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Bioterrorism Act

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Well-known member
Mar 2, 2005
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In December 2004, the FDA published a final rule requiring food and feed firms to establish and maintain records that would allow inspectors to conduct an effective and traceback investigation to protect the food and animal feed supply.Now the first set of recordkeeping rules go into effect on Dec. 09/05
The Bioterrorism Act was passed in 2002 to ensure the safety of the US food supply from a terrorist attack. Among other procedures required under the law, the act requires all domestic and foreign facilities that manufacture, process, pack or hold feed or food for human or animal consumption to register the with FDA.
Section 306 of the act, issued as an interim rule, also mandates strict record keeping requirements for those who manufacture, process, pack, transport, distribute, receive, hold or import food or feed to the US.
The US agent acts as a communications link between FDA and the foreign facility based in the US. The FDA considers providing information to the US agent the same as providing information directly to the foreign facility.
In the run-up to issuing a final rule on Section 306 the FDA also asked for comments on the assumptions underlying its estimates of the costs of hiring and
retaining a US agent. The agency also wanted comments on whether domestic small businesses had been adversely affected by trading partners that have ceased exporting to the US due to the increased costs.
The FDA found that domestic companies had not been adversely affected and so will keep the rule in place, unamended.
In the economic analyses of the proposed and interim final rules, the FDA estimated that about 90 per cent of foreign facilities did not currently have
a US agent.