This session was designed to reconfirm that the federal government considers science and risk assessment to be integral parts of the food safety decision-making process. However, other factors such as statutory authority and resources must be considered in making food safety decisions.
Presented by Jane E. Henney, M.D.
Commissioner, Food and Drug Administration
Americans enjoy the safest and most bountiful food supply in the world. This is due in part to advances in science and technology that have enabled the identification of more than five times the number of food-borne pathogens than were known 50 years ago and the development of new solutions to prevent and control these pathogens. Yet each year in our country millions of people become ill and thousands die due to food-borne illness.
Recent trends in food consumption are a major reason that ensuring a safer food supply has become more challenging as Americans both choose a greater variety of foods from a continually expanding global supply and consume an increasing amount of foods prepared outside the home. It is because of the continuing threat of food-borne illness and the increasing complexity of the food supply that the Food and Drug Administration (FDA) and other agencies within the Department of Health and Human Services (DHHS) have deemed the protection of our nation's food supply a high priority. The importance of strong federal leadership in the area of food safety cannot be overstated.
The DHHS is organized to link science to its mission. The FDA is the lead agency for applying the food and environmental laboratory science to support the regulatory and nonregulatory food safety goals. The Centers for Disease Control and Prevention (CDC) is primarily responsible for the epidemiology and laboratory science to support the infectious and non infectious disease prevention goals, while the National Institutes of Health (NIH) is the premier agency for basic and clinical biomedical research. Together these agencies promote food safety, help prevent food-borne disease, and mitigate the clinical and social impact of infectious and noninfectious illnesses.
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Page 3 2 Science as the Basis for Food Safety Policy This session was designed to reconfirm that the federal government considers science and risk assessment to be integral parts of the food safety decision-making process. However, other factors such as statutory authority and resources must be considered in making food safety decisions. GOOD SCIENCE: CRITICAL TO REGULATORY DECISION-MAKING Presented by Jane E. Henney, M.D. Commissioner, Food and Drug Administration Americans enjoy the safest and most bountiful food supply in the world. This is due in part to advances in science and technology that have enabled the identification of more than five times the number of food-borne pathogens than were known 50 years ago and the development of new solutions to prevent and control these pathogens. Yet each year in our country millions of people become ill and thousands die due to food-borne illness. Recent trends in food consumption are a major reason that ensuring a safer food supply has become more challenging as Americans both choose a greater variety of foods from a continually expanding global supply and consume an increasing amount of foods prepared outside the home. It is because of the continuing threat of food-borne illness and the increasing complexity of the food supply that the Food and Drug Administration (FDA) and other agencies within the Department of Health and Human Services (DHHS) have deemed the protection of our nation's food supply a high priority. The importance of strong federal leadership in the area of food safety cannot be overstated. The DHHS is organized to link science to its mission. The FDA is the lead agency for applying the food and environmental laboratory science to support the regulatory and nonregulatory food safety goals. The Centers for Disease Control and Prevention (CDC) is primarily responsible for the epidemiology and laboratory science to support the infectious and non infectious disease prevention goals, while the National Institutes of Health (NIH) is the premier agency for basic and clinical biomedical research. Together these agencies promote food safety, help prevent food-borne disease, and mitigate the clinical and social impact of infectious and noninfectious illnesses.
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Page 4 Effective and efficient solutions to the numerous public health threats posed by an ever-changing food supply can be achieved mainly through the development and application of sound scientific principles. Building and strengthening FDA's science base is a major priority. The impact of science on food safety policy in the past has been substantial and is illustrated in four main areas: Science has enabled the identification of recent technologies to detect new and changing public health hazards in food and FDA has instituted an expedited review process for these new technologies. For example, advances in food virological techniques are improving our ability to detect and combat the presence of food-borne viruses, such as the hepatitis A virus. Science has enabled the creation of more effective and efficient approaches to solving public health problems. For example, researchers have devised multiple means for improving the safety of sprouts including the evaluation of a wide range of potential agents as a means of decontaminating both seeds and finished sprouts. FDA developed, in just one year, Good Agricultural Practices for fresh fruits and vegetables. These guidelines are being applied both domestically and overseas. In addition, FDA developed a new approach for enhancing the safety of food imports, placing increased emphasis on evaluating underlying conditions in foreign countries. FDA is also working with the U.S. Customs Service to strengthen protection at the border to block importation of unsafe food. Science has enabled the evolution of regulatory approaches to reflect the current state of knowledge. For example, FDA was the first federal agency to issue science-based mandatory Hazard Analysis Critical Control Point (HACCP) regulations, in this case, for seafood. In addition, FDA has proposed to expand HACCP to fruit and vegetable juices and these regulations would include a mandatory performance standard. FDA issued final regulations for warning labels for unpasteurized juices, in time for the 1998 apple cider season. In the summer of 1999, FDA proposed new regulations to enhance the safety of shell eggs, while also announcing the joint development with the U.S. Department of Agriculture of a farm-to-table strategic plan for egg safety. Science has enabled the development of new ways to measure the public health impact of prevention and control efforts. For example, FDA recently completed a consumer study to identify food safety practices that consumers are employing and where trends exist. These types of impacts are the reason risk assessment is leading the Department's food safety regulations in creating solutions and the reason the DHHS and its Public Health Service (PHS) are organized in a manner that clearly links science to the goal of reducing food-borne illness. The PHS bases its public health policy on the best science available. Good science is critical to regulatory decision-making and FDA cannot solve this problem on its own. In order to achieve high standards of food safety based in sound science—a public health goal shared by FDA and other government agencies—public and private partnerships must be formed in addition to improving communication and coordination among federal and state agencies. It is only by enhancing the science underpinning decision-making that consumers will receive the level of public health protection that they expect and deserve.
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Page 5 STATUTORY AUTHORITY: DIFFERENCES AMONG AGENCIES Presented by Catherine E. Woteki, Ph.D. Undersecretary for Food Safety, U.S. Department of Agriculture It is widely recognized that science and risk assessment are key to the development of effective food safety policy. However, factors such as statutory authority and the availability of resources, budget and staff often ultimately determine how and when science and risk assessment enter into food safety regulatory decisions. Over the last century, Congress authorized numerous laws authorizing the work of the three federal food regulatory agencies—the Food Safety and Inspection Service (FSIS), the Food and Drug Administration (FDA), and the Environmental Protection Agency (EPA). These agencies make a wide range of decisions based on the their statutory authority, nature of the food safety problem, time constraints, and resources. The statutory framework guiding each of these agencies determines the different ways in which science and risk assessments are brought to bear. The FDA and FSIS apply many comparable statutory standards in determining the acceptability of food products, including the adulteration provisions of the Federal Food Drug and Cosmetic Act (FDCA), the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act. FSIS is required under the latter three statutes to maintain a continuous inspection program for meat, poultry, and egg products. FSIS inspectors must determine that these products are not adulterated before moving into commerce. In contrast, no similar requirement exists under FDCA, and therefore FDA has the burden of proving that foods other than meat and poultry products are adulterated. These statutory differences probably related to the mindset of the public and the Congress at the time of the statute's enactment. The EPA was established in 1970 long after the establishment of FSIS and FDA. It regulates pesticides under three major federal statutes: the Federal Insecticide, Fungicide and Rodenticide Act; the FDCA; and the Food Quality Protection Act. EPA's main duties under these acts are to register pesticides, prescribe labeling and other requirements to prevent adverse health and environmental effects, and establish tolerance levels for pesticide residues. Due to the requirement that EPA's decisions be based only on public health risk and not economics, the agency's activities are heavily based on risk assessment. In 1993, President Clinton signed an Executive Order mandating that for regulations having an annual economic impact of at least $100 million (1994 dollars), all federal agencies must conduct thorough risk and cost benefit analysis. This analysis must make clear the nature of the risk, list alternative ways of reducing the risk, describe the reasoning that justifies the proposed rule, and make a comparison of the likely costs and benefits of reducing the risk. Although this Executive Order on regulatory planning and review is not a statutory authority, it is relevant because it establishes requirements for analysis of risk and cost benefit. It should be noted that cost-benefit is not a component of risk assessment. In addition to making food safety policies within the boundaries imposed by these statutes, FSIS, FDA, and EPA are also limited by the amount of information and time available to make these decisions. To illustrate the impact of varying amounts of time and information, food safety decisions can be divided into four major categories. The first category includes the major policy changes or enactment of new legislation that can take years and sometimes decades to accomplish. An example is the focus that FSIS has placed in recent years on reducing the risks associated with microbial pathogens through a comprehensive farm-to-table approach to food
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Page 6 safety. A second category is the development of major rules, which can take months or years to complete. Third are the immediate regulatory decisions that agencies must make on a regular basis, ranging from weekly to annual decisions, such as the decisions a manager might make on allocating staff resources and setting priorities. The final category involves decisions that must be made in a matter of hours or perhaps weeks such as enforcement decisions that request the recall of adulterated products or the issuance of warning letters. The urgency with which these decisions must be made determines the extent to which science and risk assessment methodologies can be applied. The first two categories often allow time for decisions that are based on multi-step, quantitative assessments, involving gathering and evaluating of scientific and economic data relevant to an issue; then presenting the data in an understandable form, crafting different approaches to solve the problem, soliciting public input, and making the regulatory choice. In contrast, rapid decisions are frequently needed in the latter two categories—leaving little or no time to conduct a formal risk assessment. However, in these situations, a qualitative assessment can be appropriate and may be more than sufficient for setting priorities and allocating resources. In conclusion, there are many types of science-based decisions that food safety agencies must make within specific statutory frameworks and timeframes that result in unique decisions by FSIS, FDA, and EPA. Despite multiple barriers and constraints, food regulatory agencies have been able to accomplish significant improvements under current authority. Examples include the Hazard Analysis Critical Control Point (HACCP) system for meat, poultry, and seafood; a single risk-based pesticide standard for raw and processed food; and the establishment of FoodNet and PulseNet, two hazard identification networks that are playing important roles in outbreak investigations. Future progress in this area includes the development by the President's Food Safety Council of a full assessment report that will identify the best regulatory solutions for reducing food-borne illness as well as detect both gaps and statutory barriers to the implementation of these approaches. The need for statutory change can then better be determined and, if necessary, legislative principles developed that will assist food safety agencies in creating optimal solutions for resource allocation according to risk. ROLE OF THE JOINT INSTITUTE FOR FOOD SAFETY RESEARCH Presented by William F. Raub, Ph.D. Deputy Assistant Secretary for Science Policy U.S. Department of Health and Human Services The Joint Institute for Food Safety Research is a new administrative entity that is to be jointly funded, staffed, and operated by the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (DHHS). The purpose of the Institute is to develop a strategic approach that unifies the research agendas and thus strengthens the coordination of food safety activities in three areas: among various U.S. government agencies; between the federal government and the private sector; and between the federal government and academia. The creation of the Institute was driven by the President of the United States and his plan for an expanded food safety research agenda to improve the safety of America's food. In anticipation of the Institute, an interagency working group on food safety research has developed an extensive plan to achieve its mission of coordinating food safety research activities. Details of the estimated $1 million per year plan include:
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Page 7 Appointment of up to ten people on a rotating 2-year basis as full time staff for the Institute, headed by a leading food safety scientist, possibly using the mechanism of the Intergovernmental Personnel Act. Creation of a new public advisory committee that would incorporate outside expertise into Institute processes. Development of a policy and budget committee to ensure connections with pertinent food safety agencies across the Federal Government. In addition to developing a strategic plan to coordinate research agendas, the interagency group was also tasked with gathering and assessing an inventory of federal food safety research, in particular research funded or conducted by the USDA, the DHHS, or the Environmental Protection Agency (EPA). The assessment was organized in broad terms of the risk paradigm into two categories: the management of food-associated risks and the assessment of food-associated risks. The category on management of food-associated risks was further subdivided into detection and control of food-borne hazards. The category on assessment of food-associated diseases was subdivided into six groups: pathogenicity of food-borne microbes; drug resistance and susceptibility of food-borne microbes; epidemiology of food-associated organisms and diseases; risk assessment methods and data; food handling, distribution, and storage; and finally, economic factors associated with food safety. Analysis of the research inventory was conducted to identify undue overlap or duplication, future needs and opportunities and, to the extent possible, facilitate agency consensus regarding research priorities. In doing this, the interagency group became aware of three major differences among agencies. First, USDA, DHHS, and EPA use vastly different systems for classifying food safety research. Second, the agencies record information at different resolutions and within different time frames. Finally, agencies have generally incompatible data systems, making interoperability even more challenging. Nevertheless, for fiscal year 1998, the inventory revealed that approximately $156 million was spent on food safety-related research by the three agencies, with the breakdown being DHHS at $87 million, USDA at $64 million, and EPA at about $5 million. Approximately 900 projects were identified of which almost 500 were accounted for by the agencies within DHHS. A mechanism for regularly updating the inventory and analysis will allow further opportunity to compare and collect data of this sort and thus highlight areas for future focus. In conclusion, food safety research is essential for the further innovation of tools that can quickly detect dangerous pathogens and for the development of better interventions and solutions to reduce the risk of contamination of our food. There are increasing opportunities to base policies and practices on science to achieve these goals, and the Joint Institute for Food Safety Research should be a significant asset in that quest.