FDA reminds food facilities about biennial registration renewal period

By David Fairfield, Senior Vice President, Feed

The U.S. Food and Drug Administration (FDA) on Dec. 1 issued a constituent update to remind human and animal food facilities to renew their registration with the agency before Dec. 31 and to provide guidance on how to obtain and submit required Data Universal Numbering System (DUNS) numbers.

FDA stated in the update that it will consider the registration of a food facility to be expired if the facility does not renew its registration by Dec. 31, 2020. Owners and operators of food facilities are to submit their renewal information electronically through their FDA Industry Systems account, unless they have received a waiver to submit it in paper form. There is no fee associated with registration or renewal.

FDA’s facility registration requirement initially was established in 2003 under the Bioterrorism Act. In 2011, the Food Safety Modernization Act (FSMA) amended the food facility registration requirements by stipulating that food facilities required to register with FDA renew their registrations with the agency every other year (biennially), during the period beginning on Oct. 1 and ending on Dec. 31 of each even-numbered year.  Among the facilities required to register with FDA are grain elevators, feed mills, flour mills, corn and oilseed processors, pet food manufacturers, renderers and others.

Starting this year all facilities are to include a unique facility identifier (UFI) recognized as acceptable to FDA with the registration submission. The new requirement is being introduced in accordance with the agency’s 2016 rulemaking that further implemented the food facility registration provisions in FSMA. To date, FDA recognizes the DUNS number as an acceptable UFI. The DUNS number is assigned and managed by Dun & Bradstreet (D&B), and may be obtained or verified by visiting D&B’s website or by calling 866-705-5711. The UFI field has been added to the registration form’s Section 2-Facility Name/Address Information of Form FDA 3537 used when completing the registration process.

Because FDA recognizes there may be a delay in obtaining a DUNS number in a timely manner, the agency has released guidance with information on what facilities should do if they are unable to obtain a DUNS number prior to the end of the current renewal period. The guidance explains that FDA intends to allow registrants to enter “PENDING” in the UFI field of their registration if they anticipate not being able to obtain a DUNS number in time. Users then will have 90 days to obtain and submit a DUNS number and will receive reminders from FDA to do so via email. Failure to update the registration with a valid DUNS number will result in cancellation of the registration.

FDA also listed the following materials within the update that are available to help facilities register and renew their registration.

• Registration of Food Facilities
• Food Facility Biennial Registration Renewal Fact Sheet
• Online Food Facility Registration User Guide – Biennial Renewal
• Small Entity Compliance Guide: Registration of Food Facilities
• Guidance for Industry: Questions and Answers Regarding Food Facility Registration (seventh edition)
• Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration

In addition, facilities with questions can contact the FDA Helpdesk by phone at 800-216-7331 or 240-247-8804; or by email at FURLS@fda.gov.