Maize plants containing event DP-2Ø2216-6 (DP202216), which confers herbicide tolerance through expression of phosphinothricin acetyltransferase and enhanced grain yield potential via temporal modulation of the native ZMM28 protein, were developed for commercialization. To address current regulatory expectations, a mandatory 90-day rodent feeding study was conducted to support the safety assessment. Diets containing 50% by weight of ground maize grain from DP202216, non-transgenic control, and 3 non-transgenic reference varieties, were fully characterized, along with the grain, and diets were fed to Crl:CD®(SD) rats for at least 90 days. As anticipated, no biologically-relevant effects or toxicologically-significant differences were observed on survival, body weight/gain, food consumption/efficiency, clinical and neurobehavioral evaluations, ophthalmology, clinical pathology (hematology, coagulation, clinical chemistry, urinalysis), organ weights, or gross and microscopic pathology parameters in rats fed a diet containing up to 50% DP202216 maize grain when compared with rats fed diets containing control or reference maize grains. The results of this study support the conclusion that maize grain from plants containing event DP-2Ø2216-6 is as safe and nutritious as maize grain not containing the event and add to the significant existing database of rodent subchronic studies demonstrating the absence of hazards from consumption of edible fractions of genetically modified plants.
Keywords: DP-2Ø2216-6 maize; Mandatory; No diet-related effects; Not scientifically justified; Subchronic.
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