On April 20, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a proposed regulation under Section 6(a) of the Toxic Substances Control Act (TSCA) banning most uses of methylene chloride. The EPA stated that its unsubstantiated risk assessment for dichloromethane was due to risks associated with workers, professional non-users (ONUs), consumers, and those in close proximity to consumer use. The Environmental Protection Agency has identified the risk of adverse human health effects from inhalation and skin exposure to methylene chloride, including neurotoxicity, effects on the liver, and cancer. The EPA said its proposed risk management rule would “rapidly reduce” methylene chloride production, processing and distribution for all consumer and most industrial and commercial uses, most of which would be fully realized within 15 months. The EPA noted that for most uses of dichloromethane, it would propose to ban it. Analysis has shown that alternatives to dichloromethane with similar cost and effectiveness are generally available. Once the proposed rule is published in the Federal Register, a 60-day comment period will begin.
        Under a draft version of the proposed rule under TSCA Section 6(b), the EPA has determined that methylene chloride poses an unreasonable risk of injury to health, regardless of cost or other non-risk factors, including unreasonable risk in conditions use (COU) for those identified as potentially exposed or susceptible to the 2020 methylene chloride risk assessment. To eliminate unreasonable risk, EPA recommends, in accordance with Section 6(a) of the TSCA:
        EPA states that all TSCA COUs for dichloromethane (excluding its use in consumer paints and paint removers, which operate separately under TSCA Section 6 (84 Fed. Reg. 11420, March 27, 2019)) are subject to this offer. According to the EPA, TSCA defines COUs as the anticipated, known, or reasonably foreseeable circumstances under which a chemical is produced, processed, distributed, used, or disposed of for commercial purposes. The EPA is asking the public for comments on various aspects of the proposal.
        According to an EPA press release, the EPA consulted with the Occupational Safety and Health Administration (OSHA) in developing the proposed rule “and considered existing OSHA requirements in developing the proposed worker protections.” requirements to eliminate unreasonable risks. Employers will have one year to comply with the WCPP after the EPA releases final risk management rules and will be required to monitor their workplaces regularly to ensure workers are not exposed to methylene chloride, which can pose an unreasonable risk.
        The EPA “calls on the public to review the proposed rule and provide their comments.” The EPA said it was “particularly interested in hearing the views of the organizations needed to implement the proposed program on the feasibility and effectiveness of the proposed worker protection requirements.” EPA, it will host an open webinar for employers and workers in the coming weeks, “but will be useful to anyone looking for an overview of the proposed regulatory measures to discuss the proposed plans.” .
        Bergeson & Campbell, PC (B&C®) predicts the direction of the EPA’s proposed methylene chloride control measures and major control options. The EPA’s proposed rule is consistent with its recommendations in the proposed draft chrysotile risk management rule, including proposed regulatory measures to ban use, key regulatory alternatives for time-limited use under TSCA Section 6(g) (e.g., national security and critical infrastructure) and propose current chemical exposure limits (ECELs) that are well below current occupational exposure limits. Below, we summarize several issues that members of the regulated community should consider when preparing public comments on proposed draft rules, and remind everyone of the importance of engaging with the EPA early on in non-regulated initiatives to provide information on regulatory activity in the circumstances. Regulations, including TSCA.
        Given the EPA’s new policy direction with a “whole chemicals” approach, we are not surprised to see that the EPA’s proposed regulatory action is to “prohibit most industrial and commercial uses of dichloromethane.” However, the EPA offers a major regulatory alternative to allow certain proposed prohibited uses to continue subject to WCPP compliance. We mention this because Section 6(a) of the TSCA states that the EPA must “apply requirements to eliminate unreasonable risks to the extent necessary so that the chemical or mixture no longer poses such risks.” If WCPP with ECEL protects health and the environment, as advocated by the EPA, it would seem that bans on certain uses go beyond the “degree of necessity” rule. Even if WCPP is protective, the existing prohibition of consumer use is still justified because consumers may not be able to demonstrate and document compliance with the safeguards in WCPP. On the other hand, if the workplace can demonstrate and document compliance with the WCPP requirements, then it is likely that such use should continue to be allowed.
        As part of the WCPP requirements, the EPA stated that it would require “compliance with Good Laboratory Practice [GLP] 40 CFR Part 792″. This requirement is in conflict with most workplace monitoring efforts conducted in accordance with the Industrial Hygiene Laboratory Accreditation Program (IHLAP) standards. EPA’s expectations for GLP testing for workplace monitoring are in line with the testing order issued in 2021, but not its standard consent order. For example, the EPA TSCA Section 5(e) order template specifies the following in Section III.D:
        However, TSCA GLP compliance is not required in this new Chemical Exposure Limits section, where analytical methods are validated by a laboratory accredited by: American Industrial Hygiene Association (“AIHA”) Industrial Hygiene Laboratory Accreditation Program (“IHLAP”). or other similar program approved in writing by the EPA.
        The EPA has requested comments on specific aspects of the proposed rule, which B&C recommends that potentially affected parties consider. For example, the EPA is discussing the authority under TSCA Section 6(g) to grant time-limited exemptions for certain conditions of use such as civil aviation, and the EPA argues that compliance with the proposed requirements would “severely disrupt…critical infrastructure.” “We note that this waiver will include compliance with WCPP Similarly, if WCPP is protective and the facility can comply with WCPP (e.g. chronic non-cancerous ECEL 2 parts per million (ppm) and short term exposure limit (STEL) 16 parts per million), the term appears to be in excess of health and environmental protection requirements We believe an exemption will be used when safeguards are insufficient to address risk and a ban would significantly disrupt critical sectors (e.g. defence, aerospace, infrastructure). There appears to be an approach similar to the European Union Regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), which prohibits hazardous substances even if the safety measures are adequate in all but restricted areas. Although this approach may be appealing to all, but in our opinion, it does not meet the mandate of Section 6 of the EPA. ‘T.
        The EPA cites a 2022 paper titled “Evaluation of Alternatives to the Use of Dichloromethane” (reference 40 in the proposed rule) throughout the proposed rule. Based on this assessment, the EPA stated that it “identified products containing ingredients with certain endpoint hazard screening ratings lower than dichloromethane and some ingredients with hazard screening ratings higher than dichloromethane (ref. 40)”. At the time of this commentary, EPA has not uploaded this document to the Rulemaking Checklist, nor has EPA made it available on its online Health and Environment Research (HERO) database. Without examining the details of this document, it is not possible to assess the suitability of the alternatives for each use. Alternatives to paint stripping may not work like solvents, such as those used to clean sensitive electronic components in aircraft.
        We mentioned the lack of documentation above because organizations affected by the proposed EPA ban will need this information to determine the technical feasibility of alternatives, assess the potential risks of suitable alternatives (which could lead to future TSCA regulatory action), and prepare for public opinion. . We note that the US EPA is discussing such “alternative” issues in its proposed chrysotile rule, which includes the US EPA’s intention to ban the use of chrysotile in diaphragms used in the chlor-alkali industry. The EPA acknowledges that “alternative technologies for asbestos-containing diaphragms in chlor-alkali production have elevated concentrations of perfluoroalkyl and polyfluoroalkyl substances (PFAS) compared to the amount of PFAS compounds contained in asbestos-containing diaphragms,” but does not further compare the potential hazards and risks of alternatives.
        In addition to the above risk management issues, we believe that the US Environmental Protection Agency’s assessment of the potential risks associated with dichloromethane still has significant legal gaps. As discussed in our Nov. 11, 2022 memo, EPA consistently refers to its use of a 2018 document entitled “Applying Systematic Analysis to TSCA Risk Assessment” (“2018 SR Document”) as the basis for implementing its obligations. The requirement uses the best available scientific data and scientific evidence as specified in Section 26(h) and (i) of TSCA respectively. For example, the EPA states in its proposed regulation on methylene chloride that:
        The EPA considers the dichloromethane ECEL to represent the best available science under TSCA Section 26(h) because it was derived from information obtained from the 2020 dichloromethane risk assessment, which was the result of a thorough systematic analysis which was carried out. examinations to identify any relevant adverse health effects. [underline]
       As we wrote earlier, the National Academies of Sciences, Engineering and Medicine (NASEM) reviewed the 2018 SR document at the request of the EPA and concluded:
       The OPPT’s approach to the systematic review does not adequately reflect the reality, [and] the OPPT should reconsider its approach to the systematic review and consider the comments and recommendations contained in this report.
        Readers are reminded that TSCA Section 26(h) requires EPA to make decisions in accordance with the best available science in accordance with TSCA Sections 4, 5, and 6, which include protocols and methods such as systematic reviews. In addition, EPA’s use of the 2018 SR document in its final dichloromethane risk assessment also casts doubt on EPA’s compliance with the scientific evidence requirements set out in Section 26(i) of the TSCA, which EPA classifies as a “systematic analysis approach” for evidence or in a deterministic manner. …”
        Two EPA-proposed rules under TSCA Section 6(a), namely Chrysotile and Methylene Chloride, set out the rules for EPA’s proposed risk management rules for the remaining 10 major chemicals that EPA considers to pose unreasonable risks. Some ideas are used in the final risk assessment. Industries using these substances should prepare for an upcoming ban, WCPP, or time-limited exemption requiring WCPP compliance. The B&C recommends that stakeholders review the proposed methylene chloride regulation, even if readers do not use methylene chloride, and provide appropriate comments, recognizing that the proposed risk management options for methylene chloride are likely to become part of other future EPA standards. regulation. Chemicals with a final risk assessment (eg 1-bromopropane, carbon tetrachloride, 1,4-dioxane, perchlorethylene and trichlorethylene).
       Disclaimer: Due to the general nature of this update, the information provided here may not apply in all situations, and should not be acted upon without specific legal advice based on your particular situation.
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