On March 31, FDA published a final guidance document on acceptable unique facility identifiers (UFIs) for Foreign Supplier Verification Programs (FSVPs).[1] FDA states in the guidance that it now formally recognizes the Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP.

Background

FDA issued the final rule on FSVPs for importers of food for humans and animals on November 27, 2015, which is codified in 21 CFR 1.500 through 1.514.[2] An FSVP is a process by which an importer verifies its foreign suppliers on the basis of a risk evaluation. Importers are required under these regulations to develop and maintain a written FSVP for each food brought into the United States and the foreign supplier of that food. Specifically, the importer must (i) determine known or reasonably foreseeable hazards and evaluate their risks in the absence of controls, (ii) evaluate the degree to which processes will control or prevent such hazards, and (iii) assess foreign supplier performance related to food safety. Companies must come into compliance with the FSVP regulations beginning in May 2017.

In the proposed FSVP rule, FDA recommended that for each line entry of food products offered for importation into the United States, the FSVP importer’s name and D&B DUNS number be provided. This provision was replaced in the final rule with a requirement that the importer provide its UFI recognized as acceptable by FDA for each line entry of food product offered for importation.

The Guidance Document

The current guidance document bridges the two versions of the importer identification provision and specifies that FDA recognizes the DUNS number as an acceptable UFI for the purpose of compliance with the FSVP regulations:

FDA finds the DUNS number appropriate to meet Agency needs to accurately identify FSVP importers so [the agency] can effectively implement, monitor compliance with, and enforce the FSVP requirements.

The DUNS number is available for free to all importers and can be obtained by contacting D&B by phone at +1.866.705.5711, by email at govt@dnb.com, or by visiting D&B’s website at http://www.dnb/com/duns-number.html or https://fdadunslookup.com. Typically, a DUNS number may be obtained within a few business days, although in some circumstances it could take up to 45 days or more.

Takeaways

Notably, this guidance on UFIs is one of the few that FDA has issued regarding the FSVP program, despite its impending compliance deadline. Although the acceptance of DUNS numbers that many facilities use to satisfy other already-existing requirements is helpful, the FSVP regulation is vague with regard to other, foundational requirements—namely, the type of documentation needed to demonstrate analyses, controls, and compliance. Given the broad scope and uncertain documentation requirements under the FSVP regulation, more guidance for industry is needed.