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The Environmental Protection Agency (EPA) proposed to address the unreasonable risks of injury to health presented by carbon tetrachloride (CTC) under its conditions of use as documented in EPA’s 2020 Risk Evaluation for Carbon Tetrachloride and 2022 Revised Unreasonable Risk Determination for Carbon Tetrachloride pursuant to the Toxic Substances Control Act (TSCA). CTC is a volatile, organic compound that is primarily used as a feedstock (i.e., processed as a reactant) in the making of products such as refrigerants, aerosol propellants, and foam-blowing agents. 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 that the chemical no longer presents unreasonable risk. EPA determined that CTC presents an unreasonable risk of injury to health due to cancer from chronic inhalation and dermal exposures and liver toxicity from chronic inhalation, chronic dermal, and acute dermal exposures in the workplace. To address the identified unreasonable risk under TSCA, EPA proposed to establish workplace safety requirements for most conditions of use, including the condition of use related to the making of low Global Warming Potential (GWP) hydrofluoroolefins (HFOs), prohibit the manufacture (including import), processing, distribution in commerce, and industrial/commercial use of CTC for conditions of use where information indicates use of CTC has already been phased out, and establish recordkeeping and downstream notification requirements. The use of CTC in low GWP HFOs is particularly important in the Agency’s efforts to support the American Innovation and Manufacturing Act of 2020 (AIM Act) and the Kigali Amendment to the Montreal Protocol on Substances that Deplete the Ozone Layer, which was ratified on October 26, 2022. The Agency’s development of this rule incorporates significant stakeholder outreach and public participation. EPA engaged in discussions with industry, non-governmental organizations, other government agencies, technical experts and users of CTC, and the general public to hear from users, academics, manufacturers, and members of the public health community about practices related to commercial uses of CTC; public health impacts of CTC; the importance of CTC in the various uses subject to this proposed rule; frequently-used substitute chemicals or alternative methods or lack thereof; engineering controls, administrative controls, and personal protective equipment currently in use or feasibly adoptable; and other risk-reduction approaches that may have already been adopted or considered for industrial and commercial uses. EPA conducted Federalism, Tribal, and Environmental Justice consultations and a Small Businesses Advocacy Review Panel.  EPA's risk evaluation for CTC, describing CTC’s conditions of use, is in docket EPA-HQ-OPPT-2019-0499, with the December 2022 unreasonable risk determination and additional information in docket EPA-HQ-OPPT-2016-0733.

Statement of Need:

This rulemaking is needed to address the unreasonable risks of Carbon Tetrachloride (CTC) that were identified in a risk evaluation completed under TSCA section 6(b). EPA reviewed the exposures and hazards of Carbon Tetrachloride uses, 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 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.

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 proposed primary alternative regulatory action would implement workplace chemical protection program (WCPP) requirements, including requirements to meet an existing chemical exposure limit (ECEL) and Direct Dermal Contact Controls (DDCC) to prevent direct dermal contact in the workplace by separating, distancing, physically removing, or isolating all person(s) from direct handling of CTC or from contact with surfaces that may be contaminated with CTC (i.e., equipment or materials on which CTC may be present) under routine conditions in the workplace, for those conditions of use that would otherwise be prohibited under the proposed rule. The primary alternative regulatory action would also require compliance with prescriptive controls - specifically requirements for respirators and dermal PPE - for those conditions of use where an ECEL and DDCC are the proposed regulatory action and where PPE may address the unreasonable risk. This approach differs from the proposed regulatory action because it would not require the use of elimination, substitution, engineering controls, and administrative controls, in accordance with the hierarchy of controls, to the extent feasible as a means of controlling inhalation and dermal exposures. The primary alternative regulatory action would apply the same recordkeeping requirements, downstream notification requirements, and compliance timeframes as those specified in the proposed rule.

Anticipated Costs and Benefits:

EPA's estimate of the incremental costs of the proposed rule is $18.8 million per year annualized over 20-years at a 3% discount rate and $18.5 million per year at a 7% discount rate. The costs are estimated as incremental to baseline conditions, including current use of personal protective equipment. The costs represent a high-end cost estimate because the high estimates for the number of entities and workers affected by the regulation were used. To the extent that EPA's approach overestimates the number of entities subject to the regulation, actual realized costs of this action will be lower. The monetized benefits of the proposed rule are from avoided cases of adrenal and liver cancers. The estimated monetized benefit of the proposed regulatory action ranges from approximately $0.09 to $0.1 million per year annualized over 20-years at a 3% discount rate and from $0.04 to $0.07 million per year at a 7% discount rate. There are also non-monetized benefits due to other potential avoided adverse health effects associated with CTC exposure, including liver, reproductive, renal, developmental, and central nervous system (CNS) toxicity endpoints.

Risks:

As EPA determined in the TSCA section 6(b) risk evaluation, Carbon Tetrachloride presents unreasonable risks to human health. EPA must issue risk management requirements so that this chemical substance no longer presents an unreasonable risk. For more information, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca.