Import and processing of genetically modified soybean MON87769 expressing two desaturase genes

The present application of Monsanto Company (file EFSA/GMO/UK/2009/76) concerns the import and processing for use in feed and food of soybean line MON87769. Cultivation is not part of this application.
Soybean line MON87769 was obtained by Agrobacterium tumefaciens mediated transformation. The soybean expresses the Pj.D6D gene derived from Primula juliae and Nc.Fad3 derived from Neurospora crassa resulting in the production of stearidonic acid (SDA), an omega-3 fatty acid.
The applicant showed by Southern blot analyses that one copy of the insert was integrated at a single integration locus in the genome of MON87769 and that the backbone of the plasmid used for transformation was absent in MON87769. Sequence analyses spanning the 5’ and 3’ junctions of the insertion site and the genomic DNA indicated a 9 bp deletion of genomic DNA and two small insertions of 17 and 8 bp. No endogenous soybean open reading frames (ORFs) were disrupted. Sequence analyses also identified several sequences of eight amino acids or greater in length. No sequence similarities between any known toxins or allergens were demonstrated. In the opinion of COGEM, the molecular analysis of MON87769 has been adequately performed.

In Europe, closely related species of soybean are not present and soybean does not possess any of the attributes commonly associated with problematic weeds. Besides, establishment of feral soybean populations has never been observed in Europe. Hybridization with other species is not possible because there are no closely related species of soybean present. Due to the climatic and geographical conditions, survival of soybean is not possible in the Netherlands. Because there is no reason to assume that the inserted genes would introduce or increase the potential for soybean to establish feral populations, COGEM is of the opinion that incidental spillage of soybean will not pose a risk to  the environment.
In conclusion, COGEM is of the opinion that import and processing of soybean line MON87769 poses a negligible risk to the environment and has no objections against an authorization for import and processing of MON87769. COGEM points out that a food/feed safety assessment is carried out by other organizations. Therefore, COGEM abstains from advice on the potential risks of incidental consumption.