Category: Bioterrorism Act of 2002

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FDA Reminds Human and Animal Food Facilities to Register or Renew Registration between October 1 and December 31, 2022. The following provides all the information and links to complete your renewal.

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 (-> lnks.gd).

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

Food facilities with questions can contact the FURLS Helpdesk: by phone 1-800-216-7331; or by email at [email protected]

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The FDA has published these FAQ’s . Please read if you have any questions on registration. This process is also used to make required attestations for small facilities claiming to be “exempt” from FSMA otherwise known as a qualified facility.

All Food Facilities (including animal food) must register as such with the FDA in even years between October 1 and December 31. The FDA has published a small entity compliance guide to assist in this registration process. It is CFD’s opinion that all CFD customers of pet, animal or human food products we sell are required to register.  

Continue reading “All Animal Food Facilities must complete Registration between 10/1 – 12/31/18”

Action Required – FDA Biennial Registration due October 1, – December 31, 2016

The Bioterrorism Act of 2002 requires all Food (Human and Animal) facilities to register with the FDA. In 2011 FSMA changed the registration requirements from one-time registration to every two years in even years between Oct 1 and Dec 31. Failure to register is a federally prohibited act.

It has been CFD’s position that most members (and many customers) must register! Each facility under company ownership that has a different address requires registration. There are exceptions to the registration requirements. In the future the FDA will allow for cancelling registrations (#6 below) based on its verification that a facility is not required to register. If a member has any questions regarding the requirement to register, it may be safer to register and let the FDA exempt one or more of your facilities than to not register.

Between October 1, 2016 and December 31, 2016 go to: http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ucm2006831.htm

During registration some of the information you will be required to provide includes the following:

• The e-mail address for the contact person of the domestic facility
• Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
• Updated food product category information, as determined appropriate by FDA in already-published guidance

Changes to the rule will be implemented in the coming years (there are many but these apply to our members):

1. Unique Facility Identifier (UFI) – Will be assigned by the FDA and assist the FDA in verifying accuracy of site specific address, the FDA will verify the UFI prior to issuance of registration number or confirmation of registration. This will be implemented October 1, 2020.
2. If you use a 3^rd party to do your registration, the email of owner, operator, or agent in charge who authorized a third party to act on behalf of the facility will be required.
3. Some previously optional fields are now mandatory. Such as preferred mailing address, emergency contact email address, type of activity.
4. Electronic registration will be required as of January 4, 2020 (Changes to the waiver of electronic registration will also being made).
5. Abbreviated Registration Renewal Process
6. The FDA will have authority to cancel registrations in additional circumstances (such as: FDA independent verification that a facility is not required to register, facility address not updated in a timely manner, unauthorized registration submissions, registration expiration due to failure to renew.
7. Requirement for immediate update to incorrect registration information
8. Changes to activity types (such as Farm Mixed-Type Facility, Animal food warehouse/holding facility).

The FDA is preparing guidance on some of these changes and as more information is available we will provide updates!