The purpose of the Food Safety Modernization Act (FSMA) is the prevention of food safety hazards throughout the supply chain and to provide the FDA with the resources and authority to take actions necessary for protecting US consumers — regardless of where the food was produced.

As part of that mission, the Foreign Supplier Verification Program (FSVP) Rule mandates importers to assure all imported foods meet the same stringent food safety standards as those required for food products produced in the US.

What is the FSVP Rule?

With this FSVP rule, the U.S. Importer is defined as the entity and/or person responsible for the safety of the food that they are importing.

Every importer subject to this rule must implement and maintain FSVPs in which they evaluated and approved each of their food and beverage suppliers.

It also mandates that these Importers have conducted supplier verification activities to assure the food is both safe and in compliance with FDA food safety requirements, as applicable.

An importer’s FSVP must make sure that:

• All food is produced in a manner that meets the same level of public health protection as with established preventive controls for human food or animal food, and/or the produce safety rule, as applicable
• Imported food is not considered adulterated as defined under section 402 (§342)of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
• Food products intended for human consumption are not misbranded concerning food allergen labeling as defined under section 403(w)of the FD&C Act

Who is Subject to FSVP Compliance?

Under the Foreign Supplier Verification Program, US importers are required to evaluate and approve suppliers and to conduct supplier verification activities.

An importer is defined as the US owner or consignee of the food offered for import at time of entry. This is someone who either:

• Owns the food
• Has purchased the food
• Has agreed in writing to purchase the food at the time of US entry

If there isn’t a US owner or consignee at time of entry, the foreign owner must designate a US agent or representative to fulfill FSVP responsibilities. This must be confirmed in a signed statement of consent.

An FSVP importer must be located and conduct business in the United States meaning they must have personnel physically present in the United States.

Essentially, if there is a written agreement, paid invoice, or a purchase order for food for a specific US entity at the time of US entry, then that US entity meets the definition of owner and is therefore responsible for and subject to FSVP.

FDA is not looking at the intermediaries, but at the consignee, owner, or US Agent designated for FSVP purposes.

For more information on the Foreign Supplier Verification Program (FSVP) rule and/ or Food Facility Registration Requirements, please visit the following links:

What Do Importers Need to Know About the FSVP

https://www.fda.gov/food/conversations-experts-food-topics/what-do-importers-need-know-about-fsvp

Food Facility Registration Renewal

https://www.fda.gov/food/online-registration-food-facilities/food-facility-registration-user-guide-biennial-registration-renewal

Final Rule on Foreign Supplier Verification Programs (FSVP) At-A-Glance

https://www.fda.gov/food/food-safety-modernization-act-fsma/final-rule-foreign-supplier-verification-programs-fsvp-glance

FSVP – FDA Industry Guidance

https://www.fda.gov/files/food/published/Foreign-Supplier-Verification-Programs-for-Importers-of-Food-for-Humans-and-Animals–What-You-Need-to-Know-About-the-FDA-Regulation–Guidance-for-Industry-Small-Entity-Compliance-Guide.pdf

Should you require special assistance with the FSVP rule and requirements, Registrar Corp. can assist. https://www.registrarcorp.com/