21 CFR Part 123 - Fish and Fishery Products (Seafood HACCP)

What it says

Processors of fish and fishery products must conduct a hazard analysis and, where hazards are reasonably likely to occur, implement a written HACCP plan that identifies critical control points, critical limits, monitoring, corrective actions, verification and recordkeeping, and must monitor sanitation conditions. Importers must have procedures to verify that the fish they import was processed under comparable safeguards.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Seafood has long had its own HACCP rule, so this is a hazard-specific system separate from the Part 117 preventive controls framework.
• Hazards commonly considered include pathogens such as Clostridium botulinum, histamine formation in certain species, parasites and chemical contaminants, and the plan depends on the species and process.
• Sanitation monitoring is a separate requirement, and covers conditions such as water safety, food-contact surfaces, cross-contamination, pest control and employee health.

What FDA inspectors look for

• Whether a hazard analysis exists for each product and process and a HACCP plan where hazards require one.
• Whether monitoring records show critical limits were met and were reviewed.
• Whether sanitation monitoring is performed and documented.

Related regulations