FSMA Foreign Supplier Rule Update

The U.S. Food and Drug Administration (FDA) has updated FDA.gov to include updated fact sheets and new guidance as a resource for importers subject to the Food Safety Modernization Act (FSMA) Foreign Supplier Verification Program (FSVP) Rule, which makes them responsible for verifying that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards.

The first FSVP compliance date was May 30, 2017, for importers whose foreign supplier falls into one of these categories. The supplier:

• Will not be covered by the FSMA preventive controls or produce safety rules;
• Is subject to the Preventive Controls for Human Food rule, and is not a "small business" or "qualified facility"; 
• Is subject to current good manufacturing requirements in the FSMA Preventive Controls for Animal Food rule, and is not a "small business" or "qualified facility."

A chart on fda.gov, titled Am I Subject to FSVP?, will help you determine if your firm is subject to the rule.

Importers covered by the May 30, 2017, compliance date must provide specific identification for each line entry of food product offered for importation into the United States. The importer identification requirement includes the submission of the FSVP importer’s name, e-mail address and Unique Facility Identifier (UFI) recognized as acceptable by FDA.

The updated content on fda.gov reflects the recent guidance recognizing the Data Universal Numbering System (DUNS) number as an acceptable UFI for FSVP. The FDA expects all importers to provide their UFI starting on the applicable compliance date. However, the agency recognizes that this is a new requirement and there may be factors that prevent importers from doing so. Therefore, the FDA has issued guidance stating that for FSVP importers temporarily unable to obtain a DUNS number, FDA intends to temporarily allow filers to transmit the value "UNK" (to represent "unknown") in the UFI field for the FSVP importer. FDA will allow this beginning May 30, 2017, so that food offered for import can be processed through the ACE system, even if the importer has not yet provided a DUNS number. FDA intends to contact importers that use the "UNK" value in place of the UFI in order to provide additional information to ensure that they understand this FSVP requirement and can take appropriate steps to obtain a UFI.