Strategic roadmap guides U.S. EPA actions on PFAS

WASHINGTON—As the European Union marches ahead with its broad-based restriction proposal on PFAS chemicals, those in the market have been keeping a close eye on the U.S. as well.

Rubber industry stakeholders in the supply and use of fluoroelastomers and fluoropolymers have been nervously tracking how the regulatory activity will play out domestically for the per- and polyfluoroalkyl substances.

While the U.S. regulators, as often is the case, clearly are lagging behind the process in Europe, it's unfair to say there's been no activity in the country. That's clearly not the case either on the federal or state level.

The U.S. Environmental Protection Agency has been marching deliberately forward on its PFAS Strategic Roadmap, making progress on several fronts in its proposed regulation of the "forever chemicals."

Likewise, a number of states—some thinking the EPA is moving too slowly—are carving out their own territory in cracking down on what they see as the potential dangers PFAS pose to both humans and the environment. Maine, Minnesota and Michigan are three states observers say are leading the way.

Several themes have surfaced from the wide range of sources from agencies, associations, FKM suppliers and rubber product makers who have confided their views with Rubber News on how they see—or hope—the U.S. regulatory process moves forward.

For one, they hope regulators here take what they call a more "scientific approach" to how the 10,000 or so PFAS chemicals are classified. They don't want the U.S. to follow the approach the EU is taking, with the current proposal calling for the eventual ban of all PFAS.

Rubber industry players strongly feel that the FKM and fluoropolymers they deal with should be separated from the "long chain" chemicals that traditionally have been linked to a whole host of serious health and environmental issues.

They also fear if the U.S. EPA moves too slowly, more states will enact their own regulations resulting in a wide range of statutes, rather than one, harmonized standard.

The American Chemistry Council said it supports science-based regulations for PFAS chemistries, but that the EU disregarded the unique properties, profiles and uses of the individual chemicals in the proposed restriction put forth by the European Chemicals Agency.

"Enacting such overly broad restrictions of all PFAS throughout the EU could cost jobs, harm economic growth and hamper the ability of consumers and businesses to access critical products that they rely on every day," the ACC said in written responses to questions from Rubber News. "While we appreciate that the EU proposal grants certain derogations for some of these important applications for PFAS, we object to the 'one-size-fits-all' approach to regulating this large class of chemicals, which could have significant unintended consequences across the EU."

The ACC hopes the U.S. EPA doesn't make this same mistake, but the association thinks the federal agency doesn't go far enough in the other direction.

"In the United States, while EPA's PFAS Strategic Roadmap and National PFAS Testing Strategy have recognized some distinctions within the broad class of PFAS," the ACC said, "we believe that a more comprehensive approach to PFAS oversight acknowledges the scientific and real-world differences among PFAS chemistries and addresses them appropriately as opposed to a simplified universal ban."

EPA Administrator Michael S. Regan in October 2021 unveiled the agency's PFAS Strategic Roadmap. The agency, in emailed answers to Rubber News queries, said the document outlines a "whole-of-agency approach" that advances science and follows the law to safeguard public health, protect the environment and hold polluters accountable.

"The actions described in the PFAS Roadmap each represent important and meaningful steps to safeguard communities from PFAS contamination," the EPA said. "Cumulatively, these actions will build upon one another and lead to more enduring and protective solutions." 

Over the first year, the agency said key milestones included proposing to designate two PFAS (PFOS and PFOA) as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), commonly known as the Super Fund program.

The EPA also said it released drinking water health advisories; enhanced data on PFAS under EPA's National PFAS Testing Strategy and through nationwide sampling for 29 PFAS in public drinking water systems; and started the distribution of $10 billion in funding to address emerging contaminants under the Bipartisan Infrastructure Law. 

From there, the agency said its work continued to move forward on a number of fronts. The progress they touted was:

• Proposing a National Primary Drinking Water Regulation for six PFAS chemicals, a rule they said would be a major step to protect public health from PFAS pollution. They said the measure leverages the latest science and complements state efforts to limit PFAS by proposing to establish legally enforceable maximum contaminant level goals (MCLGs) for six PFAS known to occur in drinking water.
• Proposing a rule last December to enhance reporting of PFAS data to the Toxics Release Inventory. The EPA said the measure would eliminate an exemption that allows facilities to avoid reporting information on PFAS when those chemicals are used in small, or "de minimis," concentrations.
• Proposing a Significant New Use Rule (SNUR) that would put "needed protections in place where none currently exist to ensure that EPA can stop all unsafe uses of an estimated 300 PFAS that have not been made or used for many years without a complete EPA review and risk determination."
• Issuing a Toxic Substances Control Act (TSCA) test order requiring companies to conduct and submit testing on trifluoro(trifluoromethyl)oxirane (HFPO), a perfluoroalkyl substance used in making plastics. For this test order, EPA applied a 10-year period for purposes of identifying manufacturers of the HFPO subject to the order. This is the second test order issued under EPA's National PFAS Testing Strategy, with the agency saying it plans to issue additional such orders in the coming months.
• And releasing a framework detailing EPA's planned approach when reviewing new PFAS and new uses of PFAS. The framework, the agency claimed, will help ensure that any new PFAS won't harm human health and the environment. At the same time, however, it will allow certain PFAS to be used when exposures and releases can be mitigated, and where such use is critical for important sectors like semiconductors. 

Later this year, the EPA plans to finalize a reporting rule under TSCA that would require all manufacturers—including importers—of PFAS in any year since 2011 to report information to EPA, including on production volumes, uses and worker exposures.

"This rule would provide EPA with the most comprehensive dataset of PFAS manufactured in the United States," the agency said. 

The U.S. EPA told Rubber News its work will take into account the concerns that many industry stakeholders have expressed—including those working with FKMs and fluoropolymers—that regulations will be too generic and won't recognize the difference across the spectrum of PFAS chemicals.

But the agency also knows that one of its top mandates is to get a better and fuller understanding of PFAS materials and the potential risks they pose.

"A key priority in EPA's PFAS Strategic Roadmap is to ensure science-based decision-making," the agency said. "EPA is investing in scientific research to fill gaps in understanding of PFAS, to identify which additional PFAS may pose human health and ecological risks at which exposure levels, and to develop methods to test, measure, remove and destroy them."

Current scientific evidence, the EPA added, "clearly indicates that there are real, present and significant hazards associated with specific PFAS, but significant gaps remain related to the impacts of other PFAS on human health and in the environment. Regulatory development, either at the state or federal level, would greatly benefit from a deeper scientific understanding of the exposure pathways, toxicities and potential health impacts of less-studied PFAS."

The agency said it is conducting new research to better understand the similar and different characteristics of specific PFAS and whether and how to address groups and categories of PFAS. It will focus on improving its ability to address multiple chemicals at once, thereby accelerating the effectiveness of regulations, enforcement actions, and the tools and technologies needed to "remove PFAS from air, land and water."

"These research efforts don't treat all PFAS the same way; instead, EPA is working to identify PFAS categories," according to the agency. "For example, in the National PFAS Testing Strategy, EPA is working to break the large, diverse class of PFAS into smaller categories based on similarities across defined parameters, such as chemical structure, physical and chemical properties, and toxicological properties.

"By testing representative PFAS substances from each category, EPA can learn more about these substances."