"Detention Without Physical Examination Of Fish And Fishery Products For Importer And Foreign Processor (Manuf) Combinations"

On December 18, 1997, 21 CFR Part 123, "Fish and Fishery Products" becomes effective. This 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, 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 purposes. The importer will usually be the consignee of the product.

Districts may detain, without physical sampling and analysis, firms/fish and fishery product(s) combinations as noted in the Red List of this import alert. (Note: Districts should refer to compliance program 7303.844 "Import Seafood Products" for implementation guidance.) Districts should be aware that for inclusion to or removal from detention without physical examination of importers/products/foreign processor combinations listed on the Red List in this alert, the following procedures apply:

When the district has determined that the importer has failed to meet HACCP verification requirements for a specific product and foreign processor (manufacturer), the district may recommend that the specific
importer/product/foreign processor (manufacturer) combination be subject to detention without physical examination and included on the Red List. Importers may be listed for particular products and foreign processors (manufacturers) associated with that importer, or importers may be listed for all products and all foreign processors associated with that importer. (Note: At this time, the Red List only includes information for illustrative purposes.)

A foreign processor's (manufacturer's) product may be detained, without physical examination, when the importer and the particular product(s) being imported are identified in the Red List to this alert. Note that importers not listed in the Red List, who may receive a foreign processor's (manufacturer's) product listed next to an importer that is listed in the Red List, would not have their imported products detained unless it is determined to be subject to other directives or found to be violative based on district examination.

If it becomes apparent that an importer has no verification procedures for any imported fish or fishery products, all such products from all processors (manufacturers) imported by that importer may be subject to detention without physical examination. The importer may then be placed on the Red List for all fish and fishery products from any foreign processors (manufacturers); product will be identified as fish.

Importers listed in the Red List may be removed from the list by submitting verification 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), and that appropriate verification of such processing is maintained by the importer. When districts determine that satisfactory verification has been provided
by the importer, districts may recommend to DIOP that the importer/ product/ processor (manufacturer) be removed from the Red List. (Note: the Red List will be updated as importer/product/foreign processor combinations are either added or removed from detention without physical
examination.)

Citing 21 CFR 123.12 (a) (Importer Verification), every importer of fish and fishery products shall either:

. Have and implement written verification procedures for ensuring that the fish and fishery products that they offer for import into the United States were processed in accordance with the requirements of 21 CFR Part 123; verify product specifications that are designed to ensure that the product is not adulterated under Section 402 of the Federal Food Drug & Cosmetic Act; and verify affirmative steps which may include any of the following:

. 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;

. 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;

. 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;

. 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;

. 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;

. Other such verification measures as appropriate that provide an equivalent level of assurance of compliance with the requirements of 21 CFR 123.12; OR, II. Hire a competent third party to assist with or perform any or all of the verification activities as specified in 21 CFR 123.12(a)(2), including writing the importer's verification procedures on behalf of the importer.

Further, 21 CFR 123.12(c) states that the importer shall maintain records, in English, that document the performance and results of the affirmation steps specified in 21 CFR 123(a)(2)(ii).

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 WITH FISH/FISHERY PRODUCT HACCP MOUs OR SIMILAR AGREEMENTS

COUNTRY PRODUCT(S)/PRODUCT CODE EFFECTIVE DATE

Canada Raw Molluscan Shellfish/16E[][][][] April 30, 1948

Chile Raw Molluscan Shellfish 16E[][][] May 18, 1989
Renewed: February 23, 2001

New Zealand Raw Molluscan Shellfish/16E[][][] October 30, 1980

South Korea Raw Molluscan Shellfish/16E[][][] April 8, 1987
Renewed: October 28, 1998

Note: Raw molluscan shellfish include fresh and frozen oysters, clams, mussels and whole or roe-on scallops.

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 it may be injurious to health, due to the failure of the importer to provide verification of compliance pursuant to 21 CFR 123.12(d) [Adulteration, 402(a)(4)]."

OASIS charge code - MFRHACCP