Bioterrorism ActBy now, if your facility manufactures, processes, packs, holds or imports food intended for consumption in the United States you should have heard of the Bioterrorism Preparedness and Response Act of 2002. More than that, you should be aware that as of December 12, 2003 there were requirements within Title III of the Act (Protecting Safety and Security of Food and Drug Supply) with which such facilities must comply. The regulation required that all companies that manufacture, process, pack or hold food intended for consumption in the U.S. be registered with the FDA as of December 12th. This also applies to all foreign facilities if their product is imported into the US without further processing or packaging outside the US. Another major provision of Title III - Section 307 Prior Notice of Imported Food Shipments - requires that as of December 12th the FDA receive a prior notification of all food imported or offered for import into the U.S.The FDA is aware that there may be some confusion on the new prior notice requirements and on what types of shipments fall under the regulations. They also do not want to obstruct food imports, which account for up to 60% of all the seafood consumed in the US, according to FDA Commissioner Mark McClellan. Therefore, on December 11, 2003 the FDA issued a Compliance Policy Guide dealing with the enforcement of the new requirements. (This can be found at www.cfsan.fda.gov/~pn/cpgpn.html). While the FDA and the US Bureau of Customs and Border Protection (CBP), who will be assisting the FDA with the enforcement of the new prior notice requirements, expect a good faith effort at compliance, they also make clear in the Guidance policy that during the next 8 months they will be focusing on educating the affected firms and individuals, rather than enforcement. During this period, the FDA and CBP will use communication and education initiatives, escalating into civil fines and ultimately into refusal of shipments. This phase-in period ends on August 12, 2004. Food mailed, brought or accompanied into the US by individuals for non-personal use does come under the prior notice requirements, but the FDA and CBP will, for the most part, continue the education efforts and not refuse admission before August 12th because of inadequate or missing prior notice. As information required in the prior notice includes the registration numbers assigned to the foreign manufacturers' and shippers' facilities associated with the article of food, the FDA expects the registration requirement for foreign facilities to be primarily enforced through the prior notice provision. FDA Registration:Surefish is pleased to announce that we will offer the following services to assist companies in complying with the Bioterrorism Act of 2002, Title III, Section 305. All facilities that manufacture/process, pack or hold food for human or animal consumption in the U.S. were required to register by December 12, 2003 and foreign facilities are also required to designate a U.S. Agent when they register. The US Agent will act as a communications link between the facility and the FDA. The U.S. agent is required to reside or maintain a place of business in the United States and to be physically present in the United States. Surefish meets these requirements.
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