Import and processing of genetically modified maize line MON87460

The present application of Monsanto Company (file EFSA/GMO/NL/2009/70) concerns the import and processing for use in feed and food of maize line MON87460. Cultivation is not part of this application.
Maize line MON87460 was obtained by Agrobacterium-mediated transformation of conventional maize and expresses cold shock protein B (CspB) from Bacillus subtilis and neomycin phosphoptransferase II (NptII) from Escherichia coli. CspB functions as a RNA-chaperone and facilitates adaptation to environmental stress in both bacteria and plants. In maize line MON87460 CspB provides a reduced yield loss under water-limited conditions. NptII confers resistance to kanamycin and neomycin and was used to facilitate the selection process of transformed plant cells.
The applicant showed by Southern blot analyses that one copy of the insert was integrated at a single integration locus in the genome of MON87460 and that the backbone of the plasmid used for transformation was absent in MON87460. Bioinformatic analysis spanning the 5’ and 3’ junctions showed that no endogenous maize open reading frames (ORFs) were disrupted. Nine ORFs encoding eight or more amino acids were identified. No sequence similarities between any known toxins or allergens were identified. In the opinion of COGEM, the molecular analysis of MON87460 has been adequately performed.
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 since wild relatives of maize are not present in Europe.
Although the General Surveillance plan could be improved by a guarantee that operators will monitor for unanticipated effects, COGEM considers the current GS plan sufficient for import and processing.
In conclusion, COGEM is of the opinion that import and processing of maize line MON87460 poses a negligible risk to the environment and has no objections against an authorization for import and processing of MON87460. 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. Noteworthy is that the presence of antibiotic resistance genes in GM crops is rejected by certain factions in society. In their perception the presence of antibiotic genes is a safety risk because in their view horizontal gene flow could lead to antibiotic resistant pathogenic bacteria.