Food Fight: Litigation Continues After FDA Denies Petition to Set PFAS Tolerance Levels in Food

The petition, originally filed in November 2023 by the Tucson Environmental Justice Task Force and allied organizations, sought federal limits on PFAS contamination in a range of food and animal feed products including lettuce, blueberries, bread, milk, eggs, salmon, clams, and corn silage.

The FDA cited insufficient scientific evidence, evolving analytical methodologies, and lack of toxicological data to support the requested regulatory actions. However, the agency left open the possibility of establishing action levels for PFAS in some food products in the future.

Following the denial, petitioners filed a supplemental complaint on July 31 in the US District Court for the District of Arizona, arguing that the FDA’s decision is arbitrary and capricious under the Administrative Procedure Act (APA). The FDA’s response is due September 14. 

Currently, there are no federal limits for any PFAS in food or feed in the United States.

Background

The Citizen Petition

In November 2023, the Tucson Environmental Justice Task Force and other petitioners filed a citizen petition under the APA and the Federal Food, Drug, and Cosmetic Act (FD&C Act) requesting that the FDA set temporary tolerance levels for PFAS in food. The petition asserted that PFAS are “inadvertently transferring to [certain foods] due to the unavoidable environmental contamination of the soil, air, and water.”

Specifically, the petition requested tolerance levels at the “method detection limit” for:

• 30 specific PFAS compounds in or on head- and leaf-lettuce and blueberries.

• 26 PFAS specific compounds in or on ready-to-eat bread, milk, eggs, salmon, clams, corn silage, and corn snaplage (a livestock feed).

Total Diet Study Findings

The FDA’s Total Diet Study (TDS) monitors the levels of both nutrients and contaminants in foods consumed by people in the United States. It has been testing for PFAS through TDS since 2019. On December 19, 2025, the FDA released updated TDS findings from six regional food product samplings conducted in 2024. The results indicated that 7.2% of samples (39 of 542) had trace detections of one or more PFAS, and only four of these 39 samples showed non-trace detections, all in fish or shellfish (shrimp, clams, catfish, and tilapia). Overall, 95% of all foods tested through the TDS program (1,290 of 1,352 samples) showed no detectable PFAS.

The May 2025 Petition Supplement

Meanwhile, in May 2025, petitioners filed a supplement to the citizen petition adding an alternative request for the FDA to establish “action levels” (non-regulatory guidance limits) for PFAS in addition to or instead of formal tolerance levels. The supplement narrowed the tolerance-setting request to perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) (the most high-profile — and discontinued — PFAS) in milk, salmon, and clams, and requested action levels at the method detection limit for the 30 specific PFAS in lettuce, blueberries, bread, eggs, corn silage, and corn snaplage.

FDA’s Denial and Rationale

On June 17, Director of the FDA’s Office of Food Chemical Safety, Mark Hartman, issued a 27-page response denying the petition. The key elements of the FDA’s rationale include the following.

Insufficient Data for Tolerances: The FDA concluded that the available evidence does not support setting formal tolerance levels for PFAS in food. The agency noted that tolerance levels are set via formal rulemaking, require stable science, and have historically been rare — previously set only for polychlorinated biphenyls (PCBs).

Lack of Toxicological Data for Action Levels: The FDA determined that current toxicological data are insufficient to support establishing action levels for PFAS in food at this time.

Evolving Science: The agency emphasized that the science surrounding PFAS contamination in food is still evolving, and premature regulatory action could prove counterproductive.

Regulatory Framework Distinctions: The FDA distinguished between tolerances (set via rulemaking) and action levels (set via guidance) and noted that food contaminants are not regulated as food additives. The agency asserted that the Delaney Clause¹ does not apply.

Discretionary Authority: TheFDA emphasized its discretion to set or decline to set tolerances, noting it currently addresses PFAS contamination through case-by-case enforcement in specific geographic areas.

Future Action Levels: Importantly, while denying the petition, the FDA stated it is “currently considering setting action levels for PFAS in some products” in the future, leaving the door open for future guidance-level action.

Petitioners’ Legal Challenge

On July 31, petitioners filed a supplemental complaint in Tucson Environmental Justice Task Force, et al. v. FDA, et al., shifting their claim from unreasonable delay to a substantive challenge of the FDA’s denial under APA § 706(2). The key legal arguments include the following.

Failure to Coordinate: The complaint alleges the FDA failed to adequately coordinate with the US Environmental Protection Agency (EPA) and the US Department of Agriculture, and ignored the EPA’s determination that no safe exposure level exists for certain PFAS compounds.

Cumulative Risk Assessment: Petitioners contend that the FDA improperly evaluated PFAS risks on a compound-by-compound basis rather than cumulatively, as they argue is required by the FD&C Act.

Departure From Prior Practice: The complaint characterizes the FDA’s denial as an unexplained departure from prior agency practice, citing its previous establishment of tolerance levels for PCBs and action levels for lead and arsenic in food.

Requested Relief: Petitioners ask the court to vacate the FDA’s denial and remand for reconsideration, and to declare that the FDA is legally required to set tolerances under the FD&C Act.

The FDA’s response to the supplemental complaint is due on September 14.

Implications for the Food and Feed Industries

This case carries significant implications for food producers, processors, distributors, and retailers.

No Federal Limits Currently Exist 

There are currently no federal tolerance levels or action levels for PFAS in food or animal feed. The FDA’s denial of the petition maintains this regulatory status, though the agency signaled potential future action on guidance-level limits.

State-Level Activity 

In the absence of federal standards, states are beginning to act independently. For example, Maine’s legislature has granted its agriculture department authority to establish maximum PFAS levels in food. Additional state-level regulatory activity is likely, potentially creating a patchwork of requirements.

Ongoing TDS Monitoring 

The FDA continues to monitor PFAS in food through its TDS program. While current findings show low detection rates (approximately 5% of foods tested), continued monitoring may generate data that support future regulatory action.

Supply Chain Considerations 

Food industry participants should consider evaluating their supply chains for potential PFAS exposure, particularly for products of interest such as fish, shellfish, and products grown in areas with potential PFAS presence. Proactive assessment may mitigate risk in the event of future regulatory requirements.

Key Takeaways and What to Watch

• FDA’s September 14 Response: The FDA’s response to the supplemental complaint may provide critical insight into the agency’s legal position and signal whether the government views this case as one with broad regulatory implications.

• Potential for Court-Ordered Action: If the court finds the FDA’s petition denial arbitrary and capricious, it could vacate the decision or remand with instructions to reconsider — potentially requiring the FDA to set tolerance or action levels.

• Future Action Levels: The FDA’s acknowledgment that it is “currently considering” action levels suggests that voluntary agency guidance could emerge independently of the litigation outcome.

• State Regulation: It is important to monitor state-level legislative and regulatory developments, particularly in states with PFAS presence issues. A federal vacuum invites state action.

• Industry Preparedness: Food industry participants should consider developing compliance frameworks and testing protocols now, given the potential for some form of PFAS limits in food — federal or state — to eventually materialize.

ArentFox Schiff’s Food, Drug, Medical Device & Cosmetic group will continue to monitor this development and is available to answer any questions you may have.

[1] A 1958 provision added to the FD&C Act that prohibits the FDA from approving any intentional food or color additive if it is found to induce cancer in humans or animals at any dose.