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環(huán)境風險評估的原則

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Principles of Environmental Risk Assessment 環(huán)境風險評估的原則
Jeff Wolt        杰夫.沃而特
Biosafety Institute for Genetically Modified Agricultural Products (BIGMAP)
基因改良農(nóng)作物安全研究所
Iowa State University    美國衣阿華州立大學
Sep 2006     2006年九月
Terminology 
   術語
ERA Framework
   環(huán)境風險評估框架
Application of ERA to GE Crops
   環(huán)境風險評估在轉基因農(nóng)作物中的應用

Plan of presentation報告計劃
Risk風險
The joint consideration of exposure and the consequence of exposure
    同時考慮暴露和暴露的后果
Risk = f (hazard, exposure)
   風險= 函數(shù) (危險, 暴露)
The likelihood of harm to be manifested under realistic conditions of exposure
危害的可能性在暴露的實際條件下得以清楚地展
現(xiàn)
Risk Assessment風險評估 
The use of factual information to define the effects of exposure of individuals or populations [to stressors or actions]
    利用事實信息定義個人或群體暴露于[刺激或者行為]的結果
    after, Risk Assessment in the Federal Government: Managing the Process, NRC, 1983
聯(lián)邦政府的風險評估: 管理程序, NRC, 1983

The process used to systematically evaluate and organize data, information, assumptions, 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)評估和組織數(shù)據(jù), 信息, 假設和不確定因子,利于幫助理解和預測刺激或行為和生態(tài)結果之間的關系, 這些對于環(huán)境決策是有用的.
    
Guidelines for Ecological Risk Assessment Risk Assessment Forum, USEPA (1998) EPA/630/R-95/002F
生態(tài)風險評估指導, 風險評估論壇 美國環(huán)保局(1998) 環(huán)保局部/630/R-95/002F
ERA is a part of Risk Analysis環(huán)境風險評估是風險分析的一部分
links to the risk management process
    和風險決策步驟聯(lián)系
follows well established frameworks
   在建立好的框架之后
sets overall assessment goals
    建立總體評估目標
recursive
    遞歸性的
proceeds in tiers
   階梯性前進
quantitative to the fullest extent possible
    定量地達到全面可能性
The risk assessment process
風險評估步驟 
Risk assessment links research to risk management風險評估是研究和風險決策的橋梁

Problem
Formulation
問題定義
Exposure &amp;amp; effects
Characterization
暴露和結果描述

Risk
Characterization
風險描述

Risk Management 風險控制
Risk Assessment  風險評估
Data Acquisition, Verification, &amp;amp; Monitoring
數(shù)據(jù)的獲得, 證明, 和監(jiān)控
ERA 環(huán)境風險評估
Ecological or Environmental ?
   生態(tài)還是環(huán)境?
The term Environmental Risk Assessment is common for GE crops
   環(huán)境風險評估是轉基因農(nóng)作物的常用詞匯
An outgrowth of the widely recognized process of Ecological Risk Assessment
   被廣泛認同的生態(tài)風險評估所帶來的結果
ERA 環(huán)境風險評估
“the process 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]”
   “這是評價暴露于一個或多個刺激[或者行為]后, 負面的生態(tài)后果的可能性的過程”
Framework for Ecological Risk Assessment
	Risk Assessment Forum, USEPA (1992) EPA/630/R-92/001
    生態(tài)風險評估框架
    風險評估論壇, 美國環(huán)保局部(1992) 環(huán)保局/630/R-92/00
Guidelines for Ecological Risk Assessment
	Risk Assessment Forum, USEPA (1998) EPA/630/R-95/002F
    環(huán)保風險評估綱要
風險評估論壇, 美國環(huán)保局部(1992) 環(huán)保局/630/R-92/00
 
Keys to Regulatory Success管理成功的關鍵
Use an ERA framework 
   利用環(huán)境風險評估的框架
Flexibility – the case-by-case paradigm
   靈活性- 個案不同原則
Focus – use of problem formulation to prioritize concerns 
   焦點- 利用問題組建有限考慮焦點
Emphasis – consequential concerns
    重點-對結果的關注

Principles of ERA have been developed and in use for about 25 years環(huán)境風險評估的原則已經(jīng)在美國發(fā)展和應用了二十五年
Framework approach框架的形成
a hypothetical description of a complex process
  一個復雜過程的假設性描述
a logical process for organizing complex information
   一個組織復雜信息的邏輯過程
a road map
   一個總體的計劃
Goals of ERA Framework環(huán)境風險評估結構的目標	(Bartenhouse, 2006)
develop a unified conceptual approach to environmental assessment
   發(fā)展一個統(tǒng)一概念性方法來評估環(huán)境
facilitate cooperation/collaboration between assessment-related disciplines
  在評估相關的原則方面幫助建立合作
increase transparency of risk assessments to users (risk managers)
   對風險管理者增加風險評估的透明度
provide standardized tools &amp;amp; techniques
    提供統(tǒng)一標準的工具和技術
dispel perception that ecological risk assessment is impossible
    推翻認為環(huán)境風險評估不可能的錯誤觀點
The risk assessment process
風險評估步驟
Hazard
Identification
危害的辨別
Measures of Effects
測量結果
Risk
Characterization
  風險描述

Exposure
Assessment
暴露的評估

Problem Formulation
          問題建立

Risk Conclusion
 風險結論
Exposure Characterization
暴露描述
Effects Characterization 結果描述
ERA for GE crops …對轉基因農(nóng)作物的環(huán)境風險評估
is consistent with the framework for RA
   和危險評估的框架是一致的
however, complexities exist due to
   但是, 還存在著復雜性, 因為
relatively recent technology
   比較前沿的技術
biological information is not fully quantifiable
   生物信息沒有完全的得到認證
two perspectives as to concerns
    還要需要考慮的兩方面
effect of stressor on individuals and populations
   刺激對個人和群體的影響
effect of deployment on populations and communities
        對群體和社區(qū)發(fā)展的影響

General philosophy toward ERA for GE crops對轉基因農(nóng)作物進行環(huán)境風險評估的一般性原理
weight of evidence based on comprehensive evaluation of data
    證據(jù)的權重建立在對數(shù)據(jù)的綜合評價上
proceed from general understanding to specific entities of concern
    從總體理解到具體事例的前進
support findings with quantitative data and analyses to the fullest extent possible
     利用量化的數(shù)據(jù)分析全面各種可能性,從而支持新的發(fā)現(xiàn)
risk based findings focus on harm that may be manifested at environmentally relevant exposures
    風險側重于在環(huán)境相關的暴露后引起的危害性
seek a determination of reasonable certainty of no harm to the environment
    尋找合理對環(huán)境無害的方法
ERA for GE Crops對轉基因農(nóng)作物的環(huán)境風險評估
weight-of-evidence 事實的分量
holistic 整體的
strong emphasis on exposure 強調暴露
?

Identification of potential adverse effect
?潛在危害的認識
?	Estimation of likelihood 
OF EXPOSURE
暴露可能性的預測
Terms used:
術語的應用
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
暴露結果的評價
OF EXPOSURE
Terms used:
術語應用
Major
主要
Intermediate
中等
Minor
次要
Marginal
邊緣	Estimation of the risk
?風險的預測
Terms used:
術語應用
High
高度
Moderate
中度
Low
低度
Negligible
可忽略的
?
Hazard Identification
?風險的辨識	?
Exposure Characterization
暴露描述	?
Effects (Hazard) Characterization
結果(危害) 描述	?
Risk Characterization
風險描述
?
GE ERA follows a tiered scheme
轉基因農(nóng)作物環(huán)境風險評估遵照臺階式的程序
Toxicological risk (毒理方面的風險)
Ecological harm
生態(tài)方面的害處
stressor-mediated effects
刺激影響的結果
action-mediated effects
行為調節(jié)的結果
“direct” “直接”
“indirect” “間接”
Lab(實驗)                extended lab  (延長實驗)                semi field (半田地)                 field (田地)                landscape(地區(qū))
protein toxin effect on a putative sensitive NTO
蛋白毒性對公認敏感的NTO影響
crop deployment effect on ecological services within a landscape or region
農(nóng)作物發(fā)展對生態(tài)業(yè)務在田野或地區(qū)中的影響
Extremely conservative assumptions
to screen out negligible risks
deterministic
single scenario (generalized)
data poor
high uncertainty
第一級
Tier I
第二級
Tier II
第三級
Tier III
第四級
Tier IV
Most refined assessment
stochastic (probabilistic)
multiple scenario (regional)
data rich
uncertainty and variability defined
highly refined exposure
assumptions verified by monitoring
Risk assessment is recursive and proceeds in tiers風險評估是遞歸的，并且呈階梯狀發(fā)展
非常保守的假設用來剔除可以忽略的風險
確定的
單一現(xiàn)場（一般化的）
數(shù)據(jù)缺乏
高度的不確定性
最高精度的評估
隨機的（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
非常純凈的暴露
被監(jiān)控驗證的假設
Tiers of assessment &amp;amp;Tiers of testing 評估和測試的階梯狀發(fā)展
level of concern 
degree of uncertainty 
		… arising from a lower tier of assessment drives the need to move toward a higher tier of data generation and assessment
Tier I
Tier II
Tier III
Tier IV
Lab
Microbial protein
High dose
Lab
PIP diet
Expected dose
Long-term Lab Semi-field
Field
Assessment
Testing
  重要度
  不確定度
... 出現(xiàn)在低級別的評估中, 促使人們使用更高級的數(shù)據(jù)生成和評估手段
評估
測試
長期實驗
局部農(nóng)田試驗
農(nóng)田試驗
第一級
第二級
第三級
第四級
實驗
食物
期望的劑量
實驗
微生物蛋白
高劑量
for GE crops evaluated to date …被持續(xù)評估至今的轉基因農(nóng)作物
Laboratory studies … 
Have been adequate to determine that there is reasonable certainty of no harm associated with environmental release
Confirmed by case-by-case instances of
field surveys and census
field surveillance monitoring
experience with large scale deployment
實驗室的研究 ...
足以確認環(huán)境性釋放不存在危害, 這一點具備相當?shù)拇_定性

同時也被一個又一個的案例證實
例如
 田間調查和普查
 田間監(jiān)控和監(jiān)測
 大面積種植所積累的經(jīng)驗
Problem formulation問題的定義
和對轉基因農(nóng)作物作環(huán)境風險評估涉及的常用數(shù)據(jù)元素
&amp;amp; Common data elements of the GE crop ERA
Problem formulation問題的定義
Sets the stage for the ERA
Identifies and interprets existing information to focus on consequential concerns
Outlines the analysis plan for the RA
What studies are needed to address issues of consequence &amp;amp; ecological entities of concern
Identifies the relevant starting point (tier) and the appropriate endpoints of concern
 設定環(huán)境風險評估的步驟
 辨別和解釋現(xiàn)有的信息從而集中精力在重要的方面

列出風險評估的分析計劃
 需要開展什么研究來解決針對因果性和所關心的生態(tài)實體的問題
 對關注的事, 確認相關的起點（級別）和適當?shù)慕K點
Ecological Risk Considerations對生態(tài)風險的考慮
Product characterization 產(chǎn)品描述
Host &amp;amp; donor familiarity  宿主和供給方的熟悉性
Activity &amp;amp; specificity  活性和特異性
Protein equivalency 蛋白等價
Compositional equivalency 成份等價
Expression 表達式
Risk characterization 風險描述
Product characterization plus 產(chǎn)品描述加上
Hazard 危害
Exposure 暴露
Risk 風險
Risk conclusion 風險結論
Adequacy of the risk characterization 
    風險描述的充分性
Conservatism in balance with uncertainties 
    保守和不確定性的平衡
Host &amp;amp; donor familiarity宿主和供給者的熟悉性
History of safe use and environmental exposure
安全使用和環(huán)境暴露的歷史
Regulatory experience
制定規(guī)章的經(jīng)驗
Broad-based scientific understanding
廣博的科學理解力
Activity &amp;amp; specificity活性和特異性
Confirm or establish nature of activity
 證實活性的特征
Spectrum of activity against targets
  針對不同目標的活性范圍
insecticidal activity spectrum study
 殺蟲劑活性范圍的研究

Protein equivalency蛋白等價
Bacterially-produced protein are commonly used in toxicity testing
細菌生成的蛋白質在毒性測試中被廣泛地使用
Product characterization needs to show that the plant-produced and bacterially-produced proteins are biologically, biochemically, and immunologically equivalent
產(chǎn)品描述需要表明植物生成的蛋白質和細菌生成的蛋
白質在生物性, 生化性和免疫性方面是等價的

Compositional equivalency成份等價
Establish that for other than the intended effect of the trait, the GE crop is substantially equivalent to the comparable non GE crop
證實除了與植物的遺傳性相關的預期效果,轉基因的農(nóng)
作物和可比的非轉基因農(nóng)作物大體上等價
Considerations of agronomic performance, phenotype, nutrients, antinutrients, toxicants
考慮農(nóng)藝表現(xiàn),遺傳或環(huán)境決定的特征, 營養(yǎng)物, 抗營
養(yǎng)物, 毒物

Expression表達式
Key to prediction of exposure concentrations
是預測暴露濃度的關鍵
Should describe distribution
應該描述概率分布
over time 時間上的
among plant parts 農(nóng)作物的不同部分
Supplemented with data describing variance across generations and environments
補充描述不同時期差異和環(huán)境差異的數(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
多品種實驗室生態(tài)毒性測試被用來確認對非目標生物
體活性和危害性的預測范圍
Selection of appropriate surrogate species for testing should consider activity profile, host crop, and environment where deployed
為測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
examples of ecotoxicity tests and supporting ecological data生態(tài)毒性測試的例子和支持的生態(tài)數(shù)據(jù)
core 核心的
acute avian 鳥類
acute fish 魚類
acute invertebrate 無脊椎動物
honey bee 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 土壤變質
supplemental  補充的
activity spectrum 
活性范圍
acute mammalian
哺乳動物
chronic avian 鳥類
earthworm 蚯蚓
butterfly 蝴蝶
field census 田地普查
field fate 田地災禍
others … 其他...

Exposure暴露
On the basis of expression data determine 
在表達式數(shù)據(jù)的基礎上決定
High End Exposure Estimates (HEEE) in plant tissues, and
農(nóng)作物組織的高端暴露估計(HEEE)
Estimated Environmental Concentrations (EEC) in soil and water 
土壤和水的預測的環(huán)境濃度(EEC)
Use for comparison against hazard testing results (multi species ecotoxicity tests)
被用來和危害測試結果作比較(多品種生態(tài)毒性測試)
Exposure estimates are meant to represent the upper bound (90th percentile) of reasonably anticipated environmental concentrations
暴露預測是用來代表對環(huán)境濃度合理期望的上限(90%)

Risk = f (hazard, exposure)風險 = 函數(shù)(危害, 暴露)
Quantitatively describe risk as a function of exposure and hazard
定量地把風險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 in ecotoxicity studies to the appropriate HEEE or EEC
對于轉基因農(nóng)作物, 函數(shù)可通過分析生態(tài)毒性測試
使用的限制劑量和適當?shù)母叨吮┞豆烙嫽蛘哳A測的環(huán)境
濃度之間的關系來確定
confirmation of the adequacy of risk characterization確認風險描述的充分性
correspondence of product specific results
產(chǎn)品特定結果的一致性
with general understanding for the donor, host, and product class being considered 
對供給者,宿主和所考慮的產(chǎn)品類型的一般理解
internal consistency/directional correctness 
內部的一致性 / 定向的正確性
of overall product and risk characterization
總體的產(chǎn)品和風險描述
ability to characterize hazard at or above environmentally relevant exposure concentrations
描述不低于和環(huán)境相關的暴露濃度的危害特征的能力
confirmatory data (if available) from field studies
田間研究所獲得的確認數(shù)據(jù)(如果有的話) 
conservatism of the risk conclusion is in keeping with the degree of uncertainty
風險結論的保守性與不確定度保持一致
The ERA framework  環(huán)境風險評估的框架
enables a focused, objective science-based process
建立一個有針對性的, 客觀的, 科學的過程
ERA framework as applied to GEOs
環(huán)境風險評估的框架被應用于轉基因農(nóng)作物中
has been sufficiently flexible to deal with concerns surrounding biotechnology
非常靈活可以用來解決很多和生物技術有關的事物
Problem formulation &amp;amp; common data elements for the ERA
問題的定義和環(huán)境風險評估涉及的常用數(shù)據(jù)元素
Constrain and focus the risk assessment to consequential concerns (‘real risks’)
把風險評估限制和集中在重要的方面 (‘真正的風險’)

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