Revising the Beryllium Standard for General Industry

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Part 1910

[Docket No. OSHA-2018-0003]

RIN 1218-AD20

Revising the Beryllium Standard for General Industry

AGENCY:

Occupational Safety and Health Administration (OSHA), Labor.

ACTION:

Final rule.

SUMMARY:

OSHA is amending its existing general industry standard for occupational exposure to beryllium and beryllium compounds to clarify certain provisions and simplify or improve compliance. The revisions in this final rule are designed to maintain or enhance worker protections overall by ensuring that the rule is well understood and compliance is more straightforward.

DATES:

This final rule becomes effective on September 14, 2020.

ADDRESSES:

In accordance with 28 U.S.C. 2112(a)(2), OSHA designates Edmund C. Baird, Associate Solicitor of Labor for Occupational Safety and Health, to receive petitions for review of the final rule. Contact the Associate Solicitor at the Office of the Solicitor, Room S-4004, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210; telephone: (202) 693-5445.

FOR FURTHER INFORMATION CONTACT:

Press inquiries:

Mr. Frank Meilinger, OSHA Office of Communications, Occupational Safety and Health Administration; telephone: (202) 693-1999; email:

meilinger.francis2@dol.gov

.

General information and technical inquiries:

Ms. Maureen Ruskin, Directorate of Standards and Guidance, Occupational Safety and Health Administration; telephone: (202) 693-1950; email:

ruskin.maureen@dol.gov

.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary

II. Events Leading to the Final Rule

III. Legal Considerations

IV. Final Economic Analysis and Regulatory Flexibility Act Certification (FEA)

V. Office of Management and Budget (OMB) Review Under the Paperwork Reduction Act of 1995

VI. Federalism

VII. State Plans

VIII. Unfunded Mandates Reform Act

IX. Consultation and Coordination With Indian Tribal Governments

X. Environmental Impacts

XI. Summary and Explanation of the Final Rule

List of Subjects for 29 CFR Part 1910

Authority

Citation Method

In the docket for this rulemaking found at

http://www.regulations.gov,

every submission was assigned a document identification (ID) number that consists of the docket number (OSHA-2018-0003) followed by an additional four-digit number. For example, the document ID number for the proposed rule is OSHA-2018-0003-0016. Some document ID numbers include one or more attachments (see,

e.g.,

Document ID OSHA-2018-0003-0026).

When citing exhibits in the OSHA-2018-0003 docket in this preamble, OSHA includes the term “Document ID” followed by the last four digits of the document number; the attachment number or other attachment identifier, if necessary for clarity; and page numbers (designated “p.” or “pp.”). In a citation that contains two or more document ID numbers, the document ID numbers are separated by semi-colons. For example, a citation referring to National Jewish Health's comments and the first attachment to Materion Brush, Inc.'s comments would be indicated as follows: (Document ID 0022, pp. X-X; 0038-A1, p. X).

Occasionally this preamble refers to documents located in the rulemaking dockets that were used for previous beryllium rulemaking activities, including the 2017 final rule. When citing exhibits in other dockets, OSHA includes the term “Document ID” followed by the full document number. For example, this preamble cites a publication by Armstrong et al. (2014), titled “Migration of beryllium via multiple exposure pathways among work processes in four different facilities,” designated Document ID OSHA-H005C-2006-0870-0502.

The exhibits in the docket (and the other beryllium-rulemaking dockets cited in this preamble), including public comments, supporting materials, meeting transcripts, and other documents, are listed on

http://www.regulations.gov

. All exhibits are listed in the docket index on

http://www.regulations.gov,

but some exhibits (

e.g.,

copyrighted material) are not available to read or download from that website. All materials in the docket are available for inspection at the OSHA Docket Office, Room N-3508, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210; telephone (202) 693-2350.

I. Executive Summary

On January 9, 2017, OSHA published a final rule on Occupational Exposure to Beryllium and Beryllium Compounds (82 FR 2470). This rule created health standards for beryllium exposure in the general industry (29 CFR 1910.1024), construction (29 CFR 1926.1124), and shipyards (29 CFR 1915.1024) sectors. On December 11, 2018, OSHA published a Notice of Proposed Rulemaking (NPRM) in which the agency proposed various amendments to the beryllium standard for general industry (83 FR 63746). With the proposed revisions, OSHA sought to clarify certain provisions and simplify or improve compliance with the beryllium standard for general industry. In this final rule, OSHA is finalizing the majority of the changes proposed in the NPRM, with some revisions intended to address concerns raised by stakeholders during the comment period. OSHA believes that these changes to the standard will maintain safety and health protections for workers and will further enhance worker protections by ensuring that the standard is well-understood.

The changes to the final standard for general industry are fully discussed in Section XI, Summary and Explanation of the Final Rule. Broadly, OSHA proposed to add one definition and modify five existing terms in paragraph (b), Definitions; to amend paragraph (f), Methods of compliance; paragraph (h), Personal protective clothing and equipment; paragraph (i), Hygiene areas and practices; paragraph (j), Housekeeping; paragraph (k), Medical surveillance; paragraph (m), Communication of hazards; and paragraph (n), Recordkeeping; and to replace the 2017 final standard's Appendix A with a new appendix designed to supplement the proposed definition of

beryllium work area

.

OSHA is finalizing these provisions as proposed, with the following exceptions. First, OSHA is revising the definition of

confirmed positive

to state that the findings of two abnormal, one abnormal and one borderline, or three borderline results need to occur from beryllium lymphocyte proliferation tests (BeLPTs) conducted within a three-year period. This differs from the definition proposed in the 2018 NPRM, which would have required that any combination of test results specified in the definition must be obtained within the 30-day follow-up test period required after a first abnormal or borderline BeLPT test result. Second, OSHA is modifying the proposed paragraph (j)(3), which requires employers to take certain actions when

transferring materials that contain at least 0.1 percent beryllium by weight or that are contaminated with beryllium outside a plant for the purpose of disposal, recycling, or reuse, to clarify that only transfers outside of a plant, including between facilities owned by the same employer, are subject to the labeling requirements of paragraph (m)(3).

Third, in paragraphs (k)(2)(iii) and (iv), OSHA is modifying the proposed provisions pertaining to an employer's obligation to offer a medical examination after an employee is exposed to beryllium in an emergency. Fourth, OSHA is amending proposed paragraph (k)(7)(i) to require that an examination at a chronic beryllium disease (CBD) diagnostic center be scheduled within 30 days of the employer receiving certain types of documentation, listed in paragraph (k)(7)(i)(A) and (B), that trigger evaluation for CBD. OSHA is further revising proposed paragraph (k)(7) by adding a new provision, paragraph (k)(7)(ii), which clarifies that, as part of the evaluation at the CBD diagnostic center, the employer must ensure that the employee is offered any tests deemed appropriate by the examining physician at the CBD diagnostic center and to state that if any tests deemed appropriate by the physician are not available at the CBD diagnostic center, they may be performed at another location that is mutually agreed upon by the employer and the employee. For a full explanation of comments received and OSHA's reasoning for these revisions, see Section XI, Summary and Explanation of the Final Rule.

OSHA's examination of the technological and economic feasibility of this final rule is presented in the Final Economic Analysis and Regulatory Flexibility Analysis (FEA), in Section IV of this preamble. As explained there, OSHA finds that none of the revisions would impose any new employer obligations or increase the overall cost of compliance, while some of the revisions in this final rule will clarify and simplify compliance in such a way that results in cost savings. OSHA also finds that none of the revisions would require any new controls or other technology. OSHA therefore concludes that the final rule is both economically and technologically feasible.

Further, this final rule is considered to be an Executive Order (E.O.) 13771 deregulatory action. Pursuant to the Congressional Review Act (5 U.S.C. 801

et seq.

), the Office of Information and Regulatory Affairs designated this rule not a “major rule,” as defined by 5 U.S.C. 804(2).

II. Events Leading to the Final Rule

On January 9, 2017, OSHA published the final rule Occupational Exposure to Beryllium and Beryllium Compounds (2017 final rule) in the

Federal Register

(82 FR 2470).

1

Therein, OSHA concluded that employees exposed to beryllium and beryllium compounds at the preceding permissible exposure limits (PELs) were at significant risk of material impairment of health, specifically chronic beryllium disease (CBD) and lung cancer. The agency further determined that limiting employee exposure to an 8-hour time-weighted average (TWA) PEL of 0.2 µg/m

3

would reduce this significant risk to the maximum extent feasible. Therefore, the 2017 final rule adopted a TWA PEL of 0.2 µg/m

3

. In addition to the revised PEL, the 2017 final rule established a new short-term exposure limit (STEL) of 2.0 µg/m

3

over a 15-minute sampling period and an action level of 0.1 µg/m

3

as an 8-hour TWA, along with a number of ancillary provisions intended to provide additional protections to employees. The ancillary provisions included requirements for exposure assessment, methods for controlling exposure, respiratory protection, personal protective clothing and equipment, housekeeping, medical surveillance, hazard communication, and recordkeeping that are similar to those found in other OSHA health standards.

1

In the 2017 final rule, OSHA issued three separate beryllium standards—general industry, shipyards, and construction. This final rule amends only the general industry standard. Therefore, neither this Events Leading to the Final Rule section nor the remainder of the preamble will include information about the other two standards.

The 2017 final rule went into effect on May 20, 2017, and OSHA began enforcing the PEL and the general industry standard's provisions for exposure assessment, respiratory protection, medical surveillance, and medical removal on May 11, 2018. See Updated Interim Enforcement Guidance for the Beryllium Standards, available at

https://www.osha.gov/laws-regs/standardinterpretations/2018-12-11

. The majority of the general industry standard's other provisions became enforceable on December 12, 2018, with compliance obligations for showers and change rooms following on March 11, 2019 (83 FR 39351). OSHA began enforcing the general industry requirements for engineering controls on March 10, 2020.

In response to concerns raised by stakeholders following the publication of the 2017 final rule, OSHA published a direct final rule (DFR) in the

Federal Register

on May 7, 2018 (83 FR 19936), amending the text of the beryllium standard for general industry to clarify OSHA's intent with respect to certain terms in the standard, including the definition of

beryllium work area

(BWA), the definition of

emergency,

and the meaning of the terms

dermal contact

and

beryllium contamination

(see 83 FR at 19938). The DFR also clarified OSHA's intent with respect to provisions for disposal and recycling and with respect to provisions that the agency intended to apply only where skin can be exposed to materials containing at least 0.1% beryllium by weight (83 FR at 19938). Because the agency did not receive any significant adverse comments, OSHA published a

Federal Register

notice confirming the effective date of the DFR as July 6, 2018, and withdrawing the companion NPRM (83 FR 31045 (July 3, 2018)).

On December 11, 2018, OSHA published an NPRM in the

Federal Register

(83 FR 63746) in which the agency proposed to further amend the beryllium standard for general industry.

2

The proposal sought to clarify certain provisions-with proposed changes designed to facilitate application of the standard consistent with the intent of the 2017 final rule-and to simplify or improve compliance, preventing costs that may flow from misinterpretation or misapplication of the standard. OSHA requested public comment on the proposed changes and provided stakeholders 60 days to submit comments. OSHA received 22 comments before the comment period closed on February 11, 2019.

2

OSHA stated in the NPRM that the agency believed that the standard as modified by the proposal would provide equivalent protection to the existing standard; and OSHA would therefore accept compliance with the standard, as modified by the proposal, as compliance with the standard while the rulemaking was pending.

III. Legal Considerations

The purpose of the Occupational Safety and Health Act of 1970 (“the OSH Act” or “the Act”), 29 U.S.C. 651

et seq.,

is to assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources. 29 U.S.C. 651(b). To achieve this goal, Congress authorized the Secretary of Labor (“the Secretary”) to promulgate occupational safety and health standards pursuant to notice and comment rulemaking. See 29 U.S.C. 655(b). An occupational safety or health standard is a standard which requires conditions, or the adoption or use of one or more practices, means, methods, operations, or processes, reasonably necessary or appropriate to provide safe

or healthful employment and places of employment. 29 U.S.C. 652(8).

The Act also authorizes the Secretary to “modify” or “revoke” any occupational safety or health standard, 29 U.S.C. 655(b), and under the Administrative Procedure Act, regulatory agencies generally may revise their rules if the changes are supported by a reasoned analysis, see

Motor Vehicle Mfrs. Ass'n

v.

State Farm Mut. Auto. Ins. Co.,

463 U.S. 29, 42 (1983). “While the removal of a regulation may not entail the monetary expenditures and other costs of enacting a new standard, and accordingly, it may be easier for an agency to justify a deregulatory action, the direction in which an agency chooses to move does not alter the standard of judicial review established by law.” Id.

The Act provides that in promulgating health standards dealing with toxic materials or harmful physical agents, such as the January 9, 2017, final rule regulating occupational exposure to beryllium, the Secretary must set the standard that most adequately assures, to the extent feasible and on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. 29 U.S.C. 655(b)(5).

The Supreme Court has held that before the Secretary can promulgate any permanent health or safety standard, he must make a threshold finding that significant risk is present and that such risk can be eliminated or lessened by a change in practices. See

Indus. Union Dep't, AFL-CIO

v.

Am. Petroleum Inst. (“Benzene”),

448 U.S. 607, 641-42 (1980) (plurality opinion). OSHA need not make additional findings on risk for this revised rule because OSHA previously determined that the beryllium standard addresses a significant risk that can be eliminated or lessened by a change in practices, see 82 FR 2545-52, and the changes and clarifications in this final rule do not affect that determination. See,

e.g., Pub. Citizen Health Research Grp.

v.

Tyson,

796 F.2d 1479, 1502 n.16 (D.C. Cir. 1986) (rejecting the argument that OSHA must “find that each and every aspect of its standard eliminates a significant risk”).

OSHA standards must also be both technologically and economically feasible. See

United Steelworkers of Am., AFL-CIO-CLC

v.

Marshall

(“

Lead I

”), 647 F.2d 1189, 1264 (D.C. Cir. 1980). The Supreme Court has defined feasibility as “capable of being done.”

Am. Textile Mfrs. Inst.

v.

Donovan

(“

Cotton Dust

”), 452 U.S. 490, 508-09 (1981). The courts have further clarified that a standard is technologically feasible if OSHA proves a reasonable possibility, “within the limits of the best available evidence . . . that the typical firm will be able to develop and install engineering and work practice controls that can meet the [standard] in most of its operations.”

Lead I,

647 F.2d at 1272. With respect to economic feasibility, the courts have held that “[a] standard is feasible if it does not threaten massive dislocation to or imperil the existence of the industry.” Id. at 1265 (internal quotation marks and citations omitted).

OSHA exercises significant discretion in carrying out its responsibilities under the Act. Indeed, “[a] number of terms of the statute give OSHA almost unlimited discretion to devise means to achieve the congressionally mandated goal” of ensuring worker safety and health. See

Lead I,

647 F.2d at 1230 (citation omitted). Thus, where OSHA has chosen some measures to address a significant risk over other measures, parties challenging the OSHA standard must “identify evidence that their proposals would be feasible and generate more than a de minimis benefit to worker health.”

N. Am.'s Bldg. Trades Unions

v.

OSHA,

878 F.3d 271, 282 (D.C. Cir. 2017).

Although OSHA is required to set standards “on the basis of the best available evidence,” 29 U.S.C. 655(b)(5), its determinations are “conclusive” if supported by “substantial evidence in the record considered as a whole,” 29 U.S.C. 655(f). Similarly, as the Supreme Court noted in

Benzene,

OSHA must look to “a body of reputable scientific thought” in making determinations, but a reviewing court must “give OSHA some leeway where its findings must be made on the frontiers of scientific knowledge.”

Benzene,

448 U.S. at 656. When there is disputed scientific evidence in the record, OSHA must review the evidence on both sides and “reasonably resolve” the dispute.

Tyson,

796 F.2d at 1500. The “possibility of drawing two inconsistent conclusions from the evidence does not prevent the agency's finding from being supported by substantial evidence.”

N. Am.'s Bldg. Trades Unions,

878 F.3d at 291 (quoting

Cotton Dust,

452 U.S. at 523) (alterations omitted). As the D.C. Circuit has noted, where “OSHA has the expertise we lack and it has exercised that expertise by carefully reviewing the scientific data,” a dispute within the scientific community is not occasion for the reviewing court to take sides about which view is correct.

Tyson,

796 F.2d at 1500.

Finally, because section 6(b)(5) of the Act explicitly requires OSHA to set health standards that eliminate risk “to the extent feasible,” OSHA uses feasibility analysis rather than cost-benefit analysis to make standards-setting decisions dealing with toxic materials or harmful physical agents. 29 U.S.C. 655(b)(5). An OSHA standard in this area must be technologically and economically feasible-and also cost effective, which means that the protective measures it requires are the least costly of the available alternatives that achieve the same level of protection-but OSHA cannot choose an alternative that provides a lower level of protection for workers' health simply because it is less costly. See

Int'l Union, UAW

v.

OSHA,

37 F.3d 665, 668 (D.C. Cir. 1994); see also

Cotton Dust,

452 U.S. at 513 n.32. In

Cotton Dust,

the Court explained that Congress itself had defined the appropriate relationship between costs and benefits by prioritizing the “benefit” of worker health above all other considerations, save those that would make this “benefit” unachievable. The Court further stated that any standard based on a balancing of costs and benefits by the Secretary that strikes a different balance than that struck by Congress would be inconsistent with the command set forth in section 6(b)(5). See

Cotton Dust,

452 U.S. at 509. Thus, while OSHA estimates the costs and benefits of its proposed and final rules, in part to ensure compliance with requirements such as those in Executive Orders 12866 and 13771, these calculations do not form the basis for the agency's regulatory decisions.

IV. Final Economic Analysis and Regulatory Flexibility Act Certification (FEA)

A. Summary of Economic Impact

This rule amends OSHA's existing general industry standard for occupational exposure to beryllium and beryllium compounds (29 CFR 1910.1024) to clarify certain provisions and simplify or improve compliance. OSHA's final economic analysis shows that these changes will result in unquantifiable cost savings, largely due to the prevention of misinterpretation and misapplication of the standard.

In promulgating the 2017 final rule, OSHA determined that the beryllium rule was both technologically and economically feasible. See 82 FR at 2582-86, 2590-96, Summary of the Final Economic Analysis. The changes herein are intended to align the rule more clearly with the intent of the 2017 final rule. Because OSHA has

determined that this final rule will decrease the costs of compliance by preventing misinterpretation and misapplication of the standard, and would require no new controls or other technology, OSHA has also determined that the rule is both technologically and economically feasible.

Because this final rule only clarifies the existing beryllium standard or makes minor revisions that will generally aid in compliance, the revised beryllium standard will maintain safety and health protections for workers. And, to the extent this final rule helps employers avoid misapplication of the beryllium standard's requirements and hence achieves greater compliance with the standard's intended meaning, there will be increased protection for workers.

B. Final Economic Analysis and Regulatory Flexibility Act Certification

Executive Orders 12866 and 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1532(a)) require that OSHA estimate the benefits, costs, and net benefits of regulations, and analyze the impacts of certain rules that OSHA promulgates. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility.

This final rule is not a “significant regulatory action” under Executive Order 12866 or the UMRA. Neither the benefits nor the costs of this final rule would exceed $100 million in any given year. On the contrary, the possible effects of each provision on costs and benefits appear to be relatively small, and OSHA has not been able to quantify them. Nor has OSHA been able to quantify the cost savings it expects from preventing misinterpretation and misapplication of the standard. However, OSHA does expect that this final rule will increase understanding and compliance with the standard and, therefore, the agency expects the rule to result in some, unquantifiable cost savings. Moreover, and as discussed above, OSHA expects this final rule will maintain safety and health protections for workers.

1. Final Determinations Regarding Costs and Cost Savings Attributable to the Final Rule

In the Preliminary Economic Analysis and Regulatory Flexibility Act Certification (PEA) in the 2018 NPRM, OSHA considered whether each of the proposed changes could affect the costs and, if so, how those costs might be affected (83 FR at 63760-65). For the purposes of the preliminary analysis, the agency divided the proposed changes into two groups: (1) Proposed clarifications and (2) proposed revisions. The “proposed clarifications” were those that were solely intended to clarify provisions and would not alter the requirements and scope of the rule (83 FR at 63760-61). The items OSHA identified as clarifications included the addition of a definition of

beryllium sensitization

to paragraph (b); minor changes to the definitions of

CBD diagnostic center

and

chronic beryllium disease

in paragraph (b); minor changes to the written exposure control plan provisions in paragraphs (f)(1)(i)(D) and (f)(1)(ii)(B); a minor change in the PPE removal provision of paragraph (h)(2)(i); minor changes to provisions for the cleaning of PPE in paragraph (h)(3)(iii); minor changes to the cleaning of PPE upon entry to eating or drinking areas in paragraph (i)(4)(ii); and minor changes to provisions for employee information and training in paragraphs (m)(4)(ii)(A) and (m)(4)(ii)(E) (83 FR at 63760-61).

The “proposed revisions,” on the other hand, were those that would go beyond clarification and alter certain requirements of the beryllium standard (83 FR at 63761). The proposed provisions that OSHA identified as revisions included changes to the definitions of

beryllium work area, confirmed positive,

and

dermal contact with beryllium

in paragraph (b); a change to the requirements for washing facilities in paragraph (i)(1); a change to the requirements for provision of change rooms in paragraph (i)(2); changes to the requirements pertaining to disposal and recycling in paragraph (j)(3); a change to the requirements for medical surveillance following an employee's exposure to beryllium in an emergency in paragraph (k)(2); revision to provisions for evaluation at a CBD diagnostic center in paragraph (k)(7)(i); a change to the requirements for warning labels in paragraph (m)(3); and changes to the requirements for recordkeeping in paragraphs (n)(1)(ii)(F), (n)(3)(ii)(A), and (n)(4)(i).

After carefully reviewing the proposed clarifications and revisions, OSHA preliminarily determined that their net total effect would result in potential cost savings, mainly from improving employer understanding and facilitating application of the rule (83 FR at 63760-61). OSHA preliminarily identified a new potential cost, which would result from the proposed changes as a whole: A de minimis cost for the time employers would need to become familiar with the revised portions of this final rule (83 FR at 63761, 63765). Viewing all the proposed changes as a whole, OSHA explained that it preliminarily anticipated that the proposed provisions' net effect would result in some cost savings (83 FR at 63761). OSHA invited comment on all aspects of the PEA, including these preliminary determinations (83 FR at 63760-62, 63764-65).

Stakeholders either agreed with or did not comment on OSHA's analysis of potential costs and costs savings attributable to the vast majority of the proposed clarifications and revisions (

e.g.,

Document ID 0026, pp. 1-2; 0038, pp. 21, 26, 32). The only objections the agency received related to two of the four proposed paragraphs that OSHA is revising from the proposal in the final rule: (1) The definition of the term

confirmed positive;

and (2) the requirement related to examinations at CBD diagnostic centers (Document ID 0021, p. 4; 0022, pp. 5-6). Those comments, and OSHA's final determination that each of the four paragraphs that OSHA is revising from the proposal will result in small and unquantifiable cost savings, are discussed in detail below.

OSHA has also examined the record concerning the proposed clarifications and revisions that OSHA has finalized without change. As noted above, stakeholders either agreed with or did not comment on OSHA's analysis of potential costs and costs savings attributable to these proposed changes. Therefore, after carefully considering all the comments received and the remainder of the record, OSHA affirms its preliminary determination that these clarifications and revisions are likely to result in cost savings, largely from improving employer understanding and facilitating application of the rule. OSHA also affirms its preliminary determination that the only potential new costs are de minimis costs for the time employers would need to become familiar with the revised portions of this final rule.

In summary, OSHA finds that both the four paragraphs that OSHA is revising from the proposal and the remainder of the proposed clarifications and revisions that OSHA is finalizing without change in the final rule will result in potential cost savings mainly attributable to improving employer understanding and facilitating application of the rule, as well as preventing costs that would follow from misunderstanding the standard. OSHA expects that the cost savings attributable to these changes will offset the de minimis employer familiarization costs, resulting in a net result of cost savings. Therefore, OSHA finds that this final rule is likely to result in cost savings.

2. Analysis of Costs and Costs Savings Attributable to Provisions in the Final Rule That Differ From Those in the Proposal

In this section the agency discusses the four changes in the final rule that differ from the proposal: The definition of

confirmed positive

in paragraph (b), Definitions; a clarification to inter-plant transfers in paragraph (j), Housekeeping; and two changes to paragraph (k), Medical Surveillance: Requirements related to CBD diagnostic centers and requirements for medical examination at termination of employment. In all cases, as stated above, the agency has determined these will have de minimis cost or cost savings implications.

Definition of Confirmed Positive.

The 2017 final rule did not specify a time limit within which the BeLPT tests that contribute toward a finding of “confirmed positive” must occur. In the 2018 NPRM, OSHA proposed to modify the definition of

confirmed positive

to require that the qualifying test results be obtained within one testing cycle (including the 30-day follow-up test period required after a first abnormal or borderline BeLPT test result), rather than arguably over an unlimited time period that might have led to false positives that could needlessly concern workers and their families, could lead workers to undergo unnecessary testing, and would not enhance worker protections. In the PEA, OSHA explained that the exact effect of the proposed change was uncertain as it is unknown how many employees would have a series of BeLPT results associated with a confirmed positive finding (two abnormal results, one abnormal and one borderline result, or three borderline results) over an unlimited period of time, but would not have any such combination of results within a single testing cycle (83 FR at 63761-62). OSHA preliminarily concluded that the proposed change would not increase compliance costs and would incidentally yield some cost savings by lessening the likelihood of false positives (83 FR at 63762). The agency invited comment on its preliminary conclusion (83 FR at 63762).

As discussed in Section XI, Summary and Explanation for paragraph (b), a number of stakeholders commented that requiring results within a 30-day testing cycle could create logistical challenges, for example due to repeat testing requirements or for businesses in remote areas with limited healthcare facilities (Document ID 0022, p. 4; 0021, p. 4; 0024, p. 1; 0033, p. 5; 0027, p. 3). National Jewish Health (NJH) also commented that removing the time frame of 30 days for confirming abnormal results would allow for employee workplace protection and clinical evaluation referral at a lower cost and with less logistical burden (Document ID 0022, p. 5).

Stakeholders' logistical concerns and NJH's comment about costs reflect a misunderstanding of the proposed change. As explained in more detail in the Summary and Explanation for paragraph (b), OSHA did not intend that the initial and any follow-up tests had to be completed and interpreted within 30 days. Rather, the agency intended that the test results be obtained during one cycle of testing, that is, an initial or periodic examination followed by follow-up testing conducted within 30 days of an abnormal or borderline result. For example, if an employee received a borderline BeLPT result at his or her periodic examination, paragraph (k)(3)(ii)(E) would require the employer to offer a follow-up BeLPT within 30 days of the test results. If the follow-up BeLPT result was also borderline, paragraph (k)(3)(ii)(E) would again require the employer to offer a follow-up BeLPT within 30 days of the first follow-up test's results. If that second follow-up was borderline or abnormal, the employee would have been confirmed positive under the proposal because all of the tests that “confirmed” the results were triggered by the initial test. In other words, OSHA did not intend to suggest that the proposal would have required employers to conduct all of the tests or obtain the confirming results within a single 30-day period.

In this final rule, OSHA has revised the definition of

confirmed positive

to specify that the findings of two abnormal, one abnormal and one borderline, or three borderline results must be obtained from BeLPTs conducted within a three-year period. OSHA determined that this revision strikes the appropriate balance between the shorter time period for confirmation in the proposal and the unspecified, arguably indefinite, time period of the original definition. As explained in the Summary and Explanation section, the final three-year period will capture the identification of sensitized workers enrolled in medical surveillance. OSHA finds that the addition of a specific time period to the text of the final rule will decrease the possibility of a misinterpretation of the provision's time frame that could lead to false positive results.

As with the proposed revisions to this definition, OSHA finds that the exact effect of this change is uncertain because it is unknown how many employees would have a series of BeLPT results associated with a confirmed positive finding (two abnormal results, one abnormal and one borderline result, or three borderline results) over an unlimited period of time, but would not have any such combination of results within a three-year testing cycle, though it is likely to be small. As discussed in Section XI, Summary and Explanation of the Final Rule, NJH reported that in a group of 194 CBD patients in their care, the length of time between abnormal results ranged from 14 days to 5.8 years, with a 95th percentile of 2.9 years. This suggests that the vast majority of individuals who will have two abnormal BeLPT tests in the course of medical surveillance are likely to be confirmed positive within the three-year window of time OSHA is establishing in the definition of

confirmed positive.

The Summary and Explanation section notes further that a three-year testing cycle is consistent with practices and recommendations of the medical community, pointing to the increasing likelihood that a confirmed positive finding over longer periods of time will be a false-positive and lead to costly further medical exams with no benefit. Thus, OSHA concludes that this change will not increase compliance costs and will incidentally yield some cost savings by lessening the likelihood of false positives.

Disposal, Recycling, and Reuse.

Paragraph (j)(3) of the previous standard (29 CFR 1910.1024(j)(3)) addresses disposal and recycling of materials that contain beryllium in concentrations of 0.1 percent by weight or more or that are contaminated with beryllium. In the 2018 NPRM, OSHA proposed to modify this paragraph in a number of ways—all of which the agency preliminarily found would not increase the costs of complying with the standard and may also result in unquantifiable savings to employers by preventing misinterpretation or misapplication of the rule (83 FR at 63762-63). Stakeholders did not offer any comments objecting to this preliminary determination. With the exception of one minor clarification to the regulatory text, discussed below, OSHA is adopting all of the proposed revisions to paragraph (j)(3) in this final rule. After reviewing the record as a whole and having received no evidence or comment to the contrary, the agency reaffirms its preliminary determination that the proposed revisions to paragraph (j)(3) that are being adopted in this final rule will result in some cost savings from increased employer understanding.

OSHA has made one change to the proposed provisions in paragraph (j)(3) in this final rule. When employers transfer certain materials to another party for disposal, recycling, or reuse, proposed paragraph (j)(3)(i) would have required employers to label the materials in accordance with paragraph (m)(3) of the standard. As explained in the Summary and Explanation for paragraph (j)(3), a comment alerted the agency to a potential ambiguity in this proposed text. Specifically, OSHA realized that the phrase “to another party” could be read to suggest that transfers between two facilities owned by the same employer are exempted from the labeling requirements in paragraph (j)(3)(i). That was not the agency's intent in the proposal. To eliminate any ambiguity on this point, OSHA revised paragraph (j)(3)(i) in the final rule to strike the phrase “to another party” and add the “except for intra-plant transfers” language that is found in paragraphs (j)(3)(ii) and (iii).

As with the proposed changes to paragraphs (j)(3)(ii) and (iii), which clarified that those paragraphs' requirements did not apply to intra-plant transfers, OSHA finds that this proposed change is not a substantive change to the standard. It is simply clarifying OSHA's original intent that all transfers outside of a plant, including between facilities owned by the same employer, are subject to the labeling requirements of paragraph (m)(3). Since this change does not alter the requirements of the standard, it will not affect the costs of compliance with the standard. Therefore, OSHA finds that none of the changes this final rule makes to paragraph (j)(3) will increase the costs of complying with the standard.

Medical Surveillance.

In the 2018 NPRM, OSHA proposed two sets of changes to paragraph (k). The first set of changes proposed is in paragraph (k)(2), which specifies when and how frequently medical examinations are to be offered to those employees covered by the medical surveillance program. Paragraph (k)(2)(i)(B) of the previous standard required the employer to provide a medical examination within 30 days after determining that the employee shows signs or symptoms of CBD or other beryllium-related health effects or that the employee has been exposed to beryllium in an emergency.

Based on stakeholder feedback and other evidence indicating that the 30-day period in the previous standard may be insufficient to detect beryllium sensitization in individuals exposed one time in an emergency, OSHA proposed removing the requirement for a medical examination within 30 days of exposure to beryllium during an emergency, under paragraph (k)(2)(i)(B), and adding paragraph (k)(2)(iv), which would require the employer to offer a medical examination at least one year after but no more than two years after the employee is exposed to beryllium during an emergency (83 FR at 63757).

In the PEA, OSHA preliminarily determined that the net cost impact of these proposed changes would be slight, with some possible cost savings. Specifically, OSHA explained that, in the FEA for the 2017 final rule, the agency estimated that emergencies would affect a very small number of employees in a given year, likely less than 0.1 percent of the affected population, representing a small addition to the costs of medical surveillance for the standard (Document ID OSHA-H005C-2006-0870-2042, p. V-196). Under the 2017 final rule, some employees might have required two examinations to be confirmed positive: A first test cycle within the initial 30-day period and a second BeLPT at least two years later. Under the 2018 NPRM, OSHA expected that more of the employees who became sensitized from exposure in an emergency would be confirmed positive through a single testing cycle because that test would have been administrated one to two years following the emergency. The agency anticipated that the proposed change would result in the elimination of one premature testing, which would ensure better detection for more employees and incidentally trigger some cost savings (83 FR at 63764).

3

3

Assuming that this initial analysis does not result in a confirmed positive diagnosis, that employee would not be confirmed positive until a second test two years later under the current rule.

To the extent that lengthening the time period in which the test must be offered from within 30 days to between one and two years leads to earlier confirmed positive results (within two years, as opposed to within two years plus 30 days), OSHA preliminarily found that the proposed change could slightly accelerate costs to the employer for earlier CBD diagnostic center referral and medical removal protection. OSHA estimated that the proposed change would affect a very small percentage of an already very small population. The agency preliminarily determined that the proposed revision would only potentially change the timing of the already-required BeLPT, CBD diagnostic center referral, and medical removal protection (83 FR at 63764, 63764 n.5).

In summary, OSHA preliminarily found that the end result of the proposed changes to paragraph (k)(2) from a cost perspective would be that the cost savings from the potential avoidance of a premature BeLPT within 30 days following an emergency would likely be largely canceled out by the acceleration of the cost of the CBD diagnostic center evaluation and medical removal protection. Therefore, OSHA preliminarily determined that the net cost impact of the proposed changes would be slight, with some possible cost savings (83 FR at 63764). Stakeholders did not submit any comments related to OSHA's preliminary determinations regarding potential costs of the proposed revisions to paragraph (k)(2).

In sum, after considering the record as a whole, OSHA finds that its preliminary estimates were correct: A small change in costs, with possible cost savings. Nevertheless, as discussed in more detail in the Summary and Explanation for paragraph (k), Medical Surveillance, some stakeholders expressed concerns about possible delays in medical consultations and examinations and lack of employee knowledge of potential health effects, and one stakeholder argued that employees who terminate employment before receiving the post-emergency examination might not receive an examination at all after being exposed in an emergency (Document ID 0023, pp. 2-3; 0024, p. 2; 0027, p. 4).

OSHA is revising paragraphs (k)(2) in the final rule in two ways to address these concerns. First, OSHA has added two sub-provisions under paragraph (k)(2)(iv) to provide for post-emergency examination timing for two separate groups of employees. Final paragraph (k)(2)(iv)(A) focuses on the very small group of employees who are exposed in an emergency but have not received a medical examination under paragraph (k)(1)(i) within the previous two years. The requirement for these employees is similar to the requirement contained in the previous standard;

i.e.,

under the final standard, the employer must provide these employees with a medical examination within 30 days of the date of the emergency. Because the final standard treats these employees similarly to the manner in which the previous standard treated all employees exposed in an emergency, OSHA does not expect that there will be any change in cost attributable to this change. In other words, for those employees who have not had a medical examination within the past two years there is no change in protocol and, thus, no change in costs.

Final paragraph (k)(2)(iv)(B) focuses on employees who are exposed during an emergency, but have recently received an examination. Under this new provision, if an employee has received a medical examination under paragraph (k)(1)(i) within the previous two years, then the employer would be required to offer that employee a medical examination that meets the requirements of the standard at least one year but no more than two years after the employee was exposed to beryllium in an emergency. Because this provision treats employees who have recently received an examination similarly to the manner in which the proposal would have treated all employees exposed in an emergency, OSHA expects that this change will result in a fraction of the small cost savings preliminarily estimated in the proposal.

Second, to address concerns that delaying the medical examination to at least one year and no more than two years following the emergency may result in employees not receiving a post-emergency examination if their employment ends soon after exposure during an emergency, OSHA is revising paragraph (k)(2)(iii) to require that each employee who is exposed in an emergency and has not received an examination since the emergency exposure is provided an examination at the time employment is terminated. Because paragraph (k)(2)(iii) already requires an examination at termination if there has not been one within the last six months due to any of the standard medical exam triggers, including emergency exposure, OSHA expects that this change will affect an extremely small group of employees. This revision, however, will ensure that all employees with emergency exposure are offered a medical exam, even under this very narrow set of circumstances. The baseline of costs and cost savings of this analysis is the previous rule, which already required a medical exam within 30 days of emergency exposure. Thus, OSHA does not expect that this change will have any cost implications.

In summary, OSHA finds that this final rule's revisions to paragraph (k)(2) will result in slight cost savings. No costs or costs savings are attributable to new paragraph (k)(2)(iv)(A), which treats employees exposed in an emergency who have not received a medical examination within the previous two years pursuant to paragraph (k)(1)(i) similarly to how all employees exposed in an emergency were treated under the previous standard. The end result of final paragraph (k)(2)(iv)(B), however, will be cost savings from the potential avoidance of a premature BeLPT that are largely offset by the acceleration of the cost of the CBD diagnostic center evaluation and medical removal protection. OSHA does not attribute any costs or cost savings to result from the revisions to paragraph (k)(2)(iii). Therefore, the agency expects the new result of final paragraph (k)(2) to be a slight cost savings.

The second set of changes proposed to the standard's medical surveillance requirements is in paragraph (k)(7), which contains the requirements for evaluation at a CBD diagnostic center. Paragraph (k)(7)(i) of the previous rule required employers to provide an evaluation at no cost to the employee at a CBD diagnostic center that is mutually agreed upon by the employee and employer within 30 days of the employer receiving a written medical opinion that recommends referral to a CBD diagnostic center, or a written medical report indicating that the employee has been confirmed positive or diagnosed with CBD. To address stakeholder concerns that scheduling the appropriate tests with an examining physician at the CBD diagnostic center may take longer than 30 days, OSHA proposed that the employer provide an initial consultation with the CBD diagnostic center, rather than the full evaluation, within 30 days of the employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B). The agency noted that the consultation could occur via telephone or virtual conferencing methods and would demonstrate that the employer made an effort to begin the process for a medical examination (83 FR at 63758). Evaluation and any testing would then occur within a reasonable time after the consultation.

In the PEA, OSHA noted that while the addition of the consultation would not result in any additional costs or cost savings (since the 2017 FEA had already accounted for a 15-minute discussion between the employee and a physician (Document ID OSHA-H005C-2006-0870-2042, p. V-206)), allowing more flexibility in scheduling the tests at the CBD diagnostic center would enable employers to find more economical travel and accommodation options. To the extent that it takes longer than 30 days to schedule the tests at the CBD diagnostic center, the agency preliminarily found that employers may realize a cost savings due to retaining funds during the delay. OSHA could not quantify the effect of this flexibility, however, concluding only that it expected that the changes would produce minor, if any, cost savings. The agency invited comment on its preliminary assessment of these potential effects (83 FR at 63764).

Stakeholders did not offer any comments on the agency's preliminary estimates regarding the cost savings attributable to these proposed changes. Several commenters objected to adding the consultation requirement, however, arguing that it was an unnecessary step that would add logistical complications and costs (see,

e.g.,

Document ID 0021, p. 3; 022, p. 6). This is discussed in more detail in the Summary and Explanation for paragraph (k), Medical Surveillance. After considering these comments and the record as a whole, OSHA decided to modify paragraph (k)(7)(i) to require that the employer within 30 days of receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B) schedule an evaluation at a CBD diagnostic center. In addition, OSHA is adding a requirement that the evaluation itself must occur within a reasonable time.

OSHA finds that these changes may slightly delay the incidence of costs of an evaluation under paragraph (k)(7)(i), in that it may occur at a later date in some cases than under the existing provision. This would slightly decrease the costs of compliance with the standard. The agency also finds that allowing the evaluation to occur within a reasonable time, rather than within 30 days, may allow for more cost-effective travel and accommodation options. Thus, as with the proposal, OSHA concludes that these changes may produce minor cost savings.

To account for a proposed change to the definition of

CBD diagnostic center,

the proposed rule would also have amended paragraph (k)(7)(i) to clarify that the employer must provide, at no cost to the employee and within a reasonable time after consultation with the CBD diagnostic center, any of the following tests that a CBD diagnostic center must be capable of performing, if deemed appropriate by the examining physician at the CBD diagnostic center: A pulmonary function test as outlined by American Thoracic Society criteria testing, bronchoalveolar lavage (BAL), and transbronchial biopsy. In the PEA, OSHA explained that this proposed change would not alter the requirements of the standard and therefore would not change the costs of compliance with the standard (83 FR at 63764).

Stakeholders did not offer any comments on OSHA's determination that these proposed changes would not affect costs. Some stakeholders argued, however, that the proposed provision could be misinterpreted to mean that the employer does not have to make available other tests that the examining

physician deems appropriate for reasons such as diagnosing or determining the severity of CBD (Document ID 0021, p. 3; 0022, p. 3; 0028, p. 2). This is discussed in more detail in the Summary and Explanation for paragraph (k), Medical Surveillance. To address these concerns, OSHA is adding a new provision, paragraph (k)(7)(ii), which clarifies that, as part of the evaluation at the CBD diagnostic center, the employer must ensure that the employee is offered any tests deemed appropriate by the examining physician at the CBD diagnostic center, such as pulmonary function testing as outlined by American Thoracic Society criteria testing, bronchoalveolar lavage (BAL), and transbronchial biopsy.

4

If any of these tests deemed appropriate by the examining physician are not available at the CBD diagnostic center, the final rule allows them to be performed at another location that is mutually agreed upon by the employer and the employee.

4

As discussed in Section XI, Summary and Explanation of the Final Rule, OSHA also redesignated previous paragraphs (k)(7)(ii), (iii), (iv), and (v) as paragraphs (k)(7)(iii), (iv), (v), and (vi), respectively. This redesignation in paragraph (k) also affects a reference in paragraph (l)(1)(ii). These changes are merely administrative and do not have any substantive or monetary effect.

OSHA does not believe that requiring employers to provide any tests deemed appropriate by the examining physician would change the costs of compliance with the standard because the agency accounted for such costs in the 2017 final rule.

5

Specifically, when calculating the unit cost for going to a CBD diagnostic center in the 2017 FEA, the agency used a typical suite of tests that would be performed (Document ID OSHA-H005C-2006-0870-2042, p. V-205). Consequently, OSHA's unit cost in the 2017 final rule for an evaluation at a CBD diagnostic center was an average for standard tests that are required. The agency finds that this average set of tests by definition is constructed to give the average cost for the tests deemed appropriate by the examining physician and, thus, concludes that there are no costs or cost savings attributable to this change.

5

As discussed in the Summary and Explanation for paragraph (k), Medical Surveillance, OSHA never intended to limit the required tests to the three tests listed in the previous definition of the term

CBD diagnostic center.

Paragraph (k)(7)(ii) requires that if any test deemed appropriate by the examining physician is not available at the CBD diagnostic center, the test must be performed at another location that is mutually agreed to by the employer and employee. OSHA believes that such circumstances would be very rare. CBD diagnostic centers with the ability to perform pulmonary function testing (as outlined by the American Thoracic Society criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy are most likely to also provide other medical tests related to CBD.

6

As a result, the CBD diagnostic center in the vast majority of cases will be able to offer the additional testing deemed necessary by the examining physician. Moreover, because the three tests noted above are the tests that are commonly needed to diagnose CBD, OSHA expects that these are the tests that would most commonly be performed (see Section XI, Summary and Explanation of the Final Rule). Given that this standard requires CBD diagnostic centers to be able to perform the three tests that are most commonly performed to diagnose CBD and CBD diagnostic centers typically would be able to offer any additional tests deemed necessary, OSHA expects that employees would rarely, if ever, need to travel to a second location.

7

In those rare cases, the added flexibility of having the tests performed outside of a CBD diagnostic center gives more options for the employer and employee and should lead to cost savings. Because this situation should be quite uncommon, OSHA expects that the cost savings of allowing employees to have additional tests outside of a CBD diagnostic center are likely to be de minimis.

6

Document ID OSHA-H005C-2006-0870-0637 provides some information from the NJH website, which provides an overview of the types of tests performed.

7

OSHA also notes that it has always intended for employers to make available any additional tests deemed appropriate by the examining physician (see the discussion of paragraph (k), Medical Surveillance, in Section XI, Summary and Explanation of the Final Rule, of this preamble). The economic analysis of the 2017 final rule did not explicitly account for these rare cases where a test recommended by the examining physician of the CBD diagnostic center was not available at the same center. Hence, there would be a de minimis cost adjustment increase of the total cost of the 2017 final rule due to this consideration. This is not a change in people's behavior, simply a methodological change. The current final rule could affect people's behavior and be a true change (decrease) in costs. This change merely provides employers with a more flexible, potentially less expensive, manner to provide those tests in the rare situation where they are not available at the original CBD diagnostic center.

This change to paragraph (k)(7) clarifies OSHA's intent that the employer provide any tests deemed appropriate by the examining physician at the CBD diagnostic center, or at another location if not available at the CBD diagnostic center, but does not substantively change the requirements of the beryllium standard. OSHA expects that the changes described here would maintain safety and health protections for workers.

3. Economic and Technological Feasibility

In the FEA in support of OSHA's 2017 Beryllium Final Rule, OSHA concluded that the general industry beryllium standard was economically and technologically feasible (see 82 FR at 2471). In the 2018 NPRM, OSHA explained that it anticipated that none of the proposed changes would impose any new employer obligations or increase the overall cost of compliance, while some of the changes would clarify and simplify compliance in such a way that results in cost savings. In addition, OSHA preliminarily anticipated that the de minimis cost of any time spent reviewing the proposed changes would be more than offset by the cost savings described in the PEA. OSHA further found that none of the proposed revisions would require any new controls or other technology. OSHA therefore preliminarily determined that the proposed rule was both economically and technologically feasible. OSHA did not receive any comments objecting to or otherwise questioning this preliminary determination.

8

Therefore, after considering the record as a whole, OSHA finds that the proposed provisions that are being adopted in this final rule are economically and technologically feasible.

8

Although the agency did not receive any comments questioning the economic or technological feasibility of the proposed changes, at least one stakeholder argued that the previous standard was not economically or technologically feasible and that the proposed provisions remedied some of that stakeholder's concerns with feasibility (Document ID 0038, pp. 13, 21-22, 43). Because the feasibility of the January 2017 final rule as a whole is not at issue in this rulemaking, OSHA considers these comments indicating that these changes provide both economic and technological feasibility relief as support for the economic and technological feasibility of the proposed revisions.

OSHA also finds that the few new changes between the proposal and the final rule would not require any new controls or other technology and will result in cost savings. Therefore, OSHA finds that these final provisions, and the final rule as a whole, are economically and technologically feasible.

4. Effects on Benefits

In the 2017 FEA, OSHA attributed approximately 67 percent of the beryllium sensitization cases and the CBD cases avoided, and none of the lung cancer cases avoided, solely to the ancillary provisions of the standard (Document ID OSHA-H005C-2006-0870-2042, pp. VII-4 to VII-5, VII-24). This estimate was based on the ancillary provisions as a whole, rather than each provision separately.

In the PEA, OSHA considered the potential effect of each proposed change to ancillary provisions on employee protections. Because the proposed revisions to the standard would not remove or change the general nature of any ancillary provisions, and because the agency expected the proposed revisions to maintain safety and health protections for workers and facilitate employer understanding and compliance, OSHA preliminarily determined that the proposed changes would increase the standard's benefits as a whole by enhancing worker protections overall and by preventing costs that follow from misunderstanding the standard.

OSHA did not receive any comments related to its preliminary assessment of the proposed provisions' effects on benefits. Having considered the record as a whole, including all the comments received, OSHA finds that the changes in this final rule will maintain safety and health protections for workers while aligning the standard with the intent behind the 2017 final rule and otherwise preventing costs that could follow from misinterpretation or misapplication of the standard. And the agency reaffirms its determination that facilitating employer understanding and compliance has the benefit of enhancing worker protections overall. Therefore, OSHA finds that the changes in this final rule will increase the benefits of the standard as a whole.

5. Regulatory Flexibility Act Certification

In accordance with the Regulatory Flexibility Act, 5 U.S.C. 601

et seq.

(as amended), OSHA has examined the regulatory requirements of this final rule to revise the general industry beryllium standard to determine whether they would have a significant economic impact on a substantial number of small entities. The final rule modifies the general industry standard to clarify certain provisions and simplify or improve compliance. It does not impose any new duties or increase the overall cost of compliance, and OSHA expects it will provide some cost savings. OSHA therefore expects that this final rule will not have a significant economic impact on any small entities. Accordingly, OSHA certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

V. Office of Management and Budget (OMB) Review Under the Paperwork Reduction Act of 1995

A. Overview

This final rule revises information collection (paperwork) requirements in the occupational exposure to beryllium in general industry (29 CFR 1910.1024) standard that are subject to Office of Management and Budget (OMB) approval under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501

et seq.

) and its implementing regulations (5 CFR part 1320). OSHA is revising the previously approved paperwork package under OMB control number 1218-0267, as it pertains to general industry only. The collection of information items contained in the Information Collection Request (ICR) pertaining to occupational exposure to beryllium in the construction and shipyard sectors remain in the ICR without change.

The PRA generally requires that agencies consider the impact of paperwork and other information collection burdens imposed on the public, obtain public input, and obtain approval from OMB before conducting any collection of information (44 U.S.C. 3507). The PRA defines a

collection of information

as “the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public, of facts or opinions by or for an agency, regardless of form or format” (44 U.S.C. 3502(3)(A)). Federal agencies generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by OMB under the PRA and displays a valid OMB control number (44 U.S.C. 3507). Also, notwithstanding any other provision of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a valid OMB control number (44 U.S.C. 3512).

B. Solicitation of Comments

On January 9, 2017, OSHA published a final rule establishing new permissible exposure limits and other provisions to protect employees from beryllium exposure, such as requirements for exposure assessment, respiratory protection, personal protective clothing and equipment, housekeeping, medical surveillance, hazard communication, and recordkeeping for the general industry, construction, and shipyard sectors. OMB approved the collections of information contained in the final rule under OMB Control Number 1218-0267.

On December 11, 2018, OSHA published a Notice of Proposed Rulemaking (NPRM) to modify the general industry beryllium standard by clarifying certain provisions to improve and simplify compliance (83 FR 63746). The 2018 NPRM proposed to revise the collections of information contained in the general industry standard by modifying provisions for the written exposure control plan; the cleaning and replacement of personal protection equipment; the disposal, recycling, and reuse of contaminated materials; certain aspects of medical surveillance; and the collection of social security numbers in recordkeeping. OSHA prepared and submitted to OMB an ICR for the 2018 proposed rule for review in accordance with 44 U.S.C. 3507(d). A copy of the proposed ICR is available to the public at

http://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0267.

In accordance with the PRA (44 U.S.C. 3506(c)(2)), OSHA solicited public comments on the collection of information contained in the 2018 proposed rule. OSHA encouraged commenters to submit their comments on the information collection requirements contained in the proposed rule under docket number OSHA-2018-0003, along with their comments on other parts of the proposed rule. In addition to generally soliciting comments on the collection of information requirements, the proposed rule indicated that OSHA and OMB were particularly interested in the following items:

• Whether the proposed collection of information is necessary for the proper performance of the agency's functions, including whether the information is useful;

• The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• The quality, utility, and clarity of the information to be collected; and

• Ways to minimize the compliance burden on employers, for example, through the use of automated or other technological techniques for collecting and transmitting information (83 FR 63766).

On March 29, 2019, OMB issued a Notice of Action (NOA) stating, “Terms of the previous clearance remain in effect. OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In

addition, the agency must enter the correct burden estimates” (see OMB Conclusion Action on ICR Reference No. 201812-1218-001, dated March 29, 2019, available at:

https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=1218-0267

).

The agency did not receive any public comments in response to the proposed ICR submitted to OMB for review. Public comments submitted in response to the NPRM, however, substantively addressed provisions containing collection of information. OSHA considered these comments when it developed the revised ICR for this final rule. Summaries of comments received on the NPRM and OSHA's responses are found in Sections XI, Summary and Explanation of the Final Rule, and IV, Final Economic Analysis and Regulatory Flexibility Act Certification.

The Department of Labor submitted the final ICR concurrent with the publication of this final rule, containing the full analysis and description of the burden hours and costs associated with the final rule, to OMB for approval. A copy of this ICR will be available to the public at

http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202006-1218-006

(this link will become active on the day following publication of this notice). At the conclusion of OMB's review, OSHA will publish a separate notice in the

Federal Register

to announce the results.

C. Summary of Information Collection Requirements

As required by 5 CFR 1320.5(a)(1)(iv) and 1320.8(d)(2), the following paragraphs provide information about the ICR.

1.

Title:

Beryllium Standard for General Industry (29 CFR 1910.1024), Construction (29 CFR 1926.1124), and Maritime (29 CFR 1915.1024).

2.

Type of Review:

Revision.

3.

OMB Control Number:

1218-0267.

4.

Affected Public: Business or Other For-Profit.

This final rule applies to employers in general industry who have employees that may have occupational exposures to any form of beryllium, including compounds and mixtures, except those articles and materials exempted by paragraphs (a)(2) and (a)(3).

5. Occupational Exposure to Beryllium in General Industry only:

a.

Number of Respondents:

4,538.

b.

Frequency of Responses:

On occasion, quarterly, semi-annually, annually, biannually.

c.

Number of Responses:

134,570.

d.

Estimated Total Burden Hours:

82,822.

e.

Estimated Cost:

$18,741,540.

6. Occupational Exposure to Beryllium in Construction and Shipyard Sectors (previously-approved costs not affected by this rulemaking):

a.

Number of Respondents:

2,796.

b.

Frequency of responses:

On occasion, quarterly, semi-annually, annually, biannually.

c.

Number of responses:

39,420.

d.

Estimated Total Burden Hours:

25,269.

e.

Estimated Cost:

$8,774,874.

7. Total Estimated Burden Hours and Cost for All Three Industries:

a.

Estimated Total Number of responses:

173,990.

b.

Estimated Total Burden Hours:

108,091.

c.

Estimated Cost:

$27,516,414.

D. Summary of Changes in the Collection of Information Requirements

This final standard for occupational exposure to beryllium and beryllium compounds in general industry revises the collection of information requirements contained in the existing ICR for general industry, approved under OMB control number 1218-0267. OSHA is updating the new ICR to reflect those changes, which include changes to the written exposure control plan; the cleaning and replacement of personal protection equipment; the disposal, recycling, and reuse of contaminated materials; certain aspects of medical surveillance; and the collection of Social Security numbers in recordkeeping (see Table V.1 below). The majority of these changes were adopted by the agency as proposed. However, in response to comments on the proposed rule, OSHA has revised a few of the provisions of the final rule that affect the collection of information. Those changes are also noted in Table V.1 below.

Table V.1—Changes to Collection of Information Requirements in the Final Rule for General Industry

Information collection requirements in this final rule

Explanation of this final rule's changes to the information collection requirements

§ 1910.1024(f)(1)(i), (ii), & (iii)—Methods of Compliance—Written Exposure Control Plan

(i) The employer must establish, implement, and maintain a written exposure control plan, which must contain:

(A) A list of operations and job titles reasonably expected to involve airborne exposure to or dermal contact with beryllium;

(B) A list of operations and job titles reasonably expected to involve airborne exposure at or above the action level;

(C) A list of operations and job titles reasonably expected to involve airborne exposure above the TWA PEL or STEL;

This final rule removed the word “preventing” from (f)(i)(D), which previously contained the phrase “including preventing the transfer of beryllium.” In addition, the final rule revised (f)(1)(ii)(B) by replacing the phrase “airborne exposure to or dermal contact with beryllium” with “exposure to beryllium.” Both of these changes were adopted as proposed.

(D) Procedures for minimizing cross-contamination, including the transfer of beryllium between surfaces, equipment, clothing, materials, and articles within beryllium work areas;

(E) Procedures for keeping surfaces as free as practicable of beryllium;

(F) Procedures for minimizing the migration of beryllium from beryllium work areas to other locations within or outside the workplace;

(G) A list of engineering controls, work practices, and respiratory protection required by paragraph (f)(2) of this standard;

(H) A list of personal protective clothing and equipment required by paragraph (h) of this standard; and

(I) Procedures for removing, laundering, storing, cleaning, repairing, and disposing of beryllium-contaminated personal protective clothing and equipment, including respirators.

(ii) The employer must review and evaluate the effectiveness of each written exposure control plan at least annually and update it, as necessary, when:

(A) Any change in production processes, materials, equipment, personnel, work practices, or control methods results, or can reasonably be expected to result, in new or additional airborne exposure to beryllium;

(B) The employer is notified that an employee is eligible for medical removal in accordance with paragraph (l)(1) of this standard for evaluation at a CBD diagnostic center, or shows signs or symptoms associated with exposure to beryllium; or

(C) The employer has any reason to believe that new or additional airborne exposure is occurring or will occur.

(iii) The employer must make a copy of the written exposure control plan accessible to each employee who is, or can reasonably be expected to be, exposed to airborne beryllium in accordance with OSHA's Access to Employee Exposure and Medical Records (Records Access) standard (29 CFR 1910.1020(e)).

§ 1910.1024(h)(3)(iii)—Personal Protective Clothing and Equipment—Cleaning and Replacement

(3)(iii) The employer must inform in writing the persons or the business entities who launder, clean, or repair the personal protective clothing or equipment required by this standard of the potentially harmful effects of exposure to beryllium and that the personal protective clothing and equipment must be handled in accordance with this standard.

This final rule revised (h)(3)(iii) by replacing the phrase “airborne exposure to and dermal contact with beryllium” with “exposure to beryllium.” This change was adopted as proposed.

§ 1910.1024(j)(3)(i), (ii), & (iii)—Housekeeping—Disposal, recycling, and reuse

(3)(i) Except for intra-plant transfers, when the employer transfers materials that contain at least 0.1% beryllium by weight or are contaminated with beryllium for disposal, recycling, or reuse, the employer must label the materials in accordance with paragraph (m)(3) of this standard;

(ii) Except for intra-plant transfers, materials designated for disposal that contain at least 0.1% beryllium by weight or are contaminated with beryllium must be cleaned to be as free as practicable of beryllium or placed in enclosures that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport, such as bags or containers; and

(iii) Except for intra-plant transfers, materials designated for recycling or reuse that contain at least 0.1% beryllium by weight or are contaminated with beryllium must be cleaned to be as free as practicable of beryllium or placed in enclosures that prevent the release of beryllium-containing particulate or solutions under normal conditions of use, storage, or transport, such as bags or containers.

This final rule revised (j)(3) by explicitly addressing transferring materials for reuse; reorganizing the previous two provisions into three to allow the agency to incorporate the new reuse requirements, while also setting out each distinct obligation clearly; replacing the phrase materials “that contain beryllium in concentrations of 0.1 percent by weight or more” with a shorter, easier to understand phrase: Materials “that contain at least 0.1 percent beryllium by weight;” clarifying that the rule's requirements for disposal, recycling, and reuse do not apply to intra-plant transfers; clarifying the enclosure requirements by providing more detail on what constitutes an appropriate enclosure; allowing for the cleaning of materials bound for disposal; and removing the undefined phrase “surface beryllium contamination.”

In addition to the above actions, which were all adopted as proposed, in this final rule, OSHA revised paragraph (j)(3)(i) to explicitly incorporate the clarification that the rule's requirements for disposal, recycling, and reuse do not apply to intra-plant transfers.

§ 1910.1024(k)(2)—Medical Surveillance. (2) Frequency

The employer must provide a medical examination:

(i) Within 30 days after determining that:

(A) An employee meets the criteria of paragraph (k)(1)(i)(A), unless the employee has received a medical examination, provided in accordance with this standard, within the last two years; or

(B) An employee meets the criteria of paragraph (k)(1)(i)(B) of this standard.

(ii) At least every two years thereafter for each employee who continues to meet the criteria of paragraph (k)(1)(i)(A), (B), or (D) of this standard.

(iii) At the termination of employment for each employee who meets any of the criteria of paragraph (k)(1)(i) of this standard at the time the employee's employment terminates, unless an examination has been provided in accordance with this standard during the six months prior to the date of termination. Each employee who meets the criteria of paragraph (k)(1)(i)(C) of this standard and who has not received an examination since exposure to beryllium during the emergency must be provided an examination at the time the employee's employment terminates.

(iv) For an employee who meets the criteria of paragraph (k)(1)(i)(C) of this standard:

(A) If that employee has not received a medical examination within the previous two years pursuant to paragraph (k)(1)(i) of this standard, then within 30 days after the employee meets the criteria of paragraph (k)(1)(i)(C) of this standard; or

(B) If that employee has received a medical examination within the previous two years pursuant to paragraph (k)(1)(i) of this standard, then at least one year but no more than two years after the employee meets the criteria of paragraph (k)(1)(i)(C) of this standard.

Paragraph (k)(2)(i)(B) of the 2017 standard previously required the employer to provide a medical examination within 30 days after determining that the employee shows signs or symptoms of CBD or other beryllium-related health effects or that the employee has been exposed to beryllium in an emergency. The 2018 NPRM would have added paragraph (k)(2)(iv) to require employers to offer an examination to employees exposed to beryllium in an emergency at least one year after but no more than two years after the employee is exposed to beryllium in an emergency. It also would have amended paragraph (k)(2)(i)(B) to focus only on the frequency of examinations for employees who show signs or symptoms of CBD or other beryllium-related health effects.

This final rule's provisions differ from those in the proposal. Specifically, in this final rule, OSHA removed the requirement for a medical examination within 30 days of exposure in an emergency and added paragraph (k)(2)(iv). Final paragraph (k)(2)(iv)(A) requires the employer to offer a medical examination to an employee within 30 days after the employee was exposed to beryllium in an emergency, if the employee has not had an examination under paragraph (k)(1)(i) within the last two years, while final paragraph (k)(2)(iv)(B) requires the employer to offer a medical examination to an employee within one to two years after the employee was exposed to beryllium in an emergency, if the employee had an examination under paragraph (k)(1)(i) of the beryllium standard within the last two years. In addition, this final rule revised paragraph (k)(2)(iii) to require that each employee who is exposed in an emergency and has not received an examination since the emergency exposure must be provided an examination at the time employment is terminated.

As proposed in the 2018 NPRM, this final rule also amended paragraph (k)(2)(i)(B) to focus only on the frequency of examinations for employees who show signs or symptoms of CBD or other beryllium-related health effects.

§ 1910.1024(k)(7)—Medical Surveillance—Referral to the CBD Diagnostic Center

(7)

CBD diagnostic center.

(i) The employer must provide an evaluation at no cost to the employee at a CBD diagnostic center that is mutually agreed upon by the employer and the employee. The evaluation at the CBD diagnostic center must be scheduled within 30 days, and must occur within a reasonable time, of:

(A) The employer's receipt of a physician's written medical opinion to the employer that recommends referral to a CBD diagnostic center; or

(B) The employee presenting to the employer a physician's written medical report indicating that the employee has been confirmed positive or diagnosed with CBD, or recommending referral to a CBD diagnostic center.

(ii) The employer must ensure that, as part of the evaluation, the employee is offered any tests deemed appropriate by the examining physician at the CBD diagnostic center, such as pulmonary function testing (as outlined by the American Thoracic Society criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy. If any of the tests deemed appropriate by the examining physician are not available at the CBD diagnostic center, they may be performed at another location that is mutually agreed upon by the employer and the employee.

(iii) The employer must ensure that the employee receives a written medical report from the CBD diagnostic center that contains all the information required in paragraph (k)(5)(i), (ii), (iv), and (v) of this standard and that the PLHCP explains the results of the examination to the employee within 30 days of the examination.

(iv) The employer must obtain a written medical opinion from the CBD diagnostic center within 30 days of the medical examination. The written medical opinion must contain only the information in paragraph (k)(6)(i), as applicable, unless the employee provides written authorization to release additional information. If the employee provides written authorization, the written opinion must also contain the information from paragraphs (k)(6)(ii), (iv), and (v), if applicable.

(v) The employer must ensure that each employee receives a copy of the written medical opinion from the CBD diagnostic center described in paragraph (k)(7) of this standard within 30 days of any medical examination performed for that employee.

(vi) After an employee has received the initial clinical evaluation at a CBD diagnostic center described in paragraphs (k)(7)(i) and (ii) of this standard, the employee may choose to have any subsequent medical examinations for which the employee is eligible under paragraph (k) of this standard performed at a CBD diagnostic center mutually agreed upon by the employer and the employee, and the employer must provide such examinations at no cost to the employee.

The 2018 NPRM would have amended paragraph (k)(7) of the 2017 standard to require employers to provide, at no cost to the employee and within a reasonable time after the initial consultation with the CBD diagnostic center, any of the following tests if deemed appropriate by the examining physician at the CBD diagnostic center: Pulmonary function testing (as outlined by the American Thoracic Society criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy. The proposal also specified the timing of the initial consultation.

This final rule's provisions differ from those in the proposal. Specifically, OSHA revised paragraph (k)(7)(i) to require that the evaluation must be

scheduled

within 30 days, and must occur within a reasonable time, of the employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B). Previously, the general industry standard required employers to

provide

the examination within 30 days of the employer receiving one of the types of documentation listed in paragraph (k)(7)(i)(A) or (B).

This final rule also added a provision, in paragraph (k)(7)(ii), which specifies that the employer must ensure that, as part of the evaluation, the employee is offered any tests deemed appropriate by the examining physician at the CBD diagnostic center, such as pulmonary function testing (as outlined by the American Thoracic Society criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy. The new provision also states that if any of the tests deemed appropriate by the examining physician are not available at the CBD diagnostic center, they may be performed at another location that is mutually agreed upon by the employer and the employee.

§ 1910.1024(n)(1)(i), (ii), & (iii)—Recordkeeping—Air Monitoring Data

(i) The employer must make and maintain a record of all exposure measurements taken to assess airborne exposure as prescribed in paragraph (d) of this standard.

(ii) This record must include at least the following information:

This final rule removed the requirement for collection and recording of Social Security numbers from this provision. This change was adopted as proposed.

(A) The date of measurement for each sample taken;

(B) The task that is being monitored;

(C) The sampling and analytical methods used and evidence of their accuracy;

(D) The number, duration, and results of samples taken;

(E) The type of personal protective clothing and equipment, including respirators, worn by monitored employees at the time of monitoring; and

(F) The name and job classification of each employee represented by the monitoring, indicating which employees were actually monitored.

(iii) The employer must ensure that exposure records are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).

§ 1910.1024(n)(3)(i), (ii), & (iii)—Recordkeeping—Medical Surveillance

(i) The employer must make and maintain a record for each employee covered by medical surveillance under paragraph (k) of this standard.

(ii) The record must include the following information about the employee:

This final rule removed the requirement for collection and recording of Social Security numbers from this provision. This change was adopted as proposed.

(A) Name and job classification;

(B) A copy of all licensed physicians' written medical opinions for each employee; and

(C) A copy of the information provided to the PLHCP as required by paragraph (k)(4) of this standard.

(iii) The employer must ensure that medical records are maintained and made available in accordance with the Records Access standard (29 CFR 1910.1020).

§ 1910.1024(n)(4)(i) & (ii)—Recordkeeping—Training

(4)

Training.

(i) At the completion of any training required by this standard, the employer must prepare a record that indicates the name and job classification of each employee trained, the date the training was completed, and the topic of the training.

This final rule removed the requirement for collection and recording of Social Security numbers from this provision. This change was adopted as proposed.

(ii) This record must be maintained for three years after the completion of training.

VI. Federalism

OSHA reviewed this rule in accordance with the Executive Order on Federalism (Executive Order 13132, 64 FR 43255, August 10, 1999), which requires that federal agencies, to the extent possible, refrain from limiting state policy options, consult with states prior to taking any actions that would restrict state policy options, and take such actions only when clear constitutional and statutory authority exists and the problem is national in scope. Executive Order 13132 provides for preemption of state law only with the expressed consent of Congress. Any such preemption is to be limited to the extent possible.

Under Section 18 of the OSH Act, Congress expressly provides that states and U.S. territories may adopt, with federal approval, a plan for the development and enforcement of occupational safety and health standards. OSHA refers to such states and territories as “State Plans” (29 U.S.C. 667). Occupational safety and health standards developed by State Plans must be at least as effective in providing safe and healthful employment and places of employment as the federal standards. Subject to these requirements, State Plans are free to develop and enforce under state law their own requirements for safety and health standards.

OSHA previously concluded from its analysis for the 2017 final rule that promulgation of the beryllium standard complies with E.O. 13132 (82 FR at 2633). The amendments in this final rule do not change that conclusion. In states without OSHA-approved State Plans, Congress expressly provides for OSHA standards to preempt state occupational safety and health standards in areas addressed by the federal standards. In these states, this rule limits state policy options in the same manner as every standard promulgated by OSHA. In states with OSHA-approved State Plans, this rulemaking does not significantly limit state policy options.

VII. State Plans

When federal OSHA promulgates a new standard or more stringent amendment to an existing standard, the states and U.S. Territories with their own OSHA-approved occupational safety and health plans (State Plans) must promulgate a state standard adopting such new federal standard, or more stringent amendment to an existing federal standard, or an at least as effective equivalent thereof, within six months of promulgation of the new federal standard or more stringent amendment. The state may demonstrate that a standard change is not necessary because the state standard is already the same or at least as effective as the federal standard change. Because a state may include standards and standard provisions that are equally or more stringent than federal standards, it would generally be unnecessary for a state to revoke a standard when the comparable federal standard is revoked or made less stringent. To avoid delays in worker protection, the effective date of the state standard and any of its delayed provisions must be the date of state promulgation or the federal effective date, whichever is later. The Assistant Secretary may permit a longer time period if the state makes a timely demonstration that good cause exists for extending the time limitation (29 CFR 1953.5(a)).

Of the 28 states and territories with OSHA-approved State Plans, 22 cover public and private-sector employees: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. The remaining six states and territories cover only state and local government employees: Connecticut, Illinois, Maine, New Jersey, New York, and the Virgin Islands.

As discussed in detail below in Section XI, Summary and Explanation of the Final Rule, the majority of the changes made by this final rule will clarify certain provisions and simplify or improve employer compliance. After considering all of the changes made by this final rule and the record as a whole, OSHA believes that this final rule enhances employee safety, in part by revising provisions that may be misinterpreted. Therefore, OSHA has determined that, within six months of the rule's promulgation date, State Plans must review their state standards and adopt amendments to those standards that are at least as effective as the amendments to the beryllium general industry standard finalized herein, as required by 29 CFR 1953.5(a), unless the State Plans demonstrate that such amendments are not necessary because their existing standards are already at least as effective at protecting workers as this final rule. This decision is also informed by a comment from Materion Brush, Inc. (Materion), in which Materion argued that OSHA should require states to adopt the proposed changes (Document ID 0038-A5, p. 2).

9

No other stakeholders opined on this issue.

9

OSHA notes that Materion also argued that the State Plans that have already adopted the original OSHA standard should be required to adopt the changes OSHA previously adopted in the 2018 direct final rule, as well as the changes that result from the current rulemaking (Document ID 0038-A5, p. 1). Whether OSHA should require State Plans to adopt the changes made in the 2018 direct final rule is out of the scope of this rulemaking and, thus, will not be considered here.

VIII. Unfunded Mandates Reform Act

OSHA reviewed this final rule according to the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1501

et seq.

) and Executive Order 13132 (64 FR 43255). As discussed above in Section IV, Final Economic Analysis and Regulatory Flexibility Act Certification (FEA), of this preamble, the agency determined that this final rule will not impose significant additional costs on any private- or public-sector entity. Further, OSHA previously concluded that the rule will not impose a federal mandate on the private sector in excess of $100 million (adjusted annually for inflation) in expenditures in any one year (82 FR at 2634). Accordingly, this final rule will not require significant additional

expenditures by either public or private employers.

As noted above under Section VII, State Plans, the agency's standards do not apply to state and local governments except in states that have elected voluntarily to adopt a State Plan approved by the agency. Consequently, this final rule does not meet the definition of a “federal intergovernmental mandate” (see Section 421(5) of the UMRA (2 U.S.C. 658(5))). Therefore, for the purposes of the UMRA, the agency certifies that this final rule will not mandate that state, local, or tribal governments adopt new, unfunded regulatory obligations of, or increase expenditures by the private sector by, more than $100 million in any year.

IX. Consultation and Coordination With Indian Tribal Governments

OSHA has reviewed this final rule in accordance with Executive Order 13175 (65 FR 67249) and determined that it does not have “tribal implications” as defined in that order. This final rule does not have substantial direct effects on one or more Indian tribes, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes.

X. Environmental Impacts

OSHA has reviewed this final rule in accordance with the requirements of the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321

et seq.

), the Council on Environmental Quality NEPA regulations (40 CFR part 1500-1508), and the Department of Labor's NEPA procedures (29 CFR part 11). As a result of this review, OSHA has determined that this final rule will not have a significant impact on air, water, or soil quality; plant or animal life; the use of land; or aspects of the external environment.

XI. Summary and Explanation of the Final Rule

On December 11, 2018, OSHA published a Notice of Proposed Rulemaking (83 FR 63746) (2018 NPRM) proposing changes to a number of provisions in the general industry beryllium standard. Following publication of the 2018 NPRM, a variety of stakeholders, including representatives of industry, labor, medical groups, public health organizations, federal and state government agencies, academia, trade associations, and private citizens, submitted comments on OSHA's proposed changes. After reviewing and carefully considering these comments and the remainder of the record, OSHA has decided to adopt the majority of the changes proposed, as well as additional changes that were prompted by the comments received. These changes clarify certain provisions and simplify or improve compliance for the other provisions of the standard. OSHA believes that these changes will maintain safety and health protections for workers and will further enhance worker protections by ensuring that the standard is well understood and implemented according to the agency's intent.

The following discussion summarizes the comments received on the proposed changes to the general industry standard, lays out OSHA's responses to and final determinations regarding the issues in the comments, and explains each new or revised provision in this final rule including details on any modification made from the proposal. As discussed in detail below, the changes include the addition of one definition and modifications to five existing definitions in paragraph (b) and revisions to seven of the standard's other paragraphs, including paragraph (f), Methods of compliance; paragraph (h), Personal protective clothing and equipment; paragraph (i), Hygiene areas and practices; paragraph (j), Housekeeping; paragraph (k), Medical surveillance; paragraph (m), Communication of hazards; and paragraph (n), Recordkeeping. The final rule also replaces the 2017 standard's Appendix A with a new appendix designed to supplement the final standard's definition of

beryllium work area.

Definitions.

Paragraph (b) of the beryllium standard for general industry provides definitions of key terms used in the standard. In this final rule, OSHA is changing or adding six terms in the definitions paragraph of the standard. The terms that OSHA is changing or adding are

beryllium sensitization, beryllium work area, CBD diagnostic center, chronic beryllium disease, confirmed positive,

and

dermal contact with beryllium.

Beryllium sensitization.

OSHA is adding the following definition for

beryllium sensitization:

“a response in the immune system of a specific individual who has been exposed to beryllium. There are no associated physical or clinical symptoms and no illness or disability with beryllium sensitization alone, but the response that occurs through beryllium sensitization can enable the immune system to recognize and react to beryllium. While not every beryllium-sensitized person will develop chronic beryllium disease (CBD), beryllium sensitization is essential for development of CBD.” The agency is adding this definition to clarify other provisions in the standard, such as the definitions of

chronic beryllium disease (CBD)

and

confirmed positive,

as well as the provisions for medical surveillance in paragraph (k) and hazard communication in paragraph (m).

This definition of

beryllium sensitization

is identical to the definition proposed in the 2018 NPRM and is consistent with information provided in the 2017 final beryllium rule (82 FR 2470). In the preamble to the 2017 final rule, OSHA found that individuals sensitized through either the dermal or inhalation exposure pathways respond to beryllium through the formation of a beryllium-protein complex, which then binds to T-cells stimulating a beryllium-specific immune response (82 FR at 2494). The formation of the T-cell-beryllium-protein complex that results in beryllium sensitization rarely manifests in any outward symptoms (such as coughing or wheezing); most who are sensitized show no symptoms at all (see 82 FR at 2492, 2527). Once an individual has been sensitized, any subsequent beryllium exposures via inhalation can progress to serious lung disease through the formation of granulomas and fibrosis (see 82 FR at 2491-98). Since the pathogenesis of CBD involves a beryllium-specific, cell-mediated immune response, CBD cannot occur in the absence of sensitization (82 FR at 2492; see also NAS, 2008 (Document ID OSHA-H005C-2006-0870-1355)). Therefore, this definition's explanation that beryllium sensitization is essential for development of CBD is consistent with the agency's findings in the 2017 final rule.

Several commenters expressed support for OSHA's inclusion of a definition of

beryllium sensitization

in the beryllium general industry standard, including NJH (Document ID 0022, p. 2), the United Steelworkers (USW) (Document ID 0033, p. 1), Materion (Document ID 0038, p. 8), the U.S. Department of Defense (DOD) (Document ID 0029, p. 1), and Edison Electric Institute (EEI) (Document ID 0031, p. 2). According to the USW, the proposed definition is clear and accurate, and is necessary because the beryllium standard includes many provisions related to the recognition of and appropriate response to beryllium sensitization among beryllium-exposed workers (Document ID 0033, p. 1).

Materion similarly commented that inclusion of the proposed definition in the standard would improve workers' and employers' understanding of this term (Document ID 0038, p. 4).

While OSHA received no objections to including a definition of

beryllium sensitization

in the beryllium standard, several commenters suggested changes to the proposed definition. The National Supplemental Screening Program (NSSP) and NJH recommended that the definition of

beryllium sensitization

should include the following text, based on the ATS Statement on Beryllium: “Beryllium sensitization is a response in the immune system of an individual who has been exposed to beryllium. A diagnosis of [beryllium sensitization] can be based on two abnormal blood BeLPTs, one abnormal and one borderline blood BeLPT, three borderline BeLPTs, or one abnormal bronchoalveolar lavage (BAL) BeLPT. Beryllium sensitization is essential for development of CBD” (Document ID 0027 p. 1; 0022, p. 2; see also Document ID OSHA-H005C-2006-0870-0364, pp. 1, 44). Neither organization, however, explained why this definition of

beryllium sensitization

should be used instead of the definition OSHA proposed.

OSHA disagrees with this recommendation. The agency is providing a definition of

beryllium sensitization

to give stakeholders a general understanding of what beryllium sensitization is and its relationship to CBD. Information pertinent to medical identification of sensitization is provided in the definition of confirmed positive, which appears later in this section. OSHA has determined that the agency's definitions of

beryllium sensitization

and

confirmed positive

together provide the information suggested by NJH and the NSSP. The definition of

confirmed positive

explains how the results of BeLPT testing should be interpreted in the context of the standard's provisions that refer to that term, such as evaluation at a CBD diagnostic center and medical removal protection. The

confirmed positive

definition establishes that these benefits should be extended to workers who have a pattern of BeLPT results, obtained in a three-year period, consistent with the NJH and the NSSP's recommended definition of beryllium sensitization. The remainder of the information suggested by NJH and the NSSP, which pertains to the relationship of beryllium sensitization to beryllium exposure, the immune system, and the development of CBD, is included in the definition of

beryllium sensitization

that OSHA proposed and is including in this final standard. For these reasons, OSHA has decided not to adopt the language suggested by NJH and the NSSP.

The NSSP objected to the statement that no physical or clinical symptoms, illness, or disability are associated with beryllium sensitization alone, but did not explain the reason for their concern with this statement (Document ID 0027, p. 1). Materion supported the agency's inclusion of this information in the definition, stating that “employees deserve to understand that beryllium sensitization does not involve symptoms . . .” (Document ID 0038, p. 5). The USW also specifically supported the accuracy of this section of OSHA's proposed definition of

beryllium sensitization

(Document ID 0033, p. 1).

The agency has decided to retain this statement in the definition of

beryllium sensitization

because it is important that employers and employees understand the asymptomatic nature of beryllium sensitization and the need for specialized testing such as the BeLPT. The statement is consistent with OSHA's discussion of beryllium sensitization in the 2017 final rule (82 FR at 2492-99). As OSHA discussed in the 2017 final rule, sensitization through dermal contact has sometimes been associated with skin granulomas, contact dermatitis, and skin irritation, but these reactions are rare and those sensitized through dermal exposure to beryllium typically do not exhibit any outward signs or symptoms (see 82 FR at 2488, 2491-92, 2527). OSHA determined that while beryllium sensitization rarely leads to any outward signs or symptoms, beryllium sensitization is an adverse health effect because it is a change to the immune system that leads to risk of developing CBD (82 FR at 2498-99). The agency believes that the asymptomatic nature of beryllium sensitization, especially in the lung, should be conveyed to employers and employees to emphasize why specialized testing such as the BeLPT should be provided to workers who may have no symptoms of illness associated with beryllium exposure. For these reasons, OSHA is retaining the statement “[t]here are no associated physical or clinical symptoms and no illness or disability with beryllium sensitization alone” in the definition of

beryllium sensitization.

The State of Washington Department of Labor and Industries, Division of Occupational Safety and Health (DOSH), commented that OSHA's proposed definition of

beryllium sensitization

places unnecessary emphasis on the role that beryllium sensitization plays in the development of CBD. According to DOSH, “[t]his language may cause confusion with proper diagnosis of CBD and application of the rule requirements for workers who have developed CBD without a confirmed beryllium sensitization” (Document ID 0023, p. 1). Other commenters, however, including NJH, the NSSP, and the USW, supported including the statement that beryllium sensitization is necessary for the development of CBD in OSHA's definition of beryllium sensitization (Document ID 0022, p. 2; 0027, p. 1; 0033, p. 1).

Following consideration of DOSH's comment, OSHA has determined that this information should remain in the definition of

beryllium sensitization

(as well as the definition of

chronic beryllium disease,

discussed later). OSHA believes that an understanding of the relationship between beryllium sensitization and CBD is key to workers' and employers' understanding of the beryllium standard. By including the role that sensitization plays in the development of CBD in the definition of

beryllium sensitization,

OSHA intends to make a number of things clear to workers and employers: That beryllium sensitization, although not itself a disease, is nevertheless an adverse health effect that presents a risk for developing CBD and thus should be prevented; the need to identify beryllium sensitization through regular medical screening; and why workers who are confirmed positive should be offered specialized medical evaluation and medical removal protection. OSHA notes that DOSH does not dispute the factual accuracy of OSHA's statement regarding the role beryllium sensitization plays in the development of CBD, which the agency established in the Health Effects section of the 2017 final rule (82 FR at 2495-96).

Nevertheless, OSHA agrees with DOSH that it is not always necessary to identify a worker as beryllium sensitized by the BeLPT as part of a diagnosis of CBD, and the agency acknowledges that some sensitized individuals may not be confirmed positive for beryllium sensitization by BeLPT testing. OSHA established in the Health Effects section of the preamble to the 2017 final rule that while BeLPT testing is helpful to identify workers at risk for CBD and to differentiate CBD from respiratory diseases with similar clinical presentation, CBD can be diagnosed in the absence of a confirmed positive BeLPT (see 82 FR at 2499-5002) (discussing a number of studies conducted prior to the development of the BeLPT). At least one study in the rulemaking record found that some

beryllium workers who would not have been confirmed positive by their BeLPT results were found to be sensitized via the BAL BeLPT and went on to develop CBD (Newman et al., 2001, Document ID OSHA-H005C-2006-0870-1354, p. 234). Other studies indicate that the BeLPT has a false-negative rate of approximately 25-28 percent (that is, approximately 25-28 percent of individuals who have a single normal BeLPT result are in fact sensitized) (Middleton et al., 2011, Document ID OSHA-H005C-2006-0870-0399, p. 2 (25 percent); Stange et al., 2004, Document ID OSHA-H005C-2006-0870-1402, p. 457 (27.7 percent)). Because the BeLPT itself may have a false-negative result and because other means exist to diagnose CBD apart from the BeLPT, examining physicians should have the latitude to diagnose CBD in the absence of a “confirmed positive” pattern of BeLPT results. Moreover, as discussed below, the determination that an employee is “confirmed positive” under the beryllium standard acts only as a trigger for medical monitoring and surveillance and OSHA does not intend the phrase “confirmed positive” to be interchangeable with “beryllium sensitized.”

The standard provides a mechanism for an employee to be referred to a CBD diagnostic center and diagnosed with CBD, even in the absence of a confirmed positive blood BeLPT result. Under paragraph (k)(5)(iii), the licensed physician can recommend referral to a CBD diagnostic center if he or she deems it appropriate. As OSHA explained in the preamble to the 2017 final rule, the licensed physician could recommend an evaluation at a CBD diagnostic center based on questionable BeLPT findings (82 FR at 2714). For example, in a scenario where an employee has repeating borderline or abnormal results but does not meet the definition for confirmed positive, referral to a CBD diagnostic center may be appropriate.

Furthermore, the standard does not specify how CBD is diagnosed and gives the licensed physician at the CBD diagnostic center discretion for making that diagnosis, including by means other than blood BeLPT results. The diagnostic criteria for CBD include (1) history of beryllium exposure; (2) histopathological evidence of non-caseating granulomas or mononuclear cell infiltrates in the absence of infection; and (3) positive blood or BAL BeLPT (82 FR at 2500; see also Newman et al., 1989 (Document ID OSHA-H005C-2006-0870-0196, p. 1480)). The availability of transbronchial lung biopsy facilitates the evaluation of the second criterion, by making histopathological confirmation possible in almost all cases (82 FR at 2500). The ATS has noted that the BAL BeLPT can be useful in diagnosing CBD in individuals who have normal blood BeLPT results and considers one positive BAL BeLPT sufficient for the diagnosis of beryllium sensitization (Document ID OSHA-H005C-2006-0870-0364, pp. 44-45). OSHA expects that the licensed physician might apply such criteria in the diagnosis of CBD, without relying on a confirmed positive finding based on blood BeLPT results.

In summary, OSHA believes that emphasizing the role that beryllium sensitization plays in the development of CBD provides employers and employees with important context for understanding the beryllium standard. At the same time, the agency acknowledges that employees may be diagnosed with CBD in the absence of a confirmed positive BeLPT, and the beryllium standard allows for such a diagnosis. Thus, following consideration of the record of comments on OSHA's proposed definition of

beryllium sensitization,

the agency is finalizing the definition as proposed in the 2018 NPRM. The addition of this definition for

beryllium sensitization

does not change employer obligations under paragraphs (k) and (m) and, therefore, OSHA expects that the new definition will maintain safety and health protections for workers.

Beryllium work area.

Paragraph (b) of the final rule defines

beryllium work area

as any work area where materials that contain at least 0.1 percent beryllium by weight are processed either: (1) During any of the operations listed in Appendix A of the standard; or (2) where employees are, or can reasonably be expected to be, exposed to airborne beryllium at or above the action level. The presence of a beryllium work area triggers a number of requirements in the standard. These include the requirements under paragraphs (e)(1)(i) and (2)(i) to establish, maintain, and demarcate the boundaries of each beryllium work area, as well as requirements under paragraphs (f)(1)(i)(D) and (F), written exposure control plan requirements; paragraph (f)(2)(ii), required exposure controls; paragraphs (i)(1) and (2), general hygiene practices and change rooms requirements; paragraphs (j)(1)(i) and (2), housekeeping requirements; and paragraph (m)(4)(ii)(B), employee training. The establishment of beryllium work areas serves to ensure that employees and other persons are aware of the potential presence of airborne beryllium; to control access to these areas; and in conjunction with other provisions such as the written control plan, hygiene, and housekeeping requirements, to minimize the transfer of beryllium to other areas of the facility and reduce the potential for exposure to other employees.

The term

beryllium work area

(as revised in the 2018 direct final rule) was defined as any work area (1) containing a process or operation that can release beryllium and that involves material that contains at least 0.1 percent beryllium by weight; and, (2) where employees are, or can reasonably be expected to be, exposed to airborne beryllium at any level or where there is the potential for dermal contact with beryllium. That definition was developed in response to stakeholder comments on the 2015 NPRM, which had proposed to define a

beryllium work area

as any work area where there is potential for exposure to airborne beryllium at any level, and which did not include dermal contact as a trigger for establishment of a beryllium work area. Some stakeholders argued that the definition proposed in the 2015 NPRM was overly broad and could be interpreted as applying to most or all areas of a worksite, regardless of the work processes or operations occurring in those areas. Commenters also expressed concern that the definition was vague and should be triggered on a measurable threshold of exposure. NIOSH commented that the proposed definition's focus on airborne beryllium did not account for the potential contribution of dermal exposures to total exposure (82 FR at 2659).

In response to these comments, OSHA modified the definition in the 2017 final rule to require the presence of a beryllium-releasing process. The agency explained in the preamble that triggering the requirement of creating a beryllium work area on a specific threshold level of exposure would be insufficiently protective of workers, but also explained that the agency did not intend for a beryllium work area to be established in areas where work processes or operations that release beryllium do not occur, such as where employees handle articles containing beryllium (82 FR at 2659-60). Rather, the purpose of establishing beryllium work areas is to identify and demarcate areas within a facility where processes or operations release beryllium so that necessary control measures can be implemented, such as those designed to prevent the migration of beryllium to other areas where beryllium is not processed or released. OSHA clarified this intent by defining a

beryllium work

area

as an area that contains processes or operations that release beryllium to which workers could be exposed. Additionally, OSHA accounted for NIOSH's concern by including the potential for dermal contact with beryllium in the definition (see 82 FR at 2658-60).

In the preamble to the 2017 final rule, however, OSHA disagreed with commenters who claimed that the proposed definition of

beryllium work area

was impermissibly vague. The agency explained that, by limiting the trigger for beryllium work areas to exposures generated from a beryllium-releasing process or operation within the area, the definition made clear that the requirements were not triggered solely on the fact that an employee may be handling solid material containing beryllium. Additionally, any employer who had doubts about whether a process was releasing beryllium or created the potential for dermal contact with beryllium could use air sampling or wipe sampling to determine where the boundary of a beryllium work area should be established. OSHA reasoned that, rather than rendering the provision vague, defining a beryllium work area in a performance-based manner left employers flexibility in complying with the standard (82 FR at 2659).

Nevertheless, following publication of the 2017 standard, OSHA continued to hear from stakeholders that the definition of

beryllium work area

remained a source of substantial uncertainty and confusion. Some stakeholders expressed concern that defining a

beryllium work area

to include any area where unspecified processes can reasonably be expected to generate any level of airborne beryllium, or where there is a process or operation that can release beryllium or the potential for dermal contact with beryllium, could lead to the designation of entire facilities as beryllium work areas because minute quantities of beryllium can sometimes be detected in areas of a facility far distant from the work processes that create beryllium exposures. Stakeholders requested that OSHA provide a list of operations that are known to release airborne beryllium, which would allow employers to more accurately identify where beryllium work areas must be established and demarcated at their workplaces. As described in more detail below, stakeholders also requested that “dermal contact” be removed from the definition of

beryllium work area.

In response to this feedback, OSHA proposed in this rulemaking to modify the definition of

beryllium work area

to provide clarity for employers on where and when to establish a beryllium work area. First, OSHA proposed a new appendix to the standard (Appendix A), containing Table A.1, which includes a list of operations that are commonly performed when processing beryllium materials and are known to generate airborne beryllium. OSHA proposed to revise the definition of

beryllium work area

so that any work area where an operation that is listed in proposed Appendix A occurs, and involves materials containing at least 0.1 percent beryllium by weight, is a beryllium work area. For work areas where no operations listed in proposed Appendix A occur, the proposed definition would require a beryllium work area wherever materials containing at least 0.1 percent beryllium by weight are processed and where employees are, or can be reasonably expected to be, exposed to airborne beryllium at or above the action level. The list of operations in Table A.1 was compiled based on the experience of Materion, the primary beryllium manufacturer in the United States, and the USW, the primary union representing employees with beryllium exposure.

10

As noted in the preamble to the 2018 NPRM, OSHA intends the list to cover all operations and processes that have the potential for exposure to airborne beryllium (83 FR at 63761).

10

Table A.1 is divided into three categories: (1) Beryllium Metal Alloy Operations (generally <10% beryllium by weight); (2) Beryllium Composite Operations (generally >10% beryllium by weight) and Beryllium Metal Operations; and (3) Beryllium Oxide Operations.

Second, OSHA proposed to remove the reference to dermal contact from the definition of the term beryllium work area. OSHA preliminarily determined that this change would make it less likely that the definition could be misinterpreted as extending to areas of a facility where work processes or operations that release beryllium do not occur or even to entire facilities (83 FR at 63749). Further, the agency explained that it was unaware of beryllium-releasing processes or operations that have a potential for dermal contact that are not included in the proposed Appendix A or do not generate airborne exposures at or above the action level (83 FR at 63749). Therefore, OSHA preliminarily determined that the proposed change would be as protective as the previous definition, while more clearly avoiding the erroneous perception that the standard would require employers to treat entire facilities as beryllium work areas.

Comments submitted in response to the NPRM showed general support from employers, unions, and public health experts for OSHA's proposed approach and for providing better clarity with respect to beryllium work areas (Document ID 0017; 0022, pp. 6-7; 0029, p. 1; 0033, pp. 1-4; 0038, pp. 8-9). For example, the USW agreed with OSHA that the revisions proposed in the NPRM would make the definition more precise and help to ensure that employers can appropriately comply with the standard. The USW stated that the proposed definition “provides employers with a clearer means of understanding when and where demarcation is required” for beryllium work areas (Document ID 0033, p. 2). Materion likewise indicated that this new approach “greatly improves and simplifies an understanding of where beryllium work areas should be in a facility, allowing employers and employees to know and understand how to comply with the requirement to establish these protective work areas” (Document ID 0038, p. 9).

While there was general support for this proposed approach to beryllium work areas, several commenters expressed concerns about various aspects of the new definition and new Appendix A. For example, DOSH agreed that the addition of a new Appendix A would provide clarity to the beryllium work area requirements but expressed concern that removal of the dermal contact trigger would reduce worker protections. DOSH suggested the use of a defined lower limit for beryllium contamination on surfaces that would address this concern while maintaining the protection for workers (Document ID 0023, pp. 1-2).

OSHA does not agree that removing the reference to dermal contact from the definition of the term

beryllium work area

reduces protections. As noted above and explained in both the preambles to the 2017 final rule and the 2018 NPRM, OSHA's intent was to capture those areas of a facility where beryllium-generating processes or operations are located; OSHA never intended for dermal contact alone to trigger the standard's beryllium work area requirements (82 FR at 2659; 83 FR at 63748). Contrary to DOSH's assertion, the requirement to establish a beryllium work area was dependent on the presence of a process or operation that can release beryllium and that involves material that contains at least 0.1 percent beryllium by weight in the area in question; exposure alone, whether airborne or dermal, was never a trigger for the beryllium work area requirements.

Moreover, again as noted above, OSHA explained in the 2018 NPRM that it did not know of any beryllium-releasing processes or operations with

the potential for dermal contact that are not included in the proposed Appendix A or that do not generate airborne exposures at or above the action level. Put more simply, OSHA was unaware of any situation where an employer would be required to establish a beryllium work area under the previous definition but would not be required to do so under the proposed definition. However, in the interest of caution, OSHA asked stakeholders specifically whether there are any operations or processes that trigger beryllium work areas under the previous definition that would not be covered under the proposed definition (83 FR at 63749). Commenters did not point to any such processes. On the contrary, the only stakeholder to squarely address this issue, Materion, noted that it too was “unaware of work areas containing beryllium-releasing processes or operations that have a potential for dermal contact that are not included in the proposed Appendix A or generate airborne exposures at or above the action level” (Document ID 0038 p. 13).

Furthermore, another stakeholder, the USW commented that it supported OSHA's proposed removal of the reference to dermal contact from the definition of the term

beryllium work area

(Document ID 0033, p. 3). The USW stated that it does not have reservations about the proposed change and explained its belief “that dermal exposure is properly addressed elsewhere in the standard” (Document ID 0033, pp. 1-3). According to the USW, “[a]lthough dermal exposure to beryllium is important and must be properly addressed, removal of dermal exposure from this definition will reduce the confounding factors that might result in unnecessarily extending beryllium work areas beyond needed portions of a workplace” (Document ID 0033, p. 3).

In addition, DOSH did not explain why it believes the change would reduce worker protections. Given that DOSH did not point to any particular loss of worker protection and the lack of evidence of any differences between the coverage of the two definitions, OSHA has decided to adopt the proposed definition, which commenters have indicated reduces the confusion caused by the previous definition. OSHA expects the revised definition to provide clarity on the proper boundaries of a beryllium work area. Employers are required by paragraph (j)(1), in conjunction with paragraph (f)(1), to minimize the migration of beryllium from beryllium work areas, and clearly defining the beryllium work area ensures employees working outside of these areas receive the protective benefits of these requirements. If a beryllium work area is defined overly broadly, then more employees may inadvertently be exposed to beryllium within the beryllium work area and would not receive some of these benefits. Moreover, as stated in the 2018 NPRM, PPE requirements to protect against dermal exposure to beryllium do not depend on the existence of a beryllium work area. The standard requires employers to provide and ensure the use of appropriate PPE whenever there is a reasonable expectation of dermal contact with beryllium, regardless of whether or not the area is a beryllium work area (see 83 FR at 63749).

OSHA also does not agree with DOSH that a lower limit for beryllium contamination on surfaces is necessary as a trigger for establishing a beryllium work area. In the 2017 final rule, OSHA chose not to set quantitative limits for surface contamination because the best available scientific evidence on adverse health effects from dermal contact with beryllium made it difficult to identify an appropriate limit for surface contamination (82 FR at 2688). This remains the case today. OSHA discusses the limitations of this data more fully below in the Summary and Explanation of the definition of dermal contact with beryllium.

Two commenters objected to the exemption for materials that contain less than 0.1 percent beryllium from the definition of beryllium work area (Document ID 0022, p. 7; 0027, p. 2). However, OSHA incorporated this change in the 2018 direct final rule. At the time, OSHA explained that it was never the agency's intent that the requirements related to beryllium work areas apply to these materials (83 FR 19936, 19938 (May 7, 2018)). OSHA did not receive any adverse comments on the direct final rule and therefore finalized the change. The 2018 NPRM did not propose to amend this portion of the definition and therefore comments related to the 0.1 percent limitation are not within the scope of this rulemaking.

OSHA also received comments on the new Appendix A. NJH expressed concerns that the proposed list of operations in Appendix A was geared toward manufacturing and that it “may restrict employers' interpretations of a beryllium work area and prevent employees from the protections afforded by the beryllium standard. Employers may only consider these featured tasks as those that dictate a beryllium work area, when other tasks may be considered as such” (Document ID 0022, pp. 6-7). OSHA believes NJH's concern is misplaced. First, OSHA requested comment on whether there were additional operations that should be included on the list of operations in Appendix A, and no suggestions for additional operations were put forth by commenters. More importantly, the final standard requires that a beryllium work area be established if exposures can reasonably be expected to exceed the action level where materials that contain at least 0.1 percent beryllium by weight are processed, regardless of whether the operation is listed in Appendix A. As the USW noted, this requirement “provides a backstop for any unforeseen operation which can expose employees above the action level” (Document ID 0033, p. 2). Thus, employees who may be exposed above the action level during a process not listed in Appendix A will still receive the protections afforded by the beryllium work area requirements.

DOD, while generally supportive of the proposed definition of

beryllium work area,

expressed some concerns about Appendix A (Document ID 0029, p. 1). First, DOD suggested, without explanation, that OSHA remove the word “generally” from the description of the table in Appendix A, which describes beryllium metal alloy operations as being “generally < 10% beryllium by weight” and beryllium composite operations as being “generally > 10% beryllium by weight.” OSHA disagrees with this suggestion. The table in Appendix A reflects materials that are on the market today. However, the inclusion of the word “generally” accounts for the possibility of beryllium metal alloy operations and beryllium composite operations involving different materials. Thus, if alloys are developed with greater than 10 percent beryllium or composites less than 10 percent beryllium, these materials will be covered under Table A.1. Because OSHA does not intend to limit Table A.1 to processes involving only those materials on the market today, the agency is retaining the word “generally” in the description of the tables in Appendix A.

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11

The agency notes that DOD's comment suggests there might be some confusion as to whether beryllium alloys and beryllium composites are analogous. In fact, these materials have different structures and should be treated differently from a control strategy point of view. A metal alloy is a metal which is a homogeneous mixture of two or more metals or of a metal and another element to provide unique characteristics or properties (see

https://www.thefreedictionary.com/Metal+alloy

). A “beryllium composite,” on the other hand, is a metal matrix composite or (MMC) which typically contain at least two distinct constituent parts (see

https://www.azom.com/article.aspx?ArticleID=9843

).

DOD, along with DOSH, also questioned the deletion of the Appendix A published with the 2017 final beryllium rule. That old appendix provided non-mandatory general control strategies for common operations. These commenters thought that the old appendix was useful and should be retained in the standard (Document ID 0029, p. 1; 0023, p. 3). OSHA agrees that the old appendix contained useful information, but expects that in time it would have become either obsolete or incomplete. Instead, OSHA plans to provide this information about general control strategies in guidance materials tailored to reach the targeted audience. This will make it easier to update as new technologies or beryllium processes become available.

In addition, under paragraph (f)(2), Engineering and work practices, employers are obligated to use engineering controls in beryllium work areas. OSHA requires employers to use at least one type of control that is listed in paragraph (f)(2)(ii) (substitution, isolation, local exhaust ventilation, or process controls) unless controls are infeasible or exposures are demonstrated to be below the action level. These general controls are the same types of controls that were listed in Appendix A and are required regardless of whether that appendix is retained. For these reasons, this final standard does not retain the old Appendix A.

Materion fully supported the proposed changes to the

beryllium work area

definition and the proposed Appendix A. However, it noted a typographical error in Appendix A for “High Speed Machining (≤ 10,000 rpm),” which should be (> 10,000 rpm) (Document ID 0038, p. 10). OSHA agrees that the entry in the NPRM's Appendix A is incorrect and made the appropriate correction in this final rule.

After careful consideration of the record, OSHA has determined that the revised definition of

beryllium work area

will improve compliance with the standard by providing greater clarity to employers regarding when and where beryllium work areas should be established in the workplace. The agency further finds that properly identifying beryllium work areas will reduce potential exposure for workers outside of these areas through the various provisions triggered by beryllium work areas. In sum, OSHA has determined that the revision to the definition of

beryllium work area

will ensure that the standard's requirements related to beryllium work areas are workable and properly understood. Therefore, OSHA has decided to finalize the definition of

beryllium work area

and the corresponding update to Appendix A as proposed, with the exception of correcting the typographical error in Appendix A noted by Materion.

CBD diagnostic center.

OSHA is amending the 2017 final rule's definition of

CBD diagnostic center

to clarify certain requirements used to qualify an existing medical facility as a CBD diagnostic center. The clarification does not change the requirement for the employer to offer a follow-up examination at a CBD diagnostic center to employees meeting the criteria set forth in paragraph (k). OSHA is defining

CBD diagnostic center

to mean a medical diagnostic center that has a pulmonologist or pulmonary specialist on staff and on-site facilities to perform a clinical evaluation for the presence of CBD. The revised definition also states that a CBD diagnostic center must have the capacity to perform pulmonary function testing (as outlined by the American Thoracic Society criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy. In the revised definition, the CBD diagnostic center must also have the capacity to transfer BAL samples to a laboratory for appropriate diagnostic testing within 24 hours and the pulmonologist or pulmonary specialist must be able to interpret the biopsy pathology and the BAL diagnostic test results. This definition is identical to the definition of

CBD diagnostic center

that OSHA proposed in the 2018 NPRM.

The revised definition of

CBD diagnostic center

differs from the former definition in a number of ways. First, whereas the 2017 final rule's definition specified only that a CBD diagnostic center must have a pulmonary specialist, OSHA is adding the term “pulmonologist” to clarify that either type of specialist is qualified to perform a clinical evaluation for the presence of CBD. Additionally, the 2017 definition required that a CBD diagnostic center have an on-site pulmonary specialist. The revised definition states that the CBD diagnostic center must simply have a pulmonologist or pulmonary specialist on staff. This clarifies OSHA's intent that a specialist must be available to the CBD diagnostic center but need not necessarily be on site at all times.

In their comments on the 2018 NPRM, two commenters, NJH and the ATS, recommended that a pulmonologist, occupational medicine specialist, or physician with expertise in beryllium disease should conduct the clinical evaluation for CBD and that a pulmonologist should be on staff or available to perform the bronchoscopy (Document ID 0022, p. 2; 0021, p. 2). According to NJH, clinics that regularly evaluate patients for CBD have physicians with experience in occupational health conduct the clinical evaluation for CBD, in conjunction with a pulmonologist who performs a bronchoscopy (Document ID 0022, pp. 2-3).

OSHA notes that, although the agency is requiring facilities to have a pulmonologist or pulmonary specialist on staff who is able to interpret the biopsy pathology and the BAL diagnostic test results, OSHA does not intend that all aspects of clinical evaluation for CBD must be performed by a pulmonologist or pulmonary specialist. In the preamble to the 2017 final rule, OSHA explained that the agency was defining a

CBD diagnostic center

as a facility with a pulmonary specialist “on-site” specifically to indicate that the specialist need not personally perform the BeLPT testing (82 FR at 2645). Moreover, paragraph (k)(7), which sets out the substantive requirements for the evaluation at the CBD diagnostic center, refers to recommendations of the “examining physician,” not necessarily the pulmonologist or pulmonary specialist.

Paragraph (b), in turn, defines

physician or other licensed health care professional (PLHCP)

as an individual licensed to provide some or all of the services required by paragraph (k). As such, some parts of the evaluation, such as lung function tests, might be performed by a certified medical professional other than a pulmonologist or pulmonary specialist. The arrangement that NJH describes as typical for clinics treating CBD patients, in which physicians with experience in occupational health conduct the clinical evaluation for CBD in conjunction with a pulmonologist who performs a bronchoscopy, is consistent with OSHA's intent for the definition of

CBD diagnostic center

and other provisions of the standard related to CBD diagnosis. Therefore, OSHA has determined that it is not necessary to revise the definition of

CBD diagnostic center

to require that the clinical evaluation for CBD be conducted by a pulmonologist, occupational medicine specialist, or physician with expertise in beryllium disease.

An additional change to the definition of

CBD diagnostic center

clarifies that the diagnostic center must have the capacity to perform pulmonary function testing (according to American Thoracic Society criteria), bronchoalveolar lavage (BAL), and tranbronchial biopsy. OSHA determined that the former definition—which stated that the evaluation at the

diagnostic center “must include” these tests—could have been misinterpreted to mean that the examining physician was required to perform each of these tests during every clinical evaluation at a CBD diagnostic center. The agency's intent is not to dictate which tests an evaluation at a CBD diagnostic center should include, but to ensure that any CBD diagnostic center has the capacity to perform any of these tests, which are commonly needed to diagnose CBD. OSHA expects that these are the tests that would most commonly be requested for a CBD evaluation. Therefore, the agency is revising the definition to clarify that the CBD diagnostic center must simply have the ability to perform each of these tests when deemed appropriate. These changes clarify the definition of

CBD diagnostic center,

and OSHA expects they will maintain safety and health protections for workers.

Materion submitted comments supporting OSHA's intent to specify the required capacities of a CBD diagnostic center, rather than the contents of a CBD evaluation, in the definition of

CBD diagnostic center

(Document ID 0038, pp. 16-17). NJH expressed concern that this change to the definition may indicate that the clinical evaluation for CBD need not include certain aspects of a CBD evaluation, which NJH, the Association of Occupational and Environmental Clinics (AOEC), and the ATS recommend should typically include full pulmonary function testing (lung volumes, spirometry, and diffusion capacity for carbon monoxide), chest imaging, and cardiopulmonary exercise testing, and may also include bronchoscopy in some cases (Document ID 0022, p. 3; 0028, p. 2; 0021, pp. 1-2). Similarly, the ATS commented that not requiring certain diagnostic tests “could reduce the potential to diagnose CBD and determine disease severity” (Document ID 0021, p. 3). NJH recommended that OSHA require the ATS recommendations for diagnostic evaluation, which the NJH stated include the BeLPT; pulmonary function testing and chest imaging; and in some cases bronchoscopy (Document ID 0022, p. 3).

As explained below in the Summary and Explanation of paragraph (k)(7), that provision—which establishes the substantive requirements for the evaluation at the CBD diagnostic center—makes clear that the employer must offer any tests that the examining physician at the CBD diagnostic center deems appropriate. The definition of

CBD diagnostic center

in paragraph (b) does not alter this requirement. In light of paragraph (k), the revised definition of

CBD diagnostic center

cannot reasonably be read to limit the types of tests available to the employee (see the Summary and Explanation for paragraph (k)(7) for a full discussion of this topic). Thus, after considering these comments, OSHA has decided to retain the proposed change to the definition of

CBD diagnostic center.

Chronic beryllium disease (CBD).

OSHA is also amending the definition of

chronic beryllium disease.

For the purposes of this standard, the agency is using the term

chronic beryllium disease

to mean a chronic granulomatous lung disease caused by inhalation of airborne beryllium by an individual who is beryllium sensitized. OSHA is finalizing the definition as proposed. It includes several changes to the 2017 final rule's definition of

chronic beryllium disease,

which was “a chronic lung disease associated with exposure to airborne beryllium” (82 FR at 2645-46). The revisions serve to differentiate CBD from other respiratory diseases associated with beryllium exposure (

e.g.,

lung cancer) and to make clear that beryllium sensitization and the presence of beryllium in the lung are essential in the development of CBD (see 82 FR at 2492).

First, OSHA is adding the term “granulomatous” to the definition. A granulomatous lung formation is a focal collection of inflammatory cells (

e.g.,

T-cells) creating a nodule in the lung (see Ohshimo et al., 2017, Document ID OSHA-H005C-2006-0870-2171, p. 2). The formation of the type of lung granuloma specific to a beryllium immune response can occur only in those with CBD (82 FR at 2492-2502). Next, OSHA is removing the phrase “associated with airborne exposure to beryllium” and replacing it with “caused by inhalation of airborne beryllium.” This change is more consistent with the findings in the 2017 final rule that beryllium is the causative agent for CBD and that CBD occurs only after inhalation of beryllium (82 FR at 2513). Finally, OSHA is clarifying that CBD is caused by inhalation of airborne beryllium “by an individual who is beryllium sensitized.” Along with the revised definition of

beryllium sensitization

discussed above, this revision emphasizes to employers and employees the role that beryllium sensitization plays in the development of CBD.

NJH, the USW, and Materion agreed with OSHA that the 2017 final standard's definition of

chronic beryllium disease

should be clarified. Materion supported the changes OSHA proposed, which it characterized as a necessary clarification to ensure the definition provided is specific to chronic beryllium disease (Document ID 0038, p. 17). The USW similarly supported the proposed definition, stating that it clarifies the previous definition which “could be read to apply to any chronic lung disease caused by beryllium, including lung cancer” (Document ID 0033, p. 5). These comments reinforce OSHA's determination that adding the term “granulomatous” to the definition will better distinguish CBD from other occupationally associated chronic pulmonary diseases. As OSHA explained in the preamble to the 2017 final rule, the formation of the type of lung granuloma specific to a beryllium immune response can occur only in those with CBD (82 FR at 2492-2502).

Several commenters expressed concern that the proposed definition of

chronic beryllium disease

does not provide sufficient information to guide diagnosis of CBD, and specifically that OSHA's emphasis on the role of sensitization in the development of CBD may confuse diagnostic efforts. The ATS noted that demonstrating beryllium sensitization may be challenging in certain settings and recommended that OSHA's definition of

chronic beryllium disease

use the diagnostic criteria for CBD outlined in a 2014 ATS document on diagnosis and management of beryllium sensitivity and CBD (“the ATS Statement”). These diagnostic criteria include confirmation of an immune response to beryllium and granulomatous lung inflammation using lung biopsy and emphasize the various approaches which may be used “[d]epending on the clinical setting, feasibility of certain diagnostic tests, and degree of diagnostic certainty needed” (Document ID 0021, p. 5). DOSH similarly emphasized that individuals may be diagnosed with CBD without a confirmed positive BeLPT result and advocated that the definition of

chronic beryllium disease

“ensure employers and medical providers are given a clear expectation of how beryllium conditions are properly identified” (Document ID 0023, p. 2).

OSHA notes that the standard's definition of

chronic beryllium disease

is not intended to provide criteria for the diagnosis of CBD. The agency's intent is to provide readers who may have little or no familiarity with CBD with a general understanding of the term, rather than to provide diagnostic criteria for healthcare professionals in addressing CBD.

Due to differences in individual cases and circumstances, medical specialists may need to apply somewhat different

testing regimens and/or diagnostic criteria to different individuals they evaluate for CBD. Furthermore, the diagnostic tools and criteria available to medical specialists may change over time. As discussed in the Summary and Explanation for paragraph (k)(7), OSHA believes that the physician at the CBD diagnostic center should have the latitude to use any tests he or she deems appropriate for the purpose of diagnosing or otherwise evaluating CBD in a patient, and has revised paragraph (k)(7) to make this clear. Therefore, OSHA has determined that it is neither necessary nor appropriate to specify diagnostic criteria in the beryllium standard's definition of

chronic beryllium disease.

Instead, OSHA has decided to retain a definition that provides the reader with a general understanding of the term.

NJH suggested that the agency define

chronic beryllium disease

as a disease “characterized by evidence of granulomatous lung inflammation in an individual who is sensitized to beryllium.” According to NJH, this definition would allow for diagnosis based on different combinations of clinical evaluation results as detailed the ATS Statement (Document ID 0022, p. 3). OSHA believes that the definition the agency proposed—a chronic granulomatous lung disease caused by inhalation of airborne beryllium by an individual who is beryllium sensitized—conveys the substance of NJH's recommended definition while also emphasizing that CBD results from the inhalation of airborne beryllium. OSHA has therefore decided not to adopt the definition NJH suggested.

The ATS expressed concern that OSHA's proposed changes to the definition of

chronic beryllium disease

could create confusion in the diagnosis of CBD because it may be challenging in certain settings to identify sensitization and granulomatous lung disease based on lung pathology (Document ID 0021, p. 5). DOSH similarly commented that the proposed definition may be misleading because, although those with CBD have sensitization to beryllium, the current testing for sensitization has a high false-negative rate and individuals may be diagnosed with CBD without first being confirmed positive for beryllium sensitization (Document ID 0023, p. 2).

Although OSHA agrees that employees may be diagnosed with CBD without confirmed positive BeLPT results, the agency does not agree with these commenters that references to sensitization should be excluded from the definition of

chronic beryllium disease.

OSHA first notes that neither DOSH nor the ATS contend that OSHA's definition is inaccurate. Furthermore, as OSHA explained previously in its discussion of the

beryllium sensitization

definition, the agency believes that a correct understanding of the relationship between beryllium sensitization and CBD is key to workers' and employers' understanding of many provisions of the beryllium standard. By stating the role that sensitization plays in the development of CBD in the standard's definition of

chronic beryllium disease,

OSHA intends to convey clearly to the regulated community why protecting workers from becoming beryllium sensitized is key to the prevention of CBD and why workers who are confirmed positive for beryllium sensitization should be offered both a clinical evaluation for CBD and medical removal protection.

OSHA acknowledges that it is not always necessary to identify a worker as confirmed positive for beryllium sensitization using the BeLPT as part of a diagnosis of CBD and that the BeLPT can yield false-negative results in some individuals. For this reason, an examining physician should have the latitude to diagnose CBD even in the absence of a “confirmed positive” pattern of BeLPT results. As explained in the Summary and Explanation of paragraph (k)(7) of the 2017 final rule, that provision gives the examining physician this latitude (82 FR 2704, 2709). Because the substantive provisions of the standard leave the examining physician discretion in diagnosing CBD, OSHA does not agree that acknowledging the role of beryllium sensitization in the development of CBD will result in diagnostic confusion.

The NSSP recommended the following addition to OSHA's proposed definition of

chronic beryllium disease:

“The presence of interstitial mononuclear cell (T cell) infiltrates (lymphocytosis) is characteristic of chronic beryllium disease” (Document ID 0027, pp. 3-4). The NSSP argued that the presence of these infiltrates on lung biopsy indicates the presence of chronic beryllium disease, and should therefore be included in the standard's definition (Document ID 0027, p. 4). OSHA disagrees. The agency believes that the term “granulomatous” sufficiently addresses the presence of T-cell infiltrates, which occur at an early stage in the development of granulomas (82 FR at 2492-2502). As discussed previously, OSHA's intent in defining

chronic beryllium disease

is to provide the reader a general understanding of what CBD is, rather than provide a technical definition for diagnostic use. The suggested addition is not necessary to describe the nature of CBD in general terms. With the addition of the term “granulomatous,” the definition is sufficiently specific for OSHA's purposes in the context of paragraph (b).

In summary, for the purposes of this standard OSHA is defining

chronic beryllium disease

as a chronic granulomatous lung disease caused by inhalation of airborne beryllium by an individual who is beryllium sensitized. This definition is identical to the definition of

chronic beryllium disease

OSHA proposed in 2018 and includes only minor changes from the definition included in the 2017 final standard. OSHA is providing this definition to enhance stakeholders' general understanding of the beryllium standard; it is neither intended nor suitable to provide guidance to medical professionals on the diagnosis of CBD. OSHA expects these changes to the 2017 definition of

chronic beryllium disease

will clarify the standard, and will therefore maintain safety and health protections for workers.

Confirmed positive.

OSHA is amending the definition of

confirmed positive

to mean (1) the person tested has had two abnormal BeLPT test results, an abnormal and a borderline test result, or three borderline test results, obtained from tests conducted within a three-year period; or (2) the result of a more reliable and accurate test indicating a person has been identified as having beryllium sensitization. The revised definition includes several changes to the 2017 definition of

confirmed positive

and one change from the definition of

confirmed positive

that OSHA proposed in the 2018 NPRM.

First, the agency is removing the phrase “beryllium sensitization” from the first sentence of the definition, which previously stated that a person is confirmed positive if that person has beryllium sensitization, as indicated by two abnormal BeLPT test results, an abnormal and a borderline test result, or three borderline test results. OSHA intends that

confirmed positive

act only as a trigger for requirements such as continued medical monitoring and surveillance for the purposes of this standard, and not as a general-purpose definition of beryllium sensitization. By removing the phrase “beryllium sensitization” from the first sentence of the definition, the agency hopes to avoid confusion resulting from scientific disagreements over whether certain test results, such as three borderlines, necessarily prove that sensitization has occurred. For purposes of the beryllium

standard, any worker with the BeLPT test results specified in the definition of

confirmed positive

should be offered an evaluation for CBD with continued medical surveillance as well as the option of medical removal protection, even though some small percentage of workers who are confirmed positive by this definition may not in fact be sensitized to beryllium, as is the case for any diagnostic test (Middleton et al., 2008 (Document ID OSHA-H005C-2006-0870-0480, p. 4)).

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In the preamble to the 2017 final rule, OSHA found that three borderline BeLPT results recognize a change in a person's immune system with respect to beryllium exposure based on Middleton et al.'s 2011 finding that three borderline BeLPT results have a positive predictive value (PPV) of over 90 percent (82 FR at 2501), and therefore the agency included three borderline results in the criteria for confirmed positive (82 FR at 2646).

Both the USW and Materion supported this proposed revision. The USW stated that the former definition of

confirmed positive

had acted “as a de facto definition of sensitization” and that removing the phrase from this portion of the definition ensures that a finding of confirmed positive will trigger medical surveillance and medical removal protection “without an intermediate stop at a finding of sensitization” (Document ID 0033, p. 5). Similarly, Materion commented that the revised definition allows individuals with three borderline BeLPT results to obtain the protections of the standard, including evaluation for CBD and medical removal protection, without necessarily being “declared sensitized” (Document ID 0038, p. 18). Materion further asserted that the change enhances employee protection by increasing the number of persons eligible for further testing (Document ID 0038, p. 19).

NJH opposed the revised definition, asserting that the removal of the phrase “beryllium sensitization” could prevent individuals who meet the definition of being confirmed positive from being identified as sensitized. NJH further expressed concern that this could make it difficult for some workers to access the medical testing and workplace protections required by the rule (Document ID 0022, p. 4).

The ATS and the AOEC also disagreed with the removal of the phrase “beryllium sensitization” from the definition of

confirmed positive,

stating the medically accepted interpretation of BeLPT testing results is that they indicate beryllium sensitization, and that removing this phrase may cause confusion about what condition the term

confirmed positive

refers to (Document ID 0021, p. 3; 0028, p. 2). The ATS further stated without explanation that removing the term “beryllium sensitization” from the definition of

confirmed positive

would reduce worker protections.

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The NSSP also expressed disagreement with OSHA's proposal to remove “beryllium sensitization” from the first part of the

confirmed positive

definition, but did not state the reasons for their concern (Document ID 0027, p. 3).

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The ATS also asserted that the removal of the phrase “beryllium sensitization” would reduce workers' right to file for worker's compensation (Document ID 0021, p. 3). The ATS did not explain how the definition of

confirmed positive

in the beryllium standard could affect worker's compensation claims and at least one other commenter questioned the ATS's assertion (see Document ID 0038, p. 19). Regardless, OSHA intends the definition of

confirmed positive

to serve only as a trigger for certain provisions of the beryllium standard. How OSHA defines this phrase for purposes of the beryllium standard in no way limits healthcare professionals' ability or incentive to diagnose beryllium sensitization.

Following consideration of the concerns raised by these organizations, OSHA disagrees that removing the phrase “beryllium sensitization” from the first sentence of the definition of

confirmed positive

will create confusion or reduce worker protections. The provisions of the standard intended to benefit workers who may be sensitized (evaluation at a CBD diagnostic center and medical removal protection) are available to all workers who meet the definition of

confirmed positive.

Therefore, removing the term “beryllium sensitization” from the first sentence of the definition will not change the access to these benefits for any workers. By removing the term “beryllium sensitization” from the first sentence of the definition, OSHA seeks to ensure that workers with three borderl

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