Starting May 27, 2017, the FDA will begin implementing the FDA’s Food Supplier Verification Program (FSVP).
What is FSVP?
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. 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 that that their foreign suppliers are using safe processes and procedures and that the food is not adulterated or misbranded.
As it now stands, the FSVP Importer must be identified on ACE entry documents after May 27. As for importer responsibilities to verify foreign suppliers, we expect the FDA will do “soft” compliance initially, recognizing that this is a major change for importers. Nevertheless, each importer must determine if he is the FSVP Importer (and, if not, who is) so they can begin efforts to verify foreign suppliers.
Who Is the FSVP Importer?
The FSVP Importer might 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
- if there is no U.S. owner or consignee at the time of entry, the foreign owner of the food must appoint a U.S. agent who will be responsible for ensuring that supplier verification activities are conducted for each food product imported. The FSVP agent must be designated in a written document with signed consent by the agent. The FSVP agent should not be confused with the agent for food facility registration. They serve separate and distinct roles.
The FDA defines U.S. owner/consignee as the person who, at the time of entry, owns the food, has purchased the food, or has agreed in writing to purchase the food.
If you are the Importer of Record and the US owner or consignee, you are by definition the FSVP Importer. (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).
What Is Required of Customs Brokers?
After May 27, MIQ must provide at the time of entry for each line entry of food product offered for import into the U.S., the name, contact info, DUNS # and FDA registration number of the FSVP Importer.
Importers should check with their trade association(s) for more specific details concerning the FSVP. Additional useful information can be found here and the final rule is here.
Identify the FSVP Importer and provide MIQ with the FSVP Importer’s contact information, DUNS # and food facility registration number.
If the owner of the food product is not a U.S. person, then the foreign owner can designate a U.S. agent, with the agent’s consent in writing, who will then become the FSVP Importer responsible for ensuring that supplier verification activities are conducted for each food product imported. This is not a passive role, but requires affirmative steps to ensure that supplier verification by a qualified individual takes place. A number of FSVP-oriented consultants are available to assume this role. MIQ cannot be the U.S. Agent
The FSVP Importer can establish his own internal program to verify the suppliers, using an in-house “qualified individual,” or he can use a third-party entity qualified to assist with the verification. While the FDA allows flexibility in determining how to verify depending on the circumstances, it is very clear the program must be rigorous enough to assure that imported food is safe. For example, the FDA identifies the following as examples of verification activities: onsite auditing, sampling and testing of a food, review of the foreign supplier’s relevant food safety records, and other activities that are appropriate based on the evaluation of the risk posed by the food and foreign supplier performance.
Some food products are exempt (juice under HACCP, seafood, alcoholic beverages, among others). And, since Canada and New Zealand are recognized as having food safety systems comparable to the US, the verification activities for foods produced in Canada or New Zealand are greatly reduced. However, the FSVP Importer will still need to be identified in ACE at entry.