Seafood HACCP: a plan for each fish, and records for each lot
Each kind of fish product needs its own hazard analysis, and every lot needs records that show the plan was followed.
In Short
- Monitor sanitation in eight set areas.
- Reassess the plan at least once a year.
- Records: 1 year refrigerated, 2 years frozen or shelf-stable.
The Food Processing Operations Guide
Safe changeovers. Right labels. Every lot traceable.
- The rules and the plan
- Supplier to filled tray
- Allergen changeovers and pack checks
- Trace, recall and record review
Plus Evidence map and four worksheets.
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The Food Processing Operations Guide
Safe changeovers. Right labels. Every lot traceable.
21 CFR Part 123 is FDA's binding HACCP rule for fish and fishery products. Every processor needs a hazard analysis and, where hazards are reasonably likely, a written HACCP plan. Sanitation is monitored separately. This guide covers the sections processors ask about most. Every section cited was checked on the eCFR on 2 Oct 2026.
Hazard Analysis and the Plan
123.6 requires a hazard analysis for each kind of fish and fishery product. Where a food safety hazard is reasonably likely, the processor has a HACCP plan listing hazards, critical control points, critical limits, monitoring, corrective actions, verification and records.
More on hazard Analysis and the Plan
FDA's Fish and Fishery Products Hazards and Controls Guidance helps identify species and process hazards.
Eight sanitation areas
123.11 requires processors to monitor sanitation in eight areas: water safety; condition and cleanliness of food-contact surfaces; prevention of cross-contamination; hand washing and toilet facilities; protection from adulterants; labeling, storage and use of toxic compounds; employee health; and exclusion of pests. A written sanitation SOP is recommended.
The eight sanitation areas (123.11)
Corrective Actions
123.7 lets processors use corrective action plans written in advance. When a deviation happens without one, the affected product is segregated and held until a review decides whether it is acceptable, and the HACCP plan is reassessed.
Worked Example: Cooler Temperature Deviation
- 06:00Tuna lot TN-882 cooler reads above the critical limitReceiving
- 06:05Lot segregated and held under the corrective action planHACCP lead
- 07:30Histamine samples taken; cooler repairedQA, maintenance
- Day 2Results reviewed; trained person decides disposition and records itHACCP lead
Verification and Reassessment
123.8 requires verification that the plan is adequate and working, including reassessment at least annually and whenever changes could affect the hazard analysis. Records of monitoring, corrective actions and calibration are reviewed.
Records and who decides
123.9 requires records to be kept for at least 1 year after preparation for refrigerated products and 2 years for frozen, preserved or shelf-stable products. V5 records checks against limits, flags results outside them, and keeps corrective actions and lot trace.
More on records and who decides
Trained people decide product disposition.
Also relevant: Food Safety Control & Traceability Buyer Guide (14-page PDF, on the Food Safety page).
Questions
Is seafood HACCP law or guidance?
21 CFR Part 123 is binding law. FDA's Fish and Fishery Products Hazards and Controls Guidance is nonbinding guidance that helps processors identify hazards and controls.
How often must a seafood HACCP plan be reassessed?
Under 123.8, at least annually and whenever changes occur that could affect the hazard analysis or the plan.
How long are records kept?
Under 123.9, at least 1 year after preparation for refrigerated products and at least 2 years for frozen, preserved or shelf-stable products.
Does V5 decide what happens to product after a deviation?
No. V5 records monitoring, flags results outside limits and keeps corrective actions and lot trace. Trained people decide disposition.
Practical orientation, not legal advice. Rules differ by jurisdiction; your quality and compliance team decides what applies.
Keep reading
21 CFR 111 Readiness: Identity, Master and Batch Records
21 CFR Part 211 Guide: Scope, Batch Controls and QCU Review
21 CFR 212 PET Drug cGMP Readiness: Production Evidence Guide
BSE Feed Rule Readiness: 21 CFR 589.2000 and 589.2001 for Feed and Pet Food
21 CFR 820 to ISO 13485 Crosswalk: Re-citing Procedures Under the QMSR
21 CFR Part 11 Readiness Guide for Regulated Manufacturers