The U.S. Food and drug Administration (FDA) has announced a proposed regulation that would require domestic U.S. 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.

“Improving the FDA’s food safety inspection, detection and monitoring capabilities is and has been a top priority of the Department even before the events of 9/11. Since then we have taken strong steps to enhance the FDA’s ability to make our food supply safer,” said Secretary of Health and Human Services Tommy G. Thompson. “This FDA effort is the latest in a series of measures we are taking to build stronger safeguards for the American people.”

“This measure will bolster our ability to regulate effectively the more than 400,000 domestic and foreign facilities that deal with food within our country,” said FDA Commissioner Dr. Mark B. McClellan. “Our ability to efficiently and effectively help protect the nation’s food supply is a critical part in our agency’s counterterrorism mission. Thanks to the efforts of Senators Gregg and Kennedy, and Representatives Tauzin and Dingell, the Bioterrorism Act gives FDA this important new authority.”

Under the proposal all domestic food facilities would be required to register whether or not food from the facility enters interstate commerce. 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.
The law requires FDA to notify the registrant of receipt of registration and to assign each facility a unique registration number. The registration may be electronic, via the Internet, or by paper through surface mail. FDA strongly encourages electronic registration, however, as the Internet system FDA plans will be able to accept electronic registration from anywhere in the world 24 hours a day, 7 days a week. A registering facility also would receive confirmation of electronic registration and its registration number instantaneously once all the required fields on the registration screen are completed. There is no fee associated with registration.

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.

Single copies of the proposed regulation outlined above, which went on display today at the office of the Federal Register, may be obtained by writing to Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md., 20852. These proposals can be accessed electronically at the FDA web page on the Bioterrorism Act: www.fda.gov/oc/bioterrorism/bioact.html. FDA will accept comments on Registration of Food Facilities (Docket Number 02N-0276) for 60 days from the date it appeared in the Federal Register. Written comments on this proposed regulation can be sent to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments can be sent electronically through www.fda.gov/dockets/ecomments or through the Bioterrorism Act web page at www.fda.gov/oc/bioterrorism/bioact.html. It is important to include the docket number 02N-0276 when providing comments.