On December 18, 1995, The Food and Drug Administration (FDA) published as a final rule 21 CFR 123, "Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products" which requires processors of fish and fishery products to develop and implement Hazard Analysis Critical Control Point (HACCP) systems for their operations.
The FDA published the "Fish and Fishery Products Hazards and Controls Guide" ("the Guide") in 1996 and is sporadically updating “the Guide” online to assist processors in the development of their HACCP plans, and to provide information to help them identify hazards that may be associated with their products and formulate control strategies for those hazards.
Seafood processors/manufacturers are subject to compliance with both the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods Regulation (21 CFR Part 117 Subparts A, B and F) and the Seafood HACCP Regulation (21 CFR 123).
Frequently Asked Questions
- Seafood HACCP regulation applies to processors and importers selling fishery products for wholesale (i.e., sales to other businesses or distributors).
- Any products that are sold wholesale must be processed in accordance with the regulation, provided that the product is in interstate commerce. This is true even if the firm's primary business is retail.
Exemptions - The rule does not apply to:
- Harvesting or transporting fish or fishery products, without otherwise engaging in processing.
- Practices such as heading, eviscerating, or freezing intended solely to prepare a fish for holding on board a harvest vessel.
- Retail establishment solely selling fishery products to the end consumer.
- Fish means fresh or saltwater finfish, crustaceans, other forms of aquatic animal life (including, but not limited to, alligator, frog, aquatic turtle, jellyfish, sea cucumber, and sea urchin and the roe of such animals) other than birds or mammals, and all mollusks, where such animal life is intended for human consumption.
- Fishery product means any human food product in which fish is a characterizing ingredient.
- Molluscan shellfish means any edible species of fresh or frozen oysters, clams, mussels, or scallops, or edible portions of such species, except when the product consists entirely of the shucked adductor muscle.
- Processor means any person engaged in commercial, custom, or institutional processing of fish or fishery products, either in the United States or in a foreign country. A processor includes any person engaged in the production of foods that are to be used in market or consumer tests.
- Processing means, with respect to fish or fishery products: Handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding.
All processors must conduct, or have conducted for them, a hazard analysis to determine whether any food safety hazards are reasonably likely to occur in their product. This hazard analysis must be conducted for each location, each process, and each type of product processed. If no food safety hazards are identified, then a HACCP plan is not required.
Yes, a HACCP-trained individual must perform the hazard analysis initially, at least annually, and whenever there is a change in the firm's operations that might affect the hazard analysis, even if the product does not need a HACCP plan. However, the trained individual does not need to be an employee of the processor.
Seafood HACCP training consists of 2 courses: Basic Segment 1 and Segment 2. In-person or online virtual courses are listed on the Seafood HACCP Alliance website under the Seafood HACCP Training Course Information.
No, the seafood HACCP regulation does not require processors to have written SSOPs. However, a written plan is strongly recommended because an SSOP would help the processor identify the tasks necessary to meet the sanitation monitoring requirement in 21 CFR 123.11. In contrast, a firm is required to maintain sanitation monitoring records (e.g., sanitation schedule or checklist), regardless of whether seafood or fishery products are exposed or fully packaged in the facility.
There is no minimum percentage of fish that requires a food to be subject to the provisions of the seafood HACCP regulation. A product is subject to the regulations, if "fish" is a characterizing ingredient. For example, fish is a characterizing ingredient in "fish stew," but not in Worcestershire sauce, which contains a minor fish ingredient such as anchovy paste.
