The FDA is hoping to help companies respond to food emergencies quicker and more accurately. And it’s also updating the food product categories that companies can select when registering.
The moves, which are a response to a food safety problem, creates a system that lets the FDA use a food manufacturer’s or distributor’s category information to conduct investigations and surveillance operations.
The data also enables the agency to quickly alert facilities potentially affected by such an incident, if the FDA receives information indicating the type of food affected.
For example, if the FDA receives information that soft drinks could be affected by a bioterrorism incident or other food-related emergency, the agency can alert soft drink facilities.
Food product categories also help the FDA verify where and when imported products were produced via the prior notification requirements in 21 CFR Part 1, subpart I.
For example, if the registration information identifies a facility as producing only dairy products, and the FDA receives a prior notice for a shipment of nuts purporting to have been produced at that facility, the agency can examine the shipment to verify its contents based on the discrepancy between the registration information and prior notice data.
The changes to the food product categories made in this guidance were discussed in the July 14, 2016 rule that amended the food facility registration regulation.
The FDA issued the updated guidance in accordance with section 102 of FSMA, and food companies will be required to select appropriate food product categories from the updated categories during the October to December 2016 registration renewal period. The guidance also describes certain FSMA amendments that allow the FDA to determine appropriate food product categories through guidance. Specifically, under section 415(a)(2) of the FD&C Act, as amended by FSMA, a food facility must submit a registration containing information about the general food category (as identified in 21 CFR 170.3 or any other food categories as determined appropriate by FDA) of a food manufactured/processed, packed or held at such a facility, if the agency determines that information is necessary.