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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Codex, Committee on Food Hygiene

Remarks of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
at
Codex, Committee on Food Hygiene
San Diego, CA
November 16, 2009

Good Morning.  I am very pleased to be here with you.  I understand that I am the first U.S. FDA Commissioner to address the Codex Committee on Food Hygiene, and I’m honored to be here and to have the opportunity to recognize and commend you for the critically important work that you do.

As the leader of the regulatory agency charged with the responsibility of ensuring the safety and wholesomeness of most of the food consumed by the U.S. public, I’d like to acknowledge that this is the committee that does the “heavy lifting” of global food protection. 

You are the body which produced the very first recommended code of practice under Codex, back in 1969, and you established the international baseline standard for good manufacturing practices that forms the foundation for food safety systems in countries throughout the world today.  Since then, this committee has developed many critically important risk management guidance documents that address the prevention of some of the most virulent forms of food-borne illness such as infection from Salmonella, E coli and Listeria.  And this work is continuing in a robust fashion as evidenced by the agenda for today’s meeting.

On behalf of those living in the USA, who are better off due to your efforts in so many ways, I’d like to convey our gratitude for your excellent history of science-based public health protection.  And I know that our nation is not alone in this debt of gratitude.

Although this meeting deals with important specifics such as controlling Campylobacter  and Salmonella in chicken and meat and enhancing hygienic practices with regard to leafy greens, what we are really talking about is the myriad ways in which we are all connected to one another; how the health of our nations is inextricably linked. 

We are seeing a very vivid illustration of this global connection as we chart the path of the H1N1 influenza pandemic.  In doing so, we have noted that, while the symptoms may be more severe in some regions, while the virus may proliferate more quickly in others, the H1N1 virus is yet another reminder that we are all vulnerable to a novel infectious agent against which most people have no pre-existing immunity; that disease respects no national boundaries, and that in order to be effective, the response must be global in scale.

For me, the realization that public health protection was truly a global endeavor began in 1990 when I assumed the role of health commissioner of New York City.  Given the constant flow of tourists, workers and other visitors, the broad base of imported goods and commercial interests, hundreds of daily flights into the city from throughout the world, and the broad diversity of ethnic enclaves all with their own distinct languages, foods and customs, I discovered that New York City was part of the international community.

In fact, in some ways, it had less in common with most U.S. cities than with an international hub like Hong Kong.  It didn’t take me long as New York City Health Commissioner to realize that a local or, even, a national perspective would be too narrow for the job; what we needed was an international frame of reference.

And that point really came home to me, when I encountered diseases like malaria, neurocysticercosis, chagas disease and even pneumonic plague.  At Harvard Medical School, where I trained, diseases like these were labeled, “foreign,” “exotic” and “rare” and I was taught that, as a U.S. doctor, it was unlikely that I would ever encounter them.  And yet, here they were afflicting the people I had been appointed to serve—the residents of New York City. 

In a similar sense, to achieve true and meaningful protection of our food supply, we must view the threats of food-borne illness through a global frame, because the facts tell us that, today, there is really no such thing as a “domestic” food supply. 

This is certainly true for the United States.  Although the U.S. remains a large producer and exporter of agricultural products, consider that:

  • More than 75% of seafood eaten in this country comes from foreign waters;
  • Over the course of the last 20 years, U.S. imports of fresh produce have tripled; today up to 35%  of the fresh fruit and vegetables consumed in the U.S. comes from foreign countries, and;
  • Overall, up to 20 percent of all food consumed in the U.S. originates from foreign sources.

Food safety is an essential public health issue for all countries, which is why the work you do at meetings like this is so critically important.  It’s clear that one of the keys to achieving greater protection from food-borne illness is increased inter-government collaboration and continuing progress on harmonizing international standards, so that all of our citizens can have access to safe and wholesome food, and all nations can have the opportunity to participate in the global marketplace. 

When President Obama announced my nomination to be U.S. FDA Commissioner, he said that while America is a nation built on the strength of individual initiative, there are certain things that we can’t do on our own.  There are certain arenas in which government has a special responsibility and role to play, and one of those is ensuring that the food we eat will not cause us harm.

I absolutely agree with the President that ensuring food safety is a core responsibility of government, and in the interconnected, interdependent world in which we live today, it is a shared responsibility of all governments.

As I took on the role of U.S. FDA Commissioner, agency’s regulatory mission was expanding and becoming ever more complex.  And regrettably, the agency’s vital food safety responsibilities were not being adequately addressed.

A fundamental reason that I accepted the challenge to lead this venerable and critically important agency, is that I knew the President who asked me to serve in this role was deeply committed to strengthening food safety and that he would support me in my efforts. 

Early on, President Obama appointed a cabinet-level Food Safety Working Group to coordinate and implement an agenda for meaningful change and a sharpened public health focus on prevention.    

The ultimate goal of the President’s Food Safety Working Group--and all of the U.S. government agencies who are a part of it—will be to transform a system built on trying to react to an outbreak of food-borne illness once it occurs, to one that endeavors to prevent contaminated food from entering consumer markets in the first place. 

This is a fundamental shift.   It will not be easy, and it can not be done overnight, but for those of us who take public health protection seriously—and I believe I’m speaking to everyone in this room—prevention is the only true protection against food-borne illness. 

No one should suffer the ravages of infection from E. coli or Listeria or Salmonella contracted through the innocent and mundane act of eating a salad or making a peanut butter sandwich.  As a mother and as a physician who has devoted my entire career to public health protection, and now as the head of the agency in the United States chiefly responsible for food safety, I believe we can and must do better.

This belief is widely shared, I’m happy to say, not only among public health officials like me, but by our food industry, consumer organizations and by leaders in the U.S. Congress.  We are working closely with these stakeholders and Congress on new food safety legislation that will give the U.S. FDA the enhanced legal authorities it needs to implement the principle of prevention and meet the challenges of the 21st century. 

We expect the new law to require adoption of prevention-oriented food safety plans in all food production facilities in the United States.  These plans would be grounded in the basic principles of food hygiene adopted by this Committee, beginning with the need for manufacturers to analyze the potential food safety hazards in their operations and implement the preventive controls needed to minimize or eliminate them.  The legislation pending in Congress would also require FDA to conduct more frequent inspections and give us new enforcement tools to ensure companies are meeting their duty to prevent food safety problems.

The reliance on preventive controls -- such as Hazard Analysis and Critical Control Points, or HACCP – is of course not entirely new in the United States.  We require HACCP for meat and poultry, seafood, and juice products.  But the recognition that all food facilities should adopt such preventive controls, tailored to the hazards and needs of their particular operations, is new. 

And we think that the work of this Committee in adopting and updating its guideline on General Principles of Food Hygiene, has contributed to the consensus that science-based prevention is what we need to improve food safety.  We thank you for that.

So what does this shift to prevention as the centerpiece of the U.S. food safety system mean for our international partners in food safety and global trade? 

The starting point, of course, is that U.S. consumers expect all food reaching their plate to be safe, wholesome and consistent with U.S. standards, regardless of where it originates.  That is why we expect that Congress will require that foods imported into the United States be produced under the same preventive control standards as foods produced here. And that will require a complete overhaul of how FDA oversees food imports. 

In today’s world, with the huge volume of imports and the focus on prevention, we can’t simply be “guardians at the gate,” attempting to detect and weed out unsafe products at our ports and borders.  Instead, we need to have ways to ensure that safety is built in to the product by adoption of appropriate preventive measures in foreign food facilities and at all steps along the way.

The legislation Congress is considering, if enacted, would give us new tools for doing just that.  This would include the important authority to hold U.S.-based importers accountable for effectively demonstrating that safety and compliance with U.S. standards are built into products before they arrive at our border and ports. To carry out this new authority, we will also be increasing our inspection capacity at U.S. entry points and giving our inspectors new tools for targeting shipments that pose the greatest risk of non-compliance.  

In addition, in order to leverage our resources for overseeing the safety of imported food, we also hope to strengthen the role of 3rd party certification programs, in which foreign governments or qualified 3rd party agents certify that imported products meet U.S. safety standards. 

For foreign producers, participation in voluntary certification programs could facilitate their participation in the global marketplace.  These programs can also enable government regulators throughout the world to effectively allocate their resources in the service of greater public health protection.

Finally, we will be strengthening our oversight of food imports by increasing our own inspection of foreign food facilities and making new investments in, and within, countries and regions who are major trading partners with the U.S. 

Over the past year we have established U.S. FDA posts in China, India, Latin America and Europe and soon, we will have posts opening in the Middle East as well.  As an example of how this works, in our China office we have senior inspectors and technical advisors in place with expertise in food safety and Good Agricultural Practices.  These FDA officials work closely with our Chinese counterparts and industry to help leverage knowledge and resources about the safety of these Chinese food products and food products in general.

We think that these new FDA initiatives will go a long way to providing U.S. consumers the assurances they seek about the safety of imported food.  But we can’t get where we want to go all by ourselves. We need to pursue food safety in closer partnership with foreign governments which are concerned, both about ensuring the acceptance of their exports in the U.S. and elsewhere and improving food safety within their own borders. 

Effective international partnership on food safety depends, of course, on increasing harmonization of food safety standards, which is where Codex and the Committee on Food Hygiene play such a critical role. The key to successful harmonization is the use of sound science in the development of international standards.  We recognize and support the strong commitment of Codex to the science-based process, particularly the use of risk analysis in the development of its food safety standards.

While harmonization of international standards is critically important to effective food safety partnerships, it is equallyimportant for nations with more mature regulatory systems to take a leadership role in helping less mature regulatory authorities build the capacity they need to help assure the integrity and safety of the food supply.

Toward that end, the FDA is engaged in many efforts—bilaterally and multilaterally—to work with countries throughout the world to enhance the level of science-based standards for food safety. 

Earlier this month, a team comprised of seafood specialists from the FDA and the Joint Institute for Food Safety and Applied Nutrition—an FDA center of excellence located at the University of Maryland—went to Bangladesh to help train local officials on aquaculture safety and quality control techniques.  The goal of the trip was to work directly, in country, with Bangladeshi officials, to help the producers improve the quality and safety of their aquaculture products for both domestic and international markets.

This program uses a “train-the trainer” model.  Those who successfully complete the program will be qualified to continue training others in their country on accepted Good Aquacultural Practices.  In this way, the program becomes self-sustaining and the knowledge of techniques for raising shrimp and fish—for domestic consumption and for export—proliferates throughout the country.

Last month, FDA held the first of what will become an annual event—The International Analytical Methods conference at our central forensics laboratory in Cincinnati, Ohio.  The meeting brought together laboratory scientists and managers involved in food safety analysis from governments in North and South America, Europe, Asia and Australia, as well as representatives from the World Health Organization and the Pan American Health Organization.  These experts in microbiology and chemical analysis addressed methods of surveillance, food-borne illness testing, new technologies for rapid and specific pathogen analysis and high-throughput quick response time testing capabilities.  It is easy to see how implementing these technologies can make our response to food-borne illness faster and more efficient.

Let me close with some reflections on the relationship between food safety and trade. The stated mission of Codex is to ensure safe food and fair trade.   I know that some of you feel that this is a dual purpose mission, and that there are times when the objectives of safe food and fair trade may be at odds with each other.

As people of good faith, engaged in an international process that impacts the health and prosperity of all nations, I believe it is important to be honest about the fact that these tensions exist.

I strongly believe that the goal of public health protection should never be misused as a disguise for trade protectionism.  I also believe that strong, credible food safety standards are the essential foundation for robust trade in food.

I thus reject the notion that working in collaboration, and in the spirit of cooperation, to enhance international safety standards is at odds with fair trade. The objectives of safe food and fair trade don’t conflictwith each other; to the contrary they must drive each other.

In order to be full participants in the global marketplace, we all must continually learn to produce food products that meet international safety standards.  Doing so also creates a clear path to improving the lives of all people in all countries. 

When governments invest in the capacity of countries to produce food for export in accordance with international standards, there can be multiple and mutual benefits.  The developing countries can have both a domestic source of safe and wholesome food and a new export market.  Building the systems needed to produce food in accordance with international sanitary and phytosanitary standards often involves the creation of systems to ensure clean water and effective sanitation.  And those are the most essential building blocks for public health protection in every society.

While my duty as FDA commissioner is to ensure safe food for all Americans, my experience throughout my career has shown me, time and again, that public health protection is a global endeavor.  I fundamentally believe that all people in the world deserve food that is safe, and that all nations deserve the opportunity to participate, and prosper, in the global economy. 

That is why international bodies like the World Health Organization, the Food and Agriculture Organization and, of course, Codex are so critically important.  We must all work together to increase information sharing, leverage the most advanced scientific techniques to advance public health, and recognize that empowering all countries to produce safe food for domestic consumption and export is a shared responsibility that we all must shoulder.

Because only by strengthening food safety capacity in nations around the world, will we be truly effective in protecting the health of the public within our own nations, and the people of all nations.

I am excited by the opportunity to work with you towards achieving our common goals.  Thank you.