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| EPA/OCSPP | RIN: 2070-AK85 | Publication ID: Spring 2025 |
| Title: N-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances Control Act (TSCA) | |
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Abstract:
EPA is developing a final rule under the Toxic Substances Control Act (TSCA) to address the unreasonable risk of injury to human health presented by n-methylpyrrolidone (NMP). NMP is a widely used solvent in a variety of industrial, commercial, and consumer applications including the manufacture and production of electronics such as semiconductors, polymers, petrochemical products, paints and coatings, and paint and coating removers. EPA determined that NMP presents an unreasonable risk of injury to health due to the significant adverse health effects associated with exposure to NMP, including developmental post-implantation fetal loss from short-term exposure and reduced fertility and fecundity from long-term exposure. Additional adverse effects associated with exposure to NMP include liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, skin irritation, and sensitization. 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. On June 14, 2024, EPA proposed requirements to: prohibit the manufacture (including import), processing, and distribution in commerce and use of NMP in several occupational conditions of use; require worker protections through an NMP workplace chemical protection program (WCPP) or prescriptive controls (including concentration limits) for most of the occupational conditions of use; require concentration limits on a consumer product; regulate certain consumer products to prevent commercial use; and establish recordkeeping, labeling, and downstream notification requirements. The Agency’s development of this rule incorporated significant stakeholder outreach and public participation. EPA's 2020 final risk evaluation for NMP, describing its conditions of use is in docket EPA-HQ-OPPT-2019-0236, with the 2022 revised unreasonable risk determination and additional materials in docket EPA-HQ-OPPT-2016-0743. |
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| Agency: Environmental Protection Agency(EPA) | Priority: Economically Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: Yes | Unfunded Mandates: Private Sector |
| EO 14192 Designation: Regulatory | |
| CFR Citation: 40 CFR 751 | |
| Legal Authority: 15 U.S.C. 2605 Toxic Substances Control Act | |
Legal Deadline:
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Timetable:
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| Additional Information: Docket #: EPA-HQ-OPPT-2020-0744. | |
| Regulatory Flexibility Analysis Required: YES | Government Levels Affected: Federal, State, Tribal |
| Small Entities Affected: Businesses | Federalism: Yes |
| Included in the Regulatory Plan: Yes | |
| RIN Information URL: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-n-methylpyrrolidone-nmp | |
| Sectors Affected: 325 Chemical Manufacturing | |
| RIN Data Printed in the FR: Yes | |
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Agency Contact: Clara Hull Environmental Protection Agency Office of Chemical Safety and Pollution Prevention 1200 Pennsylvania Avenue NW, Mail Code 7404M, Washington, DC 20460 Phone:202 564-3954 Email: hull.clara@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 |
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