FSVP compliance with FSMA achievable with A, B, C approach

Provisions of the Foreign Supplier Verification Program (FSVP), under the jurisdiction of the Food and Drug Administration, were enacted in 2015. They mandate that foreign suppliers provide the same level of food safety protection for their products as domestic suppliers are required to provide for theirs.

This is needed as outbreaks of foodborne illness continue to occur both in foreign and domestically sourced foods. Under this law, importers, also known as FSVP importers, must perform a verification step to ensure that foreign suppliers of food destined for sale in the United States have complied with at least two major rules of the Food Safety Modernization Act (FSMA)— the Produce Safety Rule and the Current Good Manufacturing Processes (CGMPs) and Hazard Analysis and Risk-Based Preventive Controls Rule for Human Food.

FDA will hold importers legally liable for ensuring compliance among their foreign suppliers. Importers must approve foreign suppliers before bringing food into the United States. The level of scrutiny applied to the importer approval process is based on a risk assessment of any given supplier’s performance and the historical risk of the commodity, akin to a Hazard Analysis in a Hazard Analysis Critical Control Point (HACCP) plan.

While the traditional HACPP (Hazard Analysis and Critical Control Points) risk assessment model is complex, the FSVP makes risk assessment a straightforward process. What is required in the FSVP version of hazard analysis, which focuses on prevention, is to determine the “reasonably foreseeable hazards” based on the history of safety of the commodity, the history of the supplier meeting their own nation’s regulations, and conformance with U.S. buyers’ requirements.

To make such determinations, an importer must be a “Qualified Individual” as well as an “FSVP Importer” and must be able to read and understand food safety documents such as audits, monitoring, training records, and microbial test results. Qualifications for the person designated as the FSVP Importer are not explicitly spelled out in the rules, however, education, training and experience are mentioned.

Importers of food act as the intermediary between foreign suppliers and U.S. customers. They arrange for cross-border shipments by preparing U.S. customs filings for each food item brought into the US. The customs forms have been updated by FDA to include an entry for the “FSVP Importer” for each line item of food.

It is estimated that 15 percent of the U.S. food supply is imported, including 50 percent of fresh fruits, 20 percent of fresh vegetables and 80 percent of seafood, making the importers’ new food safety role very significant for foreign and domestic trade. For example, an importer may have to disapprove a supplier and discontinue using them, thereby preventing the supplier’s food from entry.

Placing the burden of verification of foreign suppliers’ compliance on U.S. food importers may have some unique benefits and improve public health protection, but it raises conflict of interest questions. Shifting the compliance role to importers will change how importers, suppliers, food brokers, customs brokers, manufacturers and retailers operate. The entire supply chain must communicate now, and make buying decisions considering the new FSVP regulations. How everyone in the supply chain will comply with these new laws, while protecting their business interests and maintaining transparency, remains to be seen.

Importers must be competent to make sometimes challenging decisions about their suppliers’ performance when granting entry approval.

To verify that a food item is safe to import, importers look at the hazard analysis and Food Safety Plan prepared by the supplier. The importer evaluates the plan, considering the importer’s own hazard analysis. Importers also must evaluate the supplier’s compliance with food safety laws in a food’s country of origin and research the history of reports of contamination through The Reportable Food Registry. Importers should know about past and current compliance issues with the Preventive Controls or Produce Safety rules. Perhaps most importantly, an importer must stay informed about reported foodborne illness outbreaks associated with every commodity and/or supplier, product recalls, market withdrawals, and import refusals at ports of entry.

The FSVP is both a law, and a program that importers must have in place, with policies and procedures for foreign supplier approval, evaluation, verification, and corrective actions, all of which require extensive recordkeeping.

Records are the key to compliance, and FDA will often inspect records by sending staff to the office of the registered FSVP Importer. Or, FDA can request the records be sent to them in electronic form or as paper copies.

The FSVP rule requires that the FSVP Importer be in the United States and register with Dunn and Bradstreet to obtain a unique facility identifier or “DUNS number.” The DUNS number key for filing customs forms.

It cannot be overemphasized that the FSVP Importer named on the customs record must be a “Qualified Individual” under the FSVP law, through education, training and experience, and possess the depth of knowledge needed to perform somewhat complex risk assessments at several levels of the supply chain.

Not all food importers will be comfortable in their new role as FSVP importer. Not all will have the technical and scientific knowledge and experience needed to successfully develop their own risk assessment, and assess risk assessments done by others. Additionally, the FSVP Importer must document this entire process for a variety of foods and facilities, including farms, packing houses, processors, manufacturers and distributors.

Therefore, there is a growing need for many “FSVP Qualified Individuals.” All in the food supply chain should become more familiar with the FSVP rule so they can improve compliance throughout the food industry, minimize the potential for unsafe food and protect our nation’s interests in foreign food trade.