Import Alert 16-120

"Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP"

On December 18, 1997, 21 CFR Part 123 became effective. Under this regulation, all fish and fishery products, whether foreign or domestic in origin, are required to be prepared, packed and held in facilities operating under mandatory HACCP requirements. Foreign processors who fail to meet these requirements may have entries subject to detention without physical examination until such time as such documentation demonstrating compliance is provided, as described in "GUIDANCE" section of this import alert.

FDA might determine the foreign processor's compliance through inspection of the foreign processor, inspection of an importer, review of import entry records, or through review of an importer's seafood product reconditioning proposal.

Districts may detain, without physical sampling and analysis, fish and fishery products from foreign processors(manufacturers) as noted in the Red List to this import alert.

(Note: Districts should refer to Compliance Program 7303.0844, "Import Seafood Products" for implementation guidance.

Districts should be aware that for inclusion to or removal from detention without physical examination of foreign processor/product combinations listed in the Red List to this import alert, the following procedures apply:

When CFSAN has determined that a foreign processor has failed to meet HACCP requirements for a specific product, the Center may recommend that the foreign processor/product(s) combination for detention, without physical examination, and minor revision to this alert to incorporate the foreign processor in the Red List to this import alert.

Foreign processors listed on the Red List to this import alert may be removed from that list by submitting documentation demonstrating that they are in compliance with the seafood HACCP regulation (21 CFR, Part 123). The foreign processor should provide a letter detailing its corrective actions, accompanied by documentation, to CFSAN's Office of Compliance, Division of Enforcement (HFS-605).

For technical and scientific questions regarding adequacy of foreign processor HACCP documentation, contact CFSAN's Office of Food Safety, Division of Seafood Safety.

Fish and Fishery Products (see attachment)

"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 failure of the foreign processor to comply with 21 CFR 123 [Adulteration, 402(a)(4)]."

OASIS charge code - MFRHACCP