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Section 6 of the Toxic Substances Control Act (TSCA) requires EPA to address unreasonable risks of injury to health or the environment that the Administrator has determined are presented by a chemical substance under the conditions of use. Following a risk evaluation for cyclic aliphatic bromide cluster (HBCD) carried out under the authority of the TSCA section 6, EPA initiated rulemaking to address unreasonable risks of injury to health and the environment identified in the final risk evaluation. EPA's risk evaluation for HBCD, describing the conditions of use and presenting EPA's determinations of unreasonable risk, is in docket EPA-HQ-OPPT-2019-0237, with additional information in docket EPA-HQ-OPPT-2016-0735.

Statement of Need: This rulemaking is needed to address the unreasonable risk of the Cyclic Aliphatic Bromide Cluster (or, “HBCD”) identified in a risk evaluation completed under TSCA section 6(b). EPA reviewed the exposures and hazards of HBCD 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; (2) Prohibit or otherwise restrict for a particular use or above a set concentration; (3) Require minimum warnings and instructions with respect to use, distribution in commerce, or disposal; (4) Require recordkeeping or testing; (5) Prohibit or regulate any manner or method of commercial use; (6) Prohibit or regulate any manner or method of disposal; and/or (7) Direct manufacturers or processors to give notice of the unreasonable risk to distributors and replace or repurchase products if required.

Alternatives: There are no non-regulatory alternatives to this rulemaking. 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. As required under TSCA section 6(c), EPA will consider one or more primary alternative regulatory actions as part of the development of a proposed rule.

Anticipated Costs and Benefits: EPA will prepare a regulatory impact analysis as the Agency develops the proposed rule.

Risks: As EPA determined in the TSCA section 6(b) risk evaluation, HBCD presents unreasonable risks to human health and the environment. EPA must issue regulations 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.