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Consideration of familiarity accumulated in the confined field trials for environmental risk assessment of genetically modified soybean (Glycine max) in Japan.
Transgenic Research ( IF 3 ) Pub Date : 2020-01-29 , DOI: 10.1007/s11248-020-00193-z
Akane Matsushita 1 , Hidetoshi Goto 2 , Yasuyuki Takahashi 3 , Mai Tsuda 4, 5 , Ryo Ohsawa 4, 5
Affiliation  

To date, there have been 160 regulatory approvals for environmental safety in Japan for the major genetically modified (GM) crops, including corn, soybean, canola and cotton. Confined field trials (CFTs) have been conducted in Japan for all single events, which contain various traits. The accumulated information from these previously conducted CFTs, as well as the agronomic field study data from other countries, provides a rich source of information to establish "familiarity" with the crops. This familiarity can be defined as the knowledge gained through experience over time, and used to inform the environmental risk assessments (ERA) of new GM crops in Japan. In this paper, we compiled agronomic data from the CFTs performed in Japan for 11 GM soybean events which obtained food, feed and environmental safety approvals from regulatory agencies in Japan. These CFTs were conducted by multiple developers according to Japan regulations to support the ERA of these GM soybean, covering standard measurement endpoints evaluated across developers in Japan. With this dataset, we demonstrate how familiarity gained from the CFTs of GM soybeans in Japan can be used to inform on the ERA of new GM soybean events. By leveraging this concept of familiarity, we discuss potential enhancements to the ERA process for GM soybean events in Japan.

中文翻译:

考虑到日本在转基因大豆(Glycine max)的环境风险评估的有限田间试验中积累的熟悉程度。

迄今为止,日本已获得160个有关主要转基因(GM)作物的环境安全监管批准,包括玉米,大豆,油菜和棉花。在日本,针对所有具有多种特征的单一事件进行了密闭田间试验(CFT)。这些先前进行的CFT收集的信息以及其他国家的农艺田间研究数据,为建立对作物的“熟悉度”提供了丰富的信息来源。这种熟悉程度可以定义为通过长期积累的经验而获得的知识,并可以用来为日本新的转基因作物的环境风险评估(ERA)提供依据。在本文中,我们收集了来自日本的CFT的农艺数据,这些数据涉及11个转基因大豆事件,这些事件获得了食物,获得日本监管机构的饲料和环境安全认证。这些CFT由多个开发人员根据日本法规进行,以支持这些转基因大豆的ERA,涵盖了日本各个开发人员评估的标准测量终点。借助该数据集,我们证明了如何从日本的转基因大豆CFT中获得的熟悉度可用于告知新的转基因大豆事件的ERA。利用这种熟悉的概念,我们讨论了日本转基因大豆事件对ERA流程的潜在增强。我们证明了如何从日本的转基因大豆CFT中获得的熟悉度可用于告知ERA新的转基因大豆事件。利用这种熟悉的概念,我们讨论了日本转基因大豆事件对ERA流程的潜在增强。我们证明了如何从日本的转基因大豆CFT中获得的熟悉度可用于告知ERA新的转基因大豆事件。利用这种熟悉的概念,我们讨论了日本转基因大豆事件对ERA流程的潜在增强。
更新日期:2020-01-29
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