New 2025 EPA Risk Management Rules on TCE, PCE, and CTC
The U.S. Environmental Protection Agency (“EPA”) recently enacted further restrictions for three chlorinated solvents – trichloroethylene (“TCE”), perchloroethylene (“PCE”) and carbon tetrachloride (“CTC”). On December 17 and 18, EPA issued its latest risk management rules that restrict the manufacturing and processing of TCE, PCE, and CTC. This action follows EPA’s release of a risk management rule for another solvent, methylene chloride, in May 2024.
EPA’s new rules go into effect on January 16 and January 17, 2025; however, the long-term future of the rules is uncertain in light of several lawsuits filed in federal circuit courts challenging the rule and the incoming Trump Administration.
I. Background and Authority
PCE, TCE, and CTC are toxic chemicals that EPA has evaluated as having the potential to cause human health impacts. TCE has historically been used as a solvent in consumer and commercial products, including cleaning and furniture care products, degreasers, sealants, lubricants, adhesives, paints and coatings, and in refrigerant manufacturing. PCE has historically been used as a solvent for cleaning and degreasing, and in lubricants, adhesives, and sealants. CTC is a solvent that has been used in commercial settings as a raw material for producing other chemicals, for example in refrigerants, aerosol propellants, and foam-blowing agents. CTC has been banned for use in consumer products since 1970.
EPA’s authority for these new rules originates from the Toxic Substances Control Act (“TSCA”). TSCA section 6(a) provides that if the agency determines through a risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must apply one or more requirements listed in TSCA section 6(a) to the extent necessary so that the chemical substance or mixture no longer presents such risk. (15 U.S.C. 2605(a).) EPA completed risk evaluations for TCE, PCE, and CTC between 2020 and 2023 and concluded each presents an unreasonable risk under certain conditions of use. EPA’s risk evaluations are the subject of significant controversy by regulated industry and environmental groups alike. The new risk management rules prohibit or limit the manufacture, processing, and distribution in commerce of PCE, TCE, and CTC.
II. Restrictions on TCE, PCE, and CTC
TCE: EPA’s rule bans all uses of TCE over time, including all consumer uses, with the vast majority of TCE manufacturing and processing for most commercial and consumer products eliminated within one year. The rule provides a staggering timeframe for prohibitions on TCE, beginning at the top of the supply chain. All manufacturing of TCE, unless specified elsewhere, must be phased out by March 17, 2025. EPA will allow a very limited number of TCE uses in the workplace to continue, for example using TCE to clean parts used in aircraft and medical devices, with stringent worker protections in place under a Workplace Chemical Protection Program (“WCPP”). To support cleanup activities at sites contaminated with TCE, EPA’s rule will allow essential laboratory uses and proper disposal of TCE wastewater to continue for 50 years, with the WCPP in place. The extent to which EPA’s rule imposes new WCPP requirements on entities engaged in state and federal groundwater and wastewater generating cleanups is a very significant aspect of the TCE rule.
PCE: EPA’s rule prohibits most industrial and commercial uses, manufacture, processing, and distribution of commerce of PCE. Like TCE, EPA’s rule for PCE provides a staggering timeframe for prohibitions on PCE. All manufacturing of PCE for consumer use and all industrial and commercial use of PCE, unless specified elsewhere, must be phased out by June 11, 2026. The rule allows limited continued uses of PCE, including certain national security uses and in petrochemical manufacturing, with strict workplace protections in place under a WCPP to address the unreasonable risk for certain occupational conditions of use. EPA is finalizing a phaseout for most conditions of use of PCE, including use in dry cleaning.
CTC: EPA’s final rule restricts many remaining uses of CTC including in metal recovery and as an additive in fuel and plastic components. CTC use will be allowed to continue in certain circumstances, for example, for use as a processing aid to manufacture vinyl chloride, where proper workplace protections can be implemented under a WCPP. EPA’s final rule establishes workplace safety requirements for most conditions of use, including related to the making of low Global Warming Potential hydrofluoroolefins, which is particularly important in EPA’s efforts to support the American Innovation and Manufacturing Act of 2020 and the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, which was ratified in October 2022.
III. Challenges for Industry
EPA’s new risk management rules address occupational uses and workplace safety precautions, areas that are typically overseen by the Occupational Safety and Health Administration (“OSHA”). EPA’s Existing Chemical Exposure Limit (“ECEL”) for TCE, PCE, and CTC are much lower than OSHA’s permissible exposure limit (“PEL”). The ECEL for industrial worker exposure inhalation of TCE is 0.2 parts per million (“ppm”), 500 times lower than the current OSHA PEL of 100 ppm. Similarly, the inhalation ECEL for PCE is 0.14 ppm, far lower than OSHA’s 100 ppm PEL, and the inhalation ECEL for CTC is 0.03 ppm, lower than OHSA’s PEL of 10 ppm.
This discrepancy can be partially explained by the “Whole Chemical Substance Approach” that EPA implemented for its risk determination of these chemicals. According to EPA, the Whole Chemical Substance Approach evaluates the risk of a chemical substance by considering all of its potential uses and conditions of uses together. This is a more conservative approach than EPA has taken in the past that assumes workers are using OSHA-required personal protective equipment (PPE).
EPA and OSHA also have different statutory mandates, approaches, and jurisdiction when it comes to risk evaluation. Under TSCA, EPA’s risk assessments are supposed to analyze “whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of cost or other non-risk factors” whereas OSHA must make a risk evaluation based on “the extent feasible,” taking into account economic and technological feasibility. (Compare TSCA § 6(b)(1)(B) with OSH Act, 29 U.S.C. § 655(b)(5).) Another difference is the population that each agency analyzes: OSHA analyzes risks to the specific class of workers whereas EPA looks at the whole population. As such, EPA’s implementation of workplace health restrictions raises a question of overreach as EPA’s rules overlap with OSHA’s territory and purview.
EPA’s more stringent limits for TCE, PCE, and CTC present significant new compliance questions and challenges for businesses who must comply with these lower limits, as the rules ban most uses of TCE and PCE and the WCPP requirements for limited continued use are so stringent that many view them as tantamount to a complete ban.
IV. An Uncertain Future
While these new rules go into effect this week, the long-term future of the rules is uncertain based on several legal challenges that have been filed and the incoming Trump Administration EPA that may walk the rules back.
A diverse group of plaintiffs has filed challenges to EPA’s new rules in federal circuit courts, from chemical manufacturing companies to battery manufacturers to environmental groups. The suits claim that the final rules exceed EPA’s statutory authority and are not in accordance with TSCA and the Administrative Procedure Act. As the challenges are pending in various courts – the Fifth, Sixth, Eighth, Ninth, and Eleventh Circuit Courts – a Judicial Panel on Multidistrict Litigation will determine which courts should rule over the cases.
In addition to pending legal challenges, the incoming Trump Administration may reconsider or revamp these new rules. EPA may reconsider or revise these rules as a result of the administration change.
V. More Information
EPA’s rule on TCE goes into effect on January 16, 2025 and the rules on PCE and CTC go into effect on January 17, 2025. EPA has issued fact sheets on its rules for PCE and TCE and states further guidance is forthcoming. In addition, EPA will host a webinar to provide an overview of the final risk management rule on PCE on January 15, 2025 at 12:30pm EST. You can register for the webinar at this link.
Stoel Rives LLP will continue to monitor developments related to EPA’s risk management rules and is available to assist companies with analyzing the implications for their businesses. Reach out to any of the attorneys below to get started.
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