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Statement on Food Safety by Jane Henney, M.D.
Commissioner, Food and Drug Administration
U.S. Department of Health and Human Services

Mr. Chairman, senators, ladies and gentlemen, I appeared before the Senate last year to ask you to consider me for a position in public service. Today I am honored to address you as the Commissioner of the Food and Drug Administration. I thank you and your colleagues who saw fit to entrust me with this office.

During that process, I promised the Senate that I would make food safety a high priority if I was confirmed as FDA Commissioner. It is my privilege today to begin to deliver on that promise by presenting the highlights of the Agency's food safety accomplishments for fiscal 1998, the plans for fiscal year 1999, and the expectations for food safety as reflected in the Administration's proposed budget for fiscal year 2000.

FOOD SAFETY PROBLEM

The Food and Drug Administration began as a science-based consumer protection agency nearly 100 years ago with a food safety issue. A chemist in the Bureau of Chemistry at the Department of Agriculture, Harvey Wiley, was concerned that chemical additives used as preservatives in a time when refrigeration was in its infancy were a danger to the public health. Called the "crusading chemist," his experiments on additives such as borax and formaldehyde found his original concerns to be valid and culminated in passage of the Pure Food and Drugs Act in 1906. Harvey Wiley, as you may know, was ultimately designated the first Commissioner of the Food and Drug Administration.

The food safety challenges that face FDA and other food safety agencies today may be different that those that Harvey Wiley confronted but they are no less challenging or compelling.

What people eat has changed. We are no longer a nation of meat and potato eaters only, but a people who are eating a greater variety of foods, particularly seafood and fresh fruit and vegetables. This is great for our nutrition but offers greater food safety challenges. When consumers are demanding these foods year round, safety issues surrounding transportation and refrigeration become an increasing problem. And as trade barriers break down, new challenges for ensuring the safety of the imported food arise.

Where people eat has changed. People are eating more of their meals away from home. In fact, fifty cents of every food dollar is spent on food prepared outside the home. This food is purchased not only from grocery stores and restaurants, but also is consumed in institutional settings such as hospitals, nursing homes and day care centers. The result is that as more food workers become involved in preparing our meals, both the chances for disease-producing errors and the regulatory responsibility of assuring food safety increases.

Who's eating is also changing. Nearly a quarter of the population is at higher risk for foodborne illness. This includes pregnant women, children, the elderly, and the immunocompromised. The size of the vulnerable population is growing, with aging babyboomers and increased longevity.

All are important-- different foods, more foods prepared outside the home, and increased vulnerable populations--but there's another important element in our changing world, the emergence of many new foodborne pathogens. We are aware of more than five times the number of foodborne pathogens in 1999 than we were in 1942. Many of these pathogens can be deadly, especially for people at highest risk.

As a result, outbreaks of foodborne illness are now all too prevalent. They happen frequently, in all regions of the country, and in every type of food. And we are identifying more and more outbreaks associated with FDA regulated products.

Therefore, as the world of food changes, we must be sure that the food safety system changes along with it, identifying new solutions to today's problems.

THE PRESIDENT'S FOOD SAFETY INITIATIVE

Recognizing the increasing risks to the food safety system, on January 25, 1997, the President announced a Food Safety Initiative to reduce the incidence of foodborne illness to the greatest extent possible. Four months later, recommendations for the President were delivered in a report entitled "Food Safety: From Farm to Table.". This report outlined the steps the federal government would take in the short and long term to achieve that goal. The Food Safety Initiative was enhanced by President Clinton on October 2, 1998 to provide special emphasis on ensuring the safety of imported and domestic fruits and vegetables. FDA has a central role in the Administration's efforts.

A Strong Science Base Is Critical

As critical as it was in Harvey Wiley's time, it is just as critical today to the food safety system that it be grounded in a strong scientific foundation. Equally important is that we have a strong, scientifically skilled workforce to conduct the President's Food Safety Initiative. We rely on and therefore must support the scientific work of those entrusted with carrying out FSI responsibilities at every step along the farm to table continuum. We must invest in enhancing and maintaining scientific excellence to ensure that we have the best possible data for decision-making at both the policy and implementation level.

A recent outbreak of Salmonella Agona in breakfast cereal illustrates the importance of a scientific basis to public health. In the spring of 1998, 20 states reported an increase in Salmonella Agona infections. There were 409 cases of illnesses reported. Over 102 people were hospitalized and one person died. Through molecular fingerprinting (DNA) technology we were able to link the bacteria from the food and from the patients. The bacteria was subsequently traced to one manufacturer who produced the cereal under a variety of labels. Ultimately 2 million pounds of Toasted Oat cereal was recalled.

Already, FDA has made the following scientific contributions under the FSI:

Prevention Programs

• Developed a science-based hazard analysis critical control point (HACCP) regulatory program for seafood to prevent foodborne illness. This includes extensive training for our inspectors so they provide a knowledgeable oversight role.
  
  
• Developed technology to eliminate or inactivate microbial contaminates by the use of high hydrostatic pressure techniques. This technique has been shown to inactivate a number of different pathogens in packages of fluid products while retaining the products' sensory characteristics, and provides an alternative pastuerizing technology in some situations for which thermal pasteurization and irradiation are less desirable.
  
  
• Initiated research to prevent contamination of unpasteurized juice by assessing the effectiveness of different antimicrobial technologies in an actual cider mill.
  
  
• Initiated research on safe sprout production at sprout production facilities constructed at the National Center for Food Safety and Technology (Moffett Center) in Chicago, operated in partnership with Illinois Institute of Technology. This research will evaluate the effectiveness of intervention strategies such as sanitizing agents to prevent contamination of sprouts with pathogens.

Surveillance and Outbreak Response

• Developed a comprehensive, coordinated national foodborne illness outbreak response system in collaboration with CDC and USDA among federal, state and local agencies.
  
  
• The National Antimicrobial Resistance Monitoring System (NARMS) has allowed us to increase our ability to detect emerging pathogens and identify relationships between animal and human foodborne isolates. NARMS isolates provide a pool of organisms to research for rapid tests for identification of foodborne pathogens for salmonella type.

Detection Methods

• Developed through a collaboration between federal, state, and local agencies, an improved technique to detect directly and quantify harmful Escherichia coli within 30 minutes, compared to 24 to 48 hours using conventional techniques. This pathogen was responsible for outbreaks of food-related illness in young children after they drank unpasteurized apple juice.
  
  
• Developed a rapid, sensitive and reliable method capable of detecting low levels of Norwalk viruses in contaminated shellfish.

I would endeavor to have a strong science base throughout the Food Safety Initiative.

Federal Partnerships

As you can see, many of these programs have joined FDA and its Federal partners in successful collaboration to protect the public health. Further examples include: development of an interagency Risk Assessment Consortium to coordinate priorities of risk-assessment research, such as the Listeria risk assessment currently underway that involves both USDA and FDA regulated products; the signing of a memorandum of understanding to create the Foodborne Outbreak Response Coordinating Group (FORC-G) to enhance coordination of resources and expertise during an outbreak and prepare for new and emerging threats to the food supply; collaboration between FDA and USDA with CDC on funding, protocol development, and priority setting for FoodNet; multiagency collaborations on the National Advisory Committee on Microbiological Criteria for Foods to achieve food safety advice of the highest scientific standards for all federal agencies involved in food safety; and the development of a Joint Institute for Food Safety Research (JIFSR) which allows for the joint funding and coordination of priority research projects.

Federal-State Partnerships

An integrated federal-state partnership makes sense as well from an effective use of resources perspective and provides the greatest level of public health protection. I strongly support such partnerships. For this approach to work, we need: strong federal standards; training and certification for all inspectors; shared databases; federal oversight of state activities; and effective enforcement and surveillance. The need for increased inspection coverage is sufficiently large that we will need an increased federal inspection force, and also need more qualified state and local counterparts.

Our work and cooperation with the States is central to our success in these endeavors. Currently, FDA is leading an effort to integrate federal, state and local food safety systems for FDA-regulated products. This work began in September 1998 in Kansas City with an FDA-hosted meeting of food safety and agriculture officials from all 50 states, Puerto Rico, and the District of Columbia, epidemiologists from state and local health departments, and colleagues from CDC and USDA. The focus of the meeting was to find a way for local, state, and federal food safety and public health agencies to share resources and work together to make the U.S. food supply safer than ever. Discussions centered around joint planning opportunities for increased inspections, linking data and communication systems, and improving government response to outbreaks.

Tasks of integrating the nation's food safety systems has now been divided into working groups of local, state and federal health officials. The reports from these working groups will be made available for public comment later this spring. We estimate that it will take 5-10 years to build this national system and it will require resources to enhance state and local capabilities.

FY 1998 ACHIEVEMENTS

In FY 1998, FDA received its first additional appropriation of $24 million under the initiative. The Agency used these funds to begin to set the foundation for creating a state-of-the-art science-based food safety system.

This system focuses on combating foodborne illness on two major strategic fronts. The first is the development of prevention strategies, programs that will keep bacteria out of the food, throughout the food chain, from farm to table. These prevention programs are supported by education and verification ­by educating producers, processors, food preparers, and consumers in how to use prevention techniques correctly, and by verifying, through inspections at business establishments, that the prevention techniques are, indeed, being applied properly. The second front is the early detection and containment of foodborne hazards during an outbreak. In addition to limiting the extent of the outbreak, we must seek the cause and provide a "feedback loop" of information that helps strengthen our prevention programs.

Virtually all the goals promised for the first year in the May 1997 Farm-to-Table Report were achieved. I would like to highlight some of them for you.

Prevention, Education, and Verification

Prevention is the key to reducing foodborne illness. A major focus of our prevention strategy for food safety was the implementation of a HACCP (Hazard Analysis Critical Control Points) program for seafood. HACCP is a science-based system in which a food producer identifies the hazards associated with its particular product, and then puts appropriate controls in place to prevent, reduce, or eliminate the hazard. Through a combination of FDA inspection and state contracts, all domestic seafood processors and importers were inspected to verify implementation of HACCP by the end of calendar year 1998.

We have expanded our prevention strategies by proposing HACCP regulations for juice. We also are working with small juice and cider producers to further our juice safety goals. And, together with USDA, we have launched a multi-pronged initiative to prevent illness caused by Salmonella contamination of raw eggs.

We have worked on prevention strategies involving produce as well. FDA and USDA held a series of public meetings with the agricultural community and conducted site visits to growing and packing areas to elicit detailed information on common problems involved in the production of safe produce. These meetings were held as background for the development of a guidance document for growers, packers and shippers of fresh fruits and vegetables, which provides information on agricultural and management practices that may enhance the safety of fresh produce. We were very pleased with the way the final guidance was accepted by industry. In fact, the final guidance won the endorsement of United Fresh Fruits and Vegetable Association, a large national trade organization.

In recent months, we approved the use of chlorine dioxide as an antimicrobial agent for use in produce processing, and published a policy under which we will expedite the review of food additives that would make predictable contributions to preventing or reducing pathogen contamination of foods.

Food safety education campaigns, soundly based in science, can reach large numbers of commercial and home food preparers with information on safe food handling practices that can prevent food contamination and reduce pathogen growth. Food safety education is another part of FDA's strategy to protect consumers from foodborne hazards. These activities, often sponsored in conjunction with other federal agencies, states and professional associations, provide a cost-effective means to preventing processing, preparation, handling and storage practices that could cause food to become contaminated with dangerous levels of microorganisms or other substances that could cause illnesses.

Education activities in FY 1998 included work in conjunction with USDA and CDC with the Partnership for Food Safety Education's "FIGHT BAC!" campaign. Extensive educational efforts were undertaken through the media and through community-based education programs for food handlers both in retail settings and in the home. FDA field offices across the country also launched educational efforts to help average citizens prevent food-related illnesses.

An education program was also started for health professionals. FDA and CDC signed an agreement with the American Medical Association to develop a program to educate physicians and their patients on foodborne disease.

Early Detection and Containment of Hazards

Responding to emerging pathogens in the food supply quickly and effectively is essential to preventing widespread illness. FDA scientists in the Center for Veterinary Medicine and the National Center for Toxicological Research are adapting for use in the United States an assay for detecting bovine DNA in feed to protect us against occurrence of imported "Mad Cow" disease in the United States .

We are convinced that this focus on detection and containment has had a significant, beneficial public health impact. For example, information gathered through field investigations supported by the Administration's Food Safety Initiative linked Guatemalan raspberries to cyclosporiasis; outbreaks in 1996 and 1997 caused about 2,500 cases of cyclosporiasis in this country. This past year, no Guatemalan raspberries were imported to the U.S., and no cases of cyclosporiasis were linked to raspberries. In contrast, Canada imported Guatemalan raspberries last summer and continued to suffer raspberry-associated outbreaks of Cyclospora infections. We estimate that our preventive actions avoided 1,200-1,500 Cyclospora infections for the American public and saved $2.8 to $3.5 million in health-care costs. We are continuing to work with Guatemala to permit future importation of raspberries without importing foodborne hazards.

I would also like to raise with you a food safety issue that is likely to have major public health implications: antibiotic resistance. We know that antimicrobial resistance (the resistance of disease-causing bacteria to drug treatment) can develop in some organisms when food animals are treated with certain drugs. We also know that this resistant pathogen can be transferred on food and infect humans. This drug resistant infection may cause disease in people consuming the animal derived food product and result in infections that are resistant to treatment potentially increasing the costs and risks associated with the infection. Increasing antibiotic resistance and loss of the effectiveness of antimicrobials is an emerging public health threat world-wide. We are taking several actions to combat this threat. FDA and USDA have established a nationwide surveillance system to identify and track developing antimicrobial drug resistance in food-producing animals. FDA is also collaborating with CDC and USDA to study resistance by tracking the emergence of resistant pathogens and developing scientifically sound mitigation and intervention strategies to prevent the development of resistance. FDA also plans to conduct research into the mechanisms of resistance, their dissemination and the risk factors associated with resistant human infections. We must continue to develop our scientific understanding of antibiotic resistance and take action to ensure that effective drugs remain available to treat infections in humans and animals.

I have only touched on the many FDA accomplishments for Fiscal Year 1998. A more complete listing is available in a First Year Report, FDA's Accomplishments on the President's Food Safety Initiative, which I will submit for the record.

FY 1999 PLANS

Added funds for FY 1999 allow FDA to focus on imports as well as on domestic and international education and outreach on the good agricultural practices guidance. In FY 99 we will also give further emphasis to seafood HACCP and antibiotic resistance monitoring.

Imports

On the premise that the safety of imported foods can be better enhanced where the foods are produced rather than at the U.S. border, FDA has undertaken not only to strengthen our border surveillance activities, but also to design new programs to prevent contamination in countries that export to the U.S. We are assessing foreign controls over food products exported to the U.S. and are providing technical assistance to foreign countries. We also will conduct foreign inspections of food establishments that produce food products at high risk for microbial contamination and conventional surveillance of imported food products at our borders will be increased. When foodborne illness outbreaks associated with imported foods occur, we will conduct follow up investigations in the exporting countries. I will submit for the record a more detailed plan of our FY 99 food safety import plan.

Last year, as you are aware, the Administration put forward a bill that would have expanded FDA's authority over imported foods (S.1707/H.R.3052). That bill raised many questions and concerns in Congress and as you know, ultimately did not succeed. The President recently reaffirmed his commitment to providing FDA with enhanced authority over imported foods. I want to assure you that the Agency heard and understands the questions and concerns, and I want to work with you to find the right solution to provide FDA with the tools necessary to improve the safety of imported foods.

Good Agricultural Practices Guidance

FDA will work with USDA to provide information and education on the Good Agricultural Practices guidance developed in 1998. Fresh fruit and vegetable growers may use this guidance to reduce the risk that their products will become contaminated with pathogens. Technical assistance and education programs are now under development for the domestic and international produce industry to improve the safety of fresh produce available to U.S. consumers.

Seafood HACCP

FDA continues to implement seafood HACCP during FY 1999 by conducting the second year of annual inspections of domestic seafood processors. The first year's inspections focused on providing processors with clear feedback on the status of their new HACCP systems. They were designed to be educational as long as a critical public health hazard was not found. In the last year, FDA found a range of problems with HACCP implementation that needed to be addressed by seafood facilities. Our goal is to see that HACCP is being more fully implemented in a larger proportion of the industry by the end of calendar year 1999. I will submit for the record our plan for strengthening the safety of seafood in this, our second year, of seafood HACCP implementation.

Antimicrobial Resistance

In order to assure detection of emerging resistance trends in pathogenic bacteria, we are planning to expand our program to increase the information in the National Antimicrobial Resistance Monitoring System. The collection and analysis of this data will improve our ability to detect changes in antimicrobial resistance patterns and identify trends at the local level. The identification of trends helps us target our research. For example, we are now looking at how the use of multiple drugs and multiple exposure to the drugs affect the development of antimicrobial resistance. We are also looking at how drugs are administered to determine if the route of administration affects the development of antimicrobial resistance.

FY 2000 BUDGET REQUEST

As a result of funding provided in FY 1998 and FY 1999, a solid, science-based infrastructure is being developed to improve food safety and reduce the risk of foodborne illness, for both domestic and imported foods.

The President's FY 2000 budget request for FSI includes a $30 million increase for FDA that further builds this science base and expands capabilities in surveillance and containment of foodborne outbreaks. The additional resources will be targeted to develop further a nationally integrated food safety system, and provide greater emphasis on the control of foodborne hazards in the post-harvest phase of the farm-to-table continuum.

Expand Inspections

In FY 2000 we will focus on increasing our domestic inspection coverage. Inspection and compliance efforts will be expanded during FY 2000 with additional emphasis on the frequency of inspection of domestic firms producing food that is at high risk of microbiological contamination or high risk of causing severe disease. There are a total of 6250 such firms. Inspection of these firms will increase to a schedule of once per year by 2001. By "high risk"we mean, in addition to seafood: infant formula, certain ready-to-eat foods that are not processed or only minimally processed ­ e.g., by heating, freezing, washing -- before consumption; heat and serve products; and low-acid canned foods and acidified foods. FY 2000 resources would be applied both to increasing Federal FDA inspections as well as increasing inspections by our state and local partners according to federal standards. We also will more than double the number of foreign inspections we conduct for these same types of products.

Enhance Surveillance and Investigation to Improve Outbreak Response

Funding in FY 1998 and FY 1999 expanded public health surveillance efforts, resulting in improved outbreak detection. Since it is anticipated that there will be an increase in the number of outbreaks detected, FDA must continue expansion of foodborne outbreak response and traceback activities. To that end, we need a rapid response capability directed to foodborne outbreaks. We need to increase the links between CDC surveillance and epidemiology and FDA response team, as well as between FDA laboratories and CDC's PulseNet pathogen subtyping system. This rapid response team will enable early containment of hazards, and will provide a feedback tool on new causes of outbreaks to promote development of new preventive controls.

Food Safety at the Retail Level

An additional focus for FY 2000 will be on strengthening Federal and State partnerships regarding retail food safety. I mentioned at the beginning of my statement that American consumers are increasingly eating food prepared outside their homes. That factor in itself may not seem significant. CDC data, however, clearly demonstrate the substantial occurrence of foodborne disease outbreaks in retail settings. FDA will work with its state partners to lower that risk. Reducing outbreaks associated with food service operations is a significant challenge. To appreciate the magnitude of the problem, I should point out that there are approximately 750,000 restaurants and 37,000 institutional food service operations in the U.S.

FDA will work with states and the food industry to develop and implement food production and preventive control systems. In particular, FDA will encourage the states to adopt the 1999 Food Code, a model code developed by FDA in collaboration with state officials. FDA will provide training to state and local officials as well as education to the private sector regarding safe food handling practices.

Accelerate Food Safety Research

Research will be conducted to expand methods development and prevention technology research during FY 2000. FDA will collaborate with other agencies and the private sector to translate preventive technologies and techniques into appropriate versions for use by small industry and consumers. FDA, along with CDC and USDA, will expand mechanisms to transfer technologies to States, small and large industry, foreign governments, consumers, and others.

The National Center for Food Safety and Technology (Moffett Center) and the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) are key components of FDA's efforts to achieve established food safety objectives. These partnerships with academia and industry allow for more efficient use of public and private research resources and enhance the quality of food safety and public health policy. The additional resources requested for FY 2000 will permit FDA to expand risk assessment efforts at JIFSAN and the Moffett Center to fill the critical gaps in exposure assessment of foodborne hazards. This expanded risk assessment research effort will enhance FDA's ability to characterize more rapidly and accurately the nature and size of the risk to human health associated with foodborne hazards, as well as the effects of intervention. More rapid and accurate risk assessment techniques are critical to providing consumers greater protection against potential hazards posed by foodborne pathogens. This research compliments efforts underway at CFSAN, CVM, and the National Center for Toxicological Research (NCTR).

Antimicrobial Resistance

In FY 2000, we will continue to improve and expand our National Antimicrobial Resistance Monitoring System including expanding the geographical scope and supporting international efforts to develop a global resistance database. We will conduct epidemiology studies to evaluate management, production and drug use practices in food animals to determine how such practices influence the development of antimicrobial resistance. We will get additional information from collaborative efforts with other government agencies, academic institutions, and producer groups in order to develop education material related to proper drug use. We will work with State and local authorities to develop effective educational program.

CONCLUSION

Mr. Chairman, all of us testifying todayCFDA, the U.S. Department of Agriculture and the Centers for Disease Control and PreventionCas well as other federal agencies, state and local government officials, and agriculture, industry and consumer representatives, have key roles to play in the effort to reduce the incidence of foodborne illness. This effort has been a highlight of the President's Food Safety Initiative. All the partnering agencies' and organizations' programs need a base in science and a focus on Public Health. We also need open communication between federal, state, and local governments, the industry, and consumers. Working together, we can ensure the safety of the nation's food supply.