The U.S. FDA has added several Chinese companies to its import alert 99-48, Detention without Physical Examination of Foods Due to Chemical Contamination, to prevent future entry of shipments into the U.S. of processed clams because of contamination with per- and polyfluoroalkyl substances (PFAS).

To further inform its 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 seafood surveys. The agency also continues 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 further targeted surveys to help ensure a safe and nutritious food supply. The FDA will release results of the surveys after completion. 

The FDA detected elevated levels of PFAS, notably perfluorooctanoic acid (PFOA), in samples of clams from the firms, resulting in the products being subject to refusal of admission to the U.S. market under the Federal Food, Drug, and Cosmetic Act. As the FDA continues to updat and enhance its approach and process for evaluating and monitoring chemicals, adding firms to an import alert is part of the agency’s commitment to reducing harmful exposure to chemical contaminants like PFAS in the food supply.

The firms are the first to be added to import alert 99-48 and are manufacturers or processors of clams with China listed as the country of origin. Those firms include Donggang Hongxing Food Co. Ltd; Donggang Yixing Food Co. Ltd; Donggang City Tianhong Aquatic Foodstuff Co. Ltd; Dandong Zhengrun Food Co. Ltd; Nantong Changhua Aquatic Food Co. Ltd; Liaoning Baichen Food Co. Ltd; Dandong Jiamei Food Co. Ltd; and Donggang City Gangzhu Foodstuff Co. Ltd. 

The FDA anticipates that as the agency continues sampling activities at the border, additional firms may be added to the import alert and shipments will be automatically held at the border without inspection.

The agency has taken the approach of assessing, on a case-by-case basis, whether the type and level of PFAS found in food may pose a health concern, such that the food may be deemed adulterated. To make that determination, the FDA considers factors including, but not limited to, how much of the food people typically eat, the level of PFAS detected in that food, and the toxicity of the specific type of PFAS.

The FDA says it is important to note that industry is responsible for the safety of its products and must comply with applicable regulations to ensure the safety of commercially available seafood like processed clams. Seafood processors have a responsibility to determine whether there are food safety hazards that are reasonably likely to occur, including chemical contamination such as PFAS, for each kind of fish and to identify and implement preventive measures to control those hazards.