Scientific Opinion

This scientific opinion is an evaluation of a risk assessment of the genetically modified, insect resistant, soybean MON 87701 for food and feed uses, import and processing. Soybean MON 87701 was developed through Agrobacterium-mediated transformation. It contains a single insert consisting of a cry1Ac expression cassette, encoding the Cry1Ac protein that confers resistance against specific lepidopteran insects. The stability of the insert was confirmed over multiple generations. Bioinformatic analyses of the insert and its flanking regions, and levels of newly expressed protein did not raise safety concerns. Comparative analyses of compositional, phenotypic and agronomic characteristics indicated that soybean MON 87701 is not different from its conventional counterpart (A5547) and equivalent to commercial soybean varieties, except for having an increased vitamin E content (still within normal ranges) and expressing the Cry1Ac protein. The safety assessment of the Cry1Ac protein and soybean MON 87701 identified no concerns regarding potential toxicity and allergenicity. A feeding study on broiler chickens confirmed that defatted soybean MON 87701 meal is as nutritious as conventional defatted soybean meal. There are no indications of an increased likelihood of establishment and spread of feral soybean plants. Considering its intended use as food and feed, environmental risks associated of an unlikely but theoretically possible horizontal gene transfer from soybean MON 87701 to bacteria have not been identified. Potential interactions of soybean MON 87701 with the biotic and abiotic environment were not considered due to the low level of exposure. The monitoring plan and reporting intervals are in line with the intended uses of soybean MON 87701. The EFSA GMO Panel considers that the soybean MON 87701, as described in this application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment in the context of its intended uses. © European Food Safety Authority, 2011 1 On request from the Competent Authority of Belgium for an application (EFSA-GMO-BE-2010-79) submitted by Monsanto, Question No EFSA-Q-2010-00867, adopted on 6 July 2011. 2 Panel members: Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal. Correspondence: [email protected] 3 Acknowledgement: The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food and Feed and Environment for the preparatory work on this scientific opinion; Niels Bohse Hendriksen as external expert and the EFSA‟s staff members Jaime Aguilera (MC), Christina Ehlert (ENV) and Andrea Germini (FF) for the support provided to this scientific opinion. Scientific opinion on insect resistant GM soybean MON 87701 for food and feed uses, import and processing 2 EFSA Journal 2011; 9(7):2309