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

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

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

Supply chain of food production X

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

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

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

8 But how does Risk Analysis impact on food safety management by food industry in practice? Application of MRA in the industry 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 PLANNING Product & process design IMPLEMENTATION - GMP/GHP - HACCP - Quality systems - TQM Derived from: ILSI-Europe, 1998 Level of consumer protection Food Safety Objectives RISK ANALYSIS Risk Assessment Risk Management Risk Communication POLICY MRA by FAO/WHO etc. & support POLICY Operational issues

10 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 MRA by FAO/WHO etc. & support Presented at: FAO/WHO Expert Consultation, March 2002

11 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 MRA by FAO/WHO etc. & support Presented at: FAO/WHO Expert Consultation, 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, 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, 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, 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, March 2002

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

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

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

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

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 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); MRA & predictive modelling

23 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 MRA & predictive modelling

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

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

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

27 Models are never perfect

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

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

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

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

33 Structured analysis of product safety and stability 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 Sums up, Thumbs up