Final Risk Evaluation for Trichloroethylene
In January 2023, EPA released a final revised risk determination for trichloroethylene (TCE) as a whole chemical substance. This revision supersedes the condition of use-specific risk determinations in the 2020 TCE 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 risk determination does not assume that workers exposed to TCE 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 54 conditions of use evaluated contribute to the determination that TCE presents an unreasonable risk of injury to human health under its conditions of use.
Read the Federal Register notice.
Read the final revised TCE risk determination.
Read the Response to Public Comments to the draft revised Unreasonable Risk Determination for TCE.
On this page:
- Risk evaluation findings
- Next steps and public participation
- 2020 risk evaluation and supporting documents
On other pages:
Risk Evaluation Findings
In January 2023, EPA released a final revised risk determination for TCE. The final revised risk determination finds that TCE presents an unreasonable risk of injury to health under its conditions of use.
In the November 2020 final TCE risk evaluation, EPA reviewed the exposures and hazards of TCE uses and made risk findings on this chemical substance. This risk evaluation included input from the public and peer reviewers as required by TSCA and associated regulations. EPA considered relevant risk-related factors, including, but not limited to: the hazards and exposure, magnitude of risk, exposed population, severity of the hazard, and uncertainties, as part of its unreasonable risk determination.
EPA determined that TCE, as a whole chemical substance, presents unreasonable risk to human health.
EPA assessed the impact of TCE on workers, occupational non-users, consumers, and bystanders. EPA identified health risks, including developmental toxicity, reproductive toxicity, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, and cancer from inhalation or dermal exposures to TCE. Risk from 52 out of 54 conditions of use (including manufacturing, import, processing, industrial and commercial uses, consumer uses, and disposal) contribute to the whole chemical determination of unreasonable risk of injury to health. Two out of 54 conditions of use do not contribute to the unreasonable risk: consumer use of TCE in pepper spray and distribution in commerce.
The revised risk determination for TCE 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 TCE. 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 October 2023, EPA proposed a risk management rule to address unreasonable risk posed by TCE to human health. Learn more and submit a comment.
EPA hosted a webinar on November 14, 2023 at 1:00 p.m. EST about the proposed risk management rule.
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 TCE. You can stay informed by signing up for our email alerts or checking the public dockets at EPA-HQ-OPPT-2019-0500 and EPA-HQ-OPPT-2020-0642 at www.regulations.gov.
2020 Risk Evaluation and Supporting Documents
Below are the final revised risk determination, 2020 risk evaluation for TCE, non-technical summary, response to comments, and other supporting documents. Find additional documents supporting the final risk evaluation including risk calculators and the PBPK model.
The discussion of the issues in the final revision to the risk determination supersedes any conflicting statements in the 2020 TCE risk evaluation and the response to comments document.
Read the Federal Register notice.
- Final Revised Unreasonable Risk Determination for Trichloroethylene, January 2023 (pdf)
- Nontechnical Summary of the Risk Evaluation for Trichloroethylene, January 2023 (pdf)
- Response to Public Comments, Trichloroethylene Revised Unreasonable Risk Determination, January 2023 (pdf)
- Risk Evaluation for Trichloroethylene, November 2020 (pdf)
- Summary of External Peer Review and Public Comments and Disposition for Trichloroethylene: Response to Support Risk Evaluation for Trichloroethylene, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Quality Evaluation of Physical-Chemical Properties Studies, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Quality Evaluation of Environmental Fate and Transport Studies, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Extraction for Environmental Fate and Transport Studies, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Quality Evaluation of Environmental Releases and Occupational Exposure Data, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Quality Evaluation of Environmental Releases and Occupational Exposure Common Sources, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: List of Key and Supporting Studies for Environmental Releases and Occupational Exposure, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene Supplemental File: Data Quality Evaluation for Data Sources on Consumer and Environmental Exposure, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Extraction Tables for Environmental Monitoring Data, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Extraction for Biomonitoring Data, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Quality Evaluation of Environmental Hazard Studies, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Extraction for Environmental Hazard Studies, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies - Animal and Mechanistic Data, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies - Epidemiological Data, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Updates to the Data Quality Criteria for Epidemiological Studies, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: Data Extraction for Human Health Hazard Studies, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: TCE Data Extraction and Evaluation Tables for Genotoxicity Studies, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Systematic Review Supplemental File: List of Key and Supporting Studies for Human Health Hazard Assessment, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Supplemental Information File: Environmental Releases and Occupational Exposure Assessment, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Supplemental Information File: Memorandum on Respirator Usage in Private Sector Firms, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Supplemental Information File: Aquatic Exposure Modeling Outputs from E-FAST, November 2020 (pdf)
- Risk Evaluation for Trichloroethylene, Supplemental Information File: Internal Dose BMD Modeling Results for Selgrade and Gilmour, 2010 (pdf)
- Risk Evaluation for Trichloroethylene, Supplemental Information File: PBPK Model ReadMe, November 2020 (pdf)