Final Risk Evaluation for Methylene Chloride

In November 2022, EPA released a final revised risk determination for methylene chloride as a whole chemical substance. This revision supersedes the previous condition of use-specific no unreasonable risk determinations in the 2020 methylene chloride risk evaluation (and withdraws the associated order). These chemical-specific changes are in accordance with the path forward for the first 10 risk evaluations under TSCA laid out by EPA in June 2021.

The final revised risk determination does not assume that all workers exposed to methylene chloride are always provided or appropriately wear personal protective equipment (PPE). The consideration of this information will be part of the risk management process.

EPA determined that 52 out of the 53 conditions of use evaluated would drive the determination that methylene chloride presents an unreasonable risk of injury to human health under its conditions of use.

Read the federal register notice.

Read the final revised methylene chloride risk determination.

Read the Response to Public Comments to the draft revised Unreasonable Risk Determination for Methylene Chloride.

On this page:

Risk evaluation findings
Next steps and public participation
2020 risk evaluation and supporting documents

On other pages:

Risk Evaluation Findings

In November 2022, EPA released a final revised risk determination for methylene chloride. The final revised risk determination finds that methylene chloride presents an unreasonable risk of injury to health under its conditions of use.

In the June 2020 risk evaluation, EPA reviewed the exposures and hazards of methylene chloride and made risk findings on this chemical. This risk evaluation included input from the public and peer reviewers as required by TSCA and associated regulations. EPA considered the hazards and exposures, magnitude of risk, exposed populations, severity of the hazards, uncertainties, and other factors as part of its unreasonable risk determinations.

EPA determined that methylene chloride, as a whole chemical substance, presents unreasonable risk to human health.

EPA assessed the impact of methylene chloride on workers, occupational non-users, consumers, and bystanders. The primary health risks identified in the risk evaluation are neurotoxicity from short-term exposure to the chemical and liver effects and cancer from long-term exposure. After reviewing these data, EPA determined that risk to workers, occupational non-users (workers nearby but not in direct contact with this chemical), consumers, and bystanders drive the whole chemical determination of unreasonable risk. Risk from 52 out of 53 conditions of use evaluated drive the final revised whole chemical determination of unreasonable risk of injury to health.

The revised risk determination for methylene chloride does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE), even though some facilities might be using PPE as one means to reduce worker exposure, or that there is widespread non-compliance with applicable federal standards. EPA understands there could be occupational safety protections in place at some workplace locations; however, not assuming use of PPE in its baseline exposure scenarios reflects EPA’s recognition that certain subpopulations of workers exist that may be highly exposed because they are not covered by OSHA standards, because their employers are out of compliance with OSHA standards, because OSHA’s chemical-specific Permissible Exposure Limits (largely adopted in the 1970’s) are described by OSHA as being “outdated and inadequate for ensuring protection of worker health,” or because the OSHA PEL alone may be in adequate for ensuring protection of worker health, as is the case for methylene chloride. The consideration of information on use of PPE, engineering controls, and other ways industry protects its workers, as potential ways to address unreasonable risk will be part of the risk management rule development process.

Consumers should not use paint and coating removers containing methylene chloride. In March 2019, EPA regulated sales of methylene chloride in paint and coating removers for consumer use. After November 22, 2019, all persons are prohibited from manufacturing (including importing), processing, and distributing in commerce, including distribution to and by retailers, methylene chloride for consumer paint and coating removal. Please consult your state and local government solid waste agencies to obtain proper disposal instructions for leftover or unused paint and coating removal products. Learn more about this action.

Next Steps and Public Participation

EPA will propose and take public comments on risk management actions to address the unreasonable risk identified in the risk evaluation, as updated by the final revised risk determination. EPA’s proposed regulations could include prohibitions or requirements that limit the manufacture, processing, distribution in commerce, commercial use, or disposal of this chemical substance, as applicable.

Stay up to date on additional opportunities for public participation. Just like the risk evaluation process, there will be opportunities for public comment as EPA works to propose and finalize risk management actions for methylene chloride. You can stay informed by signing for our email alerts or checking the public dockets at EPA-HQ-OPPT-2016-0742 and EPA-HQ-OPPT-2020-0465 at www.regulations.gov.

2020 Risk Evaluation and Supporting Documents

Below is the final revised risk determination, 2020 risk evaluation for methylene chloride, non-technical summary, response to comments, and other supporting documents.

The discussion of the issues in the final revision to the risk determination supersedes any conflicting statements in the prior methylene chloride risk evaluation and the response to comments document.

Read the federal register notice.