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 shipment 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 only 46 foreign firms (from around the world) on the ‘Green List’ for Import Alert #16-125. According to Benjamin L. England , of FDAImports.com, LLC , this is because “…botulism is a serious threat. It’s a threat to consumers and a threat to the legitimacy of FDA. Protecting America’s food supply is their [FDA’s] job. Botulism can be fatal, especially to infants. Therefore FDA issued an exceptional worldwide import alert to address the agency’s concerns. This is one of the few Import Alerts you want your firm’s name on. There are about 50 firms on the ‘Green List’ (those who are not subject to DWPE), nobody else will be permitted to export raw seafood in anaerobic packaging to the USA.”
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.”
Food importers and foreign food manufacturers and processors will face a more vigilant and more heavily funded FDA in 2010 and 2011. FDA’s budget was increased in 2010 by about 20% over previous years and the current administration is seeking an additional 19% increase in FDA funding for 2011. Due to all of the pressure and bad press FDA has received regarding the risks associated with imported food, a significant part of those funds will be spent on imported food safety enforcement.
If you want to obtain your IA 16-125 ‘Green Ticket’, or you currently have entries subject to detention, or are concerned about your firm’s FDA compliance, let FDAImports.com, LLC show you ‘the way through.” FDAImports.com, LLC is a consulting firm that can help you get your ‘Green Ticket’ and gain access to the U.S. market. FDAImports.com, LLC, can also advise and correct any other violations that have caused your shipments to be detained and get your products back on the market. Don’t let a lengthy detention derail your business plan and wreck your reputation. FDAImports.com implores manufacturers who are in one of the above mentioned situations, or who need assistance in getting on the ‘Green List’, to contact them promptly for advice tailored to your particular situation.
Source: FDA
