EPA Releases Draft Revised Risk Determination for n-Methylpyrrolidone for Public Comment
Released on July 1, 2022.
Today, the U.S. Environmental Protection Agency (EPA) released for public comment a draft revision to the unreasonable risk determination for n-Methylpyrrolidone (NMP) pursuant to the Toxic Substances Control Act (TSCA) section 6(b). The draft revised risk determination proposes to find that NMP, as a whole chemical substance, presents an unreasonable risk of injury to human health under the conditions of use evaluated.
The NMP draft revised risk determination incorporates policy changes announced in June 2021 to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. EPA’s proposed revisions will ensure that, when finalized, the NMP risk determination better aligns with the objectives of protecting health and the environment under the amended TSCA.
NMP is used as a solvent, 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.
EPA’s NMP risk evaluation identified adverse human health effects from acute inhalation, chronic inhalation, and dermal exposures to NMP. Health effects identified include adverse effects on fertility and fetal development.
The draft revised risk determination for PCE does not reflect an assumption that workers always and appropriately wear personal protective equipment (PPE). This decision should not be viewed as an indication that EPA believes there is widespread non-compliance with applicable OSHA standards. In fact, EPA has received public comments from industry respondents about occupational safety practices currently in use at their facilities. EPA will consider these comments, as well as other information on use of PPE and other ways industry protects its workers, as potential ways to address unreasonable risk during the risk management process.
Not assuming use of PPE in its baseline exposure scenarios reflects EPA’s recognition that certain subpopulations of workers exist that may be highly exposed because they are not covered by Occupational Safety and Health Administration (OSHA) standards, their employers are out of compliance with OSHA standards, because OSHA’s chemical-specific Permissible Exposure Limits (largely adopted in the 1970’s) are described by OSHA as being “outdated and inadequate for ensuring protection of worker health,” or because OSHA has not issued a Permissible Exposure Limit for the chemical substance, as is the case for NMP.
As EPA moves forward with risk management rules for NMP, the agency will strive for consistency with existing OSHA requirements or best industry practices when they are sufficiently protective, and EPA will propose occupational safety measures in the risk management process that meet TSCA’s statutory requirement to eliminate unreasonable risk of injury to health and the environment.
Overall, 29 of the 37 conditions of use EPA evaluated would drive the NMP whole chemical unreasonable risk determination due to risks identified for human health. Removing the assumption that workers always and appropriately wear PPE in making the whole chemical risk determination for NMP would mean that three additional conditions of use in addition to the original 26 would drive the unreasonable risk determination for NMP. Additionally, for five conditions of use, acute effects in addition to chronic effects would now drive the unreasonable risk to workers. Eight of the 37 conditions of use do not drive the unreasonable risk: consumer use of NMP in paint and coating removers; consumer use of NMP in adhesive removers; consumer use of NMP in paints and coatings in lacquer, stains, varnishes, primers and floor finishes; consumer use of NMP in paint additives and coating additives not described by other codes in paints and arts and crafts paints; consumer use of NMP in other uses in automotive care products; consumer use of NMP in other uses in cleaning and furniture care products, including wood cleaners, gasket removers; consumer use of NMP in other uses in lubricant and lubricant additives, including hydrophilic coatings; and distribution in commerce.
Separately, EPA is conducting a screening approach to assess potential risks from the air and water pathways for several of the first 10 chemicals, including NMP. Exposure pathways that were or could be regulated under another EPA-administered statute were not fully assessed as part of the 2020 risk evaluation.
During problem formulation, EPA conducted a first-tier screening analysis for the ambient air pathway to near-field populations downwind from industrial and commercial facilities releasing NMP which indicated low risk. In the final risk evaluation, EPA conducted a first-tier analysis to estimate NMP surface water concentrations and did not identify risks from incidental ingestion or dermal contact during swimming. This resulted in the ambient air and drinking water pathways for NMP not being fully assessed in the 2020 risk evaluation.
EPA’s screening approach will identify if there are risks that were unaccounted for in the risk evaluation for NMP. While this analysis is underway, EPA is not incorporating the screening-level approach into this draft revised unreasonable risk determination. If the results suggest there is additional risk, EPA will determine if the risk management approach being contemplated for NMP will protect against these risks or if the risk evaluation will need to be formally supplemented or revised.
Note that EPA has not conducted new scientific analysis on NMP as part of today’s actions. The NMP risk evaluation continues to characterize risks associated with individual conditions of use. EPA will continue to rely on the evaluation of each condition of use to support any determination of unreasonable risk for NMP as a whole chemical substance.
EPA will accept public comments on the draft revised risk determination for 30 days following publication in the Federal Register via docket EPA-HQ-OPPT-2016-0743 at www.regulations.gov.