Note: The revision of this Import Alert (IA) dated 08/7/2023 updates the guidance section including agency contacts and charge code language. Changes to the import alert are bracketed by asterisks (***). L. monocytogenes can survive and grow in low-pH, high-salt, and low-temperatures making it a hazard for food processing facilities and especially ready-to-eat (RTE) seafood. L. monocytogenes can form biofilms and persist in food processing environments for many years. It is usually found in moist environments which commonly occur in areas where raw fish are processed. It can be introduced into a food processing facility from raw materials, humans, and equipment. It is essential for seafood processors to implement strict sanitation controls to prevent food from contamination. Although L. monocytogenes has been isolated from a variety of seafood products, outbreaks have been associated with RTE seafood such as smoked mussels, smoked trout, and smoked salmon. FDA expects zero or non-detectable levels of L. monocytogenes in RTE seafood, when analyzed per FDA standard methods listed in the Bacterial Analytical Manual (BAM) or equivalent methods. RTE food means any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards (21 CFR 117.3).
Processed Seafood and Analogue Seafood (Surimi) Products
***The article is subject to refusal of admission pursuant to 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health. [Adulteration, Section 402(a)(1)]*** OASIS charge code: LISTERIA
Divisions may detain without physical examination, shipments of the specified products from firms identified on the Red List of this Alert. Release of Articles Subject to Detention Without Physical Examination Under This Import Alert: In order to secure release of an individual shipment subject to 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 Listeria monocytogenes. Such evidence could include private laboratory analysis of a representative sample of the detained product. ***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 ORA Lab Manual, Volume III, Section 7. 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.*** *** Beginning 12/02/2025, 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 *** Removal from Detention Without Physical Examination (REMOVE FROM RED LIST): In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of 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 detention without physical examination, 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 detention without physical examination under this Import Alert, all relevant information supporting the request should be sent via email to: Importalerts2@fda.hhs.gov Please see the FDA�s Removal from DWPE under Import Alert page for more information. Questions or issues involving import operations or the submission 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 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 Human Foods Program/Office 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 08/7/2023 updates the guidance section including agency contacts and charge code language. Changes to the import alert are bracketed by asterisks (***). L. monocytogenes can survive and grow in low-pH, high-salt, and low-temperatures making it a hazard for food processing facilities and especially ready-to-eat (RTE) seafood. L. monocytogenes can form biofilms and persist in food processing environments for many years. It is usually found in moist environments which commonly occur in areas where raw fish are processed. It can be introduced into a food processing facility from raw materials, humans, and equipment. It is essential for seafood processors to implement strict sanitation controls to prevent food from contamination. Although L. monocytogenes has been isolated from a variety of seafood products, outbreaks have been associated with RTE seafood such as smoked mussels, smoked trout, and smoked salmon. FDA expects zero or non-detectable levels of L. monocytogenes in RTE seafood, when analyzed per FDA standard methods listed in the Bacterial Analytical Manual (BAM) or equivalent methods. RTE food means any food that is normally eaten in its raw state or any other food, including a processed food, for which it is reasonably foreseeable that the food will be eaten without further processing that would significantly minimize biological hazards (21 CFR 117.3).
Country-specific information is available in the full alert detail on the FDA website.
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