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Con Agra
Salmonella Outbreak
The Outbreak




November 2006 - State and Local
Health Departments and CDC
noted increase in S. Tennessee
stool, urine and tissue isolates
Recall announced February 14,
2007
As of June 2007, 628 S.
Tennessee culture-positive cases
in 47 states
Actual illnesses likely
substantially higher
Salmonella Tennessee
AC Voetsch, “FoodNet estimate of the burden of illness caused by nontyphoidal Salmonella
infections in the United States,”Clinical Infectious Diseases 2004;38 (Suppl 3):S127-34
26,000
CDC Baseline - Approximately 50 per year
CDC Outbreak Date - 628 officially counted, however 13 additional cases in 2006 and 30
additional cases in 2005 share the same PFGE as one of the outbreak patterns
CDC Estimate - 38.6 multiple of reported cases of S. Tennessee
The Outbreak
Salmonella



The term Salmonella
refers to a group or family
of bacteria that cause
illness in humans.
Salmonella Tennessee is a
rare strain - .28% of total
Salmonella cases
reported.
In contrast, Salmonella
Enteritidis is 14%.
Contamination - Enteric Bacterium
Salmonella bacteria are usually transmitted to
humans by eating foods contaminated with animal
feces. Contaminated foods are often of animal
origin, such as beef, poultry, milk, or eggs, but all
foods, including vegetables or fruit, may become
contaminated.
Symptoms



The majority of persons
infected with Salmonella
have diarrhea, fever, and
abdominal cramps 6-72
hours after exposure.
The illness usually lasts 49 days - the majority of
persons recover without
treatment.
It may be several months,
however, before their
susceptibility to diarrhea
and gastrointestinal
distress disappears.
QuickTime™ and a
Sorenson Video decompressor
are needed to see this picture.
Treatment




The acute symptoms of Salmonella gastroenteritis
include the sudden onset of nausea, abdominal
cramping, and bloody diarrhea with mucous.
Treatment, therefore, tends to be palliative – although
prescription of antibiotics is common, even if usually
contraindicated.
Medical treatment is acutely important if the patient
becomes severely dehydrated or if the infection spreads
from the intestines.
Persons with severe diarrhea often require re-hydration,
usually with intravenous fluids.
Most Affected Populations

Variables such as the health
and age of the host and
virulence differences among
the Salmonella serotypes
affect the impact of the illness.

Infants, the elderly, individuals
hospitalized, and the immunesuppressed are the
populations that are the most
susceptible to disease and
tend to suffer the most severe
symptoms.
The Elderly Population

Morbidity and mortality in the
elderly from infectious disease
are far greater than in other
populations.

For instance, death rates for
infectious diarrheal disease are
five times higher in people over
74 years of age.
Reactive Arthritis

Within months of infection, a
certain percentage of ill
individuals will develop an
arthritic condition known as
reactive arthritis, which results
from an immune response to
Salmonella bacteria in the body
where the immune system
attacks cartilaginous tissues in
the joints.

The condition frequently
resolves, but it can become
chronic, even permanent.
Reiter’s Syndrome

Reiter’s Syndrome is a special
form of reactive arthritis,
autoimmune disorder triggered
by the Salmonella infection.

It occurs in persons with a
genetic predisposition and can
last for a year or more.

About 15% of patients develop a
long-term, sometimes
destructive, arthritis.
Crohn’s Disease and Irritable
Bowel Syndrome

Between 5% and 30% of patients
who suffer an acute episode of
infectious gastroenteritis, such as
Salmonella, develop chronic
gastrointestinal symptoms.

Irritable bowel syndrome (IBS) is
a chronic disorder characterized
by alternating bouts of
constipation and diarrhea, both of
which are generally accompanied
by abdominal cramping and pain.

Crohn's disease is an incurable
inflammatory disorder of the
intestine most commonly found in
the lower part of the small
intestine
Prior Warning - A Known Risk
1996 - “A multi-state Salmonella Mbandaka
outbreak associated with peanut butter: the
South Australian experience.''
What ConAgra Should Have Known
Establishment Inspection Report
February 23, 2005
“Inspection revealed the following concerns: 2 areas on
production lines where filled containers of peanut butter were
not completely covered from overhead contamination, an
accumulation of spillage and or dust at wall/floor juncture
around air handling cabinet in the ingredients room, and a
temporary baffle made of cardboard in use on an empty jar
line.”
Establishment Inspection Report
February 23, 2005
“. . . Inspection found the lot in question had been shipped
and management cited corporate policy in refusing to allow
review of production and shipping records.
The current inspection was conducted in response to several
complaints including most recently, number 29134, an
anonymous complaint alleging poor sanitation, poor facilities
maintenance, and poor quality program management.
Specifics in that complaint include an alleged episode of
positive findings of Salmonella in peanut butter in October of
2004 that was related to new equipment and that the firm
didn’t react to, insects in some equipment, water leaking onto
product, & inability to track some product.”
Establishment Inspection Report
February 23, 2005
These complaints include:
29134 dated 1/13/05, an anonymous complaint reporting
several issues at the firm that in summary allege poor
sanitation practices, poor quality program management and
poor facilities maintenance.
Microbiology Analysis Report
October 11, 2004
Sample
Number
Test Type
Results
2
Salmonella
Positive
3
Salmonella
Positive
5
Salmonella
Positive
6
Salmonella
Positive
8
Salmonella
Positive
11
Salmonella
Positive
13
Salmonella
Positive
14
Salmonella
Positive
Comments
Microbiology Analysis Report
October 11, 2004
Sample
Number
Test Type
Results
6
Salmonella
Positive
7
Salmonella
Positive
8
Salmonella
Positive
9
Salmonella
Positive
Comments
Microbiology Analysis Report
October 13, 2004
Sample
Number
Test Type
Results
7
Salmonella
Positive
9
Salmonella
Positive
10
Salmonella
Positive
11
Salmonella
Positive
13
Salmonella
Positive
Comments
Microbiology Analysis Report
November 8, 2004
Sample
Number
Test Type
Results
Comments
7
Salmonella
Positive
ID: S.
Enteritidis
group C1
11
Salmonella
Positive
ID: S.
Enteritidis
group C1
13
Salmonella
Positive
ID: S.
Enteritidis
group C1
16
Salmonella
Positive
ID: S.
Enteritidis
group C1
Group C1 includes Salmonella Tennessee
Microbiology Analysis Report
November 15, 2004
Sample
Number
Test Type
Results
Comments
27
Salmonella
Positive
ID S.
enteritidis
Cause of Outbreak
 Con Agra’s version:
-
-
Salmonella Tennessee was dormant in the plant
environment at low levels from raw peanuts and/or
dust
Water was introduced into the peanut butter
processing environment
The combination of these two factors likely resulted
in the product and product contact surface being
contaminated with Salmonella Tennessee
Presentation to FDA
Congressional Testimony
David Colo, Sr. VP ConAgra
QuickTime™ and a
h264 decompressor
are needed to see this picture.
Other Probable Causes




Salmonella Tennessee and other strains present in
plant since at least October 2004
Evidence of ongoing bird and rodent contamination
Breach of “water free” plant environment
- ongoing leaks in roof
- sprinkler malfunctions
- Air Dryer for condensed air malfunction
Maintenance and Cleaning Shift being used to
increase production
The Legal Standard: Strict
Liability

The focus is on the product; not the
conduct

You are liable if:
-
The product was unsafe
-
The product caused
the injury
What will a Jury Think?