Remarks by:

Jane E. Henney, M.D.

Commissioner of Food and Drugs

"This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some of the material may have been added or deleted during actual delivery."

______________________________________________________________________________________

We here in the United States are fortunate to enjoy an overall excellent health status. During the 20th Century, health and life expectancy in the United States have improved dramatically. Since 1900, the average lifespan has lengthened by more than 30 years, 25 years of which are attributable to advances in public health. Control of infectious diseases, decline in deaths from coronary heart disease and stroke, safer and healthier foods, and healthier mothers and babies have all contributed to the picture of robust national health. These statistics are no accident. They are the result of a strong national health department the Department of Health and Human Services -- that bases its public health policy on the best science available.

This public health mission extends to the area of food safety. As you know, although the food industry does a very credible job of producing a safe food supply, the food safety problems in this country are very real. While the United States enjoys one of the safest and most bountiful food supplies in the world, each year in our country millions of people become ill and thousands die due to foodborne illness. We can and must do better.

Today’s challenges with respect to the food supply are complex. We are eating a greater variety of foods throughout the year from all over the country and world. We are eating more and more foods prepared outside our own homes. Nearly a quarter of our population is considered "at risk," including pregnant women, children, the elderly, and the immunocompromised. And, we are aware of more than five times the number of foodborne pathogens in 1999 than we were fifty years ago, many on which are more deadly for those most at risk.

The Department of Health and Human Services and its Public Health Service have provided leadership in protecting the public health with regard to food issues. In the 1950s and 1960s it was pesticide and food additive regulation. In the 1980s and 1990s it was nutrition and ingredient labeling. Most recently, it has been the FoodNet/PulseNet and HACCP programs developed by the Centers for Disease Control and Prevention (CDC) and FDA, respectively.

The Department is organized in a manner that clearly links science to this mission. FDA is the lead agency for applied food and environmental laboratory science to support our regulatory and non-regulatory food safety mission. CDC has primary responsibility for epidemiology and laboratory science to support our infectious and non-infectious disease prevention mission. The National Institutes of Health is the premier agency for basic and clinical biomedical research. Together these agencies promote food safety, prevent foodborne disease, and mitigate the clinical and social impact of infectious and non-infectious illness that occurs.

We can only accomplish these goals if our policies are based in sound science. It is for this reason that building FDA’s science base has been one of my major priorities. It is my strong conviction that through the development and application of sound scientific principles, we will solve the numerous public health threats posed by an everchanging world. Risk Assessment is leading the Department’s food safety regulation and policy to effective and efficient, science-based solutions to these complex food safety challenges.

The importance of strong federal leadership in the area of food safety cannot be overstated. Nowhere is this better illustrated than the recent problems Europe has had with dioxin and Mad Cow disease. These incidents have eroded the public’s confidence in the government’s ability to protect them against unsafe foods. In his visit to Europe, President Clinton recognized the importance of a strong federal government that bases its decisions in sound science when he stated, "the Europeans should set up their own equivalent of the U.S. Food and Drug Administration to control food safety." We, as well as all the agencies in the federal government, must maintain our high standards and the confidence they engender.

While we may never reach the point of eliminating all foodborne illness, scientific advancements have permitted us to make great strides in reducing them. I would like to spend some time highlighting four areas that illustrate the impact of science on food safety policy.

First, science has enabled us to identify new and changing public health hazards in foods. As part of our disease prevention and health promotion efforts, we are encouraging Americans to consume a varied diet rich in fruits and vegetables. This is made easier by changes in agricultural and food technologies and refrigerated transport and storage that make an abundance of fresh fruits and vegetables available all year around. With this increased consumption, however, epidemiologic data document a substantial increase in the proportion of foodborne outbreaks being traced to fresh produce. For example, foodborne illness was associated with the ingestion of Guatemalan raspberries in 1996 and 1997 in the United States and Canada and was attributed to Cyclospora cayatenensis, a parasite that was virtually unknown at that time. FDA scientists have been studying this parasite and have developed DNA techniques that enable us to detect this pathogen on produce. Advances in food virological techniques are improving our ability to detect and combat the presence of foodborne viruses, such as Hepatitis A virus, in fresh produce as well.

In addition to improvements in our abilities to identify infectious foodborne hazards that have been made possible by resources from the President’s Food Safety Initiative, we are hard at work on non-infectious foodborne hazards as well. For example, our Center for Food Safety and Applied Nutrition (CFSAN) and National Center for Toxicology Research (NCTR) have joined forces to chemically and toxicologically characterize fumonisin, a toxin produced by the mold Fusarium moniliforme when it infects corn. This mycotoxin has been responsible for major outbreaks of acute and chronic diseases in farm animals, and has been linked to several human diseases, including certain kinds of cancer. Collaborative research has led to new analytical methods for fumonisms in a number of food types, and these methods use less solvent, are less expensive, and take less time than traditional methods.

A second area where science has had an impact on food safety policy is reflected in new approaches we take to solving public health problems. For instance, sprouts are an increasingly popular part of the American diet, regularly consumed by approximately 10% of the population. However, beginning in 1995, the CDC began to observe an increase in the number of reports of outbreaks of foodborne disease associated with sprouts. The primary problem is that sprouts, which are consumed raw in salads and sandwiches, can be contaminated with harmful microorganisms, and no steps in the traditional production of sprouts provide a means for controlling foodborne pathogens. Laboratory science has built a solid foundation to understand the problem and will offer new strategies for the elimination of microbiological hazards on sprouts. For example, research has shown that seeds occasionally are contaminated with foodborne pathogens, such as Salmonella or E. coli O157:H7, and that these pathogens grow to large numbers during seed sprouting. Other laboratory studies have shown that the contamination becomes so embedded within the seed that it is difficult to remove or inactivate.

Last fall a task force of government, university, and industry scientists was mobilized to develop a coordinated research agenda that would find solutions. With that agenda, researchers have devised multiple means for improving the safety of sprouts, including evaluating a wide range of potential agents as a means of decontaminating both seeds and finished sprouts, devising an early warning detection method for identifying contaminated sprouts by testing the irrigation water used to grow the sprouts, and applying low dose irradiation to eliminate pathogens from seeds without interfering with germination of the seed into sprouts.

The continued occurrence of sprout-associated outbreaks strengthens our resolve to put effective interventions into place and to build a comprehensive strategy to assure the safety of sprouts. Last Friday, FDA met with representatives of the sprout industry to continue efforts to improve industry practices, and issued a sprout advisory to further inform the public, especially those at greatest risk of infection and severe illness, of the risks associated with sprout consumption.

FDA established the National Center for Food Safety and Technology (NCFST) in 1988 with the Illinois Institute of Technology. The NCFST is an important player in our quest for improved methods for enhancing the safety of food. In addition to the work on sprout safety that I previously mentioned, the Center also has been hard at work on the development and use of non-thermal processes, including ultraviolet light, high hydrostatic pressure, and antimicrobials, to improve the safety of juices that will not receive heat treatment. A particular emphasis of the Center is development of processing and packaging technologies that can be easily used by small businesses.

A third area I would like to discuss is the impact of science on our regulatory approach to setting standards that help ensure a safe food supply. As our scientific knowledge evolves, so too should our regulatory policies to reflect the current state of knowledge. An example of where our regulatory standards are evolving can be found in the area of Vibrio parahaemolyticus in molluscan shellfish. New DNA-based technology employed during recent outbreaks of infections with V. parahaemolyticus helped us to better understand the potential virulence factors present in some disease-causing isolates. Data from these more recent outbreaks has also caused us to reconsider previously employed performance standards used to determine acceptable levels of V. parahaemolyticus in raw molluscan shellfish. Relying on this and other available scientific information, we are conducting a risk assessment that will help us to develop food safety guidance and polices that reduce the risk of disease from V. parahaemolyticus in raw molluscan shellfish.

In addition to improving our scientific base on infectious hazards associated with seafood, FDA also has cosponsored research to examine the relationship of maternal exposure to mercury in fish and possible effects on neurobehavioral development in children as a result of maternal exposure to mercury in the fish. This research has provided data that are now being incorporated into a risk assessment that will serve as the basis for re-evaluating our current action levels for mercury.

A fourth area of impact is how we use science to measure the public health impact of prevention and control efforts. For instance, we have recently completed a consumer study to evaluate how well public education campaigns on food safety are working. Such research has enabled us to identify what food safety practices consumers are employing and where trends exist. For example, the data showed sharp and widespread declines in reported consumption of all types of raw protein foods between 1993 and 1998. For the population as a whole, the incidence of eating pink hamburger is down 33%, the incidence of eating raw oysters or clams is down 39%, and the incidence of eating foods containing raw eggs is down 29%. In addition, measures of knowledge about microbial food pathogens show large increases between 1993 and 1998. By 1998 almost two-thirds of the adult population had heard of Salmonella in food and also knew that thorough cooking would make a contaminated food safe to eat, compared to less than two-fifths of the population in 1993, a relative increase of over 60%.

FDA has also conducted a Total Diet Study for over 30 years to track levels of contaminants, pesticides, and some nutrients in the food supply. This study documented a dramatic decrease in the levels of lead in canned foods after the elimination of the use of lead soldered cans.

In conclusion, let me just say that our food safety efforts to date have taught us many lessons. One of the most important is that FDA cannot solve this problem on its own. In addition to public/private partnerships, we must work together with other federal agencies, as well as important counterparts in the states, to accomplish our goal of a truly coordinated and effective food safety net based in sound science.

In our efforts, we must remember our public health responsibility. Our standard for food safety in this country must remain a high one. The public demands and deserves it. The science is developing to allow it. FDA, as well as the rest of the Department, must keep pace or we have failed to meet our public duty.

Although we cannot anticipate every food safety problem before it happens, we must make sure that we have a strong science-based food safety system in place that can minimize the harm to public health. By enhancing the science that underpins all of our decision-making in the food safety arena, as well as the rest of the Agency, we are helping to ensure the level of public health protection that consumers expect and deserve.

Thank you very much.