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FDA Proposes Regulation for Registering Food Facilities

BG0305E | Date: 2003-02-14

The U.S. Food and Drug Administration (FDA) announced on January 29, 2003, a proposed regulation that would require domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the agency by December 12, 2003. The proposal is one of the keystones in implementing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. This act provided FDA new authority in protecting the nation's food supply against terrorist acts and other threats.

Except for specific exemptions, the new regulation would 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.

The proposed regulation would require the owner, operator, or agent in charge of a domestic or foreign facility to submit a registration to FDA, including the name and address of each facility at which, and trade names under which, the registrant conducts business, and the categories of food the facility handles. For a foreign facility, the registration must include the name of the U.S. agent for the facility. The U.S. agent may register a foreign facility if it is authorized to do so by the facility. The proposal also would require facilities to update any changes to the information previously submitted within 30 days of the change.

The proposal specifically excludes farms, restaurants, other retail food establishments, nonprofit food establishments in which food is prepared for or served directly to the consumer, certain fishing vessels, and facilities (such as meat and poultry slaughterhouses) that are regulated exclusively by the U.S. Department of Agriculture. Also exempt are foreign facilities if the food from the facility undergoes further processing or packaging by another foreign facility before it is exported to the U.S. A foreign facility is not exempted from registration, however, if the processing or packaging activities of the subsequent facility are limited to the affixing of a label to a package or other de minimis activity. In that instance, both the facility manufacturing/processing the food and the facility performing the de minimis activity would have to register.

Under the Bioterrorism Act, facilities must register by December 12, 2003, even if FDA has not issued final regulations. In the proposed rule, FDA is offering the public 60 days to comment on the proposed rule. FDA plans to issue a final rule by October 12, 2003, after considering the comments it receives. FDA also plans to have its registration system operational by October 12, 2003, to accept early registrations. Under the Bioterrorism Act, it is a prohibited act for a facility to not be registered by December 12, 2003. If a firm does not register by the deadline, the United States can bring a civil action in federal court to enjoin persons who commit a prohibited act; or it can bring a criminal action in federal court to prosecute persons who commit a prohibited act. The Bioterrorism Act also requires food from unregistered foreign facilities to be held at the port of entry unless the FDA directs that the food be moved to a secure location.

The proposed regulation outlined above can be accessed electronically at the FDA web page on the Bioterrorism Act: