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FDA to Require DUNS Number at Entry for All FSVP Importers July 24

FDA will require that food importers transmit their Data Universal Numbering System number for entries of food subject to the Foreign Supplier Verification Program regulations beginning July 24, it said in a guidance document released April 27. The agency will on that date end a grace period that has allowed importers to instead transmit “UNK” for unknown instead of a DUNS number since 2018 (see 1705100028).

The grace period had been in place because FDA had “recognized that this was a new requirement and some factors may have prevented importers from” providing a DUNS number. However, “needs and circumstances have changed since FDA announced its temporary policy, as FSVP importers have now had ample time to familiarize themselves with the requirements,” the guidance said.

“Beginning July 24, 2022, the use of the entity identification code 'UNK' will no longer be an option,” FDA said. “Consistent with 21 CFR 1.509(a), the FSVP importer will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. CBP will reject an entry line of a food subject to the FSVP regulation when the importer’s DUNS number is not provided in the Entity Number field,” it said. The policy will apply only to entries with the affirmation of compliance (AoC) code FSVP, indicating the food is subject to FSVP requirements.

In a CSMS message on the new FDA guidance, CBP said ACE deployment dates for the new policy “will be announced in a future message.”

The FDA guidance noted that importers may get a DUNS number from Dun & Bradstreet free of charge “within 30 business days or longer,” though a fee applies for faster delivery. “To obtain a DUNS number, please contact D&B directly by phone at 866-705-5711 or at https://www.dnb.com/duns-number/get-a-duns.html. If you already have a DUNS number, you should use that DUNS number as your importer identification UFI. You do not need to obtain a separate DUNS number for FSVP,” the guidance said.

Importers with multiple locations and therefore multiple DUNS numbers “may choose to provide the DUNS number that applies to the location at which you maintain your FSVP records,” FDA said. Importers also may provide the DUNS number for another location, as the FSVP regulations permit offsite storage of records as long as they can be provided within 24 hours of request. “Once chosen, the same DUNS number should be used for all of the importer’s FSVP entries, to the extent the DUNS number is applicable to an entry line,” FDA said.