农产品膳食暴露评估模型构建及其应用
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摘要
食源性危害,一直是全球性的棘手问题,不仅危害公众健康,还造成大量经济损失。自然界的生物、化学或物理等方面的因素都可能会引发影响人体健康的食源性风险,而风险评估将是未来减少食源性疾病、强化食品安全体系的重要手段。
风险评估由危害识别、危害特征描述、暴露评估和风险特征描述4个基本步骤组成。其中,危害识别和危害特征描述可参照FAO/WHO的工作,直接采纳相关信息。暴露评估,作为风险评估重要的组成部分,是对经食物或其他途径而可能摄入人体体内的生物、化学和物理因素进行的定性和/或定量评价。国家的主管部门在实施本国的膳食暴露评估时,通常推荐使用本国的食品消费数据和化学物浓度检测数据,与国际公认的毒性参考剂量作比照。风险特征描述作为评估的最后一个阶段,是对前三个阶段所收集信息的综合描述。
当前国际上广泛使用膳食暴露评估技术评价农产品质量安全。膳食暴露评估的模型构建并不是一个新的统计问题,但一个好的膳食暴露评估模型应满足两个必要条件：一是反映现实情况、二是有良好的数据支持。为切实评价我国农产品质量安全现状,本文在简单分布模型的基础上,提出了适用于我国农产品膳食暴露评估的模型；并以稻米中总汞检测数据为参照,就评估关注的高百分位数估计与样本量的关系进行了细致的模拟研究,以期为农产品膳食暴露评估的采样量提供参考。之后,以个案评估(南方6省稻米总汞含量调查及其膳食暴露评估)的形式检验了上述模型的可靠性和实用性。同时,据膳食暴露评估的模型构建理论,研发了“膳食暴露模拟分析模型”这一软件。主要内容如下：
(1)构建了一种适用于我国农产品膳食暴露评估的模型
膳食暴露评估模型大体可分为确定性模型和概率模型两类。相对而言,确定性模型简单易行但结果保守粗糙；概率模型可度量结果的变异性和不确定性,但对数据质量的要求较高,且在评估模型从非参数向参数发展的过程中,需要大量的经验数据作支撑。由于数据交流不足,缺乏我国农产品的详细消费数据,无法满足概率评估模型的需要。为充分利用现有的信息,本文立足于我国农产品质量安全评价的需要,以农产品中的化学物浓度数据为关注点,改进传统的简单分布模型,将农产品中的化学物浓度数据定义为分布,相应的消费量设为固定值,对暴露量进行估计。为克服“最坏情况”假设导致的结果偏倚,模型基于对相关农产品的平均消费水平构建。同时,为改善这一模型的粗糙性,参照“中国居民营养与健康状况调查报告”,将中国居民分为多个性别年龄组输入模型分析,尽可能地体现消费水平在人群性别年龄间的变异,切实反映农产品的安全状况。文中还一并给出了在该模型中度量变异性和不确定性的方法。
(2)探究了膳食暴露评估中化学物浓度数据的适宜采样量
百分位数是描述偏态分布资料的重要参数。而膳食暴露评估涉及的化学物浓度数据多为右偏分布,故评估结果惯用百分位数描述。但对于偏态分布来说,如何确定样本量才能使百分位数的估计经济准确,尚少研究。本文参照稻米中总汞的检测数据,用右偏分布(Weibull分布和对数正态分布)拟合相关数据,就评估关注的高百分位数估计与样本量的关系进行了模拟研究。在此基础上,进一步以暴露评估常用的对数正态分布为代表,从分布形态、分布变异的角度对上述关系进行了细致探讨。结果表明：(1)对右偏分布来说,百分位数越高,准确估计它所需的样本量就越大。且估计值随样本量的增大而趋近理论值,精度也随之增大。样本量500时,本文考察的2种右偏分布除P99.9外的其它百分位数都得到了较为准确的估计。(2)估计相同的百分位数,对数正态分布所需的样本量要比正态分布大得多；且分布变异越大,所需的样本容量也就越大。介于化学物浓度数据呈右偏分布的特殊性,在暴露评估中,适宜的采样量是评估高效准确的保证。
(3)依托改进后的简单分布模型和采样量的指导原则开展了实例评估
实例评估对象为中国南方6省稻米中总汞的污染现状。于2009年在江西、湖北、湖南、广东、广西和四川6省抽样检测了1321份稻米样品,结合中国居民20个性别年龄组人群的稻米消费量和体重信息,采用改进后的非参数简单分布模型对稻米中总汞的膳食暴露量进行了评估。总汞含量采用电感耦合等离子体质谱仪(ICP-MS)测定,检出限(LOD)为0.0008mg·kg-1。结果表明,稻米的总汞含量在地区间存在着差异,虽然有76.2%的样本总汞含量(0.0008～0.0634mg·kg-1)高于检出限,但仅有2.3%的样本超出了最高限量(ML)0.02mg-kg-1。将评估结果比照JECFA推荐的总汞暂定每周耐受摄入量(PTWI)5μg·(kg bw)-1我国居民食用南方这6省稻米产生的总汞暴露风险较小。但在P99.9的高百分位水平下,14岁以下人群的摄入量相对较高,占PTWI的41.5%-62.9%。其中,2-4岁儿童和4-7岁男童的摄入量占PTWI的60%以上,潜在的风险较大。与前人基于总膳食所得到的评估结果相比,可证明本文提出的模型和采样量确有其可行性及实用价值。
(4)研发了“膳食暴露模拟分析模型”软件
为提升我国农产品质量安全评估水平,本研究基于膳食暴露评估模型构建理论,研发了“膳食暴露模拟分析模型”这一软件。且通过恰当的设置,适用于我国农产品质量安全评价的改进的简单分布模型也可在该软件中得到很好地分析应用。对评估实例的比较分析结果表明：该软件不仅分析结果可信,相对于@Risk和SAS软件,具有执行效率高、操作简便、便于推广应用等特点。
Food-borne hazard remains a real and formidable problem on the global scale, causing great human suffering and significant economic loss. The food-borne risk to human health can arise from hazards that are biological, chemical or physical in nature. A key discipline for future reducing food-borne illness and strengthening food safety systems is risk assessment.
Risk assessments are performed in a four-step process:hazard identification, hazard characterization, exposure assessment, and risk characterization. Information of hazard identification and hazard characterization can usually be extracted from the work of FAO/WHO, and applied directly. Exposure assessment, an essential element for quantifying risk, is defined as "the qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant". It is recommended that national authorities that will to perform their own dietary exposure assessments use national food consumption and concentration data, but international toxicological reference values. And then, the latter step (risk characterization) integrates the information collected in the preceding three steps.
Dietary exposure assessment is increasingly being performed internationally to evaluate safety and quality of agricultural products. Although model construction is by no means a new subject in the statistical literature, a good model for dietary exposure assessment must be derived from realistic scenarios and high-quality data. In order to feasibly evaluate safety and quality of agricultural products, this paper improved the simple-distribution method to bring forward a feasible and realistic model specific for the dietary exposure assessment of Chinese agricultural products. It also included an intensive simulation study on the relationship between sample size and high percentile estimates referring to contamination data of total mercury exposure in milled rice, which would be helpful to the sample survey of dietary exposure assessment. And then a case study (survey and dietary exposure assessment of total mercury in milled rice farmed in6provinces of southern China) was conducted to examine the reliability and practicality of the proposed model. Finally, software called "dietary exposure assessment model" was developed based on model construction theories. The main contents include:
(1) Proposed a feasible and realistic model specific for the dietary exposure assessment of Chinese agricultural products
Deterministic model and probabilistic model are two main approaches to combine or integrate the data to provide an estimate of exposure. Deterministic model is easy to carry out, but its single risk estimate is conservative and rough. In comparison, probabilistic model use all available data and knowledge, and that variability and uncertainty can be quantified. And also there is a high demand for empirical data through the transition from non-parametric to parametric techniques. But the insufficiency of consumption data of Chinese agricultural products resulting from the lack of data communication can't meet the data bulk requirement of probabilistic model. In order to make full use of the existed information to evaluate safety and quality of Chinese agricultural products pertinently, this paper focusing on the residue/concentration data, improved the simple-distribution method to bring forward a feasible and realistic model specific for the dietary exposure assessment of Chinese agricultural products. The improved simple-distribution was a method that employed a fixed value for food consumption variables and an empirical distribution of chemical concentrations in that food. The new model that assumed individuals with high exposure to the substance in question consume the relevant foods predominantly at average level would generally overcome this particular problem of "worst-case" assumptions. And to make the assessment more refined, age-gender groups quoting from the Chinese national health and nutrition survey were introduced into the model to take account of variation in consumption among people of interest preliminarily. The measure method of variability and uncertainty was also described in detail.
(2) Launched a simulation study on appropriate sample sizes of contaminated data for dietary exposure assessment
A percentile is the value of a variable below which a certain percent of observations fall. As exposure assessment mostly involves positively skewed data, its result should be presented in the form of percentiles. However, how to determine an appropriate sample size to obtain the most economic and effective percentile estimation has seldom been studied. With the benefit of computer simulation, this paper set out to study the relationship using contamination data of total mercury in milled rice as materials. Weibull distribution and Log-normal distribution were used to fit the data. And Log-normal distribution has been further selected to study the impact of distribution pattern and variation on percentile estimates. The simulation results showed as follows:(1) Accurately estimating a higher percentile of the positively skewed distribution would require a larger sample size. And a larger sample size always resulted in a more accurate and more stable estimated percentile. With a sample size of500, we accurately estimated all the target percentiles of the2positively skewed distributions except the result of P99.9.(2) Estimating the same percentile using Log-normal distribution required far larger sample size than it needed when using a normal distribution. Moreover, the sample size needed for Log-normal distribution estimation was positively correlated to the magnitude of the variation of the skewed distribution. Considering the positively skewed data, an economic and effective assessment must be based on an appropriate sample size.
C3) Performed a case study to verify the reliability and practicality of the proposed model and sampling guideline
The case study investigated the occurrence of total mercury in milled rice from6provinces of southern China during harvest in2009, and determined the dietary exposure of target population using an improved non-parameter simple-distribution method with information on rice consumption and body weight. Altogether1321milled rice samples were collected from Jiangxi, Hubei, Hunan, Guangdong, Guangxi and Sichuan Provinces. Total mercury was measured by inductively coupled plasma-mass spectrometry (ICP-MS), and the limit of detection (LOD) for it was0.0008mg-kg-1. The analytical results showed that76.2%of the samples contained detectable concentrations of total mercury, which ranged from0.0008to0.0634mg-kg-1, but levels were generally low, with only2.3%of the samples having concentrations above0.02mg-kg-1, the maximum level (ML). On the other hand, there was an apparent regional difference found for the concentrations of total mercury in milled rice. The provisional tolerable weekly intake (PTWI) of total mercury, as recommended by Joint FAO/WHO Expert Committee on Food Additives (JECFA) is5μg·(kg bw)-1. The estimated exposure values for populations of interest were compared to the PTWI. For the relevant population, this study confirmed the low probability of health risks from total mercury via the milled rice from the6provinces of southern China. But exposure to total mercury for the population below14years old at P99.9represented41.5%-62.9%of the PTWI. While for children aged2-4years and boy aged4-7years, their estimated exposure at P99.9were all over60%of the PTWI suggesting a potential risk. Compared with the previous research result gotten from the total dietary study, the proposed model and sampling guideline were reliable and practicable.
(4) Developed and released software "dietary exposure assessment model"
In order to enhance Chinese assessment level of quality and safety for agricultural products,"dietary exposure assessment model" was developed based on model construction theories. And through appropriately setting, the improved simple-distribution method can be implemented in the software. A case study was conducted to compare "dietary exposure assessment model" with@Risk and SAS. The results showed that:the dietary exposure assessment model not only got accurate results, but also behaved effect, feasible and friendly.
风险评估由危害识别、危害特征描述、暴露评估和风险特征描述4个基本步骤组成。其中,危害识别和危害特征描述可参照FAO/WHO的工作,直接采纳相关信息。暴露评估,作为风险评估重要的组成部分,是对经食物或其他途径而可能摄入人体体内的生物、化学和物理因素进行的定性和/或定量评价。国家的主管部门在实施本国的膳食暴露评估时,通常推荐使用本国的食品消费数据和化学物浓度检测数据,与国际公认的毒性参考剂量作比照。风险特征描述作为评估的最后一个阶段,是对前三个阶段所收集信息的综合描述。
当前国际上广泛使用膳食暴露评估技术评价农产品质量安全。膳食暴露评估的模型构建并不是一个新的统计问题,但一个好的膳食暴露评估模型应满足两个必要条件：一是反映现实情况、二是有良好的数据支持。为切实评价我国农产品质量安全现状,本文在简单分布模型的基础上,提出了适用于我国农产品膳食暴露评估的模型；并以稻米中总汞检测数据为参照,就评估关注的高百分位数估计与样本量的关系进行了细致的模拟研究,以期为农产品膳食暴露评估的采样量提供参考。之后,以个案评估(南方6省稻米总汞含量调查及其膳食暴露评估)的形式检验了上述模型的可靠性和实用性。同时,据膳食暴露评估的模型构建理论,研发了“膳食暴露模拟分析模型”这一软件。主要内容如下：
(1)构建了一种适用于我国农产品膳食暴露评估的模型
膳食暴露评估模型大体可分为确定性模型和概率模型两类。相对而言,确定性模型简单易行但结果保守粗糙；概率模型可度量结果的变异性和不确定性,但对数据质量的要求较高,且在评估模型从非参数向参数发展的过程中,需要大量的经验数据作支撑。由于数据交流不足,缺乏我国农产品的详细消费数据,无法满足概率评估模型的需要。为充分利用现有的信息,本文立足于我国农产品质量安全评价的需要,以农产品中的化学物浓度数据为关注点,改进传统的简单分布模型,将农产品中的化学物浓度数据定义为分布,相应的消费量设为固定值,对暴露量进行估计。为克服“最坏情况”假设导致的结果偏倚,模型基于对相关农产品的平均消费水平构建。同时,为改善这一模型的粗糙性,参照“中国居民营养与健康状况调查报告”,将中国居民分为多个性别年龄组输入模型分析,尽可能地体现消费水平在人群性别年龄间的变异,切实反映农产品的安全状况。文中还一并给出了在该模型中度量变异性和不确定性的方法。
(2)探究了膳食暴露评估中化学物浓度数据的适宜采样量
百分位数是描述偏态分布资料的重要参数。而膳食暴露评估涉及的化学物浓度数据多为右偏分布,故评估结果惯用百分位数描述。但对于偏态分布来说,如何确定样本量才能使百分位数的估计经济准确,尚少研究。本文参照稻米中总汞的检测数据,用右偏分布(Weibull分布和对数正态分布)拟合相关数据,就评估关注的高百分位数估计与样本量的关系进行了模拟研究。在此基础上,进一步以暴露评估常用的对数正态分布为代表,从分布形态、分布变异的角度对上述关系进行了细致探讨。结果表明：(1)对右偏分布来说,百分位数越高,准确估计它所需的样本量就越大。且估计值随样本量的增大而趋近理论值,精度也随之增大。样本量500时,本文考察的2种右偏分布除P99.9外的其它百分位数都得到了较为准确的估计。(2)估计相同的百分位数,对数正态分布所需的样本量要比正态分布大得多；且分布变异越大,所需的样本容量也就越大。介于化学物浓度数据呈右偏分布的特殊性,在暴露评估中,适宜的采样量是评估高效准确的保证。
(3)依托改进后的简单分布模型和采样量的指导原则开展了实例评估
实例评估对象为中国南方6省稻米中总汞的污染现状。于2009年在江西、湖北、湖南、广东、广西和四川6省抽样检测了1321份稻米样品,结合中国居民20个性别年龄组人群的稻米消费量和体重信息,采用改进后的非参数简单分布模型对稻米中总汞的膳食暴露量进行了评估。总汞含量采用电感耦合等离子体质谱仪(ICP-MS)测定,检出限(LOD)为0.0008mg·kg-1。结果表明,稻米的总汞含量在地区间存在着差异,虽然有76.2%的样本总汞含量(0.0008～0.0634mg·kg-1)高于检出限,但仅有2.3%的样本超出了最高限量(ML)0.02mg-kg-1。将评估结果比照JECFA推荐的总汞暂定每周耐受摄入量(PTWI)5μg·(kg bw)-1我国居民食用南方这6省稻米产生的总汞暴露风险较小。但在P99.9的高百分位水平下,14岁以下人群的摄入量相对较高,占PTWI的41.5%-62.9%。其中,2-4岁儿童和4-7岁男童的摄入量占PTWI的60%以上,潜在的风险较大。与前人基于总膳食所得到的评估结果相比,可证明本文提出的模型和采样量确有其可行性及实用价值。
(4)研发了“膳食暴露模拟分析模型”软件
为提升我国农产品质量安全评估水平,本研究基于膳食暴露评估模型构建理论,研发了“膳食暴露模拟分析模型”这一软件。且通过恰当的设置,适用于我国农产品质量安全评价的改进的简单分布模型也可在该软件中得到很好地分析应用。对评估实例的比较分析结果表明：该软件不仅分析结果可信,相对于@Risk和SAS软件,具有执行效率高、操作简便、便于推广应用等特点。
Food-borne hazard remains a real and formidable problem on the global scale, causing great human suffering and significant economic loss. The food-borne risk to human health can arise from hazards that are biological, chemical or physical in nature. A key discipline for future reducing food-borne illness and strengthening food safety systems is risk assessment.
Risk assessments are performed in a four-step process:hazard identification, hazard characterization, exposure assessment, and risk characterization. Information of hazard identification and hazard characterization can usually be extracted from the work of FAO/WHO, and applied directly. Exposure assessment, an essential element for quantifying risk, is defined as "the qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food as well as exposures from other sources if relevant". It is recommended that national authorities that will to perform their own dietary exposure assessments use national food consumption and concentration data, but international toxicological reference values. And then, the latter step (risk characterization) integrates the information collected in the preceding three steps.
Dietary exposure assessment is increasingly being performed internationally to evaluate safety and quality of agricultural products. Although model construction is by no means a new subject in the statistical literature, a good model for dietary exposure assessment must be derived from realistic scenarios and high-quality data. In order to feasibly evaluate safety and quality of agricultural products, this paper improved the simple-distribution method to bring forward a feasible and realistic model specific for the dietary exposure assessment of Chinese agricultural products. It also included an intensive simulation study on the relationship between sample size and high percentile estimates referring to contamination data of total mercury exposure in milled rice, which would be helpful to the sample survey of dietary exposure assessment. And then a case study (survey and dietary exposure assessment of total mercury in milled rice farmed in6provinces of southern China) was conducted to examine the reliability and practicality of the proposed model. Finally, software called "dietary exposure assessment model" was developed based on model construction theories. The main contents include:
(1) Proposed a feasible and realistic model specific for the dietary exposure assessment of Chinese agricultural products
Deterministic model and probabilistic model are two main approaches to combine or integrate the data to provide an estimate of exposure. Deterministic model is easy to carry out, but its single risk estimate is conservative and rough. In comparison, probabilistic model use all available data and knowledge, and that variability and uncertainty can be quantified. And also there is a high demand for empirical data through the transition from non-parametric to parametric techniques. But the insufficiency of consumption data of Chinese agricultural products resulting from the lack of data communication can't meet the data bulk requirement of probabilistic model. In order to make full use of the existed information to evaluate safety and quality of Chinese agricultural products pertinently, this paper focusing on the residue/concentration data, improved the simple-distribution method to bring forward a feasible and realistic model specific for the dietary exposure assessment of Chinese agricultural products. The improved simple-distribution was a method that employed a fixed value for food consumption variables and an empirical distribution of chemical concentrations in that food. The new model that assumed individuals with high exposure to the substance in question consume the relevant foods predominantly at average level would generally overcome this particular problem of "worst-case" assumptions. And to make the assessment more refined, age-gender groups quoting from the Chinese national health and nutrition survey were introduced into the model to take account of variation in consumption among people of interest preliminarily. The measure method of variability and uncertainty was also described in detail.
(2) Launched a simulation study on appropriate sample sizes of contaminated data for dietary exposure assessment
A percentile is the value of a variable below which a certain percent of observations fall. As exposure assessment mostly involves positively skewed data, its result should be presented in the form of percentiles. However, how to determine an appropriate sample size to obtain the most economic and effective percentile estimation has seldom been studied. With the benefit of computer simulation, this paper set out to study the relationship using contamination data of total mercury in milled rice as materials. Weibull distribution and Log-normal distribution were used to fit the data. And Log-normal distribution has been further selected to study the impact of distribution pattern and variation on percentile estimates. The simulation results showed as follows:(1) Accurately estimating a higher percentile of the positively skewed distribution would require a larger sample size. And a larger sample size always resulted in a more accurate and more stable estimated percentile. With a sample size of500, we accurately estimated all the target percentiles of the2positively skewed distributions except the result of P99.9.(2) Estimating the same percentile using Log-normal distribution required far larger sample size than it needed when using a normal distribution. Moreover, the sample size needed for Log-normal distribution estimation was positively correlated to the magnitude of the variation of the skewed distribution. Considering the positively skewed data, an economic and effective assessment must be based on an appropriate sample size.
C3) Performed a case study to verify the reliability and practicality of the proposed model and sampling guideline
The case study investigated the occurrence of total mercury in milled rice from6provinces of southern China during harvest in2009, and determined the dietary exposure of target population using an improved non-parameter simple-distribution method with information on rice consumption and body weight. Altogether1321milled rice samples were collected from Jiangxi, Hubei, Hunan, Guangdong, Guangxi and Sichuan Provinces. Total mercury was measured by inductively coupled plasma-mass spectrometry (ICP-MS), and the limit of detection (LOD) for it was0.0008mg-kg-1. The analytical results showed that76.2%of the samples contained detectable concentrations of total mercury, which ranged from0.0008to0.0634mg-kg-1, but levels were generally low, with only2.3%of the samples having concentrations above0.02mg-kg-1, the maximum level (ML). On the other hand, there was an apparent regional difference found for the concentrations of total mercury in milled rice. The provisional tolerable weekly intake (PTWI) of total mercury, as recommended by Joint FAO/WHO Expert Committee on Food Additives (JECFA) is5μg·(kg bw)-1. The estimated exposure values for populations of interest were compared to the PTWI. For the relevant population, this study confirmed the low probability of health risks from total mercury via the milled rice from the6provinces of southern China. But exposure to total mercury for the population below14years old at P99.9represented41.5%-62.9%of the PTWI. While for children aged2-4years and boy aged4-7years, their estimated exposure at P99.9were all over60%of the PTWI suggesting a potential risk. Compared with the previous research result gotten from the total dietary study, the proposed model and sampling guideline were reliable and practicable.
(4) Developed and released software "dietary exposure assessment model"
In order to enhance Chinese assessment level of quality and safety for agricultural products,"dietary exposure assessment model" was developed based on model construction theories. And through appropriately setting, the improved simple-distribution method can be implemented in the software. A case study was conducted to compare "dietary exposure assessment model" with@Risk and SAS. The results showed that:the dietary exposure assessment model not only got accurate results, but also behaved effect, feasible and friendly.
引文
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