Why FSVP doesn't apply
The Foreign Supplier Verification Program is FDA's default importer-verification framework for most FDA-regulated food. But FDA built in an exemption for foods already governed by an equivalent, dedicated safety regulation — and seafood qualifies. Fish and fishery products processed in compliance with the Seafood HACCP regulation (21 CFR Part 123) are exempt from standard FSVP. Juice, under its own HACCP rule (21 CFR Part 120), gets the same treatment.
That doesn't mean seafood importers have no verification obligation — it means the obligation lives in a different regulation, with its own mechanics: 21 CFR 123.12.
What 21 CFR 123.12 actually requires
Every importer of fish or fishery products has to satisfy one of two paths:
- Source from a country with an active FDA equivalency agreement — a memorandum of understanding covering that product, where FDA has already determined the foreign country's inspection system is equivalent to the US system.
- Take documented "affirmative steps" when no such agreement exists, which can include any of the following:
- Obtaining the foreign processor's HACCP and sanitation monitoring records for the specific lot being imported
- Obtaining a continuing or lot-by-lot compliance certificate from a foreign government authority or competent third party
- Regularly inspecting the foreign processor's facility
- Maintaining an English-language copy of the foreign processor's HACCP plan on file, with a written guarantee of compliance
- Periodically testing the imported product for the hazards relevant to that species
The paperwork looks similar to FSVP — treat it as a separate file
Because 123.12 verification and FSVP both involve supplier records, HACCP documentation, and periodic testing, it's tempting to fold seafood into an existing FSVP binder. Keep it separate. An FDA reviewer checking seafood compliance will look for the 123.12-specific documentation, not a generic FSVP file — and the two programs cite different regulatory sections if a deficiency gets written up.
Species-specific hazards the verification has to address
| Hazard | Applies to | Verified via |
|---|---|---|
| Histamine / scombrotoxin | Tuna, mahi-mahi, and other scombrotoxin-forming species | Time-and-temperature records, periodic histamine testing |
| Parasites | Species intended for raw or undercooked consumption | Documented freezing treatment logs |
| General decomposition | All species | Sensory examination records, CGMP adherence |
Frequently asked
Why is seafood exempt from FSVP?
Because it's already governed by its own dedicated food-safety regulation, the Seafood HACCP rule, which includes an equivalent importer-verification requirement at 21 CFR 123.12.
What counts as an "affirmative step" under 21 CFR 123.12?
Obtaining the foreign processor's HACCP and sanitation records for the lot, a compliance certificate from a government or third-party authority, regular facility inspection, or periodic product testing.