Yesterday the OMB’s Office of Information and Regulatory
Affairs (OIRA) announced
that it had approved a final rule from the EPA on “Perchloroethylene (PCE);
Regulation under the Toxic Substances Control Act (TSCA)”. The final rule was
sent to OIRA on May 30th, 2024. The notice of proposed
rulemaking was
published on June 16th, 2023.
According to the Spring 2024 Unified Agenda entry for the
rulemaking:
“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.”
This final rule will almost certainly be negated by the
Trump Administration soon after January 20th. An executive order stopping
any number of regulations that have yet to become effective by January 20th
is expected on January 20th, or 21st. Similar
actions were taken by the incoming Biden Administration in January 2021.
Rolling back other recently adopted regulations will take more time.
I do not expect to cover this rulemaking in any detail here, but I do
expect to announce its publication in the appropriate ‘Short Takes’ post.