Assessment of Potential Hazards Associated with n-Methylpyrrolidone (NMP)
The Environmental Protection Agency (EPA) has released a final revised risk determination for n-Methylpyrrolidone (NMP) in December 2022, following a comprehensive risk evaluation conducted in December 2020. This determination finds that NMP still presents an unreasonable risk to human health when evaluated under its conditions of use.
In June 2024, the EPA proposed a risk management rule to address the unreasonable risk posed by NMP to human health. This rulemaking process typically involves several steps:
- Key Findings: The EPA assesses human health risks, focusing on reproductive and developmental toxicity concerns linked to NMP exposure. The December 2022 final revised risk determination likely confirms or updates these risks based on new scientific data and exposure assessments.
- Next Steps: Following a risk determination that NMP poses an unreasonable risk, EPA would commence rulemaking to develop risk management regulations. This includes drafting proposed rules and inviting public comments.
- Public Participation: The EPA provides opportunities for stakeholders to participate through public comment periods on proposed rules, public meetings or webinars explaining the science and regulatory approach, and submission of data or alternatives from industry and advocacy groups.
For definitive and detailed information on the December 2022 final revised risk determination for NMP and specific upcoming opportunities to engage in the rulemaking process, it is recommended to consult the EPA’s official website or Federal Register notices where these documents and announcements are published. Alternatively, reaching out to EPA staff involved in chemical risk management programs could provide the most current status and participation details.
The final revised risk determination does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE). It includes data on the impact of NMP on workers, occupational non-users, consumers, and bystanders. The risk to workers for all occupational uses and to consumers from one consumer use of NMP drive the whole chemical determination of unreasonable risk of injury to health in the final revised risk determination.
Primary health risks identified in the risk evaluation are developmental post-implantation fetal loss from short-term exposure and reduced fertility and fecundity from long-term exposure to NMP. Risk from 29 out of 37 conditions of use, including import, processing, commercial use, consumer use, and disposal, of NMP drive the whole chemical determination of unreasonable risk to health in the final revised risk determination.
The search results do not provide specific information on the final revised risk determination, nor details on its key findings or the next steps and public participation opportunities related to the NMP risk management rule development. The final revised risk determination and a Federal Register notice can be found on the EPA's website. For more information about EPA's risk evaluation process, visit other pages on the EPA's website. This final revised risk determination is part of the path forward for the first 10 risk evaluations under the Toxic Substances Control Act (TSCA), as laid out by EPA in June 2021.
In light of the final revised risk determination from December 2022, which highlights potential health-and-wellness concerns associated with NMP exposure, the Environmental Protection Agency (EPA) is considering various therapies-and-treatments and medical-conditions that could be impacted, such as reproductive and developmental toxicity issues. The EPA is currently inviting public participation through various means, including comment periods on proposed rules, public meetings or webinars, and the submission of data or alternatives from industry and advocacy groups, as part of the rulemaking process to manage the unreasonable risk posed by NMP.
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