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On October 31, 2023, the Environmental Protection Agency (EPA) proposed to address the unreasonable risk of injury to human health presented by trichloroethylene (TCE) under its conditions of use as documented in EPA’s November 2020 Risk Evaluation for TCE and January 2023 revised Unreasonable Risk Determination for TCE pursuant to the Toxic Substances Control Act (TSCA). TCE is widely used as a solvent in a variety of industrial, commercial and consumer applications including for hydrofluorocarbon (HFC) production, vapor and aerosol degreasing, and in lubricants, greases, adhesives, and sealants. TSCA requires that when EPA determines a chemical substance presents unreasonable risk that EPA address by rule the unreasonable risk of injury to health or the environment and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. EPA determined that TCE presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to TCE, including non-cancer effects (liver toxicity, kidney toxicity, neurotoxicity, immunotoxicity, reproductive toxicity, and developmental toxicity) as well as cancer (liver, kidney, and non-Hodgkin lymphoma) from chronic inhalation and dermal exposures to TCE. TCE is a neurotoxicant and is carcinogenic to humans by all routes of exposure. The most sensitive adverse effects of TCE exposure are non-cancer effects (developmental toxicity and immunosuppression) for acute exposures and developmental toxicity and autoimmunity for chronic exposures. To address the identified unreasonable risk, EPA proposed to: prohibit all manufacture (including import), processing, and distribution in commerce of TCE and industrial and commercial use of TCE for all uses, with longer compliance timeframes and workplace controls for certain processing and industrial and commercial uses (including proposed phaseouts and time-limited exemptions); prohibit the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works, with a time-limited exemption for cleanup projects; and establish recordkeeping and downstream notification requirements. The Agency’s development of this rule incorporates significant stakeholder outreach and public participation, including 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 TCE, describing TCE’s conditions of use is in docket EPA-HQ-OPPT-2019-0500, with the January 2023 unreasonable risk determination and additional materials in docket EPA-HQ-OPPT-2016-0737.55

Statement of Need:

This rulemaking is needed to address the unreasonable risk from TCE that was identified following a risk evaluation completed under TSCA section 6(b). EPA reviewed the exposures and hazards of TCE, the magnitude of risk, exposed populations, severity of the hazard, uncertainties, and other factors. EPA sought input from the public and peer reviewers as required by TSCA and associated regulations.

Summary of the Legal Basis:

In accordance with TSCA section 6(a), if EPA determines in a final risk evaluation completed under TSCA 6(b) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, presents an unreasonable risk of injury to health or the environment, the Agency must issue regulations requiring one or more of the following actions to the extent necessary so that the chemical substance no longer presents an unreasonable risk: (1) Prohibit or otherwise restrict manufacture, processing, or distribution in commerce of the substance, or limit the amount of the substance which may be manufactured, processed, or distributed in commerce; (2) Prohibit or otherwise restrict manufacture, processing, or distribution in commerce of the substance for a particular use or for a particular use above a set concentration, or limit the amount of the substance which may be manufactured, processed, or distributed in commerce for a particular use or for a particular use above a set concentration; (3) Require minimum warnings and instructions with respect to use, distribution in commerce, or disposal; (4) Require recordkeeping or testing by manufacturers or processors; (5) Prohibit or regulate any manner or method of commercial use; (6) Prohibit or regulate any manner or method of disposal for commercial purposes; and/or (7) Direct manufacturers or processors to give notice of the unreasonable risk to distributors, other persons, and the public and replace or repurchase the substance if required.

Alternatives:

TSCA section 6(a) requires EPA to address by rule chemical substances that the Agency determines present unreasonable risk upon completion of a final risk evaluation. TSCA section 6(c) requires that EPA consider one or more primary alternative regulatory actions as part of the development of a proposed rule under TSCA section 6(a). The primary alternative regulatory action would prohibit the manufacture (including import) and processing of TCE for all uses; prohibit the distribution in commerce and industrial and commercial use of TCE, as well as prohibitions on the disposal of TCE to industrial pre-treatment, industrial treatment, or publicly owned treatment works. The primary alternative regulatory action would involve longer timeframes for the prohibition of some industrial and commercial uses and for the associated manufacturing (including import) and processing. For all manufacturing (including import), processing, and industrial and commercial use of TCE that would continue more than one year after the publication of the final rule, workplace chemical protection program (WCPP) requirements, which would include a requirement to meet inhalation exposure concentration limits and exposure monitoring as well as requirements to reduce dermal exposures to TCE for certain continued conditions of use of TCE would be in effect until the respective prohibition compliance dates or, if applicable, expiration of the TSCA section 6(g) exemptions. The inhalation exposure concentration limits under the primary alternative regulatory action would be based on the immunotoxicity endpoint instead of the developmental toxicity endpoint as under the proposed regulatory action. The primary alternative regulatory action provides certain time-limited exemptions from requirements for uses of TCE that are critical or essential.

Anticipated Costs and Benefits:

The monetized costs for this proposed rule are estimated to range from $33.1 million annualized over 20 years at a 3% discount rate and $40.5 million annualized over 20 years at a 7% discount rate. The monetized benefits are estimated to be $18.0 to $21.5 million annualized over 20 years at a 3% discount rate and $8.2 million to $10.3 million annualized over 20 years at a 7% discount rate. EPA believes that the balance of costs and benefits of this proposal cannot be fairly described without considering the additional, non-monetized benefits of mitigating the non-cancer adverse effects. These effects may include neurotoxicity, kidney toxicity, liver toxicity, immunotoxicity effects, reproductive effects, and developmental effects.

Risks:

The 2020 Risk Evaluation for TCE identified significant adverse health effects associated with short- and long-term exposure to TCE, including non-cancer effects (immunosuppression and developmental toxicity) from acute inhalation exposures and dermal exposures, and non-cancer effects (liver toxicity, kidney toxicity, neurotoxicity, autoimmunity, reproductive toxicity, and developmental toxicity) and cancer (liver, kidney, and non-Hodgkin lymphoma) from chronic inhalation exposures to TCE. In the 2023 Final Unreasonable Risk Determination, EPA determined that TCE presents an unreasonable risk of injury to health. The unreasonable risk determination, based on immunotoxicity and cancer, is driven by risks to workers and ONUs (workers who do not directly handle the chemical but perform work in an area where the chemical is present) due to occupational exposures to TCE (i.e., during manufacture, processing, industrial and commercial uses, and disposal); and to consumers and bystanders associated with consumer uses of TCE due to exposures from consumer use of TCE and TCE-containing products. For more information, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca.