The Bioterrorism Act Public Health Security and Bioterrorism Preparedness and Response Act of 2002 

On June 12, 2002, President Bush signed into law the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002," also known as the Bioterrorism Act (BTA). Title III of the Act is designed to protect the United States against bio-terrorist threats to its food supply including food from foreign sources. The law will be implemented on December 12, 2003. This law has four major provisions: Registration Prior Notice Administrative Detention Record keeping Registration and Prior Notice will have the greatest impact on the importing community and CBP. The information posted on this page will provide information on the Act and update you on any issues pertaining to the Act as they pertain to the Bureau of Customs and Border Protection. Food and Drug Administration (FDA) Notices of Proposed Rule Making The FDA issued two Notices of Proposed Rule Making (NPRM) in the Federal Register on February 3, 2003 outlining proposed regulations to implement the Prior Notice and Registration requirements of the Act. The public comment period on these NPRMs ended on April 4, 2003. Both BTA and the NPRMs are available on the FDA Web site at www.fda.gov/oc/bioterrorism/bioact.html.  Key provisions include: Registration of Facilities: The Food and Drug Administration (FDA) would require that domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States register with the FDA by December 12, 2003. FDA is proposing to exempt several types of facilities from the registration requirement including farms, retail facilities, restaurants, and nonprofit food facilities in which food is prepared for or served directly to the consumer. Prior Notice on Importation of Food: The FDA would require that U.S. purchasers or U.S. importers or their agents submit to the FDA prior notice on the importation of food starting no later than December 12, 2003. Examples of commodities listed in the proposed rules that the FDA consider to be food include: fruits; vegetables; fish; dairy products; eggs; raw agricultural commodities for use as food or components of food; animal feed, including pet food; food and feed ingredients and additives, including substances that migrate into food from food packaging and other articles that contact food; dietary supplements and dietary ingredients; infant formula; beverages, including alcoholic beverages and bottled water; live food animals (such as hogs and elk); bakery goods; snack foods; candy; and canned foods. This list is not all-inclusive and will become finalized when the final rule is published. The FDA has sole authority to determine the scope of the covered commodities. The FDA published two NPRMs concerning Administrative Detention and Record Keeping in the Federal Register on May 9, 2003. Submission of Prior Notice Originally, FDA proposed exclusive use of a separate FDA web portal to accept Prior Notice information. However, in response to significant input from the trade community, FDA and the Bureau of Customs and Border Protection (CBP) announced on May 27 that they will streamline the implementation of the prior notice requirements. The agencies intend to allow food importers to provide the required information on imports to both agencies using an integrated process. FDA and CBP plan to modify the CBP Automated Commercial System, currently used to obtain import information required by Customs to accomplish the bulk of this task. As a result of this collaboration, importers, in most circumstances, will be able to provide the required information to FDA using this existing system, making it easier for them to comply with the new law. Implementation Date The FDA anticipates publishing the Final Rules by October 12, 2003 and the Act will be implemented on December 12, 2003. 

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