This CSMS is a reminder of the entry data requirements for importers subject to FDA’s https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1#sp21.1.1.l
For purposes of the FSVP regulation, importer means:
The U.S. owner or consignee of an article of food offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulation. (21CFR 1.500) https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-L/section-1.500
For each line entry of food offered for import into the United States subject to the FSVP regulation, the importer of the food must ensure that the following importer identification information is provided electronically when filing entry with U.S. Customs and Border Protection (CBP) (21 CFR 1.509(a)): https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-L#1.509
- FSVP importer’s name, which is transmitted via ACE as PG19 Entity Name
- FSVP importer’s email address, which is transmitted via ACE as PG21 Email Address of the individual, and
- Unique Facility Identifier (UFI) for the FSVP importer recognized as acceptable by FDA, which is transmitted via ACE as both the PG19 Entity Identifier Code and PG19 Entity Number. The DUNS number is the UFI recognized as acceptable to FDA (Seehttps://www.fda.gov/media/104622/download#_blank
FSVP importers may obtain a DUNS number from Dun & Bradstreet at https://www.dnb.com/duns-number/get-a-duns.html
Currently, FDA allows FSVP Importers to submit “UNK” (unknown) in place of the DUNS number for the FSVP Importer in PG19 on a temporary basis to allow time for the importer to obtain their DUNS number. In issuing the policy allowing filers to transmit the value “UNK” in the UFI field for the FSVP importer, FDA stated that this was a temporary allowance. The “UNK” policy was issued because, at the time, the UFI requirement was a new requirement. (See https://www.fda.gov/media/111885/download).
The requirement for transmission of the data elements required under 21 CFR 1.509(a) (i.e., Entity Name, Email Address, and UFI) became effective beginning May 30, 2017. ACE data elements also needed for the FSVP importer to process electronic entries are:
- PG19 Entity Address 1
- PG20 Entity City
- PG20 Entity State
- PG20 Entity Country, and
- PG20 Entity Zip/Postal Code
For details on the data requirements for entry filing relating to the FSVP regulation, please review CBP’s Cargo Systems Messaging Service message CSMS #17-000314 on CBP’s website at https://content.govdelivery.com/accounts/USDHSCBP/bulletins/19e839a and the https://www.cbp.gov/document/guidance/fda-supplemental-guide
For questions about the FSVP requirement for FSVP importers to ensure that their name, email address, and DUNS number are provided for each line entry of food offered for entry into the United States, please contact FDA’s Division of Import Operations via email at FDAImportsInquiry@fda.hhs.gov.
For technical questions related to the FSVP regulation, please contact the FSMA Technical Assistance Network (TAN) at https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.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.S8Pi0TYSklaoMOlEwTMUFe_ahqqCyZGM1YXXhRtspUo/s/1807749295/br/113846151131-l to submit your questions electronically.
This CSMS message supersedes CSMS# 45134970 and CSMS# 17-000255.
Related Messages: CSMS #17-000314, 45134970 and 17-000255