Beginning July 24, 2022, consistent with 21 CFR 1.509(a), food importers will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. As an Importer, what does this mean for you and your operation? Simply put, without having a valid DUNS number entered at the time of entry, YOUR ENTRIES WILL BE REJECTED!
For each entry line of food subject to the Foreign Supplier Verification Program (FSVP), offered for importation into the United States, you must ensure that your name, electronic mail address, and Unique Firm Identifier (UFI) are all recognized as acceptable by the Food and Drug Administration (FDA) and are provided electronically when filing entry with Customs and Border Protection (CBP). With the rollout of the regulation, FDA issued guidance recognizing the DUNS number as the acceptable UFI for the FSVP regulation. The DUNS number, a nine-digit unique number, is assigned and managed by Dun and Bradstreet (D&B) and is location-specific.
Since the implementation of FSVP 5 years ago, FDA has utilized its Enforcement Discretion regarding the use of the UFI for fear of interfering with stopping trade. Working with CBP, an entity identification code “UNK” was developed and accepted as an “Entity Number Field” which could be used in place of a DUNS number.
Additionally, the DUNS number, which is location-specific, must correspond to your U.S. location. If you have multiple U.S. locations and, thus, multiple DUNS numbers, you may choose to provide the DUNS number that applies to the location at which you maintain your FSVP records. FDA investigators may conduct FSVP records reviews at the location associated with the DUNS number you provide to CBP at entry. For example, if you maintain your FSVP records at your corporate headquarters, you may choose to provide the DUNS number of your headquarters when you identify yourself at entry as the FSVP importer. However, because the FSVP regulation allows importers to store records offsite if they can be retrieved and provided within 24 hours of request (see 21 CFR 1.510(b)(2)), you may instead provide the DUNS number for another of your locations. Once chosen, the same DUNS number should be used for all the importer’s FSVP entries, to the extent the DUNS number is applicable to an entry line.
The DUNS number is available free of charge to all importers and can be obtained by contacting D&B by phone at 866-705-5711, via email at govt@dnb.com, or by visiting D&B’s Websites at http://www.dnb.com/duns-number.html or https://fdadunslookup.com. Although a DUN’S number may be obtained within a few business days, in some circumstances it could take longer.
Consequences of non-compliance are easily avoidable. The regulatory specialists and attorneys at FDAImports and Benjamin L. England & Associates, LLC have the substantive expertise needed to develop compliant FSVP procedures for your operation. Please feel free to contact us or call us at 410.220.2800.
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This blog/post is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
