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Systems Recognition: Designation Will Be Challenging for Most Countries
by Ted Agres
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.
“According to FDA officials, the agency expects a limited number of countries to seek comparability with the United States because, in part, most countries will not meet the FDA requirement that the foreign government‘s domestic and export food safety systems be comparable with the U.S. system for all their food products,” says a September 2012 report by the congressional Government Accountability Office (GAO). While some countries have “robust” export certification programs in place for certain food products, such as seafood, their overall food safety and domestic production systems may not be comparable with those of the U.S. “Such countries would be more suited to apply for accreditation as a third party rather than seek overall systems comparability,” FDA officials told GAO auditors.
FSMA requires FDA to establish a program for the Accreditation of Third-Party Auditors for foreign food facilities. In this, FDA will recognize accreditation bodies which, in turn, will accredit third-party auditors to conduct food safety audits and issue certifications for foreign facilities and food. A third-party auditor could be a foreign government, a foreign cooperative, or other third party as long as it has legal standing and meets other standards, such as for competency.
“FDA believes that comparability is a more efficient and appropriate tool for FDA to use in assessing whether a country‘s entire food safety system provides adequate assurances of comparable public health outcomes, and third-party certification is a more appropriate approach for FDA to use when assessing a particular segment of the food safety system,” says Jim R. Esquea, assistant secretary for legislation at the Department of Health and Human Services, FDA’s parent agency, in written comments to GAO.
GAO disagrees with FDA that the use of third parties is preferable to comparability assessments, noting that some foreign governments may object to being designated as a third party because of sovereignty issues. And then if they do agree to that designation, “there is a potential conflict of interest in having a government accreditation body accredit another government agency from the same country as a third party,” GAO says, raising questions of bias.
GAO would prefer that FDA utilize systems recognition even for specific foods or subsets of food. This would be more comprehensive than a third-party accreditation arrangement, and would produce advantages similar to those realized by the FDA’s Food Safety and Inspection Service (FSIS) and the E.U. from their use of stricter “equivalence” standards. “If FDA had a comparability assessment agreement with a foreign country, similar to an E.U. equivalence agreement, a foreign competent authority would address any identified problems and take regulatory actions across the supply chain, as necessary,” GAO says.
“Equivalence” is a much higher standard than “comparability.” When it comes to importing meat, poultry, and processed egg products into the U.S., FSIS evaluates whether a foreign country’s food regulatory system employs equivalent sanitary measures that provide the same level of protection against food hazards as is achieved domestically. As of October 2013, FSIS had approved 34 countries including Albania, Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Honduras, Hungary, Iceland, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Nicaragua, Northern Ireland, Poland, Romania, San Marino, Spain, Sweden, and Uruguay.
“Trying to demonstrate equivalence for every food item would be impossible,” Dr. Acheson says of systems recognition. “So FDA is taking a different tack of seeing whether public health protections in the foreign country are similar to those in the U.S. This gives the FDA lee-way, but it is still a heavy lift and an onerous process.”
FDA has outlined a multistep process it will use for recognition. After a country requests systems recognition, FDA will review its compliance history, trade volume, number of admission refusals and reasons, import alerts, and other information. FDA will then review these findings with food safety officials in that country. If they want to proceed, the officials will be asked to complete an International Comparability Assessment Tool (ICAT) to evaluate the extent to which the country satisfies standards in 10 areas: The regulatory foundation; training programs; inspection program; program assessment/inspection audit program; food-related illness and outbreaks; compliance and enforcement; industry and community relations; program resources; international communication and harmonization; and laboratory support.
“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.
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 firstname.lastname@example.org.