FDA Provides Additional Guidance on Filing Food Entries After FSVP Effective May 30
The Food and Drug Administration on May 10 posted to its website additional guidance (here) on entry filing for food imports after the first compliance date for the Foreign Supplier Verification Program regulations of May 30. As detailed by CBP in a recent CSMS message (see 1705030047), the guidance says FDA will temporarily allow filers to submit “UNK” (unknown) for the FSVP importer unique facility identifier if the FSVP importer has not yet obtained a DUNS number.
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Beginning May 30, when an entry is filed for any food product regulated by FDA, the filer will be prompted to submit either the entity role code “FSV,” which will indicate that the entry line is subject to FSVP requirements, or one of two Affirmation of Compliance (AoC) codes indicating that the entry line is not subject to the FSVP regulations at the time of entry. Transmission of entity role code FSV will trigger a request for the FSVP importer’s name, email address and unique facility identifier (UFI) in the form of a DUNS number (see 1703310030).
The two AoC codes that indicate the entry line is not subject to FSVP are FSX, which designates that the food is exempt from FSVP or that compliance with FSVP is not yet required due to the regulation’s staggered compliance dates (see 1602120038), and RNE, which designates that the food is being imported for research or evaluation. A specific RNE code is required because, to qualify for the FSVP exemption for food imported for research or evaluation, the FSVP regulation requires that the food be accompanied by an electronic declaration that the food will be used for that purpose and not sold to the public. The RNE code serves as that declaration, FDA said.
Failure to submit entity role code FSV or one of the two AoC codes for an entry of food regulated by FDA will result in the entry line’s rejection, FDA said. “Similar to all rejections in the ACE system, the rejection will generate an error message to the filer,” it said. “Once an error message is received, the filer can make the appropriate adjustments to the entry submission and retransmit the entry line.”
For any entry that includes the code “UNK” for FSVP importer UFI, “FDA intends to contact those FSVP importers for whom ‘UNK’ was transmitted in place of the UFI,” it said. “We will provide additional information to help ensure that FSVP importers understand this FSVP regulation requirement and take the appropriate steps to obtain a UFI.” The use of “UNK” is temporary, and intended for FSVP importers that are temporarily unable to obtain a DUNS number, FDA said. “We will update the guidance and communicate with importers at such time when we discontinue this use of the ‘UNK’ value.”