EPA Releases Draft Revised Risk Determination for Perchloroethylene for Public Comment

Released on June 30, 2022.

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

The PCE 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 PCE risk determination better aligns with the objectives of protecting health and the environment under the amended TSCA.

PCE is used as a solvent for cleaning and degreasing, and in lubricants, adhesives and sealants. A variety of consumer and commercial products use PCE, such as adhesives (arts and crafts, as well as light repairs), aerosol degreasers, brake cleaners, aerosol lubricants, sealants, stone polish, stainless steel polish, and wipe cleaners.

EPA’s PCE risk evaluation identified adverse human health effects, including neurotoxicity, from acute and chronic inhalation and dermal exposures to PCE. EPA also identified cancer as one adverse human health effect of chronic inhalation and dermal exposures to PCE.

The draft revised risk determination for PCE 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 OSHA standards. In fact, EPA has received public comments from industry respondents about occupational safety practices currently 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 exist that may be highly exposed because they are not covered by Occupational Safety and Health Administration (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,” as is the case for PCE.

As EPA moves forward with risk management rules for PCE, the agency will strive for consistency with existing OSHA requirements or best industry practices when they are sufficiently protective. 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, 60 conditions of use out of 61 EPA evaluated would drive the PCE whole chemical unreasonable risk determination. Removing the assumption that workers always and appropriately wear PPE in making the whole chemical risk determination for PCE would result in one condition of use in addition to the original 59 driving the unreasonable risk for PCE. Removing this assumption would also change many of the risks originally identified from the 59 conditions of use, including an additional route of exposure driving the unreasonable risk to workers, and additional risks for acute non-cancer effects and cancer from inhalation and dermal exposures.

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 PCE. Exposure pathways that were or could be regulated under another EPA-administered statute were excluded from the 2020 PCE risk evaluation, resulting in certain 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 PCE. 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 PCE 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 PCE as part of today’s actions. The PCE 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 PCE 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. Comment on the PCE draft revised risk determination via docket EPA-HQ-OPPT-2016-0732 at www.regulations.gov.  

Read the Draft Revised Unreasonable Risk Determination for PCE.