The revision of this Import Alert (IA) dated updates the name of the alert, the guidance section, product description, adds/updates charges, and PAF. Changes are bracketed by asterisks (***). Examination of shipments of molluscan bivalve seafood from firms on the red list have been made. Salmonella, Vibrio cholera, other bacteria and/or viruses (e.g. Hepatitis A, Norwalk, etc.) were found, or epidemiological evidence associated the product with a food-borne illness outbreak. Additionally, some shipments were labeled as "cooked" when in fact the product only received a minimal heat treatment in order to "open" the shells.
***Raw Molluscan Bivalve Shellfish***
***For bacterial and/or viral (Salmonella, Vibrio cholera, Hepatitis A, Norwalk, etc.) violations: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains: [Adulteration, Section 402(a)(1)] OASIS charge code: POISONOUS*** AND/OR ***For Epidemiological Evidence (Association with a Food-borne Illness Outbreak) reviewed and supported by a subject matter expert: The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions. [Adulteration, Section 402(a)(4)] OASIS charge code: MFR INSAN*** AND/OR ***For labeling violations: The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1) of the FD&C Act in that the labeling is false or misleading in any particular. [Misbranded, Section 403(a)(1)] OASIS Charge code: FALSE***
Divisions may detain, without physical examination, the specified product from the manufacturers on the Red List of this alert regardless of whether they are from a certified shipper under the National Shellfish Sanitation Program ***or sourced from a country with a regulatory control system determined equivalent by FDA and which is listed on the Interstate Certified Shellfish Shippers List (ICSSL). https://www.fda.gov/food/federalstate-food-programs/interstate-certified-shellfish-shippers-list*** ***Removal from Detention without Physical Examination (REMOVE FROM RED LIST): Firms (other than certified shippers) listed on the Red List of this import alert requesting removal should include documentation with sufficient evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved. In addition, a minimum of five (5) consecutive non-violative commercial shipments should be offered for import before the Agency may consider that the appearance of the violation has been overcome, and that it may be appropriate to remove a firm and product from the Red List for this import alert. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention Without Physical Examination (DWPE)." Certified shellfish shippers listed on the Red List of this import alert seeking removal can be removed when inspected and found in-compliance by the country's competent authority with the National Shellfish Sanitation Program (NSSP) as set forth in a Compliance MOU between the United States and the signatory country or in accordance with an FDA equivalence determination of that country�s regulatory control system for bivalve molluscan shellfish. The competent authority can petition that the certified shellfish shipper be removed from this Import Alert by providing evidence to CFSAN, Office of Compliance. This includes products that have been found with bacterial or viral contamination and firms whose products have been associated with a food-borne illness outbreak. A copy of the petition and all relevant information supporting the petition should be forwarded to DIO. 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 forwarded to the following address: Food and Drug Administration Division of Import Operations 12420 Parklawn Drive, ELEM-3109 Rockville, MD 20857 Or 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 Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: The revision of this Import Alert (IA) dated updates the name of the alert, the guidance section, product description, adds/updates charges, and PAF. Changes are bracketed by asterisks (***). Examination of shipments of molluscan bivalve seafood from firms on the red list have been made. Salmonella, Vibrio cholera, other bacteria and/or viruses (e.g. Hepatitis A, Norwalk, etc.) were found, or epidemiological evidence associated the product with a food-borne illness outbreak. Additionally, some shipments were labeled as "cooked" when in fact the product only received a minimal heat treatment in order to "open" the shells.
Country-specific information is available in the full alert detail on the FDA website.
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