EPA Will Hold Webinar on Reviews of New PFAS and New Uses of Existing PFAS
The U.S. Environmental Protection Agency (EPA) will hold a webinar on September 6, 2023, on its new framework (the Framework) for addressing new per- and polyfluoroalkyl substances (PFAS) and new uses of existing PFAS under the Toxic Substances Control Act (TSCA). According to EPA, the Framework outlines EPA’s planned approach when reviewing new PFAS and new uses of existing PFAS to ensure that, if allowed to enter into commerce, they will not be harmful to human health and the environment. EPA states that the Framework supports the Biden Administration’s commitment to address the impacts of PFAS and advances EPA’s PFAS Strategic Roadmap to confront the human health and environmental risks of PFAS. Registration for the webinar is open.
The Framework outlines EPA’s planned approach when reviewing new PFAS and new uses of PFAS to ensure that, before these chemicals are allowed to enter into commerce, EPA will undertake an extensive evaluation to ensure they pose no harm to human health and the environment. Under TSCA Section 5, EPA is required to review new chemicals, including new PFAS and new uses of PFAS, within 90 days, assess the potential risks to human health and the environment of the chemical, and make one of five possible risk determinations. When potential risks are identified, EPA must take action to mitigate those risks before the chemical can enter commerce.
As stated in our July 14, 2023, memorandum, Bergeson & Campbell, PC (B&C®) views EPA’s new PFAS Framework as a sensible implementation of its National PFAS Testing Strategy and a reasonable approach to EPA’s review and regulation of new PFAS. Not surprisingly, EPA will expect robust data, including data on physicochemical properties, fate, and toxicity, depending on the conditions of use. We note that entities that intend to submit premanufacture notices (PMN) and/or significant new use notices (SNUN) on PFAS should be mindful of EPA’s statements in the Framework that it “generally expects that most PFAS will be [persistent, bioaccumulative, and toxic (PBT)]” and that the Framework establishes a de facto ban pending up-front testing if data are not reasonably available. It is critical that submitters be aware of EPA’s expectations and develop the necessary data prior to submitting a PMN or SNUN.
While not all PFAS are or will be PBTs — the burden will be on the submitter to demonstrate that the PFAS in question is not a PBT — the framework provides a set of testing that can be used to evaluate whether a PFAS is a PBT. EPA makes it clear that a PBT PFAS must be well controlled for it to proceed to commercialization (no or negligible worker exposure, no release to the environment). It is less clear how EPA would view persistent, non-bioaccumulative PFAS (such as a new, high molecular weight fluoropolymer). Nevertheless, we view EPA’s implementation of its PFAS framework as a hopeful sign that EPA will view individual PFAS carefully and thoughtfully and make science-based risk management decisions.
The attorneys, scientists, regulatory specialists, and business consultants of B&C and our global consulting affiliate The Acta Group (Acta®) relentlessly participate in and track developments regarding the global regulatory approach to PFAS. We offer a constantly updated library of PFAS resources to help those in the chemical and chemical products industry understand what they need to know and what it means to their business.
B&C and Acta have prepared a 20-page memorandum that offers a high-level outline of issues, focusing on the most significant bans and restrictions, the most impactful potential legal developments regarding PFAS, and the most important steps chemical product manufacturers should be taking now to identify, diminish, and supplant, as appropriate, PFAS in their supply chains.