Covered seafood processors must conduct a hazard analysis. A written HACCP plan is required when that analysis identifies one or more food safety hazards reasonably likely to occur—not automatically for every processor or product. This guide was substantively corrected against primary sources on 5 October 2026; its genuine publication date remains 27 July 2026.
Scope and product-specific hazard analysis
21 CFR 123 applies to covered domestic and foreign processing of fish and fishery products for human consumption. Processing includes handling, storing, freezing, packing, labeling and holding. Part 123 excludes harvesting or transport without other processing, certain onboard activities solely to prepare fish for holding on a harvest vessel, and retail establishments. These scope exclusions are not themselves food-facility registration exemptions; assess registration under its separate rules. Fish of the order Siluriformes, including catfish, fall under USDA-FSIS oversight rather than ordinary FDA seafood oversight; confirm the applicable program before using this guide.
Under 123.6, assess each kind of fish/product, including hazards introduced before, during and after harvest. A required plan is specific to each processing location and kind of product. Group products or production methods only when the hazards, critical control points, critical limits and required procedures are identical. A conclusion that no written plan is required needs a sound hazard analysis, and changes that could affect that conclusion require reassessment under 123.8.
Part 123 requirements: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-123/subpart-A
Qualified functions and sanitation
Section 123.10 requires the designated plan-development, reassessment/modification and specified records-review functions to be performed by individuals with appropriate training at least equivalent to the standardized curriculum recognized by FDA, or equivalent job experience that provides the required knowledge. A particular commercial course or two-/three-day attendance certificate is not the sole qualification route. Record the relevant individual's competence and assigned functions.
Section 123.11 separately requires monitoring applicable sanitation conditions and practices and maintaining the required monitoring/correction records. Where a HACCP plan is required, its implementation, verification and corrective actions need substantive evidence, not merely a document bearing a HACCP title.
Identify the seafood importer and the whole verification framework
The 123.3(g) importer is the U.S. owner or consignee at entry, or the U.S. agent or representative of the foreign owner or consignee at entry responsible for import compliance. Ordinarily it is not the customs broker, freight forwarder or carrier. This role is distinct from the registration US Agent; do not assume one appointment automatically performs the other role.
Under 123.12, an importer may use an applicable active memorandum of understanding or similar agreement with the exporting country that covers the fish/product and functions and is enforceable in its entirety. Otherwise the importer must maintain written verification procedures containing BOTH product specifications that ensure the product is not adulterated under the stated unsafe/insanitary conditions AND appropriate affirmative steps to ensure processing complies with Part 123.
Affirmative steps can include obtaining relevant HACCP/sanitation monitoring records for the specific lot, a continuing or lot certificate from a competent authority/third party, regular inspection, an English HACCP plan together with a written processor guarantee, periodic testing together with a guarantee, or other equivalent verification measures. Select and document an appropriate permitted approach; a certificate, test or records alone does not replace the entire written-procedures/specifications framework. Competent third parties may assist. Retain English records documenting the affirmative steps and their results.
A lack of assurance can make the product appear adulterated and subject to refusal under the applicable procedures. It does not establish that every shipment or every future shipment is automatically refused, or that a commercial partner must terminate the relationship.
FSVP and preventive controls: conditional exemptions
Section 1.501(b)(1) exempts the relevant fish/fishery products from FSVP when imported from a foreign supplier required to comply with, and in compliance with, Part 123; the seafood importer obligations in 123.12 remain. Section 1.501(b)(2) separately addresses imported raw materials/other ingredients used by an importer to manufacture or process fish/fishery products subject to Part 123, provided that processor complies with Part 123 for the resulting products. Do not assume every food imported by a seafood business is exempt.
Section 117.5(b) exempts activities subject to Part 123 and compliant with it from Part 117 Subparts C and G. Applicable current good manufacturing practice duties continue; this is not an exemption from all food-safety obligations or from registration.
FSVP scope: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-L/section-1.501
Preventive-controls exemption: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-117/subpart-A/section-117.5
Species, intended use and practical controls
Use FDA's Fish and Fishery Products Hazards and Controls guidance to assess actual species, harvest source, aquaculture practices, product form, processing, packaging and intended consumption. Relevant hazards may include histamine in susceptible species, parasites in certain fish intended for raw/undercooked consumption, natural toxins, harvest-area pathogens, aquaculture drug residues, allergens and time/temperature-related pathogen growth. They are not all reasonably likely in every product.
Parasite control depends on species, source and intended use. FDA describes exceptions and conditions, including certain tuna species and properly supported aquaculture circumstances. When freezing is an appropriate control, the validated time/temperature process must suit the actual product, thickness and equipment; calling a product “frozen” is insufficient. Do not apply a universal freezing recipe to all seafood or infer that every raw tuna requires it.
Histamine controls consider harvest and handling conditions, time to chilling, ambient/water temperatures, whether fish are landed alive or dead, and subsequent storage/processing. Fish need not universally already be at 4.4°C at the instant of death. Select the guidance's applicable control strategy and maintain evidence; a universal chilling statement can hide the actual hazard.
FDA hazards and controls guidance: https://www.fda.gov/food/seafood-guidance-documents-regulatory-information/fish-and-fishery-products-hazards-and-controls
November 2024 histamine compliance policy
FDA's final compliance policy guide distinguishes a 35 ppm histamine criterion associated with decomposition/insanitary conditions from a 200 ppm health-related criterion. Its regulatory-action guidance uses applicable lot sampling and original/check analysis, including one or more subsamples at or above the relevant criterion. The described sampling framework can use up to 30 subsamples; review the actual compliance program and product circumstances rather than treating one convenient test as clearance evidence.
The guide concerns scombrotoxin-forming fish and fishery products; its regulatory-action criteria exclude dried fish and fermented fish sauces/pastes intended only as condiments or minor flavoring ingredients. Sensory evidence and illness-related evidence can also matter. This nonbinding enforcement guidance does not establish guaranteed safe levels, override applicable law or supply a company's HACCP critical limits. FDA can consider action below the stated criteria based on the evidence.
FDA November 2024 announcement: https://www.fda.gov/food/hfp-constituent-updates/fda-issues-final-compliance-policy-guide-scombrotoxin-histamine-forming-fish-and-fishery-products
Full compliance policy guide: https://www.fda.gov/media/182955/download
Recommended processor/importer handover worksheet
This original recommended workflow is not an FDA-approved HACCP plan. Create a row for each product/location/import route. Suggested columns: species and harvest/aquaculture source; product form and intended use; processing location and actual activities; hazard-analysis result and supporting rationale; applicable HACCP plan version and sanitation evidence; qualified individual's functions and training/experience evidence; responsible 123.3(g) importer; importer product specifications; applicable agreement or written-procedures route; chosen affirmative steps and English evidence; responsible processor/importer owners; unresolved gaps, action dates and review triggers.
Have the processor supply product/location-specific safety evidence and the importer document its own verification obligations. A registration number, US Agent appointment or Prior Notice confirmation does not substitute for this handover. Reassess changes in species, source, processing or intended use and keep evidence of completed corrections.
Registration, renewal and shipment steps remain separate
Assess facility registration and exemptions separately from seafood HACCP. Facilities required to register renew during 1 October–31 December 2026; registering or updating before 1 October does not replace renewal during that window. FDA charges no food registration or renewal filing fee. Annual paid US Agent coverage and professional service fees are separate from statutory biennial renewal.
Use authorized account access and retain completion evidence; never share account passwords or PINs. Legitimate Prior Notice handoffs may require the applicable food-registration number, but credentials do not belong in shipment paperwork. Prior Notice, HACCP review, importer verification and registration each have their own purposes and responsible parties.
FDABridge is an independent provider. Confirm available registration/US Agent service scope and professional terms through the existing service or contact page. This guide does not promise specialist HACCP review services, approval, compliance of an entire supply chain, processing times or shipment release.
2026 renewal guide: https://fdabridge.com/blog/fda-food-facility-registration-renewal-2026
Food registration service: https://fdabridge.com/food-facility-registration
Importer evidence guidance: https://fdabridge.com/blog/fsvp-gap-analysis-what-foreign-food-suppliers-must-document-for-us-importers
Notice-response guide: https://fdabridge.com/blog/fda-import-detention-and-refusal-why-shipments-get-held-and-how-to-prevent-it
FDA 2026 renewal reminder: https://www.fda.gov/food/hfp-constituent-updates/fda-reminds-food-facilities-biennial-renewal-requirements
Enquiries: https://fdabridge.com/contact
FDA/USDA Siluriformes oversight: https://www.fda.gov/food/hfp-constituent-updates/fda-transfers-siluriformes-fish-inspection-usda