Introduction: The purpose of this document is to provide guidance for FDA staff on aflatoxins in human food. We revised this document to update the format and to include revisions for clarity, references to other aflatoxin Compliance Policy Guides (CPGs), and a reference to the Memorandum of Understanding between the Agricultural Marketing Service (AMS) of the United States Department of Agriculture (USDA) and FDA.
Aflatoxins (B1, B2, G1, and G2) are toxic metabolites produced by the molds Aspergillus flavus, Aspergillus nomius, and Aspergillus parasiticus. Toxicological manifestations of aflatoxins include teratogenicity, mutagenicity, and carcinogenicity in susceptible animal species. Consumption of food with high levels of aflatoxins is associated with liver cancer in humans. Aflatoxins may occur in food as a result of mold growth in susceptible raw agricultural commodities. The growth of molds that produce aflatoxins is influenced by environmental factors such as temperature, humidity, and extent of rainfall during the pre-harvesting, harvesting, or post-harvesting periods. Foods most susceptible to molds that produce aflatoxins include: peanuts, corn, some tree nuts including Brazil nuts and pistachios, and some small grains such as rice. Because aflatoxins are known carcinogens to humans, the presence of aflatoxins in foods should be reduced to the lowest levels attainable using modern agricultural and processing techniques.
Regulatory Action Guidance
The following represents the criteria for submitting a recommendation for seizure or a recommendation that the article is subject to import refusal to CFSAN, Office of Compliance, Division of Enforcement (HFS-605), for aflatoxins in human food, except Brazil nuts, peanuts and peanut products, and pistachio nuts:
Both original and check analyses show total aflatoxins (i.e., aflatoxins B1, B2, G1, G2)greater than 20 ppb, and
Identity of any aflatoxin present (i.e., aflatoxins B1, B2, G1, G2) is confirmed.
Divisions should include a detention without physical examination (DWPE) request, if applicable, in the recommendation that the article is subject to import refusal. CFSAN will evaluate such requests and recommendations on a case-by-case basis, based on the information specific to each regulatory package.
See the following CPGs for guidance on aflatoxins in Brazil nuts, peanuts and peanut products, and pistachio nuts:
•CPG Sec. 570.200 Aflatoxins in Brazil Nuts
•CPG Sec. 570.375 Aflatoxins in Peanuts and Peanut Products
•CPG Sec. 570.500 Aflatoxins in Pistachio Nuts
Coordination with USDA/AMS
See the Memorandum of Understanding (MOU-225-19-031) between USDA/AMS and FDA for information regarding working arrangements for sampling and analyzing raw peanuts, Brazil nuts, and pistachio nuts for aflatoxins.
Domestic Seizure The article of food was adulterated when introduced into, and while in interstate commerce, and is adulterated while held for sale after shipment in interstate commerce, within the meaning of 21 U.S.C. 342(a)(1), in that it bears and contains a poisonous or deleterious substance, namely aflatoxins, which may render it injurious to health. Import Refusal The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be adulterated within the meaning of section 402(a)(1) of the FD&C Act in that it bears and contains a poisonous or deleterious substance, namely aflatoxins, which may render it injurious to health.* *Material between asterisks is new or revised*
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