Administration Statement
on behalf of
The President's Council on Food Safety
BEFORE THE
Senate Governmental Affairs Committee Subcommittee on Oversight of Government Management, Restructuring and
The District of Columbia
August 4, 1999
I. 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.II. 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.III. 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:IV. 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:V. 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.