Today, the U.S. Environmental Protection Agency (EPA) finalized a revision to the Toxic Substances Control Act (TSCA) risk determination for perchloroethylene (PCE), finding that PCE, as a whole chemical substance, presents an unreasonable risk of injury to human health when evaluated under its conditions of use. The next step in the process is to develop a risk management rulemaking to identify and apply measures that will manage these risks.
Uses and Risks Associated with PCE
PCE is used in production of fluorinated compounds, 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.
In its revised risk determination based on the 2020 risk evaluation, EPA found that PCE presents unreasonable risk to the health of workers, occupational non-users (workers nearby but not in direct contact with this chemical), consumers and bystanders. EPA identified risks for adverse human health effects not related to cancer, including neurotoxicity and liver effects, from acute and chronic inhalation and dermal exposures to PCE. EPA also identified risks for cancer from chronic inhalation and dermal exposures to PCE.
EPA used the whole chemical risk determination approach for PCE in part because there are benchmark exceedances for multiple conditions of use (spanning across most aspects of the chemical lifecycle from manufacturing (including import), processing, commercial use, consumer use and disposal) for health of workers, occupational non-users, consumers and bystanders, and because the health effects associated with PCE exposures are severe and potentially irreversible (specifically neurotoxicity and cancer).
Overall, EPA determined that 60 of the 61 conditions of use EPA evaluated drive the unreasonable risk determination. One condition of use does not drive the unreasonable risk: distribution in commerce. The revised risk determination supersedes the condition of use-specific no unreasonable risk determinations that were previously issued by order under section 6(i) of TSCA in the 2020 PCE risk evaluation.
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 workers’ exposure. 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 currently in use at their facilities and will consider these comments, as well as other information on use of PPE, engineering controls and other ways industry protects its workers, as potential ways to address unreasonable risk during the risk management process. The consideration of this information will be part of the risk management process.
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;
- Their employers are out of compliance with OSHA standards;
- 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
- The OSHA Permissible Exposure Limit alone may be inadequate for ensuring protection of worker health, as is the case for PCE.
Next Steps for PCE
EPA is now moving forward on risk management to address the unreasonable risk presented by PCE. Note that in revising the risk determination, EPA has not conducted a new scientific analysis on this chemical and the risk evaluation continues to characterize risks associated with individual conditions of use in the risk evaluation of PCE in order to inform risk management.
In June 2021, EPA announced a path forward for the first 10 chemicals to undergo risk evaluation under TSCA to ensure the public is protected from unreasonable risks from these chemicals in a way that is supported by science and the law. The revised risk determination for PCE was developed in accordance with these policy changes, as well as the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity and regulatory review. EPA’s revisions ensure that the PCE risk determination better aligns with the objectives of protecting health and the environment under the amended TSCA.
Separately, EPA is conducting a screening-level approach to assess risks from the air and water pathways for several of the first 10 chemicals, including PCE. The goal of the screening approach is to evaluate the surface water, drinking water, and ambient air pathways for PCE that were excluded from the 2020 risk evaluation, and to determine if there are risks that were unaccounted for in that risk evaluation. EPA expects to describe its findings regarding the chemical-specific application of this screening-level approach in its proposed risk management rule for PCE.
Additionally, EPA expects to focus its risk management action on the conditions of use that drive the unreasonable risk. However, EPA is not limited to regulating the specific activities found to drive unreasonable risk and may select from among a wide range of risk management requirements. As a general example, EPA may regulate upstream activities (e.g., processing, distribution in commerce) to address downstream activities (e.g., consumer uses) driving unreasonable risk, even if the upstream activities do not drive the unreasonable risk.
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