Final Risk Evaluation for n-Methylpyrrolidone (NMP)
As part of EPA’s mission to protect human health and the environment, the agency has completed a final risk evaluation for n-methylpyrrolidone (NMP) under the Toxic Substances Control Act (TSCA). In the final risk evaluation, EPA reviewed 37 conditions of use, such as use of NMP as a solvent for cleaning and degreasing, use in manufacturing petrochemicals, electronics, and plastic material and resins, and for producing and removing paints, coatings, and adhesives. Common consumer uses include paints and coatings, glues and adhesives, paint and adhesive removers, lubricants, and automotive care products.
The NMP risk evaluation contains the agency’s final determinations on which conditions of use present unreasonable risks to human health or the environment based on a robust review of the scientific data. To prepare the final risk evaluation, EPA reviewed extensive scientific literature, conducted modeling and other risk assessment activities, and collected toxicity, exposure, and hazard information from many sources.
Releasing a final risk evaluation is the last step in the scientific evaluation process required by TSCA and will guide the agency’s efforts to issue regulations to address unreasonable risks associated with this chemical. EPA has one year to propose and take public comments on any risk management actions and one year to finalize the risk management actions.
On this page:
- Risk evaluation findings
- Using products safely and alternatives
- Next steps and public participation
- Final risk evaluation and supporting documents
On other pages:
- Read about the steps in EPA’s risk evaluation process for NMP.
- Learn more about EPA’s risk evaluation process.
In the December 2020 final risk evaluation, EPA reviewed the exposures and hazards of NMP uses and made the following final risk findings on this chemical. This final risk evaluation includes input from the public and peer reviewers as required by TSCA and associated regulations. In making these unreasonable risk determinations EPA considered the hazards and exposure, magnitude of risk, exposed population, severity of the hazard, uncertainties, and other factors.
EPA found no unreasonable risks to the environment from any conditions of use. The agency assessed the impact of NMP on aquatic, sediment-dwelling species through surface water and sediment exposures, and to terrestrial species. After reviewing these data, EPA found no unreasonable risk to the environment.
EPA found no unreasonable risks to the general population from any conditions of use. The general population could be exposed to NMP either through releases to water and air or through waste disposal. EPA found that it was unlikely the general population would be exposed to NMP through surface water, land-applied biosolids and sediment.
Potential exposure to NMP in ambient air and hazardous waste are under the jurisdiction of other EPA-administered statutes like the Clean Air Act and RCRA. Therefore, these exposure pathways are not part of this risk evaluation. EPA evaluated acute incidental exposures from ambient water and determined that this presents no unreasonable risk to the general population from all conditions of use of NMP.
EPA found unreasonable risks to human health from 26 out of 37 conditions of use of NMP.
- Consumers: EPA found an unreasonable risk to consumers from one consumer use of NMP (in adhesives and sealants). Risks to consumers can come from short-term inhalation, direct dermal exposure (through the skin) and vapor-through-skin exposure. Other consumer uses include in automotive care products, adhesive removers, cleaning and furniture care products, and arts and craft paint.
- Workers: EPA found unreasonable risks to workers from 25 conditions of use of NMP. This chemical is commonly used commercially in the manufacture and production of electronics, agrichemicals, and petroleum products. Risks to workers can come from short-term and long-term inhalation, direct dermal exposure (through the skin) and vapor-through-skin exposure.
While EPA is working through the process required by TSCA to manage the unreasonable risks found from NMP, the information below provides ways to reduce exposure.
For any chemical product, EPA strongly recommends that users carefully follow all instructions on the product’s label and on the safety data sheets. Some labels may not state that NMP is an ingredient in the product formulation. Labels may state that the product should be used only with appropriate protective gloves and adequate cross-ventilation.
Workers using NMP products should continue to follow label instructions and applicable workplace regulations and should properly use appropriate personal protective equipment such as protective gloves. View a summary of the types of personal protective equipment, including gloves, such as those made of butyl rubber that can reduce exposure to workers and consumers using NMP.
Consumers wishing to avoid exposure should ask retailers if products contain NMP and consider not using products that do contain NMP. Consumers also can choose to not use products where they do not know the active ingredients.
There are many solvents on the market, some of which might be suitable replacements for NMP depending on the condition of use. Alternatives to NMP will vary with the condition of use. EPA has done some analysis of alternatives to NMP with respect to commercial paint and coating removal products and a variety of alternatives are available. These include other chemical products as well as mechanical methods. In the coming months, EPA will perform additional work on identifying whether alternatives exist for other NMP uses.
The next step in the process required by TSCA is risk management. EPA will propose and take public comments on actions to address the unreasonable risks identified in the risk evaluation. According to TSCA, the agency must finalize those actions within two years of completing the final risk evaluation. EPA’s proposed regulations could include requirements on how the chemical is used, or limiting or prohibiting the manufacture, processing, distribution in commerce, use, or disposal of this chemical substance, as applicable.
EPA is committed to being open and transparent as the agency follows the process required by the law for evaluating unreasonable risks from chemicals. EPA will continue to keep the public updated as the agency moves through the risk management process. Following the comprehensive risk evaluation process required by TSCA ensures that the public has confidence in EPA’s final conclusions about whether a chemical substance poses any unreasonable risks to health or the environment under the conditions of use. This then allows the public to have confidence in the risk management actions taken to ensure the safety of chemicals on the market.
There will be additional opportunities for public participation. Just like the risk evaluation process, there will be opportunities for public comment as EPA works to propose and finalize risk management actions for NMP. You can stay informed by signing up for our email alerts or checking the public docket at www.regulations.gov.
Final Risk Evaluation and Supporting Files
The final risk evaluation for NMP, non-technical summary, response to comments, and other supporting documents are below.
Please Note: The PBPK Model zip folders ("NMP Human PBPK Model Code Inputs and Outputs" and "NMP Rat PBPK Model Code Inputs and Outputs") contain several file types (.m, .aps, .ape, .ail, .csl, .dll, .obj, .cpp, .csi) associated with ASCLX software. The PBPK model equations are defined in the .csl files. The .m files set inputs to the model, including model parameters and exposure conditions, produce plots comparing model predictions to ADME data, and calculate internal dose metrics corresponding to animal bioassays or human exposure scenarios. Both .csl and .m files can be viewed in any text editor. Model inputs and outputs, in particular for human exposure scenarios, are in .csv and .xls files that can be viewed in Excel or Google Spreadsheets.
- Risk Evaluation for n-Methylpyrrolidone (pdf)
- Non-technical Summary of n-Methylpyrrolidone (pdf)
- Summary of External Peer Review and Public Comments and Disposition for n-Methylpyrrolidone (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Quality Evaluation of Environmental Fate and Transport Studies (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Quality Evaluation of Physical and Chemical Properties Studies (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Quality Evaluation of Environmental Release and Occupational Exposure Data (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Quality Evaluation of Environmental Release and Occupational Exposure - Common Sources (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Quality Evaluation of Consumer and General Population Exposure Studies (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Quality Evaluation of Ecological Hazard Studies (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies – Animal and In Vitro Studies (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies - Epidemiological Studies (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Updates to the Data Quality Criteria for Epidemiological Studies (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Systematic Review Supplemental File: Data Extraction of Epidemiological Studies (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Supplemental Information on Occupational Exposure Assessment (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Supplemental Information on Consumer Exposure Assessment (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Benchmark Dose Modeling Supplemental File (pdf)
- Final Risk Evaluation for n-Methylpyrrolidone Supplemental PBPK Model Code (pdf)