FDA HACCP Resources

The FDA's Fish and Fishery Products Hazards and Controls Guidance - Fourth Edition website provides resources to help processors of fish and fishery products to understand the hazards associated with seafood and develop their Hazard Analysis and Critical Control Point (HACCP) plans.

HACCP also applies to aquacultured or "farmed" seafood products, such as oysters and finfish. The FDA's Aquacultured Seafood website provides a general overview, including consumer information, FDA guidance documents, and education and outreach.

Included in the FDA guidance document are six educational videos about identifying and controlling seafood hazards:

• Time-Temperature Indicators (TTIs) discusses using TTIs to control growth and toxin production by Clostridium botulinum in refrigerated, reduced oxygen packaged seafood products.
• Time and Temperature Controls during Unrefrigerated Processing discusses how to control pathogen growth during unrefrigerated processing of raw ready-to-eat and cooked ready-to-eat seafood products.
• Secondary Processor Receiving and Storage Controls discusses receiving and storage controls for Secondary Processors to control scombrotoxin formation and pathogen growth in seafood products.
• Heat Process Validation discusses the general factors to consider when validating heat processes for seafood products.
• Primary Processor Scombrotoxin Controls – Overview and Testing at Receiving discusses the general strategies recommended by FDA for preventing scombrotoxin formation at the receiving critical control point.
• Primary Processor Scombrotoxin Controls – Harvest Vessel Records discusses the Harvest Vessel Record control strategy recommended by FDA for preventing scombrotoxin formation at the receiving critical control point.

Additional Guidance from the FDA

• "Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act," released in August 2017. This guidance explains requirements for seafood processors issued by the Food and Drug Administration under the federal Food Safety Modernization Act (FSMA). The document describes which parts of the FSMA rules apply to seafood processors, how the rules may affect the processors' operations, and which parts of the FSMA rules exempt seafood products.

For more information about FDA HACCP regulations and how they apply to the Maryland seafood processing industry, please contact our Extension personnel.

Maryland Sea Grant Extension Personnel   Chengchu "Cathy" Liu Seafood Technology Specialist