FDA Updates Its Food Facility Registration Guidance

November 10, 2016

By Ricardo Carvajal

FDA recently announced the issuance of the 7th edition of the Agency's Questions and Answers Regarding Food Facility Registration.  The latest edition includes nearly 60 new Q&As on a variety of registration-related topics, including:

  • Biennial registration renewal – A facility’s registration must be renewed in the last quarter of every even-numbered year.  The new Q&As address scenarios such as a facility’s obligation to renew even when an initial registration has been submitted during any of the first three quarters of a biennial renewal year.
  • Unique Facility Identifiers (UFIs) – Although these won’t be required as part of a registration until October 1, 2020, a number of new Q&As address verification and selection of UFIs.  Currently, a DUNS number is FDA’s preferred UFI, but FDA might deem other UFIs acceptable before the requirement takes effect.
  • Food product categories and activity types – A registration must include information on food product categories and the types of activity handled by the facility.  The guidance now makes clear that a facility such as a warehouse that frequently changes food product categories “may select all of the food product categories that are normally part of [its] operations.”  The guidance also provides definitions of the different activity types (e.g., “refrigerated human food warehouse/holding facility”).
  • Cancelation of registration – Among other things, the guidance explains the circumstances under which FDA will cancel a registration, and the agency’s process for informing the registrant.
  • Waiver requests – As of January 4, 2020, registration-related submissions will have to be in electronic format unless FDA grants a waiver.  New Q&As explain the process for obtaining a waiver.

Comments on the guidance are due by February 6, 2017.