization, CBD, and lung cancer removal when they provide their surveillance include: (1) Medical employers with a written medical report examinations, including a test for 35 See baseline compliance rates for medical indicating they are diagnosed with CBD surveillance in Chapter III of the FEA, Table III–20. beryllium sensitization, for employees 36 OSHA did not estimate, and the benefits or confirmed positive for beryllium who are or are reasonably expected to be analysis does not include, monetized benefits sensitization, or if a written medical exposed to beryllium at or above the resulting from early discovery of illness. opinion recommends medical removal

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

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Table Vlll-16 Cost of Regulatory Alternatives Affecting Ancillary Provisions (2015 dollars) Incremental Cost Incremental Benefits Total Cost Benefits Relative to Rule Relative to Rule 3% Discount Rate Rule $73,868,230 - $560,873,424 - Alternative 7: Update Z table 1910.1000 only (No ancillary $12,516,905 -$61,351,325 $211,870,162 -$349,003,262 provisions) Alternative 8: Ancillary provisions apply only when exposure above $35,794,047 -$38,07 4,183 PEL/STEL Alternative 9: Annual periodic monitoring between AL!STEL and $69,544,910 -$4,323,319 PEL Alternative 10: Annual periodic monitoring AL!STEL to PEL and> $69,021,502 -$4,846,728 PEL. Alternative 11: Annual periodic monitoring when exposure above $68,847,033 -$5,021 '197 AL/STEL, biannual monitoring when exposure above PEL Alternative 12: No regulated areas, ancillary provisions triggered $72,854,475 -$1,013,754 by PEL or STEL Alternative 13: No PPE wherever there is contact with beryllium or $73,387,012 -$481,217 beryllium contaminated surfaces Alternative 15: Medical surveillance applies to workers above the $69,405,421 -$4,462,809 PEL post-rule Alternative 16: No BeLPTs in medical surveillance $71 ,492,837 -$2,375,392

Alternative 17: BeLPTs part of annual exam, rather than biennially. $76,666,395 $2,798,166 Alternative 18: No CT Scans $73,236,886 -$631,343 Alternative 22: No medical removal protection $72,717,171 -$1,151,058 7% Discount Rate Rule $76,637,363 - $249,078,679 - Alternative 7: Update Z table 1910.1000 only (No ancillary $13,541,714 -$63,095,649 $94,023,516 -$155,055,163 provisions) Alternative 8: Ancillary provisions apply only when exposure above $37,894,318 -$38,743,045 PEL/STEL Alternative 9: Annual periodic monitoring between AL!STEL and $72,314,044 -$4,323,319 PEL Alternative 10: Annual periodic monitoring AL!STEL to PEL and> $71 '790,636 -$4,846,728 PEL. Alternative 11: Annual periodic monitoring when exposure above $71,616,166 -$5,021 '197 AL!STEL, biannual monitoring when exposure above PEL Alternative 12: No regulated areas, ancillary provisions triggered $75,594,292 -$1,043,071 by PEL or STEL Alternative 13: No PPE wherever there is contact with beryllium or $76,156,146 -$481,217 beryllium contaminated surfaces Alternative 15: Medical surveillance applies to workers above the $71 ,882,838 -$4,754,525 PEL post-rule Alternative 16: No BeLPTs in medical surveillance $74,214,979 -$2,422,384 Alternative 17: BeLPTs part of annual exam, rather than biennially. $79,356,557 $2,719,194 Alternative 18: No CT Scans $75,994,175 -$643,188

Alternative 22: No medical removal protection $75,338,041 -$1,299,322 Source: US DOL, OSHA, Directorate of Standards and Guidance, Office of Regulatory Analysis

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

Panel recommendation OSHA response

The Panel recommends that OSHA evaluate carefully the costs and OSHA has reviewed its cost estimates and the technological feasibility technological feasibility of engineering controls at all PEL options, es- of engineering controls at various PEL levels. These issues are dis- pecially those at the lowest levels. cussed in the Regulatory Alternatives Chapter. The Panel recommends that OSHA consider alternatives that would al- OSHA has removed the initial exposure monitoring requirement for leviate the need for monitoring in operations with exposures far workers likely to be exposed to beryllium by skin or eye contact below the PEL. The Panel also recommends that OSHA consider ex- through routine handling of beryllium powders or dusts or contact plaining more clearly how employers may use ‘‘objective data’’ to es- with contaminated surfaces. timate exposures. Although the draft proposal contains a provision The periodic monitoring requirement presented in the SBAR Panel re- allowing employers to initially estimate exposures using ‘‘objective port required monitoring every 6 months for airborne levels at or data’’ (e.g., data showing that the action level is unlikely to be ex- above the action level but below the PEL, and every 3 months for ceeded for the kinds of process or operations an employer has), the exposures at or above the PEL. The final standard, in line with SERs did not appear to have fully understood how this alternative OSHA’s normal practice, requires exposure monitoring every three may be used. 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 require- ments 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 providing some type of In the preamble to the final standards, OSHA discusses the issue of guidance to describe how to use objective data to estimate expo- objective data. While OSHA recognizes that some establishments sures in lieu of conducting personal sampling. will have objective data, for purposes of estimating the cost of this Using objective data could provide significant regulatory relief to sev- rule, the Agency is assuming that no establishments will use objec- eral industries where airborne exposures are currently reported by tive data. The Agency recognizes that this will overestimate costs. SERs to be well below even the lowest PEL option. In particular, The use of objective data is discussed in the preamble at Section XVI, since several ancillary provisions, which may have significant costs Summary and Explanation of the Standards, (d): Exposure Moni- for small entities may be triggered by the PEL or an action level, toring. OSHA should consider encouraging and simplifying the development of objective data from a variety of sources. The Panel recommends that OSHA revisit its analysis of the costs of SERs with very low exposure levels or only occasional work with beryl- regulated areas if a very low PEL is proposed. Drop or limit the pro- lium will not be required to have regulated areas unless exposures vision for regulated areas: SERs with very low exposure levels or are above the final PEL of 0.2 μg/m3. only occasional work with beryllium questioned the need for sepa- The final standards for general industry and maritime require the em- rating areas of work by exposure level. Segregating machines or op- ployer to establish and maintain a regulated area wherever employ- erations, SERs said, would affect productivity and flexibility. Until the ees are, or can be expected to be, exposed to airborne beryllium at health risks of beryllium are known in their industries, SERs chal- levels above the PEL of 0.2 μg/m3. There is no regulated area re- lenged the need for regulated areas. quirement in Construction. The Panel recommends that OSHA revisit its cost model for hygiene In General industry employers must ensure that employees who have areas to reflect SERs’ comments that estimated costs are too low dermal contact with beryllium wash any exposed skin at the end of and more carefully consider the opportunity costs of using space for the activity, process, or work shift and prior to eating, drinking, smok- hygiene areas where SERs report they have no unused space in ing, chewing tobacco or gum, applying cosmetics, or using the toilet. their physical plant for them. The Panel also recommends that OSHA In General Industry, although there is a shower requirement, OSHA consider more clearly defining the triggers (skin exposure and con- has determined that establishments required to have showers will al- taminated surfaces) for the hygiene areas provisions. In addition, the ready have them, and employers will not have to install showers to Panel recommends that OSHA consider alternative requirements for comply with the beryllium standard (Please see the Hygiene Areas hygiene areas dependent on airborne exposure levels or types of and Practices section in Chapter V of the FEA). In Construction and processes. Such alternatives might include, for example, hand wash- Maritime, for each employee required to use personal protective ing facilities in lieu of showers in particular cases or different hygiene clothing or equipment, the employer must ensure that employees area triggers where exposure levels are very low. 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 pro- vide 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. Al- ternatively, employers could renovate and rearrange their work areas in order to meet the requirements of this provision.

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Panel recommendation OSHA response

The Panel recommends that OSHA consider clearly explaining the pur- In the preamble to the final rule, OSHA has clarified the purpose of the pose of the housekeeping provision and describing what affected housekeeping provision. However, due to the variety of work settings employers must do to achieve it. in which beryllium is used, OSHA has concluded that a highly spe- For example, OSHA should consider explaining more specifically what cific directive in the preamble on what surfaces need to be cleaned, surfaces need to be cleaned and how frequently they need to be and how frequently, would not provide effective guidance to busi- cleaned. The Panel recommends that the Agency consider providing nesses. Instead, at the suggestion of industry and union stake- guidance in some form so that employers understand what they must holders (Materion and USW, 2012), OSHA’s final standards include do. The Panel also recommends that once the requirements are a more flexible requirement for employers to develop a written expo- clarified that the Agency re-analyze its cost estimates. sure control plan specific to their facilities. In general industry, the The Panel also recommends that OSHA reconsider whether the risk employer must establish procedures to maintain all surfaces in beryl- and cost of all parts of the medical surveillance provisions are appro- lium work areas as free as practicable of beryllium as required by priate where exposure levels are very low. In that context, the Panel the written exposure control plan. Other than requirements pertaining recommends that OSHA should also consider the special problems to eating and drinking areas, there are no requirements to maintain and costs to small businesses that up until now may not have had to surface cleanliness in construction or maritime. These issues are dis- provide or manage the various parts of an occupational health stand- cussed in the preamble at Section XVI, Summary and Explanation of ard or program. the Standards, (f) Methods of Compliance and (j) Housekeeping. The adoption of Regulatory Alternative #20 in the PEA reduced the fre- quency 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 Regu- latory Alternatives Chapter, Chapter VIII and in the preamble at sec- tion XVI, Summary and Explanation of the Standards, (k) Medical Surveillance. The Panel recommends that OSHA consider that small entities may Under the final standards, skin exposure is not a trigger for medical re- lack the flexibility and resources to provide alternative jobs to em- moval (unlike the draft version used for the SBAR Panel). Employ- ployees who test positive for the BeLPT, and whether medical re- ees are only eligible for medical removal if they are in a job with air- moval protection (MRP) achieves its intended purpose given the borne exposure at or above the action level and provide the em- course of beryllium disease. The Panel also recommends that if ployer with a written medical report confirming that they are sen- MRP is implemented, that its effects on the viability of very small sitized or have been diagnosed with CBD, or that the physician rec- firms with a sensitized employee be considered carefully. ommends removal, or if the employer receives a written medical opinion recommending removal of the employee. After becoming eli- gible for medical removal an employee may choose to remain in a job with exposure at or above the action level, provided that the em- ployer 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 em- ployer 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 Re- moval Protection. OSHA provides an analysis of costs and economic impacts of the provision in the FEA in Chapter V and Chapter VI, re- spectively. The Panel recommends that OSHA consider more clearly defining the As stated above, the triggers for medical surveillance in the final stand- trigger mechanisms for medical surveillance and also consider addi- ard have changed from those presented to the SBAR Panel. Where- tional or alternative triggers—such as limiting the BeLPT to a nar- as the draft standard presented at the SBAR Panel required medical rower range of exposure scenarios and reducing the frequency of surveillance for employees with skin contact—potentially applying to BeLPT tests and physical exams. The Panel also recommends that employees with any level of airborne exposure—the final standard OSHA reconsider whether the risk and cost of all parts of the med- ties medical surveillance to exposures at or above the action level ical surveillance provisions are appropriate where exposure levels for more than 30 days per year (or signs or symptoms of beryllium- are very low. In that context, the Panel recommends that OSHA related health effects, emergency exposure, or a medical opinion should also consider the special problems and costs to small busi- recommending medical surveillance on the basis of a CBD or sen- nesses that up until now may not have had to provide or manage the sitization diagnosis). Thus, small businesses with exposures below various parts of an occupational health standard or program. 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 emer- gencies. 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, in evaluating the economic OSHA has reviewed the possible effects of the final regulation on mar- feasibility of a potential regulation, consider not only the impacts of ket demand and/or foreign production, in addition to the Agency’s estimated costs on affected establishments, but also the effects of usual measures of economic impact (costs as a fraction of revenues the possible outcomes cited by SERs: Loss of market demand, the and profits). This discussion can be found in Chapter VI of the FEA loss of market to foreign competitors, and of U.S. production being (entitled Economic Feasibility Analysis and Regulatory Flexibility De- moved abroad by U.S. firms. The Panel also recommends that termination). OSHA consider the potential burdens on small businesses of dealing with 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.

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Panel recommendation OSHA response

The Panel recommends that OSHA consider seeking ways of mini- The provisions in the standard presented in the SBAR panel report ap- mizing costs for small businesses where the exposure levels may be plied to all employees, whereas the final standard’s ancillary provi- very low. Clarifying the use of objective data, in particular, may allow sions are only applied to employees in work areas who are, or can industries and establishments with very low exposures to reduce reasonably be expected to be, exposed to airborne beryllium. In ad- their costs and involvement with many provisions of a standard. The dition, the scope of the final standard includes several limitations. Panel also recommends that the Agency consider tiering the applica- Whereas the standard presented in the SBAR panel report covered tion of ancillary provisions of the standard according to exposure lev- beryllium in all forms and compounds in general industry, construc- els and consider a more limited or narrowed scope of industries. tion, 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% be- ryllium 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 cir- cumstances under which an employer may use historical and objec- tive data in lieu of initial monitoring (Section XVI, Summary and Ex- planation 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, includ- ing Exposure Monitoring, the written exposure control plan section of Method of Compliance, PPE, Housekeeping, and Medical Surveil- lance, to operations or employees with exposure levels exceeding the TWA PEL or STEL. These alternatives are discussed in the Regulatory Alternatives, Chap- ter VIII of the FEA. The Panel recommends that OSHA provide an explanation and anal- The explanation and analysis for all health outcomes (and their sci- ysis for all health outcomes (and their scientific basis) upon which it entific basis) are discussed in the preamble to the final standard at is regulating employee exposure to beryllium. The Panel also rec- Section V, Health Effects, and Section VI, Risk Assessment. They ommends that OSHA consider to what extent a very low PEL (and are also reviewed in the preamble to the final standard at Section lower action level) may result in increased costs of ancillary provi- VII, Significance of Risk, and the Benefits Chapter of the FEA. sions to small entities (without affecting airborne employee expo- As discussed above, OSHA considered Regulatory Alternatives #7 and sures). Since in the draft proposal the PEL and action level are crit- #8, which would eliminate or reduce the impact of ancillary provi- ical triggers, the Panel recommends that OSHA consider alternate sions on employers, respectively. These alternatives are discussed action levels, including an action level set at the PEL, if a very low in Chapter VIII of the FEA. PEL is proposed. The Panel recommends that OSHA consider more clearly and thor- OSHA has removed skin exposure as a trigger for several ancillary oughly defining the triggers for ancillary provisions, particularly the provisions in the final standard, including Exposure Assessment and skin exposure trigger. In addition, the Panel recommends that OSHA Medical Surveillance. For each employee working in a beryllium work clearly explain the basis and need for small entities to comply with area in general industry, and for each employee required to use per- ancillary provisions. The Panel also recommends that OSHA con- sonal protective clothing or equipment in construction and maritime, sider narrowing the trigger related to skin and contamination to cap- the employer must ensure that employees who have dermal contact ture only those situations where surfaces and surface dust may con- with beryllium wash any exposed skin at the end of the activity, proc- tain beryllium in a concentration that is significant enough to pose ess, or work shift and prior to eating, drinking, smoking, chewing to- any risk—or limiting the application of the trigger for some ancillary bacco or gum, applying cosmetics, or using the toilet. In addition, the provisions. potential for dermal contact with beryllium triggers requirements re- lated to beryllium work areas, the written exposure control plan, washing facilities, housekeeping and training: For some ancillary pro- visions, including PPE and Housekeeping, the requirements are trig- gered by visible contamination with beryllium or dermal contact with beryllium. In Construction and Maritime, for each employee required to use per- sonal 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, lan- guage involving showers has been removed and employers are re- quired to provide change rooms for employees required to use per- sonal 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.

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Panel recommendation OSHA response

Several SERs said that OSHA should first assume the burden of de- In the Technological Feasibility Analysis presented in the FEA, OSHA scribing the exposure level in each industry rather than employers has described the baseline exposure levels in each industry or appli- doing so. Others said that the Agency should accept exposure deter- cation group. minations made on an industry-wide basis, especially where expo- In the preamble to the final standards, OSHA discusses the issue of sures were far below the PEL options under consideration. objective data. While OSHA recognizes that some establishments As noted above, the Panel recommends that OSHA consider alter- will have objective data, for purposes of the economic analysis, the natives that would alleviate the need for monitoring in operations or Agency is choosing to assume that no establishments will use objec- processes with exposures far below the PEL. The use of objective tive data. The Agency recognizes that this will overestimate costs. data is a principal method for industries with low exposures to satisfy compliance with a proposed standard. The Panel recommends that OSHA consider providing some guidance to small entities in the use of objective data. The Panel recommends that OSHA consider more fully evaluating OSHA has provided discussion of the BeLPT in the preamble to the whether the BeLPT is suitable as a test for beryllium sensitization in final rule at section V, Health Effects; and in the preamble at section an OSHA standard and respond to the points raised by the SERs XVI, Summary and Explanation of the Standards, (b) Definitions and about its efficacy. In addition, the Agency should consider the avail- (k) Medical Surveillance. In the regulatory text, OSHA has clarified ability of other tests under development for detecting beryllium sen- that a test for beryllium sensitization other than the BeLPT may be sitization and not limit either employers’ choices or new science and used in lieu of the BeLPT if a more reliable and accurate diagnostic technology in this area. Finally, the Panel recommends that OSHA test is developed. re-consider the trigger for medical surveillance where exposures are As stated above, the triggers for medical surveillance in the final stand- low and consider if there are appropriate alternatives. ard have changed from those presented to the SBAR Panel. Where- as the draft standard presented during the SBREFA process re- quired medical surveillance for employees with skin contact—poten- tially 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 recom- mending 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 Stand- ards, (k) Medical Surveillance. OSHA has considered Regulatory Alternative #16, where employers would not be required to offer employees a BeLPT that tests for be- ryllium sensitization. from the final standard. This alternative is dis- cussed 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-risk processes and oper- The standard presented in the SBAR panel report had skin exposure ations: OSHA should consider alternatives for minimizing costs to in- as a trigger. The final standards require PPE when there is a rea- dustries, operations, or processes that have low exposures. Such al- sonable expectation of dermal contact with beryllium. The employer ternatives may include, but not be limited to: Encouraging the use of must ensure that employees who have dermal contact with beryllium objective data by such mechanisms as providing guidance for objec- wash any exposed skin at the end of the activity, process, or work tive data; assuring that triggers for skin exposure and surface con- shift and prior to eating, drinking, smoking, chewing tobacco or gum, tamination are clear and do not pull in low-risk operations; providing applying cosmetics, or using the toilet. OSHA uses an exposure pro- guidance on least-cost ways for low risk facilities to determine what file to determine which workers will be affected by the standards. As provisions of the standard they need to comply with; and considering a result, in General Industry and Maritime, the final standards require ways to limit the scope of the standard if it can be ascertained that regulated areas where exposures can exceed the PEL or STEL. In certain processes do not represent a significant risk. 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 air- borne beryllium at any level or where there is the potential for dermal contact with beryllium. In Construction, the written exposure control plan must contain proce- dures 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, construc- tion, 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% be- ryllium by weight where the employer has objective data dem- onstrating 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.

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Panel recommendation OSHA response

PEL-only standard: One SER recommended a PEL-only standard. This OSHA considered Regulatory Alternative #7, a PEL-only standard. This would protect employees from airborne exposure risks while relieving alternative is discussed in Chapter VIII of the FEA. the beryllium industry of the cost of the ancillary provisions. The Panel recommends that OSHA, consistent with its statutory obliga- tions, analyze this alternative. Alternative triggers for ancillary provisions: The Panel recommends that OSHA has removed skin exposure as a trigger for several ancillary OSHA clarify and consider eliminating or narrowing the triggers for provisions in the final standard, including Exposure Monitoring and ancillary provisions associated with skin exposure or contamination. Medical Surveillance. In General Industry, the employer must ensure In addition, the Panel recommends that OSHA should consider trying that employees who have dermal contact with beryllium wash any ancillary provisions dependent on exposure rather than have these exposed skin at the end of the activity, process, or work shift and provisions all take effect with the same trigger. If OSHA does rely on prior to eating, drinking, smoking, chewing tobacco or gum, applying a trigger related to skin exposure, OSHA should thoroughly explain cosmetics, or using the toilet. and justify this approach based on an analysis of the scientific or re- In Construction and Maritime, for each employee required to use per- search literature that shows a risk of sensitization via exposure to sonal protective clothing or equipment, the employer must ensure skin. If OSHA adopts a relatively low PEL, OSHA should consider that employees who have dermal contact with beryllium wash any the effects of alternative airborne action levels in pulling in many low exposed skin at the end of the activity, process, or work shift and risk facilities that may be unlikely to exceed the PEL—and consider prior to eating, drinking, smoking, chewing tobacco or gum, applying using only the PEL as a trigger at very low levels. 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 contamina- tion 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 Ef- fects, and explains the basis for specific ancillary provisions related to skin exposure in the preamble at Section XVI, Summary and Ex- planation 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 trig- gered by exposures (or a reasonable expectation of exposures) above the PEL or action level (AL). As discussed above, OSHA con- sidered 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 provisions, including eliminating the After considering comments from SERs, OSHA has revised the med- BeLPT: The BeLPT was the most common complaint from SERs. ical surveillance provision and removed the skin exposure trigger for The Panel recommends that OSHA carefully examine the value of medical surveillance. As a result, OSHA estimates that the number the BeLPT and consider whether it should be a requirement of a of small-business employees requiring a BELPT will be substantially medical surveillance program. The Panel recommends that OSHA reduced. present the scientific evidence that supports the use of the BeLPT as OSHA has provided discussion of the BeLPT in the preamble to the several SERs were doubtful of its reliability. The Panel recommends final rule at section V, Health Effects; and in the preamble at section that OSHA also consider reducing the frequency of physicals and the XVI, Summary and Explanation of the Standards, (b) Definitions and BeLPT, if these provisions are included in a proposal. The Panel rec- (k) Medical Surveillance. In the regulatory text, OSHA has clarified ommends that OSHA also consider a performance-based medical that a test for beryllium sensitization other than the BeLPT may be surveillance program, permitting employers in consultation with phy- used in lieu of the BeLPT if a more reliable and accurate diagnostic sicians and health experts to develop appropriate tests and their fre- test is developed. quency. The frequency of periodic BeLPT testing in the final standard is bien- nial, whereas annual testing was included in the draft standard pre- sented to the SBAR Panel. Regulatory Alternative #20 would reduce the frequency of physical ex- aminations from biennial to annual, matching the frequency of BeLPT testing in the final rule. In response to the suggestion to allow performance-based medical sur- veillance, 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 re- quirement from the final standard. These alternatives are discussed in the Regulatory Alternatives Chapter and in the preamble at Sec- tion XVI, Summary and Explanation of the Standards, (k) Medical Surveillance.

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Panel recommendation OSHA response

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

IX. OMB Review Under the Paperwork addition, the agency must enter the Under the PRA, Federal agency Reduction Act of 1995 correct burden estimates.’’ cannot conduct or sponsor a collection of information unless it is approved by Introduction The proposed rule invited the public to submit comments to OMB, in OMB under the PRA, and the collection The three final beryllium standards addition to OSHA, on the proposed of information notice displays a (collectively ‘‘the standards’’) for collections of information with regard to currently valid OMB control number (44 occupational exposure to beryllium— the following: U.S.C. 3507(a)(3)). Also, general industry (29 CFR 1910.1024), • Whether the proposed collections of notwithstanding any other provision of construction (29 CFR 1926.1124), and information are necessary for the proper law, no employer shall be subject to shipyard (29 CFR 1915.1024)—contain performance of the Agency’s functions, penalty for failing to comply with a collection of information (paperwork) including whether the information is collection of information if the requirements that are subject to review useful; collection of information does not by the Office of Management and • The accuracy of OSHA’s estimate of display a currently valid OMB control Budget (OMB) under the Paperwork the burden (time and cost) of the number (44 U.S.C. 3512). The major Reduction Act of 1995 (PRA), 44 U.S.C. collections of information, including the collections of information found in the 3501 et seq, and OMB’s regulations at 5 validity of the methodology and standards are listed below. CFR part 1320. The PRA requires that assumptions used; Summary of Information Collection agencies obtain approval from OMB • The quality, utility, and clarity of Requirements before conducting any collection of the information collected; and The Beryllium standards contain information (44 U.S.C. 3507). The PRA • Ways to minimize the compliance defines ‘‘collection of information’’ to collection of information requirements burden on employers, for example, by which are essential components of the mean ‘‘the obtaining, causing to be using automated or other technological obtained, soliciting, or requiring the occupational safety and health techniques for collecting and standards that will assist both disclosure to third parties or the public, transmitting information (78 FR 56438). of facts or opinions by or for an agency, employers and their employees in No public comments were received regardless of form or format’’ (44 U.S.C. identifying the exposures to beryllium specifically in response to the proposed 3502(3)(A)). and beryllium compounds, the medical ICR submitted to OMB for review. effects of such exposures, and the means In accordance with the PRA (44 However, several public comments to reduce the risk of overexposures to U.S.C. 3506(c)(2)), OSHA solicited submitted in response to the Notice of beryllium and beryllium compounds. In public comments on the Beryllium Proposed Rulemaking (NPRM), the final ICR, OSHA has expanded its Standard for General Industry (29 CFR described earlier in this preamble, coverage to include the construction 1910.1024), Information Collection substantively addressed provisions and shipyard industries—in order to Request (ICR) (paperwork burden hour containing collections of information tailor the collection of information and cost analysis) for the proposed rule and contained information relevant to requirements to the circumstances (80 FR 47555). The Department the burden hour and costs analysis. found in these sectors. The decision to submitted this ICR to OMB for review in These comments are addressed in the include standards for construction and accordance with 44 U.S.C. 3507(d) on preamble, and OSHA considered them shipyards is based on information and August 7, 2015. A copy of this ICR is when it developed the revised ICR comment submitted in response to the available to the public at http:// associated with these final standards. NPRM request for comment, and during www.reginfo.gov/public/do/PRAOMB The Department of Labor submitted the informal public hearing. History?ombControlNumber=1218- the final ICR January 9, 2017 containing 1. Title: Beryllium (29 CFR 1910.1024; 0267). a full analysis and description of the 29 CFR 1915.1024; 29 CFR 1926. 1124). On October 21, 2015, OMB issued a burden hours and costs associated with 2. Type of Review: New. Notice of Action (NOA) assigning the collections of information of the 3. OMB Control Number: 1218–0267. Beryllium Standard for General Industry standards to OMB for approval. A copy 4. Affected Public: Business or other new OMB Control Number 1218–0267 of the ICR is available to the public at for-profit. This standard applies to to use in future paperwork submissions http://www.reginfo.gov. OSHA will employers in general industry, shipyard, involving this rulemaking. OMB publish a separate notice in the Federal and construction who have employees requested that, ‘‘Prior to publication of Register that will announce the results that may have occupational exposures the final rule, the agency should provide of OMB’s review. That notice will also to any form of beryllium, including a summary of any comments related to include a list of OMB approved compounds and mixtures, except those the information collection and their collections of information and total articles and materials exempted by response, including any changes made burden hours and costs imposed by the paragraphs (a)(2) and (a)(3) of the Final to the ICR as a result of comments. In new standards. standard.

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5. Number of Respondents: 5,872 paragraph. This change in the final Employee Notification of Assessment affected employers. standards was made to align the Results, requires that employers in 6. Frequency of Responses: On provision’s purpose with the broader general industry, construction and occasion; quarterly, semi-annually, concept of exposure assessment beyond shipyards inform their employees of annual; biannual. conducting air monitoring, including results within 15 working days after 7. Number of Responses: 246,433. the use of objective data. completing an exposure assessment. 8. Average Time per Response: Varies OSHA added a paragraph (d)(2) as an Proposed paragraph (d)(5)(ii) from 5 minutes (.08 hours) for a clerical alternative exposure assessment method (paragraph (d)(6)(ii) of the final worker to generate and maintain an to the scheduled monitoring standards) would have required that employee medical record, to more than requirements in the proposed rule. whenever an exposure assessment 8 hours for a human resource manager Under this option employers must indicates that airborne exposure is to develop and implement a written assess 8-hour TWA exposure and the above the TWA PEL or STEL, the exposure control plan. 15-minute short term exposure for each employer must include in the written 9. Estimated Total Burden Hours: employee using any combination of air notification the suspected or known 196,894. monitoring data and objective data sources of exposure and the corrective 10. Estimated Cost (capital-operation sufficient to accurately characterize action(s) the employer has taken or will and maintenance): $46,158,266. airborne exposure to beryllium. take to reduce exposure to or below the Discussion of Significant Changes in the Proposed paragraph (d)(3), Periodic PELs, where feasible corrective action Collections of Information Requirements Exposure Monitoring, would have exists but had not been implemented required employers whose initial when the monitoring was conducted. Below is a summary of the collection monitoring results indicated that Final paragraph (d)(6)(ii) removes the of information requirements contained employee’s exposures results are at or requirement that employers include in the final rule, and a brief description above the action level and at or below suspected or known sources of exposure of the most significant changes between the TWA PEL to conduct periodic in the written notification. the proposal and the final rule portions exposure monitoring at least annually. of the regulatory text containing Final paragraph (d)(3), Scheduled Methods of Compliance collection of information requirements. Monitoring Option, increased the Proposed paragraph (f)(1)(i) would One of the most significant changes frequency schedule for periodic have required employers to establish, between the NPRM and this final rule is monitoring and added a requirement to implement and maintain a written that OSHA extended the scope of the perform periodic exposure monitoring control plan for beryllium work areas. rule so that the most of the provisions when exposures are above the PEL, OSHA has retained the requirement for now also apply to construction and paragraph (d)(3)(vi) and when exposures a written exposure control plan and shipyard work. As a result, while most are above the STEL in paragraph incorporated most provisions of the of the provisions are identical across all (d)(3)(viii). proposed paragraph (f)(1)(i) into the three standards (general industry, Proposed paragraph (d)(4) would have final standards for construction and construction, and shipyards), there are required employers to conduct exposure shipyards, with certain modifications technically more collections of monitoring within 30 days after a due to the work processes and worksites information. However, for purposes of change in production processes, particular to these sectors. the review and explanation that follows, equipment, materials, personnel, work Paragraph (f)(1)(i) differs from the OSHA has focused on the changes to the practices, or control methods that could proposal in that it requires a written general industry provisions and has not reasonably be expected to result in new exposure control plan for each facility, separately identified the additions to the or additional exposures. OSHA changed whereas the proposal would have construction and shipyard standard the proposed requirement to require that required a written exposure control plan unless they deviate from the employers perform reassessment of for beryllium work areas within each requirements in the general industry exposures when there is a change in facility. OSHA has modified the standard. A more detailed discussion of ‘‘production, process, control requirement of a list of operations and all the changes made to the proposed equipment, personnel, or work job titles reasonably expected to have rule, including the requirements that practices’’ that may reasonably be exposure to include those operations include identified collection of expected to result in new or additional and job titles that are reasonably information, is in Section XVIII: exposures at or above the action level or expected to have dermal contact with Summary and Explanation. The impact STEL. In addition, OSHA added ‘‘at or beryllium. Finally, OSHA modified the on information collections is also above the action level or STEL’’ to final proposed requirement to inventory discussed in more detail in Item 8 of the paragraph (d)(4). In summary, the final engineering and work practice controls ICR. rule requires that employers must required by paragraph (f)(2) of this perform reassessment of exposures standard to include respiratory Exposure Assessment when there is a change in production, protection. Paragraph (d) sets forth requirements process, control equipment, personnel, Paragraph (f)(1)(ii) of the final for assessing employee exposures to or work practices that may reasonably standards requires the employer to beryllium. Consistent with the be expected to result in new or review and evaluate the effectiveness of definition of ‘‘airborne exposure’’ in additional exposures at or above the each written exposure control plan at paragraph (b) of these standards, action level or STEL. least annually and update it when: (A) exposure monitoring results must reflect Proposed paragraph (d)(5)(i), Any change in production processes, the exposure to airborne beryllium that Employee Notification of Monitoring materials, equipment, personnel, work would occur if the employee were not Results, would have required employers practices, or control methods results or using a respirator. in general industry to inform their can reasonably be expected to result in Proposed paragraph (d) used the term employees of results within 15 working additional or new airborne exposure to ‘‘Exposure monitoring.’’ In the final days after receiving the results of any beryllium; (B) the employer is notified rule, this term was changed to exposure monitoring completed under that an employee is eligible for medical ‘‘Exposure assessment’’ throughout the this standard. Final paragraph (d)(6), removal in accordance with paragraph

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(l)(1) of this standard, referred for requirements contained in the year, rather than waiting for the 30th evaluation at a CBD Diagnostic Center, Respiratory Protection Program standard day of exposure to occur. or shows signs or symptoms associated are approved under OMB Control Paragraph (k)(1)(i)(B) has been revised with airborne exposure to or dermal Number 1218–0099. to include signs or symptoms of other contact with beryllium; or (C) the beryllium-related health effects. Personal Protective Equipment employer has any reason to believe that Proposed paragraph (k)(1)(i)(C) new or additional airborne exposure is Final paragraph (h)(3)(iii), like required employers to offer medical occurring or will occur. proposed paragraph (h)(3), requires surveillance to employees exposed OSHA made several changes to that employers to inform in writing the during an emergency. No revisions were paragraph. First, OSHA added a persons or the business entities who made to this paragraph. requirement to review and evaluate the launder, clean or repair the protective OSHA added final paragraph effectiveness of each written exposure clothing or equipment required by this (k)(1)(i)(D), which requires that medical control plan at least annually. Second, standard of the potentially harmful surveillance be made available when the OSHA changed the proposed language effects of exposure to airborne beryllium most recent written medical opinion to of (f)(1)(ii)(B) to reflect other changes in and contact with soluble beryllium the employer recommends continued the standard, including a change to compounds and how the protective medical surveillance. Under final ensure that employers are not clothing and equipment must be paragraphs (k)(6) and (k)(7), the written automatically notified of cases of handled in accordance with the opinion must contain a sensitization or CBD among their standard. recommendation for continued periodic employees. Third, OSHA modified medical surveillance if the employee is (f)(1)(ii)(B) to clarify the Agency’s Housekeeping confirmed positive or diagnosed with CBD, and the employee provides written understanding that signs and symptoms Paragraph (j)(3) requires warning of beryllium exposure may be related to authorization. labels in accordance with the Frequency: Proposed paragraph (k)(2) inhalation or dermal exposure. Finally, requirements in paragraph (m) when OSHA modified the wording of (f)(1)(ii) specified when and how frequently employer transfer materials containing medical examinations were to be offered to require the employer to update beryllium. Medical Surveillance Final ‘‘each’’ written exposure control plan to those employees covered by the paragraph (k) sets forth requirements for medical surveillance program. Under rather than ‘‘the’’ written exposure the medical surveillance provisions. control plan, since an employer who proposed paragraph (k)(2)(i)(A), The paragraph specifies which employers would have been required to operates multiple facilities is required to employees must be offered medical establish, implement and maintain a provide each employee with a medical surveillance, as well as the frequency examination within 30 days after written exposure control plan for each and content of medical examinations. It facility. making a determination that the also sets forth the information that the Paragraph (f)(1)(iii) of the proposed employee had worked in a regulated licensed physician and CBD diagnostic rule would have required the employer area for more than 30 days in the past to make a copy of the exposure control center is to provide to the employee and 12 months, unless the employee had plan accessible to each employee who is employer. received a medical examination or can reasonably be expected to be In paragraphs (k)(1)(i)(A)–(D) of the provided in accordance with this exposed to airborne beryllium in proposal, OSHA specified that standard within the previous 12 accordance with OSHA’s Access to employers must make medical months. OSHA made several changes to Employee Exposure and Medical surveillance required by this paragraph this requirement. First, OSHA revised Records (Records Access) standard (29 available for each employee: (1) Who the medical surveillance trigger of CFR 1910.1020(e)). OSHA did not has worked in a regulated area for more employees working in a regulated area receive comments specific to this than 30 days in the last 12 months; (2) to a determination that employee is or provision, and has retained it in the showing symptoms or signs of CBD, is reasonably expected to be exposed at final standard for general industry and such as shortness of breath after a short or above the action level for more than included the paragraph in the final walk or climbing stairs, persistent dry 30 days of year; or who shows signs or standards for construction and cough, chest pain, or fatigue; or (3) symptoms of CBD or other beryllium- shipyards. exposed to beryllium during an related health effects. Second, the emergency; and (4) who was exposed to Agency changed the extended the length Respiratory Protection airborne beryllium above .2 mg/m3 for of time from within the last 12 months Proposed Paragraph (g) of the more than 30 days in a 12-month period to within the last two years. standard would have established the for 5 years or more, limited to the Proposed paragraph (k)(2)(ii) required requirements for the use of respiratory procedures described in paragraph employers to provide an examination protection. OSHA added language to (k)(3)(ii)(F) of this section unless the annually (after the first examination is paragraph (g) to clarify that both the employee also qualifies for an made available) to employees who selection and use of respiratory examination under paragraph continue to meet the criteria of protection must be in accordance with (k)(1)(i)(A), (B), or (C) of this section. proposed paragraph (k)(1)(i)(A) or (B). the Respiratory Protection standard 29 OSHA revised the first proposed OSHA revised the paragraph to specify CFR 1910.134, which is cross- medical surveillance trigger to require that medical examinations were to be referenced, and to provide a powered the offering of medical surveillance made available ‘‘at least’’ every two air-purifying respirator (PAPR) when based on exposures at or above the years and to include employees who requested by an employee. The action level, rather than the PEL. In continue to meet the criteria of final Respiratory protection standard addition, OSHA revised the proposed paragraph (k)(1)(i)(D), i.e., each contains collection of information trigger to require employers to make employee whose most recent written requirements, include a written medical surveillance available to each medical opinion required by paragraph respiratory protection program and fit- employee who is or is reasonably (k)(6) or (k)(7) recommends periodic testing records (29 CFR 1910.134(c)). expected to be exposed at or above the medical surveillance. Under the final The collection of information action level for more than 30 days a standards, employees exposed in an

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emergency, who are covered by and present airborne exposure to or Licensed Physician’s Written Medical paragraph (k)(1)(i)(C), are not included dermal contact with beryllium, any Opinion in the biennial examination requirement history of respiratory dysfunction and Paragraph (k)(5) of the proposed unless they also meet the criteria of smoking history, and; (2) a physical standard provided for the licensed paragraphs (k)(1)(i)(A) or (B) or (D). examination with emphasis on the physician to give a written medical Final paragraph (k)(2)(i)(A) also differs respiratory system; (3) a physical opinion to the employer, but relied on from the proposal in that in the examination for skin rashes; and (4) a the employer to give the employee a proposed paragraph the employer did pulmonary function test, performed in copy of that opinion; thus, there was no not have to offer an examination if the accordance with guidelines established difference between information the employee had received an equivalent by the ATS including forced vital employer and employee received. The examination within the last 12 months. capacity (FVC) and a forced expiratory final standards differentiate the types of In the final rule, this was increased to volume in one second (FEV1). A more information the employer and employee within two years to align that provision detailed discussion regarding all of the receive by including two separate with the frequency of periodic changes to the content of the Medical paragraphs within the medical examinations, which is every two years examinations may be found in section surveillance section that require a in the final rule. XVI, Summary and Explanation of the Proposed paragraph (k)(2)(iii) written medical report to go to the required the employer to offer a medical Standards, under (k) Medical employee, and a more limited written examination at the termination of Surveillance. medical opinion to go to the employer. The requirement to provide the medical employment, if the departing employee Information Provided to the PLHCP met any of the criteria of proposed opinion to the employee is in paragraph paragraphs (k)(1) at the termination of Proposed paragraph (k)(4) detailed (k)(5) of the final standards; the employment for each employee who which information must be provided to requirement for providing met the criteria of paragraphs the PHLCP. Specifically, the proposed documentation to the employer is in (k)(1)(i)(A), (B), or (C), unless an standard required the employer to paragraph (k)(6) of the final standards. examination has been provided in provide to the examining PLHCP the Most significantly, OSHA removed the accordance with the standard during the following information, if known to the requirement that the medical opinion 6 months prior to the date of employer: A description of the pass through the employer to the termination. employee’s former and current duties employee. Final paragraph (k)(2)(iii) requires the that relate to the employee’s Licensed Physician’s Written Medical employer to make a medical occupational exposure ((k)(4)(i)); the Report for the Employee examination available to each employee employee’s former and current levels of who meets the criteria of final paragraph Final paragraphs (k)(5)(i)–(v) provide occupational exposure ((k)(4)(ii)); a the contents of the licensed physician’s (k)(1)(i) at the termination of description of any personal protective employment, unless the employee written medical report for the employee. clothing and equipment, including They include: The results of the medical received an exam meeting the respirators, used by the employee, requirements of the standards within examination, including any medical including when and for how long the condition(s), such as CBD or beryllium the last 6 months. OSHA extended the employee has used that clothing and requirement to employees who meet the sensitization (i.e., the employee is equipment ((k)(4)(iii)); and information confirmed positive, as is defined in criteria of final paragraph (k)(1)(i)(D). the employer has obtained from Contents of Examination. Paragraph paragraph (b) of the standard), that may previous medical examinations (k)(3) details the contents of the place the employee at increased risk examination. Paragraph (k)(3)(i) requires provided to the employee, that is from further airborne exposure; any the employer to ensure that the PLHCP currently within the employer’s control, medical conditions related to airborne advised the employee of the risks and if the employee provides a medical exposure that require further evaluation benefits of participating in the medical release of the information ((k)(4)(iv)). or treatment (this requirement was not surveillance program and the OSHA made several changes to this expressly included in the proposal); any employee’s right to opt out of any or all paragraph. First, OSHA updated recommendations on the employee’s use parts of the medical examination. paragraph (k)(4)(i) to require the of respirators, protective clothing, or Paragraphs (k)(3)(ii)(A)–(D) detail the employer to provide a description of the equipment; and any recommended content of the medical examination. The employee’s former and current duties limitations on airborne beryllium final rule made several changes to the that relate to both the employee’s exposure. content of the employee medical airborne exposure to and dermal contact Paragraph (k)(5) also provides that if examination including, but not limited with beryllium, instead of merely the employee is confirmed positive or to, revising paragraphs: (k)(3)(ii)(A), to requiring the provision of information diagnosed with CBD, or if the physician include emphasis on past and present related to occupational exposure. otherwise deems it appropriate, the airborne exposure to or dermal contact Second, OSHA changed the requirement written medical report must also with beryllium; (k)(3)(ii)(C) to require a that the employer obtain a ‘‘medical contain a referral to a CBD diagnostic physical examination for skin rashes, release’’ from the employee to ‘‘written center, a recommendation for continued rather than an examination for breaks consent’’ before providing the PLHCP medical surveillance, and a and wounds; (k)(3)(ii)(E) to require the with information from records of recommendation for medical removal BeLPT test to be offered ‘‘at least’’ every employment-related medical from airborne beryllium exposures two years, rather than every two years; examinations. Third, OSHA revised the above the action level, as described in (k)(3)(ii)(F) to include an LDCT scan provision to require that the employer paragraph (l) of the standard. Proposed when recommended by the PLHCP. ensure that the same information paragraph (k)(6) also addressed With these changes, final paragraphs provided to the PLHCP is also provided information provided to employees who (k)(3)(ii)(A)–(D) require the medical to the agreed-upon CBD diagnostic were confirmed positive or diagnosed examination to include: (1) Medical and center, if an evaluation is required with CBD, but simply required a work history, with emphasis on past under paragraph (k)(7) of the standard. consultation with the physician.

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Licensed Physician’s Written Medical request of OSHA. Based on comments employers in construction and Opinion for the Employer received during the comment period, shipyards are generally downstream Paragraph (k)(6)(i) requires employers OSHA decided not to include the users of beryllium products (blasting to obtain a written medical opinion proposed paragraph (k)(7) in the final media) and would not therefore be from the licensed physician within 45 standard. classifying chemicals. Proposed paragraph (m)(1)(iii) would days of the medical examination Referral to a Diagnostic Center have required employers to include (including any follow-up BeLPT Final paragraph (k)(7) requires that if beryllium in the hazard communication required under (k)(3)(ii)(E)). In proposed the employee wants a clinical program established to comply with the (k)(5), the physician would have been evaluation at a CBD diagnostic center, HCS, and ensure that each employee has required to share most of the the employer must provide the access to labels on containers and safety information identified now provided examination at no cost to the employee. data sheets for beryllium and is trained directly to the employee per final (k)(5) OSHA made several changes to final in accordance with the HCS and the with the employer, but in the final rule paragraph (k)(7) as compared to similar training paragraph of the standard. The OSHA limited the information that provisions in paragraph (k)(6) of the final paragraph (m)(1)(iii) applies to the could be shared with the employer. In proposal. First, OSHA changed the general industry, shipyards, and final (k)(6) the written medical opinion trigger for referral to a CBD diagnostic construction. The final provisions are for the employer must contain only the center to include both confirmed substantively unchanged from the date of the examination, a statement that positive and a CBD diagnosis for proposal. the examination has met the consistency with final paragraphs requirements of this standard, and any (k)(5)(iii) and (k)(6)(iii). Second, OSHA Recordkeeping recommended limitations on the removed the requirement for a Paragraph (n) of the final standards employee’s use of respirators, protective consultation between the physician and sets forth the employer’s obligation to clothing, and equipment; and a employee. However, final paragraph comply with requirements to maintain statement that the PLHCP explained the (k)(7)(i) requires that employers provide records of air monitoring data, objective results of the examination to the a no-cost evaluation at a CBD-diagnostic data, medical surveillance, and training. employee, including any tests center that is mutually agreed upon by Proposed paragraph (n)(1)(i) required conducted, any medical conditions the employee and employer. employers to maintain records of all related to airborne exposure that require Final paragraph (k)(7) requires the measurements taken to monitor further evaluation or treatment, and any employer to ensure that the employee employee exposure to beryllium as special provisions for use of personal receives a written medical report form required by paragraph (d) of the protective clothing or equipment. the CBD diagnostic center that contains standard. OSHA made one minor Paragraph (k)(6)(ii) states that if the all the information required in modification in the final standard: employee provides written paragraph (k)(5)(i), (ii), (iv) and (v) and OSHA added the words ‘‘make and’’ authorization, the written medical that the PLHCP explains the results of prior to ‘‘maintain’’ in order to clarify opinion for the employer must also the examination of the employee within that the employer’s obligation is to contain any recommended limitations 30 days of the examination. create and preserve such records. on the employee’s airborne exposure to Proposed paragraph (n)(1)(ii) required beryllium. The requirement for written Communication of Hazards that records of all measurements taken authorization was not in the proposal. Proposed paragraph (m)(1)(i) required to monitor employee exposure include Paragraphs (k)(6)(iii)–(v) state that if an chemical manufacturers, importers, at least the following information: The employee is confirmed positive or distributors, and employers to comply date of measurement for each sample diagnosed with CBD and the employee with all applicable requirements of the taken; the operation being monitored; provides written authorization, the HCS (29 CFR 1910.1200) for beryllium. the sampling and analytical methods written opinion must also contain a No substantive changes were made to used and evidence of their accuracy; the referral for evaluation at a CBD this paragraph. number, duration, and results of diagnostic center and recommendations Proposed paragraph (m)(1)(ii) would samples taken; the type of personal for continued medical surveillance and have required employers to address at protective clothing and equipment, medical removal from airborne exposure least the following, in classifying the including respirators, worn by to beryllium as described in paragraph hazards of beryllium: Cancer; lung monitored employees at the time of (l). effects (chronic beryllium disease and monitoring; and the name, social Paragraph (k)(6)(vi) requires the acute beryllium disease); beryllium security number, and job classification employer to ensure that employees sensitization; skin sensitization; and of each employee represented by the receive a copy of the written medical skin, eye, and respiratory tract irritation. monitoring, indicating which employees opinion for the employer within 45 days According to the HCS, employers must were actually monitored. OSHA has of any medical examination (including classify hazards if they do not rely on made one editorial modification to any follow-up BeLPT required under the classifications of chemical paragraph (n)(1)(ii)(B), which is to paragraph (k)(3)(ii)(E) of this standard) manufacturers, importers, and change ‘‘operation’’ to ‘‘task.’’ Proposed performed for that employee. A similar distributors (see 29 CFR paragraph (n)(1)(iii) required employers requirement was included in proposed 1910.1200(d)(1)). OSHA revised the to maintain employee exposure (k)(5)(iii), but the time period was two language to bring it into conformity with monitoring records in accordance with weeks. other substance specific standards so it 29 CFR 1910.1020(d)(1)(ii). OSHA has is clear that chemical manufacturers, changed the requirement that the Beryllium Sensitization Test Results importers, and distributors are among employer ‘‘maintain this record as Research (Removed) the entities required to classify the required by’’ OSHA’s Records Access Proposed paragraph (k)(7) would have hazards of beryllium. OSHA has chosen standard to ‘‘ensure that exposure required employers to convey the not to include an equivalent records are maintained and made results of beryllium sensitization tests to requirement in the final standards for available in accordance with’’ that OSHA for evaluation and analysis at the construction and shipyards since standard.

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Proposed Paragraph (n)(2) Historical proposed paragraph (n)(4)(ii)(B) to E.O. 13132, 64 FR 43255 (Aug. 10, Monitoring Data (Removed) paragraph (n)(3)(ii)(B) of the final 1999). The E.O. requires that Federal Proposed paragraph (n)(2) contained standards. agencies, to the extent possible, refrain Proposed paragraph (n)(4)(iii) the requirement to retain records of any from limiting State policy options, required the employer to maintain historical monitoring data used to consult with States before taking actions employee medical records in that would restrict States’ policy satisfy the proposed standard’s the accordance with OSHA’s Records options, and take such actions only initial monitoring requirements. OSHA Access Standard at 29 CFR 1910.1020. when clear constitutional authority deleted the separate recordkeeping OSHA has added ‘‘and made available’’ exists and the problem is of national requirement for historical data. after ‘‘maintained’’ in final paragraph scope. The E.O. allows Federal agencies Final (n)(2)(i), (ii), and (iii) Objective (n)(3)(iii) of the standards, but the to preempt State law only with the Data requirement is otherwise unchanged. expressed consent of Congress. In such As a result of deleting paragraph cases, Federal agencies must limit Paragraph (n)(4)(i) and (ii) Training preemption of State law to the extent (n)(2) Historical Data, OSHA has Records included proposed paragraph (n)(3) as possible. Paragraph (n)(4) of the final standards Under Section 18 of the Occupational paragraph (n)(2) in the final standards, (paragraph (n)(5) of the proposal) Safety and Health Act (the ‘‘Act’’ or with minor alterations. Paragraph (n)(2) requires employers to preserve training ‘‘OSH Act’’), 29 U.S.C. 667, Congress contains the requirements to keep records, including records of annual expressly provides that States may accurate records of objective data. retraining or additional training, for a adopt, with Federal approval, a plan for Paragraph (n)(2)(i) requires employers to period of three years after the the development and enforcement of establish and maintain accurate records completion of the training. At the occupational safety and health of the objective data relied upon to completion of training, the employer is standards. OSHA refers to States that satisfy the requirement for initial required to prepare a record that obtain Federal approval for such plans monitoring in paragraph (d)(2). Under includes the name, social security as ‘‘State-Plan States.’’ 29 U.S.C. 667. paragraph (n)(2)(ii), the record is number, and job classification of each Occupational safety and health required to contain at least the following employee trained; the date the training standards developed by State-Plan information: (A) The data relied upon; was completed; and the topic of the States must be at least as effective in (B) the beryllium-containing material in training. This record maintenance providing safe and healthful question; (C) source of the data; (D) requirement also applied to records of employment and places of employment description of the process, task, or annual retraining or additional training as the Federal standards. Subject to activity on which the objective data as described in paragraph (m)(4). This these requirements, State-Plan States are were based; (E) other data relevant to paragraph is substantively unchanged free to develop and enforce their own the process, task, activity, material, or from the proposal. occupational safety and health airborne exposure on which the standards. objective data were based. These Paragraph (n)(5) Access to Records While OSHA wrote this final rule to requirements included minor changes in Paragraph (n)(5) of the final standards protect employees in every State, the description of the last two changes, (paragraph (n)(6) of the proposal), Section 18(c)(2) of the OSH Act permits but were not substantively different. requires employers to make all records State-Plan States to develop and enforce Paragraph (n)(2)(iii) of the final mandated by these standards available their own standards, provided those standard (paragraph (n)(3)(iii) in the for examination and copying to the standards require workplaces to be at proposal) requires the employer to Assistant Secretary, the Director of least as safe and healthful as this final maintain a record of objective data NIOSH, each employee, and each rule requires. Additionally, standards relied upon as required by the Records employee’s designated representative as promulgated under the OSH Act do not Access standard, which specifies that stipulated by OSHA’s Records Access apply to any worker whose employer is exposure records must be maintained standard (29 CFR 1910.1020). This a state or local government. 29 U.S.C. for 30 years (29 CFR paragraph is substantively unchanged 652(5). 1910.1020(d)(1)(ii)). from the proposal. This final rule complies with E.O. 13132. In States without OSHA- Paragraph (n)(3)(i), (ii), & (iii) Medical Paragraph (n)(6) Training Records Surveillance Records approved State plans, Congress Paragraph (n)(6) of the final standards expressly provides for OSHA standards Paragraph (n)(3) of the final standards (paragraph (n)(6) in the proposal), to preempt State occupational safety (paragraph (n)(4) in the proposal), requires that employers comply with the and health standards in areas addressed addresses medical surveillance records. Records Access standard regarding the by the Federal standards. In these Employers must establish and maintain transfer of records, 29 CFR States, this rule limits State policy medical surveillance records for each 1910.1020(h), which instructs options in the same manner as every employee covered by the medical employers either to transfer records to standard promulgated by the Agency. In surveillance requirements in paragraph successor employers or, if there is no States with OSHA-approved State plans, (k). Paragraph (n)(3)(ii) lists the successor employer, to inform this rulemaking does not significantly categories of information that an employees of their access rights at least limit State policy options to adopt employer was required to record: The three months before the cessation of the stricter standards. employee’s name, social security employer’s business. This paragraph is XI. State-Plan States number, and job classification; a copy of substantively unchanged from the all licensed physicians’ written medical proposal. When Federal OSHA promulgates a opinions; and a copy of the information new standard or a more stringent provided to the PLHCP. OSHA has X. Federalism amendment to an existing standard, the moved the requirement that the record OSHA reviewed the final beryllium States and U.S. territories with their include copies of all licensed rule according to the most recent own OSHA-approved occupational physicians’ written opinions from Executive Order (‘‘E.O.’’) on Federalism, safety and health plans (‘‘State-Plan

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States’’) must revise their standards to standards must be at least as protective The final beryllium rule is reflect the new standard or amendment. as OSHA standards. The OSH Act does economically significant under E.O. The State standard must be at least as not cover tribal governments in the 12866 (see Section IX of this preamble). effective as the Federal standard or performance of traditional governmental However, after reviewing the rule, amendment, and must be promulgated functions, though it does cover tribal OSHA has determined that it will not within six months of the publication governments when they engage in impose environmental health or safety date of the final Federal rule. 29 CFR commercial activity. However, the final risks to children as set forth in E.O. 1953.5(a). Currently, there are 28 State- rule will not require tribal governments 13045. The final rule will require Plan States. to expend, in the aggregate, employers to limit employee exposure A State-Plan State may demonstrate $100,000,000 or more in any one year to beryllium and take other precautions that a standard change is not necessary for their commercial activities. Thus, to protect employees from adverse because the State standard is already the the final rule does not trigger the health effects associated with exposure same as or at least as effective as the requirements of UMRA based on its to beryllium. OSHA is not aware of any new or amended Federal standard. In impact on State, local, or tribal studies showing that exposure to order to avoid delays in worker governments. beryllium in workplaces protection, the effective date of the State Based on the analysis presented in the disproportionately affects children, who standard and any of its delayed Final Economic Analysis (see Section typically are not allowed in workplaces provisions must be the date of State VIII above), OSHA concludes that the where such exposure exists. OSHA is promulgation or the Federal effective rule would not impose a Federal also not aware that there are a date, whichever is later. The Assistant mandate on the private sector in excess significant number of employees under Secretary may permit a longer time of $100 million (adjusted annually for 18 years of age who may be exposed to period if the State makes a timely inflation) in expenditures in any one beryllium, or that employees of that age demonstration that good cause exists for year. As noted below, OSHA also are disproportionately affected by such extending the time limitation. 29 CFR reviewed this final rule in accordance exposure. One commenter, Kimberly- 1953.5(a). with E.O. 13175 on Consultation and Clark Professional, noted that children Of the 28 States and territories with Coordination with Indian Tribal may be subject to secondary beryllium OSHA-approved State plans, 22 cover Governments, 65 FR 67249 (Nov. 9, exposure due to beryllium particles public and private-sector employees: 2000), and determined that it does not being carried home on their parents’ Alaska, Arizona, California, Hawaii, have ‘‘tribal implications’’ as defined in work clothing, shoes, and hair Indiana, Iowa, Kentucky, Maryland, that Order. (Document ID 1962, p. 2). Commenter Michigan, Minnesota, Nevada, New Evan Shoemaker also noted that Mexico, North Carolina, Oregon, Puerto XIII. Protecting Children From Environmental Health and Safety Risks ‘‘beryllium can collect on surfaces such Rico, South Carolina, Tennessee, Utah, as shoes, clothing, and hair as well as Vermont, Virginia, Washington, and E.O. 13045, 66 FR 19931 (Apr. 23, vehicles leading to contamination of the Wyoming. The remaining six states and 2003), requires that Federal agencies family and friends of workers exposed territories cover only public-sector submitting covered regulatory actions to to beryllium’’ (Document ID 1658, p. 3). employees: Connecticut, Illinois, New OMB’s Office of Information and However, OSHA does not believe Jersey, Maine, New York, and the Virgin Regulatory Affairs (‘‘OIRA’’) for review beryllium exposure disproportionately Islands. pursuant to E.O. 12866, 58 FR 51735 affects children or that beryllium This beryllium rule applies to general (Oct. 4, 1993), must provide OIRA with particles brought home on work industry, construction, and shipyards. (1) an evaluation of the environmental clothing, shoes, and hair result in This rule requires that all State-Plan health or safety effects that the planned exposures at or near the action level. States revise their standards regulation may have on children, and Furthermore, Kimberly-Clark appropriately within six months of the (2) an explanation of why the planned Professional also noted that potential date of this notice. regulation is preferable to other secondary exposures can be controlled potentially effective and reasonably XII. Unfunded Mandates Reform Act through the use of personal protective feasible alternatives considered by the equipment in the workplace (Document Under Section 202 of the Unfunded agency. E.O. 13045 defines ‘‘covered ID 1676, p. 2). The final standards Mandates Reform Act of 1995 regulatory actions’’ as rules that may (1) contain ancillary provisions, such as (‘‘UMRA’’), 2 U.S.C. 1532, an agency be economically significant under E.O. personal protective clothing and must prepare a written ‘‘qualitative and 12866 (i.e., a rulemaking that has an hygiene areas, which are specifically quantitative assessment’’ of any annual effect on the economy of $100 designed to minimize the amount of regulation creating a mandate that ‘‘may million or more, or would adversely beryllium leaving the workplace. result in the expenditure by the State, affect in a material way the economy, a Therefore, OSHA believes that the final local, and tribal governments, in the sector of the economy, productivity, beryllium rule does not constitute a aggregate, or by the private sector, of competition, jobs, the environment, covered regulatory action as defined by $100,000,000 or more (adjusted public health or safety, or State, local, E.O. 13045. annually for inflation)’’ in any one year or tribal governments or communities), before promulgating a final rule. and (2) concern an environmental XIV. Environmental Impacts OSHA’s rule does not place a mandate health risk or safety risk that an agency OSHA has reviewed the final on State or local governments, for has reason to believe may beryllium rule according to the National purposes of the UMRA, because OSHA disproportionately affect children. In Environmental Policy Act of 1969 cannot enforce its regulations or this context, the term ‘‘environmental (NEPA) (42 U.S.C. 4321 et seq.), the standards on State or local governments. health risks and safety risks’’ means regulations of the Council on 29 U.S.C. 652(5). Under voluntary risks to health or safety that are Environmental Quality (40 CFR part agreement with OSHA, some States attributable to products or substances 1500), and the Department of Labor’s require public sector entities to comply that children are likely to come in NEPA procedures (29 CFR part 11). with State standards, and these contact with or ingest (e.g., through air, OSHA made a preliminary agreements specify that these State food, water, soil, or product use). determination that the proposed

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standard would have no significant include both the construction and hazards in the workplace and who has impact on air, water, or soil quality; shipyard industries in the final rule (80 authorization to take prompt corrective plant or animal life; the use of land or FR 47732–47734), presented estimated measures to eliminate or minimize aspects of the external environment. No costs and benefits associated with them. The competent person must have comments to the record questioned this extending the scope of the final rule, the knowledge, ability, and authority determination, nor has the Agency and requested comment on the necessary to fulfill the responsibilities found other evidence to invalidate it. alternative. The decision to include set forth in paragraph (e) of this Therefore, OSHA concludes that the standards for construction and standard. final beryllium standard will have no shipyards is based on information and OSHA has retained, in modified form, significant environmental impacts. comment submitted in response to this the scope exemption from the proposed request for comment and evaluated by standard for materials containing less XV. Consultation and Coordination than 0.1 percent beryllium by weight in With Indian Tribal Governments OSHA during the public comment periods and the informal public hearing. the standard for general industry and OSHA reviewed this final rule in OSHA decided to issue three separate included it in the standards for accordance with E.O. 13175 on standards because there are some construction and shipyards. The scope Consultation and Coordination with variations in the standards for each exemption has been modified in the Indian Tribal Governments, 65 FR industry, although the structure of the final standards with the additional 67249 (Nov. 9, 2000), and determined final standards for general industry, requirement that the employer must that it does not have ‘‘tribal construction, and shipyards remains have objective data demonstrating that implications’’ as defined in that order. generally consistent with other OSHA employee exposure to beryllium will The OSH Act does not cover tribal health standards. The most significant remain below the action level as an 8- governments in the performance of change is in the standard for hour TWA under any foreseeable traditional governmental functions, so construction where paragraph (e) conditions. The 0.1 percent exemption the rule will not have substantial direct Competent person, replaces paragraph was generally supported by commenters effects on one or more Indian tribes in (e) Beryllium work areas and regulated from general industry and shipyards; their sovereign capacity, on the areas in general industry and paragraph construction employers did not relationship between the Federal (e) Regulated areas in shipyards. comment. Other commenters, especially government and Indian tribes, or on the those representing workers or public distribution of power and All three final standards have a health organizations, expressed concern responsibilities between the Federal provision for methods of compliance, that these materials, in some cases, government and Indian tribes. On the although in the standard for could expose workers to hazardous other hand, employees in commercial construction this provision has an levels of beryllium. As discussed in businesses owned by tribes or tribal additional requirement to describe more detail in the summary and members will receive the same procedures used by the designated explanation for Scope and application, protections and benefits of the standard competent person to restrict access to the objective data requirement addresses as all other covered employees. work areas, when necessary, to these concerns and ensures the minimize the number of employees protection of workers who experience XVI. Summary and Explanation of the exposed to airborne beryllium above the Standards significant exposures from materials PEL or STEL. This requirement allows containing trace amounts of beryllium. OSHA proposed a standard for the competent person to perform Employers who have objective data occupational exposure to beryllium and essentially the same role as the showing that employees will not be beryllium compounds in general requirement governing regulated areas exposed at or above the action level industry and proposed regulatory in general industry and shipyards, under any foreseeable conditions when alternatives to address beryllium which is to regulate and minimize the processing materials containing less exposures in the construction and number of workers exposed to than 0.1 percent beryllium by weight are maritime industries. The proposed hazardous levels of beryllium. OSHA exempt from the standard. standard for general industry was decided to include a competent person OSHA decided to add a performance structured according to OSHA’s provision in the final standard for option in paragraph (d), Exposure traditional approach, with permissible construction because of the industry’s assessment, as an alternative exposure exposure limits, and ancillary familiarity with this concept and its past assessment method to the scheduled provisions such as exposure assessment, successful use in many OSHA monitoring requirements in the methods of compliance, and medical construction standards and documents. proposed rule, based on public surveillance. As discussed below, ‘‘Competent person’’ is defined in comment received from industry and OSHA based the proposal substantively OSHA’s Safety and Health Regulations labor. OSHA believes the performance on a joint industry and labor for Construction (29 CFR 1926.32(f)) as option, which encompasses either stakeholders’ draft occupational health being a person who is capable of exposure monitoring or assessments standard developed and submitted to identifying existing and predictable based on objective data, gives employers OSHA by Materion Corporation hazards in the surroundings or working flexibility in determining employee (Materion) and the United Steelworkers conditions which are unsanitary, exposure to beryllium based on to their (USW). The final rule, however, is based hazardous, or dangerous to employees, unique workplace circumstances. OSHA on the entirety of the rulemaking record. and who has authorization to take has provided this performance option in In the final rule, OSHA is expanding prompt corrective measures to eliminate recent health standards such as coverage to include the construction them. This generally applicable respirable crystalline silica (29 CFR and shipyard industries and definition corresponds well with the 1910.1053(d)(2)) and chromium VI (29 establishing separate final standards for definition for ‘‘competent person’’ in the CFR 1910.1026(d)(3)). occupational exposure to beryllium in standard for construction: In this OSHA also received comments about general industry, construction, and context, ‘‘competent person’’ means an other provisions in the proposed shipyards. In the NPRM, OSHA individual who is capable of identifying standard, and in some cases, OSHA discussed Regulatory Alternative 2a to existing and foreseeable beryllium responded with changes from the

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proposed rule that were based on the OSHA could adopt and that would have (Document ID 0754). Materion and USW evidence provided in the record. Any support from both labor and industry. provided OSHA with data on exposure changes made to the provisions in the They submitted their joint draft and control measures and information final standards are described in detail in standard to OSHA in February 2012. on their experiences with handling their specific summary and explanation Like the proposal, many of the beryllium in general industry settings sections. provisions in the final rules are (80 FR 47774). At the time, the Although details of the final standards identical or substantively similar to information available to OSHA on for general industry, construction, and those contained in Materion and USW’s beryllium exposures outside of general shipyards differ slightly, most of the draft standard. For example, the final industry was limited. Therefore, the requirements are the same or similar in rule for general industry and the Agency preliminarily decided to limit all three standards. Therefore, the Materion/USW draft standard both the scope of its beryllium rule proposal summary and explanation is organized include an exclusion for materials to general industry but propose according to the main requirements of containing less than 0.1 percent regulatory alternatives that would the standards, but includes paragraph beryllium; both contain many similar expand the scope of the proposed references to the standards for general definitions; both contain a time standard to also include employers in industry, construction, and shipyards. weighted average (TWA) PEL of 0.2 mg/ construction and maritime if it turned The summary and explanation uses the m3; both include exposure monitoring out the record evidence warranted it. term ‘‘standards’’ or ‘‘final standards’’ provisions, including provisions for Specifically, OSHA requested comment when referring to all three standards. scheduled monitoring, employee on Regulatory Alternative #2a, which Generally, when the summary and notification of results, methods of would expand the scope of the proposed explanation refers to the term sample analysis, and observation of standard to also include employers in ‘‘standards,’’ it is referring to the final monitoring; both contain similar construction and maritime, and standards. To avoid confusion, the term requirements for beryllium work areas Regulatory Alternative #2b, which ‘‘final rule’’ is sometimes used when and regulated areas; both mandate a would update 29 CFR 1910.1000 Tables making a comparison to or clarifying a written exposure control plan and Z–1 and Z–2, 1915.1000 Table Z, and change from the proposed rule. engineering and work practice controls 1926.55 Appendix A so that the The proposed rule applied to that follow OSHA’s traditional proposed TWA PEL and STEL would occupational exposure to beryllium in hierarchy of controls; and both include apply to all employers and employees in all forms, compounds, and mixtures in similar provisions related to respiratory general industry, shipyards, and general industry, except those articles protection, protective clothing and construction, including occupations and materials exempted by proposed equipment, hygiene areas and practices, where beryllium exists only as a trace paragraphs (a)(2) and (a)(3) of the housekeeping, medical surveillance, contaminant. OSHA also requested proposed standard. The final standards medical removal protection, training stakeholder comment and data on are identical in their application to and communication of hazards, employees in construction or maritime, occupational exposures to beryllium. In recordkeeping, and compliance dates. or in general industry, not covered in the summary and explanation sections, the scope of the proposed standard, who OSHA has changed ‘‘beryllium and (a) Scope and Application deal with beryllium only as a trace beryllium compounds’’ or anything Separate standards for general contaminant, who may be at significant specifying soluble beryllium to just industry, construction, and shipyards. risk from occupational beryllium ‘‘beryllium.’’ OSHA intends the term OSHA proposed a standard addressing exposures. ‘‘beryllium’’ to cover all forms of occupational exposure to beryllium in OSHA did not receive any additional beryllium, including compounds and general industry and regulatory exposure data for construction or mixtures, both soluble and poorly alternatives to address exposures in the shipyards in response to OSHA’s soluble, throughout the summary and construction and maritime industries.37 request in the NPRM. However, since explanation sections. Other global The proposal was modeled on a the proposal, OSHA reviewed its OIS changes in the regulatory text include suggested rule that was crafted by two compliance exposure database and changing ‘‘shall’’ to ‘‘must’’ to make it major stakeholders in general industry, identified personal exposure sample clear when a provision is a requirement Materion Corporation (Materion) and results on beryllium for abrasive and adding ‘‘personal’’ to ‘‘protective the United Steelworkers (USW) blasting workers in construction, clothing or equipment’’ and ‘‘protective general industry and maritime, which clothing and equipment’’ consistently. 37 The proposed rule did not cover agricultural can be found broken out by sector in OSHA has changed ‘‘exposure’’ to employers because OSHA had not found any FEA Table IV.68. ‘‘airborne exposure’’ to make it clear evidence indicating that beryllium is used or The vast majority of stakeholders who when referring to just airborne handled in agriculture in a way that might result submitted comments on this issue in beryllium exposure. OSHA’s authority is also exposure, and specifically noting when restricted in this area; since 1976, an annual rider supported extending the scope of the OSHA intends to cover dermal contact. in the Agency’s Congressional appropriations bill proposed rule to cover workers in the As noted above, OSHA’s proposed has limited OSHA’s use of funds with respect to construction and maritime industries rule was based, in part, upon a draft farming operations that employ fewer than ten who are exposed to beryllium (e.g., employees (Consolidated Appropriations Act, 1976, occupational health standard submitted 94, 90 Stat. 1420, 1421 (1976) (and subsequent Document ID 1592; 1625, p. 3; 1655, p. to the Agency by Materion, the leading appropriations acts)). In the Notice of Proposed 15; 1658, p. 5; 1664, pp. 1–2; 1670, p. producer of beryllium and beryllium Rulemaking (NPRM), the Agency requested 7; 1671, Attachment 1, p. 5; 1672, p. 1; products in the United States, and USW, information on whether employees in the 1675, p. 2; 1676, p. 1; 1677, p. 1; 1679, agricultural sector are exposed to beryllium in any an international labor union form and, if so, their levels of exposure and what p. 2; 1681, pp. 5, 16; 1683, p. 2; 1684, representing workers who manufacture types of exposure controls are currently in place (80 Attachment 2, p. 3; 1685, p. 2; 1686, p. beryllium alloys and beryllium- FR 47565, 47775). OSHA did not receive comment 2; 1689, p. 6; 1690, p. 2; 1693, p. 3; containing products in a number of on beryllium and the agriculture industry or 1703, p. 2; 1705, p. 1). For example, the information that would support coverage of industries (Document ID 0754). agricultural operations. Therefore, agriculture National Council for Occupational Materion and USW worked together to employers and operations are not covered by the Safety and Health (National COSH) craft a model beryllium standard that rule. urged that OSHA should ensure greater

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

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

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

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ensure that workers exposed to are more hazardous and suggested that a manufactured item other than a fluid or beryllium in the construction and OSHA establish a bifurcated standard particle: (i) Which is formed to a specific shipyard industries are provided with for insoluble beryllium versus soluble shape or design during manufacture; (ii) protection that is comparable to the beryllium compounds (Document ID which has end use function(s) dependent in protection afforded workers in general 1732, p. 3; 1678, p. 2; 1756, Tr. 18). In whole or in part upon its shape or design during end use; and (iii) which under normal industry. Therefore, OSHA has set an related testimony, NIOSH’s Dr. Aleks conditions of use does not release more than identical PEL and STEL and, where no Stefaniak discussed the dermal very small quantities, e.g., minute or trace meaningful distinctions are identified in exposure mechanisms of poorly soluble amounts of a hazardous chemical . . ., and the record, included substantially the beryllium through particle penetration does not pose a physical hazard or health risk same or approximately equivalent and particle dissolving (Document ID to employees. ancillary provisions in all three 1755, pp. 35–39). Dr. Stefaniak testified OSHA preliminarily found that items or standards. For further discussion of the that while ‘‘intact skin naturally has a parts containing beryllium that differences among the standards, see the barrier . . . [v]ery few people actually employers assemble where the physical provision-specific sections included in have fully intact skin, especially in an integrity of the item is not compromised this Summary and Explanation. industrial environment’’ (Document ID are unlikely to release beryllium that Therefore, OSHA declines to adopt 1755, p. 36). He added: would pose a physical or health hazard Regulatory Alternative #2b, which, as in fact, beryllium particles, beryllium oxide, for workers. Therefore, OSHA proposed noted above, would have updated 29 beryllium metal, beryllium alloys, all these to exempt such articles from the scope CFR 1910.1000 Tables Z–1 and Z–2, 29 sort of what we call insoluble forms actually of the standard. This proposed CFR 1915.1000 Table Z, and 29 CFR do in fact dissolve very readily in analog of provision was intended to ease the 1926.55 Appendix A so that the new human sweat. And once beryllium is in an burden on employers by exempting TWA PEL and STEL, but not the ionic form on the skin, it’s actually very easy items from coverage where they are standard’s ancillary provisions, would for it to cross the skin barrier (Document ID apply to all employers and employees in 1755, pp. 36–37). unlikely to pose a risk to employees. Commenters generally supported this general industry, shipyards, and NIOSH also provided additional proposed exemption. For example, construction, including occupations information on beryllium solubility and where beryllium exists only as a trace the development of CBD in its post- NFFS stated that the exemption was contaminant. The Agency intends for hearing brief, labeling as untrue NFFS’s ‘‘important and practical’’ (Document ID employers that are exempt from the assertion that insoluble beryllium does 1678, p. 2; Document ID 1756, Tr. 35– scope of these comprehensive standards not cause CBD (Document ID 1960, 36)). However, two commenters in accordance with paragraph (a) to Attachment 2, pp. 8–10), citing studies requested minor amendments to the comply with the preceding TWA PEL showing that workers exposed to exemption. First, ORCHSE Strategies and STEL in 29 CFR 1910.1000 Table Z– insoluble forms of beryllium have (ORCHSE) asked OSHA to ‘‘clarify’’ that 2, 29 CFR 1915.1000 Table Z, and 29 developed sensitization and CBD proposed paragraph (a)(2) ‘‘exempts CFR 1926.55 Appendix A, as applicable. (Kreiss, et al., 1997, Document ID 1360; ‘articles’ even if they are processed, Given that the Agency is issuing Schuler et al., 2005 (1349); Schuler et unless the processing releases beryllium separate beryllium standards for the al., 2008 (1291); Wegner et al., 2000, to an extent that negates the definition construction and shipyard industries, (1960, Attachment 7)). of an ‘article’ ’’ (Document ID 1691, OSHA is also adding to these tables a After careful consideration of the Attachment 1, p. 16). ORCHSE asserted cross-reference to the new standards various comments on this issue, OSHA that the standard should not apply in a and clarifying that if the new standards is not persuaded that there are workplace when ‘‘the item actually are stayed or otherwise not in effect, the differences in workers’ health risks that meets OSHA’s definition of an article’’ preceding PEL and short-term ceiling justify treating poorly soluble beryllium and that OSHA should change the limit apply. differently than soluble compounds. regulation’s language accordingly Paragraph (a)(1). Proposed paragraph The Agency is persuaded by NIOSH that (Document ID 1691, Attachment 1, pp. (a)(1) applied the standard to poorly soluble beryllium presents a 16–17). Second, the American Dental occupational exposures to beryllium in significant risk of beryllium-related Association (ADA) asked that OSHA all forms, compounds, and mixtures in disease to workers and discusses this clarify the article exemption, general industry, except those articles topic further in Section V of this specifically that employers who use but and materials exempted by paragraphs preamble, Health Effects. OSHA has do not process articles are fully exempt (a)(2) and (a)(3) of the standards. As determined that the toxicological effects from all requirements of the proposed OSHA explained in the proposal, the of beryllium exposure on the human rule, including those established for Agency preliminarily chose to treat body are similar regardless of the form recordkeeping (Document ID 1597, p. 1). beryllium generally, instead of of beryllium. Therefore, the Agency In contrast, Public Citizen objected to individually addressing specific concludes that the record supports the inclusion of this exemption because compounds, forms, and mixtures. This issuing standards that apply to exempting articles that are not decision was based on the Agency’s beryllium in all forms, compounds, and processed does not take into preliminary determination that the mixtures. Final paragraph (a)(1) is consideration dermal exposure from toxicological effects of beryllium therefore substantively unchanged from handling articles containing beryllium exposure on the human body are similar the proposal in all three standards. (Document ID 1670, p. 7). Public Citizen regardless of the form of beryllium (80 Paragraph (a)(2). Proposed paragraph pointed to OSHA’s proposed rule in FR 47774). (a)(2) excluded from the standard’s which OSHA acknowledged that Several commenters offered opinions scope articles, as defined in the Hazard beryllium absorbed through the skin can on this approach. The Non-Ferrous Communication standard (HCS) (29 CFR induce a sensitization response that is a Founders’ Society (NFFS) expressed 1910.1200(c)), that contain beryllium necessary first step toward CBD and that concern that beryllium metal was being and that the employer does not process. there is evidence that the risk is not treated the same as soluble beryllium As OSHA explained in the proposal (80 limited to soluble forms. However, compounds, such as salts, even though FR 47775), the HCS defines an ‘‘article’’ during follow-up questioning at the NFFS believes these soluble compounds as beryllium public hearings, Dr. Almashat

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of Public Citizen was unable to provide Paragraph (a)(2) of the final standards that significant risk does not exist even any examples of dermal exposure from therefore remains unchanged from the below the previous PEL of 2.0 mg/m3 articles through their handling, as proposed standard. The final standards (Document ID 1673, pp. 8–9, 11). ABMA opposed to when processing beryllium do not apply to articles, as defined in added that its members collectively materials (Document ID 1756, Tr. 178– the Hazard Communication standard have over 200 years of experience 180). And, in its post-hearing (HCS) (29 CFR 1910.1200(c)), that producing coal and/or copper slag comments, Public Citizen did not contain beryllium and that the employer abrasive material and have employed provide evidence of dermal exposure to does not process. thousands of employees in this workers handling beryllium materials Paragraph (a)(3). Proposed paragraph production process. ABMA explained: (a)(3) exempted from coverage materials that would fall under the definition of Through the years, Alliance members have article (Document ID 1964). In the final containing less than 0.1 percent worked with and put to beneficial use over standard, OSHA has decided not to alter beryllium by weight. Requesting 100 million tons of slag material that would the proposed exemption of articles. comment on this exemption (80 FR otherwise have been landfilled. Despite this OSHA is not persuaded by ORCHSE’s 47776), OSHA presented Regulatory extensive history, the Alliance members have argument that OSHA should change the Alternative #1a, which would have no history of employees with beryllium regulation’s language to exempt articles eliminated the proposal’s exemption for sensitization or beryllium-related illnesses. even if they are processed, unless the materials containing less than 0.1 Indeed, the Alliance members are not aware percent beryllium by weight, and #1b, of a single documented case of beryllium processing releases beryllium to an sensitization or beryllium-related illness extent that negates the definition of an which would have exempted operations where the employer can show that associated with coal or copper slag abrasive article. The HCS defines an article as production among their employees, or their employees’ exposures will not meet or customers’ employees working with the a manufactured item other than a fluid or exceed the action level or exceed the particle: (i) Which is formed to a specific products of Alliance members (Document ID shape or design during manufacture; (ii) STEL. The Agency asked whether it is 1673, p. 9). appropriate to include an exemption for which has end use function(s) dependent in OSHA is not persuaded by these operations where beryllium exists only whole or in part upon its shape or design arguments. The lack of anecdotal as a trace contaminant, but some during end use; and (iii) which under normal evidence of sensitization or beryllium- conditions of use does not release more than workers can nevertheless be related illness does not mean these very small quantities, e.g., minute or trace significantly exposed. And the Agency amounts of a hazardous chemical (as asked whether it should consider workers are not at risk. As noted by determined under paragraph (d) of this dropping the exemption, or limiting it to Representative Robert C. ‘‘Bobby’’ Scott, section), and does not pose a physical hazard operations where exposures are below Ranking Member of the U.S. House of or health risk to employees. (29 CFR Representatives Committee on 1910.1200(c)). the proposed action level and STEL. In addition, OSHA requested additional Education and the Workforce the U.S. Whether a particular item is an ‘‘article’’ data describing the levels of airborne House of Representatives, ‘‘medical under the HCS depends on the physical beryllium in workplaces that fall under surveillance has not been required for properties and intended use of that this exemption. Some stakeholders beryllium-exposed workers outside of item. However, employers may use and supported keeping the 0.1 percent the U.S. Department of Energy. The process beryllium-containing items in exemption as proposed (Document ID absence of evidence is not evidence of ways not necessarily intended by the 1661, p. 6; 1666, p. 2; 1668, p. 2; 1673, absence’’ (Document ID 1672). As manufacturer. Therefore, OSHA has p. 8; 1674, p. 3; 1687, Attachment 2, p. discussed in Section II of this preamble, decided not to link the processing 8; 1691, Attachment 1, p. 3; 1756, Tr. Pertinent Legal Authority, courts have limitation to the definition of an 35–36, 63). For example, the Edison not required OSHA ‘‘to support its ‘‘article’’ and is retaining the language of Electric Institute (EEI) strongly finding that a significant risk exists with proposed (a)(2) to comport with the supported the exemption and asserted anything approaching scientific intention of the exemption. ‘‘that abandoning the exemption would certainty’’ (Benzene, 448 U.S. 607, 656 In response to the ADA’s request for result in no additional benefits from a (1980)). Rather, OSHA may rely on ‘‘a clarification that employers who use but reduction in the beryllium permissible body of reputable scientific thought’’ to do not process articles are fully exempt exposure limit (PEL) or from ancillary which ‘‘conservative assumptions in from all requirements of the rule, OSHA provisions similar to those already in interpreting the data . . .’’ may be notes that paragraph (a)(2) of the final place for the arsenic and other applied, ‘‘risking error on the side of standards states that the ‘‘standard does standards’’ (Document ID 1674, p. 3). overprotection’’ (Benzene, 448 U.S. at not apply’’ to those articles. Mr. Weaver of NFFS also opposed 656). OSHA may thus act with a Furthermore, the recordkeeping eliminating the exemption, testifying ‘‘pronounced bias towards worker requirement for objective data in that without the 0.1 percent exemption, safety’’ in making its risk paragraph (n)(2) of the standards states 900 to 1,100 foundries would come determinations (Bldg & Constr. Trades that it applies to objective data used to under the scope of the rule (Document Dep’t v. Brock, 838 F.2d 1258, 1266 satisfy exposure assessment ID 1756, Tr. 55–56). (D.C. Cir. 1988). Where, as here, the requirements, but does not mention any ABMA also supported the proposed Agency has evidence indicating that a data used to determine coverage under 0.1 percent exemption, suggesting that certain operation can result in exposure paragraph (a). Therefore, OSHA has there is a lack of evidence of significant levels that the Agency knows can pose determined that no further clarification risk from working with material a significant risk—such as evidence that in the regulatory text is necessary. containing beryllium in trace amounts workers that have been exposed to In response to the comment from and that OSHA needs substantial beryllium at the final PEL of 0.2 mg/m3 Public Citizen, OSHA did not receive evidence that it is ‘‘at least more likely in primary beryllium production and any evidence on the issue of beryllium than not’’ that exposure to beryllium in beryllium machining operations have exposure through dermal contact with trace amounts presents significant risk developed CBD (see this preamble at unprocessed articles. Therefore, OSHA of harm, under court decisions section V, Risk assessment)—OSHA cannot find that such contact poses a concerning the Benzene rule (Document need not wait until it has specific risk. ID 1673, pp. 8–9). ABMA further argued evidence that employees in that

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

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to employees’’ (Document ID 1684, alternative #1b—essentially as proposed standards apply to protect that Attachment 2, pp. 1, 3). Boeing by Materion and USW and employer’s workers. suggested adding a different exemption acknowledging that workers can have As pointed out by commenters such to the scope of the standard: significant beryllium exposures even as the USW, similar exemptions are where the employer has objective data with materials containing less than included in other OSHA standards, demonstrating that a material containing 0.1%—is the most appropriate including Benzene (29 CFR 1910.1028), beryllium or a specific process, operation, or approach. Therefore, in the final Methylenedianiline (MDA) (29 CFR activity involving beryllium cannot release standard, it is exempting from the 1910.1050), and 1,3-Butadiene (BD) (29 dusts, fumes, or mists of beryllium in standard’s application materials CFR 1910.1051). These exemptions were 3 concentrations at or above 0.02 mg/m as an containing less than 0.1% beryllium by established because workers in the 8-hour time-weighted average (TWA) or at or 3 weight only where the employer has exempted industries or workplaces were above 0.2 mg/m as determined over a not exposed to the subject chemical sampling period of 15 minutes under any objective data demonstrating that expected conditions of use (Document ID employee exposure to beryllium will substances at levels of significant risk. 1667, p. 12). remain below the action level as an 8- In the preamble to the MDA standard, OSHA states that the Agency relied on Other commenters, like ABMA, hour TWA under any foreseeable conditions. data showing that worker exposure to criticized Regulatory Alternative #1b, mixtures or materials of MDA insisting that the rulemaking record As noted by NIOSH, NABTU, and the AFL–CIO, and discussed in Chapter IV containing less than 0.1 percent MDA contained no evidence to support did not create any hazards other than of the FEA, workers in abrasive blasting expanding the scope, but that if the those expected from worker exposure operations using materials that contain scope was expanded to cover trace beneath the action level (57 FR 35630, less than 0.1 percent beryllium still beryllium, a significant exemption 35645–46). The exemption in the BD have the potential for significant would be needed. ABMA argued that standard does not apply where airborne airborne beryllium exposure during such an exemption would need to go concentrations generated by mixtures abrasive blasting operations and during considerably beyond that of using the containing less than 0.1 percent BD by cleanup of spent abrasive material. action level or STEL because of the volume can exceed the action level or NIOSH and the AFL–CIO also identified substantial costs, particularly on small STEL (29 CFR 1910.1051(a)(2)(ii)). The coal-fired electric power generation and businesses, that would be incurred exemption in the Benzene standard was where there is no evidence of benefit. primary aluminum production as based on indications that exposures However, ABMA did not specify what industries that could fall under the 0.1 resulting from substances containing such an exemption would look like percent exemption but still have trace amounts of benzene would (Document ID 1673, p. 11). Similarly, significant worker exposure to generally be below the exposure limit the National Rural Electric Cooperative beryllium. Furthermore, OSHA agrees and on OSHA’s determination that the Association (NRECA) objected to with NIOSH that the Agency should exemption would encourage employers Regulatory Alternative #1b as being regulate based on the potential for to reduce the concentration of benzene unnecessary to protect employees from employee exposures and not the in certain substances (43 FR 27962, CBD in coal fired power plants concentration of beryllium in the 27968). (Document ID 1687, p. 2). material being handled. However, OSHA’s decision to maintain the 0.1 Ameren did not agree with the OSHA acknowledges the concerns percent exemption and require objective data requirement in Regulatory expressed by ABMA and EEI that employers to demonstrate, using Alternative #1b because it would be processing materials with trace amounts objective data, that the materials, when difficult to perform sampling in a timely of beryllium may not necessarily cause processed or handled, cannot release manner for the many different significant exposures to beryllium. beryllium in concentrations at or above maintenance operations that occur OSHA does not have evidence that all the action level as an 8-hour TWA infrequently. This would include in the materials containing less than 0.1 under any foreseeable conditions, is a scope of the rule activities for which percent beryllium by weight can result change from proposed paragraph (a)(3) exposures are difficult to measure, but in significant exposure to beryllium, but that specified only that the standard did are less likely to cause exposure than the record contains ample evidence that not apply to materials containing less other operations (Document ID 1675, p. there are significant exposures in than 0.1 percent beryllium by weight. 2). The NSSP also does not support operations using materials with trace This is also a change from Regulatory Regulatory Alternative #1b because amounts of beryllium, such as abrasive Alternative #1b in another respect, without first expanding the scope of the blasting, coal-fired power generation, insofar as it proposed requiring rule to cover the construction and and primary aluminum production. As objective data demonstrating that maritime sectors, employers in discussed in Section VII of this employee exposure to beryllium will construction and maritime would still preamble, Significance of Risk, remain below both the proposed action be excluded (Document ID 1677, p. 1). preventing airborne exposures at or level and STEL. OSHA removed the OSHA agrees with the many above the action level reduces the risk STEL requirement as largely redundant commenters and testimony expressing of beryllium-related health effects to because if exposures exceed the STEL of concern that materials containing trace workers. OSHA is also not persuaded by 2.0 mg/m3 for more than one 15-minute amounts of beryllium (less than 0.1 comments that claim obtaining this period per 8-hour shift, even if percent by weight) can result in exposure data is too difficult for exposures are non-detectable for the hazardous exposures to beryllium. We infrequent or short-term tasks because remainder of the shift, the 8-hour TWA disagree, however, with those who employers must be able to establish would exceed the action level of 0.1 supported completely eliminating the their eligibility for the exemption before mg/m3. exemption because this could have being able to take advantage of it. If an Further, OSHA added the phrase unintended consequences of expanding employer cannot establish by objective ‘‘under any foreseeable conditions’’ to the scope to cover minute amounts of data, including actual monitoring data, paragraph (a)(3) of the final standards to naturally occurring beryllium (Ex 1756 that exposures will not exceed the make clear that limited sampling results Tr. 55). Instead, we believe that action level, then the beryllium indicating exposures are below the

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

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

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with exposure to airborne beryllium. The Agency also replaced the word These test results need not be from The Health Effects section of this ‘‘one’’ with ‘‘an individual.’’ The consecutive BeLPTs or from a second preamble, section V, contains more Agency revised the phrase ‘‘to eliminate abnormal BeLPT result within a two-year information on CBD. CBD is relevant to them’’ to read ‘‘to eliminate or minimize period of the first abnormal result. These recommendations are based on the many several provisions of this standard. them’’ to denote there may be cases studies cited in the docket, as well as those Under paragraph (k)(1)(i)(B), employers where complete elimination would not of Middleton, et al. (2006, 2008, and 2011), must make medical surveillance be feasible. The definition of competent which showed that an abnormal and a available at no cost to employees who person also indicates that the competent borderline result provide a positive show signs and symptoms of CBD. person must have the knowledge, predictive value (PPV) similar to that of two Paragraph (k)(3)(ii)(B) requires medical ability, and authority necessary to fulfill abnormal test results for the identification of examinations conducted under this the responsibilities set forth in both beryllium sensitization and for CBD standard to include a physical paragraph (e) of the construction (Document ID 1668, p. 2). examination with emphasis on the standard, in order to ensure that the Materion Corporation (Materion) respiratory system, in order to identify competent has appropriate training, opposed changing the requirement for respiratory conditions such as CBD. education, or experience. See the two abnormal BeLPT results and Under paragraph (k)(5)(i)(A), the discussion of ‘‘competent person’’ in the opposed allowing two or three licensed physician’s report must advise summary and explanation of paragraphs borderline results to determine the employee on whether or not the (e), Beryllium work areas and regulated sensitization (Document ID 1808, p. 4). employee has any detected medical areas, and (f), Methods of compliance, Without providing scientific studies or condition that would place the in this section. other bases for its position, Materion employee at an increased risk of CBD Confirmed positive means the person argued that ‘‘[m]aking a positive BeS from further exposure to beryllium. tested has beryllium sensitization, as determination for an individual without Furthermore, CBD is a criterion for indicated by two (either consecutive or any confirmed abnormal test result is medical removal under paragraph (l)(1). non-consecutive) abnormal BeLPT test not warranted and clearly is not Under paragraph (m)(1)(ii), employers results, an abnormal and borderline test justifiable from a scientific, policy or must address CBD in classifying result, or three borderline test results. legal perspective’’ (Document ID 1808, beryllium hazards under the hazard The definition of ‘‘confirmed positive’’ p. 4). communication standard (HCS) (29 CFR also includes a single result of a more OSHA evaluated these comments and 1910.1200). Employers must also train reliable and accurate test indicating that modified the definition of ‘‘confirmed employees on the signs and symptoms a person has been identified as positive’’ accordingly for reasons of CBD (see paragraph (m)(4)(ii)(A) of sensitized to beryllium if the test has described more fully within the Health the general industry and shipyard been validated by repeat testing to have Effects section of this preamble, V.D.5.b, standards and paragraph (m)(3)(ii)(A) of more accurate and precise diagnostic including reliance on the Middleton the construction standard). capabilities within a single test result studies (2008, 2011). The original Competent person means an than the BeLPT. OSHA recognizes that definition for ‘‘confirmed positive’’ in individual on a construction site who is diagnostic tests for beryllium the proposed standard was adapted capable of identifying existing and sensitization could eventually be from the model standard submitted to foreseeable beryllium hazards in the developed that would not require a OSHA by Materion and the USW in workplace and who has authorization to second test to confirm sensitization. 2012. Having carefully considered all take prompt corrective measures to Alternative test results would need to these comments and their supporting eliminate or minimize them. The have comparable or increased evidence, where provided, the Agency competent person must have the sensitivity, specificity and positive finds the arguments from NJH, ATS, and knowledge, ability, and authority predictive value (PPV) in order to ORCHSE persuasive. In particular ATS necessary to fulfill the responsibilities replace the BeLPT as an acceptable test points out the Middleton et al. studies set forth in paragraph (e) of the standard to evaluate beryllium sensitization (see ‘‘. . . showed that an abnormal and a for construction. This definition appears section V.D.5.b of this preamble). borderline result provide a positive only in the standard for construction. OSHA received comments from NJH, predictive value (PPV) similar to that of The competent person concept has the American Thoracic Society (ATS) two abnormal test results for the been broadly used in OSHA and ORCHSE regarding the requirement identification of both beryllium construction standards (e.g., 29 CFR for consecutive test results within a two sensitization and for CBD.’’ (Document 1926.32(f) and 1926.20(b)(2)), including year time frame, and the inclusion of ID. 1688 p. 3). Therefore, the Agency in the recent health standard for borderline test results (Document ID recognizes that a borderline BeLPT test respirable crystalline silica (29 CFR 1664, p.5; 1668, p. 2; 1691, p. 20). NJH result when accompanied by an 1926.1153). Under 29 CFR 1926.32(f), and ATS submitted similar comments abnormal test result, or three separate competent person is defined as ‘‘one regarding the requirement of two borderline test results, should also be capable of identifying existing and abnormal BeLPT test results to be considered ‘‘confirmed positive.’’ predictable hazards in the surroundings consecutive and within two years. In addition, ORCHSE commented on or working conditions that are According to NJH, ‘‘the definition of the use of a single test result from a unsanitary, hazardous, or dangerous to ‘confirmed positive’ [should] include more reliable and accurate test employees and who is authorized to two abnormals, an abnormal and a (Document ID 1691, p. 20). Specifically, take prompt corrective measures to borderline test result, and/or three ORCHSE recommended revising the eliminate them.’’ OSHA has adapted borderline tests. This recommendation language to include ‘‘the result of a this definition for the beryllium is based on studies of Middleton et al. more reliable and accurate test such that construction standard by specifying (2008, and 2011), which showed that beryllium sensitization can be ‘‘foreseeable beryllium hazards in the these other two combinations result in confirmed after one test, indicating a workplace’’ instead of ‘‘predictable a PPV similar to two abnormal test person has been identified as having hazards in the surroundings or working results and are an equal predictor of beryllium sensitization’’ (Document ID conditions that are unsanitary, CBD.’’ (Document ID 1664, p. 5). In 1691, p. 20). In response to the comment hazardous, or dangerous to employees.’’ addition, the ATS stated: from ORCHSE, the Agency has included

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

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certain specifications. Paragraph general industry, construction, and not demonstrate technological (m)(4)(ii)(B) requires employers to train shipyards. feasibility at that level (see section employees on the written exposure TWA PEL. OSHA proposed a new VIII.D of this preamble, Technological control plan required by paragraph TWA PEL of 0.2 mg/m3 of beryllium— Feasibility). (f)(1), including the location of regulated one-tenth the preceding TWA PEL of 2 The TWA PEL was the subject of areas and the specific nature of mg/m3—because OSHA preliminarily numerous comments in the rulemaking operations that could result in airborne found that occupational exposure to record. Comments from stakeholders in exposure. beryllium at and below the preceding labor and industry, public health In the proposed rule, OSHA included TWA PEL of 2 mg/m3 poses a significant experts, and the general public in the definition of the term ‘‘regulated risk of material impairment of health to supported OSHA’s selection of 0.2 mg/ area’’ that it was ‘‘an area that the exposed workers. As with several other m3 as the final PEL (NIOSH, Document employer must demarcate.’’ Because the provisions of these standards, OSHA’s ID 1671, Attachment 1, p. 2; National requirement to demarcate regulated proposed TWA PEL followed the draft Safety Council, 1612, p. 3; The areas is presented elsewhere in the recommended standard submitted to the Sampling and Analysis Subcommittee standards, the reference in the Agency by Materion Corporation Task Group of the Beryllium Health and definition to ‘‘an area that the employer (Materion) and the United Steelworkers Safety Committee of the Department of must demarcate’’ is redundant, and has (USW) (see this preamble at section III, Energy’s National Nuclear Security been removed from the final definition Events Leading to the Standards). Administration Lawrence Livermore of the term. After evaluating the record, including National Lab (BHSC Task Group), 1655, This definition of regulated areas is published studies and more recent p. 2; Newport News Shipbuilding, 1657, consistent with other substance-specific exposure data from industrial facilities p. 1; National Jewish Health (NJH),1664, health standards that apply to general involved in beryllium work, OSHA is p. 2; The Aluminum Association, 1666, industry and shipyards, such as the adopting the proposed TWA PEL of 0.2 p. 1; The Boeing Company (Boeing), standards addressing occupational mg/m3. OSHA has made a final 1667, p. 1; American Industrial Hygiene exposure to cadmium (29 CFR determination that occupational Association (AIHA), 1686, p. 2; United 1910.1027 and 29 CFR 1915.1027), exposure to a variety of beryllium Steelworkers (USW), 1681, p. 7; Andrew benzene (29 CFR 1910.1028 and 29 CFR compounds at levels below the Brown, 1636, p. 6; Department of 1915.1028), and methylene chloride (29 preceding PELs poses a significant risk Defense, 1684, p. 1). Materion stated CFR 1910.1052 and 29 CFR 1915.1052). to workers (see this preamble at section that the record does not support the This standard means the beryllium VII, Significance of Risk). OSHA’s risk feasibility of any limit lower than 0.2 standard in which it appears. In the assessment, presented in section VI of mg/m3 (Document ID 1808, p. 2). OSHA general industry standard, it refers to 29 this preamble, indicates that there is also received comments supporting CFR 1910.1024. In the shipyard significant risk of beryllium selection of a lower TWA PEL of 0.1 mg/ standard, it refers to 29 CFR 1915.1024. sensitization,38 CBD, and lung cancer m3 from Public Citizen, the AFL–CIO, In the construction standard, it refers to from a 45-year (working life) exposure the United Automobile, Aerospace & 29 CFR 1926.1124. This definition to beryllium at the preceding TWA PEL Agricultural Implement Workers of elicited no comments and differs from of 2 mg/m3. The risk assessment further America (UAW), North America’s the proposal only in that it appears in indicates that, although the risk is much Building Trades Unions (NABTU), and the three separate standards. reduced, significant risk remains at the the American College of Occupational (c) Permissible Exposure Limits (PELs) new TWA PEL of 0.2 mg/m3. and Environmental Medicine (ACOEM) OSHA has determined that the new (Document ID 1689, p. 7; 1693, p. 3; Paragraph (c) of the standards TWA PEL is feasible across all affected 1670, p. 1; 1679, pp. 6–7; 1685, p. 1; establishes two permissible exposure industry sectors (see section VIII.D of 1756, Tr. 167). These commenters based limits (PELs) for beryllium in all forms, this preamble, Technological their recommendations on the compounds, and mixtures: An 8-hour Feasibility) and that compliance with significant risk of material health time-weighted average (TWA) PEL of 0.2 the new PEL will substantially reduce impairment from exposure at the TWA mg/m3 (paragraph (c)(1)), and a 15- 3 employees’ risks of beryllium PEL of 0.2 mg/m and below, which minute short-term exposure limit sensitization, Chronic Beryllium Disease OSHA acknowledges. (STEL) of 2.0 mg/m3 (paragraph (c)(2)). (CBD), and lung cancer (see section VI In addition to their concerns about The TWA PEL section of the standards of this preamble, Risk Assessment). risk, Public Citizen and the American requires employers to ensure that no OSHA’s conclusion about feasibility is Federation of Labor and Congress of employee’s exposure to beryllium, supported both by the results of the Industrial Organizations (AFL–CIO) averaged over the course of an 8-hour 3 Agency’s feasibility analysis and by the argued that a TWA PEL of 0.1 mg/m is work shift, exceeds 0.2 mg/m3. The STEL recommendation of the PEL of 0.2 mg/m3 feasible (Document ID 1756, Tr. 168– section of the standards requires by Materion and the USW. 169, 197–198). As discussed further employers to ensure that no employee’s Materion is the sole beryllium below, however, OSHA’s selection of exposure, sampled over any 15-minute producer in the U.S., and its facilities the TWA PEL in this case was limited period during the work shift, exceeds include some of the processes where by the findings of its technological m 3 2.0 g/m . While the proposed rule OSHA expects it will be most feasibility analysis. No commenter contained slightly different language in challenging to control beryllium provided information that would permit paragraph (c), i.e. requiring that ‘‘each OSHA to show the feasibility of a TWA exposures. Although OSHA also found 3 employee’s airborne exposure does not that there is significant risk at the PEL of 0.1 mg/m in industries where exceed’’ the TWA PEL and STEL, the proposed alternative TWA PEL of 0.1 OSHA did not have sufficient final language was chosen by OSHA to mg/m3, OSHA did not adopt that information to make this determination remain consistent with prior OSHA alternative because the Agency could at the proposal stage. Public Citizen health standards and to clarify that instead argued that insufficient OSHA did not intend a different 38 As discussed in section VII of this preamble, evidence that engineering and work interpretation of the PELs in this Significance of Risk, beryllium sensitization is a practice controls can maintain standard. The same PELs apply to necessary precursor to developing CBD. exposures at or below a TWA PEL of 0.1

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

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

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cross-references the shipyard standard, employers must assess the exposure of of exposure at the worksite; 1915.1024, and 29 CFR 1926.55 each employee who is or may identification and prevention of Appendix A is revised to cross-reference reasonably be expected to be exposed to employee overexposure; identification the construction standard, 1926.1124. A airborne beryllium. of the sources of exposure to beryllium; footnote is added to 29 CFR 1910.1000 In the proposed exposure monitoring collection of exposure data so that the Table Z–1, which refers to 29 CFR provision, OSHA required employers to employer can select the proper control 1910.1000 Table Z–2 for situations assess the exposure of employees who methods to be used; and evaluation of when the new exposure limits in are, or may reasonably be expected to the effectiveness of those selected 1910.1024 are stayed or otherwise not in be, exposed to airborne beryllium. This methods. Assessment enables employers effect. The preceding PELs for beryllium obligation consisted of an initial to meet their legal obligation to ensure are retained in 29 CFR 1910.1000 Table exposure assessment, unless the that their employees are not exposed in Z–2, 29 CFR 1915.1000 Table Z, and 29 employer relied on objective data to excess of the permissible exposure limit CFR 1926.55 Appendix A. Footnotes are demonstrate that exposures would be (PEL) or short-term exposure limit added to these tables to make clear that below the action level or the short term (STEL) and to ensure employees have the preceding PELs apply to any sectors exposure level (STEL) under any access to accurate information about or operations where the new TWA PEL expected conditions; periodic exposure their exposure levels, as required by of 0.2 mg/m3 and STEL of 2.0 mg/m3 are monitoring (at least annually if initial section 8(c)(3) of the Act, 29 U.S.C. not in effect. The preceding PELs are exposure monitoring indicates that 657(c)(3). In addition, exposure data also applicable during the time between exposures are at or above the action enable physicians or other licensed publication of the beryllium rule and level and at or below the time-weighted health care professionals (PLHCPs) the dates established for compliance average (TWA) PEL); and additional performing medical examinations to be with the rule, as well as in the event of monitoring if changes in the workplace informed of the extent of the worker’s regulatory delay, a stay, or partial or full could reasonably be expected to result exposure to beryllium. invalidation by the Court. in new or additional exposures to In the final standards, paragraph (d) is beryllium. In the proposed rule, now titled ‘‘Exposure assessment.’’ This (d) Exposure Assessment monitoring to determine employee TWA change from ‘‘exposure monitoring’’ in Paragraph (d) of the final standards exposures had to represent the the proposal to ‘‘exposure assessment’’ for general industry, construction, and employee’s average exposure to airborne in the final standards was made to align shipyards sets forth requirements for beryllium over an eight-hour workday. the provision’s purpose with the assessing employee exposures to STEL exposures had to be characterized broader concept of exposure assessment beryllium. The requirements are issued by sampling periods of 15 minutes for beyond conducting air monitoring, pursuant to section 6(b)(7) of the OSH each operation likely to produce including the use of objective data. Act, which mandates that any standard exposures above the STEL. Samples General Requirements. Proposed promulgated under section 6(b) shall, taken had to reflect the exposure of paragraph (d)(1)(i) contained the general where appropriate, ‘‘provide for employees on each work shift, for each requirement that the exposure monitoring or measuring employee job classification, in each beryllium assessment provisions would apply exposure at such locations and work area. Samples had to be taken when employees ‘‘are, or may intervals, and in such manner as may be within an employee’s breathing zone. reasonably be expected to be, exposed to necessary for the protection of The proposed rule also included airborne beryllium.’’ OSHA did not employees.’’ 29 U.S.C. 655(b)(7). provisions for employee notification of receive comment on this specific Consistent with the definition of monitoring results and observation of provision. However, in paragraph (d)(1) ‘‘airborne exposure’’ in paragraph (b) of monitoring. of the final standards for general these standards, exposure monitoring OSHA received comments on a industry, construction, and shipyards, results must reflect the exposure to variety of issues pertaining to the the Agency has changed the proposed airborne beryllium that would occur if proposal’s exposure monitoring requirement that ‘‘These exposure the employee were not using a provision. In hearing testimony, Dr. Lisa monitoring requirements apply when respirator. Exposures must be assessed Maier from National Jewish Health employees are, or may reasonably be using the new performance option (i.e., (NJH) expressed general support for expected to be, exposed to airborne use of any combination of air exposure monitoring in the workplace beryllium’’ to ‘‘The employer must monitoring data or objective data ‘‘to target areas that are at or above the assess the airborne exposure of each sufficient to accurately characterize action level and to regulate these areas employee who is or may reasonably be employee exposures) or by following the to trigger administrative controls’’ expected to be exposed to airborne scheduled monitoring option (with the (Document ID 1756, Tr. 108). All other beryllium.’’ This change aligns the frequency of monitoring determined by comments regarding the exposure language to other OSHA standards such the results of the initial and subsequent monitoring requirements focused on as respirable crystalline silica (29 CFR monitoring). The performance option specific areas of those requirements and 1910.1053) and hexavalent chromium provides flexibility for employers who are discussed in the appropriate subject (d1910.1026) as well as clarifies the are able to accurately characterize section below. employer’s obligation to assess each employee exposures through alternative OSHA has retained the provisions employee’s beryllium exposure. methods like objective data and has related to exposure assessment in the Additionally, for reasons discussed been successfully applied in the final standards. These provisions are below, paragraph (d)(1) of the final Chromium (VI) standard and recently important because assessing employee standards now requires the employer to included in the respirable crystalline exposure to toxic substances is a well- assess employee exposure in accordance silica standard. The scheduled recognized and accepted risk with either the new performance option, monitoring option provides a framework management tool. As the Agency noted added at paragraph (d)(2), or the that is familiar to many employers, in the proposal, the purposes of scheduled monitoring option, moved to having been a customary practice in requiring assessment of employee paragraph (d)(3) of this section. Changes past substance-specific OSHA health exposures to beryllium include from the proposed exposure monitoring standards. Under either option, determination of the extent and degree provision also include an increased

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

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used to determine employee exposures, justifiable or necessary to fulfill the the proposed short-term exposure limit but only if the employer could show requirements of the OSH Act (Document (STEL) of 2 mg/m3 has the potential for that the data were obtained during work ID 1807, Attachment 1, p. 5, Attachment being misinterpreted as requiring the operations conducted under conditions 7, p. 82; 1958, pp. 5–6). In an individual use of impractical exposure monitoring closely resembling the processes, types submission, the USW also stated that methods that would require collecting of material, control methods, work three-shift monitoring would add 32 consecutive 15-minute samples practices, and environmental conditions unnecessary compliance costs. while providing no real health in the employer’s current operations. Additionally, it commented that if the protection benefit and should be Regardless of when they were collected, operations are identical, the shift chosen dropped from the final rule (Document the data must accurately reflect current will not matter, while if they are not ID 1591, p. 3). OSHA’s intent, however, conditions. identical, then monitoring on the is that compliance with the STEL can be Any air monitoring data relied upon highest exposed shift will overestimate assessed using a task specific by employers must be maintained and exposures on the other shifts (Document monitoring strategy, during which made available in accordance with the ID 1681, Attachment 1, p. 8). representative 15-minute samples can recordkeeping requirements in Conversely, the American Federation of be taken to evaluate peak exposures. paragraph (n)(1) of the final standards Labor and Congress of Industrial OSHA maintains that consistent with for general industry, construction, and Organizations (AFL–CIO) noted in post- the comments from Materion, the shipyards. Any objective data relied hearing comments that widely accepted identification and control of short-term upon must be maintained and made industrial hygiene practice includes exposures is critical to the protection of available in accordance with the exposure monitoring during different worker health from exposure to recordkeeping requirements in shifts, tasks, and times of the year and beryllium. paragraph (n)(2) of the standards. that monitoring is specifically designed OSHA has decided to include the The scheduled monitoring option. this way to characterize exposure under scheduled monitoring option in the Paragraph (d)(3) of the final standards different conditions (Document ID 1809, final standards because it provides for general industry, construction, and p. 1). During the hearings, Dr. Virji from employers with a clearly defined, shipyards describes the scheduled NIOSH testified that because exposure structured approach to assessing monitoring option. Parts of the is variable and ‘‘different things happen employee exposures. Under paragraph scheduled monitoring option in the at different shifts,’’ including (d)(3)(i) of the final standards, final standards come from proposed maintenance activities, ‘‘it is hard to employers who select the scheduled paragraphs (d)(1)(ii)–(iv), which set out . . . gauge . . . which shift [has] the monitoring option must conduct initial the general exposure monitoring highest exposure,’’ so ‘‘it is important monitoring to determine employee requirements. Proposed paragraph that multiple shifts get representative exposure to beryllium. Air monitoring (d)(1)(ii) required the employer to sampling’’ (Document ID 1755, Tr. 50– to determine employee exposures must determine the 8-hour TWA exposure for 51). represent the employee’s 8-hour TWA each employee, and proposed paragraph OSHA agrees with the AFL–CIO and exposure to beryllium. Final paragraph (d)(1)(iii) required the employer to Dr. Virji and has retained the (d)(3)(ii) requires the employer to determine the 15-minute short-term requirement in proposed paragraphs perform initial monitoring to assess the exposure for each employee. Both (d)(1)(ii) and (iii) that samples reflect employee’s 15-minute short-term proposed paragraph (d)(1)(ii) and exposures on each shift, for each job exposure. Under both paragraphs (d)(1)(iii) required breathing zone classification, and in each work area. (d)(3)(i) and (d)(3)(ii), samples must be samples to represent the employee’s This requirement is included in final taken within the employee’s personal exposure on each work shift, for each paragraphs (d)(3)(i) and (ii). However, in breathing zone, and must represent the job classification, in each beryllium response to the comments from employee’s airborne exposure on each work area. Materion and the USW, OSHA shift, for each job classification, in each Some commenters disagreed with the restructured the exposure assessment work area. In the final standards, OSHA requirement to perform exposure requirements in order to provide has changed ‘‘in each beryllium work monitoring on each work shift. NGK employers with greater flexibility to area’’ to ‘‘in each work area’’ to avoid stated that sampling on each shift is meet their exposure assessment confusion with the beryllium work areas overly burdensome and unnecessary obligations by using either the defined in paragraphs (b) and (e) of the since samples are collected from those performance option or the scheduled final standard for general industry. In employees who are expected to have the monitoring option depending on the other OSHA standards, the term ‘‘work highest exposure (Document ID 1663, p. operation and information available. area’’ is used to describe the general 1). Materion and the United OSHA believes that conducting worksite where employees are present Steelworkers (USW) recommended exposure assessment on a specific and performing tasks or where work representative sampling instead of schedule provides employers with a processes and operations are being sampling all employees, and sampling workable structure to properly assess carried out. Employers following the from the shift expected to have the their employees’ exposure to beryllium scheduled monitoring option should highest exposures (Document ID 1680, and provides sufficient information for conduct initial monitoring as soon as p. 3). Materion separately commented employers to make informed decisions work on a task or project involving that monitoring on all three shifts is not regarding exposure prevention beryllium exposure begins so they can warranted, would be burdensome to measures. Alternatively, the identify situations where control small businesses, and does not align performance option provides employers measures are needed. well with other standards (Document ID with flexibility in accurately Representative sampling. Paragraph 1661, p. 14 (pdf)). In post-hearing characterizing employee exposures to (d)(3)(iii) of the final standards, like comments, Materion submitted an beryllium on the bases of any proposed paragraph (d)(1)(iv), describes analysis of exposure variation by shift at combination of air monitoring and the circumstances under which one of their facilities and argued that the objective data. employers may use representative data are the best available evidence that Comments submitted from Mr. Paul sampling. Proposed paragraphs monitoring on all three shifts is not Wambach, a private citizen, stated that (d)(1)(iv)(A)–(C) permitted the use of

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

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

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

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when there is a change in ‘‘production, Additionally, OSHA changed the beryllium that are capable of detecting process, control equipment, personnel, requirement that employers ‘‘use a beryllium at air concentrations below or work practices’’ that may reasonably method of exposure monitoring and the final action level of 0.1 mg/m3 and be expected to result in new or analysis’’ in the proposed rule to require the final STEL of 2.0 mg/m3 for a 15- additional exposures at or above the that employers ‘‘ensure that all samples minute sampling period (see Chapter IV action level or STEL. OSHA made these taken to satisfy the monitoring of the Final Economic Analysis, changes to provide clarity and requirements of paragraph (d) are Technological Feasibility). Therefore, consistency with other OSHA health evaluated by a laboratory’’ to clarify that OSHA has determined that the sampling standards. employers may send samples to a and analytical methods currently In addition, there may be other laboratory for analysis, and OSHA does available to employers are sufficient to situations that can result in new or not intend to require employers to have measure beryllium as required in additional exposures that are unique to a laboratory to analyze samples at the paragraph (d) of the final standards. an employer’s work situation. In order worksite. Rather than specifying a particular to cover those special situations, OSHA Under final paragraph (d)(5), the method that must be used, the final has retained the requirement in employer is required to make sure that standards allow for a performance- proposed paragraph (d)(4)(ii) that the all samples taken to satisfy the oriented approach that allows the employer must reassess exposures monitoring requirements of paragraph employer to use the method and whenever the employer has any reason (d) are evaluated by a laboratory that analytical laboratory of its choosing as to believe that a change has occurred can measure airborne levels of long as that method meets the accuracy that may result in new or additional beryllium to an accuracy of plus or specifications in paragraph (d)(5) and exposures, and has added ‘‘at or above minus 25 percent within a statistical the reported results represent the total the action level or STEL’’ to final confidence level of 95 percent for airborne concentration of beryllium for paragraph (d)(4). Under this provision, airborne concentrations at or above the the worker being characterized. Other for example, an employer is required to action level. The following methods methods, such as a respirable fraction reassess exposures when an employee meet these criteria: NIOSH 7704 (also sample or size selective sample, would has a confirmed positive result for ASTM D7202), ASTM D7439, OSHA not provide results directly comparable beryllium sensitization, exhibits signs or 206, OSHA 125G, and OSHA 125G to either PEL, and therefore would not symptoms of CBD, or is diagnosed with using ICP–MS. All of these methods are be considered valid. CBD. These conditions necessitate a available to commercial laboratories Employee Notification of Assessment reassessment of exposures to ascertain if analyzing beryllium samples. However, Results. Paragraph (d)(6) of the final airborne exposures contributed to the not all of these methods are appropriate standards, like proposed paragraph beryllium-related health effects. for measuring beryllium oxide, so (d)(5), addresses employee notification Additionally, reassessment of exposures employers must verify that the requirements. OSHA did not receive would be required following a process analytical method used is appropriate comment specifically on this provision, modification that increases the amount for measuring the form(s) of beryllium but several commenters supported the of beryllium-containing material used, present in the workplace. exposure monitoring provisions as a thereby possibly increasing employee In the NPRM, OSHA requested whole, and after reviewing the record, exposure. Reassessment of exposures comment on whether these methods OSHA has decided to retain the will also be required when a shipyard would satisfy the requirements of this employee notification requirements in or construction employer introduces a paragraph, and if there were other the final standards. OSHA has changed new beryllium-containing slag for use in methods that would also meet these the title ‘‘Employee Notification of an abrasive blasting operation. Once criteria. The BHSC Task Group Monitoring Results’’ in proposed reassessment of exposures is performed commented that OSHA’s accuracy paragraph (d)(5) to ‘‘Employee and if exposures are above the action criteria could be met for full shift Notification of Assessment Results’’ in level, TWA PEL, or STEL, the employer samples using available analytical final paragraph (d)(6) to reflect the can take appropriate action to protect methods. The BHSC Task Group agreed change in the title of paragraph (d). This exposed employees and must perform with the guidance in OSHA’s NPRM to requirement is consistent with other periodic monitoring as discussed above. use ICP–MS or fluorescence to assure OSHA standards, such as those for Methods of sample analysis. adequate sensitivity and analytical respirable crystalline silica (29 CFR Paragraph (d)(5) of the final standards, precision (Document ID 1655, p. 2). In 1910.1053), methylenedianiline (29 CFR like proposed paragraph (d)(1)(v), response to a question on whether the 1910.1050), 1,3-butadiene (29 CFR addresses methods for evaluating air current methods were sufficiently 1910.1051), and methylene chloride (29 monitoring samples. Proposed sensitive, Kevin Ashley with NIOSH CFR 1910.1052). paragraph (d)(1)(v) required employers testified that both the fluorescence Proposed paragraph (d)(5)(i) required to use a method of exposure monitoring method (NIOSH method 7704) and the employers to notify each employee of and analysis that could measure inductively coupled plasma mass his or her monitoring results within 15 beryllium to an accuracy of plus or spectrometry (ASTM method D7439) working days after receiving the results minus 25 percent within a statistical were adequately sensitive to measure at of any exposure monitoring. Both the confidence level of 95 percent for the proposed PEL and STEL (Document employees whose exposures were airborne concentrations at or above the ID 1755, Tr. 58). The DOD commented measured directly and those whose action level. This provision is largely that the current limit of quantification exposures were represented by the unchanged in the final standards. OSHA (LOQ) of 0.05 mg for beryllium using the monitoring had to be notified. The has changed the title ‘‘Accuracy of NIOSH 7300 and OSHA 125G methods employer had to notify each employee measurement’’ in the proposal’s would be adequate to detect exposures individually in writing or post the paragraph (d)(1)(v) to ‘‘Methods of below the proposed action level of 0.1 monitoring results in an appropriate sample analysis’’ in paragraph (d)(5) of mg/m3 and the proposed STEL of 2 mg/ location accessible to all employees the final standards. OSHA made this m3 (Document ID 1684, Attachment 2, required to be notified. Proposed change to more accurately describe the p. 9). OSHA has identified several paragraph (d)(5)(i) is now paragraph purpose of this requirement. sampling and analysis methods for (d)(6)(i) in the final standards, and has

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been edited to reflect the change in decided to retain it in the final of the construction standard does not language from ‘‘exposure monitoring’’ to standards because it promotes require either work areas or regulated ‘‘exposure assessment,’’ discussed occupational safety and health and is areas, but instead includes requirements earlier. This can be in print or required by the OSH Act. Section 8(c)(3) for a ‘‘competent person,’’ who has electronically as long as the affected of the Act (29 U.S.C. 657(c)(3)) responsibility for demarcating certain employees have access to the mandates that regulations requiring areas of beryllium exposure for similar information and have been informed of employers to keep records of employee purposes. the posting location. Final paragraph exposures to toxic materials or harmful Specifically, paragraph (e)(1)(i) and (d)(6)(i) for general industry, physical agents provide employees or (e)(2)(i) of the standard for general construction, and shipyards is their representatives with the industry requires employers to substantively unchanged from the opportunity to observe monitoring or establish, maintain, and demarcate one proposal. However, due to the transient measurements. or more ‘‘beryllium work area,’’ which nature of construction work and the Proposed paragraph (d)(6)(i) required is defined as a work area containing a need to receive exposure assessment the employer to provide an opportunity process or operation that can release results while the work is still occurring, to observe any exposure monitoring beryllium where employees are, or can OSHA recommends that employers in required by the standards to each reasonably be expected to be, exposed to the construction industry make every employee whose airborne exposure was airborne beryllium at any level or where effort to notify employees of their measured or represented by the there is the potential for dermal contact monitoring results as soon as possible. monitoring and to each employee’s with beryllium. OSHA intends these Proposed paragraph (d)(5)(ii) required representative(s). Proposed paragraph beryllium work area provisions to apply that, whenever exposures exceeded the (d)(6)(i) is now paragraph (d)(7)(i) in the to the area surrounding the process, TWA PEL or STEL, the written final standards, and is substantively operation, or task where airborne notification required by proposed unchanged from the proposal. When beryllium is released or the potential for paragraph (d)(5)(i) include (1) suspected observation of monitoring required dermal contact is created. Beryllium or known sources of exposure and (2) a entry into an area where the use of work areas are also referenced in the description of the corrective action(s) protective clothing or equipment was general industry standard in paragraphs that have been taken or will be taken by required, proposed paragraph (d)(6)(ii) (f)(1) (the written exposure control the employer to reduce the employee’s required the employer to provide the plan), (f)(2) (engineering and work exposure to or below the TWA PEL or observer with that personal protective practice controls), and (j) STEL where feasible corrective action clothing or equipment, at no cost. The (housekeeping). Under paragraphs exists but was not implemented at the employer was also required to ensure (e)(1)(ii) and (e)(1) of the standards for time of the monitoring. OSHA did not that the observer used such clothing or general industry and shipyards, receive comment on this specific equipment appropriately. Proposed respectively, employers are also provision, and after reviewing the paragraph (d)(6)(ii) is now paragraph required to establish and maintain record, including comments supporting (d)(7)(ii) in the final standards, and is regulated areas wherever employees are, paragraph (d) generally, OSHA has substantively unchanged from the or can reasonably be expected to be, decided to retain a notification proposal. Paragraph (d)(6)(iii) of the exposed to airborne beryllium at levels requirement focused on individual proposal required employers to ensure above the TWA PEL or STEL. As exposure assessments and the corrective that each observer complied with all indicated and discussed in more detail actions being taken for exposures above applicable OSHA requirements and the below, the final standards for shipyards the PEL or STEL. It is necessary to employer’s workplace safety and health and construction do not contain assure employees that the employer is procedures. Proposed paragraph provisions for beryllium work areas and making efforts to furnish them with a (d)(6)(iii) is now paragraph (d)(7)(iii) in the standard for construction does not safe and healthful work environment, the final standards. OSHA has changed require employers to establish regulated and to provide employees with the proposed language to require that areas. In lieu of regulated areas, information about their exposures. employers ensure that each observer paragraph (e) of the final standard for Furthermore, notification to employees follows all other applicable safety and construction, Competent Person, of exposures above a prescribed PEL health procedures to clarify that the consists of a set of requirements and the corrective actions being taken is burden to comply with OSHA designed to provide most of the same required under section 8(c)(3) of the Act requirements remains on the employer, protections as regulated areas in general (29 U.S.C. 657(c)(3)). In order to provide not the observer. industry and shipyards, using a consistency with other OSHA health competent person instead of demarcated (e) Beryllium Work Areas and Regulated standards, OSHA has removed the areas to achieve these ends. Areas (General Industry); Regulated requirement in proposed paragraph The requirements to establish Areas (Shipyards); and Competent (d)(5)(ii) that employers include beryllium work areas and regulated Person (Construction) suspected or known sources of exposure areas or designate competent persons in the written notification. Proposed Paragraph (e) of the standards for serve several important purposes. First, paragraph (d)(5)(ii), as revised, is now general industry and shipyards sets requiring employers to establish and paragraph (d)(6)(ii) in the final forth the requirements for establishing, demarcate beryllium work areas in standards. maintaining, demarcating, and limiting general industry ensures that workers Observation of monitoring. Paragraph access to certain areas of the workplace and other persons are aware of the (d)(7) of the final standards, like to aid in minimizing employee exposure potential for work processes to release proposed paragraph (d)(6), requires to beryllium. As discussed below, the airborne beryllium or cause dermal employers to provide for observation of general industry standard includes contact with beryllium. Second, the exposure monitoring. OSHA did not requirements for both ‘‘work areas’’ and required demarcation of regulated areas receive comment on this specific ‘‘regulated areas,’’ which are subsets of in general industry and shipyards in provision, and after reviewing the work areas. The shipyard standard accordance with the paragraph (m) record, including comments supporting includes requirements for regulated requirements for warning signs ensures paragraph (d) generally, OSHA has areas, but not work areas. Paragraph (e) that all persons entering regulated areas

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will be aware of the serious health A number of stakeholders commented which the applicable trigger is the TWA effects associated with exposure to on the proposed definition of a PEL or STEL. Because, as discussed in beryllium. Similarly, assignment of a beryllium work area. Some commenters, Section V, Health Effects, there is still competent person to carry out the such as NGK Metals Corporation (NGK) a potential health risk to workers provisions of paragraph (e) in the and ORCHSE Strategies (ORCHSE), exposed to beryllium below the action construction standard where exposures argued that the definition of a beryllium level, the establishment and may exceed the TWA PEL or STEL work area is vague and requested that demarcation of beryllium work areas at provides employees in construction OSHA trigger the requirement to any level of airborne exposure will with a knowledgeable on-site authority establish and maintain beryllium work provide additional protection for these to convey information about the hazards areas at a measureable threshold, such workers by ensuring that they are aware of beryllium exposure. Third, limiting as the action level (e.g., Document ID of the presence of processes that release access to regulated areas (general 1663, p. 1; 1691, Attachment 1, p. 15). beryllium. OSHA similarly finds that industry and shipyards) or areas where Edison Electric Institute (EEI), an Boeing’s suggested trigger of 0.02 mg/m3 exposures may exceed the TWA PEL or industry association representing is not suitable because OSHA has not STEL (construction) restricts the electric utility companies, also did not established a level of exposure at which number of workers potentially exposed agree with the beryllium work area beryllium does not pose a risk to to beryllium at levels above the TWA definition (Document ID 1674, p. 13). workers (see this preamble at Section PEL or STEL. Finally, provisions for Like NGK and ORCHSE, EEI VI, Risk Assessment). Therefore, OSHA respiratory protection and PPE ensure recommended that OSHA tie the finds that establishing and demarcating that those who must enter regulated beryllium work area requirements to a beryllium work areas wherever areas (general industry and shipyards) quantifiable exposure level, like the processes or operations release or areas where exposures may exceed action level or the PEL (Document ID beryllium is more protective. OSHA also the TWA PEL or STEL (construction) are 1674, p. 13). The Boeing Company does not agree with those commenters properly protected, thereby reducing the (Boeing) also recommended the use of a who find the trigger for establishing risk of serious health effects associated quantifiable trigger, but suggested a beryllium work areas vague. As with airborne beryllium exposure and much lower trigger of 0.02 mg/m3 explained previously, OSHA has dermal contact with beryllium. (Document ID 1667, p. 3). Boeing modified the beryllium work areas The remainder of this section explained that not including a specific provision in the final standard for provides detailed discussion of each threshold can lead to inconsistent general industry to specify that the provision in paragraph (e) of the final results because it depends on the source of the airborne beryllium standards for general industry, sensitivity of the measurement method exposure and potential for dermal shipyards, and construction, as well as (Document ID 1667, p. 3). contact triggering the requirement for a comments OSHA received on paragraph Other commenters supported the beryllium work area must be generated (e) of the proposed standard, OSHA’s proposed standard’s establishment of from a process or operation within that response to these comments, and the beryllium work areas at any level of area, not just the fact that an employee reasons for OSHA’s decisions regarding airborne beryllium exposure. For may be handling an article containing the provisions of paragraph (e) in each example, AWE commented that its beryllium. An employer can (but is not final standard. ‘‘supervised beryllium workspaces’’ required to) use air monitoring to Beryllium Work Areas (General align with the proposal’s beryllium determine the presence of airborne Industry). Provisions for the work areas (Document ID 1615, p. 1). beryllium in the area surrounding the establishment of beryllium work areas NIOSH observed that the proposed process, operation, or task that may be were included in the proposed standard approach is feasible and appropriate for releasing beryllium or wipe sampling to for general industry in paragraph beryllium work settings where work determine the presence of beryllium on (e)(1)(i). This proposed provision such as production, processing, surfaces that workers may come into required employers to establish and handling, and manufacturing of contact with. Affording the employer maintain beryllium work areas where beryllium products is performed and such flexibility to comply with this employees are, or can reasonably be areas where needed preventive controls performance-based provision does not expected to be, exposed to airborne can be relatively easily demarcated make it impermissibly vague. beryllium. OSHA explained that it (Document ID 1725, pp. 29–30). intended the provision to apply to all Materion and USW reiterated their Accordingly, OSHA has decided to areas and situations where employees support for provisions related to retain, as modified, the requirement that are actually exposed to airborne beryllium work areas ‘‘where operations beryllium work areas must be beryllium and to areas and situations generate airborne beryllium established and maintained where there where the employer has reason to particulate’’, which were included in is a process or operation that can release anticipate or believe that airborne the recommended model standard they beryllium and employees are, or can exposures may occur. The Agency submitted to OSHA (Document ID 1680, reasonably be expected to be, exposed to further explained that—unlike the p. 3). airborne beryllium at any level. requirements for regulated areas—the The purpose of a beryllium work area However, as discussed below, OSHA proposed requirements were not tied to is to establish a demarcated area in has somewhat modified the definition of a particular level of exposure, but rather which workers and other persons beryllium work areas in response to were triggered by the presence of authorized to be in the area are made comments from other stakeholders and airborne beryllium at any exposure aware of the potential for beryllium NIOSH. level. The provision was based on a exposure and must take certain Two electric utility companies, provision recommended by Materion precautions accordingly. OSHA finds Southern Company and Ameren Corporation (Materion) and the United that establishing beryllium work areas Corporation (Ameren), argued that a Steelworkers (USW) in their joint where exposures are at the action level work area requirement defined by any submission, (see previous discussion in or above the PEL would not adequately level of airborne beryllium exposure the Introduction to this Summary and protect exposed workers operating was subjective and would result in their Explanation section). outside demarcated regulated areas, for entire facility falling under this

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

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Newport News Shipbuilding (NNS) regulated areas would apply if any confusing and burdensome, and similarly commented that since exposure monitoring or objective data suggested that the final standard should beryllium is primarily encountered in indicate that airborne exposures are in include only areas with airborne shipyards as a trace element in coal slag excess of either the TWA PEL or STEL, beryllium above the TWA PEL or STEL, blasting media, the requirement to or if the employer has reason to which they described as better defined establish and maintain beryllium work anticipate or believe that airborne and more enforceable than the areas is not appropriate for shipyards. exposures may be above the TWA PEL provisions for beryllium work areas in NNS stated, ‘‘[i]t is relatively easy to or STEL, even if the employer has not the proposed standard (Document ID control a work area to a stated number yet characterized or monitored those 1684, Attachment 2, p. 2). After such as a permissible exposure limit or exposures. For example, if newly carefully considering the record on an action level, but controlling introduced processes involving regulated areas, OSHA has decided to ‘regardless of level of exposure’ for a beryllium appear to be creating dust and modify some of the provisions trace contaminant in dust is have not yet been monitored, the associated with regulated areas to impractical’’ (Document ID 1657, pp. 1– employer should reasonably anticipate address commenters’ concerns where 2). that airborne exposures could exceed appropriate, but to retain paragraph Recognizing the difficulties described the TWA PEL or STEL. In this situation, (e)(1)(ii) as proposed in the final by NIOSH and NNS, the Agency the employer would be required to standard for general industry. Thus, decided not to require employers in designate the area as a regulated area to final paragraph (e)(1)(ii) in general construction and shipyards to establish protect workers and other persons until industry requires employers to establish and maintain beryllium work areas. monitoring results establish that and maintain a regulated area wherever However, OSHA has modified exposures are at or below the TWA PEL employees are, or can reasonably be provisions associated with beryllium and STEL. In the proposed standard, expected to be, exposed to airborne work areas in paragraph (f)(1) and work in regulated areas triggered beryllium at levels above the TWA PEL paragraph (h) of the proposed standard additional requirements for medical or STEL. A detailed discussion of so as to provide employees in all sectors surveillance (see Summary and OSHA’s decisions and reasoning with largely equivalent protective Explanation for paragraph (k)), PPE (see follows. measures. For example, employers in all Summary and Explanation for As applied to general industry, OSHA sectors are required to create, paragraph (h)), and hazard has not accepted the DoD’s suggestion implement, and maintain a written communication (see Summary and that only work areas where exposures exposure control plan that lists jobs and Explanation for paragraph (m)). The exceed the TWA PEL or STEL need to operations where beryllium exposure construction and shipyard sectors were may occur, and that documents be demarcated as limited-access or not included in the proposed standard, regulated areas. Because employees who procedures for limiting cross- but were included in Regulatory contamination and migration of are exposed to airborne beryllium below Alternative #2a in the NPRM, which the TWA PEL and STEL and who have beryllium (see Summary and would extend all provisions of the Explanation of paragraph (f)(1)). dermal contact with beryllium are at proposed standard for general industry risk of adverse health effects, OSHA Similarly, whereas employers in general to construction and shipyards, industry are required under paragraph finds that it is appropriate to establish including provisions pertaining to and demarcate beryllium work areas (f)(2) to take certain steps to reduce regulated areas. OSHA requested airborne beryllium in beryllium work wherever work processes create such comments on this proposed regulatory areas where exposures meet or exceed exposures and are primarily located in alternative. the action level, employers in indoor settings, as OSHA finds is typical construction and shipyards have a OSHA received relatively few of operations in general industry. As nearly identical requirement to take comments on the proposed provisions discussed above, the requirement for the steps to reduce exposures where for regulated areas, which were largely establishment and maintenance of exposures meet or exceed the action similar to the regulated areas provisions beryllium work areas is necessary to level. Thus, the only provisions related included in previous substance-specific alert workers to the presence of to beryllium work areas that apply in standards. In general, commenters did beryllium and to trigger basic exposure general industry but not in construction not oppose the concept of regulated prevention methods, such as hygiene and shipyards are those OSHA is areas. Clive LeGresly with AWE noted facilities and housekeeping. However, it persuaded add protective value in that their organization establishes is also appropriate to establish regulated general industry but would be ‘‘Controlled’’ beryllium workspaces that areas with more stringent requirements, unworkable or ineffective in the align with the final standards’ regulated such as respiratory protection, limited construction and shipyard contexts of areas (Document ID 1615, p. 4). access, and warning signs, where abrasive blasting and outdoor However, some commenters suggested exposures may exceed the TWA PEL or operations, e.g., certain housekeeping modifications to OSHA’s proposed STEL. OSHA concludes that beryllium provisions related to surface definition of regulated areas. In their work areas and regulated areas serve contamination (see Summary and comments, the Sampling and Analysis distinct purposes, and each provides Explanation, paragraph (j), Subcommittee Task Group of the important protections to employees. Housekeeping, for further discussion). Beryllium Health and Safety Committee Therefore, OSHA has decided to retain Regulated Areas. Paragraph (e)(1)(ii) (BHSC Task Group) and National Jewish both beryllium work areas and regulated of the proposed standard required Health (NJH) both supported the areas in the final standard for the employers to establish and maintain concept of regulated areas but general industry standard. As explained regulated areas wherever employees are, recommended they be established when elsewhere in this section, OSHA finds or can reasonably be expected to be, exposures are at or above the action that requirements to establish and exposed to airborne concentrations of level (Document ID 1655, p. 7; 1664, p. demarcate beryllium work areas are not beryllium in excess of the TWA PEL or 3). Finally, the Department of Defense appropriate to operations in STEL. OSHA explained that the (DoD) argued that having both beryllium construction and shipyards, and that the requirement to establish and maintain work areas and regulated areas was objectives of regulated areas are better

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achieved through the use of a competent awareness for the potential hazard of due to the nature of workplaces or work person in construction. beryllium contact or exposure at levels processes in construction or shipyards. OSHA has also carefully considered below the action level. For these OSHA has additionally reviewed the recommendation by the BHSC Task reasons, OSHA believes that it is comments received on the topic of Group and NJH to use the action level appropriate to retain the proposed regulated areas in construction and rather than the TWA PEL or STEL to standard’s definition of regulated areas shipyards, to determine whether it is trigger the provisions of the proposed and related provisions for restricted appropriate to modify the requirements standard associated with regulated access and demarcation. for regulated areas in these sectors. areas, and finds that it has some merit. In addition, OSHA finds that it is Based on its review, as well as OSHA’s For example, in the proposed standard, inappropriate to extend mandatory previous experience regulating chemical employees who work in regulated areas provision and use of respirators exposures in these sectors, the Agency for more than 30 days in a 12-month (triggered by work in regulated areas in has concluded that provisions for period would be eligible for medical the proposed standard) to all workers regulated areas (as opposed to the larger surveillance. Because employees whose exposures meet or exceed the beryllium work areas) are appropriate to exposed to beryllium at levels below the action level. As discussed elsewhere in include in the final standard for TWA PEL are at significant risk of this Summary and Explanation, OSHA’s shipyards. In construction, OSHA does material impairment of health as a result longstanding policy is to avoid issuing not find regulated area requirements to of their exposure (Section VII, standards that result in widespread use be appropriate but has decided instead Significance of Risk), OSHA is of respiratory protection due to issues of to require employers to meet the goals persuaded that the action level is a more health, safety, and effectiveness that can of the regulated areas provisions using appropriate trigger for the provision of occur with employees’ regular use of a competent person approach, which medical surveillance. Eligibility for respirators (see Summary and the Agency believes will be more medical surveillance at the action level Explanation for paragraph (f), Methods effective in construction work settings. is also consistent with previous OSHA of Compliance, and paragraph (g), OSHA’s review of the record and standards where significant risk remains Respiratory Protection). reasons for these decisions follow. at the TWA PEL, such as the recently For the reasons described above, In the NPRM, OSHA requested published respirable crystalline silica OSHA has decided to adopt more comment on whether the provisions of standard. In addition, because beryllium protective triggers for some of the the abrasive blasting substandard in the sensitization can occur from dermal provisions associated with regulated Ventilation standard for construction contact with beryllium regardless of areas in the proposed standard. OSHA (29 CFR 1926.57, paragraph (f)) and the whether airborne exposures are above or has expanded eligibility for medical standard for Mechanical paint removers below the TWA PEL or STEL, OSHA surveillance to employees who work for in shipyards (29 CFR 1915.34(c)) believes it is appropriate to apply PPE at least 30 days in a 12-month period in provide adequate protection to requirements much more broadly than operations where airborne beryllium employees exposed to beryllium from the proposed standard, which relied exposures meet or exceed the action abrasive blasting operations in these heavily on work in regulated areas as a level (previously, employees who work sectors. As discussed previously in the trigger for PPE. for at least 30 days in a 12-month period Summary and Explanation for However, OSHA does not believe that in a regulated area; see Summary and paragraph (a), Scope and application, all provisions associated with regulated Explanation for paragraph (k), Medical commenters argued persuasively that areas should apply at exposure levels Surveillance). OSHA has also expanded these abrasive blasting standards do not below the TWA PEL and STEL. PPE requirements to all employees adequately protect beryllium-exposed Employers are required to restrict access whose work involves dermal contact construction and shipyard employees, to regulated areas, thereby limiting the with beryllium (see Summary and and that OSHA should extend all number of employees potentially Explanation for paragraph (h), PPE). provisions of the general industry exposed to beryllium at levels above the These expanded PPE requirements in standard to these sectors (e.g., TWA PEL or STEL and limiting others’ recognition of the dermal risk posed by Document ID 1679; 1963). However, the risk of serious health effects associated beryllium also are responsive to a Abrasive Blasting Manufacturers with such exposure. OSHA finds that request from Public Citizen that Alliance (ABMA) stated that the lowering the exposure trigger for beryllium work areas and regulated proposed provisions for regulated areas regulated areas could lead to the areas be broadly defined in order to in general industry would be creation of large restricted areas, and ensure ‘‘appropriate protections against inconsistent with regulations for therefore large numbers of employees dermal exposure to beryllium, and abrasive blasting in shipyards, which do with access to restricted areas where dermal sensitization’’ (Document ID not always require such designated exposures may range anywhere between 1756, Tr. 176–77). areas (Document ID 1673, p. 22). A the action level and high above the final As discussed in the Summary and similar concern could apply to PEL. And, as discussed previously, Explanation of paragraph (a), Scope and requirements for regulated areas in establishing and demarcating regulated application, OSHA received comments construction. areas ensures that workers and other from a variety of stakeholders on In OSHA’s view, the provisions of the persons are aware of the potential Regulatory Alternative #2a presented in abrasive blasting standards in shipyards presence of airborne beryllium at levels the NPRM, which extends all provisions and in construction provide important above the TWA PEL or STEL and of the proposed standard to the baseline requirements appropriate to ensures that all persons entering construction and shipyard sectors. any situation where abrasive blasting is regulated areas are made aware of the Following careful consideration of these conducted in these sectors. However, dangers of exposure to beryllium at comments, OSHA determined that it is the abrasive blasting standards are not these levels. Moreover, in general appropriate to extend all provisions of intended to provide comprehensive industry, the requirement to demarcate the proposed standard to cover facilities requirements for all abrasive blasting beryllium work areas triggered by any in construction and shipyards, except operations, because some operations level of beryllium exposure resulting where some provisions of the general may involve hazards unique to the from a process or operation, provides industry standard may be inappropriate particular process or blast media in use.

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Operations that use beryllium- construction, as well as in some prior reasonably be expected to have airborne containing blast media present unique construction standards. There, in lieu of exposure above the TWA PEL or STEL. risks of beryllium sensitization and CBD establishing regulated areas, the Agency In addition, requirements for provision to exposed employees (see Section V, included a requirement for a designated and use of PPE are triggered based on Health Effects), and thus require competent person to implement the potential for dermal contact with protective measures beyond those of the procedures in the written exposure beryllium in all three standards (see the abrasive blasting standards. As control plan to restrict access to work Summary and Explanation for discussed above, regulated areas and areas, where necessary, to limit paragraph (h), Personal protective related provisions include requirements exposures to respirable crystalline silica clothing and equipment). Thus, PPE is that are key to protecting employees to achieve the primary objectives of a available to all employees whose work from the effects of beryllium exposure, regulated area. OSHA has concluded may involve dermal contact with such as restricted access, respiratory that a similar approach is appropriate in beryllium, irrespective of whether they protection, and warning signs. OSHA this rulemaking. The Agency finds that work in an industry where demarcated concludes that provisions similar to the this flexible approach balances the areas are required. requirements for regulated areas in the unique conditions of the construction Demarcation of regulated areas. final standard for general industry will industry with the need to protect Proposed paragraph (e)(2) included the provide shipyard employees necessary construction employees. requirements for the demarcation of protection complementing that found in In summary, OSHA has decided to beryllium work areas and regulated the shipyard mechanical paint remover include regulated area requirements in areas. Under proposed paragraph standard, and is not in conflict with the the final standards for general industry (e)(2)(i), employers were required to provisions or intent of that standard. and shipyards. The requirements to identify each beryllium work area OSHA has similarly concluded that establish and maintain a regulated area through signs or any other methods that the beryllium standard should apply to wherever employees are, or can adequately establish and inform each construction because it will better reasonably be expected to be, exposed to employee of the boundaries of each protect employees exposed to beryllium airborne beryllium at levels above the beryllium work area. OSHA explained while abrasive blasting than application TWA PEL or STEL, can be found in that the demarcation must effectively of the Ventilation standard alone. paragraph (e)(1)(ii) of the standard for alert workers and other persons that However, comments in the record and general industry and (e)(1) of the airborne beryllium may be present. OSHA’s experience regulating chemical standard for shipyards. Other Proposed paragraph (e)(2)(ii) required exposures in construction indicate that requirements related to regulated areas, employers to demarcate each regulated the establishment of regulated areas is e.g., the requirements to identify and area in accordance with the paragraph not the most effective way to ensure that limit access to regulated areas, are (m)(2) hazard communication construction employees receive the discussed in more detail below. In provisions of this standard. OSHA did protections associated with regulated addition, OSHA has decided not to not further specify requirements for areas in the general industry standard. include requirements for regulated areas demarcation, proposing instead to offer This decision is chiefly based on the in the final construction standard, but employers flexibility in determining the Agency’s recognition that conditions at has provided analogous protections for best means to demarcate beryllium work construction worksites present construction employees through the areas and regulated areas. The Agency challenges to establishing regulated competent person provisions in requested comment on each of these areas due to the varied and changing paragraph (e) of the final construction proposed provisions, including whether nature of construction work. Some of standard. The competent person the standard should specify what types these challenges were noted in the requirements are also discussed in of demarcation employers must use or preamble to the recent respirable detail below. take a more performance-oriented crystalline silica standard (81 FR 16285) In addition, NIOSH suggested that approach. See 80 FR 47786. and also apply here. For example, since demarcated areas may be difficult OSHA received several comments on construction tasks, and specifically to establish and maintain in some demarcation in general industry and abrasive blasting, are commonly construction or maritime settings, maritime settings. First, NIOSH performed outdoors. Exposure- OSHA could consider alternative ways advocated the need for more generating tasks could be short or long to provide the protections associated specification on how to demarcate in duration and are typically performed with such areas to employees in these regulated areas (Document ID 1671, at non-fixed workstations or worksites. sectors. For example, respiratory Attachment 1, p. 6). OSHA believes, Moreover, construction tasks may move protection could be triggered by however, that allowing employers to to different locations during the exposure to a threshold airborne level, choose how to best demarcate regulated workday. Such conditions could make it or dermal protections could be triggered areas (as well as beryllium work areas) difficult to establish and maintain based on performance of tasks involving is consistent with its preference for regulated areas as required by the dermal contact with beryllium performance-based approaches where, general industry and shipyard (Document ID 1755, Tr. 21–22). OSHA as here, the Agency has determined that standards. has adopted NIOSH’s suggestion to tie employers, based on their knowledge of At the same time, OSHA finds that certain protective measures to employee the specific conditions of their construction workers, like their inhalation exposures or dermal contact workplace, are in the best position to counterparts in general industry and rather than using the intermediary step make such determinations. For example, shipyards, need to be made aware of of establishing demarcated areas where if an employer knows that exposures in those locations in their workplace such areas are not required in the a particular work area might exceed the where airborne exposures are, or can construction or maritime sectors. For PEL on one particular day only, that reasonably be expected to be, above the example, as explained below in the employer might choose a temporary TWA PEL or STEL. Therefore, OSHA discussion of competent person method of demarcation. Conversely, an has decided to adopt the method that requirements, respiratory protection employer might choose to use a more was recently included in the recent requirements apply to employees in permanent method of demarcation for a respirable crystalline silica standard for construction who have or may beryllium work area that contains a

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potentially beryllium-releasing WEAR RESPIRATORY PROTECTION AND necessary to inform employees and operation that occurs daily. In some PROTECTIVE CLOTHING AND others of the specific health hazards workplaces employers might choose to EQUIPMENT IN THIS AREA associated with beryllium exposure. use barricades, in others textured Ameren, an electric power utility, Although employees should also be flooring, roped-off areas, ‘‘No entry’’/ objected to the proposal’s demarcation made aware of other hazardous ‘‘No access’’ signs, or painted boundary requirement. Specifically, Ameren chemicals they may be occupationally lines. OSHA generally approves of each stated that ‘‘[c]onfined space areas such exposed to, training and signage of these methods, provided that the as a boiler penthouse during abrasive regarding these other chemicals must particular method or methods the blasting activities would be hard to necessarily be addressed elsewhere, and employer selects are clear and demarcate since the entrance to the these concerns should not preclude understandable enough to alert workers regulated area is small and would block OSHA from requiring appropriate to the boundaries of the beryllium work access to the area for personnel and warning signs for beryllium exposure. area or regulated area. This may mean, equipment. It would also be difficult to OSHA notes that in comments from the for example, including more than one establish areas for activities such as U.S. House of Representatives language on a sign, if the inclusion of a cleaning fly ash off of plant piping or Committee on Education and the second language would make the sign structural steel.’’ Ameren suggested Workforce, the committee urged OSHA understandable to a particular alternate, training-based means of to implement ‘‘demarcation (through workforce with limited English reading informing employees of beryllium postings of warnings) if there is abrasive skills. exposures, such as job planning and job blasting with beryllium containing OSHA has identified several factors safety briefings (Document ID 1675, p. materials’’ by shipyard workers that it considers to be appropriate 11). OSHA disagrees that its (Document ID 1672, p. 4). considerations for employers when they performance-oriented approach does not After carefully reviewing the record, are determining how to demarcate accommodate these circumstances. As OSHA finds that the proposed approach beryllium work areas and regulated discussed above, demarcation for the demarcation of beryllium work areas. These factors include the requirements for beryllium work areas areas and regulated areas strikes a configuration of the beryllium work area and regulated areas allow employers reasonable balance between the or regulated area; whether the beryllium maximum flexibility in designing forms difficulties of establishing and work area or regulated area is of demarcation that best fit the nature of maintaining these areas with the need to permanent; the airborne concentrations their facilities and processes. Forms of alert those exposed of the risks of beryllium in the beryllium work area demarcation, such as tape, that do not involved, to reduce the number of or regulated area; the number of block access to areas and can be applied employees exposed to beryllium, and to employees working in areas adjacent to in areas where fly ash is cleaned are not protect those employees exposed to high any beryllium work area or regulated difficult to design or implement. levels of airborne beryllium. In area; and the period of time the Furthermore, training to inform particular, OSHA finds that the general beryllium work area or regulated area is employees of the location of beryllium performance-oriented approach in the expected to have hazardous exposures. exposures is a valuable complement to, proposed requirements, when coupled OSHA also notes that the use of a but should not replace, demarcation in with the specificity of the signage performance-oriented approached to the the final standards. The reinforcement requirements for regulated areas, demarcation of regulated areas is of training with demarcation is an provides employers with a good balance consistent with previous health important protection to ensure that of direction and flexibility. The final standards, such as respirable crystalline employees, who may work frequently in standards do not require employers to silica (29 CFR 1910.1053) and beryllium work areas and regulated establish and demarcate beryllium work chromium (VI) (29 CFR 1910.1026). areas, are continually aware of the areas or regulated areas by permanently Moreover, although proposed location of beryllium exposures in their segregating and isolating processes paragraph (e)(2)(ii) allowed employers workplace. See summary and generating airborne beryllium. Instead, to demarcate regulated areas in a variety Explanation for paragraph (m), the standards allow employers to use of ways, it also contained specific discussing employee training temporary or flexible methods to requirements for the posting and requirements. Also, requirements for demarcate beryllium work areas and wording of a warning sign in accordance demarcation ensure that persons other regulated areas. In sum, OSHA finds with proposed paragraph (m)(2). OSHA than employees, who may enter the that these flexible, performance-based included this requirement in the worksite but may not receive training, requirements will accommodate open proposal because it preliminarily found are adequately informed of the presence work spaces, changeable plant layouts, that employees must recognize when of beryllium. and sporadic or occasional beryllium they are entering a regulated area, and Commenters also opined on the use without imposing undue costs or understand the hazards associated with signage requirement in proposed burdens. Therefore, OSHA has decided the area, as well as the need for paragraph (e)(2)(ii). Specifically, the to include paragraphs (e)(2)(i) and respiratory protection. Signs are an ABMA argued that the beryllium (e)(2)(ii), as proposed, in the final effective means of accomplishing these specific signs required in the proposed standard for general industry and to objectives. Therefore, OSHA included a standard for general industry are not include regulated areas demarcation proposed requirement for employers to appropriate for use in shipyard abrasive requirements in paragraph (e)(2) of the post all entrances to regulated areas blasting, since this operation involves shipyard standard identical to those of with signs that bear the following potential exposure to a number of paragraph (e)(2)(ii) of the general legend: hazardous chemicals (Document ID industry standard. However, OSHA DANGER 1673, p. 22). OSHA disagrees and is notes that the required legend for the BERYLLIUM maintaining the sign requirement in the signage has been amended slightly to BERYLLIUM MAY CAUSE CANCER final standards (with slightly altered include the words ‘‘REGULATED CAUSES DAMAGE TO LUNGS language, noted below). Beryllium AREA,’’ as discussed in the Summary AUTHORIZED PERSONNEL ONLY specific signs are appropriate and and Explanation for paragraph (m),

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Communication of hazards, in this PEL or STEL, and thus reduces the risk protection and PPE ensure that those preamble. (OSHA is not including the of beryllium-related health effects for who must enter regulated areas are proposed demarcation provisions in the employees and others who do not need properly protected, thereby reducing the final standard for construction because, access to regulated areas. As explained risk of serious health effects associated as discussed above, the construction previously in the Summary and with airborne beryllium exposure and standard does not require the Explanation for paragraph (a), Scope dermal contact with beryllium. As establishment or maintenance of either and application, OSHA has decided to explained previously in the Summary beryllium work areas or regulated extend all provisions of the general and Explanation for paragraph (a), areas.) industry standard to construction and Scope and application, OSHA has Paragraph (e)(3) of the proposed shipyards except where the Agency decided to extend all provisions of the standard required employers to limit finds that they are not appropriate to general industry standard to access to regulated areas. Because of the construction and shipyard settings. construction and shipyards except serious health effects of exposure to OSHA did not receive comments on this where the Agency finds that they are not beryllium and the need for persons provision in the proposed standard, and appropriate to construction and entering the regulated area to be did not receive comments or evidence shipyard settings. OSHA did not receive properly protected, OSHA proposed that indicating that restricted access areas comments on this provision in the the number of persons allowed to access are not appropriate in construction and proposed standard for general industry, regulated areas should be limited to: (i) shipyards. However, as discussed and did not receive comments or Persons the employer authorizes or previously, OSHA has determined that evidence indicating that restricted requires to be in a regulated area to protections associated with regulated access areas are not appropriate in perform work duties; (ii) persons areas in general industry will be more construction and shipyards. However, entering a regulated area as designated effectively accomplished with a as discussed previously in this section, representatives of employees for the competent person provision in OSHA has determined that protections purposes of exercising the right to construction. associated with regulated areas in observe exposure monitoring OSHA has therefore decided to retain general industry will be more effectively procedures under paragraph (d)(6) of paragraph (e)(3) as proposed in the final accomplished with a competent person this standard; and (iii) persons standard for general industry, and to provision in construction. authorized by law to be in a regulated add an identical provision to the OSHA has therefore decided to retain area. shipyard standard and an analogous paragraph (e)(4) as proposed in the final The first group, persons the employer provision to the construction standard. standard for general industry, and to authorizes or requires to be in a Thus, final paragraph (e)(3) requires add an identical provision to the regulated area to perform work duties, employers in general industry and shipyard standard and an analogous may include workers and other persons shipyards to limit access to regulated provision to the construction standard. whose jobs involve operating areas to: (i) Persons the employer Thus, final paragraph (e)(4) of the machinery, equipment, and processes authorizes or requires to be in a general industry and shipyard standards located in regulated areas; performing regulated area to perform work duties; requires employers to provide and maintenance and repair operations on (ii) persons entering a regulated area as ensure that each employee entering a machinery, equipment, and processes in designated representatives of employees regulated area uses respiratory those areas; conducting inspections or for the purposes of exercising the right protection in accordance with paragraph quality control tasks; and supervising to observe exposure monitoring (g) and personal protective clothing and those who work in regulated areas. procedures under paragraph (d)(6) of equipment in accordance with The second group encompasses this standard; and (iii) persons paragraphs (h) of the final standard for persons entering a regulated area as authorized by law to be in a regulated general industry. Wherever employees designated representatives of employees area. And paragraph (e) of the are, or can reasonably be expected to be, for the purpose of exercising the right to construction standard requires the exposed to airborne beryllium at levels observe exposure monitoring under designation of a competent person, who, above the TWA PEL or STEL in paragraph (d)(7). As explained in the among other things, will implement the construction settings, paragraph (e) of summary and explanation section on written exposure control plan under the construction standard requires the paragraph (d) for exposure assessment, paragraph (f) of this standard. As employer to designate a competent providing employees and their discussed in more detail below, person to ensure that all employees use representatives with the opportunity to paragraph (f)(1)(i)(H) of the construction respiratory protection and PPE in observe monitoring is consistent with standard requires employers to establish accordance with paragraphs (g) and (h) the OSH Act and OSHA’s other and implement procedures to restrict of the standard. substance-specific health standards, access to work areas when airborne Competent Person (Construction). To such as those for respirable crystalline exposures are, or can reasonably be balance the unique conditions present silica (29 CFR 1910.1053), cadmium (29 expected to be, above the TWA PEL or in the construction industry with the CFR 1910.1027), and methylene STEL, to minimize the number of need to protect construction industry chloride (29 CFR 1910.1052). employees exposed to airborne employees from high airborne The third group consists of persons beryllium and their level of exposure, exposures, OSHA has chosen to adopt authorized by law to be in a regulated including exposures generated by other an approach in the construction area. This category includes persons employers or sole proprietors. standard for restricting access to high- authorized to enter regulated areas by Proposed paragraph (e)(4) required exposure areas similar to that used in the OSH Act, OSHA regulations, or any employers to provide and ensure that the recent respirable crystalline silica other applicable law. OSHA compliance each employee entering a regulated area standard for construction. This officers would fall into this group. uses personal protective clothing and approach requires the employer to As discussed in the NPRM, limiting equipment, including respirators, in designate a competent person or access to regulated areas restricts the accordance with paragraphs (g) and (h) persons, who will, among other things, number of persons potentially exposed of the proposed standard. As discussed implement the written exposure control to beryllium at levels above the TWA in the NPRM, provisions for respiratory plan, including procedures used to

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restrict access to work areas when Based on these comments and the competent person must have the airborne exposures are, or can reasons described above, OSHA has knowledge, ability, and authority reasonably be expected to be, above the decided to include competent person necessary to fulfill the responsibilities TWA PEL or STEL; ensure that all requirements in the final rule for set forth in paragraph (e) of the employees use respiratory protection in construction, instead of requiring construction standard. However, OSHA accordance with paragraph (g) of this regulated areas. In paragraph (b) of the has chosen not to specify particular standard; and ensure that all employees construction standard, OSHA defines training requirements for competent use personal protective clothing and competent person as an individual who persons. The Agency finds that it is not equipment in accordance with is capable of identifying existing and practical to specify in the rule the paragraph (h) of this standard. OSHA foreseeable beryllium hazards in the elements and level of training required finds this approach offers construction workplace and who has authorization to for a competent person. And the Agency employers a flexible means of providing take prompt corrective measures to does not find it appropriate to mandate protection to their employees. eliminate or minimize them. The a ‘‘one size fits all’’ set of training The competent person requirement is definition also specifies that the requirements to establish the a well-known and accepted concept in competent person must have the competency of competent persons in OSHA standards; competent person knowledge, ability, and authority every conceivable construction setting. provisions are included in at least 20 of necessary to fulfill the responsibilities Therefore, the training requirement for a OSHA’s construction standards, set forth in paragraph (e) of the competent person is performance- including OSHA substance-specific construction standard. oriented. This approach is consistent standards for construction, such as lead In order to craft an appropriate with most OSHA construction (29 CFR 1926.62), asbestos (29 CFR definition for this term, OSHA standards, such as cadmium (29 CFR 1926.1101), cadmium (29 CFR considered stakeholder comments, 1926.1127), lead (29 CFR 1926.62) and 1926.1127), and respirable crystalline including NABTU’s above comments on respirable crystalline silica (1926.1153), silica (29 CFR 1926.1153). In addition, the need for a competent person in the which include a performance-based OSHA’s general safety and health construction standard, and the approach by not specifying training or provisions for construction require the definition of competent person in the qualifications required for a competent employer to initiate and maintain safety and health regulations for person. programs for accident prevention, as construction (29 CFR 1926.32(f)). Under Like the regulated area provisions in may be necessary, and such programs 29 CFR 1926.32(f), competent person is general industry and shipyards, require frequent and regular inspections defined as a person capable of paragraph (e)(1) of the construction of job sites, materials, and equipment by identifying existing and predictable standard applies wherever employees hazards in the surroundings or working are, or can reasonably be expected to be, a designated competent person (29 CFR conditions that are unsanitary, exposed to airborne beryllium at levels 1926.20(b)(1) and (2)). hazardous, or dangerous to employees above the TWA PEL or STEL. As Competent person provisions are also and who is authorized to take prompt discussed in more detail above with commonly included in American corrective measures to eliminate them. regard to the establishment and National Standard Institute (ANSI) OSHA’s definition for competent person maintenance of regulated areas in standards for construction. NIOSH and in the construction standard is general industry and shipyards, OSHA its state partners also routinely consistent with the 1926.32(f) definition finds that this exposure level trigger is recommend the need for, and role of, with several minor changes. For appropriate for provisions such as this designated competent persons in example, the Agency tailored this one. investigation reports conducted under definition to beryllium by specifying Paragraph (e) of the standard for NIOSH’s Fatality Assessment and ‘‘beryllium hazards’’ instead of construction further specifies that Control Evaluation program. Thus, ‘‘unsanitary, hazardous, or dangerous’’ wherever employees are, or can OSHA finds that the use of a competent conditions. In addition, OSHA replaced reasonably be expected to be, exposed to person is consistent with current the word ‘‘one’’ with ‘‘individual,’’ airborne beryllium at levels above the industry practices in that many which is merely an editorial change. TWA PEL or STEL, the employer shall construction employers are already The Agency also removed the phrase designate a competent person to: (1) using a designated competent person. ‘‘in the surroundings or working Make frequent and regular inspections Moreover, although OSHA did not conditions’’ and changed it to ‘‘in the of job sites, materials, and equipment; include a competent person requirement workplace’’ to make it specific to the (2) implement the written exposure in the proposed rule, stakeholders workplace. And the Agency removed control plan under paragraph (f) of this indicated that such a requirement the phrase ‘‘to eliminate them’’ and standard; (3) ensure that all employees would be appropriate if the Agency changed it to ‘‘to eliminate or minimize use respiratory protection in accordance chose to include the construction them’’ to denote there may be cases with paragraph (g) of this standard; and industry within the scope of this where complete elimination would not (4) ensure that all employees use rulemaking. For example, North be feasible. Finally, OSHA changed personal protective clothing and America’s Building Trades Unions ‘‘predictable’’ to ‘‘foreseeable’’ to make equipment in accordance with (NABTU) testified that beryllium the wording consistent with the scope of paragraph (h) of this standard. OSHA construction work should be done this construction standard (paragraph finds that these responsibilities, under the supervision of a competent (a)). together, offer construction employees person (Document ID 1756, Tr. 231– OSHA also decided that it was similar protection to those afforded to 232). NABTU added that the most important to detail the necessary general industry and shipyard important point of having a competent characteristics and authority of a employees while offering construction person designated in the standard is to competent person in the standard to employers more flexibility to suit their ensure there is an agent of the employer ensure that he or she is truly competent workplaces. on site who has the appropriate to carry out the tasks designated under Under paragraph (e)(1) of the authority to correct hazards (Document paragraph (e). Thus, under paragraph (b) construction standard, the competent ID 1805, Attachment 1, p. 4). of the construction standard, the person must make frequent and regular

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inspections of job sites, materials, and OSHA is offering similar protection to standards are more likely to have health equipment. OSHA included this construction employees as given to and safety professionals on staff who requirement in order to ensure that the general industry and shipyard could assist with implementation of the competent person has the necessary employees through the regulated area standard. Finally, competent persons information to carry out the rest of his provisions in the general industry and have not been included in other OSHA or her duties. For example, the shipyard standards. substance-specific standards for general competent person’s second OSHA is cognizant that the written industry. For example, a competent responsibility (as discussed below) is to exposure control plan requirement person requirement was included in the implement the written exposure control regarding the exposures generated by construction standard for cadmium plan under paragraph (f) of this other employers or sole proprietors is because of environmental variability standard. Among other things, the important in construction because at and the presence of multiple employers written exposure control plan includes multi-employer worksites, the actions of on the job site, but a competent person procedures for minimizing cross- one employer may expose employees of requirement was not included in the contamination (paragraph (f)(1)(i)(D)). In other employers to hazards. A general industry standard for cadmium order to implement these procedures on competent person can help (29 CFR 1910.1027; 29 CFR 1926.1127; a construction worksite, the competent communicate hazards to other 57 FR 42101, 42382 (9/14/1992)). A person may need to know about the employers. OSHA expects that the competent person requirement was unique characteristics of the jobsite and employers or their competent persons included in the construction standard the materials and equipment used will work with general contractors at for respirable crystalline silica for therein. Similarly, in order to carry out construction sites to avoid high similar reasons (81 FR 16811). These his or her duty to implement the exposures of employees working factors explain and support OSHA’s procedures used to restrict access to alongside others by implementing conclusion that there is no regulatory work areas when airborne exposures administrative procedures such as need for including a competent person are, or can reasonably be expected to be, scheduling high-exposure tasks when requirement in the beryllium standards above the TWA PEL or STEL, and to others will not be in the area. However, for general industry and shipyards. minimize the number of employees if this does not occur, the competent (f) Methods of Compliance exposed to airborne beryllium and their person has authority to implement other level of exposure, including exposures administrative procedures that would be Paragraph (f) of the standards generated by other employers or sole effective for protecting employees in establishes methods for reducing proprietors, as required by paragraph situations where an employer was not employee exposure to beryllium (f)(1)(i)(I), the competent person will made aware that another employer or through the use of a written exposure equally need to be familiar with the sole proprietor would be conducting control plan and engineering and work jobsite, materials, and equipment in abrasive blasting operations on the practice controls. Paragraph (f)(1)(i) of order to know where high exposures worksite. Upon encountering such each of the standards requires might occur. situations on a worksite, the competent employers to establish, implement, and Under paragraph (e)(2) of the person is expected to remind employees maintain a written exposure control construction standard, OSHA is to stay away from the abrasive blasting plan and specifies the information that requiring that the competent person site and make sure that employees he or must be included in the plan. Paragraph implement the written exposure control she oversees are positioned at a safe (f)(1)(ii) establishes requirements for plan because the plan specifies what distance from the abrasive blasting employers to review their plan(s) at must be done to consistently identify activity least annually and update it under and control beryllium hazards on a job In addition to limiting access to high specified circumstances. Finally, site. See Summary and Explanation for exposure areas, the standard for paragraph (f)(1)(iii) requires employers paragraph (f), Written exposure control construction requires the competent to make a copy of the written exposure plan. In construction, a competent person to ensure that employees use control plan accessible to each person is needed to ensure that the respiratory protection and personal employee who is, or can reasonably be requirements of the written exposure protective clothing and equipment expected to be, exposed to airborne control plan are being met under while in high exposure areas (paragraph beryllium. variable conditions. The subjects that (e)(3)–(4)). This is an important Paragraph (f)(2) of the final standards must be included in the written requirement because without requires employers to implement exposure control plan for construction demarcated regulated areas, employees engineering and work practice controls are consistent with the duties of a would not have signs to remind them of to reduce beryllium exposures to competent person in past OSHA the need to use such protective employees. Where airborne exposure standards. Therefore, this requirement equipment. It is therefore the competent exceeds the TWA PEL or STEL, the should be familiar to construction person’s responsibility to provide the employer must implement engineering employers covered by this standard. necessary warnings. and work practice controls to reduce In addition, under paragraph OSHA is not requiring a competent airborne exposure to or below the (f)(1)(i)(I) the written exposure control person for the general industry and exceeded exposure limit(s). Wherever plan must contain procedures used to shipyard standards. OSHA has the employer demonstrates that it is not restrict access to work areas when determined that in most cases, general feasible to reduce airborne exposure to airborne exposures are, or can industry scenarios are not as variable as or below the PELs by engineering and reasonably be expected to be, above the those in construction. For example, work practice controls, the employer TWA PEL or STEL, to minimize the most work is performed indoors and must implement and maintain number of employees exposed to therefore, not subject to variables such engineering and work practice controls airborne beryllium and their level of as wind shifts and moving exposure to reduce airborne exposure to the exposure, including exposures sources that could significantly affect lowest levels feasible and supplement generated by other employers or sole exposures or complicate establishment these controls by using respiratory proprietors. By requiring the competent of regulated areas. Employers covered protection in accordance with paragraph person to implement these procedures, under the general industry and shipyard (g) of this standard. In addition,

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paragraph (f)(2) includes limited exposed workers’’ (Document ID 1690, for handling beryllium-contaminated requirements for implementation of p. 1). Written exposure control plan PPE and respirators; and descriptions of exposure controls where operations requirements were also included in the procedures for minimizing cross- release airborne beryllium exceeding the draft proposed rule submitted to the contamination and migration of action level. Finally, paragraph (f)(3) Agency by Materion Corporation beryllium) are important to preventing prohibits the employer from rotating (Materion) and United Steelworkers beryllium sensitization and CBD, and employees to different jobs to achieve (USW) (Document ID 0754, p. 6). are not overly burdensome. Moreover, compliance with the TWA PEL and OSHA agrees with the opinions many of the requirements in the plan STEL. expressed by these commenters. are intended to complement the Paragraph (f)(1)(i) of the proposed rule Requiring employers to articulate where housekeeping and hygiene requirements would have required employers to exposures occur and how those that all facilities in the scope of the establish, implement, and maintain a exposures will be controlled will help to standard must already meet, and do not written exposure control plan for ensure that they have a complete create significant burdens for employers beryllium work areas, containing an understanding of the controls needed to beyond documentation of their inventory of operations and job titles comply with the rule. Thus, OSHA procedures for meeting the requirements reasonably expected to have exposure at expects a written exposure control plan of other paragraphs in the standards, or above the action level; an inventory will be instrumental in ensuring that such as (h) Personal protective clothing of operations and job titles reasonably employers comprehensively and and equipment, (i) Hygiene areas and expected to have exposure above the consistently protect their employees. practices, and (j) Housekeeping. TWA PEL or STEL; procedures for Consequently, the Agency has decided Proposed paragraph (f)(1)(i)(A)–(H) set minimizing cross-contamination, to include written exposure control plan forth the required contents of the keeping surfaces in the beryllium work requirements in paragraph (f)(1) of the written exposure control plan. Under area as free as practicable of beryllium; final standards. the proposal, the employer’s written minimizing the migration of beryllium In the preamble to the proposal, exposure control plan was required to from beryllium work areas to other OSHA explained that adherence to the include: (1) An inventory of operations locations within or outside the written exposure control plan will help and job titles reasonably expected to workplace, and removal, laundering, reduce skin contact with beryllium, have exposure; (2) an inventory of storage, cleaning, repairing, and which can lead to beryllium operations and job titles reasonably disposal of beryllium-contaminated sensitization, and airborne exposure, expected to have exposure at or above personal protective clothing and which can lead to beryllium the action level; (3) an inventory of equipment, including respirators; and sensitization, CBD, and lung cancer (80 operations and job titles reasonably an inventory of engineering and work FR 47787). Because skin contact and expected to have exposure above the practice controls required by paragraph airborne exposure can occur in any TWA PEL or STEL; (4) procedures for (f)(2) of the proposed standard. workplace within the scope of the limiting beryllium contamination, Several commenters offered broad standard, OSHA preliminarily decided including but not limited to preventing support for the inclusion of paragraph to require a written exposure control the transfer of beryllium between (f)(1)’s provisions in the final rule (e.g., plan for all employers within the scope surfaces, equipment, clothing, materials, Document ID 1681, Attachment 1, p. 9; of the standard. and articles within the beryllium work 1689, p. 11; 1690, p. 1). For example, OSHA received comments regarding area; (5) procedures for keeping surfaces United Steelworkers (USW) stated: ‘‘[a] the proposed trigger for written in the beryllium work area as free as written plan will help to ensure that exposure control plan requirements. For practicable of beryllium; (6) procedures exposure controls and safety practices example, NGK Metals Corporation for minimizing the migration of are continually followed. This will also (NGK) argued that requiring employers beryllium from beryllium work areas to provide workers and other stakeholders to develop and maintain a written other locations within or outside the with information necessary in exposure control plan for facilities workplace; (7) an inventory of evaluating the health and safety where exposures are below the action engineering and work practice controls protections and provisions provided by level is burdensome, and recommended used by the employer to comply with the employer’’ (Document ID 1681, p. 9). that the written plan be required only paragraph (f)(2) of this standard; and (8) The American Federation of Labor and where exposures exceed the action level procedures for removal, laundering, Congress of Industrial Organizations (Document ID 1663, p. 2). EEI asserted storage, cleaning, repairing, and (AFL–CIO) also supported the inclusion that a requirement for a written disposal of beryllium-contaminated of written exposure control plan exposure control plan should apply to personal protective clothing and requirements (Document ID 1689, p. 11). areas where exposures meet or exceed equipment, including respirators. It argued that ‘‘[r]equiring employers to the action level or PEL, so as to be Stakeholders offered comments on the properly make use of a written plan is consistent with other health standards proposed written control plan contents. an essential tool for continuously (Document ID 1674, p. 13). For example, the Boeing Company controlling exposures and using proper OSHA has re-examined the provisions suggested that OSHA should revise the safety practices’’ (Document ID 1689, p. of (f)(1) in light of these comments and proposed provision requiring 11). The National Council for reaffirms its preliminary decision to ‘‘procedures for keeping surfaces in the Occupational Safety and Health require all employers within the scope beryllium work area as free as (National COSH) agreed, stating that ‘‘[a] of the standard to establish, implement, practicable of beryllium’’ to define comprehensive program to protect and maintain a written exposure control specific surface contaminant levels workers from these exposures, that plan. The Agency finds that the (Document ID 1667, p. 4). The apparent includes a requirement for a written requirements that apply where advantage of providing a target surface beryllium control plan, regular exposure exposures are below the action level contaminant level is that employers monitoring, medical surveillance, (e.g., a list of operations and job titles could use surface sampling to determine medical removal protection benefits, reasonably expected to involve airborne whether they are in compliance with the and training would provide much exposure or dermal contact with standard’s requirements for surface needed protection for beryllium beryllium; descriptions of procedures cleaning. However, as OSHA explained

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in the Summary and Explanation for paragraph (f)(1)(i)(A) of the final recognition of the importance of paragraph (j), Housekeeping, the standards. Thus, the final standard for personal protective clothing and relationship between a precise amount general industry requires the employer equipment in protecting exposed of surface contamination and health risk to include a list of operations and job employees, particularly those is unknown. Therefore, OSHA cannot titles reasonably expected to involve employees who may have dermal find that a particular level of airborne exposure to beryllium or contact with beryllium. With the contamination is safe. Rather, OSHA has dermal contact with beryllium in their addition of this new provision, determined that keeping surfaces as written exposure control plan(s). proposed paragraph (f)(1)(i)(H) clean as practicable is appropriate Second, OSHA modified the language (regarding procedures for removal, because promptly removing beryllium of proposed paragraphs (f)(1)(i)(A), (B), laundering, storage, cleaning, repairing, deposits prevents them from becoming (C), and (G) by replacing the term and disposal of beryllium-contaminated airborne, thus reducing employees’ ‘‘inventory’’ with the term ‘‘list’’. This personal protective clothing and inhalation exposure, and helps to change in wording does not imply a equipment, including respirators) has minimize the likelihood of skin contact change in the intent of the provision. been redesignated as paragraph with beryllium. Moreover, the term Rather, OSHA made this change to (f)(1)(i)(I) of the final rule for general ‘‘free as practicable’’ is accepted clarify the Agency’s intent to require industry. language and has been used in previous employers to simply identify jobs, OSHA has incorporated most standards, such as standards addressing operations and controls that match the provisions of the proposed paragraph exposure to lead and chromium (VI). criteria of these provisions, and that (f)(1)(i) into the final standards for employers are not required to provide Consequently, OSHA has decided to construction and shipyards, with certain more extensive description of such jobs retain the ‘‘free as practicable’’ language modifications due to the work processes and operations. Third, OSHA modified in the final rule for general industry. (As and worksites particular to these (f)(1)(i)(D) by deleting ‘‘but not limited discussed in more detail below, the final sectors. As explained in the Summary to’’ from the phrase ‘‘including but not standards for construction and and Explanation for paragraph (j), limited to preventing the transfer of shipyards do not include this Housekeeping, OSHA has determined beryllium’’, because the term requirement.) that abrasive blasting operations are the After careful consideration of the ‘‘including’’ implies that the examples primary source of beryllium exposure in record, OSHA reaffirms the need for the to follow are not intended to be the construction and shipyard sectors written exposure control plan to contain exhaustive. This change in wording each of the provisions included in the does not imply a change in the intent of and has chosen not to include proposal. This written record of which the provision. provisions related to surface cleaning in operations and job titles are likely to Fourth, OSHA has edited the the final standards for these sectors due have exposures at certain levels and proposed text, which required an to the extreme difficulty of maintaining which housekeeping provisions and ‘‘inventory’’ of operations and job titles clean surfaces during blasting engineering and work practice controls reasonably expected to ‘‘have’’ operations. OSHA has therefore decided the company has selected to control exposure; exposure at or above the to exclude the provision regarding exposures required in paragraph (f) will action level; and exposure above the procedures for keeping surfaces as free make it easier for employers to TWA PEL or STEL. The final text as practicable of beryllium (proposed implement monitoring, hygiene requires a ‘‘list’’ of operations and job paragraph (f)(1)(i)(E)) from the practices, housekeeping, engineering titles reasonably expected to ‘‘involve’’ construction and shipyard standards. and work practice controls, and other airborne exposure to or dermal contact And due to the difficulty of controlling measures. The provisions contained in with beryllium; airborne exposure at or contamination during blasting (f)(1)(i)(D), (E), (F), and (H) of the above the action level; and airborne operations, OSHA has decided to proposed rule will work to minimize the exposure above the TWA PEL or STEL. include a more performance-oriented spread of beryllium throughout and This is an editorial change to provide provision on cross-contamination in the outside the workplace and to reduce the greater clarity to better describe the standards for construction and likelihood of skin contact and re- actual requirement, and does not change shipyards than in paragraph (f)(1)(i)(D) entrainment of beryllium particulate. the intent of the provision. Fifth, OSHA of the general industry standard. Therefore, OSHA has decided to modified the proposed requirement to Employers are still required to establish retain the proposed contents of the inventory engineering and work practice and implement procedures for written exposure control plan in the controls required by paragraph (f)(2) of minimizing cross-contamination of standard for general industry, with the this standard to include respiratory beryllium in construction and shipyard following revisions. First, OSHA has protection. This change ensures that the industries. However, the written modified the proposed requirement to respiratory protection requirement, exposure control plan provision on include an inventory of operations and which is included in (f)(2)(iv) of the cross-contamination simply requires job titles reasonably expected to have final standards, is treated in the same ‘‘procedures for minimizing cross- exposure, including by dermal contact. manner as the engineering and work contamination’’; it does not specify As discussed in detail in the Summary practices control requirements in ‘‘procedures for minimizing cross- and Explanation for paragraph (h), (f)(2)(i) and (f)(2)(iii). contamination, including preventing the Personal protective clothing and Finally, OSHA has included one transfer of beryllium between surfaces, equipment (PPE), OSHA finds that it is additional provision in the final rule for equipment, clothing, materials, and important to protect employees from general industry that was not contained articles within beryllium work areas’’ as dermal contact with beryllium. OSHA in the proposal. Specifically, paragraph in general industry. OSHA has included therefore finds that the written exposure (f)(1)(i)(H) of the final rule requires the proposed provision for minimizing control plan should inform employees employers to include within their the migration of beryllium in the and others of jobs and operations where written exposure control plan a list of standards for construction and dermal contact with beryllium is personal protective clothing and shipyards, but has removed the reasonably expected, and has added equipment required by paragraph (h) of reference to beryllium work areas since dermal contact with beryllium to this standard. This provision is added in these are not established in construction

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and shipyards. The written exposure unnecessarily. To this end, the final include any area where employees are, control plan provision on migration in standard for construction includes or can reasonably be expected to be, these sectors requires the plan to paragraph (f)(1)(i)(I), which requires exposed to airborne beryllium, include ‘‘procedures for minimizing the employers to establish, implement and regardless of the level of exposure. As migration of beryllium within or to maintain procedures used to restrict discussed previously in the Summary locations outside the workplace.’’ access to work areas when airborne and Explanation for paragraph (e), the Because the requirements pertaining exposures are, or can reasonably be final standard for general industry to surfaces contained in final paragraph expected to be, above the TWA PEL or defines a beryllium work area to include (f)(1)(i)(E) of the general industry STEL, in order to minimize the number only those areas containing a process or standard do not appear in the of employees exposed to airborne operation that releases beryllium where construction and shipyard standards, beryllium and their level of exposure, employees are, or can reasonably be the numbering of the provisions differs including exposures generated by other expected to be, exposed to airborne from that of the general industry employers or sole proprietors. beryllium at any level or where there is standard. For the construction and Significantly, the construction standard the potential for dermal contact with shipyard standards, requirements additionally includes paragraph (e), beryllium. Accordingly, OSHA made pertaining to the migration of beryllium Competent Person, which requires these changes to the wording of (f)(1)(i) appear in paragraphs (f)(1)(i)(E); employers to designate a competent and (f)(1)(i)(E) to maintain the intent of requirements for a list of engineering person to implement the written proposed paragraph (f)(1)(i)(A), to controls, work practices, and respiratory exposure control plan. The competent require employers to list all jobs and protection are in paragraphs (f)(1)(i)(F); person is therefore responsible for operations throughout their facilities requirements for a list of personal ensuring that the procedures to restrict involving beryllium exposure, and protective clothing and equipment are access are followed in the workplace. paragraph (f)(1)(i)(E) to control dermal in paragraphs (f)(1)(i)(G); and National Jewish Health (NJH) contact with beryllium wherever requirements pertaining to removal, submitted a comment to OSHA airborne beryllium may settle on laundering, storage, cleaning, repairing, regarding the importance of training, surfaces in their facilities. If employers’ and disposal of beryllium-contaminated labeling, housekeeping measures, procedures to prevent migration of personal protective clothing and restricted entry to beryllium- beryllium from work areas to other areas equipment, including respirators, contaminated areas, and technologies of the facility are fully effective appear in paragraph (f)(1)(i)(H). such as sticky mats and boot scrubbers (paragraph (f)(1)(i)(F)), further steps to Additional discussion of some of these in controlling employees’ exposure to keep surfaces as free as practicable of requirements may be found in this beryllium. NJH requested that OSHA beryllium will not be necessary. section of the preamble, Summary and emphasize the importance of such However, if the employer is unable to Explanation, at paragraph (h), Personal measures in paragraph (f) of these consistently prevent transfer of Protective Clothing and Equipment; standards (Document ID 1664, p. 6). beryllium from work areas to other areas paragraph (i), Hygiene Areas and OSHA agrees with NJH that all of these of the facility, the employer must Practices; and paragraph (j), approaches are helpful, and in some develop and implement additional Housekeeping. cases essential, to reducing employees’ procedures to keep surfaces outside of OSHA has also included paragraph exposure. Training and some forms of the beryllium work areas as free as (f)(1)(i)(I) in the construction standard labeling and access restriction are practicable of beryllium. only, requiring employers in the specifically required in other paragraphs construction sector to establish, of the standards. Specific tools such as Paragraph (f)(1)(ii) of the proposed implement and maintain procedures to sticky mats and boot scrubbers are not rule would have required the employer restrict access where airborne exposures required in the standards, but are to update the exposure control plan are, or can reasonably be expected to be, approaches employers should consider when: (A) Any change in production above the TWA PEL or STEL. This as part of their control procedures. All processes, materials, equipment, addition is related to OSHA’s decision, of the methods mentioned by NJH are personnel, work practices, or control explained in the Summary and ways to limit migration of beryllium and methods results or can reasonably be Explanation of paragraph (e), not to cross-contamination, and are therefore expected to result in new or additional include a requirement to establish appropriate for inclusion in an exposures to beryllium; (B) an employee regulated areas in the construction employer’s written exposure control is confirmed positive, is diagnosed with standard, and to achieve the protective plan(s). CBD, or shows signs or symptoms benefits associated with regulated areas The final standards’ paragraph (f)(1)(i) associated with exposure; or (C) the by other means. In the general industry differs from the proposal in that it employer has any reason to believe that and shipyard standards, the employer requires a written exposure control plan new or additional exposures are must limit access to regulated areas to for each facility, whereas the proposal occurring or will occur. OSHA did not persons who are authorized or required would have required a written exposure receive any comments on this provision. to be in a regulated area to perform work control plan for beryllium work areas However, as noted in the proposal, duties, observation, or other limited within each facility. In addition, OSHA employers such as Materion and Axsys circumstances. OSHA has determined has removed the phrase ‘‘in the Technologies, who have worked to that restricting access to areas where beryllium work area’’ from provision identify and document the exposure airborne exposures exceed or may (f)(1)(i)(E) of the final standard for sources associated with cases of reasonably be expected to exceed the general industry, so that it now reads: sensitization and CBD in their facilities, TWA PEL or STEL is appropriate to ‘‘Procedures for keeping surfaces as free have used this information to develop reduce employees’ and others’ risk of as practicable of beryllium’’. OSHA and update beryllium exposure control adverse health effects associated with made these changes because it changed plans (Document ID 0634; 0473; 0599). airborne beryllium exposure. OSHA has the definition of a ‘‘beryllium work OSHA found that this process, whereby therefore established alternative area’’ in the proposed standard for an employer uses employee health methods to ensure that construction general industry. The proposed standard outcome data to check and improve the employees do not enter such areas defined a beryllium work area to effectiveness of the employer’s exposure

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control plan, is consistent with other written medical report indicating a Proposed paragraph (f)(2) established performance-oriented aspects of these confirmed positive finding or CBD a hierarchy of controls that employers standards. Thus, after considering the diagnosis, or the employer receives a must use to reduce beryllium exposures. record on this issue, OSHA has decided written medical opinion recommending This paragraph required employers to to retain proposed paragraph (f)(1)(ii) in removal from exposure to beryllium); rely on engineering and work practice the final rule, with the modifications when the employer is notified that an controls as the primary means to reduce discussed below, to ensure that the employee is referred for evaluation at a exposures. As a general matter, where employer’s plan reflects the current CBD Diagnostic Center, or when an airborne exposure exceeded the TWA conditions in the workplace. employee shows signs and symptoms PEL or STEL, proposed paragraph (f)(2) The first modification is that OSHA associated with exposure. Third, OSHA required employers to implement added a requirement to review and further modified (f)(1)(ii)(B) to clarify engineering and work practice controls evaluate the effectiveness of each the Agency’s understanding that signs to reduce airborne exposure to or below written exposure control plan at least and symptoms may be related to the PELs. Wherever the employer annually. OSHA finds that an annual inhalation or dermal exposure, as demonstrated that it is not feasible to review is appropriate because discussed in Section V, Health Effects. reduce airborne exposure to or below workplace conditions can change. In Final paragraph (f)(1)(ii)(B) therefore the PELs through the use of engineering addition, by requiring employers to refers to signs and symptoms of and work practice controls, the check the effectiveness of their plans ‘‘airborne exposure to or dermal contact employer would have been required to annually, the standards offer employers with beryllium’’. Fourth, OSHA implement and maintain engineering the opportunity to better protect their modified the wording of (f)(1)(ii) to and work practice controls to reduce employees by reflecting on any lessons require the employer to update ‘‘each’’ airborne exposure to the lowest levels learned throughout the previous year. written exposure control plan rather feasible and supplement these controls The final annual review requirement is than ‘‘the’’ written exposure control by using respiratory protection in consistent with previous OSHA plan, since an employer who operates accordance with paragraph (g) of this standards, such as the standards multiple facilities is required to standard. In addition, proposed addressing bloodborne pathogens (29 establish, implement and maintain a paragraph (f)(2) included limited CFR 1910.1030) and respirable written exposure control plan for each requirements for implementation of crystalline silica (29 CFR 1910.1053). facility. exposure controls for each operation in Second, OSHA changed the proposed Paragraph (f)(1)(ii) of the final a beryllium work area. language of (f)(1)(ii)(B), which would standards thus requires the employer to OSHA’s long-standing hierarchy of have required employers to update their review and evaluate the effectiveness of controls policy was supported by a written exposure control plans when an each written exposure control plan at number of commenters, including USW; employee is confirmed positive for least annually and update it when: (A) the Sampling and Analysis beryllium sensitization, is diagnosed Any change in production processes, Subcommittee Task Group of the with CBD, or shows signs or symptoms materials, equipment, personnel, work Beryllium Health and Safety Committee associated with exposure. This change practices, or control methods results or (BHSC Task Group); AWE; AFL–CIO; is related to another change from the can reasonably be expected to result in 3M; and National Jewish Health (e.g., proposed standard, which would have new or additional airborne exposure to Document ID 1963, p. 12; 1655, pp. 8, required notification of employers beryllium; (B) the employer is notified 16; 1618, p. 8 (pdf); 1689, p. 11; 1625, whenever an employee is confirmed that an employee is eligible for medical p. 6 (pdf); 1664, p. 6). For example, the positive for beryllium sensitization. As removal in accordance with paragraph BHSC Task Group stated that OSHA’s explained in the Summary and (l)(1) of this standard, referred for mandate ‘‘to assure safe and healthy Explanation for paragraph (k), Medical evaluation at a CBD Diagnostic Center, workplaces requires it to reinforce Surveillance, OSHA has modified this or shows signs or symptoms associated fundamental industrial hygiene tenets. provision so that employers are not with airborne exposure to or dermal Prime among these is application of a automatically notified of cases of contact with beryllium; or (C) the hierarchy of controls’’ (Document ID sensitization or CBD among their employer has any reason to believe that 1655, p. 16). Similarly, 3M indicated employees. However, employers will new or additional airborne exposure is that it ‘‘agree[d] with OSHA that the receive a written medical opinion from occurring or will occur. hierarchy of controls—effective the licensed physician that may include Paragraph (f)(1)(iii) of the proposed engineering and work practice a referral for an evaluation at a CBD rule would have required the employer controls—should be the primary means Diagnostic Center (see (k)(6)(iii)) or a to make a copy of the exposure control to help reduce employee exposures to recommendation for medical removal plan accessible to each employee who is beryllium and its compounds’’ from exposure to beryllium (see or can reasonably be expected to be (Document ID 1625, p. 6 (pdf)). 3M (k)(6)(v)). An employee may also exposed to airborne beryllium in added that ‘‘when engineering controls provide the employer with a written accordance with OSHA’s Access to and work practices cannot reduce medical report indicating a confirmed Employee Exposure and Medical employee exposure to beryllium to positive finding or CBD diagnosis. Final Records (Records Access) standard (29 below the PEL, then the employer must paragraph (f)(1)(ii)(B) has been revised CFR 1910.1020(e)). As discussed above protect employees’ respiratory health from the proposal to reflect the and in the NPRM, access to the through the use of respirators’’ circumstances under the final standards exposure control plan will enable (Document ID 1625, p. 6 (pdf)). NJH where an employer will be notified that employees to partner with their added that an employee has, or may have, a employers in keeping the workplace beryllium-related health effect. This safe. OSHA did not receive comments . . . engineering and/or work practice includes when the employer is notified specific to this provision, and has controls are critical in reducing beryllium exposure and we have consulted with clients that an employee is eligible for medical decided to retain it in the final standard on this issue. In identifying controls, using removal in accordance with paragraph for general industry and include it in the hierarchy of industrial controls to start (l)(1) of the standard (i.e., when the the final standards for construction and with elimination or substitution . . . employee provides the employer with a shipyards. followed by engineering controls and process

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controls such as enclosures, local exhaust contaminant by supplying or exhausting respirator provides to some or all of the ventilation, and wet methods . . . is crucial air. The primary type of ventilation employees. For example, certain types (Document ID 1664, p. 6). system used to control beryllium of respirators require the user to be After a careful review of the record, exposure is local exhaust ventilation clean shaven to achieve an effective seal OSHA concludes that requiring primary (LEV). LEV is used to remove an air where the respirator contacts the reliance on engineering and work contaminant by capturing it at or near employee’s skin. Failure to ensure a practice controls is necessary and the source of emission, before the tight seal due to the presence of facial appropriate because reliance on these contaminant spreads throughout the hair compromises the effectiveness of methods is consistent with good workplace. If designed properly, LEV the respirator. industrial hygiene practice, with the systems efficiently remove Respirator effectiveness ultimately Agency’s experience in ensuring that contaminants and provide for cleaner relies on employers educating workers have a healthy workplace, and and safer work environments. employees on the necessary good work with OSHA’s traditional adherence to a Work practice controls involve practices and ensuring that employees hierarchy of controls. The Agency finds adjustments in the way a task is adopt those practices. In contrast, the that engineering controls are reliable, performed. In many cases, work practice effectiveness of engineering controls provide consistent levels of protection controls complement engineering does not rely so heavily on actions of to a large number of workers, can be controls in providing worker protection. individual employees. Engineering and monitored continually and For example, periodic inspection and work practice controls are capable of inexpensively, allow for predictable maintenance of process equipment and reducing or eliminating a hazard from a performance levels, and can efficiently control equipment such as ventilation worksite, while respirators protect only remove toxic substances from the systems is an important work practice the employees who are wearing them workplace. Once removed, the toxic control. Frequently, equipment which is correctly. Furthermore, engineering and substances no longer pose a threat to in disrepair or near failure will not work practice controls permit the employees. The effectiveness of perform normally. Regular inspections employer to evaluate their effectiveness engineering controls does not generally can detect abnormal conditions so that directly through air monitoring and depend to any substantial degree on timely maintenance can then be other means. It is considerably more human behavior, and the operation of performed. If equipment is routinely difficult to directly measure the control equipment is not as vulnerable inspected, maintained, and repaired or effectiveness of respirators on a regular to human error as is personal protective replaced before failure is likely, there is basis to ensure that employees are not equipment. less chance that hazardous exposures unknowingly being overexposed. OSHA OSHA has identified several key will occur. therefore continues to consider the use methods of reducing exposures: (1) Workers must know the proper way to of respirators to be the least satisfactory Substitution; (2) isolation (e.g., perform their job tasks in order to approach to exposure control. enclosures); (3) ventilation; and (4) minimize their exposure to beryllium In addition, use of respirators in the process controls (e.g. wet methods, and to maximize the effectiveness of workplace presents other safety and automation). Substitution refers to the control measures. For example, if an health concerns. Respirators can impose replacement of a toxic material with exhaust hood is designed to provide substantial physiological burdens on another material that reduces or local ventilation and a worker performs employees, including the burden eliminates the harmful exposure. When a task that generates a contaminant imposed by the weight of the respirator; available, substitution can replace a away from the exhaust hood, the control increased breathing resistance during toxic material in the work environment measure will be of no use. Workers can operation; limitations on auditory, with a non-toxic material, thus be informed of proper operating visual, and olfactory sensations; and eliminating the risk of adverse health procedures through information and isolation from the workplace effects. training. Good supervision further environment. Job and workplace factors Isolation, i.e., separating workers from ensures that proper work practices are such as the level of physical work effort, the source of the hazard, is another carried out by workers. By persuading a the use of protective clothing, and effective engineering control employed worker to follow proper procedures, temperature extremes or high humidity to reduce exposures to beryllium. such as positioning the exhaust hood in can also impose physiological burdens Isolation can be accomplished by either the correct location to capture the on employees wearing respirators. containing the hazard or isolating contaminant, a supervisor can do much These stressors may interact with workers from the source of the hazard. to minimize unnecessary exposure. respirator use to increase the For example, to contain the hazard, an Employees’ exposures can also be physiological strain experienced by employer might install a physical controlled by scheduling operations employees. barrier around the source of exposure to with the highest exposures at a time Certain medical conditions can contain a toxic substance within the when the fewest employees are present. compromise an employee’s ability to barrier. Isolating the source of a hazard Under the hierarchy of controls, tolerate the physiological burdens within an enclosure restricts respirable respirators can be another means of imposed by respirator use, thereby dust from spreading throughout a providing employees effective placing the employee wearing the workplace and exposing employees who protection from exposure to air respirator at an increased risk of illness, are not directly involved in exposure- contaminants. However, to be effective, injury, and even death. These medical generating operations. Or, alternatively, respirators must be individually conditions include cardiovascular and an employer might isolate employees selected, fitted and periodically refitted, respiratory diseases (e.g., a history of from the hazard source by placing them conscientiously and properly worn, high blood pressure, angina, heart in a properly ventilated space or at some regularly maintained, and replaced as attack, cardiac arrhythmias, stroke, distance from the source of the necessary. In many workplaces, these asthma, chronic bronchitis, beryllium exposure. conditions for effective respirator use emphysema), and reduced pulmonary Ventilation is another engineering are difficult to achieve. The absence of function caused by other factors (e.g., control method used to minimize any one of these conditions can reduce smoking or prior exposure to respiratory airborne concentrations of a or eliminate the protection the hazards), neurological or

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musculoskeletal disorders (e.g., workplace, while respirators protect inclusion of a requirement for controls epilepsy, lower back pain), and only the employees who are wearing where exposures do not exceed the impaired sensory function (e.g., a them and depend on the selection and TWA PEL or STEL. For example, NGK perforated ear drum, reduced olfactory maintenance of the respirator and the argued that ‘‘this provision essentially function). Psychological conditions, actions of employees, OSHA holds to halves the PEL by requiring engineering such as claustrophobia, can also impair the view that engineering and work controls above the action level’’ the effective use of respirators by practice controls offer more reliable and (Document ID 1663, p. 2). NGK asserted employees and may also cause, consistent protection to a greater that engineering controls should only be independent of physiological burdens, number of employees, and are therefore required where exposures exceed the significant elevations in heart rate, preferable to respiratory protection. TWA PEL or STEL, concluding that the blood pressure, and respiratory rate that Thus, the Agency continues to conclude ‘‘mandatory use of certain engineering can jeopardize the health of employees that engineering and work practice controls’’ should be removed (Document who are at high risk for controls provide a more protective first ID 1663, p. 4). Similarly, Ameren cardiopulmonary disease (see 63 FR line of defense than respirators and disagreed with the proposed 1152, 1208–1209 (1/8/98)). must be used first when feasible. requirement to use at least one In addition, safety problems created The provisions related to engineering engineering control in areas where, it by respirators that limit vision and and work practice controls begin in stated, there may be only minimal communication must always be paragraph (f)(2)(i). Paragraph (f)(2)(i)(A) exposures and thus no benefit to be considered. In some difficult or of the proposed rule stated that, for each gained from installing additional dangerous jobs, effective vision or operation in a beryllium work area (i.e., controls (Document ID 1675, p. 5). communication is vital. Voice any work area involving airborne The second set of commenters argued transmission through a respirator can be beryllium exposure), the employer shall that the engineering and work practice difficult, annoying, and fatiguing. In ensure that at least one of the following controls requirement in proposed addition, movement of the jaw in engineering and work practice controls paragraph (f)(2)(i) was too narrow. speaking can cause leakage, thereby is in place to minimize employee These commenters objected to the reducing the efficiency of the respirator exposure: (1) Material and/or process exemption in proposed paragraph and decreasing the protection afforded substitution; (2) ventilated partial or full (f)(2)(i)(B)(2), which exempted the employee. Skin irritation can result enclosures; (3) local exhaust ventilation employers from using one of the from wearing a respirator in hot, humid at the points of operation, material controls listed in (f)(2)(i) to the extent conditions. Such irritation can cause handling, and transfer; or (4) process that the employer could demonstrate considerable distress to employees and control, such as wet methods and that exposures are below the action can cause employees to refrain from automation. Under proposed paragraph level, using no fewer than two wearing the respirator, thereby (f)(2)(i)(B), an employer would be representative personal breathing zone rendering it ineffective. exempt from using the above controls to samples taken 7 days apart, for each These potential burdens placed on the extent that: (1) The employer can affected operation. USW commented employees by the use of respirators were establish that such controls are not that the only legitimate reasons not to acknowledged in OSHA’s revision of its feasible; or (2) the employer can require engineering controls below the respiratory protection standard, and are demonstrate that exposures are below action level are if such a requirement is the basis for the requirement (29 CFR the action level, using no fewer than technologically or economically 1910.134(e)) that employers provide a two representative personal breathing infeasible (Document ID 1681, p. 10). medical evaluation to determine the zone samples taken 7 days apart, for The AFL–CIO and National COSH employee’s ability to wear a respirator each affected operation. similarly recommended that the final before the employee is fit tested or Because OSHA recognized that these standard require engineering and work required to use a respirator in the proposed provisions are not typical for practice controls wherever airborne workplace (see 63 FR at 1152). Although OSHA standards, which usually require beryllium is present (Document ID 1689, experience in industry shows that most engineering controls only where p. 11; 1690, p. 3). The AFL–CIO based healthy employees do not have exposures exceed the PEL(s), the their recommendation on the capacity of physiological problems wearing Agency asked for comments on the beryllium at very low concentrations to properly chosen and fitted respirators, potential benefits of including such cause beryllium sensitization and its nonetheless common health problems provisions in the beryllium standard, carcinogenicity (Document ID 1689, p. can cause difficulty in breathing while the potential costs and burdens 12). an employee is wearing a respirator. associated with them, and whether OSHA has carefully reviewed the For these reasons, all OSHA OSHA should include these provisions opinions and arguments of these substance-specific health standards in the final standard (80 FR 47789). In commenters, and has concluded that the have recognized and required employers addition, the Agency examined and requirement to implement at least one to observe the hierarchy of controls, asked for comment on Regulatory form of exposure control on beryllium- favoring engineering and work practice Alternative #6, which would exclude releasing processes will serve to reduce controls over respirators. And the the provisions of proposed paragraph the significant risk of both CBD and Agency’s adherence to the hierarchy of (f)(2)(i) from the final standard. lung cancer remaining at the TWA PEL controls has been successfully upheld Comments on these provisions (see Section VII, Significance of Risk), by the courts (see Section II, Pertinent focused mainly on the trigger for and will also reduce the likelihood of Legal Authority for further discussion of proposed paragraph (f)(2)(i) or the exposures exceeding the PEL in the these cases). action level exemption in proposed absence of any engineering or work Therefore, OSHA has decided to paragraph (f)(2)(i)(B)(2) and fell into one practice control. OSHA therefore require the use of the long-established of two categories. The first group of disagrees with Ameren’s argument that hierarchy of controls in this standard. stakeholders argued that the engineering the requirements of (f)(2)(i) will not Because engineering and work practice and work practice controls requirement benefit workers, and with NGK’s controls are capable of reducing or in proposed paragraph (f)(2)(i) was too position that engineering controls eliminating a hazard from the broad. Specifically, they objected to the should not be required below the TWA

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PEL and STEL. OSHA also disagrees beryllium-related adverse health effects the types of control measures that are with NGK’s characterization of the list associated with airborne exposures at acceptable for complying with the of controls provided in (f)(2)(i) as a the TWA PEL and the action level (see provision. The Southern Company ‘‘mandatory use of certain engineering Section VII, Significance of Risk). In suggested that isolation/containment controls’’ (Document ID 1663, p. 4). addition, OSHA finds that the should be considered for inclusion in Rather, the list includes a broad range exemption in proposed paragraph the listed controls in proposed of possible approaches to eliminate, (f)(2)(i)(B)(2) will reduce the cost burden paragraph (f)(2)(i)(A) (Document ID capture or control beryllium emissions on employers with operations where 1668, p. 5). OSHA agrees that isolation at the source so as to reduce employees’ measured exposures are below the is an appropriate method of exposure exposure to airborne beryllium, and action level, and therefore less likely to control, and proposed paragraph provides employers great flexibility in exceed the PEL in the course of typical (f)(2)(i)(A)(2) listed ‘‘ventilated partial or selection of at least one such approach exposure fluctuations. OSHA notes that full enclosures’’, which are forms of where required by the standards. this exemption is similar to a provision isolation. Paragraph (f)(2)(i)(B) of the However, while the Agency upholds in 1,3-Butadiene (29 CFR 1910.1051), final standards indicates ‘‘isolation, the importance of requiring at least one which requires an exposure goal such as ventilated partial or full engineering or work practice control program where exposures exceed the enclosures’’ to make clear that where operations release beryllium, it action level. Therefore, OSHA has alternative forms of isolation are also disagrees with comments that such retained the proposed provisions of acceptable. In addition, USW and controls should be required wherever paragraph (f)(2)(i) and the proposed Materion recommended that proposed there is airborne beryllium at any level. exemptions. The Agency also revised paragraph (f)(2)(i)(A)(3), which read OSHA recognizes that a significant risk the enumeration of the paragraphs for ‘‘local exhaust ventilation at the points of developing beryllium-related adverse clarity in the final standards. of operation, material handling, or health effects remains at the action OSHA has made a number of transfer’’ be revised to read ‘‘local level. But the Agency finds that an clarifying changes to the language of exhaust ventilation such as at the points exemption from the requirement to proposed paragraph (f)(2)(i), none of of operation, material handling, or implement at least one of the controls which is meant to change the meaning transfer’’ to broaden the applicability of listed in proposed paragraph (f)(2)(i)(A) of the proposed language. First, OSHA the provision (Document ID 1680, p. 4). when exposures are demonstrably revised the proposed language of OSHA agrees that the suggested revision below the action level strikes a (f)(2)(i)(A) (paragraph (f)(2)(i) in the more accurately describes acceptable reasonable balance between providing final standards) by specifying that this control measures, and has adopted the additional protection for employees provision applies to each operation in a recommended change in the final who are at risk and the burdens beryllium work area ‘‘that releases standards (now designated as paragraph associated with implementing controls airborne beryllium.’’ The proposed (f)(2)(i)(C)). that may provide little or no benefit (i.e., language could have been interpreted to The seventh and final clarifying where airborne exposures are minimal). require controls on operations that do change to proposed paragraph (f)(2)(i) The action level serves as a reasonable not release airborne beryllium, if such pertains to the proposed requirement for and administratively convenient operations happened to be performed in employers to demonstrate that airborne benchmark for a number of provisions a beryllium work area; it was not exposures are below the action level in the standards (e.g., periodic exposure OSHA’s intent to require employers to using personal breathing zone samples monitoring, medical surveillance); apply controls to any operations that do taken 7 days apart. In response to a OSHA finds that the action level serves not release beryllium. Second, OSHA comment from Ameren Corporation, a comparable purpose with regard to the added the term ‘‘airborne’’ preceding which stated that some operations are requirement to implement at least one of ‘‘exposure’’ in proposed (f)(2)(i)(A) and short in duration and taking samples the controls listed in proposed (f)(2)(i)(B)(2) (paragraphs (f)(2)(i) and precisely 7 days apart may not be paragraph (f)(2)(i)(A) as well. (f)(2)(ii)(B) in the final standards) to possible (Document ID 1675, p. 5), Moreover, as discussed in the NPRM, clarify the type of exposure addressed OSHA changed the text of the standards the inclusion of the engineering and by these provisions. Third, OSHA to ‘‘at least 7 days apart’’, which was the work practice control provision in removed the phrase ‘‘engineering and Agency’s intention. proposed paragraph (f)(2)(i)(A) work practice controls’’ preceding the With these changes, final paragraph addresses a concern regarding the list of controls provided in proposed (f)(2)(i) of the general industry standard proposed PEL. OSHA expects that day- paragraph (f)(2)(i)(A) (paragraph (f)(2)(i) requires that, for each operation in a to-day changes in workplace conditions in the final standards) for brevity. beryllium work area that releases might cause frequent excursions above Fourth, OSHA modified the language of airborne beryllium, the employer must the PEL in workplaces where periodic proposed paragraph (f)(2)(i)(A) ensure that at least one of the following sampling indicates exposures are (paragraph (f)(2)(i) in the final is in place to reduce airborne exposure: between the action level and the PEL. standards) to require employers to (A) Material and/or process substitution; Normal variability in the workplace and ‘‘reduce’’, rather than ‘‘minimize’’ (B) isolation, such as ventilated partial work processes, such as workers’ airborne exposure because ‘‘reduce’’ is or full enclosures; (C) local exhaust positioning or patterns of airflow, can more consistent with the requirement; ventilation, such as at the points of lead to excursions above the PEL. employers are not required to operation, material handling, and Substitution or controls such as those implement more than one such control transfer; or (D) process control, such as outlined in proposed paragraph unless exposures exceed the TWA PEL wet methods and automation. Final (f)(2)(i)(A) provide the most reliable or STEL. OSHA has included a non- paragraph (f)(2)(ii) allows that an means to control variability in exposure mandatory appendix presenting a non- employer is exempt from using the levels. And, as noted above, they have exhaustive list of engineering controls above controls to the extent that: (A) the added benefit of further reducing employers may use to comply with The employer can establish that such beryllium exposures to employees paragraph (f)(2)(i) (see Appendix A). controls are not feasible; or (B) the where such means are feasible, and so The fifth and sixth clarifying changes employer can demonstrate that airborne reducing the significant risk of to proposed paragraph (f)(2)(i) address exposure is below the action level, using

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no fewer than two representative If exposures exceed the TWA PEL or It is not intended to bar the use of personal breathing zone samples taken STEL after the employer has worker rotation as deemed appropriate at least 7 days apart, for each affected implemented the control(s) required by by the employer in activities such as to operation. paragraph (f)(2)(i), paragraph (f)(2)(iii) provide cross-training or to allow Final paragraph (f)(2)(i) of the requires the employer to implement workers to alternate physically construction and shipyard standards additional or enhanced engineering and demanding tasks with less strenuous also requires employers to ensure that work practice controls to reduce activities. This same provision is one of the four enumerated types of exposures to or below the PELs. For included in the standards for asbestos control is in place to reduce airborne example, an enhanced engineering (29 CFR 1910.1001 and 29 CFR exposure and exempts employers who control may entail a redesigned hood on 1926.1101), chromium (VI) (29 CFR can establish that such controls are not a local exhaust ventilation system to 1910.1026), 1,3-butadiene (29 CFR feasible or demonstrate that airborne more effectively capture airborne 1910.1051), methylene chloride (29 CFR exposure is below the action level, using beryllium at the source. The employer 1910.1052), and cadmium (29 CFR no fewer than two representative must use engineering and work practice 1910.1027 and 29 CFR 1926.1127), and personal breathing zone samples taken controls, to the extent that such controls methylenedianiline (29 CFR 1910.1050 at least seven days apart, for each are feasible, to achieve the PELs. and 29 CFR 1926.60). OSHA did not affected operation. However, the triggers Whenever the employer demonstrates receive any objections to or comments in construction and shipyards differ that it is not feasible to reduce on this provision and includes it in all from that in general industry: whereas exposures to or below the PELs using three of the final standards to limit the the general industry standard requires the engineering and work practice number of employees at risk. controls required by paragraphs (f)(2)(i) employers to put one of the controls in (g) Respiratory Protection place for each operation in a beryllium and (f)(2)(iii), however, paragraph Paragraph (g) of the standard work area that releases airborne (f)(2)(iv) requires the employer to establishes the requirements for the use beryllium, the construction and implement and maintain engineering of respiratory protection. Specifically, shipyard standards do not require the and work practice controls to reduce this paragraph requires that employers establishment of beryllium work areas. exposures to the lowest levels feasible provide respiratory protection at no cost In lieu of that trigger, the construction and supplement these controls by using to the employee and ensure that and shipyard provision requires the respiratory protection in accordance with paragraph (g) of this standard. As employees utilize such protection placement of a control where exposures indicated previously, OSHA’s long- during the situations listed in paragraph are or can reasonably be expected to be standing hierarchy of controls policy (g)(1). As detailed in paragraph (g)(2), at or above the action level. OSHA was supported by a number of the selection and use of required selected the action level as a trigger for commenters (e.g., Document ID 1963, p. respiratory protection must comply with this requirement because, as indicated 12; 1655, pp. 8, 16; 1618, p. 8; 1689, p. OSHA’s Respiratory Protection standard above, the Agency finds that an 11; 1625, p. 6; 1664, p. 6). Paragraphs (29 CFR 1910.134). In addition, exemption from the requirement to (f)(2)(iii) and (f)(2)(iv) in the final paragraph (g)(3) requires employers to implement at least one of the controls is standards are substantively consistent provide employees entitled to appropriate when exposures are below with the proposal, with minor changes respiratory protection with a powered the action level. to clarify that the provisions address air-purifying respirator (PAPR) instead Congressman Robert C. Scott, Ranking only airborne exposures, and that of a negative pressure respirator, if a Member of the House Committee on paragraph (f)(2)(iii) applies to both the PAPR is requested by the employee. Education and the Workforce, TWA PEL and STEL. Paragraph (g)(1) requires employers to recommended that the final standards Finally, paragraph (f)(3) of the ensure that each employee required to should require abrasive blasting (the proposed rule would have prohibited use a respirator does so. Accordingly, primary source of beryllium exposure in the employer from rotating workers to simply providing respirators to construction and maritime) to be different jobs to achieve compliance employees will not satisfy an conducted within containments with the PELs. As explained in the employer’s obligations under paragraph whenever feasible (Document ID 1672, NPRM, worker rotation can potentially (g)(1) unless the employer also ensures p. 4). OSHA agrees that containment is reduce exposures to individual that each employee properly wears the an effective approach to limit exposures employees, but increases the number of respirator when required. Paragraph outside of the blasting operation, and is employees exposed. Because OSHA has (g)(1) also requires employers to provide protective of workers in nearby areas or determined that exposure to beryllium required respirators at no cost to performing ancillary activities. can result in sensitization, CBD, and employees. This requirement is However, because abrasive blasting is cancer, the Agency considers it consistent with the OSH Act’s holding performed in a wide variety of inappropriate to place more workers at employers principally responsible for occupational settings and alternative risk. Since no absolute threshold has complying with OSHA standards, with methods of exposure control (for been established for sensitization or similar provisions under other OSHA example, use of wet methods) may be resulting CBD or the carcinogenic effects standards, and specifically with OSHA’s effective in some settings, OSHA does of beryllium, it was considered prudent Respiratory Protection standard, which not require the use of containment to limit the number of workers exposed also requires employers to provide whenever feasible in blasting at any concentration by prohibiting required respiratory protection to operations. Rather, paragraph (f)(2) is employee rotation. employees at no cost (29 CFR intended to provide employers This provision is not a general 1910.134(c)(4)). flexibility to determine an appropriate prohibition of worker rotation wherever Paragraph (g)(1) requires appropriate approach to maintain airborne workers are exposed to beryllium. It is respiratory protection during certain exposures below the TWA PEL and only intended to restrict its use as a enumerated situations. Paragraph STEL and, in accordance with (f)(2)(i), compliance method for the PEL (e.g., by (g)(1)(i) requires respiratory protection reduce airborne exposures that exceed exposing twice as many workers to during the installation and the action level. beryllium for half the amount of time). implementation of feasible engineering

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and/or work practice controls where requires that employers implement and sensitization and who works in a job airborne exposures exceed or can maintain engineering and work practice with airborne exposure at or above the reasonably be expected to exceed the controls to reduce exposure to the action level is eligible for medical TWA PEL or STEL. The Agency lowest levels feasible and supplement removal protection (MRP). An employee understands that changing workplace those controls by providing respiratory who is eligible for MRP may choose conditions may require employers to protection (paragraph (f)(2)(iv)). OSHA medical removal from jobs with install new engineering controls, modify emphasizes that even where employers exposure at or above the action level, or existing controls, or make other are able to demonstrate that engineering may choose to remain in a job with workplace changes to reduce employee and work practice controls are not exposure at or above the action level exposure to or below the TWA PEL and feasible or sufficient to reduce exposure provided that the employee uses STEL. In these cases, the Agency to levels at or below the TWA PEL and respiratory protection in accordance recognizes that installing appropriate STEL the use of respirators to achieve with the provisions of this paragraph engineering controls and implementing the PELs is only a supplement, and not (g), Respiratory Protection. This proper work practices may take time, a substitute for, such ‘‘lowest level provision was not included in the and that exposures may be above the feasible’’ controls. proposed standard. However, OSHA PELs until such work is completed. See Paragraph (g)(1)(iv) requires the received comments emphasizing the paragraph (g)(1)(ii), discussed below. provision and use of respiratory importance of reducing or eliminating During this time, employers must protection in emergencies. Under the the exposure of sensitized employees. demonstrate that they are making final standards, an emergency is defined For example, National Jewish Health prompt, good faith efforts to obtain and as ‘‘any uncontrolled release of airborne (NJH) stated that ‘‘removal from beryllium’’ (see paragraph (b) of the install appropriate engineering controls exposure is the best form of prevention’’ standards). During emergencies, and implement effective work practices, (Document ID 1664, p. 4). The United engineering controls may not be and to evaluate their effectiveness for Steelworkers (USW) commented that functioning fully or may be reducing airborne exposure to beryllium workers who are sensitized to beryllium overwhelmed or rendered inoperable. to or below the TWA PEL and STEL. or are in the early stages of chronic Paragraph (g)(1)(ii) requires the Also, emergencies may occur in areas beryllium disease can significantly provision and use of respiratory where there are no engineering controls. benefit from a reduction in their protection during any operations, The standard recognizes that the exposure to beryllium, based on including maintenance and repair provision of respiratory protection is operations and other non-routine tasks, critical in emergencies, as beryllium evidence reviewed in Section VIII when engineering and work practice exposures may be very high and (Significant Risk) of the NPRM controls are not feasible and airborne engineering controls may not be (Document ID 1963, p. 13). OSHA is exposures exceed or can reasonably be adequate to control an unexpected cognizant that employees who are MRP- expected to exceed the TWA PEL or release of airborne beryllium. eligible (i.e., confirmed positive for STEL. OSHA included this provision Boeing suggested limiting beryllium sensitization or diagnosed because the Agency realizes that certain requirement of respirator use triggered with CBD) may decide not to take operations may take place when by this definition of emergency, as it medical removal protection (MRP) or engineering and work practice controls would not be practical to provide otherwise alert the employer to their are not operational or capable of respirators to and train the large number condition. Therefore, OSHA included reducing exposures to or below the of employees in the event of a fire or paragraph (g)(1)(v) in the final standards TWA PEL and STEL. The installation of explosion (Document ID 1667, pp. 4–5). to provide these employees access to necessary engineering controls, covered OSHA wishes to clarify that paragraph respiratory protection if their airborne by paragraph (g)(1)(i), is a particular (g)(1)(iv) is not intended to require exposures are expected to be at or above example of this more general employers to provide respirators to all the action level. While not as protective circumstance. For another example, employees who may pass through areas as removal from any beryllium during maintenance and repair where beryllium-releasing processes are exposure, NJH’s comments indicate that operations, engineering controls may housed, in the event of a general such protection has the potential to lose their full effectiveness or require evacuation due to an event such as a fire delay or avoid the onset of CBD in partial or total breach, bypass, or or explosion. Rather, in the event that sensitized individuals and to mitigate or shutdown. Under these circumstances, an uncontrolled release of beryllium retard the effects of CBD in employees if exposures exceed or can reasonably be occurs (f)(1)(iv) requires employers to who are in the early stages of CBD. expected to exceed the TWA PEL or provide respirators to employees who Because OSHA has not made a finding STEL, the employer must provide and work in the vicinity of beryllium- of significant risk at exposure levels ensure the use of respiratory protection. releasing processes and employees who below the action level, OSHA has Paragraph (g)(1)(iii) requires the respond to such an emergency, because chosen not to require provision and use provision and use of respiratory these employees will be in the of respirators for employees exposed protection where beryllium exposures immediate vicinity of an uncontrolled below the action level, including exceed the TWA PEL or STEL, even release. sensitized employees. However, OSHA after the employer has installed and Paragraph (g)(1)(v) requires the does not assume the absence of risk implemented all feasible engineering provision and use of respiratory below the action level, especially to this and work practice controls. OSHA protection when an employee who is particularly vulnerable population anticipates that there will be some eligible for medical removal under Indeed, it is the Agency’s situations where feasible engineering paragraph (l)(1) chooses to remain in a recommendation that employers and work practice controls are job with airborne exposure at or above voluntarily provide such protection to insufficient to reduce airborne exposure the action level. As explained in the employees who self-identify that they to beryllium to levels at or below the summary and explanation of paragraph have tested positive for sensitization if TWA PEL or STEL (see this preamble at (l), Medical Removal Protection, an they ask for it and will be exposed to section VIII.D, Technological employee who is diagnosed with CBD or beryllium below the action level, or for Feasibility). In such cases, the standard confirmed positive for beryllium whom a licensed physician has

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recommended such protection. OSHA exposure to atmospheric workplace cotton dust (1910.1043), asbestos (CFR intends to issue additional guidance contaminants. In incorporating the 1910.1001), and cadmium (1910.1027). regarding non-mandatory respiratory Respiratory Protection standard by In promulgating these standards, OSHA protection for this group of at-risk reference, OSHA intends that any future cited several reasons why PAPRs can employees along with other compliance change to that standard will provide employees with better guidance in connection with these automatically apply to this standard as protection than negative pressure standards. well. As appropriate, OSHA will note respirators, including superior OSHA received no comments the intended effect on this standard (and reliability and comfort, reduced objecting to paragraph (g)(1). Therefore, other standards) in either the text or interference with work processes, and except for minor edits for clarity preamble of the amended Respiratory superior protection, especially for explained in the introduction to this Protection standard, but does not employees who cannot obtain a good section, it is unchanged from the anticipate the need for a conforming face fit with a negative pressure proposal. amendment to this standard. respirator (e.g., 43 FR 19584, 19619; 43 Whenever respirators are used to Moreover, the situations in which FR 52952, 52993; 51 FR 22612, 22698). comply with the requirements of this respiratory protection is required under Based on these considerations, OSHA standard, paragraph (g)(2) requires that these standards are generally consistent required employers to provide PAPRs the employer implement a with the requirements in other OSHA upon request to facilitate consistent and comprehensive written respiratory health standards, such as those for effective use of respiratory protection by protection program in accordance with chromium (VI) (29 CFR 1910.1026), employees when needed, and OSHA’s Respiratory Protection standard butadiene (29 CFR 1910.1051), and particularly in situations where (29 CFR 1910.134). The Respiratory methylene chloride (29 CFR 1910.1052). respirator use is required for long Protection standard is designed to Those standards and this standard also periods of time (see 43 FR 52952, 52993; ensure that employers properly select reflect the Agency’s traditional 51 FR 22612, 22698). adherence to a hierarchy of controls in and use respiratory protection in a The PAPR provision was not included which engineering and work practice manner that effectively protects exposed in the proposed standard. However, controls are preferred to respiratory employees. Under 29 CFR OSHA solicited public comment on the protection (see the discussion of 1910.134(c)(1), the employer’s issue of whether employers should be paragraph (f) earlier in this section of respiratory protection program must required to provide employees with the preamble). include: PAPRs upon request. During the public • Procedures for selecting appropriate OSHA received no comments objecting to paragraph (g)(2). OSHA comment period and public hearing for respirators for use in the workplace; the beryllium NPRM, several • Medical evaluations of employees added language to clarify that both the commenters supported a requirement required to use respirators; selection and use of respiratory • Respirator fit testing procedures for protection must be in accordance with for employers to provide a PAPR upon tight-fitting respirators; the Respiratory Protection standard. an employee’s request, including the • Procedures for proper use of Other than that change and some minor Sampling and Analysis Subcommittee respirators in routine and reasonably edits for clarity, paragraph (g)(2) is Task Group of the Beryllium Health and foreseeable emergency situations; unchanged from the proposal. Safety Committee (BHSC Task Group) • Procedures and schedules for Paragraph (g)(3) requires the employer (Document ID 1655, p. 8), a cleaning, disinfecting, storing, to provide a powered air-purifying representative of the Department of inspecting, repairing, discarding, and respirator (PAPR) instead of a negative Defense (Document ID 1684, otherwise maintaining respirators; pressure respirator at no cost to the Attachment 2, p. 4), ORCHSE Strategies • Procedures to ensure adequate employee when an employee entitled to (ORCHSE) (Document ID 1691, p. 4), quality, quantity, and flow of breathing respiratory protection under (g)(1) of NJH (Document ID 1664, p. 5), air for atmosphere-supplying these standards requests a PAPR. The Kimberly-Clark Professional (KCP) respirators; employee may select any form of PAPR (Document ID 1676, p. 3), and North • Training of employees in the (half mask, full facepiece, helmet/hood, America’s Building Trades Unions respiratory hazards to which they are or loose fitting facepiece), so long as the (NABTU) (Document ID 1679, p. 9). Dr. potentially exposed during routine and PAPR is selected and used in Lisa Maier of the NJH stated, ‘‘The emergency situations, and in the proper compliance with the Respiratory beryllium standard should require use of respirators; and Protection standard (29 CFR 1910.134) employers to provide PAPRs when • Procedures for evaluating the and provides adequate protection to the requested by the employee. We have effectiveness of the program. employee in accordance with paragraph consulted with clients on respiratory In accordance with OSHA’s policy to (g)(2) of these standards. For example if protection for beryllium exposure and avoid duplication and to establish an employee is using a half mask found that employees are more likely to regulatory consistency, paragraph (g)(2) respirator with an APF of 10 then a comply with respiratory protection incorporates by reference the loose fitting PAPR with an APF of 25 requirements when they have an option requirements of 29 CFR 1910.134 rather would be an appropriate alternative. regarding the type of respirator they than reprinting those requirements in However, if the employee is required to wear’’ (Document ID 1664, p. 7). Joann this standard. OSHA notes that the use a full face respirator with an APF of Kline of KCP similarly commented that respirator selection provisions in 29 50 then the appropriate PAPR ‘‘[f]it, style, comfort and worker CFR 1910.134 include requirements for alternative would be a tight fitting preference are significant factors in the Assigned Protection Factors (APFs) and PAPR. effectiveness of protection . . . Maximum Use Concentrations (MUCs) The requirement to provide a PAPR Allowing a worker to choose PPE, that OSHA adopted in 2006 (71 FR upon request of the employee including PAPRs, makes it much more 50122 (Aug. 24, 2006)). The APFs and (paragraph (g)(3)) is similar to likely that it will be comfortable and MUCs provide employers with critical provisions in several previous OSHA accepted. PAPRs in particular add to information for the selection of standards, including inorganic arsenic worker comfort, especially in hot respirators to protect workers from (CFR 1910.1018), lead (CFR 1910.1025), environments, because of the flow of

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fresh air on and around the wearer’s and Daniel Shipp of the International preamble, beryllium sensitization and face’’ (Document ID 1676, p. 3). Safety Equipment Association (ISEA), CBD can result from small, short-term Likewise, ORCHSE commented that stated that respiratory protection beryllium exposure in some individuals. ‘‘[c]omfort is a significant factor in the selection should be based primarily on Accordingly, consistent and effective ability of employees to wear respiratory the required APF given the exposure respirator usage has played an protection consistently, especially concentration of beryllium (Document important role in minimizing risk during an entire work shift, and/or ID 1675, p. 12; 1682, p. 1). However, Mr. among workers in occupational settings under hot or stressful conditions. Orr also commented that workers such as beryllium processing, where it Employees experiencing discomfort, handling beryllium-containing materials has proven difficult to reduce airborne which is likely with negative-pressure should have access to loose fitting exposures below 0.2 mg/m3 using respirators, are more apt to remove or respirators for added dermal protection engineering controls. Based on this otherwise compromise the effectiveness so long as the respirator’s APF is evidence, OSHA concludes that of their respirators while in the appropriate to the work performed provision of PAPRs at the employee’s workplace. It is thus prudent for (Document ID 1675, p. 12). Mr. Orr also request will provide employees employers to provide the type of argued that a PAPR option is not necessary protection beyond that found respiratory protection employees are necessary in the beryllium context: ‘‘A in provisions of the Respiratory more likely to use consistently and PAPR should only be required if the Protection standard, where provision of correctly’’ (Document 1691, p. 4). Chris exposure level dictates that the a PAPR for reasons of fit, comfort and Trahan of NABTU cited the protection of a PAPR is necessary. The reliability is at the employer’s susceptibility of some employees to level of protection in the asbestos discretion. Contrary to the comments of beryllium sensitization as a reason to standard (CFR 1910.1001) is applicable Mr. Orr and Mr. Shipp cited above, the require employers to provide PAPRs to to protection from airborne fibers with evidence that beryllium sensitization employees upon their request the unique characteristics of asbestos. can result from short-term, low-level (Document ID 1679, p. 9). As discussed The level of protection for beryllium airborne beryllium exposure supports in Section V, some individuals are should closer resemble particulate metal the provision of PAPRs upon request genetically susceptible to beryllium- protection such as seen in the standards rather than relying on APF alone. induced sensitization and CBD, and for metals such as lead or hexavalent Finally, while OSHA agrees with the may develop these conditions from chromium’’ (Document ID 1675, p. 12). USW that PAPRs with close-fitting exposure to beryllium at levels well (As discussed above, the Agency notes facepieces can be more effective than below the PEL and STEL included in that the OSHA lead standard (CFR loose-fitting helmets, the Agency this standard. Genetically susceptible 1910.1025) does include a PAPR recognizes that loose-fitting helmets individuals may therefore benefit from requirement, as does the standard for may be required in certain work the enhanced protection provided by a cadmium (1910.1027), also a metal). conditions or due to difficulty achieving PAPR, which have APFs ranging from Finally, OSHA received a comment proper fit for some workers. Therefore, 50 to 1000 depending on type. from USW (Document ID 1681) the standards allow for selection of any OSHA also received comments recommending that OSHA limit the type type of PAPR, but require that the PAPR opposing a requirement for employers to of PAPR provided under (g)(3) to types selected provide adequate protection to provide PAPRs upon employee request. with close-fitting facepieces. USW the employee in accordance with the For example, Julie A. Tremblay of 3M stated that ‘‘[t]he types with close-fitting Respiratory Protection standard. commented that the incorporation of the face pieces can be quite effective, but it Respiratory Protection Standard (29 CFR is easy to over breathe other types, (h) Personal Protective Clothing and 1910.134) by reference, particularly especially the loose-fitting helmets’’ Equipment paragraph (d)(1)(i) and paragraph (Document ID 1681, p. 22). Paragraph (h) of the standards (e)(6)(ii), adequately addresses issues of OSHA has carefully considered all requires employers to provide appropriate respirator selection comments received on the issue of employees with personal protective (Document ID 1625, Attachment 1, p. 2). requiring employers to provide clothing and equipment (PPE) where 1910.134(d)(1)(i) directs the employer to employees with PAPRs upon request, employee exposure exceeds or can select and provide an appropriate and agrees with Dr. Maier of NJH, Ms. reasonably be expected to exceed the respirator based on the respiratory Trahan of NABTU, and other TWA PEL or STEL and where there is hazard(s) to which the worker is commenters who have argued that reasonable expectation of dermal exposed and workplace and user factors providing employees a choice in contact with beryllium. Paragraph (h) that affect respirator performance and selection of respiratory protection will also contains provisions for the safe reliability. 1910.134(e)(6)(ii) states that improve the effectiveness of respiratory removal, storage, cleaning, and if the PLHCP finds a medical condition protection in reducing risk of replacement of the PPE required by the that may place the employee’s health at sensitization and disease from standards. To protect employees from increased risk if a negative pressure occupational beryllium exposure. While adverse health effects, these PPE respirator is used, the employer shall the provisions of the Respiratory requirements are intended to prevent provide a PAPR if the PLHCP’s medical Protection standard provide important dermal exposure to beryllium, and evaluation finds that the employee can baseline requirements appropriate to all prevent the accumulation of airborne use such a respirator; however, if a situations where respiratory protection beryllium on clothing, shoes, and subsequent medical evaluation finds is required, as discussed above, OSHA equipment, which can result in that the employee is medically able to recognizes that provisions beyond those additional inhalation exposure. The use a negative pressure respirator, then of the Respiratory Protection standard requirements also protect employees in the employer is no longer required to are appropriate in some circumstances other work areas, as well as employees provide a PAPR. OSHA received a to ensure that required respiratory and other individuals outside the similar comment from Charlie Shaw of protection is used on a consistent basis workplace, from exposures that could Southern Company (Document ID 1668, and as effectively as possible. As occur if contaminated clothing were to p. 5). Two other commenters, William discussed in section V, Health Effects transfer beryllium to those areas. The Orr of Ameren Corporation (Ameren) and section VI, Risk Assessment of this standards require the employer to

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provide PPE at no cost to employees, facilities for PPE prevent cross requirements, requested public and to ensure that employees use the contamination. Finally, OSHA has made comment on proposed paragraph (h)(1), provided PPE in accordance with the a few minor changes to clarify or and presented Regulatory Alternative written exposure control plan as streamline the regulatory text. The 13. Alternative 13, as described by described in paragraph (f)(1) of these comments and OSHA’s reasoning OSHA, would replace the requirement standards and OSHA’S Personal leading to these changes are discussed for PPE where there is visible Protective Equipment standards (29 CFR below. contamination with a requirement for part 1910 Subpart I, 29 CFR part 1926 Paragraph (h)(1)(i) requires the appropriate PPE wherever there is Subpart E, and 29 CFR part 1915 provision and use of PPE for employees potential for skin contact with beryllium Subpart I). PPE, as used in the exposed to any form of airborne or beryllium-contaminated surfaces. description of paragraph (h), refers to beryllium above the TWA PEL or STEL, OSHA requested comments on this both clothing and equipment used to or where exposure can reasonably be alternative, including the benefits and protect an employee from either expected to exceed the TWA PEL or drawbacks of a broader PPE requirement airborne exposure to or dermal contact STEL, because such exposure would and any relevant data or studies the with beryllium. The requirements in likely result in skin contact by means of Agency should consider. As discussed paragraph (h) are the same in general deposits on employees’ skin or clothes below, OSHA adopted Regulatory industry, construction, and shipyards, or on surfaces touched by employees. Alternative 13 in the final standard except for the references to OSHA’s The term ‘‘reasonably be expected’’ is based on comments received in the Personal Protective and Life Saving intended to convey OSHA’s intent that public comment period and public Equipment standard for construction (29 the requirement for provision and use of hearing and on the scientific evidence CFR part 1926 Subpart E) in the PPE is defined by an employee’s in the record. construction standard and OSHA’s potential exposure, not by any The proposed requirement to use PPE Personal Protective Equipment standard particular individual’s actual exposure. where clothing or skin may become for shipyards (29 CFR part 1915 Subpart For example, if one employee’s ‘‘visibly contaminated’’ with beryllium I) in the shipyard standard. Requiring exposure assessment results indicate was a departure from most OSHA PPE is consistent with section 6(b)(7) of that the employee’s exposure is above standards, which do not specify that the OSH Act, which states that, where the PEL, it would be reasonable to contamination must be visible in order appropriate, standards shall prescribe expect that another employee doing a for PPE to be required. For example, the suitable protective equipment to be used similar task would have exposures standard for chromium (VI) (29 CFR in connection with hazards (29 U.S.C. above the PEL and thus would require 1910.1026) requires the employer to 655(b)(7)). The requirements for PPE are PPE. provide appropriate PPE where a hazard Paragraph (h)(1)(ii) requires the based upon widely accepted principles is present or is likely to be present from provision and use of PPE where and conventional practices of industrial skin or eye contact with chromium (VI). employees are reasonably expected to hygiene, and are similar to the PPE The lead (29 CFR 1910.1025) and have dermal contact with beryllium. requirements in other OSHA health cadmium (29 CFR 1910.127) standards This requirement applies to beryllium- standards, such as chromium (VI) (29 require PPE where employees are containing dust, liquid, abrasive CFR 1910.1026), lead (29 CFR exposed above the PEL or where there blasting media, and other beryllium- 1910.1025), cadmium (29 CFR is potential for skin or eye irritation containing materials that can penetrate regardless of airborne exposure level. In 1910.1027), and methylenedianiline the skin, regardless of the level of the case of MDA (29 CFR 1910.1050), (MDA; 29 CFR 1910.1050). airborne exposure. It is not intended to PPE must be provided where employees The final provisions in paragraph (h) apply to dermal contact with solid are subject to dermal exposure to MDA, are the same as the proposed provisions, objects (for example, tools made of where liquids containing MDA can be with several exceptions. First, in the beryllium alloy) unless the surface of splashed into the eyes, or where final standards OSHA has used the term such objects is contaminated with airborne concentrations of MDA are in ‘‘contact’’ instead of ‘‘exposure’’ where beryllium in a form that can penetrate excess of the PEL. While OSHA’s the standards refer to the skin, so as to the skin. Dermal contact with beryllium language regarding PPE requirements distinguish clearly between exposure can result in absorption of beryllium varies somewhat from standard to via the skin (dermal route) and the through the skin and induce standard, previous standards emphasize inhalation route of exposure in the sensitization, a necessary precursor to the potential for contact with a regulatory text. Second, OSHA has CBD, as discussed further in Health substance that can cause health effects deleted the proposed provision in Effects, section V.A.2. via dermal exposure, and do not paragraph (h)(1)(ii) requiring PPE where As mentioned above, the condition the provision and use of PPE employees’ skin may become ‘‘visibly requirements of paragraph (h)(1) of the on visible contamination with the contaminated’’ with beryllium and final standards differ from those of the substance. instead will require use of PPE proposed standard. Paragraph (h)(1) of Nearly all comments OSHA received whenever there is a reasonable the proposed standard required on the proposed requirement for expectation of dermal contact with employers to provide employees with employers to provide PPE where work beryllium. Third, the final standards’ PPE where employee exposure exceeds clothing or skin may become ‘‘visibly requirements for provision and use of or can reasonably be expected to exceed contaminated’’ with beryllium stated PPE apply where employees may the TWA PEL or STEL; where work that this provision would not be reasonably be expected to have dermal clothing or skin may become visibly sufficiently protective of beryllium- contact with beryllium regardless of contaminated with beryllium, including exposed workers (Document ID 1615, p. whether the beryllium is in a soluble or during maintenance and repair activities 8; 1625, p. 2; 1655, pp. 9–10; 1658, p. poorly soluble (sometimes called or during non-routine tasks; and where 6; 1664, pp. 3–4; 1671, Attachment 1, p. ‘insoluble’) form, instead of just soluble employees’ skin is reasonably expected 7; 1676, pp. 2–3; 1677, p. 2; 1679, p. 9; beryllium compounds as in proposed to be exposed to soluble beryllium 1685, p. 3; 1688, p. 3; 1689, p. 12; 1691, paragraph (h)(1)(iii). Fourth, paragraph compounds. In the NPRM, OSHA pp. 4–5). Dr. Paul Schulte of NIOSH (h)(2)(iii) now requires that storage discussed concerns with the proposed stated that ‘‘visibly contaminated’’ is not

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an appropriate trigger for PPE programs (See Section VI. Risk whether employers should also be requirements, citing evidence from Day Assessment). required to provide PPE to limit dermal et al. (2007, Document ID 1548) that Materion, whose joint submission contact with poorly soluble (referred to biologically relevant amounts of with the United Steelworkers union of as insoluble in the proposal) forms of beryllium can accumulate on the skin a proposed standard was the basis for beryllium. The solubility of beryllium without becoming visible, and evidence the ‘‘visibly contaminated’’ language, was a consideration in the PPE from Armstrong et al. (2014, Document discussed the use of the term in its post requirements of the proposed standard ID 0502) that work surfaces in beryllium hearing comments (Document ID 1808, because dermal absorption may occur at manufacturing facilities are typically pp. 4–5). Materion indicated that the a greater rate for soluble beryllium than contaminated with beryllium even typical workplace cannot reasonably be for poorly soluble beryllium. where airborne exposures are low expected to measure skin or surface Comments submitted on the topic of (Document ID 1671, Attachment 1, p. 7). contamination for the purpose of beryllium solubility and dermal Dr. Lisa Maier of NJH commented, determining whether PPE use is absorption indicate that beryllium in ‘‘ ‘[v]isibly contaminated’ is not an necessary. Even if this was done, ‘‘such poorly soluble forms, as well as soluble appropriate trigger for PPE measures are lagging metrics which, by forms, can be absorbed through the skin requirements; as noted by OSHA, ‘small definition, are post potential exposure’’ and cause sensitization (Document ID particles may not be visible to the naked (Document ID 1808, p. 5). Materion 1664, p. 3; 1671, p. 7; 1688, p. 3). Dr. eye’ and as such PPE to protect from believed that a standard relying on Schulte of NIOSH stated that PPE skin exposure should be worn for all visual cues to check for contamination should be required to protect against tasks where there is potential for skin is easily understood by workers and exposure to poorly soluble compounds contact with beryllium particles’’ management and is a useful part of a as these forms can produce soluble (Document ID 1664, pp. 3–4). Dr. Atul beryllium worker protection model. beryllium ions in sweat, and because Malhotra of the American Thoracic OSHA has considered Materion’s beryllium in any form can enter the Society (ATS) stated that ‘‘the use of comments supporting use of the terms body through minor abrasions, which ‘visibly contaminated’ as a trigger for ‘‘visibly contaminated’’ and ‘‘visibly are commonly found on the skin of PPE is problematic for multiple reasons clean.’’ The Agency finds that the industrial employees (Document ID . . . visual inspection cannot accurately provision in the final standard requiring 1671, p. 7). (See further discussion in estimate the amount of beryllium or its PPE wherever there is a reasonable Section V, Health Effects, subsection 2, chemical state. Use of ‘visibly expectation of any dermal contact with Dermal Exposure.) contaminated’ is also not supported by beryllium more clearly conveys to General comments on whether OSHA the literature cited, which demonstrates employers the idea that the provision should adopt more comprehensive PPE and use of PPE should be used as a requirements similar to those specified skin exposure and sensitization in work precaution against potential dermal in Regulatory Alternative 13 were, by settings considered clean, with no contact. OSHA believes the proposed and large, supportive. The Sampling visible contamination’’ (Document ID requirements for PPE where clothing or and Analysis Subcommittee Task Group 1688, p. 3). skin may become ‘‘visibly of the Beryllium Health and Safety In addition, some comments and contaminated’’ may be reasonably Committee (BHSC Task Group) testimony indicated that the term interpreted by employers to mean that (Document ID 1655, pp. 16–17), NJH ‘‘visibly contaminated’’ is ambiguous PPE is only required where work (Document ID 1664, pp. 3–4, 7), NIOSH and likely to be confusing to employers processes release quantities of beryllium (Document ID 1671, p. 7), Kimberly- and others responsible for implementing sufficient to create deposits visible to Clark Professional (KCP) (Document ID the PPE requirements of the beryllium the naked eye. If this were the case, 1676, p. 2), the DOE’s National standards. According to Mr. Daniel employers’ provision of PPE to Supplemental Screening Program Shipp of the International Safety employees would certainly lag behind (NSSP) (Document ID 1677, p. 2), ISEA Equipment Association (ISEA), potential exposure, if such provision (Document ID 1682, p. 2), the American ‘‘ ‘[v]isible contamination’ is not an occurs at all. Additionally, National College of Occupational and appropriate trigger for PPE. This term is Jewish Health agreed with OSHA that Environmental Medicine (ACOEM) too subjective to be useful’’ (Document small particles may not be visible to the (Document ID 1685, p. 3), ATS ID 1682, p. 2). naked eye (Document ID 1664 p. 4). (Document ID 1688, p. 3), the AFL–CIO Based on its evaluation of the Therefore, OSHA has determined that (Document ID 1689, p. 12), and evidence in the record, OSHA agrees the language of the final standards is ORCHSE Strategies (ORCHSE) with the commenters on these points. more easily understood and applied so (Document ID 1691, p. 4) all urged The Agency has determined that contact as to preempt dermal contact with OSHA to adopt Regulatory Alternative with and absorption of even minute beryllium and therefore prevent adverse 13 or similar requirements. The BHSC amounts of beryllium through the skin health effects caused by dermal contact, Task Group commented that its may cause beryllium sensitization (see such as beryllium sensitization. OSHA experience at Department of Energy section V, Health Effects, subsection 2, also notes that employers are not Sites ‘‘strongly suggests that this Dermal Exposure) and that a ‘‘visibly required to measure skin or surface alternative should be adopted, since the contaminated’’ standard could allow for contamination under the provisions concept of ‘visibly contaminated’ is not too much dermal exposure and be governing the use and handling of PPE. sufficient to ensure an absence of such insufficiently protective of workers. In Thus the Agency concludes that the contamination on the skin’’ (Document addition, as discussed in Section VI, changes made to the proposed rule ID 1655, p. 17). In addition, the BHSC Risk Assessment, studies conducted adequately address Materion’s concerns Task Group noted that elimination of jointly by NIOSH and Materion and more closely express OSHA’s dermal contact with beryllium helps Corporation (Materion) showed that a intent. reduce the risk of sensitization comprehensive approach to PPE is key OSHA also requested comment on (Document ID 1655, p. 17). to reducing risk of sensitization even in proposed paragraph (h)(1)’s requirement Similarly, several commenters facilities that implement stringent for PPE to limit dermal contact with indicated that a more appropriate trigger exposure control and housekeeping soluble beryllium compounds, and for the provision and use of PPE under

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paragraph (h)(1) would be whenever an naked eye and yet may pass through the maintenance and repair activities and employee has the potential for skin skin and cause beryllium sensitization. non-routine tasks that involve contact with beryllium (Document ID And although solubility may play a role beryllium-releasing processes or that are 1664, p. 3; 1671, Attachment 1, p. 7; in the level of sensitization risk, the conducted in beryllium-contaminated 1676, pp. 2–3). Dr. Lisa Maier from NJH available evidence indicates that contact areas. indicated, in her testimony, that with poorly soluble as well as soluble OSHA also received a suggestion from ‘‘personal protective equipment (PPE) beryllium can cause sensitization via the Boeing Company (Boeing) to amend such as gloves, respirators, protective dermal contact (see this preamble at proposed paragraph (h)(1)’s requirement clothing should be used wherever there section V, Health Effects). Based on to ensure use of appropriate PPE in is a potential for respiratory or skin these considerations, OSHA has accordance with the written exposure exposure’’ (Document ID 1720 p. 6). adopted Regulatory Alternative 13 in control plan, by adding ‘‘or equally as Another commenter ‘‘strongly paragraph (h)(1)(ii) of the final effective documentation’’ (Document ID recommend[ed] a PPE requirement standards, which requires the employer 1667, p. 5). Boeing argued that the wherever exposure to beryllium, soluble to provide PPE and ensure its use suggested language would allow or insoluble, is reasonably expected’’ wherever there is a reasonable employers to provide the required (Kimberly-Clark Professional, Document expectation of dermal contact with information through use of existing ID 1676, p. 3). beryllium to any extent and of any type. processes instead of through the In contrast, Ameren Corporation The USW recommended further creation of a second document (Ameren) and NGK Metals (NGK) specification of the PPE provisions, (Document ID 1667, pp. 3–5). OSHA recommended against adoption of requesting clarification of the terms considered Boeing’s comment, but Regulatory Alternative 13. According to ‘‘skin’’ and ‘‘exposure’’ in the proposed decided against adding the suggested Ameren, ‘‘[t]race beryllium in fly ash is standard’s PPE requirements (Document language. OSHA determined that it unlikely to cause sensitization issues ID 1680, p. 4; 1681, p. 12). As discussed would create unnecessary ambiguity in but PPE would be required under this previously, the term ‘‘contact’’ has the requirements for documentation in alternative’’ (Document ID 1675, p. 6). replaced ‘‘exposure’’ where the final the context of both compliance and Ameren, however, did not provide standard refers to the skin. This change enforcement, as employers and CSHOs further information or evidence to was made in order to clearly distinguish would need to determine what support this claim. NGK suggested the between airborne and contact exposure constitutes ‘‘equally effective language ‘‘visibly contaminated with in the text of the standards. OSHA’s documentation.’’ If an employer such as beryllium particulate or solutions’’ as a intention in using the term ‘‘contact’’ is Boeing already has documents trigger for the standards’ PPE straightforward, meaning any instance describing appropriate use of PPE that requirements, to clarify that PPE is not in which beryllium touches an comply with the requirements of these required when handling clean, solid employee’s body. ‘‘Skin’’ refers to the standards, OSHA believes those materials that contain beryllium exterior surface of all parts of an documents can easily be incorporated (Document ID 1663, pp. 2, 5). OSHA employee’s body including face, arms, into the employer’s written exposure does not find these comments scalp, ears, and nostrils. OSHA notes control plan. Taking this approach persuasive. OSHA included operations that processes that have the potential to would eliminate the potential for and industries where beryllium is expose workers’ eyes to beryllium will confusion or redundancy caused by present as a trace contaminant in the generally also expose the face, and implementing multiple documents on scope of the beryllium standard only forms of PPE such as face shields used PPE. when these operations and industries to protect the face generally also protect The employer must exercise have the potential to release airborne the eyes (e.g., face shields for use in reasonable judgment in selecting exposures exceeding the action level of situations where there is a danger of appropriate PPE. This requirement is 0.1 mg/m3, at which sensitization is being splashed in the face with consistent with OSHA’s current known to occur (see Section VI, Risk beryllium-containing liquid, or a standards for provision of personal Assessment). With regard to NGK’s hooded respirator where the employee protective equipment for general suggested language, the Agency believes is exposed to beryllium-containing industry (29 CFR part 1910 Subpart I), the commenter’s intention to clarify fumes). construction (29 CFR part 1926 Subpart OSHA’s position on clean, solid The USW also requested that OSHA E), and shipyards (29 CFR part 1915 materials is already captured in the include a specific requirement for Subpart I). As described in the non- regulatory text of the standards. provision of PPE to workers performing mandatory appendix providing Paragraph (h)(1)(ii) is not intended to maintenance and repair activities and guidance on conducting a hazard require the provision of PPE to during non-routine tasks, to ensure that assessment for OSHA general industry employees whose only contact with PPE is worn during tasks for which standards (29 CFR 1910 Subpart I beryllium is handling articles that do airborne exposure levels are not Appendix B), the employer should not have surface contamination with assessed (Document ID 1680, pp. 4–5; ‘‘exercise common sense and beryllium. 1681, p. 12). This comment was appropriate expertise’’ in assessing In summary, OSHA has concluded submitted in response to the proposed hazards. By ‘‘appropriate expertise,’’ that beryllium surface contamination standard, which would have required OSHA means that individuals may not be visible yet may still cause PPE where airborne exposures exceed conducting hazard assessments must be sensitization. Because small beryllium the TWA PEL or STEL, but not in all familiar with the employer’s work particles can pass through intact or cases where dermal contact occurs and processes, materials, and work broken skin and cause sensitization, airborne exposure levels are lower. environment. A thorough hazard limiting the requirements for PPE based OSHA believes the USW’s concern has assessment should include a walk- on surfaces that are ‘‘visibly been addressed by the PPE requirements through to identify sources of hazards to contaminated’’ may not adequately of the final standards, which apply employees, wipe sampling to detect protect workers from beryllium wherever there is reasonable beryllium contamination on surfaces, exposure. Submicron particles (less than expectation of dermal contact with review of injury and illness data, and 1 mg in diameter) are not visible to the beryllium, including during employee input on the hazards to which

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they are exposed. Information obtained maritime (e.g., 29 CFR 1926.57(f), 29 and contamination of the work area in this manner provides a basis for the CFR 1915.34) (Document ID 1673, pp. from beryllium residues on the PPE (i.e., identification and evaluation of 22–23). OSHA disagrees, based on the re-entrainment of beryllium particulate). potential hazards. OSHA believes that performance-oriented nature of the PPE If, however, employees are performing the implementation of a comprehensive requirements in the final beryllium tasks involving exposure intermittently and thorough program to determine standards. If an employer provides PPE throughout the day, or if employees are areas of potential exposure, consistent that is appropriate and suitable for exposed to other contaminants where with the employer’s written exposure abrasive blasting and that protects the PPE is needed, this provision requires control plan, is a sound safety and employee’s skin, this would be the employer to ensure that the health practice and a necessary element compliant with the requirements under employee wears is not intended to of ensuring overall worker protection. this final beryllium standard. prevent them from wearing the PPE Based on the hazard assessment Paragraph (h)(2) contains until the completion of their shift, results, the employer must determine requirements for removal and storage of unless it has become visibly what PPE is necessary to protect PPE. This provision is intended to contaminated with beryllium. employees from beryllium exposure. reduce beryllium contamination in the PPE that is visibly contaminated with The requirements for choosing PPE workplace and limit beryllium exposure beryllium should be changed at the under OSHA’s personal protective outside the workplace. Wearing earliest reasonable opportunity. This equipment standards (e.g., 29 CFR 1910 contaminated clothing outside the provision is intended to protect Subpart I for general industry) are beryllium work area could lengthen the employees working with beryllium and performance-oriented, and are designed duration of exposure and carry their co-workers from exposure due to to allow the employer flexibility in beryllium from beryllium work areas to accumulation of beryllium on PPE, and selecting the PPE most suitable for each other areas of the workplace. In reduces the likelihood of cross- particular workplace. The type of PPE addition, contamination of personal contamination from beryllium- needed will depend on the potential for clothing could result in beryllium being contaminated PPE. Unlike the ‘‘visibly exposure, the physical properties of the carried to employees’ cars and homes, contaminated’’ language used in beryllium-containing material used, and increasing employees’ exposure as well paragraph (h)(1)(ii) of the proposal, the conditions of use in the workplace. as exposing others to beryllium hazards. which has been removed, OSHA has For example, shipping and receiving An NJH collaborative study with NIOSH determined that it is appropriate to use activities may necessitate only work documented inadvertent transfer of the same language here. Because the uniforms and gloves. In other situations, beryllium from the workplace to purpose of PPE is to serve as a barrier such as when a worker is performing workers’ automobiles, and stressed the between an employee’s body and facility maintenance, gloves, work need for separating clean and ambient or surface beryllium, PPE uniforms, coveralls, and respiratory contaminated (‘‘dirty’’) PPE (Document becomes contaminated with beryllium protection may be appropriate. ID 0474, Sanderson, 1999). Toxic metals immediately as part of its protective Beryllium compounds can exist in brought by workers into the home via function. Requiring PPE to be changed acidic or alkaline form, and these contaminated clothing and vehicles upon contamination with any amount of characteristics may influence the choice continue to result in exposure to beryllium is unreasonable and of PPE. Face shields may be appropriate children and other household members. unnecessary to protect employees. This in situations where there is a danger of A recent study of battery recycling is because contamination of PPE with being splashed in the face with workers found that lead surface beryllium during work processes does beryllium or a liquid containing contamination above the Environmental not reduce the effectiveness of PPE or beryllium. Coveralls with a head Protection Agency level of concern (≥40 create hazards to employees unless covering may be appropriate when a mg/ft2) was common in the workers’ sufficient beryllium accumulates on the sudden release of airborne beryllium homes and vehicles (Document ID 1875, PPE to impair its function or create could result in beryllium contamination Centers for Disease Control and additional exposures, such as by of clothing, hair, or skin. Respirators are Prevention, 2012, pp. 967–970). dispersing accumulated beryllium into addressed separately in the explanation Under paragraph (h)(2)(i), beryllium- the air. Furthermore, the process of of paragraph (g) earlier in this section of contaminated PPE must be taken off at changing contaminated PPE can create the preamble. the end of the work shift, at the opportunities for both inhalation Although some personal protective completion of tasks involving beryllium exposure and dermal contact with clothing may be worn over street exposure, or when PPE becomes visibly beryllium. The use of ‘‘visibly clothing, it is not appropriate for contaminated with beryllium, contaminated’’ protects employees from workers to wear protective clothing over whichever comes first. This provision is potential exposures while changing PPE street clothing if doing so could identical to the corresponding by limiting requirements to change PPE reasonably result in contamination of paragraph in the proposed standard, during work tasks involving beryllium the workers’ street clothes. In situations except for a slight reorganization to exposure to those circumstances when in which it is not appropriate for improve clarity and readability. changing it is necessary to maintain its workers to wear protective clothing over Paragraph (h)(2)(i) is intended to convey protective function and prevent deposits their street clothes employers must that PPE contaminated with beryllium of beryllium from accumulating and select and ensure the use of protective should not be worn when tasks dispersing. clothing that is worn in lieu of (rather involving beryllium exposure have been Using the ‘‘visible contamination’’ than over) street clothing, and must completed for the day. For example, if trigger in (h)(1)(ii) to determine when provide change rooms under paragraph employees perform work tasks involving employees must wear PPE in the first (i)(2). beryllium exposure for the first two instance would have reduced the The Abrasive Blasting Manufacturers hours of a work shift, and then perform protectiveness of the standard. Thus, Alliance (ABMA) asserted that the PPE tasks that do not involve exposure, they OSHA determined that it would be requirements under this standard are should remove their PPE after the inappropriate to use such a trigger in not consistent with the abrasive blasting exposure period to avoid the possibility that context. However, as explained requirements for construction and of increasing the duration of exposure above, using ‘‘visibly contaminated’’ in

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paragraph (h)(2)(i) actually increases the laundering, cleaning, maintaining, or use of disposable PPE, which could be protectiveness of the standard. It disposing of such PPE. These items both more protective and, in some cases, provides a cue for when it is must be brought to an appropriate less costly, than reusable PPE unacceptable for a worker to continue to location away from the workplace. To (Document ID 1676, p. 3; 1682, p. 3). In work in his or her contaminated PPE, be an appropriate location for purposes response, OSHA notes that it is not regardless of whether a shift or a task of paragraph (h)(2)(iv), the facility must prohibiting the use of disposable PPE. involving beryllium exposure has been be equipped to handle beryllium- As discussed above, OSHA is leaving completed. This common sense contaminated items in accordance with the decision regarding appropriate PPE approach is supported by Materion in these standards. The standards further to employers after they do their hazard its post-hearing comments: ‘‘If a job is require in paragraph (h)(2)(v) that PPE assessments. While these commenters such that company supplied work removed from the workplace for indicated that the regulatory text seems clothing may become dirty, wear a laundering, cleaning, maintenance, or to focus on reusable PPE, the personal protective over-garment to disposal be placed in closed, requirements specifically regarding keep your work clothing and your impermeable bags or containers. These reusable PPE are necessary to ensure person clean. If your work clothing requirements are intended to minimize that workers who handle this PPE becomes dirty, change it.’’ (Document ID cross-contamination and migration of downstream (for example, workers who 1752). beryllium, and to protect employees or launder or repair PPE) are protected and Paragraph (h)(2)(ii) requires other individuals who later handle that reusable PPE is appropriately employees to remove PPE consistent beryllium-contaminated items. Required handled and cleaned before being with the written exposure control plan warning labels should alert those reused. These provisions are not meant required by paragraph (f)(1). Paragraph handling the contaminated PPE of the to indicate that OSHA prefers reusable (f)(1) specifies that the employer’s potential hazards of exposure to PPE over disposable PPE. written exposure control plan must beryllium. Such labels must conform Under paragraph (h)(3)(ii), removal of contain procedures for minimizing with the hazard communication beryllium from PPE by blowing, cross-contamination, and procedures for standard (29 CFR 1910.1200) and shaking, or any other means which the storage of beryllium-contaminated paragraph (m)(3) of these standards. disperses beryllium in the air is PPE, among other provisions. While These warning requirements are meant prohibited as this practice could result proposed paragraph (h)(2)(ii) only to reduce confusion and ambiguity in unnecessary and harmful exposure to required personal protective clothing to regarding critical hazard information airborne beryllium. Paragraph (h)(3)(iii) be removed pursuant to the written communicated in the workplace by requires the employer to inform, in exposure control plan, the final requiring that this information be writing, any person or business entity language includes personal protective presented in a clear and uniform who launders, cleans, or repairs PPE equipment as well as clothing. This manner. required by this standard of the change was made to ensure consistency Paragraph (h)(3) of the standards potentially harmful effects of exposure with the rest of paragraph (h) and to addresses the cleaning and replacement to airborne beryllium and dermal confirm OSHA’s intent that beryllium- of PPE. Proper cleaning is necessary to contact with beryllium, and of the need contaminated personal protective ensure that neither the workers who use to handle the PPE in accordance with equipment should be treated with the the PPE nor those who clean and this standard. This provision is same care as contaminated clothing in maintain it are exposed to beryllium via intended to limit dermal and inhalation order to prevent additional airborne inhalation or dermal contact. Proper exposure to beryllium, and to exposure and dermal contact. replacement is necessary to ensure that emphasize the need for hazard Paragraph (h)(2)(iii) requires the PPE continues to function awareness and protective measures employers to ensure that protective effectively in protecting workers from consistent with these standards among clothing is kept separate from exposure. Paragraph (h)(3) is unchanged persons who clean, launder, or repair employees’ street clothing and that from the proposal. beryllium-contaminated items. storage facilities prevent cross- Paragraph (h)(3)(i) requires the contamination as specified in the employer to ensure that reusable PPE is (i) Hygiene Areas and Practices written exposure control plan. The cleaned, laundered, repaired, and Paragraph (i) of the final standards for language of this provision has been replaced as needed to maintain its general industry, construction, and modified slightly from the proposed effectiveness. In keeping with the shipyards requires that, when certain standard to emphasize prevention of performance orientation of the conditions are met, the employer must cross-contamination as well as standards, OSHA does not specify how provide employees with readily implementation of the written exposure often PPE should be cleaned, repaired, accessible washing facilities and change control plan, consistent with other or replaced. Appropriate time intervals rooms. Additionally, paragraph (i) of the requirements intended to limit for these actions may vary widely based final standard for general industry beryllium migration and cross- on the types of PPE used, the nature of requires that, when certain conditions contamination. OSHA believes these the beryllium exposures, and other are met, the employer must provide provisions are necessary to prevent the circumstances in the workplace. showers for employee use. Paragraph (i) spread of beryllium throughout and However, even in the absence of a of all three standards also requires the outside the workplace. mandated schedule, these requirements employer to take certain steps to The remainder of paragraph (h)(2) is must be completed at a frequency, and minimize exposure in eating and unchanged from the proposal and did in a manner, sufficient to ensure that drinking areas, and prohibits certain not elicit comments from stakeholders. PPE continues to serve its intended practices that may contribute to To further limit exposures outside the purpose of protecting workers from beryllium exposure. The final standards’ workplace, paragraph (h)(2)(iv) requires beryllium exposure. hygiene provisions are consistent with employers to ensure that beryllium- Several commenters discussed the other OSHA standards providing similar contaminated PPE is only removed from merits of the use of disposable PPE protection. For example, OSHA health the workplace by employees who are versus reusable PPE. These commenters standards for hexavalent chromium (29 authorized to do so for the purpose of indicated that OSHA should allow the CFR 1910.1026) and lead (29 CFR

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1910.1025) include hygiene provisions As discussed in this preamble at Section not observed. A study by Sanderson et along with engineering control V, Health Effects and Section VI, Risk al. measured the levels of beryllium on requirements to protect workers from Assessment, dermal contact with workers’ skin and vehicle surfaces at a exposure to toxic substances. OSHA’s beryllium can cause beryllium machining plant. The study showed standards addressing sanitation in sensitization, the first step in the beryllium was present on workers’ skin general industry (29 CFR 1910.141), development of CBD. Compliance with and in their vehicles, demonstrating that construction (29 CFR 1926.51) and the hygiene provisions of the final workers carried residual beryllium on shipyard employment (29 CFR 1915.88) standards will reduce the amount and their hands when leaving work also include hygiene provisions, duration of employees’ dermal contact (Sanderson et al., 1999, Document ID requiring the employer to provide with beryllium, and will therefore more 0474). In addition, dermal contact with change rooms equipped with storage effectively reduce employees’ risk of beryllium has been shown to occur even facilities for street clothes and separate developing CBD than would compliance at low airborne exposure levels. For storage facilities for protective clothing with the TWA PEL alone. example, skin wipe sample analysis of whenever employees are required by an Another commenter noted that dental laboratory technicians OSHA standard to wear protective hygiene areas and practices specified in performing grinding operations clothing because of the possibility of the proposal exceed requirements for demonstrated that beryllium was contamination with toxic materials. The abrasive blasting operations discussed present on the hands of workers even sanitation standards also include in OSHA’s Ventilation standard for when airborne exposures were well provisions for washing facilities and construction (29 CFR 1926.57) and below the TWA PEL (Document ID prohibit storage or consumption of food Mechanical paint removers standard in 1878, pp. 8–9). or beverages in any area exposed to a maritime employment (29 CFR 1915.34) The requirements in the standards to toxic material. (Document ID 1673, p. 23). Ancillary use washing facilities are performance- OSHA requested comment on the provisions in standards for specific oriented, simply requiring employees to hygiene provisions of the proposed substances such as beryllium use the washing facilities to remove standard for general industry, which complement these general OSHA beryllium from their skin when the was similar in most respects to the standards. As OSHA noted in Section criteria in paragraph (i)(1) of the hygiene provisions of the final general XVIII of the NPRM, the standards for standards are met. Typically, washing industry standard. It required employers abrasive blasting provide protection facilities will consist of one or more to provide readily accessible washing primarily to blasting operators, and do sinks, soap or another cleaning agent, facilities, change rooms and showers not apply to other employees who are and a means for employees to dry and to ensure the use of these facilities likely to experience beryllium themselves after washing. OSHA does for each employee exposed to beryllium exposures, such as blasting helpers and not intend to require the use of any when necessary. The proposed standard cleanup workers. In addition, OSHA particular soap, cleaning agent, or also required employers to take certain expects the hygiene provisions in the drying mechanism. Employers can steps to minimize exposure in eating final beryllium standards to decrease provide whatever washing materials and and drinking areas and prohibited the airborne exposure and dermal equipment they choose, as long as those certain practices that may contribute to contact even of employees who wear materials and equipment are effective in beryllium exposure. The remainder of respiratory protection and PPE required removing beryllium from the skin and this section discusses general comments by other standards, and will therefore do not themselves cause skin or eye on the hygiene section; explains the reduce significant risk of beryllium- problems. hygiene provisions of the final related health effects among abrasive Washing reduces exposure by limiting standards and OSHA’s response to blasters in construction and shipyards. the period of time that beryllium is in comments on each provision; and Paragraph (i)(1) of the proposed contact with the skin, and helps prevent discusses differences between the standard required that employers accidental ingestion. Although proposed and final standards and provide, for each employee working in engineering and work practice controls differences between the final standards a beryllium work area, readily and protective clothing and equipment for each sector. accessible washing facilities to remove are designed to prevent hazardous skin Most commenters agreed with the beryllium from the hands, face, and and eye contact, OSHA realizes that in need for hygiene areas and practices to neck. It also required employers to some circumstances exposure will protect workers from airborne exposure ensure that each employee exposed to nevertheless occur. For example, an to and dermal contact with beryllium beryllium use these facilities when employee who wears gloves to protect (Document ID 1664, p. 7; 1665, pp. 10– necessary. against hand contact with beryllium 11; 1667, pp. 5–6; 1675, p. 13; 1679, p. The requirements for washing may inadvertently touch his or her face 9; 1680, p, 5; 1689, p. 12). However, one facilities will reduce employees’ skin with the contaminated glove during the commenter stated that its engineering contact with beryllium, the possibility course of the day. The purpose of control systems eliminated the need for of accidental ingestion and inhalation of requiring washing facilities is to hygiene facilities (Document ID 1615, p. beryllium, and the spread of beryllium mitigate adverse health effects when 8). OSHA disagrees that engineering within and outside the workplace. As skin or eye contact with beryllium controls alone are sufficient to eliminate discussed in Section V of this preamble, occurs. the need for hygiene areas and practices. Health Effects, respiratory tract, skin, OSHA did not receive comment on Because significant risk of beryllium eye, or mucosal contact with beryllium this provision. Therefore, paragraph sensitization and CBD remain below the can result in beryllium sensitization, (i)(1) of the final standards is TWA PEL in the final beryllium which is a necessary first step toward substantively unchanged from proposed standards, ancillary provisions such as the development of CBD. Also, paragraph (i)(1). Paragraph (i)(1) of the requirements for hygiene areas and beryllium can contaminate employees’ final standard for general industry practices are appropriate to further clothing, shoes, skin, and hair, requires the employer to provide readily reduce that risk. See Building and prolonging workers’ beryllium exposure accessible washing facilities for Constr. Trades Dept. v. Brock (Asbestos and exposing others such as family employees who work in beryllium work II), 838 F.2d 1258, 1274 (D.C. Cir. 1988). members if proper hygiene practices are areas to remove beryllium from the

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hands, face, and neck and ensure that change their clothing. Note that rooms must be designed in accordance employees who have had dermal paragraph (h) of all three standards with the written exposure control plan contact with beryllium use these requires employers to provide required by paragraph (f)(1) of all three facilities at the end of the activity, ‘‘appropriate’’ personal protective standards, and with the applicable process, or work shift and prior to clothing. It is not appropriate for Sanitation standards in general industry eating, drinking, smoking, chewing employees to wear protective clothing (29 CFR 1910.141), construction (29 tobacco or gum, applying cosmetics, or over street clothing if doing so results in CFR 1926.51), and shipyards (29 CFR using the toilet. contamination of the employee’s street 1915.88). These Sanitation standards Because the standards for clothes. In such situations, the employer require change rooms to be equipped construction and shipyards do not must ensure that employees wear with storage facilities (e.g., lockers) for require beryllium work areas, the protective clothing in lieu of (rather protective clothing, and separate storage requirements for washing facilities set than over) street clothing, and provide facilities for street clothes, to prevent forth in paragraph (i)(1) of the change rooms. cross-contamination. construction and shipyard standards Another commenter stated that the As in the proposed standard for differ from the general industry final rule should require employers to general industry, paragraph (i)(3) of the standard in that they require employers develop a program that defines final standard for general industry to provide washing facilities for each approved storage areas for protective requires employers in general industry employee required to wear personal apparel and personal hygiene towels, to provide and ensure the use of protective clothing or equipment by the restricts access to this area, provides for showers if employees are or can final standards—that is, where employee training when handling or reasonably be expected to be exposed employees are reasonably expected to be reusing previously used items, and above the TWA PEL or STEL (paragraph exposed to beryllium above the TWA establishes an objective means for (i)(3)(i)(A)) and if employees’ hair or PEL or STEL or where there is a determining when an item can no longer body parts other than hands, face, and reasonable expectation of dermal be reused and must be laundered or neck could reasonably be expected to be contact with beryllium. Otherwise, the discarded (Document ID 1962, p. 5). contaminated with beryllium (paragraph requirements for washing facilities are OSHA agrees that employers should (i)(3)(i)(B)). Employers are only required the same in all three standards. develop and document procedures for to provide showers if paragraphs Paragraph (i)(2) of the proposed limiting beryllium cross-contamination (i)(3)(i)(A) and (B) both apply. Paragraph standard required employers to provide and migration, and has included such affected employees with a designated requirements in paragraph (f), Methods (i)(3)(ii) of the final standard for general change room and washing facilities in of Compliance, and paragraph (j), industry, like the proposed standard for accordance with the proposed standard Housekeeping. These paragraphs of the general industry, requires employers to and the Sanitation standard where final standards require each employer to ensure that employees use the showers employees were required to remove develop, document, and implement at the end of the work activity or shift their personal clothing. procedures for limiting beryllium involving beryllium if the employees Change rooms allow employees to migration and cross-contamination in reasonably could have been exposed remove their personal clothing in order their facilities, which should address above the TWA PEL or STEL, and if to use personal protective clothing. storage, handling and reuse of beryllium could reasonably have Minimizing contamination of beryllium-contaminated items and contaminated the employees’ body parts employees’ personal clothes will also access to storage facilities for beryllium- other than hands, face, and neck. The reduce the likelihood that beryllium contaminated clothing and PPE, requirement is restricted to body parts will contaminate employees’ cars and including towels if these are other than the hands, face, and neck homes, and other areas outside the contaminated with beryllium during because if employees have dermal workplace. Requiring employers to washing and showering. contact with beryllium on their hands, provide employees with change rooms After carefully reviewing the record, faces, or necks, they must use the to change out of work clothes, which are OSHA has decided to keep paragraph washing facilities required by paragraph then segregated from their street clothes, (i)(2) substantively unchanged. (i)(1)(i). This language is intended to and to leave work clothing at the Paragraph (i)(2) of the final standard for convey that showers must be used workplace significantly reduces the general industry requires the employer immediately after work activities possibility of beryllium migration to provide a designated change room for involving beryllium exposure have been outside the workplace, providing added employees who work in a beryllium completed for the day. For example, if protection from take-home beryllium work area and are required to remove employees perform work activities exposure to workers and their families. their personal clothing. Paragraph (i)(2) involving beryllium exposure that meet One commenter recommended that of the final standards for construction the requirements for showers for the change rooms be required only when and shipyards requires the employer to first two hours of a work shift, and then there is required use of personal provide a designated change room for perform activities that do not involve protective clothing and equipment employees who are required by the final exposure, they should shower after the (Document ID 1667, pp. 5–6). OSHA standards to wear personal protective exposure period to avoid increasing the intends the change rooms requirement clothing or equipment and are required duration of exposure, potential of only to apply to covered workplaces to remove their personal clothing. The accidental ingestion, and contamination where employees must change their changed trigger for change rooms in the of the work area from beryllium residue clothing (i.e., take off their street construction and shipyard standards is on their hair and body parts other than clothes) to use protective clothing. In due to the fact that there are no hands, face, and neck. If, however, situations where removal of street beryllium work areas in those standards, employees are performing tasks clothes is not necessary (e.g., in a and requiring change rooms where involving exposure intermittently workplace where only gloves are used employees are required to wear personal throughout the day, this provision is as protective clothing), change rooms protective clothing or equipment intended to require them to shower after are not required. The standards do not provides a similar level of protection to the last task involving exposure, not create a requirement for employees to the general industry standard. Change after the completion of each such task.

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The requirements of paragraph (i)(3) OSHA notes that NJH and NABTU’s OSHA does not believe that air showers of the final standard for general industry comments addressed the provisions of are appropriate for removing beryllium are similar to requirements for provision the proposed standard for general from workers’ skin. Air showers are and use of shower facilities in other industry, which did not include a designed to remove accumulations of substance-specific OSHA health requirement to provide PPE wherever dust from the surface of work clothing, standards, such as the standards for there is a potential for dermal contact PPE, and exposed skin, but cannot cadmium (29 CFR 1910.1027) and lead with beryllium. As discussed previously remove residual beryllium as effectively (29 CFR 1910.1025), which also require in the Summary and Explanation for as washing with water and soap. In showers when exposures exceed the paragraph (h) of the final standards, addition, air showers can disperse TWA PEL. OSHA’s standard for coke OSHA has adopted much more beryllium-containing dust into the air oven emissions (29 CFR 1910.1029) comprehensive requirements for and cause employees additional requires employers to provide showers employers to provide and ensure the use airborne exposure, whereas water-based and ensure that employees working in a of personal protective clothing and showers do not re-entrain dust into the regulated area shower at the end of the equipment (PPE) wherever exposure air. work shift. The standard for exceeds the TWA PEL or STEL or OSHA has not included a requirement methylenedianiline (MDA) (29 CFR dermal contact with beryllium is for showers in the final standards for 1910.1050) requires employers to ensure reasonably expected to occur. The construction and shipyards. Workers in that employees who may potentially be Agency believes that employees these industries are exposed to exposed to MDA above the action level working in low-exposure contexts beryllium primarily when an abrasive shower at the end of the work shift. (where exposures do not exceed the that contains trace amounts of A majority of the comments on the TWA PEL or STEL) and using beryllium, usually coal or copper slags, proposed hygiene areas and practices comprehensive PPE as required in is used during abrasive blasting provisions for general industry paragraph (h) are unlikely to experience operations. These abrasive slags contain concerned the requirement for showers. beryllium contamination that requires less than 0.1% beryllium but may result The Sampling and Analysis shower facilities to effectively remove in significant airborne exposure to Subcommittee Task Group of the beryllium from the hair and skin. OSHA beryllium because of the high dust Beryllium Health and Safety Committee therefore concludes that the required levels generated during abrasive (BHSC Task Group) expressed support washing facilities and change rooms for blasting. However, workers conducting abrasive blasting with these abrasives for the mandatory use of showers for general industry employees working in are currently protected from dermal workers in beryllium regulated areas beryllium work areas in combination contact with beryllium under existing where airborne exposures can with the comprehensive PPE OSHA standards. The OSHA Ventilation reasonably be expected to exceed the requirements described in paragraph (h) standard for construction (29 CFR TWA PEL or STEL so that proper of the final standards are sufficient to 1926.57) and the OSHA Mechanical decontamination can occur and prevent protect workers in areas where paint removers standard for shipyard beryllium from leaving the work area, exposures do not exceed the TWA PEL or STEL and where there is no employment (29 CFR 1915.34) require and to ensure that workers and their reasonable expectation that body areas personal protective clothing and families are not exposed to beryllium other than hands, face and neck will be respiratory protection for abrasive once workers leave their place of contaminated with beryllium. OSHA blasters. The Ventilation standard employment (Document ID 1665, pp. therefore has decided not to require the requires employers to use only 10–11). Ameren Corporation (Ameren), provision of showers in general industry respirators approved by NIOSH under the United Steelworkers (USW), and workplaces where exposure does not 42 CFR part 84 for protecting employees Materion Corporation (Materion) also exceed the TWA PEL or STEL. from dusts produced during abrasive- supported the requirement for showers The Boeing Company (Boeing) blasting operations (29 CFR and their use by employees working in suggested requiring showers only when 1926.57(f)(5)(i)) and abrasive-blasting a beryllium regulated area (that is, beryllium visibly contaminates respirators must be worn by all abrasive- where airborne exposures can employees’ hair or body parts other than blasting operators (29 CFR reasonably be expected to exceed the hands, face, and neck (Document ID 1926.57(f)(5)(ii)). These abrasive TWA PEL or STEL) (Document ID 1675, 1667, p. 6). However, as discussed blasting respirators cover the entire p. 13; 1680, p. 5; 1681, p.12). previously in the Summary and head, neck and shoulder area to protect Some commenters supported the Explanation of paragraph (h), Personal the worker from rebounding abrasive requirement for showers, but suggested Protective Clothing and Equipment, during these operations and prevent that employers should be required to dermal contact with beryllium can lead beryllium exposure to the head and provide shower facilities to workers to adverse health effects regardless of neck area. The Mechanical paint exposed at lower exposure levels than whether sufficient beryllium-containing removers standard has similar the TWA PEL or STEL. National Jewish dust has accumulated to be visible to requirements for abrasive blasters Health (NJH) suggested that showers the naked eye. Therefore, OSHA has including the use of hoods and airline should be required for workers exposed determined that requiring showers only respirators, along with protective above the action level rather than the where beryllium contamination is clothing (29 CFR 1915.34(c)). TWA PEL or STEL and in facilities visible would not adequately protect Compliance with these requirements where beryllium can be expected to employees from prolonged dermal should effectively prevent contaminate the employees’ hair or contact with beryllium or adequately contamination of abrasive blasters’ other body parts (Document ID 1664, p. prevent transfer of beryllium outside the bodies with beryllium; thus, use of 7). The North America’s Building workplace. showers to remove beryllium is Trades Unions (NABTU) suggested that Another commenter suggested that air unnecessary for these workers. any beryllium work area should include showers for when employees leave the Abrasive blasting support workers all necessary decontamination facilities, work area would be more cost effective such as pot tenders and cleanup including showers (Document ID 1679, and acceptable than water-based workers are also potentially exposed to p. 9). showers (Document ID 1596, p. 1). beryllium during abrasive blasting

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activities (Chapter IV, Technological drinking area with personal protective the term ‘‘as free as practicable’’ in its Feasibility). However, their work is clothing or equipment unless, prior to substance specific standards . . . usually remote from the actual abrasive entry, surface beryllium has been OSHA’s use of this term has been blasting or occurs prior to or after the removed from the clothing or equipment understood by workers, management operation is completed, resulting in by methods that do not disperse and OSHA compliance officers. OSHA lower exposures. OSHA’s exposure beryllium into the air or onto an has successfully applied this profile for these workers shows a employee’s body. compliance term in many prior OSHA median exposure below the final A commenter with the American standards which serves to demonstrate standards’ action level (0.09 mg/m3 for Federation of Labor and Congress of that its use is understandable and pot tenders and helpers and 0.07 mg/m3 Industrial Organizations (AFL–CIO) effective in practice’’ (Document ID for cleanup helpers) which is well recommended that OSHA develop 1808, p. 5). In post-hearing comments, below the median exposure level of 0.2 stronger language to ensure that KCP states its belief that ‘‘visibly mg/m3 for abrasive blasters (Chapter IV, exposure levels are ‘‘well below’’ the contaminated’’ is an inadequate Technological Feasibility) and well action level for eating and drinking standard and should not be used as a below the trigger for provision of areas and that surfaces are truly as free stand-in for ‘‘as clean as practicable’’ showers established in the final as practicable of beryllium (Document (Document ID 1962, p. 2). standard for general industry. While ID 1689, pp. 12–13). OSHA agrees with In developing the final standards, abrasive blasting support workers are the commenter that airborne beryllium OSHA carefully considered these not exposed to the high dust levels should be maintained well below the comments on the use of ‘‘as free as experienced by the abrasive blasting action level in eating and drinking areas practicable’’ and alternative operator, these workers are nevertheless and has decided not to include the requirements in reference to surface protected under the personal protective proposal’s hygiene provision that no cleanliness in eating and drinking areas clothing and equipment requirements in employee in eating and drinking areas is and elsewhere in the beryllium paragraph (h) of the final standards exposed to airborne beryllium at or standards, and concluded that ‘‘as free which requires the use of appropriate above the action level in the final as practicable’’ is the most appropriate personal protective clothing and standards. OSHA believes that this terminology for requirements pertaining equipment where exposure can language may be interpreted to allow to surface cleanliness. Issues related to reasonably be expected to exceed the airborne exposure levels up to the use of ‘‘as free as practicable’’ and TWA PEL or STEL or where there is a action level in eating and drinking alternatives to this language are also reasonable expectation of dermal areas, which is not OSHA’s intent. The discussed in the Summary and contact with beryllium. Based on the requirements to maintain surfaces in Explanation for paragraph (j), personal protective clothing and these eating and drinking areas as free Housekeeping. The requirement to maintain surfaces equipment requirements under OSHA as practicable of beryllium and to as free as practicable of the regulated standards for abrasive blasting operators ensure that employees do not enter substance is included in other OSHA and support workers, and the low eating and drinking areas with personal health standards such as those for lead exposure levels described above and in protective work clothing or equipment in general industry (29 CFR 1910.1025), Chapter IV, Technological Feasibility, unless beryllium has been removed will lead in construction (29 CFR 1926.62), OSHA is not requiring showers in the limit contamination and airborne exposure to beryllium and provide chromium (IV) (29 CFR 1910.1026), and final standards for construction and workers with safe areas to eat and drink. asbestos (29 CFR 1910.1001). Employers shipyards. OSHA also notes that In comments on surface cleanliness therefore have the benefit of previous providing showers can be impractical in pertaining to eating and drinking areas, experience interpreting and developing some temporary worksites, such as Boeing suggested that the standard methods for compliance with those often used in construction should define specific surface requirements to maintain surfaces ‘‘as settings. contaminant levels or instead simply free as practicable’’ of toxic substances, Paragraph (i)(4) (eating and drinking rely on the existing OSHA Sanitation as well as guidance from OSHA on areas) of OSHA’s proposed rule for standard (1910.141) (Document ID 1667, compliance with such requirements. As general industry required that whenever p. 6). Kimberly-Clark Professional (KCP) OSHA explained in a January 13, 2003 the employer allows employees to suggested that OSHA should set a future letter of interpretation concerning the consume food or beverages at a worksite goal of establishing maximum allowable meaning of ‘‘as free as practicable’’ in where beryllium is present, the surface contamination standards for OSHA’s Lead in Construction standard, employer must ensure that surfaces in toxic substances (Document ID 1962, p. OSHA evaluates whether a surface is eating and drinking areas are as free as 3). Materion suggests that its ‘‘visibly ‘‘as free as practicable’’ of a contaminant practicable of beryllium to minimize the clean’’ standard is analogous to OSHA’s by the rigor of the employer’s program possibility of food contamination and standard of ‘‘as free as practicable’’ and to keep surfaces clean (OSHA, 2003, the likelihood of additional exposure to that its cleaning program ensures that Document ID 0550). A sufficient beryllium through inhalation or surfaces remain ‘‘as free as practicable’’ housekeeping program may be indicated ingestion. Proposed paragraph (i)(4) of beryllium (Document ID 1807, p. 5). by a routine cleaning schedule and the further required employers to ensure Materion and USW proposed the term use of effective cleaning methods to that no employee in eating and drinking ‘‘visibly clean’’ because they ‘‘have minimize the possibility of exposure areas is exposed to airborne beryllium at found it to be well understood by both from accumulation of beryllium on or above the action level, and that eating workers and management’’ (Document surfaces. OSHA’s compliance directive and drinking areas must comply with ID 1808, p. 4). However, Materion also on Inspection Procedures for the the Sanitation standard (29 CFR points out that the use of the term ‘‘as Chromium (VI) Standards provides 1910.141). Paragraph (i)(5)(ii) free as practicable’’ has been understood additional detail on how OSHA (prohibited activities) of the proposed by workers, management and OSHA interprets ‘‘as free as practicable’’ for rule, also related to eating and drinking compliance officers and has been enforcement purposes (OSHA, 2008, areas, required the employer to ensure successfully applied and effective in Document ID 0546, pp. 45–47). As that no employees enter any eating or practice: ‘‘[f]or decades, OSHA has used explained in the directive, if a wipe

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sample reveals a toxic substance on a removed for the reasons already exposures are, or can reasonably be surface, and the employer has not taken discussed above. And the requirement expected to be, above the TWA PEL or practicable measures to keep the surface concerning employees entering any STEL. Exposure at these levels creates a clean, the employer has not kept the eating or drinking area with personal greater risk of beryllium contaminating surface as free as practicable of the toxic protective clothing or equipment has the food, drink, tobacco, gum, or substance. Thus, OSHA believes that the been moved from the prohibited cosmetics. Prohibiting eating and term ‘‘as free as practicable’’ is clearly activities section of the proposed rule’s drinking in these areas will reduce the understood by employers through its hygiene provision to the eating and potential for this manner of exposure. use in other standards and as explained drinking areas section in the final For the foregoing reasons, OSHA has in letters of interpretation and is using standards. decided to promulgate all the this term in the hygiene provision of the Paragraph (i)(4) of the final standard requirements of the proposed hygiene final standards. for general industry and paragraph (i)(3) areas and practices provisions in the OSHA does not set quantitative limits of the final standards for construction beryllium final standard for general for surface contamination because the and shipyards do not require the industry except for the eating and best available scientific evidence on employer to provide separate eating and drinking areas action level limit noted adverse health effects from dermal drinking areas to employees at the above. For the final standards for contact with beryllium does not provide worksite. Employees may consume food construction and shipyards, OSHA has sufficient information to link risk of or beverages offsite. However, where the decided to include all of the hygiene adverse health effects with specific employer chooses to allow employees to areas and practices provisions proposed levels of surface contamination. As consume food or beverages at a worksite for general industry except for the described above, OSHA finds that wipe where beryllium is present, the requirement for showers and the eating sampling can be helpful in determining employer is required to maintain the and drinking areas action level limit. whether an employer is in compliance area in accordance with paragraph (i)(4) (j) Housekeeping with a requirement to keep surfaces as of the final standard for general industry free as practicable of toxic substances, or paragraph (i)(3) of the final standards Paragraph (j) of the final standard for but concludes that use of a specific for construction and shipyards, and general industry requires employers to target level of surface contamination with the applicable Sanitation standard maintain all surfaces in beryllium work should not define compliance with (29 CFR 1910.141, 29 CFR 1915.1915.88, areas as free as practicable of beryllium; surface cleanliness requirements of the or 29 CFR 1926.51), and the employer promptly clean spills and emergency beryllium standards. must ensure that employees do not enter releases of beryllium; use appropriate Based on these conclusions, eating and drinking areas wearing cleaning methods; and properly dispose paragraph (i)(4) of the final standards contaminated personal protective of materials containing or contaminated requires that wherever the employer clothing or equipment. with beryllium. Paragraph (j) of the final allows employees to consume food or Paragraph (i)(5)(i) of the proposed standards for construction and beverages at a worksite where beryllium standard, setting forth prohibited shipyards requires employers to follow is present, the employer must ensure activities, required the employer to the written exposure control plan that surfaces in these areas are as free as ensure that no employees eat, drink, required under paragraph (f)(1) when practicable of beryllium. The employer smoke, chew tobacco or gum, or apply cleaning beryllium-contaminated areas, must also ensure that employees do not cosmetics in regulated areas. OSHA did use appropriate cleaning methods, and enter eating and drinking areas with not receive comment on this provision. provide recipients of beryllium- personal protective work clothing or Therefore, paragraph (i)(5) of the final containing materials for use or disposal equipment unless, prior to entry, surface standards is substantively unchanged with a copy of the warning described in beryllium has been removed from the from proposed paragraph (i)(5)(i). paragraphs (m)(2) and (m)(3), clothing and equipment by methods that Paragraph (i)(4) of the final construction respectively. do not disperse beryllium into the air or and shipyard standards is substantively As discussed in more detail below, onto an employee’s body, further identical to paragraph (i)(5) of the the housekeeping requirements in the protecting workers from beryllium general industry standard. final standards are similar to those contamination in areas where eating and Paragraph (i)(5) of the final standard included in the proposal. While some drinking occurs. Eating and drinking for general industry and paragraph (i)(4) stakeholders submitted divergent areas must further comply with the of the final standard for shipyards opinions on certain aspects of the Sanitation standards (29 CFR prohibit eating, drinking, smoking, proposed provisions, several 1910.141(g), 1926.51(g), 1915.88(h)), chewing tobacco or gum, or applying commenters offered broad support for which prohibit consuming or storing cosmetics in regulated areas (areas the inclusion of housekeeping food or beverages in a toilet area or in where airborne exposure to beryllium is provisions in the final rule (e.g., any area exposed to a toxic material. In expected to exceed the TWA PEL or Document ID 1664, p. 7; 1681, the final standards, the provisions for STEL). Paragraph (i)(4) of the final Attachment 1, p. 13). For example, eating and drinking areas (paragraph standard for construction differs slightly United Steelworkers (USW) stated that (i)(4) of the general industry standard, in that the employer is required to ‘‘the proposed text provides employers paragraph (i)(3) of the construction and ensure that no employees eat, drink, with clear responsibilities and provides shipyard standards) and prohibited smoke, chew tobacco or gum, or apply strong provisions to ensure worker activities (paragraph (i)(5) of the general cosmetics in work areas where there is protection’’ (Document ID 1681, industry standard and paragraph (i)(4) a reasonable expectation of exposure Attachment 1, p. 13). USW also of the construction and shipyard above the TWA PEL or STEL. This expressed appreciation for the standards) have been retained with one difference arises because the final ‘‘precautions incorporated into this exception and one structural change. standard for construction does not have section to minimize the amount of The proposed requirement to ensure a requirement for regulated areas but particulate suspended in the air’’ that no employee in eating and drinking instead relies on a competent person (Document ID 1681, Attachment 1, p. areas is exposed to airborne beryllium at provision (paragraph (e)) to restrict 13). Another stakeholder, National or above the action level has been employee access to areas where Jewish Health (NJH), agreed with the

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proposed rule regarding housekeeping materials containing beryllium to OSHA ‘‘establish surface contamination (Document ID 1664, p. 7). Similarly, the another party for use or disposal, the standards such that all subjectivity of American Federation of Labor and employer is required to advise the surface cleanliness is removed’’ Congress of Industrial Organizations recipient of the beryllium content and (Document ID 1962, p. 2). KCP also (AFL–CIO) argued that ‘‘housekeeping hazards. These provisions complement, argued that OSHA should require an provisions are essential’’ ‘‘[b]ecause of rather than contradict, the rules set out employer’s surface cleanliness protocol the hazardous nature of beryllium and in 29 CFR 1926.57(f) and 29 CFR to be based on objective sampling and the significant risk of developing 1915.34, and are necessary for employee measurement. KCP maintained that beryllium sensitization or disease’’ protection from beryllium-related there are many examples where surface (Document ID 1689, p. 13). adverse health effects. sampling is used in economically These comments support OSHA’s Paragraph (j)(1)(i) of the proposed rule feasible ways, including in the facilities view, as expressed in the NPRM, that would have required employers to governed by the Department of Energy these provisions are important because maintain all surfaces in beryllium work (DOE). However, it acknowledged that they minimize additional sources of areas as free as practicable of the methods in other environments, exposure to beryllium that engineering accumulations of beryllium and in including the DOE protocols for controls do not completely eliminate. accordance with the exposure control beryllium control in energy facilities, Good housekeeping measures are a cost- plan required under paragraph (f)(1) and may not translate directly to industrial effective way to control worker the cleaning methods required under facilities. Nevertheless, KCP observed exposures by removing settled paragraph (j)(2) of the proposed rule. In that ‘‘there is sufficient ongoing beryllium that could otherwise become this context, the phrase ‘‘as free as successful use of such approaches to re-entrained into the surrounding practicable’’ set forth the baseline goal provide a framework for a more atmosphere by physical disturbances or in the development of an employer’s objective, data-driven protocol for air currents and could enter an housekeeping program to keep work surface control than ‘visibly employee’s breathing zone. Moreover, areas free from surface contamination. contaminated’ ’’ (Document ID 1962, p. housekeeping provisions may be For a detailed discussion of the meaning 3). The Boeing Company (Boeing) also especially critical in the final beryllium of the phrase ‘‘as free as practicable,’’ requested that ‘‘as free as practicable’’ standards because contact with see the discussion in the Summary and be replaced with defined surface contaminated surfaces can result in Explanation for paragraph (i), Hygiene contaminant levels (Document ID 1667, dermal exposure to beryllium. As areas and practices, in this section of the pp. 6). discussed in this preamble at section V, preamble. Conversely, the Department of Health Effects, researchers have Although this requirement is often Defense (DOD) commented that identified skin exposure to beryllium as included in OSHA’s substance specific employers should not be required to a pathway to sensitization. In addition, regulations, a number of commenters measure beryllium contamination on the housekeeping provisions in expressed concern about its inclusion in surfaces, as the relationship between paragraph (j) of the standards for general this rulemaking. For example, USW level of surface contamination and industry, construction, and shipyards argued that a ‘‘requirement to maintain health risk is unknown. It also stated are generally consistent with all surfaces in beryllium work areas as that wipe samples are not an housekeeping requirements in other free as practicable of accumulations of appropriate enforcement tool for OSHA standards for toxic metals, beryllium could lead to difficulties in determining that surfaces are ‘‘as free as including cadmium (29 CFR 1910.1027, assessing compliance, since ‘as free as practicable’’ of beryllium contamination 1926.1127), chromium (VI) (29 CFR practicable’ is open to interpretation’’; (Document ID 1684, Attachment 1, p. 1). 1910.1026), and lead (29 CFR instead, USW suggested that beryllium ORCHSE Strategies (ORCHSE) agreed 1910.1025, 1926.62). work areas should be required to be that OSHA should not require The Abrasive Blasting Manufacturers maintained ‘‘visibly clean’’ of measurement of beryllium Alliance (ABMA) asserted that the accumulations (Document ID 1681, p. contamination on surfaces (Document proposed housekeeping requirements 13). Materion Corporation (Materion) ID 1691, p. 18). And, the American are not consistent with the abrasive also proposed the term ‘‘visibly clean’’ Industrial Hygiene Association (AIHA) blasting requirements for construction (Document ID 1808, p. 5; 1752, p. 1). commented that ‘‘the evaluation of and shipyards (e.g., 29 CFR 1926.57(f), However, Materion stated that OSHA ‘visible’ is subjective’’ (Document ID 29 CFR 1915.34) (Document ID 1673, has long used the term ‘‘as free as 1686, p. 1). pp. 22–23). OSHA disagrees. The practicable’’ in its standards as a After carefully considering these performance-oriented provisions in the measure of cleanliness for work areas comments and other evidence in the final construction and shipyard and eating areas, and the term is well record, OSHA has chosen not to require standards for beryllium provide understood by workers, management, employers to measure beryllium employers with a great deal of flexibility and OSHA compliance officers. contamination on surfaces, as suggested in cleaning beryllium-contaminated According to Materion, ‘‘visibly clean’’ by KCP, or to otherwise ‘‘define specific areas and spills and emergency releases is similar to ‘‘as free as practicable’’ and surface contaminant levels,’’ as of beryllium and disposing of materials also well understood by workers and requested by Boeing Company. As DOD designated for disposal or recycling. In management (Document ID 1808, p. 5). explains in its comments, the essence, the text requires employers to Kimberly-Clark Professional (KCP) relationship between a precise amount choose cleaning methods that minimize stated that this ‘‘ostensible equivalence’’ of surface contamination and health risk the likelihood and level of airborne between the ‘‘as free as practicable’’ and is unknown. Therefore, OSHA cannot exposure (unless certain conditions are ‘‘visibly clean’’ standards is find that a particular level of met), handle and maintain cleaning ‘‘unfounded,’’ in part, because ‘‘[i]t is contamination is safe. Rather, OSHA has equipment in a way that minimizes practicable using readily known and determined that keeping surfaces as exposure, and protect their employees available methods to make many clean as practicable is appropriate when dry sweeping, brushing, or using surfaces clean beyond that which is because promptly removing beryllium compressed air to clean in beryllium- visibly apparent’’ (Document ID 1962, p. deposits prevents them from becoming contaminated areas. When transferring 2). Instead, KCP recommended that airborne, thus reducing employees’

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inhalation exposure, and helps to for general industry requires the to maintain all surfaces in work areas as minimize the likelihood of skin contact employer to maintain all surfaces in free as practicable of beryllium in with beryllium. The Agency notes, beryllium work areas as free as construction or shipyards as for general however, that wipe samples can be a practicable of beryllium and in industry. Therefore, OSHA has not helpful tool for employers. For example, accordance with the written exposure included a reference to surfaces in the wipe samples can be used by employers control plan required under paragraph provisions of in paragraph (j)(1)(i) of the to detect the presence of beryllium on (f)(1) and the cleaning methods required final standards for construction and surfaces and help gauge when surfaces under paragraph (j)(2) of this standard. shipyards. OSHA has modified are as free as practicable of OSHA has not included the paragraph (j)(1)(i) of these standards to accumulations of beryllium. requirement that employers maintain all require only that the employer follow Therefore, OSHA has decided to surfaces in beryllium work areas as free the written exposure control plan retain the requirement that employers as practicable of beryllium in the final required under paragraph (f)(1) when maintain all surfaces in beryllium work standards for construction and cleaning beryllium-contaminated areas. areas as free as practicable of beryllium shipyards because certain conditions When beryllium is released into the in paragraph (j)(1)(i) of the final general typical in these sectors warrant different workplace as a result of a spill or industry standard. The term ‘‘as free as approaches in the housekeeping emergency release, paragraph (j)(1)(ii) of practicable’’ is accepted language and provisions. As discussed in the the final standards, like paragraph used in other OSHA housekeeping Summary and Explanation for (j)(1)(ii) of the proposal, requires the requirements for toxic dusts (Asbestos, paragraph (a), Scope and application, in employer to ensure prompt cleanup. As 29 CFR 1910.1001 and Cadmium, 29 this preamble, although employees in defined in paragraph (b) of the final CFR 1910.1027). As the Agency has the construction and shipyard standards, the term ‘‘emergency’’ means explained in a letter of interpretation on industries may be exposed to beryllium any uncontrolled release of airborne this term as used in the lead standard, during the demolition of beryllium- beryllium. An emergency could result ‘‘the requirement to maintain surfaces contaminated buildings and metal from equipment failure, rupture of ‘as free as practicable’ is performance- recycling or through the dressing of containers, or failure of control oriented. . . . The requirement is met non-sparking tools, the primary equipment, among other causes. Spills when the employer is vigilant in his exposure source of beryllium at or emergency releases not attended to efforts to ensure that surfaces are kept construction worksites and in shipyards promptly are likely to result in free of accumulations of lead-containing is from abrasive blasting operations additional employee exposure or skin dust. The role of the Compliance Safety (Document ID 1671, Attachment 1, p. 5; contact. and Health Officer (CSHO) is to evaluate 1756, Tr. 97–99). Specifically, Boeing objected to the proposed the employer’s housekeeping schedule, employees in the construction and requirement that employers maintain the possibility of exposure from these shipyard industries are typically surfaces and clean up spills or surfaces, and the characteristics of the exposed when they use abrasive blasting emergency releases in accordance with workplace’’ (OSHA, Jan. 13, 2003, Letter media that contain beryllium. the written exposure control plans of Interpretation.) The term ‘‘surface’’ Abrasive blasting in the construction required by paragraph (f)(1), in part, has a common meaning but is not and shipyard industries often occurs because it did not believe OSHA should separately defined in the standard. This outdoors (see the Final Economic require employees to establish a written term has been used multiple times in Analysis (FEA), Chapter IV. The exposure control plan. Instead, Boeing OSHA’s substance specific standards surfaces being blasted can be large suggested the Agency revise the and OSHA has not found that it is a structures, such as buildings or ships. standard to allow employers to use source of confusion for employers. As The blasting process itself can be ‘‘existing processes, such as a written indicated in the preamble to the transient and may occur for short beryllium worksite control procedure’’ proposed standard, the term includes periods of time. The work can be (Document ID 1667, p. 4). To that end, the outer parts of objects that workers performed in the open or in temporary Boeing suggested that employers be come into contact with, such as work enclosures when abrading large allowed to ensure prompt and proper equipment, floors, and items in storage objects or structures that cannot be cleanup in accordance with the facilities, as well as objects that workers transported or are fixed. These exposure control plan, ‘‘or equally as may not directly contact, such as rafters enclosures are typically constructed of effective documentation’’ (Document ID and ledges. See 80 FR 47796. Because tarps and regularly moved from newly 1667, pp. 6–7). As explained in the all surfaces in beryllium work areas abraded areas to areas needing abrasion Summary and Explanation for could potentially accumulate beryllium over very large distances (Document ID paragraph (f), Methods of Compliance, that could become airborne or that 1632, p. 6). in this preamble, OSHA disagrees with workers could later inhale, touch, or During the abrasive blasting process, Boeing and has chosen to retain the ingest, all surfaces in beryllium works large amounts of dust become airborne requirement to establish, implement, areas must be kept as free as practicable and then settle on nearby surfaces. and maintain a written exposure control of beryllium. Spent blasting media containing trace plan. Final paragraphs (j)(1)(i) and (ii) of OSHA has also decided to remove the amounts of beryllium is cleaned up after the standards, like proposed paragraphs phrase ‘‘accumulations of’’ from (j)(1)(i), the blasting operation is complete and (j)(1)(i) and (ii), thus require employers because OSHA believes the reference to has moved to a different area of the to perform housekeeping activities in ‘‘accumulations’’ may be misinterpreted worksite. Paragraph (j)(2) of the accordance with the written exposure to suggest that cleaning is only required construction and shipyard standards control plan required by paragraph (f)(1) when substantial deposits of beryllium- requires employers to ensure that and the cleaning methods required by containing material have accumulated employees use methods that minimize paragraph (j)(2) of the standards. on surfaces. As discussed previously, beryllium exposure during this cleaning Paragraph (j)(2) of the proposed rule dermal contact with small amounts of process. However, due to the outdoor included a few requirements regarding beryllium that are not visible to the location of many worksites in cleaning methods. Because OSHA naked eye can cause beryllium construction and shipyards, OSHA finds recognizes that each work environment sensitization. Thus, the final standard it is not practical to require employers is unique, the Agency proposed

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performance-oriented requirements for surfaces. However, the Agency provision to provide employers housekeeping to allow employers to acknowledges that any housekeeping flexibility when exposure-minimizing determine how best to clean beryllium equipment may fail and that cleaning methods would not be work areas. Paragraph (j)(2)(i) of the maintaining the equipment according to effective. See 80 FR 47796. However, proposed standard would have required the manufacturer’s recommendations the Agency indicated it was not aware that surfaces in beryllium work areas be can be a critical part of ensuring that it of any circumstances in which dry cleaned by high-efficiency particulate functions as intended. (See summary sweeping or brushing would be air filter (HEPA) vacuuming or other and explanation of paragraph (j)(2)(v) necessary and requested comment on methods that minimize the likelihood which addresses maintenance of whether either of these cleaning and level of beryllium exposure. cleaning equipment.) Nevertheless, methods would ever be necessary, and Some commenters, including NJH and OSHA believes that when HEPA if so, under what circumstances. See 80 USW, expressed support for the vacuums are maintained in proper FR 47574. proposed requirement to use HEPA- working condition, it is not necessary to Some commenters expressed general filtered vacuuming (e.g., Document ID include a requirement for particle support for the prohibition on dry 1664, p. 7; 1681, p. 13). NJH indicated counting during the vacuuming. In sweeping and brushing. For example, that HEPA-filtered vacuuming is one of addition, the Agency agrees with KCP Ashlee Fitch, representing USW and the methods that it recommends using that in certain circumstances other Materion, commented that HEPA because ‘‘it has been shown to minimize cleaning methods, such as wet wiping vacuums should be used whenever exposures’’ (Document ID 1664, p. 7). with towels, may also be effective in feasible, and stated that ‘‘OSHA has USW added that HEPA vacuums are minimizing the likelihood and level of appropriately characterized this common in the manufacturing industry airborne exposure. Thus, paragraph provision relative to exceptions’’ and requiring their use should not (j)(2)(i) of the general industry standard (Document ID 1680, p. 5). ORCHSE also burden employers (Document ID 1681, retains the requirement that employers agreed that prohibiting dry sweeping or p. 13). Southern Company also noted must ensure that surfaces in beryllium brushing to clean surfaces in beryllium that where beryllium is present as a work areas are cleaned by HEPA-filter work areas is appropriate, and that trace element in coal-fired power vacuuming or other cleaning methods employers should only be permitted to generation, ‘‘surfaces are cleaned and that minimize the likelihood and level use dry sweeping and dry brushing kept free of coal dust and ash by various of airborne exposure. However, as when HEPA-filtered vacuuming have methods, including vacuuming or discussed in detail below, OSHA has been tried and found not effective washing,’’ methods that may already also added provisions to accommodate (Document ID 1691, Attachment 1, p. 5). comply with this proposed provision situations where cleaning with HEPA- Commenters AFL–CIO, AWE, the (Document ID 1668, p. 6). filtered vacuums or other cleaning BHSC Task Group, and North America’s KCP also indicated its support for methods that minimize airborne Building Trades Unions (NABTU), HEPA vacuums, stating that vacuuming exposure are not effective. recommended prohibiting the use of dry with HEPA filters is the safest way to As explained above, OSHA has sweeping under any circumstances remove dry contaminants from surfaces chosen not to include a provision (Document ID 1689, p. 13; 1615, p. 1, 9; (Document ID 1676, Attachment 1, p. 5). requiring the cleaning of surfaces in the 1655, p. 11; 1679, p. 9). For example, However, KCP added that HEPA final construction and shipyard Clive LeGresley of AWE stated that vacuums do not always work well in standards. And, as explained in the AWE does not permit dry sweeping or tight areas with recesses, crevices, and Summary and Explanation for brushing to clean surfaces and complex arrangements of equipment paragraph (e), the construction and recommended banning this practice components and that workers are likely shipyard standards do not include a (Document ID 1615, p. 1). The BHSC to use a towel to clean such areas. provision establishing beryllium work Task Group recommended that dry Because workers will naturally use areas. Thus, references to surface sweeping be prohibited because it nearby towels, KCP recommended that cleaning and beryllium work areas have disturbs settled beryllium on surfaces, OSHA specify that towels used to clean been removed from paragraph (j)(2)(i) of ‘‘which can exacerbate airborne surfaces must be wet, not dry. the construction and shipyard contamination’’ (Document ID 1655, p. The Sampling and Analysis standards. Paragraph (j)(2)(i) in these 11). It also argued that dry sweeping is Subcommittee Task Group of the standards requires employers to ensure not an effective cleaning method, and Beryllium Health and Safety Committee the use of HEPA-filter vacuuming or when dry cleaning is the only available (BHSC Task Group) also expressed other methods that minimize the option, dry pickup cloths rather than concern with the proposed provision’s likelihood and level of airborne sweeping should be used (Document ID reliance on HEPA-filtered vacuuming. exposure when cleaning spent blast 1655, p. 13). The AFL–CIO The BHSC Task Group observed that media or performing other cleaning in recommended strengthening language in although HEPA-filtered vacuuming is beryllium-contaminated areas. the final rule to prohibit dry considered to be the most effective Paragraph (j)(2)(ii) of the proposed housekeeping methods (Document ID method for cleaning surfaces, it is not rule addressed the use of dry sweeping 1689, p. 13). In addition, the AFL–CIO necessarily effective in minimizing the and brushing for cleaning in beryllium pointed out that under the DOE Chronic spread of contamination because the work areas. This proposed provision Beryllium Disease Prevention Program, vacuums fail in various ways during would have disallowed the use of dry 10 CFR 850.30 (Housekeeping), the use use. The BHSC Task Group further sweeping and brushing unless the of dry methods for cleaning floors and suggested that if OSHA were to employer had tried cleaning with a surfaces in areas where beryllium is prescribe HEPA-filtered equipment use, HEPA-filtered vacuum or another present is prohibited (Document ID it should include a requirement for method that minimizes the likelihood 1689, p. 13). NABTU argued that there particle counting during use (Document and level of exposure, and found that are no circumstances in which dry ID 1665, p. 11). the method attempted was not effective sweeping or brushing is necessary, that OSHA finds that HEPA-filtered under the particular circumstances these practices are unsafe, and the use vacuuming is a highly effective method found in the workplace. As explained in of such practices would trigger the need of cleaning beryllium-contaminated the proposal, OSHA included this to decontaminate entire work areas

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before any work could be performed circumstances where they believed the filtered vacuums may not be safe or (Document ID 1679, p. 9). AFL–CIO use of dry sweeping was necessary effective in all situations in general additionally recommended that if dry (Document ID 1676, p. 5; 1668, p. 6; industry. For example, wet sweeping in cleaning methods are necessary due to 1807, pp. 2–3; 1756, Tr. 42–43). For certain foundry work areas may be feasibility issues, ‘‘employers should be example, as noted above, KCP argued effective but is not safe because of the required to conduct an exposure that HEPA-filtered vacuums do not physical hazard created when water assessment and provide a work process always work well in tight areas with comes into contact with molten metal. description’’ (Document ID 1809, p. 2). recesses, crevices, and complex Therefore, the Agency has retained both OSHA has considered AFL–CIO’s arrangements of equipment the prohibition on dry sweeping and dry comment, and finds that the components. Materion commented that brushing and the exceptions to that requirements for exposure assessment it generally prohibits the use of dry prohibition in paragraph (j)(2)(ii) of the included in paragraph (d) of the final brushing or broom cleaning for cleaning final standard for general industry. standards adequately address AFL– but, in instances such as machining Although OSHA has decided not to CIO’s recommendation for exposure operations, the use of paint brushes to allow these methods based on a specific assessment. If an employer uses dry clean small chips is required. Materion exposure level, OSHA has revised methods for cleaning beryllium- also noted that some manufacturing (j)(2)(ii) to clarify that employers may contaminated surfaces or areas, processes may use dry brushes. It added use dry sweeping or dry brushing to exposure from these methods should be that when it permits use of a brush, it clean surfaces where HEPA-filtered included in exposure assessment, and performs an exposure assessment ‘‘to vacuuming or other appropriate re-assessment of exposures must be help ensure the task is well controlled’’ methods that minimize likelihood and conducted when an employer adopts or (Document ID 1807, Attachment 1, pp. level of exposure are not safe or changes dry methods because this could 2–3). In addition, Jerrod Weaver from effective. The proposed provision cause new or additional exposures. the Non-Ferrous Founders’ Society merely stated that employers could In addition, OSHA has considered (NFFS) testified that dry sweeping is utilize the dry sweeping or brushing AFL–CIO’s recommendation to require ‘‘not unusual’’ in the foundry industry. when HEPA-filtered vacuuming or the employers who use dry methods to He explained that the use of wet other methods were not ‘‘effective.’’ The provide a work process description, and sweeping or other wet cleaning methods Agency intended this term to finds that a work process description would be dangerous in foundries encompass those situations in which provides no clear benefit to workers because when water hits molten metal, HEPA-filtered vacuuming or the other using dry methods for cleaning. it can cause an explosion (Document ID chosen method would not accomplish However, OSHA notes that paragraph 1756, Tr. 42–43). the task at hand, i.e., cleaning, and (m) of this standard, which requires Other stakeholders offered opinions situations in which the use of HEPA- training for every employee who is or on when the use of dry sweeping and filtered vacuuming or the other methods can reasonably be expected to be dry brushing should be constrained. For were unsafe. OSHA has modified the exposed to airborne beryllium, example, the Southern Company argued text of the final rule to make this intent encompasses any use of dry cleaning that when dry sweeping does not result explicit. methods in the demarcated beryllium in exposure to beryllium above the In sum, final paragraph (j)(2)(ii) of the work areas (or, in construction and action level, it should be considered a general industry standard states that the shipyard settings, in beryllium- feasible cleaning option (Document ID employer must not allow dry sweeping contaminated areas). Paragraph (m)(4) 1668, p. 6). Similarly, Ameren or brushing for cleaning surfaces in includes requirements that employees Corporation stated that ‘‘prohibiting dry beryllium work areas unless HEPA- can demonstrate knowledge and sweeping should be based on employee filtered vacuuming or other methods understanding of hazards associated exposure at or above the action level, that minimize the likelihood and level with beryllium exposure, operations not whether it’s a beryllium work area’’ of airborne exposure are not safe or that could result in airborne exposure, (Document ID 1675, p. 6). As discussed effective. In situations where HEPA- and measures employees can take to in Section V, Health Effects, and Section filtered vacuuming or other methods protect themselves from airborne VI, Risk Assessment, the best available that minimize the likelihood and level exposure to and contact with beryllium. scientific evidence suggests that adverse of airborne exposure would be OSHA intends that employees who use health effects such as beryllium ineffective, would cause damage, or dry methods for cleaning beryllium- sensitization and CBD can result from would create a hazard in the workplace, contaminated surfaces or areas must be airborne exposures below the action the employer is not required to use trained on the potential for airborne level of 0.1 mg/m3. In addition, OSHA these cleaning methods. The revised exposure during such cleaning, the does not see this suggestion as a paragraph (j)(2)(ii) gives employers the hazards associated with such exposure, practical solution where employers may necessary flexibility to use dry sweeping and the measures they can take to feel obligated to perform exposure or dry brushing in such situations. protect themselves, including the monitoring (or exposure assessments) Although OSHA is allowing for dry requirements of final paragraphs every time housekeeping functions are sweeping and brushing, the Agency (j)(2)(iv) and (j)(2)(v) discussed later in performed. OSHA, as it has done in anticipates that the number of this section. OSHA finds that these many other standards (e.g., Chromium circumstances where these methods are training requirements serve the purpose (VI), 29 CFR 1910.1026), continues to necessary will be extremely limited. of providing information to employees believe that a general prohibition is Where the employer uses dry sweeping regarding the work process, hazards and warranted considering the risk even at or brushing, the employer must be able methods of protection related to dry the action level. to demonstrate that HEPA-filtered sweeping, as OSHA believes the AFL– After carefully reviewing the evidence vacuuming or other methods, such as CIO’s recommendation intended. in the record, OSHA finds that the use wet sweeping, that minimize the Several stakeholders cited problems of dry sweeping and dry brushing can likelihood or exposure are not safe or with the use of HEPA-filtered vacuums contribute to employee exposure. effective. To comply with the final rule, or wet methods in particular However, OSHA also finds convincing it is enough for employers to circumstances, or noted specific evidence that wet methods and HEPA- demonstrate that such cleaning methods

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are unsafe or ineffective—actually operations may incorporate compressed disposal in order to prevent dispersal of attempting the method on a particular air into manufacturing processes beryllium into workers’ breathing zones. worksite is unnecessary. However, as in (Document ID 1807, Attachment 1, p. 3). OSHA recognizes that even the the proposal, the employer bears the Materion further commented that on the limited uses permitted under these burden of providing that these methods few occasions when it permits the use standards of dry sweeping, dry are either unsafe or ineffective. OSHA of compressed air, it performs an brushing, and compressed air to clean has included a similar provision in final exposure assessment ‘‘to help ensure the can result in employee exposure to paragraph (j)(2)(ii) of the standards for task is well controlled’’ (Document ID beryllium. To help mitigate the construction and shipyards. Like the 1807, Attachment 1, p. 3). Mr. Weaver, potential health risks, OSHA included a general industry provision, final a representative of NFFS, testified that provision in the proposed rule to further paragraph (j)(2)(ii) of the standards for the use of compressed air in the foundry protect employees who are using these construction and shipyards disallows industry is ‘‘not unusual’’ (Document ID cleaning methods. Under proposed dry sweeping and dry brushing and 1756, Tr. 42). He added that compressed paragraph (j)(2)(iv), where employees includes an exception for circumstances air is useful for cleaning work surfaces use dry sweeping, brushing, or where HEPA-filtered vacuuming, or (Document ID 1756, Tr. 42). compressed air to clean beryllium- other methods that minimize the Some commenters, including the contaminated surfaces, the employer likelihood of exposure are not safe or AFL–CIO, AWE, and United was required to provide respiratory effective. Because the construction and Automobile, Aerospace & Agricultural protection and protective clothing and shipyard standards do not include a Implement Workers of America (UAW), equipment and ensure that each provision establishing beryllium work objected to the use of compressed air for employee use this protection in areas, paragraph (j)(2)(i) of these cleaning (Document ID 1615 p. 1; 1689, accordance with paragraphs (g) and (h) standards requires the employer to p. 13; 1693, p. 4). For example, the of this standard. As OSHA explained in ensure the use of HEPA-filter AFL–CIO noted that the DOE Chronic the proposal, the failure to provide vacuuming or other methods that Beryllium Disease Prevention Program proper and adequate protection to those minimize the likelihood and level of prohibits the use of compressed air and employees performing cleanup activities airborne exposure when cleaning dry methods for cleaning floors and would defeat the purpose of the beryllium-contaminated areas. surfaces in areas where beryllium is housekeeping practices required to Paragraph (j)(2)(ii) states that the present (Document ID 1689, p. 13). And, control beryllium exposure. See 80 FR employer must not allow dry sweeping UAW stated that ‘‘[c]apture hoods 47796. In its post-hearing comments, the or brushing for cleaning in beryllium- capable of reliably controlling AFL–CIO indicated support for this contaminated areas unless HEPA- particulates pushed by compressed air requirement. Specifically, the AFL–CIO filtered vacuuming or other methods do not exist’’ (Document ID 1693, p. 4). that minimize the likelihood and level argued that if dry housekeeping OSHA has carefully considered these of airborne exposure are not safe or methods are permitted, ‘‘workers should comments and finds that the use of effective. be provided a N–95 respirator—or a OSHA notes that methods that compressed air to clean beryllium- higher level of protection as required minimize the likelihood and level of contaminated surfaces may occasionally based on the exposure—and personal airborne exposure other than HEPA be necessary in general industry; protective clothing’’ (Document ID 1809, vacuuming may be appropriate for use particularly in manufacturing processes. p. 2). After considering the record on in construction and shipyards. Use of Therefore, paragraph (j)(2)(iii) of the this issue, OSHA concludes that wet methods, such as wet sweeping or final standards allows for the use of requiring employers to provide wet shoveling, or using mechanical compressed air to clean, but only where respiratory protection and protective equipment to move wetted material, the compressed air is used in clothing and equipment in the limited may be viable alternatives for cleaning conjunction with a ventilation system situations where dry sweeping, large amounts of spent blasting media designed to capture the particulates brushing, or compressed air is used is used in abrasive blasting operations. made airborne by the use of compressed essential to minimize exposure. Paragraph (j)(2)(iii) of the proposed air. This provision is consistent with Therefore, the Agency has included this rule would have prohibited the use of other recent substance-specific provision in paragraph (j)(2)(iv) of the compressed air in cleaning beryllium- standards, such as the standard for final standard for general industry. contaminated surfaces unless it was respirable crystalline silica (29 CFR OSHA has also included a similar used in conjunction with a ventilation 1910.1053). provision in paragraph (j)(2)(iv) of the system designed to capture any Because the standards for final standards for construction and resulting airborne beryllium. As OSHA construction and shipyards do not shipyards. Proposed paragraph (j)(2)(v) indicated in the proposal, this provision include a provision establishing would have required employers to was intended to limit airborne exposure beryllium work areas, paragraph ensure that equipment used to clean by preventing the dispersal of beryllium (j)(2)(iii) of these standards states that beryllium from surfaces is handled and into the air (80 FR 47796). employers must not allow the use of maintained in a manner that minimizes Stakeholders offered a number of compressed air for cleaning in employee exposure and the re- comments on the use of compressed air. beryllium-contaminated areas unless the entrainment of beryllium into the For example, NJH expressed support for compressed air is used in conjunction workplace environment. Re-entrainment this provision, and emphasized that with a ventilation system designed to occurs when particles that have settled compressed air should only be used in capture the particulates made airborne on surfaces become airborne and remain conjunction with a ventilation system by the use of compressed air. OSHA suspended in the air. Beryllium (Document ID 1664, p. 7). Several intends this paragraph to apply when particles that have been disturbed from commenters discussed the use of using compressed air to clean, for surfaces and re-entrained contribute to compressed air for cleaning and other example, surfaces in work areas, tarps employee’s airborne beryllium processes. Materion commented that it used for abrasive blasting enclosures, exposure. Commenters generally generally prohibits the use of abrasive blasting equipment, and supported the inclusion of this compressed air, but production material designated for recycling or provision in the final rule. For example,

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Materion stated that preventing discussed in the NPRM, alerting administrative burden on employers migration of beryllium requires ‘‘looking employers and employees who are who must comply with both the HCS at all those migratory pathways where involved in disposal to the potential and this rule. To that end, OSHA allows material can move around in an hazards of beryllium exposure will employers to include the information operation,’’ keeping the material as better enable them to implement required by these beryllium standards close to the source as possible, and protective measures (80 FR 47771). on the labels created to comply with the keeping it off of people and off of OSHA reasoned that employers and HCS. Thus, if NFFS’s members are surfaces (Document ID 1755, Tr. 150). employees should be similarly alerted if already supplying labels that conform to The BHSC Task Group commented that handling materials designated for the HCS, they can add the beryllium- HEPA vacuums ‘‘must be maintained recycling that have not been cleaned of specific information to the existing per the manufacturer’s visible particulate. The proposed labels. OSHA deems this information is recommendations and oriented in such requirements to use impermeable warranted and would not contradict or a manner that the exhaust side of the enclosures and/or clean materials of cast doubt on the other information HEPA vacuum is not blowing hazardous visible particulate were intended to required on the label. dust into the work area’’ (Document ID reduce employees’ risk of beryllium Some commenters, including USW, 1655, p. 11). Among other things, the sensitization from dermal contact with generally agreed with OSHA’s proposed BHSC Task Group said this provision beryllium in handling waste materials disposal and recycling requirements would cause employers to ensure that or materials designated for recycling. (e.g., Document ID 1680, p. 6). Materion cleaning and maintenance of HEPA- The options provided to employers in noted that a similar provision appeared filtered vacuum equipment is done proposed paragraph (j)(3)(iii) were in Materion and the USW’s joint draft carefully to avoid exposure to intended to allow employers flexibility model standard (Document ID 1681, p. beryllium. This provision would also to facilitate the recycling process. 12). In addition, Materion argued that require employers to ensure that filter In the NPRM, OSHA asked for OSHA should not require that all changes and bag and waste disposal be feedback on proposed paragraph (j)(3) material to be recycled be performed in a manner that minimizes (80 FR 47574). A number of decontaminated regardless of perceived the risk of employee exposure to stakeholders responded. For example, surface cleanliness or require that all airborne beryllium and accidentally NFFS argued that: material disposed or discarded be in dispersing beryllium back into the enclosures regardless of perceived [t]he sections regulating the manner in which workplace environment. After carefully waste product is labeled, packaged and surface cleanliness (Document ID 1681, reviewing these comments, OSHA finds shipped have already been regulated by both p. 12). The company maintained that that the provisions of paragraph (j)(2)(v) the [Environmental Protection Agency (EPA) this requirement would be are necessary to the protection of (e.g. treatment, recycling and reuse of waste technologically and economically employees from the adverse health materials) and the DoT (e.g. shipping and infeasible and extremely costly in many effects associated with beryllium placarding requirements, shipping containers regards, particularly with regard to exposure, and has decided to include for hazardous materials). Additionally, scrap surface residue from abrasive blasting this provision (with minor changes) in and process coproducts in the non-ferrous (Document ID 1681, p. 12). As discussed foundry industry are treated as products and paragraph (j)(2)(v) of the final standards. provided with appropriate labeling and SDS below, OSHA has decided for the OSHA notes that paragraph (j)(2)(v) information as required by OSHA and the construction and shipyard standards not complements paragraph (f)(1)(i)(F), GHS/Hazard Communication standard. to require decontamination or enclosure which requires employers to establish Requiring the non-ferrous casting industry to of materials designated for recycling or and implement a written exposure treat our process coproducts the same as disposal due in part to concerns about control plan that includes procedures waste and debris streams contradicts the the feasibility of such requirements in for minimizing the migration of requirements of the EPA and DoT regarding these sectors. beryllium. the identification, processing, packing, However, many other stakeholders handling and transportation requirements of argued in favor of cleaning or enclosing Paragraph (j)(3)(i) of the proposed rule these materials’’ (Document ID 1678, p. 5). would have required the employer to all beryllium-contaminated materials ensure that waste, debris, and materials OSHA’s requirement for warning labels designated for recycling and enclosing visibly contaminated with beryllium must be consistent with the Hazard such materials destined for disposal. For and consigned for disposal were Communication Standard. Therefore, example, the BHSC Task Group, NJH, disposed of in sealed, impermeable OSHA is not convinced that these are the National Institute for Occupational enclosures, such as bags or containers. barriers to appropriately warning Safety and Health, Southern Company, Paragraph (j)(3)(ii) would have further downstream users of beryllium NFFS, AIHA, NABTU, and ORCHSE required such bags or containers to be contamination. In the Hazard disagreed with the proposal’s use of the labeled in accordance with paragraph Communication Standard (HCS), OSHA term ‘‘visible’’ when determining (m)(3) of the proposed rule. Finally, has carefully defined when other whether the provisions for containment paragraph (j)(3)(iii) of the proposed rule Agencies have jurisdiction for labeling and labeling included in proposed would have required materials requirements such as EPA and the paragraph (j)(3) should apply to designated for recycling that are visibly Department of Transportation (DOT). materials designated for recycling or contaminated with beryllium to be Additionally, as OSHA further disposal (e.g., Document ID 1664, p. 7; either cleaned to remove visible explainsed in the Summary and 1671, Attachment 1, p. 7; 1668, p. 6; particulate, or placed in sealed, Explanation for paragraph (m), 1678, p. 5; 1686, p. 2; 1679, p. 10; 1691, impermeable enclosures, such as bags or Communication of hazards, OSHA p. 5). NJH and ORCHSE recommended containers, that are labeled in intends for the hazard communication that OSHA require all materials accordance with paragraph (m)(3) of the requirements in the final standards to be designated for recycling ‘‘be proposed rule. substantively as consistent as possible decontaminated regardless of perceived OSHA intended these provisions to with the HCS, while including surface cleanliness’’ (Document ID 1664, protect and inform workers who may be additional specific requirements needed p. 7; 1691, p. 5). NJH added that exposed to beryllium when handling to protect employees exposed to ‘‘particles may not be visible to the waste or recycled materials. As beryllium, in order to avoid duplicative naked eye’’ and ‘‘[d]econtaminating all

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materials ensures that exposure is enclosures (e.g., bags or other the proposed rule required materials minimized.’’ It also recommended that containers) are best suited to their designated for recycling to be labeled in materials designated for disposal be workplace and the nature of the accordance with paragraph (m)(3) only discarded per local hazardous waste beryllium-containing materials they are if employers choose to enclose rather regulations (Document ID 1664, p. 7). disposing or designating for reuse than clean them, the final standards ORCHSE argued that for the protection outside the facility. OSHA finds that the require employers to label materials of municipal and commercial disposal terms ‘‘sealed’’ and ‘‘impermeable’’ are designated for recycling in either case. workers, materials discarded from commonly understood and should not This modification, like OSHA’s addition beryllium work areas should be in bags cause employers confusion. OSHA of the reference to beryllium-containing or other containers (Document ID 1691, intends these terms to mean that the materials discussed above, ensures that p. 5). NFFS asserted that ‘‘visibly enclosures selected should not allow the employers and employees who work contaminated,’’ ‘‘cleaned to remove materials they contain to escape the with materials that were recycled by visible particulate,’’ and ‘‘sealed, enclosures under normal conditions of other facilities are aware of any impermeable enclosures’’ are vague use. beryllium-containing materials they terms (Document ID 1678, p. 5). In addition, the BHSC Task Group process. OSHA also modified the As discussed previously in the stated that certain beryllium- requirements of proposed paragraph Summary and Explanation for contaminated items should not be (j)(3) for the construction and shipyard paragraph (h), Personal protective considered for recycling. According to sectors. Paragraph (j)(3) of the clothing and equipment, in this the BHSC Task Group, only materials construction and shipyard standards preamble, OSHA finds that ‘‘visibly scheduled for use within beryllium requires employers who transfer contaminated’’ is a subjective trigger for regulated areas at other facilities, and materials containing beryllium to most purposes in the final standards, not by the general public, should be another party for use or disposal to and dermal contact with beryllium can recycled. The BHSC Task Group provide the recipient with a copy of the cause beryllium sensitization even if the recommended surface wipe sampling to warning described in paragraph (m)(3) beryllium is not visible to the naked determine whether items should be of the standards, for the same reasons eye. OSHA therefore agrees with the decontaminated again and should be this requirement was retained in the commenters who criticized the use of resampled prior to recycling; otherwise, final general industry standard. ‘‘visibly contaminated.’’ (see, e.g. if not meeting established limits, they However, employers in construction Document ID 1686, p. 1). The Agency should be disposed of according to and shipyards are not required to place intends that waste, debris, and materials ‘‘appropriate waste management beryllium-containing materials in be disposed of as specified in paragraph practices’’ (Document ID 1655, p. 13). sealed, impermeable enclosures for use (j)(3) regardless of particulate visibility. After careful consideration, OSHA has or disposal by other entities. OSHA However, OSHA does not intend for this decided not to adopt the BHSC Task made this change from paragraph (j)(3) requirement to extend to articles Group’s suggestion. The Agency finds of the general industry standard because containing beryllium that are outside of that the requirement to either clean and the Agency believes that spent media the scope the standard, but to beryllium label or enclose and label beryllium- from abrasive blasting operations will dust generated during processing. contaminated or containing materials constitute the great majority of Similarly, materials designated for designated for recycling should provide beryllium-containing materials recycling must be cleaned to remove protection for later recipients of these designated for disposal or recycling in particulate or placed in sealed, items, as discussed in more detail construction and shipyards and it is impermeable enclosures, such as bags or below. generally not practical for employers to containers, and labeled in accordance In addition to the previously enclose spent blasting media in sealed, with paragraph (m)(3) of the standards, discussed changes to the proposed rule, impermeable bags or containers, regardless of particulate visibility. To which were directly related to because of the large volume of waste make this intention clear to employers, comments received by OSHA, the material generated in these operations OSHA has removed the terms ‘‘visibly’’ Agency has made several changes to OSHA finds that requiring employers in and ‘‘visible’’ from paragraph (j)(3) of better implement and communicate the construction and shipyards to include a the final standard for general industry, intention of paragraph (j)(3). First, warning label on beryllium-containing and has replaced them with ‘‘as free as OSHA has modified the provisions of practicable.’’ OSHA discusses the paragraph (j)(3) to state that it applies to materials designated for disposal or meaning of ‘‘as free as practicable’’ and materials that contain beryllium as well reuse, but not requiring them to seal addresses comments on this phrase in as materials contaminated with such materials in impermeable this Summary and Explanation of beryllium. OSHA finds that employers enclosure, appropriately informs paragraph (j), Housekeeping. and employees who work with materials recipients of the potential hazards of OSHA also agrees with ORCHSE that that were recycled or discarded by other handling the materials without materials discarded from beryllium facilities should be made aware of any imposing impractical containment work areas in general industry should beryllium-containing materials they requirements on these employers. In be in bags or other containers for the process. Provisions to ensure awareness addition, these separate requirements protection of municipal and commercial of beryllium in materials received from for construction and shipyards are disposal workers (Document ID 1691, p. other facilities aid employers who responsive to Materion’s concern 5). However, OSHA disagrees with otherwise might not know they are regarding the technological and NFFS’s comment that ‘‘sealed, required to comply with the beryllium economic feasibility of cleaning or impermeable enclosures’’ is standard, and employees who otherwise enclosing materials contaminated with problematically vague (Document ID might not be appropriately protected or surface residue from abrasive blasting. 1678, p. 5). OSHA intends this term to adequately informed about potential In summary, paragraph (j)(3)(i) of the be broad and the provision beryllium exposures in their workplace. final standard for general industry performance-oriented, so as to allow Second, the requirements of (j)(3) requires that items containing or employers in a variety of industries regarding labeling materials designated contaminated with beryllium and flexibility to decide what type of for recycling have been modified. While designated for disposal be disposed of

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in sealed, impermeable bags or other The purposes of medical surveillance receive the services and/or treatment sealed, impermeable containers, and for beryllium are: (1) To identify covered under both programs. requires these containers to be marked beryllium-related adverse health effects Treatment and services for covered with warning labels in accordance with so that appropriate intervention beryllium disease of a covered paragraph (m)(3) of the standards. measures can be taken; (2) to determine beryllium employee under the EEOICPA Paragraph (j)(3)(ii) of the final standard if an employee has any condition that program will be paid for by the federal for general industry requires materials might make him or her more sensitive government to the extent that the designated for recycling that contain or to beryllium exposure; and (3) to services provided are covered under the are contaminated with beryllium be determine the employee’s fitness to use EEOICPA program. If this final standard cleaned to be as free as practicable of personal protective equipment such as requires services or treatment that are surface beryllium contamination and respirators. The inclusion of medical not covered by the EEOICPA program, labeled in accordance with paragraph surveillance in these final standards is the employer will be required to pay for (m)(3) of this standard, or to be placed consistent with section 6(b)(7) of the these additional services. in sealed, impermeable enclosures, such OSH Act (29 U.S.C. 655(b)(7)), which OSHA received numerous comments as bags or containers, that are so labeled. requires that, where appropriate, during the public comment period Paragraph (j)(3) of the construction and medical surveillance programs be regarding the inclusion of the medical shipyard standards requires employers included in OSHA health standards to surveillance provision for the beryllium who transfer materials containing aid in determining whether the health of standard. Most comments supported beryllium to another party for use or employees is adversely affected by inclusion of medical screening or disposal to provide the recipient with a exposure to the hazards addressed by surveillance in the final beryllium copy of the warning described in the standard. Almost all other OSHA standard, including those from National paragraph (m)(3) of these standards. The health standards, such as Chromium Safety Council (NSC), Materion, term ‘‘use’’ is intended to include (VI) (29 CFR 1910.1026), Methylene National Jewish Health (NJH), North recycling, as well as any other use the Chloride (29 CFR 1910.1052), Cadmium America’s Building Trades Union recipient may make of the beryllium- (29 CFR 1910.1027), and Respirable (NABTU), USW, the American College containing materials. Crystalline Silica (29 CFR 1910.1053), of Occupational and Environmental Finally, USW and Materion requested have also included medical surveillance Medicine (ACOEM), the American that OSHA make it clear that this requirements and OSHA finds that a Thoracic Society (ATS), the American Federation of Labor and Congress of provision does not apply to beryllium- medical surveillance requirement is Industrial Organizations (AFL–CIO), containing scrap metals being reused appropriate for the beryllium standards ORCHSE Strategies (ORCHSE), the within the facility (Document ID 1680, because of the health risks resulting National Institute of Occupational p. 6; 1661 p. 12). USW offered the from exposure. General. Consistent with the proposed Safety and Health (NIOSH), and Public example of copper beryllium machine standards, paragraph (k)(1)(i) of the final Citizen (e.g., Document ID 1612, p. 3; turnings being utilized within the same standards, requires employers to make 1661, p. 10; 1664, pp. 1, 8; 1679, pp. 11– facility. The union explained: ‘‘In this medical surveillance available at no 12; 1681, pp. 13–14; 1685, p. 4; 1688, p. example, it would not make sense to cost, and at a reasonable time and place, 2; 1689, pp. 13–14; 1691, Attachment 1, require cleaning or enclosing because for each employee who meets a trigger pp. 5–13; 1725, p. 33; 1964, p. 3). No they are either very clean to start with for medical surveillance. As in previous commenters opposed the inclusion of a or have a thin coating of machining OSHA standards, the ‘‘no cost, and at a medical surveillance requirement. coolant. Requiring them to be cleaned reasonable time and place’’ requirement In support of medical surveillance, before reuse in the facility might in the final beryllium standards is the AFL–CIO and others indicated that actually lead to greater worker intended to encourage employee medical surveillance is essential in exposures’’ (Document ID 1680, p. 6). participation. Under this requirement, if screening for sensitization and OSHA did not intend to require participation requires travel away from preventing CBD (Document ID 1658, p. employers to clean or enclose materials the worksite, the employer will be 3; 1689, p. 13). As noted in Section V, designated for reuse elsewhere in the required to bear the cost of travel, and Health Effects, employees in the early same facility. Therefore, OSHA clarifies employees will have to be paid for time stages of beryllium disease are often that paragraph (j)(3)(ii)’s requirements spent taking medical examinations, asymptomatic, and as a result, medical do not apply to scrap metals designated including travel time. surveillance is critical to identify those for reuse within the same facility. OSHA clarifies that employees of employees who may benefit from (k) Medical Surveillance beryllium vendors who qualify for interventions such as removal from benefits under the Energy Employees exposure. ATS also commented that Paragraph (k) of the final standards Occupational Illness Compensation medical surveillance helps to identify sets forth requirements for the medical Program Act (EEOICPA) (42 U.S.C. those with sensitization and potentially surveillance provisions. The paragraph 7384–7385s–15) and its implementing CBD, as well as to define the risk of specifies which employees must be regulations (20 CFR part 30) may also various work exposures, jobs, and tasks offered medical surveillance, as well as qualify for medical surveillance benefits (Document ID 1688, p. 3). Commenter the frequency and content of medical under this final standard. Medical Evan Shoemaker said surveillance could examinations. It also sets forth the benefits provided to covered employees ‘‘inform employers that workplace information that the licensed physician for covered beryllium diseases under controls and safeguards need updating’’ and CBD diagnostic center is to provide the EEOICPA program are paid for by (Document ID 1658, p. 3). to the employee and employer. Many of the federal government. NJH commented that early disease the provisions in the final standards are Employees covered by both the detection, before symptoms occur, is the substantively consistent with the 2012 EEOICPA program and this final cornerstone for managing work-related joint draft recommended standard by standard will not be required to choose disease (Document ID 1806, pp. 2–3). Materion Corporation (Materion) and between the programs. Rather, these Studies highlighted by NJH show that the United Steelworkers (USW) dual-coverage employees may undergo medical surveillance could be important (Document ID 0754). medical examinations where they can for identifying workers that might

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benefit from removal from exposure. eligibility for medical surveillance to Document ID 1313; Schuler et al., 2005, Those studies show that rates of CBD employees who are exposed to (0919); and Taiwao et al, 2008, (1264)) development in sensitized workers are beryllium above the proposed action that examine relationships between lower for short-term than long term level, including employees exposed for beryllium exposure and development of workers (1.4% versus 9.1% in a study fewer than 30 days per year.39 OSHA sensitization and CBD. NJH stated that by Henneberger et al., 2001, Document requested comment on these exposure levels as low as 0.01 mg/m3 ID 1313). Other studies it cited showed alternatives. were associated with the development improvements in gas exchange and OSHA received numerous comments of sensitization and disease (Document radiography with decreased peak air related to each of the proposed triggers. ID 1720; 1756, Tr. 93–94). NJH also concentrations of beryllium (Sprince et First, a number of stakeholders presented evidence showing that some al., 1978, as cited in Document ID 1806) commented on the proposed trigger of individuals are genetically susceptible and improvements in lung function in working in a regulated area, i.e., an area to developing beryllium sensitization most patients after stopping beryllium in the workplace where an employee’s and CBD (e.g., Maier et al., 2003, exposures (Sood et al., 2004, Document exposure exceeds, or can reasonably be Document ID 0484; 1720, p. 3). ID 1331). expected to exceed, either the PEL or The National Supplemental Screening NJH also submitted evidence showing the short-term exposure limit (STEL), Program (NSSP), an organization that that once employees do develop for more than 30 days in a 12-month provides medical screening for former symptoms, the knowledge that the period. For example, NIOSH argued that Department of Energy workers, and symptoms are caused by CBD could lead employees exposed above an action ACOEM supported an action level to treatment to improve outcome level of 0.1 mg/m3 for 30 days a year trigger, including for employees (Document ID 1806, pp. 2–3). NJH found should be eligible for medical exposed for less than 30 days a year that identifying disease at an early stage surveillance because ‘‘substantial risk (Document ID 1677, p. 3; 1685, p. 4; allows the use of inhaled corticosteroids for [sensitization] and [chronic 1756, Tr. 83–84). However, Lee for mild symptoms, which it found to be beryllium disease (CBD)] exists even at Newman, MD, who represented ACOEM effective for reducing expected levels of the [a]ction [l]evel’’ (Document ID 1725, at the public hearing, testified that he lung function decline and improving p. 32; 1755, Tr. 40). Public Citizen also personally felt that medical surveillance lung function and cough in employees advocated for an action level trigger should be offered to anyone who has with lower lung function (Document ID based on risk of sensitization below the worked in a beryllium work area with 1811, Attachment 8). Early detection of proposed PEL, arguing that triggering measurable beryllium exposures beryllium disease and identification of medical surveillance at the PEL, where (Document ID 1756, Tr. 84). Dr. employees who would benefit from oral significant risk remains, would be Newman stated that his personal corticosteroid treatment before fibrosis inconsistent with other OSHA health opinion was based upon his ‘‘30 years develops can result in regression of standards (Document ID 1964, p. 3). of experience of working with people signs and symptoms and possibly Public Citizen asked OSHA to consider [exposed to beryllium’’ and ‘‘the studies prevent progression of the disease the feasibility of making medical that [he and his colleagues] have done’’ (Marchand-Adam et al., 2008, surveillance available to employees (Document ID 1756, Tr. 84). Document ID 0370; 80 FR 47588). NJH exposed at any level of beryllium for In contrast, Materion argued medical concluded that early detection of any duration of time (Document ID surveillance should be triggered by beryllium disease allows for exposures 1964, p. 3). exposures above the PEL because to be decreased and symptoms to be ATS and NJH supported expanding Johnson et al. (2001) (Document ID treated at the earliest time point, which medical surveillance to all employees 1505) concluded that 2.0 mg/m3 is can result in decreases in medication exposed to beryllium in beryllium work sufficient to protect employees from doses, side effects, and risk of disease areas (above or below the action level), developing clinical CBD, most recent progression. because of remaining significant risk at scientific studies suggest that 0.2 mg/m3 In paragraphs (k)(1)(i)(A)–(C) of the the PEL and because exposure is sufficient to protect against CBD, and proposal, OSHA specified that monitoring is sporadic and may not the coke oven emissions standard and employers must ‘‘make medical always reflect higher exposures formaldehyde standards trigger medical surveillance as required by this (Document ID 1664, p. 1; 1688, pp. 2, 4). surveillance at the PEL (Document ID paragraph available’’ for each employee: Lisa Maier, M.D., from NJH further 1661, p. 10). NGK Metals Corporation (1) Who has worked in a regulated area indicated that medical surveillance (NGK) was also opposed to setting the for more than 30 days in the last 12 should be offered to these employees, medical surveillance trigger at the months; (2) showing signs or symptoms regardless of the amount of time they action level, claiming that this would be of CBD, such as shortness of breath after spend in the work areas (Document ID burdensome, costly, and cause distress a short walk or climbing stairs, 1756, Tr. 101–103). To support this in employees who receive false positive persistent dry cough, chest pain, or recommendation, NJH referenced three results (Document ID 1663, p. 5). The fatigue; or (3) exposed to beryllium studies (Henneberger et al., 2001, Department of Defense (DOD) argued during an emergency. OSHA requested that medical surveillance should be comments on these triggers and also 39 OSHA also proposed Regulatory Alternative triggered above the PEL to monitor the presented alternatives to expand #21, which would have extended eligibility for effectiveness of engineering controls medical surveillance to all employees in shipyards, eligibility for medical surveillance to a construction, and general industry who meet the and respiratory protection (Document ID broader group of employees (80 FR criteria of proposed paragraph (k)(1) (or any of the 1684, Attachment 2, p. 1–9). 47565, 47571, 47576). Under Regulatory alternative criteria under consideration). However, Based on the comments and other Alternative #14, medical surveillance under Regulatory Alternative #21, all other record evidence, OSHA finds that provisions of the standard would have been in would have been available to employees effect only for employers and employees that fell triggering medical surveillance at the who are exposed to beryllium above the within the scope of the proposed rule. As discussed action level of 0.1 mg/m3 better proposed permissible exposure limit in the Summary and Explanation for paragraph (a), addresses residual significant risk and (PEL), including employees exposed for Scope and application, OSHA has decided to varying susceptibility of employees that expand the proposal’s scope to cover construction fewer than 30 days per year. Regulatory and shipyards. Therefore, Regulatory Alternative can result in sensitization and CBD at Alternative #15 would have expanded #21 is moot. lower exposure levels. OSHA disagrees

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with Materion that a PEL trigger for health risk at both the action level and stating that eligible employees exposed medical surveillance is sufficiently PEL. However, OSHA is not persuaded less than 30 days a year should be protective because OSHA’s own risk by those commenters who advocated offered medical surveillance (Document assessment shows significant risk triggering medical surveillance below ID 1664, p. 9; 1677, p. 3; 1685, p. 4). remaining at the action level and PEL the action level, in part, because nearly Other stakeholders did not support (see Section VI, Risk Assessment). In everyone in the general population is extending medical surveillance to addition, OSHA is aware of individuals potentially exposed to beryllium as it is employees exposed for fewer than 30 who are genetically predisposed to a naturally occurring compound in days per year. For example, DOD developing beryllium sensitization and rocks and soil. In addition, the lack of commented that ‘‘[w]hile it is CBD at beryllium levels that would not conclusive evidence of non-industrial- conceivable that workers can be cause disease in other individuals (See related beryllium-related disease in the sensitized to beryllium after brief Section V, Health Effects). As a result, record suggests there is a level of exposures, it is unlikely that infrequent, OSHA is concerned that a PEL trigger is exposure at which the risk of brief exposures will cause either not sufficient to identify disease at an developing beryllium-related disease sensitization or chronic beryllium early stage in employees who are becomes negligible, but OSHA does not disease’’ (Document ID 1684, genetically susceptible to developing have information to precisely determine Attachment 2, p. 1–2). disease. that level. As a result, offering medical After careful consideration of these Moreover, OSHA finds that an action surveillance to all potentially exposed comments and other evidence in the level trigger for medical surveillance employees would result in some low- record, OSHA finds that maintaining the encourages employers to maintain risk employees receiving medical 30-day exposure-duration trigger is exposures below that level, which in examinations when they have very little appropriate in the final standards turns provides reasonable assurance that likelihood of benefiting from those because the Agency’s risk assessment exposures will not exceed the PEL on examinations. OSHA is especially shows increasing risk of health effects days when exposures are not measured concerned by this because some medical from exposure at increasing cumulative (See Summary and Explanation for examination components, such as the exposures, which considers both paragraphs (b), Definitions, and (d), BeLPT, are invasive. In addition, OSHA exposure level and duration (See Exposure Assessment). Therefore, an finds that triggering surveillance at a Section VI, Risk Assessment). OSHA action level trigger in these standards is level that is achievable for some finds that a 30-day trigger is a also appropriate to address stakeholder employers is important because it reasonable benchmark for capturing concerns, such as those raised by ATS provides employers with an incentive to increasing risk from cumulative effects and NJH, that exposure assessments keep exposures low to avoid the costs of caused by repeated exposures. Including might underestimate actual exposures providing medical surveillance. a 30-day exposure-duration trigger also due to variability in exposure levels or Employees benefit from those lower maintains consistency with other OSHA other factors. exposures because it reduces their risk standards, such as Chromium (VI) (29 Medical surveillance triggered by the of developing disease. Triggering CFR 1910.1026), Cadmium (29 CFR action level is the norm for OSHA medical surveillance at any level of 1910.1027), Lead (29 CFR 1910.1025), health standards. Materion noted two exposure eliminates the incentive to Asbestos (29 CFR 1910.1001), and exceptions, observing that medical keep exposures low and thus may be Respirable Crystalline Silica (29 CFR surveillance is not triggered at the counterproductive to protecting 1910.1053). As discussed in more detail action level in standards for employees. below, OSHA notes that the triggers in formaldehyde and coke oven emissions. In conclusion, an action level trigger final paragraphs (k)(1)(i)(B) and (C) may However, the Coke Oven Emissions is appropriate because it is a level at address employees who could be at risk, standard does not include an action which risks are measurable and found to even though they may not have had level, and the trigger for medical be lower than at the PEL, especially for repeated exposures. surveillance is employment in a employees who may be more Therefore, OSHA has decided to regulated area, which is a discretely susceptible to developing disease. The revise the first proposed medical identified area on or around the coke action level is achievable for many surveillance trigger to require the oven battery, for at least 30 days a year employers, and those employers are offering of medical surveillance based (29 CFR 1910.1029). Significantly, the likely to maintain exposures below the on exposures at or above the action Coke Oven Emissions standard requires action level to avoid the costs associated level, rather than the PEL (i.e, work in employers to assure that no employee in with exposure assessments and offering a regulated area). But the Agency will the regulated area is exposed to coke medical surveillance. Maintaining retain the 30-day-per-year-exposure- oven emissions at concentrations greater exposures below the action level also duration trigger. In addition, OSHA has than the PEL (29 CFR 1910.1029(c)). benefits employees because it decreases chosen to revise the proposed trigger to Therefore, the trigger in the Coke Oven the chances that exposures will not require employers to make medical Emissions standard, which would exceed the PEL on a day on which surveillance available to each employee include employees who are exposed to exposure assessments are not ‘‘who is or is reasonably expected to be levels no higher than the PEL for at least conducted, and it lowers the risk of exposed . . . for more than 30 days a 30 days per year, is more protective than developing disease. For those reasons, year,’’ rather than waiting for the 30th a requirement that does not trigger an action level trigger is appropriate in day of exposure to occur. OSHA made medical surveillance until exposures the beryllium standard, consistent with this revision because the proposed exceed the PEL for 30 days a year. With the majority of OSHA standards. provision, in combination with the exception of formaldehyde, OSHA Comments were also received on the paragraph (k)(2)(i)(A), may not have standards trigger medical surveillance at 30-day duration as part of the medical resulted in timely medical examinations exposure levels at or below the PEL, and surveillance trigger. NIOSH supported it for new employees who are not exposed typically at the action level. (Document ID 1725, p. 32; 1755, Tr. 40). to beryllium concentrations above the In sum, OSHA is persuaded that a However, NJH, NSSP, and ACOEM did action level every day. For example, a lower trigger for medical surveillance is not support OSHA’s proposed duration new employee exposed to beryllium necessary because of the remaining trigger of more than 30 days a year, once per week would not receive a

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medical examination until being address the STEL component of the trigger is appropriate for employees employed for up to 34 weeks. As noted proposed trigger because when covered by the standard because the risk below, several stakeholders commented exposures exceed the STEL, it is very of material impairment of health that a medical exam should be offered likely that the action level will also be remains significant at the action level before or within 30 days of placement exceeded, thus triggering medical (see Section VI, Risk Assessment). (e.g., Document ID 1664, p. 7; 1685, p. surveillance. Consequently, even employees exposed 4, 1689, p. 13). OSHA agrees that a Signs or Symptoms. Proposed at the action level for fewer than 30 days medical examination should be paragraph (k)(1)(i)(B)) required in a year may be at risk of developing conducted shortly after placement to employers to ‘‘make medical CBD and other beryllium-related allow the employee to find out if he or surveillance as required by this diseases and adverse health effects. In she has any condition that may make paragraph available’’ to each employee addition, beryllium sensitization and him or her more sensitive to beryllium showing signs or symptoms of CBD, CBD could develop in employees who exposure. For these reasons, paragraph such as shortness of breath after a short are especially sensitive to beryllium, (k)(1)(i)(A) of the final standards require walk or climbing stairs, persistent dry may have been unknowingly exposed, that employers make medical cough, chest pain, or fatigue. As OSHA or may have been exposed to greater surveillance available to each employee explained in the proposal, a sign-or- amounts than the exposure assessment who is or is reasonably expected to be symptoms trigger is necessary, in part, suggests. By requiring covered exposed above the action level for more because beryllium sensitization and employers to make a medical exam than 30 days per year. CBD could develop in employees who available when an employee exhibits The proposal’s ‘‘regulated area’’ are especially sensitive to beryllium, signs or symptoms, the final standard trigger corresponded to setting the may have been unknowingly exposed, protects all employees who may have trigger at the PEL, and so has been or may have been exposed to greater developed CBD, including employees superseded by the final rule’s action amounts than the exposure assessment who have been exposed to beryllium in level trigger. The elimination of the suggests. A signs-or-symptoms trigger an emergency or for less than 30 days ‘‘regulated area’’ trigger may also affect was also included in the draft standard above the action level. whether employees exposed above the submitted by Materion and USW OSHA also finds that signs or short-term exposure limit (STEL) (Document ID 0754). symptoms of beryllium-related health receive medical surveillance. As noted One commenter, ORCHSE, argued effects other than CBD should also above and discussed extensively in the that a symptom trigger should only trigger medical surveillance (see Section Summary and Explanation for apply to confirmed positive, i.e., V, Health Effects). As noted by NJH and paragraph (e), the proposed standard sensitized, employees because the types ACOEM, these signs or symptoms can defined the term ‘‘regulated area’’ to of symptoms listed are non-specific for be indicative of beryllium-related skin mean an area that the employer must CBD and would require employers to disease or a sign of exposure that could demarcate, including temporary work offer medical surveillance to employees lead to sensitization. For example, areas where maintenance or non-routine who were never exposed to beryllium dermatitis that is unresponsive to tasks are performed, where an (Document ID 1691, Attachment 1, pp. treatment but responsive to removal employee’s exposure exceeds, or can 5–6). However, the majority of the from exposure may be a sign of a reasonably be expected to exceed, either stakeholders who opined on the signs- beryllium-related health effect. Other of the permissible exposure limits or-symptoms trigger supported its skin symptoms, such as reddened, (PELs). Proposed paragraphs (c) and (e) inclusion in the final rule. For example, elevated or fluid-filled lesions following made clear that this definition included NJH, ATS, and NIOSH supported a contact with soluble beryllium both the proposed 8-hour TWA PEL and symptom trigger for medical compounds and ulceration or the proposed STEL. Because the revised surveillance (Document ID 1664, p. 4, 8; granulomas from soluble or poorly trigger in final paragraph (k)(1)(i)(A) 1688, p. 3; 1725, p. 32). ACOEM and soluble beryllium compounds entering focuses on the action level, rather than NJH indicated that skin symptoms through cuts or scrapes, can also be a working in a regulated area, it does not should trigger medical examinations for sign of a beryllium-related health effect directly require medical surveillance for employees exposed to beryllium (See Section V, Health Effects). employees who are exposed above the (Document ID 1664, p. 4; 1685, p. 4). Therefore, OSHA has revised paragraph STEL, provided their airborne exposure NJH and ACOEM also offered examples (k)(1)(i)(B) to include signs or symptoms levels do not exceed the action level for of specific symptoms or signs of skin of other beryllium-related health effects. more than 30 days per year. disease, including rashes or nodules and OSHA disagrees with ORCHSE’s However, as explained in Chapter IV– dermatitis that is unresponsive to recommendation that the final standards Section 15 of the Final Economic treatment but responsive to removal apply this trigger only to employees Analysis and discussed in the Summary from exposure (Document ID 1664, pp. who have been confirmed positive, i.e., and Explanation for paragraph (c), 4, 8; 1688, p. 3; 1725, p. 32). In addition, are sensitized, for several reasons. First, Permissible Exposure Limits (PELs), the United Kingdom defense contractor, limiting the sign-or-symptoms trigger in occurrence of one or more short-term AWE, indicated that it allows its this way could prevent sensitized exposures to elevated airborne employees with ‘‘insignificant employees from finding out that they concentration during a work shift can likelihood of exposure’’ to undergo a are sensitized. For example, as noted substantially increase a worker’s 8-hour medical examination if they report above, individuals who are genetically TWA exposure. For example, the TWA symptoms (Document ID 1651, p. 10). predisposed can develop beryllium exposure of a worker who is exposed to After carefully considering these sensitization and CBD at beryllium a background level at the final action comments, OSHA reaffirms its levels that would not cause disease in level of 0.1 mg/m3 will be 0.16 mg/m3 if preliminary finding that the proposed other individuals. Such an employee that worker is exposed to a single 15- signs-or-symptoms trigger serves as a could conceivably become sensitized minute period at an exposure level just valuable complement to the use of and develop CBD without meeting the above 2.0 mg/m3, the final STEL. airborne exposure triggers as a action level or 30-day exposure trigger. Therefore, OSHA finds that the revised mechanism for initiating medical Because this hypothetical employee action level trigger will frequently surveillance. A signs-or-symptoms would not otherwise be entitled to

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medical surveillance, he or she might OSHA has removed the specific emergency situations must be offered not know that they are sensitized. If this examples of signs or symptoms of CBD regardless of the airborne concentrations employee began suffering from signs or that were included in the proposal. of beryllium to which these employees symptoms of CBD, he or she would not OSHA finds that removing these are routinely exposed in the workplace. be entitled to medical surveillance examples makes it less likely that this The requirement for medical under ORCHSE’s proposal, precisely will be misinterpreted to require examinations after airborne exposure in because they are not entitled to the medical surveillance for employees an emergency is consistent with several BeLPT that would detect sensitization experiencing signs or symptoms not other OSHA health standards, including and then entitle them to further medical related to beryllium exposure. OSHA the standards for Chromium (VI) (29 surveillance. also clarifies that signs or symptoms CFR 1910.1026), Methylenedianiline (29 Second, as discussed in more detail that are indicative of CBD or other CFR 1910.1050), 1,3-Butadiene (29 CFR below, under the final standards, beryllium-related effects are typically 1910.1051), and Methylene Chloride (29 employers do not automatically find out persistent or recurring. CFR 1910.1052). whether their employees have been Finally, OSHA emphasizes that Periodic medical surveillance. As confirmed positive. If an employee although this provision requires noted above, OSHA asked stakeholders chooses not to inform his or her employers to offer medical surveillance to opine on which employees should be employer of this fact, the employer may if persistent or recurring symptoms included in medical surveillance and, as never find out. See paragraphs (k)(6) related to CBD or other beryllium- discussed in more detail below, on the and (k)(7) of the final standards. related health effects are reported to or appropriate frequency for examinations Third, OSHA recognizes that signs observed by the employer (e.g., if an (e.g., 80 FR 47574, 47541). Several and symptoms associated with adverse employee ‘‘shows’’ a persistent cough), stakeholders, including Ameren health effects of beryllium such as CBD it is not intended to force employers to Corporation (Ameren), NSSP, and ATS, and skin sensitization may be non- survey their workforce, make diagnoses, submitted pre-hearing comments specific (i.e., they may be caused by or determine causality. Self-reporting by supporting the provision of continuing factors other than beryllium exposure). employees is supported by the training medical surveillance to employees who However, it is important to realize the required under paragraph (m)(4)(ii) on are confirmed positive (Document ID context in which signs and symptoms the health hazards of beryllium and the 1675, p. 16; 1677, p. 6; 1688, p. 3). For are expected to be used in medical signs and symptoms of CBD, and the example, ATS commented that once an surveillance. Signs and symptoms are medical surveillance and medical employee is sensitized, continued generally expected to be self-reported by removal requirements of the final medical surveillance should be offered employees who could potentially be standard in paragraphs (k) and (l). to determine if progression to CBD exposed to beryllium and as such are Section 11(c) of the OSH Act gives occurs (Document ID 1688, p. 3). not intended to serve as a means for employees the right to report suspected Similarly, Ameren commented that diagnosing adverse health effects or work-related health effects and prohibits sensitized employees should have the determining their causality. Rather, they employers from retaliating against opportunity for further surveillance serve as a useful signal that an employee employees for exercising this right. based on the recommendations of a may be suffering from a beryllium Separately, OSHA’s Recordkeeping Rule pulmonologist (Document ID 1677, p. exposure-related health effect. Once gives employees the right to report 6). these signals are recognized, the work-related illnesses such as CBD or OSHA agrees that an employee who is employee should be offered medical other beryllium-related health effects, confirmed positive should continue to surveillance and see a PLHCP who can, and Section 1904.35(b)(1)(iv) of that rule receive medical surveillance to with sufficient information about the prohibits retaliation against employees determine if progression from employee’s duties, potential exposures, for reporting these health effects. sensitization to CBD occurs and to and medical and work histories (as Emergencies. Proposed paragraph monitor the severity of disease if required by this standard and discussed (k)(1)(i)(C) required employers to offer progression does occur. As discussed later), make determinations about the medical surveillance to employees below, the standards provide for beryllium-related effects, provide exposed during an emergency. Although medical surveillance every 2 years in medical treatment, and make other an emergency trigger for medical certain cases, such as when the referrals or recommendations where surveillance was not included in the employee continues to be exposed necessary. joint draft recommended standard by above the action level for more than 30 However, ORCHSE’s comment does Materion and USW, none of the days a year, when the employee raise the concern that the non-specific comments on the proposal objected to continues to have signs or symptoms of signs and symptoms listed in the its inclusion in the final rule (Document CBD or other beryllium-related health proposal, i.e., shortness of breath after a ID 0754). At least one commenter, NJH, effects, or when an employee is exposed short walk or climbing stairs, persistent supported a trigger for employees to beryllium during an emergency. dry cough, chest pain, or fatigue, might exposed in an emergency (Document ID However, under these first three cause the employer to offer medical 1664, p. 4). triggers, periodic surveillance would surveillance to employees experiencing OSHA agrees with NJH that such a end if an employee no longer met those signs or symptoms that are not related trigger is appropriate because triggers. Thus, an employee who was to beryllium exposure. OSHA emergency situations involve confirmed positive and no longer meets understands that many of these non- uncontrolled releases of airborne these triggers might not qualify for specific symptoms can have various beryllium, and the significant exposures medical surveillance again until he or causes unrelated to beryllium exposure. that can occur in these situations justify she develops signs or symptoms of For example, a dry cough could be a requirement for medical surveillance. disease. This gap in coverage is related to a respiratory infection or Therefore, OSHA has decided to include especially concerning considering the allergies. On the other hand, the this provision as part of the final potentially long lag time between symptoms listed in the proposal can standards in paragraph (k)(1)(i)(C). As in sensitization and the development of also be symptoms of CBD where they the proposal, medical surveillance CBD and the benefits of early detection are recurring or persistent. Therefore, triggered by airborne exposures in (see Section V, Health Effects).

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To allow for continued medical physician. OSHA chose to require required under the standard departs surveillance to this limited group of licensed physicians, as opposed to the from policy in recent standards, such as high risk employees who would not broader category of PLHCPs, to oversee Chromium (VI) (29 CFR 1910.1026) and otherwise be eligible for periodic medical surveillance in this standard, Respirable Crystalline Silica (29 CFR examinations, OSHA has added final and to provide certain services required 1910.1053). In the recently promulgated paragraph (k)(1)(i)(D), which requires by this standard (see, e.g., proposed Respirable Crystalline Silica standard, that medical surveillance be made paragraphs (k)(1)(ii) and (k)(5)). OSHA OSHA allowed medical services to be available when the most recent written has in the past allowed a PLHCP to provided by a PLHCP, defined as an medical opinion to the employer perform all aspects of medical individual whose legally permitted recommends continued medical surveillance, regardless of whether the scope of practice (i.e., license, surveillance. Under final paragraphs PLHCP is a licensed physician (see registration, or certification) allows him (k)(6) and (k)(7), the written opinion OSHA’s standards regulating Chromium or her to independently provide or be must contain a recommendation for (VI) (29 CFR 1910.1026) and Respirable delegated the responsibility to provide continued periodic medical surveillance Crystalline Silica (29 CFR 1910.1053)). some or all of the particular health if the employee is confirmed positive or As explained in the NPRM, OSHA services required under the rule (81 FR diagnosed with CBD, and the employee proposed that a licensed physician 16818). To ensure competency while provides written authorization. Under perform some of the requirements of increasing flexibility for employers, these provisions, the employer will only paragraph (k) in response to Materion OSHA found it appropriate to allow any receive the recommendation for and USW’s 2012 joint draft healthcare professional to perform continued periodic medical surveillance recommended standard (80 FR 47797). medical examinations and procedures with the employee’s written consent. OSHA preliminarily found that this made available under the standard However, even where the employee requirement struck an appropriate when he or she is licensed by state law provides his or her written consent, the balance between ensuring that a to provide those services. In the case of written opinion must not include any licensed physician supervises the respirable crystalline silica, such a specific findings or diagnoses that led to overall care of the employee, while decision was justified because the the recommendation for continued giving the employer the flexibility to record did not provide convincing surveillance. Instead, the licensed retain the services of a variety of evidence that such a requirement was physician or CBD diagnostic center’s qualified licensed health care not appropriate, and some stakeholders written opinion would simply professionals to perform certain other expressed concerns that healthcare recommend continued periodic medical services required by paragraph (k). professionals might be limited in certain surveillance. As discussed in more However, the Agency specifically geographical locations (81 FR 16818). detail below, OSHA chose this method requested stakeholder comment on this In contrast to the silica rulemaking to convey the need for continued proposed requirement (80 FR 47575, record, the beryllium rulemaking record medical evaluations for employees who 47797). shows support for a licensed physician are confirmed positive or diagnosed OSHA received comments on this to oversee and perform certain functions with CBD, while protecting the subject from a variety of stakeholders, of medical surveillance and lacks employee’s privacy by not revealing to including public health officials and evidence showing that licensed the employer the specific finding that representatives from industry and labor. physicians may be limited in certain triggered the recommendation for ATS stated that due to the complex areas. As a result, OSHA is requiring in continuing medical examinations. nature of CBD and sensitization, final paragraph (k)(1)(ii) that the OSHA notes that although this including multi-organ involvement and employer ensure that all medical requirement was not included in either atypical presentations, all medical examinations and procedures required the proposed standard or the joint draft procedures should be carried out by or by the standard are performed by, or recommended standard by Materion and under the direction a licensed physician under the direction of, a licensed USW (Document ID 0754), proposed (Document ID 1688, p. 4). Similar physician. In the case of the beryllium paragraph (k)(1)(i)(D) (discussed below) support for medical procedures to be standard, OSHA finds this requirement would have allowed for limited medical carried out by or under the direction of strikes an appropriate balance between surveillance (i.e., low dose a licensed physician was expressed by ensuring that a licensed physician computerized tomography (LDCT)) for NJH, Ameren, NSSP, NIOSH, and supervises the overall care of the certain high risk individuals. ACOEM (Document ID 1664, p. 8; 1675, employee, while giving the employer Low dose computerized tomography p. 18; 1677, p. 7; 1755, Tr. 27; 1756, Tr. the flexibility to retain the services of a (LDCT). The proposal included a trigger 82). Materion commented that in the variety of qualified licensed health care to provide LDCT to some employees joint draft recommended standard, professionals to perform certain other who met certain criteria regarding Materion and USW intended for a services required by paragraph (k). exposure levels, exposure duration, and licensed physician to perform certain Therefore, final paragraph (k)(1)(ii) age. The requirement is now included critical aspects of medical surveillance requires the employer to ensure that all under paragraph (k)(3)(ii)(F) as a test such as diagnosis and preparation of the medical examinations and procedures that can be selected by the PLHCP for written medical opinion (Document ID required by the standard are performed employees based on certain risk factors. 1661, Attachment 2, p. 7). NABTU by, or under the direction of a licensed A full discussion of LDCT scans and the commented that medical and nursing physician. reasons for this change is included experts supervise medical screening of Frequency. Proposed paragraph (k)(2) below under the discussion of medical Department of Energy workers in a specified when and how frequently examination contents. program that is administered by the medical examinations were to be offered Licensed physicians. Proposed Center for Construction Research and to those employees covered by the paragraph (k)(1)(ii) required that the Training (CPWR) (Document ID 1679, p. medical surveillance program. Under employer ensure that all medical 10). proposed paragraph (k)(2)(i)(A), examinations and procedures required OSHA recognizes that the employers would have been required to by the standard are performed by or requirement for a licensed physician to provide each employee with a medical under the direction of a licensed provide oversight and some services examination within 30 days after

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determining that the employee had not likely to experience signs of not aware of any comments from worked in a regulated area for more than beryllium exposure during that time, stakeholders about the time period to 30 days in the past 12 months, unless and it provides employers with offer medical examinations following a the employee had received a medical administrative convenience because it report of symptoms or exposure in an examination provided in accordance gives them time to make the emergency; however the 30-day with this standard within the previous appointment, in addition to maintaining requirement to offer medical 12 months. Under proposed paragraphs consistency with most OSHA standards, examinations to employees (k)(2)(i)(B) employers would have been such as the Respirable Crystalline Silica experiencing signs or symptoms was required to provide medical (29 CFR 1910.1053). In response to included in the joint draft proposal by examinations to employees exposed to Ameren’s comment, OSHA Materion and USW (Document ID 0754, beryllium during an emergency, and to acknowledges that an employee who p. 7). Moreover, OSHA finds that the 30- those showing signs or symptoms of was not previously exposed to day trigger is administratively CBD, within 30 days of the employer beryllium would not be at risk for convenient for post-emergency becoming aware that these employees sensitization. However, an employer surveillance as well as after CBD signs met those criteria. may not have a complete occupational or symptoms (and other beryllium- As noted above, a number of exposure history to rule out prior related effects like rashes) are reported, stakeholders supported a baseline beryllium exposure of the employee, insofar as it is consistent with other examination. For example, ACOEM and the employee may not be aware that OSHA standards and with other triggers recommended that the criteria for he or she was exposed. OSHA considers in the beryllium standards. OSHA is inclusion in the medical surveillance a baseline BeLPT within 30 days of therefore retaining paragraph program be revised to clearly indicate a when the employer determines that the (k)(2)(i)(B), as proposed, in the final baseline examination and BeLPT for employee is reasonably expected to be rule. Proposed paragraph (k)(2)(ii) employees assigned to regulated areas exposed for more than 30 days a year to would have required employers to (Document ID 1685, p. 4). Similarly, be prudent to rule out sensitization in provide an examination annually (after NABTU and AFL–CIO commented that an employee who may have previously the first examination is made available) medical screening of employees should been exposed to beryllium to employees who continue to meet the be done before they start working in a unknowingly. Providing a baseline criteria of proposed paragraph beryllium area (Document ID 1679, p. examination is also consistent with the (k)(1)(i)(A) or (B). The Agency requested 12; 1689, p. 13). NJH also recommended joint draft recommended standard by comment on the frequency of this a BeLPT at the beginning of Materion and USW, which medical surveillance (80 FR 47574). employment but stated that some of recommended that medical surveillance Ameren agreed with the proposed their clients do the exams within 30 including a BeLPT be made available to frequency of annual examinations, and days to not influence hiring practices employees who are expected to meet the USW commented that the proposed (Document ID 1664, p. 7). Ameren and trigger for medical surveillance medical surveillance requirements NSSP commented that 30 days from (Document ID 0754, pp. 7–8). initial assignment is a reasonable period Final paragraph (k)(2)(i)(A) also would allow for timely detection of to provide an examination; however, differs from the proposal in that in the sensitization and health outcomes NSSP recommended a baseline BeLPT proposed paragraph the employer did (Document ID 1675, p. 16; 1681, p. 13). at the time of employment, while not have to offer an examination if the AWE commented that it offers annual Ameren indicated that a baseline BeLPT employee had received an equivalent spirometry testing to its employees with should be at the employer’s discretion examination within the last 12 months. ‘‘significant likelihood for exposure’’ based on employment history In the final rule, this was increased to (Document ID 1615, p. 10). DOD also (Document ID 1675, pp. 15–16; 1677, p. two years to align that provision with provides annual medical surveillance 6). These comments run contrary to the the frequency of periodic examinations, for its beryllium-exposed employees proposed requirement allowing which is every two years in the final (Document ID 1684, Attachment 2, p. 1– employers to withhold offering medical standards. The reason why frequency of 5). NIOSH commented that OSHA surveillance until after more than 30 periodic examinations was changed should require an annual questionnaire days of exposure. from every year to every two years is for symptoms (Document ID 1725, p. OSHA is persuaded that it is discussed below. In sum, paragraph 32). However, other commenters argued appropriate to trigger medical (k)(2)(i)(A) requires the employer to that annual surveillance was not surveillance within 30 days after make a medical examination available routinely required. For example, NJH making the determinations described in to employees who meet the criteria of and ACOEM supported offering medical final paragraphs (k)(2)(i)(A) and (B). As paragraph (k)(1)(i)(A), unless the examinations to eligible employees a result of changes made to final employee received a medical every two years (Document ID 1664, p. paragraph (k)(1)(i)(A), the initial exam examination provided in accordance 4; 1685, p. 4); NJH indicated that after required under final paragraph with the standard, within the last two initial testing, biennial medical (k)(2)(i)(A) is now triggered within 30 years. surveillance is adequate to identify any days after the employer determines that As noted above, proposed paragraph new cases of sensitization that may the employee is or is reasonably (k)(2)(i)(B) would have required develop in the workplace. In addition, expected to be exposed at or above the employers to provide medical NJH, NSSP, and NGK were opposed to action level for more than 30 days of examinations to employees exposed to annual BeLPTs (Document ID 1664, p. 4; year. This revised trigger for medical beryllium during an emergency, and to 1677, p. 3; 1663, p. 5). ATS and NIOSH surveillance in the final beryllium those who are showing signs or recommended examinations every 1 to 3 standard is consistent with Ameren and symptoms of CBD, within 30 days of the years for sensitized individuals to NSSP recommendations to provide an employer becoming aware that these determine if progression is occurring exam within 30 days of initial employees meet the criteria of proposed (Document ID 1688, p. 3; 1725, pp. 2, assignment. OSHA finds that it is a paragraph (k)(1)(i)(B) or (C), regardless 32). Finally, NABTU agreed with the reasonable period to offer medical of whether these employees received an proposed frequency for screening but surveillance because new employees are exam in the previous 2 years. OSHA is noted that Department of Energy

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workers participating in a medical CBD and monitor possible CBD However, NABTU indicated that the screening program administered by progression. BeLPT need not be repeated if the CPWR are examined every three years Finally, OSHA revised proposed employee’s last test was done within the (Document ID 1679, pp. 10–12). paragraph (k)(2)(ii) to specify that previous 60 days because the experience After careful consideration of the medical examinations were to be made of their medical professionals indicates record on this issue, OSHA agrees with available ‘‘at least’’ every two years. that a different test result is unlikely to commenters like NJH who This change clarifies OSHA’s intent that occur within that time period recommended that a BeLPT every two the employer need not wait precisely (Document ID 1805, Attachment 1, p. 5). years is appropriate. In addition, based two years to make medical surveillance After considering these comments, on its review of beryllium health effects, available to employees who continue to OSHA reaffirms its preliminary decision which shows that CBD generally meet the criteria of (k)(1)(A), (B), or (D) to require employers to make medical progresses slowly (See Section V, Health of this standard. surveillance available at the time of Effects), the Agency finds that a two- Under the final standards, employees termination to eligible employers. Final year frequency period is also exposed in an emergency, who are paragraph (k)(2)(iii) requires the appropriate for the remaining parts of covered by paragraph (k)(1)(i)(C), are not employer to make a medical the medical examinations. This two- included in the biennial examination examination available to each employee year period is consistent with NJH’s requirement unless they also meet the who meets the criteria of final paragraph suggestion to offer medical criteria of paragraph (k)(1)(i)(A) or (B), (k)(1)(i)—the action level/30-day- examinations biennially after the initial because OSHA expects that most effects exposure based trigger, shows signs or exam and with ATS and NIOSH’s of airborne exposure will be detected symptoms of CBD, or is exposed during recommendations for examinations during the medical examination an emergency—at the termination of every 1 to 3 years for sensitized provided within 30 days of the employment, unless the employee individuals. However, OSHA disagrees emergency, pursuant to paragraph received an exam meeting the with NIOSH that a yearly questionnaire (k)(2)(i)(A). This is consistent with the requirements of the standards within proposal. An exception to this is for symptoms is needed because the the last 6 months. OSHA also finds that beryllium sensitization, which OSHA standards already permit employees to it is appropriate to extend the finds may result from exposure in an receive medical surveillance by self- requirement to employees who meet the emergency, but may not be detected reporting signs and symptoms of CBD. criteria of final paragraph (k)(1)(i)(D), within 30 days of the emergency. OSHA To align the requirements for BeLPTs i.e., each employee whose most recent received no comments on this issue. To written medical opinion required by with the medical and work history, the address possible delayed sensitization physical examination, and pulmonary paragraph (k)(6) or (k)(7) recommends in employees exposed in an emergency, periodic medical surveillance. Like the function testing, OSHA is requiring that final paragraph (k)(3)(ii)(E) requires other employees covered by this all those components of the examination biennial BeLPTs for employees who provision, those employees could be offered every two years. OSHA have not been confirmed positive, potentially have beryllium-related concludes that this approach is more including those exposed in emergencies. disease that was not present or convenient for employers to administer, This paragraph is discussed in more detectable at their last examination or while maintaining adequate protection detail later in this section of the that has advanced. of employees. Offering examinations preamble. every two years accomplishes the main Proposed paragraph (k)(2)(iii) As indicated in the proposal, OSHA goals of medical surveillance for required the employer to offer a medical finds that providing a BeLPT at the time employees exposed to beryllium, which examination at the termination of of termination, unless the employee was are to detect beryllium sensitization employment, if the departing employee tested within the last six months or the before employees develop CBD, and to met any of the criteria of proposed employee was confirmed positive, is diagnose CBD and other adverse health paragraphs (k)(1)(i)(A), (B), or (C) at the important to ensure that no employee is effects at an early stage. Requiring time the employee’s employment was unknowingly sensitized at the time he examinations to be offered every two terminated. This proposed requirement or she leaves the job. In addition, OSHA years also strikes a reasonable balance was waived if the employer provided finds that the other components of the between the resources required to the departing employee with an exam examination, such as a medical and provide surveillance and the need to during the six months prior to the date work history, the physical examination, diagnose health effects at an early stage of termination. OSHA explained that the and lung function testing are also to allow for interventions. provision of an exam at termination was important to determine if an employee In addition, OSHA finds that it is intended to ensure that no employee may have developed physical signs of appropriate to extend the requirement terminates employment while carrying a disease or if existing disease may have for biennial surveillance under final detectable, but undiagnosed, health progressed since the last examination. paragraph (k)(2)(ii) for employees who condition related to beryllium exposure OSHA disagrees with NABTU that continue to meet the criteria of final (80 FR 47798). A similar provision was another BeLPT should be conducted if paragraph (k)(1)(i)(D), i.e., each included in the draft joint the employee’s last BeLPT was done employee whose most recent written recommended standard by Materion and more than two months ago. Requiring medical opinion required by paragraph USW (Document ID 0754, p. 8). another BeLPT if the employee has not (k)(6) or (k)(7) recommends periodic Commenters generally supported the had one within the past six months is medical surveillance. As discussed inclusion of this provision in the final an abundantly cautious approach above, the recommendation for standard. NJH and NSSP agreed with considering that public health officials, continued medical surveillance is based the proposed requirement to perform a such as NJH, recommend a BeLPT every on a confirmed positive finding or a BeLPT at the time of termination and two years, since that time period is diagnosis of CBD. Employees such as Ameren stated that a BeLPT is not considered adequate to identify any new those who are confirmed positive needed if the employee was tested cases of sensitization that may develop benefit from periodic surveillance to within the last six months (Document ID in the workplace (Document ID 1664, p. determine if sensitization progresses to 1664, p. 7; 1675, p. 16; 1677, p. 6). 4). Therefore, OSHA concludes that

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offering a BeLPT at termination, if the breaks and wounds. Stakeholders from as part of an occupational health employee has not had one in the past the medical community and industry program. As indicated above, the major six months, is an approach that responded to OSHA’s request for purposes of medical surveillance for adequately protects the employee’s comment on the proposed contents for beryllium-exposed employees go health. medical examinations. Ameren, NSSP, beyond identifying disease and include Contents of Examination. Proposed and NABTU agreed with the tests that identifying conditions that put paragraph (k)(3) detailed the contents of OSHA proposed, including skin employees at increased risk from the examination. Proposed paragraph examinations (Document ID 1675, p. 16; beryllium exposure and determining the (k)(3)(i) required the employer to ensure 1677, p. 6; 1679, p. 12). ORCHESE was employee’s fitness to use personal that the PLHCP advised the employee of opposed to examining the skin for protective equipment such as the risks and benefits of participating in wounds and breaks because although respirators. The medical examination the medical surveillance program and skin injuries could allow for increased for beryllium complements the medical the employee’s right to opt out of any beryllium absorption, they are evaluation under the respiratory or all parts of the medical examination. temporary conditions that could heal protection program that must still be As OSHA explained in the proposal, the within days, thus making the finding conducted before an employee is fitted benefits of participating in medical observed during the exam irrelevant for a respirator or uses the respirator in surveillance may include early (Document ID 1691, Attachment 1, p. 7). the workplace (29 CFR 1910.134(e)(1)). detection of adverse health effects, and NIOSH and ATS supported medical and Physical examinations and lung aiding intervention efforts to prevent or work histories or questionnaires, but function tests are objective measures treat disease. However, there may also neither they nor NJH supported routine that are valuable in accomplishing the be risks associated with medical testing physical examinations and lung goals of medical surveillance for for some conditions, such as radiation function testing of beryllium exposed beryllium and to determine fitness to risks from CT scans for lung cancer (80 employees (Document ID 1664, p. 8; use personal protective equipment. For FR 47798). The employer must make 1688 p. 3; 1725, p. 32). ATS and NIOSH example, listening to heart and lung sure the PLHCP communicates those commented that physical examinations sounds with a stethoscope and conducting lung function testing might risks to the employee. This requirement and lung function testing are not identify an impairment in an employee was included in the draft proposed rule effective for identifying sensitization or who is not experiencing symptoms but submitted to the Agency by Materion CBD. NJH recommended that physical might be at risk with use of a negative and USW (Document ID 0754, p. 8). In examinations and pulmonary function pressure respirator. Such impairments the absence of public comments on this tests be offered to employees who do in employees lacking symptoms may issue, the requirement remains not have CBD but are experiencing not be identified in the medical substantively unchanged from the symptoms, while NIOSH said that evaluation for respirator use, which proposal in final paragraph (k)(3)(i). required tests should be determined by typically involves administering a OSHA did, however, make one minor the PLHCP, based on responses to the questionnaire. Lung function questionnaire and may not involve an change to clarify the intent of this examination. Another example of how provision. Under the final standards, the (spirometry) testing is the only type of examination that AWE routinely does the required tests under the beryllium PLHCP who advises the employee must standard accomplish goals of medical be the PLCHP who is conducting the on its employees with ‘‘significant likelihood for exposure’’ (Document ID surveillance is that an employee who is examination. Proposed paragraphs found to have a loss in lung function (k)(3)(ii)(A)–(D) specified that the 1615, p. 10). DOD includes a history, physical exam, a chest X-ray, and can be warned that lung function loss medical examination must consist of: A can be compounded if that employee medical and work history, with spirometry in its surveillance program, and agreed that the skin should be develops CBD. emphasis on past and present exposure, Skin examinations are also important examined (Document ID 1684, smoking history, and any history of because skin rashes could be a sign of Attachment 2, p. 1–5). 3M agreed that respiratory dysfunction; a physical dermal sensitization or also a sign that an employee’s fitness to wear a examination with emphasis on the exposures that put the employee at risk respirator should be evaluated, but they respiratory system; a physical of becoming sensitized have occurred. examination for skin breaks and argued that incorporating requirements However, OSHA agrees with ORCHESE wounds; and a pulmonary function test, of the medical evaluation under the that conditions such as breaks and performed in accordance with respiratory protection program (29 CFR wounds are temporary and has therefore guidelines established by the American 1910.134(e)) would be a better tool for revised the proposed paragraph so that Thoracic Society including forced vital evaluating fitness to wear a respirator final paragraph (k)(3)(ii)(C) requires a capacity (FVC) and a forced expiratory than the proposed medical surveillance physical examination for skin rashes, requirements. In support of this volume in one second (FEV1). Exam rather than an examination for breaks contents under the proposal also statement, it asserted that pulmonary and wounds. OSHA notes that PLHCPs included a standardized BeLPT and, in function tests are a poor predictor for will nonetheless detect skin injuries some cases, a computerized tomography fitness to wear a respirator (Document during the skin examination, and when (CT) scan, both of which are discussed ID 1625, pp. 3–5). doing so can take that as an opportunity in more detail below. OSHA asked for OSHA recognizes, as ATS, NIOSH, to educate the employee on the comment on the contents of the medical and NJH commented, that physical importance of using protective clothing, surveillance exam in the proposal (80 examinations and lung function testing because beryllium absorption can be FR 47574). Among other things, the are not effective for detecting increased through broken skin. Agency asked whether the required tests sensitization or CBD. However, OSHA OSHA also revised proposed were appropriate, if additional tests still finds that these tests should be paragraph (k)(3)(ii)(A), which would should be included, and whether the included as part of medical surveillance have required, among other things, ‘‘a skin should be examined for signs and examinations of beryllium exposed medical and work history, with symptoms of beryllium exposure or workers because they accomplish emphasis on past and present exposure’’ other medical issues, as well as for important goals of medical surveillance so that final paragraph (k)(3)(ii)(A)

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includes emphasis on past and present responding to comparisons of the BeLPT in the proposal, the biennial airborne exposure to or dermal contact against World Health Organization requirement to test for beryllium with beryllium. OSHA added dermal (WHO) (Wilson) criteria (see next sensitization applies regardless of contact to this list because, as noted by paragraph), NIOSH concluded that whether an employee is otherwise NJH and ACOEM, dermal contact can current evidence supports the use of the entitled to a medical examination in a result in skin effects and sensitization BeLPT to benefit both the individual given year. OSHA concludes that this (Document ID 1664, p. 5, 1685, p. 3). As employee and to identify improvements continuing requirement is important discussed in Section V, Health Effects, that could be made in work areas to because sensitization can occur after dermal contact with beryllium can lead prevent other workers from becoming exposures end. to respiratory and dermal sensitization sensitized (Document ID 1725, p. 33). OSHA finds that in general, the and it is therefore an appropriate factor BeLPT is also supported by or used in biennial testing required under to consider as part of the medical and medical screening by medical paragraph (k)(3)(ii)(E) is adequate to work history. With these changes, final authorities, unions, and industry monitor employees that have the paragraphs (k)(3)(ii)(A)–(D) require the stakeholders including Materion, NJH, potential to develop sensitization while medical examination to include: (1) Ameren, NSSP, USW, ACOEM, ATS, being sufficiently affordable for Medical and work history, with and ORCHSE (Document ID 1661, employers. However, one change to this emphasis on past and present airborne Attachment 2, pp. 7–8; 1664, p. 4; 1675, provision compared to the proposed exposure to or dermal contact with p. 16; 1677, pp. 5–6; 1681, p. 25; 1685, standard is to allow the test to be offered beryllium, smoking history, and any p. 4; 1688, p. 3; 1691, Attachment 1, p. ‘‘at least’’ every two years, rather than history of respiratory dysfunction; (2) a 12). Ameren also commented that a every two years as proposed. This physical examination with emphasis on BeLPT should be provided for change clarifies OSHA’s intent that the the respiratory system; (3) a physical employees diagnosed with sarcoidosis employer need not wait precisely two examination for skin rashes; and (4) a because of the potential for a years to make the BeLPT available to pulmonary function test, performed in misdiagnosis of CBD (Document ID employees. accordance with guidelines established 1675, p. 16). USW supported periodic Final paragraph (3)(ii)(E) contains a by the ATS including forced vital BeLPTs because workers with a history number of other differences compared capacity (FVC) and a forced expiratory of exposure remain at risk in the future to the proposed requirements. volume in one second (FEV1). (Document ID 1681, pp. 13–14). NJH Consistent with the definition in the Under proposed paragraph supported biennial BeLPTs, which is proposed standards, the proposed (k)(3)(ii)(E), an employee would have consistent with the draft joint paragraph considered two abnormal test been offered a BeLPT or an equivalent recommended standard by Materion and results necessary to confirm a finding of test at the first examination, and then at USW (Document ID 0754; 1664, p. 4). beryllium sensitization when using the least every two years after the first In contrast, based on a false positive BeLPT (‘‘confirmed positive’’). examination, unless the employee was rate reported in a review done by AWE Therefore, the proposal would have confirmed positive. As OSHA explained in 1990, AWE commented that it does required that the BeLPT be repeated in the preamble to the proposal, the not routinely use BeLPT in its medical within one month of an employee proposed requirement to test for surveillance program (Document ID receiving a single abnormal result. As beryllium sensitization was intended to 1615, p. 11). DOD did not support the discussed in more detail in the apply whether or not an employee was BeLPT, arguing that it has not been Summary and Explanation for otherwise entitled to a medical shown to meet WHO guidelines as a paragraph (b), Definitions, commenters examination in a given year (80 FR screening tool (often referred to as the including ACOEM and ATS indicated 47799). For example, for an employee Wilson Criteria, which evaluates factors that retesting should also be done exposed during an emergency who such as reliability of the assay and its following borderline BeLPT results, and would have normally been entitled to 1 usefulness to identify disease at an early as ACOEM noted, one borderline and exam within 30 days of the emergency stage in which treatment would be one positive test or three borderline but not annual exams thereafter, the beneficial) (Document ID 1958, p. 8). tests have a high predictive value for employer would still have been required After carefully considering these sensitization (Document ID 1685, p. 4; to provide this employee with a test for comments, OSHA agrees with NIOSH 1688, p. 2). In response to such beryllium sensitization every 2 years. that the BeLPT is appropriate based on comments, OSHA changed the OSHA further explained that this its sensitivity and low false positive rate definition of confirmed positive to two proposed biennial requirement would that is comparable or superior to other abnormal test results, an abnormal test have applied until the employee was screening tests. Unlike DOD, OSHA result and a borderline test result, or confirmed positive. The Agency finds that the BeLPT does meet a three borderline test results. Therefore, preliminarily found that the biennial number of the Wilson criteria because it to make this paragraph consistent with testing required under proposed is an acceptable, reliable test that allows the revised definition, the text was paragraph (k)(3)(ii)(E) was adequate to for a serious disease to be diagnosed at changed to indicate that a follow-up monitor employees at risk of developing an early stage, when employees with BeLPT must be offered within 30 days sensitization while being sufficiently symptoms could benefit from treatment, for results that are ‘‘other than normal’’ affordable for employers. or in the case of occupational exposures, unless the employee has been confirmed The record showed strong support for interventions such as removal from positive. This language makes it clear use of BeLPT, with limited exceptions. exposure. OSHA agrees with Ameren that not only abnormal BeLPT results, NIOSH supported the BeLPT to identify that a BeLPT is an important component but also borderline BeLPT results must sensitized employees, citing recent for diagnosing lung disease in be followed up according to the evidence that the BeLPT has a beryllium-exposed employees to definition for confirmed positive. When sensitivity of 66 to 86% and a prevent a misdiagnosis. And OSHA an other than normal result is obtained, specificity of >99%, which it stated is reaffirms that it is important to conduct testing is to be repeated within 30 days, superior or comparable to other the BeLPT at least every two years to unless the employee is confirmed common medical screening test screen for beryllium sensitization, until positive. This means that follow-up can (Document ID 1725, pp. 32–33). In the employee is confirmed positive. As stop as soon as it is determined that the

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employee is confirmed positive (e.g., sensitization, if such a test were ever requirement that laboratories after receiving an abnormal and developed. To clarify the Agency’s performing BeLPT be accredited by CAP borderline test or three borderline tests). intent, final paragraph (k)(3)(ii)(E) now and/or CLIA (Document ID 1664, pp. 8, The proposed paragraph indicated specifies that a standardized BeLPT ‘‘or 9; 1675, p. 19; 1677, p. 7; 1680, p. 7; that the requirement for a repeat BeLPT equivalent test’’ is to be offered. OSHA 1685, p. 5; 1691, Attachment 1, p. 13). was waived if a more reliable and considers an ‘‘equivalent test’’ to be a For example, NJH commented that a accurate test were to become available test that would accurately identify CAP/CLIA certification represents the that could confirm beryllium sensitization based on one test result. standard for oversight for clinical testing sensitization based on one test result. Thus, the original intent of that to ensure proper quality control and OSHA requested comments on the requirement is unchanged, but OSHA testing (Document ID 1664, p. 9). availability of more reliable and clarifies that an ‘‘equivalent test’’ could ACOEM further added that those accurate tests than the BeLPT for also be a validated test that is superior laboratories should undergo periodic identifying beryllium sensitization (80 to the BeLPT for other reasons. For proficiency testing (Document ID 1685, FR 47575). ORCHSE took issue with the example, NJH commented that p. 5). Materion and USW also statement that retesting would not be alternative tests to the BeLPT are being recommended that all laboratories that required if a more reliable and accurate developed that could require less blood conduct BeLPT have a standard test became available that could confirm and less sample manipulation and procedure and algorithm and that their beryllium sensitization based on one provide earlier results (Document ID BeLPT be approved by the FDA, but that test result. It interpreted the statement 1664, p. 9). these issues should not delay to mean that an employee who tested NJH commented on validating tests promulgation of the rule (Document ID positive would not receive a second for beryllium sensitization that might be 1680, p. 7). However, NJH indicated that BeLPT or second test that is more superior to a BeLPT (Document ID 1664, while it would be preferable, reliable and accurate than the BeLPT, p. 9). It noted that validation could standardization of interpretation leaving the employee with only one occur in a College of American algorithms across laboratories is abnormal test that was unconfirmed Pathologists (CAP)/Clinical Laboratory challenging because it is influenced by (Document ID 1691; Attachment 1, pp. Improvement Amendments (CLIA) many variables such as serum and 7–8). laboratory. Once the assay is determined reagent lots, sample quality, use of To streamline the paragraph and to be robust and reproducible, clinical round versus flat bottomed plates, and avoid misunderstandings of the validation should then be performed technician skill (Document ID 1664, p. Agency’s intent, OSHA removed the using samples from patients known to 8). NSSP commented that all current language waiving a second confirmatory be sensitized and from unexposed BeLPT laboratories have certifications test if a more accurate and reliable test controls. OSHA agrees and as explained from CAP and/or another accreditation became available that did not require in the Summary and Explanation for organization approved under CLIA and retesting for confirmation of paragraph (b), Definitions, before any have participated in inter-laboratory sensitization. Instead, final paragraph test could be considered ‘‘equivalent’’ to split specimen testing (Document ID (k)(3)(E) requires a standardized BeLPT a BeLPT for identifying sensitization but 1677, p. 7). or equivalent test, upon the first based on a single test result, the test After reviewing these comments and examination and at least every two years must undergo rigorous validation to the remainder of the record on this thereafter, unless the employee is ensure that it has comparable or issue, OSHA is convinced that requiring confirmed positive. If the results of the increased sensitivity, specificity, and that the BeLPT be conducted by CAP/ BeLPT are other than normal, a follow- positive predictive value within one test CLIA-certified laboratories would up BeLPT must be offered within 30 result than the BeLPT. OSHA also improve quality of BeLPT results. Based days, unless the employee has been recommends that before any test for on comments from NSSP, all confirmed positive. This revision sensitization is considered equivalent to laboratories conducting BeLPTs are clarifies that only other than normal a BeLPT, it should be widely accepted currently accredited. OSHA therefore BeLPT results must be followed up by authoritative sources, such as CDC/ finds that accredited laboratories are within 30 days. Because the paragraph NIOSH, ACOEM, and ATS, based on the currently available and including such a refers to follow-up testing for other than validation criteria described above. requirement in the standards would not normal ‘‘BeLPT’’ results, the Such an approach is conceptually delay promulgation of the rule. The requirement would not apply to a more consistent with that in the draft Agency also finds that CAP/CLIA accurate and reliable test that would not recommended standard by Materion and certification helps improve proficiency require an abnormal result to be USW that required the CDC to approve in terms of obtaining accurate results confirmed. a more reliable test that could eliminate that are appropriately interpreted and OSHA acknowledges that the ‘‘more the need to confirm a positive finding. ensures that quality control procedures accurate and reliable’’ alternative The joint draft recommended standard are followed. Therefore, to improve the remains hypothetical as there are by Materion and USW required that the accuracy and reliability of BeLPTs, the currently no tests for beryllium BeLPT be performed in a laboratory standards require that samples be sensitization that allow for a confirmed licensed by the CDC (Document ID analyzed by a laboratory certified under diagnosis of sensitization based on one 0754). In contrast, OSHA’s proposed CAP/CLIA guidelines to perform the test. However, if developed and provision did not require that a BeLPT BeLPT. validated as described below, such a test be conducted by a laboratory that was As a result of the changes discussed would be an improvement because it licensed or accredited. OSHA requested above, final paragraph (k)(3)(E) specifies would eliminate the need for an comment on whether testing should be that the examination must include a employee to go back to have blood performed by a laboratory accredited by standardized BeLPT or equivalent test, drawn a second and possible third time. an organization such as CLIA (80 FR upon the first examination and at least OSHA’s intent was to allow the current 47575). every two years thereafter, unless the BeLPT requirement to be replaced with Commenters including NJH, Ameren, employee is confirmed positive. If the a more accurate and reliable test that NSSP, Materion and USW, ACOEM, and results of the BeLPT are other than would not require retesting to confirm ORCHSE supported the inclusion of a normal, a follow-up BeLPT must be

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offered within 30 days, unless the within the past 15 years. Under deaths, and smoking cessation remains employee has been confirmed positive. USPSTF’s criteria, screening should be essential. Lung cancer screening has Samples must be analyzed by a discontinued once a person has not substantial harms, most notably the risk for laboratory certified under the College of smoked for 15 years or develops a false-positive results and incidental findings that lead to a cascade of testing and treatment American Pathologists (CAP)/Clinical health problem that substantially limits that may result in more harms, including the Laboratory Improvement Amendments life expectancy or the ability or anxiety of living with a lesion that may be (CLIA) guidelines to perform the BeLPT. willingness to have curative lung cancer. Overdiagnosis of lung cancer and the Proposed paragraph (k)(3)(ii)(F) surgery (Moyer et al., 2014, Document risks of radiation are real harms, although would have required a CT scan to be ID 1791). The USPSTF recommendation their magnitude is uncertain. The decision to offered to employees who had been was based on the findings of the begin screening should be the result of a exposed to beryllium at concentrations National Lung Cancer Screening Trial thorough discussion of the possible benefits, above 0.2 mg/m3 for more than 30 days (NLST), which was a large study of the limitations, and known and uncertain harms (Moyer, et al., 2014, Document ID 1791, p. in a 12-month period for 5 years or effectiveness of using x-ray and LDCT 333). more. As OSHA explained in the screening for early detection of lung preamble, the five years of exposure did cancer. In addition to the USPSTF, several not need to be consecutive (80 FR The NLST enrolled asymptomatic other organizations have recommended 47799). As with the requirement for men and women (n = 53,454), aged 55 similar lung cancer screening protocols sensitization testing explained above, to 74, that were current smokers or for high-risk individuals, including the the CT scan would have been required former smokers within the last 15 years American Cancer Society, American to be offered to an employee who met and had a smoking history of at least 30 College of Chest Physicians, American the criteria of paragraph (k)(1)(i)(D) pack-years. The participants underwent Society of Clinical Oncology, American without regard to whether the employee annual lung cancer screening with Lung Association, National was otherwise required to receive a either LDCT or chest radiography for Comprehensive Cancer Network, and medical exam in a given year. OSHA three years. The results showed a the American Association for Thoracic explained that the CT scan would have statistically significant 20-percent Surgery. Each organization’s specific been offered to employees who met the relative reduction in lung cancer screening recommendations are criteria of paragraph (k)(1)(i)(D) for the mortality with LDCT screening (Aberle, summarized by the U.S. Centers for first time beginning on the start-up date et al., 2011, Document ID 1701). Disease Control and Prevention: http:// of this standard, or 15 years after the However, the trial also showed that www.cdc.gov/cancer/lung/pdf/ employee’s first exposure to beryllium LDCT screening results in a high false- guidelines.pdf. above 0.2 mg/m3 for more than 30 days positive rate; 24.2 percent of the total With regard to occupational exposure, in a 12-month period, whichever was LDCT screening tests were classified as OSHA is not aware of any definitive later. OSHA proposed the requirement positive, with 96.4 percent of these recommendations based on a large, for CT screening based in part on the positive results ultimately being false well-conducted, randomized, controlled Agency’s consideration of the draft positives. In addition, 39.1 percent of study examining the benefit of lung recommended standard submitted by the 26,722 (or about 10,450) participants cancer screening with LDCT among industry and union stakeholders in the LDCT screening group had at occupationally-exposed workers. In its (Document ID 0754, p. 8). least one positive screening result out of pre-hearing comments, NIOSH noted OSHA requested comment on the three LDCT scans during the study that the screened population must be at proposed CT scan requirements, as part (Alberle, et al., 2011, Document ID sufficiently high risk for lung cancer in of the content of the medical 1701). Given that only 649 cancers were order to assure that the benefit of LDCT examinations (80 FR 47574). In diagnosed after a positive screening test, screening for early detection exceeds the addition, OSHA asked stakeholders to and assuming that each of these cancers harm (Document ID 1671, Attachment 1, opine on two regulatory alternatives was in a different participant, it follows p. 8). NIOSH cited a report by the related to CT scans: (1) Regulatory that only 6.2 percent of those with at Finnish Institute of Occupational Health Alternative #18, which would have least one positive test were ultimately (FIOH) that recommended LDCT dropped the CT scan requirement from diagnosed with lung cancer. This means screening in asbestos-exposed the proposed rule, and (2) Regulatory that 36.7 percent of participants in the individuals if their personal Alternative #19, which would have LDCT screening group had at least one combination of risk factors, particularly increased the frequency of periodic CT false positive result. Most positive smoking history, yields a risk for lung scans from biennial to annual scans (80 initial screening results in the NLST— cancer equal to that needed for entry FR 47571). many of which were false positives— into the NLST. NIOSH noted that the A number of stakeholders responded were followed up with a diagnostic absolute risk for lung cancer in the to the Agency’s request for comments on evaluation that included further imaging NLST and the threshold absolute risk the proposed CT scan requirements. and, infrequently, invasive procedures for lung cancer proposed by FIOH as a Two such commenters, Public Citizen (Alberle, et al., 2011, Document ID trigger for LDCT screening was 1.34% and NJH, referenced criteria for low- 1701). over 6 years (Document ID 1671, dose CT lung cancer screening set forth Given these findings, the USPSTF Attachment 1, p. 8). by the U.S. Preventive Services Task noted, in its recommendation for lung OSHA also received comments in the Force (USPSTF), an independent, cancer screening for high-risk record pointing to the LDCT lung cancer volunteer panel of national experts in individuals, the importance of shared screening recommendations of the prevention and evidence-based decision making. The USPSTF advised: National Comprehensive Cancer medicine (Document ID 1664, p. 4; Network (NCCN), a nonprofit alliance of 1964, p. 4). In December, 2013, the Shared decision making is important for 27 cancer centers (Document ID 1805, USPSTF recommended annual the population for whom screening is Attachment 1; Document ID 1959). In recommended. The benefit of screening screening for lung cancer with LDCT for varies with risk because persons who are at addition to recommending screening for adults aged 55 to 80 years with a 30- higher risk because of smoking history or individuals (current smokers or former pack-year smoking history and who other risk factors are more likely to benefit. smokers that have quit within the last either currently smoke or have quit Screening cannot prevent most lung cancer 15 years) who are 55 to 74 years of age

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with a smoking history of at least 30 and the Aluminum Association cancer already exceeded that level. pack-years, the NCCN recommended (Document ID 1664, pp. 1, 4; 1688, p. 2; Although there are uncertainties around LDCT screening for individuals age 50 1691, Attachment 1, p. 1; 1671, the NIOSH estimates (for example, use years or older with a smoking history of Attachment 1, pp. 8–9; 1964, p. 4; 1663, of 10-year rather than 6-year age at least 20 pack-years and with one or p. 3; 1666, pp. 3–4). For example, NJH intervals, which would understate the more additional risk factors; these risk commented that the risk of lung cancer required level of beryllium exposure), factors include a history of COPD or associated with exposure to beryllium at OSHA finds that the NIOSH analysis pulmonary fibrosis, a history of cancer, the final rule’s PEL of 0.2 mg/m3 was demonstrates that LDCT screening a family history of lung cancer, radon likely to be lower than that from the would benefit non-smoking workers exposure, or occupational exposure to radiation exposure received from LDCT exposed to beryllium only where the the carcinogens asbestos, arsenic, screening, particularly for workers workers were exposed to very high beryllium, cadmium, chromium, nickel, under age 50 (Document ID 1664, p. 4). concentrations of beryllium, i.e., levels silica, or diesel fumes (Document ID NJH also stated that the majority of at and above the previous PEL. 1815, Attachment 39). Like the USPSTF, beryllium-exposed workers are former Many of the rulemaking commenters NCCN noted that individuals who smokers and many would not fit the who objected to the proposed qualify under these LDCT screening criteria for the USPSTF requirement for LDCT screening also recommendations should engage in recommendations (Document ID 1664, believed that the absence of any studies shared decision making with their p. 4). ORCHSE argued that showing the effectiveness of LDCT physician and discuss the benefits and ‘‘[e]xtrapolation of the results of the screening on beryllium-exposed workers harms of LDCT screening for lung non-occupational National Lung was further reason not to require LDCT cancer (Document ID 1815, Attachment Screening Trial for implementation in screening based only on a history of 39). the occupational setting is premature, beryllium exposure (Document ID 1664, Thus, the studies and and fraught with a number of potential recommendations discussed above p. 1; 1688, p. 2; 1691, Attachment 1, p. issues and concerns [e.g., over- 1; 1756, pp. 123–125; 1806, pp. 1–2). indicate that age and smoking history diagnosis, false positives, radiation are crucial risk factors that determine For example, Dr. Newman, who dose, follow-on invasive procedures and represented ACOEM at the public when the benefits of LDCT screening are attendant complications]. The requisite likely to outweigh the risks from hearing, in response to a question 30 pack-year trigger recommended for testified that radiation exposure and false-positive screening is associated with risks orders results. The radiation exposure received of magnitude higher than that associated . . . we don’t have any data on beryllium— specifically looking at beryllium workers from periodic LDCT scans increases the with beryllium exposure’’ (Document ID risk of lung and breast cancer, as well with the cluster of risk factors [i.e., smoking 1691, Attachment 1, p. 1). Similarly, in plus Be exposure] that you’ve described. And as leukemia. Public Citizen estimated post-hearing comment, Public Citizen the risk of these cancers that could I think that absent that it means that there is remarked that it would be a ‘‘dangerous more of a question mark around . . . how far result when workers are screened as mistake’’ to provide LDCT screening for should OSHA go at this point with low dose described in OSHA’s proposed rule the majority of non-smoking beryllium- CT (Document ID 1756, pp. 124–125). (Document ID 1964, pp. 4–6). Public exposed workers who are at low risk for In contrast to these commenters, Citizen also estimated the total radiation lung cancer and thus would not benefit inclusion of LDCT screening into the dose received to range from 900 to 2,400 from such screening (Document ID mrems, depending on age at which final rule was supported by USW in 1964, p. 10). screening begins. The excess cancer written comments and at the informal risks resulting from these exposures, The suggestion that beryllium public hearing. Sara Brooks of the USW based on Public Citizen’s use of the exposure alone would lead to lung commented that cancer risks too low to warrant LDCT National Academies BIER VII report, The proposed inclusion of a low dose CT ranged from 3.7 to 29.9 deaths per 1,000 screening was illustrated by NIOSH in an analysis of risk information. NIOSH scan as part of medical surveillance is workers for solid organ cancers, and entirely justified. The low dose CT scan can from 0.5 to 2.3 deaths per 1,000 for used the mortality study by Schubauer- effectively detect lung cancer at an early leukemia (Document ID 1964, p. 6). Berigan et al. (2011 b, Document ID stage and has been demonstrated to reduce These risk estimates are comparable to 0521) to estimate the exposure levels to lung cancer mortality among high risk OSHA’s estimated lung cancer mortality beryllium that would result in a risk individuals. Since lung cancer is recognized risk resulting from exposure to level at least as high as that suggested as an outcome caused by beryllium exposure, beryllium at the PEL of 0.2 mg/m3 over by FIOH as a trigger for LDCT screening inclusion of the low dose CT scan in the a working life (see Section VI, Risk (i.e., an absolute increased risk of 1.34 proposed rule is appropriate (Document ID 1681, Attachment 1, p. 14). Assessment). False-positive results carry percent over a 6-year period). To reach the risk of additional radiation exposure risk levels of this magnitude, NIOSH Dr. Steven Markowitz of the City from repeat scans, as well as found that a 40-year-old would have University of New York, testifying on unnecessary anxiety for the workers and had to have been exposed to a mean behalf of USW, supported OSHA his or her family, unnecessary invasive daily weighted average exposure of 12 requiring LDCT screening for beryllium- 3 procedures that may have risks of mg/m to achieve a lung cancer risk level exposed workers, citing the NLST medical complications, and unnecessary sufficient to justify LDCT, and a 50-year- finding that screening reduced lung medical expenses (Document ID 1806, old worker would have had to have cancer mortality by 20 percent. He also pp. 1–2; 1964, pp. 7–8). been exposed to a mean daily weighted noted that A number of rulemaking participants average exposure of 2 mg/m3, a daily agreed that the lung cancer risks from exposure equal to the previous PEL. It [t]he use of LDCT is rapidly increasing because of just how common lung cancer is. beryllium exposure are, for the vast was not possible for NIOSH to estimate And this is an effective non-invasive majority of workers, unlikely to be so the required level of beryllium exposure technique. And that there can really [be] a high that LDCT screening would be necessary above age 60 to reach a risk display of leadership by including LDCT now beneficial, including NJH, ATS, level equal to that suggested by FIOH in the proposed medical standard for ORCHSE, NIOSH, Public Citizen, NGK, because the background rate of lung beryllium (Document ID 1755, Tr. 110).

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In post-hearing comment, Dr. to trigger LDCT screening results in a valuable medical information. The Markowitz suggested limiting the cancer risk sufficiently high to warrant Agency preliminarily found that the proposal’s requirement to apply to LDCT screening. PLHCP was in the best position to workers age 50 or more, and pointed out For the final rule, OSHA considered decide which medical tests are that this was consistent with OSHA’s increasing the threshold of beryllium necessary for each individual examined. past practice (i.e., medical surveillance exposure such that LDCT screening Although a requirement for other tests requirements under the Cadmium would be triggered at much higher deemed appropriate by the PLCHP was standard, 29 CFR 1910.1027) and with exposures to beryllium (e.g., average not included in the draft joint NCCN recommendations (Document ID exposure above 2 mg/m3 for over several recommended standard by Materion and 1959, p. 1). Second, he argued that the years), as was suggested by the NIOSH USW (Document ID 0754), similar assertion that LDCT should not be analysis. OSHA rejected this approach requirements have been included in included in the rule based on the lack for three reasons. First, as pointed out previous OSHA health standards, such of studies showing efficacy of LDCT on by ORCHSE (Document ID 1691, as Chromium (VI) (29 CFR 1910.1026) beryllium-exposures workers was Attachment 1, p. 6), it is unlikely that and Respirable Crystalline Silica (29 ‘‘without merit’’ (Document ID 1959, p. exposure records would be available for CFR 1910.1053). 1). He pointed out that many of the risk many workers to show that the trigger No stakeholders objected to the factors used by the medical community was met, except where workers had long proposal’s requirement that the medical as a basis for recommending LDCT (e.g., employment tenure with their present examination include other tests deemed family medical history, presence of employer. Second, establishing such a appropriate by the PLHCP. However, chronic obstructive lung disease) lack high exposure trigger for LDCT some commenters offered examples of empirical evidence relating the screening would, in fact, exclude tests that might be useful in certain effectiveness of LDCT to the presence of workers with a history of lesser situations. For example, for employees these risk factors. Thus, Dr. Markowitz beryllium exposure even when other diagnosed with CBD, NJH recommended argued that ‘‘[t]he decision to undergo risk factors are present such that LDCT that the test battery include pulmonary (by the individual) or to recommend (by would be beneficial. Finally, OSHA is function tests including diffusing the physician) LDCT for lung cancer reluctant to fix a hard exposure trigger capacity, exercise tolerance tests, chest screening is based on that individual’s in the standard given that, as pointed X-ray or CT scan, bronchoscopy with overall level of risk of lung cancer, not out by USW, LDCT technology is likely lavage and biopsy, and bronchoalveolar on the particular mix and magnitude of to advance and increase the efficacy of lavage BeLPT (Document ID 1806, p. screening to where screening becomes individual risk factors that constitute 12). overall risk’’ (Document ID 1959, p. 1). beneficial for those with lesser risk of lung cancer than is reflected by current After reviewing the comments on this He also argued that because cancers issue, OSHA reaffirms that allowing the caused by beryllium exposure are recommendations. Therefore, OSHA concludes that the PLHCP to select other tests is similar to the types of lung cancers from best approach is to require LDCT appropriate because there are no other causes, beryllium exposure is not screening for beryllium-exposed particular tests—beyond those listed in more or less amenable to LDCT workers based on the recommendation paragraph (k)(3)(ii)(A)–(E)—that are screening than are smoking history or of the physician conducting or necessarily applicable to all employees other risk factors (Document ID 1959, p. overseeing the medical examination, covered by the medical surveillance 2). Dr. Markowitz concluded that the after all relevant risk factors have been requirements. This provision gives the absence of studies on beryllium-exposed considered, and has accordingly examining PLHCP the flexibility to workers and LDCT screening ‘‘should reflected this approach in the final determine additional tests deemed to be not be a decisive factor in determining standards. For these reasons, paragraph appropriate for individual employees. whether LDCT should be included in (k)(3)(ii)(F) of the final standards While the tests conducted under this the final OSHA standard on beryllium.’’ requires the medical examination to paragraph are for screening purposes, (Document ID 1959, p. 3). include an LDCT scan, when diagnostic tests may be necessary to OSHA agrees in general that recommended by the PLHCP after address a specific medical complaint or beryllium exposure should be considering the employee’s history of finding related to beryllium exposure or considered as a risk factor when exposure to beryllium along with other the PLHCP may decide that the test deciding whether LDCT screening is risk factors, such as smoking history, battery needs to be expanded once an appropriate, and agrees that it is not family medical history, age, sex, and employee has been diagnosed with CBD. appropriate to wait for specific studies presence of existing lung disease. Although the tests suggested by NJH to be conducted before considering that The seventh and final item required have been demonstrated to provide a history of beryllium exposure should as part of the medical examination additional valuable medical be factored into a decision to undergo under the proposal was any other test information, OSHA considers the LDCT screening. This is, in fact, deemed appropriate by the PLHCP. PLHCP to be in the best position to consistent with the NCCN’s criteria for OSHA explained that other types of decide if any additional medical tests, LDCT screening that include tests and examinations not mentioned especially the more invasive tests, are occupational exposures along with age, in this standard, including X-ray, necessary for each individual examined. smoking history, and other risk factors. arterial blood gas, diffusing capacity, Under this provision, if a PLHCP However, LDCT screening is not and oxygen desaturation during decides another test related to beryllium triggered under these criteria based on exercise, may also be useful in exposure is medically indicated, the occupational exposures and age alone; evaluating the effects of beryllium employer must make it available. OSHA there must also be a history of smoking exposure (80 FR 47799). In addition, intends the phrase ‘‘deemed (albeit a lower trigger than when OSHA noted that medical examinations appropriate’’ to mean that additional considering only age and smoking). As that include more invasive testing, such tests requested by the PLHCP must be discussed above, there is no evidence in as bronchoscopy, alveolar lavage, and both related to beryllium exposure and the record that exposure to beryllium transbronchial biopsy, have been medically necessary, based on the alone at the level used in the proposal demonstrated to provide additional findings of the medical examination.

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Information Provided to the PLHCP. medical information to the PLHCP be requirement is in paragraph (k)(6) of the Proposed paragraph (k)(4) detailed waived if the employee refuses to sign final standards. This summary and which information must be provided to a medical release (Document ID 1691, explanation for those paragraphs first the PHLCP. Specifically, the proposed Attachment 1, pp. 10–11). After discusses the proposed requirements standard required the employer to considering this comment, OSHA finds and general comments received in ensure the examining PLHCP has a copy that a change to the provision is not response during the rulemaking. OSHA of the standard, and to provide to the needed because the employer can then explains in this subsection of the examining PLHCP the following demonstrate a good faith effort in preamble its decision in response to information, if known to the employer: meeting this requirement by these comments to change from the A description of the employee’s former documenting the employee’s refusal to proposed requirement for a single and current duties that relate to the provide a medical release. However, the opinion to go to both the employee and employee’s occupational exposure Agency has chosen to use the phrase employer and replace it with two ((k)(4)(i)); the employee’s former and ‘‘written consent’’ instead of ‘‘medical separate and distinct requirements: (1) current levels of occupational exposure release’’ in the final standards. This A full report for the employee, which ((k)(4)(ii)); a description of any personal non-substantive change brings the includes medical findings, any protective clothing and equipment, language in this provision in line with recommendations on the employee’s use including respirators, used by the the language used in final paragraphs of respirators, protective clothing, or employee, including when and for how (k)(6) and (k)(7), discussed below. equipment or limitations on airborne long the employee has used that Third, OSHA revised the provision to exposure to beryllium, and any clothing and equipment ((k)(4)(iii)); and indicate that the employer must ensure recommendations for referral to a CBD information the employer has obtained that the same information provided to diagnostic center, continued periodic from previous medical examinations the PLHCP is also provided to the surveillance, and medical removal; and provided to the employee, that is agreed-upon CBD diagnostic center, if (2) an opinion for the employer, which currently within the employer’s control, an evaluation is required under focuses primarily on any recommended if the employee provides a medical paragraph (k)(7) of this standard. OSHA limitations on respirator, protective release of the information ((k)(4)(iv)). A made this change because the CBD clothing, or equipment use, and with similar requirement was contained in diagnostic center will need the same the employee’s consent, the draft joint recommended standard information as the PLHCP in order to recommendations for referral to a CBD by Materion and USW (Document ID effectively evaluate the employee. diagnostic center, continued periodic 0754, p. 8). However, Materion and OSHA concludes that making this surveillance, and medical removal. The USW’s standard did not require written information available to the PLHCP and ensuing two subsections will then authorization from the employee for the CBD diagnostic center will aid in the discuss the specific requirements and evaluation of the employee’s health as it employer to release medical information the record comments and testimony relates to the employee’s assigned duties to the PLHCP. OSHA has included relating to those specific requirements. similar provisions, with the exception of and fitness to use personal protective Proposed paragraphs (k)(5)(i)(A)–(C) the employee’s medical release, in equipment, including respirators, when previous OSHA standards, such as necessary. Providing the PLHCP and would have required the employer to Chromium (VI) (29 CFR 1910.1026) and CBD diagnostic center with exposure obtain from the licensed physician a Respirable Crystalline Silica (29 CFR monitoring results, as required under written medical opinion containing: (1) 1910.1053). paragraph (k)(4)(ii), will assist them in The licensed physician’s opinion as to OSHA did not receive any comments determining if an employee is likely to whether the employee has any detected on the proposed requirement to provide be at risk of adverse effects from medical condition that would place the information to the PLHCP. Therefore, airborne beryllium exposure at work employee at increased risk of CBD from the Agency is including it in the final and indicate that information in the further airborne exposure to beryllium; standards with three modifications. written medical report for the employee. (2) any recommended limitations on the First, OSHA has updated paragraph A well-documented exposure history employee’s airborne exposure to (k)(4)(i) to require the employer to will also assist the PLCHP in beryllium, including the use and provide a description of the employee’s determining if a condition (e.g., limitations of protective clothing or former and current duties that relate to dermatitis, decreased lung function) equipment, including respirators; and both the employee’s airborne exposure may be related to beryllium exposure. (3) a statement that the PLHCP to and dermal contact with beryllium, Written medical reports and opinions. explained the results of the medical instead of merely requiring the Paragraph (k)(5) of the proposed examination to the employee, including provision of information related to standard provided for the licensed tests conducted, any medical conditions airborne exposures, as in the proposal. physician to give a written medical related to airborne exposure that require As indicated above with regard to the opinion to the employer, but relied on further evaluation or treatment, and any medical examination’s medical and the employer to give the employee a special provisions related to use of work history requirements, OSHA finds copy of that opinion; thus, there was no protective clothing or equipment. that this change is appropriate because difference between information the Proposed paragraph (k)(5)(ii) would the record indicates that dermal contact employer and employee received. The have required the employer to ensure with beryllium can lead to respiratory final standards differentiate the types of that neither the licensed physician nor and dermal sensitization. information the employer and employee any other PLCHP revealed to the Second, OSHA revised the receive by including two separate employer specific findings or diagnoses requirement that the employer obtain a paragraphs within the medical unrelated to airborne beryllium ‘‘medical release’’ before providing the surveillance section that require a exposure or contact with soluble PLHCP with information from records of written medical report to go to the beryllium compounds. Finally, employment-related medical employee, and a more limited written proposed paragraph (k)(5)(iii) would examinations. ORCHSE recommended medical opinion to go to the employer. have required the employer to provide that paragraph (k)(4)(iv) be revised to The former requirement is in paragraph the employee with a copy of the opinion indicate that the requirement to provide (k)(5) of the final standards; the latter within two weeks of receiving it.

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OSHA asked stakeholders to consider Physicians should disclose their recommended work-related limitations what if any information the PLHCP professional opinion to both the employer or recommendations without conveying should give to the employer. and the employee when the employee has the medical reasons for the limitations. Specifically, the Agency asked whether undergone a medical assessment for fitness to Thus, consistent with the weight of perform a specific job. However, the it should revise the medical surveillance physician should not provide the employer opinion in this rulemaking record and provisions of the proposed standard to with specific medical details or diagnoses with evolving notions about where the allow employees to choose what, if any, unless the employee has given his or her balance between preventive health medical information goes to the permission (Document ID 1815, Attachment policy and patient privacy is properly employer from the PLHCP. For example, 60, p. 1). struck, OSHA is taking a more privacy- OSHA explained, the employer could Exceptions to this recommendation and consent-based approach regarding instead be required to obtain a listed under the ACOEM guidelines the contents of the licensed physician’s certification from the PLHCP stating (1) include health and safety concerns. written medical opinion for the when the examination took place, (2) Dr. Weissman also expressed employer. The approach is similar to the that the examination complied with the concerns about employers’ ability to approach that OSHA took in the standard, and (3) that the PLHCP ensure the confidentiality of the medical recently promulgated Respirable provided the licensed physician’s information obtained from workers Crystalline Silica standard, but more written medical opinion to the (Document ID 1725, pp. 33–34). He privacy-based compared to the proposed employee. Such an approach would argued that if OSHA were to require beryllium requirements and OSHA require the employee to provide written diagnoses of beryllium sensitization to standards promulgated before the consent for the medical opinion or any be shared with employers, provisions Respirable Crystalline Silica standard. other medical information about the would be needed to ensure that These changes, which are reflected in employee to be sent to the employer. sensitive information was protected paragraph (k)(6) of the standards, and OSHA asked stakeholders to comment (Document ID 1725, p. 34). He the comments that led to these changes, on the relative merits of the proposed maintained that ‘‘[s]uch provisions are are more fully discussed below. standard’s requirement that employers especially needed because employers Reinforcing the privacy concerns, obtain the PLHCP’s written opinion or are not necessarily covered entities stakeholders testified about job loss an alternative that would provide under the Health Insurance Portability concerns when employees are employees with greater discretion over and Accountability Act (HIPPAA) diagnosed with an illness. For example, the information that goes to employers. Privacy Rule’’ (Document ID 1725, p. NABTU’s Chris Trahan testified that OSHA also asked that commenters 34). In fact, some employers who workers in the construction industry get explain the basis for their position and commented during the silica rulemaking laid off if an employer finds out they are the potential impacts of such an expressed concerns about having to ill (Document ID 1756, Tr. 237–238). approach (80 FR 47575). maintain confidential medical Mike Wright, Director of the OSHA received a number of information (81 FR 16832). Environmental Health and Safety comments related to the proposed Commenters representing employee Department, USW, testified that he has provisions and the issues raised. Many interests also objected to giving the repeatedly seen employers fire of these comments related to the opinion to the employer, and offered employees who are in the early stages of proposed contents of the PLHCP’s solutions. For example, AFL–CIO fellow occupational disease (Document ID written medical opinion and its Mary Kathryn Fletcher testified that 1751, p. 284). Dr. Weissman testified transmission to the employer. Some OSHA should consider the MSHA that if medical results are given directly commenters offered suggestions to requirements for black lung, which to the employer, employees may fear address privacy concerns regarding the requires health care providers to give that it would result in loss of their jobs content of the proposed licensed their opinion directly to the employee and that would discourage them from physician’s written medical opinion and (Document ID 1756, Tr. 201–202; 30 participating in medical surveillance the proposed requirement that the CFR 90.3). (Document ID 1755, Tr. 47–48). In opinion be given to the employer OSHA has accounted for stakeholder commenting on a proposed standard instead of the employee. For example, privacy concerns in devising the provision that required an employer to David Weissman, M.D., the director of medical disclosure requirements in the get a signed release before sending the Respiratory Health Division at rule. OSHA understands that the need medical information to a PLHCP, NIOSH, objected to providing a specific to inform employers about a licensed ORCHSE expressed concerns that diagnosis to employers and urged OSHA physician’s recommendations on work employees are not compelled to sign to adopt a policy consistent with the limitations associated with an releases (Document ID 1691, p. 10). The International Code of Ethics for employee’s exposure to beryllium must ORCHSE comment suggests that Occupational Health Professionals be balanced against the employee’s employees are reluctant to automatically established by the International privacy interests. As discussed in have their medical information shared Commission on Occupational Health further detail below, OSHA finds it with medical professionals, much less (Document ID 1725, p. 33; 1815, appropriate to distinguish between the their own employers. These comments Attachment 82). The policy licensed physician’s recommendations mirror concerns voiced in the recent recommends reporting only information and the underlying medical reasons for silica rulemaking. As part of that on fitness for work and medically those recommendations. In doing so, rulemaking, Dr. Weissman testified that related limitations to management. OSHA intends for the licensed fear of medical information being shared NIOSH, AFL–CIO, and NABTU also physician to limit disclosure to the with employers is one of the biggest recommended the ACOEM guidance on employer to what the employer needs to reasons that miners give for not confidentiality as a model for the types know to protect the employee, which participating in medical surveillance, of information submitted to the does not include an employee’s and a number of employees testified employer (Document ID 1679, p. 13; diagnosis. that they would not participate in 1689, p. 14; 1725, p. 33). The ACOEM OSHA concludes that the employer medical surveillance that lacked both guidelines state: primarily needs to know about any employee confidentiality and anti-

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retaliation and discrimination medical data to employers that would airborne exposure to or dermal contact protection (81 FR 16831–16832). In let employers know there may be a with beryllium (paragraph (f)(1)(ii)(B)). addition, the Construction Industry problem but not identify the specific OSHA also encourages analyses of Safety Coalition commented that some employees affected (Document ID 1755, aggregated data when employers have employers might refuse to hire an Tr. 47–49). He also said that employers the resources to do that and are able to employee with silicosis for fear that could foster a strong culture of safety so maintain employee confidentially, they would be held liable or have to that employees would be more likely to which is not always possible. However, offer workers’ compensation if the share medical findings. Dr. Maier, from in the case where an employee may disease progressed (81 FR 16832)). NJH, suggested a similar approach of have disease related to beryllium A number of stakeholders, including analyzing combined data based on job exposure and the employer is effectively Southern Company, Ameren, and NSSP task with employees de-identified implementing controls to maintain highlighted the importance of reporting (Document ID 1756, p. 145). However, exposures within the PEL, the only beryllium-related findings to the Terry Civic, Director of Safety Health further action required by the employer employer for reasons such as evaluating and Regulatory Affairs from Materion, would be to follow the licensed the effectiveness of workplace programs and Dr. Newman argued that such an physician’s recommendations to protect and making workplace changes to approach may not be able to maintain the employee who may be especially protect employees (Document ID 1668, employee confidentiality in many cases, sensitive to exposure and may need p. 7; 1675, p. 18; 1677, p. 7). NJH such as when very few employees are special accommodations such as reflected similar views and also involved with a process or are employed continuing medical examinations at a indicated that the employer would need by a small company (Document ID 1755, CBD diagnostic center or medical medical information for medical follow- Tr. 173–174; 1756, Tr. 145). removal if requested by the employee. up and removal and to help the Mr. Wright presented another view The employer does not need the specific employee file for workers’ when he testified that risk can be health findings that contributed to those compensation (Document ID 1664, p. 8). determined in many ways, including air recommendations. Materion opposed withholding medical sampling and analyses of work OSHA examined a number of other information from employers. It processes. He went on to say that factors in determining what the possible commented that Materion has a waiting for an employee to get sick is outcomes could be of not providing cooperative process where employees the least effective way of determining medical findings to employers. One are involved in problem identification risk (Document ID 1756, Tr. 284–285). possible outcome is that employers and resolution, and when an employee Chris Trahan of NABTU expressed would not be able to report or record is diagnosed with sensitization or CBD, similar thoughts in her testimony illness according to OSHA’s standard on senior and safety personnel conduct an (Document ID 1756, Tr. 240). Rebecca recording and reporting occupational investigation (Document ID 1755, Tr. Reindel, Senior Safety and Health injuries and illnesses (29 CFR 1904). 172–173; 1807, pp. 4–5). It indicated Specialist from AFL–CIO, added: OSHA notes that if employees do not that the approach has resulted in participate in medical surveillance improvements aimed at preventing Employers don’t need to hear about a because of discrimination or retaliation disease in order to implement engineering other workers from developing CBD in fears, illnesses associated with controls. It’s unlikely that a disease is beryllium would also generally not be the future (Document ID 1807, pp. 4–5). necessarily going to trigger engineering Although USW agreed that patient controls more than what OSHA requires in identified. Although not disclosing confidentiality is essential, it argued in its standards (Document ID 1756, Tr. 240). medical information to employers comments submitted before the hearing appears inconsistent with the objective OSHA acknowledges that identifying that the employer needs certain of recording illnesses, the net effect of workers with beryllium-related disease information to comply with the that decision to guard employee privacy has led to an increased understanding of standard, identify over-exposures, and is improving employee protections due exposures related to beryllium disease accommodate the needs of affected to more employees participating in and development of controls to protect employees; it commented that the medical surveillance. workers, and OSHA recognizes the proposed rule struck the appropriate An additional possible outcome efforts of employers who have promoted balance by giving the employer needed relating to what information goes to the a strong health and safety culture and information while prohibiting the employer is that withholding contributed to the knowledge on reporting of medical findings not related information, such as conditions that beryllium. However, OSHA also to beryllium exposure (Document ID might place an employee at risk of recognizes that many employees may 1681, p. 26). However, at the hearings health impairment with further fear possible repercussions of the USW presented a slightly different view, exposure, may leave employers with no release of medical information to their as Mike Wright testified: medical basis to aid in the placement of employers. employees. For example, DOD opposed So in this circumstance, we’d like the Moreover, OSHA agrees with withholding medical information from employer to know that there’s an operation commenters who said that employers that has caused illness. In a union setting, we employers because the information lets can usually protect people, but we only should be basing their actions on the employer know if the worker can represent a fraction of the workforce. In a exposure assessments and continue to work without undue risk nonunion setting, and even in the union implementing controls, and it (Document ID 1684, Attachment 2, pp. setting, people who report an occupational encourages employers to regularly 1–7). However, in the recent silica illness put their jobs at peril. So we tend to evaluate their beryllium programs. The rulemaking, a number of stakeholders resolve that dilemma in terms of privacy standards for beryllium require commented that because of the (Document ID 1756, Tr. 285). employers to review and evaluate the significance of job loss or modifications, When questioned how privacy written exposure control plan if the employees that are able to perform work concerns could be balanced with employer is notified that an employee is duties should make their own decisions improving the work environment, Dr. eligible for medical removal, is referred on whether to continue working and Weissman testified that medical to a CBD diagnostic center, or shows that such decisions should be made providers could provide aggregated signs or symptoms associated with with guidance from the PLHCP (81 FR

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16833). OSHA finds that this is also true maintain medical records under strict that employees can make decisions to for beryllium-exposed employees. As a confidentiality. mitigate adverse health effects and to result of participating in medical Another factor that OSHA considered possibly retard progression of the surveillance, those employees will was the value of giving health disease. receive information about any health information to all employers, when In sum, OSHA concludes that the condition they have that might put them some companies, such as small record offers compelling evidence for at further risk with exposure to businesses, may not have in-house modifying the proposed content of the beryllium and allow them to make health and safety personnel to answer licensed physician’s written medical employment choices to benefit their employee questions or emphasize the opinion for the employer. The evidence health. importance of protective measures, such includes employee privacy concerns, as Such an approach is not inconsistent as work practices or proper use of well as evidence on the limited utility with Materion’s approach of letting respirators. In such cases, employees are for giving specific medical findings to employees make some employment not likely to benefit from having their employers. OSHA is particularly decisions after learning that they are medical findings given to employers, concerned that the proposed sensitized or have CBD, although who may have no deeper knowledge requirements would have led to many Materion strongly supports providing about health risks than the employee. employees not participating in medical employers with sensitization OSHA expects that the training required surveillance and thus not receiving its information (Document ID 1807, pp. 4– under the standards will give employees benefits. OSHA therefore has limited the 5; Attachment 6, pp. 75–76). At knowledge to understand protective information to be given to the employer Materion, the confirmed positive measures recommended by the PLHCP, under this rule, but is requiring that the finding is reported to management so an and will make it more likely they will employee receive a separate written investigation can be conducted, and the authorize PLHCP recommendations to medical report with more detailed Materion Medical Director informs the be disclosed to the employer. medical information. As was the case in the silica employee about the rates of progression The requirements for the type of rulemaking, OSHA agrees that from sensitization to CBD based on information provided to the employer employees exposed to beryllium have Materion’s most recent epidemiological are consistent with those in the the most at stake in terms of their health data. If the employee is diagnosed with Respirable Crystalline Silica standard and employability, and they should not CBD by his or her personal have to choose between continued (29 CFR 1910.1053), but are different pulmonologist, the employee can employment and the health benefits from requirements in the majority of choose to provide the information to offered by medical surveillance, which OSHA standards that were promulgated Materion’s Medical Director. Materion they are entitled to under the OSH Act. before that standard. The requirements reported that employees ‘‘often do OSHA agrees that employees should in other standards remain in effect for [disclose their diagnosis of CBD] in make employment decisions, following those standards. The requirements for choosing to apply for Materion benefits discussions with the PLHCP that this rule are based on the evidence under its CBD policy’’ (Document ID include the risks of continued exposure. obtained during this rulemaking for 1807, p. 4). Under the CBD policy, Before that can happen, however, beryllium, in particular that many employees who are physically able to employees need to have confidence that employees, especially those who are not perform the job are given the choice of participation in medical surveillance represented by a labor union or who remaining in their current job, taking a will not threaten their livelihoods. After work in a company that does not foster job with lower beryllium exposures, or considering the various viewpoints a strong health and safety culture, receiving benefits for 12 months. OSHA expressed during the rulemaking on would not take advantage of medical agrees with Materion’s approach of these issues, OSHA concludes that the surveillance without stronger privacy letting employees decide how to best way to maximize employee protections. proceed if they are confirmed positive participation in medical surveillance, Licensed Physician’s written medical or diagnosed with CBD, but disagrees therefore promoting the protective and report for the employee. OSHA did not that the employer must receive specific preventative purposes of this rule, is by propose a separate report given directly health findings before that can happen. limiting required disclosures of by the licensed physician to the In review of this evidence, OSHA information to the employer to only the employee, but as discussed in detail concludes that if employees decide to bare minimum of what the employer above, several commenters requested make employment changes to protect needs to know to protect employee that a report containing medical their health, there are ways to health—recommended restrictions on information be given to the employee communicate recommended limitations respirator and protective clothing and only. OSHA agrees and in response to or medical removal, without revealing equipment use and, only with consent those comments, final paragraph (k)(5) the specific medical finding leading to of the employee, the licensed requires the employer to ensure that the those recommendations. Because of physician’s recommended limitations PLHCP explains the results of the evolving views on medical privacy, on airborne exposure to beryllium and medical examination and that the such as those set forth in ACOEM’s recommendations for evaluation at a licensed physician provides the Confidentiality Guidelines, OSHA does CBD diagnostic center, continued employee with a written medical report not find that medical reasons for medical surveillance, and removal from within 45 days of the examination limitations or medical removal should airborne exposure to beryllium. Thus, (including any follow-up BeLPT be automatically reported to employers. OSHA views this consent-based required under paragraph (k)(3)(ii)(E) of In addition, providing confidential approach to reporting of medical this standard). In other words, the medical information to all employers surveillance findings critical to the examination does not end (and trigger presents challenges in some cases. ultimate success of this provision, the 45-day disclosure period) until all of Unlike Materion, many employers do which will be measured not just in the the follow-up BeLPTs have been not have medical departments and may participation rate, but in the benefits to administered. This deadline is not therefore be aware of medical participating employees—early consistent with the deadline for the privacy laws or have the resources to detection of beryllium-related disease so licensed physician’s written medical

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opinion for the employer, which is that a specific finding such as might have recommendations on the use discussed below. ‘‘confirmed beryllium sensitization’’ be of respirators, protective clothing or The contents of the licensed included in the opinion. Because only equipment in general, e.g., that the physician’s written medical report for the employee will be receiving the employee should wear long sleeves to the employee are set forth in final written medical report, the written limit the possibility of dermal exposure. paragraphs (k)(5)(i)–(v). They include: medical report will include any specific OSHA also intends for the provision to The results of the medical examination, diagnoses, such as CBD or beryllium address recommended limitations on an including any medical condition(s), sensitization. OSHA added ‘‘CBD’’ as a employee’s use of respirators, protective such as CBD or beryllium sensitization condition to be included in the written clothing or equipment, e.g., that the (i.e., the employee is confirmed medical report to the employee because employee cannot safely wear a negative positive, as is defined in paragraph (b) employees who have CBD may be at risk pressure respirator. of the standard), that may place the of increased progression of the disease In addition to these changes, OSHA employee at increased risk from further if they continue to be exposed. added a number of recommendations airborne exposure; any medical Including a confirmed positive finding that the licensed physician is to include conditions related to airborne exposure or CBD diagnosis will also give the in the written medical report to the that require further evaluation or employee a record of his or her employee if the employee is confirmed treatment; any recommendations on the eligibility for medical removal. An positive or diagnosed with CBD: (1) employee’s use of respirators, protective additional change from the proposed to Referral for an evaluation at a CBD clothing, or equipment; and any final requirement is that the proposed diagnostic center (paragraph (k)(5)(iii)), recommended limitations on airborne phrase of ‘‘would place the employee at (2) continued medical surveillance beryllium exposure. If the employee is risk of CBD from further [airborne] (paragraph (k)(5)(iv)), and (3) medical confirmed positive or diagnosed with exposure’’ was changed to ‘‘may place removal from airborne exposure to CBD, the written medical report must the employee at increased risk from beryllium as described in paragraph (l) also contain any recommendations for further airborne exposure.’’ The change (paragraph (k)(5)(v). Aside from a referral to a CBD diagnostic center, of the word ‘‘would’’ to ‘‘may’’ was for confirmed positive or CBD diagnosis, if continued medical surveillance, and clarification because the word ‘‘would’’ otherwise deemed appropriate by the medical removal from airborne implies a certainty that does not exist. licensed physician, the written medical beryllium exposures, as described in The phrase ‘‘risk of CBD’’ was also report must also contain a referral for an paragraph (l) of the standard. Paragraph changed to ‘‘risk’’ to clarify that risks evaluation at the CBD diagnostic center. (l) specifies that medical removal may be increased by conditions other Each of these recommendations applies only to work scenarios where than CBD-related disease. For example, reflects another requirement of the final airborne exposures exceed the action the employee may have lung function standard. For example, proposed level. Paragraph (k)(5)(iii) also states loss related to a disease such as chronic paragraph (k)(6)(i) and (ii) indicated that that the licensed physician may obstructive pulmonary disease and that an evaluation at a CBD diagnostic center recommend evaluations at a CBD lung function loss might be diagnostic center based on any other compounded if the employee develops was to occur when an employee was reason deemed appropriate. For CBD. As noted in the introduction to the confirmed positive and agreed to the example, the physician might Summary and Explanation, the word examination. OSHA updated the recommend an evaluation at a CBD ‘‘airborne’’ was included as a modifier requirement to make it clear that an diagnostic center because he or she to the term ‘‘exposure’’ in many cases in evaluation at a CBD diagnostic center suspects that results from the BeLPT are the final standards to clarify that OSHA should not be limited to employees who questionable based on signs or did not intend a change from the have been confirmed positive and want symptoms in the employee or other proposal. In this provision, OSHA to find out if they have CBD, and should clinical findings that are consistent with included the term ‘‘airborne’’ to reaffirm be extended to employees already CBD and wants a specialist in beryllium its intent that the report must discuss diagnosed with CBD. Such employees disease to examine the employee. any detected medical conditions that would benefit from having a However, OSHA notes that may place the employee at increased pulmonologist familiar with beryllium recommendations for referrals for risk from further airborne exposure, disease select appropriate tests to evaluations at CBD diagnostic centers rather than dermal exposure. OSHA monitor progression of the disease. under this standard should only be finds that this distinction is appropriate OSHA therefore expanded the trigger for given for health-related reasons that because it is inhalation exposure and referral to a CBD diagnostic center to pertain to beryllium. not dermal contact that increases the include CBD in addition to sensitization The health-related information in the risk of CBD development in a sensitized in final paragraphs (k)(5)(iii), (k)(6)(iii), licensed physician’s written medical employee or increases the risk of and paragraph (k)(7)(i). report for the employee is generally progression in an employee who has The referral for continued medical consistent with the proposed written CBD. (For this same reason the word surveillance for employees who are medical opinion for the employer, with ‘‘airborne’’ was added to final paragraph confirmed positive or have been a few notable exceptions. The proposal (k)(5)(ii)(B).) diagnosed with CBD reflects the required the written medical opinion to Finally, the proposed phrase addition of paragraph (k)(1)(i)(D) that indicate ‘‘whether the employee had ‘‘including the use and limitations of allows employees whose most recent any medical condition that would place protective clothing and equipment, medical opinion required by paragraph the employee at increased risk of CBD including respirators’’ was changed to (k)(6) or (k)(7) recommends periodic from further [airborne] exposure.’’ ‘‘use of respirators, protective clothing medical surveillance to continue Although including a statement in the or equipment’’ in final paragraph receiving medical examinations, even if opinion that ‘‘the employee has a (k)(5)(ii)(A). That change reflected an they do not qualify under any other medical condition that places him or edit to remove superfluous language and trigger; a more detailed discussion is her at increased risk of CBD’’ implies the intent of that requirement has not included under the summary and that the employee is sensitized to changed. OSHA intends this provision explanation for final paragraph beryllium, the proposal did not require to cover situations where the physician (k)(1)(i)(D).

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Finally, the triggers for a medical concerns and is thus revising the the limitation on respirator use is removal recommendation in paragraph contents of the written medical opinion. consistent with information provided to (k)(5)(v) reflect the triggers under In developing the contents of the the employer under the Respiratory paragraph (l)(1)(i) and are discussed in written medical opinion for the Protection standard (29 CFR 1910.134). more detail in the summary and employer, OSHA considered what type OSHA concludes that only providing explanation for final paragraph (l), of information needs to be included to information on respirator and protective medical removal protection. OSHA provide employers with information to clothing and equipment limitations in added these recommendations to the protect employee health, while at the the written medical opinion for the written medical report to make it clear same time protecting employee privacy employer is consistent with the ACOEM to the licensed physician and employee as much as possible. NIOSH commented confidentiality guidelines that address that each of these recommendations is that the employer should only be the reporting of health and safety to occur when an employee is provided with information on the concerns to the employer (Document ID confirmed positive or diagnosed with employee’s fitness for duty, in addition 1815, Attachment 60, p. 1). The date CBD. A similar approach is applied in to restrictions and eligibility for medical and statement about the examination the Respirable Crystalline Silica removal benefits, as applicable meeting the requirements of this standard, where the PLHCP is to include (Document ID 1725, page pp. 33–34). standard are to provide both the a statement that the employee should be AFL–CIO recommended that OSHA use employer and employee with evidence examined by a specialist if that the language from the respirable that compliance with the medical employee has X-ray evidence of crystalline silica rule promulgated in surveillance requirements are current. silicosis. March of 2016, and referred OSHA to Employees will be able to show this The requirements for the health- the final brief it submitted for the silica opinion to future employers to related information to be included in rulemaking since the justifications for demonstrate that they have received the the written medical report for the increased confidentiality apply to medical examination. employee are consistent with the overall beryllium (Document ID 1809, p. 1; Paragraph (k)(6)(ii) states that if the goals of medical surveillance: To 1786). In the silica standard, OSHA employee provides written identify beryllium-related adverse required that only limitations on authorization, the written medical health effects so that the employee can respirator use be included in the written opinion for the employer must also consider appropriate steps to manage medical opinion without the employee’s contain any recommended limitations his or her health; to let the employee consent. The decision was largely on the employee’s airborne exposure to know if he or she can be exposed to influence by physician testimony that beryllium. Paragraphs (i)(6)(iii)–(v) state beryllium in the workplace without giving the employer information on an that if an employee is confirmed increased risk of experiencing adverse employee’s ability to use a respirator, positive or diagnosed with CBD and the health effects; and to determine the but not specific medical information, employee provides written employee’s fitness to use respirators. By strikes the appropriate balance between authorization, the written opinion must providing the licensed physician’s the employee’s privacy and the also contain recommendations for written medical report to employees, employer’s right to know because evaluation at a CBD diagnostic center, those who might be at increased risk of employees who are not fit to wear a continued medical surveillance, and health impairment from airborne respirator and then do so can be at risk medical removal from airborne exposure beryllium exposure will be able to of sudden incapacitation or death (81 to beryllium as described in paragraph consider interventions (i.e., health FR 16835; see also Document ID 1786; (l). If otherwise deemed appropriate by management strategies) with guidance pp. 89–90; 1805, Attachment 2, p. 133). the licensed physician and the from the licensed physician. Such Based on the record evidence, OSHA employee authorizes the information to strategies might include employment has determined that for the beryllium be included in the written medical choices to limit airborne exposures or standards, the written medical opinion opinion, the opinion must also contain using a respirator for additional for the employer must contain only the a referral for an evaluation at the CBD protection. date of the examination, a statement that diagnostic center. As noted above, The requirement for a verbal the examination has met the referrals for evaluations at CBD explanation from the PLHCP in requirements of this standard, and any diagnostic centers under this standard paragraph (k)(5) allows the employee to recommended limitations on the should only be given for health-related confidentially ask questions or discuss employee’s use of respirators, protective reasons that pertain to beryllium. concerns with the PLHCP. It also allows clothing, and equipment; and a OSHA intends for this provision to the PLHCP to inform the employee statement that the PLHCP explained the allow the employee to give about any non-occupationally related results of the examination to the authorizations for the written medical health conditions so that the employee employee, including any tests opinion for the employer to contain can follow-up as needed with his or her conducted, any medical conditions only the referral for evaluation at a CBD personal healthcare provider at the related to airborne exposure that require diagnostic center, only the employee’s expense. The requirement further evaluation or treatment, and any recommendation for continued periodic for a written medical report ensures that special provisions for use of personal surveillance, or only the the employee receives a record of all protective clothing or equipment. These recommendation for medical removal, findings. Employees would also be able requirements are set forth in paragraph or both. This will allow employees to to provide the written medical report to (k)(6)(i) of the standards. choose one or more options that best fit future health care providers. OSHA is persuaded to include their needs. For example, an employee Licensed physician’s written medical recommended limitations on the may choose to only let the employer opinion for the employer. As discussed employee’s use of respirators, protective know that he or she wants continued in detail above, some commenters clothing, and equipment, with no other medical surveillance but not at the CBD objected to OSHA’s proposed content medically-related information, in the diagnostic center because he or she is for the written medical opinion for the written medical opinion for the satisfied with the care provided by the employer based on employee privacy employer without further consent from current PLHCP. In another case, an concerns. OSHA shares these privacy the employee. The Agency notes that employee may decide that he or she

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wants only the recommendation for (Document ID 1691, p. 11). OSHA finds the written medical opinion for the evaluation at a CBD diagnostic center that removing the prohibition on employer within 45 days of any medical reported to the employer because the unrelated diagnoses and instead examination (including any follow-up employer wants to be evaluated by specifying the only information that is BeLPT required under paragraph someone who is more specialized in to be included in the written medical (k)(3)(ii)(E) of this standard) performed beryllium disease before making any opinion for the employer remedies this for that employee. The reason for the 45- major employment decisions. In a third concern because it makes the contents day deadline to provide the written case, the employee may only want the of the opinion easier to understand and medical opinion is discussed below. recommendation for removal from less subject to misinterpretation. OSHA is requiring that employees airborne exposure reported to the OSHA recognizes that some receive a copy of the written medical employer because the employee is very employees might be exposed to multiple opinion for the employer, in addition to concerned about his or her health and OSHA-regulated substances at levels the written medical report, because they wants to be immediately removed that trigger medical surveillance and can present the written medical opinion without an evaluation at the CBD requirements for written opinions. For as proof of a current medical diagnostic center. OSHA expects that example, Newport News Shipbuilding examination to future employers. This is the written authorization could easily be indicated that their employees already especially important in industries with accomplished through the use of a form undergo medical surveillance for high turnover because employees may that allows the employee to check, arsenic (Document ID 1657, p. 2). The work for more than one employer initial, or otherwise indicate which (if licensed physician can opt to prepare during a two-year period and this any) of these items discussed above the one written medical opinion for the ensures that tests are not performed employee wishes to be included in the employer for each employee that more frequently than required. addresses the requirements of all written medical opinion for the On the topic of transient employment, relevant standards, as noted in employer. OSHA concludes that NSC asked OSHA to consider workers preambles for past rulemakings, such as allowing the employee to decide what if employed by staffing agencies and Chromium (VI) (71 FR 10100, 10365 (2/ any additional information can be assigned to multiple host employers and 28/06)). However, the combined written reported to the employer is warranted possibly employees of contractors to the based on the seriousness and medical opinion for the employer must host employer, who might not receive irreversibility of beryllium disease and include the information required under medical surveillance because of the the major impact that the decision may each relevant OSHA standard. For transient nature of their employment have on the employee’s health and example, if the PLHCP opts to combine (Document ID 1612, p. 3). OSHA’s July employment. written medical opinions for an OSHA is convinced that routinely employee exposed to both inorganic 15, 2014, memorandum titled Policy including recommended limitations on arsenic and beryllium, then the Background on the Temporary Worker airborne exposure, evaluations at a CBD combined opinion to the employer must Initiative indicates that both the host diagnostic center, and especially contain the information required by and staffing agency are responsible for medical removal in the written medical paragraphs (n)(6)(i) of the inorganic the health and safety of temporary opinion for the employer absent arsenic standard (29 CFR 1910.1018) employees. For example, the policy employee consent could adversely affect and the information required by memorandum indicates that host employees’ willingness to participate in paragraphs (k)(6)(i) (and paragraphs employers are well suited for assuming medical surveillance. The requirements (k)(6)(ii)–(v) with written authorization responsibility for compliance related to for this paragraph are consistent with from the employee) of the beryllium workplace hazards, while staffing recommendations to let employees standards. agencies may be best positioned to make their own health decisions. OSHA NABTU noted that the black lung rule provide medical surveillance. Under stresses that information given to the for coal miners protects confidentiality this policy, staffing agencies are employer should not include an by prohibiting mine operators from expected to offer medical surveillance to underlying diagnosis—only the specific requiring miners to provide a copy of eligible employees, and they could send recommendation or referral called for their medical information (Document ID a copy of the written medical opinion to under the standards. OSHA considers 1679, p. 13; 30 CFR 90.3). NABTU the host employer so that the host this a reasonable approach that balances requested that the beryllium rule protect employer would know about any the need to maintain employee confidentiality by prohibiting employers limitations that might be recommended confidentiality with the employer’s from asking employees or the PLHCP for by the licensed physician. Similarly need to know that it may want to medical information (Document ID contract employers whose employees reevaluate its beryllium program. 1679, p. 13). Consistent with the work at different job sites are expected Reporting that a referral or medical Respirable Crystalline Silica standard, to offer medical surveillance to their removal is recommended, when OSHA is not including such a eligible employees. Also, OSHA revised authorized by the employee, allows the prohibition in the beryllium standard the triggers for medical surveillance in employer to reevaluate its written because employers may have legitimate paragraphs (k)(1)(i)(A) and (k)(2)(i)(A) so exposure control plan, as required reasons for requesting medical that employees must be offered medical under paragraph (f)(1)(ii)(B). information, such as BeLPT results. For surveillance within 30 days of when the OSHA finds that this new format for example, employers might request such employer determines they are the licensed physician’s medical information for doing an investigation reasonably expected to be exposed opinion for beryllium will better or helping employees file compensation above the action level for 30 or more address concerns of ORCHSE, who claims. If employees are not concerned days a year. The revised trigger allows feared it would be in violation if the about discrimination or retaliation, or for more timely medical examinations written medical opinion for the need the employer’s help in filing a than the proposed trigger, which would employer included information that claim, they could provide the health have allowed for the employee to be OSHA proposed the licensed physician information to the employer. Paragraph exposed for 30 days before the employer or PLHCP not report to the employer, (k)(6)(vi) requires the employer to had to offer medical surveillance. As a such as an unrelated diagnosis ensure that employees receive a copy of result, more temporary workers who are

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employed for short periods of time will under paragraph (k)(3)(ii)(E) of these treat a sensitized employee (Document meet the trigger for medical standards. As discussed above, if the ID 1675, p. 17). Southern Company surveillance. results of the BeLPT are other than argued that rather than requiring an As indicated above, the standards normal, paragraph (k)(3)(ii)(E) requires a evaluation at a CBD diagnostic center, require that employers ensure that follow-up BeLPT to be offered within 30 the standard should instead specify the employees get a copy of the PLHCP’s days, unless the employee has been types of exams required (Document ID written medical report and opinion and confirmed positive. In order to allow for 1668, pp. 2–3). DOD commented that that they get a copy of the written the licensed physician to consider employees should be referred to a opinion within 45 days of each medical BeLPT results and prepare the written board-certified pulmonologist who is examination (including any follow-up medical opinion, the Agency must allow capable of doing bronchoscopy, BeLPT required under paragraph time for the BeLPT to be administered, bronchial biopsy, and broncho-alveolar (k)(3)(ii)(E) of this standard) (paragraphs processed, and interpreted. Therefore, lavage (Document ID 1684, Attachment (k)(5), (k)(6)(i), (k)(6)(vi)). By contrast, OSHA has decided to require the 2, p. 1–6), NSSP, NABTU, ACOEM, and the proposed rule would have required employer to obtain a written medical ATS advocated for an examination at a that the employer obtain the licensed opinion from the licensed physician CBD center for sensitized employees physician’s written medical opinion within 45 days of the medical (Document ID 1677, p. 6; 1679, p. 12; within 30 days of the medical examination (including any follow-up 1685, p. 5; 1688, p. 3). examination and then provide a copy to BeLPT required under paragraph OSHA is not persuaded by Southern the employee within 2 weeks after (k)(3)(ii)(E) of this standard). Company’s argument that the final receiving it. NJH commented that 45 Evaluation at a CBD Diagnostic standards should detail specific tests for days is a better time period for notifying Center. OSHA proposed that within 30 confirmed positive employees, instead employers because it can take more than days after an employer learned that an of requiring an examination at a CBD 2 weeks to process the BeLPT employee was confirmed positive, the diagnostic center. As described above, (Document ID 1664, p. 8). ORCHSE licensed physician was to consult with the types of evaluations required for an expressed concern about the 30-day the employee to discuss referral to a employee who has a confirmed positive timeline, stating that the employer CBD diagnostic center that was finding or is diagnosed with CBD must would be in violation if the physician mutually agreed upon by the employer be determined on a case-by-case basis, took more than 30 days to deliver the and employee (proposed paragraph and therefore determining appropriate report (Document ID 1691, pp. 11–12). (k)(6)(i)). Following the consultation, if testing requires a pulmonologist with In light of NJH and ORCHSE’s the employee decided to be clinically the expertise described in the definition comments, OSHA has revised the evaluated at a CBD diagnostic center, for CBD diagnostic center. In addition, proposed 30-day timeline to allow for the employer was to provide the many of the procedures that a 45 days. OSHA expects that the new 45- examination at no cost to the employee pulmonologist may recommend are day period will give the licensed (proposed paragraph (k)(6)(ii)). invasive and therefore involve risks. As physician sufficient time to consider the OSHA asked stakeholders to comment a result, these tests should only be results of any tests, including a follow- on the proposed requirement for performed by a pulmonologist familiar up BeLPT, done as part of the evaluation at a CBD diagnostic center, with beryllium disease at a facility that examination. OSHA finds that especially whether the requirements for meets the definition of a CBD diagnostic delivering the report to the employer mutual agreement by the employee and center, after the pulmonologist has within 45 days will still ensure that the employer is necessary and appropriate carefully considered the employee’s employee and employer are informed in and how the diagnostic center should be medical and occupational history. For a timely manner and allows the chosen if the employer and employee these reasons, OSHA reaffirms that it is employer to take any necessary cannot agree. OSHA also asked whether essential that eligible employees be protective measures within a reasonable the standard should specify that evaluated at a CBD diagnostic center. time period. To ensure timely delivery evaluation at a diagnostic center must Requiring that the diagnostic center be of reports and opinions containing the be at a reasonable location (80 FR able to perform all the functions correct information and demonstrate a 47574–47575). described under the Definitions section good faith effort in meeting these The term CBD diagnostic center is also makes the exam more convenient requirements of the standard, the defined in paragraph (b), Definitions, of for the employer and the employee employer could inform licensed the standards. As provided in paragraph because the employee will not have to physicians about the time deadline and (b) and explained in the Summary and go to multiple facilities in order to other requirements of the beryllium Explanation, the CBD diagnostic center undergo different procedures. standard in a written agreement and can be a hospital or other facility that Southern Company disagreed with the follow up with the physician if there is has an on-site pulmonary specialist who proposed requirement that both the concern about timely delivery or can interpret biopsy pathology and employee and employer agree upon the content of these documents. Because the bronchoalveolar lavage (BAL) results. CBD diagnostic center, asserting that the licensed physician will be providing the The diagnostic center must also have requirement could conflict with employee with a copy of the written onsite facilities that can do a clinical selection of a physician under workers’ medical report, he or she could give the evaluation for CBD that includes compensation laws, because OSHA does employee a copy of the written medical pulmonary function testing according to not have a mechanism to settle disputes, opinion at the same time. This would ATS guidelines, transbronchial biopsy, and because similar requirements are eliminate the need for the employer to and BAL, with the ability to transfer not included in other OSHA standards give the employee a copy of the BAL samples to a laboratory for (Document ID 1668, pp. 6–7). Ameren PLHCP’s written medical opinion for diagnostic evaluation within 24 hours. and ORCHSE also opposed the the employer, but the employer would Ameren supported a specialist exam requirement for mutual agreement on a still need to ensure timely delivery. but asserted that an examination by a CBD diagnostic center and OSHA has also revised this provision pulmonologist was sufficient and that recommended that location be to account for the time to administer the pulmonologist could be allowed to considered when the employee and any follow-up BeLPT tests required work with a CBD diagnostic center to employer cannot reach agreement

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(Document ID 1675, p. 17; 1691, p. 10). information the employer receives. beryllium that require further follow-up; NJH supported mutual agreement on the Under final paragraph (k)(6), the any recommendations on the CBD diagnostic center between the employee must authorize the written employee’s use of respirators, protective employee and employer and stated that medical opinion to contain clothing, or equipment; and any location, expertise of the center, and recommendations for an evaluation at a recommended limitations on beryllium feasibility should all be accounted for CBD diagnostic center, and the licensed exposure. If the employee is confirmed when agreement cannot be reached physician would then provide the positive or diagnosed with CBD, the (Document ID 1664, p. 8). employer that recommendation in the written medical report must also OSHA acknowledges the concerns of written medical opinion. Under contain recommendations for continued these stakeholders, but maintains that paragraph (k)(5), the employee’s written periodic medical surveillance and the employee should be given a choice medical report is to contain medical recommendations for removal from in the selection of a CBD diagnostic findings, including a confirmed positive exposure to beryllium, as described in center because of the risks involved test result and a CBD diagnosis. The paragraph (l). The reasons why the CBD with procedures that the employee may report must also contain a referral for an diagnostic center is to give the employee have to undergo and because of the life- evaluation at a CBD diagnostic center if this information are the same as changing decisions that the employee the employee is confirmed positive or discussed above, under the might have to make based on the results diagnosed with CBD or if the licensed requirements for the licensed of the evaluation. The employer and physician otherwise deems it physician’s written medical report for employee should make a good faith appropriate. The employee has the the employee. This provision was added effort to agree on a CBD diagnostic option of providing the employer with to the final standards to ensure that the center that is acceptable to them both. a copy of the written medical report employee gets a written record from the In making the decision, the first indicating a confirmed positive finding CBD diagnostic center and to allow the consideration is identifying qualified or diagnosis of CBD, or recommending employee to consult with the CBD CBD diagnostic centers. The next referral. OSHA is providing the option diagnostic center about the findings. considerations in the decision should for a written medical report listing a Paragraph (k)(7)(iii) requires that the include requirements under other laws confirmed positive finding or diagnoses CBD diagnostic center provides the and geographical location. OSHA of CBD to be offered as proof of employer with a written medical expects that once these criteria are eligibility for an evaluation at a CBD opinion within 30 days of the medical considered, there will not be unlimited diagnostic center, in the event that a examination. The written medical options, which will help the employee licensed physician did not recommend opinion must contain the date of the and employer come to a decision. a referral to a CBD diagnostic center in examination, any recommended Although OSHA was not convinced either the written medical report or the limitations on the employee’s use of that changes needed to be made based written medical opinion. respirators, protective clothing, or on public comments, OSHA did find As the result of the changes discussed equipment, and a statement that a changes were required to make the final above, final paragraph (k)(7) requires PLHCP explained the results of the provision consistent with other that employers provide a no-cost medical examination to the employee. It requirements of the final standard. First, evaluation at a CBD-diagnostic center must also contain a statement that the OSHA changed the trigger for referral to that is mutually agreed upon by the examination met the requirements of the a CBD diagnostic center to include both employee and employer within 30 days standard, if a periodic examination was confirmed positive and a CBD diagnosis of receiving a medical opinion that conducted for an employee who chooses for consistency with paragraphs recommends the referral (paragraph examinations conducted at the CBD (k)(5)(iii) and (k)(6)(iii). The reasoning (k)(7)(i)(A)) or within 30 days after the diagnostic center as specified under for this change is described above in the employee presents the employer with a paragraph (7)(iv). If the employee discussion of paragraph (k)(5)(iii). written medical report indicating that provides written authorization, the Second, OSHA removed the the employee has been confirmed written medical opinion for the requirement for a consultation between positive or diagnosed with CBD, or employer must also contain any the physician and employee within 30 recommending referral to a CBD recommended limitations on the days after the employer learned that the diagnostic center (paragraph employee’s airborne exposure to employee was confirmed positive. (k)(7)(i)(B)). As is the case with the beryllium. If an employee is confirmed Under paragraph (k)(6)(D), the employer PLHCP’s examination, the employer is positive or diagnosed with CBD and the already must ensure that the PLHCP responsible for providing the employee employee provides written explains findings to the employee, with a medical examination at a CBD authorization, the written opinion must including conditions related to airborne diagnostic center, at no cost, and at a also contain recommendations for beryllium exposures that require further reasonable time and place. continued medical surveillance, and/or evaluation or treatment within 30 days Under paragraph (k)(7)(ii) of the medical removal from exposure to of the medical examination. The standards the employer must ensure beryllium, as described in paragraph (l). discussion about recommended referral that the CBD diagnostic center explains This provision was not in the can occur as part of that conversation, medical findings to the employee and proposed standard or the joint draft and OSHA does not find that a separate gives the employee a written medical recommended standard by Materion and consultation with the physician or report within 30 days of the USW but was added to the final PLHCP is necessary. examination. Like the licensed standards to allow for transmittal of The third major change to this physician’s written medical report, the CBD diagnostic center recommendations provision was detailing how the written medical report from the CBD to the employer without revealing the employer would be informed that the diagnostic center must contain the specific medical reason for those employee is eligible for an evaluation at results of the examination, including recommendations. The structure a CBD diagnostic center. The change conditions such as sensitization or CBD parallels the written medical opinion reflects updates made to paragraph that might increase the employee’s risk from the licensed physician, which was (k)(6) to allow the employee more from airborne exposure to beryllium; developed based on stakeholder privacy and control over the type of any medical conditions related to requests to increase confidentiality of

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medical findings. A separate written original physician, CBD diagnostic information to other organizations (80 medical opinion from the CBD center, and employee determine the FR 47575). diagnostic center is needed because the frequency of medical examinations. Some commenters did not support the recommendations may differ from those Finally, Ameren stated that the standard inclusion of this requirement in the of the licensed physician and usually should allow for follow-up based on final rule. For example, Ameren comes from a different provider. For pulmonologist recommendations commented that the proposed example, the employee may have (Document ID 1675, p. 16). requirement would be burdensome wanted only a recommendation for OSHA agrees that continued because it would be cumbersome to get evaluation at a CBD diagnostic center to evaluation at a CBD diagnostic center is signed releases for this information be included on the written medical appropriate for sensitized employees (Document ID 1675, p. 20). ORCHSE opinion from the physician, but, after and employees diagnosed with CBD. also argued that employees would have evaluation at a CBD diagnostic center, Specialized evaluation is needed to a difficult time complying with this may decide to include the determine the appropriate tests to requirement because employees would recommendation for medical removal monitor for possible progression from not likely sign a release (Document ID from exposure on the CBD diagnostic sensitization to CBD and to monitor the 1691, p. 13). DOD also claimed that the center’s written medical opinion. progression of CBD if it does occur. requirement would be burdensome and Paragraph (k)(7)(iv) requires the Therefore, after considering the record, said that it would be better to send the employer to ensure that each employee OSHA added the requirement for results to NIOSH but not routinely receives a copy of the written medical continued evaluation at a CBD (Document 1684, Attachment 2, pp. opinion from the CBD diagnostic center diagnostic center for these employees. 1–7–1–8). On the other hand, NJH described in paragraph (k)(7) of this This new requirement is contained in supported this requirement because it standard within 30 days of any medical paragraph (k)(7)(v), which specifies that believed the information would help examination performed for that after an employee has received a clinical OSHA identify industries where employee. As discussed above with evaluation at a CBD diagnostic center sensitization is occurring (Document ID regard to paragraph (k)(6)(vi), requiring described by paragraph (k)(7)(i) of the 1664, p. 9). However, NJH added that the provision of all written medical standards, the employee may choose to small companies may need help opinions to employees can permit have any subsequent medical complying with this requirement employees to provide that information examinations for which the employee is (Document ID 1664, p. 9). In addition, to future employers without divulging eligible under paragraph (k) of this NJH and ATS recommended that the private medical information and also standard performed at a CBD diagnostic rule specify that employers routinely present the opinion as proof of a current center. The evaluations must continue and systematically analyze medical examination that meets the to be done at a CBD diagnostic center screening results along with job and requirements of the beryllium standard. mutually agreed upon by the employee exposure data to identify employees The deadlines for submittal of the and employer and provided at no cost who may be at risk of sensitization and written medical opinion and report are to the employee. To allow for continued working conditions contributing to shorter for the CBD diagnostic center (30 medical surveillance for those sensitization and CBD risk (Document days) than the licensed physician (45 employees who would not otherwise be ID 1664, p. 8; 1688, 4). days). The reasoning is because CBD entitled under (k)(1) or (k)(2), the Consistent with the concerns of diagnostic centers are not expected to employee must authorize the Ameren and ORCHSE regarding getting routinely conduct BeLPTs, which as recommendation for continued periodic releases from employees, OSHA has noted above, take 2 weeks to process. medical surveillance to be included in given much thought to maintaining They will not, therefore, be affected by the most recent written medical opinion confidentiality of medical findings as the same time limitations as licensed from the CBD diagnostic center discussed in detail above. As a result of physicians. (paragraph (k)(7)(iii)). Under paragraph changes made in the standards to In the NPRM, OSHA asked (k)(2)(ii), the CBD diagnostic center can enhance employee privacy, the Agency stakeholders to comment on whether recommend continued surveillance eliminated the proposed paragraph for sensitized employees should be given every two years. OSHA is not including the written medical opinion to the the opportunity to be examined at a a provision for more frequent employer to include a statement about CBD diagnostic center more than once examinations because, as indicated whether the employee had a condition and how frequently those employees above, surveillance done every two that would put him or her at risk of should be evaluated (80 FR 47574). This years is appropriate to monitor for developing CBD with further beryllium provision was not included in the draft sensitization and CBD progression in exposure. That provision suggested that standard or the joint draft recommended most employees. the written medical opinion might standard by Materion and USW Proposed paragraph (k)(7) had include findings such as beryllium (Document ID 0754). required that employers were to convey sensitization. In the final standard, it is NABTU commented that a sensitized the results of beryllium sensitization explicit that the employer will not employee should continue to be tests to OSHA for evaluation and receive information about sensitization periodically evaluated at a CBD analysis at the request of OSHA. The or CBD in the written medical opinion diagnostic center because it cannot be employer was to remove all personally to the employer, and the employer will predicted when a sensitized employee identifiable information (e.g., names, only receive that information when an will develop CBD (Document ID 1679, social security numbers) before sending employee presents the employer with p. 12). NSSP, ACOEM, and ATS agreed the results to OSHA. A similar provision the employee’s written medical report. with continued periodic surveillance at was included in the joint draft As a result, many employers may not a CBD diagnostic center for sensitized recommended standard by Materion and have that information to submit to employees (Document ID 1677, p. 6; USW. OSHA asked for comment on this OSHA or to otherwise conduct a 1685, p. 5; 1688, p. 3). ATS provision, specifically if such a systematic analysis of medical screening recommended that sensitized employees requirement would be burdensome for results. As discussed above, even if be evaluated every one to three years employers and whether it would be employers were provided aggregated and NSSP recommended that the more appropriate to send the medical findings, it may still be difficult

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to maintain confidentiality when sensitized or developed CBD, and is an for Justice agreed, observing that ‘‘MRP companies are small or few employees appropriate means to enable them to benefits are an essential tool to ensure are involved in a process. avoid further exposure. See 80 FR that workers with signs and symptoms OSHA has other ways to obtain 47802. The Agency further explained of disease step forward without fear of medical findings if needed. For that the inclusion of MRP in the reprisal and seek medical advice’’ example, as noted in the Summary and proposal was in keeping with the (Document ID 1683, p. 3). Explanation for paragraph (n), recommendation of beryllium health Other commenters indicated that the Recordkeeping, OSHA’s Access to specialists in the medical community option for removal was necessary for Employee Exposure and Medical and with the draft recommended workers’ health. For example, the USW Records standard (29 CFR 1910.1020) standard provided by union and argued that the inclusion of MRP is requires employers to ensure that most industry stakeholders (Document ID necessary to provide a safe and employee medical records are retained 0754). healthful workplace (Document ID 1963, for the duration of employment plus 30 OSHA solicited comments on the p. 13). USW further commented that years for employees employed more health effects that should trigger MRP Section VIII (Significance of Risk) of the than one year, and requires that those and the proposed provisions for MRP. In NPRM shows that existing evidence records be made available to OSHA addition, the Agency included several within the docket indicates that workers upon request (29 CFR 1910.1020 specific questions to guide stakeholders who are sensitized to beryllium or are (d)(1)(i) and (e)(3)). OSHA therefore in their response, including whether in the early stages of chronic beryllium deleted proposed paragraph (k)(7) from beryllium sensitization and CBD are disease can significantly benefit from the final standard. appropriate triggers for medical MRP (Document ID 1963, p. 13). removal, whether there were other (l) Medical Removal National Jewish Health (NJH) generally medical conditions or findings that agreed with USW’s opinion, stating that Paragraph (l) of the standards for should trigger medical removal, and the ‘‘removal from exposure is the best form general industry, shipyards, and amount of time for which a removed of prevention’’ (Document ID 1664, p. construction provide for medical employee’s benefits should be extended. 4). removal protection (MRP). This OSHA also included questions Other stakeholders indicated that the paragraph applies only to workers with regarding the costs and benefits of MRP inclusion of a medical removal airborne exposure to beryllium at or (see 80 FR 47575). provision might lower exposures in the above the action level who are During the public comment periods workplace as a whole. For example, diagnosed with CBD or confirmed and informal public hearing, numerous USW testified that MRP provides positive and provide documentation of stakeholders submitted comments employers with a financial incentive to their diagnosis of CBD or confirmed supporting the inclusion of MRP in this keep beryllium exposures low positive status or a physician’s rulemaking (e.g., Document ID 1664, pp. (Document ID 1755, Tr. 167–68). Mike recommendations for removal from 3–4, 9; 1680, pp. 1, 7; 1681, p. 14–15; Wright from USW observed that this exposure to beryllium to their 1683, p. 3; 1688, p. 2; 1689, pp. 8, 13– incentive helped to lower exposure employers. Under this paragraph, 14; 1690, pp. 1, 3–4; 1691, Attachment levels in the context of the lead employees must provide eligible 1, pp. 13, 15; 1755, Tr. 26, 168; 1756, standard: employees with a choice of removal Tr. 142–143; 1809, p. 1; 1963, pp. 13– from exposure at or above the action 14). The commenters who commented But what really, I think, best protected level or remaining in their job with workers was medical removal protection on the issue supported MRP in general because employers did not want to pay airborne exposure at or above the action terms; none opposed inclusion of MRP people to stay at home until their blood leads level and wearing a respirator. If the in the final rule. Some of these got down. So I think if you look at the real employee chooses removal, the stakeholders noted that they supported benefits of MRP, it isn’t simply that it employer is required to remove the MRP because it promotes participation removes workers from exposure, who might employee to comparable work in a work in medical surveillance programs. For be harmed by further exposure. It is that it environment where the airborne example, National Council on really provides an incentive for employers to exposure is below the action level, if Occupational Safety and Health keep exposures low in the first place. And such work is available. If comparable (National COSH) argued that MRP that’s been our experience (Document ID 1755, Tr. 167–68). work is not available, the employer benefits are crucial to a successful must maintain the employee’s base medical surveillance program After careful consideration of these earnings, seniority, and other rights and (Document ID 1690, pp. 3–4). National comments, OSHA has decided to benefits that existed at the time of COSH maintained that ‘‘workers will include MRP in the final standards. As removal for six months or until such not willingly participate in medical noted by commenters, MRP serves three time that comparable work described in surveillance or disclose early signs and main interrelated purposes. First, it paragraph (l)(3)(i) becomes available, symptoms of disease if doing so means increases employee participation and whichever comes first. The employee’s they lose their job and can no longer pay confidence in the standards’ medical earnings under MRP can be diminished their bills. For this reason, an effective surveillance program. Under paragraph by the amount of compensation received medical surveillance program for CBD (k)(1)(i)(B), employers must offer from certain other sources. must include . . . [MRP] benefits’’ medical examinations to employees OSHA included medical removal (Document ID 1690, p. 3). NIOSH showing signs or symptoms of CBD. The provisions in the proposed rule as a similarly argued that ‘‘[f]ear of job loss success of that program will depend in protective, preventative health and associated loss of income and other part on employees’ willingness to report mechanism that was intended to work benefits is an important barrier to their symptoms, submit to in concert with the proposed medical translating medical screening and examinations, respond to questions, and surveillance provisions. As OSHA surveillance findings into secondary comply with instructions. Guaranteeing explained in the proposal, the Agency prevention. Inclusion of medical comparable work or earnings, seniority, preliminarily found that medical removal provisions is critical to and other rights and benefits for a removal is an important means of addressing that barrier’’ (Document ID period of time can help allay an protecting employees who have become 1755, Tr. 26). The American Association employee’s fear that a CBD diagnosis or

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being confirmed positive will negatively Lee Newman, testifying on behalf of the (Id. at 1232, 1237). And, in the three and affect earnings or career prospects. MRP American College of Occupational and a half decades since the Lead I decision, encourages employees to report their Environmental Medicine (ACOEM), OSHA has adopted MRP in five other symptoms and seek treatment, as OSHA commented that ‘‘removal from substance-specific health standards: has previously recognized when exposure is the right thing to do for Cadmium (29 CFR 1910.1027), Benzene including medical removal in somebody who is at a stage of being (29 CFR 1910.1028), Formaldehyde (29 regulations governing the exposure to beryllium sensitized or any stage CFR 1910.1048), Methylenedianiline (29 Lead (43 FR 52952, 52973, November beyond that’’ (Document ID 1756, Tr. CFR 1910.1050), and Methylene 14, 1978), Benzene (52 FR 34460, 34557, 143). Thus, even though CBD and chloride (1910.1052). September 11, 1987), and Cadmium (57 sensitization are considered to be Paragraph (l)(1) of the proposed FR 42102, 42367–42368, September 14, irreversible, OSHA finds removal may standard detailed the eligibility 1992). This reasoning was also cited by still benefit sensitized employees and requirements for medical removal. The the Department of Energy in support of those with CBD. provision explained that an employee the medical removal provisions of its Finally, MRP may provide employers would be eligible for medical removal if Chronic Beryllium Disease Prevention with an additional incentive to keep he or she works in a job with exposure Program, stating that the availability of employee exposures low. Precisely at or above the action level and is medical removal benefits encourages because MRP will impose additional diagnosed with CBD or confirmed worker participation and cooperation in costs on employers, MRP can increase positive for sensitization. OSHA medical surveillance (64 FR 68893). the protection afforded workers by the specifically asked for comments on beryllium standards not only directly by whether beryllium sensitization and Second, by requiring the employer to improving medical surveillance but also CBD are appropriate triggers for medical remove employees with the highest risk indirectly by providing employers with removal and whether there are other of suffering material impairment of economic incentives to comply with medical conditions or findings that health (if the employee chooses other provisions of the standard. The should trigger medical removal. removal), MRP may benefit sensitized costs of MRP are likely to decrease as Stakeholders generally supported the employees and those with CBD. OSHA employer compliance with other proposed triggers. ORCHSE Strategies notes that there remains some scientific provisions of the standard increases. (ORCHSE) argued that confirmed uncertainty regarding the effects of Employers who comply with other beryllium sensitization and CBD are exposure cessation on the development provisions of the standard may have to appropriate triggers for medical removal of CBD among sensitized individuals remove relatively few employees. With (Document ID 1691, Attachment 1, p. and the progression from early-stage to only a small number of employees 15). ORCHSE explained that since CBD late-stage CBD. For example, Steven requiring removal, complying is a chronic, progressive lung disease Markowitz, MD, a medical consultant employers are more likely to be able to with no known cure, it is imperative for USW, acknowledged during the find positions available to which that signs of health impairment be informal public hearing that ‘‘there’s a removed employees can be transferred. found early and exposure be terminated paucity of evidence that removal from By contrast, employers who make only to avoid further impairment (Document exposure results in improvement of cursory attempts to comply with the ID 1691, Attachment 1, p. 15). NJH also CBD’’ (Document ID 1755, Tr. 101). central provisions of these standards are commented that confirmed beryllium Nonetheless, most members of the likely to find that the greater their sensitization and CBD are appropriate medical community support removal degree of noncompliance, the greater the triggers for medical removal (Document from beryllium exposure as a prudent number of employees requiring medical ID 1664, p. 9). Ameren, North America’s step in the management of beryllium removal and the greater the associated Building Trades Unions (NABTU), sensitization and CBD. As noted above, MRP costs. Thus, as OSHA explained in Materion Corporation (Materion), and physicians at NJH recommend that the preambles to its substance-specific USW agreed (Document ID 1675, p. 20; individuals diagnosed with beryllium standards on Cadmium and Lead, the 1679, p. 14; 1680, p. 7; 1681, pp. 14–15). sensitization and CBD who continue to inclusion of MRP in a final rule can USW commented that medical removal work in a beryllium industry should serve as a strong stimulus for employers could prevent the progression of disease have exposure of no more than 0.01 to protect worker health and rewards in workers diagnosed with sensitization micrograms per cubic meter of employers who through innovation and or CBD (Document ID 1681, p. 15). beryllium as an 8-hour TWA, which is creativity derive new ways of protecting However the Department of Defense 10 times below the action level of 0.1 worker health not contemplated by argued that CBD but not beryllium micrograms per cubic meter (http:// these standards (57 FR 42102, 42368 sensitization is an appropriate trigger for www.nationaljewish.org/healthinfo/ (Sep. 14, 1992); 43 FR 54354, 54450 medical removal and that sensitization conditions/beryllium-disease/ (Nov. 21, 1978)). is an appropriate trigger for advising environment-management/) (Document OSHA has the authority to include employees about risk and requiring use ID 0637). Furthermore, OSHA received MRP in this standard. Indeed, the Court of personal protective equipment if the comments from Lisa Maier, MD and of Appeals for the D.C. Circuit employee chooses to return to work Margaret Mroz, MSPH from NJH during recognized the Agency’s authority to (Document ID 1684, Attachment 2, p. 1– the public comment period supporting adopt such provisions more than 35 8). The American Federation of Labor MRP for workers with sensitization or years ago in its review of the Agency’s and Congress of Industrial CBD (Document ID 1664; 1806, pp. 3– Lead standard (Lead I, 647 F.2d at 1229– Organizations (AFL–CIO) indicated 4). Specifically, Ms. Mroz commented 1236). There, the Court found that MRP support for the action level exposure that ‘‘eliminating or reducing exposure ‘‘appears to lie well within the general trigger (Document ID 1809, p. 1; 1809, can lead to improvement in symptoms’’ range of OSHA’s powers,’’ and Attachment 2, Tr. 930–931; 942–943). for beryllium workers and that reasonable in the case of lead because it After reviewing the record on this ‘‘[r]emoval or reduction in exposure would help prevent impermissibly high issue, OSHA has decided that a CBD may prevent the development of CBD’’ blood lead levels and mitigate potential diagnosis and a confirmed positive test (Document ID 1806, p. 3–4). And, employee concerns about cooperating for sensitization are appropriate triggers during the informal public hearing, Dr. with the medical surveillance program for medical removal. OSHA disagrees

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with the DOD and concludes that might do this if, consistent with the permanently. OSHA believes the worker sensitization is an appropriate trigger for approach of paragraph (k), the employee should be given a voice in such a medical removal because removal from wishes to keep the details of the fundamental life decision where the exposure may prevent the onset of CBD. condition private. confirmed positive employee may be Therefore, OSHA is retaining the • The employee may provide any able to minimize the risk of CBD triggers of both sensitization and CBD. reliable medical documentation through the consistent and careful use Final paragraph (l)(1), consistent with establishing a confirmed positive of respiratory protection in a workplace the proposal, states that the employee is finding or diagnosis of CBD, regardless where feasible controls are implemented eligible for medical removal if the of whether it was issued in compliance to maintain exposures within the PEL. employee works in a job with exposure with paragraph (k)(5). An employee Indeed, mandatory permanent removal at or above the action level, but contains might do this if, for example, the might lead workers to hide their more specificity about the types of documentation predates this standard. symptoms or not seek treatment, which documentation that are submitted to the This documentation would be a is directly contrary to the purpose of employer to demonstrate eligibility for ‘‘written medical report’’ for purposes of MRP. For these reasons, the Agency medical removal. This change was made (l)(1)(i)(A). finds mandating removal is not to track employee privacy protections • The employer receives a (k)(6) or appropriate in this rulemaking. included in the licensed physician’s (k)(7)(iii) written medical opinion Therefore, paragraph (l)(2) of the final medical opinion in paragraph (k)(6) and recommending removal from the standards requires employers to provide the CBD diagnostic center’s medical licensed physician or CBD diagnostic eligible employees with the employee’s opinion in paragraph (k)(7)(iii). Under center. choice of: (i) Removal as described in paragraphs (k)(5) and (k)(7)(ii), the OSHA added the language ‘‘in paragraph (l)(3) of these standards; or standards now specify that the licensed accordance with paragraph (k)(5)(v) or (ii) remaining in a job with airborne physician or CBD diagnostic center (k)(7)(ii) of this standard’’ to (l)(1)(i)(B) exposure at or above the action level, provides only the employee a medical and ‘‘in accordance with paragraph provided that the employee uses report that contains detailed medical (k)(6)(v) or (k)(7)(iii) of the standard’’ to respiratory protection that complies findings, such as confirmed positive (l)(1)(ii) to be clear that medical removal with paragraph (g) of these standards findings or a diagnosis of CBD. In cases is required under those provisions only whenever exposures are at or above the where the employee is confirmed when the removal recommendation is action level. positive or diagnosed with CBD, the based on a confirmed positive finding or Although paragraph (l)(2) of the final physician or CBD diagnostic center also a diagnosis of CBD. standards tracks OSHA’s intent as includes recommendations for removal Paragraph (l)(2) of the proposal laid expressed in the proposal, the final from exposure in the written medical out the options for employees who are provision contains several clarifying report. However, under paragraphs eligible for MRP. Specifically, paragraph changes. First, final paragraph (l)(2) (k)(6) and (k)(7)(iii), employers do not (l)(2) required eligible employees to explicitly places the responsibility for receive a written medical opinion that choose removal, as described under providing the choices on the employer, contains an employee’s medical paragraph (l)(3), or to remain in a job while the proposal merely implied that information (other than any with exposure at or above the action the employer would do so. OSHA recommended limitations on the level as long as they wear a respirator believes that this clarification eliminates employee’s use of respirators) without in accordance with paragraph (g) of this the possibility of confusion. Second, the employee’s written consent. The standard. While both ORCHSE and final paragraph (l)(2)(ii) refers to written opinion to the employer may Public Citizen supported the MRP paragraph (g) of these standards, instead contain a recommendation for removal provision, neither supported making of referring to the Respiratory Protection from exposure, without the medical removal optional (Document ID 1691, standard (29 CFR 1910.134). OSHA reason for the recommendation, only if Attachment 1, p. 13; 1756, Tr. 189). made this second change to bring this the employee authorizes that ORCHSE specifically stated that provision into line with a similar recommendation to be included in the utilizing respiratory protection as a provision in paragraph (e) of the final opinion. This allows an employee who means of protecting workers violates the standards; it does not affect the is eligible for medical removal and hierarchy of controls and removal is employer’s obligations as set forth in the chooses that option to provide official most prudent for worker protection proposed rule. Third, final paragraph documentation requesting removal, (Document ID 1691, Attachment 1, p. (l)(2)(ii) expressly requires employers to without disclosing a specific medical 13). ensure that employees use the condition. After careful consideration of these respiratory protection whenever Thus, paragraph (l)(1) allows an comments, OSHA has decided to allow airborne exposures meet or exceed the employee’s eligibility for removal to be employees to choose between removal action level. Again, this requirement established by four different types of and remaining in a job with airborne was implied in the proposal, but OSHA documentation: exposure at or above the action level, believes that making the requirement • The employee may provide a (k)(5) provided that the employee uses express helps employers understand or (k)(7)(ii) written medical report respiratory protection for exposures at their obligations under these standards. indicating a confirmed positive finding or above the action level, as Proposed paragraph (l)(3) contained or diagnoses of CBD and recommending contemplated in the proposal. OSHA requirements that would have applied if removal because of that finding or recognizes that removal may reduce the an eligible employee elected removal. diagnosis. risk of the onset of CBD and lead to Under the proposal, when an employee • The employee may provide a (k)(5) reduction of symptoms. However, CBD chooses removal, the employer would or (k)(7)(ii) written medical report in is unlike triggers for MRP in some other have been required to remove the which the confirmed positive finding or OSHA standards, such as lead and employee to comparable work if such diagnosis has been obscured or benzene, because CBD is not reversible. work was available. Proposed paragraph removed, but still contains the Thus, without the respirator option, (l)(3)(i) explained that comparable work recommendation of removal because of mandatory removal would require that is a position for which the employee is that finding or diagnosis. An employee the employee switch careers already qualified or can be trained

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within one month, in an environment the employee has obtained new and place the employee on paid leave under where beryllium exposure is below the equivalent employment, provided that paragraph (l)(3)(ii) (80 FR 47802). action level. As explained in the the employee is making a good faith However, because OSHA regulates preamble to the proposal, this provision effort at finding new employment employers, this requirement is better would not have required an employer to [emphasis added].’’ (Document ID 1679, expressed as a clarification to the place an employee on paid leave under p. 15). employer’s responsibilities. OSHA proposed paragraph (l)(3)(iii) if the OSHA is sympathetic to NABTU’s concludes that the opening clause to employee refused comparable work position—some employers, especially proposed and final paragraphs (l)(3)(ii), offered under paragraph (l)(3)(i). small employers, may lack the which indicates that an employer’s If comparable work was not flexibility and resources to provide obligation to maintain the employee’s immediately available, paragraph comparable positions for MRP-eligible base earnings, seniority, and other rights (l)(3)(ii) of the proposal would have employees (Document ID 0345, p. 24), and benefits that existed at the time of required the employer to place the and as a result, employees’ base removal arises ‘‘[i]f comparable work is employee on paid leave for six months earnings and benefits would only be not available’’ makes this sufficiently or until comparable work becomes maintained for a six-month period. clear. available, whichever occurs first. However, OSHA also recognizes that the Third, OSHA eliminated proposed Proposed paragraph (l)(3)(ii) further requirement to maintain the employee’s paragraphs (l)(3)(iii), which stated that explained that if comparable work base earnings, seniority, and other rights ‘‘whether the employee is removed to became available before the end of the and benefits that existed at the time of comparable work or placed on paid six month paid leave period, the removal for even a six-month period leave, the employer shall maintain for 6 employer would have been obligated to may be difficult for some employers. months the employee’s base earnings, offer the open position to the employee. After weighing these two concerns, seniority, and other rights and benefits However, OSHA explained that if the OSHA finds that the requirement to that existed at the time of removal.’’ In employee declined the position, the provide medical removal protection for the final rule, proposed (l)(3)(iii)’s employer would have had no further a six-month period strikes a reasonable requirements have been incorporated obligation to provide paid leave. balance between protecting employees into final paragraphs (l)(3)(i) and (ii). Proposed paragraph (l)(3)(iii) would and limiting the burden on employers. OSHA believes that this simplification have continued a removed employee’s Therefore, OSHA has decided to retain will clarify the Agency’s intent. rights and benefits for six months, these provisions in the final standard OSHA has also omitted the phrase regardless of whether the employee was with minor edits, as follows. ‘‘paid leave’’ from final paragraph removed to comparable work or placed First, OSHA reorganized and edited (l)(3)(ii) because, with the incorporation on paid leave. The six-month period paragraph (l)(3)(i) to clarify and of proposed paragraph (l)(3)(iii)’s would have begun when the employee emphasize the employer’s temporal and benefits requirements into was removed, which means either the responsibilities. Like the proposed final paragraph (l)(3)(ii), it is day the employer transferred the provision, final paragraph (l)(3) applies unnecessary to specify what an employee to comparable work, or the where an eligible employee chooses employee who has been removed but is day the employer placed the employee removal. If a comparable job is available not working in a comparable job would on paid leave. For this period, the where exposures to beryllium are below be doing. In addition, OSHA wishes to provision would have required the the action level, and the employee is give employers the flexibility to work employer to maintain the employee’s qualified for that job or can be trained with removed employees to create base earnings, seniority, and other rights within one month, final paragraph alternatives to merely placing the and benefits of employment as they (l)(3)(i) requires the employer to remove employee on paid leave. For example, existed at the time of removal. OSHA the employee to that job. Although each employers might choose to offer the explained that this provision is typical of these requirements was expressly employee the opportunity to train for of medical removal provisions in other stated in the NPRM in either the more than one month so that he or she OSHA standards, such as Cadmium (29 regulatory text or the preamble (80 FR could qualify for a different job. CFR 1910.1027), Benzene (29 CFR 47802), OSHA has chosen to make its Provided that the employer otherwise 1910.1028), Formaldehyde (29 CFR intent express in the final regulatory complied with final paragraph (l)(3)(ii), 1910.1048), Methylenedianiline (29 CFR text. For example, the NPRM implied in such an arrangement would be 1910.1050), and Methylene Chloride (29 regulatory text and explained in the permissible under the final standards. CFR 1910.1052). preamble that an employer’s obligation Finally, proposed paragraph (l)(4) As detailed above, there is under proposed paragraph (l)(3)(i) arose provided that an employer’s obligation widespread support among stakeholders where comparable work was available, to provide MRP benefits to a removed for the inclusion of removal and wage but the final text makes the trigger for employee would be reduced if, and to protection for eligible employees in this this obligation explicit (see 80 FR the extent that, the employee receives rulemaking. The provisions included in 47802; proposed paragraph (l)(3)(ii) compensation from a publicly or the proposal were consistent with the (which applied ‘‘if comparable work is employer-funded compensation recommendation of beryllium health not available)). program for earnings lost during the specialists in the medical community Second, OSHA omitted the proposed removal period, or receives income from and with the draft recommended requirement in paragraph (l)(3)(i) that another employer made possible by standard provided by Materion and ‘‘[t]he employee must accept virtue of the employee’s removal. OSHA USW (Document ID 0754). However, not comparable work if such work is retained this requirement unchanged in all commenters agreed with the available’’ from final paragraph (l)(3)(i). final paragraph (l)(4). OSHA clarifies proposed provisions. One commenter, As stated in the preamble to the that benefits received under the Energy NABTU, argued that ‘‘[i]f an employer proposal, OSHA included this statement Employees Occupational Illness who has placed an employee at risk in proposed paragraph (l)(3)(i), in part, Compensation Program Act (EEOICPA) cannot offer alternative employment to make clear that if the employee do not constitute wage replacement; [within six months], then a better declines an offer of comparable work, therefore, EEOICPA benefits would not solution would be to provide MRP until then the employer was not obligated to offset the employee’s MRP benefits.

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OSHA did not receive any comments safety data sheets (SDSs). These written Effects, and Section VI, Risk specifically directed to this provision, forms of communication will be most Assessment, OSHA finds that beryllium but, as noted above, several stakeholders effective when employees understand is a hazardous chemical for purposes of commented that they supported the the information presented and are aware the HCS. Therefore, the Agency MRP provisions contained in the of how to avoid or minimize exposures, includes paragraph (m)(1)(i) of the final proposal as a whole (i.e., Document ID thereby reducing the possibility of standards for general industry, 1664, pp. 3–4, 9; 1680, pp. 1, 7; 1681, experiencing adverse health effects. construction, and shipyards to require pp. 14–15; 1683, p. 3; 1688, p. 2; 1689, Several commenters, including Ameren chemical manufacturers, importers, pp. 8, 13–14; 1690, pp. 1, 3–4; 1691, Corporation (Ameren) and United distributors, and employers to comply Attachment 1, pp. 13, 15; 1755, Tr. 26, Steelworkers (USW), generally with their duties under HCS. The final 168; 1756, Tr. 142–143; 1809, p. 1; 1963, supported inclusion of a hazard provision in these standards is pp. 13–14). After considering all communication requirement in the substantively unchanged from the comments and the record as a whole on beryllium standards (e.g., Document ID proposed provision. Paragraph (m)(1)(ii) MRP, OSHA finds that a provision for 1675, p. 7; 1681, p. 15). of the proposal required employers to MRP is a necessary part of the final rule. As a general matter, the HCS requires address at least the following, in As discussed above, MRP protects an a comprehensive hazard evaluation and classifying the hazards of beryllium: employee’s rights and benefits during communication process, aimed at Cancer; lung effects (chronic beryllium the first six months of removal, and ensuring that the hazards of all disease and acute beryllium disease); OSHA structured the MRP provisions to chemicals are evaluated, and also beryllium sensitization; skin provide for ways to reduce in certain requires that the information concerning sensitization; and skin, eye, and circumstances an employer’s obligation chemical hazards and necessary respiratory tract irritation. According to to compensate employees for earnings protective measures is properly the HCS, employers must classify lost. OSHA emphasizes, however, that transmitted to employees. The HCS hazards if they do not rely on the MRP is not intended to serve as a achieves this goal, in part, by requiring classifications of chemical workers’ compensation system. The chemical manufacturers and importers manufacturers, importers, and distributors (see 29 CFR primary reason the Agency is including to review available scientific evidence MRP in this standard is to provide 1910.1200(d)(1)). Commenters did not concerning the physical and health eligible employees a six-month period object to this provision. Therefore, after hazards of the chemicals they produce to adjust to the comparable work considering the record, including the or import to determine if they are arrangement or to seek alternative general comments in favor of the hazardous. For every chemical found to employment, without any further proposed hazard communications be hazardous, the chemical exposure at or above the action level. provisions and the evidence presented manufacturer or importer must develop The Agency finds that this provision in Section V, Health Effects, and Section a container label and an SDS, and accomplishes that goal while providing VI, Risk Assessment, regarding the provide both documents to downstream for allowing the employer to control enumerated hazards of exposure to users of the chemical. All employers costs in many cases. In addition, this beryllium, OSHA has decided to retain provision is consistent with other with employees exposed to hazardous this proposed provision substantively standards such as Formaldehyde (29 chemicals must develop a hazard unchanged in final paragraph (m)(1)(ii) CFR 1910.1048), Methylenedianiline (29 communication program and ensure of the standards for general industry and CFR 1910.1050), and Methylene that all containers of hazardous shipyards. However, OSHA has revised Chloride (29 CFR 1910.1052). chemicals are labeled and employees the language to bring it into conformity For the reasons discussed above, are provided access to SDSs and are with other substance specific standards OSHA finds that maintaining the MRP trained on the hazardous chemicals in so it is clear that chemical provision, with the clarifying changes their workplace. Because OSHA manufacturers, importers, and noted above, in the final rule provides preliminarily found beryllium to be a distributors are among the entities workers the incentive to participate in hazardous chemical, the Agency required to classify the hazards of the medical surveillance program and determined that hazard communications beryllium (See 77 FR 17748–50). provides workers with sensitization or provisions should be included in the OSHA has chosen not to include an CBD the opportunity and means to proposal. OSHA intends for the hazard equivalent requirement in the final minimize further exposure to beryllium. communication requirements in the standards for construction and final standards to be substantively as shipyards since employers in (m) Communication of Hazards consistent as possible with the HCS, construction and shipyards are Paragraph (m) of the standards for while including additional specific downstream users of beryllium products general industry, construction, and requirements needed to protect (blasting media) and would not shipyards sets forth the employer’s employees exposed to beryllium, in therefore be classifying chemicals obligations to comply with OSHA’s order to avoid duplicative (Chapter IV of the Final Economic Hazard Communication Standard (HCS) administrative burden on employers Analysis). (29 CFR 1910.1200) relative to who must comply with both the HCS Proposed paragraph (m)(1)(iii) beryllium, and to take additional steps and this rule. Proposed paragraph required employers to include beryllium to warn and train employees about the (m)(1)(i) required chemical in the hazard communication program hazards of beryllium. Employees need manufacturers, importers, distributors, established to comply with the HCS, to know about the hazards to which and employers to comply with all and ensure that each employee has they are exposed, along with the applicable requirements of the HCS (29 access to labels on containers and safety associated protective measures, in order CFR 1910.1200) for beryllium. data sheets for beryllium and is trained to understand how they can minimize Stakeholders did not offer any in accordance with the HCS and potential health hazards. As part of an comments on this provision. After paragraph (m)(4) of this section. overall hazard communication program, reviewing the full record, including all Stakeholders did not object to any part training serves to explain and reinforce available evidence, and as discussed in of this provision. After reviewing the the information presented on labels and this preamble at Section V, Health record, OSHA reaffirms that employees

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exposed to beryllium need additional of other government and public health precautions necessary before entering training and information. Therefore, organizations. Furthermore, the these dangerous areas (see paragraph OSHA has decided to include the International Agency for Research on (m)(4) of this rule and 29 CFR approach set forth in the proposed rule Cancer (IARC), National Toxicology 1910.1200(h) for training requirements). in the final paragraph (m)(1)(iii) of the Program (NTP), and American OSHA does not believe it is necessary final standards for general industry and Conference of Governmental Industrial for the signs to denote the precise shipyards and final paragraph (m)(1)(ii) Hygienists (ACGIH) have all classified activity occurring within the regulated of the standard for construction. The beryllium as a known human area in order to accomplish these goals. final provisions are substantively carcinogen (Document ID 0651; 0389, However, employers may choose to unchanged from the proposal. pp. 1–3; 1304; 0345, p. 4). In light of this include additional information on the Paragraph (m)(2)(i) of the proposed evidence, OSHA finds the comments signs required under this rule, provided standard required employers to provide opposing the cancer warning language that the additional information included and display warning signs at each on signs unpersuasive. However, with is not confusing or misleading and does approach to a regulated area so that each regard to Materion’s suggested language, not detract from required warnings. employee is able to read and understand OSHA agrees that a warning that Thus, paragraph (m)(2)(i)) of the final the signs and take necessary protective beryllium can cause damage to lungs is standards for general industry and steps before entering the area. Proposed appropriate and retains that language, as shipyards requires employers to provide paragraph (m)(2)(ii) of the standards proposed, in the final standards for and display warning signs at each required employers to ensure that general industry and shipyards. approach to a regulated area so that each warning signs are legible and readily A few other stakeholders also employee is able to read and understand visible, and that they bear the following suggested edits or additions to the the signs and take necessary protective legend: proposed sign legend. For example, steps before entering the area. Pursuant DANGER NGK recommended that the phrase, to final paragraph (m)(2)(ii), employers BERYLLIUM WEAR RESPIRATORY PROTECTION must ensure that these warning signs MAY CAUSE CANCER AND PROTECTIVE EQUIPMENT IN legible and readily visible and include CAUSES DAMAGE TO LUNGS THIS AREA be changed to WEAR the specified legend. The only alteration AUTHORIZED PERSONNEL ONLY RESPIRATORY PROTECTION AND to the legend from the proposal is the WEAR RESPIRATORY PROTECTION AND PROTECTIVE EQUIPMENT PRIOR TO addition of the words, ‘‘REGULATED PROTECTIVE CLOTHING AND ENTERING THIS AREA, on warning EQUIPMENT IN THIS AREA AREA’’ following the word, ‘‘DANGER.’’ signs to emphasize that personal OSHA has not included these regulated A number of stakeholders offered protective equipment (PPE) must be put area signage requirements in the final opinions on these provisions. Some on before entering the restricted work standard for construction, because the stakeholders, like the USW, supported area (Document ID 1663, p. 3). OSHA construction standard does not contain the proposed provisions (e.g., Document agrees that employees need to don PPE requirements for establishing regulated ID 1681, p. 15). Other stakeholders prior to entering the regulated area, but area and uses the competent person offered specific critiques regarding the finds the suggested language requiring (paragraph (e) of the construction proposed required language for the respiratory protection and PPE ‘‘in this standard) to limit access to areas where signs. For example, NGK Metals area’’ is sufficient to alert the workers to exposures have the potential to be above Corporation (NGK) and Materion put their equipment and respirators on Corporation (Materion) strongly the PEL. In summary, OSHA finds that prior to entering the restricted work the use of warning signs is important to opposed having cancer warnings area. Therefore, OSHA has decided to displayed on warning signs. These make employees who are regularly retain the text ‘‘in this area’’ as stated in scheduled to work at these sites aware commenters requested that OSHA strike the final standards for general industry out the cancer warning based on the of beryllium hazards, to alert employees and shipyards. OSHA also notes that who have limited access to these sites results of a recent study by Boffetta, et this language is consistent with the HCS of beryllium hazards, and to warn those al. (2014) (Document ID 0403) that does and other previous health standards, who do not require access to regulated not show an elevated risk of cancer to such as Benzene (29 CFR 1910.1028). workers exposed to beryllium One stakeholder proposed a provision areas to avoid those areas. Access must (Document ID 1663, p. 3; 0403; 1958, particular to shipyards. In hearing be limited to authorized personnel to pp. 3–5). Materion added that the cancer testimony, Ashlee Fitch of USW ensure that those entering the area are warning masks the true risk, CBD, and commented that warning signs adequately trained and equipped, and to that the wording on warning signs ‘‘demarking abrasive blasting operations limit exposure to those whose presence should be changed to ‘‘Causes Damage with beryllium-containing materials’’ is absolutely necessary. By limiting to Lungs’’ to reflect the true hazard should be posted (Document ID 1756, p. access to authorized persons, employers (Document ID 1958, pp. 4–5). 245). OSHA has chosen not to can minimize employee exposure to OSHA has decided to retain the incorporate this suggestion. The signs beryllium in regulated areas and thereby hazard statement about cancer as a required by paragraph (m)(2) of this minimize the number of employees who requirement for the warning signs. As final rule are intended to serve as a may require medical surveillance or discussed in this preamble at Section V, warning to employees and others who may be subject to the other requirements Health Effects, and Section VI, Risk may not be aware that they are entering associated with working in a regulated Assessment, OSHA has reviewed the a regulated area, and to remind them of area. scientific literature for beryllium the hazards of beryllium so that they Proposed paragraph (m)(3) required carcinogenicity, including the Boffeta take necessary protective steps before that labels be affixed to all bags and study, and has concluded that beryllium entering the area. These signs are also containers of clothing, equipment, and is carcinogenic. The Agency’s finding is intended to supplement the training that materials visibly contaminated with based on the best available employees must receive regarding the beryllium. OSHA also included a epidemiological data, reflects evidence hazards of beryllium, since even trained requirement that the labels contain the from animal and mechanistic research, employees need to be reminded of the following statement: and is consistent with the conclusions locations of regulated areas and of the DANGER

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CONTAINS BERYLLIUM access to other more in-depth forms of generates dust, exposures of concern MAY CAUSE CANCER information. The Agency is therefore might occur more readily than with CAUSES DAMAGE TO LUNGS requiring that employers place homogenous mixtures of similar AVOID CREATING DUST appropriate warning language on bags concentration. OSHA believes the DO NOT GET ON SKIN and containers containing beryllium- clearer approach is to require all The USW supported the proposal’s contaminated materials. This provision contaminated materials with a uniform requirement that bags and containers is consistent with other substance- labelling scheme, as it has for other storing materials visibly contaminated specific health standards. substance-specific standards (e.g., Lead, with beryllium have specific warning Second, ORSCHSE argued that the 29 CFR 1910.1025; Cadmium, 29 CFR labels to alert workers of the dangers of proposed labeling requirements are 1910.1027; Coke Oven Emissions, 29 beryllium exposure (Document ID 1681, inconsistent with the HCS. It stated that CFR 1910.1029). Including this p. 15). However, as discussed in the paragraph (m)(1) required compliance provision will ensure that downstream Summary and Explanation on paragraph with the HCS, which covers warning workers who might receive the (h) on personal protective clothing and labels for hazardous chemicals other contaminated material have notice of equipment, several commenters than beryllium, ‘‘so using the same the contamination. As discussed in the objected to the use of the term ‘‘visibly standard for beryllium labels would summary and explanation for paragraph contaminated.’’ For example, the Non- promote consistency throughout the (b) the term ‘‘materials’’ includes waste, Ferrous Founder’s Society (NFFS) workplace.’’ Therefore, it suggested that scrap, debris, and any other items commented that the definition of paragraph (m)(3) be deleted, because contaminated with beryllium. ‘‘visibly contaminated with beryllium’’ paragraph (m)(1) already requires The Agency finds that the final was not provided in the proposed rule observation of ‘‘all requirements’’ of the labeling requirements will help ensure and was vague (Document ID 1679, p. HCS. Additionally, ORCHSE that all affected employees, not only the 5). OSHA agrees that the term is commented that the HCS does not employees of a particular employer, are ambiguous and has chosen to remove require labeling for carcinogens on bags apprised of the presence of beryllium- the term visibly from the final and containers unless the concentration containing materials and the hazardous standards. OSHA has therefore relied on is 1% or more (Document ID 1691, nature of beryllium exposure. With this terminology that is commonly used in Attachment 1, pp. 23–24). knowledge, employees can take steps to other substance specific standards for After considering these comments and protect themselves through proper work metals, such as Chromium (VI) (29 CFR the record on this issue, OSHA has practices established by their 1910.1026). NGK also recommended decided to retain proposed paragraph employers. Employees are also better that OSHA insert the word ‘‘particulate’’ (m)(3) with the minor alteration able to alert their employers if they (Document ID 1663, pp. 3–4). OSHA described above. The final provision, believe exposures or skin contamination declines to adopt this suggestion. The which appears in paragraph (m)(3) of can occur. addition of the term ‘‘particulate’’ is the final standards for general industry Proposed paragraph (m)(4) contained unnecessary and may cause confusion and shipyards and paragraph (m)(2) of requirements for employee information since the final standards cover the final standard for construction, and training. The proposed provisions beryllium in all forms, compounds, and requires employers to label each bag and applied to each employee who is or can mixtures. Several stakeholders also container of clothing, equipment, and reasonably be expected to be exposed to weighed in on other aspects of these materials contaminated with beryllium. airborne beryllium. ORCHSE strongly provisions. For example, NGK and The required label must, at a minimum, urged OSHA to rewrite this provision to Materion offered comments on the include the language specified in the align with the HCS training, arguing that proposed wording of the required labels, proposal. The warning label language ‘‘there is no need to include chemical which restated their requests that the for the signal word (danger) and hazard hazard training requirements in a cancer warnings be struck from the statements (may cause cancer) are substance specific standard’’ (Document proposed language (Document ID 1663, consistent with the GHS. However, ID 1691, Attachment 1, p. 20). While pp. 3–4; 1958, pp. 3–5). OSHA has OSHA has decided that the OSHA agrees that the HCS is designed decided to retain the cancer warning precautionary statements needed to be to cover all chemical hazards in the labeling requirements in the final rule slightly different due to the nature of the workplace, an employer may choose to for the reasons discussed in response to exposure and the fact that sensitization train by specific chemical or by hazard. their comments on paragraph (m)(2) can result from short term exposures In this substance specific standard, above. (see Health Effects section V of this OSHA find that employees need to be ORCHSE Strategies (ORCHSE) also preamble). trained on the hazards specifically commented on the labeling While ORCHSE correctly notes that associated with beryllium, in addition requirements of containers and bags in the HCS contains a concentration cutoff to the training they receive under the paragraph (m)(3). First, it argued that (0.1% for category 1 carcinogens, and HCS. These types of requirements are the provision would require the 1% for category 2 carcinogens), that not uncommon in substance specific precautionary statements ‘‘Avoid cutoff is difficult to apply in the case of hazards. For example, the Lead standard creating dust’’ and ‘‘Do not get on skin’’ clothing or other material that has been requires annual training on the specific for all bags and containers which it contaminated with beryllium-containing hazards associated with lead exposure maintained is inconsistent with the HCS dust. As a practical matter, it may be (see 29 CFR 1910.1025 (l)(1)). precautionary statements (Document ID difficult to determine whether the Consequently, OSHA is not persuaded 1691, Attachment 1, p. 23). OSHA cutoffs have been exceeded with dust by ORCHSE that OSHA should acknowledges that these ‘‘precautionary contamination. Moreover, the cutoffs substantially change the training statements’’ are not from Appendix C of were developed for mixtures that are provisions in the final rule. the HCS. However, OSHA is requiring products and more homogeneous in The Boeing Company (Boeing) alternate language for the unique nature, rather than materials suggested that OSHA add the text situation for bags of contaminated contaminated with dust. If ‘‘within the scope of this standard’’ to clothing or equipment where workers contaminated clothing or other the end of this requirement (Document handling these materials may not have materials are handled in a way that ID 1667, p. 7). It contended that its

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recommended language would ‘‘set a hazard communication program, 1910.1043), and 1,3-Butadiene (29 CFR measurable boundary consistent with including lists of hazardous chemicals 1910.1051). the scope of the standard,’’ while the and safety data sheets, and the location Proposed paragraph (m)(4)(ii) proposal would create an ‘‘open ended of operations in their work areas where required the employer to ensure that boundary that would confuse hazardous chemicals are present. The each employee who is or can reasonably compliance efforts.’’ OSHA has HCS also requires employers to train be expected to be exposed to airborne considered the suggestion but does not their employees on ways to detect the beryllium can demonstrate knowledge find Boeing’s argument persuasive. presence or release of hazardous of nine enumerated categories of OSHA does not believe this adds chemicals in the work area, such as any information. ORCHSE and NGK additional clarity to employer on which monitoring conducted, the physical and objected to this proposed requirement. employees should be trained. OSHA health hazards of the chemicals in the ORCHSE suggested that OSHA replace expects that once the employer is work area, measures employees can take ‘‘can demonstrate knowledge of’’ with covered under the standard they are in to protect themselves, and the details of ‘‘has been informed of’’ in paragraph the best position to determine who the employer’s hazard communication (m)(4)(ii). ORCHSE also argued that would be potentially exposed to program (29 CFR 1910.1200(h)(3)). employers can control what information beryllium. Additionally, this language is Therefore, OSHA has included they provide, but cannot control what consistent with other substance specific proposed paragraph (m)(4)(i)(A) information the employee retains, and a standards, such as Benzene (29 CFR substantively unchanged from the literal interpretation of the requirement 1910.1028). proposal in paragraph (m)(4)(i)(A) of the that employees must ‘‘demonstrate NGK also commented on the final standards for general industry and knowledge of’’ the nine enumerated proposed trigger. Specifically, it shipyards and paragraph (m)(3)(i)(A) of categories of information will result in suggested the training requirements the final standard for construction. citations whenever ‘‘any employee, at should be consistent with the lead Proposed paragraphs (m)(4)(i)(B) and any moment, is unable to recite detail’’ standard (29 CFR 1910.1025(l)(1)(ii)) in (C) specified when an employer’s on those topics (Document ID 1691, that the training should be done for obligation to train covered employees Attachment 1, pp. 21–23). Similarly, those workers exposed above the action should begin and how often training NGK commented that the requirement level (Document ID 1663, p. 4). OSHA should occur. Proposed paragraph that employers must ensure that declines to adopt this suggestion. As (m)(4)(i)(B) required initial training by employees who may be exposed to discussed in Section V, Health Effects, the time of initial assignment, which beryllium can demonstrate knowledge and Section VI, Risk Assessment, risk of means before the employee’s first day of of enumerated subjects should be material impairment to health remains work in a job that could reasonably be replaced with a requirement that at exposure levels below the action expected to involve exposure to employers ensure employee level. Because of this risk, OSHA airborne beryllium. Under proposed participation in a training program, concludes that it is necessary and paragraph (m)(4)(i)(C), employers were consistent with the lead standard (29 appropriate to train all employees who required to repeat training at least CFR 1910.1025(l)(1)(ii)) (Document ID may be exposed to airborne beryllium at annually thereafter. USW supported the 1663, p. 4). any level. The Agency finds that all requirement of initial and annual such employees will benefit from this OSHA does not find these arguments training for workers who are or can be training. Therefore, OSHA is continuing persuasive. Because beryllium is a to trigger the training requirements reasonably expected to be exposed to hazardous chemical with serious and proposed in paragraph (m)(4)(i) based beryllium (Document ID 1681, p. 15). debilitating health effects, it is on airborne exposure, or anticipated After reviewing the record on this imperative that employers can ensure exposure, at any level. The final topic, OSHA has decided to retain that employees can demonstrate that provisions are contained in paragraph proposed paragraphs (m)(4)(i)(B) and they understand the material and have (m)(4)(i) of the standards for general (m)(4)(i)(C) in paragraph (m)(4)(i)(B) and knowledge of the topics covered during industry and shipyards and paragraph (C) of the final standards for general the training sessions, as previously (m)(3)(i) of the standard for industry and shipyards and paragraph indicated. To adjust the text to read construction. (m)(3)(i)(B) and (C) of the final standard ‘‘has been informed of’’ or to require the Proposed paragraph (m)(4)(i)(A) for construction. OSHA finds that initial employer to ensure employee required employers to provide training and annual retraining are participation in training will not ensure employees who are or can reasonably be necessary due to the serious and employee comprehension and expected to be exposed to airborne debilitating health effects of beryllium consequently could lead to employees beryllium with information and training exposure, and for reinforcement of not understanding the health effects in accordance with the requirements of employees’ knowledge of those hazards. associated with beryllium exposure and the HCS (29 CFR 1910.1200(h)), The initial training requirement is safety concerns to protect themselves including specific information on consistent with the HCS, which requires from exposure. This language would beryllium as well as any other hazards that employers provide employees with also be inconsistent with the HCS, addressed in the workplace hazard effective information and training on which requires effective training which communication program. hazardous chemicals in their work area OSHA indicates must be in a manner OSHA did not receive any objections at the time of their initial assignment which an employee comprehends. to or comments on this provision. After (29 CFR 1910.1200(h)(1)). In addition, The Agency understands that a review of the rulemaking record, the while the triggers may be slightly employers would like more clarity on Agency continues to believe that the different, the initial and annual training how to determine whether training provision of information and training in requirement are consistent with other requirements are met. However, OSHA accordance with the HCS will benefit OSHA standards such as those for Lead has decided that the training employees. For example, under the (29 CFR 1910.1025), Cadmium (29 CFR requirements under the final beryllium HCS, employers must provide their 1910.1027), Benzene (29 CFR standards, like those in HCS, are best employees with information such as the 1910.1028), Coke Oven emissions (29 accomplished when they are location and availability of the written CFR 1910.1029), Cotton Dust (29 CFR performance-oriented. But, as in past

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standards, the Agency does offer some ensure that the employee understands topics covered in the written control suggestions. the topics on which he or she is trained. plan, not from a similar document. The First, although OSHA finds that the This change is consistent with suggested language makes it unclear employer is in the best position to Assistant Secretary David Michaels’ whether the employee would get the determine how the training can most memorandum to OSHA Regional appropriate training needed and still effectively be accomplished, the Agency Administrators (Document ID 1754, p. gain the same knowledge and notes that hands-on training, 2). The memorandum explains that understanding required by the videotapes, DVD or slide presentations, because employees have varying beryllium standard. OSHA, therefore, classroom instruction, informal educational levels, literacy, and has decided to retain paragraph discussions during safety meetings, language skills, training must be (m)(4)(ii)(B)’s requirements from the written materials, or any combination of presented in a language, or languages, proposed rule in these final standards. these methods may be appropriate. and at a level of understanding that That said, employers are free to Second, to ensure that employees accounts for these differences in order incorporate their current exposure comprehend the material presented to ensure that employees understand the control program into the written control during training, it is critical that trainees training. As stated by Assistant program required by paragraph (f)(1) if have the opportunity to ask questions Secretary Michaels: their program meets the requirements of and receive answers if they do not fully [A]n employer must instruct its employees that paragraph. If they do so, and train understand the material that is using both a language and vocabulary that their employees on that program, presented to them. When videotape the employees can understand. For example, paragraph (m)(4)(ii)(B) requires no presentations or computer-based if an employee does not speak or ‘‘second redundant document.’’ programs are used, this requirement comprehend English, instruction must be Proposed paragraph (m)(4)(ii)(A)–(I) may be met by having a qualified trainer provided in a language that the employee can specified the contents of training for available to address questions after the understand. Similarly, if the employee’s employees who are or can reasonably be vocabulary is limited, the training must presentation, or providing a telephone expected to be exposed to airborne account for that limitation. By the same beryllium. The proposed list required hotline so that trainees will have direct token, if employees are not literate, telling access to a qualified trainer. Although it employers to ensure that employees can them to read training materials will not demonstrate knowledge of: (1) The is important that employees be able to satisfy the employer’s training obligation ask questions, OSHA finds that the (Document ID 1754, p. 2). health hazards associated with exposure employer is in the best position to to soluble beryllium compounds, This may mean, for example, providing including the signs and symptoms of determine whether the instructor must materials, instruction, or assistance in be available for questions during CBD; (2) the written exposure control Spanish rather than or in addition to plan, with emphasis on the location(s) training or if an instructor or trainer can English if some of the employees being of beryllium work areas, including any answer questions after the training trained are Spanish-speaking and do not regulated areas, and the specific nature session. Such performance-oriented understand English. However, the operations that could result in employee requirements are intended to encourage employer is not required to provide exposure, especially employee exposure employers to tailor training to the needs training in the employee’s preferred above the TWA PEL or STEL; (3) the of their workplaces, thereby resulting in language if the employee understands purpose, proper selection, fitting, proper the most effective training program for the language used for training. use, and limitations of personal each workplace. Finally, Boeing suggested that OSHA protective clothing and equipment, Third, in addition to being add the text ‘‘or equally as effective including respirators; (4) applicable performance-oriented, these training documentation’’ to paragraph emergency procedures; (5) measures requirements are also results-oriented. (m)(4)(ii)(B), so that the employer could employees can take to protect As discussed in the respirable satisfy its obligations by ensuring that themselves from exposure to beryllium crystalline silica standard, there are a employees who are or can reasonably be and contact with soluble beryllium variety of methods employers can use to expected to be exposed to airborne compounds, including personal hygiene determine whether employees have the beryllium could demonstrate knowledge practices; (6) the purpose and a requisite knowledge. For example, of ‘‘[t]he written exposure control plan, description of the medical surveillance employers may choose to facilitate or equally as effective documentation, program required by paragraph (k) of discussions of the required training with emphasis on the location(s) of this standard, including risks and subjects or administer written tests or beryllium work areas, including any benefits of each test to be offered; (7) the oral quizzes. Any of these methods regulated areas, and the specific nature purpose and a description of the could alert an employer to an employee of operations that could result in medical removal protection provided knowledge gap. employee exposure, especially under paragraph (l) of this standard; (8) Finally, OSHA has included a employee exposure above the TWA PEL the contents of this standard; and (9) the modification in the final standards that or STEL.’’ They contend that this added employee’s right of access to records was prompted by ORCHSE and NGK’s language would allow employers ‘‘to under the Records Access Standard (29 questions. In the final standards provide the required information CFR 1910.1020). (paragraph (m)(4)(ii) of the standards for through the use of existing processes Stakeholders offered several general industry and shipyards and instead of through the creation of a comments on these proposed training paragraph (m)(3)(ii) of the standard for second redundant document’’ topics. For example, ORCHSE construction), OSHA requires that the (Document ID 1667, p. 7). commented that the employer should employer must ensure that employees OSHA has considered Boeing’s just ‘‘provide information and training demonstrate understanding, in addition suggestion but does not find its as specified in the HCS’’ (Document to knowledge. As discussed above this arguments persuasive. Paragraph 1691, Attachment 1, p. 23). OSHA has is consistent with the HCS and (m)(4)(ii)(B) of the final standards chosen not to adopt this suggestion emphasizes that it is not enough for an specifically requires the employer to because it finds that employees need employee to simply be provided with ensure that employees can demonstrate training specific to beryllium and its the information; the employer must also understanding and knowledge of the hazards, not only the general training

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required by the HCS on the hazards in employee needs additional training in construction. This is a common the workplace. The Agency concludes order to ensure that he or she has the requirement in OSHA standards such as that providing information and training knowledge, skill, and ability to be a Chromium (VI) (29 CFR 1910.1026), on the topics proposed is essential to designated competent person, but Acrylonitrile (29 CFR 1910.1045), ensuring that employees are informed because of unique scenarios in the respirable crystalline silica (29 CFR about the hazards attributed to construction and shipyard 1910.1053), and Cotton Dust (29 CFR beryllium exposures, the measures environments, those training 1910.1043). The provision leaves necessary to protect themselves, and the requirements would vary widely. OSHA employers free to determine the best rights accorded to them under these concludes, therefore, that it is the way to make the standard available, standards. employer’s responsibility to identify which could include giving the Stakeholder comments support and provide any additional training that employer a copy of the standard or OSHA’s finding that training will lead the competent person would need to placing a printed or electronic copy in to better work practices and hazard implement the written exposure control a central location that the employees avoidance. For example, in hearing plan. can easily access. In order to help testimony, Chris Trahan from North Proposed paragraph (m)(4)(iii) ensure employees are protected against America’s Building Trades Unions required employers to provide beryllium hazards, they need to be (NABTU) commented that in additional training when workplace familiar with and have access to the construction, she does not ‘‘see a high changes (such as modification of beryllium standard applicable to their level of awareness about hazards related equipment, tasks, or procedures) result workplace (general industry, shipyard, to beryllium’’ (Document ID 1756, pp. in new or increased employee exposure or construction), and be aware of the 207–08). NABTU also commented that it that exceeds or can reasonably be employer’s obligations to comply with ‘‘developed a survey to determine the expected to exceed either the TWA PEL it. level of awareness of beryllium hazards or the STEL. OSHA did not receive any and knowledge of exposures among comments on this provision, and retains (n) Recordkeeping building trades trainers,’’ and found it in the final to ensure that employees Paragraph (n) of the final standards widespread ignorance of beryllium are aware of new or additional hazards. for general industry, construction, and health risks even among survey This training must be provided at the shipyards sets forth the employer’s respondents responsible for delivering time of (or prior to) the new or increased obligation to comply with requirements hazard awareness training (Document ID exposure, even if a year has not passed to maintain records of air monitoring 1679 p. 5). Ashlee Fitch from the USW since the previous training. New data, objective data, medical testified that in her experience in training would be required under the surveillance, and training. The abrasive blasting, there was no training standard if the employer changes work recordkeeping requirements are in specific to what the material contained, production operations or personnel in a accordance with section 8(c) of the OSH and ‘‘the health effects associated with way that would require equipment to be Act (29 U.S.C. 657(c)), which authorizes . . . blasting media’’ were not discussed operated differently to avoid exposures OSHA to require employers to keep and (Document ID 1756, p. 247). Thus, above the TWA PEL or STEL. make available records as necessary or OSHA concludes that mandating Additional training would also be appropriate for the enforcement of the information and training on the topics required if employers introduce new Act or for developing information specific to beryllium as outlined in production or personal protective regarding the causes and prevention of proposed paragraph (m)(4)(ii) is equipment to employees who do not yet occupational injuries and illnesses. The particularly important. know how to properly use the new recordkeeping provisions are also In light of these comments, OSHA equipment. Misuse of either the new consistent with OSHA’s Access to reaffirms its finding that all nine of the production equipment or PPE could Employee Exposure and Medical training topics listed in proposed result in new exposures above the TWA Records (Records Access) standard at 29 paragraph (m)(4)(ii)(A)–(I) should be PEL or STEL. Similarly, employers must CFR 1910.1020, which addresses access included in the final standards. The provide additional training before to employee exposure and medical Agency has thus retained these topics in employees repair or upgrade records. final paragraphs (m)(4)(ii)(A)–(I) of the engineering controls if exposures during As discussed in more detail below, standards for general industry and these activities will exceed or can the recordkeeping requirements in the shipyards and paragraph (m)(3)(ii)(A)– reasonably be expected to exceed either final standards are similar to those (I) of the standard for construction, with the TWA PEL or the STEL. OSHA has included in the proposal. In the minor alterations for consistency with concluded that the additional training proposed rule, OSHA identified triggers that were updated from the requirement in this final rule is essential recordkeeping requirements for proposal to the final. For example, because it ensures that employees are exposure measurements, historical OSHA has changed the (m)(4)(ii)(A) able to actively participate in protecting monitoring data, objective data, medical from ‘‘contact with soluble beryllium’’ themselves under the conditions found surveillance, and training, and required to ‘‘contact with beryllium.’’ in the workplace, even if those employers to comply with Record OSHA is not mandating additional conditions change. Access standard requirements regarding training for a competent person in Proposed paragraph (m)(4)(iv) access to and transfer of these records. paragraph (m) of the standards for required the employer to make a copy Ameren Corporation (Ameren) construction. As discussed in more of the standard and its appendices expressed support for these detail in the summary and explanation readily available at no cost to each requirements (Document ID 1675, p. 7). of Written Exposure Control Plan, the employee and designated employee All other comments regarding the knowledge required by an individual representative(s). OSHA did not receive recordkeeping requirements focused on implementing the written exposure any comments on this provision, and specific areas of the recordkeeping control plan required by these standards the Agency has retained the requirement requirements and are discussed in the already ensure a high level of in paragraph (m)(4)(iv) of the standards appropriate subject section. competence. OSHA recognizes that for general industry and shipyards and Proposed paragraph (n)(1)(i) required there may be situations in which an paragraph (m)(3)(iv) of the standard for employers to maintain records of all

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measurements taken to monitor option or the scheduled monitoring interest in requiring the social security employee exposure to beryllium as option. The air monitoring requirements identifier. Instances of identity theft and required by paragraph (d) of the described in paragraph (d) and the air breaches of personal privacy are widely standard. OSHA did not receive monitoring data retention described in reported and concerning. However, comments on this provision and has this section (paragraph (n)) provide OSHA has concluded that this rule decided to retain it in the final rule, in adequate information to show whether should adhere to the past, consistent part, because it will enable both the exposure monitoring requirements practice of requiring employee social employers and OSHA to ensure are being met. Furthermore, paragraphs security numbers on exposure records compliance with exposure assessment (n)(1)(ii)(A)–(F) of the standards are mandated by every OSHA substance- requirements under paragraph (d) of the generally consistent with other OSHA specific health standard, and that any standards. It will also allow employers standards, such as respirable crystalline change to the Agency’s requirements for to ascertain which of the final silica (29 CFR 1910.1053), chromium including employee social security standards’ provisions that are triggered (VI) (29 CFR 1910.1026), and methylene numbers on exposure records should be at various exposure levels apply to their chloride (29 CFR 1910.1052). comprehensive and apply to all OSHA employees. Thus, OSHA is retaining the OSHA received several comments standards, not just the standards for proposed provision with one minor regarding the requirement in paragraph beryllium. modification. Specifically, the Agency (n)(1)(ii)(F) that the employer include OSHA is proposing to delete the has added the words ‘‘make and’’ prior employee social security numbers in requirement that employers include to ‘‘maintain’’ in order to clarify that the exposure measurement records. The employee social security numbers in employer’s obligation is to create and American Dental Association (ADA), the records required by its substance- preserve such records. This clarification Boeing Company (Boeing), and ORCHSE specific standards in the Agency’s has also been made for other records Strategies (ORCHSE) cited employee Standards Improvement Project—Phase required by the final beryllium privacy and identity theft concerns IV (SIP–IV) proposed rule (81 FR 68504, standards. The revised language is (Document ID 1597, p. 4 (pdf); 1667, pp. 68526–68528 (10/4/16)). OSHA will consistent with OSHA’s Records Access 7–8; 1691, Attachment 1, p. 19). Boeing revisit, if necessary, its decision to standard, which refers to employee and ORCHSE suggested the use of an require employers to maintain employee exposure and medical records that are identifier other than the social security social security numbers in beryllium made or maintained (29 CFR number, such as an employee records in light of the decision it makes 1910.1020(b)(3)). identification number or another unique in the SIP–IV rulemaking. In the Proposed paragraph (n)(1)(ii) required personal identification number. The meantime, OSHA has included the that records of all measurements taken ADA recommended that employers with requirement to use and retain social to monitor employee exposure include fewer than ten employees should not be security numbers in the final standards. at least the following information: The required to include employee social The ADA also urged OSHA to pursue date of measurement for each sample security numbers in records required by Regulatory Alternative #1b, which taken; the operation being monitored; the standard. It further stated that some would exempt, except for recordkeeping the sampling and analytical methods state statutes ‘‘impose data security and purposes, operations where the used and evidence of their accuracy; the breach notification requirements on employer can show that employee number, duration, and results of those who collect social security exposures will not meet or exceed the samples taken; the type of personal numbers,’’ and in small businesses, ‘‘the action level or exceed the STEL. It protective clothing and equipment, risk to employees of identity theft further argued under this option that including respirators, worn by outweighs the difficulty of identifying OSHA should limit employers’ monitored employees at the time of employee records’’ (Document ID 1597, recordkeeping requirements to those monitoring; and the name, social p. 2–4 (pdf)). records that show that employees’ security number, and job classification OSHA has considered these exposure will not meet or exceed the of each employee represented by the comments and decided to retain the action level or exceed the STEL monitoring, indicating which employees requirement for including the (Document ID 1597, p. 3 (pdf)). It were actually monitored. employee’s social security number in maintained that this is reasonable The Sampling and Analysis the recordkeeping requirements of the because the ‘‘employees are not at Subcommittee Task Group of the rule. The requirement to use an significant risk of exposure’’ and ‘‘the Beryllium Health and Safety Committee employee’s social security number is a record retention period is onerous’’ (BHSC Task Group) recommended that long-standing OSHA practice, because a (Document ID 1597, p. 3 (pdf)). the recordkeeping provision should social security number is unique to an OSHA disagrees with this suggestion include the purpose and rationale for individual, is retained for a lifetime, and for several reasons. First, the OSH Act the sampling performed as this would does not change when an employee states that standards adopted by OSHA show that the exposure monitoring changes employers. The social security must require employers maintain requirements are being met (Document number is therefore a useful tool for ‘‘accurate records of employee ID 1665, p. 2). After careful evaluating an individual’s exposure exposures to potentially toxic materials consideration, OSHA has decided not to over time, particularly where exposures or harmful physical agents which are require that records include the purpose are associated with chronic beryllium required to be monitored or measured and rationale for the sampling. The disease (CBD), which has a varying rate under section 6.’’ OSH Act § 8(c)(3). Agency points out that the purpose and of progression during which time an Thus, on its face, the Act requires rationale for the sampling performed are employee may have several employers records of all exposure measurements dictated by the exposure assessment or had beryllium exposure sometime in required by the final standards to be provision in paragraph (d), which the past. maintained, not just high ones. The requires the employer to assess the OSHA recognizes the privacy OSH Act also requires that employees airborne exposure of each employee concerns expressed by commenters have access to exposure records, (id.), who is or may reasonably be expected regarding this requirement, and and requiring the employer to maintain to be exposed to airborne beryllium in understands the need to balance that those records helps to fulfill that right. accordance with either a performance interest against the public health Further, as discussed in Section V,

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Health Effects, and Section VII, records. However, as stated earlier, ‘‘objective data’’ in the final rule Significant Risk, employees who are OSHA expects that employers will have includes all information that exposed below the action level may still a system for maintaining these records, demonstrates airborne exposure to be at risk. Maintaining records of those just as they do for their other business beryllium associated with a particular exposures may assist in the diagnosis of records. In addition, the Agency allows product or material or a specific employee disease long after the employers to use whatever method process, task, or activity. Historical data exposure occurs. It also allows works best for them in meeting these that reflects workplace conditions employees to have confidence that their requirements, paper or electronic (29 closely resembling or with a higher exposures are within the requirements CFR 1910.1020(d)(2)). airborne exposure potential than the of the final standards, and valuable In summary, paragraph (n)(1)(ii) in processes, types of material, control insights about exposure control methods the final standards is substantively methods, work practices, and may be gained through the review of unchanged from the proposed rule. environmental conditions in the exposure records, even those that are However, OSHA has made one editorial employer’s current operations would be below the action level. In addition, as modification to paragraph (n)(1)(ii)(B), considered objective data under the the Supreme Court noted in the Benzene which is to change ‘‘operation’’ to final rule. The requirement to keep case, air monitoring and medical testing, ‘‘task.’’ Both ‘‘task’’ and ‘‘operation’’ are records of objective data is addressed when done for employees exposed commonly used in describing work. under a separate paragraph. Therefore, below the PEL, ‘‘keep a constant check However, OSHA uses the term ‘‘task’’ OSHA has chosen to delete the separate on the validity of the assumptions made throughout the rule, and the Agency is recordkeeping requirement for historical in developing’’ the PEL, giving a basis using ‘‘task’’ in the recordkeeping data. to lower the PEL if necessary. Benzene, provision for consistency and to avoid Proposed paragraph (n)(3) contained 448 U.S. at 657–58. Requiring the any potential misunderstanding that the requirements to keep accurate employers to maintain those records could result from using a different term. records of objective data. Proposed furthers that purpose. Other OSHA This editorial change neither increases paragraph (n)(3)(i) required employers substance-specific rules also require nor decreases an employer’s obligations to establish and maintain accurate employee exposure records to be as set forth in the proposed rule. The records of the objective data relied upon maintained, regardless of exposure requirements of paragraph (n)(1)(ii) are to satisfy the requirement for initial level, such as the standards addressing generally consistent with those found in monitoring in proposed paragraph exposure to respirable crystalline silica other OSHA standards, such as the (d)(2). Under proposed paragraph (29 CFR 1910.1053), methylene chloride standards for respirable crystalline silica (n)(3)(ii), the record was required to (29 CFR 1910.1052), and chromium (VI) (29 CFR 1910.1053), methylene chloride contain at least the following (29 CFR 1910.1026). (29 CFR 1910.1052), and chromium (VI) information: The data relied upon; the Second, employee information and (29 CFR 1910.1026). beryllium-containing material in training requirements under paragraph Proposed paragraph (n)(1)(iii) question; the source of the data; a (m) of the standards apply to each required the employer to maintain description of the operation exempted employee who is or can reasonably be exposure records in accordance with from initial monitoring and how the expected to be exposed to airborne OSHA’s Records Access standard, data supported the exemption; and beryllium. As discussed in paragraph which specifies that exposure records other information demonstrating that (m) of the Summary and Explanation in must be maintained for 30 years (29 CFR the data met the requirements for this preamble, OSHA finds that all 1910.1020(d)(1)(ii)). The Agency did not objective data in accordance with employees who are or can be reasonably receive comment on this provision. paragraph (d)(2)(ii). expected to be exposed in this manner However, OSHA has changed the OSHA did not receive comments will benefit from the specified forms of requirement that the employer regarding this provision, and the training. The creation and maintenance ‘‘maintain this record as required by’’ Agency finds that it should be included of training records will permit both OSHA’s Records Access standard to in the final rule. Since objective data OSHA and employers to ensure that the ‘‘ensure that exposure records are may be used to exempt the employer required training has occurred on maintained and made available in from certain types of monitoring, as schedule. Finally, OSHA notes that accordance with’’ that standard. OSHA specified in paragraph (d), it is critical employers may reduce their believes that the language of the final that the use of these types of data be recordkeeping burden in some cases by standard more clearly conveys the carefully documented. Objective data ensuring their employees are only Agency’s intent that in addition to are intended to provide the same degree exposed below the action level. For maintaining records, employers must of assurance that employee exposures example, under paragraph (k), make records available to employees have been correctly characterized as employers are required to offer medical and others as specified in the Records would exposure assessment. The surveillance those employees who meet Access standard. As noted above, this specified content elements are required certain exposure thresholds. By keeping clarifying change is editorial and neither to ensure that the records are capable of exposures level below the action level, increases nor decreases an employer’s demonstrating to OSHA a reasonable employers decrease the likelihood that obligations as set forth in the proposed basis for the conclusions drawn by the their employees will fall into one of the rule. This clarification has also been employer from the objective data. enumerated groups. If employers do not made for other records required by the Therefore, OSHA has included have any employees covered by medical final beryllium standards. proposed paragraph (n)(3) as paragraph surveillance under paragraph (k), then Proposed paragraph (n)(2) contained (n)(2) in the final standards, with minor they have no medical surveillance the requirement to retain records of any alterations. Specifically, in the final records to retain under these standards. historical monitoring data used to standards, OSHA has changed As to the expense and difficulty of satisfy the proposed standard’s the paragraphs (n)(2)(ii)(D) to require the maintaining the records required under initial monitoring requirements. As record to contain ‘‘[a] description of the these standards, OSHA recognizes that explained in the Summary and process, task, or activity on which the there will be time, effort, and expense Explanation of paragraphs (b) and (d) in objective data were based,’’ and involved in maintaining medical this preamble, the definition of the term paragraph (n)(2)(ii)(E) to require the

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record to contain ‘‘[o]ther data relevant examining the requirements for social years. However, the Agency concludes to the process, task, activity, material, or security numbers separately from this that the retention periods specified in airborne exposure on which the rulemaking. 29 CFR 1910.1020 represent a objective data were based.’’ These Medical records document the results reasonable balance between the need to changes are editorial, and intended to of medical surveillance and are maintain records and the administrative clarify the maintenance and availability especially important when an burdens associated with maintaining of objective data records. They are only employee’s medical condition places those records for extended time periods. intended to aid employers in him or her at increased risk of health Because the 30-year, and the duration of determining the precise information to impairment from further exposure to employment plus 30-year, record be retained. They do not affect the beryllium in the workplace. retention requirements are currently employer’s obligations as set forth in the Furthermore, the records can be used by included in 29 CFR 1910.1020, these proposed rule. the Agency and others to identify time periods are consistent with Proposed paragraph (n)(3)(iii) illnesses and deaths that may be longstanding Agency and employer required the employer to maintain a attributable to beryllium exposure, practice. Other substance-specific rules record of objective data relied upon as evaluate compliance programs, and are also subject to the retention required by the Records Access assess the efficacy of the standards. requirements of 29 CFR 1910.1020, such standard, which specifies that exposure OSHA concludes that medical as the standards addressing exposure to records must be maintained for 30 years surveillance records are necessary and respirable crystalline silica (29 CFR (29 CFR 1910.1020(d)(1)(ii)). The appropriate for protection of employee 1910.1053), methylene chloride (29 CFR Agency did not receive comment on this health, enforcement of the standards, 1910.1052), and chromium (VI) (29 CFR provision. Objective data may include and development of information 1910.1026). Thus, OSHA finds that the employee exposure records that must be regarding the causes and prevention of 30-year retention period is necessary maintained, and therefore, the Agency occupational illnesses. Therefore, OSHA and appropriate for exposure records, has retained it in the final standards as has decided to retain proposed historical monitoring data, and objective paragraph (n)(2)(iii). OSHA notes that paragraph (n)(4)(ii)’s requirements data, and that the duration of this final provision, like all of the final regarding medical surveillance records employment plus 30-year retention provisions in this paragraph related to in paragraph (n)(3)(ii) of the final period is necessary and appropriate for the Records Access standard, includes standards. However, OSHA has changed medical surveillance records. the non-substantive change from the the requirement in proposed paragraph Therefore, OSHA has decided to proposed requirement to maintain the (n)(4)(ii)(B) that the record include include the retention periods provided record as required by the Records copies of all licensed physicians’ by the Records Access standard in Access standard, to the requirement to written opinions to the requirement that paragraph (n)(3)(iii) of the final maintain and make available the record the record include copies of all licensed standards. For the reasons discussed in accordance with the Records Access physicians’ written medical opinions for above, OSHA has added ‘‘and made standard. OSHA’s reasons for this each employee in paragraph (n)(3)(ii)(B) available’’ after ‘‘maintained’’ in change are discussed above. of the final standards. These changes are paragraph (n)(3)(iii) of the standards. Paragraph (n)(3) of the final standards, editorial and intended to clarify that Under the final standards, the employer like paragraph (n)(4) of the proposal, employees are entitled to their own is responsible for the maintenance of addresses medical surveillance records. written medical opinion, not all written records in his or her possession. The Under proposed paragraph (n)(4)(i), opinions. This change neither increases employer is also responsible for employers had to establish and maintain nor decreases an employer’s obligations ensuring the retention of records in the medical surveillance records for each as set forth in the proposed rule. possession of the licensed physician employee covered by the medical Proposed paragraph (n)(4)(iii) (e.g., the written medical reports surveillance requirements in paragraph required the employer to maintain described in paragraph (n)(3) that are (k) of the proposed standard. Proposed employee medical records for at least created pursuant to this rule’s medical paragraph (n)(4)(ii) listed the categories the duration of the employee’s surveillance requirements). This of information that an employer was employment plus 30 years in responsibility, which derives from 29 required to record: The employee’s accordance with OSHA’s Records CFR 1910.1020(b), means that name, social security number, and job Access Standard at 29 CFR employers must ensure that the licensed classification; a copy of all licensed 1910.1020(d)(1)(i). The ADA objected to physician retains a copy of medical physicians’ written medical opinions; this provision, arguing that the records for the employee’s duration of and a copy of the information provided proposed retention period is onerous employment plus 30 years. The to the PLHCP as required by paragraph (Document ID 1597, p. 3 (pdf)). OSHA employer can generally fulfill this (k)(4) of the proposed standard. has considered this comment and obligation by including the retention The ADA and ORCHSE questioned concluded that the best approach is to requirement in its agreement with the the requirement that the employee’s maintain consistency with 29 CFR licensed physician. The requirements social security number be included in 1910.1020 and its required retention are consistent with other OSHA health medical surveillance records (Document periods of (1) 30 years for exposure standards, such as Hexavalent ID 1597, pp. 2–4 (pdf); 1691, records and objective data, and (2) the Chromium (VI) (29 CFR 1910.1026), Attachment 1, p. 19). As noted above in duration of employment plus 30 years respirable crystalline silica (29 CFR the discussion on exposure for medical surveillance records. It is 1910.1053), and Methylene Chloride (29 measurement records, OSHA finds the necessary to keep medical records for CFR 1910.1052). privacy and security issues associated these extended time periods because of Paragraph (n)(4) of the final standards, with the required use of social security the varying rate of progression for CBD like proposed paragraph (n)(5), numbers are of concern. However, for and the long latency period between addresses training records. Proposed the same reasons discussed above, the exposure and development of lung paragraph (n)(5)(i) required employers Agency has decided to retain the cancer. OSHA recognizes that in some to prepare records of any training requirement for use of social security cases, the latency period for beryllium- required by these standards. At the numbers in medical records. OSHA is related cancer may extend beyond 30 completion of training, the employer

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was required to prepare a record that standards available for examination and provisions that require the included the name, social security copying to the Assistant Secretary, the establishment of change rooms and the number, and job classification of each Director of NIOSH, each employee, and implementation of engineering controls employee trained; the date the training each employee’s designated in order to give affected employers was completed; and the topic of the representative as stipulated by OSHA’s sufficient time to design and construct training. This record maintenance Records Access standard (29 CFR change rooms where necessary, and to requirement also applied to records of 1910.1020). OSHA did not receive design, obtain, and install any required annual retraining or additional training comment on this provision, and control equipment. In response to as described in paragraph (m)(4). includes it in the final standards to comments stating that more time is The ADA and ORCHSE questioned emphasize and ensure proper employee necessary to prepare for compliance, the the requirement that the employee’s and government access to records. compliance dates in the final rule have social security number be included in Paragraph (n)(6) of the final standards, been extended from those proposed. training records (Document ID 1597, p. like proposed paragraph (n)(7), Paragraph (o)(2) of the standards 2–4 (pdf); 1691, Attachment 1, p. 19). As addresses transfer of records. Proposed establishes the dates for compliance noted above in the discussions on paragraph (n)(7) required that employers with the requirements of the standard. exposure measurement and medical comply with the Records Access Several employers and industry surveillance records, OSHA finds the standard regarding the transfer of representatives commented that the privacy and security issues associated records. The requirements for the proposal’s default compliance date (90 with the required use of social security transfer of records are explained in 29 days after the effective date) provided numbers are of concern. However, for CFR 1910.1020(h), which instructs inadequate time to prepare for the same reasons discussed above, the employers either to transfer records to compliance. ORCHSE Strategies Agency has decided to retain the successor employers or, if there is no (ORCHSE) commented that an requirement for use of social security successor employer, to inform additional six months are needed ‘‘to numbers in training records. As stated employees of their access rights at least make necessary changes to facilities, above, OSHA is examining the three months before the cessation of the broad-based exposure assessments, and requirements for social security employer’s business. OSHA did not delineate work and regulated areas’’ numbers separately from this receive comment on this provision, and (Document ID 1691, Attachment 1, p. rulemaking. In the meantime, OSHA has includes it the final standards to help 24). Also, the Boeing Company (Boeing) retained the social security requirement ensure consistent records access. commented that the standard should in the final standards. require compliance two years after the (o) Dates No other comments were received on effective date, explaining that ‘‘it will this provision. Proposed paragraph Paragraph (o) of the standards for take, for a company of our size, between (n)(5)(i) is now paragraph (n)(4)(i) in the general industry, construction, and 1 and 2 years to accurately and final standards. Paragraph (n)(4)(i) in shipyards sets forth the effective date of comprehensively determine what our the final standards is substantively the standards and the dates for exposures are, prior to developing and unchanged from the proposal. compliance with their requirements. implementing an exposure plan’’ Proposed paragraph (n)(5)(ii) required OSHA proposed that the final rule (Document ID 1667, p. 8). employers to retain training records, would become effective 60 days after its The Sampling and Analysis including records of annual retraining publication in the Federal Register, and Subcommittee Task Group of the or additional training required under that employer obligations to comply Beryllium Health and Safety Committee these standards, for a period of three with most requirements of the final rule (BHSC Task Group) also commented on years after the completion of the would begin 90 days after the effective the amount of time needed to comply training. North America’s Building date (150 days after publication of the with the ‘‘Accuracy of Measurement’’ Trades Unions (NABTU) commented final rule), while the requirements for requirement in paragraph (d)(1)(v) of the that employers ‘‘must maintain establishing change rooms and proposal, which has been renamed documentation of [any] training’’ implementing engineering controls ‘‘Methods of sample analysis’’ and required for beryllium construction would begin one year and two years moved to paragraph (d)(5) in the final workers (Document ID 1679, p. 3). after the effective date, respectively. standards (Document ID 1665, p. 3). OSHA agrees. As noted above, OSHA Ameren, AFL–CIO, and United Specifically, BHSC Task Group finds that the creation and maintenance Steelworkers expressed support for the expressed concern that laboratories of training records will permit both proposed effective and compliance would need to adopt newer analytical OSHA and employers to ensure that the dates (Document ID 1675, p. 7; 1681, methods not widely used by the required training has occurred on Attachment 1, p. 15; 1689, p. 15). majority of analytical laboratories to schedule. Thus, the Agency has OSHA sets the effective date to allow perform beryllium measurements to the included this provision in the standard sufficient time for employers to obtain level of accuracy specified by the for construction, as well as the the standard and read and understand standard. BHSC Task Group standards for general industry and its requirements. Unchanged from the acknowledges that although the OSHA shipyards. Proposed paragraph (n)(5)(ii) proposal, paragraph (o)(1) provides that rule does not require it, a Department of is now paragraph (n)(4)(ii) in the final the standards will become effective on Energy requirement for accreditation standards, and is substantively March 10, 2017. that exists in their Beryllium Worker unchanged from the proposal. The OSHA sets the compliance dates to Safety and Health Program would drive three-year time period is consistent with allow sufficient time for employers to laboratories to obtain accreditation by the Bloodborne Pathogens standard (29 undertake the necessary planning and an external accrediting body to use CFR 1910.1030). preparation for compliance with the these newer methods, which can take Paragraph (n)(5) of the final standards, various provisions of the standards. In well over 150 days. (Document ID 1665, like proposed paragraph (n)(6), addition to the default compliance date p. 3–4). OSHA rejects the reasoning addresses access to records. Proposed of 90 days that applied to most behind BHSC Task Group’s concern on paragraph (n)(6) required employers to provisions, OSHA’s proposal included the amount of time needed to comply make all records mandated by these extended compliance dates for the the accuracy of measurement

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requirement, as the newer analytical provide showers, but OSHA recognizes that any changes to ventilation systems methods for beryllium are available and, that construction and shipyard to comply with the final beryllium as pointed out by BHSC Task Group, employers may also need additional standards would generally only be OSHA does not require laboratories to time to plan and establish change rooms subject to routine reporting be accredited in these methods to at construction sites and shipyard requirements or permit modifications. comply with the standards. industry establishments. Change room Cases that are unusually problematic, Nonetheless, OSHA recognizes the facilities in these industries may be however, can be addressed through concerns expressed by Boeing, permanent or temporary, including OSHA’s enforcement discretion if the ORCHSE, and BHSC Task Group that mobile units that can be purchased or employer can show that it has made employers may need additional time to rented. OSHA has thus set the good faith efforts to implement assess exposures and undertake the compliance date for the construction engineering controls, but has been necessary planning and preparation for and shipyard standards’ requirement to unable to implement such controls due compliance with the obligations of the establish change rooms to two years to the time needed for environmental standards, and has determined that after the effective date. permitting. some of those concerns are reasonable. Paragraph (o)(2)(ii) of the standards However, OSHA acknowledges that OSHA has therefore extended the final provides the date for compliance with some general industry, construction and standards’ default compliance date, the requirements in paragraph (f) to shipyard employers may need more which applies to all provisions except implement engineering controls. OSHA than two years to comply with the for those with separate compliance proposed a compliance date of two engineering control obligations in dates under paragraphs (o)(2)(i) and years after the effective date for paragraph (f), including the need to (o)(2)(ii), to one year from the effective employers to comply with the update any permits before modifying date. engineering control requirements in ventilation systems, and has extended Paragraph (o)(2)(i) of the standards paragraph (f). Boeing, however, the standards’ compliance date for the provides the date for compliance with commented that the compliance date for engineering control requirements to the requirement in paragraph (i) to implementing engineering controls three years from the effective date. establish change rooms, and in the should be extended to four years after OSHA has determined that setting a general industry standard, to provide the effective date, explaining that ‘‘for compliance date three years after the showers. OSHA proposed a compliance large companies, exposure assessments effective date will ensure that employers date of one year after the effective date and feasibility studies would have to be have sufficient time to complete the for establishing change rooms, but completed on a vast scale, and then process of designing, obtaining, and commenters indicated that more time engineering controls may have to be installing the necessary control was needed to modify their facilities. installed,’’ making four years ‘‘a equipment. Boeing requested that the compliance reasonable time frame for these OSHA’s decision here to provide date for establishing change rooms begin compliance measures’’ (Document ID employers with an extended deadline three years after the effective date, 1667, pp. 8). The Non-Ferrous for complying with engineering control stating that ‘‘for large facilities, Founders’ Society (NFFS) also requirements is consistent with what modifications such as showers, clothing commented that a two-year the Agency has done in health storage and change rooms need a implementation period was insufficient standards, including standards for significant amount of time to be because it takes 12 to 24 months to respirable crystalline silica (29 CFR planned, designed, contracted, and obtain an Environmental Protection 1910.1053(l)), Chromium (VI) (29 CFR constructed within operating factory Agency (EPA) permit for changes to 1910.1026(n)(3), 29 CFR 1915.1026(l)(3), sites’’ (Document ID 1667, p. 8). ventilation systems, and foundries 29 CFR 1926.1126(l)(3)), and Cadmium ORCHSE also indicated that additional cannot begin work to modify ventilation (29 CFR 1910.1027(p)(2)(v)). Extending time is needed to ‘‘make necessary systems until they obtain a permit the compliance deadline for changes to facilities’’ (Document ID (Document ID 1756, Tr. 61–62). implementation of engineering controls 1691, Attachment 1, p. 24). OSHA recognizes the concerns will allow those firms that need OSHA expects that most employers expressed by Boeing regarding the time extensive engineering controls time to will be able to establish change rooms needed to implement engineering adequately plan for and implement the and showers within a year of the controls, but does not agree that four controls, which will thus help to ensure effective date, but the Agency years are needed to comply with the that adequate protection is provided for understands that some employers, both engineering control requirements. workers. OSHA has also determined large and small, may need additional OSHA expects that many workplaces that the extension will have the time to plan and construct these areas. with beryllium will already have ancillary benefit of limiting the OSHA is persuaded by the concerns engineering controls in place for other economic impact of the rule by expressed by the commenters that hazardous materials that will need only providing employers with additional employers may need additional time to modification or updating to comply time to plan for and absorb the costs modify their facilities, and has extended with the final standards. For new associated with compliance. Based on the compliance date for the general installations, most types of engineering its review of the rulemaking record, industry standard’s change rooms and controls for working with materials such OSHA has concluded that employers showers requirements to two years after as beryllium are readily available. will be able to implement engineering the effective date. Providing an Furthermore, because beryllium is controls within the extended time frame extended compliance date for regulated under EPA rules as a that is established in the final rule. establishing change rooms and ‘‘hazardous air pollutant’’ with a providing showers is consistent with the relatively low volume threshold for a (p) Appendix A to 29 CFR 1910.1024— approach taken in OSHA’s general permit requirement, foundries that Control Strategies To Minimize industry standard for Cadmium (29 CFR already exhaust beryllium in any Beryllium Exposure 1910.1027(p)(2)(vi)(B)). quantity would likely already be Appendix A to the final standard for The construction and shipyard subjected to the permitting general industry, 29 CFR 1910.1024, standards do not require employers to requirements. Therefore, OSHA predicts provides information to employers on

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control options that employers could separate guidance to reflect 1910, 1915, and 1926, of the Code of use to comply with paragraph (f)(2)(i) of technological advances and changes in Federal Regulations is amended as the final rule, which requires employers recommendations from the medical follows: to ensure that at least one of the types community. Therefore, OSHA is not of controls listed in paragraph (f)(2)(i) is including proposed Appendix A in the PART 1910—OCCUPATIONAL SAFETY in place to reduce airborne exposure for final standards. AND HEALTH STANDARDS each operation in a beryllium work area OSHA has also not included any that releases airborne beryllium. appendices in the final standards for Subpart Z—[Amended] Appendix A is for informational and construction and shipyards since OSHA guidance purposes only and none of the has identified only one principle ■ 1. The authority citation for subpart Z statements in Appendix A should be operation (abrasive blasting) in these of part 1910 is revised to read as construed as imposing a mandatory sectors involving worker exposure to follows: requirement on employers that is not beryllium. otherwise imposed by the standard. In Authority: 29 U.S.C. 653, 655, 657) List of Subjects in 29 CFR Parts 1910, addition, this appendix is not intended Secretary of Labor’s Order No. 12–71 (36 FR 1915, and 1926 8754), 8–76 (41 FR 25059), 9–83 (48 FR to detract from any obligation that the rule imposes. Beryllium, Cancer, Chemicals, 35736), 1–90 (55 FR 9033), 6–96 (62 FR 111), The control strategies to minimize Hazardous substances, Health, 3–2000 (65 FR 50017), 5–2002 (67 FR 65008), beryllium exposure were in Appendix B Occupational safety and health, 5–2007 (72 FR 31160), 4–2010 (75 FR 55355), of the proposed rule, but proposed Reporting and recordkeeping or 1–2012 (77 FR 3912), 29 CFR part 1911; Appendix B has been redesignated as requirements. and 5 U.S.C. 553, as applicable. Appendix A in the final standard for Section 1910.1030 also issued under Pub. Authority and Signature general industry, following the deletion L. 106–430, 114 Stat. 1901. (discussed below) of proposed This document was prepared under Section 1910.1201 also issued under 49 Appendix A. The information on the direction of David Michaels, Ph.D., U.S.C. 5101 et seq. control strategies presented in the MPH, Assistant Secretary of Labor for ■ 2. In § 1910.1000, paragraph (e): appendix was derived from OSHA’s Occupational Safety and Health, U.S. ■ analysis of the technological feasibility Department of Labor, 200 Constitution a. Amend Table Z–1—Limits on Air of the PELs, presented in Chapter IV of Avenue NW., Washington, DC 20210. Contaminants, by revising the entry for the Final Economic Analysis. The The Agency issues the sections under ‘‘Beryllium and beryllium compounds content of Appendix A of the final the following authorities: 29 U.S.C. 653, (as Be)’’ and adding footnote 8. standard for general industry remains 655, 657; 40 U.S.C. 3704; 33 U.S.C. 941; ■ b. Amend Table Z–2 by revising the unchanged from that contained in Secretary of Labor’s Order 1–2012 (77 entry for ‘‘Beryllium and beryllium Appendix B of the proposal. FR 3912 (1/25/2012)); and 29 CFR part compounds (Z37.29–1970)’’; and adding The proposed rule also contained a 1911. footnote d. non-mandatory appendix (designated in Signed at Washington, DC, on December The revisions read as follows: the proposal as Appendix A) that 14, 2016. provided technical information on the David Michaels, § 1910.1000 Air contaminants. BeLPT test. OSHA has determined that Assistant Secretary of Labor for Occupational * * * * * the information contained in proposed Safety and Health. Appendix A is more suitable for separate guidance that will be issued in Amendments to Standards conjunction with the standards. OSHA For the reasons set forth in the will be able to more readily update this preamble, Chapter XVII of Title 29, parts

TABLE Z–1—LIMITS FOR AIR CONTAMINANTS

1 3 1 Skin Substance CAS No. (c) ppm (a) mg/m (b) designation

******* Beryllium and beryllium compounds (as Be); see 1910.1024 8 ...... 7440–41–7 ......

******* ******* 8 See Table Z–2 for the exposure limits for any operations or sectors where the exposure limits in § 1910.1024 are stayed or otherwise not in effect.

TABLE Z–2

Acceptable maximum peak above 8-hour time Acceptable the acceptable ceiling average Substance weighted ceiling concentration for an 8-hr shift average concentration Maximum Concentration duration

******* Beryllium and beryllium compounds (Z37.29–1970) d ...... 2 μg/m3 ...... 5 μg/m3 ...... 25 μg/m3 ...... 30 minutes.

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TABLE Z–2—Continued

Acceptable maximum peak above 8-hour time Acceptable the acceptable ceiling average Substance weighted ceiling concentration for an 8-hr shift average concentration Maximum Concentration duration

******* ******* d This standard applies to any operations or sectors for which the exposure limits in the beryllium standard, § 1910.1024, are stayed or is other- wise not in effect.

* * * * * on-site pulmonary specialist and on-site individual whose legally permitted ■ 3. Add § 1910.1024 to read as follows: facilities to perform a clinical evaluation scope of practice (i.e., license, for the presence of chronic beryllium registration, or certification) allows the § 1910.1024 Beryllium. disease (CBD). This evaluation must individual to independently provide or (a) Scope and application. (1) This include pulmonary function testing (as be delegated the responsibility to standard applies to occupational outlined by the American Thoracic provide some or all of the health care exposure to beryllium in all forms, Society criteria), bronchoalveolar lavage services required by paragraph (k) of compounds, and mixtures in general (BAL), and transbronchial biopsy. The this standard. industry, except those articles and CBD diagnostic center must also have Regulated area means an area, materials exempted by paragraphs (a)(2) the capacity to transfer BAL samples to including temporary work areas where and (a)(3) of this standard. a laboratory for appropriate diagnostic maintenance or non-routine tasks are (2) This standard does not apply to testing within 24 hours. The on-site performed, where an employee’s articles, as defined in the Hazard pulmonary specialist must be able to airborne exposure exceeds, or can Communication standard (HCS) interpret the biopsy pathology and the reasonably be expected to exceed, either (§ 1910.1200(c)), that contain beryllium BAL diagnostic test results. the time-weighted average (TWA) and that the employer does not process. Chronic beryllium disease (CBD) permissible exposure limit (PEL) or (3) This standard does not apply to means a chronic lung disease associated short term exposure limit (STEL). materials containing less than 0.1% with airborne exposure to beryllium. This standard means this beryllium beryllium by weight where the Confirmed positive means the person standard, 29 CFR 1910.1024. employer has objective data tested has beryllium sensitization, as (c) Permissible Exposure Limits demonstrating that employee exposure indicated by two abnormal BeLPT test (PELs)—(1) Time-weighted average to beryllium will remain below the results, an abnormal and a borderline (TWA) PEL. The employer must ensure action level as an 8-hour TWA under test result, or three borderline test that no employee is exposed to an any foreseeable conditions. results. It also means the result of a airborne concentration of beryllium in (b) Definitions. As used in this more reliable and accurate test excess of 0.2 mg/m3 calculated as an 8- standard: Action level means a concentration of indicating a person has been identified hour TWA. (2) Short-term exposure limit (STEL). airborne beryllium of 0.1 micrograms as having beryllium sensitization. The employer must ensure that no per cubic meter of air (mg/m3) calculated Director means the Director of the as an 8-hour time-weighted average National Institute for Occupational employee is exposed to an airborne Safety and Health (NIOSH), U.S. concentration of beryllium in excess of (TWA). 3 Airborne exposure and airborne Department of Health and Human 2.0 mg/m as determined over a exposure to beryllium mean the Services, or designee. sampling period of 15 minutes. exposure to airborne beryllium that Emergency means any uncontrolled (d) Exposure assessment—(1) General. would occur if the employee were not release of airborne beryllium. The employer must assess the airborne using a respirator. High-efficiency particulate air (HEPA) exposure of each employee who is or Assistant Secretary means the filter means a filter that is at least 99.97 may reasonably be expected to be Assistant Secretary of Labor for percent efficient in removing particles exposed to airborne beryllium in Occupational Safety and Health, United 0.3 micrometers in diameter. accordance with either the performance States Department of Labor, or designee. Objective data means information, option in paragraph (d)(2) or the Beryllium lymphocyte proliferation such as air monitoring data from scheduled monitoring option in test (BeLPT) means the measurement of industry-wide surveys or calculations paragraph (d)(3) of this standard. blood lymphocyte proliferation in a based on the composition of a (2) Performance option. The employer laboratory test when lymphocytes are substance, demonstrating airborne must assess the 8-hour TWA exposure challenged with a soluble beryllium exposure to beryllium associated with a and the 15-minute short-term exposure salt. particular product or material or a for each employee on the basis of any Beryllium work area means any work specific process, task, or activity. The combination of air monitoring data and area containing a process or operation data must reflect workplace conditions objective data sufficient to accurately that can release beryllium where closely resembling or with a higher characterize airborne exposure to employees are, or can reasonably be airborne exposure potential than the beryllium. expected to be, exposed to airborne processes, types of material, control (3) Scheduled monitoring option. (i) beryllium at any level or where there is methods, work practices, and The employer must perform initial the potential for dermal contact with environmental conditions in the monitoring to assess the 8-hour TWA beryllium. employer’s current operations. exposure for each employee on the basis CBD diagnostic center means a Physician or other licensed health of one or more personal breathing zone medical diagnostic center that has an care professional (PLHCP) means an air samples that reflect the airborne

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exposure of employees on each shift, for provided in paragraph (d)(4) of this The employer must establish and each job classification, and in each work standard. maintain a beryllium work area area. (4) Reassessment of exposure. The wherever the criteria for a ‘‘beryllium (ii) The employer must perform initial employer must reassess airborne work area’’ set forth in paragraph (b) of monitoring to assess the short-term exposure whenever a change in the this standard are met. exposure from 15-minute personal production, process, control equipment, (ii) The employer must establish and breathing zone air samples measured in personnel, or work practices may maintain a regulated area wherever operations that are likely to produce reasonably be expected to result in new employees are, or can reasonably be airborne exposure above the STEL for or additional airborne exposure at or expected to be, exposed to airborne each work shift, for each job above the action level or STEL, or when beryllium at levels above the TWA PEL classification, and in each work area. the employer has any reason to believe or STEL. (iii) Where several employees perform that new or additional airborne (2) Demarcation. (i) The employer the same tasks on the same shift and in exposure at or above the action level or must identify each beryllium work area the same work area, the employer may STEL has occurred. through signs or any other methods that sample a representative fraction of these (5) Methods of sample analysis. The adequately establish and inform each employees in order to meet the employer must ensure that all air employee of the boundaries of each requirements of this paragraph (d)(3). In monitoring samples used to satisfy the beryllium work area. representative sampling, the employer monitoring requirements of paragraph (ii) The employer must identify each must sample the employee(s) expected (d) of this standard are evaluated by a regulated area in accordance with to have the highest airborne exposure to laboratory that can measure beryllium to paragraph (m)(2) of this standard. beryllium. an accuracy of plus or minus 25 percent (3) Access. The employer must limit (iv) If initial monitoring indicates that within a statistical confidence level of access to regulated areas to: airborne exposure is below the action 95 percent for airborne concentrations at (i) Persons the employer authorizes or level and at or below the STEL, the or above the action level. requires to be in a regulated area to employer may discontinue monitoring (6) Employee notification of perform work duties; for those employees whose airborne assessment results. (i) Within 15 (ii) Persons entering a regulated area exposure is represented by such working days after completing an as designated representatives of monitoring. exposure assessment in accordance with employees for the purpose of exercising (v) Where the most recent exposure paragraph (d) of this standard, the the right to observe exposure monitoring monitoring indicates that airborne employer must notify each employee procedures under paragraph (d)(7) of exposure is at or above the action level whose airborne exposure is represented this standard; and but at or below the TWA PEL, the by the assessment of the results of that (iii) Persons authorized by law to be employer must repeat such monitoring assessment individually in writing or in a regulated area. (4) Provision of personal protective within six months of the most recent post the results in an appropriate clothing and equipment, including monitoring. location that is accessible to each of respirators. The employer must provide (vi) Where the most recent exposure these employees. monitoring indicates that airborne (ii) Whenever an exposure assessment and ensure that each employee entering a regulated area uses: exposure is above the TWA PEL, the indicates that airborne exposure is (i) Respiratory protection in employer must repeat such monitoring above the TWA PEL or STEL, the within three months of the most recent accordance with paragraph (g) of this employer must describe in the written standard; and 8-hour TWA exposure monitoring. notification the corrective action being (vii) Where the most recent (non- (ii) Personal protective clothing and taken to reduce airborne exposure to or equipment in accordance with initial) exposure monitoring indicates below the exposure limit(s) exceeded that airborne exposure is below the paragraph (h) of this standard. where feasible corrective action exists (f) Methods of compliance—(1) action level, the employer must repeat but had not been implemented when the Written exposure control plan. (i) The such monitoring within six months of monitoring was conducted. employer must establish, implement, the most recent monitoring until two (7) Observation of monitoring. (i) The and maintain a written exposure control consecutive measurements, taken 7 or employer must provide an opportunity plan, which must contain: more days apart, are below the action to observe any exposure monitoring (A) A list of operations and job titles level, at which time the employer may required by this standard to each reasonably expected to involve airborne discontinue 8-hour TWA exposure employee whose airborne exposure is exposure to or dermal contact with monitoring for those employees whose measured or represented by the beryllium; exposure is represented by such monitoring and each employee’s (B) A list of operations and job titles monitoring, except as otherwise representative(s). reasonably expected to involve airborne provided in paragraph (d)(4) of this (ii) When observation of monitoring exposure at or above the action level; standard. requires entry into an area where the (C) A list of operations and job titles (viii) Where the most recent exposure use of personal protective clothing or reasonably expected to involve airborne monitoring indicates that airborne equipment (which may include exposure above the TWA PEL or STEL; exposure is above the STEL, the respirators) is required, the employer (D) Procedures for minimizing cross- employer must repeat such monitoring must provide each observer with contamination, including preventing the within three months of the most recent appropriate personal protective clothing transfer of beryllium between surfaces, short-term exposure monitoring until and equipment at no cost to the observer equipment, clothing, materials, and two consecutive measurements, taken 7 and must ensure that each observer uses articles within beryllium work areas; or more days apart, are below the STEL, such clothing and equipment. (E) Procedures for keeping surfaces as at which time the employer may (iii) The employer must ensure that free as practicable of beryllium; discontinue short-term exposure each observer follows all other (F) Procedures for minimizing the monitoring for those employees whose applicable safety and health procedures. migration of beryllium from beryllium exposure is represented by such (e) Beryllium work areas and work areas to other locations within or monitoring, except as otherwise regulated areas—(1) Establishment. (i) outside the workplace;

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(G) A list of engineering controls, samples taken at least 7 days apart, for (i) Respiratory protection is required work practices, and respiratory each affected operation. by this standard; protection required by paragraph (f)(2) (iii) If airborne exposure exceeds the (ii) An employee entitled to such of this standard; TWA PEL or STEL after implementing respiratory protection requests a PAPR; (H) A list of personal protective the control(s) required by paragraph and clothing and equipment required by (f)(2)(i) of this standard, the employer (iii) The PAPR provides adequate paragraph (h) of this standard; and must implement additional or enhanced protection to the employee in (I) Procedures for removing, engineering and work practice controls accordance with paragraph (g)(2) of this laundering, storing, cleaning, repairing, to reduce airborne exposure to or below standard. and disposing of beryllium- the exposure limit(s) exceeded. (h) Personal protective clothing and contaminated personal protective (iv) Wherever the employer equipment—(1) Provision and use. The clothing and equipment, including demonstrates that it is not feasible to employer must provide at no cost, and respirators. reduce airborne exposure to or below ensure that each employee uses, (ii) The employer must review and the PELs by the engineering and work appropriate personal protective clothing evaluate the effectiveness of each practice controls required by paragraphs and equipment in accordance with the written exposure control plan at least (f)(2)(i) and (f)(2)(iii) of this standard, written exposure control plan required annually and update it, as necessary, the employer must implement and under paragraph (f)(1) of this standard when: maintain engineering and work practice and OSHA’s Personal Protective (A) Any change in production controls to reduce airborne exposure to Equipment standards (subpart I of this processes, materials, equipment, the lowest levels feasible and part): personnel, work practices, or control supplement these controls by using (i) Where airborne exposure exceeds, methods results, or can reasonably be respiratory protection in accordance or can reasonably be expected to exceed, expected to result, in new or additional with paragraph (g) of this standard. the TWA PEL or STEL; or (ii) Where there is a reasonable airborne exposure to beryllium; (3) Prohibition of rotation. The expectation of dermal contact with (B) The employer is notified that an employer must not rotate employees to beryllium. employee is eligible for medical removal different jobs to achieve compliance with the PELs. (2) Removal and storage. (i) The in accordance with paragraph (l)(1) of employer must ensure that each this standard, referred for evaluation at (g) Respiratory protection—(1) General. The employer must provide employee removes all beryllium- a CBD diagnostic center, or shows signs contaminated personal protective or symptoms associated with airborne respiratory protection at no cost to the employee and ensure that each clothing and equipment at the end of exposure to or dermal contact with the work shift, at the completion of beryllium; or employee uses respiratory protection: (i) During periods necessary to install tasks involving beryllium, or when (C) The employer has any reason to or implement feasible engineering and personal protective clothing or believe that new or additional airborne work practice controls where airborne equipment becomes visibly exposure is occurring or will occur. exposure exceeds, or can reasonably be contaminated with beryllium, (iii) The employer must make a copy expected to exceed, the TWA PEL or whichever comes first. of the written exposure control plan STEL; (ii) The employer must ensure that accessible to each employee who is, or (ii) During operations, including each employee removes beryllium- can reasonably be expected to be, maintenance and repair activities and contaminated personal protective exposed to airborne beryllium in non-routine tasks, when engineering clothing and equipment as specified in accordance with OSHA’s Access to and work practice controls are not the written exposure control plan Employee Exposure and Medical feasible and airborne exposure exceeds, required by paragraph (f)(1) of this Records (Records Access) standard or can reasonably be expected to exceed, standard. (§ 1910.1020(e)). the TWA PEL or STEL; (iii) The employer must ensure that (2) Engineering and work practice (iii) During operations for which an each employee stores and keeps controls. (i) For each operation in a employer has implemented all feasible beryllium-contaminated personal beryllium work area that releases engineering and work practice controls protective clothing and equipment airborne beryllium, the employer must when such controls are not sufficient to separate from street clothing and that ensure that at least one of the following reduce airborne exposure to or below storage facilities prevent cross- is in place to reduce airborne exposure: the TWA PEL or STEL; contamination as specified in the (A) Material and/or process (iv) During emergencies; and written exposure control plan required substitution; (v) When an employee who is eligible by paragraph (f)(1) of this standard. (B) Isolation, such as ventilated for medical removal under paragraph (iv) The employer must ensure that no partial or full enclosures; (l)(1) chooses to remain in a job with employee removes beryllium- (C) Local exhaust ventilation, such as airborne exposure at or above the action contaminated personal protective at the points of operation, material level, as permitted by paragraph (l)(2)(ii) clothing or equipment from the handling, and transfer; or of this standard. workplace, except for employees (D) Process control, such as wet (2) Respiratory protection program. authorized to do so for the purposes of methods and automation. Where this standard requires an laundering, cleaning, maintaining or (ii) An employer is exempt from using employer to provide respiratory disposing of beryllium-contaminated the controls listed in paragraph (f)(2)(i) protection, the selection and use of such personal protective clothing and of this standard to the extent that: respiratory protection must be in equipment at an appropriate location or (A) The employer can establish that accordance with the Respiratory facility away from the workplace. such controls are not feasible; or Protection standard (§ 1910.134). (v) When personal protective clothing (B) The employer can demonstrate (3) The employer must provide at no or equipment required by this standard that airborne exposure is below the cost to the employee a powered air- is removed from the workplace for action level, using no fewer than two purifying respirator (PAPR) instead of a laundering, cleaning, maintenance or representative personal breathing zone negative pressure respirator when disposal, the employer must ensure that

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personal protective clothing and employee showers at the end of the made airborne by the use of compressed equipment are stored and transported in work shift or work activity if: air. sealed bags or other closed containers (A) The employee reasonably could (iv) Where employees use dry that are impermeable and are labeled in have had airborne exposure above the sweeping, brushing, or compressed air accordance with paragraph (m)(3) of this TWA PEL or STEL; and to clean beryllium-contaminated standard and the HCS (§ 1910.1200). (B) Beryllium could reasonably have surfaces, the employer must provide, (3) Cleaning and replacement. (i) The contaminated the employee’s hair or and ensure that each employee uses, employer must ensure that all reusable body parts other than hands, face, and respiratory protection and personal personal protective clothing and neck. protective clothing and equipment in equipment required by this standard is (4) Eating and drinking areas. accordance with paragraphs (g) and (h) cleaned, laundered, repaired, and Wherever the employer allows of this standard. replaced as needed to maintain its employees to consume food or (v) The employer must ensure that effectiveness. beverages at a worksite where beryllium cleaning equipment is handled and (ii) The employer must ensure that is present, the employer must ensure maintained in a manner that minimizes beryllium is not removed from personal that: the likelihood and level of airborne protective clothing and equipment by (i) Surfaces in eating and drinking exposure and the re-entrainment of blowing, shaking or any other means areas are as free as practicable of airborne beryllium in the workplace. that disperses beryllium into the air. beryllium; (3) Disposal. The employer must (iii) The employer must inform in (ii) No employees enter any eating or ensure that: writing the persons or the business drinking area with personal protective (i) Materials designated for disposal entities who launder, clean or repair the clothing or equipment unless, prior to that contain or are contaminated with personal protective clothing or entry, surface beryllium has been beryllium are disposed of in sealed, equipment required by this standard of removed from the clothing or equipment impermeable enclosures, such as bags or the potentially harmful effects of by methods that do not disperse containers, that are labeled in airborne exposure to and dermal contact beryllium into the air or onto an accordance with paragraph (m)(3) of this with beryllium and that the personal employee’s body; and standard; and (iii) Eating and drinking facilities protective clothing and equipment must (ii) Materials designated for recycling provided by the employer are in be handled in accordance with this that contain or are contaminated with accordance with the Sanitation standard standard. beryllium are cleaned to be as free as (§ 1910.141). practicable of surface beryllium (i) Hygiene areas and practices—(1) (5) Prohibited activities. The employer General. For each employee working in contamination and labeled in must ensure that no employees eat, accordance with paragraph (m)(3) of this a beryllium work area, the employer drink, smoke, chew tobacco or gum, or must: standard, or placed in sealed, apply cosmetics in regulated areas. impermeable enclosures, such as bags or (i) Provide readily accessible washing (j) Housekeeping—(1) General. (i) The facilities in accordance with this containers, that are labeled in employer must maintain all surfaces in accordance with paragraph (m)(3) of this standard and the Sanitation standard beryllium work areas as free as (§ 1910.141) to remove beryllium from standard. practicable of beryllium and in (k) Medical surveillance—(1) General. the hands, face, and neck; and accordance with the written exposure (i) The employer must make medical (ii) Ensure that employees who have control plan required under paragraph surveillance required by this paragraph dermal contact with beryllium wash any (f)(1) and the cleaning methods required available at no cost to the employee, and exposed skin at the end of the activity, under paragraph (j)(2) of this standard; at a reasonable time and place, to each process, or work shift and prior to and employee: eating, drinking, smoking, chewing (ii) The employer must ensure that all (A) Who is or is reasonably expected tobacco or gum, applying cosmetics, or spills and emergency releases of to be exposed at or above the action using the toilet. beryllium are cleaned up promptly and level for more than 30 days per year; (2) Change rooms. In addition to the in accordance with the written exposure (B) Who shows signs or symptoms of requirements of paragraph (i)(1)(i) of control plan required under paragraph CBD or other beryllium-related health this standard, the employer must (f)(1) and the cleaning methods required effects; provide employees who work in a under paragraph (j)(2) of this standard. (C) Who is exposed to beryllium beryllium work area with a designated (2) Cleaning methods. (i) The during an emergency; or change room in accordance with this employer must ensure that surfaces in (D) Whose most recent written standard and the Sanitation standard beryllium work areas are cleaned by medical opinion required by paragraph (§ 1910.141) where employees are HEPA-filtered vacuuming or other (k)(6) or (k)(7) of this standard required to remove their personal methods that minimize the likelihood recommends periodic medical clothing. and level of airborne exposure. surveillance. (3) Showers. (i) The employer must (ii) The employer must not allow dry (ii) The employer must ensure that all provide showers in accordance with the sweeping or brushing for cleaning medical examinations and procedures Sanitation standard (§ 1910.141) where: surfaces in beryllium work areas unless required by this standard are performed (A) Airborne exposure exceeds, or can HEPA-filtered vacuuming or other by, or under the direction of, a licensed reasonably be expected to exceed, the methods that minimize the likelihood physician. TWA PEL or STEL; and and level of airborne exposure are not (2) Frequency. The employer must (B) Beryllium can reasonably be safe or effective. provide a medical examination: expected to contaminate employees’ (iii) The employer must not allow the (i) Within 30 days after determining hair or body parts other than hands, use of compressed air for cleaning that: face, and neck. beryllium-contaminated surfaces unless (A) An employee meets the criteria of (ii) Employers required to provide the compressed air is used in paragraph (k)(1)(i)(A), unless the showers under paragraph (i)(3)(i) of this conjunction with a ventilation system employee has received a medical standard must ensure that each designed to capture the particulates examination, provided in accordance

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with this standard, within the last two (4) Information provided to the (v) If the employee is confirmed years; or PLHCP. The employer must ensure that positive or diagnosed with CBD the (B) An employee meets the criteria of the examining PLHCP (and the agreed- written report must also contain a paragraph (k)(1)(i)(B) or (C). upon CBD diagnostic center, if an recommendation for medical removal (ii) At least every two years thereafter evaluation is required under paragraph from airborne exposure to beryllium, as for each employee who continues to (k)(7) of this standard) has a copy of this described in paragraph (l) of this meet the criteria of paragraph standard and must provide the standard. (k)(1)(i)(A), (B), or (D) of this standard. following information, if known: (6) Licensed physician’s written (iii) At the termination of employment (i) A description of the employee’s medical opinion for the employer. (i) for each employee who meets any of the former and current duties that relate to The employer must obtain a written criteria of paragraph (k)(1)(i) of this the employee’s airborne exposure to and medical opinion from the licensed standard at the time the employee’s dermal contact with beryllium; physician within 45 days of the medical employment terminates, unless an (ii) The employee’s former and examination (including any follow-up examination has been provided in current levels of airborne exposure; BeLPT required under paragraph accordance with this standard during (iii) A description of any personal (k)(3)(ii)(E) of this standard). The the six months prior to the date of protective clothing and equipment, written medical opinion must contain termination. including respirators, used by the only the following: (3) Contents of examination. (i) The employee, including when and for how (A) The date of the examination; employer must ensure that the PLHCP long the employee has used that (B) A statement that the examination conducting the examination advises the personal protective clothing and has met the requirements of this employee of the risks and benefits of equipment; and standard; participating in the medical surveillance (iv) Information from records of (C) Any recommended limitations on program and the employee’s right to opt employment-related medical the employee’s use of respirators, out of any or all parts of the medical examinations previously provided to the protective clothing, or equipment; and examination. employee, currently within the control (D) A statement that the PLHCP has (ii) The employer must ensure that the of the employer, after obtaining written explained the results of the medical employee is offered a medical consent from the employee. examination to the employee, including examination that includes: (5) Licensed physician’s written any tests conducted, any medical (A) A medical and work history, with medical report for the employee. The conditions related to airborne exposure emphasis on past and present airborne employer must ensure that the that require further evaluation or exposure to or dermal contact with employee receives a written medical treatment, and any special provisions beryllium, smoking history, and any report from the licensed physician for use of personal protective clothing or history of respiratory system within 45 days of the examination equipment; dysfunction; (including any follow-up BeLPT (ii) If the employee provides written required under paragraph (k)(3)(ii)(E) of (B) A physical examination with authorization, the written opinion must this standard) and that the PLHCP emphasis on the respiratory system; also contain any recommended explains the results of the examination (C) A physical examination for skin limitations on the employee’s airborne to the employee. The written medical rashes; exposure to beryllium. report must contain: (iii) If the employee is confirmed (D) Pulmonary function tests, (i) A statement indicating the results positive or diagnosed with CBD or if the performed in accordance with the of the medical examination, including licensed physician otherwise deems it guidelines established by the American the licensed physician’s opinion as to appropriate, and the employee provides Thoracic Society including forced vital whether the employee has capacity (FVC) and forced expiratory (A) Any detected medical condition, written authorization, the written volume in one second (FEV1); such as CBD or beryllium sensitization opinion must also contain a referral for (E) A standardized BeLPT or (i.e., the employee is confirmed an evaluation at a CBD diagnostic equivalent test, upon the first positive, as defined in paragraph (b) of center. examination and at least every two years this standard), that may place the (iv) If the employee is confirmed thereafter, unless the employee is employee at increased risk from further positive or diagnosed with CBD and the confirmed positive. If the results of the airborne exposure, and employee provides written BeLPT are other than normal, a follow- (B) Any medical conditions related to authorization, the written opinion must up BeLPT must be offered within 30 airborne exposure that require further also contain a recommendation for days, unless the employee has been evaluation or treatment. continued periodic medical confirmed positive. Samples must be (ii) Any recommendations on: surveillance. analyzed in a laboratory certified under (A) The employee’s use of respirators, (v) If the employee is confirmed the College of American Pathologists/ protective clothing, or equipment; or positive or diagnosed with CBD and the Clinical Laboratory Improvement (B) Limitations on the employee’s employee provides written Amendments (CLIA) guidelines to airborne exposure to beryllium. authorization, the written opinion must perform the BeLPT. (iii) If the employee is confirmed also contain a recommendation for (F) A low dose computed tomography positive or diagnosed with CBD or if the medical removal from airborne exposure (LDCT) scan, when recommended by licensed physician otherwise deems it to beryllium, as described in paragraph the PLHCP after considering the appropriate, the written report must also (l) of this standard. employee’s history of exposure to contain a referral for an evaluation at a (vi) The employer must ensure that beryllium along with other risk factors, CBD diagnostic center. each employee receives a copy of the such as smoking history, family medical (iv) If the employee is confirmed written medical opinion described in history, sex, age, and presence of positive or diagnosed with CBD the paragraph (k)(6) of this standard within existing lung disease; and written report must also contain a 45 days of any medical examination (G) Any other test deemed appropriate recommendation for continued periodic (including any follow-up BeLPT by the PLHCP. medical surveillance. required under paragraph (k)(3)(ii)(E) of

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this standard) performed for that (A) A written medical report sensitization; and skin, eye, and employee. indicating a confirmed positive finding respiratory tract irritation. (7) CBD diagnostic center. (i) The or CBD diagnosis; or (iii) Employers must include employer must provide an evaluation at (B) A written medical report beryllium in the hazard communication no cost to the employee at a CBD recommending removal from airborne program established to comply with the diagnostic center that is mutually agreed exposure to beryllium in accordance HCS. Employers must ensure that each upon by the employer and the with paragraph (k)(5)(v) or (k)(7)(ii) of employee has access to labels on employee. The examination must be this standard; or containers of beryllium and to safety provided within 30 days of: (ii) The employer receives a written data sheets, and is trained in accordance (A) The employer’s receipt of a medical opinion recommending with the requirements of the HCS physician’s written medical opinion to removal from airborne exposure to (§ 1910.1200) and paragraph (m)(4) of the employer that recommends referral beryllium in accordance with paragraph this standard. to a CBD diagnostic center; or (k)(6)(v) or (k)(7)(iii) of this standard. (2) Warning signs. (i) Posting. The (B) The employee presenting to the (2) If an employee is eligible for employer must provide and display employer a physician’s written medical medical removal, the employer must warning signs at each approach to a report indicating that the employee has provide the employee with the regulated area so that each employee is been confirmed positive or diagnosed employee’s choice of: able to read and understand the signs with CBD, or recommending referral to (i) Removal as described in paragraph and take necessary protective steps a CBD diagnostic center. (l)(3) of this standard; or before entering the area. (ii) Remaining in a job with airborne (ii) The employer must ensure that the (ii) Sign specification. (A) The exposure at or above the action level, employee receives a written medical employer must ensure that the warning provided that the employer provides, report from the CBD diagnostic center signs required by paragraph (m)(2)(i) of and ensures that the employee uses, that contains all the information this standard are legible and readily respiratory protection that complies required in paragraph (k)(5)(i), (ii), (iv), visible. with paragraph (g) of this standard and (v) of this standard and that the (B) The employer must ensure each whenever airborne exposures are at or PLHCP explains the results of the warning sign required by paragraph above the action level. (m)(2)(i) of this standard bears the examination to the employee within 30 (3) If the employee chooses removal: days of the examination. (i) If a comparable job is available following legend: (iii) The employer must obtain a where airborne exposures to beryllium DANGER written medical opinion from the CBD are below the action level, and the REGULATED AREA diagnostic center within 30 days of the employee is qualified for that job or can BERYLLIUM medical examination. The written be trained within one month, the MAY CAUSE CANCER medical opinion must contain only the CAUSES DAMAGE TO LUNGS employer must remove the employee to AUTHORIZED PERSONNEL ONLY information in paragraph (k)(6)(i), as that job. The employer must maintain applicable, unless the employee WEAR RESPIRATORY PROTECTION AND for six months from the time of removal PERSONAL PROTECTIVE CLOTHING provides written authorization to release the employee’s base earnings, seniority, AND EQUIPMENT IN THIS AREA additional information. If the employee and other rights and benefits that (3) Warning labels. Consistent with provides written authorization, the existed at the time of removal. written opinion must also contain the (ii) If comparable work is not the HCS (§ 1910.1200), the employer information from paragraphs (k)(6)(ii), available, the employer must maintain must label each bag and container of (iv), and (v), if applicable. the employee’s base earnings, seniority, clothing, equipment, and materials (iv) The employer must ensure that and other rights and benefits that contaminated with beryllium, and must, each employee receives a copy of the existed at the time of removal for six at a minimum, include the following on written medical opinion from the CBD months or until such time that the label: diagnostic center described in paragraph comparable work described in DANGER (k)(7) of this standard within 30 days of paragraph (l)(3)(i) becomes available, CONTAINS BERYLLIUM any medical examination performed for whichever comes first. MAY CAUSE CANCER that employee. (4) The employer’s obligation to CAUSES DAMAGE TO LUNGS (v) After an employee has received the provide medical removal protection AVOID CREATING DUST DO NOT GET ON SKIN initial clinical evaluation at a CBD benefits to a removed employee shall be diagnostic center described in paragraph reduced to the extent that the employee (4) Employee information and (k)(7)(i) of this standard, the employee receives compensation for earnings lost training. (i) For each employee who has, may choose to have any subsequent during the period of removal from a or can reasonably be expected to have, medical examinations for which the publicly or employer-funded airborne exposure to or dermal contact employee is eligible under paragraph (k) compensation program, or receives with beryllium: of this standard performed at a CBD income from another employer made (A) The employer must provide diagnostic center mutually agreed upon possible by virtue of the employee’s information and training in accordance by the employer and the employee, and removal. with the HCS (§ 1910.1200(h)); the employer must provide such (m) Communication of hazards—(1) (B) The employer must provide initial examinations at no cost to the General. (i) Chemical manufacturers, training to each employee by the time of employee. importers, distributors, and employers initial assignment; and (l) Medical removal. (1) An employee must comply with all requirements of (C) The employer must repeat the is eligible for medical removal, if the the HCS (§ 1910.1200) for beryllium. training required under this standard employee works in a job with airborne (ii) In classifying the hazards of annually for each employee. exposure at or above the action level beryllium, at least the following hazards (ii) The employer must ensure that and either: must be addressed: Cancer; lung effects each employee who is, or can (i) The employee provides the (CBD and acute beryllium disease); reasonably be expected to be, exposed to employer with: beryllium sensitization; skin airborne beryllium can demonstrate

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knowledge and understanding of the (B) The task that is being monitored; (iii) The employer must ensure that following: (C) The sampling and analytical medical records are maintained and (A) The health hazards associated methods used and evidence of their made available in accordance with the with airborne exposure to and contact accuracy; Records Access standard (§ 1910.1020). with beryllium, including the signs and (D) The number, duration, and results (4) Training. (i) At the completion of symptoms of CBD; of samples taken; any training required by this standard, (B) The written exposure control plan, (E) The type of personal protective the employer must prepare a record that with emphasis on the location(s) of clothing and equipment, including indicates the name, social security beryllium work areas, including any respirators, worn by monitored number, and job classification of each regulated areas, and the specific nature employees at the time of monitoring; employee trained, the date the training of operations that could result in and was completed, and the topic of the airborne exposure, especially airborne (F) The name, social security number, training. exposure above the TWA PEL or STEL; and job classification of each employee (ii) This record must be maintained (C) The purpose, proper selection, represented by the monitoring, for three years after the completion of fitting, proper use, and limitations of indicating which employees were training. personal protective clothing and actually monitored. (5) Access to records. Upon request, equipment, including respirators; (iii) The employer must ensure that the employer must make all records (D) Applicable emergency procedures; exposure records are maintained and maintained as a requirement of this (E) Measures employees can take to made available in accordance with the standard available for examination and protect themselves from airborne Records Access standard (§ 1910.1020). copying to the Assistant Secretary, the exposure to and contact with beryllium, (2) Objective data. (i) Where an Director, each employee, and each including personal hygiene practices; employer uses objective data to satisfy employee’s designated representative(s) (F) The purpose and a description of the exposure assessment requirements in accordance the Records Access the medical surveillance program under paragraph (d)(2) of this standard, standard (§ 1910.1020). required by paragraph (k) of this the employer must make and maintain (6) Transfer of records. The employer standard including risks and benefits of a record of the objective data relied must comply with the requirements each test to be offered; upon. involving transfer of records set forth in (G) The purpose and a description of (ii) This record must include at least the Records Access standard the medical removal protection the following information: (§ 1910.1020). provided under paragraph (l) of this (A) The data relied upon; (o) Dates—(1) Effective date. This standard; (B) The beryllium-containing material standard shall become effective March (H) The contents of the standard; and in question; 10, 2017. (I) The employee’s right of access to (C) The source of the objective data; (2) Compliance dates. All obligations records under the Records Access (D) A description of the process, task, of this standard commence and become standard (§ 1910.1020). or activity on which the objective data enforceable on March 12, 2018, except: (iii) When a workplace change (such were based; and (i) Change rooms and showers as modification of equipment, tasks, or (E) Other data relevant to the process, required by paragraph (i) of this procedures) results in new or increased task, activity, material, or airborne standard must be provided by March 11, airborne exposure that exceeds, or can exposure on which the objective data 2019; and reasonably be expected to exceed, either were based. (ii) Engineering controls required by the TWA PEL or the STEL, the employer (iii) The employer must ensure that paragraph (f) of this standard must be must provide additional training to objective data are maintained and made implemented by March 10, 2020. those employees affected by the change available in accordance with the (p) Appendix. Appendix A—Control in airborne exposure. Records Access standard (§ 1910.1020). Strategies to Minimize Beryllium (iv) Employee information. The (3) Medical surveillance. (i) The Exposure of this standard is non- employer must make a copy of this employer must make and maintain a mandatory. standard and its appendices readily record for each employee covered by available at no cost to each employee medical surveillance under paragraph Appendix A to § 1910.1024—Control and designated employee (k) of this standard. Strategies To Minimize Beryllium representative(s). (ii) The record must include the Exposure (Non-Mandatory) (n) Recordkeeping—(1) Air monitoring following information about each Paragraph (f)(2)(i) of this standard requires data. (i) The employer must make and employee: employers to use one or more of the control maintain a record of all exposure (A) Name, social security number, and methods listed in paragraph (f)(2)(i) to measurements taken to assess airborne job classification; minimize worker exposure in each operation exposure as prescribed in paragraph (d) (B) A copy of all licensed physicians’ in a beryllium work area, unless the operation is exempt under paragraph of this standard. written medical opinions for each (f)(2)(ii). This appendix sets forth a non- (ii) This record must include at least employee; and exhaustive list of control options that the following information: (C) A copy of the information employers could use to comply with (A) The date of measurement for each provided to the PLHCP as required by paragraph (f)(2)(i) for a number of specific sample taken; paragraph (k)(4) of this standard. beryllium operations.

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TABLE A.1—EXPOSURE CONTROL RECOMMENDATIONS

Operation Minimal control strategy * Application group

Beryllium Oxide Forming For pressing operations: ...... Primary Beryllium Produc- (e.g., pressing, extruding). (1) Install local exhaust ventilation (LEV) on oxide press tables, oxide feed tion; Beryllium Oxide Ce- drum breaks, press tumblers, powder rollers, and die set disassembly sta- ramics and Composites. tions; (2) Enclose the oxide presses; and (3) Install mechanical ventilation (make-up air) in processing areas For extruding operations: (1) Install LEV on extruder powder loading hoods, oxide supply bottles, rod breaking operations, centerless grinders, rod laydown tables, dicing oper- ations, surface grinders, discharge end of extrusion presses; (2) Enclose the centerless grinders; and (3) Install mechanical ventilation (make-up air) in processing areas. Chemical Processing Oper- For medium and high gassing operations: ...... Primary Beryllium Produc- ations (e.g., leaching, (1) Perform operation with a hood having a maximum of one open side; and tion; Beryllium Oxide Ce- pickling, degreasing, etch- (2) Design process so as to minimize spills; if accidental spills occur, perform ramics and Composites; ing, plating). immediate cleanup. Copper Rolling, Drawing and Extruding. Finishing (e.g., grinding, (1) Perform portable finishing operations in a ventilated hood. The hood should in- Secondary Smelting; Fab- sanding, polishing, clude both downdraft and backdraft ventilation, and have at least two sides and a rication of Beryllium Alloy deburring). top. Products; Dental Labs. (2) Perform stationary finishing operations using a ventilated and enclosed hood at the point of operation. The grinding wheel of the stationary unit should be en- closed and ventilated. Furnace Operations (e.g., (1) Use LEV on furnaces, pelletizer; arc furnace ingot machine discharge; pellet Primary Beryllium Produc- Melting and Casting). sampling; arc furnace bins and conveyors; beryllium hydroxide drum dumper and tion; Beryllium Oxide Ce- dryer; furnace rebuilding; furnace tool holders; arc furnace tundish and tundish ramics and Composites; skimming, tundish preheat hood, and tundish cleaning hoods; dross handling Nonferrous Foundries; equipment and drums; dross recycling; and tool repair station, charge make-up Secondary Smelting. station, oxide screener, product sampling locations, drum changing stations, and drum cleaning stations (2) Use mechanical ventilation (make-up air) in furnace building Machining ...... Use (1) LEV consistent with ACGIH® ventilation guidelines on deburring hoods, wet Primary Beryllium Produc- surface grinder enclosures, belt sanding hoods, and electrical discharge ma- tion; Beryllium Oxide Ce- chines (for operations such as polishing, lapping, and buffing); ramics and Composites; (2) high velocity low volume hoods or ventilated enclosures on lathes, vertical mills, Copper Rolling, Drawing, CNC mills, and tool grinding operations; and Extruding; Precision (3) for beryllium oxide ceramics, LEV on lapping, dicing, and laser cutting; and Turned Products. (4) wet methods (e.g., coolants). Mechanical Processing (e.g., (1) Enclose and ventilate sources of emission; Primary Beryllium Produc- material handling (includ- (2) Prohibit open handling of materials; and tion; Beryllium Oxide Ce- ing scrap), sorting, crush- (3) Use mechanical ventilation (make-up air) in processing areas ramics and Composites; ing, screening, pulverizing, Aluminum and Copper shredding, pouring, mix- Foundries; Secondary ing, blending). Smelting. Metal Forming (e.g., rolling, (1) For rolling operations, install LEV on mill stands and reels such that a hood ex- Primary Beryllium Produc- drawing, straightening, an- tends the length of the mill; tion; Copper Rolling, nealing, extruding). (2) For point and chamfer operations, install LEV hoods at both ends of the rod; Drawing, and Extruding; (3) For annealing operations, provide an inert atmosphere for annealing furnaces, Fabrication of Beryllium and LEV hoods at entry and exit points; Alloy Products. (4) For swaging operations, install LEV on the cutting head; (5) For drawing, straightening, and extruding operations, install LEV at entry and exit points; and (6) For all metal forming operations, install mechanical ventilation (make-up air) for processing areas. Welding ...... For fixed welding operations: ...... Primary Beryllium Produc- (1) Enclose work locations around the source of fume generation and use local tion; Fabrication of Beryl- exhaust ventilation; and lium Alloy Products; (2) Install close capture hood enclosure designed so as to minimize fume Welding. emission from the enclosure welding operation. For manual operations: (1) Use portable local exhaust and general ventilation * All LEV specifications should be in accordance with the ACGIH® Publication No. 2094, ‘‘Industrial Ventilation—A Manual of Recommended Practice’’ wherever applicable.

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PART 1915—OCCUPATIONAL SAFETY 71 (36 FR 8754); 8–76 (41 FR 25059), 9–83 ‘‘Beryllium and beryllium compounds AND HEALTH STANDARDS FOR (48 FR 35736), 1–90 (55 FR 9033), 6–96 (62 (as Be)’’ and adding footnote q. SHIPYARD EMPLOYMENT FR 111), 3–2000 (65 FR 50017), 5–2002 (67 FR 65008), 5–2007 (72 FR 31160), 4–2010 (75 The revisions read as follows: ■ 4. The authority citation for part 1915 FR 55355), or 1–2012 (77 FR 3912); 29 CFR * * * * * is revised to read as follows: part 1911; and 5 U.S.C. 553, as applicable. § 1915.1000 Air contaminants. Authority: 33 U.S.C. 941; 29 U.S.C. 653, ■ 5. In § 1915.1000 amend Table Z— 655, 657; Secretary of Labor’s Order No. 12– Shipyards, by revising the entry for * * * * *

TABLE Z—SHIPYARDS

Substance CAS No.d ppm a* mg/m3b* Skin designation

******* Beryllium and beryllium compounds (as Be); see 1915.1024 (q) ...... 7440–41–7 ...... 0.002 ......

******* * The PELs are 8-hour TWAs unless otherwise noted; a (C) designation denotes a ceiling limit. They are to be determined from breathing-zone air samples. a Parts of vapor or gas per million parts of contaminated air by volume at 25 °C and 760 torr. b Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when listed with a ppm entry, it is ap- proximate. ******* d The CAS number is for information only. Enforcement is based on the substance name. For an entry covering more than one metal com- pound, measured as the metal, the CAS number for the metal is given—not CAS numbers for the individual compounds. ******* q This standard applies to any operations or sectors for which the beryllium standard, 1915.1024, is stayed or otherwise is not in effect.

* * * * * Beryllium lymphocyte proliferation Emergency means any uncontrolled ■ 6. Add § 1915.1024 to read as follows: test (BeLPT) means the measurement of release of airborne beryllium. blood lymphocyte proliferation in a High-efficiency particulate air (HEPA) § 1915.1024 Beryllium. laboratory test when lymphocytes are filter means a filter that is at least 99.97 (a) Scope and application. (1) This challenged with a soluble beryllium percent efficient in removing particles standard applies to occupational salt. 0.3 micrometers in diameter. exposure to beryllium in all forms, CBD diagnostic center means a Objective data means information, compounds, and mixtures in shipyards, medical diagnostic center that has an such as air monitoring data from except those articles and materials on-site pulmonary specialist and on-site industry-wide surveys or calculations exempted by paragraphs (a)(2) and (a)(3) facilities to perform a clinical evaluation based on the composition of a of this standard. for the presence of chronic beryllium substance, demonstrating airborne (2) This standard does not apply to disease (CBD). This evaluation must exposure to beryllium associated with a articles, as defined in the Hazard include pulmonary function testing (as particular product or material or a Communication standard (HCS) (29 CFR outlined by the American Thoracic specific process, task, or activity. The 1910.1200(c)), that contain beryllium Society criteria), bronchoalveolar lavage data must reflect workplace conditions and that the employer does not process. (BAL), and transbronchial biopsy. The closely resembling or with a higher (3) This standard does not apply to CBD diagnostic center must also have airborne exposure potential than the materials containing less than 0.1% the capacity to transfer BAL samples to processes, types of material, control beryllium by weight where the a laboratory for appropriate diagnostic methods, work practices, and employer has objective data testing within 24 hours. The on-site environmental conditions in the demonstrating that employee exposure pulmonary specialist must be able to employer’s current operations. to beryllium will remain below the interpret the biopsy pathology and the Physician or other licensed health action level as an 8-hour TWA under BAL diagnostic test results. care professional (PLHCP) means an any foreseeable conditions. Chronic beryllium disease (CBD) individual whose legally permitted (b) Definitions. As used in this means a chronic lung disease associated scope of practice (i.e., license, standard: with airborne exposure to beryllium. registration, or certification) allows the Action level means a concentration of Confirmed positive means the person individual to independently provide or airborne beryllium of 0.1 micrograms tested has beryllium sensitization, as be delegated the responsibility to per cubic meter of air (mg/m3) calculated indicated by two abnormal BeLPT test provide some or all of the health care as an 8-hour time-weighted average results, an abnormal and a borderline services required by paragraph (k) of (TWA). test result, or three borderline test this standard. Airborne exposure and airborne results. It also means the result of a Regulated area means an area, exposure to beryllium mean the more reliable and accurate test including temporary work areas where exposure to airborne beryllium that indicating a person has been identified maintenance or non-routine tasks are would occur if the employee were not as having beryllium sensitization. performed, where an employee’s using a respirator. Director means the Director of the airborne exposure exceeds, or can Assistant Secretary means the National Institute for Occupational reasonably be expected to exceed, either Assistant Secretary of Labor for Safety and Health (NIOSH), U.S. the time-weighted average (TWA) Occupational Safety and Health, United Department of Health and Human permissible exposure limit (PEL) or States Department of Labor, or designee. Services, or designee. short term exposure limit (STEL).

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This standard means this beryllium but at or below the TWA PEL, the by the assessment of the results of that standard, 29 CFR 1915.1024. employer must repeat such monitoring assessment individually in writing or (c) Permissible Exposure Limits within six months of the most recent post the results in an appropriate (PELs)—(1) Time-weighted average monitoring. location that is accessible to each of (TWA) PEL. The employer must ensure (vi) Where the most recent exposure these employees. that no employee is exposed to an monitoring indicates that airborne (ii) Whenever an exposure assessment airborne concentration of beryllium in exposure is above the TWA PEL, the indicates that airborne exposure is excess of 0.2 mg/m3 calculated as an 8- employer must repeat such monitoring above the TWA PEL or STEL, the hour TWA. within three months of the most recent employer must describe in the written (2) Short-term exposure limit (STEL). 8-hour TWA exposure monitoring. notification the corrective action being The employer must ensure that no (vii) Where the most recent (non- taken to reduce airborne exposure to or employee is exposed to an airborne initial) exposure monitoring indicates below the exposure limit(s) exceeded concentration of beryllium in excess of that airborne exposure is below the where feasible corrective action exists 2.0 mg/m3 as determined over a action level, the employer must repeat but had not been implemented when the sampling period of 15 minutes. such monitoring within six months of monitoring was conducted. (d) Exposure assessment—(1) General. the most recent monitoring until two (7) Observation of monitoring. (i) The The employer must assess the airborne consecutive measurements, taken 7 or employer must provide an opportunity exposure of each employee who is or more days apart, are below the action to observe any exposure monitoring may reasonably be expected to be level, at which time the employer may required by this standard to each exposed to airborne beryllium in discontinue 8-hour TWA exposure employee whose airborne exposure is accordance with either the performance monitoring for those employees whose measured or represented by the option in paragraph (d)(2) or the exposure is represented by such monitoring and each employee’s scheduled monitoring option in monitoring, except as otherwise representative(s). paragraph (d)(3) of this standard. provided in paragraph (d)(4) of this (ii) When observation of monitoring (2) Performance option. The employer standard. requires entry into an area where the (viii) Where the most recent exposure must assess the 8-hour TWA exposure use of personal protective clothing or monitoring indicates that airborne and the 15-minute short-term exposure equipment (which may include exposure is above the STEL, the for each employee on the basis of any respirators) is required, the employer combination of air monitoring data and employer must repeat such monitoring within three months of the most recent must provide each observer with objective data sufficient to accurately appropriate personal protective clothing characterize airborne exposure to short-term exposure monitoring until two consecutive measurements, taken 7 and equipment at no cost to the observer beryllium. and must ensure that each observer uses (3) Scheduled monitoring option. (i) or more days apart, are below the STEL, such clothing and equipment. The employer must perform initial at which time the employer may (iii) The employer must ensure that monitoring to assess the 8-hour TWA discontinue short-term exposure each observer follows all other exposure for each employee on the basis monitoring for those employees whose applicable safety and health procedures. of one or more personal breathing zone exposure is represented by such air samples that reflect the airborne monitoring, except as otherwise (e) Regulated areas—(1) exposure of employees on each shift, for provided in paragraph (d)(4) of this Establishment. The employer must each job classification, and in each work standard. establish and maintain a regulated area area. (4) Reassessment of exposure. The wherever employees are, or can (ii) The employer must perform initial employer must reassess airborne reasonably be expected to be, exposed to monitoring to assess the short-term exposure whenever a change in the airborne beryllium at levels above the exposure from 15-minute personal production, process, control equipment, TWA PEL or STEL. breathing zone air samples measured in personnel, or work practices may (2) Demarcation. The employer must operations that are likely to produce reasonably be expected to result in new identify each regulated area in airborne exposure above the STEL for or additional airborne exposure at or accordance with paragraph (m)(2) of this each work shift, for each job above the action level or STEL, or when standard. classification, and in each work area. the employer has any reason to believe (3) Access. The employer must limit (iii) Where several employees perform that new or additional airborne access to regulated areas to: the same tasks on the same shift and in exposure at or above the action level or (i) Persons the employer authorizes or the same work area, the employer may STEL has occurred. requires to be in a regulated area to sample a representative fraction of these (5) Methods of sample analysis. The perform work duties; employees in order to meet the employer must ensure that all air (ii) Persons entering a regulated area requirements of paragraph (d)(3) of this monitoring samples used to satisfy the as designated representatives of standard. In representative sampling, monitoring requirements of paragraph employees for the purpose of exercising the employer must sample the (d) of this standard are evaluated by a the right to observe exposure monitoring employee(s) expected to have the laboratory that can measure beryllium to procedures under paragraph (d)(7) of highest airborne exposure to beryllium. an accuracy of plus or minus 25 percent this standard; and (iv) If initial monitoring indicates that within a statistical confidence level of (iii) Persons authorized by law to be airborne exposure is below the action 95 percent for airborne concentrations at in a regulated area. level and at or below the STEL, the or above the action level. (4) Provision of personal protective employer may discontinue monitoring (6) Employee notification of clothing and equipment, including for those employees whose airborne assessment results. (i) Within 15 respirators. The employer must provide exposure is represented by such working days after completing an and ensure that each employee entering monitoring. exposure assessment in accordance with a regulated area uses: (v) Where the most recent exposure paragraph (d) of this standard, the (i) Respiratory protection in monitoring indicates that airborne employer must notify each employee accordance with paragraph (g) of this exposure is at or above the action level whose airborne exposure is represented standard; and

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(ii) Personal protective clothing and reasonably be expected to be, at or engineering and work practice controls equipment in accordance with above the action level, the employer when such controls are not sufficient to paragraph (h) of this standard. must ensure that at least one of the reduce airborne exposure to or below (f) Methods of compliance—(1) following is in place to reduce airborne the TWA PEL or STEL; Written exposure control plan. (i) The exposure: (iv) During emergencies; and employer must establish, implement, (A) Material and/or process (v) When an employee who is eligible and maintain a written exposure control substitution; for medical removal under paragraph plan, which must contain: (B) Isolation, such as ventilated (l)(1) chooses to remain in a job with (A) A list of operations and job titles partial or full enclosures; airborne exposure at or above the action reasonably expected to involve airborne (C) Local exhaust ventilation, such as level, as permitted by paragraph exposure to or dermal contact with at the points of operation, material (l)(2)(ii). beryllium; handling, and transfer; or (2) Respiratory protection program. (B) A list of operations and job titles (D) Process control, such as wet Where this standard requires an reasonably expected to involve airborne methods and automation. employer to provide respiratory exposure at or above the action level; (ii) An employer is exempt from using protection, the selection and use of such (C) A list of operations and job titles the controls listed in paragraph (f)(2)(i) respiratory protection must be in reasonably expected to involve airborne of this standard to the extent that: accordance with the Respiratory exposure above the TWA PEL or STEL; (A) The employer can establish that Protection standard (29 CFR 1910.134). (D) Procedures for minimizing cross- such controls are not feasible; or (3) The employer must provide at no contamination; (B) The employer can demonstrate cost to the employee a powered air- (E) Procedures for minimizing the that airborne exposure is below the purifying respirator (PAPR) instead of a migration of beryllium within or to action level, using no fewer than two negative pressure respirator when locations outside the workplace; representative personal breathing zone (i) Respiratory protection is required (F) A list of engineering controls, samples taken at least 7 days apart, for by this standard; work practices, and respiratory each affected operation. (ii) An employee entitled to such protection required by paragraph (f)(2) (iii) If airborne exposure exceeds the respiratory protection requests a PAPR; of this standard; TWA PEL or STEL after implementing and (G) A list of personal protective the control(s) required by (f)(2)(i), the (iii) The PAPR provides adequate clothing and equipment required by employer must implement additional or protection to the employee in paragraph (h) of this standard; and enhanced engineering and work practice accordance with paragraph (g)(2) of this (H) Procedures for removing, controls to reduce airborne exposure to standard. laundering, storing, cleaning, repairing, or below the exposure limit(s) exceeded. (h) Personal protective clothing and and disposing of beryllium- (iv) Wherever the employer equipment—(1) Provision and use. The contaminated personal protective demonstrates that it is not feasible to employer must provide at no cost, and clothing and equipment, including reduce airborne exposure to or below ensure that each employee uses, respirators. the PELs by the engineering and work appropriate personal protective clothing (ii) The employer must review and practice controls required by paragraphs and equipment in accordance with the evaluate the effectiveness of each (f)(2)(i) and (f)(2)(iii), the employer must written exposure control plan required written exposure control plan at least implement and maintain engineering under paragraph (f)(1) of this standard annually and update it, as necessary, and work practice controls to reduce and OSHA’s Personal Protective when: airborne exposure to the lowest levels Equipment standards for shipyards (A) Any change in production feasible and supplement these controls (subpart I of this part): processes, materials, equipment, by using respiratory protection in (i) Where airborne exposure exceeds, personnel, work practices, or control accordance with paragraph (g) of this or can reasonably be expected to exceed, methods results, or can reasonably be standard. the TWA PEL or STEL; or expected to result, in new or additional (3) Prohibition of rotation. The (ii) Where there is a reasonable airborne exposure to beryllium; employer must not rotate employees to expectation of dermal contact with (B) The employer is notified that an different jobs to achieve compliance beryllium. employee is eligible for medical removal with the PELs. (2) Removal and storage. (i) The in accordance with paragraph (l)(1) of (g) Respiratory protection—(1) employer must ensure that each this standard, referred for evaluation at General. The employer must provide employee removes all beryllium- a CBD diagnostic center, or shows signs respiratory protection at no cost to the contaminated personal protective or symptoms associated with airborne employee and ensure that each clothing and equipment at the end of exposure to or dermal contact with employee uses respiratory protection: the work shift, at the completion of beryllium; or (i) During periods necessary to install tasks involving beryllium, or when (C) The employer has any reason to or implement feasible engineering and personal protective clothing or believe that new or additional airborne work practice controls where airborne equipment becomes visibly exposure is occurring or will occur. exposure exceeds, or can reasonably be contaminated with beryllium, (iii) The employer must make a copy expected to exceed, the TWA PEL or whichever comes first. of the written exposure control plan STEL; (ii) The employer must ensure that accessible to each employee who is, or (ii) During operations, including each employee removes beryllium- can reasonably be expected to be, maintenance and repair activities and contaminated personal protective exposed to airborne beryllium in non-routine tasks, when engineering clothing and equipment as specified in accordance with OSHA’s Access to and work practice controls are not the written exposure control plan Employee Exposure and Medical feasible and airborne exposure exceeds, required by paragraph (f)(1) of this Records (Records Access) standard (29 or can reasonably be expected to exceed, standard. CFR 1910.1020(e)). the TWA PEL or STEL; (iii) The employer must ensure that (2) Engineering and work practice (iii) During operations for which an each employee stores and keeps controls. (i) Where exposures are, or can employer has implemented all feasible beryllium-contaminated personal

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protective clothing and equipment (2) Change rooms. In addition to the to clean in beryllium-contaminated separate from street clothing and that requirements of paragraph (i)(1)(i) of areas, the employer must provide, and storage facilities prevent cross- this standard, the employer must ensure that each employee uses, contamination as specified in the provide employees required to use respiratory protection and personal written exposure control plan required personal protective clothing by this protective clothing and equipment in by paragraph (f)(1) of this standard. standard with a designated change room accordance with paragraphs (g) and (h) (iv) The employer must ensure that no in accordance with the Sanitation of this standard. employee removes beryllium- standard (§ 1915.88) where employees (v) The employer must ensure that contaminated personal protective are required to remove their personal cleaning equipment is handled and clothing or equipment from the clothing. maintained in a manner that minimizes workplace, except for employees (3) Eating and drinking areas. the likelihood and level of airborne authorized to do so for the purposes of Wherever the employer allows exposure and the re-entrainment of laundering, cleaning, maintaining or employees to consume food or airborne beryllium in the workplace. disposing of beryllium-contaminated beverages at a worksite where beryllium (3) Disposal. When the employer personal protective clothing and is present, the employer must ensure transfers materials containing beryllium equipment at an appropriate location or that: to another party for use or disposal, the facility away from the workplace. (i) Surfaces in eating and drinking employer must provide the recipient (v) When personal protective clothing areas are as free as practicable of with a copy of the warning described in or equipment required by this standard beryllium; paragraph (m)(3) of this standard. is removed from the workplace for (ii) No employees enter any eating or (k) Medical surveillance—(1) General. laundering, cleaning, maintenance or drinking area with personal protective (i) The employer must make medical disposal, the employer must ensure that clothing or equipment unless, prior to surveillance required by this paragraph personal protective clothing and entry, surface beryllium has been available at no cost to the employee, and equipment are stored and transported in removed from the clothing or equipment at a reasonable time and place, to each sealed bags or other closed containers by methods that do not disperse employee: that are impermeable and are labeled in beryllium into the air or onto an (A) Who is or is reasonably expected accordance with paragraph (m)(3) of this employee’s body; and to be exposed at or above the action standard and the HCS (29 CFR (iii) Eating and drinking facilities level for more than 30 days per year; 1910.1200). provided by the employer are in (B) Who shows signs or symptoms of (3) Cleaning and replacement. (i) The accordance with the Sanitation standard CBD or other beryllium-related health employer must ensure that all reusable (29 CFR 1915.88). effects; personal protective clothing and (4) Prohibited activities. The employer (C) Who is exposed to beryllium equipment required by this standard is must ensure that no employees eat, during an emergency; or cleaned, laundered, repaired, and drink, smoke, chew tobacco or gum, or (D) Whose most recent written replaced as needed to maintain its apply cosmetics in regulated areas. medical opinion required by paragraph effectiveness. (j) Housekeeping—(1) General. (i) (ii) The employer must ensure that When cleaning beryllium-contaminated (k)(6) or (k)(7) recommends periodic beryllium is not removed from personal areas, the employer must follow the medical surveillance. protective clothing and equipment by written exposure control plan required (ii) The employer must ensure that all blowing, shaking or any other means under paragraph (f)(1) of this standard; medical examinations and procedures that disperses beryllium into the air. and required by this standard are performed (iii) The employer must inform in (ii) The employer must ensure that all by, or under the direction of, a licensed writing the persons or the business spills and emergency releases of physician. entities who launder, clean or repair the beryllium are cleaned up promptly and (2) Frequency. The employer must personal protective clothing or in accordance with the written exposure provide a medical examination: equipment required by this standard of control plan required under paragraph (i) Within 30 days after determining the potentially harmful effects of (f)(1). that: airborne exposure to and dermal contact (2) Cleaning methods. (i) When (A) An employee meets the criteria of with beryllium and that the personal cleaning beryllium-contaminated areas, paragraph (k)(1)(i)(A) of this standard, protective clothing and equipment must the employer must ensure the use of unless the employee has received a be handled in accordance with this HEPA-filtered vacuuming or other medical examination, provided in standard. methods that minimize the likelihood accordance with this standard, within (i) Hygiene areas and practices—(1) and level of airborne exposure. the last two years; or General. For each employee required to (ii) The employer must not allow dry (B) An employee meets the criteria of use personal protective clothing or sweeping or brushing for cleaning in paragraph (k)(1)(i)(B) or (C) of this equipment by this standard, the beryllium-contaminated areas unless standard. employer must: HEPA-filtered vacuuming or other (ii) At least every two years thereafter (i) Provide readily accessible washing methods that minimize the likelihood for each employee who continues to facilities in accordance with this and level of airborne exposure are not meet the criteria of paragraph standard and the Sanitation standard safe or effective. (k)(1)(i)(A), (B), or (D) of this standard. (§ 1915.88) to remove beryllium from (iii) The employer must not allow the (iii) At the termination of employment the hands, face, and neck; and use of compressed air for cleaning in for each employee who meets any of the (ii) Ensure that employees who have beryllium-contaminated areas unless the criteria of paragraph (k)(1)(i) of this dermal contact with beryllium wash any compressed air is used in conjunction standard at the time the employee’s exposed skin at the end of the activity, with a ventilation system designed to employment terminates, unless an process, or work shift and prior to capture the particulates made airborne examination has been provided in eating, drinking, smoking, chewing by the use of compressed air. accordance with this standard during tobacco or gum, applying cosmetics, or (iv) Where employees use dry the six months prior to the date of using the toilet. sweeping, brushing, or compressed air termination.

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(3) Contents of examination. (i) The long the employee has used that (B) A statement that the examination employer must ensure that the PLHCP personal protective clothing and has met the requirements of this conducting the examination advises the equipment; and standard; employee of the risks and benefits of (iv) Information from records of (C) Any recommended limitations on participating in the medical surveillance employment-related medical the employee’s use of respirators, program and the employee’s right to opt examinations previously provided to the protective clothing, or equipment; and out of any or all parts of the medical employee, currently within the control (D) A statement that the PLHCP has examination. of the employer, after obtaining written explained the results of the medical (ii) The employer must ensure that the consent from the employee. examination to the employee, including employee is offered a medical (5) Licensed physician’s written any tests conducted, any medical examination that includes: medical report for the employee. The conditions related to airborne exposure (A) A medical and work history, with employer must ensure that the that require further evaluation or emphasis on past and present airborne employee receives a written medical treatment, and any special provisions exposure to or dermal contact with report from the licensed physician for use of personal protective clothing or beryllium, smoking history, and any within 45 days of the examination equipment; history of respiratory system (including any follow-up BeLPT (ii) If the employee provides written dysfunction; required under paragraph (k)(3)(ii)(E) of authorization, the written opinion must (B) A physical examination with this standard) and that the PLHCP also contain any recommended emphasis on the respiratory system; explains the results of the examination limitations on the employee’s airborne (C) A physical examination for skin to the employee. The written medical exposure to beryllium. rashes; report must contain: (iii) If the employee is confirmed (D) Pulmonary function tests, (i) A statement indicating the results positive or diagnosed with CBD or if the performed in accordance with the of the medical examination, including licensed physician otherwise deems it guidelines established by the American the licensed physician’s opinion as to appropriate, and the employee provides Thoracic Society including forced vital whether the employee has written authorization, the written capacity (FVC) and forced expiratory (A) Any detected medical condition, opinion must also contain a referral for volume in one second (FEV1); such as CBD or beryllium sensitization an evaluation at a CBD diagnostic (E) A standardized BeLPT or (i.e., the employee is confirmed center. equivalent test, upon the first (iv) If the employee is confirmed positive, as defined in paragraph (b) of examination and at least every two years positive or diagnosed with CBD and the this standard), that may place the thereafter, unless the employee is employee provides written employee at increased risk from further confirmed positive. If the results of the authorization, the written opinion must airborne exposure, and BeLPT are other than normal, a follow- also contain a recommendation for (B) Any medical conditions related to up BeLPT must be offered within 30 continued periodic medical airborne exposure that require further days, unless the employee has been surveillance. evaluation or treatment. confirmed positive. Samples must be (v) If the employee is confirmed (ii) Any recommendations on: analyzed in a laboratory certified under positive or diagnosed with CBD and the (A) The employee’s use of respirators, the College of American Pathologists/ employee provides written protective clothing, or equipment; or Clinical Laboratory Improvement authorization, the written opinion must Amendments (CLIA) guidelines to (B) Limitations on the employee’s also contain a recommendation for perform the BeLPT. airborne exposure to beryllium. medical removal from airborne exposure (F) A low dose computed tomography (iii) If the employee is confirmed to beryllium, as described in paragraph (LDCT) scan, when recommended by positive or diagnosed with CBD or if the (l). the PLHCP after considering the licensed physician otherwise deems it (vi) The employer must ensure that employee’s history of exposure to appropriate, the written report must also each employee receives a copy of the beryllium along with other risk factors, contain a referral for an evaluation at a written medical opinion described in such as smoking history, family medical CBD diagnostic center. paragraph (k)(6) of this standard within history, sex, age, and presence of (iv) If the employee is confirmed 45 days of any medical examination existing lung disease; and positive or diagnosed with CBD the (including any follow-up BeLPT (G) Any other test deemed appropriate written report must also contain a required under paragraph (k)(3)(ii)(E) of by the PLHCP. recommendation for continued periodic this standard) performed for that (4) Information provided to the medical surveillance. employee. PLHCP. The employer must ensure that (v) If the employee is confirmed (7) CBD diagnostic center. (i) The the examining PLHCP (and the agreed- positive or diagnosed with CBD the employer must provide an evaluation at upon CBD diagnostic center, if an written report must also contain a no cost to the employee at a CBD evaluation is required under paragraph recommendation for medical removal diagnostic center that is mutually agreed (k)(7) of this standard) has a copy of this from airborne exposure to beryllium, as upon by the employer and the standard and must provide the described in paragraph (l). employee. The examination must be following information, if known: (6) Licensed physician’s written provided within 30 days of: (i) A description of the employee’s medical opinion for the employer. (i) (A) The employer’s receipt of a former and current duties that relate to The employer must obtain a written physician’s written medical opinion to the employee’s airborne exposure to and medical opinion from the licensed the employer that recommends referral dermal contact with beryllium; physician within 45 days of the medical to a CBD diagnostic center; or (ii) The employee’s former and examination (including any follow-up (B) The employee presenting to the current levels of airborne exposure; BeLPT required under paragraph employer a physician’s written medical (iii) A description of any personal (k)(3)(ii)(E) of this standard). The report indicating that the employee has protective clothing and equipment, written medical opinion must contain been confirmed positive or diagnosed including respirators, used by the only the following: with CBD, or recommending referral to employee, including when and for how (A) The date of the examination; a CBD diagnostic center.

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(ii) The employer must ensure that the (ii) Remaining in a job with airborne (B) The employer must ensure each employee receives a written medical exposure at or above the action level, warning sign required by paragraph report from the CBD diagnostic center provided that the employer provides, (m)(2)(i) of this standard bears the that contains all the information and ensures that the employee uses, following legend: required in paragraph (k)(5)(i), (ii), (iv), respiratory protection that complies DANGER and (v) and that the PLHCP explains the with paragraph (g) of this standard REGULATED AREA results of the examination to the whenever airborne exposures are at or BERYLLIUM employee within 30 days of the above the action level. MAY CAUSE CANCER examination. (3) If the employee chooses removal: CAUSES DAMAGE TO LUNGS (iii) The employer must obtain a (i) If a comparable job is available AUTHORIZED PERSONNEL ONLY written medical opinion from the CBD where airborne exposures to beryllium WEAR RESPIRATORY PROTECTION AND diagnostic center within 30 days of the are below the action level, and the PERSONAL PROTECTIVE CLOTHING AND EQUIPMENT IN THIS AREA medical examination. The written employee is qualified for that job or can medical opinion must contain only the be trained within one month, the (3) Warning labels. Consistent with information in paragraphs (k)(6)(i), as employer must remove the employee to the HCS (29 CFR 1910.1200), the applicable, unless the employee that job. The employer must maintain employer must label each bag and provides written authorization to release for six months from the time of removal container of clothing, equipment, and additional information. If the employee the employee’s base earnings, seniority, materials contaminated with beryllium, provides written authorization, the and other rights and benefits that and must, at a minimum, include the written opinion must also contain the existed at the time of removal. following on the label: information from paragraphs (k)(6)(ii), (ii) If comparable work is not DANGER (iv), and (v), if applicable. available, the employer must maintain CONTAINS BERYLLIUM (iv) The employer must ensure that the employee’s base earnings, seniority, MAY CAUSE CANCER each employee receives a copy of the and other rights and benefits that CAUSES DAMAGE TO LUNGS written medical opinion from the CBD existed at the time of removal for six AVOID CREATING DUST diagnostic center described in paragraph months or until such time that DO NOT GET ON SKIN (k)(7) of this standard within 30 days of comparable work described in (4) Employee information and any medical examination performed for paragraph (l)(3)(i) becomes available, training. (i) For each employee who has, that employee. whichever comes first. or can reasonably be expected to have, (v) After an employee has received the (4) The employer’s obligation to airborne exposure to or dermal contact initial clinical evaluation at a CBD provide medical removal protection with beryllium: diagnostic center described in paragraph benefits to a removed employee shall be (A) The employer must provide (k)(7)(i) of this standard, the employee reduced to the extent that the employee information and training in accordance may choose to have any subsequent receives compensation for earnings lost with the HCS (29 CFR 1910.1200(h)); medical examinations for which the during the period of removal from a (B) The employer must provide initial employee is eligible under paragraph (k) publicly or employer-funded training to each employee by the time of of this standard performed at a CBD compensation program, or receives initial assignment; and diagnostic center mutually agreed upon income from another employer made (C) The employer must repeat the by the employer and the employee, and possible by virtue of the employee’s training required under this standard the employer must provide such removal. annually for each employee. examinations at no cost to the (m) Communication of hazards—(1) (ii) The employer must ensure that employee. General. (i) Chemical manufacturers, each employee who is, or can (l) Medical removal. (1) An employee importers, distributors, and employers reasonably be expected to be, exposed to is eligible for medical removal, if the must comply with all requirements of airborne beryllium can demonstrate employee works in a job with airborne the HCS (29 CFR 1910.1200) for knowledge and understanding of the exposure at or above the action level beryllium. following: and either: (ii) Employers must include beryllium (A) The health hazards associated (i) The employee provides the in the hazard communication program with airborne exposure to and contact employer with: established to comply with the HCS. with beryllium, including the signs and (A) A written medical report Employers must ensure that each symptoms of CBD; indicating a confirmed positive finding employee has access to labels on (B) The written exposure control plan, or CBD diagnosis; or containers of beryllium and to safety with emphasis on the location(s) of any (B) A written medical report data sheets, and is trained in accordance regulated areas, and the specific nature recommending removal from airborne with the requirements of the HCS (29 of operations that could result in exposure to beryllium in accordance CFR 1910.1200) and paragraph (m)(4) of airborne exposure, especially airborne with paragraph (k)(5)(v) or (k)(7)(ii) of this standard. exposure above the TWA PEL or STEL; this standard; or (2) Warning signs. (i) Posting. The (C) The purpose, proper selection, (ii) The employer receives a written employer must provide and display fitting, proper use, and limitations of medical opinion recommending warning signs at each approach to a personal protective clothing and removal from airborne exposure to regulated area so that each employee is equipment, including respirators; beryllium in accordance with paragraph able to read and understand the signs (D) Applicable emergency procedures; (k)(6)(v) or (k)(7)(iii) of this standard. and take necessary protective steps (E) Measures employees can take to (2) If an employee is eligible for before entering the area. protect themselves from airborne medical removal, the employer must (ii) Sign specification. (A) The exposure to and contact with beryllium, provide the employee with the employer must ensure that the warning including personal hygiene practices; employee’s choice of: signs required by paragraph (m)(2)(i) of (F) The purpose and a description of (i) Removal as described in paragraph this standard are legible and readily the medical surveillance program (l)(3) of this standard; or visible. required by paragraph (k) of this

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standard including risks and benefits of under paragraph (d)(2) of this standard, Director, each employee, and each each test to be offered; the employer must make and maintain employee’s designated representative(s) (G) The purpose and a description of a record of the objective data relied in accordance the Records Access the medical removal protection upon. standard (29 CFR 1910.1020). provided under paragraph (l) of this (ii) This record must include at least (6) Transfer of records. The employer standard; the following information: must comply with the requirements (H) The contents of the standard; and (A) The data relied upon; involving transfer of records set forth in (I) The employee’s right of access to (B) The beryllium-containing material the Records Access standard (29 CFR records under the Records Access in question; 1910.1020). standard (29 CFR 1910.1020). (C) The source of the objective data; (iii) When a workplace change (such (D) A description of the process, task, (o) Dates—(1) Effective date. This as modification of equipment, tasks, or or activity on which the objective data standard shall become effective March procedures) results in new or increased were based; and 10, 2017. airborne exposure that exceeds, or can (E) Other data relevant to the process, (2) Compliance dates. All obligations reasonably be expected to exceed, either task, activity, material, or airborne of this standard commence and become the TWA PEL or the STEL, the employer exposure on which the objective data enforceable on March 12, 2018, except: must provide additional training to were based. (i) Change rooms required by those employees affected by the change (iii) The employer must ensure that paragraph (i) of this standard must be in airborne exposure. objective data are maintained and made provided by March 11, 2019; and (iv) Employee information. The available in accordance with the (ii) Engineering controls required by employer must make a copy of this Records Access standard (29 CFR paragraph (f) of this standard must be standard and its appendices readily 1910.1020). implemented by March 10, 2020. available at no cost to each employee (3) Medical surveillance. (i) The and designated employee employer must make and maintain a PART 1926—SAFETY AND HEALTH representative(s). record for each employee covered by REGULATIONS FOR CONSTRUCTION (n) Recordkeeping—(1) Air monitoring medical surveillance under paragraph data. (i) The employer must make and (k) of this standard. Subpart D—Occupational Health and maintain a record of all exposure (ii) The record must include the Environmental Controls measurements taken to assess airborne following information about each exposure as prescribed in paragraph (d) employee: ■ 7. The authority citation for subpart D of this standard. (A) Name, social security number, and of part 1926 is revised to read as (ii) This record must include at least job classification; follows: the following information: (B) A copy of all licensed physicians’ Authority: 40 U.S.C. 3704; 29 U.S.C. 653, (A) The date of measurement for each written medical opinions for each 655, 657; Secretary of Labor’s Order No. 12– sample taken; employee; and 71 (36 FR 8754), 8–76 (41 FR 25059), 9–83 (B) The task that is being monitored; (C) A copy of the information (48 FR 35736), 1–90 (55 FR 9033), 6–96 (62 (C) The sampling and analytical provided to the PLHCP as required by FR 111), 3–2000 (65 FR 50017), 5–2002 (67 methods used and evidence of their paragraph (k)(4) of this standard. FR 65008), 5–2007 (72 FR 31160), 4–2010 (75 accuracy; (iii) The employer must ensure that FR 55355), or 1–2012 (77 FR 3912); 29 CFR (D) The number, duration, and results medical records are maintained and part 1911; and 5 U.S.C. 553, as applicable. of samples taken; made available in accordance with the Section 1926.61 also issued under 49 (E) The type of personal protective Records Access standard (29 CFR U.S.C. 5101 et seq. Section 1926.62 also issued under 42 clothing and equipment, including 1910.1020). U.S.C. 4853. respirators, worn by monitored (4) Training. (i) At the completion of Section 1926.65 also issued under 126 of employees at the time of monitoring; any training required by this standard, Public Law 99–499, 100 Stat. 1613. and the employer must prepare a record that ■ 8. In § 1926.55, amend appendix A by (F) The name, social security number, indicates the name, social security revising the entry for ‘‘Beryllium and and job classification of each employee number, and job classification of each beryllium compounds (as Be)’’ and represented by the monitoring, employee trained, the date the training adding footnote q. indicating which employees were was completed, and the topic of the actually monitored. training. The revisions read as follows: (iii) The employer must ensure that (ii) This record must be maintained § 1926.55 Gases, vapors, fumes, dusts, exposure records are maintained and for three years after the completion of and mists. training. made available in accordance with the * * * * * Records Access standard (29 CFR (5) Access to records. Upon request, 1910.1020). the employer must make all records Appendix A to § 1926.55—1970 (2) Objective data. (i) Where an maintained as a requirement of this American Conference of Governmental employer uses objective data to satisfy standard available for examination and Industrial Hygienists’ Threshold Limit the exposure assessment requirements copying to the Assistant Secretary, the Values of Airborne Contaminants

THRESHOLD LIMIT VALUES OF AIRBORNE CONTAMINANTS FOR CONSTRUCTION

Substance CAS No.d ppm a* mg/m 3b Skin designation

******* Beryllium and beryllium compounds (as Be); see 1926.1124 (q) ...... 7440–41–7 ...... 0.002 ......

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THRESHOLD LIMIT VALUES OF AIRBORNE CONTAMINANTS FOR CONSTRUCTION—Continued

Substance CAS No.d ppm a* mg/m 3b Skin designation

******* a Parts of vapor or gas per million parts of contaminated air by volume at 25 °C and 760 torr. b Milligrams of substance per cubic meter of air. When entry is in this column only, the value is exact; when listed with a ppm entry, it is ap- proximate. ******* d The CAS number is for information only. Enforcement is based on the substance name. For an entry covering more than one metal com- pound, measured as the metal, the CAS number for the metal is given—not CAS numbers for the individual compounds. ******* q This standard applies to any operations or sectors for which the beryllium standard, 1926.1124, is stayed or otherwise is not in effect.

* * * * * Beryllium lymphocyte proliferation percent efficient in removing particles test (BeLPT) means the measurement of 0.3 micrometers in diameter. Subpart Z—Toxic and Hazardous blood lymphocyte proliferation in a Objective data means information, Substances laboratory test when lymphocytes are such as air monitoring data from challenged with a soluble beryllium industry-wide surveys or calculations ■ 9. The authority for subpart Z of part salt. based on the composition of a 1926 is revised to read as follows: CBD diagnostic center means a substance, demonstrating airborne Authority: 40 U.S.C. 3704; 29 U.S.C. 653, medical diagnostic center that has an exposure to beryllium associated with a 655, 657; Secretary of Labor’s Order No. 12– on-site pulmonary specialist and on-site particular product or material or a 71 (36 FR 8754), 8–76 (41 FR 25059), 9–83 facilities to perform a clinical evaluation specific process, task, or activity. The (48 FR 35736), 1–90 (55 FR 9033), 6–96 (62 for the presence of chronic beryllium data must reflect workplace conditions FR 111), 3–2000 (65 FR 50017), 5–2002 (67 disease (CBD). This evaluation must closely resembling or with a higher FR 65008), 5–2007 (72 FR 31160), 4–2010 (75 FR 55355), or 1–2012 (77 FR 3912); 29 CFR include pulmonary function testing (as airborne exposure potential than the part 1911; and 5 U.S.C. 553, as applicable. outlined by the American Thoracic processes, types of material, control ■ Society criteria), bronchoalveolar lavage methods, work practices, and 10. Add § 1926.1124 to read as (BAL), and transbronchial biopsy. The environmental conditions in the follows: CBD diagnostic center must also have employer’s current operations. § 1926.1124 Beryllium. the capacity to transfer BAL samples to Physician or other licensed health care professional (PLHCP) means an (a) Scope and application. (1) This a laboratory for appropriate diagnostic individual whose legally permitted standard applies to occupational testing within 24 hours. The on-site scope of practice (i.e., license, exposure to beryllium in all forms, pulmonary specialist must be able to registration, or certification) allows the compounds, and mixtures in interpret the biopsy pathology and the individual to independently provide or construction, except those articles and BAL diagnostic test results. Chronic beryllium disease (CBD) be delegated the responsibility to materials exempted by paragraphs (a)(2) means a chronic lung disease associated provide some or all of the health care and (a)(3) of this standard. with airborne exposure to beryllium. services required by paragraph (k) of (2) This standard does not apply to Competent person means an this standard. articles, as defined in the Hazard individual who is capable of identifying This standard means this beryllium Communication standard (HCS) (29 CFR existing and foreseeable beryllium standard, 29 CFR 1926.1124. 1910.1200(c)), that contain beryllium hazards in the workplace and who has (c) Permissible Exposure Limits and that the employer does not process. authorization to take prompt corrective (PELs)—(1) Time-weighted average (3) This standard does not apply to measures to eliminate or minimize (TWA) PEL. The employer must ensure materials containing less than 0.1% them. The competent person must have that no employee is exposed to an beryllium by weight where the the knowledge, ability, and authority airborne concentration of beryllium in employer has objective data necessary to fulfill the responsibilities excess of 0.2 mg/m3 calculated as an 8- demonstrating that employee exposure set forth in paragraph (e) of this hour TWA. to beryllium will remain below the standard. (2) Short-term exposure limit (STEL). action level as an 8-hour TWA under Confirmed positive means the person The employer must ensure that no any foreseeable conditions. tested has beryllium sensitization, as employee is exposed to an airborne (b) Definitions. As used in this indicated by two abnormal BeLPT test concentration of beryllium in excess of standard: results, an abnormal and a borderline 2.0 mg/m3 as determined over a Action level means a concentration of test result, or three borderline test sampling period of 15 minutes. airborne beryllium of 0.1 micrograms results. It also means the result of a (d) Exposure assessment—(1) General. per cubic meter of air (mg/m3) calculated more reliable and accurate test The employer must assess the airborne as an 8-hour time-weighted average indicating a person has been identified exposure of each employee who is or (TWA). as having beryllium sensitization. may reasonably be expected to be Airborne exposure and airborne Director means the Director of the exposed to airborne beryllium in exposure to beryllium mean the National Institute for Occupational accordance with either the performance exposure to airborne beryllium that Safety and Health (NIOSH), U.S. option in paragraph (d)(2) or the would occur if the employee were not Department of Health and Human scheduled monitoring option in using a respirator. Services, or designee. paragraph (d)(3) of this standard. Assistant Secretary means the Emergency means any uncontrolled (2) Performance option. The employer Assistant Secretary of Labor for release of airborne beryllium. must assess the 8-hour TWA exposure Occupational Safety and Health, United High-efficiency particulate air (HEPA) and the 15-minute short-term exposure States Department of Labor, or designee. filter means a filter that is at least 99.97 for each employee on the basis of any

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combination of air monitoring data and employer must repeat such monitoring must provide each observer with objective data sufficient to accurately within three months of the most recent appropriate personal protective clothing characterize airborne exposure to short-term exposure monitoring until and equipment at no cost to the beryllium. two consecutive measurements, taken 7 observer. (3) Scheduled monitoring option. (i) or more days apart, are below the STEL, (iii) The employer must ensure that The employer must perform initial at which time the employer may each observer follows all other monitoring to assess the 8-hour TWA discontinue short-term exposure applicable safety and health procedures. exposure for each employee on the basis monitoring for those employees whose (e) Competent person. Wherever of one or more personal breathing zone exposure is represented by such employees are, or can reasonably be air samples that reflect the airborne monitoring, except as otherwise expected to be, exposed to airborne exposure of employees on each shift, for provided in paragraph (d)(4) of this beryllium at levels above the TWA PEL each job classification, and in each work standard. or STEL, the employer must designate a area. (4) Reassessment of exposure. The competent person to (ii) The employer must perform initial employer must reassess airborne (1) Make frequent and regular monitoring to assess the short-term exposure whenever a change in the inspections of job sites, materials, and exposure from 15-minute personal production, process, control equipment, equipment; breathing zone air samples measured in personnel, or work practices may (2) Implement the written exposure operations that are likely to produce reasonably be expected to result in new control plan under paragraph (f) of this airborne exposure above the STEL for or additional airborne exposure at or standard; each work shift, for each job above the action level or STEL, or when (3) Ensure that all employees use classification, and in each work area. the employer has any reason to believe respiratory protection in accordance (iii) Where several employees perform that new or additional airborne with paragraph (g) of this standard; and the same tasks on the same shift and in exposure at or above the action level or (4) Ensure that all employees use the same work area, the employer may STEL has occurred. personal protective clothing and sample a representative fraction of these (5) Methods of sample analysis. The equipment in accordance with employees in order to meet the employer must ensure that all air paragraph (h) of this standard. requirements of paragraph (d)(3). In monitoring samples used to satisfy the (f) Methods of compliance—(1) representative sampling, the employer monitoring requirements of paragraph Written exposure control plan. (i) The must sample the employee(s) expected (d) of this standard are evaluated by a employer must establish, implement, to have the highest airborne exposure to laboratory that can measure beryllium to and maintain a written exposure control beryllium. an accuracy of plus or minus 25 percent plan, which must contain: (iv) If initial monitoring indicates that within a statistical confidence level of (A) A list of operations and job titles airborne exposure is below the action 95 percent for airborne concentrations at reasonably expected to involve airborne level and at or below the STEL, the or above the action level. exposure to or dermal contact with employer may discontinue monitoring (6) Employee notification of beryllium; (B) A list of operations and job titles for those employees whose airborne assessment results. (i) Within 15 reasonably expected to involve airborne exposure is represented by such working days after completing an exposure assessment in accordance with exposure at or above the action level; monitoring. (C) A list of operations and job titles (v) Where the most recent exposure paragraph (d) of this standard, the reasonably expected to involve airborne employer must notify each employee monitoring indicates that airborne exposure above the TWA PEL or STEL; exposure is at or above the action level whose airborne exposure is represented (D) Procedures for minimizing cross- but at or below the TWA PEL, the by the assessment of the results of that contamination; employer must repeat such monitoring assessment individually in writing or (E) Procedures for minimizing the within six months of the most recent post the results in an appropriate migration of beryllium within or to monitoring. location that is accessible to each of locations outside the workplace; (vi) Where the most recent exposure these employees. (F) A list of engineering controls, monitoring indicates that airborne (ii) Whenever an exposure assessment work practices, and respiratory exposure is above the TWA PEL, the indicates that airborne exposure is protection required by paragraph (f)(2) employer must repeat such monitoring above the TWA PEL or STEL, the of this standard; within three months of the most recent employer must describe in the written (G) A list of personal protective 8-hour TWA exposure monitoring. notification the corrective action being clothing and equipment required by (vii) Where the most recent (non- taken to reduce airborne exposure to or paragraph (h) of this standard; initial) exposure monitoring indicates below the exposure limit(s) exceeded (H) Procedures for removing, that airborne exposure is below the where feasible corrective action exists laundering, storing, cleaning, repairing, action level, the employer must repeat but had not been implemented when the and disposing of beryllium- such monitoring within six months of monitoring was conducted. contaminated personal protective the most recent monitoring until two (7) Observation of monitoring. (i) The clothing and equipment, including consecutive measurements, taken 7 or employer must provide an opportunity respirators; and more days apart, are below the action to observe any exposure monitoring (I) Procedures used to restrict access level, at which time the employer may required by this standard to each to work areas when airborne exposures discontinue 8-hour TWA exposure employee whose airborne exposure is are, or can reasonably be expected to be, monitoring for those employees whose measured or represented by the above the TWA PEL or STEL, to exposure is represented by such monitoring and each employee’s minimize the number of employees monitoring, except as otherwise representative(s). exposed to airborne beryllium and their provided in paragraph (d)(4) of this (ii) When observation of monitoring level of exposure, including exposures standard. requires entry into an area where the generated by other employers or sole (viii) Where the most recent exposure use of personal protective clothing or proprietors. monitoring indicates that airborne equipment (which may include (ii) The employer must review and exposure is above the STEL, the respirators) is required, the employer evaluate the effectiveness of each

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written exposure control plan at least (f)(2)(i) and (f)(2)(iii), the employer must written exposure control plan required annually and update it, as necessary, implement and maintain engineering under paragraph (f)(1) of this standard when: and work practice controls to reduce and OSHA’s Personal Protective and (A) Any change in production airborne exposure to the lowest levels Life Saving Equipment standards for processes, materials, equipment, feasible and supplement these controls construction (29 CFR part 1926 Subpart personnel, work practices, or control by using respiratory protection in E): methods results, or can reasonably be accordance with paragraph (g) of this (i) Where airborne exposure exceeds, expected to result, in new or additional standard. or can reasonably be expected to exceed, airborne exposure to beryllium; (3) Prohibition of rotation. The the TWA PEL or STEL; or (B) The employer is notified that an employer must not rotate employees to (ii) Where there is a reasonable employee is eligible for medical removal different jobs to achieve compliance expectation of dermal contact with in accordance with paragraph (l)(1) of with the PELs. beryllium. this standard, referred for evaluation at (g) Respiratory protection—(1) (2) Removal and storage. (i) The a CBD diagnostic center, or shows signs General. The employer must provide employer must ensure that each or symptoms associated with airborne respiratory protection at no cost to the employee removes all beryllium- exposure to or dermal contact with employee and ensure that each contaminated personal protective beryllium; or employee uses respiratory protection: clothing and equipment at the end of (C) The employer has any reason to (i) During periods necessary to install the work shift, at the completion of believe that new or additional airborne or implement feasible engineering and tasks involving beryllium, or when exposure is occurring or will occur. work practice controls where airborne personal protective clothing or (iii) The employer must make a copy exposure exceeds, or can reasonably be equipment becomes visibly of the written exposure control plan expected to exceed, the TWA PEL or contaminated with beryllium, accessible to each employee who is, or STEL; whichever comes first. can reasonably be expected to be, (ii) During operations, including (ii) The employer must ensure that exposed to airborne beryllium in maintenance and repair activities and each employee removes beryllium- accordance with OSHA’s Access to non-routine tasks, when engineering contaminated personal protective Employee Exposure and Medical and work practice controls are not clothing and equipment as specified in Records (Records Access) standard (29 feasible and airborne exposure exceeds, the written exposure control plan CFR 1910.1020(e)). or can reasonably be expected to exceed, required by paragraph (f)(1) of this (2) Engineering and work practice the TWA PEL or STEL; standard. controls. (i) Where exposures are, or can (iii) During operations for which an (iii) The employer must ensure that reasonably be expected to be, at or employer has implemented all feasible each employee stores and keeps above the action level, the employer engineering and work practice controls beryllium-contaminated personal must ensure that at least one of the when such controls are not sufficient to protective clothing and equipment following is in place to reduce airborne reduce airborne exposure to or below separate from street clothing and that exposure: the TWA PEL or STEL; storage facilities prevent cross- (A) Material and/or process (iv) During emergencies; and contamination as specified in the substitution; (v) When an employee who is eligible written exposure control plan required (B) Isolation, such as ventilated for medical removal under paragraph by paragraph (f)(1) of this standard. partial or full enclosures; (l)(1) chooses to remain in a job with (iv) The employer must ensure that no (C) Local exhaust ventilation, such as airborne exposure at or above the action employee removes beryllium- at the points of operation, material level, as permitted by paragraph (l)(2)(ii) contaminated personal protective handling, and transfer; or of this standard. clothing or equipment from the (D) Process control, such as wet (2) Respiratory protection program. workplace, except for employees methods and automation. Where this standard requires an authorized to do so for the purposes of (ii) An employer is exempt from using employer to provide respiratory laundering, cleaning, maintaining or the controls listed in paragraph (f)(2)(i) protection, the selection and use of such disposing of beryllium-contaminated of this standard to the extent that: respiratory protection must be in personal protective clothing and (A) The employer can establish that accordance with the Respiratory equipment at an appropriate location or such controls are not feasible; or Protection standard (29 CFR 1910.134). facility away from the workplace. (B) The employer can demonstrate (3) The employer must provide at no (v) When personal protective clothing that airborne exposure is below the cost to the employee a powered air- or equipment required by this standard action level, using no fewer than two purifying respirator (PAPR) instead of a is removed from the workplace for representative personal breathing zone negative pressure respirator when laundering, cleaning, maintenance or samples taken at least 7 days apart, for (i) Respiratory protection is required disposal, the employer must ensure that each affected operation. by this standard; personal protective clothing and (iii) If airborne exposure exceeds the (ii) An employee entitled to such equipment are stored and transported in TWA PEL or STEL after implementing respiratory protection requests a PAPR; sealed bags or other closed containers the control(s) required by paragraph and that are impermeable and are labeled in (f)(2)(i) of this standard, the employer (iii) The PAPR provides adequate accordance with paragraph (m)(2) of this must implement additional or enhanced protection to the employee in standard and the HCS (29 CFR engineering and work practice controls accordance with paragraph (g)(2) of this 1910.1200). to reduce airborne exposure to or below standard. (3) Cleaning and replacement. (i) The the exposure limit(s) exceeded. (h) Personal protective clothing and employer must ensure that all reusable (iv) Wherever the employer equipment—(1) Provision and use. The personal protective clothing and demonstrates that it is not feasible to employer must provide at no cost, and equipment required by this standard is reduce airborne exposure to or below ensure that each employee uses, cleaned, laundered, repaired, and the PELs by the engineering and work appropriate personal protective clothing replaced as needed to maintain its practice controls required by paragraphs and equipment in accordance with the effectiveness.

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(ii) The employer must ensure that there is a reasonable expectation of (D) Whose most recent written beryllium is not removed from personal exposure above the TWA PEL or STEL. medical opinion required by paragraph protective clothing and equipment by (j) Housekeeping—(1) General. (i) (k)(6) or (k)(7) recommends periodic blowing, shaking or any other means When cleaning beryllium-contaminated medical surveillance. that disperses beryllium into the air. areas, the employer must follow the (ii) The employer must ensure that all (iii) The employer must inform in written exposure control plan required medical examinations and procedures writing the persons or the business under paragraph (f)(1) of this standard; required by this standard are performed entities who launder, clean or repair the (ii) The employer must ensure that all by, or under the direction of, a licensed personal protective clothing or spills and emergency releases of physician. equipment required by this standard of beryllium are cleaned up promptly and (2) Frequency. The employer must the potentially harmful effects of in accordance with the written exposure provide a medical examination: airborne exposure to and dermal contact control plan required under paragraph (i) Within 30 days after determining with beryllium and that the personal (f)(1) of this standard. that: protective clothing and equipment must (2) Cleaning methods. (i) When (A) An employee meets the criteria of be handled in accordance with this cleaning beryllium-contaminated areas, paragraph (k)(1)(i)(A), unless the standard. the employer must ensure the use of employee has received a medical (i) Hygiene areas and practices—(1) HEPA-filtered vacuuming or other examination, provided in accordance General. For each employee required to methods that minimize the likelihood with this standard, within the last two use personal protective clothing or and level of airborne exposure. years; or equipment by this standard, the (ii) The employer must not allow dry (B) An employee meets the criteria of employer must: sweeping or brushing for cleaning in paragraph (k)(1)(i)(B) or (C). (ii) At least every two years thereafter (i) Provide readily accessible washing beryllium-contaminated areas unless for each employee who continues to facilities in accordance with this HEPA-filtered vacuuming or other meet the criteria of paragraph standard and the Sanitation standard methods that minimize the likelihood (k)(1)(i)(A), (B), or (D) of this standard. (§ 1926.51) to remove beryllium from and level of airborne exposure are not (iii) At the termination of employment the hands, face, and neck; and safe or effective. for each employee who meets any of the (ii) Ensure that employees who have (iii) The employer must not allow the criteria of paragraph (k)(1)(i) of this dermal contact with beryllium wash any use of compressed air for cleaning in standard at the time the employee’s exposed skin at the end of the activity, beryllium-contaminated areas unless the employment terminates, unless an process, or work shift and prior to compressed air is used in conjunction examination has been provided in eating, drinking, smoking, chewing with a ventilation system designed to accordance with this standard during tobacco or gum, applying cosmetics, or capture the particulates made airborne the six months prior to the date of using the toilet. by the use of compressed air. termination. (2) Change rooms. In addition to the (iv) Where employees use dry (3) Contents of examination. (i) The requirements of paragraph (i)(1)(i) of sweeping, brushing, or compressed air employer must ensure that the PLHCP this standard, the employer must to clean in beryllium-contaminated conducting the examination advises the provide employees required to use areas, the employer must provide, and employee of the risks and benefits of personal protective clothing by this ensure that each employee uses, participating in the medical surveillance standard with a designated change room respiratory protection and personal program and the employee’s right to opt in accordance with this standard and protective clothing and equipment in out of any or all parts of the medical the Sanitation standard (§ 1926.51) accordance with paragraphs (g) and (h) examination. where employees are required to remove of this standard. (ii) The employer must ensure that the their personal clothing. (v) The employer must ensure that employee is offered a medical (3) Eating and drinking areas. cleaning equipment is handled and examination that includes: Wherever the employer allows maintained in a manner that minimizes (A) A medical and work history, with employees to consume food or the likelihood and level of airborne emphasis on past and present airborne beverages at a worksite where beryllium exposure and the re-entrainment of exposure to or dermal contact with is present, the employer must ensure airborne beryllium in the workplace. beryllium, smoking history, and any that: (3) Disposal. When the employer history of respiratory system (i) Surfaces in eating and drinking transfers materials containing beryllium dysfunction; areas are as free as practicable of to another party for use or disposal, the (B) A physical examination with beryllium; employer must provide the recipient emphasis on the respiratory system; (ii) No employees enter any eating or with a copy of the warning described in (C) A physical examination for skin drinking area with personal protective paragraph (m)(2) of this standard. rashes; clothing or equipment unless, prior to (k) Medical surveillance—(1) General. (D) Pulmonary function tests, entry, surface beryllium has been (i) The employer must make medical performed in accordance with the removed from the clothing or equipment surveillance required by this paragraph guidelines established by the American by methods that do not disperse available at no cost to the employee, and Thoracic Society including forced vital beryllium into the air or onto an at a reasonable time and place, to each capacity (FVC) and forced expiratory employee’s body; and employee: volume in one second (FEV1); (iii) Eating and drinking facilities (A) Who is or is reasonably expected (E) A standardized BeLPT or provided by the employer are in to be exposed at or above the action equivalent test, upon the first accordance with the Sanitation standard level for more than 30 days per year; examination and at least every two years (§ 1926.51). (B) Who shows signs or symptoms of thereafter, unless the employee is (4) Prohibited activities. The employer CBD or other beryllium-related health confirmed positive. If the results of the must ensure that no employees eat, effects; BeLPT are other than normal, a follow- drink, smoke, chew tobacco or gum, or (C) Who is exposed to beryllium up BeLPT must be offered within 30 apply cosmetics in work areas where during an emergency; or days, unless the employee has been

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confirmed positive. Samples must be (ii) Any recommendations on: (v) If the employee is confirmed analyzed in a laboratory certified under (A) The employee’s use of respirators, positive or diagnosed with CBD and the the College of American Pathologists/ protective clothing, or equipment; or employee provides written Clinical Laboratory Improvement (B) Limitations on the employee’s authorization, the written opinion must Amendments (CLIA) guidelines to airborne exposure to beryllium. also contain a recommendation for perform the BeLPT. (iii) If the employee is confirmed medical removal from airborne exposure (F) A low dose computed tomography positive or diagnosed with CBD or if the to beryllium, as described in paragraph (LDCT) scan, when recommended by licensed physician otherwise deems it (l). the PLHCP after considering the appropriate, the written report must also (vi) The employer must ensure that employee’s history of exposure to contain a referral for an evaluation at a each employee receives a copy of the beryllium along with other risk factors, CBD diagnostic center. written medical opinion described in such as smoking history, family medical (iv) If the employee is confirmed paragraph (k)(6) of this standard within history, sex, age, and presence of positive or diagnosed with CBD the 45 days of any medical examination existing lung disease; and written report must also contain a (including any follow-up BeLPT (G) Any other test deemed appropriate recommendation for continued periodic required under paragraph (k)(3)(ii)(E) of by the PLHCP. medical surveillance. this standard) performed for that (4) Information provided to the (v) If the employee is confirmed employee. PLHCP. The employer must ensure that positive or diagnosed with CBD the (7) CBD diagnostic center. (i) The the examining PLHCP (and the agreed- written report must also contain a employer must provide an evaluation at upon CBD diagnostic center, if an recommendation for medical removal no cost to the employee at a CBD evaluation is required under paragraph from airborne exposure to beryllium, as diagnostic center that is mutually agreed (k)(7) of this standard) has a copy of this described in paragraph (l). upon by the employer and the standard and must provide the (6) Licensed physician’s written employee. The examination must be following information, if known: medical opinion for the employer. (i) provided within 30 days of: (A) The employer’s receipt of a (i) A description of the employee’s The employer must obtain a written physician’s written medical opinion to former and current duties that relate to medical opinion from the licensed the employer that recommends referral the employee’s airborne exposure to and physician within 45 days of the medical to a CBD diagnostic center; or dermal contact with beryllium; examination (including any follow-up (ii) The employee’s former and (B) The employee presenting to the BeLPT required under paragraph current levels of airborne exposure; employer a physician’s written medical (iii) A description of any personal (k)(3)(ii)(E) of this standard). The report indicating that the employee has protective clothing and equipment, written medical opinion must contain been confirmed positive or diagnosed including respirators, used by the only the following: with CBD, or recommending referral to employee, including when and for how (A) The date of the examination; a CBD diagnostic center. long the employee has used that (B) A statement that the examination (ii) The employer must ensure that the personal protective clothing and has met the requirements of this employee receives a written medical equipment; and standard; report from the CBD diagnostic center (iv) Information from records of (C) Any recommended limitations on that contains all the information employment-related medical the employee’s use of respirators, required in paragraphs (k)(5)(i), (ii), (iv), examinations previously provided to the protective clothing, or equipment; and and (v) of this standard and that the employee, currently within the control (D) A statement that the PLHCP has PLHCP explains the results of the of the employer, after obtaining written explained the results of the medical examination to the employee within 30 consent from the employee. examination to the employee, including days of the examination. (5) Licensed physician’s written any tests conducted, any medical (iii) The employer must obtain a medical report for the employee. The conditions related to airborne exposure written medical opinion from the CBD employer must ensure that the that require further evaluation or diagnostic center within 30 days of the employee receives a written medical treatment, and any special provisions medical examination. The written report from the licensed physician for use of personal protective clothing or medical opinion must contain only the within 45 days of the examination equipment; information in paragraph (k)(6)(i) of this (including any follow-up BeLPT (ii) If the employee provides written standard, as applicable, unless the required under paragraph (k)(3)(ii)(E) of authorization, the written opinion must employee provides written this standard) and that the PLHCP also contain any recommended authorization to release additional explains the results of the examination limitations on the employee’s airborne information. If the employee provides to the employee. The written medical exposure to beryllium. written authorization, the written report must contain: (iii) If the employee is confirmed opinion must also contain the (i) A statement indicating the results positive or diagnosed with CBD or if the information from paragraphs (k)(6)(ii), of the medical examination, including licensed physician otherwise deems it (iv), and (v), if applicable. the licensed physician’s opinion as to appropriate, and the employee provides (iv) The employer must ensure that whether the employee has written authorization, the written each employee receives a copy of the (A) Any detected medical condition, opinion must also contain a referral for written medical opinion from the CBD such as CBD or beryllium sensitization an evaluation at a CBD diagnostic diagnostic center described in paragraph (i.e., the employee is confirmed center. (k)(7) of this standard within 30 days of positive, as defined in paragraph (b) of (iv) If the employee is confirmed any medical examination performed for this standard), that may place the positive or diagnosed with CBD and the that employee. employee at increased risk from further employee provides written (v) After an employee has received the airborne exposure, and authorization, the written opinion must initial clinical evaluation at a CBD (B) Any medical conditions related to also contain a recommendation for diagnostic center described in paragraph airborne exposure that require further continued periodic medical (k)(7)(i) of this standard, the employee evaluation or treatment. surveillance. may choose to have any subsequent

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medical examinations for which the publicly or employer-funded (E) Measures employees can take to employee is eligible under paragraph (k) compensation program, or receives protect themselves from airborne of this standard performed at a CBD income from another employer made exposure to and dermal contact with diagnostic center mutually agreed upon possible by virtue of the employee’s beryllium, including personal hygiene by the employer and the employee, and removal. practices; the employer must provide such (m) Communication of hazards—(1) (F) The purpose and a description of examinations at no cost to the General. (i) Chemical manufacturers, the medical surveillance program employee. importers, distributors, and employers required by paragraph (k) of this (l) Medical removal. (1) An employee must comply with all requirements of standard including risks and benefits of is eligible for medical removal, if the the HCS (29 CFR 1910.1200) for each test to be offered; employee works in a job with airborne beryllium. (G) The purpose and a description of exposure at or above the action level (ii) Employers must include beryllium the medical removal protection and either: in the hazard communication program provided under paragraph (l) of this (i) The employee provides the established to comply with the HCS. standard; employer with: Employers must ensure that each (H) The contents of the standard; and (A) A written medical report employee has access to labels on (I) The employee’s right of access to indicating a confirmed positive finding containers of beryllium and to safety records under the Records Access or CBD diagnosis; or data sheets, and is trained in accordance standard (29 CFR 1910.1020). (B) A written medical report with the requirements of the HCS (29 (iii) When a workplace change (such recommending removal from airborne CFR 1910.1200) and paragraph (m)(4) of as modification of equipment, tasks, or exposure to beryllium in accordance this standard. procedures) results in new or increased with paragraph (k)(5)(v) or (k)(7)(ii) of (2) Warning labels. Consistent with airborne exposure that exceeds, or can this standard; or the HCS (29 CFR 1910.1200), the reasonably be expected to exceed, either (ii) The employer receives a written employer must label each bag and the TWA PEL or the STEL, the employer medical opinion recommending container of clothing, equipment, and must provide additional training to removal from airborne exposure to materials contaminated with beryllium, those employees affected by the change beryllium in accordance with paragraph and must, at a minimum, include the in airborne exposure. (k)(6)(v) or (k)(7)(iii) of this standard. following on the label: (iv) Employee information. The (2) If an employee is eligible for employer must make a copy of this medical removal, the employer must DANGER standard and its appendices readily provide the employee with the CONTAINS BERYLLIUM MAY CAUSE CANCER available at no cost to each employee employee’s choice of: CAUSES DAMAGE TO LUNGS and designated employee (i) Removal as described in paragraph AVOID CREATING DUST representative(s). (l)(3) of this standard; or DO NOT GET ON SKIN (n) Recordkeeping—(1) Air monitoring (ii) Remaining in a job with airborne data. (i) The employer must make and exposure at or above the action level, (3) Employee information and maintain a record of all exposure provided that the employer provides, training. (i) For each employee who has, measurements taken to assess airborne and ensures that the employee uses, or can reasonably be expected to have, exposure as prescribed in paragraph (d) respiratory protection that complies airborne exposure to or dermal contact of this standard. with paragraph (g) of this standard with beryllium: (ii) This record must include at least whenever airborne exposures are at or (A) The employer must provide the following information: above the action level. information and training in accordance (A) The date of measurement for each (3) If the employee chooses removal: with the HCS (29 CFR 1910.1200(h)); sample taken; (i) If a comparable job is available (B) The employer must provide initial (B) The task that is being monitored; where airborne exposures to beryllium training to each employee by the time of (C) The sampling and analytical are below the action level, and the initial assignment; and methods used and evidence of their employee is qualified for that job or can (C) The employer must repeat the accuracy; be trained within one month, the training required under this standard (D) The number, duration, and results employer must remove the employee to annually for each employee. of samples taken; that job. The employer must maintain (ii) The employer must ensure that (E) The type of personal protective for six months from the time of removal each employee who is, or can clothing and equipment, including the employee’s base earnings, seniority, reasonably be expected to be, exposed to respirators, worn by monitored and other rights and benefits that airborne beryllium can demonstrate employees at the time of monitoring; existed at the time of removal. knowledge and understanding of the and (ii) If comparable work is not following: (F) The name, social security number, available, the employer must maintain (A) The health hazards associated and job classification of each employee the employee’s base earnings, seniority, with airborne exposure to and dermal represented by the monitoring, and other rights and benefits that contact with beryllium, including the indicating which employees were existed at the time of removal for six signs and symptoms of CBD; actually monitored. months or until such time that (B) The written exposure control plan, (iii) The employer must ensure that comparable work described in with emphasis on the specific nature of exposure records are maintained and paragraph (l)(3)(i) becomes available, operations that could result in airborne made available in accordance with the whichever comes first. exposure, especially airborne exposure Records Access standard (29 CFR (4) The employer’s obligation to above the TWA PEL or STEL; 1910.1020). provide medical removal protection (C) The purpose, proper selection, (2) Objective data. (i) Where an benefits to a removed employee shall be fitting, proper use, and limitations of employer uses objective data to satisfy reduced to the extent that the employee personal protective clothing and the exposure assessment requirements receives compensation for earnings lost equipment, including respirators; under paragraph (d)(2) of this standard, during the period of removal from a (D) Applicable emergency procedures; the employer must make and maintain

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a record of the objective data relied (A) Name, social security number, and standard available for examination and upon. job classification; copying to the Assistant Secretary, the (ii) This record must include at least (B) A copy of all licensed physicians’ Director, each employee, and each the following information: written medical opinions for each employee’s designated representative(s) (A) The data relied upon; employee; and in accordance the Records Access (B) The beryllium-containing material (C) A copy of the information standard (29 CFR 1910.1020). in question; provided to the PLHCP as required by (6) Transfer of records. The employer (C) The source of the objective data; paragraph (k)(4) of this standard. (D) A description of the process, task, must comply with the requirements (iii) The employer must ensure that or activity on which the objective data involving transfer of records set forth in medical records are maintained and were based; and the Records Access standard (29 CFR (E) Other data relevant to the process, made available in accordance with the 1910.1020). Records Access standard (29 CFR task, activity, material, or airborne (o) Dates—(1) Effective date. This exposure on which the objective data 1910.1020). (4) Training. (i) At the completion of standard shall become effective March were based. 10, 2017. (iii) The employer must ensure that any training required by this standard, objective data are maintained and made the employer must prepare a record that (2) Compliance dates. All obligations available in accordance with the indicates the name, social security of this standard commence and become Records Access standard (29 CFR number, and job classification of each enforceable on March 12, 2018, except: 1910.1020). employee trained, the date the training (i) Change rooms required by (3) Medical surveillance. (i) The was completed, and the topic of the paragraph (i) of this standard must be employer must make and maintain a training. provided by March 11, 2019; and record for each employee covered by (ii) This record must be maintained (ii) Engineering controls required by medical surveillance under paragraph for three years after the completion of paragraph (f) of this standard must be (k) of this standard. training. (ii) The record must include the (5) Access to records. Upon request, implemented by March 10, 2020. following information about each the employer must make all records [FR Doc. 2016–30409 Filed 1–6–17; 8:45 am] employee: maintained as a requirement of this BILLING CODE 4510–26–P

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