OMB Approves EPA’s N-Methylpyrrolidone NPRM

Yesterday, the OMB’s Office of Information and Regulatory Affairs (OIRA) announced that it had approved a notice of proposed rulemaking from the EPA on “N-Methylpyrrolidone (NMP); Regulation under the Toxic Substances Control Act (TSCA)”. The NPRM was submitted to OIRA on November 2^nd, 2023.

According to the Fall 2023 Unified Agenda entry for this rulemaking:

“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”

That entry also reports on the 2020 Risk Evaluation for NMP:

“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.”

I will probably not cover this rulemaking in any depth, but it’s publication will almost certainly be announced in the appropriate ‘Short Takes’ post.