The present application of Dow AgroSciences Europe (EFSA/GMO/NL/2011/91) concerns the import and processing for use in feed and food of genetically modified soybean DAS-68416-4. Cultivation is not part of this application.
Soybean line DAS-68416-4 was obtained by Agrobacterium tumefaciens mediated transformation of conventional soybean. The line expresses the aad-12 gene and the pat gene conferring tolerance to several herbicides.
In Europe, there are no wild relatives of soybean and therefore, hybridisation with other species is not possible. Soybean does not possess any of the attributes commonly associated with problematic weeds and establishment of feral soybean populations has never been observed in Europe. In addition soybean volunteers are rare throughout the world and do not effectively compete with other cultivated plants, weeds or primary colonisers. COGEM is of the opinion that the environmental risk of spread of soybean DAS-68416-4 within the Netherlands due to incidental spillage of this soybean is negligible.
In the opinion of COGEM, the molecular analysis of soybean line DAS-68416-4 is sufficient. Although the general surveillance (GS) plan could be improved by a guarantee that operators will monitor for unanticipated effects, COGEM considers the current general surveillance plan sufficient for import and processing of soybean line DAS-68416-4.
In conclusion, COGEM is of the opinion that import and processing of soybean line DAS-68416-4 poses a negligible risk to the environment. COGEM points out that a food/feed safety assessment is carried out by other organisations. Therefore, COGEM abstains from advice on the potential risks of incidental consumption.