Registration of Food Facilities
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OMB Approval Number: 0910-0502
OMB Expiration Date: 08/31/2013
See OMB Burden Statement2.
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) directs the Food and Drug Administration (FDA), as the food regulatory agency of the Department of Health and Human Services, to take additional steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply and other food-related emergencies.
To carry out certain provisions of the Bioterrorism Act, FDA has established new regulations requiring that:
Food facilities are registered with FDA, and
FDA be given advance notice on shipments of imported food.
The Bioterrorism Act requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S. to register with the FDA by December 12, 2003.
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for consumption in the U.S. are required to register the facility with the FDA.
Domestic facilities are required to register whether or not food from the facility enters interstate commerce.
Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.