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Abstract: On May 5, 2023, EPA proposed a rule under the Toxic Substances Control Act (TSCA)  to address the unreasonable risk of injury to human health from methylene chloride. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so that the chemical no longer presents unreasonable risk. Methylene chloride, also known as dichloromethane, is acutely lethal, a neurotoxicant, a likely human carcinogen, and presents cancer and non-cancer risks following chronic exposures as well as acute risks. Central nervous system depressant effects can result in loss of consciousness and respiratory depression, resulting in irreversible coma, hypoxia, and eventual death, including 85 documented fatalities from 1980 to 2018, a majority of which were occupational fatalities. Nevertheless, methylene chloride is still a widely used solvent in a variety of consumer and commercial applications including adhesives and sealants, automotive products, and paint and coating removers. To address the identified unreasonable risk, EPA proposed to: prohibit the manufacture, processing, and distribution in commerce of methylene chloride for consumer use; prohibit most industrial and commercial uses of methylene chloride; require a workplace chemical protection program (WCPP), which would include a requirement to meet inhalation exposure concentration limits and exposure monitoring for certain continued conditions of use of methylene chloride; require recordkeeping and downstream notification requirements for several conditions of use of methylene chloride; and provide certain time-limited exemptions from requirements for uses of methylene chloride that would otherwise significantly disrupt national security and critical infrastructure. The Agency’s development of this rule incorporated significant stakeholder outreach and public participation, including public webinars and over 40 external meetings as well as required Federalism, Tribal, and Environmental Justice consultations and a Small Businesses Advocacy Review Panel. EPA's risk evaluation, describing the conditions of use is in docket EPA-HQ-OPPT-2019-0437, with the 2022 unreasonable risk determination and additional materials in docket EPA-HQ-OPPT-2016-0742.

Statement of Need:

This rulemaking is needed to address the unreasonable risk from methylene chloride that was identified in a risk evaluation completed under TSCA section 6(b). EPA reviewed the exposures and hazards of methylene chloride, the magnitude of risk, exposed populations, severity of the hazard, uncertainties, and other factors. EPA sought input from the public and peer reviewers as required by TSCA and associated regulations.

Summary of the Legal Basis:

In accordance with TSCA section 6(a), if EPA determines in a final risk evaluation completed under TSCA 6(b) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Agency must issue regulations requiring one or more of the following actions to the extent necessary so that the chemical substance no longer presents an unreasonable risk: (1) Prohibit or otherwise restrict manufacture, processing, or distribution in commerce of the substance, or limit the amount of the substance which may be manufactured, processed, or distributed in commerce; (2) Prohibit or otherwise restrict manufacture, processing, or distribution in commerce of the substance for a particular use or for a particular use above a set concentration, or limit the amount of the substance which may be manufactured, processed, or distributed in commerce for a particular use or for a particular use above a set concentration; (3) Require minimum warnings and instructions with respect to use, distribution in commerce, or disposal; (4) Require recordkeeping or testing by manufacturers or processors; (5) Prohibit or regulate any manner or method of commercial use; (6) Prohibit or regulate any manner or method of disposal for commercial purposes; and/or (7) Direct manufacturers or processors to give notice of the unreasonable risk to distributors, other persons and the public and replace or repurchase the substance.

Alternatives:

TSCA section 6(a) requires EPA to address by rule chemical substances that the Agency determines present unreasonable risk upon completion of a final risk evaluation. TSCA section 6(c) requires EPA to consider one or more primary alternative regulatory actions as part of the development of a proposed rule under TSCA section 6(a). The primary alternative regulatory action for this rulemaking would, like the proposed action, prohibit the manufacture, processing, and distribution in commerce of methylene chloride for consumer use; prohibit most industrial and commercial uses of methylene chloride; require a workplace chemical protection program (WCPP), which would include a requirement to meet inhalation exposure concentration limits and exposure monitoring for certain continued conditions of use of methylene chloride; require recordkeeping and downstream notification requirements for several conditions of use of methylene chloride; and provide certain time-limited exemptions from requirements for uses of methylene chloride that would otherwise significantly disrupt national security and critical infrastructure. This primary alternative regulatory action includes longer compliance timeframes and additional uses under workplace chemical protection program, in comparison to the proposed action.

Anticipated Costs and Benefits:

EPA’s analysis of the incremental, non-closure-related costs of this proposed rule is estimated to be $13.2 million annualized over 20 years at a 3% discount rate and $14.5 million annualized over 20 years at a 7% discount rate. The proposed rule involves health benefits for the American public, some of which can be monetized and others that, while tangible and significant, cannot be monetized. Although some benefits cannot be quantified, they are not necessarily less important than the quantified benefits. The monetized benefits of this rule are approximately $17.7 to $18.5 million annualized over 20 years at a 3% discount rate and $13.4 to $13.9 million annualized over 20 years at a 7% discount rate.

Risks:

EPA determined that methylene chloride presents an unreasonable risk to human health. EPA must issue risk management requirements so that this chemical substance no longer presents an unreasonable risk. For more information, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca.