Current Status
Nature and Extent of Foodborne
Diseases
Key Strategies and Initiatives for
Reducing Foodborne Diseases
Linkages and Coordination
Barriers and Challenges
Plans for the Future
Exhibits Section
In the United States, foodborne illness is a major cause of economic burden, human suffering, and death. Each year, an estimated 6.5 to 33 million people become ill from microorganisms in food, and an estimated 9,000 of these individuals die.
Reducing foodborne illness is one of the priorities listed in the Healthy People 2000 initiative. As part of Healthy People 2000, four objectives, measured by ten indicators, were identified for determining whether efforts by the public and private sectors are successfully reducing foodborne illness. Year 2000 targets were established for each indicator.
Year 2000 targets have been met for all four measures of the first objective. The data for the remaining three objectives suggest that progress is being made toward achieving the Year 2000 targets.
The incidence of campylobacteriosis, listeriosis, and infections caused by Salmonella Enteritidis and Escherichia coli O157:H7 has decreased. Significant progress is being made toward the adoption of FDA's Food Code and in improving consumer food preparation and storage practices.
A recent report released by the Centers for Disease Control and Prevention (CDC) indicates that the rate of salmonellosis in humans caused by foodborne illness has declined. The 1998 FoodNet Surveillance Results report that the rate of salmonellosis declined 14 percent over the period 1996 to 1998, for the serotype Enteritidis.
The status of each of the four objectives is discussed in detail below. The following status report provides a summary of the major strategies that were undertaken to achieve the Healthy People 2000 objectives, the major challenges faced by public health officials, the public and private sector partnerships were formed, and the new programs that were initiated.
Ten measurable indicators for four objectives were identified to determine whether the public/private sector efforts were being successful in reducing foodborne illness. Year 2000 quantitative targets were established for each of these indicators.
The first two objectives are to lower the incidence of five foodborne bacterial diseases. The indicators were selected because they are caused by the most important foodborne bacterial pathogens in the United States. As part of objective 12.1, the first two, Salmonella spp. and Campylobacter jejuni, are the most prevalent pathogens and Salmonella is the one most well known by the public. The second two, E. coli O157:H7 and Listeria monocytogenes, while considerably less prevalent, are the two foodborne pathogens that cause the most severe illnesses and have significant impact on the very young, the elderly, and those with chronic disease or impaired immune systems. The fifth indicator, the only indicator for objective 12.2, Salmonella enterica serovar Enteritidis, was selected because outbreaks of S. Enteritidis infection increased dramatically through the 1980's, and the organism was of increasing concern to public health officials.
The overall strategy for reducing foodborne illness is to place a heavy emphasis on education about proper food storage and preparation practices, along with stricter and more targeted enforcement. Indicators were selected to measure the success of the public and private sector education efforts. In this regard, S. Enteritidis is also a very good indicator of the success of our education efforts. S. Enteritidis is most often traced to the consumption of products containing raw eggs. According to recent surveys, products containing raw eggs or partially cooked eggs are still consumed by over half of the public. If the education efforts are successful in convincing the public to thoroughly cook or use pasteurized eggs, then the incidence of illness due to S. Enteritidis will decrease.
Because foodborne illness is also traced to inappropriate food handling practices in the home, three indicators were selected that represent the practices that are most frequently improperly followed by consumers: refrigerating perishable food within 2 hours, and washing cutting boards and utensils with soap and water after contact with raw meat and poultry.
Foodborne outbreaks are also frequently traced to inappropriate food preparation practices in the retail segment of the food industry. In order to determine the extent to which this segment of the industry is following the latest government advice for preventing foodborne illness, two indicators were selected to track the adoption and use of FDA's model Food Code.
The Food Code is a book of recommendations made by U.S. Public Health Service, which the Food and Drug Administration (FDA) first published in 1993, and revises every 2 years. It consists of model requirements for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. FDA offers the Food Code for adoption by local, State, and Federal Government jurisdictions and to be administered by the units that have compliance responsibilities for food service, retail food stores, or food vending operations.
Tracking the States' adoption of FDA's Food Code was selected as an indicator because it is important for the states to incorporate the most up-to-date science in its consumer protection laws. Also, the most severe cases of foodborne illness occur in institutions such as nursing homes and it is important that the food code be applied to these institutions. Tracking the number of states that have implemented the food code for institutions was therefore selected as a separate indicator.
These ten indicators are effective measures of whether public and private sector initiatives are reducing foodborne illness. They were selected because the data needed to track them were available in the past, and resources are likely to be available to track them in the future. The status of each objective and its indicators is discussed following the data tables and charts.
Progress on Specific Objectives
Objective 12.1
Reduce infections caused by key foodborne pathogens to incidences of no more than:
Starting in 1996, foodborne illness incidence data for objective 12.1 have been obtained from the Foodborne Disease Active Surveillance Network (FoodNet). Although the data are collected in geographically distinct areas, surveillance is active, and the estimates provided are thought to be better estimates than the data we were able obtain in the past through national passive reporting of data. In addition, before FoodNet, national data and national estimates were not available for Campylobacter spp. and E. coli O157:H7..
Based on FoodNet data from the original 5 FoodNet sites, the incidence of infection per 100,000 caused by Salmonella spp. was 14.5 in 1997, for Campylobacter spp., 25.2, for E. coli O157:H7, 2, and for L. monocytogenes, 0.5. The targets all have been met for objective 12.1 (Table 12.1 and four Charts 12.1)
Preliminary 1998 data indicate that overall incidence rates of illness caused by pathogens under surveillance declined from 1996 to 1998. These data show further reductions in Salmonella spp. to 12.4 per 100,000. This decrease was particularly pronounced for serotype Enteritidis, which dropped from 2.5 per 100,000 in 1996 to 1.4 per 100,000 in 1998.
Although Campylobacter rates increased slightly from 1996 to 1997 (23.5 per 100,000 to 25.2 per 100,000), preliminary 1998 rates experienced a substantial decline (21.7 per 100,000). After showing a decline from 1996 to 1997, E. coli O157:H7 increased in 1998 to 2.8 per 100,000. Incidence rates for Listeria infections were similar for the 3 years
Annual incidence rates of foodborne illness varied by age, especially for Campylobacter and Salmonella spp. infections. For children less than 1 year of age, the rate of Salmonella infection was 128.9 per 100,000 and the rate of Campylobacter infection was 54.1 per 100,000, rates substantially higher than for other age groups.
Objective 12.2
Reduce outbreaks of infections due to Salmonella Enteritidis to fewer than 25 outbreaks yearly.
Data demonstrate that steady progress has been made in reducing the number of S. Enteritidis outbreaks from 77 in 1989 to 44 in 1997, and 45 in 1998 (Table 12.2 and Chart 12.2). Some of this progress may be attributed to adoption of on-farm risk reduction strategies for eggs (e.g., the Pennsylvania Egg Quality Assurance Program). Further emphasis on egg safety during the last 4 four years has included the Food Safety Inspection Service (FSIS) S. Enteritidis Risk Assessment and publication by FSIS of a final rule and by FDA of proposed regulations for refrigeration and warning labeling for eggs.
Objective 12.3
Increase to at least 75 percent the proportion of households in which principal food preparers routinely refrain from leaving perishable food out of the refrigerator for over 2 hours and routinely wash cutting boards and utensils with soap after contact with raw meat and poultry.
The Food Safety Survey found that the percentage of people who wash their cutting boards with soap after contact with raw meat and poultry has increased to 71% in 1998 from the 1988 baseline of 66% and the 1993 value of 65%. Questions about washing utensils and about refrigeration of food were not included in the most recent Food Safety Survey. However, the 1993 datum shows a slight increase in refrigeration of perishable foods from 70% in 1988 to 72% in 1993.
Objective 12.4
Extend to at least 70 percent the proportion of States and territories that have implemented Food Code for institutional food operations and to at least 70 percent the proportion of States and territories that have adopted the new uniform food protection code that sets recommended standards for regulation of all food operations.
The state and local agencies that have responsibility for regulating retail establishments that sell or serve food should use the Food Code as a model to help develop or update their own food safety rules and provide consistency among jurisdictions. As a result of FDA's intensive promotion, orientation and training efforts, as of July 31, 1999, at least one agency in 16 states (32% of States) had adopted one of the versions of the FDA Food Code. In addition, at least one agency in each of 23 states, 1 Territory (Puerto Rico), and the District of Columbia were involved in the process of reviewing the Food Code for adoption (48% of States and territories) and target adoptions in 1999, 2000, or 2001). The status in these latter states and territories ranges from agency and industry review and public hearings to field testing of the Food Code.
FDA monitors Food Code adoption at all levels. The count of 16 states having adopted one of the versions of the Food Code does not include the adoptions by the military, certain Indian Tribes, the National Park Service, and certain individual counties or townships within states.
Since 1993, FDA model codes have been updated and revised every two years. Based on experience gained through the earlier model food code editions for distinct sectors of the retail food industry, there is an initial lag time of a couple of years before the code is adopted, followed by a period of 3-4 years when it is adopted rapidly. The lag time represents the period necessary for jurisdictions to study and consider the provisions of the new model and to follow their legally specified administrative procedures for adoption.
Previously, approximately 80% of the states revised their requirements to be substantially equivalent to FDA's within about 8 years after publication of a new edition.
However, several factors with respect to the 1999 edition of the Food Code may serve to accelerate the code adoption process. These include a rapidly changing food industry combined with new approaches to food inspection, and intensive work with cooperating organizations, such as the Conference for Food Protection, in reviewing the various editions of the Food Code and commenting on ways to revise and improve it. In 1998 and 1999, organizations such as the National Restaurant Association and the Association for Food and Drug Officials endorsed the Food Code.
Although FDA has made good progress in working with the other federal agencies involved in food safety in institutional feeding operations, it is not yet possible to report this progress in terms of a number or percentage.
For many people, foodborne illness results in discomfort or lost time from the job. For some, including preschool age children, the elderly, those in health care facilities and those with impaired immune systems, foodborne illness is more serious and may be life threatening. In addition, some foodborne disease may be followed by serious chronic illness, such as hemolytic uremic syndrome, Guillain-Barré syndrome, or reactive arthritis. The annual cost of foodborne illness in the United States is estimated to be between $7.7 and $23 billion.
Current epidemiological data indicate that the most important foodborne diseases are caused by microbes, primarily Campylobacter spp. and Salmonella spp. In addition to the aforementioned microorganisms, Clostridium perfringens and Staphylococcus aureus remain troublesome, particularly in the area of food service. Meat and poultry products remain important sources of foodborne disease. These products may become contaminated during slaughter and processing and can lead to disease if they are undercooked or mishandled, or temperature abused..
It is not scientifically, technologically, or legally possible to ensure a zero tolerance for all pathogens in the food supply. Risk reduction and prevention strategies at every point from farm to table are needed to control foodborne disease.
Emerging Pathogens
Microorganisms continually adapt and evolve, sometimes increasing their degree of virulence. Outbreaks of illness have been caused by microorganisms that were previously unknown to be human pathogens, not expected to occur in certain foods, or that have increased resistance to antimicrobial agents. These microorganisms have been grouped and called "emerging pathogens," and include bacteria, parasites, viruses, organisms never before identified, as well as virulent strains of E. coli. A description of some of the emerging pathogens and recent outbreaks follows.
Listeria monocytogenes
Progress toward achieving the year 2000 objective for disease caused by L. monocytogenes is still encouraging, even with the occurrence of a large outbreak of listeriosis in 1998-1999. The availability and use of new molecular methods of "fingerprinting" isolates has allowed linkage of cases that are widely distributed geographically that ,in the past, might never have been linked and would have been reported as sporadic (not associated with an outbreak).
Outbreak of Listeriosis August 1998 - March 1999
An outbreak of listeriosis caused by the foodborne pathogen, L. monocytogenes, occurred from August 1998 to March 1999. In all, more than 100 people in 22 states were infected with this organism and, of those, there were 15 adult deaths and six miscarriages or stillbirths. All adult deaths occurred in persons 60 years of age, or older. The age range of those who fell ill was 5 to 94 .
In October, 1998, the state health departments of New York, Ohio, Connecticut, and Tennessee independently noticed an increase in the numbers of cases of listeriosis. By early November, DNA testing of L. monocytogenes isolates at different laboratories showed indistinguishable strains among 3 patients in Tennessee, 7 patients in New York and 5 in Ohio. Subsequent testing confirmed that the 3 clusters involved the same strain and led to a pooling of isolates and questionnaire data to attempt to identify the potential source of the outbreak. It is noteworthy that this strain, serotype is relatively uncommon and appears in less than five percent of human illness cases.
Also in November, a family in New York fell ill with gastrointestinal symptoms one day after eating sliced chicken breast. The New York State Department of Agriculture and Markets received the suspected food samples from the family's refrigerator. These samples were analyzed and found to contain the same strain of L. monocytogenes as earlier identified and traced to plant A. A subsequent serum specimen from one ill family member suggested that the illness may have been due to listeriosis. This evidence was linked with earlier data from the October and November cases.
By early December, epidemiological data from interviews with 41 patients (including 20 infected with the outbreak strain and 21 infected with a variety of other L. monocytogenes strains) showed a significant association between illness and consumption of hot dogs. A traceback investigation of the implicated hot dogs led back to plant A. On December 22, 1998, the plant in question voluntarily closed, recalled potentially contaminated products, and discontinued production.
The combined efforts of the state health departments, the Centers for Disease Control and Prevention (CDC), the Food Safety and Inspection Service (FSIS) and Cornell University's Food Safety Laboratory all led to the identification of the common strain that was traced back to the processing plant. Through DNA fingerprinting via ribotyping at Cornell University and pulsed field gel electrophoresis (PFGE) at CDC, the serotype 4b was further refined to the ribotype 1044DupA pattern and PFGE subtypes Eo , E1, or E2. Subtypes Eo and E1 were recovered from infected patients and were found in opened and unopened packages of product. Interestingly, subtype E2 was recovered from unopened packages of product, but was never recovered from these patients.
The findings of this outbreak point out that much still remains to be learned about the virulence characteristics of L. monocytogenes. Strains of this organism differ widely in virulence, even among serotypes that commonly cause human illness.
Processed meats are an important potential source of listeriosis, with its attendant high morbidity and mortality rate. Preventing the occurrence of this organism in processed products may be the only reliable means of preventing future outbreaks, such as this.
Salmonella Typhimurium DT 104
Salmonella enterica serovar Typhimurium definitive type 104 (DT 104) is an emerging multi-drug resistant Salmonella serovar. DT 104 refers to S. Typhimurium as defined by specific phage typing. DT 104 is generally resistant to ampicillin (A), chloramphenicol (C), streptomycin (S), sulfonamides (Su), and tetracycline (T). Resistance to these antibiotics is referred to as R-type ACSSuT. Some strains have also been found resistant to trimethoprim, spectinomycin and/or ciprofloxacin. Not all DT 104 are R-type ACSSuT and not all R-type ACSSuT are DT-104. As many as 91% of R-type ACSSuT isolates, since 1995, have been identified as DT 104 or as related phage types included within the DT 104 complex. The multi-drug resistance displayed by DT 104 is unusual in that it is chromosomally encoded rather than extra-chromosomally encoded (on a plasmid). Therefore, although the overuse of antibiotics probably contributed to the emergence of DT 104, it is unlikely, in the absence of selective pressure by antibiotics, that its antibiotic resistance will be lost in the future.
DT 104 has been detected worldwide, including North America and Europe. As a proportion of US S. Typhimurium isolates, R-type ACSSuT has increased from 0.6% in 1979-80 to 34% in 1996. A majority of these isolates are probably DT 104. Similarly, in the United Kingdom (UK), where it was first detected in 1984, the number of DT 104 R-type ACSSuT isolates have risen from 259 in 1990, to 4,006 in 1996. By 1995, DT 104 was second to S. Enteritidis PT 4 as the Salmonella serovar most commonly isolated from humans in the UK. In the US, S. Typhimurium is also the second most common human isolate (25% in 1996), after S. Enteritidis. Exact data, as to the relative percentage of DT 104 to non-DT 104 S. Typhimurium in the US, are unavailable because the phage typing procedures used to identify DT 104 have not commonly been performed. There have been reports of increased morbidity and mortality associated with DT 104. In the US, DT 104 has been associated with longer hospitalizations, but increased mortality has not been observed. Increased morbidity has been associated with the very young, with the very old, and with other high-risk groups.
DT 104 is frequently associated with cattle in the US, but also with a wide variety of other animals (including pigs, sheep, horses, poultry, as well as cats and dogs). Cattle may shed DT 104 for up to 18 months following an outbreak. Cats, when symptomatic, have been reported to shed DT 104 organisms from the mouth. Asymptomatic cats have been reported to shed the pathogen for up to 14 weeks. Consequently, people who live and work with animals may be at risk for infection.
Culture confirmed DT 104 outbreaks, in the US, have been most commonly associated with the consumption of unpasteurized dairy products, undercooked hamburgers, or with direct contact with cattle. The first known outbreak of DT 104 in the U.S. occurred in October 1996. The Nebraska Department of Health was notified of an outbreak of diarrheal disease in 19 of 32 children from an elementary school in Cass County. Stool cultures from several children yielded Typhimurium with the typical ACSSuT antibiogram and phage typing at CDC confirmed the isolates as DT104. The source of the outbreak was not determined.
Hepatitis A Virus
Hepatitis A virus (HAV) has been known to cause a self-limiting liver disease, that is spread by the fecal-oral route, and has been found frequently in food and in water systems, at least since the 1960s. However, because of the advances made in growing the virus in cell culture, and the advent of highly sensitive PCR techniques for the detection of minute quantities of HAV genome, this virus has occupied a more prominent place as a food borne pathogen in recent years. It is interesting that while the number of reported outbreaks has increased lately, the total number of people infected in a single episode is much lower. This may be due to increased awareness among consumers and food safety officials.
Enteric viruses in the environment, including HAV, are remarkably stable to commonly used disinfection methods for bacterial. Also, the minimum infectious dose of enteric viruses for humans is around one virus, which is lower than the infectious dose of many pathogenic bacteria. Even under ideal conditions, detection of a single infectious virus by the reverse transcriptase polymerase chain reaction (RT-PCR) method is a daunting task.
An important question is whether the RT-PCR methods are reliable enough and sensitive enough to be used by a regulatory agency. FDA scientists have established procedures for the detection of low level of HAV in shellfish, milk, shrimp, and other foods. However, each new food matrix requires unique process of preparing samples for successful virus detection.
Helicobacter pylori
Helicobacter pylori was first identified in 1982 by a pair of Australian physicians as a frequent cause of gastric ulcers. During the past decade, H. pylori has become recognized as a common human pathogen. It is the major cause of chronic gastritis and is a contributing factor in peptic ulcer disease and in the development of certain gastric carcinomas. Seroprevalence and endoscopic analyses indicate its worldwide distribution, and the organism is frequently isolated from asymptomatic persons. It is estimated that by age 60, approximately 50% of humans in developed countries are infected without necessarily showing signs of infection. The incidence of infection in developing countries may approach 100%.
This organism is well adapted to the human stomach as its preferred ecological niche. It is fastidious, slow growing, microaerophilic, and survives in the mucous layer coating the gastric epithelium. It produces a membrane-associated urease, which can neutralize the stomach acid at sites of infection. It has been cultured from both the feces and saliva of infected individuals.
Undoubtedly, H. pylori has multiple routes of transmission. Although fecal to oral and oral-to-oral modes of transmission are substantiated, there is recent evidence for the waterborne route of transmission. The organism has been shown to remain in a dormant state in river and well water for long periods. A statistically significant correlation between the presence of the organism in potable well water and incidence of gastritis has recently been documented in Pennsylvania. Although foodborne transmission has not been documented, contamination of irrigation water by raw sewage and subsequent contamination of produce is likely to be a factor in the transmission of this organism as with other gastrointestinal pathogens.
Fishborne Anisakid Nematodes
Anisakis simplex and its close relatives, Pseudoterranova decipiens and Contracaecum osculatum, are nematodes that mature and usually reproduce in the stomach of marine mammals. Fertilized anisakid eggs pass out of the mammalian host with the feces and embryonate in the water. A larva hatches from the egg; if it invades a marine microinvertebrate, and if that invertebrate is eaten by a fish, the larva penetrates into the fish's tissues. The parasite can complete its lifecycle by maturing into an adult male or female worm when the infected fish is eaten by the appropriate marine mammal. If the infected fish is eaten in a raw or semi-raw state by a human, the anisakid larva does not mature into an adult, but may cause symptoms in the human host that range from mild to severe. Severe symptoms include acute abdominal and ulcerative pain initiated by the larva's attachment to the stomach or intestinal wall. Eventually the anisakid larva dies and, if located predominantly in the digestive tract lumen, is evacuated. If the larva has penetrated into the human host's tissues, a granuloma is likely to form around the larva as it dies.
Human anisakiasis has emerged, regressed and re-emerged in various countries at various times since it was first described definitively in the Netherlands in the 1960s. This pattern is related to changes in consumer eating habits, fish processing practices and awareness of the parasites and the symptoms they cause. The Netherlands solved its initial problem by requiring herring (the only fish eaten uncooked there at the time) to be frozen if intended for raw consumption; deep freezing kills the worms. Japan, which consumes more raw fish than other nations, has had the most cases - several thousand. Eviscerating fish immediately after catch removes the majority of anisakids. However, if fish are cold stored before evisceration, the larval anisakids migrate from the viscera into the edible musculature and are more likely to cause human infection.
FDA recommends that all fish and shellfish intended for raw (or semi-raw such as marinated or partly cooked) consumption be blast frozen to -35°C (-31°F) or below for 15 hours, or be regularly frozen to -20°C (-4°F) or below for 7 days.
The recent re-emergence of anisakiasis is associated with a new awareness of human allergic symptoms caused by the live worms and, possibly, their secretory or excretory products.
Cryptosporidium parvum
Cryptosporidium parvum is a single-cell obligate intracellular protozoan parasite that infects humans as well as many herd animals (cows, goats, sheep, deer, elk, et al.). It is the only Cryptosporidium species known to infect humans. Within this species, at least two sub-groups exist, G and H. Whereas both will infect calves, only H has been associated with human illness. The infective stage of the organism, the double-wall oocyst, 3-5 m m in diameter and containing 4 sporozoites, is shed into the environment. The number of oocysts required to cause illness varies among strains, from as few as 30 to over 1,000. In some animal models, one organism may cause symptoms. Once ingested and in the intestinal tract, the sporozoites are released and penetrate cells of the intestinal epithelium where they mature. Although the predominant cryptosporidiosis illness is intestinal, pulmonary and tracheal infections have also been described. Intestinal cryptosporidiosis is characterized by severe watery diarrhea, but it can also be asymptomatic. Pulmonary and tracheal cryptosporidiosis in humans is associated with coughing and frequently low-grade fever; these symptoms are often accompanied by severe intestinal distress. The disease mechanism is unknown, but intracellular stages of the parasite can cause severe tissue damage
The 8th edition of the FDA's Bacteriological Analytical Manual contains methods for the detection of this organism in fresh produce. The current literature describes methods for determining the viability of organisms isolated from clinical, environmental, and food sources.
The organism survives in environmental extremes and in contaminated water reservoirs. Oocysts are resistant to most chemical disinfectants, but are susceptible to drying and ultraviolet light. C. parvum can occur on any food touched by a contaminated food handler or contaminated water. Salad vegetables fertilized with manure are another possible source of human infection. Large outbreaks are usually associated with contaminated drinking water supplies. Prevalence of infection varies, but is highest in young children, especially in daycare centers, and in immunocompromised individuals. Direct human surveys indicate a prevalence of about 20% of the population in North America. Of those surveyed 80% have had cryptosporidiosis as judged by seropositive reactions to C. parvum antigens.
Cyclospora cayetanensis
One of the latest human pathogens to emerge is another protozoan parasite. Described definitively in 1994 as a new species of the genus Cyclospora, this organism - C. cayetanensis - is associated with debilitating diarrhea that may last 3 weeks or longer. Endemic in humans (with similar yet not identical Cyclospora spp. in other primates), and, to date, not proven to infect other hosts, C. cayetanensis has most regularly been reported from locations in Nepal, Peru, and Haiti. In countries where freezing occurs annually and oocysts are unlikely to survive from one year to the next, C. cayetanensis was initially known as an occasional illness of travelers returning from sojourns in tropical and semitropical regions. More recently, it has been associated epidemiologically in the USA and Canada with foodborne outbreaks. Items of fresh produce, mostly imported, appear to be the vehicles - mesclun lettuce, basil, and raspberries. In Peru, C. cayetanensis oocysts were found on market vegetables. Waterborne infections seem to predominate in endemic areas.
The three largest cyclosporiasis outbreaks in the U.S. and Canada occurred in 1996 (approximately 1500 illnesses) and 1997 (approximately 1400 illnesses), and 1998 (in Canada, only). Initially, in 1996, it was difficult to identify a common source among the different berries from diverse countries that were implicated. Eventually, investigations associated cyclosporiasis with raspberries from the spring/summer crop grown in Guatemala. This association also was made for the 1997 and 1998 outbreaks, and is based on epidemiology and product traceback investigations. The parasite has not been detected on raspberries by either microscopy or DNA testing.
In response to this epidemiological association, a "Model Plan of Excellence" (MPE) was developed for raspberry production in Guatemala and subsequent transport to Canada and the USA. Will the measures called for in the MPE prevent contamination of the berries with C. cayetanensis? Until we know how and where in production or distribution the contamination occurred, this question cannot be answered with total assurance, and no full risk assessment of the situation can be made. However, a preliminary or "safety" assessment was undertaken by the Guatemalan Berry Commission, the Guatemalan Ministry of Agriculture, and the US FDA.
"Safety" assessment summary: The chance that raspberry contamination comes from spray water can be reduced by installing properly functioning microbiological filters with pore sizes that exclude the parasite's oocyst stage (8 - 10 m m). Contamination by employee handling of raspberries also can be reduced, but not as much as by controlling spray water. Other routes of field contamination (animals, rain, wind) are less likely to occur, but have not been ruled out. Established MPE security measures are enforced after the packaging of berries in retail containers in order to prevent intentional commingling. When observation and research identify the principal routes of Cyclospora contamination, it will be possible to assess the effectiveness of control measures with greater certainty. Even without such certainty, the measures being monitored by the Guatemalan authorities seem a reasonable assurance that exports of Guatemalan raspberries are safe.
Cyclospora cayetanensis was made a nationally notifiable disease and added to FoodNet in 1998. Additional information about this emerging pathogen is needed, such as the proportion of infections that are foodborne. Examination for C. cayetanensis is not universal in clinical laboratories; thus, data for this organism may be less reliable than for the other organisms.
Gastrointestinal Illness of Unknown Etiology
Healthy People 2000 objectives for foodborne illnesses are based on known pathogens that we can identify and that we monitor. However, the causative agent for a significant proportion of foodborne illnesses is never isolated or identified. The following example is a description of several outbreaks of gastrointestinal illness of unknown etiology.
From October 1997 through December 1998, 16 outbreaks of gastrointestinal illness of unknown etiology associated with school lunch beef and bean burritos and, in one case, pepperoni pizza, occurred in Florida, Georgia, Illinois, Indiana, Kansas, North Dakota, and Pennsylvania. Almost all of the approximately 1700 persons affected were elementary school-aged children. Symptoms included abdominal cramps, headache, vomiting, dizziness, and nausea. Some children experienced diarrhea. In all, the onset period was short (15 - 30 minutes) and illness was of brief duration (4.5 hours with a range of 10 minutes to 8 hours).
Epidemiologic investigations implicated burritos made of meat or vegetable filling that was wrapped in a tortilla. One investigation indicated that the agent was associated with the wheat tortilla. Investigations of burritos implicated in 15 of these school lunch outbreaks suggested that the etiologic agent was an ingredient common to the products made by different companies. Similarly, pepperoni pizza associated with illness was manufactured by a company unrelated to either burrito manufacturer. No common first-line suppliers were identified and traceback did not reveal a common source of any ingredient.
Samples of these burritos and pepperoni pizza were collected and analyzed by FSIS, FDA, and CDC laboratories for potential short-acting etiologic agents). Tests indicated low levels of dexoynivalenol (commonly known as vomitoxin) ¬0.1-0.3 m g/g| and trace levels of aluminum ¬85.8m g/g| in the burritos. All pepperoni pizza samples were found to be negative or below the detection limit for each laboratory test. It is possible that elementary school-aged children have increased sensitivity to one of these laboratory tested etiologic agents, which may account for the large numbers of children affected in these outbreaks.
FSIS requested that both burrito manufacturers initiate timely national recalls. Approximately 2 million pounds of burritos were recalled or withheld from distribution. No other schools receiving pepperoni pizza with the same shipment date and lot numbers reported illness. This product was held for analysis, but no recall was requested.
Hazard Analysis and Critical Control Point (HACCP) is an internationally recognized, science-based, and systematic approach to achieve food safety. HACCP was developed by the food industry for the space programs as a way of producing safer food by anticipating how biological, chemical, or physical hazards are most likely to occur and by installing appropriate measures to prevent them from occurring. The seven principles of HACCP are hazard analysis, determination of critical control points (CCPs), specification of critical limits, monitoring, corrective actions, verification, and documentation (record keeping). The heart of each HACCP system is monitoring "critical control points" where a breakdown could cause a safety hazard to occur, and then recording the results of that monitoring. HACCP can be used at steps from pre-harvest to consumption.
Governments in several countries have adopted HACCP in their codes or regulations as a means of attaining food safety assurance. International trade issues and equivalency associated with the Sanitary and Phytosanitary Standards provisions of the World Trade Organization agreement will likely include HACCP as a major point of discussion .
There are three mandatory HACCP or HACCP-based rules for food processing in the United States. The existing HACCP rules include FDA=s low acid canned food rule, its seafood HACCP rule, and the FSIS pathogen reduction and HACCP rule for meat and poultry. FDA proposed a HACCP rule for the production of fruit and vegetable juices on April 24, 1998, and a final rule is expected in 1999. FDA is analyzing whether more rigid adherence to good agricultural practices and good manufacturing practices, or HACCP, will be needed for other commodities, such as produce.
Several factors are needed for HACCP to be effective: 1) industry must accept HACCP, 2) HACCP must be kept achievable for both small and large firms, 3) HACCP must be applied fairly and consistently, 4) a mandatory HACCP program should serve as a catalyst for partnership between the Federal government, state governments, industry, and academia, and 5) HACCP should serve as a catalyst for research through its focus on hazards and controls.
A. Regulations for Seafood HACCP
On December 18, 1995 FDA published, and on December 18, 1997, implemented a mandatory HACCP rule for seafood processed in or imported into the United States. Since that time a number of achievements have been noted:
B. Meat and Poultry Pathogen Reduction and HACCP Rule (PR-HACCP).
FSIS is the agency within the U.S. Department of Agriculture responsible for ensuring the safety, wholesomeness, and accurate labeling of meat, poultry, and egg products. The USDA PR-HACCP rule was published on July 25, 1996 and was implemented for large plants in January 1998. The rule specifies that industry is accountable for producing safe food and that the federal government, under the Federal Meat Inspection Act and the Poultry Products Inspection Act is responsible for setting appropriate food safety standards. The PR-HACCP rule also provides for vigorous inspection oversight to ensure that HACCP standards are met, and maintains the operation of a strong enforcement program to deal with plants that do not meet regulatory standards.
The PR-HACCP rule: (1) requires all meat and poultry plants to develop and implement written standard operating procedures for sanitation (SSOPs), (2) requires meat and poultry slaughter plants to conduct microbial testing for generic E. coli to verify the adequacy of their process controls for the prevention of fecal contamination, (3) requires all meat and poultry plants to develop and implement a system of preventive controls, known as HACCP, to improve the safety of their products, and (4) sets pathogen reduction performance standards for Salmonella that slaughter plants and plants producing raw ground products must meet.
HACCP requirements of the final rule are being phased in over several years. On January 27, 1997, all plants were required to have in place written standard operating procedures for sanitation, and slaughter plants were required to begin testing for generic E. coli. On January 26, 1998, all large plants, defined as having 500 or more employees, were required to have HACCP in place and to meet the performance standards for Salmonella. Approximately 300 large plants entered the program in January 1998, accounting for 75 percent of the volume of meat and poultry production in the United States. Implementation was very smooth due to efforts of both industry and government. Large plants had a 92 percent compliance rate with the HACCP requirements during the first three months of implementation. Where few problems did occur, enforcement actions were implemented and plants responded by modifying and strengthening their HACCP plans.
Farm to Table Food Safety
FSIS recognizes the necessity for a comprehensive food safety strategy that addresses hazards at all critical points in the farm-to-table chain.
To improve food safety at the animal production and intermediate stages before slaughter voluntary measures are being sought for the farm and the distribution and marketing channels for animals to reduce food safety hazards. FSIS believes the voluntary application of food safety quality assurance programs based on HACCP principles can be useful in establishing risk reduction strategies, and many industry groups are implementing such programs.
Food safety during transportation, storage and retail sale also is an important link in the food safety chain. In these areas, FSIS, the Food and Drug Administration (FDA), and State and local governments share authority for oversight of food products. FSIS and FDA are working together to develop standards governing the safety of foods during transportation and storage. In the retail area, FSIS and FDA are working with state officials through the Conference for Food Protection to ensure the adoption of uniform, science-based standards as part of the Food Code.
Even as progress is made in reducing contamination during these stages, it will remain critical that retail food handlers and consumers follow safe food handling practices. FSIS has augmented its food handler education efforts by expanding its collaboration with industry, other government agencies, consumer and public interest groups, educators, and the media to foster the effective delivery of food safety education and information.
Pathogen Reduction Accomplishments
Two recently released reports, one from FSIS and one from CDC, indicate that the rate of contamination of meat and poultry products with Salmonella parallels the decreased incidence seen in human populations with foodborne illness caused by this organism.
The FSIS data came from the sampling of four product categories: broiler carcasses, swine, ground beef, and ground turkey. These samples were taken in a one-year period, January 26, 1998 through January 25, 1999, from about 200 large plants. The results were compared with the rates of contamination found in baseline studies conducted before the government instituted the Hazard Analysis and Critical Control Points (HACCP) Rule in meat and poultry slaughter and processing plants. The FSIS results are considered preliminary and do not represent a random sample of all domestic meat and poultry production.
In broiler carcasses, the rate of Salmonella prevalence dropped from 20 percent to 10.9 percent, a decrease of nearly 50 percent. Swine carcass contamination dropped from 8.7 percent to 6.5 percent. Ground beef positive samples dropped from 7.5 percent to 4.8 percent and ground turkey Salmonella rates dropped from 49.9 percent to 36.4 percent. Although the FSIS does not attribute these reductions solely to the implementation of HACCP, the results are encouraging.
The 1998 FoodNet Surveillance Results report a decline in the incidence rate of salmonellosis over the period 1996 to 1998. FoodNet 1998 data show that salmonellosis decreased 14 percent, which was particularly pronounced for the serotype Enteritidis. Ongoing, active, laboratory-based surveillance is being used to document the effectiveness of new food safety control measures, such as HACCP, in reducing the number of cases of foodborne diseases in the United States.
C. HACCP for Juice
FDA initiated rulemaking that will mandate the use of HACCP for the safe and sanitary processing of fruit and vegetable juices.
There have been a number of foodborne illness outbreaks associated with consumption of unprocessed juices. In October and November 1996, there was an Escherichia coli O157:H7 outbreak in Washington, California, Colorado, and British Columbia associated with consumption of unpasteurized apple juice. There were 70 confirmed cases with 14 cases of Hemolytic Uremic Syndrome (HUS) and one death
FDA proposed (April 24, 1998) and finalized (July 8, 1998) a rule to require label warning statements for juice that has not been processed to control pathogens. Juice processed in a manner to achieve a 5-log reduction in a pertinent pathogen need not bear the warning statement. This rule is now effective for apple juice or apple cider and for other juices. Proposed procedures for safe and sanitary processing in the manufacture of fruit juice were published in the Federal Register on April 24, 1998 that will require firms to use HACCP systems. It is anticipated that a final HACCP regulation for juices will be published by the end of 1999.
D. NCIMS Milk HACCP Pilot Program
The National Conference on Interstate Milk Shipments (NCIMS) Dairy HACCP Pilot Committee met in June, 1999 to prepare for the implementation of a Dairy HACCP Pilot Study approved by NCIMS. The pilot program will involve 5 or 6 firms, one in each FDA region. The committee will closely monitor the firms to assure uniformity. Under this program, HACCP audits will be used by the states on a trial basis to list (certify) milk producers to ship in interstate commerce. This HACCP-based listing will be recognized by the receiving states in lieu of the current sanitation-based ratings and listing program under the Pasteurized Milk Ordinance (PMO). FDA and the NCIMS HACCP committee conducted a workshop for milk specialists on HACCP principles and pilot program implementation in August, 1999. In support of this initiative, FDA will conduct check-ratings using agreed upon HACCP audit procedures and criteria.
On January 25, 1997, the President announced a Food Safety Initiative to reduce the incidence of foodborne illness to the greatest extent possible. Four months later, recommendations were delivered to the President outlining the steps the federal government would take in the short and long-term to achieve that goal. In addition, on October 2, 1997, President Clinton announced the Produce Initiative to ensure the safety of imported and domestic fruits and vegetables. These initiatives are broad-based and cover the farm-to-table continuum. They are based on the public health principles that the public and private sectors should identify and take preventive measures to reduce the risk of illness; should focus efforts on hazards that present the greatest risk; and should make the best use of public and private resources. Increasing collaboration among public and private organizations and improving coordination within the government as work progresses toward the common goal of improving the safety of the nation's food supply are central to a farm-to-table food safety initiative.
On August 25,1998, President Clinton issued an executive order establishing the President's Council on Food Safety. The purpose of the Council is to develop a comprehensive strategic plan for federal food safety activities and to make recommendations to the President on how to advance federal efforts to implement a comprehensive, science-based strategy to improve the safety of the food supply and to enhance coordination among Federal agencies, State, local and tribal governments and the private sector. The July 15, 1999 meeting of the President's Council on Food Safety was the first public meeting to obtain input on draft goals and objectives, as well as to provide comments and suggestions on specific action items for inclusion in the plan. A second meeting, which will be announced later during 1999, will obtain public input on a more refined draft of the strategic plan.On July 3, 1998, President Clinton directed HHS and USDA to create a Joint Institute for Food Safety Research (JIFSR) to coordinate planning and priority setting for food safety research among the two Departments, other government agencies, and the private sector and to foster effective translation of research results into practice along the farm to table continuum. Secretaries Shalala and Glickman will jointly lead JIFSR. An executive director and staff are expected to be in place by late 1999. The report can be accessed on the web at www.foodsafety.gov.
On July 3, 1999, President Clinton expanded the Administration's food safety efforts even further to focus on the safety of imported foods. The President directed the Secretaries of HHS and the Treasury to take all actions available to: (1) prevent distribution of imported unsafe food by means such as requiring food to be held until reviewed by FDA; (2) destroy imported food that poses a serious public health threat; (3) prohibit "port shopping" via FDA regulations and requiring the marking of shipping containers and/or papers of imported food that is refused admission for safety reasons; (4) set standards for private laboratories for collection and analysis of samples; (5) increase the amount of the bond posted for imported foods; (6) enhance enforcement for violations of US laws, including the imposition of civil monetary penalties.
Improving the safety of the food supply requires three main components: First, there must be in place a state-of-the art system for early detection and containment of foodborne hazards. This includes timely identification and reporting of foodborne illnesses, appropriate monitoring of the food supply for hazards, and rapid detection and control of illness outbreaks. Equally important, however, is a food safety system that is based on prevention, education and verification. Finally, the food safety system must be science-based.
A. Early Detection and Surveillance
We have made tremendous strides in enhancing surveillance of food disease, building an early warning system, enhancing responses to foodborne outbreaks and improving risk assessment. The impact of these efforts is the development of preventive control and containment systems and new technologies to stop microbial contamination.
B. Prevention, Education and Verification
Activities to improve in inspections and compliance, ensure the safety of imported and domestic produce and further the role of food safety education for producers, retailers, public health officials and consumers were undertaken in FY 98. These activities will result in a safer food supply by stemming the reoccurrence of foodborne illness situations from farm to table.
C. Risk Assessment and Research to Support the Food Safety System
Food safety research results were announced, new research and risk assessment grants were awarded, and procedures were established to better plan and coordinate research among federal partners. The necessity of the scientific progress is clear as new pathogens in food and animal feed will continue to need to be identified and new methods to replace the time-tested controls for controlling pathogens, such as heat and refrigeration, will need to be developed.
D. Future FSI Activities:
The Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables was developed in response to response the Presidential initiative to ensure the safety of imported and domestic fresh fruits and vegetables. The Guide was developed through a public process and preliminary drafts made available during public meetings for comment. The final Guide was made available to the public on October 29, 1998.
The Guide:
Basic Principles include
A. Egg Safety Rules
On July 1, 1999, the Administration announced two new measures to improve the safety of shell eggs in order to reduce the number of illnesses and deaths associated with outbreaks of Salmonella Enteritidis (SE). FDA estimates that the proposed rule will reduce between 25,000 and 66,000 illnesses and prevent an estimated 15 to 20 deaths, annually. It is estimated that in the United States 2.3 million eggs annually are contaminated with SE, putting large numbers of our citizens at risk.
When both are implemented, the FDA and FSIS rules will create, for the first time, a uniform federal refrigeration requirement for all shell eggs stored or displayed at packaging facilities, warehouses, retail outlets, and in transit.
B. Egg Safety Plans
The Administration announced that the President's Council on Food Safety will develop a strategic plan for shell eggs and processed egg products by November 1, 1999. The HHS NEWS release, dated July 1, 1999 can be accessed on the FDA homepage, http://www.cfsan.fda.gov at "What's New."
On August 26, 1999 FDA and FSIS held a public meeting to discuss the development of an action plan to address the presence of Salmonella Enteritidis (SE) in shell eggs and egg products using a farm-to-table approach. The purpose of the action plan is to
There are more than 85 state and territorial agencies and 3,000 local regulatory departments that license and inspect the more than 1 million establishments in the United States that offer food directly to consumers. Given the size and diversity of this segment of the food industry and the limitations of agency resources, FDA directs its activities toward achievement of an effective system of state/local regulatory programs nationwide.
The strategy is threefold:
A. Food Code
FDA published the first Food Code to encompass recommendations for all types of retail level establishments in 1993 and has published revisions of it in 19995, 1997, and 1999. The Food Code consists of model requirements for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to the consumer. FDA offers the Food Code for adoption by local, State, and Federal Government jurisdictions and to be administered by the units that have compliance responsibilities for food service, retail food stores, or food vending operations.
FDA tracks adoption of the Food Code at all levels: by federal, state and local agencies, and by tribal governments. It is important for the states to incorporate the most up-to-date science in their consumer protection laws. Also, the most severe cases of foodborne illness occur in institutions such as nursing homes and it is important that the Food Code be applied to these institutions.
B. Cooperation with States and U.S. Territories
FDA continues to support States and U.S. Territories in their efforts to provide safe food to consumers at retail-level food establishments in several ways:
A. Partnership for Food Safety Education
The Fight BAC!TM Campaign, launched in October 1997, is the product of a unique partnership of government, industry, and consumer groups dedicated to carrying out the FSI. The U.S. Departments of Health and Human Services, Agriculture, and Education, along with 10 consumer and industry organizations were the founding members of a partnership that has grown to 21 organizations that are combining resources and focusing a more unified food safety message. The partnership now also includes the Environmental Protection Agency and Canada, the first international affiliate. The focal point of the partnership's campaign is the BAC!TM Character, which puts a "face" on invisible foodborne bacteria. The campaign spotlights and focuses national attention on four basic messages:
Outlined below are selected examples of the tremendous number of educational and outreach activities designed to educate the public about safe food preparation and handling practices.
B. Cooperation among Federal Agencies in Food Safety Education:
C. FDA -sponsored Activities
In 1998 and 1999, FDA awarded grants to Public Affairs Specialists in the Field Offices to fund grass-roots projects. The projects have targeted young children, older adults, multicultural populations, persons of low literacy, and immune-compromised individuals.
FDA funded the development of a supplementary food science curriculum aimed at middle and high school students. Sponsored in cooperation with the National Science Teachers Association, students learn that bacteria that can enter the food supply anywhere in the continuum from farm to table may cause foodborne illness. Most importantly, through interactive web site, videotape and resource and activity guides, students learn how to prevent foodborne illness from occurring in the home through proper food handling.
FDA educated the public about the proposed egg labeling and refrigeration rule and safe handling and cooking of eggs. A video news release was developed and used by television stations and a drop-in (canned) column in English and Spanish was distributed to newspapers. Also widely distributed were the two fact sheets, "Playing It Safe with Eggs" for consumers and "Assuring the Safety of Eggs" for food service personnel.
FDA targeting older persons with food safety information through an Internet web site, educational video and large print publication. FDA cooperated with AARP in developing/producing the web site. USDA and FDA are jointly producing the video and companion publication, with 100,000 copies of the publication being readied for distribution throughout the aging network.
D. FSIS Sponsored Activities
FSIS/ARS completed study on premature browning of ground beef patties in 1998. Results confirmed that color is not a reliable indicator for judging doneness of hamburger. Conducted focus group testing to determine consumer acceptance of using food thermometers in the home. Began nationwide thermometer campaign to increase the use of thermometers in the home.
FSIS established a Food Safety in Schools Work Group with the Food and Nutrition Service in January 1999. The purpose is to share information and resources through meetings, teleconferences, and the Internet; provide materials to school food service directors, and disseminate food safety educational materials at national school food service convention.
FSIS established national standards for teaching food safety education in cooperation with Department of Education.
FSIS conducted research to determine the most appropriate classes in schools to teach food safety education.
Food Safety at Home, School and when Eating Out, An Activity Book for You to Color. Jointly published and distributed by American Culinary Federation and FSIS.
FSIS developed a consumer information campaign for listeriosis and at-risk populations. FSIS developed Listeriosis and Food Safety Tips and a companion video news release to medical and health-related organizations.
In 1992, the World Health Organization (WHO) conducted a comprehensive review of the safety of food irradiation that examined all data and information included in previous reviews as well as more recent work. WHO concluded that irradiated food is safe and nutritionally adequate.
FSIS, the public health regulatory agency within USDA, is authorized by the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act to ensure that the commercial supply of meat, poultry, and processed egg products in the United States is safe, wholesome, and accurately labeled. These three laws address radiation in the context of adulteration, and FSIS can initiate a regulatory proposal after FDA issues final regulations on ionizing radiation for the treatment of meat, poultry or processed eggs.
Packaging
FDA must also approve packaging materials for irradiation of prepackaged foods before they can be used. Most of the currently listed materials were approved as a result of petitions from the U.S. Army in the 1960's. The most recent addition to the list is a heat-shrink wrap, approved as a result of an industry petition in the late 1980's. This is the only material approved for use with electron beam radiation. No petitions f
or additional packaging for use during irradiation have been received since this last petition. Since the time of the last petition, FDA has also instituted a new policy that provides an additional regulatory route for clearing packaging materials for either general or irradiation applications: the Threshold of Regulation Policy
Labeling
FDA requires that irradiated foods be labeled as such, with both an irradiation disclosure statement and the radura, the international symbol for food irradiation. FDA does not require special labeling for irradiated ingredients. In February 17, 1999, in response to the conference report that accompanied FDAMA, FDA published an advance notice of proposed rulemaking on irradiation labeling to add language explicitly stating that the irradiation disclosure statement need not be more prominent than the declaration of ingredients.
Microbial risk assessment is a very new field of endeavor. During the last two years, a Risk Assessment Consortium was established to include all Federal agencies with food safety risk management responsibilities. The consortium has three primary functions:
The initial focus of the initiative is on pathogenic microorganisms. In the last four years microbial risk assessments have been undertaken and are completed or in progress for: S. Enteritidis in eggs, E. coli O157:H7 in ground beef, L. monocytogenes in ready-to-eat foods, Vibrio parahaemolyticus in raw shellfish, Cryptosporidium parvum in drinking water. Overviews on the status and findings of these five risk assessments are being given during a public meeting at the Joints Institute of Food Safety and Applied Nutrition (JIFSAN) on September 1, 1999. In addition, a risk assessment on bovine spongiform encephalopathy (BSE) is underway.
A. Salmonella Enteritidis Risk Assessment
A team at USDA developed a comprehensive, quantitative model that characterizes the public health effects associated with the consumption of shell eggs and egg products with Salmonella Enteritidis
This full-spectrum, farm-to-table microbial risk assessment measures the different degrees of severity of human illness due to this organism using current production practices for these commodities. Since it is a quantitative model, it has the flexibility to change variables to measure their impact on human health. For example, pathogen reduction measures might be taken that could be added to the model and then a calculation of the success of those measures in reducing human illness could be estimated. In this way, proposed interventions could be tested mathematically without ever incurring the cost of actual field trials.
As with all risk models, this one can be continually refined and updated for use in future risk assessments that look at the continuum of the production of eggs and egg products from farm to table.
B. Listeria monocytogenes Risk Assessment
FDA's Center for Food Safety and Applied Nutrition (CFSAN), in consultation with FSIS, is conducting a risk assessment to determine the prevalence and extent of consumer exposure to foodborne L. monocytogenes and to assess the resulting public health impact of such exposure. The risk assessment team is collecting data in four areas: the presence of L. monocytogenes in foods, the consumption levels of these foods, information from epidemiological investigations, and data from experimentation that defines the dose-response relationship between this pathogen and populations with different immune conditions. The risk assessment will examine a number of issues, including which foods contribute most to the consumption of L. monocytogenes, what are the numbers of organisms when a food is contaminated, how frequently are foods heavily contaminated, are there common characteristics in the composition, processing or storage of contaminated foods, are some strains of L. monocytogenes more virulent that others, what is the extent of organism growth during storage (including storage at refrigeration temperatures), and what is the likelihood of illness to various subpopulations from consuming different numbers of L. monocytogenes.
C. BSE Risk Assessment
The USDA and Harvard University's School of Public Health have a cooperative agreement to analyze and evaluate the Department's current measures to prevent bovine spongiform encephalopathy (BSE). The two-year study will review current scientific information, assess the ways that BSE could potentially enter the United States, and identify any additional measures that could be taken to protect human and animal health.
Initiating this study is the latest step in a ten-year record of aggressive measures that USDA has taken to prevent the entry of BSE into the United States. In coordination with other government agencies, the USDA BSE Working Group has been regularly reviewing the available science and implementing appropriate regulatory measures to prevent BSE. These measures include the 1989 ban of cattle and cattle products from countries where BSE has been reported, as well as an active inspection, testing, and education program. No cases of BSE have been diagnosed in the United States.
One action FDA has taken to improve food safety is to give priority to the review of petitions for food additives that are intended to decrease the incidence of foodborne illness through their antimicrobial action against human pathogens that might be present in food, i.e., to designate such petitions for expedited review.
Examples of petitions that could be designated for expedited review are those that propose the use of sources of radiation or chemicals such as chlorine dioxide intended to reduce harmful bacteria. The process of expedited review is designed to provide an incentive for manufacturers to develop these products and to ensure that such products are available for marketing as soon as possible, while still meeting the safety standard and operating within the process established by law for food additives.
EPA sets safety standards (tolerances) to limit the amount of pesticide residues that legally may remain in or on food or animal feed that is sold in the United States. Domestic and imported foods are monitored by FDA, USDA's Agricultural Marketing Service (AMS), and FSIS to ensure compliance with these safety standards. Federal, State, and local agencies take action on foods found to have pesticide residues above the EPA limits. In 1997, only 1.2 percent of all domestic and 1.6 percent of all imported food samples tested by FDA had pesticide residues exceeding the current standards levels. In its Pesticide Data Program (PDP), AMS surveys commonly eaten foods with an emphasis on food consumed by infants and children. In 1997, the PDP found presumptive violations in 5 percent of samples; 99 percent of the presumptive violations were instances with no established standard for the pesticide/commodity pair, as might be due to spray drift or crop rotation. The remaining four violative samples exceeded EPA standards.
The Food Quality Protection Act of 1996 requires that EPA reassess all existing standards for pesticides by the year 2006. The safety standard that must be met is a "reasonable certainty of no harm." Under this act, EPA considers the risk from dietary exposures from all food uses of pesticides, dietary exposure from drinking water, non-occupational exposure, such as the use of the pesticides for lawn care, and any special sensitivities for children. In addition, EPA considers exposure from pesticides with common mechanisms of toxicity. As a result, exposure from one use of a pesticide will affect whether the exposure from another use can be permitted. In all, 9,728 standards are being reassessed.
The US Department of Agriculture established the Office of Pest Management Policy in September, 1997 with the following mandate:
Coordinate the Department's role in the pesticide regulatory process and related interagency affairs, primarily with the Environmental Protection Agency. Integrate the Department's communications with and responsiveness to the agriculture community in developing alternative pest management practices that may be needed as a result of regulatory change.
The USDA and its land-grant university partners assist EPA in the implementation of the Food Quality Protection Act (FQPA) by providing the EPA with the most accurate data available on actual agricultural practices relative to pesticide tolerance reassessments and developing risk mitigation plans and transition strategies on a commodity-by-commodity basis to reduce reliance on organophosphates and carbamates. In addition, USDA staff and land-grant experts participate in the review of EPA's preliminary risk assessments for organophosphates. This review is a valuable contribution to quality assurance in the assessment process.
Preventing Emerging Infectious Diseases: A Strategy for the 21st Century describes CDC's plan to combat today's infectious diseases and prevent those of tomorrow. It represents the second phase of the effort launched in 1994 with the publication of CDC's Addressing Emerging Infectious Disease Threats: A Prevention Strategy for the United States. The updated plan outlines specific objectives under four major goals: a) surveillance and response, b) applied research, c) infrastructure and training, and d) prevention and control. Achieving these objectives will enhance understanding of infectious diseases and bolster their detection, control, and prevention.
The plan also targets nine categories of problems that cause human suffering and place a burden on society. The aim of this plan is to build a stronger, more flexible U.S. public health system that is well-prepared to respond to known disease problems, as well as to address the unexpected. The implementation of this plan will require the dedicated efforts of many partners, including state and local health departments, other federal agencies, professional societies, universities, research institutes, health-care providers and organizations, the World Health Organization, and many other domestic and international organizations and groups.
CDC decided to update its strategy for addressing emerging infectious diseases because of progress in implementing the highest priorities in the 1994 plan as well as several recent developments, including emerging threats, scientific findings, tools and technologies, changes in healthcare delivery, and public and policy issues. The emerging threats included those that are foodborne:
CDC's future FoodNet plans for foodborne illness surveillance include:
| Department | Agency | Food Oversight |
|---|---|---|
| U.S. Department of Health and Human Services | Food and Drug Administration | All domestic and imported food sold in interstate commerce, including shell eggs, and products with less than 3% meat and products with less than 2% poultry; bottled water; and wine beverages with less than 7 percent alcohol |
| U.S. Department of Health and Human Services | Centers for Disease Control and Prevention | Investigation and surveillance for foodborne disease outbreaks (all foods) |
| U.S. Department of Agriculture | Food Safety and Inspection Service | Domestic and imported meat and poultry and related products; processed egg products |
| U.S. Department of Agriculture | Cooperative State Research, Education, and Extension Service | Research and education programs for all domestic foods, some imported foods |
| U.S. Department of Agriculture | National Agricultural Library | Database on preventing foodborne illness (all foods) |
| U.S. Environmental Protection Agency | Establishes drinking water standards; and pesticide tolerances | |
| U.S. Department of Commerce | National Oceanic and Atmospheric Administration | Fish and seafood products fee-for service program (voluntary) |
| U.S. Department of the Treasury | Bureau of Alcohol, Tobacco and Firearms | Alcoholic beverages (except wine beverages containing less than 7 percent alcohol) |
| U.S. Department of the Treasury | U.S. Customs Service | Works with federal regulatory agencies on imported foods |
| U.S. Department of Justice | Prosecutes those suspected of violating food safety laws, seizes unsafe food products, for all foods | |
| Federal Trade Commission | Enforces consumer protection laws for all foods (including advertising) | |
| State and local governments | Work with federal regulatory agencies; inspect retail food establishments; dairy farms, milk processors, grain mills, and food manufacturing plants for all foods within their jurisdictions |
Other agencies that help enforce food safety laws: Consumer Product Safety Commission, Federal Bureau of Investigation, Department of Transportation, and the U.S. Postal Service
B. Coordination With Federal And Non-Federal Partners
National Advisory Committee on Microbiological Criteria for Foods
The National Advisory Committee on Microbiological Criteria For Foods (NACMCF) provides advice and recommendations on the development of microbiological criteria for foods, including a variety of scientific issues related to foodborne diseases, research, and risk assessment. Sponsoring agencies determine how scientific recommendations provided by NACMCF will be applied in the development of policies that ensure the safety and wholesomeness of food. NACMCF is co-sponsored by the Food Safety and Inspection Service of the U.S. Department of Agriculture, the Food and Drug Administration and the Centers for Disease Control and Prevention within the Department of Health and Human Services, the Department of Commerce's National Marine Fisheries Services, and the Department of Army, Department of Defense.
National Advisory Committee on Meat and Poultry Inspection
Another advisory committee deals with meat and poultry issues. In 1971, Congress established the National Advisory Committee on Meat and Poultry Inspection (NACMPI) to address policy issues. Under the Federal Meat Inspection and the Poultry Products Inspection Acts, the Secretary of Agriculture is required to consult with the NACMPI before issuing product standards and labeling changes or regulatory policy affecting federal and state program activities. NACMPI serves as a forum for providing advice and guidance to USDA's Food Safety and Inspection Service (FSIS) on policy matters related to food safety issues for meat and poultry.
Partnership for Food Safety Education
The U.S. Departments of Health and Human Services, Agriculture, and Education, along with 10 consumer and industry organizations were the founding members of a partnership that has grown to 21 organizations that are combining resources and focusing a more unified food safety message. The partnership now also includes the Environmental Protection Agency and Canada, the first international affiliate. The focal point of the partnership's campaign is the BAC!TM Character, which puts a "face" on invisible foodborne bacteria. The campaign spotlights and focuses national attention on four basic messages:
National Center for Food Safety and Technology (NCFST)
The National Center for Food Safety and Technology (NCFST) is the nation's only research consortium of industry, government and academia which addresses the food safety implications of emerging food processing and packaging technologies. The aim is to create a neutral ground for food safety research, education and information exchange among government, academia and industry. Staffing at NCFST includes food scientists from the Illinois Institute of Technology and University of Illinois in Urbana-Champaign, from 50 food companies, and from the Food and Drug administration (Division of Food Processing and Packaging). All research programs--cooperative, individual, multi-client and proprietary--draw scientific expertise from this pool. These researchers are experienced in the disciplines that affect food safety and quality, including food science and technology, food process engineering, biotechnology, chemistry, chemical engineering, packaging, microbiology, nutrition, and polymer chemistry. In addition, visiting experts from member companies and other universities enrich the pool of available staff. . With its research program, the NCFST contributes important data to the food safety database thereby:
Joint Institute for Food Safety and Research
On July 3, 1998, President Clinton directed DHHS and USDA to develop a plan to create a Joint Institute for Food Safety Research (JIFSR), and to issue a report within 90 days. The Institute is to (1) coordinate planning and priority setting for food safety research among the two Departments, other government agencies, and the private sector and (2) foster effective translation of research results into practice along the farm-to-table continuum.
The ultimate goal of the Institute is to coordinate food safety research, such that the incidence of foodborne illness is reduced to the greatest extent feasible. The result of these coordinated and expanded efforts will be the more efficient delivery of the scientific information needed to develop effective food safety guidance, policies, and regulations in support of public health goals.
Specifically, the Institute will:
DHHS and USDA will have joint leadership of the Institute and will use existing resources to support it. This acknowledgement of the critical need to expand and coordinate food safety research also emphasizes the companion needs to expand and strengthen public-private partnerships and to augment collaboration among state, local, and other Federal agencies, thereby effectively providing the scientific information required to help achieve public health goals.
National Food Safety System
The integration of federal, state, and local food safety activities is an on-going effort. This concept is an outgrowth of the 1997 National Food Safety Initiative and of discussions at the 1998 Association of Food and Drug Officials (AFDO) conference on the need to better coordinate outbreak investigations and responses. Discussions revealed that difficulties in coordination were caused by a lack of common standards among laboratories, incompatible data systems, ineffective communications, and inadequate resources. There was general agreement that the need to coordinate on outbreaks raised many issues of mutual concern. It was recommended that State Public Health and Agriculture Departments be brought together in order to more effectively reduce foodborne illness in the U.S. At the AFDO conference, FDA made a commitment to facilitate this process.
In September 1998, FDA co-sponsored, in cooperation with USDA and CDC, a "50-State" meeting in Kansas City, Missouri, of state food safety officials to discuss working towards a seamless, integrated food safety system. From that meeting, it was decided to form six groups to work on ideas and recommendations for advancing an integrated system. In December 1998, FDA co-sponsored a follow-up meeting with USDA, CDC, and EPA in Baltimore, Maryland with the work groups and a coordinating committee. The work groups were charged by the coordinating committee to come up with ideas and recommendations on things that could be done to achieve an integrated system. There was agreement that an integrated system should include: federal oversight, a common vision, national uniform standards, uniform inspections and enforcement, uniform laboratory practices, adequate training, and enhanced communications. In March 1999, the coordinating committee met in St. Louis, Missouri to review the reports of the Work Groups and consider next steps for this project.
FDA has met with industry and consumer groups to discuss the integration project and a public workshop was held at the AFDO Annual Conference on June 5, 1999 in San Antonio, Texas. Presentations at the workshop included an update on work group activities as well as perspectives from industry and consumer groups.
International HACCP Alliance
The International HACCP Alliance was developed on March 25, 1994. It is housed within the Institute of Food Science and Engineering at Texas A&M University in College Station, TX. The International HACCP Alliance was developed to provide a uniform program to assure safer meat and poultry products.
Seafood HACCP Alliance
FDA's seafood HACCP regulations triggered the creation of the Seafood HACCP Alliance, a consortium of Federal agencies, the Association of Food and Drug Officials, industry trade associations and academia, to develop and provide an extremely low cost basic HACCP training to seafood processors. This training course for industry has been taught around the country, especially in locations with many seafood processors. FDA worked with the Alliance to create a follow-on course for processors that are having difficulty installing or implementing a HACCP system. The follow-on course was first available in Spring 1999.
Foodborne Illness Education Information Center
The USDA/FDA Foodborne Illness Education Information Center was cooperatively developed by FSIS, FDA, the National Agricultural Library and the Cooperative State Research, Extension and Education Service. The USDA/FDA Foodborne Illness Educational Materials database contains descriptions and ordering information for food safety training materials, including games and teaching guides for school children; materials for the management and workers of retail food markets, food service establishments and institutions; audiovisuals; and posters. The USDA/FDA HACCP Training Programs and Resources Database contains listings of HACCP training programs, HACCP resource materials, and HACCP consultants offering training programs or advice.
FoodNet
The Foodborne Diseases Active Surveillance Network (FoodNet) is a collaborative project conducted by CDC, the participating States, the FSIS, and FDA that began in 1996. FoodNet produces national estimates of the burden and sources of specific diseases in the United States through active surveillance and other studies. California, Connecticut, Georgia, Maryland, Minnesota, New York, Oregon, and Tennessee, with a total population of 28 million (approximately 10 percent of the U.S. population) are the eight FoodNet sites.
PulseNet
CDC, FDA, and USDA established PulseNet, a computerized database of bacterial DNA subtypes, in conjunction with participating state and local health departments. Through PulseNet, two seemingly independent E. coli O157:H7 outbreaks in Michigan were traced back to a common source-alfalfa sprouts, and in another instance, PulseNet helped confirm that about 50 cases of E. coli O157:H7 in Wisconsin were attributable to cheese curds from a single facility, after initial inspections did not reveal the source of the contamination
Activities and Coordination on Antimicrobial Resistance
Public Health Action Plan
On July 19-21, 1999, FDA, CDC, and NIH held a public meeting in Atlanta to hear from invited consultants on a Public Health Action Plan. The plan, when published, will serve as a blueprint for the Federal government to combat antimicrobial resistance. The agenda will focus on the areas of surveillance, prevention and control, research, and product development.
National Antimicrobial Resistance Monitoring System (NARMS)
The National Antimicrobial Resistance Monitoring System(NARMS) is a surveillance system started in 1996, and augmented in 1998 through the National Food Safety Initiative, for monitoring the antimicrobial resistance of pathogen isolates, including Salmonella spp., Campylobacter spp. and E. coli O157:H7. Salmonella spp. isolates from humans (every 10th Salmonella spp. isolate from each of 17 locations, representing 32% of the U.S. population), are tested for resistance to antimicrobial drugs. CDC, FDA, USDA, 15 states (CA, CO, CT, FL, GA, KS, MA, MD, MN, NJ, NY, OR, TN, WA, WV), plus Los Angeles and New York City, cooperate in this program. Data for isolates from humans for NARMS is supported by additional surveillance and research activities associated with Foodborne Disease Active Surveillance Network (FoodNet) sites and ongoing activities of FDA, CDC, and USDA. Salmonella spp. isolates from animals at slaughter (isolates from the FSIS HACCP and pathogen reduction program testing for Salmonella spp.) are tested for resistance to antimicrobial drugs.
Collaboration with Mexico: Antimicrobial Resistance Monitoring System
On June 29 - July 3, staff from CVM and USDA traveled to Morelia, Michoacan, Mexico to help start a monitoring system for antimicrobial resistance. This collaboration between the U.S. NARMS and the Mexican antimicrobial surveillance group represents the launch of the first international human and animal monitoring system for foodborne antimicrobial drugs susceptibility surveillance in the Americas.
Foodborne Outbreak Response Coordinating Group (FORCG)
The Foodborne Outbreak Response Coordinating Group (FORCG) was established to improve the approach to interstate outbreaks of foodborne illness by Federal, state and local agencies charged with responding to such outbreaks. It was formed in response to one of the recommendations in the1997 National Food Safety Initiative, and includes the federal agencies charged with responding to outbreaks of foodborne and waterborne illness: USDA (FSIS), FDA, CDC, and EPA. The group also has members representing states and local agencies charged with responding to foodborne illnesses.
FORCG is co-chaired by the Under Secretary for Food Safety , USDA and the Commissioner for Food and Drugs. During the past year, FORCG has improved the coordinated approach to outbreaks of foodborne illness, most remarkably during a large outbreak of hepatitis.virus that affected over 200 school children in Michigan. Federal and state agencies are now working more effectively together, following recommended procedures for outbreak response coordination.
USDA Food Emergency Rapid Response & Evaluation Team (FERRET)
The USDA Food Emergency Rapid Response and Evaluation Team was established to 1) facilitate a prompt, effective and coordinated USDA response to food safety emergencies and 2) evaluate emergency episodes and use what is learned to improve long-term strategies for preventing food safety emergencies
Membership includes the Under Secretary for Food Safety (chair), Under Secretary for Food Nutrition and Consumer Services, Under Secretary for Farm and Foreign Agricultural Services, Under Secretary for Research, Education, and Economics, Under Secretary for Marketing and Regulatory Programs, General Counsel, Inspector General, and Director of the Office of Communication.
The Food Emergency Rapid Response and Evaluation Team held its first meeting on June 15, 1998. During the past year, the team has met whenever levels of contaminants in food threaten to pose a human health hazard. The team has dramatically improved the pace at which the USDA responds to public health problems. Because of this new team, the USDA can better ensure a speedy and effective response to contamination (either accidental or deliberate) of foods, thereby better protecting the American consumer.
Council of State and Territorial Epidemiologists
The Council of State and Territorial Epidemiologists (CSTE) is a professional association of public health epidemiologists in states and territories working together to detect, prevent, and control conditions of public health significance. CSTE works to establish more effective relationships among state and other health agencies, and to provide technical advice and assistance to the Association of State and Territorial Health Officials (ASTHO) and federal public health agencies, such as CDC. CSTE has more than 400 members with surveillance and epidemiology expertise in a broad range of areas, including communicable diseases, immunizations, environmental health, chronic diseases, occupational health, injury control, and maternal and child health.
Some of the primary barriers and key challenges that the Agencies face in striving to achieve the Healthy People 2000 objectives are summarized below:
Great strides have been made in improving food safety over the past few years. HACCP initiatives have focussed processors and regulatory agencies on using preventive methods to make these improvements. The 1997 Food Safety Initiative was the result of systematically looking at food safety for all phases of food production and availability, regulation, surveillance, and education. It recommended changes or improvements in disease surveillance, inspection and traceback coordination, education at all levels, the use of risk assessments to aid in risk management, and suggested areas of needed research. Additional funding through the Food Safety Initiative is being used to improve food safety through many of the initiatives and coordinated projects summarized in this report. Although it may be too soon to see results of the early efforts, progress has been made as noted in the accomplishments section of this document (above).
Following on the heels of the publication of the FSI document, preparations were starting for the development of objectives for Healthy People 2010. One of the changes for the next decade is a separation of the Healthy People 2000 Food and Drug Safety priority area into two focus areas: Food Safety, co-led by FDA and USDA/FSIS, and Medical Product Safety, led by FDA. The Healthy People 2010 food safety objectives were developed from the Healthy People 2000 food safety objectives based to a large extent on the emphasis given in the Food Safety Initiative. Changes include expanded surveillance and tracking of illness cases and outbreaks caused by foodborne bacteria and parasites, antimicrobial resistance of Salmonella spp. isolates from animals and humans, and deaths from anaphylaxis caused by food allergies:
Other objectives have been added or revised to have a basis on science:
Two other new developmental objectives have been added on reducing levels of chemical contaminants and mycotoxins in foods.