Principles of Environmental Risk Assessment 环境风险评估的原则

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

2. Plan of presentation报告计划 • 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

3. 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

4. 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

5. ERA is a part of Risk Analysis环境风险评估是风险分析的一部分

6. The risk assessment process 风险评估步骤 • 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

7. Risk Assessment 风险评估 Problem Formulation 问题定义 Exposure & effects Characterization 暴露和结果描述 Risk Characterization 风险描述 Risk Management 风险控制 Risk assessment links research to risk management风险评估是研究和风险决策的桥梁 Data Acquisition, Verification, & Monitoring 数据的获得, 证明, 和监控

8. 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

9. 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

10. 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

11. Principles of ERAhave 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

12. 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

13. 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 & 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

14. Hazard Identification 危害的辨别 Measures of Effects 测量结果 Problem Formulation 问题建立 Risk Conclusion 风险结论 Risk Characterization 风险描述 Exposure Assessment 暴露的评估 The risk assessment process 风险评估步骤 Effects Characterization 结果描述 Exposure Characterization 暴露描述

15. 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

16. 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

17. 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

18. 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 Lab(实验) extended lab (延长实验) semi field (半田地) field (田地) landscape(地区) “direct” “直接” “indirect” “间接” 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 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

19. Risk assessment is recursive and proceeds in tiers风险评估是递归的，并且呈阶梯状发展 第四级 Tier IV 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 第三级 Tier III Most refined assessment stochastic (probabilistic) multiple scenario (regional) data rich uncertainty and variability defined highly refined exposure assumptions verified by monitoring 第二级 Tier II 第一级 Tier I 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 Extremely conservative assumptions to screen out negligible risks deterministic single scenario (generalized) data poor high uncertainty

20. Assessment Tier IV Testing Field Long-term Lab Semi-field Tier III Lab PIP diet Expected dose Tier II Tier I Tiers of assessment &Tiers of testing 评估和测试的阶梯状发展 • 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 • 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 第四级 评估 第三级 测试 农田试验 第二级 长期实验 局部农田试验 第一级 实验 食物 期望的剂量 Lab Microbial protein High dose 实验 微生物蛋白 高剂量

21. for GE crops evaluated to date …被持续评估至今的转基因农作物 • 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 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

22. 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 ERA

23. Problem formulation问题的定义 • 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 • 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 & ecological entities of concern • Identifies the relevant starting point (tier) and the appropriate endpoints of concern

24. Product characterization 产品描述 Host & donor familiarity 宿主和供给方的熟悉性 Activity & 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 Ecological Risk Considerations对生态风险的考虑 • 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

25. Host & 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

26. Activity & 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

27. 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

28. 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

29. 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

30. 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

31. 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... 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

32. 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%)

33. 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

34. 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

35. Conclusions结论 • 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 & 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’)