Plant characterization of Roundup Ready 2 Yield® soybean, MON 89788, for use in ecological risk assessment

Abstract

During the development of a genetically modified (GM) crop product, extensive phenotypic and agronomic data are collected to characterize the plant in comparison to a conventional control with a similar genetic background. The data are evaluated for potential differences resulting from the genetic modification process or the GM trait, and the differences--if any--are subsequently considered in the context of contributing to the pest potential of the GM crop. Ultimately, these study results and those of other studies are used in an ecological risk assessment of the GM crop. In the studies reported here, seed germination, vegetative and reproductive growth, and pollen morphology of Roundup Ready 2 Yield(®) soybean, MON 89788, were compared to those of A3244, a conventional control soybean variety with the same genetic background. Any statistically significant differences were considered in the context of the genetic variation known to occur in soybean and were evaluated as indicators of an effect of the genetic modification process and assessed for impact on plant pest (weed) characteristics and adverse ecological impact (ecological risk). The results of these studies revealed no effects attributable to the genetic modification process or to the GM trait in the plant that would result in increased pest potential or adverse ecological impact of MON 89788 compared with A3244. These results and the associated risk assessments obtained from diverse geographic and environmental conditions in the United States and Argentina can be used by regulators in other countries to inform various assessments of ecological risk.

Characterization of the ecological interactions of Roundup Ready 2 Yield® soybean, MON 89788, for use in ecological risk assessment

“…15 For MON 89788 there were no or few differences detected across the germination, phenotypic, and pollen studies that would increase the weediness and invasive characteristics of MON 89788, so the hazard for these particular endpoints would be negligible. 10 Based on a tiered assessment approach, the germination, emergence and plant growth, and reproduction data presented in Horak et al 10 did not indicate any differences that would indicate the need for further assessments of weediness and invasiveness. However, in order to address specific regulatory requirements and the other needs described above, the studies reported herein were conducted.…”

“…The studies reported in Horak et al 10 Protocol 12 or other publications. 6,7 However, from a practical standpoint, these characterization studies provide regulators with information that is either required by government authorities or assists in decision making by addressing perceived uncertainty.…”

“…5 In most cases where the crop will be cultivated, exposure is considered to be 100%, meaning that the plant will be introduced into the environment via crop planting and thus environmental exposure will occur. The data reported here and in Horak et al 10 were used to assess potential hazards and relevant exposure scenarios, focusing on weediness and adverse environmental effects, to address specific regulatory requirements and anticipated questions and ultimately to characterize the environmental risk of MON 89788.…”

“…Horak et al10 outlines the stepwise process used to determine whether a statistically significant difference between MON 89788 and A3244 for any of the characteristics assessed was potentially adverse in terms of pest potential or ecological impact. A -No‖ answer at any step indicated that the difference did not contribute to a biological or ecological concern for MON 89788, and subsequent steps were not considered.…”

“…A -No‖ answer at any step indicated that the difference did not contribute to a biological or ecological concern for MON 89788, and subsequent steps were not considered. A detailed explanation of this decision method as applied to MON 89788 is given in Horak et al10 Downloaded by [New York University] at 13:54 16 July 2015…”