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On June 16, 2023, EPA proposed a rule under the Toxic Substances Control Act (TSCA) to address the unreasonable risk of injury to health from perchloroethylene (PCE). TSCA requires that EPA address by rule any unreasonable risk identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. PCE is a widely used solvent in a variety of occupational and consumer applications including fluorinated compound production, petroleum manufacturing, dry cleaning, and aerosol degreasing. EPA determined that PCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to PCE, including neurotoxicity effects from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures to PCE. TSCA requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. PCE, also known as perc and tetrachloroethylene, is a neurotoxicant and a likely human carcinogen. Neurotoxicity, in particular impaired visual and cognitive function and diminished color discrimination, are the most sensitive adverse effects driving the unreasonable risk of PCE, and other adverse effects associated with exposure include central nervous system depression, kidney and liver effects, immune system toxicity, developmental toxicity, and cancer. To address the identified unreasonable risk, EPA proposed to prohibit most industrial and commercial uses of PCE; the manufacture (including import), processing, and distribution in commerce of PCE for the prohibited industrial and commercial uses; the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use; and, the manufacture (including import), processing, distribution in commerce, and use of PCE in dry cleaning and related spot cleaning through a 10-year phaseout. For certain conditions of use that would not be subject to a prohibition, EPA also proposed to require a PCE workplace chemical protection program that includes requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact. EPA also proposed to require prescriptive workplace controls for laboratory use, and to establish recordkeeping and downstream notification requirements. Additionally, EPA proposed to provide certain time-limited exemptions from requirements for certain critical or essential emergency uses of PCE for which no technically and economically feasible safer alternative is available. The Agency’s development of this rule incorporated significant stakeholder outreach and public participation, including public webinars and over 40 external meetings as well as required Federalism, Tribal, and Environmental Justice consultations and a Small Businesses Advocacy Review Panel. EPA's risk evaluation for PCE, describing the conditions of use is in docket EPA-HQ-OPPT-2019-0502, with the 2022 unreasonable risk determination and additional materials in docket EPA-HQ-OPPT-2016-0732.

Statement of Need:

This rulemaking is needed to address the unreasonable risk from PCE that was identified in a risk evaluation completed under TSCA section 6(b). EPA reviewed the exposures and hazards of PCE, the magnitude of risk, exposed populations, severity of the hazard, uncertainties, and other factors. EPA sought input from the public and peer reviewers as required by TSCA and associated regulations.

Summary of the Legal Basis:

In accordance with TSCA section 6(a), if EPA determines in a final risk evaluation completed under TSCA 6(b) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Agency must issue regulations requiring one or more of the following actions to the extent necessary so that the chemical substance no longer presents an unreasonable risk: (1) Prohibit or otherwise restrict manufacture, processing, or distribution in commerce of the substance, or limit the amount of the substance which may be manufactured, processed, or distributed in commerce; (2) Prohibit or otherwise restrict manufacture, processing, or distribution in commerce of the substance for a particular use or for a particular use above a set concentration, or limit the amount of the substance which may be manufactured, processed, or distributed in commerce for a particular use or for a particular use above a set concentration; (3) Require minimum warnings and instructions with respect to use, distribution in commerce, or disposal; (4) Require recordkeeping or testing by manufacturers or processors; (5) Prohibit or regulate any manner or method of commercial use; (6) Prohibit or regulate any manner or method of disposal for commercial purposes; and/or (7) Direct manufacturers or processors to give notice of the unreasonable risk to distributors, other persons and the public and replace or repurchase the substance.

Alternatives:

TSCA section 6(a) requires EPA to address by rule chemical substances that the Agency determines present unreasonable risk upon completion of a final risk evaluation. TSCA section 6(c) requires EPA to consider one or more primary alternative regulatory actions as part of the development of a proposed rule under TSCA section 6(a). The primary alternative regulatory action for this rulemaking includes longer compliance timeframes and prohibits fewer uses than the proposed regulatory action. This primary alternative regulatory action would prohibit most industrial and commercial uses of PCE; prohibit the manufacture (including import), processing, and distribution in commerce of PCE for the prohibited industrial and commercial uses; prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use; prohibit the manufacture (including import), processing, distribution in commerce, and use of PCE in dry cleaning and related spot cleaning through a 15-year phaseout; require prescriptive workplace controls for certain conditions of use; and require a workplace chemical protection program for certain conditions of use. The second alternative regulatory action for this rulemaking includes shorter compliance timeframes and prohibits more uses than the proposed regulatory action. This second alternative regulatory action would prohibit most industrial and commercial uses of PCE; prohibit the manufacture (including import), processing, and distribution in commerce of PCE for the prohibited industrial and commercial uses; prohibit the manufacture (including import), processing, and distribution in commerce of PCE for all consumer use; prohibit the manufacture (including import), processing, distribution in commerce, and use of PCE in dry cleaning and related spot cleaning through a 5-year phaseout; require a workplace chemical protection program that includes requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact for certain conditions of use; require prescriptive workplace controls for laboratory use; and provide certain time-limited exemptions from requirements for several conditions of use of PCE that would otherwise significantly disrupt national security or critical infrastructure.

Anticipated Costs and Benefits:

The monetized costs for this proposed rule are estimated to range from $14.0 million annualized over 20 years at a 3% discount rate and $14.3 million annualized over 20 years at a 7% discount rate. The monetized benefits are estimated to be $10.2 to $46.3 million annualized over 20 years at a 3% discount rate and $4.72 million to $29.4 million annualized over 20 years at a 7% discount rate. EPA believes that the balance of costs and benefits of this proposal cannot be fairly described without considering the additional, non-monetized benefits of mitigating the non-cancer adverse effects. These effects may include neurotoxicity, kidney toxicity, liver toxicity, immunological and hematological effects, reproductive effects, and developmental effects.

Risks:

EPA determined that PCE presents an unreasonable risk to human health. EPA must issue risk management requirements so that this chemical substance no longer presents an unreasonable risk. For more information, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca.