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环境风险评估的原则

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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
Terminology 
   术语
ERA Framework
   环境风险评估框架
Application of ERA to GE Crops
   环境风险评估在转基因农作物中的应用

Plan of presentation报告计划
Risk风险
The joint consideration of exposure and the consequence of exposure
    同时考虑暴露和暴露的后果
Risk = f (hazard, exposure)
   风险= 函数 (危险, 暴露)
The 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 
The use of factual information to define the 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, 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 Forum, 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-95/002F
ERA is a part of Risk Analysis环境风险评估是风险分析的一部分
links to the risk management process
    和风险决策步骤联系
follows well established frameworks
   在建立好的框架之后
sets overall assessment goals
    建立总体评估目标
recursive
    递归性的
proceeds in tiers
   阶梯性前进
quantitative 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

Problem
Formulation
问题定义
Exposure &amp;amp; effects
Characterization
暴露和结果描述

Risk
Characterization
风险描述

Risk Management 风险控制
Risk Assessment  风险评估
Data Acquisition, Verification, &amp;amp; Monitoring
数据的获得, 证明, 和监控
ERA 环境风险评估
Ecological or Environmental ?
   生态还是环境?
The 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
An 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 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]”
   “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”
Framework for Ecological Risk Assessment
	Risk 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(1992) 环保局/630/R-92/00
Guidelines for Ecological Risk Assessment
	Risk 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
Use an ERA framework 
   利用环境风险评估的框架
Flexibility – the case-by-case paradigm
   灵活性- 个案不同原则
Focus – use of problem formulation to prioritize concerns 
   焦点- 利用问题组建有限考虑焦点
Emphasis – 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
a hypothetical description of a complex process
  一个复杂过程的假设性描述
a logical process for organizing complex information
   一个组织复杂信息的逻辑过程
a 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)
develop a unified conceptual approach to environmental assessment
   发展一个统一概念性方法来评估环境
facilitate cooperation/collaboration between assessment-related disciplines
  在评估相关的原则方面帮助建立合作
increase transparency of risk assessments to users (risk managers)
   对风险管理者增加风险评估的透明度
provide standardized tools &amp;amp; techniques
    提供统一标准的工具和技术
dispel 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
Hazard
Identification
危害的辨别
Measures of Effects
测量结果
Risk
Characterization
  风险描述

Exposure
Assessment
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
is consistent with the framework for RA
   和危险评估的框架是一致的
however, complexities exist due to
   但是, 还存在着复杂性, 因为
relatively recent technology
   比较前沿的技术
biological information is not fully quantifiable
   生物信息没有完全的得到认证
two perspectives as to concerns
    还要需要考虑的两方面
effect of stressor on individuals and populations
   刺激对个人和群体的影响
effect 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
weight of evidence based on comprehensive evaluation of data
    证据的权重建立在对数据的综合评价上
proceed from general understanding to specific entities of concern
    从总体理解到具体事例的前进
support 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
risk based findings focus on harm that may be 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
seek 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
weight-of-evidence 事实的分量
holistic 整体的
strong emphasis on exposure 强调暴露
?

Identification of potential adverse effect
?潜在危害的认识
?	Estimation of likelihood 
OF EXPOSURE
暴露可能性的预测
Terms used:
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	Evaluation of consequence
暴露结果的评价
OF EXPOSURE
Terms used:
术语应用
Major
主要
Intermediate
中等
Minor
次要
Marginal
边缘	Estimation of the risk
?风险的预测
Terms used:
术语应用
High
高度
Moderate
中度
Low
低度
Negligible
可忽略的
?
Hazard Identification
?风险的辨识	?
Exposure Characterization
暴露描述	?
Effects (Hazard) Characterization
结果(危害) 描述	?
Risk Characterization
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
“direct” “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 assumptions
to screen out negligible risks
deterministic
single scenario (generalized)
data poor
high uncertainty
第一级
Tier I
第二级
Tier II
第三级
Tier III
第四级
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
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 &amp;amp;Tiers of testing 评估和测试的阶梯状发展
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 release
Confirmed by case-by-case instances of
field surveys and census
field surveillance monitoring
experience with large scale 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
&amp;amp; Common data elements of the GE crop ERA
Problem formulation问题的定义
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
 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
Product characterization 产品描述
Host &amp;amp; donor familiarity  宿主和供给方的熟悉性
Activity &amp;amp; specificity  活性和特异性
Protein equivalency 蛋白等价
Compositional equivalency 成份等价
Expression 表达式
Risk characterization 风险描述
Product characterization plus 产品描述加上
Hazard 危害
Exposure 暴露
Risk 风险
Risk conclusion 风险结论
Adequacy of the risk characterization 
    风险描述的充分性
Conservatism in balance with uncertainties 
    保守和不确定性的平衡
Host &amp;amp; donor familiarity宿主和供给者的熟悉性
History of safe use and environmental exposure
安全使用和环境暴露的历史
Regulatory experience
制定规章的经验
Broad-based scientific understanding
广博的科学理解力
Activity &amp;amp; specificity活性和特异性
Confirm or establish nature of activity
 证实活性的特征
Spectrum of activity against targets
  针对不同目标的活性范围
insecticidal activity spectrum study
 杀虫剂活性范围的研究

Protein equivalency蛋白等价
Bacterially-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
Product characterization 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
Establish that for other than the intended effect of the trait, the GE crop is substantially 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
Considerations 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
Key to prediction of exposure concentrations
是预测暴露浓度的关键
Should describe distribution
应该描述概率分布
over time 时间上的
among plant parts 农作物的不同部分
Supplemented 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
Multi 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
Selection 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
core 核心的
acute avian 鸟类
acute fish 鱼类
acute invertebrate 无脊椎动物
honey bee larvae 蜜蜂的幼虫
parasitic hymenoptera
寄生的膜翅目昆虫
lady beetle 甲虫
collembola 跳虫
soil degradation 土壤变质
supplemental  补充的
activity spectrum 
活性范围
acute mammalian
哺乳动物
chronic avian 鸟类
earthworm 蚯蚓
butterfly 蝴蝶
field census 田地普查
field fate 田地灾祸
others … 其他...

Exposure暴露
On the basis of expression data determine 
在表达式数据的基础上决定
High End Exposure Estimates (HEEE) in plant tissues, and
农作物组织的高端暴露估计(HEEE)
Estimated Environmental Concentrations (EEC) in soil and water 
土壤和水的预测的环境浓度(EEC)
Use for comparison against hazard testing results (multi species ecotoxicity tests)
被用来和危害测试结果作比较(多品种生态毒性测试)
Exposure 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)
Quantitatively 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
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
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
correspondence of product specific results
产品特定结果的一致性
with general 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
internal consistency/directional correctness 
内部的一致性 / 定向的正确性
of overall product and risk characterization
总体的产品和风险描述
ability to characterize hazard at or above environmentally relevant exposure concentrations
描述不低于和环境相关的暴露浓度的危害特征的能力
confirmatory data (if available) from field studies
田间研究所获得的确认数据(如果有的话) 
conservatism 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
The ERA framework  环境风险评估的框架
enables a focused, objective science-based process
建立一个有针对性的, 客观的, 科学的过程
ERA framework as applied to GEOs
环境风险评估的框架被应用于转基因农作物中
has 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
Problem formulation &amp;amp; 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
Constrain 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

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