A Summary: The Foreign Supplier Verification Program
According to the United States Department of Agriculture (USDA), the average person in the U.S. consumes 1,996 pounds of food per year, and about one-fifth of that is imported. Since NAFTA’s inception, food imports have tripled. The 2011 Food Safety Modernization Act responds to rising foreign food imports by requiring that foreign suppliers meet the same standards that domestic suppliers do.
Accordingly, three final rules were published in the Federal Register on November 27, 2015, among them “Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals.”
Many importers have 18 months from the publish date to comply with FSVP requirements. Others have six months from the date that their foreign suppliers must be in compliance.
The FDA defines an FSVP as “a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.”
Many groups have a vested interest in FSVP compliance, including importers, foreign food suppliers, agents of foreign owners, brokers and foreign government representatives. Many are eager to comply with the provisions of the FSVP final rule because it offers reduced recall potential and attendant adverse publicity. FSVP compliance can even represent a competitive advantage as it enhances one’s brand and reputation.
The overall importance of the FSMA’s Foreign Supplier Verification Program is underscored by statistics regarding the number of foreign food facilities registered with the FDA. As of January 1, 2016, 120,822 of the 207,655 FDA-registered food facilities were outside the United States, according to a report in Food Safety News. The top five foreign countries in terms of the volume of FDA registrations are, in order, Japan, France, Italy, China and Mexico.
The FDA requires the registration of all food facilities that process, pack, manufacture or store food, beverages and dietary supplements for domestic consumption. Although facilities in the United States account for about four-fifths of all food consumed, 58 percent of the FDA-registered food facilities are outside the country.
Data regarding foreign FDA registrations tends to be more reliable, because such suppliers must notify the FDA every time they ship food to the U.S. The form they file must include the registration number - an absolute incentive to keep registrations current. Under FSMA, food facility registrations were required beginning October 1, 2012. Renewals are due in even-numbered years.
Importers are now required to:
Determine known or reasonably foreseeable food hazards
Evaluate risks using both hazard analysis and a foreign supplier’s performance
Conduct supplier verification
Take corrective measures as necessary
Importantly, an importer must develop and follow an FSVP for each food product brought into the country. If a given food is obtained from multiple foreign suppliers, the importer must maintain an FSVP for each and every one.
Importers can customize FSVPs using a variety of options, although annual on-site audits of supplier facilities is most common. Such audits are required when there is a reasonable likelihood of adverse health impacts without them. Other means of verification are possible as long as they provide adequate guarantees that the food being produced meets U.S. safety standards.
Risk evaluations must re-occur every three years, or any time new data emerges regarding a possible hazard or issues regarding the performance of a foreign supplier.
If you work with foreign suppliers it’s imperative that you understand the foreign supplier verification rules taking effect with FSMA, and we partnered with Matt Regusci of WQS Food Verification and TrainToComply to teach you exactly what to watch for and why it matters for your company.