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Attempt of Bayesian Estimation from Left-censored Data Using the Markov Chain Monte Carlo Method: Exploring Cr(VI) Concentrations in Mineral Water Products. 使用马尔可夫链蒙特卡洛方法对左删失数据进行贝叶斯估计的尝试:探索矿泉水产品中的六(Cr)浓度。
Pub Date : 2020-12-25 eCollection Date: 2020-12-01 DOI: 10.14252/foodsafetyfscj.D-20-00007
Yoshinari Suzuki, Noriko Tanaka, Hiroshi Akiyama

Hexavalent chromium (Cr(VI)) is toxic, carcinogenic, and mutagenic substances. Oral exposure to Cr(VI) is thought to be primarily from drinking water. However, under the certain reporting limit (~0.1 µg/L), percentage of Cr(VI) concentration in mineral water products under the reporting limit were estimated higher than 50%. Data whose values are below certain limits and thus cannot be accurately determined are known as left-censored. The high censored percentage leads to estimation of Cr(VI) exposure uncertain. It is well known that conventional substitution method often used in food analytical science cause severe bias. To estimate appropriate summary statistics on Cr(VI) concentration in mineral water products, parameter estimation using the Markov chain Monte Carlo (MCMC) method under assumption of a lognormal distribution was performed. Stan, a probabilistic programming language, was used for MCMC. We evaluated the accuracy, coverage probability, and reliability of estimates with MCMC by comparison with other estimation methods (discard nondetects, substituting half of reporting limit, Kaplan-Meier, regression on order statistics, and maximum likelihood estimation) using 1000 randomly generated data subsets (n = 150) with the obtained parameters. The evaluation shows that MCMC is the best estimation method in this context with greater accuracy, coverage probability, and reliability over a censored percentage of 10-90%. The mean concentration, which was estimated with MCMC, was 0.289×10-3 mg/L and this value was sufficiently lower than the regulated value of 0.05 mg/L stipulated by the Food Sanitation Act.

六价铬(Cr(VI))是一种有毒、致癌和致突变物质。人们认为口腔接触六价铬主要来自饮用水。然而,在一定的报告限值(~0.1 µg/L)下,矿泉水产品中六价铬浓度低于报告限值的百分比估计高于 50%。数值低于特定限值而无法准确确定的数据被称为 "左删减 "数据。高删减百分比导致对六价铬暴露量的估计不确定。众所周知,食品分析科学中常用的传统替代法会造成严重偏差。为了估算矿泉水产品中六价铬浓度的适当汇总统计量,在对数正态分布假设下,使用马尔可夫链蒙特卡罗(MCMC)方法进行了参数估计。Stan 是一种概率编程语言,用于 MCMC。我们使用随机生成的 1000 个数据子集(n = 150)和获得的参数,通过与其他估计方法(丢弃非检测项目、替换报告限值的一半、Kaplan-Meier、阶次统计回归和最大似然估计)进行比较,评估了 MCMC 估计的准确性、覆盖概率和可靠性。评估结果表明,在这种情况下,MCMC 是最好的估计方法,在 10-90% 的删减百分比范围内,具有更高的准确性、覆盖概率和可靠性。用 MCMC 估算的平均浓度为 0.289×10-3 mg/L,该值低于《食品卫生法》规定的 0.05 mg/L 的规定值。
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引用次数: 0
Deoxynivalenol and Nivalenol (2nd edition) [Assuring the Maximum Level of Deoxynivalenol in Wheat] (Natural Toxins and Mycotoxins). 脱氧雪腐镰刀菌醇和雪腐镰刀菌醇(第2版)[确保小麦中脱氧雪腐镰刀菌醇的最高水平](天然毒素和真菌毒素)。
Pub Date : 2020-12-25 eCollection Date: 2020-12-01 DOI: 10.14252/foodsafetyfscj.D-20-00031

Food Safety Commission of Japan (FSCJ) was requested by the Ministry of Health, Labour and Welfare (MHLW) to conduct a risk assessment of deoxynivalenol (DON) to assure the maximal level for DON in foods. Previously, FSCJ had conducted a self-tasking risk assessment of DON and nivalenol (NIV) in 2010. In the current 2nd edition, only the assessment of DON has been revised. Grains contaminated with DON may be also contaminated with its derivatives, namely, 3-acetyldeoxynivalenol (3-Ac-DON), 15-acetyldeoxynivalenol (15-Ac-DON) and deoxynivalenol-3-glucoside (DON-3-glucoside). However, these substances orally ingested are rapidly biotransformed into DON. Therefore, FSCJ identified the total DON (sum of DON and its derivatives) to be assessed. The toxicity of DON was assessed based on the data of absorption-distribution-metabolism-excretion (ADME), acute toxicity, sub-acute toxicity, chronic toxicity, carcinogenicity, reproductive/developmental toxicity, genotoxicity, and immunotoxicity. DON was considered to have no significant genotoxic activity in vivo. The no-observed-adverse-effect level (NOAEL), based on the two-year chronic toxicity study in mice, was set at 0.1 mg DON/kg bw/day. By applying an uncertainty factor (UF) of 100, the TDI for DON was determined as 1 µg /kg bw/day. The average estimated exposure levels of total DON were 0.09 µg /kg bw/day and 0.22 µg/kg bw/day in the whole population and the 1-6 years group, respectively, by the Monte-Carlo method. The average exposure level in Japan was thus judged to be below the TDI, although a chance to exceed the TDI remains possible in the 1-6 years group depending on eating habits and DON contamination. For NIV, the genotoxic property was not able to be assessed due to the limited availability of the experimental data. No carcinogenic effect was observed in a two-year chronic toxicity study in mice, and the International Agency for Research on Cancer (IARC) also classifies Fusarium spp toxins including NIV to be in group 3. FSCJ thus judged that TDI can be set for NIV. Based on various toxicity studies, the TDI of NIV was determined at 0.4 µg/kg bw/day by taking into account of LOAEL 0.4 mg NIV/kg bw/day in a subacute toxicity study in rats with 90-day oral administration and UF of 1,000. The exposure level of NIV in Japan was estimated to be below the TDI. FSCJ judged it's unlikely that NIV intake leads to adverse health effects in general population.

日本卫生、劳动和福利部(MHLW)要求食品安全委员会(FSCJ)对脱氧雪腐镰刀菌醇(DON)进行风险评估,以确保食品中DON的最高水平。此前,FSCJ于2010年进行了DON和nivalol (NIV)的自我任务风险评估。在目前的第2版中,只修改了DON的评估。被DON污染的谷物也可能被其衍生物3-乙酰脱氧雪腐腐菌醇(3-Ac-DON)、15-乙酰脱氧雪腐腐菌醇(15-Ac-DON)和脱氧雪腐腐菌醇-3-葡萄糖苷(DON-3-葡萄糖苷)污染。然而,这些物质口服后会迅速生物转化为DON。因此,FSCJ确定了待评估的总DON (DON及其衍生物的总和)。根据吸收-分布-代谢-排泄(ADME)、急性毒性、亚急性毒性、慢性毒性、致癌性、生殖/发育毒性、遗传毒性和免疫毒性等指标评估DON的毒性。DON在体内被认为没有显著的遗传毒性活性。根据为期两年的小鼠慢性毒性研究,未观察到的不良反应水平(NOAEL)设定为0.1 mg DON/kg bw/day。采用不确定因子(UF)为100,确定DON的TDI为1µg /kg bw/day。通过蒙特卡罗方法估计,整个人群和1-6岁组的总DON平均暴露水平分别为0.09µg/kg bw/day和0.22µg/kg bw/day。因此,日本的平均暴露水平被判断为低于TDI,尽管1-6岁年龄组仍有可能超过TDI,这取决于饮食习惯和DON污染。对于NIV,由于实验数据的有限可用性,无法评估其遗传毒性。在一项为期两年的小鼠慢性毒性研究中没有观察到致癌作用,国际癌症研究机构(IARC)也将镰刀菌毒素包括NIV归为第3组。FSCJ由此判断TDI可以设置为NIV。根据各种毒性研究,在一项亚急性毒性研究中,大鼠口服90天,UF为1000,考虑LOAEL 0.4 mg NIV/kg bw/day,确定了NIV的TDI为0.4µg/kg bw/day。据估计,日本的NIV暴露水平低于TDI。FSCJ认为,在一般人群中,NIV的摄入不太可能导致不利的健康影响。
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引用次数: 1
Changes in the Risk Perception of Food Safety between 2004 and 2018. 2004 - 2018年食品安全风险认知的变化
Pub Date : 2020-11-20 eCollection Date: 2020-12-01 DOI: 10.14252/foodsafetyfscj.D-20-00015
Aiko Abe, Kazuo Koyama, Chie Uehara, Azusa Hirakawa, Itsuko Horiguchi

To afford the future agenda of risk communication through an evaluation of the past, we examined the changes in risk perception in the food safety sector over the 15 years (2004-2018) since the establishment of the Food Safety Commission of Japan (FSCJ) in 2003 by analyzing the data of the food safety monitor survey. Hazards such as contaminants including cadmium, methylmercury and arsenic, and pesticide residues caused high levels of concern among the public in 2004. In contrast, hazards such as food poisoning by harmful microorganisms and so-called "Health foods" have been ranked high among concerns since 2008 and 2014, respectively. Scoring of concern levels showed that concern related to food additives and pesticide residues intentionally added to foods and controlled has gradually decreased in a time-dependent manner. These concern scores were considerably lower in male monitors than in female ones; the scores were also lower for individuals with professional experience in the food sector than without the experience. The concern scores for contaminants were lower for males with professional experience. The concern scores related to food poisoning and health foods were not decreased and were remained high in recent years. These scores did not show clear dependence on job experience or gender of the monitors. A gap between food specialists and other attributes in the basic recognition of risk seems to make it difficult to communicate effectively and constructively among various interested individuals. To improve the quality of risk communication in the food safety field, it will be necessary to provide scientific knowledge and information regarding food safety management mechanisms for individuals without professional experience in the food sector, taking into account the changes in information media and influence on risk perception.

为了通过对过去的评估来提供风险沟通的未来议程,我们通过分析食品安全监测调查的数据,研究了自2003年日本食品安全委员会(FSCJ)成立以来的15年间(2004-2018年)食品安全领域风险认知的变化。2004年,镉、甲基汞和砷等污染物以及农药残留等危害引起了公众的高度关注。相比之下,有害微生物引起的食物中毒和所谓的“健康食品”等危害分别自2008年和2014年以来一直是人们关注的重点。关注程度评分表明,对食品中有意添加和控制的食品添加剂和农药残留的关注程度呈时间依赖性逐渐降低。男性监测员的这些担忧得分明显低于女性监测员;在食品行业有专业经验的人的得分也低于没有专业经验的人。具有专业经验的男性对污染物的关注得分较低。与食物中毒和保健食品相关的关注得分近年来没有下降,一直保持在较高水平。这些分数并没有显示出对工作经验或性别的明确依赖。在对风险的基本认识上,食品专家和其他属性之间的差距似乎使各种感兴趣的个人之间难以进行有效和建设性的沟通。为了提高食品安全领域风险沟通的质量,有必要向没有食品行业专业经验的个人提供有关食品安全管理机制的科学知识和信息,同时考虑到信息媒介的变化及其对风险认知的影响。
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引用次数: 6
Risk Management Knowledges about Oysters for Raw Consumption and Norovirus. 有关生食牡蛎和诺如病毒的风险管理知识。
Pub Date : 2020-09-25 eCollection Date: 2020-09-01 DOI: 10.14252/foodsafetyfscj.D-20-00014
Kazuo Koyama, Azusa Hirakawa, Chie Uehara, Itsuko Horiguchi

This study used questionnaires to evaluate knowledge levels of risk management of raw-consumption of oysters and of norovirus as health hazards among monitors signed up for Food Safety Commission of Japan (FSCJ) having work experiences in food fields. The mean scores of monitors on norovirus knowledge were relatively high (79%), but on oyster raw-consumption were low (64%). Scores varied depending on occupational experiences; highest among administrative officials, high among researchers in food companies, and low among medical workers and educators. The higher scores with more practical experiences for risk management of oyster raw-consumption and norovirus were observed among the monitors. These monitors were expected better to recognize the risks, wheres only few monitors among the opinion-leaders replied correctly to all the questions. These results suggest the need of improvement on the management system for oyster raw-consumption, from the current complicated to the more precise and reinforced for consumers. To efficiently manage the risk associated with the consumption of raw oysters, the government should provide more relevant information of risk management to persons having interest, particularly influencers, in order to disseminate information and to improve knowledge among cooks and consumers.

本研究采用问卷调查的方式,对日本食品安全委员会(FSCJ)中具有食品领域工作经验的监督员对生吃牡蛎和诺如病毒危害健康的风险管理知识水平进行了评估。监测员对诺如病毒知识的平均得分相对较高(79%),但对生吃牡蛎知识的平均得分较低(64%)。职业经历不同,得分也不同;行政官员的得分最高,食品公司研究人员的得分较高,而医务工作者和教育工作者的得分较低。监测人员在生食牡蛎和诺如病毒风险管理方面的实践经验越丰富,得分越高。在意见领袖中,只有少数监测员能正确回答所有问题,而这些监测员被认为能更好地识别风险。这些结果表明,有必要改进生食牡蛎的管理系统,从目前的复杂化改进为更精确、更适合消费者的系统。为了有效管理与生吃牡蛎相关的风险,政府应向利益相关者,特别是有影响力的人提供更多相关的风险管理信息,以传播信息,提高厨师和消费者的知识水平。
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引用次数: 0
Cattle Meat and Offal Imported from the United States of America, Canada and Ireland to Japan (Prions). 从美利坚合众国、加拿大和爱尔兰进口到日本的牛肉和内脏(朊病毒)。
Pub Date : 2020-09-25 eCollection Date: 2020-09-01 DOI: 10.14252/foodsafetyfscj.D-20-00019

Food Safety Commission of Japan (FSCJ) was requested by the Ministry of Health, Labour and Welfare (MHLW) to conduct a risk assessment of cattle meat and offal imported from the United States of America (U.S.A.), Canada and Ireland. FSCJ assessed potential influences on bovine spongiform encephalopathy (BSE) risks to human health in cases of the alteration of cattle age to be allowed to import of cattle meat and offal from the three countries, from the current under 30 months of age to no age limitation, in line with the international standards for mitigating BSE risks. FSCJ judges that the control measures regarding "risks related to slaughtering and meat processing" are appropriately implemented in the three countries. FSCJ concludes that potential variations of BSE risks to human health by removing the age limit on cattle meat and offal excluding specified risk material (SRMs) imported from the three countries in line with the international standards is negligible.

日本食品安全委员会应厚生劳动省(MHLW)的要求,对从美利坚合众国(美国)、加拿大和爱尔兰进口的牛肉和内脏进行风险评估。FSCJ根据减轻疯牛病风险的国际标准,评估了在允许从这三个国家进口牛肉和内脏的牛的年龄发生改变的情况下,对牛海绵状脑病(BSE)对人类健康的潜在影响,从目前的30个月以下年龄限制到没有年龄限制。FSCJ认为有关“屠宰和肉类加工相关风险”的控制措施在这三个国家得到了适当的实施。FSCJ的结论是,取消从上述三个国家进口的牛肉及内脏(不包括指明风险物料)的年龄限制后,疯牛病对人类健康的潜在风险变化可以忽略不计。
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引用次数: 1
Elution of Radioactive Cesium from Tofu by Water Soaking. 水浸法洗脱豆腐中放射性铯。
Pub Date : 2020-08-07 eCollection Date: 2020-09-01 DOI: 10.14252/foodsafetyfscj.D-20-00011
Mitsuru Yoshida, Hitomi Kaino, Saori Shidara, Kazuhiro Chiku, Mayumi Hachinohe, Shioka Hamamatsu

Elution of cesium-137 (137Cs) from tofu into water was investigated to know the behavior of 137Cs during preservation and cooking. The food processing retention factor (Fr) reached 0.55 when tofu was soaked in water at a ratio of 1:2 w/w for 24 h at 4°C. Doubling the amount of water did not further significantly decrease Fr. When tofu was held in water at a ration of 1:2 w/w at a temperature of 80℃ for 50 min, Fr was 0.72. Increasing the amount of water to 10 times the tofu weight did not further reduce Fr significantly. Cesium-137 is mostly bound to tofu and does not freely diffuse into water. Tofu was then soaked in water at a ratio of 1:2 w/w at 4℃ for 24 h, placed in new water at a ratio of 1:2 w/w, and held at 80℃ for 50 min, resulting in an Fr 0.33. This value is close to an estimated Fr calculated by multiplying the Fr of 0.55 from soaking at 4°C by the Fr of 0.72 from the hot water treatment. The calculated Fr from soybeans sequentially processing into tofu, soaking tofu at 4°C for 24 h and in hot water at 80°C for 50 min was about 0.1, indicating 90% removal of 137Cs. Degree of decrease in 137Cs during preservation and cooking of tofu demonstrated in this study will be useful for exposure assessment of 137Cs through oral intake of contaminated soybeans after processing and cooking.

研究了豆腐中铯-137 (137Cs)在水中的洗脱,以了解137Cs在保存和烹饪过程中的行为。豆腐在4℃条件下以1:2 w/w的比例浸泡24 h,食品加工保留系数Fr达到0.55。当豆腐以1:2 w/w的比例在80℃的温度下保存50 min时,Fr为0.72。将水分增加到豆腐重量的10倍并没有进一步显著降低Fr。铯-137主要与豆腐结合在一起,不会自由扩散到水中。将豆腐按1:2 w/w的比例在4℃下浸泡24 h,再按1:2 w/w的比例放入新水中,80℃保存50 min,得到Fr 0.33。这个值接近于用4°C浸泡得到的0.55的Fr乘以热水处理得到的0.72的Fr计算出的Fr值。4℃浸泡24 h和80℃热水浸泡50 min后,大豆依次加工成豆腐的Fr约为0.1,表明137Cs去除率为90%。本研究显示的豆腐在保存和烹饪过程中137Cs的减少程度,将有助于评估污染大豆在加工和烹饪后通过口服摄入137Cs的暴露。
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引用次数: 1
Prediction and Characterization of CYP3A4-mediated Metabolisms of Azole Fungicides: an Application of the Fused-grid Template* system. CYP3A4 介导的唑类杀真菌剂代谢的预测和特征描述:融合网格模板*系统的应用。
Pub Date : 2020-06-26 eCollection Date: 2020-06-01 DOI: 10.14252/foodsafetyfscj.D-20-00010
Yasushi Yamazoe, Takashi Yamada, Kiyoshi Nagata

Human CYP3A4 is involved in metabolisms of diverse hydrophobic chemicals. Using the data of therapeutic azole fungicides known to interact with CYP3A4, applicability of CYP3A4 Template system was first confirmed to reconstitute faithfully the interaction on Template. More than twenty numbers of pesticide azoles were then applied to the Template system. All the azole stereo-isomers applied, except for talarozole, interacted through nitrogen atoms of triazole or imidazole parts and sat stably for inhibitions through fulfilling three-essential interactions. For their CYP3A4-mediated oxidations, clear distinctions were suggested among the enantiomers and diastereomers of azole pesticides on Templates. Thus, the stereoisomers would have their-own regio- and stereo-selective profiles of the metabolisms. A combined metabolic profile of each azole obtained with CYP3A4 Template system, however, resembled with the reported profile of the in vivo metabolism in rats. These results suggest the major roles of CYP3A forms on the metabolisms of most of azole pesticides in both rats and humans. Free triazole is a metabolite of azole fungicides having a methylene-spacer between triazole and the rest of the main structures in experimental animals and humans. During the simulation experiments, a placement for the oxidation of a methylene spacer between the triazole and main carbon-skeleton was found to be available throughout the azole fungicides tested on Template. The occurrence of this reaction to lead to triazole-release is thus discussed in relation to the possible involvement of CYP3A forms.

人类 CYP3A4 参与多种疏水性化学物质的代谢。利用已知与 CYP3A4 有相互作用的治疗性唑类杀菌剂的数据,首先确认了 CYP3A4 模板系统的适用性,以忠实地重建模板上的相互作用。然后将 20 多种唑类杀虫剂应用于模板系统。除他拉唑外,所有应用的唑类立体异构体都通过三唑或咪唑部分的氮原子相互作用,并通过满足三要素相互作用而稳定地发挥抑制作用。在 CYP3A4 介导的氧化作用中,唑类杀虫剂的对映体和非对映体在模板上有明显的区别。因此,立体异构体在代谢过程中具有各自的区域和立体选择性。不过,利用 CYP3A4 模板系统获得的每种唑类的综合代谢图谱与所报道的大鼠体内代谢图谱相似。这些结果表明,CYP3A 形式对大多数唑类杀虫剂在大鼠和人体内的代谢都起着重要作用。游离三唑是唑类杀菌剂的代谢产物,在实验动物和人体中,三唑和其他主要结构之间有一个亚甲基间隔物。在模拟实验中发现,在模板上测试的所有唑类杀菌剂中,都存在三唑和主碳骨架之间的亚甲基间隔物氧化的位置。因此,我们讨论了这种导致三唑释放的反应的发生与 CYP3A 形式可能参与其中的关系。
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引用次数: 0
Quantitative Release Assessment of mcr-mediated Colistin-resistant Escherichia Coli from Japanese Pigs. 日本猪mcr介导的耐粘菌素大肠杆菌的定量释放评价。
Pub Date : 2020-06-26 eCollection Date: 2020-06-01 DOI: 10.14252/foodsafetyfscj.D-20-00004
Kohei Makita, Yuri Fujimoto, Nami Sugahara, Takeshi Miyama, Masaru Usui, Tetsuo Asai, Michiko Kawanishi, Manao Ozawa, Yutaka Tamura

Colistin is a critically important antibiotic for humans. The Japanese government withdrew colistin growth promoter and shifted therapeutic colistin to a second-choice drug for pigs in 2017. A quantitative release assessment of mcr-mediated colistin-resistant Escherichia coli (E. coli) in Japanese finisher pigs was conducted under the World Organisation for Animal Health (OIE) risk assessment framework. Input data included colistin resistance and mcr-1-5 test results for E. coli isolates in the Japan Veterinary Resistance Monitoring System (JVARM), postal survey results regarding indication disease occurrence and colistin use by swine veterinarians in 2017 and 2018, and colistin resistance and mcr monitoring experiments at four pig farms in 2017-2018. An individual-based model was developed to assess the risk: the proportion of Japanese finisher pigs with mcr-1-5-mediated colistin-resistant E. coli dominant in the gut on an arbitrary day. Before implementing risk management measures, the risk was estimated to be 5.5% (95% CI: 4.2%-10.1%). At 12 months after stopping colistin growth promoter, the proportion of pigs with plasmid-mediated colistin-resistant E. coli declined by 52.5% on the experiment farms (95% CI: 8.7%-80.8%). The probability of therapeutic colistin use at the occurrence of bacterial diarrhea declined from 37.3% (95% CI: 30.3%-42.5%) in 2017 to 31.4% (95% CI: 26.1%-36.9%), and that of edema disease declined from 55.0% (95% CI: 46.0%-63.7%) to 44.4% (95% CI: 36.9%-52.0%). After risk management implementation, the risk was estimated to have declined to 2.3% (95% CI: 1.8%-4.3%; 58.2% reduction). Scenario analyses showed that pen-level colistin treatment effectively reduces the risk from 5.5% to 4.7% (14.5% reduction), an effect similar to stoppage of therapeutic colistin (16.4% reduction to 4.6%).

粘菌素是一种对人类至关重要的抗生素。2017年,日本政府撤回了粘菌素生长促进剂,并将治疗性粘菌素转变为猪的第二选择药物。在世界动物卫生组织(OIE)风险评估框架下,对日本育肥猪中mcr介导的耐粘菌素大肠杆菌(E. coli)进行了定量释放评估。输入数据包括日本兽医耐药性监测系统(JVARM)中大肠杆菌分离株的粘菌素耐药性和mcr-1-5检测结果,2017年和2018年猪兽医关于指征性疾病发生和粘菌素使用的邮政调查结果,以及2017-2018年4个猪场的粘菌素耐药性和mcr监测实验。开发了一种基于个体的模型来评估风险:在任意一天肠道中具有mcr-1-5介导的耐粘菌素大肠杆菌的日本育肥猪比例。在实施风险管理措施之前,风险估计为5.5% (95% CI: 4.2%-10.1%)。停用粘菌素生长促进剂12个月后,实验猪场中质粒介导的耐粘菌素大肠杆菌比例下降了52.5% (95% CI: 8.7% ~ 80.8%)。细菌性腹泻发生时使用治疗性粘菌素的概率从2017年的37.3% (95% CI: 30.3% ~ 42.5%)下降到31.4% (95% CI: 26.1% ~ 36.9%),水肿疾病的使用概率从55.0% (95% CI: 46.0% ~ 63.7%)下降到44.4% (95% CI: 36.9% ~ 52.0%)。实施风险管理后,估计风险已降至2.3% (95% CI: 1.8%-4.3%;减少58.2%)。情景分析显示,笔级粘菌素治疗有效地将风险从5.5%降低到4.7%(降低14.5%),效果与停止治疗粘菌素相似(从16.4%降低到4.6%)。
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引用次数: 6
Betamethasone (Veterinary Medicinal Products). 倍他米松(兽药产品)。
Pub Date : 2020-06-26 eCollection Date: 2020-06-01 DOI: 10.14252/foodsafetyfscj.D-20-00016

The Food Safety Commission of Japan (FSCJ) conducted a risk assessment of betamethasone (CAS No. 37-44-9), a synthetic adrenocortical hormone, based on the documents including assessment reports from the European Medicines Evaluation Agency (EMEA). Among results of various studies, a no-observed-adverse-effect level (NOAEL) of betamethasone (as betamethasone dipropionate) was shown as 0.02 mg/kg bw per day in a fertility and early embryonic development study in rats. FSCJ concluded that it is appropriate to set an acceptable daily intake (ADI) of betamethasone by applying the same ADI as dexamethasone. The ADI for dexamethasone at 0.01 μg/kg bw per day (0.00001 mg/kg bw/day) was specified based on the NOAEL of 0.001 mg/kg bw per day of the endocrine toxicity study in rats1). Consequently, FSCJ specified the ADI for betamethasone at 0.01 μg/kg bw per day.

日本食品安全委员会(FSCJ)根据欧洲药品评价机构(EMEA)的评估报告等文件,对合成肾上腺皮质激素倍他米松(CAS No. 37-44-9)进行了风险评估。在各种研究的结果中,在大鼠生育和早期胚胎发育研究中,倍他米松(如倍他米松二丙酸酯)的未观察到的不良反应水平(NOAEL)显示为每天0.02 mg/kg bw。FSCJ得出结论,采用与地塞米松相同的每日可接受摄入量来设定倍他米松的可接受日摄入量(ADI)是合适的。地塞米松每日摄入量0.01 μg/kg体重(0.00001 mg/kg体重/天)是根据大鼠内分泌毒性研究中0.001 mg/kg体重/天的NOAEL确定的(1)。因此,FSCJ规定倍他米松的每日推荐摄入量为0.01 μg/kg体重/天。
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引用次数: 0
Flumequine (Veterinary Medicinal Products). 氟甲喹(兽药产品)。
Pub Date : 2020-03-27 eCollection Date: 2020-03-01 DOI: 10.14252/foodsafetyfscj.D-20-00005

FSCJ conducted a risk assessment of an antimicrobial, flumequine (CAS No. 42835-25-6), based on reports of JECFA (Joint FAO/WHO Expert Committee on Food Additives) and EMEA (European Medicines Agency) and other documents including the mechanism for liver tumor. Data used in the assessment include pharmacokinetics, acute toxicity, subacute toxicity, chronic toxicity/carcinogenicity, reproductive toxicity, genotoxicity, and microbiological effects. FSCJ specified the ADI of flumenquine as 0.071 mg/kg bw per day, that is the microbiological ADI calculated using the equation for VICH.

FSCJ根据JECFA(粮农组织/世卫组织食品添加剂联合专家委员会)和EMEA(欧洲药品管理局)的报告以及包括肝肿瘤机制在内的其他文件,对抗微生物药物氟喹(CAS编号42835-25-6)进行了风险评估。评估中使用的数据包括药代动力学、急性毒性、亚急性毒性、慢性毒性/致癌性、生殖毒性、遗传毒性和微生物效应。FSCJ规定氟喹的每日推荐摄入量为0.071 mg/kg体重/天,即使用VICH公式计算的微生物推荐摄入量。
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Food safety (Tokyo, Japan)
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