ABSTRACT

Event DP-Ø23211-2 (hereafter referred to as DP23211) maize expresses the DvSSJ1 double-stranded RNA (DvSSJ1 dsRNA) and the IPD072Aa protein, encoded by the ipd072Aa gene. DvSSJ1 dsRNA and the IPD072Aa protein each provide control of corn rootworms (Diabrotica spp.) when expressed in plants. As part of the environmental risk assessment (ERA), the potential hazard to non-target organisms (NTOs) exposed to the DvSSJ1 dsRNA and the IPD072Aa protein expressed in DP23211 maize was assessed. Worst-case estimated environmental concentrations (EECs) for different NTO functional groups (pollinators and pollen feeders, soil dwelling detritivores, predators and parasitoids, aquatic detritivores, insectivorous birds, and wild mammals) were calculated using worst-case assumptions. Several factors that reduce exposure to NTOs under more realistic environmental conditions were applied, when needed to provide more environmentally relevant EECs. Laboratory bioassays were conducted to assess the activity of DvSSJ1 dsRNA or the IPD072Aa protein against selected surrogate species, and margins of exposure (MOEs) were calculated by comparing the Tier I hazard study results to worst-case or refined EECs. Based on specificity and MOE values, DvSSJ1 dsRNA and the IPD072Aa protein expressed in DP23211 maize are not expected to be harmful to NTO populations at environmentally relevant concentrations.

 抽象的

事件 DP-Ø23211-2（以下简称 DP23211）玉米表达 DvSSJ1 双链 RNA (DvSSJ1 dsRNA) 和由ipd072Aa基因编码的 IPD072Aa 蛋白。当在植物中表达时，DvSSJ1 dsRNA 和 IPD072Aa 蛋白均可以控制玉米根虫（ Diabrotica spp.）。作为环境风险评估 (ERA) 的一部分，评估了暴露于 DP23211 玉米中表达的 DvSSJ1 dsRNA 和 IPD072Aa 蛋白的非目标生物 (NTO) 的潜在危害。使用最坏情况假设计算了不同 NTO 功能类群（传粉者和花粉饲养者、土生碎屑动物、捕食者和拟寄生物、水生碎屑动物、食虫鸟类和野生哺乳动物）的最坏情况估计环境浓度 (EEC)。当需要提供与环境更相关的 EEC 时，应用了在更现实的环境条件下减少 NTO 暴露的几个因素。进行实验室生物测定，以评估 DvSSJ1 dsRNA 或 IPD072Aa 蛋白针对选定替代物种的活性，并通过将 I 级危害研究结果与最坏情况或改进的 EEC 进行比较来计算暴露裕度 (MOE)。根据特异性和 MOE 值，预计 DP23211 玉米中表达的 DvSSJ1 dsRNA 和 IPD072Aa 蛋白在环境相关浓度下不会对 NTO 种群造成危害。