FDA Overview of FSMA’s Proposed Produce Safety Rule and Chamberlain Farms Environmental Assessment

1. FDA Overview of FSMA’s Proposed Produce Safety Rule and Chamberlain Farms Environmental Assessment 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

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

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

4. FDA Proposed Ruleon Produce Safety

5. Five Proposed Rules EstablishFood Safety Framework • 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

6. 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. Qualitative Assessment of Risk Reflects Science Behind ProduceRule • 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. Standards for Produce Safety Focus on 5 identified routes of microbial contamination: • Agricultural water • Biological soil amendments of animal origin • Worker health and hygiene • Equipment, tools, buildings and sanitation • Domesticated and wild animals Additional requirements for: • Sprouts • Growing, harvesting, packing and holding

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

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

11. 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.

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

13. Epidemiology* • 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 data (and map) as reported by CDC: http://www.cdc.gov/salmonella/typhimurium-cantaloupe-08-12/

14. Regulatory InspectionAugust 14-31, 2012 • 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 Photo Credit: Indiana Department of Health

15. 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. 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. Growing EnvironmentField 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. 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. 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. 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. 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. 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. Packinghouse Design • Harborages existed in the packinghouse structures • The drip-line of the packinghouse roof extends over the conveyor belt and brush washer

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

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

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

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

31. 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 introducingSalmonella. • Agricultural water may not have been of adequate quality • Cannot be eliminated as a potential contributor in the spread of Salmonella

32. 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. 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

34. 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.

35. 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

36. 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

37. 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

38. 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)

39. 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

40. Questions and Answers

41. Questions and Answers 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.

42. Questions and Answers 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.

43. Questions and Answers 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).

44. Questions and Answers 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/CFSANFOIAElectronicReadingRoom/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.

45. List of Resources • FDA Guidance Documents for Melons and Fruits/Vegetables: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ProducePlantProducts/ucm174171.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/ucm064574.htm • Form FDA 483-General Observations: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CFSAN/CFSANFOIAElectronicReadingRoom/ucm341029.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/ucm341029.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