Globalization and FDA’s New Partnerships to Ensure Product Safety

By: Howard Sklamberg

Globalization is posing challenges for public health. For FDA, part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.

Howard SklambergIn fiscal year 2015, there were more than 34 million shipments of FDA-regulated products into the United States, up from just 15 million shipments a decade ago. These products are handled by 130,000 importers, and are manufactured, processed, or packaged at more than 300,000 foreign facilities.

We know this global trade expansion has ramifications for our nation’s public health. We also know we cannot be the inspectors for the world. Hence, we need to effectively direct our resources in a risk-based manner as we grapple with this tremendous volume of imported goods.

How? One way is to identify foreign regulators whom we can rely upon to partner with in verifying that safety standards are being met and then construct an approach that will meet the requirements of multiple regulatory jurisdictions. We are currently engaged in three innovative programs that meet this challenge.

The Medical Device Single Audit Program

The Medical Device Single Audit Program, or MDSAP, is an international approach to the auditing and monitoring of the manufacture of medical devices to ensure their safety and efficacy. This audit program will allow a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.

Currently, five nations – Australia, Brazil, Canada, Japan, and the U. S. – are participating in the MDSAP Pilot. It began 18 months ago and will run through the end of 2016. The program’s goals include:

  • Enabling regulatory oversight of medical device manufacturers’ quality management systems;  and,
  •  Promoting more efficient use of regulatory resources through work-sharing and mutual acceptance among regulators.

Mutual Recognition Agreements

In 2014, FDA launched the Mutual Reliance Initiative (MRI), a strategic collaboration between the FDA and the EU Member States. The goal of the program is to determine if the FDA and EU can agree to recognize each other’s drug Good Manufacturing Practice (GMP) inspections, a potentially time-saving approach.

If successful, we could rely upon EU experts to inspect facilities within their own borders, a more practical way of overseeing the large number of drug manufacturing sites outside of the United States. And it would be similarly more practical if the EU relied on FDA experts to inspect facilities within the United States.

Both the EU and the FDA are in the process of evaluating each other’s processes. The EU has visited several of FDA’s district offices in the United States and one drug laboratory and evaluated the work they do. The FDA has a different challenge since each country in the EU has at least one inspectorate, and in Germany, each state has their own inspectorate. To date, FDA has observed eight audits – in Sweden, Greece, Croatia, Germany, Hungary, Italy, the Czech Republic, and the United Kingdom – and will continue to observe audits of other Member States this year and in 2017.

Food Safety Systems Recognition

Preventing problems at relevant points along the global food supply chain can be a daunting job. FDA is soliciting help by leveraging foreign food safety systems that are similar to our own.

The agency’s Systems Recognition program determines whether another country has comparable regulatory programs and public health outcomes to what we have in place in the U.S.

A major advantage of Systems Recognition is that it allows FDA to be more risk-based in its oversight of imported food and we can more wisely plan our overall inspection activities, including foreign facility inspections, import field exams, and import sampling.

Thus far, we’ve completed: New Zealand and the U.S. signed a Systems Recognition Agreement (in 2012) and recently another agreement was signed with the Canadian Food Inspection Agency.

What’s Next? 

The three initiatives I’ve briefly outlined represent the best of FDA innovation and expertise in grappling with the increasing amount of imported FDA-regulated products. Our work will focus on a continued careful reliance on trusted foreign partners; a move away from duplicative work; more risk-based inspections; better data; and the minimization of public health risks globally.

Howard Sklamberg is FDA’s Deputy Commissioner for Global Regulatory
Operations and Policy

Marking the Beginning of a New Era in Food Safety

By: Stephen Ostroff, M.D.

The promises embodied in the FDA Food Safety Modernization Act (FSMA) add up to this: The foods that we eat and serve our families must be as safe as we can make them.

Stephen Ostroff, M.D.These promises mandate that food be produced, packed and transported with an awareness of potential hazards and a commitment to taking whatever systematic steps are necessary to eliminate or greatly reduce any risks. They envision a world in which families can share foods produced halfway around the world, knowing that they are held to the same rigorous safety standards as those produced in the United States.

The past nine months have seen the finalization of the seven rules that make FSMA’s promises a reality – for both domestic and imported foods. The last of those rules, one that adds protections against intentional adulteration, became final on May 27. Together, and individually, these rules represent a paradigm shift from simply responding to outbreaks of foodborne illness to preventing them from happening in the first place.

There’s a lot of work to be done in the implementation phase. But even as we look forward, it’s important to recognize that getting to this point with rules that are final is a spectacular achievement, and that many deserve the credit.

Members of Congress joined together to pass FSMA in 2010 because of widespread concern over multistate outbreaks, and lawmakers like Sen. Jerry Moran of Kansas and Rep. Rosa DeLauro of Connecticut have been unwavering in their support since then. Consumers, such as activists in STOP Foodborne Illness, who became sick themselves or who lost loved ones to contaminated food, put their sorrow aside and became champions for the greater good. Public policy organizations like the Pew Charitable Trusts have been steadfast partners throughout the rulemaking and budget processes.

The food industry mobilized to help FDA find the most effective, practical ways to implement these regulations. We worked with national associations that include the Grocery Manufacturers Association and groups with a more regional focus, such as the New England Farmers Union. Farmers, manufacturers, distributors, retailers and many others whose livelihood is directly affected by these rules brought their concerns to the table and worked with us to make the rules as feasible as possible.

We found dedicated partners in other government agencies at the federal, state and international levels. Leanne Skelton of the U.S. Department of Agriculture has been part of the FDA team. The National Association of State Departments of Agriculture is playing an important role in helping FDA meet the challenges of implementing the produce safety rule. State agriculture leaders like Chuck Ross in Vermont, Katy Coba in Oregon and Steve Troxler in North Carolina became a bridge between FDA and the food producers in their states. Our regulatory counterparts in other nations, such as SENASICA and COFEPRIS in Mexico, have joined the fight to increase food protections worldwide.

The people of FDA, under the leadership of Michael R. Taylor, worked tirelessly to find the right intersection between science and policy; to develop innovative and practical solutions to complex challenges; and, to engage in open and meaningful discussions with the many communities within the diverse food supply system. I recently succeeded Mike as deputy commissioner, and I want to acknowledge the importance of his dedication to public health and food safety.

The FDA teams who drafted and revised the rules worked in tandem with teams laying the groundwork for eventual implementation. They have traveled the nation, and the world, to meet with food producers and government officials. They have worked 24/7 on these rules since FSMA became law.

The road ahead towards full implementation of FSMA is a long one. There are miles to go, but thanks to the commitment and hard work of all those who are making this journey, we will keep the promises of FSMA.

Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine

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

Reducing Sodium in the Food Supply

By: Susan Mayne, Ph.D.

As the former Chair of the Department of Chronic Disease Epidemiology at the Yale School of Public Health, I have looked critically at the totality of evidence on the link between sodium and chronic disease. The data are clear: Americans are getting too much sodium in their diets. As a scientist, a former academician, and now as a policy maker, I am confident that FDA is on the right path in announcing today draft, voluntary guidance for the industry on meeting short-term and longer-term sodium targets for a wide variety of foods. This guidance is meant to build on existing efforts already underway by many manufacturers to reduce sodium.

Susan MayneBecause we recognize the essential role played by food companies and restaurants on this issue, we are committed to working with the food industry on a gradual approach to sodium reduction.

What the Science Tells Us

The link between sodium consumption and blood pressure is strong and well documented. High blood pressure is a key risk factor for heart disease and stroke. There is strong agreement among expert bodies such as the Institute of Medicine (IOM) on the need to reduce consumption to less than 2,300 milligrams per day (mg/day). And this level of consumption for most people is further supported by the recently issued 2015-2020 Dietary Guidelines for Americans, which involved expert review of the current body of research by the Dietary Guidelines Advisory Committee and federal experts who reviewed the Committee’s recommendations. The totality of scientific evidence, as reviewed by many well-respected scientific organizations, continues to support lowering sodium consumption from current levels.

In fact, it’s very difficult in the current marketplace NOT to consume too much sodium. The average intake today is over 3,400 milligrams—significantly more than the 2,300 milligram limit recommended by federal guidelines. And it’s not just adults who are eating too much sodium: Children and teens consume more than is recommended.

Our Approach

The FDA’s approach takes into account the technological challenges involved in solving this problem. To that end, the FDA assessed the sodium content of thousands of products in the marketplace and engaged with experts in industry, academia, and government to get the best available scientific and technical input. We know that sodium has important functions in many foods, such as taste, texture, and microbial safety, and it simply can’t be removed without careful consideration of those factors.

Our approach encourages gradually reducing sodium in the majority of foods that contain it. Sodium comes from a lot of different types of foods—not just the ones we think of as high in sodium. So we have divided the foods containing sodium into about 150 categories ranging from cereals to combination foods like pizzas and sandwiches, and draft sodium targets for each category. Not only is this approach more precise than a “one size fits all” strategy, but it also recognizes that different foods have different potential for sodium reduction.

Moreover, our draft targets apply to processed and prepared foods that are eaten both at home and outside the home. The fact that about one-half of each food dollar is spent on foods prepared outside the home* makes this a common-sense strategy and helps to create a level playing field for industry.

Why the 2-year and 10-year targets? The answer is simple. We recognize that some reductions can be made in the short term, but that further reductions may require strategies that take time to develop.  We are confident that the two-year targets are readily achievable and that it makes sense to act on them first. That’s in part because many companies have already taken steps on their own initiative to reduce sodium in certain foods, and we applaud these efforts.

The facts speak for themselves. Our food supply is still too high in sodium, and there is important work yet to be done. With today’s announcement we commit to working closely with industry on the best path forward to reduce sodium in our food supply and improve the public’s health.

Susan Mayne, Ph.D., is Director of FDA’s Center for Food Safety and Applied Nutrition

(*One-half of each food dollar spent on foods prepared outside the home- Citation: ERS/USDA)

Unveiling the New Nutrition Facts Label

By: Robert M. Califf, M.D., and Susan Mayne, Ph.D.

Today, the FDA has finalized the new Nutrition Facts label on packaged foods with changes that will make it easier for consumers to make informed choices about what they’re eating.

Robert Califf

Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug Administration

Our goal is to help people make better informed food choices that support a healthy diet. The changes are based on updated science that reinforces the link between diet and chronic conditions such as obesity, heart disease and diabetes.

This is not about telling people what they should eat. It’s about making sure that they know what they’re eating. With that knowledge, they can make more healthful choices. For example, the new Nutrition Facts label includes the addition of information about added sugars. Studies have shown that healthy dietary patterns that include lower amounts of sugar-sweetened foods and beverages are strongly associated with reduced cardiovascular disease.

Obesity continues to be an epidemic in this country, and excess weight can lead to a host of health problems. People who want make healthier food choices will really benefit from the more prominent display of calories and updated information about serving sizes that more accurately reflects what people are likely to eat in one serving.

Susan Mayne

Susan Mayne, Ph.D., FDA’s Director of the Center for Food Safety and Applied Nutrition

We all play many different roles in life. In addition to taking care of ourselves, we’re parents and grandparents who want to take good care of our families. We have busy lives, and we need ready access to information about the nutritional value of the foods we eat. That’s why design changes to the label will make it easier to see essential information at a glance; including calories and information about serving sizes and servings per container.

The label also reflects new or updated Daily Values (DVs), which are the reference amounts of nutrients to consume or not to exceed and the basis of the percent Daily Value (% DV) on the nutrition label. In addition to added sugars, new nutrients that must be declared include Vitamin D, which is important in bone development, and potassium, which is good for controlling blood pressure; both nutrients of which people aren’t getting enough.

Across the board, this is a better label for all of us. And you can have confidence in the science on which it is based, including evidence used to support the Dietary Guidelines for Americans, nutrition intake recommendations from the Institute of Medicine, and nutrition intake information from the National Health and Nutrition Examination Survey (NHANES).

We’ve reached an important milestone, but our work is not yet done. Our next step is to reach out to the larger community to provide education and outreach on the new label and what it means for consumers and families.

The Nutrition Facts label can make a real difference in helping consumers have the information they need to make dietary choices that support a healthy diet.

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

Susan Mayne, Ph.D., is FDA’s Director of the Center for Food Safety and Applied Nutrition

Protecting Trade in Safe Food is a Global Concern

By: Sharon Mayl and Debbie Subera-Wiggin

Protecting consumers from contaminated foods is a global concern—as well as a key FDA priority. This was clear to us when we attended a World Trade Organization (WTO) conference in Geneva earlier this spring to provide outreach on FDA’s new food safety regulations.

Debbie Subera-Wiggin, left, and Sharon Mayl at the World Trade Organization meeting in Geneva.

Debbie Subera-Wiggin, left, and Sharon Mayl at the World Trade Organization meeting in Geneva.

This was the 65th meeting of the WTO’s Committee for Sanitary and Phytosanitary Measures (SPS), an important body that provides a forum for the discussion of food safety and animal and plant health issues that affect the international food trade. While enhancing free trade is WTO’s focus, members understand the importance of facilitating trade in safe food products.

Working with the WTO Secretariat, the U.S. Mission in Geneva and the Office of the United States Trade Representative, we shared information about the FDA Food Safety Modernization Act (FSMA) rules that aim to help ensure the safety of foods exported to the United States. It was exciting to look out at the audience and see public health and trade officials from more than 33 countries and international organizations seeking to learn more about the new food safety regulations.

The United States has been a member of the WTO, which has 162 member nations and observer organizations, since 1995. Under the auspices of this SPS Committee, U.S. trade and regulatory agencies, including FDA, work with governments worldwide on trade issues related to food safety. Their work includes ensuring that the regulations of each nation support the rights and obligations of WTO agreements.

FDA incorporates these obligations into our regulatory process, specifically to ensure that our regulations are risk- and science-based, are created through a transparent process, and are equitable to both domestic and foreign producers, while protecting public health. The WTO SPS Committee is an ideal international venue for sharing information on FDA’s food safety rules.

Our job during this meeting was to share insights on three of the new FSMA rules — in particular, produce safety, foreign supplier verification programs, and accredited third-party certification.

We were very impressed by the interest that the countries’ representatives had in these rules. More than 50 representatives even skipped their lunch to participate in the outreach session and many returned that evening, after the main session closed, to continue the discussion!

WTO members are interested in understanding and meeting the regulatory requirements in FSMA rules so that they can continue to ship safe products to the U.S. Several of the participants expressed their government’s support for working cooperatively with us to strengthen food safety controls.

We left the outreach session with a better understanding that our trading partners are highly motivated to put mechanisms in place that will help their producers and manufacturers comply with the FSMA rules and contribute to robust trade partnerships.

Sharon Mayl, J.D., is a Senior Advisor for Policy in FDA’s Office of Food and Veterinary Medicine; Debbie Subera-Wiggin is a Consumer Safety Officer on the International Affairs Staff in FDA’s Center for Food Safety and Applied Nutrition.

Engagement and Collaborative Problem Solving: Two Ingredients for FSMA Success

By: Michael R. Taylor and Stephen Ostroff

As we’ve developed the rules needed to implement the FDA Food Safety Modernization Act, we’ve done a great deal of outreach to explain the new requirements and obtain feedback from stakeholders.

group touring Florida citrus grove

Tim Dooley (top of photo, center right), vice president of Blue Goose Growers in Fort Pierce, Florida, leads a tour of the company’s citrus groves.

We’ve got to continue doing this with the people working on the nation’s farms–since the produce safety rule issued in late 2015 primarily involves them.

This was a lesson learned in our recent trip to southern Florida, where we toured citrus farmlands and took part in a public meeting on the final FSMA rules at the University of Florida’s Institute of Food and Agricultural Sciences (UF/IFAS). We found that growers want to meet the new standards in the produce safety rule but need greater clarity and understanding about how the rule can be applied to their specific farm setting.

Florida farmers are under a lot of pressure that has nothing to do with the FSMA rules. The citrus groves there have been hard hit in recent years by a disease called citrus greening that results in stunted, bitter, green fruit and drastically reduced harvests. The stark backdrop to our conversations is that these growers are fighting for survival–and every cost counts.

That makes it especially important that they, and all farmers covered by the produce rule, understand what will be required. And, just as important, what won’t be required.

For example, we talked to growers who have dozens of wells on their farms and are worried about the rule’s water testing requirements and associated costs. But in many cases, only a fraction of those wells are used to apply water in a way that is intended or likely to contact crops during growing, or for other uses that are  subject to the microbial water quality criteria in the produce rule.

Some growers pull surface water out of extensive canal systems where the water from any one canal may deliver water to many farmers. Other growers use seep irrigation systems in which the water seeps from a surface water source through the soil. The growers told us that the soil filters the water, which comes in contact with root vegetables like carrots, beets and radishes.

Their questions were: How are we covered by the produce safety rule and how do we achieve compliance? One of the growers produces beets and our answer to him was that beets are not covered because the produce rule exempts specific crops that FDA identified as rarely consumed raw, such as garden beets and sugar beets. We explained that water used in seep irrigation that contacts root crops covered by the rule does have to meet the applicable microbial standard. But farms have the option of establishing and using alternatives for certain agricultural water requirements if they have scientific evidence to support them.

Each region of the country has its own complexities, and Florida has a dramatically diverse landscape of crops, settings, and soils. The soil around Lake Okeechobee transitions from sandy at one end to densely dark muck at the other. Within the citrus industry, agricultural water can come from completely different sources, surface and ground water that have different testing requirements. We at FDA are constantly learning about the complexities that are part of everyday life for our nation’s food producers.

This trip highlighted how important it will be for us to be continually engaged at the local, state and federal levels in collaborative problem solving with growers and others in the food industry as we implement the FSMA rules.

We value the leadership of Florida Commissioner of Agriculture Adam Putnam, Deputy Commissioner Lisa Conti and others on their team. We have long been partners with Martha Roberts of UF/IFAS, an authority on food safety issues. And Florida itself is a pioneer in food safety, in 2008 establishing the first mandatory state regulatory program for produce with provisions for inspections and audits for tomato handling, production and packing.

Susan Turcovski, the director of FDA’s Florida District, and her team accompanied us on this visit. They are also on the front lines of implementation and their role will be critical in the months and years ahead. We were joined by Leanne Skelton, the U.S. Department of Agriculture’s liaison to FDA on FSMA issues, and spent time at USDA’s Horticultural Research Lab in Fort Pierce.

Education is an important part of our FSMA efforts. Another member of our group was Dr. Michelle Danyluk, one of the leads for the Southern Training, Education, Extension, Outreach, and Technical Assistance Center at the University of Florida. The center is one of four regional centers funded by USDA and FDA that will coordinate and implement FSMA-related training.

We’ve got our work cut out for us but every conversation brings us closer to the food safety system envisioned by FSMA that systematically takes steps to prevent the causes of foodborne illness. Working together, we’ll get there.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1, 2016.

FDA-State Partnership Propels FSMA Implementation

By: Michael R. Taylor and Stephen Ostroff, M.D.

Ever since the FDA Food Safety Modernization Act (FSMA) was enacted in 2011, we’ve said that successful implementation is not possible without a meaningful partnership between FDA and its counterparts in state government. This is especially critical in the new area of produce safety regulation.

Michael R. Taylor

Michael R. Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine

After years of rulemaking – of planning, discussing and revising – this partnership is no longer just an aspiration. Instead, it’s evolving into a real union of public health and regulatory colleagues at the state and federal levels who together are taking concrete steps to make the produce safety protections envisioned by FSMA a reality.

An example of this forward movement is a conference we both attended on March 22 in Orlando, Florida, where the National Association of State Departments of Agriculture (NASDA) unveiled its proposed framework for state participation in the implementation of FDA’s new produce safety rule. This rule—for the first time—establishes enforceable federal safety standards for the production and harvesting of produce on farms.

In 2014, FDA entered into a five-year cooperative agreement with NASDA to work with state partners to collaboratively plan implementation of the produce rule. The NASDA framework will help guide and inform states that are working to develop a state produce safety regulatory program that is aligned with the FSMA rule.

The NASDA framework was developed with the active involvement of 24 state departments of agriculture and five national public health organizations. Key areas addressed include education and compliance, information sharing, regulator training, accessing laboratory resources, technical assistance, and infrastructure.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1

All 50 states were represented at the Orlando meeting to review and discuss the proposed framework, which is intended by NASDA to be a living document that can be refined and improved over time as experience is gained with implementation of the produce safety rule. The level of alignment and energy among participants at the conference – which included 46 agriculture departments and 19 public health departments – was inspiring and demonstrates that we are very much on the right path toward a sustained partnership with our state colleagues.

The states have always been clear in conversations with us, and we have been clear in conversations with Congress, that federal funding is necessary for the work ahead. State agriculture and public health personnel are the ones who have built relationships with and knowledge of local farming communities and practices and can often deliver oversight most efficiently. But almost all states will have to build produce safety programs largely or completely from scratch. We want to rely on them, not only to deliver education and technical assistance, but also to provide ongoing compliance support and oversight.

But this requires resources.

The President’s Fiscal Year 2017 budget request includes $11.3 million in new funds for the National Integrated Food Safety System. We have been building this system to fully integrate the more than 3,000 state, local and tribal government agencies involved in food safety in FDA’s work to meet the FSMA mandate. The FY 2017 funding, which Congress is considering, will be used primarily to support state produce safety programs through cooperative agreements and grants.

The FY 2017 funding builds upon resources for states that Congress provided for FSMA implementation in FY 2016. Earlier this month we took an important step toward distributing these funds – $19 million – to support state produce safety programs by soliciting applications for cooperative agreements with state regulatory agencies. These funds will make an important down payment on the capacity states need to be our full FSMA partners in produce safety. The FY 2017 funding request recognizes that more will be needed – both next year and beyond — to realize this goal.

There is a great diversity in where states are right now in planning and developing their produce safety programs. Some may already have developed multi-tiered plans and are ready to begin implementing. Others may just be starting to consider what’s ahead. This program is designed to give states the support they need at whatever stage they’re in.

Our goal is to get the initial funding to a number of states before the end of this fiscal year.

This has been a long road. But we are gaining real momentum toward the ultimate goal of having a food safety system in place in which government agencies at all levels are working in partnership with each other – and collaboratively with farmers – to ensure that we are doing everything we can to prevent or reduce the risk of foodborne illness. Safe and widely available produce is good for consumers, good for public health, and good for growers. That’s why we’re all in this together.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1.

Priorities – Teamwork to Achieve Common Goals

By: Robert M. Califf, M.D.

With my appointment as Commissioner of Food and Drugs comes a rare and humbling opportunity—to make a positive difference at an institution that does vitally important work for the nation and its citizens. During my vetting process I received hundreds of emails and had almost as many conversations with a large and diverse group of stakeholders. Over the course of these discussions, a recurring theme emerged: namely, that setting priorities would be critical to success.

Robert M. Califf, M.D., Commissioner of the U.S. Food and Drug AdministrationThis is hardly surprising. FDA regulates about 20 percent of the nation’s economy and, given the vast number of options, it would be easy to get lost in an overwhelming swirl of activity. In fact, at times I have been (rightfully) accused of having an excessively lengthy to-do list! But my interactions with so many of the knowledgeable, dedicated, and mission-driven people here at FDA have helped foster a clear, realistic, and focused sense of priorities and have further heightened an already strong enthusiasm for helping this awesome organization reach these ambitious goals.

FDA makes decisions in a remarkably effective and responsible way. Guided by the lodestone of our mission to protect and promote the public health, and supported by the concerted efforts of dedicated and talented professionals who examine issues within team-based systems, FDA’s Centers that form the core of our organization are able to make an enormous number of decisions every day. The vast majority of these decisions, many of which are vital to the well-being of all Americans, are made possible by a system sustained by professionalism and a well-earned reputation for high-quality and impartial judgments—despite the fact that many decisions must ultimately disappoint (or at least not fully satisfy) one or more constituencies.

I strongly believe my most important responsibility during my time at FDA is to encourage and support a professional environment that enables our remarkably dedicated workforce to thrive and to reach its fullest potential. Dramatic advances in biotechnology and information sciences, as well as continuously accelerating trends toward globalization, are ushering in an era of rapid change. But amid this change, the key to success for the Agency in accomplishing its mission remains constant—sustaining and expanding our talented workforce and ensuring that we both hire the people we need for the future while we continue to enhance our environment to ensure that we retain existing staff. To that end, I will pursue a workforce initiative designed to 1) improve the hiring system, 2) ensure that the Agency has the best possible working conditions for staff, and 3) foster professional homes for the diverse professions that make up our teams so that we are able to recruit and retain them in a very competitive market.

My top programmatic priority will likely come as no surprise, given the astonishing changes that are currently rippling through society: we must do everything possible to rapidly adapt our national and global systems of evidence generation to meet the challenges and opportunities presented by technological advances. What does this mean? I’ve noticed that when high-quality evidence is available, FDA’s scientific decision making is often straightforward. But it can be particularly challenging for the Agency when it must make scientific decisions in the absence of optimal information. In such cases, opinions may carry greater weight, and there can be an increased likelihood of dissension both inside and outside of FDA, as well as a greater risk that we may fail to most fully protect or advance the welfare of patients and the public.

FDA is a science-based, science-led organization that focuses on the needs of patients and consumers; protecting their well-being is our charge as a public health agency. The state of the art as it pertains to understanding the needs and choices of patients and the public is progressing rapidly, and we must continue to keep pace by incorporating the best methods for taking patient preferences, experiences, and outcomes into account in every part of our work.

Biomedical science is nearing a tipping point where the amount of high-quality evidence available to support our decisions is likely to increase exponentially. As a nation, we have invested over $50 billion to provide an electronic health record (EHR) for almost every American. Further, computational storage capacity and analytical power are increasing by orders of magnitude from year to year. At the same time, the advent and wide diffusion of social media are enabling direct communication with patients and consumers on an unprecedented scale. When projects such as Sentinel and the National Medical Device Evaluation System are linked with the many complementary initiatives under way at our sister agencies and at organizations outside of the government, we can (and I believe in short order will!) build a robust foundation for a system in which both private and public sectors can produce much more useful knowledge at a fraction of the cost such efforts have previously required. Indeed, a major function of FDA is to support the continued development of an effective system for evidence generation, so that the private and academic sectors can make it happen.

Accordingly, FDA is thoroughly committed to working with the many partners in our ecosystem to help build and sustain an infrastructure that produces the high-quality scientific evidence needed to guide FDA’s decisions about the drugs, medical devices, tobacco products, and food products it’s charged with regulating, as well as the decisions that healthcare providers, patients, and consumers make about their health and well-being.

In addition to this overarching priority, a number of specific critical issues are on my front burner this morning and will remain there for the foreseeable future:

  • Pain. The present epidemic of opioid overdose deaths now exceeds deaths from automobile crashes. FDA cannot solve this problem on its own—and indeed, no single entity can—but we have a critical role to play, as described in our FDA Opioids Action Plan.
  • Tobacco product deeming. Much effort has gone into developing the framework for the approach to the regulation of the broad array of tobacco products. FDA is working hard to finalize the deeming rule, which in its proposed form would extend FDA regulation over virtually all tobacco products, including electronic cigarettes, either all cigars or all but premium cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.
  • Implementation of the FDA Food Safety Modernization Act (FSMA). This statutory directive to transform the food safety system is well on its way to being implemented, with critical regulations issued and more to come. The effort involves the complex development of a new control and risk-based system that includes the entire chain of food safety. Effective implementation of this system will require the application of cutting-edge analytical and biological science, as well as the most modern approaches to human systems management.
  • Antimicrobial resistance. Concerns about the proliferation of multidrug-resistant pathogens, as well as the sustainability of the product pipeline needed to meet this threat, continue to grow. We have a major responsibility in the federal plan, one that will involve many parts of the Agency and require that we work with the broad ecosystem, both to ensure that appropriate antimicrobials are used appropriately on farms, and that novel antimicrobials are developed, approved, and used responsibly within a framework of effective stewardship.
  • Interagency effectiveness. When we consider our mission to protect and advance the public health, as well as our duty to balance benefit and risk for patients and consumers of medical products, much of our success can be enhanced by coordinated effort across government. We have therefore continued the FDA-NIH Joint Leadership Council and the FDA-CDC meetings, and also initiated similar discussions with CMS. The Biomarkers, Endpoints and other Tools (BEST) Resource offers a powerful example of the ability of FDA and NIH to contribute to solving scientific and regulatory issues together.
  • Precision Medicine. President Obama’s Precision Medicine Initiative represents more than just a project. Rather, it is a window that provides a clear view of the future for biomedicine and agriculture, a future in which powerful new technologies and methods allow the precise targeting of interventions using an array of genetic, genomic, biological, clinical, social, and environmental data according to the scale needed to achieve improved health outcomes.
  • Cross-Cutting Issues. There are a great many other issues (truthfully, the number reaches triple digits) on my list of concerns. But those issues that cut across the Agency, including optimizing our approach to combination products, medical countermeasures, and improving product labeling, will benefit most from my attention and support.

A single introductory blog post is not suited for giving details about priorities or individual programs. However, I hope I’ve conveyed my enthusiasm for the work at hand, as well as my confidence that we will be able to make real and lasting improvements in many critical areas. I promise that we will follow up with frequent updates, as fostering effective communication is itself an overarching priority of immense importance to me. So expect to hear from me again soon!

Robert M. Califf, M.D., is Commissioner of the U.S. Food and Drug Administration

Border Crossings: Working With Partners to Verify the Safety of Imported Produce

By: Michael R. Taylor

One of the vivid images that sticks with me from my tenure at FDA is of the port of entry at Nogales, Arizona. There, I saw large trucks from Mexico lined up as far as the eye could see, awaiting entry into the United States‎, many loaded full with fresh produce. I was told by our FDA team that, during the busy season, as many as 1,500 produce trucks enter the United States there daily, and Nogales isn’t even the busiest port of entry on the 2,000-mile U.S.-Mexico border.

Michael R. TaylorThat visit to Nogales was in the early phase of our food safety modernization initiative at FDA‎, but it had a lasting effect on me. It drove home the degree of difficulty we would face in fulfilling the produce safety vision embodied in the FDA Food Safety Modernization Act (FSMA).

With 50 percent of our fresh fruit and 20 percent of our vegetables coming from growers in other countries, the challenge was not only to establish produce safety rules that would be effective and workable across the hugely diverse produce sector, but also to verify with reasonable confidence that those standards are being met consistently, every day, regardless of where the produce is grown.

‎The FSMA produce ‎safety rule is now on the books, but implementation and the task of achieving and verifying compliance is just getting started. We know that success will take an enormous amount of education, training, and technical assistance to support the vast majority of farmers who will want to comply.

It will take a concerted effort by government and industry alike to verify that compliance is happening. And all of that demands active public-private collaboration and partnership to meet high consumer expectations.

‎‎Within the United States, this means working with our state government partners to build state produce safety programs that will provide our primary interface with U.S. growers on all aspects of produce safety. We will also work with growers and their customers to strengthen the reliability of private audits as a source of verification that can complement, but never replace, the essential role of government inspection.

‎But what about those 1,500 truckloads coming into Nogales daily from Mexican farms? How do we verify their compliance?

‎The answer is this: only by using every tool in our import tool kit‎, and, of course, by building partnerships.

‎I’m writing this while en route to Tubac, Arizona, for the annual Spring Policy Summit of the Fresh Produce Association of the Americas (FPAA). FPAA represents those producing and trading fresh produce across the U.S.-Mexico border. For good business reasons, FPAA and its members focus heavily on ensuring the safety of that huge volume of food.

At this meeting, my colleagues and I will be discussing implementation of the foreign supplier verification program (FSVP) final rule, which places new responsibility on importers to ensure the safety of the food they import. This responsibility includes ensuring and verifying that their foreign suppliers use processes and procedures that meet U.S. safety standards. The result is that importers’ private verification efforts will help ensure the public health. At the same time, they are accountable to FDA.

FSVP is the regulatory linchpin of FSMA’s historic paradigm‎ shift for imported food from reaction at the border to accountability for prevention at the point of production. But Congress recognized that FSVP alone is not enough. FSMA also mandates that FDA conduct more foreign inspections and work more closely with foreign governments to ensure the safety of imported food.

‎So‎ also gathering in Tubac are our regulatory colleagues from the two Mexican agencies responsible for produce safety on the farm (SENASICA) and after the produce leaves the farm (COFEPRIS).

In 2014, we formed the US -Mexico Produce Safety Partnership, through which we are collaborating with our Mexican colleagues – much the way we do with our state partners – on education and technical assistance, inspection and compliance, and response to outbreaks. We’ll be reviewing our progress and discussing our challenges in a partnership working group meeting and sharing our government perspectives with FPAA, which has formed its own working group to collaborate with the government effort.‎

‎This degree of collaboration on food safety is unprecedented‎. But it is necessary because neither government nor industry alone can provide the level of verification FSMA envisions and consumers demand.

And it is possible because of the deep alignment of strategic interests ‎on food safety that exists among industry, government and consumers. We all have a huge stake in seeing that modern preventive practices are being used consistently to make produce safe. That is the foundation for real partnership. We all have different roles to play, but we all have the same goal.

‎That’s why we are gathering in Tubac. And, that’s why I’ll be traveling to Mexico City in April with Dr. Stephen Ostroff, my successor at FDA when I leave the agency in June, to work with our Mexican colleagues and the Mexican industry on FSMA implementation. That’s why we’re holding a public meeting in Washington today to discuss import safety with consumer, industry, and foreign stakeholders.

‎And it’s why hundreds of my FDA colleagues are working tirelessly with partners across the food system to prepare for FSMA implementation. I’m grateful for the opportunity I’ve had to work with so many people dedicated to food safety.  I think we are all fortunate that Steve Ostroff and other leaders across the food system have their hands on the helm.

And I am confident that we are on the way to success in fulfilling the FSMA vision, from the farms of Vermont and California to that line of trucks at Nogales.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine