OMB Approves EPA’s Methylene Chloride Final Rule

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a final rule for the EPA on “Methylene Chloride (MC); Regulation Under the Toxic Substances Control Act (TSCA)”. The final rule was submitted to OIRA on January 24^th, 2024. The notice of proposed rulemaking was published on May 3^rd, 2023.

According to the Fall 2023 Unified Agenda entry for this rulemaking:

“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.”

The EPA maintains a methylene chloride risk management web site.

We could see the final rule published in the Federal Register in the next couple of weeks. I do not expect to cover the final rule in any depth, but I will announce its publication on the appropriate ‘Short Takes’ post.