What Type of Facilities Need to Register Under the Bioterrorism Statute?
What Type of Facilities Need to Register Under the Bioterrorism Statute?
We are a specialty display packaging company. Is registration under the food bioterrorism statute required for a facility that receives a finished food product (i.e., canned peas), puts it in display boxes (without opening the cans or in any way altering them), and ships the newly boxed cans to the final customer?
All facilities that manufacture/process, pack or hold food for consumption in the U.S. are required to register under the Bioterrorism Act and regulations. See 21 CFR 1.230. This includes warehouses or distributors that only hold packaged food. More information on registration is available here.
We should point out that, in addition to the registration requirements, facility operators also may be responsible for establishing and maintaining records and making those records available to FDA in certain cases, e.g., if the Agency "receives credible threat of serious adverse health consequences or death to humans or animals." Notably, one has 24 hours to respond to FDA's request, so time is of the essence. See 21 CFR Part 1 Subpart J. Persons who manufacture, process, pack, transport, distribute, receive, hold or import food in the U.S. must adhere to the recordkeeping requirements with some exceptions. More information on the recordkeeping requirements is available here.