EPA Sends PCE TSCA Final Rule to OMB

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had received a final rule form the EPA on Perchloroethylene (PCE); Regulation under the Toxic Substances Control Act (TSCA). The notice of proposed rulemaking for this action was published on June 16^th, 2023.

According to the Fall 2023 Unified Agenda entry for this rulemaking:

“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.”

I am unlikely to cover this rulemaking in any detail. It’s publication, however, will be noted in the appropriate ‘Short Takes’ post.