FDA Update

It is registration time again reminds the FDA…

Human and Animal Food Facilities to Register or Renew Registration between October 1 and December 31, 2022

Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA. The registration and renewal period is open between October 1 and December 31, 2022.

The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2022. There is no fee associated with registration or renewal. Owners, operators, or agents in charge of food facilities must submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver that allows for paper submission.

All facilities must include a unique facility identifier (UFI) recognized as acceptable to the FDA with the registration submission. The UFI is used to verify that the facility-specific address associated with the UFI is the same address associated with the facility’s registration. Currently, the FDA recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI. The DUNS number is assigned and managed by Dun & Bradstreet (D&B) and can be obtained or verified by visiting D&B’s website at https://www.dnb.com/duns-number/get-a-duns.html.

Food facility registration is critical to helping the FDA identify the location and possible source of a foodborne illness outbreak or potential bioterrorism incident. Food facility registration requirements were initiated with the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and amended by the FDA Food Safety Modernization Act (FSMA) in 2011. FSMA requires facilities to submit additional information to the FDA and to renew their registrations every other year.

The following resources are available to assist in the registration and renewal process:

• Registration of Food Facilities
• Food Facility Registration User Guide: Step-by-Step Instructions | FDA
• Food Facility Biennial Registration Renewal Fact Sheet
• Webinar on Food Facility Registration (FFR), Biennial Renewal, and Unique Facility Identifiers (UFI)
• Small Entity Compliance Guide: Registration of Food Facilities
• Questions and Answers Regarding Food Facility Registration (Seventh Edition)
• Guidance for Industry: Determination of Status as a Qualified Facility | FDA
• Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for the Foreign Supplier Verification Programs for Food Importers Regulation | FDA

For more information on registration of human and animal food facilities, please visit us at: info@mdiconsultants.com and ref: FDA registration of human and animal facilities.