Food Safety: Reducing the Threat of Foodborne Illnesses (Testimony,
05/23/96, GAO/T-RCED-96-185).

Pursuant to a congressional request, GAO discussed foodborne pathogens
and their impact on public health. GAO noted that: (1) millions of
illnesses and thousands of deaths result annually from contaminated
foods; (2) the actual incidence of foodborne illnesses is unknown
because most cases go unreported; (3) public health officials believe
that the risk of foodborne illnesses has increased over the last 20
years because of food production changes, broader distribution, food
mishandling, demographic changes, and new and more resistant bacteria;
(4) the Department of Agriculture estimates that the costs of foodborne
illnesses range from $5.6 billion to over $22 billion per year; (5)
foodborne illnesses can also cause long-term disabilities, such as
reactive arthritis and paralysis; (6) states are not required to report
all foodborne illnesses or their causes; (7) more uniform and
comprehensive data on the number and causes of foodborne illnesses could
lead to the development of more effective control strategies, but
federal officials are not sure they can continue to fund such data
collection efforts if budget cuts continue; (8) federal agencies often
do not address emerging food safety concerns because there are different
rules for foods posing the same risks and limited inspection resources;
and (9) unsuccessful coordination of food safety activities results from
agencies' fragmented responsibilities.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  T-RCED-96-185
     TITLE:  Food Safety: Reducing the Threat of Foodborne Illnesses
      DATE:  05/23/96
   SUBJECT:  Food inspection
             Safety regulation
             Contaminated foods
             Interagency relations
             Public health research
             Economic analysis
             Consumer protection
             Data collection operations
             Jurisdictional authority
             Health hazards
IDENTIFIER:  Atlanta (GA)
             California
             Connecticut
             Minnesota
             Oregon
             FSIS Hazard Analysis and Critical Control Point System
             E. coli Bacteria
             Salmonella Enteritidis Bacteria
             Listeria monocytogenes Bacteria
             Campylobacter jejuni/coli Bacteria
             Chicago (IL)
             Los Angeles (CA)
             
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Cover
================================================================ COVER


Before the Subcommittee on Human Resources and
Intergovernmental Relations, Committee on
Government Reform and Oversight
House of Representatives

For Release
on Delivery
Expected at
10:00 a.m.  EDT
Thursday
May 23, 1996

FOOD SAFETY - REDUCING THE THREAT
OF
FOODBORNE ILLNESSES

Statement of Robert A.  Robinson, Director
Food and Agriculture Issues,
Resources, Community, and Economic Development Division

GAO/T-RCED-96-185

GAO/RCED-96-185T


(150642)


Abbreviations
=============================================================== ABBREV

  GAO -
  CDC -
  FDA -
  USDA -
  FSIS -
  ERS -
  HACCP -

============================================================ Chapter 0

Mr.  Chairman and Members of the Subcommittee: 

We are pleased to be here today to participate in this hearing on
foodborne pathogens and their impact on public health.  In previous
reports and testimonies, we have discussed many aspects of food
safety, including inspection and coordination activities and efforts
to protect against unsafe chemical residues and microbiological
hazards.  Today, as you requested, we will focus on what is and is
not known about the scope, severity, and cost of foodborne illnesses
in the United States.  We will also summarize our prior work on the
structural problems that limit the federal government's ability to
ensure food safety. 

In summary, in our May 1996 report on foodborne illnesses,\1 we
reported that existing data, although incomplete, indicate that
foodborne illnesses are widespread and costly.  Specifically, the
best available data on foodborne illnesses demonstrate the following: 

  -- Millions of illnesses and thousands of deaths in the United
     States each year can be traced to contaminated food.  Moreover,
     the actual incidence may be much higher because public health
     experts believe that most cases are not reported.  These experts
     also believe that the risk of foodborne illnesses has been
     increasing over the last 20 years. 

  -- Foodborne illnesses generally cause temporary disorders of the
     digestive tract, but they can also lead to serious, long-term
     health consequences.  Recent estimates of the cost of foodborne
     illnesses range from over $5 billion to over $22 billion
     annually.  For example, the cost of medical treatment and lost
     productivity related to foodborne illnesses from seven of the
     most harmful bacteria ranged from $5.6 billion to $9.4 billion
     in 1993. 

While providing useful indicators concerning the extent of foodborne
illnesses, existing data have limitations.  Public health and food
safety experts believe that current data on foodborne illnesses do
not provide a complete picture of the risk level and do not depict
the sources of contamination and the populations most at risk in
sufficient detail.  More uniform and comprehensive data on the number
and causes of foodborne illnesses could enable the development of
more effective control strategies.  While federal and state agencies
have begun to collect such data in five areas across the country,
federal officials expressed some concern about whether they would be
able to continue funding this discretionary effort. 

Providing more comprehensive data would help federal food safety
officials develop better control strategies but would not address the
structural problems with the food safety system.  As we have
previously reported,\2 the system evolved over many years in response
to specific health threats and new technological developments,
resulting in a patchwork of inconsistent approaches that weaken its
effectiveness.  Food products with similar risks are subject to
different rules, limited inspection resources are not efficiently
used, and agencies must engage in extensive and often unsuccessful
coordination activities in an attempt to address food safety
activities. 


--------------------
\1 Food Safety:  Information on Foodborne Illnesses (GAO/RCED-96-96,
May 8, 1996). 

\2 Food Safety and Quality:  Uniform, Risk-Based Inspection System
Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992). 


   BACKGROUND
---------------------------------------------------------- Chapter 0:1

The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services is the federal agency
primarily responsible for monitoring the incidence of foodborne
illness in the United States.  In collaboration with state and local
health departments and other federal agencies, CDC investigates
outbreaks of foodborne illnesses and supports disease surveillance,
research, prevention efforts, and training related to foodborne
illnesses.  CDC coordinates its activities concerning the safety of
the food supply with the Food and Drug Administration (FDA), which is
also in the Department of Health and Human Services.  With respect to
the safety of meat, poultry, and eggs, CDC coordinates with the Food
Safety and Inspection Service (FSIS) in the U.S.  Department of
Agriculture (USDA). 

CDC monitors individual cases of illness from harmful bacteria,
viruses, chemicals, and parasites (hereafter referred to collectively
as pathogens) that are known to be transmitted by foods, as well as
foodborne outbreaks, through voluntary reports from state and local
health departments, FDA, and FSIS.  In practice, because CDC does not
have the authority to require states to report data on foodborne
illnesses, each state determines which diseases it will report to
CDC.  In addition, state laboratories voluntarily report the number
of positive test results for several diseases that CDC has chosen to
monitor.  However, these reports do not identify the source of
infection and are not limited to cases of foodborne illness.  CDC
also investigates a limited number of more severe or unusual
outbreaks when state authorities request assistance. 

At least 30 pathogens are associated with foodborne illnesses.  For
reporting purposes, CDC categorizes the causes of outbreaks of
foodborne illnesses as bacterial, chemical, viral, parasitic, or
unknown pathogens.  Although many people associate foodborne
illnesses primarily with meat, poultry, eggs, and seafood products,
many other foods--including milk, cheese, ice cream, orange and apple
juices, cantaloupes, and vegetables--have also been involved in
outbreaks during the last decade. 

Bacterial pathogens are the most commonly identified cause of
outbreaks of foodborne illnesses.  Bacterial pathogens can be easily
transmitted and can multiply rapidly in food, making them difficult
to control.  CDC has targeted four of them--E.  coli O157:H7,
Salmonella Enteritidis, Listeria monocytogenes, and Campylobacter
jejuni--as being of greatest concern. 


   FOODBORNE ILLNESSES ARE
   BELIEVED TO BE A SIGNIFICANT
   AND GROWING PROBLEM
---------------------------------------------------------- Chapter 0:2

The existing data on foodborne illnesses have weaknesses and may not
fully depict the extent of the problem.  In particular, public health
experts believe that the majority of cases of foodborne illness are
not reported because the initial symptoms of most foodborne illnesses
are not severe enough to warrant medical attention, the medical
facility or state does not report such cases, or the illness is not
recognized as foodborne.  However, according to the best available
estimates, based largely on CDC's data, millions of people become
sick from contaminated food each year, and several thousand die.  In
addition, public health and food safety officials believe that the
risk of foodborne illnesses is increasing for several reasons. 

Between 6.5 million and 81 million cases of foodborne illness and as
many as 9,100 related deaths occur each year, according to the
estimates provided by several studies conducted over the past 10
years.  The wide range in the estimated number of foodborne illnesses
and related deaths is due primarily to the considerable uncertainty
about the number of cases that are never reported to CDC.  For
example, CDC officials believe that many intestinal illnesses that
are commonly referred to as the stomach flu are caused by foodborne
pathogens.  People do not usually associate these illnesses with food
because the onset of symptoms occurs 2 or more days after the
contaminated food was eaten. 

Furthermore, most physicians and health professionals treat patients
who have diarrhea without ever identifying the specific cause of the
illness.  In severe or persistent cases, a laboratory test may be
ordered to identify the responsible pathogen. 

Finally, physicians may not associate the symptoms they observe with
a pathogen that they are required to report to the state or local
health authorities.  For example, a CDC official cited a Nevada
outbreak in which no illnesses from E.  coli O157:H7 had been
reported to health officials, despite a requirement that physicians
report such cases to the state health department.  Nevertheless, 58
illnesses from this outbreak were subsequently identified.  In the
absence of more complete reporting, researchers can only broadly
estimate the number of illnesses and related deaths. 

Food safety and public health officials believe that several factors
are contributing to an increased risk of foodborne illnesses.  First,
the food supply is changing in ways that can promote foodborne
illnesses.  For example, as a result of modern animal husbandry
techniques, such as crowding a large number of animals together, the
pathogens that can cause foodborne illnesses in humans can spread
throughout the herd.  Also, because of broad distribution,
contaminated food products can reach more people in more locations. 
Subsequent mishandling can further compound the problem.  For
example, leaving perishable food at room temperature increases the
likelihood of bacterial growth and undercooking reduces the
likelihood that bacteria will be killed.  Knowledgeable experts
believe that although illnesses and deaths often result from improper
handling and preparation, the pathogens were, in many cases, already
present at the processing stage. 

Second, because of demographic changes, more people are at greater
risk of contracting a foodborne illness.  In particular, certain
populations are at greater risk for these illnesses:  people with
suppressed immune systems, children in group settings like daycare,
and the elderly. 

Third, three of the four pathogens CDC considers the most important
were unrecognized as causes of foodborne illness 20 years
ago--Campylobacter, Listeria, and E.  coli O157:H7. 

Fourth, bacteria already recognized as sources of foodborne illnesses
have found new modes of transmission.  While many illnesses from E. 
coli O157:H7 occur from eating insufficiently cooked hamburger, these
bacteria have also been found more recently in other foods, such as
salami, raw milk, apple cider, and lettuce. 

Fifth, some pathogens are far more resistant than expected to
long-standing food-processing and storage techniques previously
believed to provide some protection against the growth of bacteria. 
For example, some bacterial pathogens (such as Yersinia and Listeria)
can continue to grow in food under refrigeration. 

Finally, according to CDC officials, virulent strains of well-known
bacteria have continued to emerge.  For example, one such pathogen,
E.  coli O104:H21, is another potentially deadly strain of E.  coli. 
In 1994, CDC found this new strain in milk from a Montana dairy. 


   FOODBORNE ILLNESSES CAN BE
   DEBILITATING AND COSTLY
---------------------------------------------------------- Chapter 0:3

While foodborne illnesses are often temporary, they can also result
in more serious illnesses requiring hospitalization, long-term
disability, and death.  Although the overall cost of foodborne
illnesses is not known, two recent USDA estimates place some of the
costs in the range of $5.6 billion to more than $22 billion per year. 
The first estimate, covering only the portion related to the medical
costs and productivity losses of seven specific pathogens, places the
costs in the range of $5.6 billion to $9.4 billion.  The second,
covering only the value of avoiding deaths from five specific
pathogens, places the costs in the range of $6.6 billion to $22
billion. 

Although often mild, foodborne illnesses can lead to more serious
illnesses and death.  For example, in a small percentage of cases,
foodborne infections can spread through the bloodstream to other
organs, resulting in serious long-term disability or death.  Serious
complications can also result when diarrhetic infections resulting
from foodborne pathogens act as a triggering mechanism in susceptible
individuals, causing an illness such as reactive arthritis to flare
up.  In other cases, no immediate symptoms may appear, but serious
consequences may eventually develop.  The likelihood of serious
complications is unknown, but some experts estimate that about 2 to 3
percent of all cases of foodborne illness lead to serious
consequences.  For example: 

  -- E.  coli O157:H7 can cause kidney failure in young children and
     infants and is most commonly transmitted to humans through the
     consumption of undercooked ground beef.  The largest reported
     outbreak in North America occurred in 1993 and affected over 700
     people, including many children who ate undercooked hamburgers
     at a fast food restaurant chain.  Fifty-five patients, including
     four children who died, developed a severe disease, Hemolytic
     Uremic Syndrome, which is characterized by kidney failure. 

  -- Salmonella can lead to reactive arthritis, serious infections,
     and deaths.  In recent years, outbreaks have been caused by the
     consumption of many different foods of animal origin, including
     beef, poultry, eggs, milk and dairy products, and pork.  The
     largest outbreak, occurring in the Chicago area in 1985,
     involved over 16,000 laboratory-confirmed cases and an estimated
     200,000 total cases.  Some of these cases resulted in reactive
     arthritis.  For example, one institution that treated 565
     patients from this outbreak confirmed that 13 patients had
     developed reactive arthritis after consuming contaminated milk. 
     In addition, 14 deaths may have been associated with this
     outbreak. 

  -- Listeria can cause meningitis and stillbirths and is fatal in 20
     to 40 percent of cases.  All foods may contain these bacteria,
     particularly poultry and dairy products.  Illnesses from this
     pathogen occur mostly in single cases rather than in outbreaks. 
     The largest outbreak in North America occurred in 1985 in Los
     Angeles, largely in pregnant women and their fetuses.  More than
     140 cases of illness were reported, including at least 13 cases
     of meningitis.  At least 48 deaths, including 20 stillbirths or
     miscarriages, were attributed to the outbreak.  Soft cheese
     produced in a contaminated factory was confirmed as the source. 

  -- Campylobacter may be the most common precipitating factor for
     Guillain-Barre syndrome, which is now one of the leading causes
     of paralysis from disease in the United States.  Campylobacter
     infections occur in all age groups, with the greatest incidence
     in children under 1 year of age.  The vast majority of cases
     occur individually, primarily from poultry, not during
     outbreaks.  Researchers estimate that 4,250 cases of
     Guillain-Barre syndrome occur each year and that about 425 to
     1,275 of these cases are preceded by Campylobacter infections. 

While the overall annual cost of foodborne illnesses is unknown, the
studies we reviewed estimate that it is in the billions of dollars. 
The range of estimates among the studies is wide, however,
principally because of uncertainty about the number of cases of
foodborne illness and related deaths.  Other differences stem from
the differences in the analytical approach used to prepare the
estimate.  Some economists attempt to estimate the costs related to
medical treatment and lost wages (the cost-of-illness method); others
attempt to estimate the value of reducing the incidence of illness or
loss of life (the willingness-to-pay method).  Two recent estimates
demonstrate these differences in analytical approach. 

In the first, USDA's Economic Research Service (ERS) used the
cost-of-illness approach to estimate that the 1993 medical costs and
losses in productivity resulting from seven major foodborne pathogens
ranged between $5.6 billion and $9.4 billion.  Of these costs, $2.3
billion to $4.3 billion were the estimated medical costs for the
treatment of acute and chronic illnesses, and $3.3 billion to $5.1
billion were the productivity losses from the long-term effects of
foodborne illnesses. 

CDC, FDA, and ERS economists stated that these estimates may be low
for several reasons.  First, the cost-of-illness approach generates
low values for reducing health risks to children and the elderly
because these groups have low earnings and hence low productivity
losses.  Second, this approach does not recognize the value that
individuals may place on (and pay for) feeling healthy, avoiding
pain, or using their free time.  In addition, not all of the 30
pathogens associated with foodborne illnesses were included. 

In the second analysis, ERS used the willingness-to-pay method to
estimate the value of preventing deaths for five of the seven major
pathogens (included in the first analysis) at $6.6 billion to $22
billion in 1992.  The estimate's range reflected the range in the
estimated number of deaths, 1,646 to 3,144, and the range in the
estimated value of preventing a death, $4 million to $7 million. 
Although these estimated values were higher than those resulting from
the first approach, they may have also understated the economic cost
of foodborne illnesses because they did not include an estimate of
the value of preventing nonfatal illnesses and included only five of
the seven major pathogens examined in the first analysis. 


   BETTER DATA COULD LEAD TO MORE
   EFFECTIVE CONTROL STRATEGIES
---------------------------------------------------------- Chapter 0:4

The federal food safety system has evolved over the years as changes
were made to address specific health threats and respond to new
technological developments.  Often such changes occurred in reaction
to a major outbreak of foodborne illness when consumers, industry,
regulatory agencies, and the Congress agreed that actions needed to
be taken.  The system has been slow to respond to changing health
risks, for a variety of reasons, including a lack of comprehensive
data on the levels of risk and the sources of contamination. 

While current data indicate that the risk of foodborne illnesses is
significant, public health and food safety officials believe that
these data do not identify the level of risk, the sources of
contamination, and the populations most at risk in sufficient detail. 
According to these experts, the current voluntary reporting system
does not provide sufficient data on the prevalence and sources of
foodborne illnesses.  There are no specific national requirements for
reporting on foodborne pathogens.  According to CDC, states do not
(1) report on all pathogens of concern, (2) usually identify whether
food was the source of the illness, or (3) identify many of the
outbreaks or individual cases of foodborne illness that occur. 

Consequently, according to CDC, FDA, and FSIS, public health
officials cannot precisely determine the level of risk from known
pathogens or be certain that they can detect the existence and spread
of new pathogens in a timely manner.  They also cannot identify all
factors that put the public at risk or all types of food or
situations in which microbial contamination is likely to occur. 
Finally, without better data, regulators cannot assess the
effectiveness of their efforts to control the level of pathogens in
food. 

More uniform and comprehensive data on the number and causes of
foodborne illnesses could form the basis of more effective control
strategies.  A better system for monitoring the extent of foodborne
illnesses would actively seek out specific cases and would include
outreach to physicians and clinical laboratories.  CDC demonstrated
the effectiveness of such an outreach effort when it conducted a
long-term study, initiated in 1986, to determine the number of cases
of illness caused by Listeria.  This study showed that a lower rate
of illness caused by Listeria occurred between 1989 and 1993 during
the implementation of food safety programs designed to reduce the
prevalence of Listeria in food. 

In July 1995, CDC, FDA, and FSIS began a comprehensive effort to
track the major bacterial pathogens that cause foodborne illnesses. 
These agencies are collaborating with the state health departments in
five areas across the country to better determine the incidence of
infection with Salmonella, E.  coli O157:H7, and other foodborne
bacteria and to identify the sources of diarrheal illness from
Salmonella and E.  coli O157:H7.\3 Initially, FDA provided $378,000
and FSIS provided $500,000 through CDC to the five locations for 6
months.  For fiscal year 1996, FSIS is providing $1 million and FDA
is providing $300,000.  CDC provides overall management and
coordination and facilitates the development of technical expertise
at the sites through its established relationships with the state
health departments. 

CDC and the five sites will use the information to identify emerging
foodborne pathogens and monitor the incidence of foodborne illness. 
FSIS will use the data to evaluate the effectiveness of new food
safety programs and regulations to reduce foodborne pathogens in meat
and poultry and assist in future program development.  FDA will use
the data to evaluate its efforts to reduce foodborne pathogens in
seafood, dairy products, fruit, and vegetables. 

The agencies believe that this effort should be a permanent part of a
sound public health system.  According to CDC, FDA, and FSIS
officials, such projects must collect data over a number of years to
identify national trends and evaluate the effectiveness of strategies
to control pathogens in food.  Funding was decreased (on an
annualized basis) for this project in 1996, and these officials are
concerned about the continuing availability of funding, in this era
of budget constraints, to conduct this discretionary effort over the
longer term. 


--------------------
\3 The areas are (1) the greater metropolitan area of Atlanta, (2) an
area that is comprised of two northern California counties, (3) an
area that is comprised of two Connecticut counties, (4) the state of
Minnesota, and (5) the state of Oregon. 


   STRUCTURAL PROBLEMS LIMIT THE
   FEDERAL GOVERNMENT'S ABILITY TO
   ENSURE FOOD SAFETY
---------------------------------------------------------- Chapter 0:5

While providing more comprehensive data would help federal food
safety officials develop better control strategies, it would not
address the structural problems that adversely affect the federal
food safety system.  As we previously testified to this Committee,
the current system was not developed under any rational plan but
evolved over many years to address specific health threats from
particular food products and has not responded to changing health
risks.\4 As a result, the food safety system is a patchwork of
inconsistent approaches that weaken its effectiveness.  For example,
as we reported in June 1992, food products posing the same risk are
subject to different rules, limited inspection resources are
inefficiently used, and agencies must engage in extensive and often
unsuccessful coordination activities in an attempt to address food
safety issues. 

While federal agencies have made progress in moving towards a
scientific, risk-based inspection system, foods posing similar health
risks, such as seafood, meat, and poultry, are still treated
differently because of underlying differences in regulatory approach. 
For example, FDA's hazard analysis critical control point (HACCP)
requirement for seafood processors differs from FSIS' proposed HACCP
program for meat and poultry processors.\5 Under FSIS' proposal, meat
and poultry plants would be required to conduct microbiological tests
to verify the overall effectiveness of their critical controls and
processing systems.\6 In comparison, FDA's HACCP program for seafood
products has no testing requirement.  Furthermore, because the
frequency of inspection is based on the agencies' regulatory
approach, some foods may be receiving too much attention, while other
foods may not be receiving enough.  FSIS will conduct oversight of
industries that use HACCP programs on a daily basis and will continue
to inspect every meat and poultry carcass.  Conversely, FDA will
inspect seafood plants about once every 2 years and will only inspect
other food plants under its jurisdiction an average of about once
every 8 years.  As we stated in our June 1992 report, such widely
differing inspection frequencies for products posing similar risk is
an inefficient use of limited federal inspection resources. 

Moreover, federal agencies are often slow to address emerging food
safety concerns because of fragmented jurisdictions and
responsibilities.  For example, in April 1992, we reported that
jurisdictional questions, disagreement about corrective actions, and
poor coordination between FDA and USDA had hindered the federal
government's efforts to control Salmonella in eggs for over 5
years.\7 At that time, we stated that the continuing nature of such
problems indicated that the food safety structure--with federal
agencies having split and concurrent jurisdictions--had a systemic
problem.  The system's fragmented structure limited the government's
ability to deal effectively with a major outbreak of foodborne
disease, especially when such an outbreak required joint agency
action. 

Today, federal agencies are concerned with the potential impact on
public health posed by Bovine Spongiform Encephalopathy (the
so-called mad cow disease), which was the subject of your May 10,
1996, hearing.  Because there is still no single, uniform food safety
system, jurisdiction remains split between agencies.  Ironically,
FSIS is responsible for the safety of meat products sold to the
public, but is not responsible for preventing cattle from being given
feeds that could endanger public health.  FDA is responsible. 


--------------------
\4 Food Safety:  A Unified, Risk-Based Food Safety System Needed,
(GAO/T-RCED-94-223, May 25, 1994). 

\5 Food Safety:  New Initiatives Would Fundamentally Alter the
Existing System (GAO/RCED-96-81, Mar.  27, 1996). 

\6 Meat and Poultry Inspection:  Impact of USDA's Food Safety
Proposal on State Agencies and Small Plants (GAO/RCED-95-228, June
30, 1995) and Analysis of HACCP Costs and Benefits (GAO/RCED-96-62R,
Feb.  29, 1996). 

\7 Food Safety and Quality:  Salmonella Control Efforts Show Need for
More Coordination, (GAO/RCED-92-69, Apr.  21, 1992). 


-------------------------------------------------------- Chapter 0:5.1

Mr.  Chairman, this concludes my prepared remarks, we would be happy
to respond to any questions you may have. 


*** End of document. ***