Protecting the Nations's Food Supply

Statement of

the President's Council on Food Safety

before

the Subcommittee on Oversight of Government Management, Restructuring, and the District of Columbia
Senate Committee on Governmental Affairs

August 4, 1999

INTRODUCTION

Mr. Chairman, Members of the Subcommittee, we are pleased to be here this morning to discuss the extremely important issue of protecting our nation's food supply- an area that is a very high priority for the Administration. I am Jane E. Henney, M.D., Commissioner of Food and Drugs, Food and Drug Administration (FDA), and I am Catherine E. Woteki, Ph.D., Under Secretary for Food Safety, U.S. Department of Agriculture (USDA). We applaud your continued interest in ensuring the safety of our nation's food supply and look forward to a full discussion of the issues you are raising today. In our testimony, we will discuss the current status of our nation's food supply and the complex challenges we face, the history of the food safety system, the substantial improvements we have made - particularly over the last several years, and the next steps we are taking to continue to improve the safety of our food.

The Food Safety Challenge

While the American food supply is among the safest in the world, there are still too many Americans stricken by illness every year caused by the food they consume, and some-mostly the very young, elderly, and immune compromised - die every year as a result. The threats are numerous and varied - among them are Escherichia coli (E.coli) O157:H7 in meat and apple juice; Salmonella in eggs, on vegetables and on poultry; Vibrio in shellfish; Cyclospora and hepatitis A virus on fruit; and Cryptosporidium in drinking water.

Today's challenges with respect to the food supply are complex. Much has changed in what we eat and where we eat. Americans are eating a greater variety of foods, particularly poultry, seafood and fresh fruit and vegetables. This is beneficial to our health, but presents greater food safety challenges. More consumers demand these foods year round, making safety issues surrounding transportation and refrigeration of increasing importance. And as international trade expands, shifting regional commerce and products to a global marketplace, our role in ensuring the safety of food expands as well. Americans 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 schools, hospitals, nursing homes and day care centers. The result is that, as more people become involved in preparing our meals, the chance for disease-producing errors increase.

Our vulnerable population will be growing, with, increased longevity, and increasing numbers of immune-compromised individuals. Now nearly a quarter of the population is at higher risk for foodborne illness.

These are all important factors-different foods, more foods prepared outside the home, and increased vulnerable populations-but perhaps the most important elements in our changing world are the recognition that foodborne diseases are a substantial contributor to ill health, that these diseases are largely preventable, and that new and more virulent foodborne pathogens continue to emerge. 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 the system of food production and distribution changes, we must be sure that the food safety system changes with it. There are many difficult challenges to preventing foodborne illnesses. To meet them, we need a strong science base that addresses all the complex issues involved in continuing to improve food safety and public health.

The Origins of the Federal Food Safety System

Until the first decade of the 20th Century, the regulation of food safety was primarily the responsibility of State and local officials. The Meat Inspection Act and the Pure Food and Drugs Act were both passed by Congress in 1906, establishing the federal framework which has survived to this day. From their inception, these laws focused on different areas of the food supply, and they took different approaches to ensure food safety.

The Meat Inspection Act emerged in 1906, as a result of Congressional acknowledgment of risk after publication of Upton Sinclair's book The Jungle, which focused public attention on filthy conditions in Chicago's meatpacking plants. Infectious agents were the leading cause of human morbidity and mortality in this country, and the links between some animal diseases and human diseases, what we would now call zoonotic diseases, were known. This Act and its successors, required continuous inspection, including ante-mortem and post mortem inspection, to identify animal diseases, and prevent contamination during slaughter. It also created an inspector force, which continues to this day as the Food Safety and Inspection Service (FSIS) at USDA. Over the years FSIS was also given authority to oversee poultry and egg products via the Poultry Products Inspection Act and the Egg Products Inspection Act. Starting in 1967, the Acts provided for a shared funding and cooperative agreement system permitting States to operate meat and poultry inspection programs. Twenty-five (25) States have their own programs as of today.

The genesis of the original Pure Food and Drug Act of 1906 began with debates around substitute foods, such as margerine for butter, and the use of questionable "ingredients" or additives in foods, such as coal tar, borax, and colors. Thus, the Pure Food and Drugs Act, as originally enacted, forbade adulteration and misbranding of foods in interstate commerce, placing the initial responsibility on the food industry to produce safe and wholesome food, with the government in effect policing the industry. In addition to authority under the Federal Food, Drug, and Cosmetic (FD&C) Act (formerly the Pure Food and Drug Act), FDA has authority under the Public Health Service Act, which gives FDA two valuable additional tools: very broad authority to adopt regulations to control the spread of communicable disease when food is involved, and the ability to both provide assistance to, and accept assistance from, our state and local counterparts in the regulation of communicable disease.

THE U.S. FOOD SAFETY TEAM

Despite split jurisdictions and differing statutory responsibilities across several Federal agencies, the Administration has adopted a farm-to-table approach that looks at food safety as an integrated and interdependent system.

Under the current structure, two Federal agencies have primary statutory responsibility for assuring the safety of our food supply - FDA of the Department of Health and Humans Services (DHHS) and FSIS of USDA. FSIS has regulatory and inspection responsibility for meat, poultry, and egg products, and FDA has regulatory responsibility over the remainder of the food supply.

FDA has jurisdiction over 78 percent of domestic and imported foods that are marketed in interstate commerce. FDA seeks to ensure that these products are safe, sanitary, nutritious, wholesome, and adequately labeled. FDA has jurisdiction where food is produced, processed, packaged, stored, or sold. FDA's jurisdiction includes much more than food processing plants; it also includes approval and surveillance for new animal drugs, medicated feed, and all food additives (including coloring agents, preservatives, food packaging, sanitizers and boiler water additives) that can become part of food. FDA shares with FSIS responsibilities for egg safety. FDA has authority for shell eggs and FSIS has authority for egg products.

FSIS is charged by statute to prevent the shipment of adulterated meat products to consumers, and to oversee appropriate labeling and provision of other consumer information. FSIS also has authority to oversee poultry and egg products, via the Poultry Products Inspection Act and the Egg Products Inspection Act. The Acts also require any country wishing to ship meat, poultry or egg products to the United States to maintain an inspection program that is equivalent to the United States' inspection. FSIS inspects each meat and poultry food animal, both before and after slaughter.

The Centers for Disease Control and Prevention (CDC), in DHHS, plays a critical and unique role as a disease monitoring, investigative, and advisory agency that is separate from, but, works closely with both food regulatory agencies. CDC leads Federal efforts to gather data on foodborne illness and investigate outbreaks, and monitors the effectiveness of prevention and control efforts. Through its on-going public health efforts, CDC also plays a pivotal role building State and local health department epidemiology and laboratory capacity to support foodborne disease surveillance and outbreak response.

The Environmental Protection Agency (EPA), another important partner, protects our water supply by setting drinking water standards under the Safe Drinking Water Act (SDWA). It also regulates pesticide products used in this country and establishes tolerances or maximum limits for pesticide residues allowed on imported and domestic food commodities and animal feed.

State and local partners also have an important role to play in food safety. The Administration has a long history of reaching out to its State and local partners and has worked effectively with them utilizing a variety of mechanisms: cooperative agreements, contracts, grants, memoranda of understanding and partnerships.

Food safety can only be effective if it has a strong underpinning in scientific research and risk assessment. The Federal government has major capabilities to perform both basic and applied research related to food safety problems. Our Federal research resources include research conducted at CDC, National Institute of Health (NIH), and FDA, as well as that performed at FDA's National Institute for Food Safety Technology (Moffet Center), and that performed by USDA's Agricultural Research Service (ARS), and USDA's partnerships with the nation's land grant universities via the Cooperative State Research, Education and Extension Service (CSREES).

Together these Federal agencies promote food safety and prevent foodborne illness and food hazards through inspections; surveillance; enforcement; research and risk assessment; pre-market approval of food and color additives, pesticides, and new animal drugs; establishing controls for safe processing; working with State, local, and foreign governments; partnering with academia and the private sector, and education.

BUILDING AN EFFECTIVE FOOD SAFETY SYSTEM

The Administration has consistently worked to build an effective food safety system that is grounded in science and that includes strong surveillance, research, education, risk assessment, and enforcement. In January of 1997, the President directed three Cabinet members - the Secretary of Agriculture, the Secretary of Health and Human Services, and the Administrator of the Environmental Protection Agency - to identify specific steps to improve the safety of the food supply. A program designed to fill the existing gaps was presented to the President in the May 1997 report entitled, "Food Safety from Farm to Table: A National Food-Safety Initiative."

The goal of this initiative was to further reduce the incidence of foodborne illness due to microbial contamination to the greatest extent feasible. The initiative recognized foodborne illness as an emerging public health hazard that required aggressive government action, identified critical gaps in the food safety system for controlling or eliminating foodborne pathogens from the food supply, and proposed a strategy for closing those gaps. The initiative focused our efforts on hazards that present the greatest risk and sought to make the best use of public and private resources. These elements have been key to the success of our efforts. We will discuss later all of the Administration's accomplishments in these areas.

The 1998 National Academy of Sciences (NAS) report, "Ensuring Safe Food from Production to Consumption" reaffirmed these principles. The NAS report defined the operational charge or mission of an effective food safety system as "to protect and improve the public health by ensuring that foods meet science-based safety standards through the integrated activities of the public and private sectors." It defined the elements of a good system as:

• Adequate surveillance and monitoring
• A science-based foundation using risk analysis
• Focused education and research
• Effective and consistent regulation and enforcement
• Response and adaptation to new technology and changing consumer needs
• Adequate human and financial resources
• Partnerships with Federal, State, local and private sector stakeholders

Recognizing the need to go further, the President established the Council on Food Safety in August 1998, jointly chaired by Agriculture Secretary Glickman, Health and Human Services Secretary Shalala, and Dr. Neal Lane, the President's science advisor and Director of the White House Office of Science and Technology Policy. The Council's goal is to make the food supply even safer through a seamless, science-based food safety system supported by well-coordinated surveillance, standards, inspection, enforcement, research, risk assessment, education, and strategic planning.

ACCOMPLISHMENTS OF THE U.S. FOOD SAFETY SYSTEM

Food safety has been a high priority for the Administration since it took office. Beginning in 1993, actions taken by the Administration have led to significant improvements in the safety of our food supply. These achievements range from regulatory initiatives including promulgating rules on seafood, meat, and poultry Hazard Analysis and Critical Control Points (HACCP) and declaring E. coli O157:H7 as an adulterant in raw ground beef - to statutory changes such as passage of the Food Quality Protection Act in 1996 and significant amendments to the Safe Drinking Water Act in 1996 This year, for the third consecutive year, the Administration has coordinated a multi-agency effort to protect the health of the American public by improving the safety of the Nation's food supply. Through joint planning, coordination, and implementation, the Administration has worked to maximize the use of its resources and has continued to improve food safety.

Following on these efforts, the recommendations in the May 1997 report were comprehensive and ambitious and led to a needed shift in attention and resources toward the growing problem of microbial contamination of food. The recommendations included:

• Developing and expanding an early warning system for food-borne illness
• Creating a national electronic network for fingerprint comparison
• Improving outbreak containment through better Federal-State-local coordination
• Establishing a risk assessment consortium
• Improving pathogen detection methods
• Understanding antibiotic resistance
• Improving prevention techniques to avoid, reduce, or eliminate pathogens
• Implementing seafood, meat, and poultry HACCP
• Enhancing the safety of foods at retail
• Enhancing coverage of imported foods;Improving consumer, retail, and food service education
• Conducting research to identify barriers to safe food handling; and
• Developing a strategic plan.

In just two years the Administration has delivered on these extensive commitments. The vast majority of the recommendations have been implemented and already are leading to important improvements in our food safety system.

These successes were aided by the tremendous support we have received from Congress over the last several years.

The following examples highlight key achievements of this Administration - including accomplishments under the Food Safety Initiative -- and demonstrate how the U.S. food safety system is founded on the elements of a good system consistent with those articulated by the National Academy of Sciences. (See also attached list of accomplishments.)

Surveillance, Monitoring, and Outbreak Response

The primary objective of the American system of public health is to prevent disease before it occurs. Surveillance and monitoring are critical to meet this objective. Outbreak response is also critical because even an ideal food safety system will not be able to prevent all foodborne illness, but rapid action can contain an outbreak once it is identified.

FoodNet Surveillance Network. A strong food safety system starts with knowing where the problems are and identifying new problems rapidly. In July 1995, HHS and USDA began a collaborative project to collect more precise information on foodborne illnesses, and to conduct related epidemiologic investigations to help public health officials better understand the epidemiology of foodborne disease in the U.S. Now expanded under the President's Food Safety Initiative, FoodNet provides a strong network for responding to new and emerging foodborne diseases of national importance, monitoring the burden of foodborne diseases, and identifying the source of specific foodborne diseases - all with a view toward developing and implementing effective prevention and control measures. Recent results from FoodNet show a 44 percent decrease in the infection rate for Salmonella Enteritidis (SE), a serious infection associated with poultry and eggs, from 1996 to 1998 in the areas of the country under surveillance, and a 15 percent decline in illnesses caused by Campylobacter, the most common bacterial foodborne pathogen in the U.S. Also, FoodNet data help to document the effectiveness of new food safety control measures such as USDA's Pathogen Reduction and HACCP Rule as well as HACCP programs undertaken by the FDA for seafood and other food products. For example, some of the changes in rates of food-borne illness may reflect that FDA and FSIS prevention efforts are working.

PulseNet. PulseNet, developed by CDC, enables a national network of public health laboratories to perform DNA "fingerprinting" on bacteria that may be foodborne and compare results through an electronic database maintained by CDC. Now a collaborative effort among HHS, USDA and several states, PulseNet permits rapid and accurate detection of food-borne illness outbreaks and traceback to their sources, including detection of disparate multi-state outbreaks that may have gone undetected. PulseNet has been key in rapidly detecting and controlling numerous outbreaks of foodborne illness, including multi-state outbreaks. For example, last year PulseNet connected two seemingly independent E.coli O157:H7 outbreaks in Michigan to a common source-alfalfa sprouts; helped confirm that about 50 cases of E. coli O157:H7 in Wisconsin were attributable to cheese curds from a single facility, after initial inspections did not reveal the source of contamination; and connected E.coli O157:H7 outbreaks from ground beef with specific processors. In addition, without PulseNet, it is very unlikely that the recent outbreak of listeriosis from ready to eat meat products would have been recognized and identified as emanating from one source. Since the illnesses were dispersed across a wide geographic region, the comparative matching of pathogen strains via PulseNet facilitated the epidemiological investigation that led to the recall of contaminated product.

Antibiotic Resistance. The National Antibiotic Resistance Monitoring System (NARMS) was established in 1996 as an interagency cooperative activity to monitor emerging resistance to antibiotics in foodborne pathogens, beginning with Salmonella. The effort is coordinated and directed by HHS and USDA. NARMS was enhanced in FY98 to improve our ability to detect emerging antibiotic resistance among foodborne pathogens. Using NARMS, HHS and USDA collaborated in response to an outbreak of salmonellosis among residents of a Vermont dairy farm. NARMS helped determine that Salmonella Typhimurium DT 104 was widespread in the U.S., prompting CDC to warn State health departments of its presence and provide preventive steps to minimize its spread.

In addition, under the leadership of HHS, and with USDA as a full participant, a Task Force has been formed to produce a public health action plan to combat antimicrobial resistance. The Task Force is chaired by FDA, NIH and CDC. A public meeting was recently held in Atlanta with federal participants and experts from across the country. This public meeting covered many issues concerning human medical use and misuse, animal agriculture use and misuse, and plant protection uses of antimicrobial agents. Work to develop this action plan will proceed over the next year.

FORC G. In 1998, Vice President Gore announced the formation of the Foodborne Outbreak Response Coordinating Group (FORC G), a partnership of Federal, State, and local agencies established to better respond to foodborne illness outbreaks. The role of this interagency group is to coordinate and develop procedures for managing outbreaks, share information on potential sources of outbreaks and pathogens, and coordinate interdepartmental action on those issues when necessary.

Science-Based Foundation Using Risk Analysis

The Administration's food safety efforts are firmly grounded in science. Thus, we agree with the NAS report's focus on the use of scientific risk assessment to develop rules that will have the most positive influence on public health. Risk analyses are helpful in defining the extent of scientific certainty and in helping decision-makers make the tough decisions a science-based food safety system requires.

Risk Assessment Consortium. The Risk Assessment Consortium (RAC), formed in 1997, is composed of USDA, HHS, and EPA. The RAC has accomplished numerous interagency activities that have helped advance the science of microbial risk assessment. The RAC established an intramural research program with projects intended to provide data for use in microbial risk assessment modeling. In addition, the Risk Assessment Clearinghouse was established, through FDA's joint Institute for Food Safety and Applied Nutrition (JIFSAN) to serve as a repository for data, methods, and tools for food safety risk assessment.

Risk Assessments. In 1998, USDA and HHS completed a farm-to-table quantitative risk assessment for Salmonella Enteritidis in eggs and egg products, which served as the foundation for both agencies' regulatory actions to address the safety of eggs and egg products. In addition, the Administration is conducting or supporting needed risk assessments and analyses on Bovine spongiform encephalopathy (BSE), listeria monocytogenes in food, vibrio parahaemolyticus in shellfish, antimicrobial resistance in food producing animals, and E. coli 0157:H7 in beef.

Focused Research

Since 1997, research has been a key component of the President's Food Safety Initiative and these efforts have been supported by Congress. From developing new tools to identify, prevent, or eliminate hazards from contaminated food, to performing basic research on pathogens and their impact on humans and animals, to researching and conveying important information for consumers about safe food handling methods, food safety research plays an integral role in the Administration's food safety strategy. The Administration has taken additional steps in recent years that have provided an expanded role for research in the U.S. Food Safety System. In 1999, Congress supported this effort and supplied to HHS and USDA additional funding for research and risk assessment. We are grateful for support for research in 1997 and 1998 as well, having received a total of $68.7 million in 1997, $83.8 million in 1998, and $107.5 million in 1999.

Joint Institute for Food Safety Research. In July 1998, building on the work of the Interagency Working Group on Food Safety Research, the President directed the Secretaries of HHS and USDA to create the Joint Institute for Food Safety Research (JIFSR), through the President's Council on Food Safety. JIFSR will coordinate planning and priority setting for food safety research among the two Departments, other government agencies, and the private sector and will foster effective translation of research results into practice. The JIFSR, expects to optimize food safety research investments, channel Federal resources to research that is needed to minimize the impact of current and emerging food safety problems, and avoid research redundancies. In addition, USDA through the direction of the ARS and its National Agricultural Library, is developing a national database on food safety research which will be housed under JIFSR. The database will contain information on all Federal food safety research and will attempt to document private sector investments in food safety research. The database will provide one additional mechanism for communicating the range of food safety research and potential applications.

Interagency Working Group on Food Safety Research. Late last month, the Interagency Working Group on Food Safety Research, through the National Science and Technology Council, completed its report documenting the government-wide inventory of microbial food safety research, which has helped identify information gaps and priorities for future research. The analysis contained in this report will contribute to the planning activities of JIFSR. The report should now be available on the OSTP homepage.

Advancements in Research. The investment in food safety research already is paying off for the industries. Some examples of recent research breakthroughs include the discovery by NIH of a potential vaccine for E. coli O157:H7; development by ARS of new animal drugs which can help preempt the growth of Salmonella in the intestines of newly hatched broiler chicks; the development of a five minute rapid test to identify generic bacteria on meat and an improved technique to directly detect and quantify harmful E.coli within 30 minutes (improved from previous times of 24 to 48 hours); and the isolation of Norwalk virus from shellfish by FDA. In addition, the FDA's Moffett Center is working on non-thermal processes, including ultraviolet light, high hydrostatic pressure, and antimicrobials, to improve the safety of juices that will not receive heat treatment.

Effective and Consistent Regulation, Guidance, and Enforcement

The Administration has concluded that Hazard Analysis and Critical Control Point (HACCP) systems provide a more effective and efficient way to reduce hazards that may be present in food products. HACCP systems, which may be tailored to individual processing and distribution conditions, place emphasis on the prevention of contamination in processed foods. Because these systems attempt to identify and control microbial, chemical and physical hazards during processing, they significantly reduce the possibility that the final product will contain hazards that could cause human illness.

Pathogen Reduction and HACCP. In December 1995, FDA published its rule to assure seafood safety using HACCP principles. The program is a tool for the enforcement of FDA standards for toxins, pathogens, contaminants and residues. FDA has also proposed to expand HACCP to fruits and vegetable juices. In July 1996, USDA published its "Pathogen Reduction and HACCP" rule. The rule requires all industry plants that slaughter and process meat and poultry to implement HACCP systems as a means of preventing or controlling contamination from pathogens and other hazards. Initial reports following HACCP implementation are encouraging. An independent study conducted by the Sea Grant University at Stony Brook, N.Y., has reported that the seafood HACCP regulations are having a positive impact on the seafood industry. In addition, the meat and poultry performance standards, which require FSIS testing to determine if plants are meeting or exceeding standards for the occurrence of salmonella in a product, and its mandate that plants test for the occurrence of generic E. coli as an indicator of their controls for fecal contamination, have led to recognizable results as cited by CDC in March 1999. Also, as a result of pre HACCP testing and post HACCP implementation tests for performance, FSIS was able to report declines in salmonella on broilers by almost 50 percent.

Good Agricultural Practices (GAPs)/Good Manufacturing Practices (GMPs). In response to a Presidential directive, and after receiving significant public input, FDA, working with USDA, published its October 1998 Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables. The guide addresses key areas where precautions should be taken to ensure safety: water quality, worker hygiene, field and facility sanitation, manure management, and transportation. The agencies are now working together to educate the agricultural industry - both domestically and internationally - on the recommendations included in the guidance.

Improved Protection for Imported Foods. The increasingly global nature of the food safety system that FDA regulates presents significant challenges. On July 3, 1999, President Clinton directed FDA and the U.S. Customs Service to strengthen our border protection through all available actions - such as preventing "port shopping", destroying imported food that poses a health risk, increasing the amount of bond posted for imported food to deter premature entry in the U.S., and enhancing enforcement actions, including increased civil monetary penalties. A report is due to the President in 90 days. The President also called on Congress to pass legislation that would further enhance Federal authority over FDA-regulated imported food - USDA already having adequate authority to inspect and enforce.

Responding and Adapting to New Technology and Changing Consumer Needs

Going beyond the basics of GAPs/GMPs, and HACCP approaches, the Administration also is working to encourage the application of new technologies to solve food safety problems. These efforts are focused in research and development, particularly on technologies suitable for small businesses, and in streamlining reviews in those cases where pre-market approval is required for use of a new technology.

New Technology Development. Some of the exciting and new technologies developed by industry as well as our food safety agencies include irradiation, steam pasteurization for meat and poultry carcasses, pulsed light to reduce pathogens on raw or cooked food products, hydrostatic pressure for shellfish, antimicrobial rinses to reduce pathogens on raw products, and competitive exclusion to reduce Salmonella levels in poultry on farms. FDA and EPA have also expedited pre-market reviews of food additives and safer pesticides as a means to encourage development of these new technologies and tools.

Adequate Human and Financial Resources

The Administration has requested and Congress has funded increases for the food safety initiative over the last two fiscal years, which has served as the foundation for many of our successes. Funding this year's request, an increase of more than $70 million for the Initiative, is critical if we are to continue advancing our food safety agenda. Our food safety programs must be adequately funded so that the Federal agencies can meet their statutory responsibilities to protect American consumers.

One immediate organizational change that the Administration currently is seeking is the transfer of the Seafood Inspection Program (a voluntary fee-for-service program of the National Oceanic and Atmospheric Administration at the Department of Commerce) to FDA, which will consolidate all Federal seafood inspection activities into one agency. This voluntary program inspects and certifies fishing vessels, seafood processing plants, and retail facilities for federal sanitation standards, and bases its safety inspections on FDA's seafood HACCP standards. To achieve these efficiencies, the Administration's proposal is contingent on the President's request of $3 million to effect the transfer.

Coordinated Budget. As part of Executive Order 13100, the President directed the Council on Food Safety to develop annual coordinated food safety budgets. The goal is to develop coordinated budgets that sustain and strengthen existing capacities, eliminate duplication, help identify priority areas for investment, and ensure the most effective use of resources for improving food safety. Efforts are currently underway to develop a coordinated budget in FY 2001.

Education

Education is another key element of the President's Food Safety Initiative which has continued to receive Congressional support. The Administration has developed educational approaches that span the farm-to-table continuum - from educating farmers, producers, and distributers, to food handlers and preparers, to consumers.

Consumer Education. The President's Food Safety Initiative has spurred new consumer education programs within the Administration as well as expanded cooperative ventures with public and private partners, including other Federal agencies. One example is the "Fight BAC!" campaign sponsored by the Partnership for Food Safety Education, a public-private partnership, with participation of both USDA, HHS and the States. The campaign was created to reduce the incidence of foodborne illness by educating Americans about safe food handling practices.

Consumer Labels. In 1994, safe handling labels were mandated for meat and poultry at retail sale, to ensure consumers understood time and temperature requirements for safe cooking. The Administration also has adopted product-specific messages, including a warning label on unpasteurized juices and, just last month, proposed safe handling instructions for shell eggs.

Partnerships with State and Local Governments

The NAS report recognized the important role that State and local governments play in food safety. Both FDA, FSIS, and EPA historically have strong partnerships with States. For example, the states are directly involved with FDA in the regulation of milk and shellfish safety through the National Conference of Interstate Milk Shippers, and the Interstate Shellfish Shippers Conference,(ISSC) as well as through the Seafood HACCP Alliance, which provided extensive training to seafood processors after publication of the final seafood HACCP regulation. Twenty-five States operate inspection programs for meat and poultry under cooperative agreements and with shared funding from FSIS.

Food Code. FDA and FSIS work with the States to encourage uniformity among the State laws affecting food safety in retail and food service establishments. The principal mechanism for this is the Food Code - a model code published by FDA intended for adoption by State and local authorities for use in regulating retail food and food service establishments. It is essential that the Federal government provide training both to the States and local governments, as well as to the retail and food service industry, to be sure that the critical elements of the Food Code are properly applied. Currently, 14 States have adopted the Food Code and adoption is pending in 22 others.

WHERE DO WE GO FROM HERE?

At the beginning of his first term, President Clinton set a course to strengthen the nation's food safety system. Under the President's leadership, we have enhanced surveillance of foodborne disease and better coordinated our response to outbreaks. We have improved coordination of food safety programs, issued regulations that are science-based, and targeted important new research and risk assessment to critical scientific gaps. And, we have strengthened education and training, especially for those who handle food at critical points from the retail setting to the home.

The Administration is proud of all we have accomplished, particularly the great strides we have made over the last few years. However, this is only the beginning. As good as the nation's food system is, there is much more to be done. As the challenges to our food safety system continue to evolve, we must adapt our system to meet these changing needs. And, we must ensure that our food safety system is capable of responding to and preventing foodborne illness and food hazards through the most effective means possible.

For these reasons, the President directed his Council on Food Safety to develop a comprehensive strategic food safety plan. The plan will address the full range of food safety issues, long- and short-term, to further ensure the health and safety of the nation's food supply. The plan will help set priorities, improve coordination and efficiency, identify gaps in the current system and ways to fill those gaps, enhance and strengthen prevention and intervention strategies, and identify reliable measures to indicate progress.

As part of this process, the Council will conduct a thorough assessment of the existing statutes, evaluate the degree of regulatory flexibility that currently exists and determine what improvements will require statutory changes. In addition, the Council will conduct an assessment of structural and organizational options and other mechanisms that could strengthen the federal food safety system before recommending major legislative or administrative actions on reorganization.

To draft the strategic plan, the Council established an interagency Strategic Planning Task Force, which we co-chair. The Task Force, along with five working groups, has developed a draft set of goals and objectives which have been shared with various stakeholders to seek their input. Those stakeholders and Council representatives engaged on July 15, 1999, in an important exchange of views on the food safety system of the future at a public meeting in Washington. A second public meeting is scheduled for October 1999 to review strategic planning progress that will be made over the next few months. The Council expects to provide a draft plan to the public in early 2000 and invite additional comments. The final document is due to the President in July 2000. We firmly believe that establishing a seamless, science-based food safety system is critical to ensuring the safety of our food supply and protecting public health. How we get there should be carefully thought through with all of our partners and stakeholders. We assure you that we are approaching this effort seriously and expeditiously, and are considering the full range of options available to us.

Thank you for the opportunity to discuss our food safety program and our continued efforts in this area. We look forward to working with the Subcommittee on the next steps to continue to improve the nation's food supply.

Clinton/Gore Administration Accomplishments in Improving Food Safety

Although our food supply is already among the safest in the world, the Clinton/Gore Administration has made further reductions in foodborne illness a national priority. The Administration has put in place improved safety standards for meat, poultry, and seafood products. Research, education, and surveillance efforts have also been greatly expanded. Here are some significant milestones in the Administration's food safety efforts.

August 1999. Completed review of one-third of all allowable pesticide residue levels on food by the August 3rd deadline, as called for by FQPA, and significantly reduced the use of two organophosphates used on foods eaten by children.

July 1999. Public meeting of the President's Council on Food Safety Strategic Planning Task Force goals.

July 1999. Established a control plan for Vibrio parahaemolyticus in oysters.

July 1999. Announced grants to five land grant universities that will serve as models for very small meat and poultry plants due to implement the final phase of HACCP.

July 1999. Advised consumers of the risks associated with eating raw sprouts.

July 1999. Proposed efforts to improve egg safety by requiring that shell eggs be stored at 45 degrees or below during transport, in warehouses, and at retail stores; and by requiring safe handling statements on egg cartons.

July 1999. Released Interagency Working Group on Food Safety Research report, which compiles an inventory of food safety research on microbial contamination.

July 1999. Directed the Departments of Health and Human Services and Treasury to explore additional actions they could take to protect U.S. consumers from unsafe imported foods, with reports due back to the President by late 1999.

July 1999. Directed the Strategic Planning Task Force of the President's Council on Food Safety to develop immediate recommendations concerning the regulation of eggs.

June 1999. PulseNet expanded to include Salmonella, Shigella, and Listeria, as well as E coli 0157:H7 bacteria fingerprinting.

May 1999. Published Federal Register notice advising meat and poultry plants to reassess their HACCP preventive control plans to ensure they are adequately addressing Listeria monocytogenes in ready-to-eat products, and provided guidance to industry recommending environmental and end-product testing for presence of Listeria moncytogenes in ready-to-eat products.

May 1999. Implemented extensive educational efforts targeted to at-risk consumers about Listeria monocytogenes in ready-to-eat products

Spring 1999. Held two public conferences to educate foreign and domestic agriculture communities on Good Agricultural Practices'/Good Manufacturing Practices' guidance document.

March 1999. FoodNet surveillance data announced by CDC that indicate important decreases in Salmonella and Campylobacter infections since 1996, including a 15 percent decrease in Campylobacter and a 44 percent drop in Salmonella Enteritdids infections.

February 1999. Proposed rule on irradiation for raw meat and meat products.

February 1999. FSIS and FDA signed a Memorandum of Understanding (MOU) to facilitate the exchange of information at the field level about food establishments and operations that are subject to the jurisdiction of both agencies.

January 1999. Implemented new procedures to expedite the review of food additives that are intended to decrease the incidence of foodborne illnesses through their antimicrobial actions against human pathogens that may be present in food.

January 1999. Implemented HACCP in almost 3,000 small meat and poultry plants. Preliminary results from the 300 largest meat and poultry plans that implemented HACCP in 1998, show significant reductions in the prevalence of pathogens on meat and poultry products.

January 1999. Announcement of new technique to detect DT104, a potentially deadly strain of Salmonella that resists many antibiotics.

November 1998. FoodNet expanded to include an eight state, and now represents more than 10 percent of the U.S. population.

November 1998. Held "National Conference on Food Safety Research" with a goal of answering the question: "What should our food safety research be as we move forward?" Participants included Federal agency representatives as well as academics, and industry and consumer group representatives. Discussion focused on the research needs of regulatory and action agencies, and on the research needs for detection, prevention, and risk assessment.

October 1998. Published guidance for growers, packers and shippers of fresh fruits and vegetables to provide information on agricultural and management practices they might apply to enhance the safety of fresh produce.

August 1998. Finalized a regulation that requires eggs to be stored and transported at 45 degrees fahrenheit or less. By law this regulation becomes effective in August 28, 1999.

August 1998. Created the President's Council on Food Safety, which is charged with developing a comprehensive strategic plan for Federal food safety activities and with ensuring that all Federal agencies involved in food safety work together to develop coordinated food safety budgets each year.

August 1998. Initiated a public awareness campaign on the risk that unpasteurized or untreated fruit and vegetable juices may present to vulnerable populations.

July 1998. Announced new warning labels that would be required on packaged fresh fruit and vegetable juices not processed to kill harmful bacteria.

July 1998. Announced the Joint Institute of Food Safety Research,(JIFSR) which will develop a strategic plan for conducting and coordinating all federal food safety research activities, including with the private sector and academia.

May 1998. Formed a national computer network of public health laboratories--called PulseNet--to help rapidly identify and stop episodes of foodborne illness. The new system enables epidemiologists to respond up to five times faster than before in identifying serious and widespread food contamination problems by performing DNA "fingerprinting" on foodborne pathogens.

April 1998. Proposed a regulation to require processors of packaged fruit and vegetable juices to implement HACCP to preempt contamination of their products.

April 1998. Implemented a pilot HACCP program for the retail sector of the food industry, including restaurants, grocery stores, institutional food service and vending operations.

March 1998. Isolated Norwalk viruses from shellfish by developing a rapid, sensitive and reliable method capable of detecting low levels in contaminated shellfish. Until this method was developed there was no direct proof that shellfish transmit viral disease to humans from contaminated waters.

February 1998. Announced Administration's proposed food safety budget, which requests approximately $101 million increase for food safety initiatives.

January 1998. Implemented new, science-based HACCP system for 300 of the largest meat and poultry plants.

December 1997. Implemented HACCP regulation for the seafood industry, a uniquely complex industry consisting of more than 4,000 domestic seafood producers mostly small businesses processing more than 300 varieties of seafood from numerous different habitats.

December 1997. Approved irradiation for red meat as a food additive.

October 1997. Issued Presidential Directive to improve the safety of domestic and imported fruit and vegetables.

October 1997. Established the Partnership for Food Safety Education, an ambitious federal-private partnership to reduce the incidence of foodborne illness by educating Americans about safe food handling practices. The Partnership has launched a multi-year, broad-based public education campaign "Fight BAC!", to teach Americans about safe food-handling practices. Federal partners include the U.S. Department of Agriculture, U.S. Department of Education, and U.S. Department of Health and Human Services.

May 1997. Reported to the President a comprehensive new plan to improve the safety of nation's food supply, "Food Safety from Farm to Table", detailing a $43 million food safety program, including measures to improve surveillance, outbreak response, education, and research.

January 1997. Unveiled National Food Safety Initiative, a five-point plan to strengthen and improve food safety. Working with consumers, producers, industry, states, universities, and the public, the administration recommended actions to reduce foodborne illness.

January 1997. Announced new early warning system, the Foodborne Outbreak Response Coordinating Group (FORC-G), a partnership of Federal and State agencies established to develop a comprehensive, coordinated national foodborne illness outbreak response system to increase coordination and communication among Federal, State, and local agencies; guide efficient use of resources and expertise during an outbreak and prepare for new and emerging threats to the U.S. food supply.

August 1996. President signed Safe Drinking Water Act of 1996 (SDWA). The law requires drinking water systems to protect against dangerous contaminants such as Cryptosporidium, and gives people the right to know about contaminants in their tap water.

August 1996. President signed Food Quality Protection Act of 1996, which streamlines regulation of pesticides by EPA and puts important new public-health protections in place, especially for children.

July 1996. President announced new HACCP regulations that modernize the nation's meat and poultry inspection system for the first time in 90 years. New standards help prevent E. coli bacteria contamination in meat.

April 1996. Established the Joint Institute for Food Safety and Applied Nutrition (JIFSAN), a collaborative effort between FDA and the University of Maryland. JIFSAN will be a jointly administered multi-disciplinary research and education program.

January 1996. Began collecting data through the Foodborne Diseases Active Surveillance Network (FoodNet), a collaborative effort among FSIS, FDA, and CDC along with state health departments and local investigators around the country to better track the incidence of foodborne illness and monitor the effectiveness of food safety programs in reducing foodborne illness.

December 1995. Issued new rules to ensure seafood safety, using HACCP regulatory programs to require food industries to design and implement preventive measures and increase the industries' responsibility for and control of their safety assurance actions.

October 1995. Declared E. coli O157:H7 an adulterant in raw ground beef.

Spring 1994. Issued new rule requiring the application of safe handling instructions on labels on raw meat and poultry products.

1994. Embarked on strategic CDC program to detect, prevent, and control emerging infectious disease threats, some of which are foodborne, making significant progress toward this goal in each successive year.

1994. Reorganized USDA to establish the Office of the Under Secretary for Food Safety as a means of increasing the visibility of food safety within USDA and separating food safety functions from marketing functions carried out by other parts of USDA. Reorganization also created a new Office of Public Health and Science within FSIS to improve the scientific base needed to make good regulatory decisions that are based on public health.

1993. Vice President's National Performance Review issued report recommending that government and industry move toward a system of preventive controls for food safety.