From: Food Quality & Safety magazine, August/September 2013

Global Food Partnerships

by Ted Agres

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.

Facing Reality

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.

Canada appears to be outpacing the U.S. in terms of implementing traceability. On June 2, the Canadian Food Inspection Agency (CFIA) published a discussion document outlining in general terms proposed regulatory mechanisms for product traceability as well as for licensing, preventive control measures, foreign inspections, and foreign regulatory systems equivalency. According to “A New Regulatory Framework for Federal Food Inspection,” Canada will implement “at a minimum” the international standard for traceability established by the Codex Alimentarius Commission—namely recordkeeping to identify product movement one step forward and one step back in the supply chain. Retailers who are covered by the regulation would not be required to trace food products sold to the final consumer, however.

David Acheson, MD

“The question is whether Canada can draw the rest of the world in traceability.”

—David Acheson, MD, director of the food and import safety ­practice, Leavitt Partners

“There is a big opportunity for Canada under the Safe Food for Canadians Act to move forward more quickly than the U.S. on traceability standards,” Henry says. “They can put a stake in the ground and state, ‘This is what we will require from anyone moving product into my country or [from product that is] domestically produced.’”

Cameron Prince, vice president for inspection modernization at the CFIA, says implementation of the traceability regulation is “fairly imminent in terms of how bureaucracy goes” with a final regulation expected by the end of 2014 or in early 2015. “It would be naïve to say this will be nice and smooth because there are many perspectives on this,” Prince told the Food Safety Summit. “Some industry players say they don’t want the long arm of the government involved directly with information like that and prefer the government to have just an oversight role. Others want to see more rigorous traceability standards in place. So the debate is just beginning.” Combined with an already established identification framework for beef and pork, the traceability mechanism would create a “farm-to-fork approach,” according to Prince. “It’s a broad vision and many countries share that vision. The question is how to get there.”

But whether Canada’s traceability mechanism will become the de facto international standard remains to be seen. “The question is whether Canada can draw the rest of the world in traceability,” says Acheson. “Typically, they haven’t been able to [influence the world] because they are too small. Europe and the U.S. could, but for Canada, maybe, maybe not.”

Mutual Recognition

Australia’s Parker ties growth in world food trade with the way governments cooperate and recognize each other’s food safety systems. “This is no small body of work by any stretch of the imagination. But we see the Food Safety Modernization Act as an opportunity for us to work with FDA and, through some of those issues, work out exactly what each of our systems should be doing to provide confidence in both countries over their food safety systems,” he says.

“The additional audits mandated by FSMA may be viewed by some in industry as regulatory duplication,” Parker explains. “Accordingly, Australia is working with the FDA and the outcome we are hoping for is for simplified compliance arrangements under which Australia’s regulatory system is recognized, similar to how New Zealand’s regulatory system is recognized by the FDA.”

This is in reference to the fact that, in December 2012, the FDA and New Zealand regulators signed a voluntary “systems recognition agreement” acknowledging that each other’s food safety system provides “comparable” levels of safety assurances. Expected benefits from this first-ever arrangement will include enhanced information sharing to allow food products to be imported without duplicated inspections.

Under such a comparability agreement, “nations can concentrate more resources, including inspections, on foods that present a greater risk, providing for improved food safety overall,” wrote Deborah M. Autor, deputy FDA commissioner for global regulatory operations and policy, and Michael R. Taylor, deputy FDA commissioner for foods and veterinary medicine in a Dec. 13, 2012 blog posting. While comparability certification is not required for countries to export food into the U.S., “any country that believes it can meet the very high bar will have the option of seeking recognition.”

Mark FeDuke

“Hundreds of customs brokers have served notice that they will no longer act as U.S. agents for any foreign food facility.”

—Mark FeDuke, director of trade compliance, VLM Foods

An FDA systems recognition pilot project is currently underway in Canada. “Canada and the United States are working in parallel towards strong food safety systems. Enhancements over the next couple of years will mean a stronger food safety culture, safer food supply, better trade opportunities, and better regulatory cooperation,” says Prince.

According to Katherine Bond, director of FDA’s Office of Strategy, Partnerships, and Analytics, the agency has many approaches to facilitate increased collaboration. “Local, state, federal, and international regulators should ultimately form one network protecting our respective consumers to build one global product safety net. FDA is committed to working with specific countries to identify which approaches make the most sense,” she told the Food Safety Summit.

Partnering with food agencies in other countries is one of four “pillars” the FDA has established to improve product safety. The others are:

  • Building global information systems and networks and proactively share data with peers,
  • Expanding intelligence gathering with an emphasis on risk analytics, and
  • Allocating agency resources based on risk leveraging the combined efforts of government, industry, and public and private third parties.

FSMA includes several provisions intended to improve imported food safety, including the Foreign Supplier Verification Program, third-party auditor accreditation, and the voluntary qualified importer program, among others. The White House OMB is still reviewing these regulations and some of them are expected to be released this year for public comment. Under the expected rules, imported foods will be held to the same safety standards as domestic foods, and importers and foreign suppliers must have controls in place to ensure product safety. Over the next several years, assuming adequate funding, the FDA will spend nearly $1.4 billion to hire hundreds of new staff and pay third-party private contractors to inspect foreign food suppliers, especially for high-risk foods.

Under the law, the FDA must establish offices in foreign countries and enter into agreements with foreign countries to facilitate inspections of their facilities. This expanded inspection and verification regime has the potential to trigger reciprocal requirements from other countries. As Mexico’s Fragoso puts it, “We need to recognize Mexico [will be] having third parties in the U.S. and the U.S. having third parties in Mexico.” In South Korea, lawmakers have introduced legislation that would allow Korean authorities to inspect food manufacturing facilities in foreign countries and require all food importers to supply the addresses of foreign manufacturing facilities before filing an import declaration.

“While FSMA will surely lead to improved food safety outcomes, one has to consider the potential for unintended consequences such as the impact on America’s export food supply chain when our trading partners create their own FSMA-like administrative requirements,” says Mark FeDuke, director of trade compliance at VLM Foods Inc., an international supplier of processed foods. FSMA will require U.S. importers to certify that foreign products meet all domestic food safety standards. In many cases, this means a U.S. agent or representative of a foreign company may be held liable for FDA reinspection fees and product recall-related fees and fines, he says.

“Given the potential for open-ended liabilities, hundreds of customs brokers have served notice that they will no longer act as U.S. agents for any foreign food facility,” FeDuke tells Food Quality & Safety magazine. “Meanwhile, surety providers are hawking their coverage with premiums to be paid by those entities that have sufficient risk appetite to continue acting as U.S. agents for foreign food facilities.” If a Korean food facility ends up paying a U.S. agent as a condition of market access in the U.S., “why wouldn’t they, and all the dozens if not scores of other countries buying American food exports, impose the same requirements on U.S. food facilities?” FeDuke adds.

Wayne Ellefson

“To me, harmonizing the test methods on a global basis is an issue of concern.”

—Wayne Ellefson, senior program manager, Covance

Quest for Global Standards

It’s possible that these and many other issues would be more easily addressed if countries adopted a uniform set of food safety standards established not by any particular private certifying organization but by an international body such as the United Nations, says Covance’s Ellefson, who is coauthor of a recent book, Improving Import Food Safety, that examines the differing approaches to food safety problems taken by the U.S., Latin America, Europe, and Asia.

While such an outcome is unlikely to happen anytime soon, Ellefson says there is an immediate need to standardize laboratory testing not only internationally but within single countries, including the U.S. “How do you know if you will get the same test result from laboratory to laboratory?” Ellefson asks. “How do you know if they are using the same harmonized methods? Expand that to the whole world–Canada, Europe, Asia, South America–how do you know the quality of the methods they are using for testing is equivalent in all locations? To me, harmonizing the test methods on a global basis is an issue of concern.”

The issue is being addressed. For example, AOAC International (formerly the Association of Analytical Communities) is one of several groups developing analytical and other standards for global acceptance. AOAC has assembled an expert stakeholder panel on infant formula and adult nutritionals and, with industry funding, is developing standard method performance requirements for nutrients and analytical methods for validation studies. “They are working on getting global buy-in. They are trying to carry this to food items other than infant formula, but you have to start somewhere,” Ellefson says.

As Acheson puts it, the global food supply situation is “already critical and is becoming increasingly more so.”

“It’s also becoming increasingly challenging and complicated through these regulatory requirements and hurdles and potentially reciprocal arrangements. Unquestionably, this is a very complex field that needs to be watched carefully over the coming months and years,” Acheson says.

Agres is based in Laurel, Md. Reach him at



For more information on global food trends, click on this issue's online exclusive "Is Europe Outpacing the U.S. in Traceability?"





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