EPA Releases Draft Revised Risk Determination for Trichloroethylene for Public Comment

Released on July 7, 2022.

Today, the U.S. Environmental Protection Agency (EPA) released for public comment a draft revision to the unreasonable risk determination for trichloroethylene (TCE) pursuant to the Toxic Substances Control Act (TSCA) section 6(b). The draft revised risk determination proposes to find that TCE, as a whole chemical substance, presents an unreasonable risk of injury to human health under the conditions of use evaluated.  

The TCE draft revised risk determination incorporates policy changes announced in June 2021 to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. EPA’s proposed revisions will ensure that, when finalized, the TCE risk determination better aligns with the objectives of protecting health and the environment under the amended TSCA.  

TCE is a volatile organic compound used mostly in industrial and commercial processes. Consumer uses include cleaning and furniture care products, arts and crafts spray coatings, and automotive care products like brake cleaners.  

EPA’s TCE risk evaluation identified adverse human health effects for workers, occupational non-users, consumers, and bystanders who have inhalation or dermal exposures to TCE, including:  

• Immunotoxicity;  

• Reproductive and developmental effects;  

• Cardiac and lung effects;  

• Kidney and liver effects; and  

• Cancer. 

The draft revised risk determination for TCE does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE). This decision should not be viewed as an indication that EPA believes there is widespread non-compliance with applicable Occupational Safety and Health Administration (OSHA) standards. In fact, EPA has received public comments from industry respondents about occupational safety practices in use at their facilities. EPA will consider these comments, as well as other information on use of PPE and other ways industry protects its workers, as potential ways to address unreasonable risk during the risk management process. 

Not assuming use of PPE in its baseline exposure scenarios reflects EPA’s recognition that certain subpopulations of workers may be highly exposed because they are not covered by OSHA standards, their employers are out of compliance with OSHA standards, or because OSHA’s chemical-specific Permissible Exposure Limits (largely adopted in the 1970s) are described by OSHA as being “outdated and inadequate for ensuring protection of worker health,” or because the OSHA permissible exposure limit alone may be inadequate for ensuring protection of worker health, as is the case for TCE.  

As EPA moves forward with a risk management rule for TCE, the agency will strive for consistency with existing OSHA requirements or best industry practices when they are sufficiently protective, and EPA will propose occupational safety measures in the risk management process that meet TSCA’s statutory requirement to eliminate unreasonable risk of injury to health and the environment. 

Overall, 52 conditions of use out of 54 EPA evaluated would drive the TCE whole chemical unreasonable risk determination. Removing the assumption that workers always and appropriately wear PPE in making the whole chemical risk determination for TCE would not add additional conditions of use to the original 52 conditions that drive the unreasonable risk determination.  

Removing this assumption would also add to many of the risks originally identified from the 52 conditions of use, including the identification of additional risks for acute non-cancer effects and cancer effects from inhalation and dermal exposures as driving the unreasonable risk within many of those conditions of use.  

Two out of 54 conditions of use do not drive the unreasonable risk: consumer use of TCE in pepper spray and distribution in commerce. 

Separately, EPA is conducting a screening approach to assess potential risks from the air and water pathways for several of the first 10 chemicals, including TCE. Exposure pathways that were or could be regulated under another EPA-administered statute were excluded from the 2020 TCE risk evaluation, resulting in ambient air and water pathways not being fully assessed. EPA’s screening approach will identify if there are risks that were unaccounted for in the risk evaluation for TCE. While this analysis is underway, EPA is not incorporating the screening-level approach into this draft revised unreasonable risk determination. If the results suggest there is additional risk, EPA will determine if the risk management approach being contemplated for TCE will protect against these risks or if the risk evaluation will need to be formally supplemented or revised. 

Note that EPA has not conducted new scientific analysis on TCE as part of today’s actions. The TCE risk evaluation continues to characterize risks associated with individual conditions of use. EPA will continue to rely on the evaluation of each condition of use to support any determination of unreasonable risk for TCE as a whole chemical substance. 

EPA will accept public comments on the draft revised risk determination for 30 days following publication in the Federal Register via docket EPA-HQ-OPPT-2016-0737 at www.regulations.gov.   

Read the Draft Revised Unreasonable Risk Determination for TCE.