1. Presented To: Purdue University Extension 11 April 2013 Presented By: FDA CFSAN Produce Safety Staff FDA Office of Regulatory Affairs FDA Coordinated Outbreak Response and Evaluation Network FDA Overview of FSMA’s Proposed Produce Safety Rule and Chamberlain Farms Environmental Assessment

2. Outline FSMA Environmental Assessment (EA) – Background EA – Epidemiology EA – Assessment Conclusions Select Recommendations Questions and Answers

3. US Food and Drug Administration Part 1: Food Safety Modernization Act Part 2: Environmental Assessment: Factors Potentially Contributing to the Contamination of Fresh Whole Cantaloupe Implicated in a Multi-State Outbreak of Salmonellosis

4. FSMA FDA Proposed Rule on Produce Safety

5. FSMA Produce Safety Standards - Published Jan. 2013 Preventive Controls for Human Food - Published Jan. 2013 Foreign Supplier Verification Program Preventive Controls for Animal Food Accredited Third Party Certification Five Proposed Rules Establish Food Safety Framework

6. FSMA Produce Rule: Key Principles Flexible across the diversity of production Considers risk posed by practices, conditions, and commodities Science- and Risk-based –Identified routes of microbial contamination –Excludes “rarely consumed raw” and produce to be commercially processed with a “kill-step”

7. FSMA Qualitative Assessment of Risk Reflects Science Behind Produce Rule Draft qualitative assessment of risk helps to inform proposed rule Provides a scientific evaluation of potential adverse health effects resulting from human exposure to hazards in produce Available for public comment as part of the proposed rule

8. FSMA Standards for Produce Safety Focus on 5 identified routes of microbial contamination: 1.Agricultural water 2.Biological soil amendments of animal origin 3.Worker health and hygiene 4.Equipment, tools, buildings and sanitation 5.Domesticated and wild animals Additional requirements for: Sprouts Growing, harvesting, packing and holding

9. Web site: http://www.fda.gov/fsma Subscription feature available Official site: http://www.regulations.gov More Information Available

10. EA - Background Environmental Assessment conducted at Chamberlain Farms: Background and Epidemiology

11. EA - Background In August 2012, the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and state and local health departments began to investigate a multi-state outbreak of salmonellosis. Background

12. EA - Background Graphic Credit: http://www.ledc.org/where.html Cantaloupes from Chamberlain Farms, located in the southwest region of Indiana were implicated based upon: –Epidemiological evidence –Product traceback investigation evidence Background

13. EA - Background * Epidemiology data (and map) as reported by CDC: http://www.cdc.gov/salmonella/typhimurium-cantaloupe-08-12/ Final case count: –261 reported cases from 24 states Two outbreak strains were identified: –Salmonella Typhimurium: 228 reported cases –Salmonella Newport: 33 reported cases Illness onset dates: –07/06/2012 – 09/16/2012 94 ill persons hospitalized Three deaths reported from Kentucky Epidemiology*

14. EA - Background Photo Credit: Indiana Department of Health Multiple samples were collected, including: –Whole cantaloupe –Environmental (non-product) from the Packinghouse Cantaloupe from the fields were positive for both outbreak strains Six of 70 sub-samples from the packinghouse were positive for one of the outbreak strains Several deficiencies were noted in the packinghouse including: –Equipment design –Packing and holding Regulatory Inspection August 14-31, 2012

15. EA - Background Decision to Initiate a Second Regulatory Inspection with an Environmental Assessment Decision based upon: –Isolation of one of the outbreak strains in the packing environment –Isolation of both outbreak strains on whole cantaloupe collected from production fields and storage –A positive watermelon field sample

16. Environmental Assessment September 21 – 22, 2012

17. EA - Assessment Growing Environment Environmental samples –Cantaloupe and watermelon growing fields –Included: Soil from each parcel/field Wild animal excreta Well water Pooling water on field perimeters Drainage ditch water Cantaloupe

18. Sample Results Parcel A Non-outbreak strains of Salmonella detected in soil and puddle water Outbreak strain detected in soil Parcel B Non-outbreak strains of Salmonella detected in soil, plant root, and drip tape Parcel C Non-outbreak strains of Salmonella detected in soil and animal excreta Parcel D Outbreak and Non-outbreak strains of Salmonella detected in soil

19. EA - Assessment Growing Environment Field Product Non-commercial cantaloupe collected from Parcel D One cantaloupe (of 10 collected) was positive for Salmonella. –Although still pathogenic, it was not one of the two outbreak strains.

20. EA - Background Agricultural Water Wells Five wells provided water for irrigation and packinghouse One well served a greenhouse used to grow melon seedlings The aquifer that serves these wells is approximately 36 feet below the surface

21. EA - Assessment Agricultural Water Wells None of the wells tested positive for Salmonella Each of the five wells tested positive for enteric bacteria/fecal indicator: –E. coli –Total Coliforms

22. EA - Assessment Scott Ditch The ditch is a narrow, shallow, flowing, man- made waterway located in a gulley ~15 feet deep Discharges into the Wabash River several miles northwest Located ~100 feet from one of the agricultural water wells The ditch tested positive for: –Salmonella Non-outbreak strain –Enteric bacteria/fecal indicator: E. coli Total Coliform

23. EA - Assessment Packing and Holding Factors that may have contributed to the introduction, growth, or spread of Salmonella: –Packinghouse Design –Equipment Design –Packing or Holding Practices Note: some of these issues were from the August regulatory inspection and were not observed during the EA

24. EA - Assessment Packinghouse Design Packinghouse design allowed for the pooling of water on the packinghouse floor adjacent to equipment The packinghouse floor was constructed in a manner that was not amenable to cleaning

25. EA - Background Packinghouse Design Harborages existed in the packinghouse structures The drip-line of the packinghouse roof extends over the conveyor belt and brush washer

26. EA - Assessment Equipment Design Packing equipment not easily cleaned and sanitized –Used porous materials –Likely to have retained microorganisms and moisture –Brush rollers Design flaws similar to equipment previously associated with cantaloupe-related foodborne illness outbreaks

27. EA - Assessment *Cantaloupe line, during August regulatory inspection only. During EA, only positive from watermelon line – separate and not in operation at the time Visible product and filth buildup Visible signs of corrosion Environmental positive for Salmonella* Equipment Design

28. EA - Assessment Packing and Holding Practices No pre-cooling before storing and shipping Cantaloupes packed while still moist from washing

29. EA - Assessment Un-emptied garbage receptacles (pest harborage) Inadequate cleaning and sanitizing procedures –Equipment –Wash water disinfectant –Maintained no records of any sanitary procedures Packing and Holding Practices

30. EA - Assessment Discussion of Findings Salmonella on even a few incoming cantaloupe may introduce bacteria – lack of sanitary control measures allow persistence and cross contamination

31. EA - Assessment Discussion of Findings Agricultural water sources were negative for Salmonella –Agricultural water used for irrigation, crop protection sprays, and in the packinghouse were not a likely route for introducing Salmonella. Agricultural water may not have been of adequate quality –Cannot be eliminated as a potential contributor in the spread of Salmonella

32. EA - Assessment Possible Sources and Routes of Contamination Biological soil amendments –May have been the source of the pathogen –However, the firm reported no use Adjacent or previous land use may have played a role in this (unknown) Significant poultry (turkey) production is located in the local region

33. EA - Assessment Possible Sources and Routes of Contamination It was hypothesized that agricultural water may have been a vehicle for the spread of contamination. Chamberlain Farms did report that subsurface drip irrigation was used on three of the four fields visited during the EA. However, Chamberlain Farms reported that they did not use any irrigation water for the production of cantaloupe or watermelons on Parcel A (a parcel where, both watermelon (collected by ISDH) and soil samples (collected by FDA) were found to be positive for Salmonella). –This is extraordinary given the water use demands typically required to commercially produce cantaloupe and watermelon, particularly given the extreme heat and drought conditions which occurred in Southwest Indiana during the summer growing season of 2012.

34. EA - Assessment Possible Sources and Routes of Contamination Wells tested negative for Salmonella, but positive for generic E. coli and total coliform –It is unusual to note indicators of fecal contamination to be recovered from ground water sources –Possible that Scott Ditch is influencing the aquifer –Some of the wells were poorly constructed – may have been subject to contamination by run-off, or through subsurface influences

35. EA - Assessment Discussion of Packing and Holding Practices Several areas on both the washing and drying equipment appeared to be uncleanable, and dirt and product buildup was visible on some areas of the equipment. The pooling of water in close proximity to packing equipment, including conveyors, may have extended and spread the pathogen to food contact surfaces. –Therefore, this aspect of the packinghouse design is a factor that may have contributed to the introduction, growth, or spread of Salmonella. – Wet fruit packed still warm with field heat may have potentially created conditions that would allow for Salmonella persistence and possible growth

36. Conclusions Based on the positive test results from the environmental samples collected from the Chamberlain Farms production fields and packinghouse during two separate FDA inspections, it is likely that the initial contamination of the melons occurred in the production fields and was spread by operations and practices within the packinghouse. It is also likely that the contamination proliferated during storage and transport to market.

37. Select Recommendations Follow good agricultural practices for handling animal manure to reduce the introduction of microbial hazards to produce, such as using properly composted manures Assess produce packinghouse and equipment design to ensure adequately cleanable surfaces and eliminate opportunities for introduction, growth, and spread of Salmonella and other pathogens

38. Select Recommendations Assess and minimize opportunities for introduction of Salmonella and other pathogens in packing facilities Implement and verify regular cleaning and sanitizing procedures Periodically evaluate the processes and equipment used to assure they do not contribute to contamination

39. Select Recommendations Ensure that water is of adequate microbial quality for its intended use. Using dump tank water with sufficient disinfectant present and monitor the levels to reduce the potential risk of cross-contamination Note: The primary purpose of the water disinfectant is not to sanitize melons, but rather to prevent the water from becoming contaminated and acting as a source of contamination for incoming melons

40. Select Recommendations Implement melon handling operations that minimize the incidence of melon surface moisture to reduce potential plant and human pathogen growth Cooling and cold storing melons as soon as possible after harvest (if cooled)

41. Select Recommendations Growers should further consider the recommendations put forth in FDA’s documents: Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Produce and Vegetables; and Draft Guidance for Industry: Guide to Minimizing Microbial Food Safety Hazards of Melons

42. FSMA Questions and Answers

43. Question: Are the Regional Industry Guidance Documents a suggested source of information beyond FDA’s guidance documents? Answer: Yes, these documents may contain additional information. Question: Was there any rodent control observed during the environmental assessment? Answer: No. Monitoring and control of pests is urged. Question: How were the cantaloupes contaminated in the field? Answer: There are many possible routes of contamination; no one single route was identified. Pathogen, however, was found in the soil and puddles and on equipment. Questions and Answers

44. Question: How often was the dunk tank changed? Use of water temperature and disinfection in reducing risk for water to melon cross- contamination? Answer: The dunk tank was changed daily at the farm. Evaluating and monitoring water disinfectant levels is important to ensure that disinfectant is present at levels sufficient to reduce the potential risk of cross-contamination when melon cooling water is re-circulated. If melons are fully submerged in water as a means of cooling, they are more likely to have cooling water infiltrate into the melons and consideration should be given to cooling water quality variables such as pH, soil (including organic) load, turbidity, and product through-put capacity, to ensure that the wash water disinfectant of choice is effective in reducing the potential for water-to-melon cross-contamination. Questions and Answers

45. Question: How do I obtain a copy of the Environmental Assessment? Answer: The environmental assessment is available to the public and is available on the FDA website. (See Slide 47 of this presentation for the link.) Question: Did the Environmental Assessment include other farms? Answer: No, the Environmental Assessment was limited to the Chamberlain Farms. Question: What are the considerations for the water wash of cantaloupes? Answer: Those considerations are the depth and length of time the fruit is in the wash. Also, soaps should be avoided as surfactants in the soap can lead to uptake of water (and potentially pathogens). Questions and Answers

46. Question: Is there any information that can be shared about upcoming nationwide FDA inspection of cantaloupe firms? Answer: There was a letter from FDA released February 25, 2013 which may be found at: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/C FSANFOIAElectronicReadingRoom/ucm341029.htm In short, the inspections are limited to cantaloupe. They are focused on packing houses and not fields. The FDA will be assessing current practices and identifying insanitary conditions that may affect the safety of cantaloupe to consumers. Finally, outreach to states by FDA will occur regarding timing of inspections. Questions and Answers

47. List of Resources FDA Guidance Documents for Melons and Fruits/Vegetables: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ProducePlantProducts/uc m174171.htm Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Produce and Vegetables: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ProducePlantProducts/uc m064574.htm Form FDA 483-General Observations: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm3410 29.htm FDA Environmental Assessment: Factors Potentially Contributing to the Contamination of Fresh Whole Cantaloupe Implicated in a Multi-State Outbreak of Salmonellosis http://www.fda.gov/Food/FoodSafety/FoodborneIllness/ucm341476.htm The letter to industry may be found at: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm3410 29.htm FSMA http://www.fda.gov/fsma Outbreak Information http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm272347.htm http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/WhatWeDo/ucm211758.htm