Eckerstorfer Michael F, Grabowski Marcin, Lener Matteo, Engelhard Margret, Simon Samson, Dolezel Marion, Heissenberger Andreas, Lüthi Christoph
Umweltbundesamt-Environment Agency Austria (EAA), Landuse & Biosafety Unit, Spittelauer Lände 5, 1090 Vienna, Austria.
Ministry of Climate and Environment, Department Nature Conservation, GMO Unit, Wawelska 52/54, 00-922 Warszawa, Poland.
BioTech (Basel). 2021 Jun 22;10(3):10. doi: 10.3390/biotech10030010.
An intensely debated question is whether or how a mandatory environmental risk assessment (ERA) should be conducted for plants obtained through novel genomic techniques, including genome editing (GE). Some countries have already exempted certain types of GE applications from their regulations addressing genetically modified organisms (GMOs). In the European Union, the European Court of Justice confirmed in 2018 that plants developed by novel genomic techniques for directed mutagenesis are regulated as GMOs. Thus, they have to undergo an ERA prior to deliberate release or being placed on the market. Recently, the European Food Safety Authority (EFSA) published two opinions on the relevance of the current EU ERA framework for GM plants obtained through novel genomic techniques (NGTs). Regarding GE plants, the opinions confirmed that the existing ERA framework is suitable in general and that the current ERA requirements need to be applied in a case specific manner. Since EFSA did not provide further guidance, this review addresses a couple of issues relevant for the case-specific assessment of GE plants. We discuss the suitability of general denominators of risk/safety and address characteristics of GE plants which require particular assessment approaches. We suggest integrating the following two sets of considerations into the ERA: considerations related to the traits developed by GE and considerations addressing the assessment of method-related unintended effects, e.g., due to off-target modifications. In conclusion, we recommend that further specific guidance for the ERA and monitoring should be developed to facilitate a focused assessment approach for GE plants.
一个备受争议的问题是，对于通过包括基因组编辑（GE）在内的新型基因组技术获得的植物，是否应该以及如何进行强制性环境风险评估（ERA）。一些国家已经将某些类型的基因编辑应用排除在其针对转基因生物（GMO）的法规之外。在欧盟，欧洲法院于2018年确认，通过新型基因组技术进行定向诱变培育的植物被作为转基因生物进行监管。因此，它们在有意释放或投放市场之前必须进行环境风险评估。最近，欧洲食品安全局（EFSA）就欧盟现行环境风险评估框架对通过新型基因组技术（NGTs）获得的转基因植物的相关性发表了两份意见。关于基因编辑植物，这些意见确认现有的环境风险评估框架总体上是合适的，并且当前的环境风险评估要求需要根据具体情况应用。由于欧洲食品安全局没有提供进一步的指导，本综述探讨了与基因编辑植物具体评估相关的几个问题。我们讨论了风险/安全性通用指标的适用性，并阐述了需要特定评估方法的基因编辑植物的特征。我们建议将以下两组考虑因素纳入环境风险评估：与基因编辑培育的性状相关的考虑因素，以及针对方法相关意外效应评估的考虑因素，例如由于脱靶修饰导致的效应。总之，我们建议应制定关于环境风险评估和监测的进一步具体指导，以促进对基因编辑植物的重点评估方法。
