Michael A. Friedman, M.D.

Remarks to

The Committee to Ensure Safe Food

From Production to Consumption

The National Academy of Science

Washington, D.C.

March 24, 1998

My name is Michael Friedman. I am acting as the commissioner of the Food and Drug Administration. With me is Joe Levitt, the director of the Center for Food Safety and Applied Nutrition and Steve Sundlof, director of the Center for Veterinary Medicine. Bern Schwetz our Chief Scientist and Ron Chesemore our associate commissioner of the Office of Regulatory Affairs could not be here but offer their regrets. Our goal is to help provide useful information to you for your consideration.

In addition to our presentation today, we will provide the committee with a written summary as well as other supplemental material. And, of course, we will be happy to answer your questions and provide any other background you might find helpful.

You have posed two questions for this opening session: What does food safety mean to the FDA and how does FDA participate in assuring the safety of the nation’s food supply?

Quite simply, the food safety mission of the FDA is to promote and protect public health by ensuring that foods are safe, wholesome, sanitary and properly labeled and that veterinary drugs for food-producing animals are safe and effective. The agency strives to prevent or eliminate hazards in the food supply.

But we also recognize that there are no absolute protections. Since we cannot prevent every outbreak of food-borne illnesses, our mission also includes the early detection, containment and management of unforeseeable or unpreventable hazards.

And you recognize that there are many hazards. Living in a biologically dynamic world that gives rise to new micro-organisms such as E. coli O157:H7. There are also many food safety issues like chemical contamination from pesticide residues, allergens and animal drug residues. Beyond these hazards, FDA has responsibility for many other critical issues, such as nutrition and dietary supplements.

Because of the general robustness of the nation’s food safety programs, consumers expect that food will be extremely safe. But this safety is not absolute. Science struggles to identify the true source of hazards, and even when identified, the actual risk to humans is not always precisely quantified. Sometimes, FDA must make food safety decisions based on incomplete science or risk assessment information. So public policy and good judgement have a significant role to play.

Let me describe the characteristics of FDA’s approach to protecting the safety of the food supply.

First of all, FDA is a science-based regulatory agency. This is a special combination embodying scientific framework and a regulatory efferent limb -- and each strengthens the other. Objective science and public health provide the basis for our regulatory decisions, divorced from commercial concerns.

FDA has direct and indirect access to extensive scientific expertise in a wide range of fields. Microbiology, chemistry and nutrition sciences make fundamental contributions to the agency’s efforts. But, we also call on many other disciplines, from molecular biology to botany, from epidemiology to molecular genetics, risk assessment to sanitary engineering.

In addition to science, FDA relies on its long list of legislative mandates to protect the food supply. The agency’s foundation was laid by the Federal Food and Drugs Act of 1906, which protected against adulteration. Congress has continued to update the act – right up to last fall’s FDA Modernization Act of 1997. Through this cascade of laws, Congress assigned FDA responsibility for the safety of most segments of the nation’s food supply.

The agency acts nationwide through its inspection force and a strong cadre of scientific and regulatory experts in headquarters. These trained individuals inspect all types of food establishments, collecting and analyzing samples. They conduct laboratory studies to develop and improve testing methods, set standards through regulation to transfer our scientific knowledge to actual practice, determine the health effects of food contaminants, and the effects of processing on food.

Moreover, they monitor imports, review food and color additives and animal drugs prior to marketing and work with the states to develop and implement the model Food Code. We also work to share our knowledge internationally through Codex and by providing technical assistance to foreign countries.

Lastly, we work to educate both the affected industries and consumers.

All of this work is primarily carried out by four of FDA’s centers. CFSAN takes the lead in the food safety initiative, as well as responsibility for the premarket review of food and color additives, for the chemical/microbiological safety of food and dietary supplements, nutrition and related food labeling, and cosmetics safety. Lastly, the center works to assure that these products are properly labeled.

The Center for Veterinary Medicine (CVM) promotes and protects the public health by ensuring that animal drugs and medicated feeds are safe and effective for intended use and that food produced from treated animals is safe for human consumption.

The Office of Regulatory Affairs (ORA) conducts food safety inspections in the production plants, collects and analyzes food samples, and monitors imports for compliance with U.S. requirements.

The National Center for Toxicological Research carries out scientific research and testing in support of the Agency’s mission.

The work of these four centers is closely coordinated within the Agency and FDA is establishing even stronger cross-organizational ties in such critical areas as microbiology.

FDA’s food safety program is also integrated with other federal, state and local food safety authorities. In the Department of Health and Human Services, for example, we work closely with the Centers for Disease Control and Prevention and the National Institutes of Health.

We also collaborate closely with the Department of Agriculture’s Food Safety and Inspection Service, the Agricultural Research Service, Animal and Plant Health Inspection Service and the Food and Nutrition Information Center. At the Department of Commerce, we work with the National Marine Fisheries Service and at the Department of the Treasury, there’s the Bureau of Alcohol, Tobacco and Firearms, and the U.S. Customs Service. Lastly, we collaborate with the Environmental Protection Agency and combine forces on research with the Department of Defense.

We also work closely with state and local authorities, including the Association of Food and Drug Officials and state, county and city health and agricultural departments.

Coordination is essential because the agency has broad responsibility for most domestic and imported food products, ranging from fresh fruits and vegetables to dairy products, fish, even bottled water.

That’s some 230,000 products sold as 45,000 brands that are produced by some 50,000 food and cosmetic processors and sold in more than half a million commercial food service establishments. FDA regulates 10,000 food additives and enforces tolerences for 300 pesticides registered in the U.S. Because so many products come from oversees, FDA monitored 2.5 million import entries in FY 1997. To do that efficiently, FDA relies on a state-of-the-art-computerized system to screen all food imports. Less than 5 percent of all food imports are physically examined using targeted approaches and the import monitoring is done in partnership with the U.S. Customs Service.

To help us stay on the cutting edge in food science, FDA participates in academic collaborations. In April 1996, FDA and the University of Maryland established the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) on the College Park campus. The new, multidisciplinary research and education program was created to increase the quantity and quality of food safety research. It’s also designed to promote food safety, human nutrition, and animal health and production through an integrated academic and regulatory science program. In addition to JIFSAN, the National Center for Food Safety and Technology was established with the Illinois Institute of Technology 10 years ago to study the safety of new food processing and packaging technologies.

This is a very long and rapid recitation of a lot of facts. Perhaps a specific example of how we put it all together in a regulatory system would be useful.

Because seafood is primarily caught in the open ocean globally, there are many hazards that could affect it. The traditional inspection system is not satisfactory.

To address these circumstances, FDA initiated the application of Hazard Analysis and Critical Control Point, or HACCP, starting with seafood. Originally developed for NASA, this program identifies the steps in food production where contamination is most likely to occur and then puts in place preventive measures. Under FDA regulations that went into effect in December 1997, commercial seafood processors identify hazards that are reasonably likely to occur with the seafood products they produce and then implement preventive controls to keep those hazards from occurring.

The HACCP concept has been widely hailed as a sensible approach, including by the National Academy of Sciences, the National Advisory Committee on Microbiological Criteria for Foods and the European Community. Most major developed nations that export seafood have adopted or are in the process of adopting HACCP for their own seafood products.

Inspection and conformation is important. In 1998, FDA expects to inspect, either on its own or through state contracts, virtually all U.S. seafood processors and more than 1,500 importers to make sure they have implemented this new approach.

The HACCP program demonstrates the best features of FDA’s food safety programs: It is science-based and designed to prevent food-borne illness. It coordinates the work of several centers within the agency and works closely with state agencies that conduct many of the seafood inspections.

Moreover, seafood HACCP points to the future. Last summer, FDA announced its intention to develop HACCP regulations for fresh fruit and vegetable juices. A very ambitious, but similar HACCP program is being implemented by the Department of Agriculture for meat and poultry.

I hope my remarks provide something of an overview but they cannot provide much of a feel for what actually takes place in the factories or on the docks. If you are interested, we invite you to consider a visit with our scientists and inspectors so that the committee can see how we operate.

We recognize that food safety is a critical national issue. While improvements can be made, and will be made, FDA’s food safety system is very strong. Its scientifically based regulatory approach is rational and provides objective decision-making that is free of commercial interest. FDA’s remains focused on its primary roles of public health and consumer protection. Through its collaborations, the agency helps provide an integrated food safety system that involves other agencies at the federal, state and local level.

The public expects FDA to be vigilant to protect it from hazards in the food it sets on the family table. This is an important public health trust and one that this agency intends to do everything it can to keep.