In addition to being regulated under 21 CFR Part 110, Good Manufacturing Practices, wholesalers of seafood are also regulated under 21 CFR Part 123, Fish and Fishery Products. The term "fish" includes all fresh or saltwater fin fish, molluscan shellfish (see shellfish program
for more information), crustaceans, and other forms of aquatic animal life.
Every processor must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur for each kind of fish and fishery product processed by that processor and to identify the preventive measures that the processor can apply to control those hazards. Every processor must also have and implement a written hazard analysis of critical control points (HACCP) plan whenever a hazard analysis reveals one or more food safety hazards that are reasonably likely to occur. Additionally, each processor should have and implement written standard sanitation operating procedures
(SSOP´s). The SSOP´s must be monitored and monitoring records must be maintained by the firm.
On November 9, 2011, FDA issued a "letter to industry"
which explains the agency's expectation for industry's compliance with the changes in the 4th edition of the Fish and Fishery Products Hazards and Controls Guidance document. FDA explains that guidance in the 4th edition was effective when released on April 28, 2011 and that investigators are using the information in the new Guide to evaluate HACCP plans. If violations of the HACCP regulations are observed during inspections, FDA will consider the extent to which a firms HACCP plan is based on recommendations from the 3rd edition of the guidance prior to determining regulatory action.
Links to additional seafood HACCP information:
Title 21 CRF Part 110 Good Manufacturing Practices Title 21 CFR Part 123 Fish and Fishery Products Title 21 CFR Part 113 Low Acid Canned Foods
Fish and Fishery Products Hazards Control Guide, 4th Edition
Q&A: HACCP regulations for fish and fishery products
OSU Seafood Network Information Center
Oregon Department of Agriculture publications:
Key points for seafood HACCP
The basic HACCP guide