1. 1 Useful Microbiological Testing in Food Safety & Quality Management Katherine M.J. Swanson, Ph.D. Vice President Food Safety Ecolab President-Elect IAFP Arkansas Association for Food Protection Springdale, AR September 14, 2011

2. 2 Discussion Topics  International Association for Food Protection greeting  Different tests serve different purposes  Testing for maximum value

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12. 12 Different Tests Serve Different Purposes

13. 13 Microbial Testing  “Microbial testing” means different things to different people  Reams of data  Detective game to identify unknown or causative agent  Presence/absence or qualitative reaction that’s observed  Quantitative measurement of the microbiological status of a sample or lot OR Presentation focuses on process control and product acceptance

14. 14 The Purpose of a Test Determines: The target Indicator or pathogen The method Time to results, accuracy, repeatability, etc. The sample Environment, line residue, end product, location collected, size/ number of samples The frequency Daily, weekly, monthly, etc. or event triggered The interpretation Investigational, routine, regulatory, etc. The action Rejection, process adjustment, recall, outbreak investigation, etc.

15. 15 International Commission on Microbiological Specifications for Foods  Founded in 1962 to advance scientific concepts for government and industry consideration to:  Reduce foodborne illness  Facilitate global food trade  Focus on testing applied to foods  Membership  6 Academia, 6 Government, 5 Industry from 11 Countries  All work is voluntary and without honoraria  Partners with FAO, WHO, ILSI, IUFoST, IAFP etc.  Provides advice through books, papers, workshops, etc.  Advice has no official status

16. 16 When & Where to Test for Food Safety Management  When there is good evidence that:  There is a microbiological problem -Food safety or quality -Historical or current AND  Testing will help to control the problem

17. 17 Target Organism Examples EXAMPLES Utility Spoilage, reduced shelf life, no health concern Total counts, yeast, mold, etc. Indicator Measure of GHP or process controlColiforms, generic E. coli, Enterobacteriaceae, etc. Moderate hazard Not life threatening, short duration, self limiting, no sequelae S. aureus, B. cereus, C. perfringens, Norovirus, etc. Serious hazard Incapacitating, usually not life threatening Salmonellae, Shigella flexneri, Yersinia enterocolitica, etc. Severe hazard Life threatening, chronic sequelae, or long duration OR Designed for sensitive sub- population E. coli O157:H7, C botulinum toxin or Cronobacter (infants) ICMSF Hazard Categories From ICMSF Book 7

18. 18 Key ICMSF Sampling Plan Terms nNumber of sample units analyzed cMaximum number of sample units with unsatisfactory test results mLevel that separates acceptable quality from marginally acceptable or unacceptable quality MLevel above which is unsatisfactory or requires further investigation

19. 19 Choosing m and M m M Relative proportion of sample units in a lot Mean log count No concern Decisive concern Some concern

20. 20 ICMSF Suggested Sampling Plans Hazard Group Likely Change Before Consumption ReduceNo ChangeIncrease UtilityCase 1 n=5, c=3 Case 2 n=5, c=2 Case 3 n=5, c=1 IndicatorCase 4 n=5, c=3 Case 5 n=5, c=2 Case 6 n=5, c=1 ModerateCase 7 n=5, c=2 Case 8 n=5, c=1 Case 9 n=10, c=1 SeriousCase 10 n=5, c=0 Case 11 n=10, c=0 Case 12 n=20, c=0 SevereCase 13 n=15, c=0 Case 14 n=30, c=0 Case 15 n=60, c=0 FOR LOT ACCEPTANCE TESTING Analytical unit = 25g

21. 21 Sample Size Influence on Probability of Acceptance m = 0 86% 74% 55% 1%

22. 22 Testing to Maximize Value

23. 23 Useful Microbial Testing  Identification of contamination sources  Environmental monitoring to identify potential harborage sites  Utility and indicator organisms to verify effective controls & trends  Effective processing  Effective control of post process contamination  Investigation sampling for problem solving

24. 24 Process Example Process 1 Process 2 Process 3 Packaging Line A Packaging Line B Ingredients What action do you take when an unacceptable result is found on Line B?

25. 25 Result Format Influences Information Provided Positive Negative

26. 26 0 1 2 3 4 5 01020 Lot Number Log (CFU/g) Trend Analysis Can Inform Process Control 0 1 2 3 4 5 01020 Lot Number Log (CFU/g) 0 1 2 3 4 5 01020 Lot Number Log (CFU/g) 0 1 2 3 4 5 01020 Lot Number Log (CFU/g)

27. 27 Testing Considerations  Primary production  Ingredients  In-process  Processing environment  Shelf life  End product

28. 28 Book 8 Contents  Part 1-Principles  Utility of microbial testing for safety & quality  Validation of control measures  Verification of process control  Verification of environmental control  Corrective action to re-establish control  Microbial testing in customer- supplier relationships  Part 2 – Product Categories  Meats  Poultry  Seafood  Feed & pet food  Vegetables  Fruits  Spices, dried soups, flavorings  Cereals  Nuts, oilseeds, dried legumes  Cocoa and confectionery  Oil based foods  Sugar, syrups, honey  Beverages  Water  Dairy products  Eggs  Shelf stable, heat treated foods  Infants and young children  Formulated foods

29. 29 Primary Production  Included when production conditions have a major influence on the microbial quality or safety  Fruits, vegetables, spices, meat, poultry and fish products  Examples of samples to consider  Irrigation water  Fertilizer  Feed  Other on-farm practices

30. 30 Ingredient Testing  May be useful for some applications and not others  Example - cocoa powder:  Used in chocolate, no heat treatment ?Used in ice cream mix that is subsequently pasteurized  Question  Is control at the ingredient step necessary?

31. 31 In-Process Testing  Verify a kill step or predict potential re- contamination  Examples  Intermediate product, line residues, tailings, wash water  Typically indicators with quantitative results  Questions:  Is the process needed to control a microbial concern?  Is testing needed to verify: - the process is functioning as intended or - contamination is not occurring in the process?

32. 32 Processing Environment Testing  Use to verify that the environment is under appropriate hygienic control  Examples  Swabs or sponges for equipment or in the environment  Rapid testing to verify cleaning & sanitation adequacy  Identify harborage sites that can contaminate end product  Frequently, earlier detection of issues than end product testing  Questions considered:  Does the environment need to be controlled to prevent contamination?  Will testing be beneficial to verify control?

33. 33 Shelf Life Testing  Relevant for products subject to microbial spoilage  Purpose – verify microbial stability for the product life cycle  May predict issue before they are experienced in the market place  Questions considered:  Is shelf life limited by a microbiological safety or quality concern?  Is shelf-life testing feasible?

34. 34 End Product Testing  Demonstrate successful application of controls or assess the status of a lot when no other information exists.  Alternative sampling plans may be appropriate, for example:  Fewer samples for on-going surveillance activity  More samples when investigating significant process deviations or outbreaks.  Questions considered:  Is end product testing necessary to verify the overall manufacturing process?  Is end product testing relied upon for ensuring the safety or quality of the lot?

35. 35 Example: Dried Ready-to-Eat Cereal Relative importance Useful testing Critical ingredients MediumTest for mycotoxins if confidence in raw grains is low Test nuts, cocoa, and other sensitive ingredients with no subsequent kill step for Salmonella if confidence in supplier is low. In-processHighTest appropriate product residues and in-line samples for Salmonella. Typical guidance levels: Salmonella – absent Processing environment HighTest for Salmonella and Enterobacteriaceae in the processing environment Typical guidance levels: Enterobacteriaceae – 100-1000 cfu/g Salmonella – absent Shelf-lifeNot relevant -

36. 36 Example: Dried Ready-to-Eat Cereal (continued) Relative importanceUseful testing End product HighTesting for Enterobacteriaceae is recommended to verify process control. ProductMicroorganism Analytical method Sampling plan & limits/g CasencmM Dried cereal Enterobacter- iaceae ISO 21528-2 2521010 2 LowTesting for pathogens is not recommended during normal operation when GHP and HACCP are effective as confirmed by above tests. When above testing or process deviations indicate a possible safety issue, test for Salmonella. ProductMicroorganism Analytical method Sampling plan & limits/25g CasencmM Dried cereals SalmonellaISO 6579111000-

37. 37 Example: Comminuted Meat Relative importance Useful testing Critical ingredients Low to high Pre-testing beef trimmings for E. coli O157:H7 may be useful when confidence in supplier control is low. In-processLowRoutine in-process samples are not normally collected. Samples of meat at various stages of processing can be used to establish a baseline and understand changes in the microbial population during processing. Processing environment LowSample equipment surfaces before start-up to verify efficacy of cleaning and disinfecting. Typical levels encountered may vary by surface type. Shelf lifeLowRoutine shelf life testing of refrigerated raw meat is not recommended. Shelf life testing may be useful to validate code dates of new retail products or when new packaging systems are installed.

38. 38 Example: Comminuted Meat (continued) Relative importanceUseful testing End pro- duct MediumTest freshly packaged product for indicators for on-going process control and trend analysis using internally developed guidelines. Levels for processing do not apply during distribution or at retail. ProductMicroorganism Analytica l method Sampling plan & limits/g CasencmM Raw, comminuted meat E. coliISO 16649-24500- MediumRoutine testing is not recommended for salmonellae. In regions where ground beef is a continuing source of E. coli O157:H7 illness, the following criteria are recommended. ProductMicroorganism Analytical method Sampling plan & limits/25g CasencmM Ground beefE. coli O157:H7ISO 16654143000-

39. 39 Microbial Sampling Summary  Testing safety “into” products usually does not work because of sampling probability  Testing is recommended to generate meaningful data  Impact quality or safety  Verify appropriate controls or direct corrective action  Focus on verification of process control preferred  Environmental monitoring  Selected sampling tailored to the line to verify control

40. 40 Acknowledgements ICMSF  Dr. Martin Cole, CSIRO, Australia (Chair)  Dr. Fumiko Kasuga, National Institute of Health, Japan (Secretary)  Dr. Jeff Farber, Health Canada (Treasurer)  Dr. Wayne Anderson, Ireland Food Safety Authority  Dr. Lucia Anelich, Consumer Goods Council, South Africa  Dr. Robert Buchanan, University of Maryland, United States  Dr. Jean-Louis Cordier, Nestle, Switzerland  Dr. Ratih Dewanti, Bangalore Agricultural University, Indonesia  Dr. Russ Flowers, Silliker Group, United States  Dr. Bernadette Franco, Universidade de São Paulo, Brazil  Dr. Leon Gorris, Unilever, China  Dr. Anna Lammerding, Public Health Agency, Canada  Dr. Xiumei Liu, CDC China  Dr. Tom Ross, University of Tasmania,, Australia  Dr. Katie Swanson, Ecolab, United States  Dr. Marta Taniwaki, Instituto de Tecnologia de Alimentos, Brazil  Dr. Marcel Zwietering Wageningen University, The Netherland

41.  Reference  www.slideshare.com 41