FSVP: Food Safety Importer Compliance

“The United States imports about 15 percent of its overall food supply.” – U.S. Food & Drug Administration

Who wants to get sick from the food they eat? Most likely no one. The Federal government estimates that there are 48 million cases of foodborne illness a year. With approximately 15 percent of the U.S. food supply being imported, it’s not hard to understand why food safety is the responsibility of the importer.

One way the U.S. Food and Drug Administration (FDA) keeps consumers safe from food-borne illness is through the Food Safety Modernization Act (FSMA). Under the Act, one of several rules, the Foreign Supplier Verification Programs (FSVP), requires importers to verify the safety of the food before they import it into the U.S. Are you in compliance?

What is FSVP?

The Foreign Supplier Verification Programs (FSVP) rule requires importers to establish and follow written procedures to perform risk-based supplier verification activities to verify that food imported from other countries meets U.S. safety standards.

Importers will need to verify that:

• Food is produced in a manner that provides the same level of public health protection as section 418 (concerning hazard analysis and risk-based preventive controls) or 419 (concerning standards for the safe production and harvesting of certain fruits and vegetables that are raw agricultural commodities (RACs) of the FD&C Act (21 U.S.C. 350g and 350h), if applicable;
• Food is not adulterated under section 402 of the FD&CAct (21 U.S.C. 342); and
• The human food is not misbranded under section 403(w) of the FD&C Act (21 U.S.C.343(w)(concerning food allergen labeling).

What are the responsibilities of an Importer under FSVP?

To develop, maintain, and follow an FSVP for each food imported unless an exemption applies.

Importers are responsible for actions that include:

• Determining known or reasonably foreseeable hazards with each food

• Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
• Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
• Conducting supplier verification activities such as annual onsite audits of a supplier’s facility, sampling and testing of food, review the supplier’s relevant safety records.
• Conducting corrective actions in the case it becomes known that a supplier is not doing something right or up to standard.

Who is Subject to FSVP?

An importer who is the U.S. owner or consignee of the food being imported into the U.S. If there is no U.S. owner or consignee at the time of entry, the FSVP importer is the U.S. agent/representative of the foreign owner/consignee, as confirmed in a signed statement of consent.

Food Categories Not Subject to FSVP

• Juice, fish, and fishery products subject to and in compliance with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for those products, and certain ingredients for use in juice and fish and fishery products subject to the HACCP regulations.
• Food for research or evaluation
• Food for personal consumption
• Alcoholic beverages and certain ingredients for use in alcoholic beverages
• Food that is imported for processing and future export
• Low-acid canned foods (LACF), such as canned vegetables, but only with respect to microbiological hazards covered by other regulations, as well as certain ingredients for use in LACF products (but only with respect to microbiological hazards).
• Certain meat, poultry and egg products regulated by the U.S. Department of Agriculture at the time of importation

Declaring the FSVP Importer

Food covered by the FSVP rule is declared to the FDA at the time of importation. FDA wants to know who the FSVP Importer is for each imported food. FSVP Importers will need to provide their name, email address, and DUNS number for each food product.

Compliance with the FSVP rule can be harrowing. We recommend that importers understand this rule before importing food products into the U.S. Not only is food safety paramount, but importers need to understand what they are required to do and the records they must maintain in case they are investigated by FDA.

FDA has many resources available to help importers comply with this rule:

• What Do Importers Need to Know?
• List of Records Required by the FSVP regulation
• Am I Subject to FSVP?
• What to Expect During a Foreign Supplier Verification Programs Inspection
• FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals | FDA

Author

Tatiana Snigurski is a Licensed U.S. Customs Broker and the Business Development Manager of Customs & Trade Compliance at NNR Global Logistics USA Inc.