Tag: 16-81
Import Alert 16-81
Import Alert 16-81: Detention of Seafood Products
Background
FDA created this Import Alert for listing foreign seafood firms that have had Salmonella contamination problems. This import alert does not include shrimp from Bangladesh, Hong Kong, India, Indonesia, Taiwan, and Thailand, covered by Import Alert 16-18, or shrimp from India, covered by Import Alert 16-35. All other seafood and shrimp products tested and found to contain Salmonella appear on the Red List for this Import Alert. Although FDA created this Import Alert because of the severity of the food-borne illness caused by Salmonella, it covers raw, uncooked seafood as well as cooked Ready to Consume seafood. Of course, unless fresh or frozen raw seafood is intended for raw consumption, later cooking would destroy any Salmonella in the product. This demonstrates FDA’s “zero-tolerance” for Salmonella in food, which is mostly due to the cross contamination risks represents.
How do Firms get on this Import Alert?
FDA adds firms to this Import Alert if any of their products test positive for Salmonella. Just one positive sample will prompt FDA to refuse the tested shipment, resulting in destruction or exportation of the entire tested lot, and t0 place the firm on the Red List of this Import Alert, resulting in Automatic Detentions of all future shipments of the same (or even similar) products from that foreign processor.
Effects on Businesses Involved
Raw seafood is highly perishable. Consequently, this Import Alert can significantly restrict a company’s access to the U.S. market because of the delays caused by FDA Automatic Detentions. It is not uncommon that resolving FDA Automatic Detentions through private laboratory testing can take longer than the shelf life of raw, fresh seafood. Because Salmonella is considered a significant food safety risk the public nature of this Import Alert can be very damaging to a company’s business with existing customers. Even if future shipments are clean, FDA will Automatically Detain them until the processor and its products are removed from the Red List. FDA may also require foreign processors to submit corrective actions and a new Hazard and Critical Control Point (HACCP) plan for Agency review prior to releasing shipments. That HACCP plan review, if required, will significantly increase delays because the plans are rarely reviewed by the FDA officer detaining the shipment but have to be submitted to FDA Headquarters for review.
How do Companies get off this Import Alert?
Firms can be removed from this Red List, but shipping five consecutive clean shipments alone will not solve the problem. Rather, evidence must be submitted to FDA in the form of a Import Alert Petition proving that the reasons that led FDA to add the firms to the Red List have been resolved. Companies should consider requesting an Import Alert Petition Viability Review to determine whether there is adequate evidence to prepare and submit an Import Alert Petition.
