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.
On this page:
- Risk evaluation findings
- Next steps and public participation
- 2020 risk evaluation and supporting documents
On other pages:
- Learn more about risk management for methylene chloride.
- Read about the steps EPA is taking in the risk evaluation process for methylene chloride.
- Learn more about EPA’s risk evaluation process.
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 as a whole chemical substance 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 inadequate for ensuring protection of worker health, as is the case for methylene chloride. EPA considered information on use of PPE, engineering controls, and other ways industry protects its workers, as part of the risk management process.
Consumers should not use any products 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.
In April 2024, EPA finalized a risk management rule that prohibits manufacturing, processing and distribution of methylene chloride for all consumer uses and most industrial and commercial uses.
Methylene Chloride should only be used in highly industrialized workplaces as specified by this rulemaking. For uses that will continue, the rule creates strict workplace protections to ensure that workers will not be harmed by methylene chloride use. Workers must be protected under a Workplace Chemical Protection Plan.
Uses that will continue are:
1) Manufacturing (domestic manufacture);
(2) Manufacturing (import);
(3) Processing: as a reactant;
(4) Processing: incorporation into a formulation, mixture, or reaction product;
(5) Processing: repackaging;
(6) Processing: recycling;
(7) Industrial and commercial use as a laboratory chemical;
(8) Industrial or commercial use for paint and coating removal from safety-critical, corrosion-sensitive components of aircraft and spacecraft
(9) Industrial or commercial use as a bonding agent for solvent welding;
(10) Industrial and commercial use as a processing aid;
(11) Industrial and commercial use for plastic and rubber products manufacturing;
(12) Industrial and commercial use as a solvent that becomes part of a formulation or mixture, where that formulation or mixture will be used inside a manufacturing process, and the solvent (methylene chloride) will be reclaimed;
(16) Disposal;
Next Steps and Public Participation
In April 2024, EPA finalized a risk management rule to address unreasonable risk posed by methylene chloride to human health. Learn more.
You can stay informed by signing for our email alerts or checking the public docket at 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.
- Final Revised Unreasonable Risk Determination for Methylene Chloride, November 2022 (pdf)
- Nontechnical Summary of the Risk Evaluation for Methylene Chloride, November 2022 (pdf)
- Response to Public Comments, Methylene Chloride Revised Unreasonable Risk Determination, November 2022 (pdf)
- Risk Evaluation for Methylene Chloride, June 2020 (pdf)
- Summary of External Peer Review and Public Comments and Disposition for Methylene Chloride, June 2020 (pdf)
- Systematic Review Supplemental File: Data Quality Evaluation of Environmental Fate and Transport Studies, June 2020 (pdf)
- Systematic Review Supplemental File: Data Quality Evaluation of Environmental Releases and Occupational Exposure Data, June 2020 (pdf)
- Systematic Review Supplemental File: Data Quality Evaluation of Environmental Releases and Occupational Exposure Common Sources, June 2020 (pdf)
- Systematic Review Supplemental File: Data Quality Evaluation on Data Sources on Consumer and Environmental Exposure, June 2020 (pdf)
- Systematic Review Supplemental File: Data Extraction Tables for Consumer and Environmental Exposure Studies, June 2020 (pdf)
- Systematic Review Supplemental File: Data Quality Evaluation of Environmental Hazard Studies, June 2020 (pdf)
- Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies – Animal and in Vitro Studies, June 2020 (pdf)
- Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies - Epidemiological Studies, June 2020 (pdf)
- Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies - Human Controlled Experiments, June 2020 (pdf)
- Systematic Review Supplemental File: Updates to the Data Quality Criteria for Epidemiological Studies, June 2020 (pdf)
- Systematic Review Supplemental File: Data Extraction Tables for Human Health Hazard Studies, June 2020 (pdf)
- Supplemental Information on Surface Water Exposure Assessment, June 2020 (pdf)
- Supplemental Information on Releases and Occupational Exposure Assessment, June 2020 (pdf)
- Systematic Review Supplemental File: Data Extraction Tables for Environmental Fate and Transport Studies, June 2020 (pdf)
- Supplemental File: Methylene Chloride Benchmark Dose and PBPK Modeling Report, June 2020 (pdf)
- Systematic Review Supplemental File: Data Quality Evaluation of Physical-Chemical Property, June 2020 (pdf)