View Rule

This proposed rulemaking will address the unreasonable risk of injury to health presented by n-methylpyrrolidone (NMP). Section 6(a) of the Toxic Substances Control Act (TSCA) 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. 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-2016-0743.6

Statement of Need:

This rulemaking is needed to address the unreasonable risk from NMP that were identified following 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 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 if required.

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 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 an economic analysis as the Agency develops the proposed rule.

Risks:

The 2020 Risk Evaluation for NMP identified potential health effects for NMP including non-cancer adverse health effects such as liver toxicity, kidney toxicity, immunotoxicity, reproductive toxicity, developmental toxicity, neurotoxicity, and irritation and sensitization. In the 2022 Final Unreasonable Risk Determination, EPA determined that NMP presents an unreasonable risk of injury to health. The unreasonable risk determination is driven by risks to workers due to occupational exposures to NMP (i.e., during manufacture, processing, industrial and commercial uses, and disposal); and to consumers due to exposures from consumer use of NMP and NMP-containing products. For more information, visit: https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-management-existing-chemicals-under-tsca.