FDA’s Hazard Analysis & Critical Control Points (HACCP) – Seafood & Juice

Foreign Seafood or Juice Manufacturers

FDA has issued regulations requiring seafood and juice manufacturers, processors, handlers, and importers follow HACCP principles. When FDA finds a problem with imported seafood or juice, the agency often will ask to see the importer's and the foreign supplier’s HACCP plan.

If your product is subject to FDA’s HACCP requirements, it is important to conduct a hazard analysis of the product and the manufacturing-handling-shipping processes, to correctly identify potential hazards. Those potential hazards must be controlled at appropriate points and using relevant strategies and measurements. These controls must be documented.

On many occasions, international suppliers and processors borrow HACCP plans from others in the market place and substitute it as their own. This is a common and dangerous mistake. Each HACCP plan must be specifically tailored to the products and processes undertaken in a given facility. Another common mistake, particularly among multiple food processors, is to over-commit in the HACCP plan and then fail to implement the plan completely. If this is detected, FDA will take specific action against the processor for failing to follow the processor’s own HACCP plan.

Seafood or juice products that were not manufactured under a valid HACCP plan are adulterated due to manufacturing, packing or storage under insanitary conditions. FDA regularly places foreign processors with inadequate (or no) HACCP plans on Import Alert. Consequently, FDA will detain future entries from that processor without physical examination or sampling. Because the articles appear to be adulterated due to insanitary conditions at the manufacturer, FDA will not permit the detained articles to be reconditioned to obtain their release. This effectively bans the supplier's product from the U.S. market.

FDAImports.com consultants and affiliated attorneys routinely assist clients in conducting hazard analyses and preparing HACCP plans. FDAImports.com has been able to leverage a client’s adherence to the HACCP regulations and guidance documents to obtain removal from FDA import alert or release of FDA detained products.

Domestic HACCP Inspections

FDA regularly inspects domestic seafood and juice manufacturers, processors, packers, storage facilities, and importers to ensure they have implemented the agency's HACCP requirements. FDAImports.com consultants and affiliated attorneys regularly assist domestic facilities in preparing for FDA or state HACCP inspections.

In addition, when FDA detains imported seafood or juice based upon violations FDA detected through sampling and analysis, the agency requires submission of evidence of the importer's HACCP verification and affirmative steps before accepting an application to recondition the imported article. FDAImports.com assists importers in complying with FDA's special importer requirements and record keeping regulations.