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Know and Prepare for New Food and Drug Regulations

Tuesday, October 7, 2003 - 00:00

On June 12, 2003 President George W. Bush signed into law the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) which includes a large number of provisions to help ensure the safety of the U.S. from bioterrorism, including new authority for the Secretary of Health and Human Services (HHS) to take action to protect the nation's food supply against the threat of intentional
contamination. The Food and Drug Administration (FDA), as the food regulatory arm of HHS, is responsible for developing and implementing these food safety measures, including four major regulations.

Additional information about provisions of the Bioterrorism Act under FDA's jurisdiction and the agency's implementation plans is available at

New Regulations

FDA will propose regulations on the following major provisions of the Bioterrorism Act. Except for the specified exemptions, these new regulations will apply to all facilities for all foods and animal feed products regulated by FDA, including dietary supplements, infant formula, beverages (including alcoholic beverages), and food additives.

Registration of Food Facilities--Domestic or foreign facilities that manufacture, process, pack, distribute, receive, or hold food for consumption by humans or animals in the U.S. must register with the FDA no later than December 12, 2003. Registration will consist of providing information, including firm name, address, etc., to FDA. Farms, restaurants, retail food establishments, non-profit establishments that prepare or serve food, and fishing vessels not engaged in processing as defined in 21 CFR 123.3 (k), and facilities that are regulated exclusively by the U.S. Department of Agriculture are exempt from this requirement. Also exempt are foreign facilities if the food from the facility undergoes further processing or packaging by another facility outside of the U.S. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities would be required to register. FDA must have final
regulations in effect no later than December 12, 2003, but facilities must register by this date in accordance with the Bioterrorism Act even if the regulations are not in effect. There is no fee associated with registration.

Prior Notice of Imported Food--Beginning on December 12, 2003, FDA must receive
advance notice of each shipment of food into the U.S. The notice must include a description of all articles, each article's manufacturer and shipper, grower (if known), originating country, country from which the article is shipped, and anticipated port of entry. FDA must have final regulations in effect by December 12, 2003. If the regulations are not in effect by that date, the Act still requires importers to provide notice to FDA no less than 8 hours and no more than 5 days prior to shipment until the regulations take effect.

Establishment and Maintenance of Records--Persons that manufacture, process, pack, transport, distribute, receive, hold, or import food will be required to create and maintain records that FDA determines are necessary to identify the immediate previous sources and the immediate subsequent recipients of food (i.e., where it came from and who received it). This would allow FDA to follow up on credible threats of serious adverse health consequences or death to humans or animals by tracing the food back to its source. Farms and restaurants are exempt from this requirement. FDA must issue final regulations by December 12, 2003.

Administrative Detention--Authorizes FDA to administratively detain food if the agency has credible evidence or information that the food presents a threat of serious adverse health consequences or death to humans or animals. The Act requires FDA to issue regulations to provide procedures for instituting on an expedited basis certain enforcement actions against perishable foods, but does not specify a deadline.

Additional information about provisions of the Bioterrorism Act under FDA's jurisdiction and the agency's implementation plans is available at

Source: Canadian Consulate General, Detroit

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