Pedersen Ragnor
EFSA J. 2017 Jul 27;15(7):e04906. doi: 10.2903/j.efsa.2017.4906. eCollection 2017 Jul.
Applicability of the is tested in the context of an EFSA Reasoned Opinion on the modification of pesticide maximum residue levels (MRLs). EFSA purchased services for the preparation of a non-regulatory Evaluation Report with example non-standard uncertainties related to a fictitious application for the modification of MRLs. The Evaluation Report was assessed by EFSA in the format of a Reasoned Opinion and case-specific examples of non-standard uncertainty in the acute and chronic dietary risk assessments were analysed. Methods were selected from the general framework outlined in the Scientific Committee draft Guidance in order to apply a relatively simple strategy that could be considered for use in a regulatory context. The individual non-standard uncertainties were assessed by sensitivity analysis with iterative back-calculation of the parameter values that would lead to exceedance of the toxicological reference value (exceedance limit calculation), and quantified by subjective probability estimation. Non-standard uncertainties affecting the chronic risk assessment were quantified by subjective upper bound probability percentile estimation and the combined estimated non-standard uncertainty calculated by probability bounds analysis. Probability bounds analysis provides a relatively simple approach for calculating the probability related to a combination of uncertainties. The draft Guidance was found to provide a comprehensive range of methods for uncertainty analysis. However, process-specific guidelines and practical procedures may need to be developed in order to implement the uncertainty assessment framework in routine pesticide risk assessments. The uncertainty assessment is intended to provide additional information on how certain the conclusions of the risk assessment are and thereby support the risk-based decision-making process by enabling risk managers to take account of uncertainty. The outcome of the pilot study will inform the EFSA Scientific Committee Working Group on how to further tailor the draft Guidance on uncertainty for the needs of the EFSA panels and units.
在欧洲食品安全局（EFSA）关于农药最大残留限量（MRL）修改的有理意见背景下，对[具体内容未提及]的适用性进行了测试。EFSA购买了服务，以编制一份非监管评估报告，其中包含与虚构的MRL修改申请相关的非标准不确定性示例。EFSA以有理意见的形式对评估报告进行了评估，并分析了急性和慢性膳食风险评估中特定案例的非标准不确定性示例。从科学委员会指南草案概述的总体框架中选择方法，以便应用一种相对简单的策略，该策略可考虑用于监管背景。通过对导致超过毒理学参考值的参数值进行迭代反算的敏感性分析（超标限值计算）来评估各个非标准不确定性，并通过主观概率估计进行量化。影响慢性风险评估的非标准不确定性通过主观上限概率百分位数估计进行量化，并通过概率边界分析计算综合估计的非标准不确定性。概率边界分析为计算与不确定性组合相关的概率提供了一种相对简单的方法。发现指南草案提供了一系列全面的不确定性分析方法。然而，可能需要制定特定流程的指南和实际程序，以便在常规农药风险评估中实施不确定性评估框架。不确定性评估旨在提供关于风险评估结论的确定性程度的额外信息，从而通过使风险管理者能够考虑不确定性来支持基于风险的决策过程。试点研究的结果将告知EFSA科学委员会工作组如何进一步根据EFSA各小组和部门的需求调整不确定性指南草案。
