By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 11, 2023, that it will hold a webinar on June 7, 2023, at 1:00 p.m. (EDT) on its proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) that would ban all consumer uses and most commercial uses of methylene chloride, “a chemical in commercial and consumer products known to cause serious health risks and even death.” As reported in our April 25, 2023, memorandum, EPA proposes prohibitions and protections, with a rapid phase-down for manufacturing, processing, and distribution of methylene chloride for all consumer uses and most industrial and commercial uses, a majority of which would be fully implemented in 15 months after the final rule is issued. For industrial manufacturing, industrial processing, laboratory use, and federal uses that EPA is not proposing to prohibit, EPA proposes a workplace chemical protection program (WCPP) with strict exposure limits to protect workers better. The WCPP would require employers and others covered by it to comply with safety requirements within one year. They would also be required to periodically monitor their workplaces to ensure that workers and others on site are not being exposed to levels of methylene chloride that would lead to an unreasonable risk. Comments on the proposed rule are due July 3, 2023.
 
According to EPA, the webinar “will be useful for anyone looking for an overview of the proposed regulatory action or to provide input on the proposed program, including industry groups, nonprofit organizations, Tribes, and other stakeholders.” EPA states that it is particularly looking for participation from employers and workers “who can give perspective on the feasibility and efficacy of the proposed requirement for worker protections.”
 
Participants can register as listeners or to make prepared remarks. To provide remarks during the webinar, registration must be completed by May 24, 2023, at 5:00 p.m. (EDT). Registration as a listener can be completed up until the start of the webinar. Details on how to access the webinar and slides will be sent to participants after registering via Eventbrite.com. EPA states that it will provide copies of the presentation material on its website following the webinar.

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By Lynn L. Bergeson and Carla N. Hutton
 
On May 3, 2023, the U.S. Environmental Protection Agency (EPA) announced its intent to extend the January 6, 2023, compliance date on the prohibition on the processing and distribution of decabromodiphenyl ether (decaBDE) for use in wire and cable insulation in nuclear power generation facilities, and decaBDE-containing wire and cable insulation. As reported in our December 23, 2020, memorandum, decaBDE is one of the persistent, bioaccumulative, and toxic (PBT) chemicals that are the subject of risk management rules under the Toxic Substances Control Act (TSCA) issued in 2021. EPA states that it “expects to propose this compliance date extension as part of a rulemaking on the chemical this fall.”
 
EPA also issued a related temporary “Enforcement Statement,” which indicates that it does not intend to pursue violations of this prohibition on processing and distribution of decaBDE-containing wire and cable insulation for use in nuclear power generation facilities, “as long as the entities involved are diligently working to qualify their alternative components in accordance with Nuclear Regulatory Commission regulations and guidance.” EPA also announced a settlement agreement with RSCC Wire & Cable, LLC (RSCC), “the only known supplier of qualified decaBDE-containing wire and cable, regarding TSCA violations.”
 
According to EPA, it only became aware in late 2022 that RSCC would not be able to meet the January 6, 2023, deadline due to its inability to transition fully to an alternative. EPA states that as a result, downstream customers such as nuclear power plants could face potential shutdowns due to being unable to source and obtain decaBDE-free qualified wires and cables that meet NRC regulations. EPA notes that “[t]his issue was exacerbated by a lack of effective communication by the nuclear power sector with EPA despite multiple opportunities to comment on EPA’s rulemaking decisions.”
 
EPA notes that the Enforcement Statement also covers related recordkeeping requirements and the use of decaBDE-containing wire and cable. EPA states that the Enforcement Statement does not cover the prohibition of all processing and distribution in commerce of decaBDE (i.e., raw or compounded) for use in wire and cable insulation in nuclear power generation facilities.
 
According to EPA, on May 1, 2023, EPA reached a settlement with RSCC, “which is the Agency’s first settlement under TSCA section 6 since TSCA was amended in 2016.” EPA states that “[s]pecifically, this settlement with RSCC resolves import violations of the manufacturing prohibition of decaBDE-containing products for nine imports that occurred between March 8, 2021 and January 6, 2023.” Under the 2021 TSCA rules for PBT chemicals, EPA set an extended compliance date for the processing and distribution of decaBDE-containing wire and cable of January 6, 2023. The compliance date for the import of decaBDE-containing wire and cable was March 8, 2021. Therefore, RSCC’s import of decaBDE-containing products after this date was a violation of TSCA. EPA notes that the settlement includes conditions to allow both the continued manufacturing, processing, and distribution of decaBDE-containing wire and cable insultation and the processing, and distribution of decaBDE (including raw and compounded) while the nuclear power generation industry undergoes transition to a decaBDE-free alternative.

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By Lynn L. Bergeson and Carla N. Hutton
 
On May 3, 2023, the U.S. Environmental Protection Agency (EPA) proposed to prohibit most uses of methylene chloride under Section 6(a) of the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 28284. EPA states in its April 20, 2023, press release that its unreasonable risk determination for methylene chloride was driven by risks associated with workers, occupational non-users (ONU), consumers, and those in close proximity to a consumer use. EPA identified risks for adverse human health effects, including neurotoxicity, liver effects, and cancer from inhalation and dermal exposures to methylene chloride. According to EPA, its proposed risk management rule would “rapidly phase down” manufacturing, processing, and distribution of methylene chloride for all consumer uses and most industrial and commercial uses, most of which would be fully implemented in 15 months. EPA notes that for most of the uses of methylene chloride that it proposes to prohibit, its analysis found that alternative products with similar costs and efficacy to methylene chloride products are generally available. Comments on the proposed rule are due July 3, 2023. EPA notes that under the Paperwork Reduction Act, “comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before June 2, 2023.”
 
According to the proposed rule, pursuant to TSCA Section 6(b), EPA determined that methylene chloride presents an unreasonable risk of injury to health, without consideration of costs or other non-risk factors, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the 2020 methylene chloride risk evaluation, under the conditions of use (COU). To address the unreasonable risk, EPA proposes, under TSCA Section 6(a), to:

• Prohibit the manufacture, processing, and distribution of methylene chloride for all consumer use;
   
• Prohibit most industrial and commercial use of methylene chloride;
   
• Require a workplace chemical protection program (WCPP), including inhalation exposure concentration limits and related workplace exposure monitoring and exposure controls, for ten COU of methylene chloride (including manufacture; processing as a reactant; laboratory use; industrial or commercial use in aerospace and military paint and coating removal from safety-critical, corrosion-sensitive components by federal agencies and their contractors; industrial or commercial use as a bonding agent for acrylic and polycarbonate in mission-critical military and space vehicle applications, including in the production of specialty batteries for such by federal agencies and their contractors; and disposal);
   
• Require recordkeeping and downstream notification requirements for manufacturing, processing, and distribution in commerce of methylene chloride;
   
• Provide a ten-year time-limited exemption under TSCA Section 6(g) for civilian aviation from the prohibition addressing the use of methylene chloride for paint and coating removal to avoid significant disruptions to critical infrastructure, with conditions for this exemption to include compliance with the WCPP; and
   
• Provide a ten-year time-limited exemption under TSCA Section 6(g) for emergency use of methylene chloride in furtherance of the National Aeronautics and Space Administration’s mission for specific conditions which are critical or essential and for which no technically and economically feasible safer alternative is available, with conditions for this exemption to include compliance with the WCPP.

More information on EPA’s proposed rule is available in our April 25, 2023, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) will hold a virtual public preparatory meeting for the Science Advisory Committee on Chemicals (SACC) members, ad hoc reviewers, and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions to be used for the May 8-11, 2023, review of two draft documents related to cumulative risk assessment under the Toxic Substances Control Act (TSCA). As reported in our March 1, 2023, memorandum, earlier this year, EPA released for public comment and peer review a set of principles for evaluating cumulative risks under TSCA and an approach for applying those principles to the evaluation of the cumulative risk posed by certain phthalate chemicals undergoing TSCA Section 6 risk evaluation.

• Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act: The document discusses what cumulative risk assessment is and how it could be used in the scientific and regulatory context of TSCA. EPA notes that a cumulative risk assessment “will not always be the best approach, or possible to complete in the statutory timeframes provided for TSCA risk evaluations. But when chemicals are sufficiently similar toxicologically and are found to present co-exposures -- meaning people are . . .  exposed to multiple chemicals at the same time -- a cumulative risk assessment may be appropriate.”
   
• Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer-Requested Phthalate under the Toxic Substance Control Act: The document describes a proposed methodology for evaluating cumulative risk for the phthalate chemicals currently under review. EPA proposes in its approach submitted for public comment and peer review that di-ethylhexyl phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), di-isobutyl phthalate (DIBP), dicyclohexyl phthalate (DCHP), and di-isononyl phthalate (DINP) (but not di-isodecyl phthalate (DIDP)) are toxicologically similar (and pose an additive hazard) and that the U.S. population is co-exposed to these phthalates. Therefore, EPA proposes to group these phthalates for cumulative risk assessment under TSCA as described in the “Draft Proposed Approach” document. EPA notes that this proposed approach “is not itself a cumulative risk assessment nor does it make a finding of risk, but rather is a methodology that EPA proposes to use and seeks public input about and peer review on.”

Registration for the virtual preparatory meeting is open. To participate as a listen-only attendee, registration will be open up to the end of the meeting. Requests to make brief (up to five minutes) oral comments to the SACC during the preparatory meeting can be submitted when registering and will be accepted until April 21, 2023.
 
The two draft documents, draft charge questions, and other supporting materials are available online in docket EPA-HQ-OPPT-2022-0918. Written comments are due April 28, 2023, for distribution to SACC before the meeting.

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By Lynn L. Bergeson, Richard E. Engler, Ph.D., and Carla N. Hutton
 
On October 11, 2022, the U.S. Chemical Safety Board (CSB) released its final investigative report into “a massive fire and explosions” at the Philadelphia Energy Solutions Refinery in Philadelphia, Pennsylvania, that occurred in June 2019. According to CSB, the incident occurred when a corroded pipe elbow ruptured, releasing process fluid into the refinery’s hydrofluoric acid (HF) alkylation unit. CSB states that over 5,000 pounds of “highly toxic” HF were released, “a 38,000-pound vessel fragment launched off-site and landed on the other side of the Schuylkill River, and an estimated property damage loss of $750 million resulted.”
 
In its final report, CSB notes that the U.S. Environmental Protection Agency (EPA) has not yet prioritized HF or performed a risk evaluation of HF under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act. According to CSB, HF “is one of the eight most hazardous chemicals regulated by the EPA Risk Management Program (RMP).” CSB states that it concludes that EPA should initiate prioritization to evaluate whether HF is a high-priority substance for risk evaluation under TSCA. If HF is determined to be a high-priority substance, EPA should conduct a risk evaluation of HF and implement any identified corrective actions, as required by TSCA. CSB “recommends to EPA to take such action.”

Commentary

While we agree that HF is a highly hazardous substance that warrants prioritization for review under Section 6 of TSCA, it is not clear how a TSCA risk evaluation will address the risks related to accidents, such as the one that was the subject of this CSB investigation. Congress clearly stated that “reasonably foreseen” conditions of use exclude misuse of a chemical substance. CSB concluded that the facility had failed to meet its obligations under the Occupational Safety and Health Administration (OSHA) and other EPA regulations, and the accident was the result of the failure of a section of pipe that was decades old. We would argue that such a failure was a misuse of HF. As a result, we would expect a TSCA risk evaluation to conclude that as long as appropriate engineering controls are used to prevent worker exposure and prevent releases to the neighboring communities under the intended and reasonably foreseen conditions of use, there is not an unreasonable risk. EPA’s review might lead to the imposition of a lower workplace exposure limit (than the OSHA permissible exposure limit (PEL)) and might lead to a lower Hazardous Air Pollutant standard under the Clean Air Act. Neither of these protective measures would have prevented the accident. Others may argue that an accidental release is reasonably foreseen (after all, it did happen), but, in our view, this accident was the result of misuse, so it is outside the definition of reasonably foreseen conditions of use.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on May 24, 2022, that it is extending the public comment period for the April 12, 2022, proposed rule that would prohibit ongoing uses of chrysotile asbestos to give stakeholders more time to review the proposed regulation and prepare comments. EPA is extending the comment period an additional 30 days, from June 13, 2022, to July 13, 2022.
 
As reported in our April 7, 2022, memorandum, the proposed rule would ban chrysotile asbestos, the only known form of asbestos that is currently imported into the United States and is found in products like asbestos diaphragms used by the chlor-alkali industry, sheet gaskets, brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets also imported into the United States. EPA also proposed targeted disposal and recordkeeping requirements in line with industry standards, Occupational Safety and Health Administration (OSHA) requirements, and the Asbestos National Emission Standards for Hazardous Air Pollutants (NESHAP). The proposed disposal and recordkeeping requirements would take effect 180 days after the effective date of the final rule.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) proposed on April 12, 2022, to prohibit ongoing uses of chrysotile asbestos, the only known form of asbestos currently imported into the United States. 87 Fed. Reg. 21706. EPA proposes under Section 6(a) of the Toxic Substances Control Act (TSCA) to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos in bulk or as part of chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA proposes that these prohibitions take effect two years after the effective date of the final rule. EPA also proposes to prohibit manufacture (including import), processing, distribution in commerce, and commercial use of 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 National Aeronautics and Space Administration (NASA) Super Guppy Turbine aircraft use), and other chrysotile asbestos-containing gaskets. EPA proposes that these prohibitions take effect 180 days after the effective date of the final rule. EPA further proposes to prohibit 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. EPA proposes that these prohibitions take effect 180 days after the effective date of the final rule. EPA also proposes disposal and recordkeeping requirements under which regulated parties would document compliance with certain proposed prohibitions. Comments on the proposed rule are due June 13, 2022. A detailed analysis of the proposed rule is available in our April 7, 2022, memorandum.

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By Lynn L. Bergeson and Carla N. Hutton
 
The U.S. Environmental Protection Agency (EPA) announced on February 14, 2022, that it will reopen the comment period for its draft revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). As reported in our December 29, 2021, memorandum, EPA is reconsidering two key aspects of the risk determinations for HBCD. First, EPA proposes that the appropriate approach to these determinations under TSCA and implementing regulations is to make an unreasonable risk determination for HBCD as a whole chemical substance, rather than making unreasonable risk determinations separately on each individual condition of use (COU) evaluated in the risk evaluation. Second, EPA proposes that the risk determination should be explicit that it does not rely on assumptions regarding the use of personal protective equipment (PPE) in making the unreasonable risk determination under TSCA Section 6; rather, the use of PPE would be considered during risk management. EPA “finds that HBCD, as a whole chemical substance, presents an unreasonable risk of injury to health and the environment when evaluated under its conditions of use.” EPA will publish a Federal Register notice on February 17, 2022, to reopen the comment period for 15 days. Comments will be due March 3, 2022.

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By Lynn L. Bergeson and Carla N. Hutton
 
On December 16, 2021, the U.S. Environmental Protection Agency (EPA) submitted to the Office of Management and Budget (OMB) a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) on asbestos (part 1: chrysotile asbestos). According to an item in the fall 2021 Unified Agenda, the TSCA Section 6(a) rulemaking is needed to address the unreasonable risks of chrysotile asbestos that were identified in a risk evaluation completed under TSCA Section 6(b). EPA reviewed the exposures and hazards of chrysotile asbestos, the magnitude of risk, exposed populations, severity of the hazard, uncertainties, and other factors. As reported in our January 4, 2021, memorandum on the final risk evaluation, EPA found unreasonable risks to human health for the following uses of chrysotile asbestos:

• Consumers and Bystanders: EPA found unreasonable risks to consumers and bystanders from all consumer uses of chrysotile asbestos. Most consumer products containing chrysotile asbestos have been discontinued. Consumer products still available and for which EPA found unreasonable risk include aftermarket automotive brakes/linings and certain gaskets. Risks to consumers can come from the inhalation of chrysotile asbestos; and
   
• Workers and Occupational Non-Users (ONU): Commercial chrysotile asbestos uses for which EPA found unreasonable risk to workers include chlor-alkali diaphragms, sheet gaskets, brake blocks, aftermarket automotive brakes/linings, other vehicle friction products, and other gaskets. Additionally, EPA found unreasonable risks to workers nearby but not in direct contact with chrysotile asbestos for the use of chlor-alkali diaphragms, sheet gaskets, brake blocks, and other gaskets. Risks to workers and ONUs can come from the inhalation of chrysotile asbestos.

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