Advancing ecological risk assessment on genetically engineered breeding stacks with combined insect-resistance traits.

To inform the ecological risk assessment (ERA) of a transgenic crop with multiple insecticidal traits combined by conventional breeding (breeding stack), a comparative field study is customarily conducted to compare transgenic protein concentrations in a breeding stack to those in corresponding component single events used in the breeding process. This study tests the hypothesis that transgenic protein expression will not significantly increase due to stacking, such that existing margins of exposure erode to unacceptable levels. Corroboration of this hypothesis allows for the use of existing non-target organism (NTO) effects tests results, where doses were based on the estimated environmental concentrations determined for a component single event. Results from over 20 studies comparing expression profiles of insecticidal proteins produced by commercial events in various combinations of conventionally-bred stacks were examined to evaluate applying previously determined no-observed-effect concentrations (NOECs) to stack ERAs. This paper presents a large number of tests corroborating the hypothesis of no significant increase in insecticidal protein expression due to combination by conventional breeding, and much of the variation in protein expression is likely attributed to genetic and environmental factors. All transgenic protein concentrations were well within conservative margins between exposure and corresponding NOEC. This work supports the conclusion that protein expression data generated for single events and the conservative manner for setting NTO effects test concentrations allows for the transportability of existing NOECs to the ERA of conventionally-bred stacks, and that future tests of the stated hypothesis are no longer critically informative for ERA on breeding stacks.

Nontarget organism effects tests on eCry3.1Ab and their application to the ecological risk assessment for cultivation of Event 5307 maize.

Event 5307 transgenic maize produces the novel insecticidal protein eCry3.1Ab, which is active against certain coleopteran pests such as Western corn rootworm (Diabrotica virgifera virgifera). Laboratory tests with representative nontarget organisms (NTOs) were conducted to test the hypothesis of no adverse ecological effects of cultivating Event 5307 maize. Estimates of environmental eCry3.1Ab concentrations for each NTO were calculated from the concentrations of eCry3.1Ab produced by 5307 maize in relevant plant tissues. Nontarget organisms were exposed to diets containing eCry3.1Ab or diets comprising Event 5307 maize tissue and evaluated for effects compared to control groups. No statistically significant differences in survival were observed between the control group and the group exposed to eCry3.1Ab in any organism tested. Measured eCry3.1Ab concentrations in the laboratory studies were equal to or greater than the most conservative estimates of environmental exposure. The laboratory studies corroborate the hypothesis of negligible ecological risk from the cultivation of 5307 maize.