Main Content

Food Law Casebook

Food Facility Registration

As the excerpt from the Congressional Research Service report on agroterrorism notes, the Bioterrorism Act of 2001 included a for facility registration requirement. The Act mandates domestic and foreign facilities that manufacture, process, produce, pack, or hold food for human consumption in the United States to register with the FDA. See 21 C.F.R. 1.225-1.243. These registration rules were strengthened by FSMA which amended Section 415 of the FDCA Act, see 21 U.S.C. sec. 350(d). In particular, FSMA section 102(c) increased the frequency of registration and also expanded the scope of information that must be disclosed in the registration.