Note: The revision of this Import Alert (IA) dated 09/6/2024 updates the guidance section and charge code language. Changes to the import alert are bracketed by asterisks (***). There has been an extensive commercialization and an increased consumption rate of aquaculture seafood products. Aquaculture, also known as fish and shellfish farming, refers to the breeding, rearing and harvesting of aquatic food animals under environmentally controlled conditions with some form of intervention to enhance production, such as regular stocking, feeding, prevention and treatment of diseases, protection from predators, etc. Aquaculture activities are conducted in all types of water environments, freshwater, coastal and marine, inland ponds, tanks, reservoirs, rivers, lakes, estuaries, bays, fjords, and open sea. Aquaculture production is vulnerable to diseases and changing environmental conditions. The use of veterinary drugs in animal production is necessary to treat and control diseases; however, this use may result in the residues found in products for human consumption. The use of unapproved drugs and the misuse of FDA approved new animal drugs in aquaculture species is a concern. These uses may increase due to limited availability of treatment options, specifically for new emerging diseases. Veterinary drugs can also be administered to improve the production, e.g., to enhance feed efficiency and rate of weight gain. Residues of animal drugs, the parent compound, or its metabolite, in food may cause acute or chronic effects. As this industry grows, the use of unapproved new animal drugs and the misuse of approved new animal drugs in seafood raised through aquaculture also grows. The use of unapproved new animal drugs will have an impact on the safety of aquaculture products for consumers.
Aquaculture seafood (breeding, rearing and harvesting of aquatic food animals under environmentally controlled conditions with some form of intervention)
***"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a food that appears to bear or contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512." [ADULTERATION, 402(a)(2)(C)(ii)]*** OASIS charge code: VETDRUGRES
Divisions may detain without physical examination, all specified products from the firm(s) identified on the Red List of this import alert. ***Note: IA #16-124 applies to all unapproved animal drugs in seafood, with the exception of chloramphenicol and nitrofuran findings, which are subject to IA #16-127 (Chloramphenicol) and IA #16-129 (Nitrofurans).*** ***Recommendations for DWPE addition to Red List require documentation of Center/Program concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE additions to Red List 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 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 unapproved drugs. Such evidence could include private laboratory analysis of a representative sample of the detained product. Importers should provide analytical results for the specific parent drug and its metabolite(s) identified on the firm's listing on the Red List of this Alert. Evidence should be submitted to the appropriate FDA Division compliance office for consideration per the notice of detention. For further information regarding private laboratory analyses, please reference FDA's Laboratory Procedure-Private Laboratory Analytical Packages. Following receipt and review of private laboratory analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article. The methods found in the Analytical section of FDA's Compliance Program (CP) 7304.018, PART IV ANALYTICAL, Section 3.B., relevant to the specific residues may be utilized. Alternatively, other methods that adhere to FDA-recognized method validation/verification procedures for the specific residue under consideration may be used with inclusion of supporting documentation in the submission of analytical test results. For information on reporting analytical test results by drug class, i.e., individual drugs and their metabolites, refer to CP7304.018 (PART IV - ANALYTICAL, Section 3.C.). 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 demonstrate 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 request 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 should be addressed to OII/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. For technical and scientific questions regarding adequacy of foreign processor HACCP documentation, contact CFSAN's Office of Microbiological Food Safety, Division of Seafood Safety at (240)402-2300 or SeafoodHACCP@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 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 09/6/2024 updates the guidance section and charge code language. Changes to the import alert are bracketed by asterisks (***). There has been an extensive commercialization and an increased consumption rate of aquaculture seafood products. Aquaculture, also known as fish and shellfish farming, refers to the breeding, rearing and harvesting of aquatic food animals under environmentally controlled conditions with some form of intervention to enhance production, such as regular stocking, feeding, prevention and treatment of diseases, protection from predators, etc. Aquaculture activities are conducted in all types of water environments, freshwater, coastal and marine, inland ponds, tanks, reservoirs, rivers, lakes, estuaries, bays, fjords, and open sea. Aquaculture production is vulnerable to diseases and changing environmental conditions. The use of veterinary drugs in animal production is necessary to treat and control diseases; however, this use may result in the residues found in products for human consumption. The use of unapproved drugs and the misuse of FDA approved new animal drugs in aquaculture species is a concern. These uses may increase due to limited availability of treatment options, specifically for new emerging diseases. Veterinary drugs can also be administered to improve the production, e.g., to enhance feed efficiency and rate of weight gain. Residues of animal drugs, the parent compound, or its metabolite, in food may cause acute or chronic effects. As this industry grows, the use of unapproved new animal drugs and the misuse of approved new animal drugs in seafood raised through aquaculture also grows. The use of unapproved new animal drugs will have an impact on the safety of aquaculture products for consumers.
Country-specific information is available in the full alert detail on the FDA website.
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