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EPA/OCSPP RIN: 2070-AK85 Publication ID: Fall 2024 
Title: N-Methylpyrrolidone (NMP); Regulation Under the Toxic Substances Control Act (TSCA) 
Abstract:

On June 24, 2024, EPA proposed a rule under section 6(a) of the Toxic Substances Control Act (TSCA) to address the unreasonable risk of injury to human health presented by n-methylpyrrolidone (NMP) under its conditions of use as documented in EPA’s risk evaluation and risk determination for NMP. TSCA section 6(a) requires EPA to address by rule any unreasonable risk identified in a TSCA section 6(b) risk evaluation by applying requirements to the extent necessary so the chemical no longer presents unreasonable risk. 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. To address the identified unreasonable risk, EPA is proposing 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. As discussed in detail in Unit III.A.1. and 2. of the preamble of the proposed rule,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 2020 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.

 
Agency: Environmental Protection Agency(EPA)  Priority: Section 3(f)(1) Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 40 CFR 751   
Legal Authority: 15 U.S.C. 2605 Toxic Substances Control Act   
Legal Deadline:  None

Statement of Need:

This rulemaking is needed to address the unreasonable risk of NMP that was identified in a risk evaluation completed under TSCA section 6(b). EPA reviewed the exposures and hazards of NMP, 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 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.

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. While in some ways similar to the proposed regulatory action, the primary alternative regulatory action for the rulemaking to address the unreasonable risk presented by NMP would require a workplace chemical protection program (WCPP), including direct dermal contact controls, for some conditions of use that would otherwise be prohibited or be subject to prescriptive controls under the proposed regulatory action. Additionally, the primary alternative regulatory action would involve the prohibition of one industrial and commercial use and the manufacturing, processing, and distribution in commerce for one consumer use, all of which would be required to have prescriptive controls under the proposed regulatory action. The primary alternative regulatory action would not include restrictions on the container size of consumer products that may feasibly be used for commercial purposes. Finally, the primary alternative regulatory action would also provide longer compliance timeframes for implementation of the WCPP and prescriptive controls. See also discussions in Unit IV. and V. of the preamble in the proposed rule.

Anticipated Costs and Benefits:

EPA estimates the incremental monetized costs of the proposed rule to be $396 million annualized over 20 years at a 3% discount rate and $397 million annualized over 20 years at a 7% discount rate. 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 NMP 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 actions proposed in this rulemaking are expected to achieve significant health benefits for the American public. Although tangible and significant, most health benefits of the proposed rule currently cannot be monetized. This is 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. Non-monetized benefits include risk reduction of developmental and reproductive effects, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation, and sensitization. While the benefits to human health associated with risk reduction of developmental and reproductive effects, liver toxicity, kidney toxicity, immunotoxicity, neurotoxicity, irritation, and sensitization cannot be monetized at present, reductions in occurrence of these conditions have monetary value to society.

Risks:

As EPA determined in the TSCA section 6(b) risk evaluation, NMP 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.

Timetable:
Action Date FR Cite
NPRM  06/14/2024  89 FR 51134   
Final Rule  08/00/2025 
Additional Information: 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 
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