環(huán)境風(fēng)險(xiǎn)評(píng)估的原則

PrinciplesofEnvironmentalRiskAssessment

環(huán)境風(fēng)險(xiǎn)評(píng)估的原則JeffWolt杰夫.沃而特BiosafetyInstituteforGeneticallyModifiedAgriculturalProducts(BIGMAP)基因改良農(nóng)作物安全研究所IowaStateUniversity美國(guó)衣阿華州立大學(xué)Sep20062006年九月第一頁(yè)，共三十六頁(yè)。Terminology術(shù)語(yǔ)ERAFramework環(huán)境風(fēng)險(xiǎn)評(píng)估框架ApplicationofERAtoGECrops環(huán)境風(fēng)險(xiǎn)評(píng)估在轉(zhuǎn)基因農(nóng)作物中的應(yīng)用Planofpresentation

報(bào)告計(jì)劃第二頁(yè)，共三十六頁(yè)。Risk

風(fēng)險(xiǎn)Thejointconsiderationofexposureandtheconsequenceofexposure

同時(shí)考慮暴露和暴露的后果Risk=f(hazard,exposure)風(fēng)險(xiǎn)=函數(shù)

(危險(xiǎn),暴露)Thelikelihoodofharmtobemanifestedunderrealisticconditionsofexposure危害的可能性在暴露的實(shí)際條件下得以清楚地展現(xiàn)第三頁(yè)，共三十六頁(yè)。RiskAssessment

風(fēng)險(xiǎn)評(píng)估Theuseoffactualinformationtodefinetheeffectsofexposureofindividualsorpopulations[tostressorsoractions]

利用事實(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,RiskAssessmentintheFederalGovernment:ManagingtheProcess,NRC,1983聯(lián)邦政府的風(fēng)險(xiǎn)評(píng)估:管理程序,NRC,1983Theprocessusedtosystematicallyevaluateandorganizedata,information,assumptions,anduncertaintiesinordertohelpunderstandandpredicttherelationshipsbetweenstressors[oractions]andecologicaleffectsinawaythatisusefulforenvironmentaldecisionmaking

步驟用來(lái)系統(tǒng)評(píng)估和組織數(shù)據(jù),信息,假設(shè)和不確定因子,利于幫助理解和預(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.

GuidelinesforEcologicalRiskAssessmentRiskAssessmentForum,USEPA(1998)EPA/630/R-95/002F生態(tài)風(fēng)險(xiǎn)評(píng)估指導(dǎo),風(fēng)險(xiǎn)評(píng)估論壇美國(guó)環(huán)保局(1998)環(huán)保局部/630/R-95/002F第四頁(yè)，共三十六頁(yè)。ERAisapartofRiskAnalysis

環(huán)境風(fēng)險(xiǎn)評(píng)估是風(fēng)險(xiǎn)分析的一部分第五頁(yè)，共三十六頁(yè)。linkstotheriskmanagementprocess

和風(fēng)險(xiǎn)決策步驟聯(lián)系followswellestablishedframeworks在建立好的框架之后setsoverallassessmentgoals

建立總體評(píng)估目標(biāo)recursive遞歸性的proceedsintiers

階梯性前進(jìn)quantitativetothefullestextentpossible

定量地達(dá)到全面可能性Theriskassessmentprocess風(fēng)險(xiǎn)評(píng)估步驟

第六頁(yè)，共三十六頁(yè)。Riskassessmentlinks

researchtoriskmanagement

風(fēng)險(xiǎn)評(píng)估是研究和風(fēng)險(xiǎn)決策的橋梁ProblemFormulation問(wèn)題定義Exposure&effectsCharacterization暴露和結(jié)果描述RiskCharacterization風(fēng)險(xiǎn)描述RiskManagement風(fēng)險(xiǎn)控制RiskAssessment風(fēng)險(xiǎn)評(píng)估DataAcquisition,Verification,&Monitoring數(shù)據(jù)的獲得,證明,和監(jiān)控第七頁(yè)，共三十六頁(yè)。ERA

環(huán)境風(fēng)險(xiǎn)評(píng)估EcologicalorEnvironmental?生態(tài)還是環(huán)境?ThetermEnvironmentalRiskAssessmentiscommonforGEcrops

環(huán)境風(fēng)險(xiǎn)評(píng)估是轉(zhuǎn)基因農(nóng)作物的常用詞匯AnoutgrowthofthewidelyrecognizedprocessofEcologicalRiskAssessment

被廣泛認(rèn)同的生態(tài)風(fēng)險(xiǎn)評(píng)估所帶來(lái)的結(jié)果第八頁(yè)，共三十六頁(yè)。ERA環(huán)境風(fēng)險(xiǎn)評(píng)估“theprocessthatevaluatesthelikelihoodthatadverseecologicaleffectsmayoccurorareoccurringasaresultofexposuretooneormorestressors[oractions]”“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)后果的可能性的過(guò)程”FrameworkforEcologicalRiskAssessment RiskAssessmentForum,USEPA(1992)EPA/630/R-92/001生態(tài)風(fēng)險(xiǎn)評(píng)估框架風(fēng)險(xiǎn)評(píng)估論壇,美國(guó)環(huán)保局部(1992)環(huán)保局/630/R-92/00GuidelinesforEcologicalRiskAssessment RiskAssessmentForum,USEPA(1998)EPA/630/R-95/002F環(huán)保風(fēng)險(xiǎn)評(píng)估綱要風(fēng)險(xiǎn)評(píng)估論壇,美國(guó)環(huán)保局部(1992)環(huán)保局/630/R-92/00

第九頁(yè)，共三十六頁(yè)。KeystoRegulatorySuccess

管理成功的關(guān)鍵UseanERAframework利用環(huán)境風(fēng)險(xiǎn)評(píng)估的框架Flexibility–thecase-by-caseparadigm

靈活性-個(gè)案不同原則Focus–useofproblemformulationtoprioritizeconcerns焦點(diǎn)-利用問(wèn)題組建有限考慮焦點(diǎn)Emphasis–consequentialconcerns

重點(diǎn)-對(duì)結(jié)果的關(guān)注第十頁(yè)，共三十六頁(yè)。PrinciplesofERA

havebeendevelopedandinuseforabout25years

環(huán)境風(fēng)險(xiǎn)評(píng)估的原則

已經(jīng)在美國(guó)發(fā)展和應(yīng)用了二十五年第十一頁(yè)，共三十六頁(yè)。Frameworkapproach

框架的形成ahypotheticaldescriptionofacomplexprocess

一個(gè)復(fù)雜過(guò)程的假設(shè)性描述alogicalprocessfororganizingcomplexinformation一個(gè)組織復(fù)雜信息的邏輯過(guò)程aroadmap

一個(gè)總體的計(jì)劃第十二頁(yè)，共三十六頁(yè)。GoalsofERAFramework

環(huán)境風(fēng)險(xiǎn)評(píng)估結(jié)構(gòu)的目標(biāo)

(Bartenhouse,2006)developaunifiedconceptualapproachtoenvironmentalassessment

發(fā)展一個(gè)統(tǒng)一概念性方法來(lái)評(píng)估環(huán)境facilitatecooperation/collaborationbetweenassessment-relateddisciplines在評(píng)估相關(guān)的原則方面幫助建立合作increasetransparencyofriskassessmentstousers(riskmanagers)對(duì)風(fēng)險(xiǎn)管理者增加風(fēng)險(xiǎn)評(píng)估的透明度providestandardizedtools&techniques提供統(tǒng)一標(biāo)準(zhǔn)的工具和技術(shù)dispelperceptionthatecologicalriskassessmentisimpossible推翻認(rèn)為環(huán)境風(fēng)險(xiǎn)評(píng)估不可能的錯(cuò)誤觀點(diǎn)第十三頁(yè)，共三十六頁(yè)。Theriskassessmentprocess風(fēng)險(xiǎn)評(píng)估步驟HazardIdentification危害的辨別MeasuresofEffects測(cè)量結(jié)果RiskCharacterization

風(fēng)險(xiǎn)描述ExposureAssessment暴露的評(píng)估ProblemFormulation

問(wèn)題建立RiskConclusion

風(fēng)險(xiǎn)結(jié)論ExposureCharacterization暴露描述EffectsCharacterization結(jié)果描述第十四頁(yè)，共三十六頁(yè)。ERAforGEcrops…

對(duì)轉(zhuǎn)基因農(nóng)作物的環(huán)境風(fēng)險(xiǎn)評(píng)估isconsistentwiththeframeworkforRA和危險(xiǎn)評(píng)估的框架是一致的however,complexitiesexistdueto但是,還存在著復(fù)雜性,因?yàn)閞elativelyrecenttechnology比較前沿的技術(shù)biologicalinformationisnotfullyquantifiable生物信息沒(méi)有完全的得到認(rèn)證twoperspectivesastoconcerns還要需要考慮的兩方面effectofstressoronindividualsandpopulations

刺激對(duì)個(gè)人和群體的影響effectofdeploymentonpopulationsandcommunities對(duì)群體和社區(qū)發(fā)展的影響第十五頁(yè)，共三十六頁(yè)。GeneralphilosophytowardERAforGEcrops

對(duì)轉(zhuǎn)基因農(nóng)作物進(jìn)行環(huán)境風(fēng)險(xiǎn)評(píng)估的一般性原理weightofevidencebasedoncomprehensiveevaluationofdata證據(jù)的權(quán)重建立在對(duì)數(shù)據(jù)的綜合評(píng)價(jià)上proceedfromgeneralunderstandingtospecificentitiesofconcern

從總體理解到具體事例的前進(jìn)supportfindingswithquantitativedataandanalysestothefullestextentpossible

利用量化的數(shù)據(jù)分析全面各種可能性,從而支持新的發(fā)現(xiàn)riskbasedfindingsfocusonharmthatmaybemanifestedatenvironmentallyrelevantexposures風(fēng)險(xiǎn)側(cè)重于在環(huán)境相關(guān)的暴露后引起的危害性seekadeterminationofreasonablecertaintyofnoharmtotheenvironment

尋找合理對(duì)環(huán)境無(wú)害的方法第十六頁(yè)，共三十六頁(yè)。ERAforGECrops

對(duì)轉(zhuǎn)基因農(nóng)作物的環(huán)境風(fēng)險(xiǎn)評(píng)估weight-of-evidence事實(shí)的分量holistic整體的strongemphasisonexposure強(qiáng)調(diào)暴露

Identificationofpotentialadverseeffect

潛在危害的認(rèn)識(shí)

EstimationoflikelihoodOFEXPOSURE暴露可能性的預(yù)測(cè)Termsused:術(shù)語(yǔ)的應(yīng)用Highlylikely高度可能性Likely可能性Unlikely不可能性Highlyunlikely高度不可能性Evaluationofconsequence暴露結(jié)果的評(píng)價(jià)OFEXPOSURETermsused:術(shù)語(yǔ)應(yīng)用Major主要Intermediate中等Minor次要Marginal邊緣Estimationoftherisk

風(fēng)險(xiǎn)的預(yù)測(cè)Termsused:術(shù)語(yǔ)應(yīng)用High高度Moderate中度Low低度Negligible可忽略的

HazardIdentification

風(fēng)險(xiǎn)的辨識(shí)

ExposureCharacterization暴露描述

Effects(Hazard)Characterization結(jié)果(危害)描述

RiskCharacterization風(fēng)險(xiǎn)描述

第十七頁(yè)，共三十六頁(yè)。GEERAfollowsatieredscheme轉(zhuǎn)基因農(nóng)作物環(huán)境風(fēng)險(xiǎn)評(píng)估遵照臺(tái)階式的程序Toxicologicalrisk(毒理方面的風(fēng)險(xiǎn))Ecologicalharm生態(tài)方面的害處stressor-mediatedeffects刺激影響的結(jié)果action-mediatedeffects行為調(diào)節(jié)的結(jié)果“direct”“直接”“indirect”“間接”Lab(實(shí)驗(yàn))extendedlab(延長(zhǎng)實(shí)驗(yàn))semifield(半田地)field(田地)landscape(地區(qū))proteintoxineffectonaputativesensitiveNTO蛋白毒性對(duì)公認(rèn)敏感的NTO影響cropdeploymenteffectonecologicalserviceswithinalandscapeorregion農(nóng)作物發(fā)展對(duì)生態(tài)業(yè)務(wù)在田野或地區(qū)中的影響第十八頁(yè)，共三十六頁(yè)。Extremelyconservativeassumptionstoscreenoutnegligiblerisksdeterministicsinglescenario(generalized)datapoorhighuncertainty第一級(jí)TierI第二級(jí)TierII第三級(jí)TierIII第四級(jí)TierIVMostrefinedassessmentstochastic(probabilistic)multiplescenario(regional)datarichuncertaintyandvariabilitydefinedhighlyrefinedexposureassumptionsverifiedbymonitoringRiskassessmentisrecursiveandproceedsintiers

風(fēng)險(xiǎn)評(píng)估是遞歸的，并且呈階梯狀發(fā)展非常保守的假設(shè)用來(lái)剔除可以忽略的風(fēng)險(xiǎn)確定的單一現(xiàn)場(chǎng)（一般化的）數(shù)據(jù)缺乏高度的不確定性最高精度的評(píng)估隨機(jī)的（概率的）多處現(xiàn)場(chǎng)（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凈的暴露被監(jiān)控驗(yàn)證的假設(shè)第十九頁(yè)，共三十六頁(yè)。Tiersofassessment&

Tiersoftesting評(píng)估和測(cè)試的階梯狀發(fā)展levelofconcerndegreeofuncertainty …arisingfromalowertierofassessmentdrivestheneedtomovetowardahighertierofdatagenerationandassessmentTierITierIITierIIITierIVLabMicrobialproteinHighdoseLabPIPdietExpecteddoseLong-termLabSemi-fieldFieldAssessmentTesting

重要度不確定度...出現(xiàn)在低級(jí)別的評(píng)估中,促使人們使用更高級(jí)的數(shù)據(jù)生成和評(píng)估手段評(píng)估測(cè)試長(zhǎng)期實(shí)驗(yàn)局部農(nóng)田試驗(yàn)農(nóng)田試驗(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)微生物蛋白高劑量第二十頁(yè)，共三十六頁(yè)。forGEcropsevaluatedtodate…

被持續(xù)評(píng)估至今的轉(zhuǎn)基因農(nóng)作物L(fēng)aboratorystudies…HavebeenadequatetodeterminethatthereisreasonablecertaintyofnoharmassociatedwithenvironmentalreleaseConfirmedbycase-by-caseinstancesoffieldsurveysandcensusfieldsurveillancemonitoringexperiencewithlargescaledeployment實(shí)驗(yàn)室的研究...足以確認(rèn)環(huán)境性釋放不存在危害,這一點(diǎn)具備相當(dāng)?shù)拇_定性同時(shí)也被一個(gè)又一個(gè)的案例證實(shí)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經(jīng)驗(yàn)第二十一頁(yè)，共三十六頁(yè)。Problemformulation

問(wèn)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)估涉及的常用數(shù)據(jù)元素&CommondataelementsoftheGEcropERA第二十二頁(yè)，共三十六頁(yè)。Problemformulation

問(wèn)題的定義SetsthestagefortheERAIdentifiesandinterpretsexistinginformationtofocusonconsequentialconcernsOutlinestheanalysisplanfortheRAWhatstudiesareneededtoaddressissuesofconsequence&ecologicalentitiesofconcernIdentifiestherelevantstartingpoint(tier)andtheappropriateendpointsofconcern設(shè)定環(huán)境風(fēng)險(xiǎn)評(píng)估的步驟

辨別和解釋現(xiàn)有的信息從而集中精力在重要的方面列出風(fēng)險(xiǎn)評(píng)估的分析計(jì)劃需要開(kāi)展什么研究來(lái)解決針對(duì)因果性和所關(guān)心的生態(tài)實(shí)體的問(wèn)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)第二十三頁(yè)，共三十六頁(yè)。EcologicalRiskConsiderations

對(duì)生態(tài)風(fēng)險(xiǎn)的考慮Productcharacterization產(chǎn)品描述Host&donorfamiliarity宿主和供給方的熟悉性Activity&specificity活性和特異性Proteinequivalency蛋白等價(jià)Compositionalequivalency成份等價(jià)Expression表達(dá)式Riskcharacterization風(fēng)險(xiǎn)描述Productcharacterizationplus

產(chǎn)品描述加上Hazard危害Exposure暴露Risk風(fēng)險(xiǎn)Riskconclusion風(fēng)險(xiǎn)結(jié)論Adequacyoftheriskcharacterization風(fēng)險(xiǎn)描述的充分性Conservatisminbalancewithuncertainties保守和不確定性的平衡第二十四頁(yè)，共三十六頁(yè)。Host&donorfamiliarity

宿主和供給者的熟悉性Historyofsafeuseandenvironmentalexposure安全使用和環(huán)境暴露的歷史Regulatoryexperience制定規(guī)章的經(jīng)驗(yàn)Broad-basedscientificunderstanding廣博的科學(xué)理解力第二十五頁(yè)，共三十六頁(yè)。Activity&specificity

活性和特異性Confirmorestablishnatureofactivity證實(shí)活性的特征Spectrumofactivityagainsttargets針對(duì)不同目標(biāo)的活性范圍insecticidalactivityspectrumstudy殺蟲(chóng)劑活性范圍的研究第二十六頁(yè)，共三十六頁(yè)。Proteinequivalency

蛋白等價(jià)Bacterially-producedproteinarecommonlyusedintoxicitytesting細(xì)菌生成的蛋白質(zhì)在毒性測(cè)試中被廣泛地使用Productcharacterizationneedstoshowthattheplant-producedandbacterially-producedproteinsarebiologically,biochemically,andimmunologicallyequivalent產(chǎn)品描述需要表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)的第二十七頁(yè)，共三十六頁(yè)。Compositionalequivalency

成份等價(jià)Establishthatforotherthantheintendedeffectofthetrait,theGEcropissubstantiallyequivalenttothecomparablenonGEcrop證實(shí)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)Considerationsofagronomicperformance,phenotype,nutrients,antinutrients,toxicants考慮農(nóng)藝表現(xiàn),遺傳或環(huán)境決定的特征,營(yíng)養(yǎng)物,抗?fàn)I養(yǎng)物,毒物第二十八頁(yè)，共三十六頁(yè)。Expression

表達(dá)式Keytopredictionofexposureconcentrations是預(yù)測(cè)暴露濃度的關(guān)鍵Shoulddescribedistribution應(yīng)該描述概率分布o(jì)vertime時(shí)間上的amongplantparts農(nóng)作物的不同部分Supplementedwithdatadescribingvarianceacrossgenerationsandenvironments補(bǔ)充描述不同時(shí)期差異和環(huán)境差異的數(shù)據(jù)第二十九頁(yè)，共三十六頁(yè)。Hazard

危害Multispecieslaboratoryecotoxicitytestingisusedtoconfirmtheanticipatedspectrumofactivityandhazardtonon-targetorganisms多品種實(shí)驗(yàn)室生態(tài)毒性測(cè)試被用來(lái)確認(rèn)對(duì)非目標(biāo)生物體活性和危害性的預(yù)測(cè)范圍Selectionofappropriatesurrogatespeciesfortestingshouldconsideractivityprofile,hostcrop,andenvironmentwheredeployed為測(cè)試選擇合適的替代品種需要考慮活性描述,宿主農(nóng)作物和種植的環(huán)境第三十頁(yè)，共三十六頁(yè)。examplesofecotoxicitytestsandsupportingecologicaldata

生態(tài)毒性測(cè)試的例子和支持的生態(tài)數(shù)據(jù)core核心的acuteavian鳥(niǎo)類acutefish魚(yú)類acuteinvertebrate無(wú)脊椎動(dòng)物honeybeelarvae蜜蜂的幼蟲(chóng)parasitichymenoptera寄生的膜翅目昆蟲(chóng)ladybeetle甲蟲(chóng)collembola跳蟲(chóng)soildegradation土壤變質(zhì)supplemental補(bǔ)充的activityspectrum活性范圍acutemammalian哺乳動(dòng)物chronicavian鳥(niǎo)類earthworm蚯蚓butterfly蝴蝶fieldcensus田地普查fieldfate田地災(zāi)禍others…其他...第三十一頁(yè)，共三十六頁(yè)。Exposure

暴露Onthebasisofexpressiondatadetermine在表達(dá)式數(shù)據(jù)的基礎(chǔ)上決定HighEndExposureEstimates(HEEE)inplanttissues,and農(nóng)作物組織的高端暴露估計(jì)(HEEE)EstimatedEnvironmentalConcentrations(EEC)insoilandwater土壤和水的預(yù)測(cè)的環(huán)境濃度(EEC)Useforcomparisonagainsthazardtestingresults(multispeciesecotoxicitytests)被用來(lái)和危害測(cè)試結(jié)果作比較(多品種生態(tài)毒性測(cè)試)Exposureestimatesaremeanttorepresenttheupperbound(90thpercentile)ofreasonablyanticipatedenvironmentalconcentrations暴露預(yù)測(cè)是用來(lái)代表對(duì)環(huán)境濃度合理期望的上限(90%)第三十二頁(yè)，共三十六頁(yè)。Risk=f(hazard,exposure)

風(fēng)險(xiǎn)=函數(shù)(危害,暴露)Quantitativelydescriberiskasafunctionofexposureandhazard定量地把風(fēng)險(xiǎn)定義為暴露和危害的函數(shù)ForGEcropsthisistypicallydonebyconsideringtherelationshipofthelimitdoseusedinecotoxicitystudiestotheappropriateHEEEorEEC對(duì)于轉(zhuǎn)基因農(nóng)作物,函數(shù)可通過(guò)分析生態(tài)毒性測(cè)試使用的限制劑量和適當(dāng)?shù)母叨吮┞豆烙?jì)或者預(yù)測(cè)的環(huán)境濃度之間的關(guān)系來(lái)確定第三十三頁(yè)，共三十六頁(yè)。confirmationoftheadequacyofriskcharacterization

確認(rèn)風(fēng)險(xiǎn)描述的充分性correspondenceofproduc