Controlling Salmonella and Listeria in Low Moisture Food Manufacturing Facilities

1. Controlling Salmonella and Listeria inLow Moisture Food Manufacturing Facilities Frederick Cook DFA Annual Conference April 3, 2013

2. Contamination of Low Moisture Foods Pathogen Contamination Examples Raw GrainsSpicesSeedsTree NutsGround Nuts Wheat flour Pepper Sesame Almonds Peanuts Cookie dough Paprika Sunflower Pistachios Peanut butter Cake batter ice cream Oregano Celery Hazelnuts Peanut paste Pumpkin Pecans Walnuts

3. Low Moisture Foods Lower moisture can eliminate the ability of pathogenic bacteria to multiply Not a “Potentially Hazardous Food” (Aw >0.85 and pH >4.6) requiring time/temperature control to prevent growth for safety But in dry conditions: Bacteria have increased heat resistance Bacteria may survive for very long periods of time Bacteria can transfer and contaminate the product stream

4. Finished Product Testing for Pathogens Source: International Commission on Microbiological Specifications for Food 5% of Samples Contaminated 1% of Samples Contaminated Probability of Probability of Probability of Probability of n Lot Acceptance Lot Rejection Lot Acceptance Lot Rejection 1 0.95 0.05 0.99 0.01 5 0.77 0.23 0.95 0.05 15 0.46 0.54 0.86 0.14 30 0.21 0.79 0.74 0.26 60 0.05 0.95 0.55 0.45 <0.01 >0.99 0.05 0.95

5. General Controls for Food Safety in Facilities - Preventive Food Safety Plan – HACCP based – including validated CCPs Prerequisite Programs • Raw material control • Pest control • Allergen control • Glass/physical hazard control • Sanitation SOPs • Water control • Personal Hygiene • Environmental contamination control

6. General Controls for Food Safety in Facilities Conditions that Allow Multiplication of Pathogenic Bacteria • Food • Acidity • Temperature • Time • Oxygen • Moisture Exclusion of Moisture will prevent multiplication of pathogens in the food facility and reduce risk of their spread

7. Water Control WAR ON WATER Time Microbial Growth Food Water Minimize presence of water by eliminating , reducing and controlling it wherever possible

8. Water Control WAR ON WATER 1. Determine areas where water is exposed in the facility 2. Map the Facility for Presence of Water / Dry Areas 3. Understand why water is used 4. Determine strategies for eliminating/reducing/controlling Necessary Water Strategy Processing Reduce/control Wet cleaning/sanitizing Eliminate/reduce Unnecessary Water Strategy Condensation Fix root cause Leaks Ingress Fix root cause Internal Fix root cause Drains Backup Fix root cause Leaks Fix root cause

9. Water Control WAR ON WATER Minimize water usage where possible Reduce frequency of cleaning/sanitizing if appropriate Enhance sanitary design (reduce wet time) Accessible - Cleanable – Sanitizable – Dryable – Inspectable Substitute dry cleaning/dry sanitizing methods for wet methods and validate them (scrape, brush, vacuum, wipe, alcohol-quat) Visibly clean – ATP standard criteria – Allergen test negatives – APC standard criteria Enhance water control Pipe directly to drains Establish dedicated wash rooms Fix leaks / backups Track water use and water exposure events

10. Environmental Pathogen Control Program HYGIENIC ZONING Prevent transfer of potentially contaminated materials associated with risk to food product safety Conduct hazard analysis Determine boundaries for control Hygienic Zones different from Product Zones Establish physical controls Establish procedural controls

11. Hazard Analysis – Identify Risks Location Line, process step Potential contamination type Origin of potential contamination Possible Transfer method(s) Areas that may be affected Product stream affected Risk score

12. Hazard Analysis - Score Risks Severity of contamination type Likelihood of presence Detectability of presence Likelihood that product will be contaminated Detectability of product contamination

13. Barriers to Sources of Contamination Barriers to outside sources Pest control Security Physical barrier to water Physical barrier to air Physical barrier to other materials

14. Barriers to Sources of Contamination Barriers to potentially contaminated materials brought in Pallets: wooden, plastic New manufacturing equipment: hygienic condition Other equipment: hygienic condition Construction materials: contain People: captive footwear, uniforms, visitor smocks & shoe cover Ingredients: sourcing

15. Employee Entrance

16. Employee Entrance

17. Employee Entrance

18. Hygienic Zones Within the Plant Barriers to contamination by materials, people, and equipment GMP Support Zones: employee welfare areas, offices, maintenance shop, inner docks GMP Zones - High Sensitivity GMP Zone: exposed to high sensitivity materials - General GMP Zone - High Hygiene GMP Zone: protect post kill product

19. Hygienic Zone Map of Plant Non GMP Zone Non GMP Zone General GMP Zone High Hygiene Zone Non GMP Zone GMP Support Zone High Sensitivity Zone GMP Support Zone

20. Physical & Procedural Barriers Between Hygienic Zones GMP Support Zone into General GMP Zone Handwashing

21. Physical & Procedural Barriers Between Hygienic Zones

22. Physical & Procedural Barriers Between Hygienic Zones GMP Support Zone into General GMP Zone Handwashing Footwear sanitation

23. Physical & Procedural Barriers Between Hygienic Zones Sanitizer Spray Unit for Footwear 23 Source:

24. Physical & Procedural Barriers Between Hygienic Zones GMP Support Zone into General GMP Zone Footwear sanitation Handwashing Hairnet/beardnet Safety items: glasses, hearing protection GMP policies for jewelry, no eating, etc Illness restriction policy

25. Physical & Procedural Barriers between Hygienic Zones High Sensitivity Zones: Contain high sensitivity materials Walls and doors Limited access Air balancing Hygienic Entrance Area (HEA) – for people Hygienic Transfer Area (HTA) – for materials and equipment

26. Example of Hygienic Entrance Area Layout High Sensitivity GMP Hygienic Zone General GMP Hygienic Zone Supplies Shoe Sanitize Hand wash sink T Brown Smocks Vac Brush Box V Bench Mirror Blue Smocks Mirror

27. HEA Procedure – Into High Sensitivity Zone

28. HEA Procedure – Out of High Sensitivity Zone

29. Physical & Procedural Barriers between Hygienic Zones Vacuum Brush Box for Footwear

30. Physical & Procedural Barriers between Hygienic Zones Protect High Hygiene Zones to reduce contamination risk Walls and doors Limited access Air balancing Hygienic Entrance Area (HEA) Hygienic Transfer Area (HTA)

31. HEA Procedure – Into High Hygiene Zone

32. Hygienic Transfer Area Procedure – into High Sensitivity Zone

33. Hygienic Transfer Area Procedure – out of High Sensitivity Zone

34. Hygienic Transition Zone (HTA)

35. Hygienic Transfer Area Procedure – into High Hygiene Zone

36. Acceptance of Hygienic Zoning Implementation Safety #1 - committment Communicate risk mitigation Minimize cost Minimize disruption of manufacturing operations Training

37. Footwear Sanitation – Decontamination Efficacy Objectives: • Determine amounts of microbial reduction on footwear soles using several decontamination treatments. • Determine amounts of microbial transfer to floors following various footwear decontamination treatments.

38. Footwear Sanitation – Decontamination Efficacy Post-treatment boot swab Pre-treatment boot swab c R a b Slide courtesy Scott Burnett

39. Footwear Sanitation – Decontamination Efficacy

40. Log CFU Reduction Aqueous QAC IPA/QAC & Dry QAC Dry QAC IPA/QAC No Treatment Reductions on Footwear Soles Burnett, Egland, McKelvey and Cook, 2013. Food Protection Trends 33:74-81.

41. Log CFU/sample Site ‘b’ IPA QAC Site ‘c’ IPA QAC Site ‘c’ None Sole IPA QAC Sole None Site ‘b’ None IPA/QAC under wet floor conditions Burnett, Egland, McKelvey and Cook, 2013. Food Protection Trends 33:74-81.

42. Footwear Sanitation – Footwear Sanitation Conclusions: Aqueous QAC footbath achieved about 0.5 log reduction under conditions of the study. Nonaqueous IPA-QAC spray achieved > 2.0 log reduction under conditions of the study. Drawback of dry QAC outweighed the benefit. Recommendations: Consider the use of IPA-QAC spray instead of QAC footbath. • Four times more effective under brief exposure conditions • Reduces water exposure in the facility

43. Footwear Sanitation – Particulate Pickup and Cleanability Objective: To classify and determine the ability of various footwear tread patterns to pick up particulate materials. To evaluate the cleanability of soles having various tread patterns.

44. Footwear Sanitation – Particulate Pick-up & Cleanability Wheat berries Corn grits Rice kernels Dry and wet floor conditions

45. Footwear Sanitatioin - Particulate Pick-up & Cleanability

46. Footwear Sanitation – Particulate Pickup and Cleanability Conclusions: Footwear tread patterns can be classified for their ability to pick up particles. Soles classified as "A" picked up wheat berries, corn grits and rice kernels much less readily than those classified as "C". The ability to pick up particles correlates directly with difficulty of particle removal by brushing or use of a picking tool. Footwear classified as "C" were much more difficult to clean than those classified as "A". Recommendations: Consider the use of “A” soles for enhanced footwear sanitation. This may have benefit for reducing risks of transfer of potentially contaminated materials within plants, that could pose food safety risk.

47. Summary War on Water Hygienic Zoning Footwear Sanitation Fred Cook, Ph.D. Microbiology Fellow MOM Brands fkcook@mombrands.com

48. Thank You!