DEEP DIVE: Stakeholders Agree There Are Issues with Proposed U.S. Regulation of N-Methylpyrrolidone but Disagree with Each Other

The U.S. Environmental Protection Agency (EPA) has received more than 50 comments from stakeholders offering their concerns and insight about a proposed regulation for n-methylpyrrolidone (NMP). The comment period closed at the end of July.

For some stakeholders, n-methylpyrrolidone (NMP) is a literal lifesaver: a component of Kevlar, the high-strength material that was first used commercially in the early 1970s as a replacement for steel in racing tires and more recently spun into the fabric of ballistic-resistant armor. The EPA's 2020 NMP risk evaluation, however, determined the chemical poses threats to human health in reproduction, the liver and kidney, and immune and nervous systems. Some stakeholders argue that the risks of the chemical outweigh the benefits and take issue with an exemption for mission- or safety-critical uses.

The proposed regulation would require manufacturers to cap NMP concentration in products, expand labeling requirements for consumer products containing NMP, and impose container size limits. Additionally, the agency proposes an NMP workplace chemical protection program (WCPP), which would require companies to implement further measures for employees exposed to NMP, enforce use of personal protective equipment (PPE), and control concentration limits. There is a special focus on Direct Dermal Contact Control (DDCC), as research suggests NMP is most dangerous when it comes into contact with the skin.

“Our proposed commonsense worker protections would keep people safe while also ensuring that NMP could continue to be used, as needed,” said Michal Freedhoff, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention. WCPP would go into effect one year after the rule is finalized.

Proposed Regulation Prompts Concerns for National Security

NMP is used in various industrial and commercial products including electronics, polymers, paints and sealants, petrochemicals, and agricultural chemicals. In addition to its use in ballistic-resistant armor, Kevlar is also used in PPE like hand protection, aerospace innovations, and industrial ropes and cables, among many other industrial uses.

One of the most frequent concerns mentioned in the comments centers on how the rule would affect the production of Kevlar, which is manufactured by Virginia-based chemical company DuPont. Industry leaders and Virgina politicians alike shared their concern over the potential ruling with the EPA. The Department of Defense (DOD) contracts with DuPont to produce Kevlar for the U.S. military.

“Simply put, without being able to continue to use NMP (under a suitable Workplace Chemical Protection Program), the global supply of Kevlar and next generation Kevlar EXO will cease, putting the U.S. at a military, worker safety and economic disadvantage,” DuPont commented following a meeting with EPA discussing the NMP Risk Management Proposal in 2023.

When asked for comment on the recent proposed regulation, DuPont Public Affairs Manager Dan Turner said the company is evaluating the rule and “will comply with the final risk management rule as we continue to protect our workers and the environment.”

Other stakeholders, however, submitted comments to the docket voicing support for DuPont, taking a stance against measures that would compromise Kevlar production.

“The Kevlar produced in Virginia is critical to national security and is among the most used protective equipment for servicemembers and law enforcement agencies nationally,” Virginia Governor Glen Youngkin wrote to the EPA. “While I agree worker safety is crucial, it would be imprudent for EPA to implement restrictions to a degree that would unnecessarily put national safety in jeopardy.”

Youngkin also spoke up for the 2,000 DuPont employees in Virginia, highlighting the 500 workers who specifically manufacture Kevlar and would lose their jobs if the regulation were to halt production.

Kim Glas, president and CEO of the National Council of Textile Organizations (NCTO) also weighed in: “In times of military conflict and threats to national security, having a U.S. site manufacturing Kevlar for body armor, helmets, and ground vehicles is essential.”

Virginia Representatives Robert Whittman and Jennifer McClellan and Virginia Senators Mark Warner and Tim Kaine all voiced similar concerns in their respective letters to the EPA.

EPA Addresses NMP Used by Federal Contractors

The EPA issued similar responses addressing commenters' concerns, stating in its response to Glas: “The EPA has extensively engaged with stakeholders from a wide array of sectors while developing the proposed rule on NMP, including those manufacturing Kevlar, to inform the decision-making process.”

The agency also assured commenters that it has worked and will continue to work in collaboration with the DOD in creating the proposed NMP regulation.

As of now, the EPA acknowledges that NMP is an essential component in the products utilized by the DOD and the National Air and Space Administration (NASA). EPA's proposal offers an exemption to allow for greater concentrations of NMP to be used by the DOD and NASA contractors for mission- or safety-critical uses if proper WCPP measures are in place. The agency is also allowing federal contractors 36 months to implement WCPP practices, rather than the otherwise required 12.

“The allowed use proposed by the agency will enable the aerospace and defense industry to continue its operations without compromising safety and performance,” wrote Thiess Lindsay, Director of Remediation and Policy Risk for the Boeing Company, also a DOD contractor.

Not Regulated Enough?

Not everyone agrees with the exemption offered by the EPA. The Environmental Defense Fund's (EDF) submission argues that the risks the chemical poses to human reproductive health are too great and the proposed rule does not regulate NMP enough. The EDF says that allowing federal contractors to continue using NMP at higher concentrations than allowed in other contexts is counterproductive to the regulation if the end goal is safety.

“EPA's failure to prohibit more uses, and to employ more protective risk management actions for those uses allowed to continue…will continue to put the American public at risk of harm from NMP,” noted EDF in its comments.

Additionally, wrote EDF, the longer phase-in period for the agreed WCPP measures to be implemented, combined with the exception for higher concentrations of NMP, “could subject federal workers to unreasonable risks from NMP.”

The EDF asked the EPA to broaden the proposed regulation to include more products and implement stricter worker safety standards in its WCPP.

Critiques From Other Industries

While the EPA is currently suggesting exemptions to regulations for federal uses of NMP, many other industries and companies who rely on products containing NMP are not offered the same leniency in the proposal. The U.S. Chamber of Commerce estimates that 60,000 establishments may use NMP in their production and implored the EPA to be careful not to overregulate a chemical so many businesses rely on. “Overregulating NMP could impede this administration's priorities, such as rebuilding U.S. infrastructure and incentivizing U.S. manufacturing,” wrote the Chamber.

The proposed regulation seeks to ban NMP in fertilizers, and The Fertilizer Institute (TFI) wrote that since WCPP measures are attainable for most fertilizer producing groups, which already have safety measures in place to prevent dermal contact, it is asking the EPA to “reconsider its proposed ban and adopt the WCPP alternative, which balances safety, environmental protection, and economic considerations.”

Similarly, the American Coatings Association spoke up for its members and said banning uses of NMP is “not necessary to mitigate risk from products containing NMP,” and implementing WCPP, with an extended compliance deadline of two years, rather than one, would eliminate risk.

Karyn Schmidt, Senior Director, Regulatory & Scientific Affairs for the American Chemistry Council (ACC), submitted a comment that criticized the EPA for not providing adequate alterative analysis. “We are struck by the absence of any discussion of substitution risk or substantial discussion about the loss of producer/consumer surplus under the proposed rule,” wrote Schmidt.

Other grievances raised by the ACC include a lack of scientific support for implementing concentration limits, proposed labeling requirements, and limiting container sizes.

Accusations of Flawed Science

The ACC was not the only stakeholder that accused the EPA of utilizing flawed science in the proposal. The Center for Environmental Accountability (CEA) called the agency's risk assessment flawed, adding that although the EPA acknowledges the benefits of NMP, “unrealistic and implausible occupational exposure assumptions coupled with exaggerated hazard concerns for NMP play the starring roles” in the proposal. The CEA specifically criticized the EPA's evaluation of dermal exposures, saying that instead of accurately estimating the risks of dermal exposure, the agency used “unreasonably exaggerative assumptions about how NMP is used.”

The NMP Producers Group was also critical of the research cited in the proposal, stating, “The study on which EPA has chosen to base its chronic point of departure is the incorrect toxicology study and toxicological endpoint.” The NMP comment went on to accuse the EPA of using “non-reproducible science” to come to its risk management conclusions, asking the EPA to reconsider the research it is using to back its claims as it proceeds with the regulatory process.

Concern for Small Businesses

Adjusting to new chemical regulations takes time and money, and while some companies may be able to meet the criteria set by the EPA, others are worried that the regulation will disproportionately affect small businesses.

The Office of Advocacy of the U.S. Small Business Administration voiced its concern for the impact the proposed regulation would have on small businesses, primarily by “increasing costs, creating more hazard from disposal, and potentially creating a de facto prohibition on the use of NMP-containing products, as small entities are more likely to be unable to obtain large quantities of NMP-containing products.”

The comment submitted by the U.S. Chamber of Commerce pointed out that the EPA met with the Small Business Advisory Review Panel, but few recommendations were implemented into the proposal, including one to increase the compliance window for implementing WCPP measures for small businesses that may not have the resources to comply with the 12-month deadline.

The EPA held a public webinar on 20 July and opened the floor for public remarks. One attendant was Michael Purser, owner of Rosebud Company, a small wood floors restoration company in Atlanta, Ga. He said he has used NMP products in his wood restoration business for more than 30 years, and he is worried that a lower concentration of NMP in the products he uses will reduce efficiency. “From the standpoint of somebody who’s working with it, if you decrease that then you will more than likely extend the amount of time needed to do the restoration work because of poor performance,” he told the EPA.

He said he started taking precautions to protect himself and his workers from getting products containing the chemical on their skin when he learned of the health concerns in 2010. He asked the EPA if it would be offering any certifications or exemptions his business could apply for to continue using products with higher concentrations of NMP.

“We work in isolated areas; the public is not at risk of walking in on us,” Purser said. “We’re using it for specific products under very controlled circumstances.”

The EPA did not issue responses at the public webinar, and comments made during the webinar were not considered official and were not added to the comments submitted before the deadline.

Moving Forward

While the majority of the comments are critical of the EPA's proposal, Dow Chemical issued a comment voicing its support for the way the EPA has set a de minimis level for NMP, which is currently 0.1% to account for impurities that do not contribute to the unreasonable risks associated with NMP.

Although Dow does not manufacture or use NMP, it asked the EPA to clarify how it set the de minimis level so the approach can be applied to other chemicals, “This would be very valuable to both EPA and industry because it would help focus resources as EPA moves forward in their evaluation of prioritized chemicals.”

In the comment, Dow offered to assist the EPA in developing a framework for setting a de minimis procedure for risk management practices in future chemical evaluations.

The EPA will consider the submitted comments as it moves forward with its regulation and risk management proposal for NMP.

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This article has been revised with additional comments submitted after initial publication.

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