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EPA/OCSPP | RIN: 2070-AK73 | Publication ID: Fall 2024 |
Title: 1-Bromopropane (1-BP); Regulation Under the Toxic Substances Control Act (TSCA) | |
Abstract:
On August 8, 2024, EPA proposed a rule under section 6(a) of the Toxic Substances Control Act (TSCA) to address the unreasonable risk of injury to health presented by 1-bromopropane (1-BP). TSCA section 6(a) requires EPA address by rule any unreasonable risk identified in a TSCA risk evaluation and apply requirements to the extent necessary so the chemical no longer presents unreasonable risk. 1-BP is a widely used solvent in a variety of occupational and consumer applications, including vapor degreasing, aerosol degreasing, adhesives and sealants, and in insulation. EPA determined that 1-BP presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to 1-BP, including neurotoxicity, developmental toxicity from acute and chronic inhalation exposures and dermal exposures, and cancer from chronic inhalation exposures. 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 the chemical no longer presents unreasonable risk. To address the identified unreasonable risk, EPA is proposing requirements to, among other things, prevent consumer access to the chemical, restrict the industrial and commercial use of the chemical while also allowing for a reasonable transition period where an industrial and commercial use of the chemical is being prohibited, and protect workers from the unreasonable risk of 1-BP while on the job. The Agency’s development of this rule incorporated significant stakeholder outreach and public participation, including public webinars and over 40 external meetings as well as required Federalism, Tribal, and Environmental Justice consultations and consultations with potentially affected small entities by a Small Businesses Advocacy Review Panel. As discussed in detail in Unit III.A.1. and 2. of the preamble of the proposed rule, EPA also engaged in discussions with industry, non-governmental organizations, other government agencies, technical experts and users of 1-BP, and the general public to hear from users, academics, manufacturers, and members of the public health community about practices related to commercial uses of 1-BP. EPA's risk evaluation for 1-BP, describing the conditions of use, is in docket EPA-HQ-OPPT-2019-0235, with the 2022 unreasonable risk determination and additional materials in docket EPA-HQ-OPPT-2016-0741. |
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Agency: Environmental Protection Agency(EPA) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: No | Unfunded Mandates: No |
CFR Citation: 40 CFR 751 | |
Legal Authority: 15 U.S.C. 2605 Toxic Substances Control Act |
Legal Deadline:
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Statement of Need: This rulemaking is needed to address the unreasonable risk of 1-BP that was identified in a risk evaluation completed under TSCA section 6(b). EPA reviewed the exposures and hazards of 1-BP, 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. |
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Summary of the Legal Basis: In accordance with TSCA section 6(a), if EPA determines in a final risk evaluation completed under TSCA section 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. |
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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. As required under TSCA section 6(c), EPA considered one or more primary alternative regulatory actions as part of the development of a proposed rule. For 1-BP, EPA considered two alternative regulatory actions. While in some ways similar to the proposed regulatory action, EPA only considered alternative regulatory options that would eliminate the unreasonable risk from 1-BP and notes that TSCA section 6(a) requires that EPA impose regulatory requirements to the extent necessary to address unreasonable risk. The primary alternative regulatory action considered by EPA combines prohibitions, requirements for a WCPP, a requirement for self-certification by facilities engaged in certain conditions of use that each facility engaged in such conditions of use is implementing and complying with all aspects of the WCPP, and prescriptive controls to address the unreasonable risk from 1-BP contributed by the various conditions of use. This primary alternative regulatory action differs from the proposed regulatory action by considering prescriptive workplace controls and implementation of a personal protective equipment (PPE) program for some conditions of use that would be subject to a WCPP under the proposed regulatory action. The primary alternative regulatory action additionally considers alternative compliance timeframes for prohibitions and implementation of a WCPP and prescriptive controls. The second alternative regulatory action considered by EPA prohibits all occupational uses of 1-BP and the manufacture, processing, and distribution in commerce of 1-BP for all consumer uses, except for the consumer use of 1-BP in building/construction materials (insulation) and distribution in commerce for non-prohibited uses, to address the unreasonable risk from 1-BP contributed by the various conditions of use. The second alternative regulatory action differs from the proposed regulatory action by prohibiting the conditions of use that would have requirements for a WCPP, self-certification, and/or prescriptive controls under the proposed regulatory action. Regarding the compliance timeframes, the second alternative regulatory action would include a longer timeframe for implementation of prohibition than the proposed regulatory action. Additionally, EPA would not stagger the compliance dates for manufacturers, processors, and distributors. The prohibitions for the manufacturing, processing, distribution in commerce, and use for the occupational conditions of use, except for the commercial use of 1-BP in insulation, would take effect 3 years after the publication date of the final rule. With regard to the compliance timeframe for the manufacturing, processing, and distribution in commerce for consumer use, except the consumer use of 1-BP in insulation, the prohibitions would take effect 3 years after the publication date of the final rule. |
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Anticipated Costs and Benefits: EPA estimates the incremental monetized costs of the proposed rule to be $14.8 million annualized over 20 years at a 3% discount rate and $15.5 million annualized over 20 years at a 7% discount rate. These costs take compliance with implementation of a WCPP into consideration, which would include an existing chemical exposure limit (ECEL) of 0.05 ppm (0.25 mg/m3) for inhalation exposures as an 8-hour time-weighted average (TWA), applicable personal protective equipment (PPE) requirements, and reformulation costs of numerous products. These are central estimates for the number of sites and workers affected rather than the low- or high-end estimates. These costs take into consideration compliance with implementation of a WCPP, which would include dermal controls to prevent direct dermal contact, applicable personal protective equipment requirements including as part of prescriptive controls requirements, and costs for reformulation and container size restrictions of numerous products. The most notable unquantified costs include possible costs from prohibition of use of 1-BP for certain conditions of use as changes in labor time or differences in efficacy for a specific firm's use are unknown to EPA. The economic impact on users of 1-BP for vapor degreasing is unclear because some users may not be able to continue using their current equipment (open-top vapor degreasers). Based on engagement with industry, including public comments received on the draft risk evaluation and draft revised unreasonable risk determination for 1-BP, EPA expects workplaces engaged in vapor degreasing to have the ability to implement a WCPP that would include an ECEL, PPE requirements, and ancillary requirements. EPA estimates that complying with the WCPP would cost vapor degreasing users $13.8 million while prohibition would cost vapor degreasing users $174.8 million (3% discount rate annualized over 20 years). Vapor degreasing is used in several advanced manufacturing industries, including aerospace, automotive, energy, medical devices, and others. The actions proposed in this rulemaking are expected to achieve health benefits for the American public, some of which can be monetized and others that, while tangible and significant, cannot be monetized. The monetized benefits of this rulemaking are approximately $27.2 million annualized over 20 years at a 3% discount rate and $12.9 million annualized over 20 years at a 7% discount rate. The monetized benefits include potential reductions in risk of colon and lung cancers. Non-monetized benefits include risk reduction of liver toxicity, kidney toxicity, reproductive toxicity, developmental toxicity, and neurotoxicity (peripheral neuropathy). EPA is currently unable to monetize these noncancer benefits primarily due to a lack of applicable dose-response functions, which are the relationships between exposures and any incremental adverse effects. This issue is not unique to EPA and is a government-wide issue for many noncancer endpoints. While the benefits to human health associated with the risk reduction that EPA seeks to achieve through this rulemaking cannot be monetized at present, reductions in occurrence of these conditions have monetary value to society. |
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Risks: As EPA determined in the TSCA section 6(b) risk evaluation, 1-BP presents an unreasonable risk 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. |
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Timetable:
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Additional Information: EPA-HQ-OPPT-2020-0471. | |
Regulatory Flexibility Analysis Required: YES | Government Levels Affected: Federal, State |
Small Entities Affected: Businesses | Federalism: Yes |
Included in the Regulatory Plan: Yes | |
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest. | |
RIN Information URL: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-1-bromopropane-1-bp | |
Sectors Affected: 325 Chemical Manufacturing | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Olivia Bailey Environmental Protection Agency Office of Chemical Safety and Pollution Prevention 1200 Pennsylvania Avenue NW, Washington, DC 20460 Phone:202 566-0894 Email: bailey.olivia.m@epa.gov Joel Wolf Environmental Protection Agency Office of Chemical Safety and Pollution Prevention 1200 Pennsylvania Avenue NW, Mail Code 7404M, Washington, DC 20460 Phone:202 564-0432 Email: wolf.joel@epa.gov |