Note: The revision of this Import Alert (IA) dated 05/31/2024 updates the guidance section for use of Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory for release of articles subject to DWPE and for removal of a firm/product from DWPE under this Alert. Changes to the import alert are bracketed by asterisks (***). Mycotoxins are toxic metabolites produced by molds that infect food crops. Occurrence of mycotoxins in foods is not entirely avoidable. Food products containing certain mycotoxins, including aflatoxins, deoxynivalenol, fumonisins, and ochratoxin A, might be considered adulterated and, if adulterated, are subject to refusal of admission. Aflatoxins (aflatoxin B1, B2, G1, and G2) are mycotoxins produced by certain Aspergillus species (e.g., A. flavus and A. parasiticus). Aflatoxins may occur as a result of mold growth in a number of susceptible commodities, including peanuts, corn, tree nuts, and some small grains. Aflatoxins are animal and human carcinogens https://ntp.niehs.nih.gov/ntp/roc/content/profiles/aflatoxins.pdf Deoxynivalenol (DON), also called vomitoxin, is a mycotoxin produced by several Fusarium molds, especially Fusarium graminearum, which is a common contaminant of several grains, including wheat, corn, barley, and rye. DON has been associated with a number of adverse health effects in humans and animals. Fumonisins (fumonisin FB1, fumonisin FB2, and fumonisin FB3) are mycotoxins produced by Fusarium verticillioides and other Fusarium molds that commonly contaminate corn. Fumonisins have been linked to fatalities in horses and swine. Recent studies have demonstrated the presence of fumonisins in human foods. Epidemiological investigations demonstrate a possible association of Fusarium verticillioides with esophageal cancer. Ochratoxin A (OTA) is a nephrotoxic mycotoxin produced by certain species of Aspergillus and Penicillium. Ochratoxin A can contaminate cereals (corn, barley, wheat, and oats), dried beans, spices, raisins, coffee, and soy flour. Ochratoxin A has been classified as reasonably anticipated to be a human carcinogen. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/ochratoxina.pdf
See Red List
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous and deleterious substance, namely a mycotoxin (aflatoxin, deoxynivalenol, fumonisin, or ochratoxin A), which may render it injurious to health. Bears or contains: [Adulteration, Section 402(a)(1)] OASIS charge code: MYCOTOXIN
Divisions may detain without physical examination, shipments of identified products from firms identified on the Red List of this import alert. Release of Articles Subject to Detention without Physical Examination under this Import Alert: *** Beginning 12/01/2024, food testing in support of admission of an article of food detained under section 801(a) of the Federal Food, Drug, and Cosmetic Act must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm *** In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee and/or other responsible party for the affected goods should provide evidence which demonstrates that the product does not bear or contain mycotoxins which may render it injurious to health. Such evidence could include Private Laboratory analysis of a representative sample(s) collected from the affected article. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's Laboratory Procedure-Private Laboratory Analytical Packages. Third party laboratories may use any methods that are found acceptable to FDA. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article. 'Removal from Detention without Physical Examination...': �Resources for private laboratory testing are available at https://www.fda.gov/science-research/field-science-and-laboratories/private-laboratory-testing. For applicable methodologies, navigate to �Import Alert Resources� and select �View Import Alerts: Specific Method/Preparation Recommendations.�� For recommendations for additions to the Red List, Divisions should submit a recommendation to DIO. Divisions should recommend firms/products for addition to the Red List when analysis of products indicates levels of aflatoxins, deoxynivalenol (DON), fumonisins, and ochratoxin A (OTA) as described in CPGM 7307.001: Mycotoxins in Domestic and Imported Foods or in one of the following Compliance Policy Guides (CPGs) or guidance documents: 1) CPG Sec. 555.400 Foods Adulteration with Aflatoxin 2) CPG Sec. 570.200 Brazil Nuts Adulteration with Aflatoxin 3) CPG Sec. 570.375 Aflatoxin in Peanuts and Peanut Products 4) CPG Sec. 570.500 Pistachio Nuts Aflatoxin Adulteration 5) Guidance for Industry and FDA: Advisory Levels for Deoxynivalenol (DON)in Finished Wheat Products for Human Consumption and Grains and Grain By-Products used for Animal Feed 6) Guidance for Industry: Fumonisin Levels in Human Foods and Animal Feeds Regulatory packages will be evaluated on a case-by-case basis. DIO and CFSAN will recommend products/firms for DWPE based on the information specific to each regulatory package. Removal from Detention without Physical Examination (REMOVE FROM RED LIST): *** Beginning 12/01/2024, private laboratory analytical analyses to support removal from an import alert through successful consecutive testing must be conducted by a Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory (21 CFR 1.1107). The LAAF-accredited laboratories capable of conducting analysis for this analyte group are available at: https://datadashboard.fda.gov/ora/fd/laaf.htm *** In order to remove a firm/product from detention without physical examination (REMOVE FROM RED LIST), information should be provided to FDA to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance. For further guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov *** Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to FDAPRIVATELABIMPORTALERTS@fda.hhs.gov related to a detained entry, should be addressed to Human Foods Program Division of Enforcement at hfp-oce-officeofenforcement@fda.hhs.gov. ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 05/31/2024 updates the guidance section for use of Laboratory Accreditation for Analyses of Food (LAAF)-accredited laboratory for release of articles subject to DWPE and for removal of a firm/product from DWPE under this Alert. Changes to the import alert are bracketed by asterisks (***). Mycotoxins are toxic metabolites produced by molds that infect food crops. Occurrence of mycotoxins in foods is not entirely avoidable. Food products containing certain mycotoxins, including aflatoxins, deoxynivalenol, fumonisins, and ochratoxin A, might be considered adulterated and, if adulterated, are subject to refusal of admission. Aflatoxins (aflatoxin B1, B2, G1, and G2) are mycotoxins produced by certain Aspergillus species (e.g., A. flavus and A. parasiticus). Aflatoxins may occur as a result of mold growth in a number of susceptible commodities, including peanuts, corn, tree nuts, and some small grains. Aflatoxins are animal and human carcinogens https://ntp.niehs.nih.gov/ntp/roc/content/profiles/aflatoxins.pdf Deoxynivalenol (DON), also called vomitoxin, is a mycotoxin produced by several Fusarium molds, especially Fusarium graminearum, which is a common contaminant of several grains, including wheat, corn, barley, and rye. DON has been associated with a number of adverse health effects in humans and animals. Fumonisins (fumonisin FB1, fumonisin FB2, and fumonisin FB3) are mycotoxins produced by Fusarium verticillioides and other Fusarium molds that commonly contaminate corn. Fumonisins have been linked to fatalities in horses and swine. Recent studies have demonstrated the presence of fumonisins in human foods. Epidemiological investigations demonstrate a possible association of Fusarium verticillioides with esophageal cancer. Ochratoxin A (OTA) is a nephrotoxic mycotoxin produced by certain species of Aspergillus and Penicillium. Ochratoxin A can contaminate cereals (corn, barley, wheat, and oats), dried beans, spices, raisins, coffee, and soy flour. Ochratoxin A has been classified as reasonably anticipated to be a human carcinogen. https://ntp.niehs.nih.gov/ntp/roc/content/profiles/ochratoxina.pdf
Country-specific information is available in the full alert detail on the FDA website.
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