环境风险评估的原则56181.pptx

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1、Principles of Environmental Risk Assessment 环境风险评估的原则Jeff Wolt 杰夫.沃而特Biosafety Institute for Genetically Modified Agricultural Products(BIGMAP)基因改良农作物安全研究所Iowa State University 美国衣阿华州立大学Sep 2006 2006年九月nTerminology 术语nERA Framework 环境风险评估框架nApplication of ERA to GE Crops 环境风险评估在转基因农作物中的应用Plan of pre

2、sentation报告计划Risk风险nThe joint consideration of exposure and the consequence of exposure 同时考虑暴露和暴露的后果nRisk=f(hazard,exposure)风险=函数(危险,暴露)nThe likelihood of harm to be manifested under realistic conditions of exposure危害的可能性在暴露的实际条件下得以清楚地展现Risk Assessment风险评估 nThe use of factual information to define t

3、he effects of exposure of individuals or populations to stressors or actions 利用事实信息定义个人或群体暴露于刺激或者行为的结果 after,Risk Assessment in the Federal Government:Managing the Process,NRC,1983联邦政府的风险评估:管理程序,NRC,1983nThe process used to systematically evaluate and organize data,information,assumptions,and uncert

4、ainties in order to help understand and predict the relationships between stressors or actions and ecological effects in a way that is useful for environmental decision making 步骤用来系统评估和组织数据,信息,假设和不确定因子,利于帮助理解和预测刺激或行为和生态结果之间的关系,这些对于环境决策是有用的.Guidelines for Ecological Risk Assessment Risk Assessment Fo

5、rum,USEPA(1998)EPA/630/R-95/002F生态风险评估指导,风险评估论坛 美国环保局(1998)环保局部/630/R-95/002FERA is a part of Risk Analysis环境风险评估是风险分析的一部分vlinks to the risk management process 和风险决策步骤联系vfollows well established frameworks 在建立好的框架之后vsets overall assessment goals 建立总体评估目标vrecursive 递归性的vproceeds in tiers 阶梯性前进vquanti

6、tative to the fullest extent possible 定量地达到全面可能性The risk assessment process风险评估步骤 Risk assessment links research to risk management风险评估是研究和风险决策的桥梁ProblemFormulation问题定义问题定义Exposure&effectsCharacterization暴露和结果描述暴露和结果描述RiskCharacterization风险描述风险描述Risk Management 风险控制风险控制Risk Assessment 风险评估风险评估Data A

7、cquisition,Verification,&Monitoring数据的获得数据的获得,证明证明,和监控和监控ERA 环境风险评估nEcological or Environmental?生态还是环境?nThe term Environmental Risk Assessment is common for GE crops 环境风险评估是转基因农作物的常用词汇nAn outgrowth of the widely recognized process of Ecological Risk Assessment 被广泛认同的生态风险评估所带来的结果ERA 环境风险评估“the proces

8、s that evaluates the likelihood that adverse ecological effects may occur or are occurring as a result of exposure to one or more stressors or actions”“这是评价暴露于一个或多个刺激或者行为后,负面的生态后果的可能性的过程”nFramework for Ecological Risk AssessmentRisk Assessment Forum,USEPA(1992)EPA/630/R-92/001 生态风险评估框架 风险评估论坛,美国环保局部

9、(1992)环保局/630/R-92/00nGuidelines for Ecological Risk AssessmentRisk Assessment Forum,USEPA(1998)EPA/630/R-95/002F 环保风险评估纲要风险评估论坛,美国环保局部(1992)环保局/630/R-92/00 Keys to Regulatory Success管理成功的关键nUse an ERA framework 利用环境风险评估的框架nFlexibility the case-by-case paradigm 灵活性-个案不同原则nFocus use of problem formul

10、ation to prioritize concerns 焦点-利用问题组建有限考虑焦点nEmphasis consequential concerns 重点-对结果的关注Principles of ERA have been developed and in use for about 25 years环境风险评估的原则已经在美国发展和应用了二十五年Framework approach框架的形成na hypothetical description of a complex process 一个复杂过程的假设性描述na logical process for organizing compl

11、ex information 一个组织复杂信息的逻辑过程na road map 一个总体的计划Goals of ERA Framework环境风险评估结构的目标(Bartenhouse,2006)ndevelop a unified conceptual approach to environmental assessment 发展一个统一概念性方法来评估环境nfacilitate cooperation/collaboration between assessment-related disciplines 在评估相关的原则方面帮助建立合作nincrease transparency of

12、risk assessments to users(risk managers)对风险管理者增加风险评估的透明度nprovide standardized tools&techniques 提供统一标准的工具和技术ndispel perception that ecological risk assessment is impossible 推翻认为环境风险评估不可能的错误观点The risk assessment process风险评估步骤HazardIdentification危害的辨别Measures of Effects测量结果RiskCharacterization 风险描述Expo

13、sureAssessment暴露的评估Problem Formulation 问题建立Risk Conclusion 风险结论Exposure Characterization暴露描述Effects Characterization 结果描述ERA for GE crops 对转基因农作物的环境风险评估nis consistent with the framework for RA 和危险评估的框架是一致的nhowever,complexities exist due to 但是,还存在着复杂性,因为nrelatively recent technology 比较前沿的技术nbiologica

14、l information is not fully quantifiable 生物信息没有完全的得到认证ntwo perspectives as to concerns 还要需要考虑的两方面neffect of stressor on individuals and populations 刺激对个人和群体的影响neffect of deployment on populations and communities 对群体和社区发展的影响General philosophy toward ERA for GE crops对转基因农作物进行环境风险评估的一般性原理nweight of evid

15、ence based on comprehensive evaluation of data 证据的权重建立在对数据的综合评价上nproceed from general understanding to specific entities of concern 从总体理解到具体事例的前进nsupport findings with quantitative data and analyses to the fullest extent possible 利用量化的数据分析全面各种可能性,从而支持新的发现nrisk based findings focus on harm that may b

16、e manifested at environmentally relevant exposures 风险侧重于在环境相关的暴露后引起的危害性nseek a determination of reasonable certainty of no harm to the environment 寻找合理对环境无害的方法ERA for GE Crops对转基因农作物的环境风险评估nweight-of-evidence 事实的分量nholistic 整体的nstrong emphasis on exposure 强调暴露Identificationofpotentialadverseeffect潜在

17、危害的认识EstimationoflikelihoodOFEXPOSURE暴露可能性的预测暴露可能性的预测Termsused:术语的应用Highly likely高度可能性Likely可能性Unlikely不可能性Highly unlikely高度不可能性Evaluationofconsequence暴露结果的评价暴露结果的评价OFEXPOSURETermsused:术语应用Major主要Intermediate中等Minor次要Marginal边缘Estimationoftherisk风险的预测Termsused:术语应用High高度Moderate中度Low低度Negligible可忽略的

18、HazardIdentification风险的辨识风险的辨识ExposureCharacterization暴露描述暴露描述Effects(Hazard)Characterization结果结果(危害危害)描述描述RiskCharacterization风险描述风险描述GE ERA follows a tiered scheme转基因农作物环境风险评估遵照台阶式的程序Toxicological risk(毒理方面的风险)Ecological harm生态方面的害处stressor-mediated effects刺激影响的结果action-mediated effects行为调节的结果“dir

19、ect”“直接”“indirect”“间接”Lab(实验)extended lab (延长实验)semi field(半田地)field(田地)landscape(地区)protein toxin effect on a putative sensitive NTO蛋白毒性对公认敏感的NTO影响crop deployment effect on ecological services within a landscape or region农作物发展对生态业务在田野或地区中的影响Extremely conservative assumptionsto screen out negligible

20、 risksdeterministicsingle scenario(generalized)data poorhigh uncertainty第一级Tier I第二级Tier II第三级Tier III第四级Tier IVMost refined assessmentstochastic(probabilistic)multiple scenario(regional)data richuncertainty and variability definedhighly refined exposureassumptions verified by monitoringRisk assessm

21、ent is recursive and proceeds in tiers风险评估是递归的，并且呈阶梯状发展非常保守的假设用来剔除可以非常保守的假设用来剔除可以忽略的风险忽略的风险确定的单一现场（一般化的）数据缺乏高度的不确定性最高精度的评估最高精度的评估随机的（概率的）多处现场（区域的）丰富的数据明确定义的不确定性和变化度非常纯净的暴露被监控验证的假设Tiers of assessment&Tiers of testing 评估和测试的阶梯状发展vlevel of concern vdegree of uncertainty arising from a lower tier of ass

22、essment drives the need to move toward a higher tier of data generation and assessmentTier ITier IITier IIITier IVLabMicrobial proteinHigh doseLabPIP dietExpected doseLong-term Lab Semi-fieldFieldAssessmentTestingv 重要度v 不确定度.出现在低级别的评估中,促使人们使用更高级的数据生成和评估手段评估测试长期实验局部农田试验农田试验第一级第二级第三级第四级实验食物期望的剂量实验微生物蛋

23、白高剂量for GE crops evaluated to date 被持续评估至今的转基因农作物Laboratory studies Have been adequate to determine that there is reasonable certainty of no harm associated with environmental releaseConfirmed by case-by-case instances offield surveys and censusfield surveillance monitoringexperience with large scal

24、e deployment实验室的研究.足以确认环境性释放不存在危害,这一点具备相当的确定性同时也被一个又一个的案例证实例如 田间调查和普查 田间监控和监测 大面积种植所积累的经验Problem formulation问题的定义和对转基因农作物作环境风险评估涉及的常用数据元素&Common data elements of the GE crop ERAProblem formulation问题的定义nSets the stage for the ERAnIdentifies and interprets existing information to focus on consequentia

25、l concernsnOutlines the analysis plan for the RAnWhat studies are needed to address issues of consequence&ecological entities of concernnIdentifies the relevant starting point(tier)and the appropriate endpoints of concern 设定环境风险评估的步骤 辨别和解释现有的信息从而集中精力在重要的方面 列出风险评估的分析计划 需要开展什么研究来解决针对因果性和所关心的生态实体的问题 对关

26、注的事,确认相关的起点（级别）和适当的终点Ecological Risk Considerations对生态风险的考虑nProduct characterization 产品描述nHost&donor familiarity 宿主和供给方的熟悉性nActivity&specificity 活性和特异性nProtein equivalency 蛋白等价nCompositional equivalency 成份等价nExpression 表达式nRisk characterization 风险描述nProduct characterization plus 产品描述加上nHazard 危害nExp

27、osure 暴露nRisk 风险nRisk conclusion 风险结论nAdequacy of the risk characterization 风险描述的充分性nConservatism in balance with uncertainties 保守和不确定性的平衡Host&donor familiarity宿主和供给者的熟悉性nHistory of safe use and environmental exposure安全使用和环境暴露的历史nRegulatory experience制定规章的经验nBroad-based scientific understanding广博的科学

28、理解力Activity&specificity活性和特异性nConfirm or establish nature of activity 证实活性的特征nSpectrum of activity against targets 针对不同目标的活性范围ninsecticidal activity spectrum study 杀虫剂活性范围的研究Protein equivalency蛋白等价nBacterially-produced protein are commonly used in toxicity testing细菌生成的蛋白质在毒性测试中被广泛地使用nProduct charact

29、erization needs to show that the plant-produced and bacterially-produced proteins are biologically,biochemically,and immunologically equivalent产品描述需要表明植物生成的蛋白质和细菌生成的蛋白质在生物性,生化性和免疫性方面是等价的Compositional equivalency成份等价nEstablish that for other than the intended effect of the trait,the GE crop is substa

30、ntially equivalent to the comparable non GE crop证实除了与植物的遗传性相关的预期效果,转基因的农作物和可比的非转基因农作物大体上等价nConsiderations of agronomic performance,phenotype,nutrients,antinutrients,toxicants考虑农艺表现,遗传或环境决定的特征,营养物,抗营养物,毒物Expression表达式nKey to prediction of exposure concentrations是预测暴露浓度的关键nShould describe distribution

31、应该描述概率分布nover time 时间上的namong plant parts 农作物的不同部分nSupplemented with data describing variance across generations and environments补充描述不同时期差异和环境差异的数据Hazard危害nMulti species laboratory ecotoxicity testing is used to confirm the anticipated spectrum of activity and hazard to non-target organisms多品种实验室生态毒

32、性测试被用来确认对非目标生物体活性和危害性的预测范围nSelection of appropriate surrogate species for testing should consider activity profile,host crop,and environment where deployed为测试选择合适的替代品种需要考虑活性描述,宿主农作物和种植的环境examples of ecotoxicity tests and supporting ecological data生态毒性测试的例子和支持的生态数据ncore 核心的nacute avian 鸟类nacute fish

33、鱼类nacute invertebrate 无脊椎动物nhoney bee larvae 蜜蜂的幼虫nparasitic hymenoptera寄生的膜翅目昆虫nlady beetle 甲虫ncollembola 跳虫nsoil degradation 土壤变质nsupplemental 补充的nactivity spectrum 活性范围nacute mammalian哺乳动物nchronic avian 鸟类nearthworm 蚯蚓nbutterfly 蝴蝶nfield census 田地普查nfield fate 田地灾祸nothers 其他.Exposure暴露nOn the bas

34、is of expression data determine 在表达式数据的基础上决定nHigh End Exposure Estimates(HEEE)in plant tissues,and农作物组织的高端暴露估计(HEEE)nEstimated Environmental Concentrations(EEC)in soil and water 土壤和水的预测的环境浓度(EEC)nUse for comparison against hazard testing results(multi species ecotoxicity tests)被用来和危害测试结果作比较(多品种生态毒性测

35、试)nExposure estimates are meant to represent the upper bound(90th percentile)of reasonably anticipated environmental concentrations暴露预测是用来代表对环境浓度合理期望的上限(90%)Risk=f(hazard,exposure)风险=函数(危害,暴露)nQuantitatively describe risk as a function of exposure and hazard定量地把风险定义为暴露和危害的函数nFor GE crops this is typ

36、ically done by considering the relationship of the limit dose used in ecotoxicity studies to the appropriate HEEE or EEC对于转基因农作物,函数可通过分析生态毒性测试使用的限制剂量和适当的高端暴露估计或者预测的环境浓度之间的关系来确定confirmation of the adequacy of risk characterization确认风险描述的充分性ncorrespondence of product specific results产品特定结果的一致性nwith ge

37、neral understanding for the donor,host,and product class being considered 对供给者,宿主和所考虑的产品类型的一般理解ninternal consistency/directional correctness 内部的一致性/定向的正确性nof overall product and risk characterization总体的产品和风险描述nability to characterize hazard at or above environmentally relevant exposure concentration

38、s描述不低于和环境相关的暴露浓度的危害特征的能力nconfirmatory data(if available)from field studies田间研究所获得的确认数据(如果有的话)nconservatism of the risk conclusion is in keeping with the degree of uncertainty风险结论的保守性与不确定度保持一致nThe ERA framework 环境风险评估的框架nenables a focused,objective science-based process建立一个有针对性的,客观的,科学的过程nERA framewo

39、rk as applied to GEOs环境风险评估的框架被应用于转基因农作物中nhas been sufficiently flexible to deal with concerns surrounding biotechnology非常灵活可以用来解决很多和生物技术有关的事物nProblem formulation&common data elements for the ERA问题的定义和环境风险评估涉及的常用数据元素nConstrain and focus the risk assessment to consequential concerns(real risks)把风险评估限制和集中在重要的方面(真正的风险)Conclusions结论