Seafood HACCP: Fish and Fishery Products

Coverage follows the definitions of fish, fishery products and processing in Part 123. The analysis considers species-related hazards as well as hazards introduced through handling, packaging or processing. A product description should capture intended use and distribution conditions. Ownership alone is not the same activity as processing, and retail exclusions need to be assessed under the actual definition. Part 123.

A written HACCP plan is required when the hazard analysis identifies a hazard reasonably likely to occur. Critical control points, limits, monitoring, corrective action, verification and records must address that hazard. Histamine formation, parasites, pathogens and environmental contaminants do not share a single control strategy. FDA’s guidance organizes hazards by fish species and processing conditions. Fish-hazards guidance.

The sanitation provisions cover conditions including water safety, food-contact surfaces, cross-contamination and employee practices. Sanitation monitoring is not a substitute for an HACCP control that is needed for a product hazard. A written sanitation procedure can support management, but the distinction between a recommended document and a specifically required record must remain clear. FDA HACCP questions and answers.

The plan and hazard analysis require reassessment under the regulation, including at least the prescribed annual reassessment. Certain HACCP activities require an appropriately trained or otherwise qualified individual. Monitoring records, corrective actions and verification evidence should correspond to the actual lot and control. A general course certificate alone does not establish that a processor’s plan is adequate. Part 123 verification and training.

Importers have specific verification responsibilities under section 123.12. Molluscan shellfish source controls and smoked-fish provisions address additional hazards. The relationship between seafood HACCP and FSMA provisions requires attention to the product and activity; it should not be reduced to a statement that seafood is outside all modern food-safety requirements. Part 123 import and product provisions.

Use the current regulatory text to establish duties, then locate the relevant species and process chapters in the FDA guide. The linked guidance page identifies its June 2022 edition and nonbinding status. Its examples support a reasoned hazard analysis; they are not universal limits for every product. FDA does not issue a seafood HACCP logo proving processor compliance. Guidance · FDA explanation.