李晶, 徐军, 董丰收, 刘新刚, 单炜力, 郑永权. 由规范残留试验数据推荐农药最大残留限量的方法概述[J]. 农药学学报, 2010, 12(3): 237-248.
    引用本文: 李晶, 徐军, 董丰收, 刘新刚, 单炜力, 郑永权. 由规范残留试验数据推荐农药最大残留限量的方法概述[J]. 农药学学报, 2010, 12(3): 237-248.
    LI Jing, XU Jun, DONG Feng-shou, LIU Xin-gang, SHAN Wei-li, ZHENG Yong-quan. Overview on the statistically-based methods for establishing MRLs based on supervised field trial data[J]. Chinese Journal of Pesticide Science, 2010, 12(3): 237-248.
    Citation: LI Jing, XU Jun, DONG Feng-shou, LIU Xin-gang, SHAN Wei-li, ZHENG Yong-quan. Overview on the statistically-based methods for establishing MRLs based on supervised field trial data[J]. Chinese Journal of Pesticide Science, 2010, 12(3): 237-248.

    由规范残留试验数据推荐农药最大残留限量的方法概述

    Overview on the statistically-based methods for establishing MRLs based on supervised field trial data

    • 摘要: 农药最大残留限量(MRLs)是指农药在食品和饲料中的最高法定容许残留浓度。MRLs的制定可检验食品生产过程中是否严格执行良好农业规范(GAP),对农产品的进出口贸易影响很大,因而,制定MRLs所依据的方法也尤为重要。综述了欧盟、北美自由贸易协定(NAFTA)成员国及经济合作与发展组织(OECD)等管理机构提出的几种基于统计学原理的估算方法,比较并讨论了各方法的优缺点。EU methodⅠ方法目前已在欧盟各国广泛使用,对于相同或相近的数据集,采用该方法可得出一致的评估结果,但该方法建立在残留数据呈正态分布这一假设基础之上,而欧盟却并未对此假设的合理性作出相应的评估和测试;EU methodⅡ方法适用于对任意分布的数据集的MRLs进行评估,涉及到的计算不会受到数据集中高残留数据的影响,该方法建立在将第75百分位数值加倍以确保估算得出的MRLs足够高且不会被超过的原理基础之上,但目前尚未从统计学角度对该原理予以证明;NAFTA对数正态分布方法是在EU methodⅠ基础上的改进方法,也称作"95/99法则",该方法能对所有呈对数正态分布的残留数据第95百分位数的95%置信上限提供无偏估计,但要求田间试验数据集接近对数正态分布,数据集必须具有足够大的样本量以确保能准确评估第99百分位数和第95百分位数的置信上限,且数据集中必须有足够数量的高于检测限的残留数据;目前最新版本的OECD计算器方法不再对数据分布进行讨论,方法的精确度能随着数据集样本量的增加而提高,且能对高百分位数,如至少具有15到20个数据点的数据集的第95百分位数提供十分准确的估算。 目前,OECD工作组正在探索"平均值+4倍标准差"的评估方法,该方法能对呈对数正态分布数据集的第95百分位数进行更好的估计。

       

      Abstract: Maximum residue limits (MRLs) are legal limits for residue concentrations of pesticides on/in foods and feeds.MRLs are intended primarily as a check that the GAP is being followed and to assist international trade in importing and exporting produce treated with pesticides.Therefore the methods used for setting these MRLs were also of great concern.Several statistically-based calculation methods that had been developed and available to the international regulatory community were reviewed.The technical details of each of these methods are provided followed by a discussion of their merits and shortcomings.For example,the EU methodⅠwas in use and accepted internationally in the EU and the method could result in consistent estimates when the same or similar data was used.However,this method assumes that pesticide residues data are distributed normally and the EC provides no recommendation for testing the validity of this assumption even though the calculation produces biased estimates if the normality assumption is not met.As for EU Method Ⅱ,one advantage of the calculation used in this method is that it is not based on any distributional assumptions.And the calculation involved is generally not influenced by the presences of high values in the data set.However,when using Method Ⅱ,the estimated MRLs is unaffected by the upper quartile of the data set.Additionally,there is no statistical support provided for the rationale of this method.NAFTA Lognormal Method,is the modified version of EU Method Ⅰ ,it is also referred to as the "95/99 Rule".The method could produce unbiased estimates of the 95% UCL of the 95th percentile for the data that are distributed lognormally.However,the method requires that the data set approximate a lognormal distribution;that the data set be of sufficient size such that a reasonable UCL on the 95th percentile or point estimate of the 99th percentile can be estimated;and that there be a sufficient number or proportion of detectable ( >LOD) residue values such that the method can be used.The OECD working group has recently dropped the distributional approaches from the calculator.The precision of the OECD calculator method is increasing as the dataset size increases and the method can provide reasonably good estimates of high percentiles like the 95th for datasets that have at least between 15 and 20 points.The specific method now being explored is the "Mean+4×Standard Deviation" method,where the number of standard deviations taken is increased to four to get a better estimate of the 95th percentile of a lognormal distribution.

       

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