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Margaret A. Hamburg, M.D., -- National Food Policy Conference

Keynote Address by Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
National Food Policy Conference
September 8, 2009


Good afternoon.

It is an honor to be with you today. In my short time at the Food and Drug Administration, I have become aware of the tremendous opportunity we now have to reshape our national approach to food safety and nutrition. I also know that many of you have worked for years very hard , even lifetimes, to make this moment possible…and success will depend on all our work together.

Certainly it is time to overhaul our current and inadequate food safety system. The system is complex and global, and as a nation we have been late in recognizing its many shortcomings. This has not been a trivial failing, and we have seen the consequences in many ways

As a public health organization, FDA has a compelling interest in the companion challenges of protecting the safety of our food, and at the same time promoting good health. I am optimistic that we can make real progress.

For one thing, President Obama has committed this Administration to making dramatic improvements in our food safety system. He appointed a Cabinet-level Food Safety Working Group and has pushed hard for a meaningful agenda for change. As one important step in this direction, the President requested the largest-ever budget increase for the FDA's food programs in 2010, seeking an additional $250 million and almost 300 new employees.

Also, our Secretary of Health and Human Services, Kathleen Sebelius, has placed food safety and nutrition among her top priorities. She has asked all of the HHS agencies to work together to integrate research, surveillance, public health programs and regulation to improve the health of the American people. I am certain that you will enjoy hearing her message tomorrow.

Congress is also engaged. The House has recently passed food safety legislation to modernize FDA's authorities, and we hope this legislation will soon be taken up by the Senate.

At FDA, we are committed to strengthening our food programs and policies—both food safety and nutrition. Importantly, we are moving forward to appoint a Deputy Commissioner for Foods. This new position reflects the fundamental importance of safe food and proper nutrition for the protection and advancement of the public health. It will ensure that food issues receive appropriate visibility and priority within the agency, and that there will be a high level individual with authority, responsibility and accountability on food- related concerns.

We are pressing forward with a new agenda: to shift the agency’s emphasis away from mitigating public health harm by removing unsafe products from the market place, to a new overriding objective.

And that objective is to prevent harm by keeping unsafe food from entering commerce in the first place.

Our efforts are guided in part by the recent findings of the Food Safety Working Group which adopted a public-health approach based on three core principles: prioritizing prevention, strengthening surveillance and enforcement, and improving response and recovery if prevention fails.

We have started to move on this new strategy.

One example is the FDA's new egg safety rule, which requires science-based measures to prevent Salmonella enteriditis contamination of shell eggs at the farm, as well as safe handling temperature controls throughout the distribution chain.

Our guidance on leafy greens, melons and tomatoes is another measure to foster preventive controls from farm to market. We are committed to build on this guidance to set and enforce mandatory produce safety standards through rulemaking.

But the FDA can only do so much with its existing authorities. To do a better job, we will require new powers, some of which are included in the bills pending in Congress.

We need authority to ensure proper implementation of modern preventive controls in all food facilities. Many firms already implement such controls, but we need to ensure that what is now the food industry’s best practices become increasingly the common practice for all.

Toward this end, we need to enhance our ability to establish and enforce performance standards to ensure the proper implementation of preventive controls.

We also need a modern legislative mandate to ensure that we inspect food facilities more frequently AND that we make use of the best information and the most modern strategies to conduct inspections that are risk-based and oriented for prevention.

In order to significantly upgrade our performance, we must have better tools to foster compliance with science-based standards. For example, if problems occur, we need to have prompt access to food safety records, modern traceback and administrative detention tools, and mandatory recall authority.

And we need new powers to modernize and substantially strengthen the FDA’s ability to ensure that food imports meet U.S. food safety standards. This includes authorities to hold importers accountable for managing their supply chain and preventing food safety problems from entering the United States, conducting more overseas inspections, working more closely with foreign governments, and developing rigorous, independent and accredited third-party certification systems to supplement FDA’s overseas and border inspections.

But none of these authorities and innovative measures will provide the desired protections unless they are supported by new and adequate resources. To carry out more inspections, to strengthen our laboratory testing infrastructure, and to enhance our inspectional and scientific expertise will require additional funding.

We need to build up FDA’s foods program resource base over a period of years to the necessary level and then sustain it for the long term. We are pleased that the adopted House bill includes a fee-based revenue stream, but we need to keep working with the administration and Congress to ensure adequate budgets for food safety.

If this sounds like an ambitious agenda, it is. But our needs must be calibrated so that they are commensurate to the wholesale and long-term strengthening -- and real transformation -- of the food safety system that will enable the FDA to live up to its mandated responsibility to prevent disease and protect the safety of the food supply.

We all know that this is a huge challenge, with major stakes for the health and well-being of practically every American. While reports vary, the Center for Disease Control and Prevention estimates that each year some 76 million cases of food-borne illness occur in the United States. Of those who become ill, about 325,000 are hospitalized and an estimated 5,000 die.

To reduce these numbers, our preventive measures must address the hazards that threaten food safety all the way from the farm to the dinner table.

And to accomplish this, we need to improve partnerships across the country and around the world.

Working closely with state and local governments, we intend to create the integrated national food safety system called for by the Food Safety Working Group. Only such a comprehensive network of cooperating authorities can make the optimal use of all available resources to prevent and contain food safety problems.

We also are strengthening alliances with federal partners such as the Centers for Disease Control and Prevention and the U.S. Department of Agriculture.

CDC is already our critical partner on outbreak response, but we will also depend more than ever on its collaboration in generating the epidemiological data and analysis that informs our prevention efforts. And we are already collaborating more closely with USDA in the leadership of the Food Safety Working Group, and in such areas as produce safety, and on seafood inspection pursuant to the 2008 Farm Bill.

Moreover, in our increasingly global world, we must also look beyond our borders. We must seek better cooperation and stronger collaboration with our international counterparts. We need to harmonize food safety standards, share information and approaches, and share responsibilities. And over the longer term, a key necessity will also be to strengthen the regulatory capacities and performance in developing nations whose products are imported for our market.

And we need to work with members of the food industry, many of whom have been making important innovations in food safety practices and technology, and all of whom bear primary responsibility to produce and market safe food.

Because strengthening our capacity to perform inspections is integral to transforming our food safety system, I want to say a little more about some of the changes we plan to implement to improve inspections.

With a larger workforce, we can and will do more inspections, but to be maximally effective, we must do these using upgraded tools and techniques and with increased reliance on microbial testing and better and more sophisticated signal detection. When we find ominous signals, we will act promptly, without waiting for people to become ill.

Our focus will be not be solely on the number of inspections or enforcement cases, but also on how well we’re ensuring compliance with prevention-oriented food safety standards.

Our strategy must be to perform a full complement of inspections, bring enforcement cases if and when needed, and above all to use all the tools at our disposal to prevent illness.

In this regard, I am pleased to announce that the FDA is today launching our Reportable Food Registry. Under this program, food manufacturers, processors, packers and warehouses must submit an electronic report to the registry when there is a reasonable probability that the use of, or exposure to, an article of food will seriously harm the health of humans or animals. The reporting firm must investigate the cause of the adulteration, if the adulteration of the food may have originated with the reporting firm, and all reporting parties must consult with the FDA about follow-up measures.

In the short term, this registry will help us identify where risk lies in our complex food safety system – and then enable us to respond quickly.

For example, when a food processor receives an ingredient from a supplier which the processor’s testing shows is a reportable food, the processor must submit a report to the registry informing FDA of the problem with the ingredient. That will allow us to go quickly to the source of the problem and find out who else may have received shipments of that ingredient . . . ultimately enabling us to do a better job protecting the public.

Over time, we will use information in the registry to target areas for preventive intervention -- and through guidance, regulations, and inspections to hopefully keep many problems from ever developing in the first place.

This represents an important advance, and I want to take this opportunity to thank our colleagues and collaborators at the National Institutes of Health, whose work on MedWatchPlus helped make possible the Reportable Food Registry Portal we are opening today. The portal will become part of MedWatchPlus, the single point of entry for reports of adverse events for all FDA-regulated products, when it opens later this year.

The many changes I’ve outlined today represent a great challenge for the FDA, but we know they also mean that change is coming for others in the food system as well.

Many in the food industry have already adopted modern preventive controls, but these companies will in the future be more clearly accountable for properly implementing such food safety controls. And all commercial food facilities will eventually need to develop modern preventive controls to protect the public.

I understand that the prospect of this kind of change can cause anxiety. But I want to emphasize that we recognize that what's needed is not a one-size-fits-all solution to food safety but rather an adaptable set of principles and practices.

In the agricultural sector, FDA will carefully focus its standard setting on produce commodities and issues that are important for improving food safety, and we will be very sensitive to the wide diversity of practices, which we know vary by commodity, geography and scale of operation. My colleagues and I are committed to listen to and learn from the agricultural community about their concerns, including particularly the concerns of small growers and the organic community.

I am looking forward to some upcoming field visits to learn more about these issues. But certainly our goal is to only issue rules that we are confident will improve food safety, and they will be scale and circumstance appropriate.

Finally, I want to add that our plans for improving food safety include important issues under the purview of our Center for Veterinary Medicine. One of them is the safety of animal feed and animal drug residues; another is antimicrobial resistance in human medicine that can be exacerbated by the injudicious use of antibiotics in agriculture. These are very important elements of the food safety landscape.

And there is also the issue of pet food safety. The melamine episode underscored the importance Americans place on the safety of food they feed their pets. It’s important for us to act on the basis of the reality that it’s just one food supply, and we fully intend to apply the same preventive control principles to pet food that we apply to human food. These matters have not received the attention they deserved in the past, and we're determined to change that.

And, as much as we are focused on building up FDA’s food safety program, we also want to strengthen FDA’s focus on nutrition. As we work to reduce sickness and hospitalizations from such pathogens as salmonella and e.coli . . . we are also acutely conscious of the broader nutrition crisis affecting millions of Americans. To contribute to good health and well-being, our food supply must not only be safe, but it must also be comprised, as much as possible, of nutritious and healthy foods and food products that people can choose to build healthy diets. We need to be considering nutritional efforts to reduce the risk of such illnesses as heart disease, diabetes, and stroke.

The best and most alarming evidence of the current nutrition crisis is the fact that 65% of Americans are obese or overweight, and almost 17% of youngsters under 20 are obese. Obesity, of course, increases the risk of heart disease, certain cancers, and stroke.

And as Secretary Sebelius recently pointed out, obesity costs our health care system as much as $147 billion a year -- a staggering amount that has almost doubled since it was last calculated by the CDC in 1998.

This brings into sharp focus the public health importance of food labeling as an essential means for informing consumers about proper nutrition. It is an issue that's critical for the health and vitality of our nation, and yet it is a concern that has not been substantially addressed since the FDA implemented the Nutrition Labeling and Education Act, more than 16 years ago.

Back then, the FDA labeling rules addressed a “Tower of Babel” on food packages proclaiming nutritional and sometimes specific disease-related health benefits that were either unfounded or misleading.

Recently, however, we’ve seen the emergence of claims that may not provide the full picture of their products’ true nutritional value. It will be important to re-establish a science-based approach to protect the public. And we all have a role to play, whether it is educating the public and accurately communicating the health and nutrition information that they need, or ensuring that consumers, in fact, have healthy food choices.

There are many ways to encourage and support Americans who are seeking to gain control over their diets. For instance, I am following with great interest the local initiatives to require restaurant menu labeling . . . and the ongoing legislative discussion of a national menu labeling requirement.

With approximately one-third of all meals consumed outside the home— and given the many well-documented examples of very high calorie menu items in many popular restaurants-- it is important for consumers to have meaningful access to nutritional information in order to make well-informed choices about the foods they eat.

With information in hand, consumers still need healthy options to choose. A case in point relates to sodium. Consuming too much sodium increases hypertension, and hypertension increases the risk for heart disease and stroke. A major problem is that many foods are prepared with large amounts of sodium, making sticking to the dietary recommendations for salt very difficult.

At FDA, we are following closely efforts through public-private partnerships to lower the sodium in the food supply, potentially creating many more healthy options for consumers. The effort led by my former home base, New York City, to create a voluntary program by government and industry that would gradually decrease the amount of sodium used in packaged processed foods and restaurants, is particularly intriguing and potentially laudable.

I am also looking forward to seeing the recommendations of the Institute of Medicine study underway to examine strategies to reduce sodium intake in the population. Such efforts can form the foundation for national progress.

It truly is a historic time for food safety and nutrition. I feel very privileged to be at the helm of the FDA at this critical time, and I am delighted to be part of this meeting today. As our agency moves forward, we will seek the partnership and support of consumer groups, industry, and others to bring about meaningful change. With so much in the balance, I thank you in advance for your participation and for your support.