Food and Drug Administration
U. S. Department of Agriculture
U. S. Environmental Protection Agency
Centers for Disease Control and Prevention
May 1997

FOOD SAFETY FROM FARM TO TABLE:
A NATIONAL FOOD SAFETY INITIATIVE

REPORT TO THE PRESIDENT
MAY 1997


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


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) O157: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 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.

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 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 O157:H7, and hepatitis A virus in a variety of foods, especially foods already associated with foodborne illness.

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 O157: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 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.


A NEW INTERAGENCY STRATEGY
TO PREVENT FOODBORNE DISEASE

In his radio message on January 25, 1997, President Clinton announced a new initiative to improve the safety of the nation's food supply. The President announced he would request $43.2 million in his 1998 budget to fund a nationwide early-warning system for foodborne illness, enhance seafood safety inspections, and expand food-safety research, risk assessment, training, and education (see Appendix A). President Clinton also directed the Secretary of Agriculture, the Secretary of Health and Human Services, and the Administrator of the Environmental Protection Agency to work with consumers, producers, industry, states, universities, and the public to identify additional ways to reduce the incidence of foodborne illness and to ensure our food supply is the safest in the world. The President directed Secretaries Glickman and Shalala and Administrator Browner to report to him with recommendations in 90 days. He instructed them to consult with a broad range of stakeholders in the food-safety system and to explore opportunities for public-private partnerships to improve food safety. And he asked that their recommendations include ways to improve surveillance, inspections, research, risk assessment, education, and coordination among local, state, and federal health authorities.

To start the discussion, the agencies issued a draft document summarizing their initial ideas. Subsequently, the agencies held two public meetings on March 5 and March 31-April 2, and established public dockets for written comments.

This report is the result of that 90-day process of deliberation and discussion among all stakeholders in the nation's food-safety system, including federal, state, and local agencies, consumers, academia, food producers, processors, manufacturers, distributors, representatives of the retail and restaurant sectors, veterinarians and health professionals, and many others.

The goal of this initiative is to reduce the incidence of foodborne illness to the extent possible. The recommendations presented in this report are based on the public-health principles that society should identify and take preventive measures to reduce the risk of illness and that it should focus its efforts on hazards that present the greatest risks.


FOODBORNE ILLNESS:
A SIGNIFICANT PUBLIC-HEALTH PROBLEM

The Council for Agricultural Science and Technology, a private nonprofit organization, estimated in its 1994 report, Foodborne Pathogens: Risks and Consequences, that as many as 9,000 deaths and 6.5 to 33 million illnesses in the United States each year are food-related. The Department of Agriculture (USDA) estimates that medical costs and productivity losses for 7 specific pathogens in food have been estimated to range between $6.5 billion and $34.9 billion annually. Total costs for all foodborne illnesses are likely to be much higher. Those estimates do not include the total burden placed on society by the chronic illness caused by some foodborne pathogens.

Several population groups have increased susceptibility to foodborne infections, such as persons with lowered immunity due to HIV/AIDS and those on medications for cancer treatment or for organ transplantation, as well as pregnant women and their fetuses, young children, and the elderly. Patients taking antibiotics or antacids are also at greater risk of infection from some pathogens. The consequences of foodborne disease are particularly serious for those with inadequate access to health care, such as homeless people, migrant farm workers, and others of low socioeconomic status.

Sources of Foodborne Contamination

Bacteria and other infectious organisms are pervasive in the environment.

Some microbial pathogens give rise to diseases that are far more serious than the uncomfortable but relatively temporary inconvenience of diarrhea and vomiting, which are the most common symptoms of so-called "food poisoning." Foodborne infections can result in very serious immediate consequences, such as spontaneous abortion, as well as long-lasting conditions, such as reactive arthritis, Guillain-Barré syndrome (the most common cause of acute paralysis in adults and children), and hemolytic uremic syndrome (HUS), which can lead to kidney failure and death, particularly in young children. Some of the microbial pathogens that have been the source of foodborne illness cases and outbreaks recently include, Salmonella, Campylobacter, Shiga-like toxin-producing Escherichia coli, Vibrio, Toxoplasma gondii, Cryptosporidium parvum, Norwalk virus, and hepatitis A. A full description of these pathogens, the foodborne illnesses they cause, and frequently implicated foods may be found in Appendix B. In addition to microbial pathogens, other substances may contaminate foods and cause foodborne illness. Among these are naturally occurring mycotoxins and marine toxins.


THE CURRENT SYSTEM FOR PROTECTING FOOD

Our food-safety system, although generally successful in protecting the public, is characterized by complexity and diversity. Regulatory authority is divided among federal, state, and local governments. The private sector has the primary responsibility for ensuring the safety of the food that it produces. From the farm to the consumer's dinner table, the responsibilities can be summarized as follows:


THE FOOD-SAFETY SYSTEM MUST BE PREPARED
FOR THE 21st CENTURY

The system for identifying and preventing foodborne illnesses described above was largely created in the early 1900s. It must be modernized. The system cannot properly identify, track, and control food-related illness, or prevent, to the extent possible, future cases from occurring. In 1981, FDA inspected food firms every 2-3 years, but can now visit those firms, on average, only once every 10 years (although some plants that produce higher-risk foods may be inspected more frequently). State and federal resources are not closely coordinated. Our understanding of some disease-causing organisms is so limited that our ability to protect the public health is seriously constrained.

The Clinton Administration has already taken a number of steps to improve the safety of the food supply.

These advances are significant, but they are not enough. New pathogens, new food products, huge increases in imported foods, the growing importance of food exports, and increasing antimicrobial resistance among foodborne pathogens present new challenges to the nation's food-safety programs. The food-safety system is in need of change, especially change that builds on the preventive principles embodied in HACCP.

IMMEDIATE ACTIONS TO IMPROVE FOOD SAFETY

Because there are many causes of foodborne illness, many points at which foods can become contaminated, and many factors that make some groups of people more susceptible than others, no single preventive measure will ensure the safety of all foods. However, practical preventive steps can be taken immediately to reduce the incidence of foodborne infections.

The Administration's food-safety efforts focus on the hazards and foods that present the greatest risks to public health and impose the greatest economic burden on the nation, emphasize development and implementation of preventive controls of those risks, and seek to ensure that preventive controls are cost-effective. The Administration is emphasizing the use of HACCP principles, and seeks opportunities for such controls through a collaborative process with the responsible sectors of the food industry and all other stakeholders.

Under this initiative, the federal government, in concert with state and local governments, industry and academia, would conduct research and risk assessments and cost-benefit analyses to determine how foodborne illnesses occur and can be prevented or controlled in the most efficient and cost-effective manner; improve surveillance and investigative efforts to locate and monitor illnesses caused by food; achieve more effective and efficient monitoring of the safety of the food supply through inspections of food processors; and reinvigorate education of all those involved in food preparation focusing on the use of safe practices. These issues, and actions and recommendations for addressing them are described below. Because the components of the food-safety initiative are interrelated, overlapping activities will be noted throughout this report (for example, among research and risk assessment, and education and inspection).

A NEW EARLY-WARNING SYSTEM FOR FOODBORNE DISEASE SURVEILLANCE

Background

The primary objective of the American system of public health is to prevent disease before it occurs. Although prevention of all disease might not be possible, stopping outbreaks of foodborne illness before they affect large numbers of people is a major goal. America needs an effective early-warning system that can detect and stop outbreaks before they spread. Such a system will also advance understanding of foodborne illness and further prevention efforts. In his January 25 radio address, the President announced a new national early-warning system for foodborne illness for which he is requesting funds in his FY98 budget.

Problem

The current public-health system in the United States has limited means to identify and track the causes of foodborne illness. A more effective early-warning system is needed to detect and stop outbreaks early before they spread. Also, the national and global increase in antimicrobial resistance is a compelling public-health problem. Human infections caused by resistant pathogens increase morbidity and mortality and increase health care costs as newer, more expensive antibiotics are needed to treat common infections.

Recommendations

Surveillance and investigation are powerful tools to detect new foodborne disease challenges, to determine what specific food sources are implicated in foodborne illness, and to learn how best to keep foods from becoming contaminated in the first place. Surveillance for antimicrobial resistance will allow early detection of resistance and containment of its spread. Rapid detection of outbreaks is critical to stopping them before they affect many people. A key element in an early-warning system is the ability to detect, compare, and communicate unusual patterns of illness and laboratory findings within and among states and federal partners.

Enhancing the capacity of states to monitor foodborne disease and to investigate and control outbreaks will lead to better general control measures and fewer illnesses. One way to achieve this is to enhance and expand the existing Foodborne Disease Active Surveillance Network (FoodNet) to identify, investigate, and control a broad spectrum of foodborne diseases. A second important way to enhance early warning is to increase the capacity of many states to deal with new foodborne challenges. These enhancements will help us identify outbreaks and other foodborne disease challenges early, and prevent illness and premature deaths related to foodborne diseases.

In cooperation with state and local health departments, the federal government is proposing to take the following steps to establish a national early-warning system for foodborne diseases, and to enhance surveillance of such disease. These changes will result in an improved system for promptly and accurately detecting and reporting foodborne illnesses and outbreaks so public-health agencies can rapidly institute appropriately and correctly focused measures to control the spread of foodborne disease. This system will also collect critical data to recognize trends and target prevention strategies, including systems based on HACCP principles, and to evaluate the effectiveness and efficiency of prevention strategies already in place.

Enhance and Expand Foodborne Disease Active Surveillance

CDC, FDA, and FSIS support five FoodNet sites at state health departments to track cases of foodborne infections and to determine the sources of the most common ones. The existing sites will be strengthened, and their number increased to seven in FY97, and to at least eight in the following year. The sites and federal food-safety agencies will be electronically linked to create a powerful new network to detect, respond to, and prevent outbreaks of foodborne illness. Adding additional sites will improve geographic and demographic representation, making this network more likely to detect diseases and outbreaks that are regional rather than national in distribution.

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Enhance Early Detection of Foodborne Disease Nationwide

The early-warning system will enhance improved early detection of foodborne disease in additional states in FY98 by providing resources for improved surveillance, investigation, control, and prevention of foodborne disease outbreaks. Although sophisticated laboratory studies can identify causes of illness and show relationships among pathogens, laboratory methods are insufficient without investigators who can collect samples, interview people, and trace the source of contamination to find out why the illness occurred. New electronic tools need to be developed to enable rapid detection of outbreaks and to enhance communication about outbreaks to appropriate agencies. CDC also should provide additional resources to states to increase their surveillance and response capacity for the serious long-term consequences of foodborne disease, such as hemolytic uremic syndrome (HUS).

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Modernize Public-Health Laboratories

CDC should provide resources and training to upgrade public-health laboratory capabilities in FoodNet sites and in states without those sites so the laboratories can rapidly identify a broad range of foodborne pathogens, including parasites and viruses, and can use new techniques like DNA fingerprinting. The new capacities would allow rapid identification of the cause of some outbreaks that currently go undiagnosed.

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Create a National Electronic Network for Fingerprint Comparison

CDC should fund a new computer network and database system that would capture fingerprints of pathogens in a national database, linking CDC, FDA, FSIS, and states that have that new capacity into a national network. This technology would, for example, permit rapid recognition that an E. coli O157:H7 bacterium cultured from a patient in Washington was indistinguishable from one isolated from another patient in California. That might suggest to public-health investigators that a product distributed in California and Washington was contaminated with the same organism.

In addition to identifying, investigating, and reporting cases of foodborne disease in humans, microbiological surveillance of pathogens in foods, in food animals and their manures, and in animal feed, is important to control and prevent foodborne diseases and to evaluate the measures that reduce the risk of exposure. Therefore, to make the early-warning system fully operational and to translate its findings into long-term improvements in the safety of the food supply, additional surveillance activities would be required.

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Increase National Surveillance for Antimicrobial Resistance of Foodborne Pathogens

The problem of foodborne disease is increasing, in part, because foodborne infections are becoming more serious. One of the ways foodborne pathogens become more virulent is by acquiring resistance to antimicrobial agents, making such infections very difficult to treat. Therefore, CDC should expand surveillance for antimicrobial resistance in Campylobacter, Salmonella, and E. coli O157:H7 isolated in humans, and FDA and FSIS should take similar steps for those bacteria isolated from food-producing animals and their manures and from food products in a way that permits those data to be compared. CDC, FDA and FSIS should develop standard procedures for sharing information and for responding to increases in resistance or other "red-flag events" such as the discovery of an important new resistant bacterium.

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Conduct Surveillance of Human Pathogens in Food-Animal Populations and Enhance Oversight of Animal Feedstuffs, Feeds, and Manures for the Effect of Drugs and Other Therapies

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

INTERSTATE OUTBREAK CONTAINMENT AND RESPONSE COORDINATION

Background

Four federal agencies are charged with responding to outbreaks of foodborne illness (including waterborne illness): FDA and CDC (at HHS), USDA, and EPA. All states, and many local governments, with widely varying expertise and resources, share responsibility with the federal government for response to such outbreaks. When an outbreak occurs, all of the relevant entities must work together to efficiently and effectively prevent deaths and minimize the number of illnesses. The better coordinated the response, the more quickly the outbreak will be contained.

Each of the four federal agencies has a potentially critical role when an outbreak occurs. CDC's primary responsibility is to assist state and local health departments in investigating outbreaks of illness and in identifying the cause of the outbreak. FDA, FSIS, and EPA also have responsibility for determining whether a product they regulate may be causing illness, and of halting the spread of illness by taking regulatory action against the suspect products, or wastes (other than animal manures) that have the potential to contaminate the air, land, or waters used to produce the food product. The type of food affected determines which regulatory agency has primary jurisdiction: FSIS regulates meat, poultry, and egg products; FDA regulates all other foods including shell eggs; and EPA regulates water and pesticides and manages organic and inorganic wastes used or disposed of on agricultural land. While each agency has clearly defined areas of responsibility, the successful containment of many outbreaks of foodborne illness involves more than one agency.

The states and many local governments also have a critical role. Identification and investigations of foodborne illness often begin at the community or state level. States share with the federal government the legal responsibility for protecting the health of their residents. Although foodborne outbreaks are sometimes local, most outbreaks implicate federal agency jurisdiction. Illnesses cross state borders, and most foods or food ingredients are processed or produced in another state or by international trading partners. Federal involvement is also necessary when contaminated food from a common source has been distributed to grocery stores, restaurants, and homes in more than one state.

In many outbreaks of foodborne illness, federal agencies work with state and local health authorities in their investigations and in implementation of control measures through consultation, diagnostic assistance, and by regulatory action against the products. In some instances, on-site assistance is requested by the local and state authorities from the CDC to establish the cause of an outbreak, and from other agencies to help find the source of the problem. For large or multistate outbreaks, federal agencies play a critical coordination role to ensure consistency of approach and implementation of needed control measures.

Companies responsible for affected products also have a critical role to play. Food companies are sometimes the first to recognize that their product is causing illness. In addition, food-product recalls are voluntary, although FDA may request a company to recall products. Federal and state agencies can benefit from industry's expertise about food products and their distribution patterns.

Problem

Although significant coordination already occurs among federal, state, and local agencies, better coordination is needed to meet new and growing threats to the nation's food supply. More than one agency is involved in virtually every large foodborne outbreak. Joint efforts are often hindered by a lack of communication or a misunderstanding of each agency's role in a particular situation.

Recommendations

Federal, state, and local governments should improve the coordinated management of interstate outbreaks. Improved coordination among the federal agencies, among federal, state, and local agencies, among the various state agencies, and between state and local agencies would enhance the level of public health protection, leverage agency resources and experience, and avoid duplication of effort.

The early-warning capability, comprised of FoodNet and strengthened state-surveillance capacity, and improved federal-state communications will enhance appropriate involvement of federal agencies in the investigation of foodborne disease outbreaks. Communication and exchange of information among the appropriate federal, state, and local government agencies must be improved.

Improve Outbreak Containment Through Better Federal-State-Local Coordination of the Evaluation of and Response to Foodborne Illness

There are probably hundreds of times a year when at least one federal agency, working with state and local agencies, plays a role in detection, investigation, and containment of illnesses that may be caused by contamination of food. Occasionally (typically once or twice a year) the outbreak is sufficiently significant and complex to require the involvement of the highest level officials in the responsible federal agencies. When this occurs, it is essential that federal agencies speak with one voice.

A critical element of an effective, rapid response to a foodborne illness outbreak is ready communication by all the involved parties at the federal, state, and local level. Although there are communication systems in place, they need to be expanded and coordinated to achieve rapid exchange of information and data between key outbreak-response personnel in each agency at the federal, state, and local levels. This strengthened system will complement the data and information exchange systems described in the "Early Warning for Foodborne Disease Surveillance" section of this report.

As part of this initiative, the agencies have streamlined their outbreak-response procedures. The departments with a role in any foodborne illness outbreak will be determined by public-health responsibility and regulatory jurisdiction over the food products (or water) implicated in the outbreak. Each department with public-health responsibility and regulatory jurisdiction over food products (or water) implicated in an outbreak will designate a Coordinator responsible for that Department's activities related to the outbreak.

This new management system will provide a common set of objectives and strategies and one spokesperson that will speak on behalf of the federal government. Once there are indications to federal or state agencies of a large-scale problem, the staff will tell the Coordinator who will then coordinate the response among federal and state agencies.

Each agency has specific mechanisms in place to aid in this effort. FSIS has established an Emergency Response Program to prevent and control foodborne disease outbreaks involving meat, poultry, and egg products. Likewise, FDA's Division of Emergency and Investigational Operations serves this function for all other food products. Both FDA and FSIS maintain 24-hour telephone service staffed with a duty officer trained to respond to emergencies and ongoing illnesses, including foodborne illness and outbreaks, who have access to emergency personnel throughout the agency, as well as with emergency contacts in other agencies. FDA's Division of Emergency and Investigational Operations will serve to coordinate with other agencies. CDC provides 24-hour emergency consultation for botulism and other foodborne disease clinical emergencies and stations Epidemic Intelligence Service officers in 15-20 states each year to support surveillance and emergency response at the state level.

In order to improve communications with state agencies, FDA has adopted a fax-on-demand and fax broadcast system. The fax broadcast system, containing a database of more than 900 state officials, permits messages to be sent any time of day or night to any list of state contacts, providing an early alert or update to foodborne illness investigations. The fax-on-demand system provides access to press releases from federal agencies, press releases from firms about their recall, as well as other information. FSIS communicates with state departments of health and coordinates outbreak response through CDC WONDER (Internet) and both FDA and USDA maintain liaisons at CDC to facilitate food-safety activities, including outbreak investigations. CDC has established rapid communication links with all state and territorial epidemiologists and public health laboratory directors providing rapid group electronic mail and group fax links, and conference calls in outbreak settings.

FDA has also instituted a 50-state conference call system to keep all state agencies up-to-date on major foodborne outbreaks. This system was first used for the outbreak involving E. coli O157:H7 in apple juice and was most recently used for the hepatitis A outbreak associated with frozen strawberries. FDA and CDC jointly participate in these calls to assure more effective follow up and control of outbreaks. FDA will modify the conference call system to involve appropriate states in the very early stages of any multistate outbreak, as well as continuing the 50-state update conference calls, in order to ensure better communication among state and federal agencies.

FY97 Activities

Enhance State and Local Infrastructure for Foodborne Outbreak Detection, Evaluation, and Response Coordination

The epidemiology offices and laboratories within state and local health departments are charged with the surveillance of infectious and non-infectious conditions, and, along with other state and local officials, with the investigation of outbreaks. They collect surveillance data from physicians, laboratories, local health departments, and other sources. Yet, the resources available in many states and communities for the surveillance and investigation of foodborne diseases are limited and decreasing, thereby limiting the effectiveness of their response. As a result, outbreaks may go undetected or are never investigated.

CDC, EPA, FDA, and FSIS will address the problem first by assessing and cataloguing available state resources, and then by working with states and providing support for foodborne-disease-surveillance programs and assistance to better investigate outbreaks of foodborne illness.

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

RISK ASSESSMENT

Background

The impact of increased funding for development of methods and models directed at improving risk assessments will be to focus public resources on reducing those risks that have the greatest consequences for human health. Risk assessment provides a strong foundation upon which efficient allocation of scarce food-safety resources can be made. While obvious severe hazards in the food supply will be addressed through the larger food-safety initiative, risk assessment provides an objective foundation upon which efficient allocation of scarce food-safety resources can be established. Furthermore, risk assessment often plays a central role in the development of any science-based system of preventive controls.

There has been a long history of performing safety assessments or risk assessments for foods, particularly chemicals and drug residues. Risk assessments, cost-benefit analyses, and evaluations of alternative risk-management strategies are required for all major regulations in USDA, a requirement imposed by the Federal Crop Insurance Reform and Reorganization Act of 1994 (P.L. 103-354). EPA is developing methods for required risk assessments under the Safe Drinking Water Amendments of 1996, including both microbial and chemical hazards. Sound risk assessments are important in various aspects of international trade, including the provisions of Codex Alimentarius and the World Trade Organization, the international bodies that govern standards for food safety, among other issues. Carefully formulated risk assessments based on high-quality data and scientific information generated from research lead to more informed risk management and better decisions.

Risk assessment also provides essential information for estimating and analyzing the costs and benefits of policy alternatives. Risk estimates are used to characterize the state of the world in the baseline and the alternative states expected to occur after taking action, whether through regulation, guidelines, or education campaigns. Ideally, results of risk estimates are in the form of distributions that capture the scientific uncertainty and population variability, but where that is not possible, point estimates of risk need to reflect the impact on the entire population.

Risk management and risk assessment must mutually inform each other but must remain separate and independent entities. Risk communication must be an integral part of all risk-related activities, including the public, industry, and all affected parties.

Good risk assessment requires good risk communication. Participation from industry, academia, and private risk organizations will be ensured in the interagency consortium's risk-assessment activities. Good risk communication must be ensured by interfacing with educators. Active communication between the risk assessment consortium and the research community is crucial to a successful initiative.

Risk assessment characterizes the nature and size of the risk to human health associated with hazards, and to make clear the degree of scientific certainty of the data and the assumptions used to develop the estimates. Risk assessments require specific information on the hazard and on the exposed population to provide meaningful information for those making risk-management decisions. Even for chemical hazards, for which risk-assessment force the use of assumptions about exposure, hazard potency, and characteristics of the population at risk.

Problem

Risk assessment is far less developed for foodborne pathogens. Intensive commitment is necessary to develop critically needed methods of analyzing the available data and addressing its uncertainty; methods that account for variability, specifically of living microbial pathogens, are essential. Chemical and radiological risks do not pose these special challenges, so extending these established methods to microbial risk is not sufficient.

The research needed to develop improved methods and models that will make it possible to perform quantitative microbial risk assessments to the degree of complexity required for most food-safety issues will require the integration of work in biological sciences, predictive microbiology, and applied mathematics. In some instances, the research needs overlap with those identified in the research section of this document. However, to reflect the multidisciplinary nature of the needed research programs and to highlight the critical nature of the research needs, research needs related to risk assessment are being presented as a separate item for consideration.

Recommendations

This initiative emphasizes the development, testing, and validation of microbial risk assessment and foodborne illness valuation methods. These efforts should support effective and efficient public response to foodborne illness concerns, whether the response is improved surveillance plans, better prevention stategies, or stronger inspection models. The initiative's activities focus on developing models for inproving risk assessment, thereby more precisely targeting the prevention of foodborne disease by informing surveillance plans, prevention stategies for process-control systems and for food inspections based on HACCP principles, and research programs to fill critical food-safety information gaps. Recommendations are being made in three areas.

Establish a Risk Assessment Consortium

All federal agencies with risk-management responsibilities for food safety will establish jointly a consortium at which federal agencies can collectively advance the science of microbial risk assessment, and to assist agencies in fulfilling their specific food-safety regulatory mandates. The consortium should be inclusive in its risk-assessment activities, seeking expertise from risk-assessment professionals and scientists from public and private sources, as well as industry and consumer groups. The goal of the consortium would be to improve the quality of risk-assessment research by coordinating research priorities, eliminating redundancies of effort, and encouraging multidisciplinary research efforts. The consortium will have three primary functions:

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Develop and Validate Exposure Assessment Models Based on Probabilistic Methodology

Risk assessment of foodborne illness is dependent on accurately estimating the probability that various quantities of a toxin or pathogen will be ingested by the consumer (i.e., exposure assessment). This initiative addresses numerous data and modeling deficiencies in estimating exposure to microbial and chemical contaminants. Specifically, research will be conducted into the development of models and simulations based on probabilistic methods for the occurrence of microbial pathogens and chemical hazards in food at all stages of the food chain; typical behaviors of commercial and home preparation operations; validation of dynamic exposure assessment models; evaluation of intake data regarding food-consumption patterns of the general population and sensitive subpopulations; and specific data on microbial behavior in food vehicles of sporadic and epidemic disease. Research on how to incorporate data related to biomarkers should be pursued. (Biomarkers are surrogates that indicate that exposure has occurred or that some effect has occurred, particularly when actual evidence of exposure or effect is difficult or impossible to obtain.)

FY98 Activities with Food-Safety Initiative Funds

Working with FDA, EPA, and USDA, the consortium will identify priority research programs in two areas that are in need of augmentation: exposure assessment methods, and techniques for acquisition and analysis of experimental data for model development. Initial areas identified include:

Long-term Activities

Future initiatives would be fluid to adjust to results of short-term research, emerging food-safety needs, and changes in the direction of research programs within individual agencies. Additional research would likely include the development of modeling techniques to assess human exposure resulting from the subtherapeutic use of veterinary antibiotics in food-producing animals. To reduce uncertainties in exposure estimates, the consortium will work with researchers who are conducting focused food-consumption surveys targeting foods consumed by a variety of subpopulations (e.g., the elderly, children).

Develop and Validate Dose-Response-Assessment Models for Use in Risk Assessment

Research is needed to accurately estimate the relationship between the quantity of a biological agent and the frequency and magnitude of adverse human health effects in a population. Dose-response assessments typically include estimates of the rates of infection, morbidity, and mortality.

FY98 Activities with Food-Safety Initiative Funds

Working with FDA, EPA, and USDA, the consortium will identify priority research programs in dose-response-assessment methods and models that need to be augmented. Initial areas identified include:

Long-term Activities

Risk-assessment research priorities in this area will be collectively established by the interagency consortium. Additional research includes studying whether threshold or non-threshold models for infectivity are more appropriate for describing low-dose infectivity rates for infectious and toxicoinfectious microorganisms. Further research is also needed into the use of biomarkers of susceptibility, chronic sequelae, microbiological toxicokinetics, and infectious dose.

RESEARCH

Background

Food-safety research is critically needed to develop the means to identify and characterize more rapidly and accurately foodborne hazards, to provide the tools for regulatory enforcement, and to develop effective interventions that can be used as appropriate to prevent hazards at each step from production to consumption. FDA, CDC, EPA, NIH, ARS, and CSREES, conduct research related to pathogenic microorganisms and other contaminants that threaten the safety of food. That research supports the needs of both the federal and state food-safety agencies and the many food industries.

Problem

New foodborne pathogens have emerged over the past ten years. Other microorganisms, previously thought to be innocuous, have been linked to life-threatening diseases after acquiring new virulence genes and antimicrobial resistance. Many of those organisms cannot be detected readily due to either a lack of suitable methods or their sporadic occurrence in foods. Certain foodborne pathogens are increasingly associated with resistance to time-tested controls, such as heating, refrigeration, and acid. In some cases, that ability appears to be linked with increased virulence or new ways to evade our immune defenses. The various research programs of FDA, ARS, CSREES, CDC, EPA, and NIH need to better coordinate their research efforts on the highest-priority issues and work together more effectively to leverage each other's resources.

Recommendations

Prevention of foodborne pathogens in foods requires an understanding of how foods become contaminated during their production, processing, and distribution, and the availability of practical interventions to control or eliminate the biologic agent. Selection of target pathogens and foods ideally are guided by risk assessment. Research is also needed to support HACCP implementation to verify that critical control points in HACCP systems are working, and to target the data gaps that hamper HACCP and risk assessment. Among the recognized data gaps, the following areas were identified as priority research needs. (Research activities listed for FY97 and FY98 are not necessarily completed in those years. Therefore, activities listed as long-term are additional activities.)

Improved Detection Methods

Many pathogens cannot be easily detected in foods, e.g., Cyclospora in raspberries. Among the needs for improved diagnostics, methods are needed for rapid, cost-effective testing for pathogens in food animals and their manures, in agriculture and aquaculture products, animal feeds, and processed food products. Methods development must address the low-level, sporadic incidence of many pathogens in foods. Research will be coordinated with EPA's efforts to develop better test methods for Cryptosporidium and other pathogens in water and drinking water. Improved methods are needed for the identification and subtyping of foodborne pathogens in human and animal clinical specimens. The development of effective sampling plans and enrichment techniques are vital parts of detection methodology.

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Understanding Resistance to Traditional Preservation Technologies

Microorganisms that are resistant to antimicrobial agents and processing techniques that have been relied on traditionally to eliminate or prevent the growth of foodborne pathogens have become increasingly important causes of serious foodborne disease. Research is needed to determine how microorganisms associated with foodborne disease become tolerant to various types of antimicrobials and to traditional food-safety safeguards, such as heat or cold, low pH, high salt, and disinfectants, and to elucidate factors in animal- and plant-production systems and processing environments that influence the development of resistance. The physiological and genetic bases of resistance are not understood well enough to prevent breakthrough of newly emerging pathogens. Such research will help identify food production, processing, and handling practices that are likely to contribute to pathogen contamination or proliferation. That research is also needed to guide improvement of traditional techniques and the development of new interventions.

Long-term Activities

Understanding Antibiotic Drug Resistance

Pathogens in food-producing animals and their manures may become resistant to antibiotics and drugs, particularly when used improperly. One possible solution might be to modify drug withdrawal periods. Such an approach would require scientific data to be developed on how the resistance profiles of microbial populations in animals changes in response to the elimination of a drug. Work involving resistance to traditional preservation technologies and antibiotic drug resistance must be based on a sound understanding of microbial, physiologic, and genetic adaptive mechanisms.

FY98 Activities with Food-Safety Initiative Funds

Prevention Techniques: Pathogen Avoidance, Reduction, and Elimination

Contaminants are introduced into the food supply at numerous points along the way from farm to table. Food animals and their manures can carry human pathogens, without any clinical manifestations. Likewise, fresh fruits, fresh vegetables, and grains can harbor pathogens or mycotoxins without any discernable loss of quality. In such cases, traditional approaches of segregating contaminated foods are ineffective, and active interventions are needed. In particular, new interventions are needed to prevent and control the pathogens listed below in raw agricultural commodities and seafood. Developments in this area would be expected to provide new approaches for controlling a variety of other foodborne contaminants.

FY98 Activities with Food-Safety Initiative Funds

For Campylobacter, Salmonella, Toxoplasma, E. coli O157:H7, and other Shiga-like toxin-producing E. coli, and Cryptosporidium, FDA and ARS, often in partnership with universities and industry, will:

Long-term Activities

Food Handling, Distribution, and Storage

Food production, processing, and consumption often occur thousands of miles apart. Stresses associated with the transportation of live animals and fresh produce can contribute to the dissemination of foodborne pathogens. Effective packaging and proper food-storage conditions are critical to maintaining the level of safety achieved by processing.

Long-term Activities

Charge an Interagency Committee Convened by the Office of Science and Technology Policy (OSTP) to Coordinate Federal Research Priorities and Planning

Numerous opportunities exist for collaboration and the development of research partnerships among federal and state agencies, the private sector, and academia. A mechanism is needed to coordinate food-safety research among federal agencies, to link research with the activities and needs of the agencies, to better leverage agency resources and experience, and avoid duplication of effort. Such a coordination mechanism could be provided by an OSTP-convened interagency committee. That committee would review food-safety responsibilities and research programs of the various agencies with a view to recommending direction of research funds and programs in accordance with those responsibilities.

IMPROVING INSPECTIONS AND COMPLIANCE

Background

Inspection of commercial food processors is an integral part of the food-safety assurance system. Inspections are carried out by federal, state and local authorities. In addition to other food-inspection responsibilities, state and local officials also have primary responsibility for inspecting restaurants, supermarkets, and other retail establishments. At the federal level, FSIS has responsibility for meat and poultry inspection in slaughter and processing plants and egg-product-processing plants, and for all imported meat, poultry, and egg products. FDA conducts periodic, random inspections of all other food-processing plants; that entails fewer than 700 inspectors and laboratory personnel for 53,000 U.S. plants and for all other imported foods.

Problem

The number of inspections conducted by FDA has decreased steadily since 1981, when 21,000 inspections were conducted, so that today resources exist to carry out only about 5,000 inspections per year. An FDA-regulated plant is inspected by FDA, on average, only once every 10 years. FDA also relies upon the states to conduct some inspections under contract, but that number has dropped from 12,000 in 1985 to 5,000 now. Moreover, because the number of imports has doubled over 5 years, with no real increase in inspectors, a smaller percentage of imports are inspected at entry.

Given the limited inspection coverage, FDA is finding an increasing number of problems--the number of products recalled for life-threatening microbial contamination has increased almost five-fold since 1988. Federal budget constraints will likely prohibit significant funding increases in the future, so FDA must find new ways to provide adequate inspection coverage.

Recommendations

Scientists and other food-safety experts have concluded that the most effective and efficient mechanism to ensure that food processors identify and control hazards that could threaten food is the application of HACCP principles. FDA's seafood HACCP regulations go into effect in December 1997. FSIS began to implement its HACCP and Pathogen Reduction Requirements for the meat and poultry industries in 1997 with phase-in to be completed in 2000. HACCP programs allow government and industry resources to be used more appropriately, allowing the government and industry to focus on the greatest risks. To ensure that HACCP is properly implemented, and to ensure more efficient and effective monitoring of the safety of the food supply, recommendations are being made in the following areas.

Enhance Development of HACCP Procedures

FY97 Activities:

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Enhance the Safety of Foods in Retail Food Establishments Particularly at State and Local Levels

More than 3,000 state and local regulatory agencies have primary responsibility for monitoring retail food establishments to ensure that consumers are protected. U.S. retail establishments include approximately 785,000 commercial and institutional food establishments, 128,000 grocery and convenience stores, and 1.5 million vending operations. Workers in these establishments have highly diverse backgrounds and training.

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Enhance Federal-State Inspection Partnerships

State inspection programs are an important component of the nation's food-safety inspection system. The move toward HACCP will pose a challenge to the states that federal agencies can help the state system to meet. If HACCP is to be an effective program for ensuring that food processors have modern, state-of-the-art food-safety procedures in effect, FDA must improve its inspection capabilities, so that the highest-risk food plants are inspected at least once per year. New federal-state partnerships focused on coordinating inspection coverage (particularly between FDA and the states), are major steps in this direction.

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Enhance Coverage of Imported Foods with Specific Attention to Foods Regulated by FDA

Wharf examinations and sampling of foods being offered for import into the United States have dropped by 50% in just the past four years. Today, FDA is responsible for about 2.2 million import food entries (i.e., shipments), an increase from 1.5 million entries just 5 years ago, with the same number of staff.

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Enhance Safety of Foods During Transportation

In considering whether and how to regulate the transportation of meat, poultry, seafood, eggs, and other foods to safeguard the public from pathogenic microorganisms and other hazards, FSIS and FDA published an ANPR on November 22, 1996.

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

EDUCATION

Background

An integral part of the overall food-safety initiative is providing food-safety education to a variety of audiences: consumers (the general public and specific groups at risk for foodborne illness); public-health professionals and physicians; retail, food-service, and institutional food preparers; veterinarians, animal and other food producers; and food-transportation workers. The challenge is to create educational messages that address the risks relevant to each audience throughout the food chain. Research and risk assessment are important elements in identifying these risks and devising appropriate messages. Realizing that educational efforts are cost-effective investments, federal, state and local governments, private organizations, consumer groups, and industry have fostered educational programs to address foodborne illness.

Problem

Despite educational efforts, foodborne illness remains prevalent throughout the United States. For example, from 1988 to 1992, Salmonella caused 69% of the 796 bacterial foodborne disease outbreaks; 60% of those Salmonella outbreaks were caused by Salmonella Enteritidis. S. Enteritidis also resulted in more deaths than any other pathogen, with 85% of these deaths occurring among residents of nursing homes.

One reason is that food preparers and handlers at each stage of the food chain lack the knowledge of risks involved and the related safe food-handling practices. Food preparers in the retail sector must be made aware of how they can prevent food contamination and reduce pathogen growth, particularly by preventing cross-contamination with other foods and by properly cooking foods such as eggs. Without the knowledge of food-safety practices and proper food-handling procedures, foodborne illness cannot be significantly reduced. Food-safety messages should be developed to reach individuals at each stage from the farm to the table.

Risk assessment and research are needed to determine the most effective ways to overcome barriers to use of safe food-handling practices and to ensure use of safe food-handling practices by specific audiences. Consumers' food-handling practices and the choices they make in the foods they eat will either increase or decrease the chances of foodborne illness. Studies show that more than 50% of the public eats raw or undercooked eggs, 23% eats undercooked hamburger, 17% eats raw clams and oysters, and 26% do not wash cutting boards after using them for raw meat or poultry.

Health professionals and physicians also need specific knowledge about causes and effects of foodborne illness to more effectively detect and treat the illnesses. Producers of animals used in human food production and veterinarians treating such animals must be made aware of food-safety aspects of drugs and drug residues. Finally, those responsible for the transportation of food are often unaware that mishandling of food during shipment can result in contamination.

Recommendations

The goal of this initiative is to target and change unsafe food-handling practices by people throughout the food chain, including food-service workers, and especially those providing food to populations at high risk of foodborne illness. Objectives include: 1) forming partnerships and alliances to maximize resources and broaden the impact and scope of educational efforts; 2) designing messages by conducting research to identify barriers to safe food handling, upon which educational programs will be centered; and 3) expanding the use of innovative outreach methods, including the use of new technologies.

Implementation of the education goals and objectives of the initiative combined with the other elements of the initiative will significantly increase the number of consumers and food-service workers being reached with effective and persuasive food-safety messages.

Improve Consumer, Retail, and Food Service Education

FY97 Activities

The 1997 Consumer Food-Safety Education Partnership

A memorandum of understanding was signed in May 1997, formalizing a food-safety education partnership that includes industry, consumer groups, FDA, CDC, USDA, and the Department of Education. Participants in the partnership will launch a nationwide food-safety education campaign for the general public. The campaign will center on four key food-safety concepts tested for maximum consumer understanding and will include a slogan, logo or identifiable character. At present, the Partnership is reviewing proposals from national public-relations and communications firms to conduct a public awareness and education campaign. The industry groups have contributed almost $500,000 to date. Plans for the nationwide campaign will be announced at the food-safety education conference, "Changing Strategies: Changing Behaviors," sponsored by FSIS, CSREES, FDA, and CDC to be held June 12-13 in Washington, DC. The partnership will promote September as National Food Safety Month, as already designated by industry, and launch the food-safety education campaign during the month.

Identify key food-safety education principles through establishment of an expert council

Convene the National Food Safety Education Council, an independent scientific review board to periodically review food-safety education messages. The Council, which will include food scientists and educators, will serve to identify emerging food-safety risks that require public education. Risk assessment will be used to identify at-risk audiences for targeted food-safety education programs.

Other FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Conduct Research to Identify Barriers to Safe Food-Handling, Upon Which Educational Programs Will Be Centered

FY97 Activities

Under the auspices of the National Food Safety Education Council:

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Expand Existing Information Systems

FY97 Activities

FY98 Activities with Food-Safety Initiative Funds

Long-term Activities

Improve Veterinarian and Producer Education

Long-term Activities

Improve Health-Professional Education

Long-term Activities

Improve Industry Education in the Transportation Area

Long-term Activities

A BLUEPRINT FOR A BETTER FOOD-SAFETY SYSTEM

Background

The actions described in this report will significantly improve the safety of the nation's food supply, but the agencies recognize that this 90-day report does not address a number of critical issues facing our food-safety programs. The agencies recommend a longer-term strategic planning effort to consider how to best address important challenges and make the best use of the agencies' limited resources. This process will involve all public and private stakeholders, including consumer groups, affected families, state and local governments, and industry. One function of the strategic-planning process is to consider how to make the best use of each agency's limited resources.

Through this initiative, and previous activities, we have laid the groundwork for a strategic planning effort. For example, federal agencies, consumer groups, and industry have worked together to incorporate HACCP into meat, poultry, and seafood regulatory programs. And there is now a broad recognition of the need to carefully implement these programs, and to consider how to apply preventive measures in other areas of concern. A strategic-planning effort could build on this common ground, and tackle some of the difficult public-health, resource, and management questions facing federal food-safety agencies.

As discussed throughout this report, USDA, HHS, and EPA have responsibilities for ensuring the safety of the U.S. food supply. USDA and HHS also have ancillary responsibilities for the quality of our food. These responsibilities include the grading of agricultural commodities and grain by the Agricultural Marketing Service and the Grain Inspection Service, the importation of foreign plants and animals by APHIS, and the quality and wholesomeness of food purchased by the federal school lunch program. FDA sets standards of quality for a variety of food products. Regulatory requirements applicable to food products are largely established by FSIS for meat, poultry and egg products, and by FDA for all other products.

In recent years, there has been increasing evidence that foodborne diseases can be caused by microbial contamination in seafood, fresh fruits, vegetables, and other products. Moreover, during the Clinton Administration, both agencies have looked to a new and similar approach to food regulation. FSIS has adopted HACCP for the products that it regulates and FDA has adopted HACCP for seafood products, and is considering the HACCP approach for other products. During the next few years, the HACCP regulations that these agencies have adopted will go into effect, and more may well follow.

Developing a Strategic Plan

Over the past 90 days, the federal food-safety agencies have engaged a wide range of stakeholders in discussions about food-safety issues through a series of public meetings and through written comments to public dockets. Although these discussions have identified some ideas for approaches to strategic planning, they have more clearly established the need for continuing discussions about the process for developing a strategic plan.

Therefore, the agencies will initiate a longer-term strategic planning process to develop a strategic plan for improving the food-safety system. The process will facilitate the participation of all interested parties. Extensive, structured discussions will be needed to build trust in the process, and to obtain agreement on priorities, strategies for achieving change, and ways for measuring progress.

Because it is critical that the process be inclusive and equitable, the agencies will give interested parties an opportunity to comment on the possible approaches for structuring the dialogue before its implementation. The agencies will provide specific information regarding the general objective, scope, and conduct of the dialogue and strategic-planning process, management of the process, selection criteria for participants, and other relevant factors. Unanimous agreement is unlikely. Therefore, the agencies will use a general consensus to shape the planning process.

Broad participation of stakeholders is central to the success of the discussions. The achievement of such broad participation can be accomplished in a number of ways. The agencies will hold meetings in various regions of the United States, which will also ensure broad participation. These meetings will involve multiple sectors to ensure broad and balanced participation of all stakeholders in the food-safety system. The meetings will be open and their proceedings, products, and the process for producing those products transparent.

Issues for Consideration

A major challenge in developing a strategic plan will be attaining consensus on priorities for action to enhance food safety within the highly complex food-safety oversight system. Reaching agreement on priorities is compounded by the complexity of the food supply and the different perspectives of the various oversight agencies and groups. Federal and state agencies have established programs in research, risk assessment, education, surveillance, and inspection, and agencies are working to better coordinate activities within these programs. Nevertheless, a better system of identifying and setting priorities within these areas is essential to maximizing the use and effect of limited agency resources in reducing the incidence of foodborne illness and enhancing the safety of the food supply.

During the course of the stakeholder discussions, a variety of issues, ranging from specific to broad, surfaced as priority topics for discussion. A number of stakeholders suggested the need to consider such broad policy questions as:

More focused, technical issues were also suggested for consideration, among them:

Prepare a 3- to 5-Year Strategic Plan

Participants in the planning process would be charged with developing a strategic long-range agenda that could be used to help set priorities, improve coordination and efficiency, identify gaps in the current system, and enhance and strengthen prevention and intervention strategies, and identify measures to show progress. Each agency will incorporate the relevant parts of the strategic plan into its Government Performance and Results Act (GPRA) strategic plan, commensurate with its budget.

Measure Progress to Evaluate the Effectiveness of the Plan in Reducing the Annual Incidence of Foodborne Illness

After the plan's implementation, progress would be reviewed to determine the strategic plan's effect on reducing the annual incidence of foodborne illness. Measurable goals and objectives would provide a basis for establishing progress. Measurements could be based on a decline in the number of foodborne illnesses and deaths, a decline in the number of outbreaks, more effective prevention and intervention programs, more rapid, coordinated, and effective responses to foodborne illness outbreaks, increases in inspection coverage for domestic and imported products, changes in behavior, and better detection and quantification methodologies.


APPENDIX A
FY98 Budget -- Food Safety Initiative

HHS:
 
Food and Drug Administration
    Foods:
          Surveillance                            1,660,000
               Monitoring pathogen levels
               Support sentinel sites
          Coordination                              550,000
          Risk Assessment                         3,950,000
               Risk assessment consortium
               Exposure assessment
          Research                                3,900,000
               Analytical Methods
               Pathogen Control
               Food Handling
          Inspections                             7,870,000
               Implement seafood HACCP
               State partnerships
               Lab certification
          Education                               2,070,000
                   Consumer/retail education
                    Total Foods                  20,000,000
 
     Animal Drugs and Feeds:
                  Surveillance                    1,500,000
                  Research                        2,500,000
                      Total Animal Drugs & Feeds  4,000,000
 
Centers for Disease Control:
                  Surveillance                   10,000,000
 
                Total, HHS                       34,000,000
 
USDA:
 
Agricultural Research Service
                Research                          4,114,000
 
Cooperative State Research, Education
    and Extension Service
              Research                            2,000,000
              Education                           2,000,000
               Total, CSREES                      4,000,000
 
Food Safety and Inspection Service
 
          Surveillance                              500,000
          Inspections                               565,000
               Total, FSIS                        1,065,000
 
               Total, USDA                        9,179,000
 
    Total Initiative                             43,179,000




APPENDIX B
SOME IMPORTANT MICROBIAL PATHOGENS ASSOCIATED WITH FOODBORNE ILLNESS

Bacteria

Salmonella
Salmonella species cause diarrhea and systemic infections, which can be fatal in particularly susceptible persons, such as the immunocompromised, the very young, and the elderly. Animals used for food production are common carriers of salmonellae, which can subsequently contaminate foods, such as meat, dairy products, and eggs. Foods often implicated in outbreaks include poultry and poultry products, meat and meat products, dairy products, egg products, seafood, and fresh produce. An estimated 800,000 to 4 million infections occur each year in the United States, most of them as individual cases apparently unrelated to outbreaks. Between 128,000 and 640,000 of those infections are associated with Salmonella Enteritidis in eggs. Over the past decade, more than 500 outbreaks have been attributed to S. Enteritidis with more than 70 deaths. In 1994, an estimated 224,000 people became ill from consuming ice cream in one outbreak alone.

Campylobacter
The bacterium Campylobacter is the most frequently identified cause of acute infectious diarrhea in developed countries and is the most commonly isolated bacterial intestinal pathogen in the United States. It has been estimated that between 2 and 4 million cases of campylobacteriosis occur each year with an associated 120-360 deaths. Campylobacter jejuni and Campylobacter coli (two closely related species) are commonly foodborne, and are the infectious agents most frequently described in association with Guillain-Barré syndrome, as frequently as 1 in 1000 cases. Several prospective studies have implicated raw or undercooked chicken as major sources of C. jejuni/coli infections. Unpasteurized milk and untreated water have also caused outbreaks of disease.

Shiga-like toxin-producing Escherichia coli
Several strains of the bacterium E. coli cause a variety of diseases in humans and animals. E. coli O157:H7 is a type associated with a particularly severe form of human disease. E. coli O157:H7 causes hemorrhagic colitis, which begins with watery diarrhea and severe abdominal pain and rapidly progresses to passage of bloody stools. It has been associated with HUS, a life-threatening complication of hemorrhagic colitis characterized by acute kidney failure that is particularly serious in young children. E. coli O157:H7 is found in cattle, but there may be other reservoirs; the dynamics of E. coli O157:H7 in food-producing animals are not well understood. Approximately 25,000 cases of foodborne illness can be attributed to E. coli O157:H7 each year with as many as 100 deaths resulting. E. coli O157:H7 outbreaks have recently been associated with ground beef, raw milk, lettuce, and minimally processed and fresh fruit juices. The most recent outbreak in the Fall of 1996 in three western states and British Columbia was associated with unpasteurized apple juice, sickened 66 people, and caused the death of one child.

Vibrio
Vibrio species are gram-negative bacteria most commonly associated with seafood-containing dishes. Vibrio parahemolyticus is the species that is most commonly reported as a cause of foodborne disease; it generally causes watery diarrhea and abdominal pain lasting 1-7 days, and commonly follows consumption of improperly handled cold-seafood salads. V. vulnificus is one of the more serious foodborne pathogens, with a case-fatality rate for invasive disease that exceeds 50%. Most cases of foodborne V. vulnificus infections occur in persons with underlying illness, particularly liver disorders, who eat raw molluscan shellfish. Since the late 1980s, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Gulf Coast states have intensified efforts to collect information on Vibrio infections, and on the microorganisms' ecology, to improve our ability to prevent foodborne infections.

Protozoa

Toxoplasma gondii
T. gondii is a parasitic protozoan. Some 1.4 million cases of toxoplasmosis occur annually with an associated 310 deaths. Healthy adults who become infected usually have no symptoms but might get diarrhea. Pregnant women who become infected can pass the disease to their fetuses. In infants infected before birth, fatality is common. Should the infant survive, the effects of infection are typically severe (i.e., mental retardation). The disease can be life-threatening in persons with weakened immune systems and often is fatal to people with HIV/AIDS. T. gondii has been found in virtually all food animals. The two primary ways that humans become infected are consumption of raw or undercooked meat containing T. gondii or contact with cats that shed cysts in their feces during acute infection. Under some conditions, the consumption of unwashed fruits and vegetables can contribute to infections.

Cryptosporidium parvum
C. parvum is a parasitic protozoan. The most common consequence of infection in healthy people is profuse watery diarrhea lasting up to several weeks. Children are particularly susceptible. Cryptosporidiosis can be life-threatening among people with weakened immune systems. The largest recorded outbreak of Cryptosporidiosis was a waterborne outbreak in Milwaukee, Wisconsin, in 1993, affecting more than 400,000 people. More recently, a waterborne outbreak in Las Vegas resulted in at least 20 deaths. The first large outbreak of cryptosporidiosis from a contaminated food occurred in 1993. That outbreak was attributed to fresh-pressed apple cider. Cryptosporidium also is found in animal manures.

Viruses

Norwalk virus
Norwalk viruses are important causes of sporadic and epidemic gastrointestinal disease that involve overwhelming, dehydrating diarrhea. An estimated 181,000 cases occur annually with no known associated deaths. In January 1995, a multistate outbreak of viral gastroenteritis due to Norwalk virus was associated with the consumption of oysters. A 1993 Louisiana outbreak of Norwalk virus gastroenteritis involved 70 ill people and was associated with the consumption of raw oysters. In 1992, another outbreak resulted in 250 cases. Outbreaks of Norwalk virus intestinal disease have been linked to contaminated water and ice, salads, frosting, shellfish, and person-to-person contact, although the most common food source is shellfish. Several such outbreaks are believed to have been caused by oysters contaminated by sewage dumped overboard by oyster harvesters and recreational boaters.

Hepatitis A
Hepatitis A (HAV) is a virus that infects the liver and causes hepatitis A, an illness with an abrupt onset that can include fever, malaise, nausea, abdominal discomfort, dark urine, and jaundice after a prolonged incubation period (e.g, more than 2 months). In children less than 6 years old, most (70%) infections are asymptomatic, but in older children and adults, infection is usually symptomatic, with jaundice occurring in more than 70% of patients. Signs and symptoms of hepatitis A usually last more than 2 months, and there are no chronic consequences. About 130,000 infections with HAV and 100 deaths occur each year in the United States. The primary mode of transmission for HAV is person-to-person by the fecal-oral route. Recognized foodborne hepatitis A outbreaks account for only 2% to 5% of hepatitis A cases reported in the United States each year, most of which are caused by an infected food handler. Outbreaks due to foods contaminated before preparation, while uncommon, have been associated with widely distributed products such as shellfish, lettuce, frozen raspberries, and frozen strawberries. Hepatitis A can be prevented by good personal hygiene and safe food-handling practices. It can also be prevented before exposure by hepatitis A vaccine, and after exposure by immune globulin, if given within 14 days of exposure.



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