风险评估技术讲稿

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第一期污染场地调查与风险评估培训班风险评估的基本理论RiskAssessmentFundamentals毒理参数的概念与搜集ConceptandCollationofToxicityData制定污染场地环境基准的常用模型CommonlyUsedModelsintheDerivationofSoilGenericAssessmentCriteria1.风险评估的基本理论RISKASSESSMENTFUNDAMENTALS第一期污染场地调查与风险评估培训班风险评估的基本理论(RiskAssessmentFundamentals)主要内容(KEYTOPICS)风险评估概述(OverviewofRiskEvaluation)毒性评估(ToxicityAssessment)暴露评估(ExposureAssessment)风险表征(RiskCharacterization)风险评估(RiskAssessment)风险评估概述(OverviewofRiskEvaluation)风险量化(Quantifyingrisks)...风险(RISK)=危害(Hazard)x暴露(Exposure).危害(Hazard)暴露(Exposure)极端风险(Extremerisk)非常高(Veryhigh)高(High)中(Moderate)低(Low)非常低风险(Verylowrisk)极微的(Minimal)严重的(Severe)极端的(Extreme)可忽略的(Negligible)风险评估概述(OverviewofRiskEvaluation)风险的认知(RiskPerception)什么是“可接受的风险”?(Whatis„acceptable‟?)可控制的vs.不可控制的(Controllablevs.Uncontrollable)自发的vs.非自发的(Voluntaryvs.Involuntary)可见的vs.不可见的(Seenvs.Unseen)灾难性的vs.长期的(Catastrophicvs.Chronic)认知到的风险≠计算得到的风险:(PerceivedRisk)(CalculatedRisk)风险评估的主要步骤(PrincipalStepsinRiskAssessment)2暴露评估(ExposureAssessment)3风险表征(RiskCharacterization)1毒性评估(ToxicityAssessment)风险评估概述(OverviewofRiskEvaluation)毒性评估(ToxicityAssessment)风险评估概述(OverviewofRiskEvaluation)这种物质的危害性到底有多大?(Howbadisthisstuff?)表征(Characterization):i)化学品暴露产生的危害或疾病的类型。(typeofinjuryordiseaseproducedbychemicalexposureand)ii)相关的剂量效应关系。(associateddose-responserelation.)确定暴露人群的性质和规模和潜在化学品摄入。(Definenatureandsizeofexposedpopulationandthepotentialchemicalintake.)暴露评估(ExposureAssessment)风险评估概述(OverviewofRiskEvaluation)污染物能否发生迁移?谁住在那里?他们如何处置污染物?(Canitgettherefromhere?Wholivesthere?Andwhatdotheydowithit?)风险表征(RiskCharacterization)风险评估概述(OverviewofRiskEvaluation)量化暴露人群受关注化学物质毒性影响的可能性。(Quantifylikelihoodthatexposedpopulationwillexperiencetoxiceffectsassociatedwithchemicalofconcern.)负面影响的风险如何?(What‟stheriskofnegativeimpact?)风险评估概述(OverviewofRiskEvaluation)达标点vs.暴露点(PointofCompliancevs.PointofExposure)达标点(POC)PointofCompliance暴露点(POE)PointofExposure位置(LOCATION)受体Receptor清理标准CleanupStandard目标风险或暴露限值Targetriskorexposurelimit污染源区SourceZone应用限值(APPLICATIONLIMIT)POEPOC主要内容(KEYTOPICS)风险评估概述(OverviewofRiskEvaluation)毒性评估(ToxicityAssessment)暴露评估(ExposureAssessment)风险表征(RiskCharacterization)风险评估的基本理论(RiskAssessmentFundamentals)毒性评估(ToxicityAssessment)n危害特性鉴定(HazardCharacterization)n剂量-效应参数(Dose-ResponseParameters)流行病研究(Epidemiologicalstudies)动物毒理学研究(Animaltoxicologicalstudies)生化结构/活性关系(Biochemicalstructure/activitycorrelations)毒性评估(ToxicityAssessment)危害特性鉴定(HazardCharacterization)目标(Goal):判定与化合物暴露相关的健康影响。(Identifyanyhealtheffect(s)associatedwithexposuretochemical)方法(Methodologies):毒性评估(ToxicityAssessment)危害类型(TypesofHazards)致癌:Cancer恶性肿瘤细胞的增殖(Malignantcelldevelopment)非致癌:Non-Cancer影响生长发育、体型大小、整个身体或特殊器官的功能(Impactongrowth,size,functioningofwholebodyorspecificorgans)毒性评估(ToxicityAssessment)剂量-效应参数(Dose-ResponseParameters)危害(Effect)n致癌(Cancer)n非致癌(Non-Cancer)剂量-效应参数(Dose-ResponseParameter)斜率因子(SF):单位剂量的风险SlopeFactor:Riskperunitdose最大容许日吸入量(TDI):剂量阈值[美国:参考剂量(RfD)]TolerableDailyIntake(TDI):Thresholddose[inUS:ReferenceDose(RfD)]毒性评估(ToxicityAssessment)斜率因子vs.参考剂量(Slope-Factorvs.ReferenceDose)斜率因子(SlopeFactor)每日容许摄入量(TolerableDailyIntake)CancerriskperbiteThresholdnumberofbitesresultingintoxiceffect致癌风险CancerRisk剂量Dose可能存在影响毒性影响ToxicEffect剂量Dose无影响TDI123SF毒性评估(ToxicityAssessment)剂量-效应评估(Dose-ResponseAssessment)确定剂量多少与负面健康影响之间的定量关系(Definequantitativerelationshipbetweenmagnitudeofdoseandadversehealtheffect.)影响Effect剂量Dose风险限值RISKLIMIT安全剂量是多少?Whatisasafedose?毒性评估(ToxicityAssessment)LOAEL-可观察到负面影响的最低水平(LowestObservedAdverseEffectLevel)LOEL-可观察到影响的最低水平(LowestObservedEffectLevel)NOAEL–无可见负面影响的水平(NoObservableAdverseEffectLevel)NOEL–无可见影响的水平(NoObservedEffectLevel)NEL-无影响的水平(NoEffectLevel)非致癌物的剂量效应曲线(Non-CarcinogenDoseResponseCurve)RfDNELNOAELLOELLOAEL剂量Dose(mg/kg/day)%效应ResponseXX肾功能衰竭KidneyFailure头发减少/体重减轻Hair/WeightLoss睡眠减少SleepLoss毒性评估(ToxicityAssessment)TDI的发展(参考剂量)DevelopmentofTDI(ReferenceDose)TDI=非致癌影响的日容许摄入量(TolerableDailyIntakefornon-cancereffects)NOAEL=无可见负面影响的水平(NoObservedAdverseEffectLevel)UF=不确定因子(UncertaintyFactor)MF=修正因子(ModifyingFactor)TDI=NOAEL(UF1×UF2×...×MF)毒性评估(ToxicityAssessment)应用于TDI值的安全因子(SafetyFactorsAppliedtoTDIValue)非确定性因子种群变异(10×)动物到人类的外推法(10×)基于亚慢性数据的慢性的NOAEL(10×)从LOAEL估算得到的NOAEL(10×)修正因子一般数据库的不确定性(10×)RfD=NOAEL(10-10,000)毒性评估(ToxicityAssessment)非致癌物的剂量效应曲线(CarcinogenicDose-ResponseCurve)斜率因子SlopeFactor斜率因子:推导时假设任意剂量化合物都会产生风险;没有安全剂量。SLOPEFACTOR:Derivationisbasedontheassumptionthateverydoseposesarisk;thereisnosafedose.剂量Dose(mg/kg/day)癌症发生的可能(OccurrenceofCancer)斜率因子(SlopeFactor)=风险/剂量Risk/Dose=05001000|人类暴露范围||动物实验的范围|HumanExposurerangeAnimalexperimentsrange毒性评估(ToxicityAssessment)假设的斜率因子曲线(HypotheticalSlopeFactorCurve)剂量Dose(mg/kg/day)癌症发生的可能OccurrenceofCancer00.050.1******95%UCL斜率因子=低剂量效应外推曲线95%置信上限值的斜率.SlopeFactor=Slopeof95%UCLonextrapolatedlow-doseresponsecurve.毒性评估(ToxicityAssessment)斜率因子的应用(ApplicationofSlopeFactors)低剂量部分的剂量-效应曲线的95%置信上限值Upper95%confidencelimitonlow-doseportionofdose-responsecurve.癌症的发病率上限与给定的终身摄入率有关Estimatesupperboundprobabilityofcancerincidenceassociatedwithagivenlifetimeintakerate.主要内容(KE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