Import and processing of insect resistant soybean line MON87701

Advisory reports | 10.08.2010 | 100810-01

The present application of Monsanto Company (file EFSA/GMO/BE/2010/79) concerns the import and processing for use in feed and food of genetically modified soybean line MON87701. Cultivation is not part of this application.
Soybean line MON87701 was developed through Agrobacterium tumefaciens mediated transformation. The soybean line expresses the cry1Ac gene derived from Bacillus thuringiensis, conferring resistance to certain lepidopteran insects.
The applicant confirmed by Southern blot analyses that one intact copy of the insert was integrated at a single insertion locus in the genome of MON87701 and that the plasmid’s backbone, used for transformation, was absent in MON87701. Sequence analysis spanning the 5’ and 3’ junctions of the insertion site and the genomic DNA indicated a 32 bp deletion as well as a 14 bp insertion at the 5’end of the insert in MON87701. Furthermore, several sequences of eight amino acids or greater in length spanning the 5’ junction and 3’ junction of the insert and the genomic DNA were identified. No sequence similarities between any known toxins or allergens were demonstrated. In the opinion of COGEM, the molecular analysis of MON87701 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 MON87701 poses a negligible risk to the environment and has no objections against an authorization for import and processing of MON87701. 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.

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