Title 21 of the United States  (U.S.)  Code of Federal Regulations (CFR), Chapter I, Subchapter A, Part 1, Subpart H and Section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002  (Bioterrorism Act)  require that all domestic and foreign facilities that are engaged in the manufacturing/processing, packing, or holding of food for human or animal consumption, register with the U.S. Food and Drug Administration (FDA).

Registration must occur: 1) before the facility begins to manufacture, process, pack, or hold food for consumption in the U.S., and 2) bi-annually thereafter. Bi-annual registration, also known as “renewal” registration, must be submitted to the FDA during the period beginning October 1 and ending December 31 of each even-numbered year. Facilities located outside of the United States must also designate a U.S. Agent for FDA communications.