Occupational Exposure to Beryllium and Beryllium Compounds in Construction and Shipyard Sectors

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1915 and 1926

[Docket No. OSHA-H005C-2006-0870]

RIN 1218-AD29

Occupational Exposure to Beryllium and Beryllium Compounds in Construction and Shipyard Sectors

AGENCY:

Occupational Safety and Health Administration (OSHA), Labor.

ACTION:

Final rule.

SUMMARY:

OSHA is amending its existing construction and shipyard standards for occupational exposure to beryllium and beryllium compounds to clarify certain provisions and simplify or improve compliance. These changes are designed to accomplish three goals: to more appropriately tailor the requirements of the construction and shipyards standards to the particular exposures in these industries in light of partial overlap between the beryllium standards' requirements and other OSHA standards; to aid compliance and enforcement across the beryllium standards by avoiding inconsistency, where appropriate, between the shipyards and construction standards and recent revisions to the general industry standard; and to clarify certain requirements with respect to materials containing only trace amounts of beryllium. This final rule does not affect the general industry beryllium standard.

DATES:

This rule is effective September 30, 2020.

ADDRESSES:

For purposes of 28 U.S.C. 2112(a), OSHA designates Mr. 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.

Copies of this

Federal Register

document and news releases: Electronic copies of these documents are available at OSHA's web page at

https://www.osha.gov.

FOR FURTHER INFORMATION CONTACT:

Press inquiries:

Mr. Frank Meilinger, OSHA Office of Communications; telephone: (202) 693-1999; email:

meilinger.francis2@dol.gov.

General information and technical inquiries:

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

ruskin.maureen@dol.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background

II. Pertinent Legal Authority

III. Summary and Explanation of the Final Rule

IV. Final Economic Analysis

V. Economic Feasibility Analysis and Regulatory Flexibility Certification

VI. OMB Review Under the Paperwork Reduction Act of 1995

VII. Federalism

VIII. State Plans

IX. Unfunded Mandates Reform Act

X. Environmental Impacts

XI. Consultation and Coordination With Indian Tribal Governments

Authority and Signature

I. Background

On January 9, 2017, OSHA published its final rule

Occupational Exposure to Beryllium and Beryllium Compounds

in the

Federal Register

(82 FR 2470). The final rule established three comprehensive health standards to protect workers from occupational exposure to beryllium and beryllium compounds in the general industry (29 CFR 1910.1024), construction (29 CFR 1926.1124), and shipyards (29 CFR 1915.1024) sectors. In the final rule, 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. The 2017 final rule went into effect on May 20, 2017, and OSHA began enforcing the PEL and STEL in the construction and shipyard sectors 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.

On June 27, 2017, based on stakeholder feedback and a review of applicable existing standards, OSHA published a notice of proposed rulemaking (NPRM) proposing to revoke the ancillary provisions for both the construction and shipyards standards while retaining the new lower PEL of 0.2 µg/m

3

and STEL of 2.0 μg/m

3

for those sectors (82 FR 29182).

1

OSHA stated in the proposal that it was also considering extending the compliance dates in the January 9, 2017, final rule by a year for the construction and shipyard standards. OSHA reasoned that this potential extension would give affected employers additional time to come into compliance with the final rule's requirements, which could be warranted by the uncertainty created by the proposal. OSHA also stated in the proposal that it would not enforce the construction and shipyard standards without further notice while the rulemaking was underway.

2

1

For a full discussion of the events leading to the proposed rule, see the preamble to the 2017 NPRM (82 FR at 29185-88).

2

Subsequently, in March 2018, OSHA stated that it would begin enforcing the PEL and STEL on May 11, 2018 (see Memorandum for Regional Administrators, Delay of Enforcement of the Beryllium Standards under 29 CFR 1910.1024, 29 CFR 1915.1024, and 29 CFR 1926.1124, Mar. 2, 2018, available at

https://www.osha.gov/laws-regs/standardinterpretations/2018-03-02

).

On May 7, 2018, OSHA issued a direct final rule (DFR) adopting a number of clarifying amendments to the general industry beryllium standard to address the application of that standard to materials containing trace amounts of beryllium (83 FR 19936). The DFR amended the text of the general industry standard to clarify OSHA's intent with respect to certain terms in the standard, including the definition of beryllium work area, the definition of emergency, and the meaning of the terms dermal contact and beryllium contamination. 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 percent beryllium by weight. The DFR became effective on July 6, 2018, because OSHA did not receive significant adverse comment in response to the DFR (see 83 FR 1045).

On December 11, 2018, OSHA published another NPRM to modify several of the general industry beryllium standard's definitions, along with the provisions for methods of compliance, personal protective clothing and equipment, hygiene areas and practices,

housekeeping, medical surveillance, communication of hazards, and recordkeeping (83 FR 63746). OSHA reasoned in part that the proposed modifications would provide clarification and simplify or improve compliance. OSHA recently finalized this proposal in a final rule published on July 14, 2020 (85 FR 42582).

On September 30, 2019, OSHA issued a final rule in which the agency declined to revoke the ancillary provisions of the construction and shipyards standards as proposed in the June 27, 2017 NPRM (84 FR 51377). Based on comments received and the record as a whole, the agency determined that there is not complete overlap in protections between the beryllium standards' ancillary provisions and existing standards applicable to these sectors. Thus, revoking all of the ancillary provisions and leaving only the PEL and STEL would be inconsistent with OSHA's statutory mandate to protect workers from the demonstrated significant risks of material impairment of health resulting from exposure to beryllium and beryllium compounds. However, after careful review, OSHA determined that some revisions to the construction and shipyards standards were appropriate. To give the agency time to finalize a new proposal with these more limited changes to the construction and shipyards standards, the final rule delayed the compliance dates for all ancillary provisions of these standards until September 30, 2020. The final rule did not impact the PEL or STEL, which OSHA has been enforcing since May 11, 2018.

On October 8, 2019, OSHA published the proposal being finalized here (84 FR 53902). In the NPRM, the agency proposed several revisions to the ancillary provisions of the construction and shipyard standards to more appropriately tailor the standards to these industries, to align certain provisions with recent changes to the general industry standard, and to clarify OSHA's intent with respect to materials containing trace amounts of beryllium. The NPRM proposed revisions to the paragraphs for definitions, methods of compliance, respiratory protection, personal protective clothing and equipment, hygiene areas and practices, housekeeping, medical surveillance, hazard communication, and recordkeeping. In developing its proposal, OSHA considered relevant comments received in response to the June 2017 construction and shipyards proposal, as well as general industry stakeholder input that led to the 2018 general industry DFR. In addition, OSHA proposed some revisions to align with changes proposed in the December 12, 2018 general industry NPRM (83 FR 39351).

OSHA consulted with the Advisory Committee on Construction Safety & Health (ACCSH) regarding this proposal on September 9, 2019. ACCSH recommended that OSHA proceed with the proposal to “revise the beryllium standard for construction to ensure that the ancillary provisions are tailored to the construction industry and align with the general industry standard, where appropriate,” and unanimously recommended that OSHA do so as soon as possible (see Document ID OSHA-2018-0012-0125, Tr. 62-67).

OSHA requested comments on the proposed changes and provided stakeholders 30 days to submit comments. In addition, OSHA held a public hearing on the proposal on December 3, 2019, where the agency heard testimony from several stakeholders (see Document ID 2222; 2223). Participants who filed notices of intention to appear at the hearing were permitted to submit additional evidence and data relevant to the proceeding for a 44-day period following the hearing. That period ended on January 16, 2020. The record remained open for an additional 15 days, until January 31, 2020, for the submission of final briefs, arguments, and summations. OSHA received twenty-five timely comments during this rulemaking by the close of the last post hearing comment period of January 31, 2020.

OSHA estimates that these changes will lead to total annualized cost savings of $2.5 million at a 3 percent discount rate over 10 years; at a discount rate of 7 percent over 10 years, the annualized cost savings would be $2.6 million. OSHA has determined that these changes will maintain safety and health protections for workers, while facilitating compliance with the standards and yielding some cost savings.

This rule is not an Executive Order (E.O.) 13771 regulatory action because this rule is not significant under E.O. 12866. 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. Pertinent Legal Authority

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 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, 5 U.S.C. 551

et seq.,

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. at 43.

The Act provides that in promulgating health standards dealing with toxic materials or harmful physical agents, such as the beryllium standards, the Secretary must set the standard which most adequately assures, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. 29 U.S.C. 665(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 Dept., AFL-CIO

v.

Am. Petroleum Inst.,

448 U.S. 607, 641-42 (1980) (plurality opinion) (“

Benzene”

). OSHA need not make additional findings on risk for this proposal because OSHA previously determined that the beryllium standards address a significant risk, see 82 FR 2545-52, and reaffirmed that finding in the rule finalizing the 2017 shipyards and construction proposal, the final rule published September 30, 2019. See

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

v.

Marshall,

647 F.2d 1189, 1248 (D.C. Cir. 1980) (“

Lead I”

). The Supreme Court has defined feasibility as “capable of being done.”

Am. Textile Mfrs. Inst.

v.

Donovan,

452 U.S. 490, 509-10 (1981) (“

Cotton Dust”

). 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 wide discretion to devise means to achieve the Congressionally-mandated goal of ensuring worker safety and health. See

Lead I,

647 F.2d at 1230. Thus, where OSHA has chosen some measures to address a significant risk over other measures, those 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 514 n.32. In

Cotton Dust,

the Court explained that Congress itself defined the basic relationship between costs and benefits, by placing the “benefit” of worker health above all other considerations save those making attainment of this “benefit” unachievable. 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).

Cotton Dust,

452 U.S. at 509. Thus, while OSHA estimates the costs and benefits of its proposed and final rules, partly in accordance with Executive Orders 12866 and 13771, these calculations do not form the basis for the agency's regulatory decisions.

III. Summary and Explanation of the Final Rule

The following discussion summarizes and explains the changes OSHA proposed to the beryllium standards for construction and shipyards, discusses the comments received on the proposal, and explains OSHA's determination with respect to each proposed change.

The 2017 final rule promulgated three standards designed to protect workers from the serious health effects caused by occupational exposure to beryllium and beryllium compounds (see 82 FR 2470 (Jan. 9, 2017)). Each of the three standards, which cover general industry (29 CFR 1910.1024), construction (29 CFR 1926.1124), and shipyards (29 CFR 1915.1024), contains a comprehensive set of protections, consisting of the exposure limits in paragraph (c) and a number of ancillary provisions, typical of OSHA health standards, in paragraphs (d) through (n) (see 82 FR at 2476). The ancillary provisions encompass requirements for exposure assessment, competent person (construction) or regulated areas (shipyards), methods of compliance, respiratory protection, personal protective clothing and equipment, hygiene, housekeeping, medical surveillance and medical removal, communication of hazards, and recordkeeping (29 CFR 1915.1024(d)-(n); 29 CFR 1926.1124(d)-(n)).

Since the publication of the 2017 final rule, OSHA has sought to revise the beryllium standards in a number of separate rulemakings. Those bearing on this proposal include (1) the June 27, 2017, construction and shipyards proposal (82 FR at 29182); (2) the May 7, 2018, general industry direct final rule (DFR) (83 FR at 19936); (3) the December 11, 2018, general industry proposal (83 FR at 63746), (4) the October 8, 2019, construction and shipyards proposal (84 FR at 53902); and (5) the (July 14, 2020) general industry final rule (85 FR 42582) (see Section I, Background, above for more details). In light of the comments OSHA received on these rulemakings and the evidence in the record, OSHA is revising several paragraphs of the beryllium standards for construction and shipyards.

OSHA has determined that, taken together, the limited exposures in the construction and shipyards industries and the partial overlap between the beryllium standards and other OSHA standards make revisions to both the construction and shipyards beryllium standards appropriate. The rationales for these revisions fall into three categories. First, OSHA is removing or modifying some provisions which—although appropriate in the general industry context—may be unnecessary or require revision to appropriately protect employees in the construction and shipyards industries. As will be explained further, operations with beryllium exposure in the construction and shipyards industries are significantly less varied and employees are exposed to materials with significantly lower content beryllium than in the general industry sector. In addition, employees in these industries receive the protections of several other OSHA standards, as the agency explained in the June 27, 2017, construction and shipyards proposal, in the final rule published on September

30, 2019, and in the subsequent construction and shipyards proposal published on October 8, 2019.

Second, OSHA is revising some provisions of the construction and shipyard standards to avoid inconsistencies with the clarifying changes the agency has made in the (July 14, 2020) general industry final rule. OSHA is aligning these standards to the extent possible because the agency believes that, where there is no substantive difference among industries with respect to a particular provision, applying similar requirements across industries aids both compliance and enforcement. Conversely, applying different requirements to identical situations may lead to confusion. While most of the changes in the July 14, 2020, final rule were designed specifically for general industry, OSHA is aligning changes to paragraph (b), medical definitions; paragraph (k), medical surveillance; and paragraph (n), recordkeeping, because the rationale underlying these changes applies equally in the construction and shipyards contexts.

Third, OSHA is revising certain paragraphs of the construction and shipyard standards to address the application of provisions related to dermal contact to materials containing beryllium in trace quantities. In the general industry DFR, OSHA clarified that provisions triggered by dermal contact with beryllium or beryllium contamination would apply only for dust, fumes, mists, or solutions containing beryllium in concentrations greater than or equal to 0.1 percent by weight (83 FR at 19939). OSHA's rationale regarding this final set of proposed changes dates back to the agency's August 7, 2015, beryllium NPRM (which led to the 2017 final rule) (80 FR at 47565). There, OSHA proposed to exempt materials containing less than 0.1 percent beryllium by weight on the premise that workers exposed only to beryllium as a trace contaminant are not exposed at levels of concern (80 FR at 47775). However, the agency noted evidence of high airborne exposures in construction and shipyard sectors, in particular during blasting operations and cleanup of spent media (80 FR at 47733). Therefore, OSHA proposed for comment several regulatory alternatives, including an alternative that would expand the scope of the proposed standard to include all operations in general industry where beryllium exists only as a trace contaminant (80 FR at 47730) and an alternative that would expand the scope to include employers in the shipyard and maritime sectors (80 FR at 47777).

In the 2017 final rule, after considering stakeholders' comments, OSHA decided to apply the exemption for materials containing less than 0.1 percent beryllium by weight only where the employer has objective data demonstrating that employee exposure to airborne beryllium will remain below the action level of 0.1 µg/m

3

, measured as an 8-hour TWA, under any foreseeable conditions (82 FR at 2643). OSHA noted that the action level exception ensured that workers with airborne exposures of concern were covered by the standard. OSHA agreed with the many commenters and public hearing testimony expressing concern that hazardous exposures to beryllium can occur with materials containing trace amounts of beryllium. While the agency acknowledged concerns expressed by the Abrasive Blasting Manufacturing Alliance (ABMA) and the Edison Electric Institute that processing materials with trace amounts of beryllium may not necessarily produce significant exposures to beryllium, evidence in the record showed significant exposures in some operations using materials with trace amounts of beryllium. OSHA explicitly identified abrasive blasting as one such operation. The agency determined that preventing airborne exposures at or above the action level, even to trace amounts of beryllium, reduces the risk of beryllium-related health effects to workers (82 FR at 2643; see also 82 FR at 2552).

While adopting this limited exemption for trace materials, OSHA also adopted the regulatory alternative expanding the scope of the rule to include both construction and shipyards, but recognized that these sectors had limited operations that generated airborne beryllium exposures of concern and issued separate standards for these sectors. Nonetheless, OSHA applied similar ancillary requirements across the general industry, construction, and shipyards beryllium standards. At the same time, the agency acknowledged that different approaches may be warranted for some provisions in construction and shipyards than for general industry due to the nature of the materials and work processes typically used in those industries (82 FR at 2690). Specifically, exposures to beryllium in construction and shipyards are limited to only a few operations, primarily abrasive blasting in construction and shipyards and some welding operations in shipyards (see Document ID 2042, FEA Chapter III, pp. 103-11 and Table III-8e). While the high airborne exposures during the blasting operation can expose workers to beryllium in excess of the PEL, the blasting materials contain only trace amounts of beryllium (materials such as coal slag normally contain approximately 11 µg/g or 0.0001 percent) (Document ID 2042, Chapter IV, Technological Feasibility, Table IV.69). Furthermore, the rulemaking record contains evidence of beryllium exposure only during limited welding operations in shipyards (only 4 of 127 sample results showed detectable levels of airborne beryllium) (Document ID 2042, Chapter IV, Technological Feasibility, p. IV-580).

As the regulatory history suggests, OSHA intended to protect employees working with trace beryllium when those employees experience significant airborne exposures. OSHA did not intend for provisions aimed at protecting workers from the effects of dermal contact to apply in the case of materials containing only trace amounts of beryllium in the absence of significant airborne beryllium exposure. For this reason, OSHA clarified in the general industry DFR that provisions triggered by dermal contact with beryllium or beryllium contamination would apply only for dust, fumes, mists, or solutions containing beryllium in concentrations greater than or equal to 0.1 percent by weight (83 FR at 19939). In construction and shipyards, where beryllium exposure occurs almost exclusively from materials that contain beryllium in concentrations less than or equal to 0.1 percent by weight, OSHA proposed to remove provisions triggered by dermal contact or beryllium contamination entirely, except for certain provisions the agency deemed important to limit airborne exposure (through re-entrainment of beryllium-containing dust from PPE or other surfaces) to those workers who have significant airborne exposures (see,

e.g.,

84 FR at 53913). Additionally, although limited welding operations in shipyards may include base materials or fume containing more than 0.1 percent beryllium by weight, OSHA has reason to believe that skin or surface contamination is not an exposure source of concern in these operations (84 FR at 53906).

Based on the foregoing, OSHA proposed and is now finalizing revisions to the following paragraphs of the beryllium standards for construction and shipyards: Paragraph (b), definitions; paragraph (f), methods of compliance; paragraph (g), respiratory protection; 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. OSHA is finalizing the standards as proposed, except for minor modifications to the following paragraphs: (1) Paragraph (b), specifically, by amending the definition of

CBD diagnostic center

and removing the definition of

high efficiency particulate air (HEPA) filter;

(2) paragraph (f)(1), the written exposure control plan; (3) paragraph (h), personal protective clothing and equipment; and (4) paragraph (k), medical surveillance.

OSHA notes that in response to the October 8, 2019 NPRM, several industry commenters responded that OSHA's proposed changes to simplify and better tailor the construction and shipyards standards would not go far enough, and that none of the beryllium standards' ancillary provisions are necessary (see,

e.g.,

Document ID 2203, p. 1-2, 11; 2199, p. 3; 2205, p. 2; 2206, pp. 10-13; 2209, pp. 1-2; 2241, pp. 3-4). For example, the Abrasive Blasting Manufacturing Alliance (ABMA) claimed that “[t]here is no evidence that the pre-existing standards governing abrasive blasting are insufficient to protect employees, and there is no evidence that exposure to the trace amounts of naturally occurring beryllium in abrasive blasting (or welding) has resulted in any material impairment of health to employees in all of the many years this work has been performed” (Document ID 2206, p. 11).

Comments suggesting that OSHA entirely eliminate the ancillary provisions of the construction and shipyards standards are beyond the scope of this rulemaking and were already addressed in the September 30, 2019, final rule (84 FR 51377). OSHA did not propose in this rulemaking to remove the standards' ancillary provisions in their entirety, and in fact, explained in the NPRM that the September 2019 final rule established that removing the ancillary provisions in their entirety would not sufficiently protect workers in these industries from airborne exposure to beryllium (84 FR at 51390-97).

After reviewing the comments and evidence in the record, OSHA determined that beryllium construction and shipyards standards consisting only of the TWA PEL and STEL would not be sufficiently protective (84 FR at 51390-91). Other OSHA standards do contain some requirements that overlap with, or duplicate, the requirements of the beryllium standards for construction and shipyards. In particular, as explained below in the Summary and Explanation for the removal of paragraph (i), OSHA has determined that other OSHA standards overlap with the previous hygiene requirements of the construction and shipyards standards. However, for most ancillary provisions, there is only partial overlap, and for the remainder, there is no overlap at all. Thus, in the September 30, 2019 final rule, OSHA determined not to adopt its proposal to remove all ancillary provisions from the construction and beryllium standards (84 FR at 51390-91). In that final rule, OSHA also reaffirmed its finding that beryllium exposure presents a significant risk of material health impairment to workers in the construction and shipyards sectors (84 FR at 51388-90). Commenters to the October 8, 2019, proposal have provided no new information indicating that protections are unnecessary in these sectors, and OSHA finds that the ancillary provisions that it is retaining in this final rule are necessary and appropriate to protect workers in the construction and shipyards industries.

The remainder of this summary and explanation provides detail on the changes OSHA is finalizing to the beryllium standards for construction and shipyards, including the agency's review of the evidence in the record and the reasoning for its determinations.

Paragraph (b) Definitions

Paragraph (b) of the beryllium standards for construction and shipyards specifies the definitions of terms used in the beryllium regulatory text. This final rule modifies several definitions of the 2017 standards:

CBD diagnostic center, chronic beryllium disease (CBD),

and

confirmed positive;

adds a definition of

beryllium sensitization;

and eliminates the definitions of

emergency

and

high-efficiency particulate air (HEPA) filter.

The revised definitions include several changes from previous paragraph (b) that OSHA proposed in the October 2019 NPRM, and all of the changes apply to both the construction and shipyards standards. A discussion of each definition affected by OSHA's proposed changes to paragraph (b), comments and testimony received on the proposal, and the final version of each revised definition follows.

OSHA proposed to modify the definitions of

CBD diagnostic center, chronic beryllium disease (CBD),

and

confirmed positive

and add a definition of

beryllium sensitization

to align these definitions in the construction and shipyards standards with changes the agency had already proposed to the beryllium standard for general industry. OSHA proposed these modifications for the general industry standard in December 2018 to clarify the meaning of the terms used in that standard (83 FR at 63747). OSHA provided a sixty-day comment period for the general industry proposal, which closed on February 11, 2019. OSHA's rationale for including these definitions applies equally in the construction and shipyards contexts. Therefore, as discussed in the NPRM, in addition to the comments received during this rulemaking OSHA has considered the comments that were submitted in response to the proposed changes to definitions in the general industry standard along with comments received during this rulemaking on the proposed definitions in determining whether to finalize the proposed definitions in the construction and shipyards standards. The comments to the general industry proposal can be found in Docket OSHA-2018-0003 at

http://regulations.gov.

In addition, OSHA proposed to remove references to the term

emergency

throughout the construction and shipyards standards, including the definition in paragraph (b).

Beryllium Sensitization

This final rule defines the term

beryllium sensitization

as a response in the immune system of a specific individual who has been exposed to beryllium. The definition also states that there are no associated physical or clinical symptoms and no illnesses 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. It further states that while not every beryllium-sensitized person will develop 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).

As also explained in the 2020 beryllium final rule for general industry (85 FR 42582), this definition of

beryllium sensitization

is identical to the definition proposed in the 2018 NPRM for general industry and the 2019 NPRM for construction and shipyards, and is consistent with information provided in the 2017 final beryllium rule (82 FR at 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; Document ID 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 (82 FR at 2470).

Several commenters expressed support for the proposed inclusion of a definition of

beryllium sensitization

in OSHA's beryllium standards, including National Jewish Health (NJH) (Document ID 2211, p. 3; 2243 p. 1; OSHA-2018-0003-0022, p. 2), the United Steelworkers (USW) (Document ID 2222, Tr. 24-25; 2242, p. 2; OSHA-2018-0003-0033, p. 1), and Materion Brush (Materion) (Document ID 2237, p. 4; OSHA-2018-0003-0038, p. 8). For example, USW stated that the proposed definition of sensitization 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 OSHA-2018-0003-0033, p. 1). The agency also received supportive comments in response to the beryllium general industry NPRM, which proposed an identical definition of beryllium sensitization, from the U.S. Department of Defense (DOD) (OSHA-2018-0003-0029, p. 1), and Edison Electric Institute (Document ID OSHA-2018-0003-0031, p. 2).

Some commenters expressed concerns regarding OSHA's proposed definition of

beryllium sensitization.

3

First, NJH stated that OSHA's definition is “at odds with” the definition of sensitization included in the guidelines of the American Thoracic Society (ATS), which, in 2014, published a Statement on Beryllium (ATS Statement) that included the following definition: “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 2243, p. 2; OSHA-2018-0003-0027 p. 1; OSHA-2018-0003-0022, p. 2; OSHA-2018-0003-0364, pp. 1, 44).

4

The American College of Occupational and Environmental Medicine (ACOEM) similarly stated that the definition of beryllium sensitization “has always been two abnormal, one abnormal and one borderline, or three borderline LPT results,” which it characterized as consistent with the research literature and with how the term “beryllium sensitization” is used in clinical practice and medical surveillance. In contrast, it said, OSHA's less precise proposed definition for beryllium sensitization could-together with its use of the term “confirmed positive” (see discussion below)-create confusion in clinical practice (Document ID 2213, p. 2). In response to OSHA's general industry NPRM, the National Supplemental Screening Program (NSSP) and NJH also recommended that OSHA's definition of

beryllium sensitization

should include text based on the ATS Statement on Beryllium (Document IDs OSHA-2018-0003-0027, p. 1; OSHA-2018-0003-0022, p. 2).

3

Comments from the U.S. House of Representatives Committee on Education and Labor (CEL) stated that decoupling the term

beryllium sensitization

from OSHA's definition of

confirmed positive

(discussed later in this Summary and Explanation) would have consequences for workers who leave employment already sensitized to beryllium because their medical records would only state “confirmed positive,” rather than “beryllium sensitized” (Document ID 2208, pp. 4-5). OSHA addresses CEL's comments in the Summary and Explanation of the definition of

confirmed positive.

4

NJH also stated that in order for a medical condition to be covered under Worker's Compensation, it needs to meet the statutory language requirements. NJH expressed concern that the statement that there is “no illness or disability with beryllium sensitization alone” in OSHA's proposed definition could preclude workers with beryllium sensitization from obtaining Workers' Compensation coverage and medical follow up in some states, including clinical evaluation for CBD once they leave employment (Document ID 2243, pp. 2-3). At the hearing, NJH further explained that, in light of how diagnoses of pleural plaque have affected the individuals' ability to obtain benefits for lung cancer or mesothelioma, OSHA's definition could adversely affect workers' ability to obtain benefits for CBD in the future by prematurely triggering the statute of limitations for such claims. (Document ID 2222, Tr. 39-41).

OSHA intends for 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.

NJH proposed that OSHA should modify its definition of

beryllium sensitization

to the following: “Beryllium sensitization is the result of a beryllium specific cell-mediated immune response 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, or one abnormal bronchoalveolar lavage (BAL) BeLPT. Three borderline BeLPTs may also indicate sensitization” (Document ID 2211, p. 3; 2243, p.2). NJH believes that its proposed definition would be more consistent with ATS' definition and would not preclude follow-up examinations of sensitized workers for CBD under workers' compensation coverage.

Materion disagreed with NJH's argument, stating that OSHA's definition of

beryllium sensitization

and its complementary definition of

confirmed positive

(discussed later) “align well with the ATS definitions,” and also stated that the definitions in the beryllium standards “should exist to best serve the understanding of employers and employees, not the medical community” (Document ID 2237, p. 3).

OSHA has considered the comments submitted by NJH, ACOEM, Materion, and NSSP, and has concluded that the proposed definition of

beryllium sensitization,

when properly read in the context of the standards and in combination with the definition of

confirmed positive,

does not contradict the definitions used by ATS or other organizations, and is not likely to create confusion in clinical practice. The agency is providing a definition of

beryllium sensitization

to give stakeholders, such as employers and employees, a general understanding of what beryllium sensitization is and its relationship to CBD.

The definition of

confirmed positive

explains how the results of BeLPT testing should be interpreted in the context of the standard's provisions that benefit beryllium-exposed workers, specifically, medical surveillance 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's recommended definition of

beryllium sensitization.

In their comments on the general industry standard, NSSP objected to the statement in the definition that no physical or clinical symptoms, illness,

or disability are associated with beryllium sensitization alone, but did not explain the reason for their concern (Document ID OSHA-2018-0003-0027, 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 OSHA-2018-0003-0038, p. 5). USW also specifically supported the accuracy of this section of OSHA's proposed definition of beryllium sensitization (Document ID OSHA-2018-0003-0033, p. 1).

As explained in the Summary and Explanation for paragraph (b) of the July 14, 2020, final rule revising the general industry standard (85 FR 42582), OSHA decided to retain the statement that there is no illness or disability with beryllium sensitization 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 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.

As discussed in greater detail in the beryllium final rule for general industry (85 FR 42582), 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 OSHA-2018-0003-0023, p. 1). However, other commenters, including NJH, NSSP, and USW, supported including the statement that beryllium sensitization is necessary for the development of CBD in OSHA's definition of beryllium sensitization (Document ID OSHA-2018-0003-0022, p. 2; OSHA-2018-0003-0027, p. 1; OSHA-2018-0003-0033, 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 essential 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 standard (82 FR at 2495-96).

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. In the preamble to the general industry final rule, OSHA provides additional discussion of the provisions that allow for referral to a CBD diagnostic center and diagnosis with CBD in the absence of a confirmed positive blood BeLPT result (85 FR 42598).

Thus, following consideration of the record of comments on OSHA's proposed definition of

beryllium sensitization

(which includes the comments and response detailed in the beryllium general industry final rule, 85 FR 42596), OSHA is finalizing the definition as proposed in the 2019 NPRM. The addition of this definition for beryllium sensitization does not change employer obligations under paragraphs (k) and (m) and therefore maintains employee protections under the construction and shipyards standards for beryllium.

CBD Diagnostic Center

This final rule defines a

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), bronchoalveolar lavage (BAL), and transbronchial biopsy. In the revised definition, a CBD diagnostic center must have the capacity to transfer the 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 2019 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 pulmonary specialist must be available to the CBD diagnostic center, but need not necessarily be on site at all times.

In their comments on the proposed changes to the definition of

CBD diagnostic center,

NJH and ATS recommended that a pulmonologist,

occupational medicine specialist, or physician with expertise in beryllium disease conduct the clinical evaluation for CBD, and that a pulmonologist should be on staff or available to perform the bronchoscopy (Document ID 2211, pp. 3-4; OSHA-2018-0003-0022, p. 2; OSHA-2018-0003-0021, p. 2). According to NJH, clinics that regularly evaluate patients for CBD have physicians with experience in occupational medicine conduct the clinical evaluation for CBD, in conjunction with a pulmonologist who performs a bronchoscopy (Document ID 2211, pp. 3-4; OSHA-2018-0003-0022, 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 that 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 ATS criteria), bronchoalveolar lavage (BAL), and transbronchial biopsy. OSHA has 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 is not dictating which tests an evaluation at a CBD diagnostic center should include, but ensuring that CBD diagnostic centers have the capacity to perform these tests, which are commonly needed to diagnose CBD. 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.

NJH expressed concern that the proposed definition does not specify the tests to be performed at the CBD diagnostic center, but only that the CBD diagnostic center have the capacity to conduct the tests (Document ID 2222, Tr. 70-72). NJH commented that by specifying the required capacities of a CBD diagnostic center, rather than the contents of a CBD evaluation, OSHA's change to the definition may indicate that the clinical evaluation for CBD need not include certain aspects of a CBD evaluation. NJH, the Association of Occupational and Environmental Clinics (AOEC), and ATS recommended that, at minimum, examinations should include full pulmonary function testing (including 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 2211, p. 4; OSHA-2018-0003-0022, p. 3; OSHA-2018-0003-0028, p. 2; OSHA-2018-0003-0021, pp. 1-2). NJH recommended that OSHA require 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 2211, p. 4; OSHA-2018-0003 0022, p. 3). In their comments on the general industry NPRM, Materion supported 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 OSHA-2018-0003-0038, pp. 16-17).

OSHA believes that the concerns expressed by NJH are already covered by the standard, as discussed more thoroughly in the Summary and Explanation for paragraph (k), Medical Surveillance, in this final rule. First, paragraph (k)(3) sets the requirements for contents of an examination. For the initial and periodic medical examinations, OSHA already requires under (k)(3) that employees be offered: A physical exam with emphasis on the respiratory system and skin rashes; pulmonary function tests, performed in accordance with established guidelines by ATS, including forced vital capacity (FVC) and forced expiratory volume in one second (FEV

1

); a BeLPT or equivalent test; a low dose computed tomography (LDCT) scan, if recommended by the PLHCP; and any other test deemed appropriate by the PLHCP. OSHA believes this information should be available to the CBD diagnostic center upon request.

Second, paragraph (k)(7)—which establishes the substantive requirements for the evaluation at the CBD diagnostic center—also provides the examining physician at the CBD diagnostic center flexibility to determine which additional tests are appropriate. As explained below in the Summary and Explanation of paragraph (k)(7), OSHA is adding a provision (paragraph (k)(7)(ii)) to make 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 (CBD).

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

chronic beryllium disease

or

CBD

to mean a chronic granulomatous lung disease caused by inhalation of 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. “Granulomatous” is meant to indicate an infiltration of inflammatory cells (

e.g.,

T-cells) leading to the focal collection of cells, and eventual creation of nodules in the lung (Ohshimo et al., 2017, Document ID 2171, p. 2; Williams and Williams, Document ID 2228, pp. 727-30; ATS, Document ID 0364). The formation of the type of lung granuloma specific to a beryllium immune response can only occur in those with CBD (82 FR at 2492-502). 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 only occurs 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, USW, and Materion agreed that OSHA's definition of CBD should be clarified (Document ID 2211, p. 4; 2222, Tr. 50-51; Document ID OSHA-2018-0003-0038, p. 17; Document ID OSHA-2018-0003-0033, p. 5). Materion supported the changes that OSHA proposed, which it characterized as a necessary clarification to ensure the definition provided is specific to chronic beryllium disease (Document ID 2237, pp. 4-5; OSHA-2018-0003-0038, p. 17). 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 OSHA-2018-00003-0033, 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 only occur in those with CBD (82 FR at 2492-502).

Several commenters expressed concern that the proposed definition of

chronic beryllium disease

does not provide sufficient information to guide the diagnosis of CBD, or that aspects of OSHA's proposed definition of CBD could complicate the diagnosis of CBD. Comments expressing such concern from NJH, ACOEM, ATS, DOSH, and NSSP are discussed in detail below. 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, not to provide diagnostic criteria for healthcare professionals. This is evident from the broadly written 2017 final rule definition of chronic beryllium disease: “a chronic lung disease associated with exposure to airborne beryllium” (82 FR at 2645-46).

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 and ATS commented that OSHA should adopt a definition of

chronic beryllium disease

based on the previously-mentioned 2014 ATS document on diagnosis and management of beryllium sensitization and CBD (Document ID 2211, p. 4; 2222, Tr. 50; OSHA-2018-0003-0021, p. 5). NJH suggested the following definition: “Chronic beryllium disease (CBD) is a granulomatous inflammatory response in the lungs of an individual who is beryllium sensitized” (Document ID 2211, p. 4).

5

In the beryllium informal hearing, they appeared to object to the term “granulomatous inflammation” and to prefer the term “granuloma inflammatory process” (Document ID 2222, Tr. 50). NJH stated that OSHA should adopt a definition based on the ATS beryllium statement “that says, `Chronic beryllium disease is a granuloma inflammatory process,' and note that this is different than granulomatous inflammation or granulomas. . . chronic beryllium disease is a granulomatous inflammatory process in the lungs of an individual who is beryllium sensitized” (Document ID 2222, Tr. 50). NJH further stated that their proposed definition “allows for some flexibility” in diagnosing CBD (Document ID 2222, Tr. 50). OSHA notes that the ATS statement primarily discusses CBD as a granulomatous inflammatory response in the lungs (Document ID 0364).

5

In their comments on the general industry NPRM, NJH previously 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 in the ATS Statement (Document ID OSHA-2018-0003-0022, p. 3). OSHA's response to NJH's new suggested definition also pertains to this previously suggested definition.

As discussed above, OSHA has determined that it is neither necessary nor appropriate to provide 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. 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—adequately conveys that CBD is granulomatous in nature, and that it is not necessary for the agency's purposes to further specify that it is an inflammatory process. OSHA has therefore decided not to adopt the definition that NJH suggested.

ACOEM objected to the inclusion of the term “granulomatous” in the definition of

chronic beryllium disease

(Document ID 2213, p. 3). ACOEM contended that CBD does not always include the presence of granulomas and the lung pathology is more consistent with “mononuclear cell interstitial infiltrates.” According to ACOEM, it is established in the medical literature that the lung pathology found in CBD does not always include granulomas; lung biopsies may not detect granulomas, either due to practical limitations of the

test or because the patient's stage of disease is too early (

i.e.,

the cells of the immune system that form granulomas have accumulated in the lungs, but have not yet formed into clusters) (Document ID 2213, p.3). ACOEM expressed concern that, if OSHA's [a]ddition of the term “granulomatous” to the definition excludes cases where granulomas are not present, it “may result in some workers being unnecessarily excluded from appropriate medical care under the OSHA rule, and may affect their ability to receive workers' compensation, due to the overly narrow definition” (Document ID 2213 p. 3). ACOEM further noted that the presence of beryllium sensitization “lends specificity to the diagnosis”; therefore, it is not necessary to use the term “granulomatous” for the sake of specificity in the definition.

OSHA disagrees with ACOEM's contention that including the term “granulomatous” in the agency's definition of

chronic beryllium disease

would be inaccurate or overly narrow, and could thereby prevent workers from obtaining appropriate medical care or benefits for CBD. To begin with, OSHA's definitions in paragraph (b) of the standard are intended only to clarify the meaning of terms that appear in the standard. The definition of

chronic beryllium disease

is written with the goal of providing readers of the standard, who may have little or no familiarity with CBD, with a general understanding of the term. The definition does not provide diagnostic criteria for healthcare professionals to follow when diagnosing and addressing CBD.

Moreover, ACOEM's concerns are unfounded because including the term “granulomatous” does not exclude cases of CBD where granulomas have not yet formed or are not detected by lung pathology. OSHA agrees with ACOEM that CBD includes mononuclear cell infiltrates and can be diagnosed in the absence of lung pathology findings of granulomas in the lung. As described in the Health Effects section of the 2017 final rule, CBD is a pathological continuum which results from lung exposure to beryllium. The continuum consists of an asymptomatic early response with the recruitment of inflammatory T-cells and other mononuclear cells through to the formation of granulomas and frank, chronic disease (82 FR at 2491-2502). However, the term “granulomatous” does not refer only to the presence of granulomas; the term “granulomatous” inflammation is described in the literature as beginning with chronic inflammation predominated by mononuclear phagocyte cells leading to the eventual aggregation of these cells into focal lesions called granulomas (ATS, Document ID 0364; Ohshimo et al., 2017, Document ID 2171, p. 2; Williams and Williams, 1983, Document ID 2198). OSHA finds that adding the term “granulomatous” to the definition of CBD, contrary to the concerns raised by ACOEM, does not imply that CBD cannot be diagnosed where granulomas have not yet formed or are not detected by lung pathology.

ACOEM also noted that “the presence of beryllium sensitization (as measured in BeLPT using either blood or lung cells) lends specificity to the diagnosis,” which makes including the term “granulomatous” unnecessary (Document ID 2213, p. 3). OSHA disagrees. First, including the term “granulomatous” is consistent with the ATS statement “the diagnosis of CBD is based on the demonstration of both BeS and granulomatous inflammation on lung biopsy.” (Document ID 0364, p. e35, e43-e45, e55). Based on the ATS statement, NJH also recommended a definition of chronic beryllium disease that included a reference to “granulomatous inflammation” (Document ID 2211, p. 4).

Second, as noted in the summary and explanation section for the 2020 general industry beryllium final rule (85 FR 42598), OSHA acknowledges that it may not always be possible to identify a worker for beryllium sensitization using the BeLPT as part of a diagnosis of CBD because the BeLPT can yield false-negative results in some individuals (see Document ID 0399). This means some individuals may actually be sensitized to beryllium even though they have a negative BeLPT result; therefore, there is value to adding the term “granulomatous” to lend further specificity. An examining physician should have the latitude to diagnose CBD even in the absence of a “confirmed positive” pattern of BeLPT results 85 FR 42598), for example, in the presence of lung inflammation. The latitude and flexibility provided under these standards affords physicians the discretion to diagnose CBD in patients that may not have the classic hallmarks of sensitization or CBD (

e.g.

positive BeLPT or granuloma), but have a work history of exposure to beryllium and an undiagnosed health issue. However, OSHA emphasizes that the definition of

chronic beryllium disease

is to inform the general reader of this preamble and final rule, and is not intended to guide physician diagnosis of CBD.

In their comments on the 2018 general industry NPRM, ATS recommended including diagnostic criteria in the definition, such as confirmation of an immune response to beryllium and granulomatous lung inflammation using lung biopsy, and that the definition 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 OSHA-2018-0003-0021, p. 5). ATS also expressed concern that OSHA's proposed changes to the definition of

chronic beryllium disease

could create confusion in the diagnosis of CBD because, “[w]hile beryllium sensitization is essential to the development of CBD, demonstrating beryllium sensitization, as well as granulomatous lung disease on lung pathology, can be challenging in certain settings” (Document ID 0021, p. 5). DOSH stated that the proposed definition “emphasizes beryllium sensitization as a factor in chronic beryllium disease in a manner that may be misleading” and emphasized that individuals may be diagnosed with CBD without a confirmed positive BeLPT result. DOSH 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 OSHA-2018-0003-0023, p. 2).

Although OSHA agrees with ATS and DOSH that diagnosing CBD does not always require confirmation of beryllium sensitization, the agency does not believe that references to sensitization should be excluded from the definition of

chronic beryllium disease.

OSHA first notes that neither DOSH nor 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 beryllium final rule (2017), that provision gives the examining physician this latitude (82 FR at 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. As stated above, the agency does not intend for the definition to be used for diagnostic criteria, but rather to add clarity to the standard and provide readers who may have little or no familiarity with CBD with a general understanding of the term.

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). 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 2019 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. After considering these comments and after reviewing the record as a whole (which includes the comments and responses detailed in the July 14, 2020, general industry final rule (82 FR 42602)), OSHA has decided to amend the definition of

chronic beryllium disease (CBD)

as proposed.

Confirmed Positive

This final rule defines

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 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 2019 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 the term

confirmed positive

act only as a trigger for requirements in the standards, such as continued medical monitoring and surveillance for the purposes of these standards, 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 standards, 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 0480, p. 4).

6

6

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). While Materion contests the findings of the Middleton et al study (2011) regarding three borderline BeLPTs, Materion was generally supportive of removing sensitization from the definition, stating that the agency “wisely splits[s] the definition of beryllium sensitization, which is a medical determinant, from confirmed positive, which is a testing regimen outcome” (Document ID 2237, pp. 3-4).

Both USW and Materion supported this proposed revision. USW supported removing the phrase beryllium sensitization because, “[w]hile it is true that a confirmed positive result of BeLPT testing currently leads to a diagnosis of sensitization, linking the two in the same definition could lead to unintended hardships for beryllium workers” (Document ID 2242, p. 3). At the December 3, 2019 public hearing, USW also explained that a finding of beryllium sensitization could, in some states, trigger a statute of limitations under laws governing claims for compensation for other adverse health effects (Document ID 2222, Tr. 24-25). According to USW, “the word `sensitized' is more likely to trigger a statute-of-repose deadline for filing a tort suit than the words `confirmed positive,'” and should that happen, “the worker would not be able to receive adequate compensation if they later developed chronic beryllium disease” (Document ID 2242, p. 3). Materion commented that “OSHA's separation of beryllium sensitization from confirmed positive can increase the number of employees eligible to accept further medical testing by institutions such as NJH or to seek OSHA's medical removal option,” as well as the number of employees “who may choose to be medically monitored on a more routine basis at institutions such as NJH” (Document ID 2237, p. 4).

In its comments on the general industry NPRM, USW also commented that the former definition of

confirmed positive

had acted “as a de facto definition of sensitization” and that removing the phrase “beryllium sensitization” 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 OSHA-2018-0003-0033, p. 5). Similarly, Materion commented in their response to the general industry

NPRM 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 OSHA-2018-0003-0038, p. 18). Materion further asserted that the change enhances employee protection by increasing the number of persons eligible to go on to further testing (Document ID OSHA-2018-0003-0038, p. 19).

Several commenters disagreed with OSHA's proposal to remove the phrase “beryllium sensitization” from the definition of

confirmed positive.

NSSP generally 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 its concern (Document ID OSHA-2018-0003-0027, p. 3).

Several commenters expressed concern that OSHA's proposed revision would create confusion. NJH stated that removal of “beryllium sensitization” would cause confusion as to what the term “confirmed positive” refers, and stated that workers need to understand that, if they are confirmed positive, they have a specific T-cell mediated response to beryllium that can result in development of CBD (Document ID 2222, Tr. 64; 2211, p. 5). ACOEM commented that “[s]eparating the definition of `confirmed positive' from the definition of beryllium sensitization is confusing, unnecessary, and contradicts the accepted terminology and definitions employed in the fields of immunology, beryllium medical research, and clinical practice . . .” ACOEM further stated that, “[i]n clinical practice, [the change] will add significant confusion, to the detriment of workers and patients,” because “[t]he medical community is not accustomed to diagnosing a patient's medical condition as `confirmed positive,' ” and instead refers to patients as being “beryllium sensitized” based on “the presence of confirmed positive BeLPTs.”

7

(Document ID 2213, p. 2).

7

ACOEM also stated that the proposed change would create confusion by creating “misalignment with existing legislation, including the Energy Employee Occupational Illness Compensation Program Act (1999) and the U.S. Department of Energy's beryllium rule (Document ID 2213, p. 2). To the extent that ACOEM suggests that OSHA is obliged to adopt definitions that match those used in other statutes of federal regulations for the same or similar terms, ACOEM is mistaken. OSHA has discretion to adopt appropriate definitions for the terms in its beryllium standards, including the definition of confirmed positive, which serves as a trigger for certain provisions of the beryllium standards. As explained further below, OSHA does not agree that the definition of

confirmed positive

that it is adopting in this rule will result in confusion.

ATS and AOEC also expressed concern that, because the medically-accepted interpretation of BeLPT testing results is that they indicate beryllium sensitization, removing the phrase “beryllium sensitization” from the definition of

confirmed positive

may cause confusion about the condition to which

confirmed positive

refers (Document ID OSHA-2018-0003-0021, p. 3; OSHA-2018-0003-0028, p. 2). CEL cited to, and expressed support for, ATS' and AOEC's comments regarding this change, and also expressed concern that, after a worker leaves employment, their medical record might only state that they were “confirmed positive,” rather than “beryllium sensitized,” which could create confusion for medical personnel who may later evaluate or treat the worker (Document ID 2208, p. 5).

Commenters also expressed concern that removing “beryllium sensitization” from the definition could negatively affect workers' ability to obtain workplace protections and other benefits. NJH stated that removing “beryllium sensitized” from the definition of

confirmed positive,

in conjunction with OSHA's proposal to place a time constraint on confirmation testing results in the definition (discussed below), might reduce workers' ability to obtain medical testing and workplace protections that are required by the rule (Document ID 2243, p. 3). NJH also opposed the revised definition in their comments on the 2018 general industry NPRM, asserting that the removal of the phrase “beryllium sensitized” could prevent individuals who meet the definition of being confirmed positive from being identified as sensitized (Document ID OSHA-2018-0003-0022, p. 4). ATS also stated (without explanation) that removing the term “beryllium sensitization” from the definition of

confirmed positive

would reduce worker protections (Document ID OSHA-2018-0003-0021, p. 3).

Additionally, NJH, ATS, and CEL expressed concern that removing “beryllium sensitization” from the definition of

confirmed positive

would adversely affect workers' ability to obtain workers compensation benefits. NJH commented that the proposed change, in conjunction with OSHA's proposal to place a time constraint on confirmation testing results (discussed below), would prevent individuals from being diagnosed with beryllium sensitization, which is medically compensable under workers' compensation programs in many states (Document ID 2243, p. 3). CEL cited to ATS's stated concern that removing the phrase “beryllium sensitization” would reduce workers' right to file for worker's compensation (Document ID 2208, p. 5 (citing 0021, p. 3)).

Commenters also expressed concern that the proposed revision of the

confirmed positive

definition was inconsistent with other parts of the standard. CEL and ACOEM claimed that the change would create an inconsistency with the definition of

Chronic Beryllium Disease (CBD),

which defines CBD as “a chronic granulomatous lung disease caused by inhalation of airborne beryllium by an individual

who is beryllium-sensitized”

(emphasis added) (Document ID 2208, p. 5; 2213, p. 2). CEL also expressed concern that “the definition of beryllium sensitized no longer refers to the definition of `confirmed positive,' which defines the criteria for being determined beryllium sensitized.” Additionally, CEL noted that, paragraph (k)(5)(i)(A) of the rule, which articulates the necessary contents of the written medical report given to the employee under the standard's medical surveillance requirements, “equates `beryllium sensitization' with an employee's status as `confirmed positive' which is consistent with the original 2017 standards, but not consistent with the decoupling of these terms in the current proposal” (Document ID 2208, p. 5).

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, reduce worker protections, or conflict with other aspects of the regulatory text. The provisions of the standards intended to benefit workers who may be sensitized (specifically, 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 sensitized” from the first sentence of the definition will not change the access to these benefits for any workers. By removing the term “beryllium sensitized” from the first sentence of the definition, OSHA seeks to ensure that workers with three borderline BeLPT results (or other patterns of test results that some PLHCPs may consider ambiguous) will receive the benefits of the standard regardless of whether their PLHCP views their results as firm evidence of

sensitization.

8

Furthermore, OSHA disagrees that removing the reference to “beryllium sensitized” will lead to confusion about what the BeLPT results are supposed to indicate because the second sentence of the definition of

confirmed positive

makes clear that a worker who has been diagnosed with beryllium sensitization would also meet the definition of

confirmed positive:

“It [

i.e.,

confirmed positive] also means the result of a more reliable and accurate test indicating a person has been identified as having beryllium sensitization.”

8

OSHA is also unpersuaded by the comments expressing concern that OSHA's revision of the definition of

confirmed positive

in the beryllium standards would affect workers' ability to obtain workers compensation benefits. ATS's comment did not explain how the definition of confirmed positive in the beryllium standard could affect worker's compensation claims, but at least one other commenter questioned the ATS's assertion (see Document ID 0038, p. 19). NJH expressed concern that the change would prevent individuals from being diagnosed with beryllium sensitization, which would trigger their eligibility for benefits under some states' workers compensation programs (Document ID 2243, p. 3). OSHA intends for the definition of confirmed positive in paragraph (b) to serve only as a trigger for certain provisions of the beryllium standards. How OSHA defines this phrase for purposes of the beryllium standards in no way limits healthcare professionals' ability or incentive to diagnose beryllium sensitization.

OSHA also disagrees with the commenters' concern that the proposed definition will create inconsistencies within the standard. CEL's concern that removing the term “beryllium sensitized” from the first sentence of

confirmed positive

will create an inconsistency with paragraph (k)(5)(i)(A) because that provision “equates `beryllium sensitization' with an employee's status as `confirmed positive' is misplaced. Paragraph (k)(5)(i)(A), which is not being changed in this final rule, requires that the licensed physician's written medical report for the employee include any detected medical condition, such as CBD or beryllium sensitization (

i.e.,

the employee is confirmed positive, as defined in paragraph (b) of the standard), that may place the employee at increased risk from further airborne exposure. As explained above, the purpose of the agency's definition of

confirmed positive

is to establish the test results that trigger the benefits in the standards aimed at protecting potentially beryllium-sensitized individuals (specifically, an evaluation for CBD with continued medical surveillance, and the option of medical removal protection). The phrasing of the

confirmed positive

definition does not affect the relevant detectable medical conditions that physicians are instructed to include in their written reports under paragraph (k)(5)(i)(A). The reference to

confirmed positive

in paragraph (k)(5)(i)(A) is intended to signal that, where a physician has identified a worker as having beryllium sensitization, that individual also satisfies the definition of

confirmed positive.

Nor does removing the reference to “beryllium sensitized” from the definition of

confirmed positive

create an inconsistency with the standards' definitions of

chronic beryllium disease

or

beryllium sensitization.

As discussed above, the definition of

confirmed positive

explains the test results that, in the context of these beryllium standards, triggers the benefits intended to protect individuals who may be beryllium-sensitized. Such results include both employees who are identified as having beryllium sensitization, and employees who have three borderline BeLPT results (or other patterns of test results that some PLHCPs may consider ambiguous) but may not be affirmatively identified by the physician as beryllium-sensitized. The definitions of

beryllium sensitization

and

chronic beryllium disease (CBD)

are informational definitions that do not trigger any specific protections in the standards, and are solely included to help readers generally understand those terms. The definition of

chronic beryllium disease (CBD)

clarifies that individuals that have CBD have beryllium sensitization, and the definition of

beryllium sensitization

explains that “[w]hile not every beryllium-sensitized person will develop CBD, beryllium sensitization is essential for development of CBD.” OSHA finds no conflict between these definitions and the definition of

confirmed positive.

An additional change to the definition of

confirmed positive

provides that the findings of two abnormal, one abnormal and one borderline, or three borderline results need to occur from BeLPTs conducted within a three-year period. This change in the definition of

confirmed positive

differs from the proposal and is based on comments submitted to the record following publication of the 2018 NPRM for general industry and the 2019 NPRM for construction and shipyards.

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. After publication of the 2017 final rule, stakeholders suggested to OSHA that the definition of

confirmed positive

could be interpreted as meaning that findings of two abnormal, one abnormal and one borderline, or three borderline results over any time period, even as long as 10 years, would result in the employee being confirmed positive and automatically referred to a CBD diagnostic center for evaluation. As discussed in the preamble to the 2017 standard, clinical evaluation for CBD involves bronchoalveolar lavage and biopsy (82 FR at 2497) which, like all invasive medical procedures, carry risks of infection and other complications.

9

Given such risks, and the possibility that some repeat abnormal or borderline results obtained over a long period of time could be false positives, it was not the agency's intent that workers with rarely recurring abnormal or borderline BeLPT results should necessarily proceed to evaluation at a CBD diagnostic center unless recommended to do so by their examining physician. At the same time, OSHA notes that under paragraph (k)(5)(iii), the licensed physician performing the BeLPT testing retains the discretion to refer an employee to a CBD diagnostic center if the licensed physician deems it appropriate, regardless of the BeLPT result.

9

Bronchoalveolar lavage is a method of “washing” the lungs with fluid inserted via a flexible fiberoptic instrument known as a bronchoscope, removing the fluid and analyzing the content for the inclusion of immune cells reactive to beryllium exposure (82 FR at 2497).

In the 2019 NPRM, OSHA proposed that any combination of test results specified in the definition of

confirmed positive

must result from the tests conducted in one cycle of testing, including the initial BeLPT and the follow-up retesting offered within 30 days of an abnormal or borderline result (paragraph (k)(3)(ii)(E)). As outlined in proposed paragraph (k)(3)(ii)(E), an employee would be offered a follow-up BeLPT within 30 days if the initial test result is anything other than normal, unless the employee had been confirmed positive (

e.g.,

if the initial BeLPT was performed on a split sample and showed two abnormal results). Thus, for example, if an employee's initial test result was abnormal, and the result of the follow-up testing offered to confirm the initial test result was abnormal or borderline, the employee would be confirmed positive. Alternatively, if the result of the follow-up testing offered to confirm the initial abnormal test result was normal, the employee would not be confirmed positive. Any additional abnormal or borderline results obtained from the next required BeLPT for that employee (typically, two years later) would not identify that employee as confirmed positive under the proposed modification to

confirmed positive.

OSHA requested comments on the appropriateness of this proposed time period.

Several stakeholders, including Materion, NJH, ACOEM, AFL-CIO, CEL, and USW, submitted comments regarding OSHA's proposal to require that the test results specified in the agency's definition of confirmed positive must occur within a single testing cycle. OSHA also received comments from Materion, NJH, ATS, DOSH, NSSP, USW, and AOEC on this proposed revision in the 2018 NPRM for general industry.

Commenters focused on several aspects of the proposed timing. First, many of the comments focused on the logistics of OSHA's proposed change. NJH, ACOEM, AFL-CIO, USW, ATS, DOSH, AOEC, and NSSP all indicated that requiring results with a 30-day testing cycle could create logistical challenges, for example due to repeat testing requirements or for businesses in remote areas with access to limited healthcare facilities (Document ID 2211, pp. 5-7; 2213, pp. 2-3; 2244, pp. 17-18; OSHA-2018-0003-0033, p. 5; OSHA-2018-0003-0022, p. 4; OSHA-2018-0003-0021, p. 4; OSHA-2018-0003-0024, p. 1; OSHA-2018-0003-0027, p. 3). Materion agreed with these commenters that “the 30 day initial testing period may not allow enough time to complete retesting of workers due to issues beyond the control of the employer or employee” (Document ID 2237, p. 5).

10

10

In their comments on the 2018 general industry NPRM, Materion supported the proposed definition of

confirmed positive,

stating that a 30-day allowance for follow-up testing after a first abnormal or borderline BeLPT result is appropriate to ensure that testing is completed in a timely manner (Document ID OSHA-2018-0003-0038, p. 17).

In this final rule and preamble, OSHA clarifies that it did not intend that the initial and follow-up tests had to be completed and interpreted within 30 days. OSHA intended that the test results used to determine if a worker is confirmed positive be obtained during one cycle of testing (

i.e.,

an initial or periodic examination), including follow-up testing conducted within 30 days of an abnormal or borderline result.

Secondly, stakeholders commented on the appropriateness of limiting the use of the BeLPT from one test cycle in determining if a worker is confirmed positive. Commenters from public health organizations raised concerns that limiting test results to one test cycle would affect the ability to identify workers who should be referred for a CBD evaluation and receive other protections under the standard. NJH stated that OSHA's proposal to place a time constraint on confirmation testing results would reduce workers' ability to obtain medical testing and workplace protections that are required by the rule.

11

NJH proposed the following definition be used: “Confirmed positive means the person tested has beryllium sensitization as demonstrated by two abnormal BeLPT test results, an abnormal and a borderline test result, three borderline test results or the result of a more reliable and accurate test for sensitization” (Document ID 2243, p. 3).

11

As discussed above, NJH expressed concern that OSHA's proposed definition of confirmed positive could prevent individuals from being diagnosed with beryllium sensitization, and thereby prevent them from receiving workers' compensation benefits (Document ID 2243, p. 3). OSHA intends the definition of confirmed positive to serve only as a trigger for certain provisions of the beryllium standards. How OSHA defines this phrase for purposes of the beryllium standards in no way limits healthcare professionals' ability or incentive to diagnose beryllium sensitization.

Other public health organizations, including ACOEM, DOSH, ATS, NSSP, AOEC, and CEL, agreed with NJH that workers who are sensitized to beryllium may show varying test results over time, and restricting the time period for determining “confirmed positive” status to 30 days would cause sensitized individuals to go undetected (Document ID 2213, pp. 2-3; 2208, pp. 3-4; OSHA-2018-0003-0023, p. 2; OSHA-2018-0003-0021, p. 2; OSHA-2018-0003-0027, p. 3; OSHA-2018-0003-0028, p. 2). ACOEM commented that the 30-day cycle would exclude workers who might have confirmatory tests several years after the initial first positive result, and stated that there is potential for confirmatory results could take up to 10 years to occur. ACOEM also stated that “[t]here is no justification or need for a restrictive time limit for the occurrence of confirmatory tests,” but if OSHA determined that a time limit was needed as a practical matter, ACOEM stated that at least three years should be permitted for repeat testing to identify confirmed positive results (Document ID 2213, p. 2).

ATS and AOEC recommended that results from tests performed up to at least three years after the initial abnormal or borderline test result should be used to determine whether the person is confirmed positive for beryllium sensitization (Document ID OSHA-2018-0003-0021, p. 2; OSHA-2018-0003-0028, p. 2). ATS stated that a timeframe of at least three years, which encompasses two rounds of regularly scheduled testing required biennially by the beryllium standard, would adequately address its concerns regarding logistical feasibility, would improve diagnostic accuracy, and would help ensure that sensitized workers are identified (Document ID OSHA-2018-0003-0021, p. 4). The ATS Statement on beryllium sensitization recommends a three-year testing cycle to confirm beryllium sensitization (Document ID 0364, p. e35). AOEC agreed that consideration of BeLPT test results obtained during a time period of at least three years “will increase the potential that workers are accurately diagnosed with beryllium sensitization [and] will receive the necessary care” (Document ID OSHA-2018-0003-0028 p. 2). NABTU noted that the Department of Energy's (DOE) Building Trades Screening Program also uses a three year testing cycle to confirm workers positive for sensitization (Document ID 2236, p. 2). CEL also commented that “OSHA should significantly lengthen the period allowed between initial and confirmatory testing and develop a testing protocol that is both practicable and based on science” (Document ID 2208, p. 4).

The approaches recommended by the ATS and the AOEC are similar to the approach used by NJH in providing medical surveillance consultation to workforces that use beryllium. NJH stated that, if an individual's BeLPT results are abnormal and normal on their initial round of BeLPT testing, they will usually request another BeLPT within a month. If the result of that test is normal, they do not request further testing until the next regularly scheduled BeLPT. If the result of the next regularly scheduled BeLPT comes back abnormal, they refer the worker for clinical evaluation even though the tests are separated by the two-year testing cycle (Document ID OSHA-2018-0003-0022, p. 5).

NJH submitted new, unpublished evidence to the record supporting the appropriateness of extending the test period to at least three years (Document ID 2243, p. 5). NJH's unpublished data was collected from patients that were ultimately diagnosed with CBD by either NJH or Oak Ridge Associated Universities (ORAU). The data (as reported in Tables 1 and 2 below) shows the timeframe from the initial abnormal BeLPT to the second abnormal BeLPT that is required to trigger a clinical evaluation for CBD (Document ID 2243, p. 5).

Table 1—NJH Days To Confirmed Positive

Number of days

Number

confirmed

Percent

confirmed

30

44

23

60

93

48

90

122

63

120

136

70

150

144

74

180

155

80

1 year

169

87

2 years

181

93

3 years

186

96

> 3 years

194

100

Table 2—ORAU Days To Confirmed Positive

Number of days

Number

confirmed

Percent

confirmed

30

42

17

60

107

44

90

126

52

120

139

58

150

147

61

180

148

61

1 year

182

76

2 years

201

83

3 years

206

85

> 3 years

241

100

Tables 1 & 2 adapted from Document ID 2243, p. 5

.

As indicated by the evidence in Tables 1 and 2, many workers who develop CBD have abnormal or borderline results that do not immediately repeat upon retesting. To the contrary, many CBD patients have a series of tests which alternate between normal and abnormal. BeLPT data from Table 1, based on NJH's extensive experience, show that the BeLPT does not yield consistently abnormal results among CBD patients. Of 194 patients diagnosed with CBD at NJH, the length of time between abnormal results ranged from 14 days to 5.8 years, with a 95th percentile of 2.9 years. In this group, 150 patients (or 77 percent) would not have been evaluated for CBD if two abnormal BeLPT results were required to occur within a 30-day testing cycle (Document ID 2243, p. 5; OSHA-2018-0003-0022, p. 5). Similar findings are shown in Table 2 (BeLPT data from ORAU, also submitted by NJH (Document ID 2238, p. 5)). Data from Table 2 indicates that 83 percent (199 patients) of individuals who went on to develop CBD would not have been evaluated for CBD if two abnormal BeLPT results were required to occur within a 30-day testing cycle (Document ID 2243, p. 5).

Although the information NJH submitted to the record is unpublished, their findings are consistent with published studies. Kreiss et al. (1997) reported that nine individuals had initial abnormal BeLPT results followed by two normal tests; six of those individuals were re-tested approximately one year later and four were confirmed positive for beryllium sensitization based on abnormal BeLPT results (Document ID 1360, pp. 610-12). These findings suggest a high rate of false-negative results and are consistent with results reported in a study by Stange et al. (2004). That study found an average false-positive rate of 1.09 percent, and a false-negative rate of 27.7 percent for the BeLPT (Document ID 1402, p. 459).

Stakeholders provided similar comments, in response to OSHA's proposed definition of

confirmed positive

in the 2018 general industry NPRM, which was identical to the revised definition of

confirmed positive

proposed in the 2019 NPRM for construction and shipyards. For example, NSSP cited ORAU data (the same data submitted by NJH and shown in Table 2) from healthcare providers to demonstrate that a 30-day testing cycle is insufficient to properly identify sensitized workers. NSSP noted that, in over 20 years of conducting BeLPTs in worker populations, ORAU observed approximate median times of 45 days (range of 3 days to 16 years) between first and second abnormal tests, 1.5 years (range of 30 days to 11 years) for the abnormal/borderline test combination and 1 year (range of 30 days to 11 years) for three borderlines (Document ID OSHA-2018-0003-0027, p. 3). Under the proposed 30-day requirement, the NSSP stated that the majority of workers who have been identified as sensitized in the past would not meet the proposed definition of confirmed positive (Document ID OSHA-2018-0003-0027, p. 3).

Following consideration of the comments and of the new evidence submitted to the record following the proposal, OSHA is convinced that some workers who are ultimately found to be sensitized to beryllium or diagnosed with CBD may have alternating abnormal and normal BeLPT results, and that the time period for abnormal or borderline results to repeat can be months or years. OSHA is also convinced that requiring two abnormal, an abnormal and borderline, or three borderline results to occur in one cycle of an initial or periodic exam before an employee can be confirmed positive could result in beryllium sensitization or CBD going undetected in many employees. This is demonstrated by the unpublished data submitted by NJH showing that a substantial percentage of individuals with CBD (77 percent) may not have been referred for further testing based on results obtained within a 30-day cycle of testing and is confirmed by the data from ORAU that NSSP presented in response to the 2018 general industry NPRM (85 FR42605). Therefore, OSHA finds that its proposed change would have the unintended and unacceptable consequence of reducing employee protections because some employees who are sensitized or have CBD would be deprived of the benefits available through the standard, such as a timely evaluation at a CBD diagnostic center. In addition, requiring that results be obtained in one test cycle is not consistent with the approaches currently applied or supported by the medical community.

For these reasons, OSHA is revising 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 agrees with the ATS and the AOEC that a three-year period will facilitate the identification of sensitized workers enrolled in medical surveillance (see Document ID OSHA-2018-0003-0022, p. 5; OSHA-2018-0003-0028, p. 2; Document ID 0364, p. e35). In addition, this approach is consistent with the practices and recommendations from the public health community, including NJH and DOE, which provides beryllium-related medical surveillance consultation. OSHA believes that allowing a worker to be confirmed positive based on BeLPT results obtained over a three-year time period strikes a reasonable balance that would allow a timely evaluation for CBD, while at the same time, maintaining OSHA's original intent that a confirmed positive finding not be based on results obtained over an indefinite time period.

OSHA emphasizes that this revision does not modify the requirements of paragraph (k)(3)(ii)(E). Under that paragraph, if the results of the BeLPT are other than normal, a follow-up BeLPT must be offered within 30 days of receiving the results, unless the employee has been confirmed positive. Only other than normal BeLPT results must be followed up within 30 days of the same test cycle (

i.e.,

an initial or periodic medical examination).

As an example, an employee who receives a borderline result during one periodic examination conducted in 2020 would be retested within 30 days, and if the follow-up test is normal, testing would stop. That employee would be offered another BeLPT at the next

periodic examination conducted in 2022. However, if the result of the 2022 test is borderline, the employee would be retested within 30 days of that test result receipt, and if the follow-up test is borderline, the employee would be confirmed positive because of receiving three borderline tests within three years. A three-year period for the employee to be confirmed positive would ensure sufficient time for such follow-up tests that may need to be conducted over two cycles of medical examinations.

In their comments on the 2018 NPRM for general industry, the U.S. Department of Defense (DOD) recommended changing the term “confirmed positive” to another term such as “confirmed non-negative,” “confirmed finding of concern,” or “pattern of concern.” According to the DOD, the term “confirmed positive” typically “implies an initial positive test that was repeated with another test or another, more sensitive test, which confirms the initial positive test result” (Document ID OSHA-2018-0003-0029, p. 2). As OSHA explained in the general industry final rule Summary and Explanation (85 FR 42606), however, the CBD literature, commonly treats individuals as confirmed positive for sensitization through sequentially conducted BeLPTs (see, for example, the ATS Statement on Diagnosis and Management of Beryllium Sensitivity and Chronic Beryllium Disease, ATS 2014, Document ID 0364, p. e41; see also Document ID 1543, 0603, 0398, 1403, 1449). Additionally, OSHA again emphasizes that terms defined in the beryllium standards are defined only for purposes of the standard and are not intended as diagnostic, scientific, or all-purpose definitions. OSHA believes that its definition of

confirmed positive

clearly indicates what that term means for purposes of the beryllium standards and therefore disagrees with DOD's concern that the term may cause confusion. Accordingly, OSHA is retaining the term “confirmed positive” in this final standard.

Emergency

Finally, OSHA proposed to remove references to the term

emergency

throughout the construction and shipyards standards, including the definition in paragraph (b). The agency explained that, unlike in general industry, the construction and shipyards industries—where exposure to beryllium is almost exclusively limited to trace quantities from abrasive blasting and welding operations—do not have emergencies in which exposures to beryllium will differ from the normal conditions of work. Specifically, OSHA reasoned that an uncontrolled release of airborne beryllium in these industries (such as a release resulting from a failure of the blasting control equipment, a spill of the abrasive blasting media, or failure of the ventilation system for welding operations) would occur only during the performance of routine tasks already associated with the airborne release of beryllium; that is, during abrasive blasting or welding processes. The agency explained that it anticipates employees working in the immediate vicinity of an uncontrolled release of airborne beryllium in these contexts would already be protected from exposure by the standards' existing requirements for respiratory protection (paragraph (g)), medical surveillance (paragraph (k)), and hazard communication (paragraph (m)) due to their existing exposure to airborne beryllium (84 FR at 53909; see also id. at 53912, 53918-20).

Accordingly, OSHA preliminarily determined that no requirements should be triggered for emergencies in construction and shipyards and proposed to remove references to emergencies in provisions related to respiratory protection (paragraph (g)), medical surveillance (paragraph (k)), and hazard communication (paragraph (m)). The agency also preliminarily determined that without these provisions it would be unnecessary to define the term

emergency

in paragraph (b) (84 FR 53909).

Some commenters objected to the proposed removal of provisions relating to emergencies. Specifically, these commenters took issue with OSHA's determination that an uncontrolled release of beryllium in the construction and shipyards industries would not create exposures that differ from normal operations. For a full discussion of these comments and the agency's response, see the summary and explanation for paragraph (g). In short, the agency is not persuaded that the types of uncontrolled releases that necessitated emergency provisions in the general industry standard are present in the construction and shipyards industries. Accordingly, OSHA is finalizing its proposal to remove all references to “emergency” or “emergencies” throughout the construction and shipyards standards. Because those terms no longer appear in the standards' requirements, OSHA is also finalizing its proposal to remove the definition of the term “emergency” from paragraph (b).

This final rule makes one additional revision to paragraph (b) in both standards. As explained in the Summary and Explanation for paragraph (j), OSHA is removing the reference to HEPA-filtered vacuuming in the housekeeping requirements of revised paragraphs (j)(1) and (2). In the NPRM, OSHA neglected to remove the definition for

high-efficiency particulate air (HEPA) filter

in paragraph (b), despite the fact that there are no longer any provisions in either standard that reference HEPA-filters. OSHA has removed this definition in this final rule. This change has no substantive effect on any requirements in the standards and OSHA considers this a technical correction.

Paragraph (f) Methods of Compliance

Paragraph (f) of the beryllium standards for construction and shipyards requires employers to implement methods for reducing employee exposure to beryllium through a detailed written exposure control plan, engineering and work practice controls, and a prohibition on rotating employees to achieve compliance with the PEL. In the 2017 final rule, OSHA determined that written plans would “be instrumental in ensuring that employers comprehensively and consistently protect their employees” (82 FR at 2668). OSHA also concluded that requiring reliance on engineering and work practice controls, rather than on respirator use, is consistent with good industrial hygiene practice and with OSHA's traditional approach to health standards (82 FR at 2672).

While extending these provisions to the construction and shipyards industry in the 2017 final rule, OSHA acknowledged that exposures to beryllium in these industries are limited primarily to a few operations, abrasive blasting in construction and shipyards and some welding operations in shipyards (82 FR at 2637-38). With respect to abrasive blasting, while the extremely high exposures to airborne particulate during the blasting operation can expose workers to beryllium in excess of the PEL, the blasting materials contain only trace amounts of beryllium (materials such as coal slag normally contain approximately 0.11 µg/g or 0.00001%) (see 2017 FEA, Document ID 2042, p. IV-632, Table IV.69; 82 FR at 2638). Moreover, OSHA had evidence of beryllium exposure during only limited welding operations in shipyards (only 4 of 127 sample results showed detectable levels of airborne beryllium) (see 2017 FEA, Document ID 2042, p. IV-580). Nonetheless, OSHA applied the same requirements to these industries as to general industry, where the operations with beryllium exposure are significantly more varied and employees

are exposed to materials with significantly higher beryllium content.

In the 2019 NPRM, OSHA proposed to revise the requirements in paragraph (f) in light of the very narrow set of affected operations and the limited extent of beryllium exposure in the construction and shipyards industries. OSHA explained that some provisions in paragraph (f)—although appropriate in the general industry context—may be unnecessary to protect employees in the construction and shipyards industries (84 FR at 53909-10). Likewise, OSHA preliminarily determined that provisions relating solely to dermal contact with beryllium should not apply in the construction and shipyards industries, where exposures primarily involve materials containing only trace amounts of beryllium (84 FR at 53909) or, in the case of welding, where OSHA believes the process and materials do not present a dermal contact risk (see 84 FR at 53906). Accordingly, OSHA proposed several revisions to both paragraph (f)(1) (Written exposure control plan) and (2) (Engineering and work practice controls) in the construction and shipyards standards.

For both the construction and shipyards beryllium standards, paragraph (f)(1) in this final rule requires the employer to establish, implement, and maintain a written exposure control plan that includes: a list of operations and job titles reasonably expected to involve exposure to beryllium; a list of engineering controls, work practices, and respiratory protection required by paragraph (f)(2); and a list of personal protective clothing and equipment required by paragraph (h) (see paragraphs (f)(1)(i)(A), (B) and (C), respectively). For the construction standard, the written plan must also include procedures to restrict access to work areas where exposures to beryllium could reasonably be expected to exceed the TWA PEL or STEL (paragraph (f)(1)(i)(D)). Both the construction (paragraph (f)(1)(i)(E)) and shipyards (paragraph (f)(1)(i)(D)) standards require the employer to include procedures to ensure the integrity of each containment used to minimize exposures to employees outside of containments (such as tarps or structures used to keep sandblasting debris within an enclosed area during abrasive blasting operations). Paragraphs (f)(1)(ii) and (iii) further provide requirements for maintaining, reviewing, and evaluating the written exposure control plan and providing access to the plan to each employee who is, or can reasonably be expected to be, exposed to airborne beryllium. In the construction standard, the written exposure control plan must be implemented by a competent person, as defined by paragraph (b) (paragraph (e)(2)).

Paragraph (f)(1) in this final rule contains several changes from the prior standards, as proposed in the December 2019 NPRM. First, OSHA proposed to revise paragraph (f)(1)(i)(A) by removing the words “airborne” and “or dermal contact with” as qualifiers for exposure to beryllium, so as to require simply a list of operations and job titles reasonably expected to involve exposure to beryllium. Second, OSHA proposed to revoke paragraphs (f)(1)(i)(B) and (C), which required additional lists of operations and job titles involving exposure at or above the action level and above the TWA PEL or STEL, respectively. OSHA reasoned that, given the small number of operations with beryllium exposure in construction and shipyards, the list of operations and job titles in these categories would be the same as those required by paragraph (f)(1)(i)(A). As such, any additional lists would be unnecessary and redundant (84 FR at 53910-11).

OSHA also proposed to revoke the requirements that the employer include in the written exposure control plan procedures for minimizing cross-contamination (paragraph (f)(1)(i)(D)) and procedures for minimizing the migration of beryllium within or to locations outside the workplace (paragraph (f)(1)(i)(E)) (84 FR at 53910). OSHA explained that the original intent of these requirements was to ensure that workers not involved in beryllium-related operations would not be unintentionally exposed to beryllium in excess of the PEL. With respect to the construction standard, OSHA reasoned that the requirement to include procedures in the written exposure control plan to restrict access to work areas where exposures to beryllium could reasonably be expected to exceed the TWA PEL or STEL (formerly paragraph (f)(i)(E), renumbered as (f)(i)(D)), along with the requirement that these procedures be implemented by a competent person (paragraph (e)(2)), would be sufficient to control cross-contamination and migration of beryllium from abrasive blasting operations. For the shipyard standard, OSHA retained requirements for regulated areas (paragraph (e)), which require that employers designate areas where exposures to beryllium could exceed the PELs and limit access to authorized employees. To further limit cross-contamination and migration, OSHA proposed to add a new paragraph in both the construction ((f)(1)(i)(E)) and shipyards ((f)(1)(i)(D)) standards to require that the written exposure control plan include procedures to ensure the integrity of each containment used to minimize exposures to employees outside the containment (such as tarps or structures used to keep sandblasting debris within an enclosed area during abrasive blasting operations).

OSHA next proposed to remove the requirement that the employer include in the written exposure control plan procedures for removing, laundering, storing, cleaning, repairing, and disposing of beryllium-contaminated personal protective clothing and equipment, including respirators (paragraph (f)(1)(i)(H)), because the agency had also proposed to remove several requirements pertaining to such procedures (84 FR at 53911). Specifically, OSHA proposed to remove the requirements that the employer ensure that: Beryllium-contaminated PPE is stored and kept separate from street clothes and that storage facilities prevent cross-contamination as specified in the written exposure control plan (paragraph (h)(2)(iii)); beryllium-contaminated PPE is only removed from the workplace by employees who are authorized to do so for the purpose of laundering, cleaning, maintaining, or disposing of such PPE (paragraph (h)(2)(iv)); PPE removed from the workplace for laundering, cleaning, maintenance, or disposal be placed in closed, impermeable bags or containers and labeled appropriately (paragraph (h)(2)(v)); and any person or business entity who launders, cleans or repairs PPE required by the standards be informed, in writing, of the potentially harmful effects of beryllium and of the need to handle the PPE in accordance with OSHA's beryllium standards (paragraph (h)(3)(iii)). With the proposed removal of those paragraphs, the remaining requirements that would relate to paragraph (f)(1)(i)(H) include paragraphs (h)(2)(i) and (ii), pertaining to removal of PPE; paragraph (h)(3)(i), pertaining to cleaning and maintenance of PPE; and paragraph (h)(3)(ii), pertaining to methods of removing beryllium from PPE. In light of the proposed removal of several of the requirements for removing, laundering, storing, cleaning, repairing, and disposing of beryllium-contaminated PPE, OSHA stated that it believed it unnecessary to include such procedures in the written plan (84 FR at 53911).

Finally, as with paragraph (f)(1)(i)(A), OSHA proposed to revise paragraph (f)(1)(ii)(B) to refer simply to “exposure to” rather than “airborne exposure to or dermal contact with” beryllium (84 FR

at 53911).

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OSHA's proposal to revise this paragraph, which previously required the employer to review, evaluate, and update the written exposure control plan, as necessary, when notified that an employee shows signs or symptoms associated with airborne exposure to or dermal contact with beryllium, is consistent with other paragraphs where the agency is simplifying the language in a similar manner (

e.g.,

paragraphs (k)(3)(ii)(A) and (k)(4)(i), Medical surveillance) and is not intended to alter the meaning of the provision. OSHA received a number of comments on its proposed revisions to paragraph (f). These comments and OSHA's final determinations are discussed below.

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In the Amendments to Standards section of the NPRM (84 FR at 53951-54), which identifies precisely how the proposal would amend the Code of Federal Regulations, OSHA inadvertently failed to remove the word “airborne” as a qualifier for “exposure” in paragraph (f)(1)(ii)(B) of both standards. However, the summary and explanation of paragraph (f) clearly identified OSHA's intent to remove both “airborne” and “dermal contact with” from the provision and leave simply “exposure to beryllium” (see 84 FR at 53911). The only commenter to address the change referred to the correct language (NJH, Document ID 2211, p. 9). Accordingly, OSHA considers this a harmless error and has corrected the appropriate language in the Amendments to Standards section of this final rule.

Comments on the Nature and Extent of Beryllium Exposure in the Construction and Shipyards Industries

A primary issue raised by several commenters, both with respect to the proposed changes to paragraph (f) and to the rest of the proposal, involved whether OSHA has appropriately characterized the jobs and operations in the construction and shipyards industries that present beryllium exposures of concern. On the one hand, the National Electrical Contractors Association (NECA), the National Demolition Association (NDA), and the Construction Industry Safety Coalition (CISC) argued that a written exposure control plan is unnecessary in the construction industry in light of the limited operations that create exposures of concern. Specifically, NECA contended that beryllium exposure in construction is limited to abrasive blasting, and therefore “promulgating a rule that would require all employers to document and implement a written exposure control plan for beryllium creates additional and undue burdens on employers and employees in the construction industry” (Document ID 2209, p. 1). CISC and NDA both stated that, in order to create a written exposure control plan, construction employers “will be required to assess all workplace exposures, jobs, tasks, and work to be performed to determine whether beryllium is present in trace amounts” (Document ID 2203, p. 16; 2205, p. 2). According to CISC, this is a particular problem in the construction industry because of the “range of exposures that could exist as a result of naturally occurring beryllium or airborne exposures of beryllium from aggregate or other components of construction material containing trace amounts of beryllium” (Document ID 2203, p. 2). Like NECA, CISC argued that it would be inappropriate to require employers to engage in the “daunting task” of analyzing beryllium exposures on their worksites, given that OSHA has not identified exposures of concern in construction outside of abrasive blasting with certain media (Document ID 2203, p. 16). NDA echoed CISC, asserting that this would be an “unnecessary burden” and “inappropriate” in the construction industry (Document ID 2203, p. 2).

CISC suggested that, instead of including a written exposure control plan provision in the beryllium standard for construction, OSHA should consider adding new requirements to paragraph (f) of the ventilation standard for construction (29 CFR 1926.57) that set forth additional protective measures to be used when abrasive blasting with media containing <0.1 percent by weight of beryllium. These new provisions, CISC stated, could include the requirements of written exposure control plans, regulated areas, specified PPE, and other provisions to protect workers in and around such abrasive blasting (Document ID 2203, p. 16). While industry representatives NECA, NDA, and CISC argued that OSHA's approach to the written exposure control plan is too broad, other commenters representing unions and public health organizations argued that the proposal is too narrow. Specifically, these commenters took issue with OSHA's focus on abrasive blasters and welders. Several commenters suggested potential exposure sources apart from abrasive blasting and welding operations and argued that some of these exposures could involve beryllium in greater than trace amounts. For example, NJH contended that there are “other operations, jobs and tasks that can generate beryllium exposure in the construction and shipyard sectors, not limited to abrasive blasting and welding” (Document ID 2211, p. 7). NJH cited studies involving demolition operations at an Army site in Ohio (

https://www.lrb.usace.army.mil/Missions/HTRW/FUSRAP/Luckey-Site

); construction trades workers exposed to beryllium in DOE facilities (Welch et al., 2004 & 2013); workers performing clean-up of beryllium-using sites (Sackett et al., 2004); workers grinding beryllium-composite tools (Kreiss et al., 1993); and workers resurfacing copper-beryllium tools (Mikulski et al, 2011) (Document ID 2211, p. 7) (see detailed discussion of studies later in this section). NJH also noted, anecdotally, that it has diagnosed CBD in contract construction workers who worked in primary beryllium and beryllium manufacturing facilities (Document ID 2211, p. 7).

AFL-CIO similarly indicated that construction workers such as laborers, welders, carpenters, surveyors, and electricians involved in demolition, renovation, maintenance, repair, and construction projects performed in general industry sites where beryllium was previously used, as well as those who may use non-sparking tools, could be exposed to beryllium (Document ID 2210, p. 5; 2239, p. 1). ACOEM likewise argued that workers in the construction industry can be exposed from decommissioning and demolition work (Document ID 2213, p. 3). Some members of Congress also identified the maintenance of non-sparking tools and working with unspecified beryllium alloys in high-tech naval vessels as activities that expose workers to materials containing beryllium above trace levels (Document ID 2208, p. 6).

Relying largely on studies performed at Department of Energy nuclear weapon sites (some of the same studies cited by NJH), NABTU commented that workers performing maintenance, renovation, repair, and demolition in beryllium processing facilities may be exposed to residual beryllium in ventilation systems, floors, insulation materials, and in floor crevices (Document ID 2202, p. 2; 2240, p. 3). Referencing OSHA's decision in the 2017 final rule to apply the construction standard to all occupational exposures to beryllium, rather than limiting the requirements to abrasive blasting operations, NABTU contended that OSHA's proposal departs from the agency's prior conclusions without explaining this supposed departure. According to NABTU, OSHA has abandoned its position that the construction standard should “cover all occupational exposures to beryllium” and instead “decided only to address the `primary' means of exposure” (Document ID 2240, pp. 2-5).

In addition to potential exposures from existing operations, USW contended that the proposed revisions to the construction and shipyard standards fail to account for “all future operations” that might use beryllium. By tailoring the standards to the specific exposures in abrasive blasting and

welding operations, USW contends that OSHA is making a “dangerous assumption” that it makes “in no other health standard” (Document ID 2212, p. 2). According to USW: “If a new chemical product is synthesized from 1,3-butadiene, the 1,3-butadiene standard will apply in its entirety. If arsenic finds a new use in semiconductors, the employer will be expected to comply with the entire arsenic standard. . . . However, under the OSHA proposal, if metallic beryllium, a beryllium alloy, ceramic or other compound is someday used on a construction site or in a shipyard, exposed workers will lack important protections enjoyed by their counterparts in general industry” (Document ID 2212, p. 2). USW echoed NABTU's assertion that OSHA's proposal neglects workers beyond abrasive blasters and welders and concluded that “[o]nly by including all the general industry protections in the shipyard and construction standards can OSHA fulfill [its] mandate” to protect all workers (Document ID 2212, p. 4).

Those commenters who participated in the public hearing also raised these concerns in their testimony. Specifically, both NJH and USW again identified potential exposures from beryllium-containing non-sparking tools (Document ID 2222, Tr. 17-19, 48) and NJH discussed their organization's past diagnoses of CBD in contract construction workers in the primary beryllium and manufacturing industries (Document ID 2222, Tr. 48). USW again expressed concern about possible future applications of beryllium-containing materials in construction and shipyard work (Document ID 2222, Tr. 17-19). NABTU and AFL-CIO both reiterated their position that construction workers are exposed through activities other than abrasive blasting, particularly demolition, renovation, cleanup, and similar work in facilities that make and use beryllium-containing alloys (Document ID 2222, Tr. 84, 114-15). NABTU concluded that construction workers operating in facilities that use beryllium “are not only potentially exposed to beryllium, but also, they will have dermal exposure to dust and debris that can contain beryllium at greater than trace amounts” (Document ID 2222, Tr. 84-85).

On the whole, these commenters contend that, because there are work processes other than abrasive blasting and welding that could expose construction and shipyard workers to beryllium, OSHA should not remove or modify provisions of the beryllium standards—such as the written exposure control plan requirements—to tailor the standards to abrasive blasting and welding operations.

After reviewing all of these comments and the record as a whole, OSHA has determined that the record continues to lack sufficient data for the agency to characterize the nature, locations, or extent of beryllium exposure in application groups in current-day construction and shipyards sectors other than abrasive blasting and certain welding operations. Further, although OSHA continues to recognize the possibility of exposures beyond abrasive blasting and welding, the agency has reason to believe concerns regarding construction workers' dermal exposure to more than trace beryllium at general industry sites, although potentially justified in the past, likely do not reflect current exposures in these contexts.

As a result, OSHA finds that it is appropriate to follow through with its proposal to tailor certain provisions of the beryllium standards for construction and shipyards—including the written exposure control plan requirements—to those operations for which the agency has data. At the same time, OSHA disagrees with NECA, NDA, and CISC that the agency should strictly limit application of the beryllium standards to abrasive blasting and welding operations. Accordingly, both standards will continue to cover all occupational exposures to beryllium in these industries that meet the requirements of paragraph (a). OSHA's reasoning and the agency's response to each of the comments received on these topics is explained below.

OSHA's Analysis of the Record With Respect to Beryllium Exposures in the Construction and Shipyards Sectors

In the 2017 final rule, OSHA based its assessment of applications involving beryllium exposure, including its determination that abrasive blasting and welding are the only known sources of beryllium exposure in construction and shipyards, on the best evidence available in the record. This included a comprehensive review of the industrial hygiene literature; National Institute for Occupational Safety and Health (NIOSH) Health Hazard Evaluations and case studies of beryllium exposure; site visits conducted by an OSHA contractor (Eastern Research Group (ERG)); inspection data from OSHA's Integrated Management Information System (IMIS) and OSHA's Information System (OIS); and information submitted to the rulemaking docket in response to the notice of proposed rulemaking and informal public hearings, such as a comprehensive data set submitted by the Navy of beryllium sampling in a wide variety of operations (see 82 FR at 2583; 2017 FEA, Document ID 2042, pp. IV-17 to IV-22; Document ID 0144, 0145).

This review also included comments and testimony on potential exposure from sources other than abrasive blasting and welding (82 FR 2636-40). At the time, several commenters identified many of the same jobs and operations as those identified in this rulemaking. NIOSH commented that construction workers may be exposed to beryllium when demolishing buildings or building equipment, based on a study of workers demolishing oil-fired boilers (Document ID 1671, Attachment 1, pp. 5, 15; 1671, Attachment 21). At the initial public hearing in 2016, NJH testified that numerous studies had documented beryllium exposure, sensitization, and CBD in construction workers performing demolition and decommissioning and among workers who use non-sparking tools (Document ID 1756, Tr. 98). USW also testified that workers in the maritime industry use and may sharpen or grind beryllium-containing non-sparking tools and that shipyards might use beryllium for other tasks in the future. USW further stated that beryllium is a high-tech material and that exposure from beryllium containing alloys cannot be ruled out in high-tech operations such as aircraft carrier or submarine production (Document ID 1756, Tr. 270).

After reviewing the record, OSHA determined in the 2017 final rule that it did not have sufficient data on beryllium exposures in the construction and shipyard industries to characterize exposures in application groups other than abrasive blasting with beryllium-containing slags and certain welding operations in shipyards, and that it could not develop exposure profiles for construction and shipyard workers engaged in activities involving non-sparking tools, demolition of beryllium-contaminated buildings or equipment, or work with beryllium-containing alloys (82 FR at 2639). Even so, OSHA acknowledged USW's concerns about future beryllium use and found “that there is potential for exposure to beryllium in construction and shipyards operations other than abrasive blasting.” OSHA concluded that workers engaged in any such operations are exposed to the same hazard of developing CBD and other beryllium related disease (82 FR at 2639). Thus, OSHA chose to cover all occupational exposures to beryllium in those industries in order to ensure that the standards are broadly effective and address all potentially harmful beryllium exposures (82 FR at 2639).

While extending comprehensive beryllium standards to construction and shipyards and broadly aligning the ancillary provisions across the three sectors, OSHA also identified evidence in the record demonstrating meaningful distinctions between the sectors, and therefore promulgated different requirements for some ancillary provisions. For example, OSHA included requirements pertaining to beryllium work areas (BWAs)

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in the standard for general industry but did not include such requirements in the standards for construction and shipyards. OSHA explained that commenters such as Newport News Shipbuilding (NNS) (Document ID 1657) and NIOSH (Document ID 1725, p. 30; 1755, Tr. 21) had brought to its attention difficulties in establishing and maintaining BWAs in an operation such as abrasive blasting (82 FR at 2660-61). NNS specifically highlighted the difficulty of such a requirement where beryllium is encountered in trace concentrations (82 FR at 2661; Document ID 1657, pp. 1-2).

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As originally promulgated, the beryllium standard for general industry required employers to establish a beryllium work area in any area that (1) contains a process or operation that can release beryllium, 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 (82 FR at 2736). BWAs must be demarcated by signs or other methods that establish and inform each employee of the boundaries of the area (29 CFR 1910.1024(e)(2)). Through the May 7, 2018 DFR, OSHA later revised the definition of a BWA so that the requirements apply only where the process or operation involves material containing at least 0.1 percent beryllium by weight (83 FR at 19938).

Recognizing that the known exposures in construction and shipyards are to trace beryllium, and further recognizing the difficulties involved in establishing and maintaining BWA requirements in that context, OSHA decided not to require employers in construction and shipyards to establish and maintain BWAs (82 FR 2660-61). In this way, OSHA differentiated the construction and shipyards standards from the general industry standard and tailored portions of the former to the particular exposures in abrasive blasting operations. OSHA thereby made the standards more workable to implement in those sectors while maintaining an overall framework of protections broadly similar to those in general industry.

After publication of the 2017 final rule, on May 7, 2018, OSHA published a direct final rule (DFR) to clarify certain provisions of the beryllium standard for general industry as they related to materials containing trace amounts of beryllium (84 FR 19936). Specifically, the DFR clarified that provisions triggered by dermal contact with beryllium or beryllium contamination would apply only for dust, fumes, mists, or solutions containing beryllium in concentrations greater than or equal to 0.1 percent by weight (83 FR at 19939). OSHA made clear that the agency only intended to regulate contact with trace beryllium to the extent that it caused airborne exposures of concern (83 FR at 19938).

In the 2019 NPRM, OSHA sought to more fully tailor the construction and shipyards standards to the known exposures in these sectors; that is, to abrasive blasting and welding operations. OSHA recognized that, in applying some provisions developed for general industry into the construction and shipyards standards in the 2017 final rule, the agency may have not fully accounted for the trace levels of beryllium in these operations. At the same time, the agency remained open to considering additional sources of exposure. In the NPRM and multiple times at the public hearing, OSHA requested information and data on any additional application groups (industries, occupations, processes, etc.) with potential exposure to beryllium in the construction and shipyards sectors beyond abrasive blasters and welders (84 FR at 53922; Document ID 2222, Tr. 33-35; 44-45; 75-76; 95-96; 125-26).

Although a number of commenters responded to OSHA's request, as outlined above, their comments in many cases relied on anecdotal or unverifiable assertions about additional exposure sources. For example, NABTU and AFL-CIO listed several jobs that they contend could involve exposure to beryllium, but provided nothing documenting current exposures in these operations. Likewise, NJH indicated anecdotally that they had diagnosed beryllium sensitization and CBD in contractors who had performed work at a primary beryllium facility, but due to the restrictions under the Health Insurance Portability and Accountability Act (HIPAA), they did not disclose any further information about these cases (Document ID 2238, p. 1; 2222, Tr. 65). Such information provides little on which the agency can rely to evaluate these suggested exposure sources.

While commenters did provide some evidence in the form of studies, OSHA believes the studies referenced have limited value in analyzing current exposures to workers in these industries. NABTU (Document ID 2240), AFL-CIO (Document ID 2239, 2244), and NJH (Document ID 2211, 2238) cited a number of studies that they contend demonstrate workers in the construction trades are at risk of exposure to beryllium in greater than trace quantities through work at general industry sites that process or previously processed beryllium. Several of these studies examined beryllium sensitization and CBD among construction trades workers and others who had worked at DOE nuclear weapons facilities. Two studies involved exposures at private facilities. Of the studies submitted, OSHA had previously reviewed Kreiss et al. (1993) and Stange et al. (2001) in the Health Effects section of the preamble to the 2017 final rule (82 FR 2506; 2510).

Kreiss et al. (1993) conducted a screening of current and former workers at a plant that manufactured beryllium ceramics between 1958 and 1975, and then transitioned to metalizing circuitry onto beryllium ceramics produced elsewhere (Kreiss et al. (1993), “Beryllium Disease Screening in the Ceramics Industry” (Document ID 1478)). Five hundred and five of the plant's then-current and retired workers who had not previously been diagnosed with CBD or sarcoidosis participated, including 377 current and 128 former workers. Workers' airborne beryllium exposure was not estimated in this survey, and potential for skin contact with beryllium was not explicitly discussed. Surveillance for CBD was conducted on this population in 1989-1990 (Document ID 1478, p. 270).

Kreiss et al. (1993) reported nine newly identified cases of CBD (Document ID 1478, p. 257). The individuals diagnosed with CBD had begun work at the facility between September 1946 and June 1983, with most (7 of 9) hired between 1956 and 1973 (Document ID 1478, Table 2, p. 270). Two cases (11.1 percent) of newly diagnosed CBD occurred among 18 workers who performed ventilation maintenance (Document ID 1478, Table 7, p. 273).

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However, the authors noted that all workers with CBD who reported work in ventilation maintenance had also reported work in dry pressing and/or process development, job categories which also had particularly high prevalence of CBD (15.8 percent and 13.6 percent, respectively) (Document ID 1478, p. 272; Table 7, p. 273). Moreover, the authors stated that “persons who had worked at dusty tasks in which [beryllium] exposures were harder to control or unlikely to be monitored, such as dry pressing and

beryllia process development/engineering, had beryllium disease rates between 11 percent and 16 percent,” rates that “are higher than those described historically in other beryllium industries” (Document ID 1478, p. 273). The authors also noted one case of CBD in an employee who had begun employment eight years after beryllium production ended (a “dust disturber” case) who recalled regularly dry-sweeping for a period of 6 months in 1983 in an area that was later shown to be contaminated by beryllium dust and had no other known source of beryllium exposure (Document ID 1478, p. 271). NJH cited Kreiss et al. (1993) as evidence that cleanup workers and tool grinders at general industry sites can face risk from beryllium exposures (Document ID 2211, p. 7).

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The authors did not provide detail on this ventilation maintenance activity and it is unclear whether such work represents a typical construction activity or a routine general industry maintenance activity.

Virji et al. (2019) published a study of short-term workers employed at a primary beryllium manufacturing facility that processed beryllium salts, beryllium metal and alloys, and beryllium oxide (Virji et al. (2019), “Associations of Metrics of Peak Inhalation Exposure and Skin Exposure Indices with Beryllium Sensitization at a Beryllium Manufacturing Facility” (Document ID 2239)). This study examined a group of 264 short-term workers who were hired after January 1, 1994, and who participated in testing for beryllium sensitization in 1999. The authors used exposure data such as personal full-shift exposure sampling, task and area exposure measurements, and glove measurements to create qualitative and quantitative peak inhalation metrics and skin exposure indices (Document ID 2239, pp. 858-9). The authors reported that their data represent “historical workplace conditions, before the implementation of a redesigned comprehensive prevention program” which included measures to reduce both inhalation and skin exposure through improvements in engineering controls and use of personal protective equipment and clothing; improved housekeeping; measures to minimize migration of beryllium from work areas; and improved health and safety and work practice training, beginning in 2000 (Document ID 2239, pp. 863, 866).

Twenty-six of the study participants (9.8 percent) were beryllium-sensitized, of whom six were also diagnosed with CBD. The authors noted that maintenance work was associated with the highest rate of beryllium sensitization (0.154 per person-year of work in the maintenance category, which had 52.1 person-years of work in total) (Document ID 2239, Table 4, p. 865). The authors found that peak inhalation metrics, indices, and other evidence of skin exposure, and use of material containing beryllium salts were significantly associated with beryllium sensitization (Document ID 2239, p. 865). It was not possible to distinguish the effects of skin exposure from inhalation exposure because these exposures tended to occur together (Document ID 2239, p. 867). The authors concluded that multiple beryllium exposure pathways and types were associated with sensitization and that efforts to prevent beryllium sensitization should focus on controlling airborne beryllium exposures with particular attention to exposure peaks; process characteristics (the likelihood of upset conditions, which can lead to high short-term exposures); and minimizing skin exposure to beryllium particles, in particular, eliminating skin contact with beryllium salts (Document ID 2239, p. 867).

NABTU and AFL-CIO referenced Virji et al. (2019) in support of their objection to OSHA's proposed removal of dermal protections in the construction and shipyard standards (Document ID 2239, p. 2; 2240, pp. 5-6). NABTU noted that some workers at the beryllium producing facility who were not directly involved in beryllium-related operations nevertheless became sensitized to beryllium; that maintenance work (including shutdown maintenance, as is performed by contract construction workers) was associated with the highest rates of beryllium sensitization; and that the study authors found a strong association between dermal exposure and beryllium sensitization (Document ID 2240, pp. 5-6). NABTU concluded that Virji et al.'s study “lends further support to the need to ensure workers handle their clothing and other personal protective equipment in ways that minimize the potential that either they, their family members or others who may handle the PPE are incidentally exposed.” Furthermore, “despite the importance of the required procedures to restrict access to work areas where exposures may exceed the PEL and the presence of a competent person—provisions NABTU fully supports—those protections do not adequately compensate for the potential that beryllium will migrate into other work areas” (Document ID 2240, pp. 5-6). AFL-CIO also commented that Virji et al. showed the importance of controlling skin exposure to beryllium in order to prevent beryllium sensitization (Document ID 2239, p. 2).

Several of the studies cited by NABTU, AFL-CIO, and NJH examined beryllium sensitization and CBD among construction trades workers and others who had worked at DOE nuclear weapons facilities, including Stange et al. (2001), Sackett et al. (2004), Welch et al. (2004), and Welch et al. (2013). The commenters cited these studies as evidence that construction trades people can be exposed to greater than trace amounts of beryllium while conducting cleanup, demolition, and deconstruction activities in buildings where beryllium was previously released and accumulated in settled dust.

Stange et al. (2001) examined the prevalence of beryllium sensitization and CBD by job category among 5,713 individuals tested in the Rocky Flats Beryllium Health Surveillance Program, which offered surveillance for any current or former employee who believed they may have been exposed to beryllium at the Rocky Flats Environmental Technology Site (Stange, et al. (2001), “Beryllium sensitization and chronic beryllium disease at a former nuclear weapons facility” (Document ID 1403)).

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Eighty-one cases of CBD and an additional 154 cases of beryllium sensitization were identified among workers for whom job and location (building) histories could be verified (Document ID 1403, p. 408). The prevalence of beryllium sensitization was found to be highest among beryllium machinists (11.4 percent) and health physics technicians (11.9 percent) (Document ID 1403, Table III, p. 410). Cases were also identified among custodial employees (5.64 percent) and other job titles that were thought to have only minimal potential for exposure to beryllium (Document ID 1403, pp. 405, 410). AFL-CIO and NJH have referenced Stange et al.'s (2001) findings as evidence that construction work at beryllium-using facilities can involve risk from beryllium exposures (Document ID 2244, p. 3; 0155, p. 3).

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In 1991, the Beryllium Health Surveillance Program (BHSP) was established at the Rocky Flats Nuclear Weapons Facility to offer BeLPT screening to current and former employees who may have been exposed to beryllium (Stange et al. (1996), Document ID 0206).

Sackett et al. (2004) examined BeLPT results and medical evaluations of 2,221 workers employed at a nuclear weapons facility during decontamination and decommissioning (Sackett et al. (2004), “Beryllium medical surveillance at a former nuclear weapons facility during cleanup operations” (Document ID 1811, Att. 13)). Workers' airborne beryllium exposure was not estimated in the study, and potential for skin contact with beryllium was not explicitly discussed. The authors found

19 cases of beryllium sensitization. Of eight sensitized individuals who underwent full clinical evaluation for CBD, two were diagnosed with CBD. Seven beryllium-sensitized workers were hired after the start of decontamination and decommissioning (Document ID 1811, Att. 13, p. 953). AFL-CIO, quoting a previously submitted comment from the Colorado School of Public Health (Document ID 2136), stated that Sackett et al.'s study showed “that beryllium can cause harm to workers during this process [of decontamination and decommissioning], even when workers have been provided, certified, and trained in the appropriate use of PPE” (Document ID 2244, p. 9). NJH similarly commented that this study demonstrates the potential for exposure during cleanup of beryllium-using sites (Document ID 2211, p. 7).

Welch et al. (2004) presented BeLPT surveillance results among construction trades workers who had formerl

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