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Key Takeaways
While the future directions and priorities of federal regulation of PFAS remain uncertain, the recent lawsuit against FDA demonstrates that public focus on the issue is unchanged by the presidential transition. Given the broader shifts on governmental policy, this could also presage a more prominent role by states and environmental groups on PFAS issues, including a potentially growing focus on food content.
Last month, an Arizona-based environmental group, German agricultural consultant, and North Carolina-based law firm sued the U.S. Food and Drug Administration ("FDA") for failing to act on the plaintiffs' November 2023 petition to set limits on the amount of polyfluoroalkyl substances ("PFAS") allowed in certain foods sold in the United States. Tucson Envtl. Justice Task Force v. U.S. Food & Drug Admin., No. 4:25-cv-35 (D. Ariz.). The lawsuit claims that the FDA's delay in deciding the petition violates FDA regulations and federal law.
FDA states that "PFAS in the environment can enter the food supply through crops and animals grown, raised, or processed in contaminated areas. It is also possible for small amounts of PFAS to enter foods through food packaging, processing, or cookware." In November 2023, the plaintiffs petitioned FDA to set enforceable limits on over two dozen PFAS they claimed were found in lettuce, blueberries, bread, eggs, milk, salmon, clams, and certain corn products. After FDA allegedly failed to decide their petition or provide a timeline for doing so, the plaintiffs filed a lawsuit to compel FDA to answer the petition. The plaintiffs contend that the Federal Food Drug and Cosmetic Act requires FDA to act "promptly and efficiently" to ensure that "foods are safe" by setting tolerances of "poisonous or deleterious substances unavoidably added to foods." Alleging PFAS toxicity and PFAS detections in certain foods, the plaintiffs claim that FDA's delay is unreasonable. Although the lawsuit seeks only to compel FDA to decide the petition, the plaintiffs also allege that FDA is obligated to set a PFAS limit and that its "only discretion" extends to the level to be set.
FDA has not commented publicly on the lawsuit. In contrast to the Biden administration's efforts to regulate PFAS, the new presidential administration has not yet announced its views on regulating PFAS. And last month, President Trump directed agencies to withdraw all unpublished and unenacted rules pending further review, which included a Biden-era proposal to set limits on PFAS in wastewater discharges from manufacturing facilities.
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