Beulke Sabine, van Beinum Wendy, Suddaby Laura
The Food and Environment Research Agency, Sand Hutton, York, United Kingdom.
Integr Environ Assess Manag. 2015 Apr;11(2):276-86. doi: 10.1002/ieam.1607. Epub 2015 Jan 15.
First-tier regulatory exposure assessments for pesticides assume that pesticide sorption is instantaneous and fully reversible. In European Union (EU) regulatory guidance, an increase in sorption over time ("aged sorption") can be considered at the higher tier to refine predicted environmental concentrations in groundwater. Research commissioned by the UK Chemicals Regulation Directorate (CRD), funded by the Department for Environment Food & Rural Affairs (Defra), formed the basis of a draft regulatory guidance document proposing 1) a protocol on how to measure aged sorption of parent compounds in laboratory studies, 2) procedures to fit kinetic models to the experimental data, 3) criteria to test the reliability of the parameters, and 4) procedures for use of the parameters in the groundwater exposure assessment. The draft guidance was revised after feedback from stakeholders and testing of the guidance was performed against real data sets by an independent consultancy. The Chemicals Regulation Directorate submitted the revised document to the European Food Safety Authority (EFSA) for scrutiny. This article gives an overview of the draft guidance and explains the reasoning behind the recommendations made.
农药的一级监管暴露评估假定农药吸附是即时且完全可逆的。在欧盟(EU)的监管指南中,随着时间推移吸附增加(“老化吸附”)可在更高层级予以考虑,以完善对地下水中预测环境浓度的估算。由英国化学品监管局(CRD)委托开展、环境食品与农村事务部(Defra)资助的研究,构成了一份监管指南草案的基础,该草案提议:1)关于在实验室研究中如何测量母体化合物老化吸附的方案;2)将动力学模型拟合到实验数据的程序;3)检验参数可靠性的标准;4)在地下水暴露评估中使用这些参数的程序。在收到利益相关者的反馈后,对该指南草案进行了修订,并由一家独立咨询公司针对实际数据集对该指南进行了测试。化学品监管局将修订后的文件提交给了欧洲食品安全局(EFSA)进行审查。本文概述了该指南草案,并解释了所提建议背后的理由。