“We are what we eat,” goes the old saying. Assuming this is indeed the case, we’re all better off now that the Foreign Supplier Verification Program (FSVP) is in place.
The FSVP, part of the Food Safety Modernization Act, requires importers in the United States to perform activities verifying that the food they bring into the country meets applicable domestic safety standards. While the FDA has long required American food producers to conform to public health standards, importers of food basically got a free pass. So did U.S. food manufacturers importing ingredients that went into their final products.
FSVP makes sure this is no longer the case. “Previously, a company that makes frozen dinners could import spices and cheese for the finished product that were not subject to the same health protections that existed for those foods domestically,” explains Marc Sanchez, managing partner at FDA Atty, a Washington-based law firm focused on FDA laws and regulations. “Now the FDA is holding American food manufacturers accountable to ensure foreign foods and ingredients are consistent with U.S. requirements.”
The final rule, now in the process of implementation, is designed to give American consumers confidence in the safety of the foods we eat, no matter where in the world they're produced. To comply with the regulation, importers must specifically know who is actually providing the food, whether or not this supplier is using appropriate processes in producing and packaging the item, ensure the product has not been adulterated or misbranded, and perform written procedures testifying to these and other attestations.
These requirements are not for the faint of heart. The importer — the party that interacts with the foreign supplier — must craft a supplier verification program for each food brought into the U.S. If the company acquires a particular food from several different suppliers, it must develop separate verification programs for each supplier. In these regards, the importer must conduct a hazard analysis on each food plus a separate supplier performance evaluation to discern whether or not it has a history of safety issues. “In effect, the importer has to verify that its upstream and downstream suppliers are meeting the new safety standards,” Sanchez says.
These verifications must be backed up with scientific reports and food-illness data. The FDA recommends that importers (or third-party inspection entities retained by the companies) conduct on-site audits of foreign suppliers, examining their food harvesting, manufacturing, processing, storage and packaging procedures. Food sampling and testing are also encouraged. If these evaluations indicate noncompliance, the importer must ensure the foreign entity has taken corrective actions before bringing the product into the U.S.
“FSVP marks a fundamental shift in food safety,” says Sanchez. “It made no sense to have a domestic rule governing food safety that didn’t extend to imported foods. Now there is parity.”
Supplier Relationships Reimagined
Obviously, this is good news for the American consumer. Previously, no controls existed to determine if many foreign foods contained disease-causing bacteria, allergens, parasites, unapproved food or color additives, and pesticides. The regulation provides greater assurance that all foods in the U.S. are free of such hazards.
Some foods are exempted from the new rule, as there are already systems in place that their manufacturers rely upon. These items include juice, seafood, alcoholic beverages and low acid canned foods. Nevertheless, importers must carefully examine whether or not they are conforming to the exemption description.
FSVP effectively alters the historic relationship between American food importers and their foreign suppliers. “The old paradigm was a salesperson-to-salesperson conversation that was based largely on volume and price,” says Sanchez. “Now the conversation must shift to food quality and compliance. This means salespersons may no longer be the right individuals to conduct the transaction.”
Buying and selling parties may need to train their respective salespeople in food hazards and safety to meet the aims of the verification program. Alternatively, they may decide to recruit qualified individuals for the assignment. In either case, the parties must be able to identify and evaluate potential hazards, audit the extent of serious hazards, ensure the hazard is controlled and document these various activities in a report to the FDA.
“The old deal-driven discussion is no longer relevant,” Sanchez says. “The importer must coordinate with the foreign supplier to verify that identified food hazards are controlled and documented.”
Software tools can help importers attend to the administrative aspects of the verification program. Such automated food-safety and quality-assurance solutions are designed to manage foreign-supplier qualification, documents and relationships. Providers include TraceGains and Safefood 360, among others.
Sanchez recommends that American food importers either develop similar digital solutions in-house or retain the services of the third-party software providers. “Technology gives you the means to monitor each supplier in terms of their compliance, knowing specifically where problems remain at a given point in time,” he explains. “Not only does this assist the current compliance agenda, it also prepares importers for the possibility that the FDA will at some point mandate the use of electronic records.”
If the FDA moves in this expected direction, U.S. food importers will be prepared well ahead of the requirement to confirm expeditious compliance, he adds. “The bottom line for all importers of food is that they must now seek to engage their foreign suppliers in robust dialogues and a close partnership,” says Sanchez. “Only together can they ensure the aims of the verification program are fully met with confidence.”