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| United States Department of Agriculture | Department of Health and Human Services | United States Environmental Protection Agency |
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| United States Department of Agriculture | Department of Health and Human Services | United States Environmental Protection Agency |
February 21, 1997
Dear Stakeholder:
On January 25, 1997, President Clinton announced a new initiative to improve the safety of the Nation's food supply. Recognizing that food safety is not simply a responsibility of the Federal Government, the President directed us to work with consumers, producers, industry, States, tribes, universities, and the public to identify additional ways to improve food safety through Government and private sector action, including public-private partnerships. The President asked us to report back with our recommendations within 90 days.
We are strongly committed to an open process that includes a full discussion of the wide range of issues that may be raised by our various constituencies. Our experience has shown that we are most successful in solving problems when we proceed in this manner. In short, we need your participation and your advice to develop the best possible recommendations for the President.
To begin this dialogue, we are inviting you to attend a public meeting on March 5, 1997, in Washington, D.C., to discuss the initiative. Our staffs have been meeting for several months to identify major issues in a number of key areas, including surveillance, research, risk assessment, inspections, coordination, and education. A document which outlines those issues and identifies possible ways in which they could be addressed is enclosed with this letter.
We want to emphasize two things. First, this document reflects the current thinking of our food safety experts. But we recognize that you and other constituencies may identify other issues or approaches that should be included in the initiative. We encourage you, then, not only to think critically about the enclosed document, but to bring other issues that you may have to the meeting on March 5.
Second, this is only the beginning of the process. We are planning a longer meeting in late March or early April in which all interests would work through the issues we have collectively identified. While the President directed us to complete our report within 90 days, we want to assure you that we are committed to a continuing dialogue and partnerships that will generate great benefits for all Americans throughout the next 4 years of this Administration.
We have made substantial improvements in food safety over the past 4 years, and we once again thank you for your efforts. We look forward to working with you as we pursue this initiative and build upon the progress we have made to date.
Sincerely,
| DAN GLICKMAN | DONNA E. SHALALA | CAROL M. BROWNER |
| Secretary of Agriculture | Secretary of Health and Human Services | Administrator, Environmental Protection Agency |
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 will request $43 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. President Clinton also directed the Secretary of Health and Human Services and of Agriculture, 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 Shalala and Glickman, and Administrator Browner to report back to him with recommendations in 90 days. He instructed them 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.
We need your advice. Your perspective is essential in providing the President with a report that identifies current needs in food safety, as well as assuring the future safety of our food supply and the health of consumers. We need the perspective and suggestions of all groups who are concerned about food safety and public health to make this a successful endeavor.
The goal of this initiative is to reduce, to the greatest extent possible, the incidence of foodborne illness. The thoughts in this draft focus on the public health principle that society should identify and take preventive measures to reduce the risk of illness, and that it should focus its efforts on those hazards that present the greatest risks.
The ideas in this draft represent our preliminary thoughts on this subject. A comprehensive food
safety plan, describing actions and resources necessary to achieve the goals of reduced foodborne
illness, will require extensive deliberation and in-depth discussion with all stakeholders in food
safety, including consumers, state, tribal, and local public health officials, industry, and members
of the scientific community. This draft is intended not as a prelude to government action, but an
exploration of what might result from the upcoming seminars and conferences. While this
initiative focusses on reducing the incidence of microbial foodborne illnesses, we recognize that
chemical contaminants are also a cause of foodborne illness, but with chronic long term effects.
The American food system provides consumers with an abundant supply of convenient, economical, high-quality, and safe food products. This system is built on the enterprise and innovative capacities of those who produce and market food in the United States, and it is driven by the high expectations of American consumers for the foods they purchase for their families.
Foodborne illness, however, still occurs in the United States. Over the last four years the Clinton Administration has developed and implemented major steps towards reinventing food regulation:
While these advances are significant, they may not be 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 reform, especially reform that
builds on the preventive principles embodied in HACCP.
Achieving a significant reduction in the incidence of foodborne illnesses requires the cooperative efforts of public health and regulatory agencies at the federal, state, tribal and local levels, as well as all other parties responsible for and concerned about food safety and reducing the incidence of foodborne illness (i.e., consumers, industry, and academia). Partnerships - between public agencies and industry, federal agencies and state, tribal or local agencies, public agencies and academia, to name a few possibilities - will be invaluable in leveraging the resources focused on reducing the incidence of foodborne illness and enhancing communication.
Representatives of various government agencies have drafted a structure for the food safety initiative for your further deliberations. Ad hoc working groups, representing the varied perspectives of the FDA, CDC, the Department of Agriculture's Research, Education and Extension agencies, as well as the FSIS and Animal and Plant Health Inspection Service (APHIS), and the Environmental Protection Agency (EPA), have been meeting for several months to identify major food safety concerns and propose recommendations on what resources and activities are needed to have a significant impact on reducing the incidence of foodborne illness both in the short term and over the long term. The working groups worked from the premise that an effective food safety initiative must have several, interrelated components which, together, have far greater impact on reducing the incidence of foodborne illness than is possible to attain with any single component. Moreover, these elements must form the groundwork for the design and implementation of strategies to meet current needs, for continually evaluating the effectiveness of ongoing activities, and for identifying and implementing strategies to meet future needs. These elements include surveillance, coordination, risk assessment, research, inspections, and education.
This draft, which primarily defines short-term activities, describes the elements of a food safety initiative and tentatively identifies critical issues and the working groups' current thinking on preliminary recommendations. In some cases these recommendations have been included as part of the President's FY98 budget. However, no specific decision as to what will constitute the final food safety initiative, including how the strategic planning process is structured, have been made. Input from groups and individuals such as yourself, state, tribal and local agencies, consumers, industry, academia, and other stakeholders will be incorporated into the food safety initiative.
Two open public meetings of all parties interested in food safety are planned to take place in Washington, DC. The first, scheduled for March 5, 1997, is an information meeting to familiarize interested parties with the President's initiative and introduce the draft discussion document. A second meeting is tentatively scheduled for late March-early April to discuss the food safety initiative. The purpose of the second meeting is to present the key issues and solicit both comment on the preliminary recommendations and additional suggestions for inclusion in the report to President Clinton.
Using this draft as a starting point, we are asking for your perspective on how best to enhance the
safety of the food supply and reduce foodborne illness. Please consider the following questions in
guiding your response, considering both the immediate future and the long term:
The comments, suggestions, and information from these meetings will be used in preparing the report to the President.
Foodborne infections remain a major public health problem. The Council for Agricultural Science and Technology, a private non-profit 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. Hospitalization costs alone for these illnesses are estimated at over $3 billion a year. Costs for lost productivity for 7 specific pathogens have been estimated to range between $6 billion and $9 billion. Total costs for all foodborne illnesses are likely to be much higher. These estimates do not take into account the total burden placed on society by the chronic, often life-long consequences caused by some foodborne pathogens.
Additional, important safety concerns are associated with the greater susceptibility to foodborne
infections of several population groups. These include persons with lowered immunity due to
HIV/AIDS, those on medications for cancer treatment or for organ transplantation, as well as
pregnant women (and their fetuses), young children, and elderly persons. Patients taking
antibiotics, or antacids, are also at greater risk of infection from some pathogens. Other groups
who may be disproportionately affected include persons living in institutional settings, such as
hospitals and nursing homes, and those with inadequate access to health care, such as homeless
persons, migrant farm workers, and others of low socioeconomic status.
Sources of food contamination are almost as numerous and varied as the contaminants
themselves. Bacteria and other infectious organisms are pervasive in the environment.
Salmonella enteritidis enters eggs directly from the hen. Bacteria (occasionally pathogenic)
inhabit the surfaces of fruits and vegetables in the field. Molds and their toxic byproducts can
develop in grains during unusually wet or dry growing seasons, damage and stress during
harvesting, or during improper storage. Seafood may become contaminated from agricultural and
other runoff, as well as by sewage, microorganisms, and toxins present in marine environments.
Many organisms that cause foodborne illness in humans can be part of the normal flora of the
gastrointestinal tract of food-producing animals without any adverse effects to the animal. Milk,
eggs, seafood, poultry, and meat from food-producing animals may become contaminated due to
contaminated feed, misuse of veterinary drugs, or poor farming practices, including production
and harvesting activities, or disposal of solid waste on land. Foods may become contaminated
during processing due to malfunctioning or improperly sanitized equipment; misuse of cleaning
materials; rodent and insect infestations; and improper storage. Foods may become contaminated
in retail facilities and in the home through use of poor food handling practices.
Although many hazards threaten the safety of our food, certain foodborne hazards are of
particular public health concern, and would be targeted for immediate attention by this initiative.
Studies have shown that the following microbial pathogens are the predominant foodborne
pathogens. They are: Salmonella species, Campylobacter jejuni/coli, Escherichia coli O157:H7
and other related strains; the parasites Toxoplasma gondii and Cryptosporidium parvum; and the
Norwalk virus.
The microbial pathogens listed above, and discussed in greater detail below, may 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. The microbial
pathogens described below are not listed in order of importance or severity.
Salmonella
Salmonella species cause diarrhea and systemic infections, which can be fatal in particularly susceptible persons, such as the immuno-compromised, the very young, and the elderly. 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. Animals used for food production are common carriers of salmonellae, which may 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. Between 128,000 and 640,000 of these infections are associated with Salmonella enteritidis (SE) in eggs. Over the past decade, more than 500 outbreaks have been attributed to SE with over 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 170,000 and 2.1 million cases of campylobacteriosis occur each year with an associated 120-360 deaths. Campylobacter jejuni and Campylobacter coli (2 closely related species) are commonly foodborne, and are the infectious agents most frequently described in association with Guillain-Barré syndrome, perhaps as frequently as 1 in 1000 cases. Several prospective studies have implicated raw or undercooked chicken as major sources of C. jejuni/coliinfections. Unpasteurized milk and untreated water have also caused outbreaks of disease.
Escherichia coli O157:H7
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, and has been associated with HUS. HUS is a
life-threatening complication of hemorrhagic colitis characterized by acute kidney failure, and is
particularly serious in young children. E. coliO157:H7 has its reservoir in cattle, but the dynamics
of E. coli O157:H7 in food-producing animals are not well understood. It has been estimated that
approximately 25,000 cases of foodborne illness can be attributed to E. coli O157:H7 each year
with an estimated 6 deaths. 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 3 western states and British Columbia, was associated with
unpasteurized apple juice and sickened 66 people and caused the death of one child.
Toxoplasma gondii
T. gondii is a parasitic protozoan. It has been estimated that 1.4 million cases of toxoplasmosis occur annually with an associated 310 deaths. Otherwise healthy adults who become infected usually have no symptoms, but may get diarrhea. Pregnant women who become infected during pregnancy may pass the disease to their fetuses. In infants infected before birth, fatal results are common. Should the infant survive, the effects of infection are typically severe. The disease can also be serious 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 may contribute to these infections.
Cryptosporidium parvum
C. parvum is a parasitic protozoan. The most common consequence of infection in otherwise
healthy people is profuse watery diarrhea lasting up to several weeks. Children are particularly
susceptible. Cryptosporidiosis can be life-threatening among persons with weakened immune
systems. The largest recorded outbreak of cryptosporidiosis was a waterborne outbreak that
occurred in Milwaukee, Wisconsin in 1993, affecting over 400,000 people. More recently, a
waterborne outbreak in Las Vegas resulted in at least 20 deaths attributed to Cryptosporidium.
The first large outbreak of cryptosporidiosis from a contaminated food occurred in 1993. This
outbreak was attributed to fresh-pressed apple cider. Cryptosporidium is found in feces of
infected mammals and has been transmitted through contaminated water and food.
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 multi-state outbreak of viral gastroenteritis due to Norwalk virus was associated with the consumption of oysters. A 1993 Louisiana outbreak of Norwalk virus gastroenteritis, involved seventy ill people and was associated with the consumption of raw oysters. In 1992, another outbreak occurred which included 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.
Ensuring the safety of food is one of the core functions of government. It is carried out by a system that, while generally successful in protecting the public, can be confusing for its complexity and diversity. Authority is divided among federal, state, and local governments; and the private sector also plays an important role. From the farm to the consumer's dinner table, the responsibilities can be summarized as:
The system for identifying and preventing foodborne illnesses described above was largely
created in the early years of this century. It must be modernized. The current system is
inadequate to properly identify, track, and prevent food-related illness and to prevent
future cases from occurring. State and federal resources are not closely coordinated and
duplication of effort is not uncommon. In 1981, FDA inspected food firms every 2-3 years,
but can now visit those plants, on average, only once every 10 years. Our understanding of
some disease causing organisms is so limited that our ability to protect the public health is
seriously constrained. Food processors, restauranteurs, supermarket managers, and
consumers often don't understand the threat from foodborne pathogens and the methods
available to prevent and control them.
There are many causes of foodborne illness, many points at which foods can become contaminated, and numerous factors that make some groups of people more susceptible than others. Needless to say, no single preventive measure will ensure the safety of all foods. However, a number of practical preventive steps can be taken immediately to reduce the incidence of many foodborne infections.
Any initiative designed to improve the safety of the food supply should focus on the hazards and foods that present the greatest risks to public health, should emphasize development and implementation of preventive controls of those risks, and should seek opportunities for such controls through a collaborative process with the responsible sectors of the food industry and all other stakeholders. This prevention-control concept is HACCP, a science-based, state-of-the-art process for building safety into the production, handling and storage of food. HACCP is being implemented by the meat, poultry, and seafood industries with FSIS and FDA regulatory oversight. The application of such preventive controls to other types of food may be important to protecting food in the years to come.
Under this initiative, the federal government, in concert with state and local governments would conduct research and risk assessments to determine how foodborne illnesses occur and can be prevented or controlled; 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 focussing on the use of safe practices. These issues, and our current thinking about them, are described below.
Background
The primary goal of the American system of public health is to prevent disease before it occurs. While prevention of all disease may not be possible, stopping outbreaks of foodborne illness before they affect large numbers of people is a major goal. America needs a more effective early warning system that can catch outbreaks early, preventing illness and death. Such a system will also advance our understanding of foodborne illness and further our prevention efforts. In his January 25 radio address, the President announced a new national early warning system for foodborne illness that he is funding in his FY98 budget.
Preliminary Problem Identification
Surveillance and investigation of foodborne disease are powerful tools to detect new foodborne disease challenges, to determine what the specific food sources are, and to learn how best to keep the foods from becoming contaminated in the first place. 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 among 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 expand the existing Active Foodborne Disease Surveillance Network (sentinel sites) 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 deaths.
Current Thinking
The federal government in cooperation with state and local health departments is proposing to take the following steps to establish a new national early warning system for, and enhance surveillance of, foodborne disease. These changes will result in an improved system for detecting and reporting foodborne illnesses and outbreaks that will enable public health agencies to rapidly put into place measures to control the spread of foodborne disease. This system will also collect critical data to recognize trends and target prevention strategies, including HACCP systems, and to evaluate the effectiveness and efficiency of prevention strategies already in place.
CDC, FDA, and USDA currently support five food sentinel sites at state health departments to track cases of foodborne infections and to determine the sources of the most common ones. The existing sites should be strengthened, and the number of "enhanced" sites should be increased to 7 in FY 97, and to at least 8 in the following year. The sites and federal food safety agencies should be electronically linked together to create a powerful new network to detect, respond to, and prevent outbreaks of foodborne illness. Adding additional states will improve geographic and demographic representation, making this network more likely to detect diseases and outbreaks that are regional rather than national in distribution.
In addition to establishing enhanced food sentinel sites, an early warning system would require improved early detection of foodborne disease in additional states in FY 98 by providing resources for improved surveillance, investigation, control, and prevention of foodborne disease outbreaks. While sophisticated laboratory studies can identify causes of illness and show relationships among bacteria, 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.
CDC should provide resources and training to upgrade public health laboratory capabilities in the Active Surveillance sites and in other states so that they can rapidly identify a broad range of foodborne infections including new parasitic and viral pathogens, and can use new techniques of DNA "fingerprinting." CDC would work with states to develop, standardize, and transfer those methods. These new capacities would allow rapid identification of the cause of some outbreaks that currently go undiagnosed.
CDC should fund a new computer network and database system that would capture bacterial "fingerprints" in a national database, linking CDC, FDA, USDA, and states that have this new capacity as well as the federal laboratories into a new 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, which would suggest to public health investigators that a product distributed in both California and Washington may be contaminated with the organism.
In addition to identifying, investigating, and reporting cases of foodborne disease in humans, surveillance of contamination levels in foods, in animals used for food, and in their feed is important to control and prevent foodborne diseases, and to monitor 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.
CDC should expand surveillance for antimicrobial resistance in Campylobacter, Salmonella, and E. coli O157:H7 isolated in humans, and FDA and USDA should take similar steps for bacterial samples from food-producing animals and food products, in a way that permits these data to be compared. CDC, FDA and USDA should develop standard procedures for sharing necessary information, and for responding to increases in resistance, or other "red flag events" such as the discovery of an important new resistant bacterium.
FDA may consider increasing monitoring of animal feed processing to determine the nature and extent of pathogen contamination and the impact of control strategies on pathogen reduction in animals.
Background
At the federal level, there are four agencies charged with responding to outbreaks of foodborne illness (including waterborne illness): FDA and CDC at HHS, FSIS at USDA, and EPA. While CDC's primary responsibility is to work with state and local health departments to identify and investigate sporadic cases and outbreaks of illness, FDA, FSIS, and EPA have the additional responsibility of taking regulatory action against the suspect products, or those who contaminate the air, land, or waters used to produce the food product. Which regulatory agency gets involved depends on the type of food involved, with FSIS having primary jurisdiction over meat, poultry, and egg products, FDA over all other foods including shell eggs and EPA over water and pesticides. While each agency has clearly defined areas of responsibility, most outbreaks of foodborne illness involve more than one agency.
In addition, investigations of foodborne illness usually begin at the community or state level. These illnesses may cross jurisdictional boundaries and may be linked to foods or food ingredients that were processed or produced in another state or by international trading partners, necessitating the involvement of federal agencies. Federal involvement is also necessary when contaminated foods from the same sources may be in grocery stores, restaurants, and homes in other parts of the country. Companies responsible for affected products also have a critical role to play as many product recalls are voluntary.
In most outbreaks of foodborne illness, federal agencies work with state and local health
authorities in their investigations and implementation of control measures through
consultation, diagnostic assistance, and recommendations for control measures. In some
instances on-site assistance is requested by the local and state authorities. For large or
multi-state outbreaks, federal agencies play a critical coordination role to assure
consistency of approach and implementation of needed control measures.
Preliminary Problem Identification
Although significant coordination already occurs among the federal and state agencies, the mere fact that more than one agency is involved in any one outbreak of foodborne illness can cause some confusion. Many times a joint effort is hindered by a lack of communication or a misunderstanding of each agency's role in a particular situation.
Current Thinking
Improved coordination among the federal agencies, between federal and state agencies, and among the various state agencies would enhance the level of public health protection, make the best use of interagency collaboration, and avoid duplication of effort.
A Foodborne Outbreak Response Coordinating Group made up of representatives of the federal and state agencies charged with responding to outbreaks of foodborne illness should be created to coordinate the investigation and response to significant outbreaks of foodborne illness. The overall goal of this group should be to ensure that a coordinated and professional response, with all governmental resources pulling together, is undertaken to effectively investigate and respond to foodborne illness. The group should determine jointly each agency's responsibilities during the various phases of outbreak investigations, and who would play the role of spokesperson for each phase or component of an outbreak. In addition, the group should coordinate communications and decisions about appropriate actions during outbreaks and appropriate follow-up to prevent similar outbreaks. The coordinating group should also meet several times a year to review its work and the response to outbreaks.
Each participating agency could fund and enhance programs that provide opportunities to exchange employees, on a temporary basis, among federal agencies and between federal and state agencies. Such an exchange would facilitate coordination by sharing expertise and providing an opportunity to better understand the various roles each agency plays in an investigation of a foodborne illness.
Better coordination between federal and state agencies and among the various state agencies would speed the identification and subsequent control of foodborne illness and the removal of the contaminated foods from the distribution chain.
In order to improve coordination, the federal agencies can sponsor a national meeting with state and local officials to develop recommendations on how to better coordinate the overall government response to foodborne illness.
For example, one specific issue that is discussed in FDA's FY98 budget is the occurrence of Salmonella enteritidis in layer hens and improved monitoring of the hens and liquid bulk egg products (before pasteurization) for contamination. The federal agencies should work to establish a federal/state cooperative program to solve this problem.
The epidemiology offices and laboratories within state health departments are charged with the surveillance of infectious and non-infectious conditions, and, along with other state 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 for the surveillance and investigation of foodborne diseases are limited and decreasing, thereby limiting the states' effectiveness. As a result, outbreaks may go undetected or are never investigated.
This problem could be rectified by making sure that, given an assessment and cataloguing of available state resources, states are provided support for foodborne disease surveillance programs and assistance to better investigate outbreaks of foodborne illness.
Background
It is a basic public health tenet that public resources devoted to reducing risks should be in proportion to the toll they take on human health. Risk assessment is the tool best suited to set priorities among public health risks. Furthermore, risk assessment is a requirement for any science-based system of preventive controls. Indeed, risk assessments and evaluations of alternative risk management strategies are often carried out for major federal regulations. Pursuant to the USDA's Reorganization Act of 1994, USDA is required to conduct risk analyses for all major regulations. Such evaluations ensure that risk reduction strategies are cost effective and promote the maximum net benefit to society of efforts to reduce foodborne illness. Sound risk assessments, including bacterial, parasitic, and viral food contaminants, are also critical to World Trade Organization treaty negotiations, which require that U.S. food safety standards be based on scientifically valid measures derived through risk assessment.
Preliminary Problem Identification
Risk assessment's objective is to characterize 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 a substantial amount of 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 methods have been most thoroughly developed, data gaps force the use of assumptions about exposure, hazard potency, and characteristics of the population at risk, and mathematical "models" of chemical action or of the way that the body deals with a chemical.
Risk assessment is far less developed for foodborne pathogens. Intensive commitment is
necessary to develop critically needed data such as pathogen behavior in numerous foods
under hundreds of conditions, and information about especially sensitive populations, such
as children.
Current Thinking
This initiative's risk assessment activities would focus on developing better use of data and better models to inform surveillance plans, HACCP-based prevention strategies for process control systems and for food inspections, and research programs to fill critical food safety information gaps.
All federal agencies with risk management responsibilities should establish jointly a new consortium at which federal agencies can set collective priorities for risk assessment research and collective priorities and strategies for the further development and implementation of risk assessment and risk management. The consortium should be established at the Joint Institute for Food Safety and Applied Nutrition, a collaborative activity of FDA's Center for Food Safety and Applied Nutrition and the University of Maryland.
The consortium should focus federal research on developing data for risk assessments, focused and applied specifically to address the scientific, risk-based goal of preventive control that is the central principle of this food safety initiative.
Research supported and conducted through this initiative should cover several areas critical to developing our ability to conduct risk assessments for foodborne disease-causing organisms and to assess the effectiveness of control measures. Data and methods developed in response to the Safe Drinking Water Act Amendments of 1996, for example, will be relevant to food safety evaluations.
Risk assessment of foodborne illness is dependent on accurately estimating the quantity of a toxin or pathogen ingested by the consumer (i.e., exposure assessment). This initiative would address the numerous data and modeling deficiencies in estimating exposure to microbial and chemical contaminants. Specifically, research should be conducted in: incidence and prevalence of microbial pathogens and chemical hazards in food; typical behaviors of commercial and home preparation operations; validation of dynamic exposure assessment models; intake data regarding food consumption patterns of the general population and sensitive subpopulations; and specific data on food vehicles of sporadic and epidemic disease. Research using 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 and effect are difficult or impossible to obtain.
Research is needed to 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. For bacterial hazards, the World Health Organization's Expert Consultation on the Application of Risk Analysis to Food Standards Issues (FAO/WHO, March 1995) refers to these steps as "hazard characterization."
Background
Currently, one of the most critical needs in food safety research is for techniques to more rapidly and accurately identify and characterize foodborne hazards. FDA, CDC, EPA, and the USDA's Research, Education, and Economics agencies (the Agricultural Research Service, the Cooperative State Research, Education, and Extension Service) conduct research related to pathogenic microorganisms and other contaminants that threaten the safety of food.
Preliminary Problem Identification
New pathogens, some of them foodborne, have emerged over the last 10 years. Many of these organisms can not be easily detected, or detected at all in foods. Other microorganisms, previously thought to be innocuous, have emerged as more virulent. Just because organisms are present at levels that can not be easily detected, however, does not mean that the organisms can not cause human illness. Newly recognized pathogens are causing serious disease outbreaks. Foodborne pathogens are increasingly overcoming time-tested controls, such as heating and refrigeration, and are developing new virulence and new ways to evade our immune defenses.
Current Thinking
Effective control of foodborne pathogens requires that prevention be targeted at high-risk foods and at high-risk points in their production and distribution. These interventions ideally are guided by risk assessment, for which all too often we have insufficient data. Research is needed to support HACCP implementation, to enable verification that critical control points in HACCP systems are working, and to target the data gaps that hamper risk assessment. Among the data gaps and information needs identified here are numerous opportunities for collaboration and resource leveraging among federal agencies, the private sector, and universities.
As stated above, many foodborne pathogens cannot be easily detected, or detected at all in foods. Methods need to be developed, validated, and implemented for rapid testing of very low levels of Campylobacter, Salmonella, Toxoplasma, Vibrio, E. coli O157:H7, Cyclospora, Cryptosporidium, Norwalk virus and naturally occurring toxins in food animals, in agricultural and aquaculture products, animal feeds, and processed food products. Some research efforts may initially focus on Campylobacter, because those foodborne infections are so prevalent and may lead to chronic diseases (Guillain-Barré syndrome); also methods to isolate and identify this pathogen are time-consuming and expensive. Research could be coordinated with EPA's efforts to develop better test methods and assessments of health effects from Cryptosporidium and other contaminants in drinking water. Improved methods are needed for identifying foodborne pathogens, including emerging pathogens, in clinical specimens and to subtype known foodborne pathogens.
Microorganisms can become resistant to antimicrobial agents and conditions that have been traditionally relied on to eliminate or prevent the growth of foodborne pathogens, but have become insufficient to prevent breakthrough of newly emerging pathogens. 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. This research will lead to the identification of food production and processing practices that are likely to permit pathogen contamination or proliferation and will provide guidance in the modification of traditional techniques or the development of new techniques to prevent or control pathogen growth.
Pathogens in food-producing animals may become resistant to drugs partially due to improper use of the drugs, particularly antibiotic drugs, in those animals. One possible way to deal with this problem might be to adjust the required period of drug withdrawal prior to slaughter. For example, studies should be conducted to explore possible changes to "withdrawal time" requirements that could reduce transfer of resistant pathogens with minimal disruption to industry production practices. In addition, industry in collaboration with federal agencies could determine the basis for the ability of microorganisms to rapidly adapt to changing environments and, together, develop animal production and treatment mechanisms to minimize this adaptive ability.
Contaminants are introduced into the food supply at numerous points along the way from farm to store. Food animals may carry pathogens, but remain healthy themselves, complicating controls at the point of slaughter. Animal feed and drinking water can be "hidden" but significant sources of contamination. Possible research recommendations to address these problems for Salmonella, Campylobacter, Toxoplasma, Vibrio, E. coli O157:H7, Cyclospora, Cryptosporidium , and Norwalk virus in all food products are the following (to be carried out in conjunction with universities and the private sector):
Food production and processing often occur thousands of miles apart. Transportation systems for live animals, fresh produce, and packaged foods offer many opportunities for contamination, such as heat, cold, and other stresses that make animals and plants more susceptible to infection, and cross-contamination from the vehicle itself. Possible research recommendations include the following:
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, with state and local officials focusing primarily on restaurants, supermarkets and other retail establishments. At the federal level, consistent with legal mandates, FSIS has carcass-by-carcass inspection in meat, poultry, and slaughter plants while they are operating, and continuous inspection in meat, poultry, and egg-product processing plants--in all, about 8,000 inspectors for 6,500 domestic plants and for all imported meat, poultry, and egg products. FDA does periodic, random inspections of all other food processing plants--less than 700 inspectors and analysts for 53,000 U.S. plants and for all other imported foods.
Preliminary Problem Identification
At FDA, the number of inspections 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. The result is that an FDA-regulated plant gets inspected by FDA, on the 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, the inspectional coverage of imported foods has dropped as well, as the same number of import inspectors are now inspecting almost twice as many imports as just five years ago. Certainly FDA is finding greater problems, e.g., the number of products recalled for life-threatening microbial contamination has increased almost 5-fold since 1988 and inspectors are finding more hazardous conditions in the plants they inspect. FSIS is faced with a similar challenge of continually providing the most effective inspection program with limited resources and growing threats to food safety.
Current Thinking
Scientists and other food safety experts have concluded that the most effective and efficient mechanism for assuring that food processors identify and control hazards that could threaten food is the application of the HACCP concept of built-in preventive controls. FDA has begun to implement HACCP for the seafood industry, and FSIS for the meat and poultry industries; FSIS intends to publish an ANPR requesting comments on HACCP systems for egg processing plants, and FDA plans to work with the food industry, as it has in a pilot program over the last 2 years. To ensure that HACCP is properly implemented, and to ensure more efficient and effective monitoring of the safety of the food supply, the following preliminary recommendations are being made.
FDA is considering whether and how to implement HACCP throughout the non-meat/poultry food industry for all appropriate food commodities. It is recognized that staged implementation, by commodity, might be necessary because of resource limitations. To ensure that HACCP is being properly implemented, FDA should conduct inspections and provide necessary training and outreach activities. FSIS will continue development of a HACCP-based inspection system. FSIS plans to conduct a public meeting and then subsequent field trials to gather data to support future decisions on designing new inspection procedures in a HACCP environment.
FDA has included implementation of seafood HACCP in its FY98 budget request. 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 (such as seafood) are inspected at least once per year. To maximize the joint federal/state role in inspections, development of new partnerships with the states may be considered, that focus on coordinating the inspection coverage and preventing duplication of effort.
FSIS and FDA may consider expanding and re-focussing existing cooperative agreements under which plants producing both meat and non-meat foods are inspected solely by FSIS inspectors, who have been trained in FDA inspectional standards. FSIS inspectors are already in these plants; their presence could be better utilized to maximize use of federal resources.
FSIS and FDA are considering whether and how to regulate the transportation of meat, poultry, seafood, eggs and other foods in order to safeguard the public from pathogenic microorganisms, as reflected in the ANPR published on November 22, 1996.
Additional federal/state partnerships can ensure improved coordination between the federal food safety agencies and state regulators for the training of state inspectors in federal food safety standards, as well as provide the states with equipment and technology for the rapid sharing of inspection results and for a national database for the monitoring of all food inspections. This information sharing would help both federal and state regulators make inspections more effective and efficient.
FDA may consider establishing a process for certifying private laboratories that would be authorized to test samples of food products for contaminants. This may embody a similar process currently being discussed by a coalition of industry, private laboratories, professional associations, and accrediting bodies with input from federal agencies. Such private parties would provide a service to food firms wishing to demonstrate that their products meet applicable federal standards.
FDA should develop more Mutual Recognition Agreements (MRAs) with foreign countries, under which both countries agree to inspect each other's food exporting firms under equivalent procedures for ensuring safety. Once such MRAs are in place, FDA could better focus its import inspections on foods coming from countries with the least reliable safety standards.
Background
Educating people about steps they must take to prevent and control foodborne illness is a vital link in the food preparation chain. Educational efforts have already been made at the federal level. For example, FDA has a website which offers information on many food safety issues, has established a 24-hour seafood hotline, and has published brochures on such topics as food safety advice for persons with AIDS and posters on such topics as listeria in soft cheese. USDA has taken similar steps through its Cooperative Extension network, its Meat and Poultry Hotline, and by requiring safe handling instruction labels for meat and poultry products.
Preliminary Problem Identification
Despite these efforts, and the work that states, consumer groups and the food industry have done in this area, foodborne illness still occurs from a lack of knowledge of the risks involved at all stages of food preparation. For instance, choices consumers make about how they handle food prepared at home and whether they eat food that increases the risk of foodborne illness can have a significant impact on the incidence of foodborne illness. Studies show, for example, that 53% of the public eat food with raw eggs, 23% eat undercooked hamburger, 17% eat raw clams and oysters, and 26% do not wash their cutting boards after using them for raw meat or poultry.
Foodborne illnesses have also been traced to commercial food establishments. For example, many food establishments do not know that the pooling and undercooking of eggs can increase the risk of Salmonella enteritidis. Currently, a much higher percentage of those who receive their food in an institutional environment are victimized by the more serious consequences of foodborne illness. For example, during 1988 to 1992, Salmonella caused 69% of the 796 bacterial foodborne disease outbreaks; 60% of these Salmonella outbreaks were caused by S. enteritidis. S. enteritidis also resulted in more deaths than any other pathogen with 85% of these deaths occurring among residents of nursing homes.
Producers of animals used in human foods production and veterinarians treating such animals also need education in food safety practice. Drugs used to treat these animals are not always used appropriately, and can be purchased over the counter by non-veterinarians and mis-used, resulting in harmful residues in meat and milk, decreased effectiveness of these drugs, and increased antimicrobial resistance.
Finally, those responsible for the transportation of food are often unaware of unsafe
practices that result in the contamination and mishandling of food during shipment.
Current Thinking
Understanding and practicing proper food handling procedures from farm to table would significantly reduce foodborne illness.
An alliance including industry and consumer groups should mount a comprehensive food safety awareness campaign for consumers, highly focused on messages and tactics targeted to the general public and to special populations such as high-risk consumers. The campaign should be centered around an easily recognized symbol or catch phrase and should include a national print and broadcast media campaign and incorporate food safety messages into school curricula. An emphasis should be placed on multilingual activities to ensure the widest coverage.
Innovative methods for sharing information related to food handling behaviors should be developed in order to reach larger audiences. As part of this effort, a National Food Safety Education Alliance of industry, consumer, trade, state and local food protection agencies, and academic organizations focused on changing unsafe food handling practices should be convened. Research should be conducted to determine effective methods of providing information and evaluation of educational programs. A national clearinghouse should be established to provide consumers and food safety educators with food safety information.
A highly focused campaign should be developed to change food workers' unsafe food preparation behaviors. A multilingual approach should be developed. An alliance of federal, state, and local health agencies, as well as private parties, should be formed to develop education efforts on food safety issues. Activities of the alliance should include educating retail food service workers about the safe handling perishable food product provisions in the 1997 Food Code.
In addition, guidelines should be developed by USDA and the states for retail and food service operations which process meat and poultry products to train state level inspectors to identify hazards at the retail level. Efforts should also be undertaken to educate the retail, food service and institutional industries in order to increase the use of HACCP principles.
Development and implementation of a program could be considered to educate producers of animals for human food consumption, veterinarians, state and local regulators about proper drug use and the incorporation of HACCP principles into industry quality assurance programs. The program could entail regularly scheduled training sessions, including satellite teleconferences, educational symposia, and presentations at producer and practitioner meetings. Guidelines and educational materials could also be developed and disseminated through a national clearinghouse to food producers and the veterinary medical community.
Government agencies could form an alliance to develop educational materials and train food transportation vehicle owners and operators and food processing establishments on hazards associated with the transportation of food products, particularly hazards associated with temperature controls, prior cargoes, and sanitation methods. Training and education for state and local health and transportation authorities could also be conducted so they can apply this information during inspections of food processing facilities and transportation vehicles in their jurisdiction.
Background
The broad issues of a sustainable safe food system include, among other issues, improving the infrastructure for rapid identification and response to outbreaks, improving coordination among all food safety participants in numerous aspects of prevention and response, and developing a strategic, long-range research agenda. Stakeholders include food producers and manufacturers, consumers, academic institutions, representatives from the food service sector, including retail, restaurant, and institutional food service settings, veterinary and medical professionals, and federal, state, and local public health and agricultural officials.
Preliminary Problem Identification
Making the necessary improvements in the food safety system will not be easy. Because so many lines of authority must be crossed, so many new working relationships established, and so many fundamental changes in infrastructure made, the current system must be "reinvented." For example, the federal government needs to develop a long-term, coordinated research agenda to truly address research needs to support a fundamentally improved food safety system, and strategies for developing such an agenda would need to be developed through such a planning process. Extensive dialogue will be required among the many stakeholders in various regions of the country to agree upon priorities, strategies for achieving change, and a process for achieving change.
Current Thinking
A significant activity proposed as part of this food safety initiative is the creation of a process that facilitates the participation of all stakeholders in discussing the issues and setting an agenda for consideration of fundamental change in the food safety system.
A contract could be established with an independent organization to bring together all major stakeholders for discussion of fundamental changes to the present food safety system. A major purpose of this strategic planning exercise would be to identify changes that should be made to the present organizational and procedural structure that would bring about permanent improvements in efficiency and coordination. Dialogue groups could be established to develop a strategic plan. Opportunities for input could include symposia held in geographically dispersed sites to encourage stakeholder participation.
Documents developed from the deliberations and recommendations of these symposia could
be the focus of further discussion during a series of open meetings. The product of this
series of dialogues, symposia, and hearings could form a report, which would provide the
outline necessary for targeting needed structural changes in the federal/state food safety
system.
February 20, 1997
Hypertext updated by dms 2001-NOV-19