Seafood and International Trade Law
Navigating FDA’s import alerts
Monday,14 May,2012 14:33:24
The U.S. Food and Drug Administration (FDA) almost daily issues “Import Alerts.” A recent one that affects many seafood importers was issued on May 1, 2012, is Import Alert #16-81, and is entitled “Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella.” The Import Alert identified hundreds of specific companies from countries all over the world. Any seafood from those listed companies on the “Red List” will not be allowed to enter the United States, but instead be detained because of the suspected presence of salmonella pursuant to 21 USC 801(a)(3).
Fortunately, there is a procedure to clear the seafood through FDA for any automatically detained seafood, even if it is on the Red List. Although many people mistakenly believe that adulterated food may come from certain countries such as China, the truth is that there are hundreds of companies listed from countries including Korea, Japan, Thailand, India, Philippines, etc. An importer must establish to the FDA that the particular shipment of seafood has been tested using the Salmonella Analyses described in the Bacteriological Analytical Manual (BAM), 7th Edition (1992). Use of a private laboratory familiar with food testing for FDA import procedures must be contacted, and samples obtained, submitted and analyzed by the food testing laboratory. A laboratory report must then be issued by the private laboratory to the FDA. Once the FDA laboratory reviews the report and determines that the particular shipment is not adulterated with salmonella, the FDA compliance officer at the local port where the food is being detained will authorize the release of the shipment through an FDA Notice of Action. Otherwise, the seafood will be “refused” by the FDA, and, within 90 days, must be destroyed under FDA supervision or exported from the United States under the supervision of the U.S. Customs and Border Protection (CBP). An attorney familiar with both CBP and FDA import procedures often works with the importer to coordinate the activities of the private laboratory with the local FDA compliance officer.
Moreover, there is a specific procedure for foreign suppliers identified on the Import Alert’s Red List to be removed from detention without physical examination through a request to the FDA’s Division of Import Operations and Policy (DIOP). That means that a foreign manufacturer or supplier of seafood can permanently get off the Red List so that the seafood it ships to the United States will automatically proceed through FDA without being detained and examined. The process may take several weeks to several months before the FDA issues a decision on the request for removal from the Red List.