The U.S. Food and Drug Administration (FDA) recently released an updated Fourth Edition of its Guidance for Industry entitled, “Fish and Fishery Products Hazards and Control Guidance, Fourth Edition – August 2019” (“the Seafood HACCP Guide”).1 The Seafood HACCP Guide is intended to assist processors of fish and fishery products in developing their Hazard Analysis Critical Control Point (HACCP) plans. Technically, the Seafood HACCP Guide is not binding, but in practice, FDA will expect companies either to follow the Seafood HACCP Guide or to be able to support the appropriateness of deviations from the guidance.
The Fourth Edition of the Seafood HACCP Guide was originally released in 2011, and the August 2019 updates reflect the agency’s ongoing effort to update the document. FDA determined specific chapters and appendixes of the Seafood HACCP Guide warranted updating based on the availability of new science and chose to publish those portions instead of withholding until a fully revised Guidance was ready for publication. The introduction chapter summarizes the changes and marks the updated portions with “as of August 2019” language. Going forward, FDA plans to treat the Seafood HACCP Guide as a “living document,” making updates to individual chapters on an as-needed basis and posting updates to FDA’s Seafood website (www.fda.gov/seafood).
On the whole, the updates largely reflect incremental changes in the Seafood HACCP Guide and do not reflect fundamental shifts in agency policy. FDA updated three chapters and two appendices. Perhaps most significantly, however, FDA has added two new appendices focused on allergen control. Processors should review the August 2019 changes carefully and in light of current company programs and practices, and the allergen control recommendations may also be useful for companies not operating under seafood HACCP.