Note: The revision of this Import Alert (IA) dated 12/18/2024 updates the reason for alert, guidance section including agency contacts, and product description section. Changes to the import alert are bracketed by asterisks (***). Salmonella is a pathogenic bacterium that is a leading cause of human foodborne illness. All age groups are susceptible to Salmonella infections. The U.S. Centers for Disease Control and Prevention estimates that Salmonella bacteria cause about 1.35 million infections, 26,500 hospitalizations, and 420 deaths in the United States every year with food being the source for most of these illnesses. Salmonella in seafood is directly attributable to fecal contamination of the water environment of the fish, or insanitary conditions and/or temperature abuse in the post-harvest handling/processing. Salmonella are not endemic to the intestinal tracts of finfish, crustaceans, or mollusks. The occurrence of Salmonella in seafood is associated with human or animal fecal contamination of the water environment and/or by contamination of the seafood after the catch or harvest. FDA expects zero or non-detectable levels of Salmonella in seafood, when analyzed per FDA standard methods listed in the Bacterial Analytical Manual (BAM) or equivalent methods. When seafood is found to be contaminated with Salmonella by BAM methodology or its equivalent, FDA considers the product to be adulterated regardless of whether it is intended to be consumed raw or cooked. This alert applies to seafood products that appear to be adulterated due to the presence of Salmonella. This import alert has been developed for seafood products from firms/countries which do not readily fit into previously existing import alerts. This may not be the only Import Alert to identify seafood products found to be contaminated with salmonella.
Multiple � Seafood Products
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health." [Adulteration, Section 402(a)(1)] OASIS charge code - SALMONELLA
Divisions may detain without physical examination, all shipments of the specified seafood product(s) from the manufacturers/shippers ***or finished products of other commodity types that are identified as being composed, in whole or in part, of any seafood products listed from the firms identified on the Red List for this alert*** due to the presence of Salmonella. Bacteriological Analytical Manual (BAM), Chapter 1, is used for Salmonella sampling plans and Chapter 5, is used for Salmonella analysis. Recommendations for additions to the Red List of this import alert, should be forwarded to the Division of Import Operations (DIO). Release of Articles Subject to Detention Without Physical Examination under This Import Alert: ***In order to secure the release of an individual shipment identified for detention without physical examination (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 Salmonella. Such evidence could include private laboratory analysis of samples that were collected to be representative of the affected article. 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. Following receipt and review of private laboratory 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 (REMOVE FROM RED LIST): ***To remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the food producer has resolved the conditions that gave rise to the violation. 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 DWPE, refer to FDAs 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 DWPE 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 or the submissions of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed 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: Note: The revision of this Import Alert (IA) dated 12/18/2024 updates the reason for alert, guidance section including agency contacts, and product description section. Changes to the import alert are bracketed by asterisks (***). Salmonella is a pathogenic bacterium that is a leading cause of human foodborne illness. All age groups are susceptible to Salmonella infections. The U.S. Centers for Disease Control and Prevention estimates that Salmonella bacteria cause about 1.35 million infections, 26,500 hospitalizations, and 420 deaths in the United States every year with food being the source for most of these illnesses. Salmonella in seafood is directly attributable to fecal contamination of the water environment of the fish, or insanitary conditions and/or temperature abuse in the post-harvest handling/processing. Salmonella are not endemic to the intestinal tracts of finfish, crustaceans, or mollusks. The occurrence of Salmonella in seafood is associated with human or animal fecal contamination of the water environment and/or by contamination of the seafood after the catch or harvest. FDA expects zero or non-detectable levels of Salmonella in seafood, when analyzed per FDA standard methods listed in the Bacterial Analytical Manual (BAM) or equivalent methods. When seafood is found to be contaminated with Salmonella by BAM methodology or its equivalent, FDA considers the product to be adulterated regardless of whether it is intended to be consumed raw or cooked. This alert applies to seafood products that appear to be adulterated due to the presence of Salmonella. This import alert has been developed for seafood products from firms/countries which do not readily fit into previously existing import alerts. This may not be the only Import Alert to identify seafood products found to be contaminated with salmonella.
Country-specific information is available in the full alert detail on the FDA website.
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