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Opinion of the Scientific Panel on Genetically Modified Organisms on application (reference EFSA-GMO-NL-2006-36) for the placing on the market of the glyphosate-tolerant genetically modified soybean MON89788, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto
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This document provides an opinion of the Scientific Panel on Genetically Modified Organisms (GMO Panel) of the European Food Safety Authority (EFSA) on genetically modified soybean MON89788 (Unique Identifier MON-89788-1) developed to provide tolerance to glyphosate by expressing the CP4 EPSPS protein.
In delivering its scientific opinion, the GMO Panel considered the new application EFSA-GMO-NL-2006-36, additional information provided by the applicant (Monsanto) and the scientific comments submitted by the Member States. The scope of application EFSA-GMO-NL-2006-36 is for food and feed uses, import and processing of soybean MON89788 and all derived products, but excluding cultivation in the EU.
The GMO Panel assessed soybean MON89788 with reference to the intended uses and the appropriate principles described in the Guidance Document of the Scientific Panel on Genetically Modified Organisms for the risk assessment of genetically modified plants and derived food and feed (EFSA, 2006). The scientific assessment included molecular characterization of the inserted DNA and expression of the new protein. A comparative analysis of agronomic traits and composition was undertaken and the safety of the newly expressed protein and the whole food/feed was evaluated with respect to potential toxicity, allergenicity and nutritional quality. An assessment of environmental impacts and the post-market environmental monitoring plan were undertaken.
Soybean MON89788 was transformed by Agrobacterium tumefaciens-mediated gene transfer technology. Soybean MON89788 expresses the codon-optimized epsps from Agrobacterium sp. strain CP4 encoding CP4 EPSPS that confers glyphosate tolerance to the plant.
The molecular characterisation data established that a single insert with one copy of the intact cp4 epsps expression cassette is integrated in the soybean genomic DNA. Appropriate analyses of the integration site including sequence determination of the inserted DNA and flanking regions and bioinformatics analysis have been performed. Bioinformatics analysis of junction regions demonstrated the absence of any potential new ORFs coding for known toxins or allergens. The expression of the genes introduced by genetic modification has been sufficiently analysed and the stability of the genetic modification has been demonstrated over several generations. The GMO Panel is of the opinion that the molecular characterisation of the DNA insert and flanking regions of soybean MON89788 does not raise any safety concern, and that sufficient evidence for the stability of the genetic modification was provided.
The GMO Panel compared the composition and agrono¬mic characteristics of soybean MON89788 and its non-GM counterpart, assessed all statistical differences identified, and came to the conclusion that soybean MON89788 is compositionally equivalent to conventional soybean lines, except for the introduced transgenic trait. The risk assessment included an analysis of data from analytical studies, bioinformatics, and in vitro and in vivo studies. The GMO Panel concluded that the soybean MON89788 is as safe as its non GM counterpart and that the overall allergenicity of the whole plant is not changed.
The application for soybean MON89788 concerns food and feed uses, import and processing of soybean MON89788 and all derived products, but excluding cultivation in the EU. There is therefore no requirement for scientific assessment of possible environmental effects associated with the cultivation of soybean MON89788. Considering the scope of the application, not for cultivation, the GMO Panel is of the opinion that the likelihood of the spread and establishment of soybean MON89788 is very low and that unintended environmental effects due to this soybean will be no different from that of conventional soybean varieties. The scope of the post-market environmental monitoring plan provided by the applicant is in line with the intended uses of soybean MON89788. The monitoring plan provided by the applicant is in line with the EFSA Guidance Document (EFSA, 2006) and the Opinion of the GMO Panel on post-market environmental monitoring (EFSA, 2006).
In conclusion, the GMO Panel considers that the information available for soybean MON89788 addresses the scientific comments raised by the Member States and that the GM soybean MON89788 is as safe as its non genetically modified counterpart with respect to potential effects on human and animal health or the environment. Therefore the GMO Panel concludes that soybean MON89788 is unlikely to have any adverse effect on human or animal health or on the environment in the context of its intended uses.
GMO, soybean, MON89788, glyphosate tolerance, EPSPS, MON-89788-1, human and animal health, environment, import, processing, food, feed, Regulation (EC) No 1829/2003