On May 3, 2023, the EPA issued a proposed Section 6(a) Toxic Substances Control Act (TSCA) risk management rule imposing restrictions on the production, import, processing, distribution, and use of dichloromethane. used solvent in various consumer and commercial applications. This is the EPA’s first proposed risk management rule since it published a revised risk definition last year based on its new “all-chemical approach” and policy that requires workers not to wear personal protective equipment (PPE). . It also reflects a significant expansion of regulatory prohibitions applicable to chemicals that are already subject to TSCA risk management restrictions, although those restrictions were more restrictive under the previous EPA risk management action framework.
The EPA proposes to ban the commercial production, processing and distribution of dichloromethane for domestic use; ban most industrial and commercial uses of dichloromethane; requires that a use-specific chemical workplace protection plan (WCPP) remain in effect and provide certain time-limited critical use exemptions in accordance with TSCA Section 6(g) for methylene chloride use that could otherwise cause severe damage to national security and critical infrastructure. Stakeholders have until July 3, 2023 to comment on the proposed rule.
In proposing risk management measures for dichloromethane, the EPA found that repeated use of the substance in consumer, commercial, and industrial applications requires regulatory action, primarily a ban, as shown in Table 3 of the proposed rule. Many of these use conditions include, but are not limited to, the industrial and commercial use of methylene chloride for cleaning solvents, paints and coatings (and washes), steam degreasing, adhesives, sealants, sealants, textiles and fabrics, and car care products. , lubricants and lubricants, pipe insulation, oil and gas drilling, toys, play and sports equipment, and plastic and rubber products. The EPA has also determined that all assessed consumer uses of dichloromethane need to be banned.
The EPA claims that the proposal’s requirements prohibit uses that account for approximately one-third of the total annual production (TSCA and non-TSCA use) of methylene chloride produced, “leaving enough circulating stocks to provide the source the EPA proposes to allow.” continued use These critical or primary uses are through the Critical Use Exemption or WCPP.
Once the EPA finds that a certain substance has an unreasonable risk of harm to human health or the environment in its risk assessment, it must propose risk management requirements to the extent necessary so that the substance no longer has such risks. When imposing risk management restrictions on a chemical, the EPA should consider the economic implications of the rule, including costs and benefits, cost-effectiveness, and the impact of the rule on the economy, small businesses, and technological innovation. whether the substance should be banned Technically and economically viable alternatives exist.
The EPA proposes the following bans on the use of methylene chloride and their effective dates:
The EPA has also introduced notification and record keeping requirements for companies supplying methylene chloride to customers.
The use of dichloromethane to remove paints and coatings for consumer use is not included in this ban, as this use is already covered by the current EPA risk management rule issued in 2019, which is codified in 40 CFR § 751.101.
Section 6(g) of the TSCA allows the EPA to exempt alternatives from the requirements of the risk management rule for critical or essential uses that the EPA deems available. It also allows waivers if the EPA determines that compliance with this requirement would cause serious damage to the national economy, national security, or critical infrastructure. The US Environmental Protection Agency recommends a critical use exemption for methylene chloride in the following cases:
EPA’s proposed WCPP for the permitted use of dichloromethane includes comprehensive requirements for protecting workers from exposure, including respiratory protection, use of PPE, exposure monitoring, training, and regulated areas. It is worth noting that EPA has proposed an existing chemical exposure limit (ECEL) for airborne methylene chloride concentrations above 2 parts per million (ppm) based on an 8-hour time-weighted average (TWA), which is significantly lower than OSHA’s current Permissible Exposure Limit ( PEL) for dichloromethane is 25 ppm. The proposed action level would be half the ECEL value, which would trigger additional monitoring activities to ensure that workers are not exposed to concentrations above the ECEL. The EPA also recommends setting a short-term exposure limit (EPA STEL) of 16 ppm over a 15-minute sampling period.
Instead of a ban, EPA proposes requirements to protect workers under the following conditions of use:
Processing: As a reagent. Note that the EPA allows this use to continue under WCPP because it considers that a significant amount of dichloromethane is recycled for these uses, almost all of which is used to produce HFC-32. HFC-32 is one of the controlled substances under the American Innovation and Manufacturing Act (AIM Act) of 2020. The EPA expects that by authorizing HFC-32, this rulemaking will not hinder efforts to move to lower global warming potential chemicals.
Industrial or commercial use for removing paint and coatings from safety-critical, corrosion-sensitive aircraft and spacecraft components owned or operated by the U.S. Department of Defense, NASA, Homeland Security, and the Federal Aviation Administration, an agency, or an agency performing contractors at locations, controlled by an agency or agency contractor
Industrial or commercial use as an adhesive for acrylic and polycarbonate in mission-critical military and space vehicles, including for the production of specialty batteries or agency contractors.
Stakeholders who manufacture, process, distribute, or otherwise use methylene chloride for any EPA-assessed use environment may be interested in commenting on many aspects of this proposed precedent-setting rule. Interested parties may consider contributing to the EPA in the following areas:
Assessing the Risk Management Approach to Conditions of Use: Stakeholders may wish to evaluate whether the proposed risk management requirements for each condition of use are consistent with EPA’s methylene chloride risk assessment for each condition of use and the EPA. ™ Statutory powers under Section 6 of TSCA. For example, if the EPA finds that skin exposure to methylene chloride under certain conditions of use poses an unreasonable risk, and if the EPA requires more than skin protection to mitigate the risk, stakeholders may wish to evaluate the appropriateness of such additional requirements. .
Costs: The EPA estimates incremental non-closure costs associated with this proposed rule at $13.2 million over 20 years at a 3% discount rate and $14.5 million over 20 years at discount rate of 7%. Stakeholders may wish to evaluate whether these projected costs cover all aspects of implementing the proposed rule, including the cost of re-enactment (prohibition of use) or compliance with the WCPP conditions to allow continued use, including compliance with ECEL 2 ppm.
WCPP Requirements: For conditions of use that the EPA proposes to ban, stakeholders may assess whether they have data supporting WCPP compliance that will adequately mitigate exposure rather than ban (especially for conditions of use where EPA proposes WCPP as a primary alternative, proposed in the proposed rule Alternatives to a ban in Stakeholders may also wish to evaluate the feasibility of WCPP requirements and consider compliance with the OSHA standard for methylene chloride.
Timeline: Stakeholders may consider whether the proposed ban schedule is feasible and other uses are eligible for consideration for a time-limited critical-use exemption in accordance with statutory criteria for a critical-use exemption.
Alternatives: Stakeholders can comment on the EPA’s evaluation of alternatives to methylene chloride and see if there are affordable, safer alternatives to transition to the proposed prohibited uses under the rule.
Minimum Levels: The EPA has specifically requested comment on the number of facilities that could fail and the associated costs, and prohibits the use of dichloromethane under certain conditions of industrial and commercial use specified in the proposed rule. The EPA would also like to comment on whether minimum levels of methylene chloride (e.g. 0.1% or 0.5%) in certain formulations for sustainable industrial and commercial use should be considered when finalizing the ban, and if so, what levels should regarded as a bare minimum.
Certification and Training: In its proposal, the EPA explained that it also considered the extent to which certification and restricted access programs restrict the use of methylene chloride to trained and licensed users to ensure that only certain plant workers can purchase and use dichloromethane. Stakeholders may wish to comment on whether certification and training programs may be effective in reducing worker exposure as a risk management approach under certain conditions of use, including conditions of use that the EPA proposes to ban.
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