21 CFR Part 123 requires a HACCP plan for each kind of fish and fishery product processed, along with sanitation control records and, for importers, procedures to verify that imported product was processed under conditions consistent with the rule. It is not satisfied by a generic HACCP template.
What makes seafood distinctive is that the hazards attach to species and to harvest conditions as much as to process. Scombrotoxin formation, ciguatera, parasites in fish intended for raw consumption, aquaculture drug residues and environmental chemical contaminants all require species-level analysis.
The hazards that drive the plan
The FDA Fish and Fishery Products Hazards and Controls Guidance is the reference regulators expect controls to be built from. Working through it species by species is the substance of the job.
- Histamine (scombrotoxin) in susceptible species — formed through temperature abuse in harvest or transport and not reversible by cooking, so receiving controls and supplier history carry the control
- Parasites in fish intended for raw or undercooked consumption, generally requiring a specified freezing time and temperature with records or supplier documentation
- Ciguatera toxin associated with certain reef species from certain harvest areas
- Aquaculture drug residues, requiring supplier documentation and in some cases testing
- Environmental chemical contaminants and metals depending on species and origin
- Pathogen growth and toxin formation during processing, cooling and storage
- Allergen and species substitution issues, including economically motivated adulteration
Where existing plans fail review
The most common defect is a single plan covering "seafood" rather than a plan for each kind of fish and fishery product, with hazards that do not differentiate between a tuna loin destined for raw service and a farmed white fish that will be fully cooked.
The second is critical limits with no citable basis. Parasite destruction parameters, cooling parameters and histamine-related receiving criteria should trace to FDA guidance or another defensible source. "Industry practice" is not a basis.
The third is receiving records that do not evidence the control. Where the histamine control is at receiving, the record needs to show the temperature measured, by whom, against what criterion, and what happened when it failed — including the disposition decision.
Importers and retail sushi programs
Seafood importers have obligations under Part 123 Subpart A, including procedures to verify that imported product was processed in accordance with HACCP requirements. Seafood subject to Part 123 is generally exempt from FSVP for hazards controlled under that rule, so importers should confirm which framework they are being inspected against before building a program.
Retail sushi programs sit in a different regulatory space — the jurisdiction's adopted food code — but face overlapping hazards. Parasite destruction documentation for fish served raw, and a HACCP plan (and often a variance) for sushi rice acidification, are the two items health departments raise most often.
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