The Future Is Now for TSCA Risk Management Rulemaking for Asbestos and Other Chemicals
EPA has proposed a ban on the ongoing uses of chrysotile asbestos, illustrating EPA’s strong authority under section 6 of the Toxic Substances Control Act (TSCA). Nevertheless, it is the alternatives to a ban that EPA considered but did not adopt that have the most implications for companies that make or use other chemicals for which EPA is conducting risk evaluations. The proposal heralds a new era of EPA promulgating much stricter workplace protections than OSHA has done or that it could do under its statute.
This is the first risk management rule that EPA has proposed following a risk evaluation since the 2016 amendments to TSCA. The proposed rule, 87 Fed. Reg. 21706 (Apr. 12, 2022), would add Subpart F to 40 C.F.R. Part 751. Comments are due by June 13, 2022.
1. The Proposed Asbestos Ban
EPA banned essentially all uses of asbestos that were not then ongoing with a 2019 significant new use rule, 40 C.F.R. § 721.11095. The new proposed rule would ban the ongoing uses.
The proposed rule would prohibit the manufacture, including import, processing, distribution in commerce, and commercial use of bulk chrysotile asbestos for, or as part of, chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. These prohibitions would take effect two years after the effective date of the final rule.
It would also ban the same actions for chrysotile asbestos-containing brake blocks used in the oil industry; aftermarket automotive chrysotile asbestos-containing brakes/ linings; other chrysotile asbestos-containing vehicle friction products (not including the NASA Super Guppy Turbine aircraft use); and other chrysotile asbestos-containing gaskets.
The proposed rule would prohibit the manufacture (including import), processing, and distribution in commerce of aftermarket automotive chrysotile asbestos-containing brakes/linings for consumer use, and other chrysotile asbestos-containing gaskets for consumer use. These prohibitions would each become effective 180 days after the final rule’s effective date.
Companies that import chrysotile asbestos, other than in articles, would have to ensure that their import certifications take the risk management rule into account in certifying compliance with TSCA. Because of the SNUR, the export of chrysotile asbestos has already become subject to export notification requirements, even if the chrysotile asbestos is manufactured, processed, or distributed in commerce solely for export from the United States.
This proposed rule follows the TSCA section 6(b)(4)(A) risk evaluation for chrysotile asbestos completed in December 2020. EPA determined there that chrysotile asbestos presents an unreasonable risk of injury to health or the environment. TSCA requires EPA, following such a finding, to issue a rule under section 6(a), without consideration of costs or other non-risk factors, so that the chemical substance no longer presents such risk under the conditions of use.
2. Implications for Other Chemicals Undergoing Risk Evaluations
This proposed rule provides considerable insights into EPA’s planned approach for other chemicals following their risk evaluations.
Phase-out periods for a ban.
Requests by industry for long phase-out periods must be substantiated. Asbestos industry stakeholders had voiced concern about the proposed deadlines, emphasizing that replacing chrysotile asbestos-containing diaphragms will take longer than two years to replace and that replacing them will be extremely expensive. EPA acknowledged industry concern but did not extend the phase-out period, noting that “these companies did not provide EPA with delineated cost estimates or a detailed timeline for the conversion process.” Other industries should be prepared to present extensive data demonstrating the need for longer phase-out periods in future section 6(a) rulemaking. EPA’s position in this proposed rule confirms EPA’s approach in the PIP (3:1) rulemaking, which limited the current compliance deadline for articles of October 31, 2024, despite industry assertions that much more time is needed to remove PIP (3:1) from imported articles.
Expect EPA to supplement CPSC and OSHA standards.
Under TSCA section 9(a), EPA must consider whether another federal agency can adequately manage the risk; if so, EPA must defer to that agency. The preamble suggests that EPA is likely to conclude that the Consumer Product Safety Commission (CPSC) and Occupational Safety and Health Administration (OSHA) can never manage the risks of a chemical reviewed by EPA in a risk evaluation adequately, in light of TSCA’s 2016 amendments. Under its statutes, CPSC must consider costs and benefits in deciding whether a risk is unreasonable, whereas EPA must ignore costs and benefits in its unreasonable risk determinations. CPSC must implement the least burdensome alternative, whereas the 2016 amendments deleted that requirement from TSCA. EPA must protect populations not subject to OSHA requirements (such as self-employed persons and state and local government workers in states subject to OSHA jurisdiction). OSHA may only impose restrictions to the extent that they are economically and technologically feasible, whereas EPA must consider feasibility but must impose restrictions to the extent that a chemical does not present an unreasonable risk.
Expect TSCA exposure limits to be much more stringent than those of OSHA.
The preamble explained that EPA considered imposing an “existing chemical exposure limit” (ECEL) for asbestos. EPA has previously used “new chemical exposure limits” (NCELs) in some TSCA section 5(e) orders and significant new use rules (SNURs).
The ECEL would have effectively supplanted OSHA’s permissible exposure limit (PEL) in its asbestos standard, 29 C.F.R. § 1910.1001(c). OSHA’s PEL is 0.1 fiber per cubic centimeter (f/cc) as an 8-hour time-weighted average (TWA). That is also the National Institute for Occupational Safety and Health (NIOSH) Recommended Exposure Limit (REL), Cal/OSHA PEL, and the American Conference of Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV). EPA’s ECEL would have been 0.05 f/cc TWA, or 95% lower than the OSHA PEL, NIOSH REL, Cal/OSHA PEL, and the ACGIH TLV. EPA’s action level would have been half the ECEL, or 0.025 f/cc. EPA acknowledged that “[i]t is also unknown whether facilities could, under the ECEL provision, routinely monitor at or below the ECEL or ECEL-action level with reasonable certainty.”
EPA claimed that it calculated its ECEL based on a 10-4 risk level, so it is not based on a more stringent risk level than that used by OSHA. The difference appears to be based on EPA’s different statutory requirements, in that the feasibility of compliance is not a critical factor.
The next proposed risk management rule to be announced is likely to be for methylene chloride. As with asbestos, OSHA has a full health standard for methylene chloride. The OSHA PEL for methylene chloride is 25 ppm (8-hour TWA), with a short-term exposure limit (STEL) of 125 ppm. 29 C.F.R. § 1910.1052(c). OSHA also has full health standards for 1,3-butadiene and formaldehyde, high-priority substances that are the subjects of ongoing risk evaluations. The OSHA PEL for 1,3-butadiene is 1 ppm (8-hour TWA), with a 5 ppm STEL. 29 C.F.R. § 1910.1051(c). The OSHA formaldehyde PEL is 0.75 ppm (8-hour TWA), with a STEL of 2 ppm. 29 C.F.R. § 1910.1048(c). If the eventual risk management rules for those chemicals do not ban them, the rules may have sharply lower exposure limits than those of OSHA.
Expect PPE usage to be ignored in setting exposure limits.
EPA calculated its 10-4 risk level on the assumption of no use of personal protective equipment (PPE). It stated that PPE is often, but not always, used by persons exposed to asbestos. Since EPA must protect even groups who may be at greater risk through greater exposure (citing the TSCA section 3(12) definition of “potentially exposed or susceptible subpopulation”), EPA felt it should not consider PPE use in setting a risk level. EPA did indicate that PPE use could supplement engineering and work practice controls to achieve compliance with the ECEL. Furthermore, the preamble said, “EPA can use the information developed during its risk evaluation to determine whether the alignment of EPA’s risk management requirements with existing OSHA requirements or industry best practices will adequately address unreasonable risk as required by TSCA.” Thus, in EPA’s view, evidence of actual PPE use is of value to EPA, but only as showing the efficacy of EPA-required mitigation measures, not as a substitute for such mitigation measures.
Expect monitoring requirements to be more stringent than those of OSHA.
Monitoring would be more burdensome than that under OSHA, in part because it would require compliance with Good Laboratory Practices. According to the preamble, “under the primary alternative regulatory action, EPA would require the use of appropriate sampling and analytical methods to determine asbestos exposure, including:
- Use of analytical method with a limit of detection below the ECEL-action level,
- Compliance with the Good Laboratory Practice Standards at 40 CFR part 792;
- Documentation of information regarding air monitoring equipment, including Maintenance, performance tests, limits of detection, and any malfunctions.”
Exemptions for replacement parts and articles are not assured.
TSCA section 6(c)(2)(D) requires EPA to exempt replacement parts unless EPA finds that replacement parts “contribute significantly to the risk.” Similarly, section 6(c)(2)(E) allows EPA to restrict chemicals in articles “only to the extent necessary to address the identified risks” from the articles themselves. The proposed asbestos rule would not exempt either replacement parts or articles from the ban, due to the asserted potential for exposure to asbestos coming from those articles. Thus, for EPA to grant exemptions for replacement parts or articles in future risk management rules, industry would need to demonstrate that the requirements for the exemptions are met based on information in the rulemaking record.
The proposed asbestos risk management rule has implications far beyond asbestos. Stakeholders for other chemicals being reviewed under TSCA section 6 can expect EPA eventually to consider proposing restrictions much more stringent than those of OSHA. They should work to ensure that the rulemaking record supports a conclusion that current OSHA requirements are sufficient to prevent those chemicals from presenting an unreasonable risk, and, where relevant, that the record supports exemptions for replacement parts and articles.
Beveridge & Diamond’s Chemicals Regulation practice group and Chemicals industry group provide strategic, business-focused advice to the global chemicals industry. We work with large and small chemical companies whose products and activities are subject to EPA’s broad chemical regulatory authority under TSCA and state chemical restrictions. For more information, please contact the authors.