1. Con Agra Salmonella Outbreak

2. 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

3. 26,000 Salmonella Tennessee 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 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

4. The Outbreak

5. 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%.

6. 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.

7. Symptoms  The majority of persons infected with Salmonella have diarrhea, fever, and abdominal cramps 6-72 hours after exposure.  The illness usually lasts 4- 9 days - the majority of persons recover without treatment.  It may be several months, however, before their susceptibility to diarrhea and gastrointestinal distress disappears.

9. 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.

10. 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 immune- suppressed are the populations that are the most susceptible to disease and tend to suffer the most severe symptoms.

11. 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.

12. 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.

13. 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.

14. 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

15. Prior Warning - A Known Risk 1996 - “A multi-state Salmonella Mbandaka outbreak associated with peanut butter: the South Australian experience.''

16. What ConAgra Should Have Known

17. 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.”

18. 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.”

19. 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.

20. Microbiology Analysis Report October 11, 2004 Sample Number Test TypeResultsComments 2SalmonellaPositive 3SalmonellaPositive 5SalmonellaPositive 6SalmonellaPositive 8SalmonellaPositive 11SalmonellaPositive 13SalmonellaPositive 14SalmonellaPositive

21. Microbiology Analysis Report October 11, 2004 Sample Number Test TypeResultsComments 6SalmonellaPositive 7SalmonellaPositive 8SalmonellaPositive 9SalmonellaPositive

22. Microbiology Analysis Report October 13, 2004 Sample Number Test TypeResultsComments 7SalmonellaPositive 9SalmonellaPositive 10SalmonellaPositive 11SalmonellaPositive 13SalmonellaPositive

23. Sample Number Test TypeResultsComments 7SalmonellaPositiveID: S. Enteritidis group C1 11SalmonellaPositiveID: S. Enteritidis group C1 13SalmonellaPositiveID: S. Enteritidis group C1 16SalmonellaPositiveID: S. Enteritidis group C1 Microbiology Analysis Report November 8, 2004 Group C1 includes Salmonella Tennessee

24. Microbiology Analysis Report November 15, 2004 Sample Number Test TypeResultsComments 27SalmonellaPositiveID S. enteritidis

25. 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

26. Presentation to FDA

27. Congressional Testimony David Colo, Sr. VP ConAgra

28. 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

29. 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

30. What will a Jury Think?