Remarks prepared for delivery by Elisabeth Hagen, Under Secretary for Food Safety, at the Pew Charitable Trusts and Center for Science in the Public Interest conference, “Managing the Risk of Foodborne Hazards: STECs and Antibiotic-Resistant Pathogens,” January 25, 2011, in Washington, DC.

Introduction

Good morning. Caroline, thanks so much for that introduction and for the work you do on behalf of food safety.

I also want to thank the Center for Science in the Public Interest and the Pew Charitable Trusts for hosting this important—and timely—event. You've been a consistent presence on the food safety front and we all benefit from your work.

And to the members of the advisory committee for today's conference…Paula Cray; Art Liang; Mike Robach; Steve Roach; Bill Marler…thank you for being a part of the planning effort for this event.

Managing the risk of foodborne hazards is a complex challenge. And it takes the kind of diversity of expertise and experience represented among you all, to address it.

I'm pleased to be in a room with so many knowledgeable people; people who are dedicated to the same goal that we at the Department of Agriculture are dedicated to: preventing foodborne illness.

We have a unique challenge—and opportunity—in our food safety work. Because there's something that can be said about the problem of foodborne illness, that can't be said of many other public health problems of the day, and that is: Foodborne illness is preventable.

We can prevent it. It should not be a fact of life that people will get sick from or die from the food they eat. American consumers should not expect, nor accept that.

There are steps we can take, practices we can promote and policies we can enact, that will prevent foodborne illness.

Of course, if the solutions were simple, we would've already found them all. And that's why this conference today is so important.

Some of the best minds in food safety are here. And what USDA and our federal partners are so excited about, is that you're here to share your knowledge and find ways to combat two challenging groups of pathogens: shiga-toxin producing E. coli (STECs) and antibiotic-resistant pathogens.

In the short time that I have with you, I'd like to discuss how prevention-based policies and practices are the key to meeting the challenge of STECs and resistant pathogens; and how science is the best way to get us there.

MEETING THE CHALLENGE: A Focus on Prevention

Those of you gathered here know that right now, we have leadership from President Obama, Secretary Vilsack, and Secretary Sebelius to strengthen our approach to food safety.

My job, and the job of the 10,000 employees in USDA's Food Safety and Inspection Service, is to protect public health through science-based policies. Policies that help drive an industry—an innovative and committed industry—to produce the safest products possible.

Some of you may have heard me talk about the three pillars that we are building on at USDA.

First, is preventing foodborne illness. We are a public health agency. If we aren't preventing people from getting sick, we aren't doing our job. Next, we're developing the right tools to protect public health—tools that industry needs; tools that we at USDA need, and tools that consumers need. And finally, we're focusing on people—the reason FSIS exists and why our work matters.

We're very clear about our goal and who we're here to protect.

There are more than 300 million people who count on us, every time they serve dinner, pack lunch, or eat a meal. 1 in 6 of them, every year, is getting sick from that food.

Today, I want to focus on prevention. Because that's what you're here to do. That's what your work at this conference is about. If we implement policies…explore research…develop strategies to manage the risk of STECs and resistant pathogens now, we'll be preventing illnesses in the future.

Unfortunately, for these two groups of pathogens, we've seen them, and the food safety challenges they pose, coming for some time.

The Challenge of STECs
First, are STECs in the food supply. We know, with certainty, that they are a public health risk.

E. coli O157:H7 caught us unprepared in 1993, when a large outbreak in ground beef caused illness in 400 people and tragically, the death of 4 children.

We reacted. USDA declared O157:H7 an adulterant in ground beef, issued the HACCP [Pathogen Reduction/Hazard Analysis and Critical Control Point] rule and shifted our focus to reduction of microbial pathogens on raw products. We implemented a robust sampling program to ensure that our efforts were effective, and we have expanded our approach to include components and precursors to ground beef.

And the data tells us that our efforts have been worthwhile.

Since 1996, when FoodNet launched, O157 illnesses have been reduced by about 41 percent. In 2009, as a nation, we even met the national Healthy People 2010 target for this pathogen.

But while we were making progress with O157, we learned a great deal more about non-O157 STECs.

According to CDC, these pathogens cause an estimated 36,700 illnesses, 1,100 hospitalizations and 30 deaths in this country each year. And currently, they're not explicitly addressed by our policies.

In order to be a truly prevention-based food safety system, we need to stay one step ahead of these threats. We should not wait for a public health emergency to force our hand to address the range of E. coli threats in ground beef that exist in 2011.

The Challenge of Antimicrobial-Resistant Pathogens
A second and very complex challenge to managing foodborne hazards is the emergence of antimicrobial resistant pathogens.

In the last century, antimicrobial agents have been developed—and used—as wonder drugs, both in human medicine and animal agriculture. They've helped control major infectious diseases, and they've absolutely saved lives.

But today, they present us with a new challenge: How do we retain their effectiveness when pathogens can and have adapted to antibiotics?

There's been a lot of debate about how to control antibiotic-resistant bacteria, but one thing is clear: any policies or decisions, especially regulatory policies or decisions, must be based in science, not our natural inclination or beliefs. The issue of emerging antimicrobial resistance is a complex one. While the use of antibiotics in the agricultural sector is a concern, it is not the only concern. There is clearly an issue with antibiotic use in human medicine that requires scrutiny as well.

So USDA and other agencies have taken on a national action plan including strategies for surveillance, prevention and control, and research under an Interagency Task Force on Antimicrobial Resistance.

And to help gather meaningful data on resistant pathogens in humans and animals, several USDA agencies contribute to the National Antimicrobial Resistance Monitoring System, or NARMS.

The information from NARMS on prevalence and trends has been informative and has reinforced, with data, our belief that pathways to antimicrobial resistance—both human and animal—must be managed.

FSIS, of course, is not the sole USDA agency concerned with resistant pathogens in the food and agricultural sectors. FSIS is challenged with management of these bugs as food hazards. Our partners at the Animal and Plant Health Inspection Service share the belief that strategies are needed to preserve the utility of these valuable drugs. APHIS, with their mandate to ensure the health and care of animals and plants, really functions as the USDA lead on this issue.

In addition, the Center for Veterinary Medicine at the Food and Drug Administration, which is responsible for regulating food additives and drugs that will be given to animals, has the leading role in this conversation about what policies the federal government should set to help preserve the utility of antibiotics.

Of course, farmers and ranchers are facing these challenges, and identifying what role they can play in the control of antibiotic resistance. And members of the meat and poultry industries that FSIS regulates are considering how to best address multi-drug resistant Salmonella in their products.

For example, in 2009 one recall involved more than 825,000 pounds of ground beef, potentially tainted with Salmonella Newport—a pathogen that, in its various forms, can be resistant to some of our most potent antibiotics.

Ampicillin…tetracycline…sulfamethoxazole. Even ceftriaxone—a very useful drug for combating salmonellosis in children, one of the populations most vulnerable to foodborne pathogens.

So regulators and industry are thinking about this challenge. And we know that you all have much more information to offer on addressing resistant bacteria.

I'm really looking forward to the report that CSPI will issue today on antibiotic-resistant outbreaks, as well as the white paper that will come from this conference.

I believe that all of these projects, reports and systems will be useful to the food safety community as we grapple with these pathogens.

Prevention is a Shared Opportunity
We can't wait for a historic outbreak, from these and other foodborne pathogens, before we take steps to improve our protection of public health. We're striving to be a prevention-based system.

Prevention isn't just one person or group's responsibility; it's a shared one. It's shared among producers, government and the food service industry at large. And it's something we can't achieve without the input of scientists or our stakeholders. While it is the responsibility of industry and government to make sure food is safe, there are steps that consumers can take to supplement these systematic efforts to prevent foodborne illness. At FSIS we work continuously to make sure consumers are empowered with the knowledge of safe food preparation techniques.

Developing the tools to prevent foodborne illness is—and must continue to be—a collaborative effort. As you well know, challenges like STECs and antibiotic resistant pathogens demand it.

So we need to develop and implement prevention-based policies. And the most effective way to do that is by relying on science.

MEETING THE CHALLENGE: A Science-Based Approach

After decades on the frontlines of food safety, regulatory agencies have come to understand what those of you in in the research community know: Science is the best tool we have to protect public health.

It allows us to respond quickly to emerging public health threats and to continually update our system as new discoveries are made. Pathogens, we all know, are moving targets.

And it's 2011; we know more now about food safety than we did in the past. There was a time when we saw…smelled…touched our way to safe food. To the group assembled here today, many of you who are experts in the science and technology of food, that must seem simple and rudimentary. But it was the best we could do.

Science finally helped us catch up to foodborne pathogens, but not before lives were lost. If we make the right investments…identify emerging threats…improve our policies on threats we already know…use data to make more informed decisions now, we can get ahead of these growing food safety threats.

USDA Investments in Science, Data and Research
So at USDA, prevention is the anchor, and science is the basis of every food safety decision we make. We have a cadre of scientists in the Food Safety and Inspection Service, in the Agriculture Research Service, and in other agencies that inform our approach to food safety. Science, data and research are primary tools we use to protect public health.

And investments like the Public Health Information System, or PHIS, which we expect to launch this spring, will help.

PHIS will be a way for us to gather and make better use of the enormous amount of data obtained in the more than 6000 plants we regulate. That data, in turn, helps us make better decisions to keep food safe.

Lab research, trials, and risk assessments are also important. Pathogens and other threats evolve, and our understanding must evolve as well.

For that reason, USDA recently revamped our research arm to help answer some of the difficult questions that we have to ask in a 21st century agricultural environment, including our approach to food safety.

And last year, USDA officially organized the National Institute of Food and Agriculture, modeled after National Institutes of Health. NIFA, as we call it, has a strong food safety focus.

It's another investment in the kind of research, education and extension activities that it will take to meet the changing needs of agricultural producers, processors and the American people. It's the kind of forward-thinking that we need to reduce foodborne illnesses and help provide a safer food supply.

Treating Pathogens Throughout the Food System
Pathogens follow a long and complex food chain that we're all a part of, at every stage along the farm-to-fork system, and we need the best science, data and research to combat those pathogens.

We know that the condition of animals leading up to and including the point of slaughter, including the microbial environment in which they were produced, contamination rates on their hides and elsewhere, and a number of other factors, affect the risk of contamination going forward.

To be more prevention-based, we must treat pathogens the way they occur: throughout the food system. And in order to do that, we must base our efforts in science.

We Need Your Help
USDA is investing heavily in this kind of prevention-based, science-based approach. But you are the experts. We need your help.

We need the work of experts like Jeff LeJune and Craig Hedberg…or Stuart Levy and H. Morgan Scott…and of all of you in this room today.

We need your expertise on microbial ecology and management of resistant bacteria; on drug development; on interventions for STECs; and on the impact that preharvest technologies and practices have on what we eat every day.

Science helps us meet some of the most pressing challenges we face.

That puts you in an especially important position to help USDA and our federal partners build a stronger, science-based food safety system.

CONCLUSION

Before I close, I just want to thank you so much for your work on food safety.

Keeping food safe, from start to finish, truly is a collaborative effort. It's not something that I can figure out alone. It's not something that my partner at the Food and Drug Administration, Mike Taylor, can figure out alone.

It's going to take the best scientific minds. It's going to take input from industry and collaboration with consumers. It's going to take knowledgeable and prudent regulators. We all have a role to play. I believe that if we do…if we each play that role and play it well…consumers will be better for it.

If we implement policies…explore research…develop scientifically-proven strategies to manage the risk of STECs and AMR pathogens now, we'll be preventing illnesses in the future. That's what food safety is really about.

I hope this conference is as successful and productive as we all know it can be, given all of the experts gathered here.

Thanks again for being a part of this, and thanks for inviting me to be part of it with you, today.