Most importers who take seafood HACCP seriously land on the same arrangement. They ask each foreign processor for an English copy of its HACCP plan and a written guarantee, put both in a folder, and renew them once a year. That is affirmative step (d) under §123.12(a)(2), and it is a legitimate choice among the six.
It is also the step most likely to be found inadequate, for a reason that has nothing to do with whether the paperwork is on file.
What the regulation says
§123.12(a)(2) requires an importer to have written verification procedures with two parts: product specifications designed to ensure the product is not adulterated, and at least one affirmative step per product and per processor. The six steps are listed in §123.12(a)(2)(ii):
| Step | |
|---|---|
| (a) | Obtaining the foreign processor's HACCP and sanitation monitoring records for the lot |
| (b) | Obtaining a continuing or lot-by-lot certificate from a foreign government authority or a competent third party |
| (c) | Regularly inspecting the processor's facility |
| (d) | Obtaining an English copy of the processor's HACCP plan plus a written guarantee |
| (e) | Periodically testing the product plus a written guarantee |
| (f) | Other verification measures that provide an equivalent level of assurance |
Nothing in the text ranks them. An importer choosing (d) is doing what the regulation contemplates.
Where (d) comes apart
The gap is between holding a plan and the plan being adequate.
FDA's Compliance Program 7303.842, the instruction its investigators work from on seafood HACCP inspections, directs the investigator to look at the plan the importer is holding and compare it against the hazards the Fish and Fishery Products Hazards and Controls Guidance (Fourth Edition, June 2022) identifies for that species and that process. Where the processor's plan does not address a significant hazard the Guide identifies, the affirmative step is treated as inadequate — because a plan that omits the hazard cannot give the importer assurance about the hazard.
Put plainly: step (d) is not "do you have the plan," it is "is the plan you have any good." The importer is on the hook for a document written by someone else, in another country, that they may never have read against the Guide.
What that looks like in practice
Take farm-raised shrimp from a BAP-certified plant. A common hazard analysis reads: farms are BAP-certified, therefore antibiotic residue is not reasonably likely to occur, and no control is applied at receiving.
The Guide treats unapproved aquaculture drug residues as a significant hazard for farm-raised product (Chapter 11). Third-party certification is not a control for it — certification schemes audit farm practice on a cycle; they do not verify the residue status of the lot in front of you. An importer holding that plan under step (d) is holding a plan with a gap, and the gap is the finding.
The same shape recurs: a histamine-forming species with no time and temperature control from harvest; a ready-to-eat cooked product with no control for recontamination after the cook; a molluscan shellfish plan with no harvest-area control.
What an importer can actually do about it
Three things, in order of effort:
- Read each plan against the Guide's chapter for that species and process, and write down what you checked. The Guide's Chapter 3 tables are the index: Table 3-2 for vertebrates, Table 3-3 for invertebrates, Table 3-4 for process-related hazards. A short memo per supplier-product, dated and signed, is the record that the review happened.
- Send the gap back to the processor and keep the reply. A gap you identified and closed is a stronger file than a plan with no gaps you ever looked for.
- Use a trained individual. §123.10 requires one to perform or review the hazard analysis — and it says expressly that this person need not be an employee of the firm. An importer without in-house seafood HACCP expertise is not stuck; it can engage one.
The honest caveat
The Guide is guidance. Its own cover page says it "contains nonbinding recommendations" and describes FDA's current thinking. It is not a regulation, and a processor is free to reach a different conclusion with a documented rationale. What it is, in practice, is the document the investigator is holding during the inspection — which makes checking against it the cheapest way to know what you will be asked.
Citations: 21 CFR 123.9, 123.10, 123.12. FDA Compliance Program Guidance Manual 7303.842, Domestic and Imported Fish and Fishery Products. FDA, Fish and Fishery Products Hazards and Controls Guidance, Fourth Edition, June 2022. Nothing here is legal advice, and it is not a determination about any particular firm's compliance.