Clearing red-listed seafood through the FDA? There’s a procedure for that.
by Peter Quinter, guest columnist
The US Food and Drug Administration (FDA) issues “Import Alerts” almost daily. A recent one that affects many seafood importers is Import Alert #16-81, issued May 1 and 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. 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. Any seafood from companies on the “Red List” will not be allowed to enter the United States, but will instead be detained because of the suspected presence of salmonella pursuant to 21 USC 801(a)(3).
Fortunately, there is a procedure to clear seafood that has been automatically detained, even if it is on the Red List, through the FDA. 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). A private laboratory familiar with food testing for FDA import procedures must be used, with samples obtained, submitted, and analyzed by that food testing laboratory. A lab 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 US 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.
There is a separate procedure for foreign suppliers identified on the Import Alert’s Red List for detention without physical examination to submit a request that they be removed from the list 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.
Please call or email me with any questions or comments at [email protected] or (954) 270-1864.
Copyright © 2012 GrayRobinson
About Peter Quinter
Long-time Datamyne Blog contributor Peter Quinter is a Shareholder in the law firm of GrayRobinson and Chair of the firm’s Customs & International Trade Law Group. Based in the firm’s Miami and Ft. Lauderdale offices, Quinter principally represents persons and companies involved in international trade and transport. He is editor of the GrayRobinson Customs and International Law Blog. Quinter is widely recognized for his expertise in international and trade law: He was appointed by the US Secretary of Commerce to the Florida District Export Council; Florida Trend magazine recognizes him among its “Legal Elite” in the area of International Law; Florida Super Lawyer magazine includes him in the top 5% of Florida attorneys; and he is recognized in “Best Lawyers in America” in the area of FDA Law.
You can contact Peter Quinter at [email protected] or at (954) 270-1864.
The opinions expressed in this article are those of its author and do not purport to reflect the opinions or views or Descartes Datamyne. In addition, this article is for general information purposes only and it’s not intended to provide legal advice or opinions of any kind and my not be used for professional or commercial purposes. No one should act, or refrain from acting, based solely on this article without first seeking appropriate legal or other professional advice.