The Role of the "FSVP Importer" in FSMA

The Foreign Supplier Verification Program (FSVP) under FDA, was enacted in 2015 to require that foreign suppliers of food provide the same level of food protection for their food as provided by our public health system. 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” for the purpose of the FSVP law, as explained below) must perform a verification that a foreign supplier of food has complied with at least two new major FDA-FSMA federal rules; Produce Safety, and the CGMP and Hazard Analysis and Risk-Based Preventive Controls for Human Food Rules.

FDA will hold the importer legally liable to ensure compliance with their requirements. The importer must approve the foreign supplier before bringing food into the US. The level of scrutiny applied to the importer’s approval process is based on a risk assessment of the supplier’s performance and historical risk of the commodity, akin to a Hazard Analysis in a Hazard Analysis Critical Control Point (HACCP) plan. While the traditional HACPP risk assessment model is complex, the FSVP makes the risk assessment a straightforward process. What is required in the FSVP version of the Hazard Analysis is to determine the “reasonably foreseeable hazards” in the commodity, based on the history of safety of the commodity, the history of the supplier meeting their own nation’s regulations, and conformance with US buyer’s requirements.

To make such approval decisions, the 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 the foreign supplier and customers in the US. They arrange for cross-border shipments by preparing the US Customs filings for each food item brought into the US. The Customs forms have been changed 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 importer’s new food safety role very significant for both 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 legal compliance by the supplier on the food importer may have some unique benefits and improve public health protection, but raises conflict of interest questions. Shifting the compliance role to the importer will change how importers, suppliers, food brokers, customs brokers, manufacturers and retailers operate. The entire supply chain must communicate, 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 the supplier’s performance in granting entry approval. To accomplish the verification that a food item is safe to import, importers look at the hazard analysis and Food Safety Plan prepared by the supplier, and evaluate it considering the importer’s own hazard analysis. They must also evaluate compliance with the supplier’s own food safety laws and rules in the country of origin and research the history of reports of contamination through The Reportable Food Registry. They should know about past and current compliance issues with the Preventive Controls or Produce Safety Rule. Perhaps most importantly an importer must stay informed about reported foodborne illness outbreaks associated with the commodity and/or supplier, product recalls, and withdrawals, and import refusals at the port 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 records.

Records are the key to compliance, and FDA will inspect records by coming to the office of the registered FSVP importer. Or otherwise, 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 US. and register with Dunn and Bradstreet to obtain a unique facility identifier or “DUNS number”. The DUNS number is a key part of the customs filing. It cannot be overemphasized that The FSVP importer placed 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 risks 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 a risk assessment 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.

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