The use of a mainstay of the dry-cleaning industry – perchloroethylene – may be coming to an end. On June 16, 2023, EPA proposed to ban, under the Toxic Substance Control Act’s Section 6(a) authority, most uses of perchloroethylene (PCE) and establish a workplace chemical protection program (WCCP) for uses not prohibited by the rule (Proposed Rule). PCE is a widely used solvent that, along with utilization in dry cleaning, is also used in fluorinated compound production, petroleum manufacturing and degreasing. Consumer uses include adhesives, paints and coatings, and stainless-steel polish.
Background
The Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety Act in 2016 (2016 Amendments), requires EPA to evaluate the safety of existing chemicals with priority on those most likely to cause risks. Once identified as high priority, EPA is required to complete a risk evaluation on that chemical to determine if the manufacture, processing, distribution in commerce, use or disposal of the that chemical presents an unreasonable risk of injury to health or the environment and, if so, EPA must promulgate a rule to impose restrictions to the extent necessary to address those risks.
The 2016 Amendments required EPA to identify 10 high priority chemicals by December 2016. Perchloroethylene was included in this December 2016 list, triggering the requirement to conduct risk evaluations and, if necessary, promulgation of regulations to address identified risks. While the 2016 Amendments imposed aggressive timelines for the completion of risk evaluations and proposal of regulations to address the adverse risks, all except the earliest of those deadlines have been missed for a multitude of reasons as detailed in a February 2023 GAO Report. The Proposed Rule reflects renewed efforts on TSCA §6 existing chemical responsibilities and is the third chemical in the list of ten to be addressed in a Proposed Rule.
The Proposed Rule
EPA determined, per a December 2020 TSCA §6(b) Risk Evaluation (as revised in December 2022), 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 and as a likely human carcinogen. The Proposed Rule identifies the requirements that EPA has determined are necessary to impose so that the chemical is no longer presents an unreasonable risk.
The Proposed Rule would prohibit all consumers, commercial and most industrial uses of PCE, including the manufacture, processing, importing and distribution in commerce to support those uses. For the 16 industrial uses not subject to the ban, EPA will require a workplace chemical protection program (WCCP), including measures to meet an inhalation exposure concentration limit and prevent direct dermal contact with PCE.[1] In addition, the Proposed Rule would require strict workplace controls for laboratories.
EPA proposes an aggressive 24-month timeline for phaseout of PCE and implementation of the strict WPCP controls for the limited uses that may continue. EPA states that the Proposed Rule “would rapidly phase down manufacturing, processing and distribution of PCE for all consumer uses and many industrial and commercial uses, most of which would be fully phased out in 24 months.”
More Time Provided for Dry Cleaning Industry to Comply.
While most of the changes required by the Proposed Rule would be implemented in 24 months, EPA recognizes unique considerations presented by the dry-cleaning and spot-cleaning industry. EPA estimates that 6,000 dry cleaners still use PCE, a majority of which are small businesses, and that the transition to an alternative dry-cleaning process or solvent could require significant time and investment. In addition, EPA notes that an overall year-to-year decline of the use of PCE in dry cleaning is already occurring and that very few PCE machines are being produced or sold in the U.S. market.[2] Further, the existing PCE machines have a 15-to-25-year life span. Considering all this, the Proposed Rule would impose a 10-year phaseout period with interim compliance dates based on the type and age of the dry-cleaning machine and thus allow the dry cleaners time to transition to an alternative process.
While EPA has proposed a 10-year timeline to phase out the manufacture, processing, and use of PCE for dry cleaning, EPA admits that they do not have a significant amount of information on potential impacts on the industry. EPA states that “it is still unclear as to the impact of a prohibition of PCE for dry cleaning through a gradual phaseout; EPA has not been able to estimate the number of dry-cleaning facility closures that may be associated with this phaseout.” As a result, EPA requests comment on the amount of time needed for dry cleaners to transition to an alternative process or solvent, the number of entities that could potentially close; and as associated costs with a 10-year phaseout of PCE. EPA notes that it may finalize significantly shorter or longer compliance timeframes based on consideration of public comments.
Comments must be received on or before August 15, 2023, and are to be submitted via docket EPA-HQ-OPPT-2020-0720 atwww.regulations.gov.
What's Next?
EPA has a significant amount of work to get back on and stay on schedule to assess risks of high-priority chemicals. As stated above, EPA proposed 10 chemicals for TSCA §6 review in December 2016 -- 1,4-Dioxane; 1-Bromopropane; Asbestos; Carbon Tetrachloride; Cyclic Aliphatic Bromide Cluster (HBCD); Methylene Chloride; N-Methylpyrrolidone (NMP); Pigment Violet 29 (PV29); Trichloroethylene (TCE); and perchloroethylene. Risk evaluations have been prepared for these 10 chemicals; however, risk management rules have been proposed for only three - chrysotile asbestos (March 2023), methylene chloride (May 2023) and perchloroethylene (June 2023). In addition, several of the risk evaluations completed under the Trump administration, were reopened early in the Biden administration and revised out of a concern regarding previous risk assumptions.[3] An additional 20 high-priority chemicals were identified in 2019 and TSCA requires that upon completion of a risk evaluation, EPA must designate at least one additional High-Priority chemical to take its place, thus ensuring that the EPA’s risk evaluation queue always remains full.
EPA’s 2022 Regulatory Agenda indicated that rules would be proposed for TCE, 1-Bromopropane and NMP in the summer of 2023, with final rules in 2024.[4] EPA also identified conducting risk evaluations on at least eight high-priority chemicals by 2026 in its FY 2022-2026 EPA Strategic Plan. These aggressive schedules, along with EPA’s TSCA PFAS other initiatives and rulemaking requirements (including reporting, SNURs, and testing), will require significant resources, the source of which is unclear and is part of the reason for previous delays. Although EPA plans to propose a new TSCA fee rule in September 2023, it is unlikely to generate additional funding until 2024. In addition, although EPA’s TSCA budget was increased under the Consolidated Appropriations Act of 2023, additional funding continues to be needed. Additional budget increases are likely to face the gauntlet of acrimonious Congressional review and, as a result, only time will tell whether EPA will meet these deadlines.
[1] Industrial uses allowed to continue include the use of PCE in the manufacture of certain hydrofluorocarbon refrigerants, petrochemical manufacturing, and limited aerospace applications. The press release for the Proposed rule describes these as “uses related to national security, aviation and other critical infrastructure, and the Agency’s efforts to combat the climate crisis.”
[2] EPA also notes that pollution prevention grants proposed in President Biden’s Fiscal Year 2024 budget request could be used to support small businesses like dry cleaners in their transition away from PCE.
[3] For example, in the initial risk evaluations, EPA assumed that employees would follow OSHA workplace restrictions; EPA subsequently has determined that such compliance could not be assumed for purposes of risk evaluations.
[4] No dates were provided for PV29, 1,4 dioxane or HBCD.
