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EPA/OCSPP RIN: 2070-AK84 Publication ID: Spring 2024 
Title: Perchloroethylene (PCE); Regulation Under the Toxic Substances Control Act (TSCA) 
Abstract:

On June 16, 2023, EPA proposed a rule under the Toxic Substances Control Act (TSCA) to address the unreasonable risk of injury to human health presented by perchloroethylene (PCE). 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 is proposing 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 is also proposing to require a PCE workplace chemical protection program that includes requirements to meet an inhalation exposure concentration limit and prevent direct dermal contact. EPA is also proposing to require prescriptive workplace controls for laboratory use, and to establish recordkeeping and downstream notification requirements. Additionally, EPA proposes 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.

 
Agency: Environmental Protection Agency(EPA)  Priority: Section 3(f)(1) Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 40 CFR 751   
Legal Authority: 15 U.S.C. 2605 Toxic Substances Control Act   
Legal Deadline:
Action Source Description Date
Final  Statutory  TSCA sec. 6(c)  12/28/2021 
NPRM  Statutory  TSCA sec. 6(c)  12/28/2021 
Timetable:
Action Date FR Cite
NPRM  06/16/2023  88 FR 39652   
Final Rule  08/00/2024 
Additional Information: EPA-HQ-OPPT-2020-0720.
Regulatory Flexibility Analysis Required: YES  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Information URL: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-perchloroethylene  
Sectors Affected: 325 Chemical Manufacturing 
RIN Data Printed in the FR: Yes 
Agency Contact:
Kelly Summers
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
1200 Pennsylvania Avenue NW, Mail Code 7405M,
Washington, DC 20460
Phone:202 564-2201
Email: summers.kelly@epa.gov

Joel Wolf
Environmental Protection Agency
Office of Chemical Safety and Pollution Prevention
1200 Pennsylvania Avenue NW, Mail Code 7404M,
Washington, DC 20460
Phone:202 564-0432
Email: wolf.joel@epa.gov