Fish and Fishery Products (Seafood HACCP)
FDA's seafood HACCP regulation — the original mandatory HACCP regime in US food law, final 18 December 1995 and effective December 1997, two decades before FSMA. Processors of fish and fishery products must conduct a hazard analysis and operate a written HACCP plan controlling the hazards reasonably likely to occur, with dedicated provisions for smoked fish and raw molluscan shellfish and verification duties for importers.
What this does not cover
stated in the document's own scope- Covers processors and importers of fish and fishery products; other food categories follow the FSMA preventive-controls regime in Part 117, not this part.
- A processing regulation: harvesting-vessel and farm activities are largely outside it, and molluscan-shellfish harvest-area classification runs through the National Shellfish Sanitation Program framework it references.
- Mandates HACCP for seafood; it predates and is distinct from FSMA — describing it as a FSMA rule misstates twenty years of regulatory history.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
21 CFR Part 123, "Fish and Fishery Products", is the seafood HACCP regulation — the first mandatory HACCP regime in US food law, finalised in December 1995 and effective from December 1997, nearly two decades before FSMA generalised preventive controls. Every processor of fish and fishery products must conduct a hazard analysis and, where hazards are reasonably likely to occur, operate a written HACCP plan: critical control points, critical limits, monitoring, corrective actions, verification, and records. The part adds sanitation-control monitoring keyed to eight key sanitation conditions, processor-specific provisions for smoked and smoke-flavored fishery products and raw molluscan shellfish, and a verification duty on importers to ensure their foreign suppliers process under equivalent controls.
Scope & applicability
Domestic and foreign processors of fish and fishery products for the US market, plus importers. Distinct from the FSMA preventive-controls regime: facilities complying with Part 123 are exempt from the Part 117 preventive-controls subpart for their seafood HACCP-covered activities.
Legal basis & how it acquires force
A regulation issued under the FD&C Act's adulteration and general rulemaking authorities, published as a final rule on 18 December 1995 (60 FR 65096) and effective 18 December 1997. Fish and fishery products processed in violation of Part 123 are deemed adulterated. FSMA left the regime intact: seafood HACCP-covered activities are exempt from the preventive-controls subpart of 21 CFR Part 117 precisely because Part 123 already occupies the ground.
Document structure
| Part | Covers |
|---|---|
| Subpart A — General provisions | Definitions, the hazard analysis and HACCP plan requirement (§123.6), corrective actions, verification, records, training, and sanitation control |
| Importer verification | The affirmative steps importers must take to verify foreign suppliers process under HACCP-equivalent controls |
| Subpart B — Smoked and smoke-flavored fishery products | Process-specific controls for smoked fish |
| Subpart C — Raw molluscan shellfish | Source controls, including harvest-area and tagging requirements, for raw molluscan shellfish |
Key requirements
- Hazard analysis identifying food-safety hazards reasonably likely to occur (§123.6)
- A written HACCP plan with critical control points, critical limits, monitoring, and corrective actions
- Sanitation monitoring keyed to the eight key sanitation conditions
- Specific controls for smoked and smoke-flavored fishery products and raw molluscan shellfish
- Importer verification that foreign suppliers operate equivalent HACCP controls
Implementation tips
- Build the plan from the FDA Fish and Fishery Products Hazards and Controls Guidance — it is the reference FDA reviews plans against, species by species and process by process
Revision notes
Final rule of 18 December 1995 (60 FR 65096), effective 18 December 1997. FSMA left the seafood HACCP regime in place rather than folding it into Part 117.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
Part 123 applies the Codex-style HACCP model — hazard analysis, CCPs, limits, monitoring, corrective action, verification, records — as binding US law for one commodity sector. It coexists with FSMA: Part 117 preventive controls exempt seafood HACCP activities, while the Foreign Supplier Verification Program (21 CFR Part 1 Subpart L) and Part 123's own importer-verification provisions divide the import-assurance work. FDA's Fish and Fishery Products Hazards and Controls Guidance is the reference against which plans are built and reviewed.
21 CFR Part 123: frequently asked questions
Quick answers to common questions about 21 CFR Part 123.
Is seafood HACCP part of FSMA?
No. Part 123 was finalised in 1995 and effective in 1997, long before FSMA (2011). FSMA deliberately left it in place: facilities conducting seafood HACCP-covered activities are exempt from Part 117's preventive-controls subpart for those activities, because Part 123 already imposes a hazard-control system.
What must a seafood HACCP plan contain?
For each hazard reasonably likely to occur: the critical control points, critical limits, monitoring procedures, corrective-action procedures, verification procedures, and a record-keeping system documenting monitoring at the CCPs. The plan must be product- and process-specific and signed by the most responsible individual.
What are importers required to do under Part 123?
Take affirmative steps to verify that the fish and fishery products they import were processed in accordance with HACCP-equivalent requirements — for example obtaining the foreign processor's HACCP plan and evidence of compliance — and keep records of the verification.
Which products get extra requirements under Part 123?
Smoked and smoke-flavored fishery products (Subpart B) and raw molluscan shellfish (Subpart C), the latter tying processors to approved harvest areas and shellstock tagging under National Shellfish Sanitation Program-based controls.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.