Food facilities are required to register with the Food and Drug Administration (FDA) to help the agency determine the location and sources of bioterrorism incidents or an outbreak of food-borne illness. This registration also allows the agency to quickly contact facilities that may be affected by such an event.
Section 102 of the Food Safety Modernization Act (FSMA) mandates several major changes in the food facility registration process. This section requires facilities to provide additional information when they register with the FDA; that all facilities renew their registration every two years to ensure accurate information; provides for the suspension of registration if the Secretary of Health and Human Services (“Secretary”) determines that food manufactured, processed, packed, received or held by a facility has a reasonable probability of causing serious adverse health consequences or death in humans or animals; and outlines the due process protection provided to facilities in regards to the suspension of their registration.
This primer provides information on Section 102 and its requirements.