On June 29, 2023, the U.S. Environmental Protection Agency (EPA) announced a framework for its approach to reviewing new per- and polyfluoroalkyl substances (PFAS) and significant new uses of existing PFAS. Stakeholders in sectors such as food packaging, textiles, semiconductors, and aerospace industries that continue to rely on PFAS compounds should take note. In general, EPA’s approval of new PFAS or new significant uses of existing PFAS may require additional testing — with substantial additional testing in some cases.
Under the Toxic Substances Control Act, EPA generally reviews new chemicals (i.e., those not already in commerce in the U.S.) for whether they present an unreasonable risk to human health or the environment prior to allowing import or manufacture. For certain existing chemicals (i.e., those already in commerce in the U.S.), EPA also reviews proposed significant new uses for whether they present an unreasonable risk. EPA’s new framework is intended to make more rigorous the review of new PFAS compounds or new uses of existing PFAS compounds.
EPA’ new framework establishes four steps: identifying PFAS; evaluating hazard information and determining persistent, bioaccumulative, and toxic (PBT) status; assessing exposures; and providing risk assessment conclusions with testing recommendations.
- Identifying PFAS comprises determining whether the substance (i) has an alkyl and alkyl ether structure with all the saturated carbons fully fluorinated or (ii) has a chemical structure with a mixture of fully fluorinated, partially fluorinated, and/or nonfluorinated saturated carbons.
- After EPA has determined that a substance is a PFAS, EPA will determine PBT status using a weighting-of-evidence approach. The agency may consider further testing if the available information is insufficient.
- EPA will then assess potential exposures in the workplace and to the general population.
- Lastly, EPA will identify exposure pathways and receptors and assess risks posed by the PFAS to human health and the environment. The agency may recommend further testing under TSCA Section 5(e) if the available information is insufficient to make a reasoned evaluation of these risks. For PFAS that EPA deems to be a PBT chemical, the agency will divide the new PFAS or significant new uses for existing PFAS into three categories and differentiate the level of scrutiny required based on the likelihood of exposure as follows.
- PFAS with negligible exposure and environmental release potential: EPA generally expects to allow entry into commerce after reviewing basic information such as the physical and chemical properties data provided the agency can ensure that the substance can be disposed of properly and no consumer exposure is expected.
- PFAS with low — but greater than negligible — exposure and environmental release potential: The agency generally expects to require physical and chemical properties as well as the test data, including toxicokinetic data, before allowing it to enter into commerce. EPA may require additional testing and risk mitigation if the initial data cause concern.
- PFAS that are expected to lead to exposure and environmental releases: EPA would generally require extensive testing on physical and chemical properties, toxicity, and fate. If unsatisfied with this extensive testing, the agency may require yet further testing along with risk mitigation. The regulated community should expect that these testing requirements will largely be handled on a case-by-case basis, depending heavily on what existing data is available.
EPA stated that this approach would allow a controlled use of PFAS — including in important sectors such as semiconductors — while protecting human health and the environment. EPA will apply this framework going forward, including for those new PFAS and notices of significant new use of PFAS that the agency is currently reviewing.
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