Naegeli Hanspeter, Birch Andrew Nicholas, Casacuberta Josep, De Schrijver Adinda, Gralak Mikołaj Antoni, Jones Huw, Manachini Barbara, Messéan Antoine, Nielsen Elsa Ebbesen, Nogué Fabien, Robaglia Christophe, Rostoks Nils, Sweet Jeremy, Tebbe Christoph, Visioli Francesco, Wal Jean-Michel, Poeting Annette, Álvarez Fernando, Broll Hermann, Ramon Matthew
EFSA J. 2017 Mar 30;15(3):e04746. doi: 10.2903/j.efsa.2017.4746. eCollection 2017 Mar.
Cotton MON 88701 was developed through -mediated transformation to express the dicamba mono-oxygenase (DMO) protein, conferring tolerance to dicamba, and the phosphinothricin -acetyltransferase PAT protein, conferring tolerance to glufosinate ammonium-based herbicides. The molecular characterisation data and bioinformatics analyses did not identify issues requiring further assessment for food/feed safety. The agronomic and phenotypic characteristics tested revealed no relevant differences between cotton MON 88701 and its conventional counterpart. Since complete compositional results were reported for only three sites, the EFSA Panel on Genetically Modified Organisms (GMO Panel) is not in the position to complete the assessment of the compositional analysis. Moreover, as no 28-day toxicity study in rodents on the MON 88701 DMO protein was provided, the GMO Panel is not in the position to complete the safety assessment of this protein in cotton MON 88701. Consequently, the GMO Panel cannot complete the toxicological, allergenicity and nutritional assessment of food/feed derived from cotton MON 88701. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the PAT protein newly expressed in cotton MON 88701. Considering the routes of exposure and limited exposure levels, the GMO Panel concludes that cotton MON 88701 would not give rise to safety concerns in the event of accidental release of viable seeds into the environment. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of cotton MON 88701. In conclusion, in the absence of an appropriate comparative assessment and an appropriate assessment of the MON 88701 DMO protein, the GMO Panel is not in a position to complete its food/feed risk assessment of cotton MON 88701. The GMO Panel concludes that the cotton MON 88701 is unlikely to have any adverse effect on the environment in the context of the scope of the application.
抗虫棉MON 88701是通过介导转化培育而成，可表达麦草畏单加氧酶（DMO）蛋白，从而赋予对麦草畏的耐受性，以及表达膦丝菌素-N-乙酰转移酶PAT蛋白，赋予对草铵膦类除草剂的耐受性。分子特征数据和生物信息学分析未发现需要对食品/饲料安全性进行进一步评估的问题。所测试的农艺和表型特征显示，抗虫棉MON 88701与其传统对照品种之间没有相关差异。由于仅报告了三个地点的完整成分结果，欧洲食品安全局转基因生物小组无法完成成分分析的评估。此外，由于未提供关于抗虫棉MON 88701 DMO蛋白的啮齿动物28天毒性研究，转基因生物小组无法完成该蛋白在抗虫棉MON 88701中的安全性评估。因此，转基因生物小组无法完成对抗虫棉MON 88701衍生的食品/饲料的毒理学、致敏性和营养评估。安全性评估未发现对抗虫棉MON 88701中新表达的PAT蛋白的潜在毒性和致敏性有任何担忧。考虑到接触途径和有限的接触水平，转基因生物小组得出结论，在有活力的种子意外释放到环境中的情况下，抗虫棉MON 88701不会引起安全问题。上市后环境监测计划和报告间隔符合抗虫棉MON 88701的预期用途。总之，在缺乏适当的比较评估和对抗虫棉MON 88701 DMO蛋白的适当评估的情况下，转基因生物小组无法完成其对抗虫棉MON 88701的食品/饲料风险评估。转基因生物小组得出结论，在应用范围内，抗虫棉MON 88701不太可能对环境产生任何不利影响。
