FDA Shares Testing Results for PFAS in Clams

Constituent Update

December 18, 2024

Today, the U.S. Food and Drug Administration (FDA) is sharing our latest testing results for per- and polyfluoroalkyl substances (PFAS) in clams as follow up to the agency’s findings in the 2022 PFAS in seafood survey, which included eight of the National Fisheries Institute’s (NFI) top ten most popular types of seafood in the U.S. in 2018. In the 2022 seafood survey, the agency detected high levels of perfluorooctanoic acid (PFOA), a type of PFAS, in samples of canned clams from China intended for human consumption and determined that the estimated exposure to PFOA from the samples was likely a health concern. After learning the results of the FDA’s testing of their products, the two distributors of the samples with the two highest levels of PFOA voluntarily took action to protect consumers by recalling their canned clam products.

The agency continued sampling processed clams that were intended for human consumption as they came into the U.S. at import from the two processors associated with the highest levels of PFOA detected during the 2022 seafood survey. Between October 2022 and September 2024, the FDA collected and analyzed 12 samples of processed clams with China as the country of origin. All 12 samples had detectable levels of at least one type of PFAS, and PFOA was detected in all samples. Three shipments were refused entry into the U.S.

In 2023, the agency also conducted a small survey of nine domestically acquired clam samples, six of which specifically identified the U.S. as their country of origin, collected at retail establishments in the Washington, D.C. metro area. All but one of those nine samples had PFOA concentrations under the method detection limit, which is the minimum concentration of a substance that can be measured and reported with 99% confidence that the analyte concentration is greater than zero. All clam products remained on the U.S. market. The agency is actively engaging with both imported and domestic clam firms to better understand potential sources of contamination and ways in which PFOA concentrations may be reduced.

The FDA has been consistently testing for PFAS in human foods in the U.S. market since 2019. To further inform our understanding of PFAS in seafood, the FDA recently issued a request for information to help fill data gaps that remain regarding PFAS in seafood and is conducting two ongoing surveys. First, we are conducting a targeted survey for PFAS in molluscan shellfish, including clams (e.g., domestic and imported clams, both raw and processed), mussels, oysters, and scallops. Second, we are separately conducting a survey of the NFI’s top ten most consumed seafood in the U.S. in 2020, plus additional seafood types. We also continue to analyze foods from the FDA’s Total Diet Study. The results of FDA’s testing are used to help the agency better understand PFAS in commercially available foods and identify foods or types of foods that would benefit from targeted surveys, to help ensure a safe and nutritious food supply. The FDA will release results of the surveys after completion.

We continue to evaluate our approach to assessing PFAS in food as the science evolves. When the FDA detects PFAS in food, we may conduct an assessment to evaluate whether the levels detected present a possible human health concern. The FDA’s approach considers several factors, including whether there is an established action level or tolerance at the time of detection, how much of the specific food people typically eat, the level of the PFAS detected in that food, and if there is scientific information on the toxicity of the specific type of PFAS.

In addition to the FDA’s actions to protect public health, the seafood industry is responsible for the safety of its products and must comply with applicable regulations to ensure the safety of seafood that is commercially available. By law, food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed, including chemical contaminants like PFAS.

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