Scientific Opinion on an application (EFSA-GMO-NL-2005-24) for the placing on the market of the herbicide tolerant genetically modified soybean 40-3-2 for cultivation under Regulation (EC) No 1829/2003 from Monsanto

This Scientific Opinion reports on an evaluation of a risk assessment for the placing on the market for cultivation of genetically modified soybean 40-3-2, and updates the previous EFSA GMO Panel Scientific Opinion on the renewal applications for the continued marketing of soybean 40-3-2. The EFSA GMO Panel considered that soybean 40-3-2 is unlikely to raise additional environmental safety concerns compared with conventional soybean, but that the management of its cultivation could result in environmental harm under certain conditions. The Panel therefore recommended managing the use of glyphosate on soybean 40-3-2 in ways that result in similar or reduced environmental impacts compared with conventional soybean cultivation. There is no evidence of adverse effects on non-target organisms (including pollinators) due to the expression of the CP4 EPSPS protein, and there are no indications of the occurrence of adverse effects on non-target predators, herbivores and decomposers due to potential unintended changes in soybean 40-3-2. Owing to the lack of event-specific data on plant-pollinator interactions, scientific uncertainty on the occurrence of adverse effects on pollinators, due to potential unintended changes in soybean 40-3-2, remains, and strategies for resolving this uncertainty are discussed. The Panel recommended the deployment of case-specific monitoring to address: (1) changes in weed community diversity; and (2) the evolution of resistance to glyphosate in weeds due to changes in herbicide and cutivation regimes. The Panel agreed with the general surveillance plan of the applicant, but requested that the Panel‟s proposals to strengthen general surveillance are implemented. The Panel concluded that the information available for soybean 40-3-2 addresses the scientific comments raised by Member States and that soybean 40-3-2, as described in this application, is as safe as its conventional counterpart and commercial non-GM soybean varieties with respect to potential adverse effects on human and animal health. If subjected to appropriate management measures, the cultivation of soybean 40-3-2 is unlikely to have environmental effects any more adverse than those associated with conventional soybean cultivation.