PFAS in Foods: Another Dimension to the Issue
Washington, D.C. (November 22, 2019) - Multiple federal agencies have recently taken steps to assess and regulate per- and poly-fluoroalkyl substances (PFAS), based on evolving science and concerns about potential human health and environmental impacts from historic or future releases of PFAS chemicals (see our previous legal alert). This alert summarizes actions of the Food and Drug Administration (FDA) and their implications for the food supply. Businesses in that sector, as well as operations that manufactured PFAS, used PFAS to manufacture products, or used PFAS-containing products should pay close attention to this rapidly evolving issue.
The FDA’s Milk Sampling Shuts Down a Dairy
The FDA has conducted periodic studies of PFAS levels in food since at least 2012. However, in 2019, the FDA determined that the milk from one dairy farm in Clovis, New Mexico, with known PFAS groundwater contamination from a nearby Air Force Base, must be discarded because the levels of PFAS chemicals in milk samples from the farm presented “a potential human health concern.” As a result, milk production from cows at that farm “has been suspended” (a first for FDA decisions involving PFAS in food). The FDA analyzed not just for PFOS and PFOA (the PFAS with the highest production volumes), but also for GEN X chemicals and a dozen or so other less common PFAS chemicals. The highest PFAS concentrations that the FDA found were PFOS in the low parts per billion range. The FDA has not made public the evaluation that led it to conclude that this milk presented a potential human health concern.
Other FDA Food Sampling
From 2012 through 2019, the FDA sampled a broad array of food and found either no detectable levels of PFAS (in 42 cranberry samples and 30 bottled water samples in 2016) or such low levels of PFAS that the FDA was able to conclude there was “no indication that … [the] levels presented a human health concern.” Samples with detectable levels of PFAS included one of twelve raw milk (although none of 49 retail milk) samples tested in 2012; eleven of 46 fish and shellfish samples tested in 2013; 16 of 20 produce samples tested in 2018; and two of 91 samples of food in the average U.S. diet collected in 2017 and analyzed in 2019. The FDA cautioned that the “sample size was limited and should not be used to draw definitive conclusions.” Nonetheless, “based on the best available current science,” the FDA stated there was “no indication that these substances at the levels found in the limited sampling present a human health concern.”
While the FDA’s shutdown of the New Mexico dairy made headlines, it is premature to draw broad conclusions about widespread PFAS exposure based on the sampling of one dairy farm with known PFAS groundwater contamination. The state is conducting an ongoing environmental regulatory investigation of the source of contamination, which may shed light on precisely the mechanism by which these levels of PFAS entered the milk. However, it is highly likely that these recent developments will be evaluated by regulators across the country, particularly at farms located in areas with known PFAS groundwater contamination. Congress may also consider these results in response to proposals authorizing the Department of Defense to compensate farmers for PFAS contamination of their livestock.
Responding to continuing questions about the presence of PFAS chemicals in foods, the FDA announced on June 11 that, going forward, it will include sampling for 16 PFAS chemicals in the Total Diet Study. The FDA sampling also includes six lesser-known PFAS that are not yet on the list of PFAS toxicity assessments being planned. Although various federal agencies are evaluating an increasing number of PFAS, interpretation of the FDA Total Diet Study will be complicated by the paucity of toxicity information on most PFAS chemicals.
As more and more federal agencies are increasing the intensity of their focus on PFAS chemicals, current and former users of these compounds face increased legal vulnerability, particularly in light of proliferating state and private plaintiff litigation. Affected parties should take time to review their potential liability for PFAS contamination and consider engaging proactively on these rapidly developing regulatory developments.
For more information, contact the authors of this alert, or visit our Environmental & Administrative Law Practice page to find an attorney in your area.
William J. Walsh, Partner
Jane C. Luxton, Partner
Karen C. Bennett, Partner
Amanda L. Tharpe, Associate