证据权重法在双酚A人群流行病学数据危害评估中的应用研究

目的 使用证据权重法对双酚A（BPA）人群流行病学数据进行评估,推断BPA暴露与人体不良健康效应之间的关系。方法 基于证据权重法,对2013—2020年发表的BPA人群流行病学文献进行系统检索、筛选、分类,依据国家食品安全风险评估中心制定的毒理学数据相关性与可靠性评价指南进行评价,按不同毒性效应终点进行危害评估。结果 对检索的134 897篇文献进行筛选后共获得文献188篇,其中68篇文献相关性评价等级为“A/B”或“B”,其余文献相关性评价等级为“C”。仅对相关性评价等级为“A/B”或“B”的文献进行可靠性评价,其中6篇文献可靠性评价等级为“高”,62篇文献可靠性评价等级为“中”,涉及的毒性效应终点包括代谢、生殖发育、神经、免疫、心血管效应等,但各研究结局由于人群、暴露期限、指标设计等原因,具有一致性的效应指标较少。结论 基于现有人群流行病学证据,尚无法明确BPA暴露与人体不良健康效应之间的因果关系。     

基于管理毒理学的毒性实验数据的系统评价

毒理学实验数据是反映化学品安全性的重要依据,在化学品的风险评估和风险管理中起着重要的作用。有效地利用不同实验室提供的毒理学数据,为管理毒理学服务,需要建立一套科学、可行的评价体系来评价毒理学数据的质量。目前国际上对毒理学数据评价系统的研究还刚刚起步,缺乏获得广泛共识的毒理学数据评价系统。本文简要论述了国际上现有的化学品毒理学数据评价系统的情况,为建立我国用于风险评估和风险管理的毒理学数据评价系统提供思路。     

食品毒理学数据库构建研究

目的 建立食品毒理学数据库（FoodTox）。方法 建立食品毒理学数据库网站,确定数据库优先入库名单,通过文献检索的方式收集相关物质的毒理学资料,利用系统文献综述（SLR）方法整理入库物质的毒理学数据。结果 食品毒理学数据库已收录1 600余种物质,相关数据包括代谢、急性毒性、遗传毒性、生殖发育毒性、亚慢性毒性、慢性毒性和致癌、人群资料、健康指导值等毒理学资料和国内外管理法规、相关食物和症状等,已经向相关领域工作者开放使用。结论 本数据库的建立将为食品毒理学工作者提供第一手的参考资料,为相关优先物质的毒理学安全性评价提供依据,为应急风险评估提供技术支持。     

日本修订食品添加削列表和食品添加州使用标准

据日本厚生省消息，6月18日厚生省更新《食品添加剂列表》和《食品添加剂使用标准》。截至6月18日，共有442种食品添加剂获得批准。日本政府对食品添加剂的批准流程为：提交申请—确认申请——审核——提请风险评估——风险评估。风险评估包括：慢性毒理学数据、致癌毒性、致畸毒性。具体见下图。     

毒理学关注阈值方法在食品接触材料风险评估中的应用

食品接触材料中包含诸多有意添加的化学助剂,在生产和使用过程中还会引入大量非有意添加物。食品接触材料中的有意和非有意添加物质种类繁多,难以得出所有物质完整的毒理学数据;而且食品接触材料中存在一些低暴露量的物质,它们对人体造成的风险较小而不必要进行传统的风险评估。毒理学关注阈值（threshold oftoxicological concern,TTC）方法作为一种新的风险评估工具,可以对缺乏完整毒理学数据且暴露量较低的化学物质进行风险评估。本文综述TTC方法对食品接触材料中的物质（结构确定和结构未知的物质）进行风险评估的具体应用。对结构已知的物质,可以参照欧洲国际生命科学学会（European International Life Sciences Institute,ILSI）专家组提出的TTC决策树方法;对于未鉴定结构的物质,可以引用一个分步分析的方法,得出未知物质是否需要进行安全关注。本文还指出了TTC方法在食品接触材料风险评估中应用的难点和今后需解决的问题,可为食品接触材料中缺乏毒性数据物质的风险评估提供依据。     

中国常用食品添加剂毒理学数据库研究

目的建立我国常用的食品添加剂毒理学数据库。方法通过文献检索的方式,收集相关的食品添加剂毒理学资料,利用系统文献综述(SLR)方法整理所研究的食品添加剂毒理学数据。结果数据库收录了20大类共374种食品添加剂,毒理学资料包括代谢、急性毒性、遗传毒性、生殖发育毒性、亚慢性毒性、慢性毒性和致癌、人群资料等7个方面。结论该数据库的建立有利于我国食品添加剂的安全使用、保护消费者健康,并促进对我国特有的食品添加剂的研究和应用。     

药食两用天麻的安全性评价研究进展

天麻是我国的名贵中药材,作为药食同源物质被广泛食用及药用。国家相关部门已经批准,将天麻按照传统既是食品又是中药材的物质进行试点管理。随着天麻药食同源在现代食品领域的广泛应用,有关天麻食品、功能性食品、活性物质、复方制剂等天麻制品的研究开发会越来越多。天麻制品的毒理学研究还不够深入,多为急性、遗传毒性试验,而亚急性、长期毒性试验的数据较少;天麻素、天麻复方制剂的临床安全性评估多为联合用药评价分析,缺乏单独使用的安全性数据。因此,探讨天麻的食用安全性对天麻制品开发具有一定的参考意义。本文概述了天麻制品的毒理学研究、临床安全性评价及环境污染风险评估研究现状,为未来天麻制品的安全性评价研究提供了新方向和思路。     

近江牡蛎糖胺聚糖毒理学的初步评价

目的:研究近江牡蛎糖胺聚糖作为保健食品使用的安全性。方法:采用急性毒性实验、遗传毒性实验(Ames实验、小鼠骨髓细胞微核实验、小鼠精子畸形实验)进行毒理学研究与评价。结果:小鼠经口最大耐受剂量(MTD)均大于20.0g/kg;3项遗传毒性实验的结果皆为阴性,未显示出致突变性。结论:近江牡蛎糖胺聚糖急性毒性分级属无毒级,无遗传毒性。     

食品中遗传毒性致癌物风险评估方法研究

目的研究目前国际上食品中遗传毒性致癌物风险评估方法,为建立我国遗传毒性致癌物风险评估技术体系提供方法学支持。方法收集目前国际上食品中遗传毒性致癌物风险评估方法的科研文章和指南文件,梳理、对比各种方法的优缺点及其适用范围,研究其中可为我国风险评估借鉴和参考的内容。结果目前国际上对食品中遗传毒性致癌物进行风险评估的主要方法包括尽可能低作用水平(ALARA),毒理学关注阈值(TTC),低剂量外推和暴露限值(MOE)。尽管ALARA原则容易理解,但是它不能给出任何一个风险程度的指导,所以不能为制定现实的风险管理建议提供可靠的依据。在致癌剂量-反应关系数据缺乏或不足的情况下,若符合毒理学关注阈值适用范围,可以采用毒理学关注阈值的方法进行筛选评估。当来自动物试验的致癌数据可用时,可以采用暴露限值法,也可采用低剂量外推的方法,但推荐优先采用暴露限值法。结论我国应在充分参与国际遗传毒性物质风险评估相关工作的基础上,深入开展遗传毒性物质基础研究,尽快建立遗传毒性物质风险评估技术体系。     

含L-精氨酸和抗氧化物质组方的毒理学安全性研究

为探究含L-精氨酸和抗氧化物质组方的毒理学安全性,该文按照《保健食品检验与评价技术规范》(2003年版)重点开展了含L-精氨酸、山楂提取物、知母提取物和虾青素组方的毒理学评价。毒理实验显示,该组方小鼠经口急性毒性试验中最大耐受剂量值(maximum tolerance dose,MTD)>20.0 g/(kg·BW),Ames试验、小鼠骨髓微核试验和小鼠精子畸形试验均未见该组方样品有致突变作用。大鼠30 d喂养试验各项指标也均未见明显毒性反应。该组方属于无毒级、无遗传毒性,不会引起突变,为其临床应用及保健食品研发提供毒理学方面的科学依据。     

提高环境监测数据可靠性的途径

环境监测工作在我国环境保护工作当中扮演着越来越重要的角色。在环境监测工作当中可以通过可靠性比较高的环境监测数据来对我国目前的环境现状进行真实反馈。环保部门可以根据反馈的情况制定行之有效的环境保护措施对目前存在的环境问题进行及时防治,大大提高了环保部门的工作效率和工作质量。本文首先针对提高环境监测数据可靠性的积极意义进行了分析,然后针对影响监测数据可靠性的相关因素进行了探究,最后针对提升监测数据可靠性的主要途径进行了阐述,希望能够为我国的环境监测工作的开展提供有效的参考价值。     

结合数据融合技术与近红外光谱的休闲苹果脆片综合品质评价

以加工过程中的苹果脆片为对象,对其水分、可溶性固形物、总糖、可滴定酸和硬度5个品质指标进行综合分析,得到各指标的权重和脆片品质的综合得分,根据综合得分情况,将脆片分为A(高品质)、B(中品质)、C(低品质)三类。利用近红外光谱技术获取苹果脆片光谱信息,运用偏最小二乘判别分析(partial least-squares discriminant analysis,PLSDA)方法建立基于光谱特征的苹果脆片综合品质得分的判别模型,对3类脆片进行分类的实际值和预测值的相关系数R分别为0.84,0.63,0.89,均方根误差RMSEC分别为0.26,0.34,0.22,预测集样本的判别准确率分别为83.33%,80.0%,93.33%,说明了结合数据融合技术与近红外光谱评价加工过程中苹果脆片综合品质具有较好的可行性。     

Introduction of a quality index,based on Generalizability theory,as a measure of reliability for univariate- and multivariate sensory descriptive data

In the sensory industry there is a need to quantify the overall usability or reliability of the final results of a sensory study. The sensory field has developed various statistical methods and techniques resulting in graphs or plots aimed at identifying assessors that contribute high error variance. Most of these methods are focused on estimating levels of repeatability, discriminability and agreement. Yet not much attention has gone to estimating the general level of quality of the dataset as a whole. Quality indicators could be helpful to quickly determine which attributes still require panel training, when panel training has been done in a sufficient manner and to determine the usability of the final results.This contribution proposes to use a statistical method, Generalizability theory (G theory), to monitor reliability (or generalizability) (Cronbach, Rajaratnam, & Gleser, 1963; Gleser, Cronbach, & Rajaratnam, 1965; Rajaratnam, Cronbach, & Gleser, 1965) and to study the univariate and multivariate reliability of the dataset. Generalizability theory (G theory) can characterize, disentangle, and estimate all different sources of variation as defined by the investigator. This makes G theory a useful tool for characterizing products, when dealing with multiple different sources of variance in a set of product evaluations. Univariate generalizability coefficients (or univariate quality index) could serve as quality indicators to determine which attributes are sufficiently reliable and in which cases panel training is beneficial for the discriminative ability of the panel or when panel training is redundant. Multivariate generalizability coefficients (or multivariate quality index) could capture reliability of an entire study expressed in one easily interpretable measure and could answer questions related to the overall quality of the experimental design of the study.In this study, a demonstration will be given on how G theory is used to test attribute reliability and to assess panel performance.     

基于北京市某城区和张家口崇礼地区食品调查数据的镉暴露评估

目的 预先评估北京冬奥会周边地区主要食品中镉（Cd）暴露水平及可能存在的健康风险,为2022北京冬奥会及周边居民食品安全风险评估和安全保障提供部分参考依据。方法 在对镉进行危害评估和限量标准分析的基础上,采用2019—2020年北京市某城区和张家口崇礼地区现场采样调查数据,结合2018年北京市主要食品消费量调查数据,运用点评估的方法,对镉的膳食暴露风险进行评估。结果 采集的各类食品中镉总体平均含量为0.010 6 mg/kg,总体超标率为0.47%。北京市居民通过摄入主要食品的镉平均暴露量为5.92 μg/（kg·BW·m）,占粮农组织/世界卫生组织食品添加剂联合专家委员会（JECFA）推荐的可耐受月摄入量（PTMI）25 μg/kg·BW的23.66%,且粮谷和蔬菜类食品是本次调查膳食镉的主要暴露来源。按其现行GB 2762—2017《食品安全国家标准 食品中污染物限量》中镉的限量标准,除了这两类食品外,其余食品中的镉理论暴露量均未超过PTMI。蔬菜类和粮谷类的推算关注阈值（LOC）为0.172和0.199 mg/kg,略小于国标规定的最大限量值。结论 冬奥会及北京市居民主要食品镉暴露预期总体处于安全水平,健康风险较低。     

纬纱红外光电检测方法与可靠性

在纺织生产中,气流引纬的纬纱光电检测误检测率较高。本文对纬纱信号的检测处理的一般方法作了较完整的分析,指出纬纱信号的波动与增益放大电路与阀值比较电路的可调电阻的阻值成正态分布,是造成检测可靠度不高的主因。并对可能产生的误判原因进行了分析,给出了改进方法。通过实验,说明纬纱信号的增益过饱和和欠饱和是造成误判的主要原因,对于数字处理方式和模拟方式进行的纬纱信号处理,在放大电路采用增益自动调节的运算放大器是提高检测率的重要手段。     

Impact of refining the assessment of dietary exposure to cadmium in the European adult population

Exposure assessment constitutes an important step in any risk assessment of potentially harmful substances present in food. The European Food Safety Authority (EFSA) first assessed dietary exposure to cadmium in Europe using a deterministic framework, resulting in mean values of exposure in the range of health-based guidance values. Since then, the characterisation of foods has been refined to better match occurrence and consumption data, and a new strategy to handle left-censoring in occurrence data was devised. A probabilistic assessment was performed and compared with deterministic estimates, using occurrence values at the European level and consumption data from 14 national dietary surveys. Mean estimates in the probabilistic assessment ranged from 1.38 (95% CI = 1.35–1.44) to 2.08 (1.99–2.23) µg kg^–1 bodyweight (bw) week^–1 across the different surveys, which were less than 10% lower than deterministic (middle bound) mean values that ranged from 1.50 to 2.20 µg kg^–1 bw week^–1. Probabilistic 95th percentile estimates of dietary exposure ranged from 2.65 (2.57–2.72) to 4.99 (4.62–5.38) µg kg^–1 bw week^–1, which were, with the exception of one survey, between 3% and 17% higher than middle-bound deterministic estimates. Overall, the proportion of subjects exceeding the tolerable weekly intake of 2.5 µg kg^–1 bw ranged from 14.8% (13.6–16.0%) to 31.2% (29.7–32.5%) according to the probabilistic assessment. The results of this work indicate that mean values of dietary exposure to cadmium in the European population were of similar magnitude using determinist or probabilistic assessments. For higher exposure levels, probabilistic estimates were almost consistently larger than deterministic counterparts, thus reflecting the impact of using the full distribution of occurrence values to determine exposure levels. It is considered prudent to use probabilistic methodology should exposure estimates be close to or exceeding health-based guidance values.     

圆柱齿轮传动的模糊可靠性优化设计

运用模糊数学和机械可靠性优化设计理论。对圆柱齿轮传动设计建立了以模糊可靠度为约束条件，以体积最小为优化目标的数学模型。并对实例进行了计算。结果表明，模糊可靠性优化设计是一种更具科学性，更符合客观实际要求的设计方法。     

Hierarchical Bayesian analysis of censored microbiological contamination data for use in risk assessment and mitigation

Microbiological contamination data often is censored because of the presence of non-detects or because measurement outcomes are known only to be smaller than, greater than, or between certain boundary values imposed by the laboratory procedures. Therefore, it is not straightforward to fit distributions that summarize contamination data for use in quantitative microbiological risk assessment, especially when variability and uncertainty are to be characterized separately. In this paper, distributions are fit using Bayesian analysis, and results are compared to results obtained with a methodology based on maximum likelihood estimation and the non-parametric bootstrap method. The Bayesian model is also extended hierarchically to estimate the effects of the individual elements of a covariate such as, for example, on a national level, the food processing company where the analyzed food samples were processed, or, on an international level, the geographical origin of contamination data. Including this extra information allows a risk assessor to differentiate between several scenario’s and increase the specificity of the estimate of risk of illness, or compare different scenario’s to each other. Furthermore, inference is made on the predictive importance of several different covariates while taking into account uncertainty, allowing to indicate which covariates are influential factors determining contamination.     

Risk assessment of azo dyes as food additives: Revision and discussion of data gaps toward their improvement

The food industry uses dyes mainly to overcome color loss during the processing and storage of products, with the azo dyes currently being the most employed. Studies on the safety of using these dyes in foods started in the 1950s and have indicated the potential for concern. This review discusses the risk assessment of food intake containing artificial azo dyes. There are case reports and, subsequently, double-blind placebo-controlled trials in some individuals who may experience adverse effects from the intake of azo dyes, but it is unclear whether these adverse effects are restricted to specific populations or more generalized. In view of this, different toxicological endpoints are evaluated to verify toxic effects in in vitro and in vivo models and to establish the no observed adverse effect level. Exposure estimation studies have shown that human exposure to azo dyes via oral intake is mainly below the acceptable daily intake established by advisory bodies. However, most countries do not have studies that estimate the oral intake of azo dyes. In this case, local food diversity and racial–ethnic specificities are not considered when stating the exposure estimate is below the acceptable daily intake for the human population and thus may not represent actual intake. Concerning the scenario established above, this review discusses the most critical gaps to be overcome to contribute to the direction of future studies and the development of more effective public policies concerning the safety of the intake of artificial azo dyes.