Update: use of the benchmark dose approach in risk assessment
Update: use of the benchmark dose approach in risk assessment
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DOI：
10.2903/j.efsa.2017.4658
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发表时间：
2017-01-01
期刊：
影响因子：
3.3
通讯作者：
Schlatter, Josef R.
中科院分区：
文献类型：
--
作者：
Hardy, Anthony;Benford, Diane;Schlatter, Josef R.
科学委员会（SC）再次确认，与NOAEL方法相比，基准剂量（BMD）方法是一种更先进的科学方法，用于推导参考点（RP）。对2009年SC指南所做的大部分修改涉及提供如何应用BMD方法的指导的部分。建议将模型平均值作为计算BMD置信区间的首选方法，同时承认相关工具仍在开发中，可能不容易为所有人所用。因此，选择或拒绝模型仍然被认为是一个次优的选择。已审查了用于BMD分析的默认模型集，并引入了Akaike信息准则（AIC），而不是对数似然，以验证不同数学模型对剂量-反应数据集的拟合优度。在本更新中还插入了一个流程图，以指导读者在进行BMD分析时逐步进行，以及一个关于剂量-反应模型分布部分的章节和一个以完整和透明的方式报告BMD分析的模板。最后，建议始终报告BMD置信区间，而不是BMD值。需要下限（BMDL）作为潜在的RP，需要上限（BMDU）来建立反映BMD估计不确定性的BMDU/BMDL/比值。本更新指南不要求对使用2009年SC指南中所述NOAEL方法或BMD方法的既往评估进行一般性重新评价，特别是当暴露量明显小于（例如，超过一个数量级）基于健康的指导值时。最后，鉴于BMD方法的预期广泛应用，SC坚定地重申重新考虑测试指南。(C)2017年欧洲食品安全局。由John Wiley and Sons Ltd代表欧洲食品安全局出版的EFSA期刊。
The Scientific Committee (SC) reconfirms that the benchmark dose (BMD) approach is a scientifically more advanced method compared to the NOAEL approach for deriving a Reference Point (RP). Most of the modifications made to the SC guidance of 2009 concern the section providing guidance on how to apply the BMD approach. Model averaging is recommended as the preferred method for calculating the BMD confidence interval, while acknowledging that the respective tools are still under development and may not be easily accessible to all. Therefore, selecting or rejecting models is still considered as a suboptimal alternative. The set of default models to be used for BMD analysis has been reviewed, and the Akaike information criterion (AIC) has been introduced instead of the log-likelihood to characterise the goodness of fit of different mathematical models to a dose-response data set. A flowchart has also been inserted in this update to guide the reader step-by-step when performing a BMD analysis, as well as a chapter on the distributional part of dose-response models and a template for reporting a BMD analysis in a complete and transparent manner. Finally, it is recommended to always report the BMD confidence interval rather than the value of the BMD. The lower bound (BMDL) is needed as a potential RP, and the upper bound (BMDU) is needed for establishing the BMDU/BMDL per ratio reflecting the uncertainty in the BMD estimate. This updated guidance does not call for a general re-evaluation of previous assessments where the NOAEL approach or the BMD approach as described in the 2009 SC guidance was used, in particular when the exposure is clearly smaller (e.g. more than one order of magnitude) than the health-based guidance value. Finally, the SC firmly reiterates to reconsider test guidelines given the expected wide application of the BMD approach. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.