The Food and Drug Administration (FDA) has taken a new and unnerving approach to directing warnings to foreign seafood processors even though the Agency has not inspected the foreign facility. Recently, FDA issued warning letters to three Indonesian tuna factories alleging those foreign facilities were committing ongoing Hazard Analysis and Critical Control Point (HACCP) violations without even entering the plants. Based upon this, FDA is also intending to automatically detain shipments of affected seafood from those facilities – and the Agency could go further.
Last October, FDA inspected a domestic seafood importer, Gourmet Fusion Foods Inc., located in California. During the inspection, FDA collected copies of the HACCP plans from its suppliers. In December 2017, FDA issued warning letters to Gourmet Fusion Foods Inc.’s three Indonesian tuna suppliers after reviewing only their HACCP Plans and finding multiple inadequacies. From that review, FDA determined seafood processed at those facilities were (or at least appeared to be) adulterated.
In the warning letters FDA identified significant deviations, such as the failure to establish cumulative time and temperature controls for the histamine hazard and pathogen controls for the potential of C. botulinum in a Ready-to-Eat (RTE) seafood product. Also, FDA found that proposed corrective actions recited in the HACCP plan did not stress discovery and correction of root causes of failures. FDA requested a response within the normal 15 days seeking an explanation of the actions the factory will take to address the violations. Specifically, FDA wanted to see a revised HACCP plan and five days of implementation records demonstrating use of a corrected and adequately revised plan. This means that FDA not only wanted to see what is revised on paper (a revised HACCP plan), but documents proving new and adequate measures have been consistently put into action. In addition, FDA also requested information about the factories’ supply chains; whether the facilities received tuna directly from vessels or from another processor to evaluate whether the proposed controls will actually address the relevant hazards.
Of course, it is not uncommon for FDA to list these companies on Import Alert 16-120, “Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP.” Listing on Import Alert 16-120 will result in automatic detention of seafood from the affected facilities. Because the importer is unable to test a seafood shipment from a foreign facility lacking an adequate HACCP program into compliance, this import alert acts as an effective ban of the listed companies’ products from the United States market. Obtaining removal from Import Alert 16-120 is a lengthy process – sometimes years – of proving to FDA seafood experts that the foreign supplier’s seafood HACCP plan is adequate and compliant. Once FDA is reviewing a HACCP plan (and implementation records) there are always more and new questions to ask and refinements the Agency wants to see. There are many examples where factories have made the revisions according to an FDA Warning Letter only to find out FDA has new issues and concerns – and the Import Alert 16-120 remained in force until all questions were resolved.
Important points to note:
- It is certainly easier for FDA to inspect a domestic importer and review its suppliers’ HACCP plans for compliance rather than conducting a foreign inspection of the suppliers. And FDA is comfortable using this tactic to place the foreign supplier on Import Alert. Therefore, foreign suppliers and importers should be sure their HACCP plans are compliant and accurate.
- Importers should ensure they have on file up-to-date copies of their suppliers’ HACCP plans and that the plans are adequate. Otherwise, FDA can shut down their supply chains after a domestic importer inspection.
- Commercial transactions between foreign suppliers and U.S. importers should be evaluated to ensure commercial risks are properly allocated among the parties. These risks could arise from an FDA inspection at the importer, an inspection at the foreign supplier’s facility, or at the border during importation of a seafood shipment.
The team at FDAImports.com assist importers and suppliers with HACCP planning and Import Alert green listing. Importers attending the Seafood Expo North America in Boston, March 11-13, 2018, are welcome to meet with our team there. Click here to learn about our panel discussion, “FDA and Customs Enforcement Actions: What to Expect in 2018.”
