Monsanto Company, Saint Louis, Missouri, United States of America.
BioMath, Rostock-Warnemünde, Germany.
PLoS One. 2020 Apr 24;15(4):e0217272. doi: 10.1371/journal.pone.0217272. eCollection 2020.
In European regulations for the deliberate release into the environment of genetically modified organisms (GMO), the objective of General Surveillance in Post-Market Environmental Monitoring is defined as the identification of the occurrence of adverse effects of the GMO or its use which were not anticipated in the environmental risk assessment (ERA). Accompanying the commercial cultivation in the EU of maize event MON 810, General Surveillance was implemented by Monsanto, the authorization holder, on a voluntary basis. We carried out a statistical analysis on the pooled results of ten years of farmer questionnaires, which were a part of this General Surveillance, amounting to 2,627 farmer fields in eight European countries in the period 2006-2015. This analysis did not reveal any unexpected adverse effects associated with the cultivation of MON 810. Results from farmer questionnaires confirmed that the cultivation of MON 810 resulted in a significant reduction in the use of pesticides, efficient protection against the target pests, and healthier, higher yielding crops compared to conventional maize. MON 810 also had reduced susceptibility to disease and pests when compared to conventional maize. Monitoring characteristics related to environment and wildlife revealed no significant differences between MON 810 and conventional maize. Literature searches, that were also conducted as part of General Surveillance, identified a comprehensive set of publications addressing environmental safety as well as food and feed safety aspects of MON 810. None of the publications indicated any adverse effect of MON 810 that was not anticipated in the initial ERA, nor did they lead to a change in the conclusions of the initial risk assessment that demonstrated the safety of MON 810. The development of resistance by the target pests (Ostrinia nubilalis, ECB and Sesamia nonagrioides, MCB) was the only potential adverse effect identified in the ERA of MON 810 cultivation in the EU. The extensive safety data package for MON 810, the robust weight of evidence demonstrating both its safety and benefits, and the history of safe use of MON 810 for 15 years in the EU, indicates that focussing the General Surveillance of MON 810 on literature searches and farmer complaint systems would be appropriately protective. This will allow the identification of potential adverse effect not anticipated in the initial ERA without the intensive effort and organizational challenges of farmer questionnaires.
在欧洲对转基因生物（GMO）的蓄意环境释放的法规中，上市后环境监测的一般监测的目标被定义为识别 GMO 的不利影响或其在环境风险评估（ERA）中未预期到的使用。在欧盟，孟山都公司作为授权持有者，自愿对玉米事件 MON 810 的商业化种植进行了一般监测。我们对这一一般监测的十年农民调查问卷的汇总结果进行了统计分析，这些调查问卷来自 2006 年至 2015 年期间欧洲八个国家的 2627 个农民地块。该分析未发现与 MON 810 种植相关的任何意外不利影响。农民调查问卷的结果证实，与传统玉米相比，MON 810 的种植导致农药使用显著减少，对靶标害虫的有效保护，以及作物更健康、更高产。与传统玉米相比，MON 810 还具有降低的疾病和害虫易感性。与环境和野生动物监测相关的特征表明，MON 810 与传统玉米之间没有显著差异。作为一般监测的一部分进行的文献检索也确定了一套全面的出版物，涉及 MON 810 的环境安全以及食品和饲料安全方面。没有一份出版物表明 MON 810 有任何在初始 ERA 中未预期到的不利影响，也没有导致改变最初风险评估的结论，该结论表明 MON 810 是安全的。靶标害虫（斜纹夜蛾、欧洲玉米螟和亚洲玉米螟）产生抗药性是 MON 810 种植在欧盟的 ERA 中确定的唯一潜在不利影响。对 MON 810 的广泛安全数据包、有力的证据表明其安全性和益处，以及 MON 810 在欧盟 15 年的安全使用历史，表明将 MON 810 的一般监测重点放在文献检索和农民投诉系统上是适当的保护措施。这将允许识别初始 ERA 中未预期到的潜在不利影响，而无需进行农民调查问卷那样的密集工作和组织挑战。
