The Future Is Now for Creating TSCA Risk Management Rules for Asbestos and Other Chemicals – JD Supra | Region & Cash

The EPA has proposed a ban on the ongoing use of chrysotile asbestos, illustrating the EPA’s strong authority under Section 6 of the Toxic Substances Control Act (TSCA). Still, it is the alternatives to a ban that the EPA has considered but not adopted that have the greatest impact on companies that make or use other chemicals for which the EPA conducts risk assessments. The proposal heralds a new era for EPA to promulgate much stricter occupational safety and health measures than OSHA has done or could do under its charter.

This is the first risk management rule that the EPA has proposed following a risk assessment since the TSCA was amended in 2016. The proposed rule, 87 Fed. Registration number. 21706 (April 12, 2022) would add Subpart F to 40 CFR Part 751. Comments are required no later than June 13, 2022.

1. The proposed ban on asbestos

The EPA banned essentially all uses of asbestos that were not then in progress with a significant new 2019 use rule, 40 CFR § 721.11095. The new proposed rule would ban the current uses.

The proposed rule would limit the manufacture, including import, processing, trade distribution and commercial use of chrysotile asbestos in bulk for or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and gaskets containing chrysotile asbestos used therein , ban chemical production. These bans would come into effect two years after the effective date of the final rule.

It would also ban the same measures on brake pads containing chrysotile asbestos used in the oil industry; automotive aftermarket brakes/pads containing chrysotile asbestos; other vehicle friction products containing chrysotile asbestos (excluding use in NASA Super Guppy turbine aircraft); and other gaskets containing chrysotile asbestos.

The proposed rule would ban the manufacture (including import), processing and commercial distribution of consumer automotive aftermarket brakes/pads containing chrysotile asbestos and other consumer chrysotile asbestos-containing gaskets. These bans would each come into effect 180 days after the effective date of the final rule.

Companies importing chrysotile asbestos other than in articles would need to ensure their import certifications incorporate the risk management rule to certify compliance with TSCA. Under the SNUR, the export of chrysotile asbestos is already subject to export notification, even if the chrysotile asbestos is manufactured, processed, or commercialized solely for export from the United States.

This proposed rule follows the TSCA Section 6(b)(4)(A) risk assessment for chrysotile asbestos completed in December 2020. The EPA found that chrysotile asbestos posed an unacceptable risk of harm to health or the environment. TSCA requests EPA to issue a Section 6(a) rule upon such determination, without consideration of cost or other non-risk factors, so that the chemical no longer poses such a risk under the conditions of use.

2. Effects on other chemicals subject to risk assessment

This proposed rule provides significant insight into EPA’s planned approach to other chemicals following their risk assessments.

expiry dates for a ban.

Industry requests for long phase-out periods must be justified. Stakeholders in the asbestos industry have expressed concerns about the proposed deadlines, emphasizing that replacement diaphragms containing chrysotile asbestos will take more than two years and will be extremely expensive to replace. EPA acknowledged industry concerns but did not extend the phase-out period, noting that “these companies have not provided EPA with accurate cost estimates or a detailed timeline for the transition process.” Other industries should be prepared to provide extensive data demonstrating the need for longer phase-out periods in future Section 6(a) rulemaking. The EPA’s position on this proposed rule confirms the EPA’s approach to PIP (3:1) rulemaking, which limits the current compliance deadline for items to October 31, 2024, despite industry claims that much longer is needed to remove PIP (3:1). from imported items.

Expect the EPA to supplement the CPSC and OSHA standards.

TSCA Section 9(a) requires EPA to determine whether another federal agency can adequately manage the risk; In this case, the EPA must contact this agency. The preamble suggests that the EPA is likely to conclude that the Consumer Product Safety Commission (CPSC) and the Occupational Safety and Health Administration (OSHA) should review the risks of a chemical under EPA risk assessment in light of the changes to TSCA from 2016 can never adequately handle . Under its charter, the CPSC must consider costs and benefits when deciding whether a risk is inappropriate, while the EPA must ignore costs and benefits in determining the inappropriate risk. CPSC must implement the least onerous alternative, while the 2016 amendments removed this requirement from TSCA. EPA must protect populations not subject to OSHA requirements (e.g., self-employed persons and state and local government employees in states subject to OSHA jurisdiction). OSHA may impose restrictions only to the extent that they are economically and technologically feasible, while EPA must evaluate feasibility but impose restrictions to the extent that a chemical does not pose an unreasonable risk.

Expect TSCA exposure limits to be much stricter than OSHA’s.

The preamble stated that the EPA is considering introducing an Existent Chemical Exposure Limit (ECEL) for asbestos. EPA has previously used “new chemical exposure limits” (NCELs) in some TSCA regulations in Section 5(e) and significant new rules of use (SNURs).

The ECEL would have effectively replaced OSHA’s Permissible Exposure Limit (PEL) in its asbestos standard 29 CFR §1910.1001(c). OSHA’s PEL is 0.1 fibers per cubic centimeter (f/cc) as an 8-hour time-weighted average (TWA). This 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 ECEL would have been 0.05 f/cc TWA or 95% lower than OSHA PEL, NIOSH REL, Cal/OSHA PEL and ACGIH TLV. The EPA action level would have been half the ECEL or 0.025 f/cc. The EPA confirmed that “[i]It is also not known whether facilities under the ECEL provision could routinely monitor with reasonable confidence at or below the ECEL or ECEL action level.”

The EPA claimed that they calculated their ECEL based on a 10-4 Risk level, so it is not based on a stricter risk level than that used by OSHA. The difference appears to be due to the different legal requirements of the EPA, as the feasibility of compliance is not a critical factor.

The next proposed risk management rule to be announced will likely concern methylene chloride. As with asbestos, OSHA has a complete 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 CFR § 1910.1052(c). OSHA also has complete health standards for 1,3-butadiene and formaldehyde, high priority substances that are the subject of ongoing risk assessments. The OSHA PEL for 1,3-butadiene is 1 ppm (8 hour TWA) with a STEL of 5 ppm. 29 CFR § 1910.1051(c). The OSHA formaldehyde PEL is 0.75 ppm (8-hour TWA) with a STEL of 2 ppm. 29 CFR § 1910.1048(c). Unless the eventual risk management rules for these chemicals prohibit them, the rules can have exposure limits significantly lower than OSHA’s.

Expect the use of PPE to be ignored when setting exposure limits.

The EPA calculated their 10-4 Risk level assuming no personal protective equipment (PPE) is used. It found that PPE is often, but not always, worn by people exposed to asbestos. Since the EPA must protect even groups that may be at higher risk from greater exposure (citing the TSCA definition in Section 3(12) of “potentially exposed or susceptible subpopulation”), the EPA believed that it should not consider the use of PPE when setting a risk level. EPA indicated that the use of PPE could complement engineering and labor practice controls to achieve ECEL compliance. In addition, the preamble states, “EPA may use information developed during its risk assessment to determine whether aligning EPA’s risk management requirements with existing OSHA requirements or industry best practices adequately addresses inappropriate risks, as required by TSCA.” .” Therefore, EPA believes that evidence of actual use of PPE is of value to EPA, but only to demonstrate the effectiveness of EPA-required mitigation actions, not as a substitute for such mitigation actions.

Expect monitoring requirements to be more stringent than OSHA’s.

Monitoring would be more cumbersome than that under OSHA, in part because it would require compliance with good laboratory practice. According to the preamble, “As part of the primary alternative regulatory action, EPA would require the use of appropriate sampling and analysis methods to determine exposure to asbestos, including:

  • use of an analytical method with a detection limit below the ECEL action limit,
  • Compliance with Good Laboratory Practice standards at 40 CFR Part 792;
  • Documentation of air surveillance equipment information, including maintenance, performance testing, detection limits and malfunctions.”

Exceptions for spare parts and articles are not guaranteed.

Section 6(c)(2)(D) of TSCA requires EPA to exempt replacement parts unless EPA determines that replacement parts “contribute materially to the risk.” Similarly, Section 6(c)(2)(E) of the EPA allows chemicals in articles “only to the extent necessary to address the identified risks” to be restricted from the articles themselves. The proposed asbestos rule would not replace either nor exempt items from the ban because these items are said to be potentially exposed to asbestos. Therefore, in order for the EPA to grant exemptions for spare parts or items in future risk management regulations, the industry would need to demonstrate that the requirements for the exemptions are met based on information in the rulemaking protocol.

Conclusion

The proposed asbestos risk management rule has implications far beyond asbestos. Stakeholders for other chemicals reviewed under TSCA Section 6 can expect that EPA will eventually consider proposing restrictions that are much more stringent than OSHA’s. You should work to ensure that the rulemaking records support the conclusion that current OSHA requirements are sufficient to prevent these chemicals from posing an undue risk and that the records support replacement parts and items exceptions where appropriate.

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