Explore this issueAugust/September 2013
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While the FDA and the White House Office of Management and Budget (OMB) slowly roll out regulations to implement the Food Safety Modernization Act (FSMA), regulators in other countries are pushing ahead with standards for such key areas as product traceability, potentially outpacing the U.S. Meanwhile, concern is growing among many food safety experts that expanded FSMA requirements for foreign facility inspections and certifications may trigger a backlash from other nations requiring their own expanded inspections and certifications of U.S. firms and growers.
“If FDA starts to ramp up requirements for imported foods, which they clearly said they are going to, we may see reciprocal challenges or requirements from other foreign countries that will affect U.S. exporters,” says David Acheson, MD, director of the food and import safety practice at Leavitt Partners and a former FDA associate commissioner of foods. “I see that as a potential area for U.S. companies to look at.”
And as major exporting countries review their food production and certification mechanisms in light of expected FSMA requirements, the desirability of global food safety standards is becoming apparent. “Companies would prefer to understand one set of rules and requirements that are good everywhere. But that’s a long way from happening,” Acheson tells Food Quality & Safety magazine. It would be a “big thing” if global standards were established, adds Wayne Ellefson, senior program manager, Covance. “It’s an interesting concept but it will take awhile before it happens. In the current day it may not be practical, but in the future, it may come to exist,” Ellefson tells Food Quality & Safety.
As pleasant as speculation about global standards may be, the reality is that many countries are struggling to formulate national standards that will comply with expected FSMA requirements while also fitting within their own political and business environments.
“We have a deep commitment to work with the U.S. to achieve the least-burdensome approach of achieving compliance with the Food Safety Modernization Act and all other U.S. import requirements,” says Chris Parker, agriculture minister-counselor for the Embassy of Australia in Washington, D.C. “Given that there are equivalent food safety outcomes contained in Australia’s food export systems, we believe that Australia is already in strong compliance with the Food Safety Modernization Act. The only significant effect we see is increased audit frequency,” Parker said during a four-hour panel discussion on FSMA at the Food Safety Summit in Baltimore in April.
His concerns were echoed by Hugo Fragoso, director general of animal health at SENASICA, Mexico’s agency for National Health Service, Food Safety, and Quality. “We need to comply with regulations of food safety not only with FSMA but we are trying to establish a national program to comply with every country in the world,” Fragoso told the gathering. “Mexico is working to educate our people to know about FSMA. We understand it’s very, very important for us to comply with FSMA. FDA and SENASICA should work better and coordinate on food safety,” he said.
Craig Henry, a director at Deloitte & Touche LLP and panel moderator, noted that “the diversity of approaches among the different countries to food safety is very evident, but there are also many commonalities.” Among the latter is the need for food traceability standards. Currently, the FDA is evaluating comments submitted to recommendations made by the Institute of Food Technologists (IFT). In a recently released report, the IFT recommended that FDA establish a uniform set of recordkeeping requirements for all regulated foods and not allow exemptions based on risk categories or the size of the firm involved.
After considering public comments, the FDA will submit recommendations to Congress on traceability standards and prepare proposed regulations—steps required by Section 204 of FSMA. While the law requires FDA to establish recordkeeping requirements only for “high-risk” foods, the IFT recommended that these requirements be extended to all food categories because “low-risk” products quickly become “high-risk” when an unexpected outbreak occurs.