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Participatory RiskAssessmentDelia Grace1

Risk analysisa tool for decision-makingunder uncertainty2

Risk Analysis‣OIE framework‣HACCP‣Codex alimentarius3

OIEImport riskassessmentReleaseassessmentExposureassessmentHazardidentificationConsequenceassessmentRiskassessmentRiskmanagementRisk communication4

IRA roadmap0. Scope the risk question by defining the issue tobe covered and the boundaries of theinvestigation1. Hazard Identification to determine thepathogens of concern to importing countries2. Risk assessment2a. Release Assessment to qualitatively evaluate the risk of pathogens beingpresent in export of carcases, meat, or meat products or live animals2b. Exposure Assessment of the steps needed for pathogens of concern to becomeintroduced and established in importing countries, (pathways to a susceptiblehost).2c. Consequence Assessment of the potential biological, environmental and socioeconomicimpacts of introduction and establishment.Risk estimate integrating the previous steps to arrive at a qualitativeestimate of the probability and impact of introduction andestablishment.5

Could diseases be present in the animal of origin?NoHazard identificationIs the disease/agent exotic?Or strain?YesYesNationalNotablyNocontrolNo lower Noprogram?prevalence?YesCan the agent/disease persist in the import?YesYesNoAre there ways the agent could come in contact withsusceptible animals or people?YesNo6

Hazard identification‣ 175 diseases of potential concern– 85 occur in cattle or shoat– 33 Not transmitted by ingestion– 53 Not present in meat e.g. LSD– 47 Susceptible will not eat meat or meatscraps e.g. CBPP‣ 24 diseases for which carcases a concern– 0 exotic, 6 with different strains– 7 for which control programmes exist or arefeasible– 1 for which importation likely to lead to higherexposure7

Release Assessmentharbours POC in meat atslaughtershoat meatchilled or frozenand importedPOC survives storage & transportPOC does NOT survives storage &transportChilled or frozen meatharbours POC whenimportedshoatsent toslaughterinfected prior toslaughterNOT infected prior toslaughterShoatslaughtereddoes NOT harbour POC inmeat at slaughterChilled or frozen meatdoes NOT harbour POCwhen importedChilled or frozen meatdoes NOT harbour POCwhen importedChilled or frozen meatdoes NOT harbour 8POCwhen imported

Exposure Assessmentmeat harbourspathogen whenimportedmeat sold forhumanconsumptionscraps generated priorto preparing foodscraps NOT generatedprior to preparing foodRaw scrapsdiscardedscraps NOT fed to asusceptible animalmeat cookedprior toconsumptionscraps fedhazard inactivatedat least one animalbecomes infectedSusceptible eatscrapshazard NOT inactivatedscraps generatedmeatconsumedNO animal becomeinfectedCookedscrapsdiscardedscraps NOT generatedscraps fedat least 1 animal infectedSusceptibleeat scrapsscraps NOT fed to asusceptible animalDiseaseoutbreakNo diseaseoutbreakNo diseaseoutbreakNo diseaseoutbreakDiseaseoutbreakNO animal infectedNo diseaseoutbreakNo diseaseoutbreak9No diseaseoutbreak

Consequenceassessment‣ Potential biological, environmental and socioeconomicimpacts of introduction andestablishment. These many include effects on:– Animal health– Human health– Social (e.g. traditional community structure)– Psycho-social (e.g. distress,– Economy (e.g., loss of jobs, loss of exports, COI )– Food security and nutritional quality– Animal genetic resources– Environment (through effects on domestic or wildanimals)10

Risk EstimationRisk Estimate MatrixProbabilityHigh Negligible Very low Low Moderate High ExtremeModerate Negligible Very low Low Moderate High ExtremeSlight Negligible Very low Low Moderate High ExtremeLow Negligible Negligible Very low Low Moderate HighVery low Negligible Negligible Negligible Very low Low ModerateExtremely low Negligible Negligible Negligible Negligible Very low LowNegligible Negligible Negligible Negligible Negligible Negligible Very lowNegligible Very low Low Moderate High ExtremeConsequences11

Risk management‣ Break transmission: Treat farm workers; ensure adequatesanitary facilities; education. Maintenance of animalsource records.‣ Diagnostics: Inspection about 10%. Ag-ELISA sensitivity(92.3%) in cattle > 50 cysts, but low (12.8%) if < 50 .‣ Vaccination: An effective recombinant vaccine has beendeveloped but is not yet available commercially.‣ Detect cysts in meat: experimental ultrasound or x-ray todetect cysts in meat, but commercial systems are notavailable. Detect non-viable cysts which would not bedetected by Ag-ELISA.12

Participatory Import RiskAnalysis?‣Gathering data– Disease presence– Disease prevalence– Consequence‣For qualitative IRA13

HACCP FrameworkHACCP-readiness check list Are the buildings and equipment of acceptable standard? Are suppliers reputable and hygienic? Is staff personal hygiene and hand-washing codeadequate? Is a cleaning plan of the buildings and equipment applied? Is there control of food processing conditions (e.g. time,temperature)? Does a sampling and analysis plan of the finish productsexist? Are staff trained in food safety? Are staff literate and able to spend 5 to 10% time indocumentation14

HACCP 12 step roadmap‣ Assemble HACCP team and engage stakeholders‣ Determine scope of HACCP study‣ Describe product‣ Describe intended use‣ Flow diagram and verification‣ Identify hazards‣ Establish CCP‣ Determine critical limits‣ Establish procedures to monitor CCPs‣ Establish corrective actions‣ Establish verification procedures‣ Establish documentation and record keeping18

Hints: Scope‣System of concern‣Hazards considered‣Level of detail19

Hints: Intended Use andUsers‣ Cultural practices, as in Ethiopia where raw meatis commonly eaten.‣ Urban/rural differences, as in East Africa whereurban populations typically consume milk boiled intea while rural communities are likely to consumeraw milk.‣ Health beliefs, as in Kampala, where raw eggsare given to sick people as a nutraceutical.‣ Sub-populations varying in susceptibility: YOPIare more vulnerable to many diseases‣ Sub-populations varying in dietary exposure:children may be given more raw milk20

Hints: Hazard identification‣ The level of detail depends on the situation. If a streetvendor is preparing hot beef stew, all pathogens in raw meatcan be considered together as the cooking process willeliminate all alike. However, if stew is going to re-heated,spore-forming bacteria should be considered separately, asonly these may cause harmful effects.‣ Do not include agents that are unwanted in food but nothazardous to health (e.g. insect wings)‣ Include hazards which are reasonably likely to occur, andnot those which could conceivably occur. It is useful todocument why a particular hazard is included in theanalysis.‣ Using the term ‘problem’ rather than ‘hazard’ may make theconcept more easily understood.21

Hints: CCP identification‣Generally there are only a few CCPfor any process‣Examples of process steps that maybe critical control points include:– cooking, cooling, re-heating, holding‣Make CCP visible with a sign orspecial colour22

Hints: CCP identification‣ To determine CCPs ask the following questions:– At this step can food become contaminated and/or cancontamination increase?– Can this hazard be prevented through correctiveaction(s)?– Is there no subsequent step where the hazard can beprevented, eliminated or reduced?– Can you monitor the CCP?– Can you measure the CCP?– Can you document the CCP‣ If the answer to any of these questions is “No”,then this is not a CCP23

HazardBacterialpathogens(non-spore)CCPPasteurizationCritical limit72°C for at least 15 secondsMetal fragmentsMetal detectorMetal fragments larger than 0.5 mmBacterialpathogensDrying ovenA w

Hints: monitoring CL at CCP‣Real time to allow correction‣Physical and chemical often preferredto microbiological‣Operating limits may be used insteadof CL25

Hints: corrective actionExampleDeviation Procedure for milk reception‣ All milk brought to the co-operative is tested witha lactometer. If the detected level exceeds theestablished critical limit (5%) the deviationprocedure is applied.‣ The deviation procedure states that the milk is tonot to be accepted by the co-operative. Theprocedure also describes the follow-up action. Inthis case: The processor will follow up with themilk supplier involved.26

Hints: verification‣Not to be confused with routinemonitoring activities for critical limits.‣The major role of regulatory agenciesin a HACCP system is to verify thatHACCP plans are effective and arebeing followed.– Is it working? CCP calibration, records– Does it deliver safety? Review, tests27

Hints: documentation andrecord keeping‣Documentation and record keepingshould be appropriate to the natureand size of the operation.– Level of records– Storage of records– Review of records28

7 principles of HACCP‣ 1 –Hazard Analysis;‣ 2 –Critical Control Points;‣ 3 –Critical Limits;‣ 4 –System to Monitor CCPs;‣ 5 –Corrective Actions for when CCPs are Not Under Control;‣ 6 –Verification Procedures to Confirm HACCP is Working;‣ 7 –Record-keeping and Documentation Procedures29

Salford Model1. Safety message2. Safety point3. Checking point4. What to do when things go wrong?5. Prove it works!30

Salford Model‣ Safety message – e.g. cooking kills bad bugs(HA)‣ Safety point – e.g. don’t pack birds tightly(CCP)‣ Checking point – e.g. check a hands widthbetween birds in oven (CCP monitoring)‣ What to do when things go wrong – e.g.remove some birds to give more space (CA)‣ Prove it e.g. maintain records (VD)31

Codex Alimentarius riskassessment frameworkHazard HazardidentificationHazardHazardExposurecharacterizationassessmentRisk RiskcharacterizationRiskAssessmentRiskCommunicationRiskManagement34

CA Roadmap‣Develop a risk profile‣Scope the risk assessment– Hazard identification (presence)– Hazard characterisation (harm & DR)– Exposure assessment (path & intake)– Risk characterisation‣Identify management options‣Decide ALOP35

Risk Management‣K2U: Develop a risk profile‣K2U: Use the risk profile to decide ifa risk assessment is warranted36

‣ A risk assessment may not be needed if: an issue requires immediate action the risk is well described by definitive data a management decision can be made without one the problem is relatively simple the issue is not of regulatory concern a response based on common sense is sufficientA risk assessment will most likely be needed if: there is little data and much uncertainty multiple values are in potential conflict the issue is of great concern to regulators or stakeholders continuous decision-making is required managers need information to guide research managers want to establish a baseline estimate of the risk the hazard is an emerging pathogen or agent, serious public health and/ortrade concern a national standard is more demanding than an international one a country wants to export or import a new commodity there are several possible ways of addressing the risk in question37

Setting and scoping the riskquestion‣What is the risk question?‣Who are the stakeholders?‣What are the boundaries?38

HazardHazardidentificationidentificationHazardExposureHazardExposurecharacterization assessmentcharacterization assessmentRiskRiskcharacterizationcharacterizationHazard identification‣ Hazard Identification - The identificationof biological, chemical, and physicalagents capable of causing adverse healtheffects and which may be present in aparticular food or group of foods.‣ Can something cause harm to health?‣ Could it be present?39

ExampleHazard identification for toxigenic E. coli (TEC)Describe the hazard.Is it harmful?Known health effectsTEC comprises strains of Escherichia coli, an obligateparasite of the mammalian intestine.The minimum temperature for growth is 7C and the highestis 44C, with an optimum of 37C; it is eliminated bypasteurization and cooking (70C).Cattle appear to be the main reservoir and transmission isfecal-oral via food, drinking water or recreational watercontaminated with human or animal faeces containing thebacterium.Foods commonly associated with infection includeundercooked beef burgers, unpasteurized milk and cheese,and raw vegetablesThe most common symptom of infection is bloody diarrhoea,but some people show no symptoms or have abdominalcramps and watery diarrhoea without blood. Up to 10% ofpatients may develop haemolytic uraemic syndrome, whichcan result in renal failure and up to 10% case fatality; it isincreasingly common and in some countries the mostimportant cause of kidney failure in children..40

HazardHazardidentificationidentificationHazardExposureHazardExposurecharacterization assessmentcharacterization assessmentRiskRiskcharacterizationcharacterizationHazard identification1. Is it a hazard?‣ Conventional– Epidemiology– Experiments‣ Participatory– Ethno-botany– Traditional practices41

Hazard identification2. Is it there?‣ Conventional– Presence surveys– Prevalence surveys– AnalysisHazardHazardidentificationidentificationHazardExposureHazardExposurecharacterization assessmentcharacterization assessmentRiskRiskcharacterizationcharacterization‣ Participatory– Ranking– Matrices– Calendars– Time lines– Transects– Syndromic surveillance42

HazardHazardharacterizationcharacterizationHazardHazardidentificationidentificationExposureExposureassessmentassessmentRiskRiskcharacterizationcharacterizationHazard characterisation‣ The evaluation of the nature of the adverse healtheffects associated with biological, chemical andphysical agents which may be present in food. Forchemical agents, a dose-response assessment shouldbe performed. For biological or physical agents, adose-response assessment should be performed if thedata are obtainable‣ Where is it found?‣ What harm does it do?‣ How does it respond to differentprocessing/environment conditions?‣ What is the relation between dose and response?43

‣ • Virulence and pathogenicity‣ • Survival and growth‣ • Surrogates or indicators‣ • Clinical characteristics of disease‣ • Severity and duration of disease‣ • Routes of transmission‣ • Potential for secondary spread– Dose Response44

‣ Dose response– Experiments– Analogies– Models‣ Campylobacter jejuni low numbers ~ 500‣ ETEC low numbers 10-100‣ Salmonella species needs to multiply >100 000‣ Salmonella Typhi low numbers

‣K2U: Develop a hazard characterisation‣Where is it found?‣What harm does it do?‣How does it respond to differentprocessing/environment conditions?‣What is the relation between dose andresponse?46

ExampleHazard characterisation for toxigenic E. coli (TEC)What harm does itcause?Characteristics ofthe host-agentfoodmatrixHow does harmdepend on doseThe adverse effects from TEC depend on thevirulence of the pathogen, the susceptibilityof the host and the dose ingested. We didnot investigate virulence of TEC buthousehold questionnaires showed thatpopulations comprised a high proportion ofchildren aged less than 15 who are mostvulnerable to the disease (40% in the greaterNairobi milkshed (n=1390 households);comparable data were not available forKampala). HIV infection may increasesusceptibility to TEC (10) and secondarydata indicates 7% of the adult population inKenya and Uganda are infected.the infectious dose of TEC is less than 100organisms and possibly as low as ten47

Hazard characterisation1.What harm does it cause?‣ Conventional– Experiments– Longitudinalstudies– Clinical studies‣ Participatory– Vulnerabilitymapping– Livelihood impactsHazardHazardidentificationidentificationHazardHazardcharacterizationcharacterizationExposureExposureassessmentassessmentRiskRiskcharacterizationcharacterization48

HazardHazardidentificationidentificationHazardHazardcharacterizationcharacterizationExposureExposureassessmentassessmentExposure assessmentRiskRiskcharacterizationcharacterization‣ The qualitative and/or quantitativeevaluation of the likely intake of biological,chemical, and physical agents via food aswell as exposures from other sources ifrelevant.‣ What is the path from source to victim?‣ What happens along the way?49

‣ Information is needed on:– Presence and level in food– Control or treatment– Consumption‣ Modelling techniques used in exposureassessment include– Event tree:– Fault tree:– Modular Process Risk ModelHazardHazardcharacterizationcharacterizationHazardHazardidentificationidentificationExposureExposureassessmentassessmentRiskRiskcharacterizationcharacterization50

Fault treeIngestion Milk of Crypto oocystsIngestfood/waterTouch mouthSwallowwaterMilk contam. Water contam. VegetablescontamHandsunwashedPlaying inwaterMilk notboiledWater nottreatedVeg. eaten rawContactstacked faecesContact freshfaecesFaeces in waterFaeces inmilkFaeces inwaterSoil onvegetablesCow sheddingcryptoCow sheddingcryptoCrypto infaecesCrypto infaecesCrypto in soilAND GateOR GateCow sheddingcryptoCow sheddingcryptoCow sheddingcryptoTop EventInitiating Event51

What is the implications of acow harbouring EC O157:H7on safety of informallymarketed milk?Event tree52

HazardHazardidentificationidentificationHazardHazardaracterizationharacterizationExposureExposureassessmentassessmentModular Process Risk ModelRiskRiskcharacterizationcharacterizationPROCESSMicrobial processes•growth•inactivationFood handling processes•mixing•partitioning•cutting•cross-contamination53

StepProductionProductionTransportDistributionProcessingConsumptionDescriptionCows are milked by hand into openbucketMilk is transferred from bucket intolarger containerMilk is transferred from farmerscontainers to transporterscontainersMilk is sold to hawkersMilk is boiled with tea and sugarTea is drunkBasic processContaminationMixing; somepartitioningMixingPartitioningRemovalPartitioningRemovalInactivationCross contaminationExposureConsumptionContaminated objects transferinfectionExposure54

Exposure assessmentpathways through which a pathogen is introduced, distributedand removed.‣ ConventionalHazardHazardidentificationidentification–Surveys– Pathway studies– Models‣ Participatory– Focus Groups– Role play– Activity calendars– Venn diagrams– Event countersHazardHazardcharacterizationcharacterizationExposureExposureassessmentassessmentRiskRiskcharacterizationcharacterization55

K2U: Develop a exposure assessment‣ Which foods, how often and what levelof contamination?‣ What qualities of the food or microbewill affect growth/inactivation?‣ How will the pathogen behave duringstorage, processing, preparation?‣ How is the pathogen distributed infood?‣ How good are the control measures?‣ Who eats the food, how often and howdo they cook it?56

Risk characterisation‣Integrating the steps of hazardidentification, hazard characterizationand exposure assessment allows usto answer the risk questionHazardHazardidentificationidentificationHazardHazardcharacterizationcharacterizationExposureExposureassessmentassessmentRiskRiskcharacterizationcharacterization57

QualitativeTypes of risk characterisationSemiquantitativeRanksscoresQuantitativeDeterministicStochasticPointRangeMCS58

StepMovement of milkalong pathwayBasic processLevel ofconcernReason for assigning effectConsumptionMilk consumedEnd-pointModerateHigh proportion of young (40%) and immunesuppressed(7%)ProcessingMilk boiled with teabefore 7 a.m.InactivationVery lowShort time between purchase and processing(

Best guessBest caseWorst caseLower CIUpper CIProportion cows with contaminated milk0.0050.0000.0100.0010.028Volume of milk contaminated by one cow (litres)15.00210.00024.9930.00031.566Proportion who drink unpasteurised milk0.0330.0000.0730.0010.017Proportion exposed STEC becoming infected (attack rate)0.3390.1010.6690.00016.519Proportion infected who are symptomatic0.5200.4500.5800.2400.240Proportion of households with contaminated milk0.0090.0000.0200.0170.040Number of household members5.2605.0005.5000.5300.530Number of cows in smallholder dairy sectorConstant taken from official figuresTotal volume of milk from smallholders consumed daily (litres)Constant taken from official figuresSTEC infections per 10,000 milk meals (method 1)2.4020.00120.2870.0009.105STEC infections per 10,000 milk meals (method 2)2.8350.00322.7480.00015.99660

FAO/WHO Risk assessment ofSalmonella in (1) eggs and (2)poultry =(1) 2-45 illnesses probable per10,000,000 servings(2) ~30 illnesses/100,000 populationif contamination of carcasses is20% and consumption per annum is26 servings61

Cow infected withSTEC andcontaminates milkMilk drunkrawMilk mealscontaminated perinfectedcow00.005 0.01 0.015 0.02 0.025Infections with STEC62

Conclusion‣Risk assessment is a tool forbetter focusing food safety efforts‣Requires a commitment within apolicy and management context‣Needs not be overly complex andresource intensive‣To do effectively, requires trainingand experience and collaboration64

HAZARD IDENTIFCIATIONEntry assessmentLikelihood of entering importerNegligibleNon NegligibleNon NegligibleExposure assessmentLikelihood of exposure (andestablishment)Consequence assessmentImpact on economy, naturalresources, societyNegligibleNegligibleRisk Estimation: thepathogen is not a hazardNon NegligibleRisk Estimation: the pathogenis a hazardWhat are the options for RiskManagement?OIE import riskassessment frameworkWhat is the effect of eachmeasure on the level of risk?65

ExposureAssessmentRISK ASSESSMENTRiskCharacterisationHazardCharacterisationHazardIdentificationRisk AssessmentPolicyOptionAssessmentImplementationMonitoring &reviewRISK MANAGEMENTRISK COMMUNICATION66

(Quantitative)risk analysisAppropriate levelof protectionFood safetyobjectivesIncorporation inHACCPHACCP1. Assemble team2. Scope study3. Describe product4. Describe use5. Flow diagram6. Identify hazards7. Establish CCPs8. Set critical limits9. Monitor CCPs10. Corrective actions11. Verification procedures12. Documentation67

Acknowledgements68