Seafood HACCP Program (FDA 21 CFR Part 123)

A complete seafood HACCP program for processors, packers, warehouses that process, and importers of fish and fishery products. It is written to FDA 21 CFR Part 123 and the FDA Fish and Fishery Products Hazards and Controls Guidance. It includes 51 editable Word documents: a program manual, 19 procedures, 5 worked HACCP plans and 24 forms.

FDA requires every fish and fishery product processor to conduct a hazard analysis and, where a hazard is reasonably likely to occur, to have and follow a written HACCP plan. You must also monitor eight key sanitation conditions every day, keep records for one to two years and reassess the plan at least once a year. Importers must also have written verification procedures for every foreign supplier.

This program gives you each of those pieces, ready to adapt to your own products:

• Seafood HACCP Program Manual (HPM-SEA): scope, HACCP policy, team and a section-by-section map of 21 CFR 123.6 to 123.12.

• 19 procedures, covering:

  • hazard analysis and plan development

  • scombrotoxin (histamine)

  • Clostridium botulinum in reduced oxygen packaged and smoked fish

  • parasites

  • cooking and pasteurization

  • natural toxins and molluscan shellfish source controls

  • allergens and species labeling

  • receiving

  • importer verification

  • monitoring, corrective actions and verification

  • the eight key sanitation conditions

  • calibration

  • complaints and recall

• 5 worked example HACCP plans:

  • fresh tuna and mahi-mahi

  • cold-smoked vacuum-packed salmon

  • vacuum-packed raw fish portions

  • live oysters for raw consumption

  • cooked ready-to-eat shrimp

  Each plan has its hazard analysis worksheet, critical limits, monitoring, corrective actions, verification and records.

• 24 forms, including:

  • receiving logs with harvest vessel records

  • cooler and freezer logs

  • cooking and pasteurization logs

  • brining and water-phase salt log

  • histamine sampling record

  • shellstock tag log

  • importer affirmative step record

  • daily sanitation record

  • corrective action record

  • records review

  • annual reassessment

Who it is for

• Seafood processors, smokers, packers and cold storage operations that process

• Importers of fish and fishery products who need verification under 21 CFR 123.12

• Companies preparing for an FDA seafood HACCP inspection or answering a warning letter

What you receive

An instant download of one organized zip file. It contains a READ ME, the manual and master document list, the procedures, the HACCP plans and the forms. All 51 documents are editable Microsoft Word files.

Good to know

• 21 CFR 123 requires a trained individual to develop the plan, reassess it and review records. A Seafood HACCP Alliance course meets this requirement, and the training procedure explains the options.

• The example critical limits come from the FDA Hazards Guidance. Confirm each limit against your own process before you use it.

• Do you also need ISO 22000 or FSSC 22000 certification? See the Food Safety Management System products.