Risk Assessment Methods for Biological and Chemical Hazards in Food

Section I. General AspectsFood Risk Assessment Framework: Foundations and ConceptINTRODUCTIONHAZARD VERSUS RISKRISK ASSESSMENT AND ITS ROLE IN RISK ANALYSISRISK ASSESSMENT FRAMEWORKMicrobial Risk Assessment ConceptsChemical Risk Assessment ConceptsDETERMINISTIC VERSUS STOCHASTIC RISK ASSESSMENTUNCERTAINTY AND VARIABILITY IN RISK ASSESSMENTSLIMITATIONS AND CHALLENGES OF RISK ASSESSMENT IN FOODSCURRENT DEVELOPMENTS AND FUTURE PERSPECTIVESREFERENCESRisk Ranking Moving towards a Risk-Based Inspection and Surveillance SystemTHE NEED FOR A RISK-BASED FOOD INSPECTION AND SURVEILLANCE SYSTEMIDENTIFYING FOOD SAFETY RISKS: RISK RANKINGRISK RANKING FRAMEWORKDefining the ScopeScreeningApproachRisk Variables and MetricsRisk Ranking ModelData Collection and EvaluationRisk Ranking ResultsRISK RANKING TOOLSDecision TreesDecision/Risk MatricesSpreadsheet CalculatorsScoring Systems and Multicriteria Decision AnalysisWeb-Based ToolsCASE STUDY: DEVELOPMENT OF A RISK-BASED INSPECTION SYSTEMCONCLUSIONSREFERENCESRisk Metrics Quantifying the Impact of Adverse Health EffectsINTRODUCTION: FROM REACTIVE TO RISK-BASED FOOD SAFETY SYSTEMSBURDEN OF ILLNESSBottom-Up versus Top-Down ApproachesOutcome TreesFrom Burden of Illness to Burden of DiseaseHEALTH IMPACT METRICSECONOMIC IMPACT METRICSCosts Associated with Foodborne DiseaseMethods Used to Estimate CostsCost-of-IllnessWillingness to PayRISK RANKINGRISK-BENEFIT ASSESSMENTCONCLUSIONSACRONYMSREFERENCESRisk-Benefit Assessment of FoodsINTRODUCTIONThe Need for Risk-Benefit AssessmentThe Risk-Benefit Assessment Approach and the Role of the Risk-Benefit QuestionRISK-BENEFIT ASSESSMENT IN FOOD SAFETY AND NUTRITIONQUALITATIVE AND QUANTITATIVE RISK-BENEFIT ASSESSMENT APPROACHESIdentification of the Overall Health Impact: The Tiered ApproachQuantification of the Overall Health ImpactRISK-BENEFIT ASSESSMENT AT DIFFERENT LEVELS OF AGGREGATIONRisk-Benefit Assessment for Food Components, Foods and DietsFood Component Risk-Benefit AssessmentFood Risk-Benefit AssessmentDiet Risk-Benefit AssessmentFUTURE PERSPECTIVES AND CHALLENGES OF RISK-BENEFIT ASSESSMENT OF FOODSACKNOWLEDGEMENTREFERENCESApplication of Quantitative Risk Assessment Methods for Food QualityINTRODUCTIONCONCEPTS OF RISK ASSESSMENT FOR MICROBIAL SPOILAGEASSESSMENT OF MICROBIOLOGICAL SPOILAGE OF FOOD AND BEVERAGES: CHEMICAL AND MICROBIOLOGICAL CHANGESSTAGES OF RISK ASSESSMENT FOR MICROBIAL SPOILAGEMODELING APPROACHES FOR SPOILAGE RISK ASSESSMENTQualitative and Quantitative Exposure AssessmentModel DevelopmentModel Types and AvailabilityApplication of Predictive Microbiology within Exposure AssessmentVARIABILITY, UNCERTAINTY, AND SENSITIVITY FOR SPOILAGE RISK ASSESSMENTEXAMPLES OF RISK ASSESSMENT FOR FOOD SPOILAGECONCLUDING REMARKSREFERENCESEstimating Concentration Distributions The Effect of Measurement Limits with Small DataINTRODUCTION: MODELING THE OBSERVATIONPARAMETER ESTIMATION FROM CENSORED DATA OF KNOWN POSITIVE CONCENTRATIONSBayesian ComputationBAYESIAN ESTIMATION FOR TRUE ZEROS WITH REPORTED MICROBIAL COLONY FORMING UNITS PER GRAMBAYESIAN ESTIMATION FOR TRUE ZEROS WITH REPORTED MICROBIAL PLATE COUNTSCONCLUDING REMARKSAPPENDIX 6: VISUAL EXPLORING USING R AND OPENBUGSA.6.1 Censored Data and Likelihood Contour PlotsA.6.2 Bayesian Model with Censored DataA.6.3 Bayesian Model with Censored Data and True ZerosA.6.4 Bayesian Model with Plate Count DataREFERENCESUnderstanding Uncertainty and Variability in Risk AssessmentINTRODUCTIONSOME CLASSICAL DEFINITIONSVariabilityUncertaintyUNDERSTANDING UNCERTAINTY AND VARIABILITYA Proposal to Better Understand and Consider Variability and UncertaintyWhy Is There a Lack of Understanding?Things Get Worse: When Uncertainty and Variability Are ExchangeableVARIABILITY AND UNCERTAINTY IN PRACTICEConduct an Uncertainty AnalysisConsidering Uncertainty and Variability SeparatelyCharacterize the Variability/Uncertainty from the DataUse Monte-Carlo Simulations to Integrate VariabilityCharacterize the UncertaintyPrioritize the Different Sources of UncertaintyCommunicating Uncertainties and Their Impact on the OutcomeDISCUSSIONREFERENCESApplication of Sensitivity Analysis Methods in Quantitative Risk AssessmentINTRODUCTIONDESCRIPTION OF METHODS AND APPROACHES FOR SENSITIVITY ANALYSISMathematical MethodsNominal Range Sensitivity Analysis (NRSA)Break-Even Analysis (BEA)Statistical MethodsModel Independent MethodsModel Dependent MethodsGraphical MethodsREFERENCESSection II. Microbial Risk AssessmentQuantitative Methods for Microbial Risk Assessment in FoodsINTRODUCTIONQUANTITATIVE RESOURCES FOR RISK ASSESSMENTHuman DataData on Human CasesData on Foodborne OutbreaksAnimal/Food DataEFSA Monitoring DataEU-Wide Baseline Survey DataEU Rapid Alert System for Food and Feed DataOther Resources, e.g. Data/Models from Scientific LiteratureConsumption DataEFSA Consumption DataOther Consumption DataConsumer BehaviourDose-Response DataRISK MODELLING PROCESS AND MODEL INTEGRATIONFrom Data to Risk: Data TreatmentDeterministic Models vs. Stochastic ModelsPrevalence and ConcentrationModels and Modelling ApproachesModel Integration: Population Risk versus Individual RiskModelling and Simulation ToolsRISK ASSESSMENT OUTPUT INTERPRETATION: IMPORTANCE OF UNCERTAINTY ANALYSISElements in Uncertainty AnalysisInterpretation of Uncertainty Analysis in MRAKNOWLEDGE EXCHANGE TO IMPROVE MICROBIAL RISK ASSESSMENTCurrent Limitations of Knowledge ExchangeCurrent Status of Knowledge ExchangeNovel Initiatives to Improve Knowledge ExchangeDISCLAIMERNOTESREFERENCESHazard Identification Microbial Risks along the Food ChainOVERVIEW AND APPROACHES TO HAZARD IDENTIFICATIONHazard Identification Incorporating a Quantitative Approach: Listeria monocytogenes in Ready-to-Eat FoodsQualitative Approach to Hazard Identification: Microbial Risks for Primary Producers of Leafy VegetablesMICROORGANISMS IN FOODSGeneral Pathogen CharacteristicsSources of MicroorganismsExposure Routes to MicroorganismsSurvival and Growth of Microorganisms in FoodsFood Production and BeyondHUMAN ADVERSE HEALTH OUTCOMESTHE POPULATION BURDEN OF DISEASEPublic Health SurveillanceEstimating the Burden of Foodborne DiseaseAttributing Illnesses to FoodsCONCLUSIONSREFERENCESPredictive Microbiology Tools for Exposure AssessmentPREDICTIVE MICROBIOLOGY FOR QUANTITATIVE MICROBIOLOGICAL RISK ASSESSMENTPREDICTIVE MICROBIOLOGY MODEL TYPESPRIMARY MODELS: GROWTH, INTERACTION AND INACTIVATION MODELSGrowth ModelsGompertz and Logistic ModelsBaranyi and Roberts ModelBuchanan Three-Phase Linear ModelInteraction ModelsJameson Effect ModelLotka-Volterra ModelPhoenix Phenomenon ModelInactivation ModelsBigelow ModelWeibull ModelShoulder/Tail Model (Geeraerd Model)SECONDARY MODELSRatkowsky or Square Root ModelArrhenius-Type ModelPolynomial or Response Surface ModelsBigelow ModelTRANSFER MODELSMIXING, PARTITIONING AND OTHERSMixingPartitioningRemovalGROWTH PROBABILITY MODELS (GROWTH/NO GROWTH)MODEL GENERATION PROCESSData Generation: Experimental Design, Data Acquisition and Data ProcessExperimental DesignData CollectionData ProcessingModel Fitting and Goodness-of-Fit IndexesModel FittingGoodness-of-Fit IndexesModel ValidationCONCLUSIONSREFERENCESModelling Cross-Contamination in Food ProcessingINTRODUCTION: TRANSFER AND CROSS-CONTAMINATIONCROSS-CONTAMINATION AS A NON-LOG- LINEAR PROCESS: IMPLICATIONS FOR CROSSCONTAMINATION MODELS AND RISK ASSESSMENTTOWARDS A GENERIC MECHANISTIC MODEL FOR CROSS-CONTAMINATION IN FOOD PROCESSINGModels for Cross-Contamination during Industrial Broiler ProcessingModels for Cross-Contamination during Grinding and SlicingOVERVIEW OF MODELS IN LARGE-SCALE FOOD PROCESSINGCAUSE AND IMPLICATIONS OF THE TAILING PHENOMENONEVALUATION OF THE PERFORMANCE OF CROSS-CONTAMINATION MODELSSUMMARY AND OUTLOOKAPPENDIX 12.1 COMPARISON OF THE MODELS USED BY SHEEN AND HWANG (2010), NAUTA ET AL (2005) AND M0LLER ET AL (2012)REFERENCESExpert Systems Applied to Microbial Food SafetyINTRODUCTIONSOFTWARE PRESENTATIONUSER PERSPECTIVECHALLENGES AND OPPORTUNITIESREFERENCESDose-Response Models for Microbial Risk AssessmentINTRODUCTIONEXPONENTIAL MODELBETA-POISSON MODELFITTING CHALLENGE TRIALS DATA TO EXPONENTIAL AND BETA-POISSON MODELSDOSE-RESPONSE MODEL FROM HUMAN OUTBREAK DATADOSE-RESPONSE MODEL COMBINING SURVEILLANCE EPIDEMIOLOGICAL DATA AND EXPOSURE DATACONCLUSIONSREFERENCESSection III. Chemical Risk AssessmentQuantitative Chemical Risk Assessment MethodsINTRODUCTIONCHEMICAL RISK ASSESSMENTHazard IdentificationHazard CharacterizationExposure AssessmentRisk CharacterizationRISK ASSESSMENT METHODSConceptual Model of Risk AssessmentDeterministic ApproachProbabilistic ApproachTiered ApproachUncertainty AnalysisCURRENT AND FUTURE CHALLENGES IN CHEMICAL RISK ASSESSMENTMixture Risk AssessmentHow to Group Substances in a MixtureHow to Assess the Risk of a Chemical MixtureAggregate Exposure and Biomonitoring DataIntegrating Toxicokinetic Models in Chemical Risk AssessmentEPIDEMIOLOGY AND CHEMICAL RISK ASSESSMENTCONCLUSIONACRONYMSREFERENCESUncertainty Analysis in Chemical Risk AssessmentINTRODUCTIONDEFINITION OF UNCERTAINTYCLASSIFICATION OF UNCERTAINTY SOURCESUNCERTAINTY ANALYSIS APPROACHPreliminary Step: Planning the Uncertainty AnalysisStep 1: Identification and Description of Uncertainty SourcesStep 2: Individual Assessment of UncertaintiesStep 3: Assessing the Impact of the Combined UncertaintiesStep 4: Prioritization of Sources of UncertaintyStep 5: Communication of the Results of the Uncertainty AnalysisCONCLUSIONREFERENCESExamples of Quantitative Mycotoxin Risk Assessments Use and Application in Risk ManagementINTRODUCTIONMYCOTOXINSRISK ASSESSMENTDietary Exposure Assessment of MycotoxinsQUANTITATIVE EXPOSURE ASSESSMENT OF MYCOTOXINS THROUGH DIETARY EXPOSURE MODELLINGAcute vs. Chronic Dietary Exposure AssessmentsChronic Exposure Assessment ModelsAcute Exposure Assessment ModelsCase StudiesQuantitative Assessment of Risk Derived from Dietary Intake of OTAQuantitative Assessment of Risk Derived from Dietary Exposure to DeoxynivalenolQuantitative Assessment of Risk Derived from Dietary Intake of T2-HT2(Integrative) Quantitative Assessment of Carcinogenic Risk Derived from Dietary Intake of Aflatoxin B1QUANTITATIVE EXPOSURE ASSESSMENT OF MYCOTOXINS BASED ON FOOD CHAIN DATACase Study 1: Simulation of Consumer Exposure to Deoxynivalenol According to Wheat Crop Management and Grain Segregation (Le Bail et al. 2005)PreharvestPostharvestProcessingCase Study 2: Evaluation of Strategies for Reducing Patulin Contamination of Apple Juice Using a Farm- to-Fork Risk Assessment Model (Baert et al., 2012)PreharvestPostharvestProcessingCase Study 3: A Stochastic Simulation Model for the Quantitative Assessment of the Concentration of Mycotoxins in Milk and the Related Human Exposure (Signorini et al. 2012)CONCLUDING REMARKSREFERENCES
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