Import and processing of genetically modified maize line 5307

The present application by Syngenta Crop Protection AG (file EFSA/GMO/DE/2011/95) concerns import and processing for use in feed and food of the genetically modified maize line 5307. Cultivation is not part of this application.
Maize line 5307 expresses the ecry3.1Ab gene conferring resistance to certain coleopteran insects. In addition, this maize line expresses the pmi gene which acts as a selectable marker enabling transformed plant cells to utilize mannose as a carbon source.
The applicant showed by Southern blot analyses that one copy of the insert is integrated at a single integration locus in the genome of maize line 5307 and that the backbone of the plasmid used for transformation is absent in maize line 5307. Bioinformatic analysis of the junctions of the insert and the maize genomic DNA identified twelve open reading frames (ORFs) that are delimited by putative stop codons. These junction sequences were analyzed for similarity to known toxins or allergens. No similarities were found. The molecular characterization of maize line 5307 meets the criteria of COGEM.
During its long domestication process, maize has lost its ability to survive in the wild. In the Netherlands, the appearance of maize volunteers is rare and establishment of volunteers in the wild has never been reported. There are no reasons to assume that the introduced traits will increase the potential of maize to establish feral populations. The introduced genes cannot spread to closely related species since wild relatives of maize are not present in Europe.
In view of the above, COGEM is of the opinion that the risks for humans and the environment associated with import and processing of maize line 5307 are negligible. A food/feed safety assessment is carried out by other organizations. Therefore, COGEM abstains from advice on the potential risks of incidental consumption.