Safety & Environmental Assurance Centre

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1 International Commission on Microbioloical Specifications for Foods (ICMSF) Outline Workin with Risk-based Metrics in the Food Industry LEON GORRIS Risk-based food safety manaement Risk Analysis & Microbioloical Risk Assessment Examples of usin risk-based metrics in food industry Unilever, UK Punta del Este, Uruuay Monday 5 October 2009 Operation level Food Safety Control & Foods Safety Manaement Policy Standards Specific Hazard Manaement Food Safety Control (Risk Manaement): hih level, eneric policy bases uidance specific standards, criteria Food Safety Manaement: Local, specific manaement at supply chain level INCLUDES ALL HAZARDS Codex Alimentarius Commission Basic facts Interovernmental body Established in 1962 by FAO and WHO 180 Member countries and One Member Oranization (EC) Coverin 99% of the worlds population 157 International NGO observers from science, industry, consumers Generic Hazard Manaement Risk Analysis = the common framework Codex Alimentarius RA Framework Risk Analysis: Risk Manaement Risk Assessment Risk Communication Triered by World Trade Oranisation (WTO) Advocated by many overnments and interovernmental oranisations (FAO, WHO) RA Codex FSO/PO GHPs/GMPs/GAPs Risk Assessment Hazard Identification Hazard Characterisation Exposure Assessment Risk Characterisation Risk Manaement Risk Communication Interactive exchane of information and opinions concernin risks Risk Evaluation Option Assessment Option Implementation Monitorin & Review 1

2 Microbioloical hazards: process steps Types of Risk Assessment Hazard identification Identify food-borne pathoen of interest Hazard Characterization Determine the dose-response relationship (volunteers, animals) when possible, or investiate outbreaks Exposure Assessment Calculate the exposure to the hazard at consumption from hazard level and consumption volume/frequency Risk Assessment Combine exposure and dose-response to obtain an estimation of the prevailin risk level or rate of illness Product/Pathoen Pathway - absolute risk estimate - One pathoen / one food Risk Rankin - relative risk estimate - One pathoen / multiple foods - One food / multiple pathoens Georaphical risk estimate - Risk of introduction into a reion (e.. BSE/TSE) Risk/Risk Trade-off Microbioloical Risk Assessment estimates Population level: - Estimated number of cases of illness per year per population (e persons) caused by a micro-oranism in a food or food roup Consumer level - Chance of illness due to consumption of a specific food-product to which a hazard can be associated (risk per servin / event) Relevance of Risk Analysis for Industry? A harmonised approach for overnments around the world to evaluate risk and prioritise issues / solutions Links food safety control to public health protection Supports the overnmental / societal move away from hazard-based to risk-based decision-makin Enabler to provide quantitative benchmarks for hazard control: FSO, PO, which can relate to microbioloical criteria, performance standards Risk Manaement decision-makin Risk Level (RL) Explicit, risk-based uidance of levels of a hazard not to be surpassed Exposure RISK ANALYSIS Risk Risk Assessment Manaement Risk Communication Decisions? RL < PL: e.. no action needed RL = PL: e.. no action needed RL > PL: e.. risk reduction action needed primary production manufacturin transport retail Preparation / cookin for consumption Food Safety Policy Level of risk (PL): ALOP 1 or public health oal FSO Micro standard 1 : ALOP, Appropriate Level Of Protection Leon Gorris (2008) Operational food chain level Operational actions, buildin onto and Good practices 2

3 ICMSF s conceptual equation 1 Interatin steps alon the food supply chain H 0 - Σ R + Σ I PO or FSO Startin hazard level at step Level at moment of consumption H 0 -ΣR + ΣI PO Reduction Level at step in the food chain Increase (Growth, Recontamination) Σ = sum of events PO: FSO: Food Safety Farm H 0 -ΣR +ΣI PO Production & distribution H 0 -ΣR +ΣI FSO Kitchen 1 Microbioloical testin in Food Safety Manaement, ICMSF (2002); Book 7 How to work with the risk-based metrics? Makin the connection Incomin Hazard level (H 0 ) Primary production (step 1) Process 1 Criterion () objective (PO) Process 2 Packain Transport (step 3) Manufacturin (step 2) Retail (step 4) Process criteria: e.. pasteurisation or sterilisation time/temp Product criteria: ph, aw, salt, acid, etc Control measures: e.. refrieration, control of cross-contamination, education Operation level Policy Standards ALOP - FSO - PO - Food Safety Control/Risk Manaement hih level, eneric policy bases uidance specific standards, criteria Hazard Control/Food Chain Manaement: Local and specific manaement at supply chain level GHPs/GMPs/GAPs Role of FSO-PO- hierarchy in desinin safe foods Desinin safe foods : examples Allows for a quantitative benchmark that interates the performance of the whole food supply chain, disreardin its make-up.. The FSO ives the hazard level that should not be surpassed in the food at consumption.. The various players in the food chain can then establish what the maximum hazard level can be at the output of the step that they control (H 0 ; PO). (H 0 - ΣR + ΣI PO or FSO) Identify most heat-resistant realistic hazard Determine worst-case initial levels of hazard (H 0 ), based on literature/internal studies/expert opinion Determine Criterion () based upon reulation/standard or risk based metric benchmark (FSO or PO) Consider implementation aspects 3

4 Example: Cooked chicken & L. monocytoenes Example: Cooked chicken & Salmonella <0C = no rowth <7C = no rowth Chicken intake Frozen storae Final product Acceptable level Chicken intake After storae frozen or chill Final product Acceptable level 1x cfu/ 1x cfu/ 2.2 lo reduction 100cfu/ 1500cfu/ 1500cfu/ 4.6 lo reduction 0.04cfu/ Hypothetical PO/FSO Absent in 25 Desinin safe foods - > desin plan (H 0 - ΣR + ΣI PO or FSO) Identify most heat-resistant realistic hazard Determine worst-case initial levels of hazard (H 0 ), based on literature/internal studies/expert opinion Determine Criterion () based upon reulation/standard or risk based metric benchmark (FSO or PO) Consider implementation aspects Manain L. monocytoenes on Fresh-cut Lettuce From Farm to Fork Minimize initial numbers: Water manaement Choice of fertilizer Sanitation of equipment Rapid coolin Hyiene of personnel Antimicrobial washin aents Physical & chemical washin steps GHP and systems Environmental surveillance H 0 -ΣR + ΣI FSO Temperature manaement Choice of storae atmosphere Shelf-life Settin and Process Criteria (Deterministic) H 0 - R + I FSO Settin and Process Criteria (Stochastic) Production & Primary Handlin Processin & Packain Distribution & Shelf-life R R 0.8 lo CFU/ Criterion Minimizin initial levels Reducin levels Minimizin an increase in levels Food Safety Example: 120 ppm sodium hypochlorite for 2 minutes provides 0.8 lo reduction Process Criterion H 0 - ΣR + ΣI FSO 4

5 Industry s Safe Food Desin Toolbox Usin Risk-based Metrics in Food Industry Expertise, scientific and technical knowlede Historical evidence (products with history of safe performance) Product desin performance simulation n Predictive mathematical modellin n MRA approaches & techniques for exposure assessment Validation of desin n Modellin approaches n Challene and shelf-life tests Benchmarks n reulatory requirements (Microbioloical criteria, performance standards) n Industry standards (microbioloical uidelines; process uidelines) n FSO/PO/ as product safety tarets for desin. Requires industry to understand risk-based food safety manaement better. Acquire skills to use it in the desin of (new) food products. No need to chane operational manaement systems! GHP/GMP and will still be the systems to run. Fosterin innovation, utility of new technoloies. 5