ACE Codes Required for Food Imports Subject to FSVP Rule; FDA Focusing on Education
U.S. Customs and Border Protection states that as of May 30, the first compliance date under the Foreign Supplier Verification Program rule mandated by the Food Safety Modernization Act, the Automated Commercial Environment is prompting filers to transmit one of three codes when a food product under Food and Drug Administration oversight is offered for entry into the U.S.
FSVP importers subject to this compliance date should use the entity role code FSV to indicate that the entry line is subject to the FSVP regulation. This will trigger a request for the FSVP importer’s name and email address and the unique facility identifier recognized as acceptable by the FDA. To date the FDA has recognized only the DUNS number as acceptable, but for FSVP importers temporarily unable to obtain a DUNS number the FDA intends to allow filers to transmit the value UNK (to represent “unknown”) in the UFI field for a limited time.
If the entry line is not subject to the FSVP rule or the May 30 compliance date the filer should use affirmation of compliance codes FSX, which indicates that the food is exempt from the rule or that compliance is not yet required, or RNE, which indicates that the food will be used for research or evaluation and is therefore exempt.
CBP states that if one of these codes is not transmitted the entry line will be rejected, generating an error message to the filer. Once that message is received the filer can make the appropriate adjustments to the entry submission and retransmit the entry line.
A senior FDA official said recently that while importers will be required to provide their identification information through ACE the FDA will not be enforcing overall compliance with the FSVP rule on a shipment-by-shipment basis at the port of entry. Instead, the official said, the agency intends to “educate while we regulate to create a culture of compliance.” Importers can expect interactive FDA inspections with opportunities to explain how their programs meet the applicable requirements and how they will take corrective actions if deficiencies are observed. At the same time, the FDA “will act swiftly” to address any food safety problems that pose an imminent public health risk.