環(huán)境風(fēng)險(xiǎn)評(píng)估的原則ppt課件

1、Principles of Environmental Risk Assessment 環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)的原那么Jeff Wolt 杰夫.沃而特Biosafety Institute for Genetically Modified Agricultural Products (BIGMAP)基因改良農(nóng)作物平安研討所Iowa State University 美國衣阿華州立大學(xué)Sep 2006 2006年九月.Terminology 術(shù)語ERA Framework 環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)框架Application of ERA to GE Crops 環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)在轉(zhuǎn)基因農(nóng)作物中的運(yùn)用Plan of pre

2、sentation報(bào)告方案.Risk風(fēng)險(xiǎn)The joint consideration of exposure and the consequence of exposure 同時(shí)思索暴露和暴露的后果Risk = f (hazard, exposure) 風(fēng)險(xiǎn)= 函數(shù) (危險(xiǎn), 暴露)The likelihood of harm to be manifested under realistic conditions of exposure危害的能夠性在暴露的實(shí)踐條件下得以清楚地展現(xiàn).Risk Assessment風(fēng)險(xiǎn)評(píng)價(jià) The use of factual information to de

3、fine the effects of exposure of individuals or populations to stressors or actions 利用現(xiàn)實(shí)信息定義個(gè)人或群體暴露于刺激或者行為的結(jié)果 after, Risk Assessment in the Federal Government: Managing the Process, NRC, 1983聯(lián)邦政府的風(fēng)險(xiǎn)評(píng)價(jià): 管理程序, NRC, 1983The process used to systematically evaluate and organize data, information, assumpti

4、ons, and uncertainties 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 步驟用來系統(tǒng)評(píng)價(jià)和組織數(shù)據(jù), 信息, 假設(shè)和不確定因子,利于協(xié)助了解和預(yù)測(cè)刺激或行為和生態(tài)結(jié)果之間的關(guān)系, 這些對(duì)于環(huán)境決策是有用的. Guidelines for Ecological Risk Assessment

5、 Risk Assessment Forum, USEPA (1998) EPA/630/R-95/002F生態(tài)風(fēng)險(xiǎn)評(píng)價(jià)指點(diǎn), 風(fēng)險(xiǎn)評(píng)價(jià)論壇 美國環(huán)保局(1998) 環(huán)保部分/630/R-95/002F.ERA is a part of Risk Analysis環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)是風(fēng)險(xiǎn)分析的一部分.links to the risk management process 和風(fēng)險(xiǎn)決策步驟聯(lián)絡(luò)follows well established frameworks 在建立好的框架之后sets overall assessment goals 建立總體評(píng)價(jià)目的recursive 遞歸性的proceeds

6、in tiers 階梯性前進(jìn)quantitative to the fullest extent possible 定量地到達(dá)全面能夠性The risk assessment process風(fēng)險(xiǎn)評(píng)價(jià)步驟 .Risk assessment links research to risk management風(fēng)險(xiǎn)評(píng)價(jià)是研討和風(fēng)險(xiǎn)決策的橋梁ProblemFormulation問題定義Exposure & effectsCharacterization暴露和結(jié)果描畫RiskCharacterization風(fēng)險(xiǎn)描畫Risk Management 風(fēng)險(xiǎn)控制Risk Assessment 風(fēng)險(xiǎn)評(píng)價(jià)Data A

7、cquisition, Verification, & Monitoring數(shù)據(jù)的獲得, 證明, 和監(jiān)控.ERA 環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)Ecological or Environmental ? 生態(tài)還是環(huán)境?The term Environmental Risk Assessment is common for GE crops 環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)是轉(zhuǎn)基因農(nóng)作物的常用詞匯An outgrowth of the widely recognized process of Ecological Risk Assessment 被廣泛認(rèn)同的生態(tài)風(fēng)險(xiǎn)評(píng)價(jià)所帶來的結(jié)果.ERA 環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)“the process th

8、at evaluates the likelihood that adverse ecological effects may occur or are occurring as a result of exposure to one or more stressors or actions “這是評(píng)價(jià)暴露于一個(gè)或多個(gè)刺激或者行為后, 負(fù)面的生態(tài)后果的能夠性的過程Framework for Ecological Risk AssessmentRisk Assessment Forum, USEPA (1992) EPA/630/R-92/001 生態(tài)風(fēng)險(xiǎn)評(píng)價(jià)框架 風(fēng)險(xiǎn)評(píng)價(jià)論壇, 美國環(huán)保部分(

9、1992) 環(huán)保局/630/R-92/00Guidelines for Ecological Risk AssessmentRisk Assessment Forum, USEPA (1998) EPA/630/R-95/002F 環(huán)保風(fēng)險(xiǎn)評(píng)價(jià)綱要風(fēng)險(xiǎn)評(píng)價(jià)論壇, 美國環(huán)保部分(1992) 環(huán)保局/630/R-92/00 .Keys to Regulatory Success管理勝利的關(guān)鍵Use an ERA framework 利用環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)的框架Flexibility the case-by-case paradigm 靈敏性- 個(gè)案不同原那么Focus use of problem fo

10、rmulation to prioritize concerns 焦點(diǎn)- 利用問題組建有限思索焦點(diǎn)Emphasis consequential concerns 重點(diǎn)-對(duì)結(jié)果的關(guān)注.Principles of ERA have been developed and in use for about 25 years環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)的原那么曾經(jīng)在美國開展和運(yùn)用了二十五年.Framework approach框架的構(gòu)成a hypothetical description of a complex process 一個(gè)復(fù)雜過程的假設(shè)性描畫a logical process for organizing

11、complex information 一個(gè)組織復(fù)雜信息的邏輯過程a road map 一個(gè)總體的方案.Goals of ERA Framework環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)構(gòu)造的目的(Bartenhouse, 2006)develop a unified conceptual approach to environmental assessment 開展一個(gè)一致概念性方法來評(píng)價(jià)環(huán)境facilitate cooperation/collaboration between assessment-related disciplines 在評(píng)價(jià)相關(guān)的原那么方面協(xié)助建立協(xié)作increase transparency

12、 of risk assessments to users (risk managers) 對(duì)風(fēng)險(xiǎn)管理者添加風(fēng)險(xiǎn)評(píng)價(jià)的透明度provide standardized tools & techniques 提供一致規(guī)范的工具和技術(shù)dispel perception that ecological risk assessment is impossible 推翻以為環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)不能夠的錯(cuò)誤觀念.The risk assessment process風(fēng)險(xiǎn)評(píng)價(jià)步驟HazardIdentification危害的區(qū)分Measures of Effects丈量結(jié)果RiskCharacterization 風(fēng)

13、險(xiǎn)描畫ExposureAssessment暴露的評(píng)價(jià)Problem Formulation 問題建立Risk Conclusion 風(fēng)險(xiǎn)結(jié)論Exposure Characterization暴露描畫Effects Characterization 結(jié)果描畫.ERA for GE crops 對(duì)轉(zhuǎn)基因農(nóng)作物的環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)is consistent with the framework for RA 和危險(xiǎn)評(píng)價(jià)的框架是一致的however, complexities exist due to 但是, 還存在著復(fù)雜性, 由于relatively recent technology 比較前沿的技術(shù)bi

14、ological information is not fully quantifiable 生物信息沒有完全的得到認(rèn)證two perspectives as to concerns 還要需求思索的兩方面effect of stressor on individuals and populations 刺激對(duì)個(gè)人和群體的影響effect of deployment on populations and communities 對(duì)群體和社區(qū)開展的影響.General philosophy toward ERA for GE crops對(duì)轉(zhuǎn)基因農(nóng)作物進(jìn)展環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)的普通性原理weight of

15、evidence based on comprehensive evaluation of data 證據(jù)的權(quán)重建立在對(duì)數(shù)據(jù)的綜合評(píng)價(jià)上proceed from general understanding to specific entities of concern 從總體了解到詳細(xì)事例的前進(jìn)support findings with quantitative data and analyses to the fullest extent possible 利用量化的數(shù)據(jù)分析全面各種能夠性,從而支持新的發(fā)現(xiàn)risk based findings focus on harm that may

16、be manifested at environmentally relevant exposures 風(fēng)險(xiǎn)偏重于在環(huán)境相關(guān)的暴露后引起的危害性seek a determination of reasonable certainty of no harm to the environment 尋覓合理對(duì)環(huán)境無害的方法.ERA for GE Crops對(duì)轉(zhuǎn)基因農(nóng)作物的環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)weight-of-evidence 現(xiàn)實(shí)的分量holistic 整體的strong emphasis on exposure 強(qiáng)調(diào)暴露Identification of potential adverse effect

17、潛在危害的認(rèn)識(shí)Estimation of likelihood OF EXPOSURE暴露可能性的預(yù)測(cè)Terms used:術(shù)語的應(yīng)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Evaluation of consequence暴露結(jié)果的評(píng)價(jià)OF EXPOSURETerms used:術(shù)語應(yīng)用Major主要Intermediate中等Minor次要Marginal邊緣Estimation of the risk風(fēng)險(xiǎn)的預(yù)測(cè)Terms used:術(shù)語應(yīng)用High高度Moderate中度Low低度Negligible可忽略的

18、Hazard Identification風(fēng)險(xiǎn)的辨識(shí)Exposure Characterization暴露描述Effects (Hazard) Characterization結(jié)果(危害) 描述Risk Characterization風(fēng)險(xiǎn)描述.GE ERA follows a tiered scheme轉(zhuǎn)基因農(nóng)作物環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)遵照臺(tái)階式的程序Toxicological risk (毒理方面的風(fēng)險(xiǎn))Ecological harm生態(tài)方面的害處stressor-mediated effects刺激影響的結(jié)果action-mediated effects行為調(diào)理的結(jié)果“direct “直接“ind

19、irect “間接Lab(實(shí)驗(yàn)) extended lab (延伸實(shí)驗(yàn)) semi field (半田地) field (田地) landscape(地域)protein toxin effect on a putative sensitive NTO蛋白毒性對(duì)公認(rèn)敏感的NTO影響crop deployment effect on ecological services within a landscape or region農(nóng)作物開展對(duì)生態(tài)業(yè)務(wù)在田野或地域中的影響.Extremely conservative assumptionsto screen out negligible risks

20、deterministicsingle scenario (generalized)data poorhigh uncertainty第一級(jí)Tier I第二級(jí)Tier II第三級(jí)Tier III第四級(jí)Tier IVMost refined assessmentstochastic (probabilistic)multiple scenario (regional)data richuncertainty and variability definedhighly refined exposureassumptions verified by monitoringRisk assessment

21、 is recursive and proceeds in tiers風(fēng)險(xiǎn)評(píng)價(jià)是遞歸的，并且呈階梯狀開展非常保守的假設(shè)用來剔除可以忽略的風(fēng)險(xiǎn)確定的單一現(xiàn)場普通化的數(shù)據(jù)缺乏高度的不確定性最高精度的評(píng)價(jià)隨機(jī)的概率的多處現(xiàn)場區(qū)域的豐富的數(shù)據(jù)明確定義的不確定性和變化度非常純真的暴露被監(jiān)控驗(yàn)證的假設(shè).Tiers of assessment &Tiers of testing 評(píng)價(jià)和測(cè)試的階梯狀開展level of concern degree of uncertainty arising from a lower tier of assessment drives the need to move to

22、ward a higher tier of data generation and assessmentTier ITier IITier IIITier IVLabMicrobial proteinHigh doseLabPIP dietExpected doseLong-term Lab Semi-fieldFieldAssessmentTesting 重要度 不確定度. 出如今低級(jí)別的評(píng)價(jià)中, 促使人們運(yùn)用更高級(jí)的數(shù)據(jù)生成和評(píng)價(jià)手段評(píng)價(jià)測(cè)試長期實(shí)驗(yàn)部分農(nóng)田實(shí)驗(yàn)農(nóng)田實(shí)驗(yàn)第一級(jí)第二級(jí)第三級(jí)第四級(jí)實(shí)驗(yàn)食物期望的劑量實(shí)驗(yàn)微生物蛋白高劑量.for GE crops evaluated to dat

23、e 被繼續(xù)評(píng)價(jià)至今的轉(zhuǎn)基因農(nóng)作物L(fēng)aboratory 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 scale deployment實(shí)驗(yàn)室的研討 .足以確認(rèn)環(huán)境性釋放不存在危

24、害, 這一點(diǎn)具備相當(dāng)確實(shí)定性同時(shí)也被一個(gè)又一個(gè)的案例證明例如 田間調(diào)查和普查 田間監(jiān)控和監(jiān)測(cè) 大面積種植所積累的閱歷.Problem formulation問題的定義和對(duì)轉(zhuǎn)基因農(nóng)作物作環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)涉及的常用數(shù)據(jù)元素& Common data elements of the GE crop ERA.Problem formulation問題的定義Sets the stage for the ERAIdentifies and interprets existing information to focus on consequential concernsOutlines the analysi

25、s plan for the RAWhat studies are needed to address issues of consequence & ecological entities of concernIdentifies the relevant starting point (tier) and the appropriate endpoints of concern 設(shè)定環(huán)境風(fēng)險(xiǎn)評(píng)價(jià)的步驟 區(qū)分和解釋現(xiàn)有的信息從而集中精神在重要的方面 列出風(fēng)險(xiǎn)評(píng)價(jià)的分析方案 需求開展什么研討來處理針對(duì)因果性和所關(guān)懷的生態(tài)實(shí)體的問題 對(duì)關(guān)注的事, 確認(rèn)相關(guān)的起點(diǎn)級(jí)別和適當(dāng)?shù)慕K點(diǎn).Ecologic

26、al Risk Considerations對(duì)生態(tài)風(fēng)險(xiǎn)的思索Product characterization 產(chǎn)品描畫Host & donor familiarity 宿主和供應(yīng)方的熟習(xí)性Activity & specificity 活性和特異性Protein equivalency 蛋白等價(jià)Compositional equivalency 成份等價(jià)Expression 表達(dá)式Risk characterization 風(fēng)險(xiǎn)描畫Product characterization plus 產(chǎn)品描畫加上Hazard 危害Exposure 暴露Risk 風(fēng)險(xiǎn)Risk conclusion 風(fēng)險(xiǎn)結(jié)論

27、Adequacy of the risk characterization 風(fēng)險(xiǎn)描畫的充分性Conservatism in balance with uncertainties 保守和不確定性的平衡.Host & donor familiarity宿主和供應(yīng)者的熟習(xí)性History of safe use and environmental exposure平安運(yùn)用和環(huán)境暴露的歷史Regulatory experience制定規(guī)章的閱歷Broad-based scientific understanding廣博的科學(xué)了解力.Activity & specificity活性和特異性Confirm

28、 or establish nature of activity 證明活性的特征Spectrum of activity against targets 針對(duì)不同目的的活性范圍insecticidal activity spectrum study 殺蟲劑活性范圍的研討.Protein equivalency蛋白等價(jià)Bacterially-produced protein are commonly used in toxicity testing細(xì)菌生成的蛋白質(zhì)在毒性測(cè)試中被廣泛地運(yùn)用Product characterization needs to show that the plant-p

29、roduced and bacterially-produced proteins are biologically, biochemically, and immunologically equivalent產(chǎn)品描畫需求闡明植物生成的蛋白質(zhì)和細(xì)菌生成的蛋白質(zhì)在生物性, 生化性和免疫性方面是等價(jià)的.Compositional equivalency成份等價(jià)Establish that for other than the intended effect of the trait, the GE crop is substantially equivalent to the comparable

30、 non GE crop證明除了與植物的遺傳性相關(guān)的預(yù)期效果,轉(zhuǎn)基因的農(nóng)作物和可比的非轉(zhuǎn)基因農(nóng)作物大體上等價(jià)Considerations of agronomic performance, phenotype, nutrients, antinutrients, toxicants思索農(nóng)藝表現(xiàn),遺傳或環(huán)境決議的特征, 營養(yǎng)物, 抗?fàn)I養(yǎng)物, 毒物.Expression表達(dá)式Key to prediction of exposure concentrations是預(yù)測(cè)暴露濃度的關(guān)鍵Should describe distribution應(yīng)該描畫概率分布o(jì)ver time 時(shí)間上的among pla

31、nt parts 農(nóng)作物的不同部分Supplemented with data describing variance across generations and environments補(bǔ)充描畫不同時(shí)期差別和環(huán)境差別的數(shù)據(jù).Hazard危害Multi species laboratory ecotoxicity testing is used to confirm the anticipated spectrum of activity and hazard to non-target organisms多種類實(shí)驗(yàn)室生態(tài)毒性測(cè)試被用來確認(rèn)對(duì)非目的生物體活性和危害性的預(yù)測(cè)范圍Selectio

32、n of appropriate surrogate species for testing should consider activity profile, host crop, and environment where deployed為測(cè)試選擇適宜的替代種類需求思索活性描畫,宿主農(nóng)作物和種植的環(huán)境.examples of ecotoxicity tests and supporting ecological data生態(tài)毒性測(cè)試的例子和支持的生態(tài)數(shù)據(jù)core 中心的acute avian 鳥類acute fish 魚類acute invertebrate 無脊椎動(dòng)物honey bee

33、 larvae 蜜蜂的幼蟲parasitic hymenoptera寄生的膜翅目昆蟲lady beetle 甲蟲collembola 跳蟲soil degradation 土壤蛻變supplemental 補(bǔ)充的activity spectrum 活性范圍acute mammalian哺乳動(dòng)物chronic avian 鳥類earthworm 蚯蚓butterfly 蝴蝶field census 田地普查field fate 田地災(zāi)禍others 其他.Exposure暴露On the basis of expression data determine 在表達(dá)式數(shù)據(jù)的根底上決議High En

34、d Exposure Estimates (HEEE) in plant tissues, and農(nóng)作物組織的高端暴露估計(jì)(HEEE)Estimated Environmental Concentrations (EEC) in soil and water 土壤和水的預(yù)測(cè)的環(huán)境濃度(EEC)Use for comparison against hazard testing results (multi species ecotoxicity tests)被用來和危害測(cè)試結(jié)果作比較(多種類生態(tài)毒性測(cè)試)Exposure estimates are meant to represent the

35、upper bound (90th percentile) of reasonably anticipated environmental concentrations暴露預(yù)測(cè)是用來代表對(duì)環(huán)境濃度合理期望的上限(90%).Risk = f (hazard, exposure)風(fēng)險(xiǎn) = 函數(shù)(危害, 暴露)Quantitatively describe risk as a function of exposure and hazard定量地把風(fēng)險(xiǎn)定義為暴露和危害的函數(shù)For GE crops this is typically done by considering the relationship of the limit dose used