1. The impact of pre-harvest practices on the microbial safety of produce— the US experience IAFP Latin America Symposium on Food Safety Campinas, SP, Brazil May 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. Outbreaks 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

4. Outbreaks 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

5. Outbreaks 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

6. Recent Outbreaks 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

7. Increase in Outbreaks 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.

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

9. Increase in Outbreaks 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 Unpublished data compiled by FDA indicate that from 1996 to 2006 there were approximately 71 reported outbreaks associated with fresh produce.

10. Vehicle Categories 1996 - 2006 CategoryOutbreaksIllnesses Processed Foods533,219 Produce718,734 Sprouts271,633 Seafood992,822 Eggs2076,558

11. Opportunities for Contamination Before and During Harvest

12. Contamination Opportunities Animal Management Issues

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

14. Contamination Opportunities Animal Management Issues Processing/Packing Operations

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

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

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

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

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

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

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

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

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

24. Investigation Findings Related to Growing 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

25. Investigation Findings Related to Growing 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

26. Investigation Findings Related to Growing 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

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

28. Other Investigation Findings 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

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 Microbiology Research Unit USDA, Agricultural Research Service, Western Regional Research Center

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

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

32. Salinas Valley Watershed Study 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

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

34. Salinas Valley Watershed Study 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

35. Salinas Valley Watershed Study 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

36. Salinas Valley Watershed Study 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

37. Salinas Valley Watershed Study 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

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

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

40. Potential Effect of Food Safety Practices 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

41. Potential Effect of Food Safety Practices 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

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

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

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

45. Best Practices 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

46. Best Practices 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

47. Best Practices 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

48. Best Practices 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?

49. Best Practices 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?

50. Best Practices 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?

51. Best Practices 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 Use of guidance to identify the best practices and solutions

52. Next Steps “Future Strategies and Activities for Produce Safety”

53. A closer examination of the measures and their effectiveness and determination of what additional or different interventions might be appropriate.

54. Potential Interventions Identify risk factors for contamination of fresh produce associated with agricultural and manufacturing practices

55. Potential Interventions Identify risk factors for contamination of fresh produce associated with agricultural and manufacturing practices –Leafy Green Safety Initiative

56. Leafy Green Safety Initiative Collaborative effort, initiated in 2006, between U.S. Food and Drug Administration (FDA) and State of California’s Departments of Public Health and Food and Agriculture

57. Leafy Green Safety Initiative Collaborative effort, initiated in 2006, between FDA and State of California’s Departments of Public Health and Food and Agriculture –Part of a risk-based strategy intended to reduce public health risks by heightening the focus of preventative food safety efforts on specific products, practices, pathogens, and growing areas of concern

58. Leafy Green Safety Initiative Collaborative effort, initiated in 2006, between FDA and State of California’s Departments of Public Health and Food and Agriculture –Part of a risk-based strategy intended to reduce public health risks by heightening the focus of preventative food safety efforts on specific products, practices, pathogens, and growing areas of concern –In 2007, FDA, State of California Departments of Public Health and Food and Agriculture, with the cooperation of industry began visiting farms: to assess the prevalence of factors in and near the field environment which may contribute to potential contamination

59. Leafy Green Safety Initiative Collaborative effort, initiated in 2006, between FDA and State of California’s Departments of Public Health and Food and Agriculture –Part of a risk-based strategy intended to reduce public health risks by heightening the focus of preventative food safety efforts on specific products, practices, pathogens, and growing areas of concern –In 2007, FDA, State of California Departments of Public Health and Food and Agriculture, with the cooperation of industry began visiting farms: to assess the prevalence of factors in and near the field environment which may contribute to potential contamination to assess the extent to which Good Agricultural Practices (GAPs) and other preventative controls are being implemented

60. Potential Interventions Identify risk factors for contamination of fresh produce associated with agricultural and manufacturing practices –Leafy Green Safety Initiative –Tomato Safety Initiative

61. Tomato Safety Initiative Collaborative effort, initiated in 2007, between FDA and state health and agriculture departments in Virginia and Florida, in cooperation with several universities and members of the produce industry

62. Tomato Safety Initiative Collaborative effort, initiated in 2007, between FDA and state health and agriculture departments in Virginia and Florida, in cooperation with several universities and members of the produce industry –Part of a risk-based strategy to reduce foodborne illness by focusing efforts on specific products, practices, and growing areas found to be problematic in the past

63. Tomato Safety Initiative Virginia based tomato farms and packing facilities were visited: –To assess food safety practices

64. Tomato Safety Initiative Virginia based tomato farms and packing facilities were visited: –To assess food safety practices –To assess what degree Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) are implemented

65. Tomato Safety Initiative Virginia based tomato farms and packing facilities were visited: –To assess food safety practices –To assess what degree Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) are implemented –To assess a variety of environmental factors including:

66. Tomato Safety Initiative Virginia based tomato farms and packing facilities were visited: –To assess food safety practices –To assess what degree Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) are implemented –To assess a variety of environmental factors including: Irrigation water

67. Tomato Safety Initiative Virginia based tomato farms and packing facilities were visited: –To assess food safety practices –To assess what degree Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) are implemented –To assess a variety of environmental factors including: Irrigation water Wells

68. Tomato Safety Initiative Virginia based tomato farms and packing facilities were visited: –To assess food safety practices –To assess what degree Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) are implemented –To assess a variety of environmental factors including: Irrigation water Wells Procedures for mixing chemicals

69. Tomato Safety Initiative Virginia based tomato farms and packing facilities were visited: –To assess food safety practices –To assess what degree Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) are implemented –To assess a variety of environmental factors including: Irrigation water Wells Procedures for mixing chemicals Drought and flooding events

70. Tomato Safety Initiative Virginia based tomato farms and packing facilities were visited: –To assess food safety practices –To assess what degree Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs) are implemented –To assess a variety of environmental factors including: Irrigation water Wells Procedures for mixing chemicals Drought and flooding events Animal proximity to growing fields

71. Potential Interventions Identify risk factors for contamination of fresh produce associated with agricultural and manufacturing practices Identify possible measures to improve safety

72. Potential Interventions Identify risk factors for contamination of fresh produce associated with agricultural and manufacturing practices Identify possible measures to improve safety Develop additional guidance –Refine Good Agricultural Practices –Commodity and/or Region Specific

73. Summary Fruit and vegetables are major components of a healthy diet, but eating fresh uncooked produce is not risk free.

74. Summary Fruit and vegetables are major components of a healthy diet, but eating fresh uncooked produce is not risk free. Greater application and implementation of good agricultural practices and good manufacturing practices are key to minimizing the microbial hazards and associated risks.

75. Summary Fruit and vegetables are major components of a healthy diet, but eating fresh uncooked produce is not risk free. Greater application and implementation of good agricultural practices and good manufacturing practices are key to minimizing the microbial hazards and associated risks. Solutions must balance agricultural, food safety, and environmental needs.

76. Summary Fruit and vegetables are major components of a healthy diet, but eating fresh uncooked produce is not risk free. Greater application and implementation of good agricultural practices and good manufacturing practices are key to minimizing the microbial hazards and associated risks. Solutions must balance agricultural, food safety, and environmental needs. Increasing scientific knowledge and understanding of the risk factors are key to development and implementation of effective risk management strategies.

77. Summary Fruit and vegetables are major components of a healthy diet, but eating fresh uncooked produce is not risk free. Greater application and implementation of good agricultural practices and good manufacturing practices are key to minimizing the microbial hazards and associated risks. Solutions must balance agricultural, food safety, and environmental needs. Increasing scientific knowledge and understanding of the risk factors are key to development and implementation of effective risk management strategies. Success in improving the safety of fresh produce requires collaboration and cooperation.