A New Partnership with Canada on Food Safety

By: Caroline Smith DeWaal

With a shared border that is more than 5,500 miles long, Canada and the United States have a lot in common — including a shared food supply. So it is no surprise that Canadian food safety agencies and the U.S. Food and Drug Administration (FDA) have signed a “systems recognition arrangement” to mark an important new food safety partnership.  Notably, this is only the second arrangement of this type. The first was signed in December 2012 between FDA and New Zealand’s food safety authority.

Caroline DeWaalSystems recognition not only allows FDA to better plan its oversight of high risk foods, it also increases our reliance on regulators in other parts of the world that have demonstrated they provide a similar system of food safety protection. This is one tool that we use to help ensure that consumers have confidence that their food is safe, whether produced in the U.S. or elsewhere.

Under this arrangement between FDA and Canadian food safety authorities signed on May 4, 2016, FDA recognizes that Canada operates a national food safety control system with regulatory programs comparable to ours. A major advantage of this arrangement is that it allows FDA to be more risk-based in its oversight of imported food.

With systems recognition in place with Canada and New Zealand, FDA can plan more wisely its overall inspection activities, including foreign facility inspections, import field exams, and import sampling. In this reciprocal arrangement, both countries benefit.  Systems recognition advances cooperation and confidence building between our two regulatory systems and it paves the way for sharing information related to food safety.

Systems recognition is a very high bar to reach. Why? For one, the strength of food safety regulatory systems varies widely around the globe. At FDA, systems recognition is an option for countries with domestic food safety systems that have preventive, risk-based programs in place. We understand that any country can have a food safety incident.

For systems recognition to work well, we want to know that the country’s regulatory authorities have the ability to swiftly track down the source of a foodborne illness and take action to stop contaminated food in its tracks –and to follow up to prevent such events from happening again. While systems recognition arrangements are entirely voluntary for the two countries that enter into them, they mark a high degree of trust in participating countries’ abilities to both prevent and respond to food-related outbreaks and contamination events. Following a rigorous review, we are confident that Canada has systems in place to accomplish this.

Before entering into a systems recognition arrangement with Canada, FDA undertook an evidence-based assessment of Canada’s domestic food safety system. We used the International Comparability Assessment Tool (ICAT) to evaluate all aspects of the system, from the regulatory foundation, to the training, inspection, and compliance programs, to the investigation of outbreaks and trackbacks to find contaminated food sources. Onsite reviews were an important part of the assessment process; those reviews allowed FDA to see first-hand how Canada implements the programs they’ve described in the ICAT and Canada conducted a similar review of the way FDA operates its food safety programs.

Systems recognition is intended to facilitate discussions that lead to a continuous improvement process for regulators on both sides of the border. For example, in recent years, new legislation was adopted in each country that emphasizes preventive control systems and import safety: The FDA Food Safety Modernization Act became law in 2011 and the Safe Food for Canadians Act was passed in 2012. As our respective food safety systems, regulatory frameworks, programs and oversight continue to improve, we are committed to this partnership with Canada for the benefit of consumers on both sides of the border.

Caroline Smith DeWaal is the International Food Safety Policy Manager on the International Affairs Staff at FDA’s Center for Food Safety and Applied Nutrition

FDA Continues its Collaboration with Canada in Phase 2 of the U.S.-Canada Regulatory Cooperation Council

By: Lou Valdez, M.S.M.

For more than 30 years, FDA has enjoyed a robust partnership with our Canadian regulatory colleagues. In FDA, we are excited to build upon this relationship in Phase 2 of the U.S.–Canada Regulatory Cooperation Council (RCC).

Lou ValdezThe RCC was established in 2011 by U.S. President Barack Obama and Canadian Prime Minister Stephen Harper to develop smarter and more efficient and effective approaches to regulatory cooperation between the two countries. The RCC aims to bring the U.S. and Canadian regulators and stakeholders closer in terms of sharing information, combining expertise, eliminating duplicative work and creating an enabling environment to foster and facilitate ideas.

In Phase 1 of the RCC, our governments identified important regulatory issues to work together to improve. For example, as a result of the cooperation between FDA and Health Canada, we reduced the regulatory burden for industry through the development of the Common Electronic Submission Gateway (CESG). Led by our FDA Medical Product Centers, the CESG allows industry to simultaneously submit electronic applications to both FDA and Health Canada for pharmaceutical and biological products.

In Phase 2, over the next three years, FDA has committed to work with the Canadian Food Inspection Agency (CFIA) and Health Canada in the areas of:

  • Food Safety
  • Medical Devices
  • Over-the-Counter Drug Products
  • Pharmaceutical and Biological Products, and
  • Veterinary Drugs.

Together with CFIA and Health Canada, we developed five individual work plans describing specific activities within the above areas and two Regulatory Partnership Statements outlining the institutional frameworks for this cooperation.

Throughout the implementation of these work plans, American and Canadian stakeholders will have opportunities to engage with the regulatory agencies to provide updates on significant industry and consumer trends and associated implications for regulatory systems.

FDA is committed to continuing our valued partnership with Canada and using the RCC as an important tool upon which to build. Learn more about FDA’s work under the RCC at http://www.trade.gov/rcc/.

Lou Valdez, M.S.M., is FDA’s Associate Commissioner for International Programs

U.S. and Canada Working Together To Provide Access to Needed Veterinary Drugs

en  français

By: Bernadette Dunham, D.V.M, Ph.D. and Murray M. Lumpkin, M.D., M.Sc.

Bernadette Dunham, D.V.M, Ph.D., Director of FDA’s Center for Veterinary Medicine

The first simultaneous review and approval of a veterinary drug by the United States and Canada marks a successful start to a collaboration aimed at providing quicker access to needed veterinary medicines. The collaboration is also intended to remove trade barriers and reduce costs for consumers, regulators and manufacturers.

Here’s the background: Last year, President Obama and Canada’s Prime Minister Stephen Harper announced the creation of the U.S.-Canada Regulatory Cooperation Council (RCC). The council’s goal is to better align several regulatory approaches, to remove duplicative requirements, and to better share regulatory resources.

Eliminating overlapping efforts is expected to result in reduced costs and more timely access to products while encouraging trade and investment.

Murray M. Lumpkin, M.D., M.Sc., FDA Commissioner's Senior Advisor and Representative for Global Issues


After the agreement to create the council was signed, one of the first projects was to have drug regulators in both countries simultaneously review the same effectiveness data for approval of Elanco’s new animal drug, Comfortis, used to kill fleas and prevent flea infestation in cats. That effort culminated in this week’s announcement that FDA’s Center for Veterinary Medicine and Health Canada’s Veterinary Drugs Directorate had simultaneously approved the drug.

Regulators in both countries have determined that several other veterinary drugs are also potentially eligible for simultaneous review by both countries under the RCC action plan.


Because of this successful initial collaboration, there is much potential opportunity going forward to continue to improve our review efficiency and the use of our review resources to improve access to safe and effective products on both sides of the border.

Bernadette Dunham, D.V.M, Ph.D., is Director of FDA’s Center for Veterinary Medicine.

Murray M. Lumpkin, M.D., M.Sc., is FDA Commissioner’s Senior Advisor and Representative for Global Issues.


Global Cooperation Helps Expand Safety Net

By: Margaret A. Hamburg, M.D.

En Español

Em Português

Ensuring that the millions of FDA-regulated products that flood into the U.S. from 150 foreign countries every year are safe and effective can be daunting task. That’s why it was heartening for me to sign two cooperative arrangements this week with some of our international partners that will make this task a little easier. The arrangements also represent encouraging developments in the quest for a global safety net created through international cooperation.

One arrangement, a “Statement of Cooperation” with FDA’s counterpart in Brazil, outlines procedures for enhanced collaboration between our nations on common regulatory issues. The arrangement is particularly critical at a time when Brazil is dramatically increasing its trade with the U.S. The U.S.imported $31.4 billion worth of products (both FDA-regulated and not regulated) from Brazil last year — an increase of 126% from 2000.

Top regulatory officials from four countries, meeting at a summit in Brazil, prepare to sign the “Statement of Cooperation” among their respective agencies. They are, left to right, Paul Glover, assistant deputy minister of Canada’s Health Products and Food Branch, Margaret A. Hamburg, M.D., commissioner of the U.S. Food and Drug Administration, John Skerritt, national manager of Australia’s Therapeutic Goods Administration, and Dirceau Barbano, director chairman of Brazil’s National Agency for Sanitary Vigilance.

The second arrangement, a “Statement of Cooperation” is between the FDA and our regulatory counterparts in Australia, Brazil and Canada. The arrangement creates stronger regulatory oversight that is less burdensome for both industry and regulators as we pool resources to cover a larger global array of medical device manufacturers.

I signed both arrangements while in Manaus, Brazil, in the heart of the Amazon River basin. The heads of counterpart regulatory agencies from around the world had come together to collaborate on ways to help better ensure the safety of products in all countries—an approach we refer to as the global safety net. Thus, this summit was a particularly appropriate occasion for signing these two arrangements.

The already difficult job of ensuring the safety of FDA-regulated products has grown exponentially due to two megatrends: the expansion of global trade, and the need for ever-greater expertise from regulators as innovations bring increasingly sophisticated products to market.

Our strategy is to create coalitions of regulators that bring together the best minds from around the world to work on the common goal of improving product safety and quality. As I outlined in a keynote address I delivered at the conference, we need to develop a strategy that moves us towards routine regulatory coherence and mutual reliance with our regulatory counterparts. While maintaining national sovereignty and individual agency decision-making responsibility, we can do much more to share regulatory information, strategies and resources.

The arrangements I signed while in Brazil stood as concrete examples of the broader concepts discussed at the conference.

The arrangement between the FDA and regulatory agencies in Australia, Brazil and Canada provides for the creation of a single audit program for medical device quality management systems. The four countries, in accordance with their respective legal authorities, would develop a plan to audit, or inspect, a device facility and then the other countries would utilize the regulatory findings.

The four countries also pledged to promote greater global alignment of regulatory approaches and technical requirements.

Standardized oversight procedures will bring more consistency, predictability and transparency to the regulatory process.

FDA Commissioner Hamburg and Dirceau Barbano, director chairman of the National Agency for Sanitary Vigilance in Brazil, review a “Statement of Cooperation” between their respective agencies.

The broad arrangement between Brazil and the U.S. includes a number of provisions. Both countries will consider exchanging information collected during investigations or facility inspections. They will also identify research that supports the scientific basis for regulations and actions.

What is expected is increased understanding of each other’s regulatory systems and an opportunity to explore how to leverage each country’s resources to expand the safety net for both countries.

The arrangements, and the conference, are steps towards a future with better outcomes through global cooperation. I was pleased to be a part of it.

Margaret A. Hamburg, M.D., is Commissioner of the U.S. Food and Drug Administration.