In the draft N-methylpyrrolidone (NMP) risk evaluation, EPA reviewed over 30 potential NMP uses, such as adhesives, sealants, arts and craft paints, paint and coating removers, adhesive removers, and degreasers. Below are the draft risk evaluation and support documents for NMP.
The Agency will be accepting comment on the draft risk evaluation until January 21, 2020 in docket EPA-HQ-OPPT-2019-0236. EPA also held a peer review meeting of EPA’s Science Advisory Committee on Chemicals (SACC) on the draft risk evaluation for this chemical’s conditions of use on December 5-6, 2019.
To prepare a draft risk evaluation, EPA reviews extensive scientific literature, conducts modeling and other risk assessment activities, and collects exposure, fate, and transport information from many sources. EPA looks at how the chemical is used today, what we know about the chemical’s fate, transport, and toxicity, and whether any of the chemical’s uses could pose unreasonable risk to human health or the environment under the known conditions. Read about the steps EPA is taking in the risk evaluation process for NMP. Learn more about EPA’s risk evaluation process.
On this page:
- Draft risk evaluation findings
- Using products safely and alternatives
- Public participation, peer review, and next steps
- Draft risk evaluation and supporting documents
In the November 2019 draft risk evaluation, EPA reviewed a suite of potential NMP exposures and made the following initial determinations on risk. These preliminary determinations may change as EPA's evaluation becomes more refined through the public comment and peer review processes.
EPA did not find risk to the environment, bystanders, or occupational non-users. For all the conditions of use included in the draft risk evaluation, EPA has preliminarily found no unreasonable risks to the environment, bystanders, or occupational non-users from NMP.
EPA’s draft risk evaluation preliminarily found unreasonable risks associated with acute and chronic inhalation and dermal exposure to NMP under a variety of conditions of use. EPA found that workers and consumers could be adversely affected by NMP under certain conditions of use. These initial determinations are based on a draft risk evaluation of the reasonably available information and are not EPA’s final determinations on whether this chemical presents unreasonable risks under the conditions of use. The Agency will use feedback received from the public comment and peer review processes to inform the final risk determinations.
This draft risk evaluation and the initial risk determinations are not a final action. This draft represents the Agency’s preliminary conclusions, findings, and determinations on NMP and will be peer reviewed by independent scientific experts. The draft risk evaluation includes input from other EPA offices as well as other federal agencies.
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. Other labels state that the product should be used only with appropriate protective gloves. Additionally, safety data sheets developed by the manufacturer remind users to only use the product in well-ventilated areas and, if they notice a strong odor or experience dizziness, the users should stop and leave the area immediately.
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.
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, that can reduce exposure to workers and consumers using NMP.
There are many solvents on the market, some of which might be suitable replacements for NMP depending on the condition of use. EPA has done some analysis of alternatives to NMP with respect to 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 Agency will be accepting comment on the draft risk evaluation until January 21, 2020 in docket EPA-HQ-OPPT-2019-0236. This public comment period is an opportunity for the public to submit any additional information to assist EPA in completing the final risk evaluation for NMP. EPA will consider all comments submitted on the draft risk evaluation when developing a final risk evaluation.
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 evaluation process. Following the comprehensive risk evaluation process required by TSCA ensures that EPA has confidence in our final conclusions about whether a chemical substance poses any unreasonable risks to health or the environment under the specific conditions of use. This then allows the public to have confidence in the safety of chemicals on the market.
The next step in the risk evaluation process is public participation. EPA is asking the public to provide input on the draft risk evaluation to ensure that the Agency is using the best available science and making decisions based on the weight of scientific evidence.
The draft risk evaluation was peer reviewed by a panel of independent, scientific experts on December 5-6, 2019. EPA goes beyond what TSCA requires by peer reviewing the risk evaluations it releases in order to increase public transparency in the risk evaluation process and receive expert feedback on the science that underlies the risk determinations. Learn more about the peer review.
EPA’s preliminary risk determinations may change in response to comments from the public and from scientific experts conducting a peer review on the draft risk evaluation. If EPA’s final risk evaluation finds there are unreasonable risks associated with this chemical under the specific conditions of use, the Agency will propose actions to address any unreasonable risks within the timeframe required by TSCA. This could include proposed regulations to prohibit or limit the manufacture, processing, distribution in the marketplace, use, or disposal of this chemicals, as applicable.
Draft Risk Evaluation and Supporting Files
NMP Human PBPK Model Code Inputs and outputs(100 MB, December 13, 2019)
NMP Rat PBPK Model Code Inputs and Outputs(791 K, December 13, 2019)
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.You may need a PDF reader to view some of the files on this page. See EPA’s About PDF page to learn more.
- Draft Risk Evaluation for N-Methylpyrrolidone (NMP) (PDF)(487 pp, 9 MB)
- Prepublication Version of the Federal Register Notice Announcing the Availability of Draft Risk Evaluation and Peer Review for NMP (PDF)(14 pp, 728 K)
- Draft Charge to the Panel for N-Methylpyrrolidone (NMP) (PDF)(7 pp, 176 K)
- Systematic Review Supplemental File: Data Quality Evaluation of Environmental Fate and Transport Studies (PDF)(55 pp, 1 MB)
- Systematic Review Supplemental File: Data Quality Evaluation of Physical Chemical Properties Studies (PDF)(17 pp, 1 MB)
- Systematic Review Supplemental File: Data Quality Evaluation of Environmental Release and Occupational Exposure Data (PDF)(611 pp, 3 MB)
- Systematic Review Supplemental File: Data Quality Evaluation of Environmental Release and Occupational Exposure Data Common Sources (PDF)(53 pp, 1 MB)
- Systematic Review Supplemental File: Data Quality Evaluation of Consumer and General Population Exposure Studies (PDF)(26 pp, 1 MB)
- Systematic Review Supplemental File: Data Quality Evaluation of Ecological Hazard Studies (PDF)(37 pp, 1 MB)
- Systematic Review Supplemental File: Data Quality Evaluation of Human Health Hazard Studies Animal Studies (PDF)(101 pp, 1 MB)
- Systematic Review Supplemental File: Data Quality Evaluation of Epidemiological Studies (PDF)(27 pp, 432 K)
- Systematic Review Supplemental File: Updates to the Data Quality Criteria for Epidemiological Studies (PDF)(16 pp, 2 MB)
- Systematic Review Supplemental File: Data Extraction Tables for Epidemiological Studies (PDF)(4 pp, 114 K)
- Supplemental Information on Occupational Exposure Assessment (PDF)(228 pp, 4 MB)
- Supplemental Information on Consumer Exposure Assessment (PDF)(13 pp, 300 K)
- Benchmark Dose Modeling Supplemental File (PDF)(84 pp, 2 MB)
Exxon 1991 multigenerational reproductive study (PDF)(1965 pp, 290 MB,
NMP multigenerational reproductive study and docket submission information for NMP Proposed test rule