Systems Recognition Assessment

As part of its implementation of the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP), the FDA is developing procedures for evaluating the food safety and inspection regimes of foreign countries to determine whether they are “comparable” with those of the U.S. Obtaining “comparable” food safety status from the FDA will be beneficial because food exporters and U.S. importers will enjoy a streamlined process devoid of much of the additional red tape and scrutiny expected under FSMA. So far, only New Zealand has been granted this coveted status, but the FDA has pilot projects underway with Canada and the European Union to evaluate how it will perform “systems recognition assessment” (previously called “comparability assessment”) going forward. The agency is also seeking comments from foreign countries, U.S. companies, and other stakeholders on its proposed methodology.

“Under the FSVP proposal, there is a provision that if you are importing from a ‘recognized’ country—such as New Zealand right now—the only verification you have to do for that supplier is get a certificate from the government that it is in good standing,” says Joseph Levitt, a partner with the Hogan Lovells law firm in Washington, D.C. and a former director of FDA’s Center for Food Safety and Applied Nutrition (CFSAN). “That’s an enormous savings of time and energy that companies can devote elsewhere.”

The U.S. importer would be required to list its foreign supplier, identify itself at the point of entry, and ensure that FSVP records are available to the FDA, adds David Acheson, MD, founder and CEO of The Acheson Group and a former FDA associate commissioner for foods. “The value of systems recognition is that it adds economic positives by reducing burdens on both the private and public sectors,” Dr. Acheson tells Food Quality & Safety magazine. “There are good reasons to do it, but it needs to be done right,” he says.

Even FDA acknowledges that doing it right will be challenging. “Globally, there is substantial variation in the robustness of food safety systems, ranging from systems in the early stages of development to highly mature food safety systems. This variation heightens the challenge to FDA in developing effective import control systems,” the agency says in an explanatory document posted September 5, 2013. Another challenge is that FDA must design a system that enhances imported food safety but doesn’t violate World Trade Organization and other international agreements that prohibit foreign products from being held to tougher standards than domestically produced counterparts.

The corollary is also true, says Michael R. Taylor, FDA deputy commissioner for foods and veterinary medicine. “U.S. food producers and processors also have a stake in the safety of food and ingredients from overseas and rightly want to know that there’s a level playing field—that imported food would have to meet the same safety standards as food produced in the U.S. under the new food safety rules,” Taylor wrote in a recent online posting. “And it makes sense that European firms and governments are interested in the FSMA requirements we are developing because they want to maintain market access in the U.S.,” he says.

A Promising Approach

Food safety experts generally laud the systems recognition approach. “This initiative by FDA holds a lot of promise if the agency is able to ‘recognize’ a number of other countries as having advanced food safety systems that are comparable to those of the U.S.,” Levitt tells Food Quality & Safety magazine. “Only time will tell whether the New Zealand recognition is isolated or a preview of what’s to come.” This is a key point because even FDA officials think the program will have limited attractiveness.

About Ted Agres

Ted Agres covers food safety regulatory and legislative issues from the nation’s capital. He has 40 years of experience in reporting on issues such as health policy, medical technology, and pharmaceutical development. He holds an MBA from Johns Hopkins University and a bachelor’s degree from the University of Chicago. He enjoys playing the piano, amateur radio, and paintball. He lives in Laurel, MD.

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