Food safety rules for seafood processors in Puerto Rico

Who does part 123 apply to?

The rule defines "fish" broadly: fresh or saltwater finfish, crustaceans, other aquatic animal life (the rule names, among others, aquatic turtles, jellyfish, sea cucumbers and sea urchins) and all mollusks intended for human consumption (21 CFR 123.3(d)).

It also defines "processing" broadly: handling, storing, preparing, heading, eviscerating, shucking, freezing, changing market forms, manufacturing, preserving, packing, labeling, dockside unloading or holding. It does not apply to harvesting or transporting without other processing, to practices on board solely to hold the catch, or to operating a retail establishment (21 CFR 123.3(k)).

Hazard analysis and HACCP plan

Each processor must conduct a hazard analysis for each kind of fish or fishery product and have a written HACCP plan, specific to each location and product, when the analysis finds hazards reasonably likely to occur (21 CFR 123.6(a) and (b)). The rule asks you to consider:

• Natural toxins.
• Microbiological contamination.
• Chemical contamination, pesticides and drug residues.
• Decomposition in scombrotoxin (histamine) forming species, or in others where it is linked to a hazard.
• Parasites, when the product will be eaten without a process that kills them.
• Unapproved use of direct or indirect food or color additives.
• Physical hazards.

Who can develop the plan

Developing the plan, reassessing it and reviewing records must be done by someone who completed seafood HACCP training equivalent to an FDA-recognized curriculum, or who is qualified by equivalent job experience. They need not be an employee of the processor (21 CFR 123.10).

Sanitation: the eight areas you monitor

The rule recommends a written SSOP for each location and requires monitoring sanitation often enough in eight areas: water and ice, food-contact surfaces, cross-contamination (including raw to cooked product), hand washing and toilets, protection from contaminants, handling of toxic compounds, employee health and pest exclusion. Problems are corrected in a timely manner and the monitoring and corrections are documented (21 CFR 123.11).

Records and imports

Records are kept at least 1 year for refrigerated products and at least 2 years for frozen, preserved or shelf-stable products. Records on the adequacy of equipment or processes, such as scientific studies, are kept at least 2 years after they stop applying (21 CFR 123.9(b)).

If you import fish or fishery products, the rule requires that they come from a country with an active agreement with FDA covering the product, or that you have written verification procedures for the foreign supplier (21 CFR 123.12).

Part 123 also has specific subparts for smoked and smoke-flavored fishery products (subpart B) and raw molluscan shellfish (subpart C). When you comply with part 123, subparts C and G of 21 CFR 117 do not apply to those activities (21 CFR 117.5(b)).

Facility registration

Every plant in Puerto Rico that manufactures, processes, packs or holds food for consumption in the United States is a "domestic facility" to FDA and must register before it starts, even if its product never leaves the island (21 CFR 1.225 and 1.227). Registration is renewed every other year, between October 1 and December 31 of each even-numbered year (21 CFR 1.230).