New Customs Entry Requirement Associated With Food Imports

The U.S. Food & Drug Administration (FDA) is implementing its Food Supplier Verification Program (FSVP).

The FSVP regulations require food importers to verify their suppliers’ compliance with food safety requirements that are equivalent to U.S. regulations, including: hazard analysis, supplier evaluation and verification activities, and recordkeeping; all of which must be performed by a “qualified individual,” though modified requirements and exemptions may apply.

A central feature of the Food Safety Modernization Act (FSMA), the FSVP is intended to be a flexible, risk-based program to verify foreign suppliers and the safety of the food they produce. The FSVP will require:

• Identification of the "FSVP importer" for food products imported into the U.S.

• The FSVP Importer is responsible for establishing foreign supplier verification programs to verify their foreign suppliers are using safe processes and procedures and the food is not adulterated or misbranded

Effective May 30, 2017, the “FSVP Importer” must be identified on the Customs entry.

For each line entry of food product offered for import into the U.S., the name, contact info, DUNS number and FDA registration number of the FSVP Importer must be provided at that time.

Per US Customs CSMS message 17-000255, for an onboarding period, the FDA will temporarily allow the submission of “UNK” (unknown) as the syntax for the DUNS number for the FSV Importer. “UNK” should only be used if the nine-digit, site-specific DUNS number is not available at the time the entry is transmitted. Another CSMS message will be issued at a later date to indicate when UNK will no longer be accepted.

*The FSVP Importer may be, but is not necessarily, the same party as the Importer of Record. The FSVP Importer must be a U.S. party with a direct financial interest in the food product. Specifically, the FSVP Importer is:

• The U.S. owner or consignee of the product at the time of entry, who owns the food, has purchased the food, or has agreed in writing to purchase the food; or,

• If there is no U.S. owner or consignee at the time of entry, a U.S. agent* appointed by the foreign owner of the food.

*The FSVP agent must be designated in a written document with signed consent by the agent. The FSVP agent acts as FSVP Importer and is responsible for ensuring supplier verification activities are conducted for each food product imported. This is not a passive role, but requires affirmative steps to ensure supplier verification by a qualified individual takes place.

Note: Customs brokers, warehouses or other similar intermediaries are not considered by FDA to be the FSVP Importer because they are not an owner or consignee and do not have a direct financial interest in the food product. A number of FSVP-oriented consultants exist that offer services on this matter. If you require such services, you will want to do a web search for such entities.

Food importers are recommended to start pulling together and providing the FSVP Importer's contact information, DUNS number and food facility registration number for their importations. The information should be included in the import documentation or otherwise supplied to your Customs broker prior to arrival.

FDA description of the Food Safety Modernization Act

Federal Register Notice on Final Rule for FVSP

For a list of specific data elements required for FSVP, refer to the FDA Supplemental Guide V2.5

For questions related to FSVP, please contact FDAExternal Link

For questions related to the submission of data elements for FSVP, contact FDA’s ACE Support, 6:00 a.m. to 10:00 p.m., 7 days a week or telephone: 877-345-1101undefined, or 571-620-7320undefined.

Obtain a DUNS number for free. DUNS numbers should be unique for each firm, i.e., a corporate headquarters with multiple company locations should not have the same DUNS number for each site. Each unique site (address) should have a unique DUNS number.