The U.S. Environmental Protection Agency (EPA) has released a new review framework specifically targeting per- and polyfluoroalkyl substances (PFAS). This framework primarily describes EPAs approach when reviewing new PFAS and their new uses. The goal is to conduct comprehensive assessments through pre-manufacture notices (PMNs) and significant new use notices (SNUNs) before PFAS are allowed into commerce, to protect human health and the environment from their hazards.

Clarifying the Definition of PFAS: The PFAS framework first determines whether the substance under review (as a PMN or SNUN) meets the definition of the PFAS chemical class. EPAs Office of Pollution Prevention and Toxics (OPPT) defines PFAS as substances with alkyl and alkyl ether structures where all saturated carbon atoms are fully fluorinated (i.e., perfluorinated) or have a mixed chemical structure of fully fluorinated, partially fluorinated, and/or non-fluorinated saturated carbon atoms.

Evaluating Information and Determining PFAS PBT Status: As required by the framework, when the submitted substance is a PFAS, the PMN or SNUN must include all information available to the submitter for EPA to assess the chemicals potential impact on human health or the environment. EPA will determine whether the PFAS is likely to be a persistent, bioaccumulative, and toxic (PBT) substance based on the information, modeling data, and/or supplementary information provided by the PMN or SNUN submitter.

Cases Where PFAS Environmental Release and Potential Exposure Are Negligible:

Enterprises only need to submit the substances physicochemical property data for EPA review before production is allowed. If EPA confirms that such PBT PFAS can be properly managed with no risk of exposure, it may be allowed into commerce.

Cases Where PFAS Environmental Release and Potential Exposure Are Low:

Enterprises must submit the substances physicochemical property data and other tests (e.g., toxicokinetic tests) for EPA review before production is allowed. Based on the preliminary data review, EPA may require the enterprise to implement necessary restrictions during production to reduce exposure and environmental release.

Cases Where Exposure and Environmental Release Are Expected:

Enterprises must submit a complete set of test data for EPA review before production is allowed, including physicochemical property tests, toxicokinetic tests, and human health and/or environmental toxicity tests. Based on the preliminary data review, EPA may require the enterprise to implement necessary restrictions during production to reduce exposure and environmental release or prohibit the substances production.

Through the implementation of the new framework, EPA ensures that any new PFAS will not harm human health or the environment while allowing the use of certain PFAS in critical industries like semiconductors where exposure and environmental release can be effectively controlled.

Since early 2021, EPA has taken a series of measures to ensure strict review and appropriate protections for new PFAS, including improving policies and processes for reviewing new chemicals to better align with the requirements of the 2016 TSCA amendments. Current scientific research indicates that exposure to certain PFAS, even at very low concentrations, may adversely affect health and the environment, and most PFAS are persistent and bioaccumulative chemicals. Therefore, the PFAS framework aims to stop the environmental release of PBT PFAS at the source and eliminate unreasonable risks before any manufacturing begins. Additionally, by leveraging TSCA Section 5 testing authority, the frameworks implementation will ensure EPA uses the best available information in PFAS assessments while advancing understanding of this large and diverse group of chemicals.

EPA plans to host a public webinar on the framework this summer, with specific dates, times, and registration information to be announced soon.