Import and processing of genetically modified maize 4114

Advisory reports | 28.05.2015 | CGM/150528-01

The present application (EFSA/GMO/NL/2014/123) concerns import and processing for use in feed and food of genetically modified maize 4114. Cultivation is not part of this application.
Maize line 4114 was generated by Agrobacterium mediated transformation of the parental Pioneer proprietary maize line PHWWE and expresses the pat, cry1F, cry34Ab1 and cry35Ab1 genes. As a result, maize 4114 is tolerant to glufosinate-ammonium containing herbicides, and resistant to certain lepidopteran and coleopteran insects.
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 allow 4114 maize to establish feral populations. The introduced genes cannot spread to closely related species since wild relatives of maize are not present in Europe.
The applicant showed by Southern blot analyses that maize line 4114 contains one copy of the insert at a single integration locus and that the backbone of the plasmid used for transformation is absent.
Bioinformatic analysis of the junctions of the inserted sequences and the maize genomic DNA, identified eleven open reading frames (ORFs). These ORFs were analysed for similarity to known proteins or allergens. No similarities to allergens and toxins were found. The molecular characterization of maize 4114 meets the criteria of COGEM. COGEM considers the appended General Surveillance plan adequate for import of maize 4114.
In conclusion, COGEM is of the opinion that incidental spillage of maize 4114 poses a negligible risk to the environment. COGEM abstains from giving advice on the potential risks of incidental consumption since a food/feed assessment is already carried out by other organizations. COGEM considers the environmental risks associated with import and processing of maize 4114 to be negligible.

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