MRA in practice Application of MRA in the industry

1. MRA in practice Application of MRA in the industry Suzanne van Gerwen Leon Gorris UNILEVER Unilever R&D Vlaardingen Olivier van Noortlaan 120 Vlaardingen, The Netherlands SUZANNE-VAN.GERWEN@UNILEVER.COM UNILEVER SEAC - Risk Analysis Group Colworth House, Sharnbrook, UK, MK44 1LQ LEON.GORRIS@UNILEVER.COM

2. People in food safety management & control Government Industry Research institutes/universities

3. Food Industry: • Producers, manufacturers, processors, handlers, vendors etc. of all sizes and in all phases of the supply chain

4. Supply chain of food production X

5. Where to control a Hazard? At different levels : farm production preparation consumption Control is the responsibility of the different stakeholders

6. Risk assessment - government level Risk Assessment concerns a specific product or group of related products, manufactured by different companies on a multitude of locations and production-lines

7. HACCP - industry level HACCP concerns a specific product, manufactured on a specific location/production-line

8. Application of MRA in the industry But how does Risk Analysis impact on food safety management by food industry in practice? • How can MRA studies by FAO/WHO, FDA, etc. support food safety control in the industry? • How can the tool MRA be applied by the industry?

9. MRA by FAO/WHO etc. & support Operational issues Product & process design Risk Management Risk Assessment Risk Communication Level of consumer protection Food Safety Objectives - GMP/GHP - HACCP - Quality systems - TQM POLICY POLICY PLANNING RISK ANALYSIS IMPLEMENTATION Derived from: ILSI-Europe, 1998

10. MRA by FAO/WHO etc. & support • Language and terminology • Understanding governmental risk management interventions • Transparency, auditability • Recording knowledge/data and rationale for use/disregard • Analysis of risk management options • Analysing equivalence between food products/categories Presented at: FAO/WHO Expert Consultation,18 -22 March 2002

11. MRA by FAO/WHO etc. & support • Sharing of risk assessment tools and data • Tools: predictive modelling included in MRA • Tools: deterministic/probabilistic modelling techniques • Use of MRA elements/tools may help industry to become increasingly more pro-active • Depending on an industry’s or producer’s capabilities and capacities Presented at: FAO/WHO Expert Consultation,18 -22 March 2002

12. Differences in PURPOSE between Governmental MRA and use of MRA tools in industry • Governmental MRA • Consumer health and safety protection & common concept for world trade issues • Basis for Risk Management decision on ALOP/TL and FSO • Means to re-evaluate current food safety practices on the market • MRA tools in Industry • Aid to built in safety and to engineer out hazards in new food products before marketing by using similar tools as used in MRA • Transparency and auditability of the assessment study and the resulting HACCP plan • Basis to re-evaluate food safety status of a product in future when necessary and for changing the HACCP plan accordingly Presented at: FAO/WHO Expert Consultation,18 -22 March 2002

13. Differences in SCOPE between Governmental MRA and use of MRA tools in industry • Governmental MRA • Consumer population nationally, regionally or globally • Pathogen-pathway for a range of similar food products on a market made by different producers • Risk Ranking, comparison risk of potential hazards in a foods/category or of a specific hazard in different foods/categories on the market • Often a complete food chain (primary production to consumption) is covered • MRA tools in Industry • Consumer population in the intended market for a new product • Pathogen-pathway for a specific product produced by or for a specific company • Mostly covering hazard levels from raw material up to consumption Presented at: FAO/WHO Expert Consultation,18 -22 March 2002

14. Differences in INPUT between Governmental MRA and use of MRA tools in industry • Governmental MRA • Detailed data/knowledge on hazard dose-response effect in consumers, epidemiology and pathogenicity of hazard • Typical or simulated data/knowledge on effect of producing, processing/product formulation/handling during and after manufacture • MRA tools in Industry • No detailed data/knowledge on hazard dose-response effect in consumers, but generic epidemiology and pathogenicity of hazard, when available for the specific product - pathogen combination • Typical/specific operational or simulated data/knowledge on raw material, effect of processing/product formulation and handling during and after manufacture, recontamination etc. Presented at: FAO/WHO Expert Consultation,18 -22 March 2002

15. Differences in OUTPUT between Governmental MRA and use of MRA tools in industry • Governmental MRA • A risk estimate in absolute or relative term • e.g. an estimation of the number of people in a population that may get a certain illness as the consequence of consuming a certain food containing a (certain level of a) certain pathogen • e.g. a categorisation of different foods in order of increasing or decreasing relative risk • MRA tools in Industry • The endpoint in general is the exposure assessment • Food safety benchmarking is used to compare an estimated level of a certain pathogen in the food to be marketed with a similar food already on the market with a good safety record. Presented at: FAO/WHO Expert Consultation,18 -22 March 2002

16. Industry • Safe and stable product and process design • HACCP plan • Implementation • Monitoring, verification

17. Outbreak due to unsafe design 1998: 27 cases of botulism in Preston and Blackpool Reformulated canned hazelnut conserve used to manufacture diet yoghurt

18. Outbreak due to unsafe design Cause: reformulated conserve received the same pasteurization treatment ....but..... spores were now able to germinate and grow in final product

19. Basic principle Identification & Control of microbial hazards at Product & Process design is first step to Ensure quality and realise consumer safety From QC to QA

20. Risk Characterisation - how to interpret outcome? Hypothetical production process

21. MRA & predictive modelling • Rapid new product development • Product diversification • Prevent long shelf life testing • Efficient product innovation & process optimisation • Pro-active prediction of microbial behaviour • Less experiments • Risk assessment: exposure assessment

22. MRA & predictive modelling In a product development expert system: Consider..... - experimental set up often inadequate; - media; - type of microorganisms used; - little information on food composition; - little information on specific preservation parameters; - no confidence intervals; - spoilage often not observed/recorded; - interaction of parameters (e.g. spoilage/pathogens);

23. MRA & predictive modelling Does it matter which type of model is chosen? Yes: what do we want to know? 1. growth/no growth boundaries 2. inactivation in formulation 3. Lag time, growth rate 4. Inactivation by heat

24. MRA & predictive modelling • Infectious pathogens: • Inactivation • e.g. Listeria, Salmonella, E.coli • Toxigenic pathogens: • Prevent growth, inactivation • e.g. Staphylococcus, C. botulinum • Spoilage: • Delay & prevent growth, inactivatione.g. Yeast, lactobacilli

25. MRA & predictive modelling temperature Growth.xls,Ecoli garlic,pH7,aw0.99

26. MRA & predictive modelling Growth.xls,Lmono garlic,pH7,aw0.99

27. Models are never perfect

28. Overcome the problems: • careful choice in experimental set up • validate the model predictions in real products!! • ask expert opinion and apply additional rules

29. Example of application Unilever expert system, systematic approach • Identification of microbial hazards • Procedure to design out the identified hazards • 5 design stages identified: formulation, pack, process, storage/distrib. consumer use • Display of results in hazard matrix

30. Specific and generic knowledge Product type 3 Product type 1 Product type 2 Product type 1 Product type 2 Expert system Expert system Generic rules Ingredient rules

31. E.g. specific knowledge water droplets in oil: physical barrier micro. growth

32. Objective expert system Help the operating companies design microbiological safety and stability into their products and processes Thus: Consumer safety re microbiology Increase speed to market

33. Sums up, Thumbs up • MRA currently not a tool for most players in food supply chain • Useful as a basis for advice for improvement and optimisation • Comparison of risks of various products and product categories • Relevance of various phases of supply chain for risk • Biggest uncertainties in supply chain wrt risks Structured analysis of product safety and stability