Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters
Guidance on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters
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DOI：
10.2903/j.efsa.2013.3290
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发表时间：
2013-07-01
期刊：
影响因子：
3.3
通讯作者：
Van der Linden, Ton
中科院分区：
文献类型：
--
作者：
Aagaard, Alf;Brock, Theo;Van der Linden, Ton
EFSA的植物保护产品及其残留物（PPR）小组负责根据理事会指令91/414/EEC（SANCO/3268/2001修订版4（最终版），2002年10月17日）修订水生生态毒理学指导文件（GD）。PPR小组的这份指南是本任务范围内三项要求交付成果中的第一项。它的重点是分层的急性和慢性影响评估计划，详细指导了对农田边缘表面沃茨中水生生物的第1级和更高级别的影响评估，以及关于如何将影响与接触估计数联系起来的建议。未对接触评估方法进行审查，并假定目前的FOCUS地表水接触评估方法将继续用于欧盟一级的接触评估。现行GD旨在用于欧盟层面的活性物质授权以及成员国层面的植物保护产品授权。本GD中的影响评估方案允许根据两个选项推导监管可接受浓度（RAC）：（1）生态阈值选项（ETO），仅接受可忽略的人口影响，以及（2）生态恢复选项（ERO），如果生态恢复在可接受的时间段内发生，则接受一些人口水平的影响。在分层效应评估办法中，原则上，所有层次（1、2和3）都能够处理ETO，而示范生态系统方法（3）在某些条件下也能够处理ERO。指导文件为农田边缘表层沃茨水生生物的风险评估提供了科学背景，并在结构上为所有评估步骤提供了详细指导。提供了一份执行摘要，以简洁的方式将指南和决策方案的所有部分结合在一起，旨在帮助申请人和监管机构日常使用。(C)欧洲食品安全局，2013年。
EFSA`s Panel on Plant Protection Products and their Residues (PPR) was tasked to revise the Guidance Document (GD) on Aquatic Ecotoxicology under Council Directive 91/414/EEC (SANCO/3268/2001 rev. 4 (final), 17 October 2002). This Guidance of the PPR Panel is the first of three requested deliverables within this mandate. It has its focus on tiered acute and chronic effect assessment schemes with detailed guidance on tier 1 and higher tier effect assessments for aquatic organisms in edge-of-field surface waters and on proposals regarding how to link effects to exposure estimates. The exposure assessment methodology was not reviewed and it is assumed that the current FOCUS surface water exposure assessment methodology will continue to be used for exposure assessment at EU level. The current GD is intended to be used for authorisation of active substances at EU level as well as for plant protection products at Member State level. The effect assessment schemes in this GD allow for the derivation of regulatory acceptable concentrations (RACs) on the basis of two options: (1) the ecological threshold option (ETO), accepting negligible population effects only, and (2) the ecological recovery option (ERO), accepting some population-level effects if ecological recovery takes place within an acceptable time period. In the tiered effect assessment schemes, in principle, all tiers (1, 2 and 3) are able to address the ETO, while the model ecosystem approach (tier 3), under certain conditions, is able to also address the ERO. The GD provides the scientific background for the risk assessment to aquatic organisms in edge-of-field surface waters and is structured to give detailed guidance on all assessment steps. An executive summary joining all parts of the guidance and decision schemes in a concise way is provided and is intended to help applicants and regulatory authorities in day-to-day use. (C) European Food Safety Authority, 2013.