“Under systems recognition we assess a country’s entire food safety control system, from soup to nuts and every other food that FDA regulates,” says Julie Callahan, an international policy manager at CFSAN. “Of course, how things look on paper doesn’t always reflect how they work in practice. So we include onsite reviews as part of the systems recognition assessment process to see firsthand how a country implements the programs they’ve described in the ICAT,” Callahan said in a recent online posting. The draft ICAT is modeled after FDA’s 2010 U.S. Manufactured Food Regulatory Program Standards, a tool to evaluate the regulatory oversight of food facilities at the state level.
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FDA’s systems recognition pilot with New Zealand concluded with formal recognition in December 2012. A pilot with Canada on its food safety system is underway and a systems recognition pilot with the European Commission is attempting to see how that approach might help further equivalence assessments of each other’s systems for shellfish. The FDA hopes to expand these efforts to more countries “in the near future,” Callahan says.
Some may be concerned about the potential for backlash should a country seek systems recognition but fail to get it. “Trade issues will get stirred up,” Dr. Acheson says. “If, for example, FDA chooses not to recognize Mexico’s food safety systems under FSMA, it may not go over too well. But if Mexico is smart, it will not request recognition because it knows what the answer will be.”
Levitt, however, is not worried. “When this process is done, if similar countries are included as being ‘recognized’ as having advance food regulatory systems while other countries with less-sophisticated systems are not included, then it will be all right.”
Agres is based in Laurel, Md. Reach him at email@example.com.