Import Alert 99-48: Detention without physical examination of foods due to chemical contamination

The FDA has not set levels for most chemical contaminants in food, including PFAS. However, the FDA generally has taken the approach of assessing, on a case-by-case basis, whether the type and level of the contaminant found in the food may pose a health concern, such that the food is considered to be adulterated in that the levels may render the food injurious to health.

This Import Alert covers specific firms and their food products with levels of chemical contaminants that may render a product injurious to health and that may be detained without physical examination in accordance with the guidance in FDA's Regulatory Procedures Manual (RPM) Chapter 9-8.

When the FDA finds detectable levels of a chemical contaminant in food, the agency conducts a safety assessment to evaluate whether the levels present a possible human or animal health concern that warrants further FDA action. The FDA’s approach considers a number of factors, including, but not limited to, whether there is an established action level or tolerance, how much of the food is typically consumed, the level of the contaminant detected in that food, the accumulation of the contaminant in food producing animals and their byproducts, and the toxicity of the specific contaminant(s). As part of the FDA’s ongoing effort to use the best available current science to assess the safety of exposure to PFAS from foods, the agency monitors the scientific literature and available toxicological reference values for PFAS and updates the values we use in our evaluations as warranted.

In 2022, FDA conducted a targeted survey for PFAS analytes in 81 retail seafood samples consisting of clams, cod, crab, pollock, salmon, shrimp, tuna, and tilapia, most of which were imported to the United States. The FDA determined that the estimated exposure to perfluorooctanoic acid (PFOA), a type of PFAS, from certain samples of canned clams from China, was likely a health concern.

Note: This alert does not cover hazards/products addressed by other import alerts, such as: - Pesticides in Raw Agricultural Products covered by Import Alert 99-05. - Pesticides in Processed Human and Animal Foods covered by Import Alert 99-08. - Countrywide DWPE of Raw Agricultural Products for Pesticides covered by Import Alert 99-14. - Countrywide DWPE of Processed Foods for Pesticides covered by Import Alert 99-15. - Food Products Due to the Presence of Melamine or Melamine Analogs covered by Import Alert 99-31. - Foods Due to Heavy Metal (Toxic Element) Contamination covered by import alert 99-42. - Foods containing Unsafe Food Additives covered by import alert 99-45.