Genetically modified DP915635 maize is agronomically and compositionally comparable to non-genetically modified maize

Abstract

ABSTRACTDP915635 maize was genetically modified (GM) to express the IPD079Ea protein for corn rootworm (Diabrotica spp.) control. DP915635 maize also expresses the phosphinothricin acetyltransferase (PAT) protein for tolerance to glufosinate herbicide and the phosphomannose isomerase (PMI) protein that was used as a selectable marker. A field study was conducted at ten sites in the United States and Canada during the 2019 growing season. Of the 11 agronomic endpoints that were evaluated, two of them (early stand count and days to flowering) were statistically significant compared with the control maize based on unadjusted p-values; however, these differences were not significant after FDR-adjustment of p-values. Composition analytes from DP915635 maize grain and forage (proximates, fiber, minerals, amino acids, fatty acids, vitamins, anti-nutrients, and secondary metabolites) were compared to non-GM near-isoline control maize (control maize) and non-GM commercial maize (reference maize). Statistically significant differences were observed for 7 of the 79 compositional analytes (16:1 palmitoleic acid, 18:0 stearic acid, 18:1 oleic acid, 18:2 linoleic acid, 24:0 lignoceric acid, methionine, and α-tocopherol); however, these differences were not significant after FDR-adjustment. Additionally, all of the values for composition analytes fell within the range of natural variation established from the in-study reference range, literature range, and/or tolerance interval. These results demonstrate that DP915635 is agronomically and compositionally comparable to non-GM maize represented by non-GM near-isoline control maize and non-GM commercial maize.

Keywords

• agronomics
• composition
• genetically modified
• safety assessment
• substantial equivalence
• Zea mays L.