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New FDA Draft Guidance Impacts Seafood Importers & Processors

On February 9, 2024, FDA issued “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal of a Foreign Manufacturer’s Goods from DWPE.” This draft guidance covers collecting samples for seafood products subject to Detention without Physical Examination (DWPE) under an Import Alert “because of the appearance of adulteration caused by pathogens, unlawful animal drugs, scombrotoxin (histamine), and/or decomposition.”

This is a major change in FDA’s Import Alert policies, and it will impact all seafood importers eventually and many foreign seafood processors immediately. How many? Just look at how many seafood companies are on FDA import alert (see FDA industry code 16) and then consider all the other country-wide import alerts affecting seafood (e.g., in industry code 99).  Ben England, CEO and Founder of FDAImports comments, “And as usual, this is a “draft” policy guidance – FDA never wants to call something final for fear of a (well-deserved) lawsuit.”

Here FDA is extending its totally unworkable “draft” policy guidance on reconditioning portions of untested seafood shipments in circumstances where FDA finds a violation in one line of several lines. FDA is extending that policy into its expectations for sampling product already on Import Alert to obtain release after detention or to use as evidence for removal from automatic detention.  England points out, “This overall approach is unworkable for several reasons.”

One/ The FDA’s Office of Seafood in CFSAN (Center for Food Safety and Applied Nutrition) is rarely satisfied with any evidence submitted that relates to seafood processing (e.g., HACCP plans or CAPAs) without finding more HACCP violations and creating more problems.

Two/ The minimum number of recommended subsamples is so high it would overwhelm a private lab and be cost prohibitive. FDA gives the following example (pp 5-6)—

“Example: An importer has an article of frozen tilapia fillets subject to DWPE due to the appearance of unlawful animal drug residues. The article consists of seven line items delineated by the size or weight of the fillets. . . . In this example, the 150 sample units recommended in the sampling Table in Appendix A for unlawful animal drugs are collected proportionately by the volume of product in the lines. In addition, consistent with the recommendations above for sampling by lines, assurances should be made that a cross representation of production codes are included within the group of sample units collected from each line as may be applicable to that line”

150 subsamples! For unapproved drugs, and that assumes there are not multiple lots/product codes!

Three/ The FDA field compliance officers will largely have no idea how to implement this so every import alert automatic detention will have to become a reconditioning and have to be reviewed by . . . wait for it . . . CFSAN/Office of Seafood.

Four/ “In my opinion, this will be treated like an invalid regulation (lacking notice and comment),” England adds.

You should notice FDA is requesting comment – but this is in effect now.

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