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

                       REPORT TO THE PRESIDENT
                                       MAY 1997


While the American food supply is among the safest in the world, there are still millions of Americans stricken by illness
every year caused by the food they consume, and some 9,000 a year--mostly the very young and elderly--die as a
result. The threats are numerous and varied, ranging from Escherichia coli (E. coli) O157:H7 in meat and apple juice,
to Salmonella in eggs and on vegetables, to Cyclospora on fruit, to Cryptosporidium in drinking water--and most
recently, to hepatitis A virus in frozen strawberries.
[E. coli 0157:H7 wasn't in vegetables?]



The Council for Agricultural Science and Technology, a private nonprofit organization, estimated in its 1994 report,
Foodborne Pathogens: Risks and Consequences, that as many as
9,000 deaths and 6.5 to 33 million illnesses in
the United States each year are food-related. The Department of Agriculture (USDA) estimates that medical costs and
productivity losses for 7 specific pathogens in food have been estimated to range between $6.5 billion and $34.9 billion
annually. Total costs for all foodborne illnesses are likely to be much higher. Those estimates do not include the total
burden placed on society by the chronic illness caused by some foodborne pathogens.
[The numbers jumped to 76
million in 1999, with only half the deaths? The numbers haven't increase in the last 8 years?]

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

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


New foodborne pathogens have emerged over the past ten years. Other microorganisms, previously thought to be
innocuous, have been linked to life-threatening diseases after acquiring new virulence genes and antimicrobial
resistance. Many of those organisms cannot be detected readily due to either a lack of suitable methods or their
sporadic occurrence in foods. Certain foodborne pathogens are increasingly associated with resistance to time-tested
controls, such as heating, refrigeration, and acid. In some cases, that ability appears to be linked with increased
virulence or new ways to evade our immune defenses.

[You will notice disease organisms contaminating reclaimed sewage effluent water irrigating food crops is
not a problem, nor is disease organisms contaminating sewage sludge biosolids a problem?]

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

Modernize Public-Health Laboratories  [Laboratories are being closed]

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

Establish a Risk Assessment Consortium

All federal agencies with risk-management responsibilities for food safety will establish jointly a consortium at which
federal agencies can collectively advance the science of microbial risk assessment, and to assist agencies in fulfilling
their specific food-safety regulatory mandates. The consortium should be inclusive in its risk-assessment activities,
seeking expertise from risk-assessment professionals and scientists from public and private sources, as well as
industry and consumer groups. The goal of the consortium would be to improve the quality of risk-assessment
research by coordinating research priorities, eliminating redundancies of effort, and encouraging multidisciplinary
research efforts.
[How can these Agencies possible do a risk assessment when they promote the spreading
disease causing organisms on food crops and have done so since 1981?]

FY98 Activities with Food-Safety Initiative Funds
For Campylobacter, Salmonella, Toxoplasma, E. coli O157:H7, and other Shiga-like toxin-producing E. coli, and
Cryptosporidium, FDA and ARS, often in partnership with universities and industry

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

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




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

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

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

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


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

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


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

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