September 20, 2000
INTRODUCTION
Good morning, Mr. Chairman and Members of the Committee. I am Joseph A. Levitt, Director of the Center for Food Safety and Applied Nutrition in the Food and Drug Administration (FDA or Agency). Thank you for this opportunity to discuss how our food safety system should address microbial contamination. As you know, food safety has been a top priority for this Administration. I am pleased to be here today representing my FDA colleagues at our Office of Regulatory Affairs, Center for Veterinary Medicine (CVM), and National Center for Toxicological Research, and to be here with my colleagues from the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture (USDA).
It is especially appropriate that you are holding this hearing now as September is National Food Safety Education Month. This year's theme is as follows: Be Smart. Keep Foods Apart. Don't Cross Contaminate. The goals of the Month are to reduce microbial contamination and prevent foodborne illness by reinforcing food safety education and training among restaurant and foodservice workers and by educating the public on how to handle and prepare food safely at home. This year's theme reinforces the simple messages of washing hands, cutting boards, utensils, and dishes with hot soapy water and of keeping raw meats, poultry, seafood, and eggs separate from prepared or ready-to-eat foods.
The key methods for addressing microbial contamination and preventing foodborne illness are through surveillance, education, research, risk assessment, outbreak containment, and improved inspections and compliance. The Federal food agencies, in cooperation with our State and local government partners and with private partners, have been working vigorously and successfully on all these fronts. I will describe some of FDA's activities in these areas below.
THE PROBLEM
CDC has estimated that foodborne diseases cause approximately 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths in the United States (U.S.) each year. There are many challenges that food safety agencies face in trying to reduce those numbers. People are eating a greater variety of foods, particularly fresh fruits and vegetables. As many of these foods are becoming available all year round, safety concerns associated with transportation and refrigeration arise. The rising amount of imported foods increases dramatically the number of potential sources of food contamination. 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. As more food workers become involved in preparing our meals, the opportunity for disease-causing errors also increases. This problem is especially important for persons at greatest risk who eat foods prepared in hospitals, nursing homes, and daycare centers. Indeed, persons at highest risk for foodborne illness -- children, the elderly, pregnant women, and immuno-compromised persons -- now comprise nearly a quarter of the population.
The most important change, however, is the emergence of new foodborne pathogens and the ability of existing pathogens to overcome traditional food safety barriers such as temperature and acidity. We are aware of more than five times the number of foodborne pathogens now than we were in 1942. Many of these pathogens can be deadly, especially to those at highest risk. A strong scientific foundation is critical to meeting these challenges and continuing to ensure the safety of the food supply.
THE FOOD SAFETY INITIATIVE
While there are many challenges, there are also many successes. The American food supply continues to be among the safest in the world. To reduce the incidence of foodborne illness due to microbial contamination to the greatest extent possible, President Clinton launched the Food Safety Initiative (FSI) three years ago. Thanks to the budgetary support provided by Congress, this multi-agency effort has successfully built a strong foundation for a state-of-the-art, science-based food safety system and has promoted partnering among the key Federal agencies, States, academia, industry, and consumers. This foundation constitutes the main building blocks of an effective food safety system that will drive future progress for years to come. These building blocks are the surveillance systems that have been put in place -- FoodNet and PulseNet through CDC and the National Antimicrobial Resistance Monitoring System (NARMS)-- and preventive controls such as Hazard Analysis and Critical Control Point (HACCP) systems.
In just three years, FSI has resulted in tremendous achievements. The risk of foodborne illness and death related to microbial contamination of both domestic and imported foods has decreased dramatically for a number of pathogens. CDC published data this March that reflect a 20 percent decrease from 1997 to 1999 in illness due to the most common bacterial foodborne pathogens. Foodborne outbreaks have been contained more quickly, thus preventing illness. Research conducted with FSI funding has led to significant advances in our ability to detect or eliminate pathogens. As noted, numerous interagency and Federal/State partnerships have been formed to more efficiently utilize our collective resources. I have provided information about some of these partnerships in an appendix to this statement. These partnerships include: the Joint Institute for Food Safety Research (JIFSR), the Foodborne Outbreak Response Coordinating Group (FORC-G), the Risk Assessment Consortium (RAC), the National Food Safety System, and the Partnership for Food Safety Education.
FDA'S FOOD SAFETY PROGRAM
I would like to highlight actions FDA has taken to address microbial contamination. FDA has jurisdiction over 78 percent of domestic and imported foods that are marketed in interstate commerce. As you know, the Agency regulates all food products except for meat, poultry, and egg products, which are regulated by USDA. We seek to ensure that these products are safe, nutritious, wholesome, and adequately labeled. Our jurisdiction is extensive and includes places where food is produced, processed, packaged, stored, or sold.
Prevention
If we are to make significant progress in reducing foodborne illness, prevention is the key. Prevention is a combination of better understanding of the risk and potential sources of contamination, increased training, education, and development of systematic preventive controls, including HACCP.
HACCP
An important method for reducing the risk of microbial contamination is the HACCP approach. HACCP is a systematic approach to the identification and control of the biological, chemical, and physical hazards associated with a particular food production process. There are a vast array of microbiological and chemical contaminants that have the potential to affect the safety of foods. However, for any particular food, there are only a few specific hazards that must be controlled to ensure a safe product. HACCP is a risk-based, food safety management system that helps food manufacturers determine which hazards are reasonably likely to affect their products and then to develop safety assurance programs targeted to the specific steps that must be controlled to safeguard consumers. Over the course of the past 30 years, HACCP has been adopted by numerous industry and regulatory agencies worldwide as it is a focused, flexible, verifiable, and cost effective approach. As HACCP systems place an emphasis on prevention, they significantly reduce the possibility that the end product will contain illness-causing hazards.
FDA has been applying HACCP principles for many years, beginning with the 1979 low-acid canned food regulations. FDA implemented seafood HACCP in 1997. In 1998, FDA proposed HACCP for fruit and vegetable juices. FDA has incorporated HACCP into its Food Code, a guidance document that serves as model legislation for State and territorial agencies that license and inspect food service establishments, retail food stores, and food vending operations in the U.S.
FDA's HACCP requirement for seafood went into effect in December 1997. It requires all 4,100 seafood processors, covering 150 species of fish, to implement complete HACCP systems. Beginning in 1998, our goal has been to inspect domestic seafood processors annually. Now in its third year, we are seeing across-the-board progress by the seafood industry. We have just completed our first enforcement action, and additional actions will be considered as inspectional findings are reported. We are also in the final stages of completing an evaluation of our seafood HACCP program and would be happy to share the results with the Committee upon completion.
To help ensure effective implementation of the HACCP system, FDA continues to train and assist the seafood industry. For example, FDA published the "Fish and Fishery Products Hazards and Controls Guide." The guide is being used worldwide, both by industry and by foreign regulatory authorities, and is becoming an international standard. The training requirements in our regulations were the catalyst for the creation of the Seafood HACCP Alliance to provide low-cost, uniform training to industry on seafood hazards and controls and the application of HACCP.
Fresh Fruits and Vegetables
In 1998, FDA issued a guide for growers, packers, and shippers of fresh fruits and vegetables. The "Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables" provides science-based guidance to help reduce microbiological hazards common to the growing, harvesting, washing, sorting, packing, and transporting of fruits and vegetables. This guide was produced in consultation with USDA and has been published in four languages. We have conducted numerous training sessions on the guidance for domestic and foreign government and industry officials. We also produced and distributed a video that provides an overview of the practices outlined in the guidance.
In 1998, due to increasing numbers of foodborne illness outbreaks associated with unprocessed juices, FDA published a proposed rule that would require processors and importers to apply HACCP principles to ensure the safe and sanitary processing of fruit and vegetable juices. FDA believes the most effective way to ensure the safety of juice products is to implement a system of preventive controls based on HACCP principles. The Agency is currently in the process of finalizing this regulation.
Pending finalization of the HACCP requirement, FDA implemented a warning statement requirement on unprocessed juices as an interim measure. The purpose of the warning statement is to advise vulnerable persons that the unprocessed juice may cause serious illness. The warning statement allows at-risk persons to avoid potentially dangerous products.
Last year, in response to several foodborne illness outbreaks associated with sprouts, FDA issued a warning to consumers of the potential hazards associated with eating raw sprouts and issued guidance documents for the sprouts industry. These documents, "Reducing Microbial Food Safety Hazards for Sprouted Seeds" and "Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production" advise sprout growers and seed suppliers of the steps they should take to reduce microbial contamination.
In addition to issuing the guidance documents, FDA and the California Department of Health Services produced and are distributing an educational video on good agricultural and manufacturing practices for sprout producers. To assess the extent to which the sprout industry is following the recommended practices, we issued a special assignment this year to inspect 150 sprout producers. FDA is also working with academia and the sprout industry on research to identify techniques to prevent contamination.
Egg Safety
In coordination with USDA, FDA is implementing an Egg Safety Action Plan to reduce the incidence of Salmonella enteritidis (SE) illnesses. While eggs are an important source of protein in the diet, an estimated 1 in 20,000 eggs in the U.S. contains the SE bacteria and can cause illness if eaten raw or not thoroughly cooked. The Egg Safety Action Plan is a comprehensive nationwide strategy to address this important food safety and public health concern.
The President has set a goal of reducing SE illnesses associated with eggs by 50 percent by the year 2005. We have been working closely with our Federal partners, with Congress, the industry, and consumer organizations to develop a workable plan to achieve this goal. In addition, FDA will establish final regulatory standards on temperature storage and egg safety labeling this year.
Domestic Inspections
Domestically, we are expanding inspections of establishments that produce food that is at high risk of microbiological contamination or high risk of causing severe disease. High-risk foods include infant formula, ready-to-eat foods, heat-and-serve products, seafood, low-acid canned foods and acidified foods. Our goal is to conduct annual inspections of the approximately 6,250 high-risk facilities by 2001. We are also re-evaluating our establishment inventory to be sure we have identified all the firms that appropriately fit within the definition of high risk.
Imports
To carry out the President's initiative to improve the safety of imported food, we have been working closely with our colleagues at the U.S. Customs Service. To prevent problem importers who have evaded our laws in the past from moving unsafe food into U.S. markets, we are developing guidance for field personnel to ensure that food offered for import by problem importers will be held in secure storage until FDA has reviewed and released the shipment. We are also developing guidance for field personnel on procedures for requiring the destruction of food that poses a significant health risk. FDA plans to issue a proposed rule this year to require the marking of refused food shipments to prevent attempts at re-importation.
In addition, FDA is completing a 1,000 sample survey of imported fresh produce that was initiated last year. The purpose of the survey is to determine the incidence of microbial contamination of these commodities. This type of surveillance activity will help the Agency protect consumers from foodborne illness and will provide baseline information that will help us focus our research and regulatory efforts on the foods that pose the greatest risk. We are conducting a similar survey of domestic produce.
In addition to increased surveillance and tighter controls at the border, we have concluded we need to expand our foreign presence to address food safety at its source. For example, we have begun a project with Mexico to start a monitoring system for antimicrobial resistance in Salmonella. To start, Mexico will collect isolates from children in daycare settings to characterize the carriage rates of Salmonella in children and identify the antimicrobial resistance patterns of the isolates. This collaboration between the U.S. and Mexico represents the first international human and animal monitoring system for foodborne antimicrobial drug susceptibility surveillance of the Americas. Also, we are assessing foreign controls over food products exported to the U.S. and are providing technical assistance to foreign countries. We are increasing our number of foreign inspections and are focusing our inspections on food establishments that produce food products that are at high risk for microbial contamination.
Research and Risk Assessment
Research and risk assessment are critical to ensuring the strong scientific basis necessary for our regulatory programs to be effective. I would like to mention just a few examples of some recent advances in research regarding microbial contamination. For example, we developed a new technique to detect harmful Escherichia coli O157: H7 in food within thirty minutes, compared to the 24 to 48 hours required by conventional techniques. FDA has developed a rapid and reliable method to detect low levels of Norwalk virus in shellfish. We developed an improved polymerase chain reaction method for the detection of Cyclospora in produce. Use of this method provided the first isolation of this pathogen from a food product associated with human illness.
FDA has also established an extramural grant program to support research in the areas of produce safety, egg safety, antimicrobial resistance, methods to detect foodborne viruses in foods, and for research on food service, transportation, and consumer practices. So far, FDA's CFSAN has funded eight new research and risk assessment grants totaling two million dollars. CFSAN is currently reviewing proposals and anticipates awarding six to seven new grants totaling $900,000 this year. FDA's CVM has awarded approximately one million dollars in grants per year over the last three years for antimicrobial resistance research.
FDA's involvement with two academia/industry/government research consortia, the National Center for Food Safety and Technology (NCFST or the Moffett Center) and the Joint Institute for Food Safety and Applied Nutrition, have been instrumental in developing solutions to new food safety problems. For example, collaborative research projects have led to new techniques to help small businesses improve the safety of sprouts and apple cider.
One of the partnering efforts that has played a critical role in FDA's food safety efforts is the NCFST. The NCFST, which is located at the Illinois Institute of Technology in Chicago, is a consortium of FDA, academic members, and 70 industry members. The core of the NCFST mission is the identification of emerging food safety problems and the development of techniques to prevent the problems from becoming public health crises. Collaborative research spans the breadth of technologies from sophisticated new processing and packaging methods to the development of effective techniques for use by small processors.
Most recently, FDA scientists worked with representatives of the sprout industry and academia to develop techniques to improve the safety of sprouts and to monitor these products for the presence of pathogens. The results of these studies were incorporated in FDA's guidance to the sprout industry. NCFST scientists worked with the State of California, University of California, and USDA in a small cider mill to evaluate preventive technologies such as washing and sanitizing fruit and using ultraviolet (UV) light to destroy pathogens. This research was used in the proposed juice HACCP regulation and in the evaluation of UV processing.
Another important collaborative effort is the NARMS. This is a surveillance program by FDA, CDC, and USDA that monitors when foodborne bacteria that can cause disease in humans begin to develop resistance to antimicrobials used in food animals. State and local health departments also participate by providing samples for analysis. Increasing antibiotic resistance and loss of the effectiveness of antimicrobials is an emerging public health threat worldwide. NARMS is proving to be a valuable tool in helping to identify the emergence of resistant pathogens and to develop effective intervention strategies.
One of the payoffs from both government and industry research is the development of new technologies to reduce microbial contamination. To ensure new technologies are available and to provide an incentive, FDA implemented an expedited review mechanism to give priority to the review of petitions for additives intended to reduce foodborne pathogens. As of September 2000, FDA has reviewed and issued final rules for seven such agents, which range from chemical agents to sources of irradiation. There are 12 additional expedited review food additive petitions in process.
Microbiological food safety risk assessment is one of the powerful new tools that is becoming available for evaluating the public health impact of microbial contamination of food and the potential impact of control programs. The Food Safety Initiative has been instrumental in allowing FDA and our Federal partners to become world leaders in the application of these new techniques to food safety concerns. FDA is in the process of finalizing risk assessments of Listeria monocytogenesand Vibrio parahaemolyticus. We are also conducting a risk assessment of the emergence of antimicrobial resistance in Campylobacter. Integral to these rapid advances in microbial risk assessment has been the high degree of cooperation and mutual support among Federal agencies. Through the RAC initially established by FDA, 14 Federal food safety agencies have been working together to advance our capabilities to conduct risk assessments.
Education
The issuance of guidance documents is an important way to assist industry in preventing microbial contamination. Of equal importance are education programs for consumers and foodservice workers on safe methods for storing and preparing foods. FDA is a member of the Partnership for Food Safety Education, which includes representatives from several government agencies as well as from industry and consumer organizations. The Partnership was formed to develop and disseminate effective educational messages for a variety of audiences: consumers, food producers, food preparers, food transportation workers, and public health professionals.
The "Fight Bac" campaign created through the Partnership educates consumers on four simple principles (clean, chill, separate, and cook to proper temperatures) to prevent contamination during preparation of food in the home. Now in its third year, the "Fight Bac" campaign has greatly increased its range and its impact. Last year, major corporations began to include the "Bac" character and the food safety messages in their national consumer education initiatives. For example, McDonald's distributed some 12 million family safety brochures, which opened with the "Fight Bac" message. Pfizer incorporated the "Fight Bac" video and brochure in their traveling teaching exhibit, "Microbes: Invisible Enemies. . . Amazing Allies." This exhibit opened at the Smithsonian last spring and will be shown at museums around the country over the next two years.
These education programs are making a difference in consumer' food safety behavior. Consumer research data show a 39 percent reduction in the consumption of raw protein foods such as oysters and eggs. The data show nearly a 40 percent increase in safe practices such as washing their hands, utensils, and cutting boards when handling raw fish or eggs. And, perhaps more importantly, the data indicate an increase of 50 percent in consumer knowledge about how microbial pathogens contaminate food products and about how to prevent that from happening.
Outbreak Response
Responsibility for responding to foodborne disease outbreaks is shared among local, State, and Federal governments. Local and State governments are often the first to detect the occurrence of an outbreak and initiate an investigation if appropriate. It is important to note that many episodes of foodborne illness are addressed exclusively at the local level. The States play a major role in outbreak surveillance and investigation. The role of the Federal agencies in large or complex multi-state outbreaks is to assist the State and local agencies in preventing additional cases of illness from occurring. FDA's objectives in outbreak investigation and response are verification of the association with a regulated product, identification of the source of the product and the extent of distribution, prevention of any further exposure to the contaminated product, and initiation of regulatory action if indicated. In addition, a critical role of outbreak investigation is to identify contributing factors so similar problems can be avoided in the future.
To improve outbreak detection and response by the Agency and our State and local partners, FDA has developed several training courses. FDA's satellite courses on food microbiology, foodborne disease epidemiology, and traceback in outbreak investigations, have been attended by thousands of government and industry representatives from around the country. FDA has also conducted presentations on how to conduct tracebacks to determine the source of an outbreak at numerous conferences in the U.S., Mexico, and Latin America.
CONCLUSION
Mr. Chairman, through the efforts of the government and private partners, much progress has been made in the effort to reduce microbial contamination of foods. I have briefly described some of the achievements and partnerships that have resulted under the Food Safety Initiative. The work done so far has created a strong foundation but is just the beginning.
In 1998, the President created the Council on Food Safety to strengthen and focus our efforts to coordinate food safety policy and resources. FDA, CDC, Environmental Protection Agency, and USDA have been working together and with State and local governments, academia, industry, and consumer organizations to develop a strategic plan to address actions necessary to ensure the safety of the food and water Americans consume. The plan, which will be released soon, provides a long-range method to set priorities, improve coordination and efficiency, identify gaps in the current system and ways to fill the gaps, enhance and strengthen prevention and intervention strategies, and identify measures to demonstrate progress.
Within that broader context, we at FDA stand ready to continue our science-based regulatory program to systematically reduce the incidence of foodborne illness for American consumers.
Thank you again for this opportunity to discuss this important public health issue. I would be happy to answer any questions.
Appendix
USDA, FDA, and EPA joined together to create the RAC. RAC has established an intramural research program to provide data for use in microbial risk assessment modeling. Risk assessment is a valuable tool for evaluating the public health impact of microbial contamination of food.
The FORC-G is a partnership of Federal, State, and local agencies that was formed to provide a more efficient response to foodborne illness outbreaks and to prepare for emerging threats to the food supply. FORC-G partners have drafted a document, "Foodborne Outbreak Response and Coordination," that is intended to guide Federal agencies and State or local officials on procedures for coordinating multi-state outbreaks.
The increased coordination among the FORC-G partners has resulted in quicker containment of outbreaks, thus preventing further illnesses. For example, effective investigation and coordination among local, State, and Federal officials resulted in a recall of contaminated orange juice in several western states within a few days of the first indication that illnesses were occurring.
At the President's direction, USDA and the Department of Health and Human Services (DHHS) have created the Joint Institute for Food Safety Research (JIFSR). This institute coordinates planning and priority setting for food safety research among the two Departments, other government agencies, and the private sector. This coordination optimizes food safety research investments, channels Federal resources to research priorities, and avoids research redundancies. JIFSR also fosters the effective translation of research results into practice along the farm-to-table continuum.
FDA is leading an effort with Federal, State, and local officials from health, agricultural, and environmental agencies, to improve coordination and communication at all levels of government, particularly for foodborne illness outbreaks. Known as the National Food Safety System, this project will lead to more effective implementation of existing food safety programs. One of the joint projects currently underway is one to develop standards for testing methods and for the exchange of data regarding Escherichia coli O157: H7. A contract has been awarded for a pilot project to demonstrate the feasibility of food safety laboratories securely sharing data using Internet technology.
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