Nakai Shuichi, Roberts Andrew F, Simmons Abigail R, Hiratsuka Kazuyuki, Miano Douglas W, Vesprini Facundo
Bayer CropScience K.K., Tokyo, Japan.
International Life Science Institute Japan, Tokyo, Japan.
Front Bioeng Biotechnol. 2024 Feb 21;12:1359388. doi: 10.3389/fbioe.2024.1359388. eCollection 2024.
The concept of Data Transportability (DT) of Confined Field Testing (CFT) to support the Environmental Risk Assessment (ERA) of Genetically Modified (GM) plants was first introduced in the literature by Garcia-Alonso et al., in 2014. Since then, DT has been discussed in many countries and regions as a concept to prevent duplication of regulatory studies without compromising quality of the ERA. However, despite its usefulness and scientific justification, DT is not well adopted at this time and many regulatory agencies around the world require additional in-country CFT be conducted before approving GM plants. Based on the current circumstances, the authors organized a parallel session entitled "" at 16th ISBR (the International Society for Biosafety Research). This session mainly consisted of the following three parts. The first two speakers, Andrew Roberts and Abigail Simmons provided an overview of DT and examples of conditions for the transportability of field data/conclusions advocated in the peer-reviewed scientific journals. Next, the current status of DT adoption in some countries/regions such as Japan and Africa, and a theoretical case study for Argentina were introduced by Kazuyuki Hiratsuka, Douglas Miano, and Facundo Vesprini, respectively. Lastly, a risk hypothesis-based approach for DT which was developed in advance by the five speakers of this parallel session, was introduced. During the discussion, there was a common understanding that transition to the risk hypothesis-based approach for DT was scientifically appropriate, considering the accumulated evidences that several countries have conducted confirmatory local CFT for more than 20 years but they have not detected any differences related to the ERA assessment endpoints in GM crops. The risk hypothesis-based approach for DT introduced here is expected to play an important role in discussions on the implementation of DT in various parts of the world in the future.
2014年，加西亚 - 阿隆索等人首次在文献中提出了受限田间试验（CFT）的数据可转移性（DT）概念，以支持转基因（GM）植物的环境风险评估（ERA）。从那时起，DT作为一种在不影响ERA质量的前提下防止监管研究重复的概念，在许多国家和地区得到了讨论。然而，尽管DT有用且有科学依据，但目前尚未得到广泛采用，世界各地的许多监管机构在批准转基因植物之前，仍要求进行额外的国内CFT。基于当前情况，作者在第16届国际生物安全研究学会（ISBR）组织了一场题为“”的平行会议。本次会议主要包括以下三个部分。前两位发言者安德鲁·罗伯茨和阿比盖尔·西蒙斯概述了DT，并列举了同行评审科学期刊中主张的田间数据/结论可转移性条件的示例。接下来，分别由平冢和之、道格拉斯·米亚诺和法昆多·韦斯普里尼介绍了日本和非洲等一些国家/地区采用DT的现状，以及阿根廷的一个理论案例研究。最后，介绍了由本次平行会议的五位发言者预先制定的基于风险假设的DT方法。在讨论过程中，大家达成了一个共识，即考虑到几个国家已经进行了20多年的验证性本地CFT，但未发现转基因作物在ERA评估终点方面存在任何差异这一积累的证据，向基于风险假设的DT方法转变在科学上是合适的。这里介绍的基于风险假设的DT方法有望在未来世界各地关于DT实施的讨论中发挥重要作用。
