Robert E. Brackett, Ph.D. Senior Vice President and Chief Science and Regulatory Affairs Officer

1. The impact of pre-harvest practices on the microbial safety of produce—the US experienceIAFP Latin America Symposium on Food SafetyCampinas, SP, BrazilMay 26, 2008 Robert E. Brackett, Ph.D. Senior Vice President and Chief Science and Regulatory Affairs Officer Grocery Manufacturer’s Association

2. Outbreaks of foodborne illness associated with fresh produce are becoming more apparent.

3. Seen an increase in the number of reported outbreaks of foodborne illnesses from fresh produce E. coli O157:H7 outbreaks From spinach – 204 cases in 26 States From lettuce at Taco John’s – 81 cases in 3 States From lettuce at Taco Bell – 71 cases in 5 States Outbreaks

4. Seen an increase in the number of reported outbreaks of foodborne illnesses from fresh produce E. coli O157:H7 outbreaks Salmonella Typhimurium outbreak from tomatoes 186 cases in 21 States Outbreaks

5. Seen an increase in the number of reported outbreaks of foodborne illnesses from fresh produce E. coli O157:H7 outbreaks Salmonella Typhimurium outbreak from tomatoes Salmonella Newport from tomatoes 98 cases 19 States Outbreaks

6. Seen an increase in the number of reported outbreaks of foodborne illnesses from fresh produce There are several possible explanations for the apparent increase Better and more rapid detection of outbreaks Increase in sale of fresh-cut produce Globalization of the produce supply Increase in the numbers of consumers at high risk for foodborne illnesses Recent Outbreaks

7. Data reported to CDC indicate that between 1973 and 1997 reported outbreaks associated with fresh produce increased. From 0.7% in the 1970s to 6% of all outbreaks in the 1990s. Increase in Outbreaks

8. Average annual number of produce-associated outbreaks by decade, USA,1973-2002* Outbreaks/year * Decade * Preliminary data

9. Data reported to CDC indicate that between 1973 and 1997 reported outbreaks associated with fresh produce increased. Unpublished data compiled by FDA indicate that from 1996 to 2006 there were approximately 71 reported outbreaks associated with fresh produce. Increase in Outbreaks

10. Vehicle Categories 1996 - 2006

11. Opportunities for Contamination Before and During Harvest

12. Animal Management Issues Contamination Opportunities

13. Animal Management • Wild animals in the field • Domestic animals in the field • Animal manure in the field

14. Animal Management Issues Processing/Packing Operations Contamination Opportunities

15. Unsanitary conditions Produce not cleaned Packing in the field Vermin Processing and Packing Operations

16. Animal Management Issues Processing/Packing Operations Worker Health/Hygiene Contamination Opportunities

17. Inadequate handwashing Inadequate hygiene training Unsanitary worker facilities Unexplained worker absences Community illnesses Work Health and Hygiene

18. Animal Management Issues Processing/Packing Operations Worker Health/Hygiene Harvest Tools/Equipment Contamination Opportunities

19. Bare hand or unknown glove use Cross contamination issues Non-sanitized tools Non-cleanable tools Harvest Tools and Equipment

20. Animal Management Issues Processing/Packing Operations Worker Health/Hygiene Harvest Tools/Equipment Water Issues Contamination Opportunities

21. Inadequate chlorination Hydrocooler Issues Storage tank issues Ice issues Cross connection issues Water Issues

22. E. coli O157:H7 Outbreak Associated with Pre-Packaged Spinach Findings

23. E. coli O157:H7 found in environmental samples collected near the fields that provided the spinach River water Cattle feces Wild pig feces Findings Related to Growing

24. E. coli O157:H7 found in environmental samples collected near the fields that provided the spinach Ready-to-eat crops are being grown in close proximity to livestock or livestock waste Investigation Findings Related to Growing

25. E. coli O157:H7 found in environmental samples collected near the fields that provided the spinach Ready-to-eat crops are being grown in close proximity to livestock or livestock waste Evidence of wildlife activity in proximity to fields where ready-to-eat crops are grown Riparian habitats Investigation Findings Related to Growing

26. E. coli O157:H7 found in environmental samples collected near the fields that provided the spinach Ready-to-eat crops are being grown in close proximity to livestock or livestock waste Evidence of wildlife activity in proximity to fields where ready-to-eat crops are grown Irrigation wells used for ready-to-eat produce exposed to feces from cattle and wildlife via surface waterways Investigation Findings Related to Growing

27. E. coli O157:H7 was not found in the samples taken from the processor. Other Investigation Findings

28. E. coli O157:H7 was not found in the samples taken from the processor. Number of other conditions observed that may provide opportunities for spread of pathogens, if pathogens arrived on incoming products. Harvesting Cooling Processing Other Investigation Findings

29. E. coli O157:H7 in the Salinas Valley Watershed Study* January 2005 – August 2006 *Robert E. Mandrell, Ph.D.Research Leader, Produce Safety and MicrobiologyResearch UnitUSDA, Agricultural Research Service, Western Regional Research Center

30. Prompted by identification of a farm that supplied leafy vegetables associated with 3 separate outbreaks Salinas Valley Watershed Study

31. Prompted by identification of a farm that supplied leafy vegetables associated with 3 separate outbreaks “Farm” investigation: soil, water, plants, feces tested Salinas Valley Watershed Study

32. Prompted by identification of a farm that supplied leafy vegetables associated with 3 separate outbreaks “Farm” investigation: soil, water, plants, feces tested E. coli O157:H7 isolated from samples obtained from 15 of 22 different Salinas Valley (California) watershed locations Highest incidence occurred after heavy rainfall Salinas Valley Watershed Study

33. E. coli strains representing at least 203 different genetic fingerprint types (MLVA) were identified for all isolates tested Salinas Valley Watershed Study

34. E. coli strains representing at least 203 different genetic fingerprint types (MLVA) were identified for all isolates tested Sets of strains with identical MLVA types were isolated from watershed samples up to eight months apart, and samples collected at, near, and up to 20 miles away from, a point source on same and different days Salinas Valley Watershed Study

35. E. coli strains representing at least 203 different genetic fingerprint types (MLVA) were identified for all isolates tested Sets of strains with identical MLVA types were isolated from watershed samples up to eight months apart, and samples collected at, near, and up to 20 miles away from, a point source on same and different days Strains with nearly identical MLVA types were isolated from 3 farm/ranches separated approximately 18 to 45 miles apart Salinas Valley Watershed Study

36. Results from the Salinas watershed study and the spinach outbreak investigation indicate that E. coli O157 was isolated more frequently from samples obtained near or on grazing land compared to other locations Salinas Valley Watershed Study

37. Results from the Salinas watershed study and the spinach outbreak investigation indicate that E. coli O157 was isolated more frequently from samples obtained near or on grazing land compared to other locations Results are consistent with the frequent incidence of E. coli O157 reported in numerous surveys of incidence in cattle in other locations of the country and incidence in water Salinas Valley Watershed Study

38. Time for a More Holistic View “Balancing Agriculture, Food Safety, and Environmental Concerns”

39. Concern about the potential conflict between food safety, environmental and wildlife preservation efforts Potential Conflict with Environmental and Wildlife Preservation Efforts

40. Concerns about the effects of food safety practices on water quality Riparian buffers, grassed waterways, filter strips and other forms of non-crop vegetation are critical conservation measures for reduction of sedimentation and filtering of other pollutants Potential Effect of Food Safety Practices

41. Concerns about the effects of food safety practices on habitats Riparian vegetation provides important substrates for aquatic invertebrates, cover for predator avoidance, and resting habitats Removal of non-crop vegetation may increase sedimentation and lead to habitat degradation Increased suspended solids from runoff have damaging physical and biological effects Potential Effect of Food Safety Practices

42. Where Do We Go From Here? “Working Together with the Agricultural and Environmental Communities To Find Solutions”

43. Must work TOGETHER to solve the problem instead of each of us solving our piece of the problem We Are In This Together

44. Need to better understand the dynamics of agriculture, food safety practices, and the environment Best Practices

45. Need to better understand the dynamics of agriculture, food safety practices, and the environment We know cattle are a principal source of E. coli because the organism lives in the intestines of healthy cattle Best Practices

46. Need to better understand the dynamics of agriculture, food safety practices, and the environment We know cattle are a principal source of E. coli because the organism lives in the intestines of healthy cattle We know cattle manure is an important source of E. coli infection and can contaminate the environment, including streams that flow through produce fields and are used for irrigation, pesticide application, or washing Best Practices

47. Need to better understand the dynamics of agriculture, food safety practices, and the environment Need to identify and better understand the “stumbling blocks” so that we can work together to develop and implement solutions Best Practices

48. Need to better understand the dynamics of agriculture, food safety practices, and the environment Need to identify and better understand the “stumbling blocks” so that we can work together to develop and implement solutions Are vertebrate populations sources of E. coli O157:H7 contamination of watersheds? Best Practices

49. Need to better understand the dynamics of agriculture, food safety practices, and the environment Need to identify and better understand the “stumbling blocks” so that we can work together to develop and implement solutions Are vertebrate populations sources of E. coli O157:H7 contamination of watersheds? Do climate, landscape attributes and irrigation management practices correlate with an increased risk of contamination? Best Practices

50. Need to better understand the dynamics of agriculture, food safety practices, and the environment Need to identify and better understand the “stumbling blocks” so that we can work together to develop and implement solutions Are vertebrate populations sources of E. coli O157:H7 contamination of watersheds? Do climate, landscape attributes and irrigation management practices correlate with an increased risk of contamination? Is in-field contamination associated with management production practices and environmental risk factors? Best Practices