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Biosafety of Genome Editing Applications in Plant Breeding: Considerations for a Focused Case-Specific Risk Assessment in the EU

机译:植物育种中的基因组编辑应用的生物安全:欧盟集中于集中案例的风险评估的考虑因素

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摘要

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.
机译:一种强烈的争论问题是,应如何为通过新型基因组技术获得的植物进行强制性环境风险评估(时代),包括基因组编辑(GE)。一些国家已从他们的法规中豁免某些类型的GE申请,这些法规涉及转基因生物(GMOS)。在欧洲联盟,欧洲司法法院于2018年确认,由新型基因组技术开发的指导诱变的植物被调控为GMO。因此,他们必须在故意释放或被放置在市场之前进行一次时代。近日,欧洲食品安全管理局(EFSA)就通过新型基因组技术(NGT)获得的目前欧盟时代框架的相关性发表了两项意见。关于GE植物,意见证实,现有的时代框架通常是适合的,并且当前的时代要求需要以特定的方式应用。由于EFSA没有提供进一步的指导,本综述解决了对GE植物的具体评估有关的几个问题。我们讨论了需要特定评估方法的GE植物风险/安全性和地址特征的普通分母的适用性。我们建议将以下两组考虑集成到时代:与GE和GE开发的特征相关的考虑因素,并且考虑因素相关的方法相关的意想不到的效果,例如,由于偏离目标修改。总之,我们建议应制定进一步的ERA和监测指导,以促进GE植物的重点评估方法。

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