A year into the EPA’s PFAS framework for new chemicals, what is the agency approving?

Background: PFAS

• Per- and polyfluoroalkyl substances (PFAS) are a large class of synthetic organic chemicals that have been utilized in variety of commercial, industrial, and consumer applications since the chemicals were discovered in the 1940s. Although there are consistent disagreements between state, federal, and international bodies on the exact definition of what a PFAS is, most definitions focus on one or more fully fluorinated carbon atoms. This means that at least one carbon atom has all hydrogen bonds replaced with fluorine bonds, creating an extremely strong molecule. Carbon-fluorine bonds are some of the strongest in nature, meaning that PFAS can persist in the environment and resist a wide variety of environmental stressors.
• PFAS have been used in many different products, including textiles, cleaning products, high-performance coatings, and firefighting foams. The ability of the chemicals to repel both water and oil, in addition to resisting heat and other stressors has led to wide adoption of the chemicals over the past 80 years.

Background: TSCA and SNURs

• The EPA implements the Toxic Substances Control Act (TSCA), which provides the basis for much of the chemical regulation in the United States. TSCA underwent numerous changes in 2016 via the Lautenberg amendments, which were the first truly major amendments to the law in 40 years. TSCA covers reporting, recordkeeping, and regulation of more than 86,000 chemical substances listed on the TSCA Chemical Substance Inventory. The Inventory contains all existing chemical substances manufactured, processed, or imported in the U.S. that do not qualify for an exemption or exclusion under TSCA. The Inventory does not include substances that are governed by other U.S. statues such as pesticides, cosmetics, drugs, food, and food additives, among others.
• Under TSCA section 5, the EPA may also issue Significant New Use Rules (SNURs) for chemicals that require a manufacturer or importer to notify the EPA before manufacturing or importing a chemical for a “significant new use.” The agency defines a “significant new use” by looking at a variety of factors, including how much of the chemical will be manufactured or imported, any changes to exposure patterns for residential or occupational exposures to the chemical based on the new use, the extent to which the changes may cause additional exposures, and any “reasonably anticipated” methods for manufacturing or importing the chemical that may cause adverse impacts. The Lautenberg amendments also changed the procedure for significant new uses, and now require the EPA to make an affirmative finding of safety for the new use before the chemical is allowed into the marketplace.
• After issuing a SNUR, the EPA will receive a Significant New Use Notice (SNUN) from the manufacturer or importer at least 90 days prior to the planned start of manufacturing or importing the substance. The agency then begins to review the risks associated with that new use and determines whether to apply additional risk management requirements to handling, manufacturing, importing, using, or disposing of the substance.

The EPA’s June 2023 framework for PFAS subject to SNURs

• On June 29, 2023, the EPA released the Framework for TSCA New Chemicals Review of PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs). The new framework is part of a greater PFAS strategy from the agency detailed in the agency’s strategic roadmap for PFAS. The document targets new PFAS or significant new uses of existing PFAS and details the agency’s plan for reviewing these substances in the future.
• The framework uses a newer definition of PFAS utilized by the agency in 2023. The EPA considers PFAS to include substance with alkyl or alkyl ether structures where all saturated carbons are fully fluorinated (e.g., that all hydrogen atoms have been replaced with fluorine atoms) with a mixture of fully fluorinated, partially fluorinated, or non-fluorinated saturated carbons. The agency defines “PFAS” in the framework as a chemical substance that contains one of the following three structures: (1) “R–(CF2)–CF(R′)R′′, where both the CF2 and CF moieties are saturated carbons”; (2) “R–CF2OCF2–R′, where R and R′ can either be F, O, or saturated carbons”; or (3) “CF3C(CF3)R′R′′, where R′ and R′′ can either be F or saturated carbons.” This definition has been utilized by the EPA since January 2023, when it proposed adding Significant New Use Rules (SNURs) for PFAS on the TSCA that have been inactive since 2006.
• The agency considers potential metabolites or degradants of PFAS also to be within the definition of “PFAS” for the purposes of the framework. The agency explained that it has reviewed natural processes that can break down PFAS into degradants or metabolites that are potentially more stable and deleterious to human health or the environment, and that certain PFAS can break down into stable and bioaccumulative end products. The agency will focus on any of these potential metabolites or degradants when reviewing a chemical for TSCA section 5 purposes.
• The agency expects that “most PFAS” will be considered PBTs. The agency will review both the chemical itself as well as metabolites or degradants when assessing environmental releases and worker exposures. The agency will only qualitatively, not quantitatively assess the potential extent of exposures to the general population. The framework explains that quantitatively assessing exposures may only provide a snapshot of an exposure at one time and may not accurately reflect the overall exposure and health risks of the chemicals due to persistence and bioaccumulation.

PFAS present in SNURs in the following year

• Since the agency has released the framework, the EPA has published several notices for SNURs. From a review of this information, there are five substances that appear to be PFAS that have received proposed SNURs from the agency. Each one and its associated listed use are detailed in the table below.

What are the industries the agency is allowing new PFAS uses in?

• In a June 29, 2023 keynote speech, Dr. MICHAL FREEDHOFF, the Assistant Administrator at the Office of Chemical Safety and Pollution Prevention, explained that the agency was most focused on whether a chemical’s planned uses would result in releases into the environment. During the speech, Freedhoff had a positive outlook on PFAS utilized in closed-loop environments, particularly the use of PFAS in the semiconductor industry including the use of photo acid generators (PAGs) for photolithography in the semiconductor production process.
• The agency thus appears to be “putting its money where its mouth is” in the case of the semiconductor industry, with three of the five chemicals covered under SNURs used in photolithography or as a PAG. The other two, for use as a component in batteries and for “molded or extruded items” also likely fit within the agency’s plans.
• The EPA also appears to acknowledge that these chemicals are likely PBTs. In the proposed rules, the agency stated that “based on the physical/chemical properties of the PMN substances . . . and in the absence of data, the PMN substances and photolysis products are potentially persistent, bioaccumulative, and toxic (PBT) chemicals.” The agency noted a wide variety of potential concerns for the chemicals, including “ concerns for thyroid, liver, and reproductive (developmental) toxicity” based on perfluoro analogue data from the agency.
• The proposed protections lend themselves to closed-loop environments, as recommended by Freedhoff. Under the proposed orders, substances would be covered by strict manufacturing time limits unless the company submits specific testing data to the EPA, the use of PPE, and the inclusion of a hazard communication program for the substances. The proposed orders would also ensure that no “modification of the processing or use of the PMN substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process,” as well as no uses outside of the ones provided for in the order could be undertaken.
• The EPA does not want these substances manufactured in the country and included “ import only” requirements for several substances in the orders. For two chemicals, this included import restrictions for the substances in a solution in a sealed container weighing 5 kilograms or less. The EPA’s insistence on no domestic manufacture likely means that the agency believes that there is some form of risk of release at the manufacturing stage, and it would like to export that risk as much as it can.

What do new PFAS chemical uses look like going forward, based on the information available?

• New PFAS uses will likely continue to be approved for critical infrastructure and defense uses. The Biden Administration has been clear about its support for battery and semiconductor production, including providing billions of dollars to boost domestic manufacturing of batteries and the mammoth CHIPS Act. The EPA itself has explained that it will work with semiconductor and other critical technology companies or consortiums to figure out a process to effectively mitigate the risk.
• Closed-loop systems for PFAS are the most likely form that will be approved by the EPA. The agency’s chief focus now seems to be on potential occupational exposures and environmental releases for new uses of PFAS. Going forward, it’s likely that successful applications will be able to demonstrate PFAS use within a closed-loop system or in other uses with a low chance of exposure.
• The agency appears to be focused on ensuring new PFAS manufacturing doesn’t happen in the U.S. The specific prohibitions on domestic manufacture of some of the substances indicate that the EPA may allow the use of PFAS in industrial processes, but it does not wish to allow additional domestic production of those chemicals going forward.

To contact the author of this analysis, please email Walker Livingston ( wlivingston@agencyiq.com).

To contact the editor of this analysis, please email Kari Oakes ( koakes@agencyiq.com).

Key Documents and Dates

• Significant New Use Rules on Certain Chemical Substances (22-4.5e) (May 11, 2024)
• Significant New Use Rules on Certain Chemical Substances (23-3.5e) (May 11, 2024)
• Significant New Use Rules on Certain Chemical Substances (21-4.F) (April 8, 2024)
• Significant New Use Rules on Certain Chemical Substances (22-2.5e) (December 18, 2023)