C Food Safety from Farm to Table: A National Food-Safety Initiative*

A Report to the President May 1997

Executive Summary

* SOURCE: Copied from internet location: http://vm.cfsan.fda.gov/¬dms/fsreport.html.



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C Food Safety from Farm to Table: A National Food-Safety Initiative* A Report to the President May 1997 Executive Summary * SOURCE: Copied from internet location: http://vm.cfsan.fda.gov/¬dms/fsreport.html.

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TABLE OF CONTENTS     Executive Summary         A New Interagency Strategy to Prevent Foodborne Disease         Foodborne Illness: A Significant Public-Health Problem         Sources of Foodborne Contamination         The Current System for Protecting Food         The Food-Safety System Must Be Prepared for the 21st Century         Immediate Actions to Improve Food Safety         A New Early-Warning System for Foodborne Disease Surveillance         Interstate Outbreak Containment and Response Coordination         Risk Assessment         Research         Improving Inspections and Compliance         Education         A Blueprint for a Better Food-Safety System         Appendix A:Budget Request for Food-Safety Initiative Activities: FY98         Appendix B:Microbial Pathogens     *   This appendix reproduces only the Executive Summary of Food Safety from Farm to Table. The contents of the entire report, from which the Executive Summary has been extracted are given here for the reader information—

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EXECUTIVE SUMMARY While the American food supply is among the safest in the world, there are still millions of Americans stricken by illness every year caused by the food they consume, and some 9,000 a year—mostly the very young and elderly—die as a result. The threats are numerous and varied, ranging from Escherichia coli (E. coli) 0157:H7 in meat and apple juice, to Salmonella in eggs and on vegetables, to Cyclospora on fruit, to Cryptosporidium in drinking water—and most recently, to hepatitis A virus in frozen strawberries. In his January 25, 1997 radio address, President Clinton announced he would request $43.2 million in his 1998 budget to fund a nationwide early warning system for foodborne illness, increase seafood safety inspections, and expand food-safety research, training, and education. The President also 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. He directed them to consult with consumers, producers, industry, states, universities, and the public, and to report back to him in 90 days. This report responds to the President's request and outlines a comprehensive new initiative to improve the safety of the nation's food supply. The goal of this initiative is to further reduce the incidence of foodborne illness to the greatest extent feasible. The recommendations presented in this report are based on the public-health principles that the public and private sectors should identify and take preventive measures to reduce risk of illness, should focus our efforts on hazards that present the greatest risk, and should make the best use of public and private resources. The initiative also seeks to further collaboration between public and private organizations and to improve coordination within the government as we work toward our common goal of improving the safety of the nation's food supply. Six agencies in the federal government have primary responsibility for food safety: two agencies under the Department of Health and Human Services (HHS)—the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC); three agencies under the Department of Agriculture (USDA)—the Food Safety and Inspection Service (FSIS), the Agricultural Research Service (ARS), and the Cooperative State Research, Education, and Extension Service (CSREES); and the Environmental Protection Agency (EPA). Over the last 90 days, these agencies have worked with the many constituencies interested in food safety to identify the greatest public-health risks and design strategies to reduce these risks. USDA, FDA, CDC, and EPA have worked to build consensus and to identify opportunities to better use their collective resources and expertise, and to strengthen partnerships with private organizations. As directed by the President, the agencies have explored ways to strengthen

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systems of coordination, surveillance, inspections, research, risk assessment, and education. This report presents the results of that consultative process. It outlines steps USDA, HHS, and EPA will take this year to reduce foodborne illness, and spells out in greater detail how agencies will use the $43.2 million in new funds requested for fiscal year 1998. It also identifies issues the agencies plan to consider further through a public planning process. The actions in this report build on previous Administration steps to modernize our food-safety programs and respond to emerging challenges. As part of the Vice President's National Performance Review (NPR), the agencies have encouraged the widespread adoption of preventive controls. Specifically, the NPR report urged implementation of Hazard Analysis and Critical Control Point (HACCP) systems to ensure food manufacturers identify points where contamination is likely to occur and implement process controls to prevent it. Under HACCP-based regulatory programs there is a clear delineation of responsibilities between industry and regulatory agencies: Industry has the primary responsibility for the safety of the food it produces and distributes; the government's principle role is to verify that industry is carrying out its responsibility, and to initiate appropriate regulatory action if necessary. The Administration has put in place science-based HACCP regulatory programs for seafood, meat, and poultry. In late 1995, the Administration issued new rules to ensure seafood safety. In July 1996, President Clinton announced new regulations to modernize the nation's meat and poultry inspection system. The Early-Warning System the President announced in January will gather critical scientific data to further improve these prevention systems. Additional actions outlined in this report will encourage the use of HACCP principles throughout the food industry. The need for further action is clear. Our understanding of many pathogens and how they contaminate food is limited; for some contaminants, we do not know how much must be present in food for there to be a risk of illness; for others, we do not have the ability to detect their presence in foods. The public-health system in this country has had a limited ability to identify and track the causes of foodborne illness; and federal, state, and local food-safety agencies need to improve coordination for more efficient and effective response to outbreaks of illness. Resource constraints increasingly limit the ability of federal and state agencies to inspect food processing facilities (e.g., years can go by before some plants receive a federal inspection.) Increasing quantities of imported foods flow into this country daily with limited scrutiny. Some food processors, restauranteurs, food-service workers, supermarket managers, and consumers are unaware of how to protect food from the threat of foodborne contaminants. These and other deficiencies will be addressed by key Administration actions outlined in this report and described below.

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Enhance Surveillance and Build an Early-Warning System As the President announced in January, the Administration will build a new national early-warning system to help detect and respond to outbreaks of foodborne illness earlier, and to give us the data we need to prevent future outbreaks. For example, with FY98 funds, the Administration will: Enhance Surveillance. The Administration will expand from five to eight the number of FoodNet active surveillance sentinel sites. Personnel at these sentinel sites actively look for foodborne diseases. Existing sites are in Oregon, Northern California, Minnesota, Connecticut, and metropolitan Atlanta. New sites will be in New York and in Maryland, with an eighth site to be identified. CDC will also increase surveillance activities for certain specific diseases. For example, CDC will begin a case-control study of hepatitis A to determine the proportion of cases due to food contamination, FDA will strengthen surveillance for Vibrio in Gulf Coast oysters, and CDC will strengthen surveillance for Vibrio in people. Equip FoodNet sites and other state health departments with state-of-the-art technology, including DNA fingerprinting, to identify the source of infectious agents and with additional epidemiologists and food-safety scientists to trace outbreaks to their source. Create a national electronic network for rapid fingerprint comparison. CDC will equip the sentinel sites and other state health departments with DNA fingerprinting technology, and will link states together to allow the rapid sharing of information and to quickly determine whether outbreaks in different states have a common source. Improve Responses to Foodborne Outbreaks At the federal level, four agencies are charged with responding to outbreaks of foodborne and waterborne illness: CDC, FDA, FSIS, and EPA. States and many local governments with widely varying expertise and resources also share responsibility for outbreak response. The current system does not assure a well-coordinated, rapid response to interstate outbreaks. To ensure a rapid and appropriate response, with FY98 funds, agencies will: Establish an intergovernmental Foodborne Outbreak Response Coordinating Group. Federal agencies will form an intergovernmental group, the Foodborne Outbreak Response Coordinating Group, to improve the approach to interstate outbreaks of foodborne illness. This group will provide for appropriate participation by representatives of state and local agencies

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charged with responding to outbreaks of foodborne illness. It will also review ways to more effectively involve the appropriate state agencies when there is a foodborne outbreak. Strengthen the infrastructure for surveillance and coordination at state health departments. CDC, EPA, FDA, and FSIS will assess and catalogue available state resources, provide financial and technical support for foodborne-disease-surveillance programs, and other assistance to better investigate foodborne-disease outbreaks. Improve Risk Assessment Risk assessment is the process of determining the likelihood that exposure to a hazard, such as a foodborne pathogen, will result in harm or disease. Risk-assessment methods help characterize the nature and size of risks to human health associated with foodborne hazards and assist regulators in making decisions about where in the food chain to allocate resources to control those hazards. To improve risk-assessment capabilities, with FY98 funds, the agencies will: Establish an interagency risk assessment consortium to coordinate and guide overarching federal risk-assessment research related to food safety. Develop better data and modeling techniques to assess exposure to microbial contaminants, and simulate microbial variability from farm to table. Such techniques will help scientists estimate, for example, how many bacteria are likely to be present on a food at the point that it is eaten (the end of the food chain), given an initial level of bacteria on that food as it entered the food chain. Develop New Research Methods Today, many pathogens in food or animal feed cannot be identified. Other pathogens have developed resistance to time-tested controls such as heat and refrigeration. With FY98 funds, the agencies will focus research immediately to: Develop rapid, cost-effective tests for the presence in foods of pathogens such as Salmonella, Cryptosporidium, E. coli 0157:H7, and hepatitis A virus in a variety of foods, especially foods already associated with foodborne illness.

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Enhance understanding of how pathogens become resistant to food-preservation techniques and antibiotics. Develop technologies for prevention and control of pathogens, such as by developing new methods of decontamination of meat, poultry, seafood, fresh produce, and eggs. Improve Inspections and Compliance With FY98 funds, the agencies will pursue several strategies to increase inspections for higher-risk foods; the agencies will, among other things: Implement seafood HACCP. FDA will add seafood inspectors to implement new seafood HACCP regulations, and will work with the Commerce Department to integrate Commerce's voluntary seafood-inspection program with FDA's program. Propose preventive measures for fresh fruit and vegetable juices. Based on the best science available, FDA will propose appropriate regulatory and non-regulatory options, including HACCP, for the manufacture of fruit and vegetable juice products. Propose preventive measures for egg products. Based on the best science available, FSIS will propose appropriate regulatory and non-regulatory options, including HACCP, for egg products. Identify preventive measures to address public-health problems associated with produce such as those recently associated with hepatitis A virus in frozen strawberries and E. coli 0157:H7 on lettuce. These measures will be identified through a comprehensive review of current production and food-safety programs including inspection, sampling, and analytical methods. Improve coverage of imported foods. FDA will develop additional mutual recognition agreements (MRAs) with trading partners, initiate a federal-state communication system covering imported foods, and FDA and FSIS will provide technical assistance to countries whose products are implicated in a foodborne illness. Further Food-Safety Education Foodborne illness remains prevalent throughout the United States, in part because food preparers and handlers at each point of the food chain are not fully

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informed of risks and related safe-handling practices. Understanding and practicing proper food-safety techniques, such as thoroughly washing hands and cooking foods to proper temperatures, could significantly reduce foodborne illness. The Administration—working in partnership with the private sector—will use FY98 funds to, among other things: Establish a Public-Private Partnership for Food-Safety Education. FDA, USDA, CDC, and the Department of Education will work with the food industry, consumer groups and the states to launch a food-safety public awareness and education campaign. The Partnership will develop, disseminate, and evaluate a single food-safety slogan and several standard messages. Industry has pledged $500,000 to date to support the partnership's activities and plans to raise additional funds. Educate professionals and high-risk groups. Agencies will better educate physicians to diagnose and treat foodborne illness; strengthen efforts to educate producers, veterinarians, and state and local regulators about proper animal drug use and HACCP principles; and work with the Partnership to better train retail- and food-service workers in safe handling practices and to inform high-risk groups about how to avoid foodborne illness, e.g., in people with liver disease, illness that may be caused by consuming raw oysters containing Vibrio vulnificus. Enhance federal-state inspection partnerships. New federal-state partnerships focused on coordinating inspection coverage (particularly between FDA and the states) will be undertaken, in an important step towards ensuring the effectiveness of HACCP and ensuring that the highest-risk food plants are inspected at least once per year. Continue the Long-Range Planning Process Through this initiative, and through previous activities, HHS, USDA, and EPA have laid the groundwork for a strategic planning effort. There is a broad recognition of the need to carefully implement the initiative's programs, and to consider how to apply preventive measures in other areas of concern. A strategic-planning effort is needed to build on this common ground, and to tackle some of the difficult public-health, resource, and management questions facing federal food-safety agencies. The federal food-safety agencies are committed to continuing to meet with stakeholders, ultimately to produce a strategic plan for improving the food-safety system.