September 26, 2016
The U.S. Food and Drug Administration (FDA) issued updated guidance today that will help enhance FDA’s ability to respond quickly and accurately to food-related emergencies by updating the food product categories that companies can select when registering with the agency.
Information about the categories of food a facility manufactures or distributes currently helps the FDA conduct investigations and surveillance operations in response to food-related emergencies. These categories also enable 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 indicating that soft drinks could be affected by a bioterrorism incident or other food-related emergency, the agency is able to alert soft drink facilities about the incident.
Food product categories also help the FDA verify that imported products are correctly identified by where and when they were produced. Food product categories help FDA do this in connection with 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 FDA’s food facility registration regulation. The rule also stated that FDA would address further amendments of the food product categories on the registration form through updates in guidance documents.
- Acidified foods and low acid canned foods are no longer listed as food product categories because they are now activity types
- Additions to animal food categories of botanicals and herbs, direct fed microbials, animal protein products, forage products, human food by-products not otherwise listed and technical additives (The “animal protein products” category replaces the previous “animal derived products” category, and the “processed animal waste products” category replaces the “recycled animal waste products” category.)
- Molluscan shellfish is now a food product category (previously, molluscan shellfish establishment was listed among the optional activity types)
The FDA issued the updated guidance in accordance with section 102 of the FDA Food Safety Modernization Act (FSMA) and food companies will be required to select appropriate food product categories from the updated categories during the October – 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 to FDA 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, including by guidance) of a food manufactured/processed, packed or held at such facility, if the Agency determines through guidance that such information is necessary.