13 Carcinogens (4-Nitrobiphenyl, etc.)
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Federal Register › Vol. 90 › 90 FR 28312
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have made some provisions of the 13 Carcinogens standard outdated, and would allow employers to take advantage of future technological advances. This proposed standard is intended to account for modern knowledge and technology and to streamline the selection of respirators.
II. Legal Authority and Preliminary Findings
The purpose of the Occupational Safety and Health Act (29 U.S.C. 651 et seq. ) (“the Act” or “the OSH Act”) is “to assure so far as possible every working man and woman in the Nation safe and healthful working conditions and to preserve our human resources” (29 U.S.C. 651(b)). To achieve this goal, Congress authorized the Secretary of Labor (“the Secretary”) to promulgate standards to protect workers, including the authority “to set mandatory occupational safety and health standards applicable to businesses affecting interstate commerce” (29 U.S.C. 651(b)(3); see also 29 U.S.C. 654(a)(2) (requiring employers to comply with OSHA standards), 29 U.S.C. 655(a) (authorizing summary adoption of existing consensus and established federal standards within two years of the Act's enactment), 29 U.S.C. 655(b) (authorizing promulgation, modification or revocation of standards pursuant to notice and comment), and 29 U.S.C. 655(b)(7) (authorizing OSHA to include among a standard's requirements labeling, monitoring, medical testing, and other information-transmittal provisions)). An occupational safety and 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))
quirements labeling, monitoring, medical testing, and other information-transmittal provisions)). An occupational safety and 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 Secretary may also issue regulations requiring employers to keep records regarding their activities relating to the Act, as well as records of work-related
Before OSHA may promulgate a health or safety standard, it must find that a standard is reasonably necessary or appropriate within the meaning of section 652(8) of the OSH Act, which OSHA did here in 1974 when it published the first Carcinogens standard (39 FR 3756). The Supreme Court, in its decision on OSHA's benzene standard, interpreted OSHA's obligation under section 652(8) as requiring it to evaluate “whether significant risks are present and can be eliminated or lessened by a change in practices” ( Indus. Union Dep't, AFL-CIO v. Am. Petroleum Inst., 448 U.S. 607, 642 (1980) (plurality opinion)). OSHA originally published this standard as an emergency temporary standard (ETS) and found that these carcinogens posed a grave danger, which is a higher threshold than significant risk (38 FR 10929). When, as here, OSHA has previously determined that its standard substantially reduces a significant risk, it is unnecessary for the agency to make additional findings on risk for every provision of that standard ( see, e.g., Pub. Citizen Health Research Grp. v. Tyson, 796 F.2d 1479, 1502 n.16 (D.C. Cir. 1986) (rejecting the argument that OSHA must “find that each and every aspect of its standard eliminates a significant risk”)). Rather, once OSHA makes a general significant risk finding in support of a standard, the next question is whether a particular requirement is reasonably related to the purpose of the standard as a whole ( see Asbestos Info. Ass'n/N. Am. v
CFR 1910.134, which it first promulgated in 1971 (39 FR 9835). OSHA published a revised respiratory protection standard on January 8, 1998 (63 FR 1152). The respiratory protection standard contains worksite-specific requirements for program administration, as well as procedures for respirator selection, employee training, fit testing, medical evaluation, and respirator use, among other provisions. OSHA noted that the revised standard was to “serve as a `building block' standard with respect to future standards that may contain respiratory protection requirements” (63 FR 1265). In 2006, OSHA revised the respiratory protection standard again to incorporate assigned protection factors (APFs) in the respirator selection process (71 FR 50122-01).
Several OSHA standards regulating exposure to toxic substances and harmful physical agents, including the 13 Carcinogens standard, require compliance with many provisions of 29 CFR 1910.134. However, when revising the respirator rule, the Agency decided to retain several special respirator selection provisions in the existing substance-specific standards. In this regard, OSHA noted that the respirator selection requirements retained in the substance-specific standards were developed in rulemakings to provide protection against a hazardous characteristic or condition unique to the regulated substance. Consequently, OSHA felt that preserving these provisions in the individual substance-specific standards would maintain the level of respiratory protection afforded to employees.
In this proposal, OSHA is revisiting some of those determinations; the agency now believes that there are additional ways that substance-specific standards can rely on 29 CFR 1910.134 without compromising employee safety. The purpose of revising the respirator-related provisions of OSHA's 13 Carcinogens standard is to conform them, to the extent possible, with other substance-specific standards and to the revised 29 CFR 1910.134 in general
f those determinations; the agency now believes that there are additional ways that substance-specific standards can rely on 29 CFR 1910.134 without compromising employee safety. The purpose of revising the respirator-related provisions of OSHA's 13 Carcinogens standard is to conform them, to the extent possible, with other substance-specific standards and to the revised 29 CFR 1910.134 in general. The proposed updates will improve these substance-specific standards, including 13 Carcinogens, because they will now refer to the APFs in the respiratory protection standard, which is based on current technology and practices for respirator use. OSHA also believes that advances in technology have made the substance-specific standards outdated in some areas. This revised standard is intended to take account of new knowledge and technology.
OSHA expects that the rule would ultimately reduce the compliance burden on the regulated community, without compromising worker safety. Therefore, OSHA believes this proposed rule is consistent with Executive Order (E.O.) 14219, “Ensuring Lawful Governance and Implementing the President's `Department of Government Efficiency' Deregulatory Initiative,” E.O. 14192, “Unleashing Prosperity Through Deregulation,” and the goal of removing regulations that harm the national interest by impeding technological innovation or private enterprise and entrepreneurship.
IV. Summary and Explanation of the Proposed Requirements
OSHA is proposing to revise paragraph (c)(4)(iv) of its general industry 13 Carcinogens standard (29 CFR 1910.1003) to reduce compliance
The proposed changes to paragraph (c)(4)(iv) of the 13 Carcinogens standard would replace two requirements for the use of respiratory protection
innovation or private enterprise and entrepreneurship.
IV. Summary and Explanation of the Proposed Requirements
OSHA is proposing to revise paragraph (c)(4)(iv) of its general industry 13 Carcinogens standard (29 CFR 1910.1003) to reduce compliance
The proposed changes to paragraph (c)(4)(iv) of the 13 Carcinogens standard would replace two requirements for the use of respiratory protection. The first change would remove the requirement for employers to provide each employee engaged in handling operations involving the carcinogens 4-Nitrobiphenyl, alpha-Naphthylamine, 3,3′-Dichlorobenzidine (and its salts), beta-Naphthylamine, Benzidine, 4-Aminodiphenyl, 2-Acetylaminofluorene, 4-Dimethylaminoazo-benzene, and N-Nitrosodimethylamine with National Institute for Occupational Safety and Health (NIOSH) certified air-purifying, half-mask respirators with particulate filters. In place of the deleted requirement, this proposal would add a requirement to provide and ensure the use of a NIOSH-certified respirator for protection against particulates with an APF of 10 under those same working conditions. Second, the requirement for employers to ensure that each employee engaged in handling operations involving the carcinogens methyl chloromethyl ether, bis-Chloromethyl ether, Ethyleneimine, and beta-Propiolactone wears and uses any self-contained breathing apparatus that has a full facepiece would be replaced with a requirement to provide and ensure the use of any respirator with an APF of 10,000. The standard would continue to allow employers to substitute a respirator affording employees higher levels of protection than these respirators, but now would also allow them to use additional types of respirators that provide equivalent levels of protection (based on APFs in 29 CFR 1910.134) as the respirators required under the existing 13 Carcinogens standard
eriod to allow the public to provide comments on those recommendations.
OSHA requests comments on this proposal, including responses regarding the following issues:
1. Are there any concerns that making this change would decrease worker safety?
2. In some other substance-specific standards OSHA currently limits the use of filtering facepiece respirators (see, e.g., 29 CFR 1910.1001(g)(3)(i)). OSHA is interested in obtaining information from commenters about whether there are reasons to limit the use of filtering facepiece respirators in the 13 Carcinogens standard.
3. Is there an alternative approach OSHA should consider?
V. Economic Analysis
This proposed rule would expand compliance options for employers under the 13 Carcinogens standard, 29 CFR 1910.1003, and therefore OSHA has preliminarily concluded that there would be no additional costs imposed by the proposed revisions. OSHA also anticipates that there may be some cost savings associated with this rule, including a reduction of the burden associated with fit testing for those employees able to wear a loose fitting PAPR or similar. Because this rule would impose no new costs, OSHA has made a preliminary determination that the rule would be economically feasible.
The changes to the requirements for 13 carcinogens would expand compliance options for employers by allowing them to provide any respirator meeting the minimum assigned protection factor, including respirators with a helmet or hood, rather than mandating half mask respirators and full facepiece self-contained breathing apparatuses (SCBA). OSHA anticipates that the expanded compliance options may lead to some employers switching to types of respirators that do not require fit testing, eliminating costs for that procedure.
Based on the Supporting Statement for the Information Collection Request for the 13 Carcinogens standard, 1 OSHA estimates that 770 employees are exposed to the chemicals covered by the standard
nomic impact on a substantial number of small entities,” and that the preparation of an IRFA is not warranted. OSHA will transmit this certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).
B. Review Under Executive Order 12866
E.O. 12866, “Regulatory Planning and Review” (58 FR 51735 (Oct. 4, 1993)), requires agencies, to the extent permitted by law, to (1) propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs (recognizing that some benefits and costs are difficult to quantify); (2) tailor regulations to impose the least burden on society, consistent with obtaining regulatory objectives, taking into account, among other things, and to the extent practicable, the costs of cumulative regulations; (3) select, in choosing among alternative regulatory approaches, those approaches that maximize net benefits; (4) to the extent feasible, specify performance objectives, rather than specifying the behavior or manner of compliance that regulated entities must adopt; and (5) identify and assess available alternatives to direct regulation, including providing economic incentives to encourage the desired behavior, such as user fees or marketable permits, or providing information upon which choices can be made by the public.
Section 6(a) of E.O. 12866 also requires agencies to submit “significant regulatory actions” to the Office of Information and Regulatory Affairs (OIRA) for review. OIRA has determined that this proposed rule would not constitute a “significant regulatory action” under section 3(f) of E.O. 12866. Accordingly, this proposal was not submitted to OIRA for review under E.O. 12866.
VI. Additional Requirements
A. Requirements for States With OSHA-Approved State Plans
Under section 18 of the OSH Act (29 U.S.C. 651 et seq
d Regulatory Affairs (OIRA) for review. OIRA has determined that this proposed rule would not constitute a “significant regulatory action” under section 3(f) of E.O. 12866. Accordingly, this proposal was not submitted to OIRA for review under E.O. 12866.
VI. Additional Requirements
A. Requirements for States With OSHA-Approved State Plans
Under section 18 of the OSH Act (29 U.S.C. 651 et seq. ), Congress expressly provides that States may adopt, with Federal approval, a plan for the development and enforcement of occupational safety and health standards that are “at least as effective” as the Federal standards in providing safe and healthful employment and places of employment (29 U.S.C. 667). OSHA refers to these OSHA-approved, State-administered occupational safety and health programs as “State Plans.” 4
4 Of the 29 States and U.S. territories with OSHA-approved State Plans, 22 cover public and private-sector employees: Alaska, Arizona, California, Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, and Wyoming. The remaining six States and one U.S. territory cover only State and local government employees: Connecticut, Illinois, Maine, Massachusetts, New Jersey, New York, and the Virgin Islands.
When Federal OSHA promulgates a new standard or a more stringent amendment to an existing standard, State Plans must either amend their standards to be identical to, or “at least as effective as,” the new Federal standard or amendment, or show that an existing State Plan standard covering this issue is “at least as effective” as the new Federal standard or amendment (29 CFR 1953.5(a)). However, when OSHA promulgates a new standard or amendment that does not impose additional or more stringent requirements than an existing standard, State Plans do not have to amend their standards, although they may opt to do so
ard or amendment, or show that an existing State Plan standard covering this issue is “at least as effective” as the new Federal standard or amendment (29 CFR 1953.5(a)). However, when OSHA promulgates a new standard or amendment that does not impose additional or more stringent requirements than an existing standard, State Plans do not have to amend their standards, although they may opt to do so. OSHA has preliminarily determined this proposed rule does not impose additional or more stringent requirements than the existing standard, and therefore State Plans are not required to amend their standards. OSHA seeks comment on this assessment of its proposal.
B. OMB Review Under the Paperwork Reduction Act of 1995
The Paperwork Reduction Act (PRA) defines “collection of information” to mean “the obtaining, causing to be obtained, soliciting, or requiring the disclosure to third parties or the public, of facts or opinions by or for an agency, regardless of form or format” (44 U.S.C. 3502(3)(A)). Under the PRA, a Federal agency cannot conduct or sponsor a collection of information unless it is approved by OMB under the PRA and the agency displays a currently valid OMB control number (44 U.S.C. 3507). Also, notwithstanding any other provisions of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number (44 U.S.C. 3512(a)(1)). The process for OMB approval is found in 5 CFR part 1320.
This proposed rule would impose no new information collection requirements. Because the revisions are deregulatory and affect only minor changes to the existing information collections in the 13 Carcinogens standard (OMB Control Number 1218-0085), OMB has waived the requirements of 5 CFR part 1320 and approved the modified Information Collection Request (ICR) under existing OMB Control Number 1218-0085 ( see 5 CFR 1320.18(d)).
C
2 FR 31160), 4-2010 (75 FR 55355), 1-2012 (77 FR 3912), or 8-2020 (85 FR 58393); 29 CFR part 1911; and 5 U.S.C. 553, as applicable.
All of subpart Z issued under 29 U.S.C. 655(b), except those substances that have exposure limits listed in Tables Z-1, Z-2, and Z-3 of § 1910.1000. The latter were issued under 29 U.S.C. 655(a).
Section 1910.1000, Tables Z-1, Z-2 and Z-3 also issued under 5 U.S.C. 553, but not under 29 CFR part 1911 except for the arsenic (organic compounds), benzene, cotton dust, and chromium (VI) listings.
Section 1910.1001 also issued under 40 U.S.C. 3704 and 5 U.S.C. 553.
Section 1910.1002 also issued under 5 U.S.C. 553, but not under 29 U.S.C. 655 or 29 CFR part 1911.
Sections 1910.1018, 1910.1029, and 1910.1200 also issued under 29 U.S.C. 653.
Section 1910.1030 also issued under Public Law 106-430, 114 Stat. 1901.
Section 1910.1201 also issued under 49 U.S.C. 1801-1819 and 5 U.S.C. 553.
2. 1910.1003(c)(4)(iv) is revised and republished to read as follows:
Employers must provide each employee engaged in handling operations involving the carcinogens 4-Nitrobiphenyl, alpha-Naphthylamine, 3,3′-Dichlorobenzidine (and its salts), beta-Naphthylamine, Benzidine, 4-Aminodiphenyl, 2-Acetylaminofluorene, 4-Dimethylaminoazo-benzene, and N-Nitrosodimethylamine, addressed by this section, with, and ensure that each of these employees wears and uses, a NIOSH-certified respirator for particulates that has an assigned protection factor (APF) of 10. Employers also must provide each employee engaged in handling operations involving the carcinogens methyl chloromethyl ether, bis-Chloromethyl ether, Ethyleneimine, and beta-Propiolactone, addressed by this section, with, and ensure that each of these employees wears and uses a respirator that has an APF of 10,000. Employers may substitute a respirator affording employees higher levels of protection than these respirators.
[FR Doc. 2025-11631 Filed 6-30-25; 8:45 am] BILLING CODE 4510-26-P
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