We work for a public health regulatory agency—the United States Food and Drug Administration (FDA)—that oversees products accounting for 20 percent of US consumer spending. FDA regulates industries that meet fundamental human health needs in the areas of pharmaceuticals, vaccines, blood and blood products, and medical devices. FDA also regulates the tobacco, dietary supplement, and cosmetic industries. In addition, we regulate the food industry. Twenty-five years ago, the FDA could afford to think and act as the domestic agency we were. Today we can’t. Every industry we regulate has become global in terms of how they source ingredients, manufacture finished products, and seek markets for the products they make here in the United States. Annual import entries of FDA-regulated products have almost tripled from 2004 to 2014, rising to about 33 million. The companies we regulate are often multinationals that have an international outlook and are affected by international standards, which they seek to harmonize.
So, FDA has had to become global, too. Since 2011, the US Congress has given us two new import safety laws with mandates and tools to ensure that imported medical and food products are as safe as domestic products. We now have offices in seven foreign countries compared to zero in 2007. We have full-time staff working on international harmonization of regulatory standards, trade policy issues, and regulatory partnerships with foreign governments. Our international engagement—and the importance of international relations to our success — is only increasing. In this article, we will highlight the international dimension of our food program, which has responsibility for the safety, composition, and labeling of all human and animal food products—except meat, poultry, and some processed egg products regulated by the US Department of Agriculture. We will focus specifically on the global public health and economic challenge of protecting the safety of our food supply to show how fully intertwined our domestic consumer protection mission is with challenges facing the global food system. Furthermore, we will explain how implementation of the FDA Food Safety Modernization Act (FSMA) of 2011 brings home the lesson that when it comes to food safety, we’re all in this together.
Congress and FDA share a vision of how the United States must engage internationally on food safety for the good of its citizens and the good of the global community. Our work in the years ahead is to fully execute that vision.
The Global Food System and Food Security
The global food system is a multi-trillion-dollar economic enterprise that is present in every corner of the globe and affects every person on the planet. It is diverse almost beyond description.
Today’s food system ranges from the hundreds of millions of subsistence farmers in Africa, Latin America, and Asia to the millions of small-scale but commercial farms in New England and Oregon, all across Europe, and all over the world. It includes massive soybean farms in Brazil and large-herd California dairy operators; cattle, hog, and poultry producers in the United States, Argentina, and New Zealand; and fish farmers in Mississippi, the American Midwest, China, and Vietnam. Connecting these agricultural producers to consumers are all the millions of businesses that transport food and food ingredients across often extensive supply chains; process meat, grain, fruit, and vegetables into packaged food; and market food to consumers in grocery stores and restaurants.
This vast system is the means by which seven billion people seek to feed themselves daily, for their survival certainly, but also with the hope of enhancing their well-being through good nutrition and healthy diets. It is the system that must meet the food needs of a population expected to reach nine billion by 2050, in the face of scarce land and water resources.
In the United States, we import food from over 200 countries, comprising about 15 percent of total food consumption.
All of this means there is no more important challenge for the long-term well-being of the world’s population than the success of the global food system in meeting the basic human need for food security—ensuring that all people at all times have physical and economic access to sufficient, safe, and nutritious food. Much of what happens to achieve food security takes place at a local level or through activities that occur within a nation’s own borders. But for millennia, people have been trading food across borders and between continents: trade in spices goes back to 3,000 BC and Europeans were harvesting cod in waters off what is now New England before the first Pilgrims arrived in 1620. Today, international trade in food—driven by climate differences, wage differentials, and cheap transport—is a central feature of how many countries meet basic food needs. In the United States, we import food from over 200 countries, comprising about 15 percent of total food consumption, but more than 90 percent of our seafood, 50 percent of our fresh fruit, and 20 percent of our vegetables—all helping provide Americans a diverse, nutritious, and affordable food supply all year. We’re not alone in relying on imports. For example, the European Union was the top importer of agricultural products in 2013, with Japan and China also in the top 10, according to the Food and Agriculture Organization of the United Nations.
Most people reading this publication have the good fortune to be able to take food security for granted, but food insecurity, in every dimension, remains a grave challenge in the United States and around the world. With regard to accessing sufficient amounts of food, 795 million people worldwide suffer from chronic undernourishment, and almost 15 percent of US households lack sufficient food to some degree. With regard to safety, foodborne illness globally afflicts an estimated 600 million people and kills 420,000, including 125,000 children under five years old per year. In the United States, the Centers for Disease Control and Prevention (CDC) estimates that 48 million people are sickened annually, 126,000 hospitalized, and 3,000 killed by a foodborne illness. Regarding nutritional adequacy, many people in developing countries depend for adequate calorie intake on staple crops, including maize and rice, that don’t fully meet their nutritional needs, while in developed countries most people have ready access to foods high in sugar, salt, and fat, but too often lack ready access to more nutritious and healthful foods.
FDA is not a food security agency. Nor is it a development agency. But we do see ourselves as part of the global food system, with an important contribution to make to food security, primarily in the realm of food safety. Easily two-thirds of FDA’s food-related resources are devoted to addressing the persistent public health problem of foodborne illness caused by microbiological pathogens in food—a challenge made all the more complex by the globalization of the food system.
Following a series of illness outbreaks and contamination incidents involving both domestic and imported food — ranging from bagged spinach and tomatoes to peanut butter, dairy products, and shell eggs—Congress enacted FDA Food Safety Modernization Act (FSMA), which directs a complete overhaul of the US food safety system to be more effective in preventing foodborne illnesses and the severe market disruptions and economic costs these illnesses impose. In implementing FSMA, we are focused on our central mission to protect the health of American consumers, but the experience of implementing this historic new food safety law has only driven home for FDA the importance of thinking and acting as part of a world-wide food system whose goal is food security.
Though FSMA is first a food safety law, it is clear, if one looks at the origins of FSMA and all of the mandates it gives FDA, that Congress sees food safety in the broader context of food security and the overall success of the food system. Therefore, as we do our public health and food safety regulatory job, we believe we have a responsibility to be mindful of how that job affects and is affected by the broader realities of today’s global food system, and how we can work well within that system.
Food Safety and FDA’s Role in the Food System: FSMA’s Goals
The story begins with the origins and goals of FSMA. Congress passed FSMA in response to the demands of a broad coalition of stakeholders—produce growers, food processors, retailers, and consumers — who were disturbed by a series of illness outbreaks and contamination incidents. These events harmed consumers, undermined consumer confidence, and imposed costly disruptions on food producers and marketers. Worse, they were largely preventable. This stakeholder coalition saw the progress that the food industry had made in developing best practices for preventing food safety problems and asked Congress to make these practices the norm for all those supplying the US market, whether from farms and facilities in the United States or in other countries. That is what FSMA does through a comprehensive new tool kit that includes extensive new authority and mandates to ensure the safety of imported food. While protecting consumer health was FSMA’s central goal, FSMA’s supporters also wanted to protect the food system from the loss of consumer confidence and the market disruptions and high costs to industry resulting from foodborne illness.
FDA is not a food security agency. Nor is it a development agency. But we do see ourselves as part of the global food system.
These goals all relate directly to US food security in both its food safety and nutrition dimensions. This is so even among people who generally enjoy food security. To use just one example, when American consumers lose confidence in the safety of fresh produce, or its availability is diminished due to outbreaks or recalls, they have less access to important components of a healthy diet and thus less food security.
FSMA pursues its broad goals by fundamentally changing FDA’s food safety role and its relationship with other participants in the food system.
FDA-Industry Collaboration on Food Safety
First, FSMA explicitly embraces the food safety role of the food industry. It rests on the core principle that those who produce food for the commercial market have the responsibility and capability to make this food safe in accordance with recognized best practices for preventing harmful contamination. FDA has the job of establishing the framework of standards that help define such practices and then overseeing their implementation to achieve high rates of compliance with the standards.
In the past, FDA worked on food safety largely at arm’s length from the industry, as the agency inspected and investigated problems after they had occurred. Under FSMA, and FDA’s implementation strategy, FDA will be working in direct collaboration with industry to prevent problems by actively fostering voluntary compliance with food safety standards. This means providing guidance, education, training, and technical assistance so that producers know what is expected and are supported in doing it. It also means carrying out inspections in a way that focuses less on possible regulatory violations and more on whether food producers are meeting their responsibility to achieve good food safety outcomes.
In this way, FDA will be functioning more as an integral part of the food system, rather than standing apart from the system as primarily an enforcer of rules. FDA will of course take swift enforcement action when needed to protect consumers, adding new tools provided by FSMA to ones FDA has traditionally used. But our goal under FSMA is food safety, not enforcement for the sake of enforcement.
Embracing the Diversity of the Food System
Another key feature of FSMA is its recognition of the great diversity of today’s food system, as it operates both globally and locally. This diversity is important for both sustainability and food security. With its new import safety mandate, Congress recognized the need to address food safety at a global scale to address the wide range of commodities the United States imports from over 200 countries and territories, and to ensure that food is safe regardless of its source. Much of this trade is conducted on a large scale by some of the world’s largest companies.
In addition to recognizing the global reach of large companies, Congress noted that prevalence of thousands of small-scale growers and embraced their value to the food system and the emergence in recent years of a vibrant local food movement. In some US communities, this movement, which responds to consumer interest in buying food grown closer to home, provides central features of the social fabric and important contributions to economic sustainability and development.
We believe this diversity is a real strength of the food system—for many economic, social, and consumer preference reasons — and FDA is implementing FSMA in a way that respects this diversity, including the contribution to diversity made by imported food. We are pleased that the FSMA regulatory mandates, including for import safety, are risk-based and inherently adaptable to the diversity of commodities, as well as types and scales of operations, in today’s food system.
Collaborating Locally and Globally with Food System Partners
Finally, in enacting FSMA, Congress recognized that FDA cannot succeed on its own but rather must work collaboratively with a wide range of food system partners—both public and private—to achieve our food safety goals. We fully agree.
Food industry collaboration is part of the partnership picture, but FDA has also enthusiastically embraced the FSMA mandate to partner with our government counterparts, in both the United States and other countries. At home, we are continuing to build a national integrated food safety system that includes expanded collaboration with our federal government partners but also a true operational partnership with the 50 states, whose frontline engagement with fresh produce farmers will be especially crucial to carrying out our new FSMA mandate to regulate the safety of on-farm practices.
We see international collaboration and partnership on food safety as equally important, and potentially even more transformational than our domestic alliances. A major political factor in the enactment of FSMA was the rapid expansion of food imports to the United States, recurring outbreaks and contamination incidents, and a resulting loss of consumer confidence in imported food. That’s why Congress directed FDA to build a new import safety program. This program will include new accountability for importers to verify the food safety practices of their foreign suppliers, as well as an expanded FDA presence overseas to conduct inspections and collaborate on food safety with other governments.
This new mandate for FDA must be seen in the context of similar efforts to strengthen food safety systems all over the world. In fact, one of the reasons this is such a historic time for food safety is the great degree of alignment that exists across the global food system on the need to build modern preventive measures into food production operations and, equally important, to verify that those measures are in place and working. The world’s international food safety standard setting body—the Codex Alimentarius Commission of the United Nations—calls for that approach. Implementing that philosophy is what FSMA is all about.
Role of International Collaboration in Implementing FSMA
One of the biggest food safety challenges we face, however, is providing the level of verification necessary for food safety and consumer confidence in a world of expanding scale and diversity of international trade in food, coupled with always finite and often inadequate resources available for food safety.
That is the reason why one of our central FSMA implementation themes is working closely with foreign governments that share our food safety goals and whose own food safety efforts can contribute to the assurances we seek regarding the safety of imported food. We are motivated by our need to make the best use of the resources we have which means risk-based targeting of what we do and avoiding duplication of effort when we can.
The overarching goal of our international collaboration is mutual reliance, which entails the ability of FDA and its foreign food safety partners to depend on each other in a range of possible ways. Here are a few examples:
A systems recognition agreement is a recently developed vehicle for regulatory cooperation and mutual reliance between FDA and countries whose food safety systems are found, based on a careful FDA assessment, to be comparable to ours in their capacity and food safety effectiveness. With a systems recognition agreement in place, we can avoid duplication of effort and better target our foreign inspection and border surveillance resources where there is a greater risk of non-compliance with US requirements. Similarly, under our new import safety system, US importers may have reduced burdens when importing from a foreign supplier that is in good standing in a country whose system we have recognized as comparable to ours.
So far we have entered into a systems recognition agreement with New Zealand and we are in the late stages of assessments and development of agreements with Australia and Canada. We have also begun the assessment dialogue with our counterparts at the European Commission.
In addition to system-wide mutual recognition, we see great opportunity for commodity-specific collaboration with foreign partners.
A prominent example is the Produce Safety Partnership we launched in 2014 with our Mexican regulatory counterparts. This partnership is based on our common interest in the safety of Mexican produce and our shared commitment to make FSMA’s prevention strategy a success.We are exchanging information and expertise and working with Mexican authorities as they engage their growers and packers in preparation for implementing our new FSMA produce safety rule. We consider Mexico a full partner on produce safety and indispensable to achieving our shared food safety goals.
Another example is our several years of work with China’s Administration for Quality Supervision and Quarantine (AQSIQ) to improve compliance with US limits on the use of animal drugs in aquaculture. We have invested much effort and made significant progress through education and technical assistance for Chinese producers and regulators and joint inspections to build our confidence in Chinese government oversight in this arena. We are doing this work under a broad 2006 memorandum of agreement with China to pursue mutual reliance on food safety, and it shows that working together on food safety pays off. In March 2015, we signed a similar agreement with India to collaborate on food safety.
Food safety capacity building—involving education, training, and laboratory harmonization—is part of our collaboration with Mexico and China and has been a part of FDA’s engagement with the international community for many years. Under FSMA, however, we have a new mandate to foster improved food safety capacity in countries that export food to the United States. Congress directed us “to develop a comprehensive plan to increase the technical, scientific, and regulatory food safety capacity” of governments and food industries in these countries, which we completed in 2013. Our plan makes clear that the capacity building challenges are enormous, but so too are the opportunities to improve food safety by strengthening capacity across the global food system. The plan emphasizes the limits on what FDA can do unilaterally in this arena, given funding and other realities, but outlines ways we can make a difference on training, laboratories, regulatory oversight, and other capacity building through strategic partnerships with foreign governments, international development agencies, and the private sector.
We see the FSMA mandate on capacity building as another example of how Congress takes seriously the role of the United States and FDA as part of a global food system that has to work together to be successful. FDA totally embraces this congressional expectation and our role as a member of the international food safety community.
That’s why we have supported enthusiastically the establishment of the Global Food Safety Partnership at the World Bank. The Partnership is a public-private initiative aimed at providing food safety training and technical support so developing countries can improve their food safety systems and benefit from better compliance with food safety standards. FDA has provided seed money to help get the Partnership started and supports developing it into an important part of the capacity-building landscape. We also work in partnership with the US Agency for International Development on food safety capacity building in developing countries to facilitate their access to the US market.
Food Safety, Food Security, and Development
We’ll close by coming back to the link between food safety and food security, especially in the developing countries that are important sources of food for the US and other countries. In these countries, agriculture and the food system are typically the dominant economic activity and are widely seen as key drivers of economic development. At the same time, food security—as affected by inadequate supply, poor distribution, and lack of safety—is too often an acute concern.
That’s why—whether seen from the perspective of public health, agriculture, or broader economic development and poverty reduction—there is such a strong common interest in the overall success of the food system, including its role in making food safe. By investing in a developing country’s food safety capacity, we make food safer for our markets while at the same time we foster food security and economic development in less well-off nations.
FDA is thus very pleased that the Global Food Safety Partnership is lodged at the World Bank, as a reflection of this synergy between food safety and development. We hope the Partnership will be a vehicle for mobilizing trade- and development-oriented resources to work at the nexus of food safety and food security. The World Trade Organization’s Standards and Trade Development Facility is another international vehicle for pooling resources to support food safety capacity building, in recognition of its link with food security, development, and trade. FDA’s food safety capacity building strategy is based on partnering with entities like these. We want to contribute our expertise to making food safer, and food systems more successful, for consumers wherever they live.
Note: This article reflects the views of the authors and should not be construed to represent FDA’s views or policies.