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 16th, 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.
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