All firms around the world that export to the USA vacuum packaged or modified atmosphere packaged raw seafood are automatically subject to Import Alert #16-125, “Detention without Physical Examination of Refrigerated Vacuum Pak or Modified Atmosphere Packaged Raw Fish and Fishery Product” (IA 16-125). Under IA 16-125, FDA automatically detains all shipments from firms that are not on an FDA ‘Green List’. The alert was designed by FDA to prevent fatal botulism poisoning (Clostridium botulinum), which can be a risk associated with raw seafood shipped in packages that prevent the seafood from oxygen exposure (anaerobic conditions). Since September 2009, FDA had only placed 46 foreign firms (from around the world) on the ‘Green List’ for Import Alert #16-125.
A report from Benjamin L. England, from FDAImports.com, states that there are such a small number of companies on the Green List due to the serious nature of botulism. This can present a significant danger for consumers, and can also threaten the trustworthiness of the FDA. The FDA’s main job is to protect the food supply of the United States. Botulism is a deadly threat, most notably when it comes to babies. Because of this situation, the FDA has created an international alert concerning imports. Ultimately, it’s a good thing to get your firm listed on this Green List report. Only 46 companies do not have to undergo DWPE and are listed on this Green List. No other firm is allowed to send raw seafood into the United States using anaerobic packages.
Importers of vacuum packaged (Vac-pac) and modified atmosphere packaged (MAP) raw fish and fishery products are automatically subject to IA 16-125. To be permitted to ship to the U.S. at all, foreign processors must first get on the ‘Green List’ or get their “Green Ticket”. FDA and Customs Agents detain all refrigerated (not frozen), raw fish in Vac-pac or MAP packaging. “Not even discussing the legality of this alert, this is a case of being declared guilty until you prove you are innocent.” stated Mr. England, “It’s not impossible, it’s just costly. Getting on the Green List is the only ‘way through’ in this case.”
Foreign companies that import, make, or process food are looking at a more powerful and watchful FDA in the upcoming years. The FDA received 20% more in funds in 1010, and the president is asking for 19% more funds for the FDA in the year 2011. Thanks to the damage the FDA has taken in recent years concerning the dangers inherent in imported food items, a lot of that money is going toward the enforcement of food safety regulations.
In order to get listed under IA #16-125’s Green List and avoid having your exports detained on their way into the US, or if you are uncertain regarding the compliance of your firm with the FDA’s regulations, visit FDAImports.com, LLC, for more guidance. FDAImports.com operates as a consulting firm which will assist your company when attempting to get Green Listed. FDAImports.com will also help you correct any existing violation which have caused the detention of shipments into the US, and advise you regarding accessing the US market again. You shouldn’t allow these detention periods to hinder your business or destroy your good name. FDAImports.com urges firms who find themselves in these situations to contact them for specific advice on establishing themselves on the FDA’s Green List.
FDAImports.com was founded by Benjamin L. England, Esq., a former FDA professional with 20 years of direct FDA experience, 17 years of which were obtained inside FDA. Mr. England is now a privately practicing FDA lawyer managing food, drug, medical device, cosmetic, and electronic product regulatory compliance, international trade and customs law. FDAImports.com specializes in making the complex understandable.