Final Health and Environmental Risk Assessment of Genetically Modified Cotton GHB614

ABSTRACT

Genetically modified cotton GHB614 from Bayer Crop Science expresses a modified epsps gene (2mepsps) gene from maize encoding the enzyme 5-enolpyruvylshikimate 3-phosphate synthase (2 mEPSPS), which confers tolerance to the herbicide glyphosate. Updated bioinformatics analyses of the inserted DNA and flanking sequences in GHB614 have not indicated potential production of putatively harmful toxins or allergens caused by the genetic modification. Genomic stability of the functional insert and consistent expression of the 2mepsps gene has been shown over several generations of cotton GHB614. Field trials indicate that with the exception of the introduced trait, cotton GHB614 is compositionally, phenotypically and agronomically equivalent to its conventional counterpart Coker 312 and other cotton cultivars. A 42-day nutritional assessment trial with broilers did not reveal adverse effects of cottonseed meal from GHB614. The 2mEPSPS protein produced in GHB614 does not show amino acid sequence resemblance to known toxins or IgE-dependent allergens, nor has it been reported to cause IgE-mediated allergic reactions. It is therefore unlikely that the 2 mEPSPS protein will cause toxic or IgE-mediated allergic reactions to food or feed containing cotton GHB614 compared to conventional cotton cultivars. Cotton is not cultivated in Norway, and there are no cross-compatible wild or weedy relatives of cotton in Europe. Based on current knowledge and with the exception of the introduced trait, the VKM GMO Panel concludes that cotton GHB614 is nutritionally, compositionally, phenotypically and agronomically equivalent to and as safe as its conventional counterpart and other cotton cultivars. Considering the intended uses, which exclude cultivation, the VKM GMO Panel concludes that GHB614 does not represent an environmental risk in Norway.