III Simpósio Internacional de Inocuidade de Alimentos (ABRAPA) VIII Simpósio Brasileiro de Microbiologia de A

1. Control of Pathogens in the Food Industry: A Global Food Company’s PerspectiveControle de Patógenos na Industria de Alimentos: A Perspectiva de una Empresa Multinacional de Alimentos III Simpósio Internacional de Inocuidade de Alimentos (ABRAPA) VIII Simpósio Brasileiro de Microbiologia de Alimentos (SBM) Dr. Paul A. Hall Sr. Director Microbiology and Food Safety Glenview, IL October 26, 2004 Sao Paulo, Brasil

2. Kraft Foods – Company Facts • 2003 net revenues of more than $31 billion. • Largest food and beverage company in North America and second largest in the world. • Brands marketed in over 150 countries globally. • More than 100,000 employees operating in more than 68 countries. • 197 manufacturing facilities worldwide at the end of 2003.

3. Kraft Foods – Company Facts • The Kraft brand portfolio is one of the strongest in the world. • Number one share position in 11 global categories, 22 of the top 25 categories in the U.S., and 18 of the top 25 categories internationally.

6. Producing Safe Food is our First Priority • Consumer Protection & Trust • Consumertrust • Food Safety is critical to that trust • Business Survival • Our brands are most important assets • Industry Responsibility • Committed to food safety across thefood chain

7. Methods to Reduce the Risk from Pathogens in Food* • Prevent inadvertent contamination • Inhibit growth • Remove contamination * Adapted from Sofos, et al., 1998

8. Public health is best protected by control of Pathogens via: Aggressive environmental monitoring Effective corrective actions Proper equipment design Adherence to GMPs and SSOPs Proper handling practice Refrigerate perishable RTE products at <40 F (<4.40º C) Consume perishable RTE products quickly Appropriate intervention strategies Formulation (e.g. lactate salts/sodium diacetate) Post-packaging treatments Top Line Summary

9. Pathogen Control Approaches/ Interventions • HACCP and Prerequisite Programs • Sanitation and GMP’s • Environmental Monitoring Program • Ingredient Specifications • Product Formulation • Vendor Qualification & Quality Expectations • Auditing and Certification Programs • New Processing Technologies • Improved Detection Methods • Good agricultural Practices/On-Farm Controls

10. Pathogen Control - Listeria monocytogenes as an Example • Certain foods pose an increased risk of being associated with listeriosis • These foods have the following properties: • Have the potential for contamination with LM • Support the growth of LM to high numbers • Are ready-to-eat foods • Require refrigeration • Stored for extended periods of time

11. Pathogen Control - Listeria monocytogenes as an Example • Foods can be classified according to their risk based on their properties and history of known illness

12. US FDA Listeria Risk Assessment Decreased Risk per Annum Decreased Risk per Serving

13. Differentiating Risk in Processed Meats • Reheated versus unheated hot dogs • Dried and semi-dried meats • Pate • A significant portion (>70%, hot dogs and>50 % deli meats) of RTE processed meats have been formulated with growth inhibitors • Deli meats really are four product categories • With and without inhibitors • In store sliced and packaged • Commercially prepackaged

14. Industry actions to reduce the risk L. monocytogenes in RTE products • Training of industry through comprehensive Listeria control workshops. • Review of Listeria control workshop materials with USDA staff • The use of a thermal treatment after a product has been packaged to destroy Listeria monocytogenes. • Use of new ingredients to inhibit the growth of Listeriamonocytogenes on ready-to-eat meat and poultry. Many products now contain these ingredients. • Development of new principles for processing equipment design that facilitate sanitation and reduce the possibility of bacteria being "harbored" in tiny spaces like the thread of an exposed screw or a hollow roller on a conveyer belt.

15. Industry actions to reduce the risk L. monocytogenes in RTE products • Sophisticated new environmental sampling programs that work to target Listeria in the plant environment so it can be destroyed before it is transferred to products. • Research to discover new technologies. • Declaration by the meat and poultry industry that food safety is a "non-competitive issue," which resulted in the free exchange of food safety information among competitors.

16. Prevalence of Listeria monocytogenes* in Sliced Lunchmeats and Franks * FSIS Results of ready-to-eat products analyzed for Listeria monocytogenes

17. Incidence of Foodborne Illness 1996-2002: Listeria* National Health Objective: .25 *Preliminary FoodNet Data on the Incidence of Foodborne Illnesses --- Selected Sites, United States, 2002

18. Pathogen Control - Listeria monocytogenes as an Example • Product reformulation can be a powerful tool for reducing consumer risk • Microbial models can be used to optimize product quality and product safety

19. Modeling Approaches • Kinetic Models • Fit growth curves, derive rate constants. • Develop multiple regression model for growth rate constants as a function of predictor variables. • Predict amount of growth after time. • Boundary model: • Define growth threshold  measure time to growth. • Develop generalized regression model for time to growth as a function of predictor variables. • Predict time before growth occurs.

20. Intro to Boundary Models • Predict time-to-event (e.g., failure, spoilage, growth) as a function of “predictor” variables. • Commonly used in: • Engineering: time-to-failure of a new design • Medicine: efficacy of different drugs and doses on mortality • Social sciences: prisoner recidivism by treatment program • Use generalized regression to get predictive model and develop contour maps to show boundary between “growth” and “no-growth”. • Handles censored observations. • Uses maximum likelihood estimation (get log likelihood, not R2.)

21. Define Growth Threshold An increase of 1 log10 or more in L. monocytogenes count, determined by expert review of growth curves: • Smallest change distinguishable from “noise”. • IFT expert panel 2001 …“a 1 log increase [is] an appropriate level of control for L. monocytogenes”. • Evaluation and definition of potentially hazardous foods. December 31, 2001. IFT/FDA contract no. 223-98-2333 task order no.4. Chapter 6 section 9 pass/fail criteria.    http://www.foodprotect.org/pdf/hazard_foods/chapter6.pdf

22. Experimental Design – Processed Meats Central composite design for four continuous variables: NaCl % : 0.8 1.5 2.2 2.9 3.6 Moisture %: 45.5 55.0 64.5 74.0 83.5 Na diacetate %: 0.0 0.05 0.10 0.15 0.20 K lactate syrup %: 0.25 2.5 4.75 7.0 9.25 • Repeated for uncured products,  5th variable (cured/uncured). • Model products were made, inoculated, stored at 4 °C, and assessed every 2 weeks for LM count. • Seman, D.L., et al. (2002) J. Food Protection, 65, 651-658.

23. 100 100 % Equivalence Observed weeks to 1 log10 growth 10 Censored observations 1 1 10 100 Predicted weeks to 1 log10 growth Model Performance: Summary Model gives good description of the data used to create it.

24. 10 10 10 Key Shaded graphs show model design space 8 6 45.5 Lactate % 18 weeks 4 24 weeks 2 30 weeks 0 36 weeks 10 10 42 weeks 8 48 weeks 6 55.0 Lactate % 4 Model: growth 2 Model: no growth Validation: growth 0 10 Validation: no growth 8 ≥ 1 but < 2 logs of growth 6 Moisture % 64.5 Lactate % 4 N.B. Positions of validation points are approximate 2 0 10 Growth and No-growth space Inhibitory pressure on growth increases from left to right and from bottom to top on both the outside and individual x and y axes. Hence, “growth space” is always below and to the left of the contours. “No growth space” is always to above and to the right of the contours. The primary concern is to avoid growth points in “no growth” space. 0 0.05 0.1 8 6 74.0 Lactate % 4 2 0 10 10 8 6 83.5 Lactate % 4 2 0 0.2 0 0.05 0.1 0.15 0 0.05 0.05 0.1 0.15 0.2 0 0.2 0 0.15 0.1 0.15 0.2 0.05 0.1 0.2 0.05 0.1 0.15 Diacetate % Diacetate % Diacetate % Diacetate % Diacetate % 2.2 0.8 1.5 2.9 3.6 Salt % Contours of weeks to 1 log growth of L. monocytogenes in cured products calculated using the boundary model with growth and no-growth modeling and validation observations 0

25. Base and modified formulas relative to boundary for 1 log of growth (If base formula is not shown, salt and/or moisture have been changed) Product is: Test 4 8.0 No-growth region Cured ? = yes 7.0 Salt = 2.50% Moisture = 75.0% 6.0 67.5 days (target - 10 %) 5.0 Lactate syrup % 75 days (target) 4.0 3.0 82.5 days (target + 10 %) 2.0 No lactate/ diacetate 1.0 With lactate/ diacetate Growth region 0.0 0 0.05 0.1 0.15 0.2 Diacetate % Potential Graphical Output from Boundary Model

26. Application • Simple spreadsheet • Calculate time to growth from formula • Calculate lactate from shelf-life • Plot growth boundary • Available from Purac America on free CD

27. PROJECTZERO 8.00 7.00 6.00 5.00 4.00 3.00 2.00 1.00 Listeria Growth InhibitionEstimated Benefit to Public Health* Predicted Log Counts/gm 1/7,500 risk 1/75 MM risk 1/750 MM risk *Based on Growth Model and median mortality risk for neonates published in FDA/USDA risk analysis Figure IV-5

28. Estimated 95th Percentile Mortality Risk - 50 g serving of product- Lm growth from an initial level of 1CFU/g Source: Interpolation from FDA Fall 2003 Listeriamonocytogenes Risk Table IV-12

29. Project Forward controls Listeria in the environment Using environmental sampling we systematically seek out and find sources and take corrective action PROJECT FORWARD PROJECT ZERO • Goal - Identify possible technology solutions to achieve zero pathogen risk in RTE meat products • Through formulation, we can further reduce risk resulting in greater public health protection

30. Concurrent Approach to AddressPublic Health PROJECT FORWARD Preventative & Corrective Actions PROJECT ZERO Potential Technical Solutions • Internal Plants • External Network • Formulation • Product/Process Handling • Post Packaging Pasteurization

31. PROJECTFORWARD Project Forward - ListeriaControl Program 3-Stage Approach to Address Preventative & Corrective Actions Sanitation / Environmental Practices Facility / Equipment Design PersonnelTraining • Intensive Environmental swabbing • Footwear / clothing • Traffic patterns • Sanitation • Maintenance • Facility layout • Floors • Design for Sanitation • GMPs • Maintenance • Sanitation • Behavior based food safety

32. PROJECTFORWARD Logic Behind Environmental Control Program • Listeria Control Equation based on premise that intensive environmental monitoring is effective in understanding the plant environment to control Listeria

33. PROJECTFORWARD Listeria Equation Dry,Uncracked,CleanFloors TrafficPatterns SanitaryDesign Sanitation Procedures + + + + GMPs =Listeria Control Mismanagement of any of the components may increase the risk of cross contamination.

34. PROJECTFORWARD Logic Behind Environmental Control Program • Listeria Control Equation based on premise that intensive environmental monitoring is effective in understanding the plant environment to control Listeria • Systematic, disciplined approach to seek out, find and eliminate the undesirable conditions which could support harborage or transference of indicator organisms

35. PROJECTFORWARD Zone 2 Exterior of equipment; chill units; framework; equipment housing Zone 3 Phones; hand trucks; forklifts; walls; floors; drains Zone 1 Product contact surfaces: e.g. slicers; conveyors; peelers; strip tables; utensils; racks; work tables; employee hands Sanitary Zones Zone 4 Locker rooms; cafeteria; halls

36. PROJECTFORWARD Environmental Monitoring Approach • Timely assessment of control of RTE environment • Biased intensive sampling during production to validate all components • Large surface areas sampled for Listeria genus • Sampling is randomized (by the day of the week and shift) • Every RTE processing line must be sampled weekly • Sampling plans need to be flexible and tailored to each specific line and facility

37. PROJECTFORWARD Logic Behind Environmental Control Program • Listeria Control Equation is based on premise that environmental monitoring is effective in understanding the plant environment to control Listeria • Systematic, disciplined approach to seek out, find and eliminate the undesirable conditions which could support harborage or transference of indicator organisms • Focus improvement efforts (capital and resources) as directed by results—”follow the data”

38. PROJECTFORWARD Logic Behind Environmental Control Program Finished product testing has significant limitations. Probability of Missing Contamination % Contamination in Lot Number ofSamples Tested 10% 2% 1% 0.5% 3 73% 94% 97% 99% 10 35% 82% 90% 95% 60 <0.5% 30% 55% 74% 120 <0.5% 8.5% 30% 55% 180 <0.5% 2.6% 16% 41% 240 <0.5% 0.8% 9% 30%

39. PROJECTFORWARD Logic Behind Environmental Control Program • Statistics demonstrate that finished product testing has severe limitations • Finished product sampling is not preventative and does not help identify root cause of contamination • Disciplined approach to monitoring promotes knowledge and awareness of the environmental conditions that could result in product contamination • If there is an effective kill step in the process, and if there is no Listeria in the environment, there will be no Listeria in the finished product • Public health protection is better served with an aggressive environmental program

40. PROJECTFORWARD Logic Behind Environmental Control Program • To verify effectiveness of the program, we monitor all components in the Listeria equation • Of ~100 RTE meat production lines • 50% no positive contact surfaces • 84% single occurrence • These results indicate the level of Listeria is very low in our environment • Low levels in the environment are not likely to result in product contamination

41. PROJECTFORWARD Low Levels in the EnvironmentEnumeration Data • Counts of >10 per area swabbed only seen on floor after 2 shifts, or in niches • Environmental samples of product contact surfaces tested for Listeria have been enumerated. Positive samples that were enumerated contained less than the detection limit of the methods (MOX and MPN) • Data supports concept that random positive product contact surfaces contain few Listeria (<10) that can be transferred to product

42. PROJECTFORWARD Corrective Actions In the event of a positive Listeria species environmental sample, Kraft requires follow up/corrective actions. Typical corrective actions include: • Review of cleaning records • Review of environmental data of the area as well as adjacent areas

43. PROJECTFORWARD Corrective Actions (cont’d) • Review of line records, for mechanical downtime • Audit and interview employees concerning practices during sanitation, set-up, and production • Inspections of the area and equipment for potential harborage points • Complete a targeted clean

44. PROJECTFORWARD Results — Reduced Zone 1 +’s 85% since ‘99 Benefits of Aggressive Environmental Monitoring / Corrective Actions Percent Positive Zone 1 Positive Percent Listeriaspp. Positive Annual Year Graph 1 values calculated with the formula (total zone 1 composite + total follow up positive) / (total zone 1 composite samples * 5) + (total follow up samples)

45. PROJECTFORWARD Project Forward Validation Program • To measure monitoring program effectiveness, a validation program is in place to assure that the samples taken represent the actual conditions of the entire environment at a given time. • Includes multiple sampling points during: • Pre-op • Operation • 2nd shift operation • One day for two consecutive weeks • Completed once every six months

46. Regulatory Goal • Protect public health • Success depends upon locating Listeria--finding positive results--and taking proper action • Even with effective control, environment will not be completely Listeria negative • Utilize appropriate interventions to reduce public health risk

47. Summary Public Health is best protected by: • Implementation of a validated Listeria control program • Aggressive environmental monitoring • Effective corrective actions • Incorporation of appropriate intervention technologies • Proper handling practices • No Listeria monocytogenes exceeding regulatory limit in food in commerce

48. Obrigado pela atenção! Perguntas?