FDA Systems Recognition: Ensuring Imported Foods Are Safe

By: Julie Callahan

FDA works on many fronts when it comes to making sure our food supply is safe—not just the foods we grow and process here in the United States, but also those that are shipped here from overseas.

And there are many. In fact, imports of food to the U.S. have more than doubled in the past decade.      

FDA has systems in place to help ensure that foods imported are as safe as those produced in the U.S., and under the FDA Food Safety Modernization Act (FSMA), consumers can have even more confidence in the safety of imported food.  Under FSMA, FDA is setting standards for domestically produced and imported foods that would prevent contamination and is requiring that importers verify that their overseas suppliers are producing food consistent with these requirements. 

But FDA has even more tools in its toolbox to make imported food safer. For example, FDA is working with countries to build their capacity so that their food safety systems improve. FDA also wants to recognize countries that are so reliable that we can consider them “comparable.” 

New Zealand is the first country with which FDA completed a systems recognition assessment, and we signed a systems recognition arrangement with its food safety authority, the Ministry for Primary Industries, in December 2012. Today, we published “Information for Foreign Governments: Frequently Asked Questions on Systems Recognition,” to provide more information on this topic.

Recognition under this new program, which we continue to pilot test, is a high bar to reach. These are countries that have preventive, risk-based programs in place and can respond and follow up on any food safety incidents that may occur. In recognizing countries under this program, we want assurance that the country’s authorities will be able to swiftly track down the source of a foodborne illness and take corrective actions as necessary to stop it in its tracks—and to help prevent such an incident from happening again. 

If a country does not have a systems recognition arrangement in place it can still export products to the U.S. However, participating in a reciprocal systems recognition arrangement with the FDA offers countries that have very robust food safety control systems an opportunity to participate in a closer regulatory partnership. For example, with New Zealand, we can use some of the data they generate to help us make decisions about their imports. We can also use systems recognition determinations as one factor in prioritizing resources dedicated to foreign facility inspections, import field exams, and import sampling. 

As we tackled ways to identify the top-performing food safety systems in an objective, transparent, and importantly, reproducible way, we first looked at the way that we evaluate our own food safety programs in every state. In doing so, we developed the International Comparability Assessment Tool (ICAT). The ICAT is based on the approach that we use here in the U.S.; that is, evaluating all aspects of the system, from the regulatory foundation, to training, inspection, compliance programs, and how outbreaks and trace-backs to identify the contaminant are conducted.

Under systems recognition we assess a country’s entire food safety control system, from soup to nuts and every other food that FDA regulates. Of course, how things look on paper doesn’t always reflect how they work in practice. So we include on-site reviews as part of the systems recognition assessment process, to see first-hand how a country implements the programs they’ve described in the ICAT. It’s the difference between actually using a Smartphone and just reading the user manual.

Why New Zealand? In the past, New Zealand and the U.S.had certain commodity-specific arrangements in place, such as ones for seafood and certain dairy products. Our next scheduled review of these arrangements coincided with the time FDA was starting to develop its systems recognition program. As we were already working closely with New Zealand to update these arrangements, it made sense to expand our review.

Here’s where things get interesting.

Recently, you may have seen New Zealand’s food safety system in the news, associated with a potentially contaminated whey protein product commonly used in infant formula and sports drinks. Although the product had not been exported to the U.S., the New Zealand authorities discovered that a package of 21 candy bars containing whey protein from the potentially dangerous batch had been sent to a company here for market testing. As soon as they identified the product, they contacted FDA to let us know that they had traced it to a particular company and had contacted the company. They made sure that the product had not been sold to any consumers in the U.S. and accounted for all of the candy that had been shipped here.

In the end, the whey protein that was recalled had not been contaminated after all—it proved to be a false alarm. 

New Zealand authorities had acted swiftly and effectively, exhibiting a level of detail, commitment to communication, and sophistication that confirmed FDA’s assessment of their food safety system. The New Zealand authorities brought the same care to notifying other countries that had received the recalled product, as well as any other product that contained the whey protein as an ingredient.

Currently, we are in the process of piloting another systems recognition assessment with Canada, and we hope to expand our effort to more countries in the near future. As we move from the pilot phase towards implementing a new program and identifying additional countries with food safety systems that are comparable to our own, we will continue to strengthen our regulatory partnerships and focus our resources where most needed, to ensure that consumers in the U.S. can feel safe, whether their food was grown here in the U.S. or far away across the globe.

Julie Callahan, Ph.D., is an International Policy Manager in FDA’s Center for Food Safety and Applied Nutrition.

A New Partnership with New Zealand

By: Deborah M. Autor, J.D. and Michael R. Taylor, J.D.

This week, for the first time, FDA and New Zealand’s Ministry for Primary Industries recognized each other’s food safety systems as providing a comparable degree of food safety assurance at a signing ceremony at the Embassy of New Zealand in Washington, D.C.

One practical result of this arrangement is enhanced information exchanges to avoid duplication of efforts: for example, if the two food-exporting countries decide that their food safety programs and practices provide a comparable level of food safety assurance, they can take this into account as appropriate in determining the type and frequency of inspections to conduct of foreign manufacturing establishments and of imported food shipments.

This means the comparable nations can concentrate more resources, including inspections, on foods that present a greater risk, providing for improved food safety overall.

The arrangement with New Zealand is part of an overall strategy for strengthening the global food safety net through closer collaboration with regulators around the world, highlighted in FDA’s report “Pathway to Global Product Safety and Quality.”

Mike Taylor, J.D.FDA recognizes that, while import examinations are an important tool in helping to ensure that imported foods are safe, we can’t examine every food headed for or arriving at our borders. Instead we make risk-based decisions about which shipments need the least and the most scrutiny at the border. Under the new Food Safety Modernization Act (FSMA), FDA is mandated to expand its import tool kit beyond FDA’s border screening to include stronger importer accountability for verifying the safety of food imports, a much strengthened system of private audits, more FDA inspections overseas, and importantly, greater collaboration with foreign regulatory authorities.

Globally, however, there are major differences in the strength of food safety regulatory systems. For years, we have conducted reviews of various food safety policies and programs in place in other countries to provide assurances of the safety of individual products. The systems recognition process that we completed with New Zealand goes beyond our previous commodity-specific evaluation strategy, covering the overall food safety system that is in place, and how it is implemented, and extending to all FDA-regulated food products.

 

In the past, New Zealand and the U.S. had certain commodity-specific arrangements in place such as ones for seafood and dry dairy products. A scheduled review of these arrangements coincided with the time FDA was starting to consider ways to expand the global safety net through enhanced cooperation with other nations. Both countries thought: Why not try to expand beyond these products to include every product regulated by FDA and its counterpart in New Zealand?

Carol Barnao, Deputy Director General Standards, New Zealand Ministry for Primary Industries, and Mike Taylor, FDA Deputy Commissioner for Foods and Veterinary Medicine, at the signing ceremony.

That was the start of intense work which began in 2010. FDA, working with New Zealand regulators, comparing every facet of each country’s food safety system—the training of inspectors, procedures for identifying and responding to food safety issues, and legal authority, to name a few.

Once we had confidence in the system on paper, we conducted on-site reviews of the implementation of their programs, to give us an understanding of how their programs worked in practice.

Both countries retain the right to conduct inspections of each other’s products as appropriate. But assured about each other’s competency and commitment, both are more likely to focus their resources on higher risks. Importantly, if a problem does occur, each country intends to work cooperatively on follow up.

The process for conducting systems recognition is still being pilot tested with Canada. FDA will continue to update and refine our process as we work through the pilot with Canada. Systems recognition is voluntary and not required in order for a country to export FDA-regulated foods to the U.S., but any country that believes it can meet the very high bar will have the option of seeking recognition. Meanwhile, we will continue working to foster a global food safety net for all.

Deborah M. Autor, J.D., is Deputy Commissioner for Global Regulatory Operations and Policy

Michael R. Taylor, J.D., is Deputy Commissioner for Foods and Veterinary Medicine