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As part of the Food and Drug Administration's efforts to protect the nation's food supply against terrorism and other food-related emergencies, the FDA has published two interim final regulations of the Bioterrorism Act that require:
Registration with FDA of all domestic and foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the U.S.
Advance notice to FDA of any shipment of human or animal food imported or offered for import beginning December 12, 2003.
Since the Act was passed last year, FDA and the Bureau of Customs and Border Protection (CBP) have worked together to find ways to modify CBP's Automated Commercial System, currently used to obtain import information required by Customs. 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.
Nearly 20% of all imports into the U.S. are food and food products. Congress passed the Bioterrorism Act as part of its ongoing effort to combat terrorism.
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The Act requires that FDA receive prior notice before food is imported or offered for import into the United States. The advance notice of import shipments will allow FDA and CBP to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies.
This new regulation pertains only to facilities that manufacture/process, pack or hold food, as defined in the regulation, for consumption in the U.S.
Who must register? The owner, operator, or agent in charge of a domestic or foreign facility that manufactures/processes, packs, or holds food for human or animal consumption in the U.S., or an individual authorized by one of them, must register that facility with FDA by December 12, 2003. A domestic facility must register whether or not food from the fa
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cility enters interstate commerce. A foreign facility must designate a U.S. agent (for example a facility's importer or broker), who must live or maintain a place of business in the U.S. and be physically present in the U.S., for purposes of registration. There is no fee for registration or for updates of any registration. Registrants must use Form 3537 to register or update a registration. Facilities may register online via the Internet at www.access.fda.gov, which will operate 24 hours a day, seven days a week, beginning October 16, 2003.
What happens if a facility does not register? If a foreign facility is required to register but fails to do so, food from that facility that is offered for import into the U.S. is subject to being held within the port of entry for the article unless otherwise directed by FDA or the Bureau of Customs and Border Protection (CBP).
Regularly updated information on this interim final rule and how to comment on it can be accessed electronically at: http://www.fda.gov/oc/bioterrorism/bioact.html.
Moreover, prior notice must be received and confirmed electronically by FDA no more than 5 days before arrival and, as specified by the mode of transportation as
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