Papadopoulou Nikoletta, Devos Yann, Álvarez-Alfageme Fernando, Lanzoni Anna, Waigmann Elisabeth
Genetically Modified Organisms Unit, Department of Scientific Evaluation of Regulated Products Development, European Food Safety Authority, Parma, Italy.
Front Plant Sci. 2020 Apr 21;11:445. doi: 10.3389/fpls.2020.00445. eCollection 2020.
Genetically modified plants (GMPs) intended for market release can be designed to induce "gene silencing" through RNA interference (RNAi). The European Food Safety Authority (EFSA) and other international risk assessment bodies/regulatory agencies have taken several actions to determine whether the existing risk assessment approaches for GMPs are appropriate for the risk assessment of RNAi-based GMPs or require complementary or alternative approaches. To our knowledge, at the international level, no dedicated guidelines have been developed for the risk assessment and regulation of RNAi-based GMPs, confirming that existing science-based risk assessment approaches for GMPs are generally considered suitable for RNAi-based GMPs. However, some specificities have been identified for the risk assessment of RNAi-based GMPs. Here, we report on some of these specificities as identified and addressed by the EFSA GMO Panel for the molecular characterisation, food/feed safety assessment and environmental risk assessment of RNAi-based GMPs, using the DvSnf7 dsRNA-expressing maize MON87411 as a case study.
旨在投放市场的转基因植物（GMP）可设计为通过RNA干扰（RNAi）诱导“基因沉默”。欧洲食品安全局（EFSA）和其他国际风险评估机构/监管机构已采取多项行动，以确定现有的转基因植物风险评估方法是否适用于基于RNAi的转基因植物的风险评估，或者是否需要补充或替代方法。据我们所知，在国际层面，尚未制定专门针对基于RNAi的转基因植物风险评估和监管的指南，这证实了现有的基于科学的转基因植物风险评估方法通常被认为适用于基于RNAi的转基因植物。然而，已确定基于RNAi的转基因植物风险评估存在一些特殊性。在此，我们以表达DvSnf7 dsRNA的玉米MON87411为例，报告欧洲食品安全局转基因生物小组在基于RNAi的转基因植物的分子特征、食品/饲料安全性评估和环境风险评估中所确定并解决的一些特殊性。
