Import and processing of genetically modified maize DAS-40278-9

The present application by Dow AgroSciences Europe (file EFSA/GMO/NL/2010/89) concerns import and processing for use in feed and food of the genetically modified maize line DAS-40728-9. Cultivation is not part of this application.
Maize line DAS-40728-9 was produced by the introduction of an aad-1 expression cassette using whisker mediated transformation. As a result, the line tolerates a broad spectrum of selective herbicides. The plant is tolerant for several synthetic auxin acting herbicides like ‘2,4-dichlorophenoxoxyacetic acid’ and certain ‘aryloxyphenoxypropionate’ containing herbicides. Maize line DAS-40728-9 has not been previously assessed by COGEM. The applicant showed by Southern blot analyses that one copy of the insert was integrated at a single integration locus in the genome of DAS-40728-9 and that the backbone of the plasmid used for transformation was absent in DAS-40728-9. Bioinformatic analysis showed that no endogenous maize open reading frames (ORFs) were disrupted. Ten ORFs, encoding eight or more amino acids, spanning the 5’ and 3’ junctions of the insert and the genomic
DNA were identified. The amino acid sequence was deduced and analyzed in silico for similarity to known toxins or allergens. No similarity was found. The molecular characterization of maize line DAS-40728-9 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 trait will increase the potential of maize to establish feral populations. The introduced gene 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 DAS-40728-9 are negligible. A food/feed safety assessment is carried out by other organizations. Therefore, COGEM abstained from advice on the potential risks of incidental consumption.