Note: The revision of this Import Alert (IA) dated 07/27/2022 updates the reason for alert section, guidance section, agency contacts, and charge code language. Changes to the import alert are bracketed by asterisks (***). ***In 21 CFR Part 123, "Fish and Fishery Products" the regulation provides special requirements for imported products under 21 CFR 123.12. Importers who import fish or fishery products and fail to meet these requirements may have their entries subject to detention without physical examination (DWPE), until such time as verification of compliance by the importer is provided, as noted in the "Guidance" section of this Import Alert. For compliance with 21 CFR 123.12 "Special Requirements for Imported Products," the term "importer" is defined by 21 CFR 123.3(g) as "...either the U.S. owner or consignee at the time of entry into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States, who is responsible for ensuring that the goods being offered for entry into the United States are in compliance with all laws affecting the importation. For the purposes of this definition, ordinarily the importer is not the custom house broker, the freight forwarder, the carrier, or the steamship representative." NOTE: The definition of "importer" for the purpose of enforcing 21 CFR 123.12 is significantly different from the definition traditionally used for U.S. Customs and Border Patrol (CBP) purposes. ***
Fish and fishery products (See the Red List for specific firm(s)/product(s) combinations)
"The article is subject to refusal of admission, pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions, or may have become injurious to health, due to the failure of the importer to provide verification of compliance pursuant to 21 CFR 123.12." [Adulteration, Section 402(a)(4)] OASIS charge code � IMPTRHACCP
Divisions may detain, without physical examination, shipments of the specified product/foreign processor/importer combinations as noted on the Red List of this import alert. Divisions should be aware that for inclusion to DWPE of importers/products/foreign processor combinations to the Red List of this alert, ***one of the following must apply: � When the Division determines that the importer has failed to meet HACCP verification requirements for a specific product and foreign processor (manufacturer), the division may recommend that the specific importer/product/foreign processor (manufacturer) combination be added to the Red List of this Alert. � When FDA has requested assurances that the products from a foreign processor (manufacturer) were processed in compliance with Part 123 and the importer has failed to obtain and provide the requested records and documentation demonstrating compliance under 21 CFR 123.12(d). � Importers may also be listed for all products and all foreign processors associated with that importer when it becomes apparent that they have no verification procedures for any imported fish or fishery products. Note: � Foreign processors (manufacturer's) shipments should subject to DWPE only when the importer and product are identified within the manufacturer's firm listing found on the Red List of this Alert. � Foreign processors (manufacturer's) shipping product identified on the Red List of this Alert to an importer which is NOT identified within the manufacturer's firm listing found on the Red List of this Alert, would not be subject to DWPE.*** ***Removal from Detention without Physical Examination (REMOVE FROM RED LIST): In order to remove a product/foreign processor/importer combination from the Red List, information should be provided to the Agency that adequately demonstrates that the importer implemented the verification procedure required in 21 CFR 123.12. Importers listed on the Red List of this import alert may be removed by submitting the required verification procedure for the foreign processor/product which may include: � Written product specifications for the detained product(s); and/or � Evidence of the implementation of an affirmative step for the detained product and foreign processor (manufacturer), including: � Obtaining from the foreign processor the HACCP and sanitation monitoring records required by 21 CFR 123 that relate to the specific lot of fish or fishery products offered for import; OR � Obtaining either a continuing or lot-by-lot certification from an appropriate foreign government inspection authority or a third party, certifying that the imported fish or fishery product is or was processed in accordance with the requirements of 21 CFR 123; OR � Regularly inspecting the foreign processor's facilities to ensure that the imported fish or fishery product is being processed in accordance with the requirements of 21 CFR 123; OR � Maintaining on file a copy, in English, of the foreign processor's HACCP plan, and a written guarantee, in English, from the foreign processor that the imported fish or fishery product is processed in accordance with the requirements of 21 CFR 123; OR � Periodically testing the imported fish or fishery product, and maintaining on file a copy, in English, of a written guarantee from the foreign processor that the imported fish or fishery product is processed in accordance with 21 CFR 123; OR � Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of 21 CFR 123.12. When the importer/foreign processor/product has been added to the Red List for failure to meet the requirements of 21 CFR 123.12(d), the importer must provide the previously requested assurances per 21 CFR 123.12(d) that the fish or fishery product(s) in question has/have been processed in compliance with the seafood HACCP regulation (21 CFR part 123). 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)."*** NOTE: Importers who obtain fish and fishery products from a country that has an active Memorandum of Understanding (MOU) or similar agreement with the Food and Drug Administration that covers the fish and fishery product and documents the equivalency or compliance of the inspection system of the foreign country with the U.S. system, accurately reflects the current situation between the signing parties, and is functioning and enforceable in its entirety, are not required to provide verification as in 21 CFR 123(a)(2)(i) and (ii). As seafood HACCP MOUs or similar agreements with foreign governments are established, a list of these MOUs will be included in the guidance section of this import alert. COUNTRIES AND ASSOCIATED PRODUCT CODES WITH FISH/FISHERY PRODUCT HACCP MOUs OR SIMILAR AGREEMENTS Canada Raw Molluscan Shellfish/ 16E[][][] New Zealand Raw Molluscan Shellfish/ 16E[][][] South Korea Raw Molluscan Shellfish/ 16E[][][] Mexico Raw Molluscan Shellfish/ 16E[][][] Note: Raw molluscan shellfish include fresh and frozen oysters, clams, mussels and whole or roe-on scallops. ***If a firm and/or a representative thereof would like to submit a petition for removal from DWPE 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 ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov For technical and scientific questions regarding adequacy of foreign processor HACCP documentation, contact CFSAN's Office of Food Safety, Division of Seafood Safety at (240) 402-2300 or via email to: SeafoodHACCP@fda.gov. ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 07/27/2022 updates the reason for alert section, guidance section, agency contacts, and charge code language. Changes to the import alert are bracketed by asterisks (***). ***In 21 CFR Part 123, "Fish and Fishery Products" the regulation provides special requirements for imported products under 21 CFR 123.12. Importers who import fish or fishery products and fail to meet these requirements may have their entries subject to detention without physical examination (DWPE), until such time as verification of compliance by the importer is provided, as noted in the "Guidance" section of this Import Alert. For compliance with 21 CFR 123.12 "Special Requirements for Imported Products," the term "importer" is defined by 21 CFR 123.3(g) as "...either the U.S. owner or consignee at the time of entry into the United States, or the U.S. agent or representative of the foreign owner or consignee at the time of entry into the United States, who is responsible for ensuring that the goods being offered for entry into the United States are in compliance with all laws affecting the importation. For the purposes of this definition, ordinarily the importer is not the custom house broker, the freight forwarder, the carrier, or the steamship representative." NOTE: The definition of "importer" for the purpose of enforcing 21 CFR 123.12 is significantly different from the definition traditionally used for U.S. Customs and Border Patrol (CBP) purposes. ***
Country-specific information is available in the full alert detail on the FDA website.
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