The US Environmental Protection Agency (EPA) has issued final rules banning the majority of uses of two solvents, trichloroethylene (TCE) and perchloroethylene (PCE), under the 2016 amendments to the Toxic Substances Control Act (TSCA). TCE and PCE have been used in many consumer and commercial products, such as cleaning products, degreasers, brake cleaners, dry cleaners, sealants, lubricants, adhesives, paints, coatings, and in the manufacture of some refrigerants. The new requirements pose hurdles for industry members, who will be tasked to implement alternatives and new safety protocols. These rules, issued on December 9, 2024, are planned to take effect 30 days after federal register publication.

For TCE, the rules implement a total ban under a shorter, one-year phaseout for the majority of uses, and, ultimately, a complete ban on all commercial uses over time. For PCE, the rules allow for a longer phaseout of three years for the majority of uses. Dry cleaners will be allowed a longer ten-year phaseout and continued use will be allowed for “highly sophisticated workplaces” that are regulated under a Workplace Chemical Protection Program (WCPP).

While the rules are the culmination of EPA’s long-term effort to address PCE and TCE under the 2016 TSCA amendments, which granted it expanded authority to regulate chemicals posing “unreasonable risks” to human health or the environment, the fate of the rules remains to be seen following the change in presidential administration and the potential for legal challenge.

EPA’s expanded authority under the TSCA amendments

In 2016, the Lautenberg Chemical Safety Act amended TSCA to expand EPA’s authority to promulgate rules to address an unreasonable risk of injury to health or the environment following an unreasonable risk determination. In January 2023, EPA issued its final revised unreasonable risk determination for TCE, and in 2022 it issued the same for PCE. In support of its action and risk determinations, the Assistant Administrator for EPA’s Office of Chemical Safety and Pollution Prevention, Michal Freedhoff, stated that the final TCE and PCE rules “are grounded in the best-available science that demonstrates the harmful impacts of PCE and TCE.”

The TCE rule will ban almost all uses within one year with some exceptions

The final TCE rule prohibits the manufacture, import, processing, and distribution of TCE for all uses, including consumer applications, within one year, with some exceptions.

Importantly, industrial and commercial uses will have extended compliance timeframes that require stronger worker protections until prohibitions take effect. These requirements include an interim existing chemical exposure limit of airborne TCE of 0.2 parts per million (ppm) calculated at an eight-hour time weighted average (TWA) (which marks an increase from the initial proposal to set the exposure limit to 0.0011 ppm) and compliance with a TCE WCPP.

Gradual TCE phaseouts include:

• Seven-year phaseout: Designated for vapor degreasing for essential aerospace parts and components, and narrow tubing used in medical devices.

• Eight-and-a-half-year phaseout: Designated for the manufacturing of the refrigerant HFC-134a.

• Ten-year phaseout: Designated for solvents for closed-loop batch vapor degreasing rayon fabric scouring for end use in rocket booster nozzle product by Federal agencies and their contractors; a laboratory chemical for asphalt testing and recovering; certain industrial and commercial uses of TCE for vessels of the Armed Forces and their systems; the emergency, industrial, and commercial use of TCE in furtherance of the NASA mission for specific conditions that are critical or essential, and for which no technically and economically feasible safer alternative is available.

• Fifteen-year phaseout: Designated for processing aids for manufacturing specialty polymeric microporous sheet materials.

• Twenty-year phaseout: Designated for processing aids for manufacturing battery separators for lead acid batteries.

• Fifty-year phaseout: Designated for products facilitating cleanups in progress, essential laboratory activities, and some research and development activities; and for disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works.

The rule will also establish requirements for recordkeeping and downstream notification. In response to industry comments recommending that provisions for monitoring results and recordkeeping be allowed from any accredited laboratory, EPA has broadened the scope of laboratory accreditation.

The PCE rule bans the majority of uses and allows some longer term uses under a WCPP

The rule imposes a three-year phaseout for the majority of commercial and industrial uses of PCE, with a ten-year phaseout for use in dry cleaning, and a finalized exposure limit of 0.14 ppm at an eight-hour TWA. The PCE rule will also prohibit the use of PCE in newly acquired dry cleaning machines after six months, which is identical to the agency’s prior proposal in June 2023.

EPA recognizes that some conditions of PCE use may be important for national security applications or other critical needs in aviation, petrochemical manufacturing, and adhesives. To that end, the rule allows certain continued uses of PCE provided that sufficient worker protections are in place under a WCPP, including an inhalation exposure concentration limit, direct dermal contact controls, and related workplace exposure controls.

The rule expressly identifies the following continued uses:

• Production of other chemicals, including refrigerant chemicals that may aid efforts to phase down climate-damaging hydrofluorocarbons under the bipartisan American Innovation and Manufacturing Act.

• Petrochemical manufacturing.

• Agricultural chemical manufacturing (originally proposed for prohibition).

• Cold cleaning of tanker vessels (originally proposed for prohibition).

• Maskant for chemical milling.

• Vapor degreasing solvents.

• Adhesives and sealants.

• Energized electrical cleaning (originally proposed for prohibition).

• Processing into formulation, mixture, or reaction products.

• Import, recycling, disposal, processing by repackaging, and domestic manufacturing of PCE.

Next steps

While EPA indicates that it seeks to balance safety with industry feasibility and the needs of critical industries through the rules, it acknowledges the challenges of implementing low-level exposure monitoring for TCE and adjusts the PCE rule to allow certain uses under specific safety conditions in a WCPP. The rules therefore may face potential legal and administrative challenges, with the possibility of the Trump Administration seeking to reverse or modify them through court challenges or administrative petitions.

EPA will host a webinar on January 15, 2025 at 12:30 pm EST to give an overview of the PCE final rule. Industry members and stakeholders can also stay apprised on the regulation of TCE and PCE by checking dockets at EPA-HQ-OPPT, EPA-HQ-OPPT-2016-0732, and EPA-HQ-OPPT-2020-0720 here.

DLA Piper’s Environmental practice group advises and assists businesses through the continuously evolving regulatory landscape in the US and abroad. To learn more about EPA’s TCE and PCE rules or for discussion on all matters relating to these rules, please contact the authors.