Import and processing of cotton T304-40

The present application by Bayer CropScience (file EFSA/GMO/NL/2011/97) concerns the import and processing for use in feed and food of cotton T304-40. Cultivation is not part of this application.
Cotton line T304-40 was produced by Agrobacterium tumefaciens mediated transformation of conventional cotton. T304-40 expresses the cry1Ab gene and bar gene. As a result, T304-40 cotton is resistant to certain lepidopteran pests and tolerant to glufosinate ammonium based herbicides. T304-40 has not been previously assessed by COGEM.
In Northwest Europe, no wild relatives of cotton are present. Modern cotton cultivars do not possess any of the attributes commonly associated with problematic weeds. COGEM does not know of reasons to assume that the introduced traits will increase the potential of cotton to establish feral populations. Moreover, cotton cannot survive the climatologic conditions in Northwest Europe. Therefore, COGEM is of the opinion that incidental spillage of T304-40 seeds will not pose a risk to the environment in Northwest Europe.
The applicant showed by Southern blot analyses that one nearly complete copy of the insert (with the bar and cry1Ab gene) flanked by an inverted incomplete copy (without the bar gene) is integrated at a single locus. The applicant further showed that the backbone of the plasmid used for transformation is absent in T304-40. Bioinformatic analysis of the insert itself and the junctions of the insert and the cotton genomic DNA identified a total of 291 open reading frames (ORFs). These sequences were analyzed for similarity to known toxins or allergens. No similarities were found. The molecular characterization and provided General Surveillance plan meet the criteria of COGEM .
In view of the above, COGEM is of the opinion that the risks for humans and the environment associated with import and processing of cotton line T304-40 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.