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INFORM 2013: Integrated Foodborne Outbreak Response and Management

Remarks by Margaret A. Hamburg, MD
Commissioner of Food and Drugs
INFORM 2013: Integrated Foodborne Outbreak Response and Management
San Antonio, TX
November 18, 2013

Thank you, David, for that kind introduction. And thank you Scott, for hosting this event. It is a pleasure to be with you here in San Antonio. I also want to thank CDC, FDA, FSIS, APHL, AFDO, CSTE, and NEHA, as well as local and state public health and regulatory agencies and so many others, for supporting, planning and participating in this important meeting to promote strong partnerships that can work together to combat outbreaks of foodborne illness. 
 

I am only sorry that I stand  between you and dinner…but since our subject matter is food safety, maybe it is better to  discuss it before rather than during dinner.


But this is such an important topic and such an important group. Each of you in this room plays a critical role in efforts to find, stop, and prevent foodborne outbreaks. And the expertise each of you brings to the table has been an essential piece in achieving these goals. But what I want to focus on this evening is something even more crucial -- the teamwork that you and your agencies have collectively demonstrated and continue to build through meetings like this one.
 

It is this cooperation, which is still a work in progress, that -- more than anything else -- is responsible for our increased success in comprehensively addressing these kinds of crises…and in achieving our shared mission.
 

Now this kind of collaboration may seem second nature to some, but you know that it doesn’t come without real effort and planning.  Take PulseNet, for example, which has provided an excellent model of local, state, and federal collaboration. It is now just part of our work landscape, but it certainly took a great deal of effort to build … and I know that because I lived through it. 
 

And today’s meeting is an exciting example how you are further strengthening  this kind of coordination.  I understand that you have a new name and acronym, but more significantly, a new strategic emphasis. You have brought together all of the key players from the different teams across federal, state, and local governments. Groups that previously met independently or in various combinations – including USDA, CDC, and FDA -- as well as officials from the state and local levels who are on the front lines of battles during an outbreak, and they are all represented here in this room today. 

Equally important, this meeting includes a full complement of experts from across the spectrum of disciplines and expertise, including epidemiologists, laboratory scientists, environmental health specialists, microbiologists, veterinarians, consumer safety officers, policy analysts, and others.  I am delighted to be here as part of the regulatory contingent. Certainly, we’ve learned that no one agency, person, or scientific discipline, can do this by themselves.
 

All of you understand the scope of this undertaking and why it matters. According to CDC, about 48 million Americans, or 1 in 6, get sick each year from the food they eat, and of those, 128,000 are hospitalized, and 3,000 die.
 

But, as many of you know from first-hand experience, behind these numbers are real people with real illnesses – children, parents, and grandparents; friends and loved ones.  And even beyond the lingering effects of outbreak associated illnesses that may persist, there are the disruptions in work or school for individuals and families, and the loss of consumer confidence and market revenues for companies, even if their products were not part of the actual outbreak. 
 

And statistics fail to capture many of the additional challenges—and the human and dollar costs -- that underlie our ability to respond to a crisis, for example, to trace the source of an outbreak or track its spread.
 

And that’s in part because the outbreaks themselves are more complex. For most outbreak situations, we are no longer talking about the case of a church picnic that might generate a handful of sick people; today the source could very easily be a widely used ingredient or a mass produced food distributed nationally that can lead to vast exposures and, potentially, illness for thousands.
 

Our increasingly complex ecosystem includes everything from small family farms to big industrial conglomerates; from individually owned bakeries to large-scale processed food manufacturers; from corner food stands to restaurant chains with thousands of outlets.
 

How we produce, ship, distribute, sell, and prepare food today is constantly changing. Processed foods use complex technologies for their manufacture, combining ingredients in ways that make it challenging to differentiate between them. As a result, epidemiologic analysis is harder than ever, and sometimes limited in what it can tell us.
 

As you well know, sometimes these complicated investigations tell us only that the pathogen is associated with an individual restaurant chain or multi-ingredient food such as tacos, but they can’t identify the particular ingredient within a multi-ingredient product or determine the farm or even processing site that the ingredient came from.
 

There are other complications.  New strains of pathogens such as E.coli are constantly emerging.  And we are finding disease-causing organisms, new and old, in foods where we least expect them, or at least have never seen them before.

And of course, looming on the horizon as a serious public health concern is the growth of antibiotic and other anti-microbial resistance, which has increased the danger of disease and the challenge of fighting illness.
 

Perhaps the most significant challenge is due to our ever-expanding global marketplace.
 

Today, we have the luxury of being able to eat almost any food we want at any time of the year. But these foods, which we once thought of as exotic or rare, (or I would use the now almost defunct term of “seasonal”), these foods are available all year round, and arriving on our shores from lands, farms, and factories far removed from our borders, and after having undergone many steps in their journey to our tables. 
 

In short, combatting food-borne illnesses, tracing pathogens, and preventing future outbreaks is an ever more challenging process that requires coordination of a vast array of resources and agencies to do it quickly and effectively.  And the pressure is on, as we not only have to be fast, but also we also have to be right.

I am particularly pleased that FDA is here today as a full partner in these public health efforts. Sadly, more of us would have been here today if it weren’t for the recent budget realities and complications. But food safety has been a central part of our mission – indeed, a driving force –  behind  more than 100 years of discovery, collaboration, and achievement by this agency.

We have long understood the importance of working together within a broad-based, integrated food safety system to accomplish this goal, and we are now closer than ever before to achieving that integrated system. 
 

Let me underscore what sometimes even our partners overlook.  Yes, we are a regulatory agency, but we are also a public health agency.  We are a science-based regulatory agency with the mission to promote and protect the health of the public. Over the years, through this focus, FDA has brought necessary tools and resources to the food safety enterprise, guided always by our public health mission and an  increasing emphasis on the importance of regulatory science.
 

Regulatory science allows us to apply the newest and best available  knowledge to ensure the safety and quality of the nation’s food supply.  We must apply it at every link of the food chain:  wherever food is grown, however it is processed and stored, and wherever it is served.  And we must apply it, especially, when we are tracking and tracing the source of foodborne illness.
 

We strive to use cutting edge research with real world applications to help us identify food pathogens more quickly and accurately and find links between affected individuals and the source of contamination. Of course, the best science does little good if it is not being applied in the best ways. That’s why so much of our work to build a 21st century food safety system is grounded in collaboration.
 

While FDA has long worked collaboratively with state and local food safety agencies on inspection, laboratory analysis, retail food safety and response to outbreaks, we have sought to enhance these efforts in recent years. Two years ago, for instance, FDA created the Coordinated Outbreak Response and Evaluation Network (or CORE), which exemplifies  the vision of the FDA Food Safety Modernization Act of 2011 (or FSMA, which I will talk more about shortly). I’m delighted that Dr.Kathleen Gensheimer, who came from the ranks of State public health, agreed to come on board to head up CORE, and she is with us for this meeting.
 

CORE created specialized teams that work on outbreak response issues full time. But CORE also strengthened our coordination with the CDC, and state and local regulatory, public health, and agriculture departments as well as our laboratory partners at the state and federal level. We think this approach is making a difference.
 

These and other cooperative regulatory and enforcement efforts allow us to more rapidly share specific information related to foodborne illness outbreak investigations, including investigation data, traceback information, enforcement actions, food-related product information, and inspectional information.
 

We are able to readily use case and outbreak surveillance data collected by state and local officials that are essential to the analyses we need to estimate the total number of foodborne illnesses, hospitalizations and deaths in the United States and their attribution to food commodities.  It is this information that guides FDA and FSIS in establishing priorities and policies in food safety.
 

And we’ve dedicated resources to support 18 Rapid Response Teams (RRTs), located in State food regulatory program agencies that are working closely with state, local, and federal epidemiologists and laboratory scientists.  
 

This increased coordination and cooperation has helped us succeed against some long odds. For example, last fall, our coordinated system with states, local, and federal agencies recognized the signs of an emerging outbreak of Salmonella Bredeney in peanut butter produced by one company.
 

Early on, CDC identified a cluster of children as the primary victims. FDA and CDC then joined forces with state and local public health and agriculture agencies, which began sending exposure data to CDC. It all pointed to a common source, Trader Joe’s Valencia Creamy Peanut Butter. 
 

But this food was produced by an unknown contract manufacturer. Research on U.S. farming of Valencia peanuts discovered that almost the entire crop is grown in and around Portales, New Mexico.  State and federal investigators quickly tracked the outbreak to Sunland, Inc.’s plant, which was the sole producer of the peanut butter linked to the outbreak. 
 

Once investigators confirmed the source with hundreds of environmental swabs from the plant, the team followed the trail of the many food products that include Sunland-produced nuts and nut butters, working with the company to get them off store shelves and facilitate voluntary recalls. Ultimately, hundreds of products were recalled by Sunland.
 

A quick and effective response by an entire team, using technology, research, hard work, and good old fashioned intelligence, helped limit the episode to just a few weeks and a limited segment of the population. One final note: in November of last year, FDA for the first time used its new authority under FSMA to suspend Sunland’s registration, which prevented the company from distributing food from that facility.
 

Ultimately, according to the CDC, 41 people in 20 states were infected, with symptoms of diarrhea, fever, and abdominal cramps. That number did not increase, thanks to the quick response and hard work by an array of federal and state public health and regulatory agencies, working constructively with the private sector.
 

Soon thereafter, the FDA, CDC, and State of California convened a call with Trader Joe’s Corporate Office to inform them of the results of the initial epidemiologic interviews, in which 10 out of 10 ill persons reported consuming peanut butter purchased at Trader Joes. This action resulted in Trader Joes pulling the product off store shelves around the country within 90 minutes of receiving this information.
 

Now I know you will spend a good deal of time here this week discussing other cases and the success of the integrated response. As you know, not all responses are as successful as the one I just described.
 

What is more, I will be the first to acknowledge that while we’ve had some real successes with our coalition efforts, we know there have been bumps along the way. Sometimes the coordination hasn’t worked as well as we might have hoped…or with the level of success that we know we can and must achieve.
 

But this is a dynamic, learning enterprise. That’s why the coalition must continue to refine and enhance efforts to strengthen these partnerships, and continue to regularly evaluate and improve upon our efforts. Each outbreak is unique and we cannot afford to remain stagnant in our response – even when it is successful.
 

We need to continually examine, improve, and where necessary, redesign our efforts, from tracing pathogens to information-sharing.  For example, for too long we’ve shared information the old fashioned way – by sending data and spreadsheets to individual agencies. That’s inadequate for the tasks we face and the times we live in.
 

And today, technology offers us better options. Consider the recently launched pilot effort by CDC, FDA, and a number of states called the Palantir system, which is helping us create a seamless data system that will increase efficiency and speed response time.
 

There are also many other exciting rapidly developing technologies that will help us strengthen our ability to respond to food-borne outbreaks. One such innovation is the Whole Genome sequencing program being developed by FDA’s Center for Food Safety and Applied Nutrition (CFSAN), which will allow us to identify a pathogen by its specific mutations or genetic types in one rapid assessment. 

Knowing the precise details of an organism’s genome allows FDA researchers to quickly and accurately identify specific strains of pathogens in the foods that are making people ill. It enables our specialists to globally link the pathogens’ geographic location with DNA, determine if we have seen the strains before, and help us swiftly trace back foodborne illnesses to the source of contamination. 

The public benefits are enormous, particularly in light of the challenges we face in the global marketplace. This is a technology that holds huge promise, to both strengthen and speed our response to foodborne illness.

Before I conclude my remarks I want to focus briefly on the FDA Food Safety Modernization Act. This historic law, the first major overhaul of our food safety laws in more than 70 years, has had a profound impact on how we approach food safety and, in my view, has focused our efforts squarely  on the hazards to public health.
 

We all have long recognized that prevention must be the cornerstone of our work. Years ago, the great politician-scientist-philosopher, Ben Franklin, coined the oft-cited, though too infrequently followed adage that an ounce of prevention is worth a pound of cure. 
 

Well in passing FSMA, Congress apparently took those words to heart. It shifted our focus from one of reaction and response to outbreaks to one that emphasizes earlier prevention of foodborne illness. It placed new responsibilities on food producers and processors to identify and control potential hazards, and created new importer accountability requirements. 
 

And it reflected the fact that a growing percentage of our food comes from other countries, with some 80% of our seafood, 20% of our vegetables, and 50% of our fruit originating beyond our borders. Recognizing this new reality, FSMA gave FDA new inspection and enforcement tools domestically and internationally to ensure that companies are carrying out their responsibilities for keeping contaminated products out of our marketplace.

I want to underscore that this change in emphasis is designed to complement your work, make it more effective, and ultimately, minimize the need for crisis response.

This is exciting, but we are still in the early stages of FSMA implementation.  I am hopeful that in recognizing the importance of the work -- as well as the immensity of the challenges we face -- in addressing food safety, Congress will also provide us with  resources— other than mandates and authorities-- that are equal to the new tasks. 

For without that support we are in danger of not being able to build and sustain the systems and capacity we need to conduct investigations, to undertake the necessary scientific analyses, to develop new tools and approaches, to enhance collaboration, to identify outbreaks as rapidly as we need to, and ultimately to prevent outbreaks in the first place. 
 

And we are all in this together. The work you do is as critical as any in our country. It affects our food industry, our economy, the confidence Americans have in our food supply system, and most importantly, the health, safety and well-being of all Americans.
 

These are challenging times.  And as if the work wasn’t hard enough, we must perform it amid much uncertainty. Tightening budgets, increasing political divisiveness and distrust, and even the possibility of furloughs and government shutdowns.  But it is amazing how everyone rises to the challenges before us.  It is impressive how day-in and day-out, the work gets down with professionalism, expertise, dedication, and resourcefulness.
 

Though it may not always feel like it, your hard work is recognized and valued by the public and policy makers alike.  You make a difference every day. So for that I thank you, applaud your work, and look forward to our continuing work together.