Final Risk Evaluation for Perchloroethylene (PCE)
In December 2022, EPA released a final revised risk determination for perchloroethylene (PCE) as a whole chemical substance. This final revision supersedes the previous condition of use-specific risk determinations in the 2020 PCE 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 PCE 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 60 out of 61 conditions of use evaluated drive the determination that PCE presents an unreasonable risk of injury to human health under its conditions of use.
Read the federal register notice.
Read the final revised PCE risk determination.
Read the Response to Public Comments to the draft revised Unreasonable Risk Determination for PCE.
On this page:
- Risk evaluation findings
- Next steps and public participation
- 2020 risk evaluation and supporting documents
On other pages:
- Read about the steps in EPA’s risk evaluation process for PCE.
- Learn more about EPA’s risk evaluation process.
Risk Evaluation Findings
In December 2022, EPA released a final revised risk determination for PCE. The final revised risk determination finds that PCE presents an unreasonable risk of injury to health under its conditions of use.
In the December 2020 risk evaluation, EPA reviewed the exposures and hazards of PCE 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 exposure, magnitude of risk, exposed population, severity of the hazard, uncertainties, and other factors as part of its unreasonable risk determination.
EPA determine that PCE, as a whole chemical substance, presents unreasonable risk to human health.
EPA assessed the impact of PCE on workers, occupational non-users, consumers and bystanders. The primary health risks identified in the risk evaluation are neurological effects from short- and long-term exposure to the chemical 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 60 out of 61 conditions of use, including manufacture (including import), processing, industrial and commercial use, consumer use and disposal, of PCE, drive the final revised whole chemical determination of unreasonable risk to human health.
The revised risk determination for PCE 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 PCE. 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.
Next Steps and Public Participation
In June 2023, EPA proposed a risk management rule to address unreasonable risk posed by PCE to human health. Learn more and submit a comment.
EPA held a webinar providing an overview of the proposed risk management rule for PCE on July 19, 2023. View materials from the webinar.
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 PCE. You can stay informed by signing up for our email alerts or checking the public dockets at EPA-HQ-OPPT-2016-0732 and EPA-HQ-OPPT-2020-0720 at www.regulations.gov.
2020 Risk Evaluation and Supporting Documents
Below are the final revised risk determination, 2020 risk evaluation for PCE, 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 PCE risk evaluation and the response to comments document.
Read the federal register notice.
- Final Revised Unreasonable Risk Determination for Perchloroethylene, December 2022 (pdf)
- Nontechnical Summary of the Risk Evaluation for Perchloroethylene, December 2022 (pdf)
- Response to Public Comments, Perchloroethylene Revised Unreasonable Risk Determination, December 2022 (pdf)
- Risk Evaluation for Perchloroethylene, December 2020 (pdf)
- Summary of External Peer Review and Public Comments and Disposition for Perchloroethylene, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Extraction Tables of Environmental Fate and Transport Studies, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Quality Evaluation of Environmental Fate and Transport Studies, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Quality Evaluation of Physical-Chemical Properties Studies, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Quality Evaluation of Environmental Release and Occupational Exposure Common Sources, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Quality Evaluation of Environmental Release and Occupational Exposure, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Consumer and General Population Exposure Monitoring Data Extraction Tables, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Quality Evaluation for Data Sources on Consumer and Environmental Exposure, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Quality Evaluation of Ecological Hazard Studies, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Extraction Tables of Environmental Hazard Studies, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Updates to the Data Quality Criteria for Epidemiological Studies, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies – Epidemiological Studies, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Extraction for Human Health Hazard Studies, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies – Animal and in Vitro Studies, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Supplemental File: Releases and Occupational Exposure Assessment, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Supplemental File: Perchloroethylene Exposure from Consumer Products and Articles, December 2020 (pdf)
- Final Risk Evaluation for Perchloroethylene Supplemental File: E-FAST Surface Water Modeling Outputs, December 2020 (pdf)