CACGL 30 1999 Principles and Guidelines for the Co

CAC/GL30Page1of6PRINCIPLESANDGUIDELINESFORTHECONDUCTOFMICROBIOLOGICALRISKASSESSMENTCAC/GL-30(1999)TableofContentsINTRODUCTION...................................................................................................................................................11.SCOPE.............................................................................................................................................................12.DEFINITIONS................................................................................................................................................13.GENERALPRINCIPLESOFMICROBIOLOGICALRISKASSESSMENT.............................................34.GUIDELINESFORAPPLICATION.............................................................................................................34.1GENERALCONSIDERATIONS............................................................................................................................34.2STATEMENTOFPURPOSEOFRISKASSESSMENT...............................................................................................44.3HAZARDIDENTIFICATION...............................................................................................................................44.4EXPOSUREASSESSMENT.................................................................................................................................44.5HAZARDCHARACTERIZATION.........................................................................................................................54.6RISKCHARACTERIZATION...............................................................................................................................54.7DOCUMENTATION..........................................................................................................................................64.8REASSESSMENT..............................................................................................................................................6INTRODUCTIONRisksfrommicrobiologicalhazardsareofimmediateandseriousconcerntohumanhealth.MicrobiologicalRiskAnalysisisaprocessconsistingofthreecomponents:RiskAssessment,RiskManagement,andRiskCommunication,whichhastheoverallobjectivetoensurepublichealthprotection.ThisdocumentdealswithRiskAssessmentwhichisakeyelementinassuringthatsoundscienceisusedtoestablishstandards,guidelinesandotherrecommendationsforfoodsafetytoenhanceconsumerprotectionandfacilitateinternationaltrade.TheMicrobiologicalRiskAssessmentprocessshouldincludequantitativeinformationtothegreatestextentpossibleintheestimationofrisk.AMicrobiologicalRiskAssessmentshouldbeconductedusingastructuredapproachsuchasthatdescribedinthisdocument.Thisdocumentwillbeofprimaryinteresttogovernmentsalthoughotherorganizations,companies,andotherinterestedpartieswhoneedtoprepareaMicrobiologicalRiskAssessmentwillfinditvaluable.SinceMicrobiologicalRiskAssessmentisadevelopingscience,implementationoftheseguidelinesmayrequireaperiodoftimeandmayalsorequirespecializedtraininginthecountriesthatconsideritnecessary.Thismaybeparticularlythecasefordevelopingcountries.AlthoughMicrobiologicalRiskAssessmentistheprimaryfocusofthisdocument,themethodcanalsobeappliedtocertainotherclassesofbiologicalhazards.1.SCOPEThescopeofthisdocumentappliestoRiskAssessmentofmicrobiologicalhazardsinfood.2.DEFINITIONSThedefinitionscitedherearetofacilitatetheunderstandingofcertainwordsorphrasesusedinthisdocument.Whereavailablethedefinitionsarethoseadoptedformicrobiological,chemical,orphysicalagentsandRiskManagementandRiskCommunicationonaninterimbasisatthe22ndSessionoftheCodexAlimentariusCAC/GL30Page2of6Commission.TheCACadoptedthesedefinitionsonaninterimbasisbecausetheyaresubjecttomodificationinthelightofdevelopmentsinthescienceofriskanalysisandasaresultofeffortstoharmonizesimilardefinitionsacrossvariousdisciplines.Dose-ResponseAssessment-Thedeterminationoftherelationshipbetweenthemagnitudeofexposure(dose)toachemical,biologicalorphysicalagentandtheseverityand/orfrequencyofassociatedadversehealtheffects(response).ExposureAssessment-Thequalitativeand/orquantitativeevaluationofthelikelyintakeofbiological,chemical,andphysicalagentsviafoodaswellasexposuresfromothersourcesifrelevant.Hazard-Abiological,chemicalorphysicalagentin,orconditionof,foodwiththepotentialtocauseanadversehealtheffect.HazardCharacterization-Thequalitativeand/orquantitativeevaluationofthenatureoftheadversehealtheffectsassociatedwiththehazard.ForthepurposeofMicrobiologicalRiskAssessmenttheconcernsrelatetomicroorganismsand/ortheirtoxins.HazardIdentification-Theidentificationofbiological,chemical,andphysicalagentscapableofcausingadversehealtheffectsandwhichmaybepresentinaparticularfoodorgroupoffoods.QuantitativeRiskAssessment-ARiskAssessmentthatprovidesnumericalexpressionsofriskandindicationoftheattendantuncertainties(statedinthe1995ExpertConsultationdefinitiononRiskAnalysis).QualitativeRiskAssessment-ARiskAssessmentbasedondatawhich,whileforminganinadequatebasis