Risk Assessment for Birds and Mammals Revision of Guidance Document under Council Directive 91/414/EEC (SANCO/4145/2000 - final of 25 September 2002) 1 Scientific Opinion of the Panel on Plant protection products and their Residues (PPR) on the Science behind the Guidance Document on Risk Assessment for birds and mammals
Risk Assessment for Birds and Mammals Revision of Guidance Document under Council Directive 91/414/EEC (SANCO/4145/2000 - final of 25 September 2002) 1 Scientific Opinion of the Panel on Plant protection products and their Residues (PPR) on the Science behind the Guidance Document on Risk Assessment for birds and mammals
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DOI：
10.2903/j.efsa.2008.734
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发表时间：
2008-07-01
期刊：
影响因子：
3.3
通讯作者：
Vleminckx, Christiane
中科院分区：
文献类型：
--
作者：
Culleres, Damia Barcelo;Boesten, Jos;Vleminckx, Christiane
欧洲食品安全局（EFSA）向其植物保护产品及其残留物科学小组询问（PPR小组）根据理事会指令91/414/EEC修订鸟类和哺乳动物风险评估指导文件（SANCO/4145/2000 - 2002年9月25日定稿）在修订过程中，很明显，这项任务包含了几个不属于EFSA和PPR小组职权范围的风险管理问题。因此，PPR小组采取了两个阶段的方法，首先使用模块方法编写了本“关于鸟类和哺乳动物风险评估指导文件（GD）背后科学的科学意见”。在第二阶段，由欧洲食品安全局、欧盟委员会和成员国代表组成的联合工作组将考虑风险管理问题，并最终确定修订后的/新的指导文件。然而，这一意见将保持不变，因此将作为一份参考文件，为鸟类和哺乳动物的风险评估提供全面的科学背景。在这两种情况下，均采用分层方法评估死亡率和生殖影响的风险，PPR小组针对包括不同作物和不同类型农药使用（例如颗粒剂、种子处理和喷雾剂）在内的大量情景制定了第一级评估程序。每一种设想方案都是受影响物种的生态特征和与受影响有关的其他因素的组合，例如作物的类型和结构以及农药产品的配方类型。技经评估组采用了现有的最佳数据来界定每一种设想情况，在大多数情况下，评估得出了毒性-接触-比率，作为风险的衡量标准。然而，在喷洒杀虫剂对鸟类造成急性风险的情况下，PPR小组还提供了一种基于每平方米施用的致死剂量数量的替代方法（LD 50/m（2））. PPR小组评估了每一第一级程序提供的保护水平，同时考虑到所用假设的保守性，评估中遗漏的因素引起的不确定性（如皮肤接触），以及在现场研究或事件监测中获得的实际影响证据（如可用）。PPR专家组就可用于更高级别风险评估的各种选项提供指导，例如，利用有关物种生态学的实际数据进行精确的饮食接触评估;或进行实地研究，以获得更好的残留数据、更好的生态数据或衡量影响。PPR专家组还就如何将来自更高级别风险评估的不同类型的证据联合收割机结合起来，形成对风险水平的总体判断提出了指导意见，并对每种证据的优势和不确定性给予了适当的权重。关于更高风险评估的具体方面的更详细指导见本意见的一系列附录。其他附录提供了一级评估程序的详细科学背景和基础数据。评估小组亦提交了生殖风险评估的工作例子，并将拟议新评估程序的结果与现行风险评估计划的结果作比较。
The European Food Safety Authority (EFSA) asked its Scientific Panel on Plant protection products and their Residues (PPR Panel) to revise the Guidance Document on Risk Assessment for Birds and Mammals under Council Directive 91/414/EEC (SANCO/4145/2000 - final of 25 September 2002).In the course of the revision it became apparent that the task embraced several risk management issues that are not within EFSA's and the PPR Panel's remit. Therefore, the PPR Panel has adopted a two-stage approach and first has prepared the present 'Scientific Opinion on the Science behind the Guidance Document (GD) on risk assessment for birds and mammals' using a modular approach. In the second stage, a joint working group of representatives from EFSA, the European Commission and Member States will consider the risk management issues and finalise the revised/new Guidance Document. However, this opinion will remain unchanged and hence be a reference document giving the full scientific background to the risk assessment for birds and mammals.The opinion addresses approaches to risk assessment for birds and mammals. In both cases, a tiered approach is used to assess the risk of mortality and reproductive effects.The PPR Panel has developed a first-tier assessment procedure for a large range of scenarios including different crops and different types of pesticide uses (e.g. granules, seed treatment, and sprays). Each scenario is a combination of the ecological characteristics of exposed species and other factors relevant to exposure, e.g. the type and structure of crop, and the type of formulation of the pesticide product. The Panel has used the best available data to define each scenario.In most cases the assessment results in a toxicity-exposure-ratio (TER) as a measure of risk. However, in the case of acute risks to birds from sprayed pesticides, the PPR Panel has also offered an alternative approach based on the number of lethal doses applied per square meter (LD50/m(2)).The PPR Panel evaluated the level of protection provided by each first-tier procedure, taking account of the conservatism of the assumptions used, uncertainties arising from factors omitted from the assessment (e.g. dermal exposure) and, where available, evidence on actual effects in field studies or from incident monitoring.The PPR Panel provides guidance on the range of options available for higher-tier risk assessment, e.g. refined dietary exposure assessments using realistic data on the ecology of relevant species; or field studies in order to get better residue data, better ecological data, or to measure effects. The PPR Panel also presents guidance on how to combine different types of evidence from higher-tier risk assessment to form an overall judgement on the level of risk, giving appropriate weight to the strengths and uncertainties of each type of evidence.More detailed guidance on specific aspects of higher risk assessment is given in a series of Appendices to the opinion. Further Appendices provide detailed scientific background and underlying data for the first-tier assessment procedures. The Panel has also submitted worked examples for the reproductive risk assessment and compared the outcome of the proposed new assessment procedures with the existing risk assessment scheme.