Genome editing techniques, especially the CRISPR/Cas technology, increase the possibilities and the speed of altering genetic material in organisms. So-called genome editing is increasingly being used to achieve agriculturally relevant novel traits and/or genetic combinations in both plants and animals, although predominantly as proof of concept studies, with commercial growing or rearing so far limited to the U.S. and Canada. However, there are numerous reports of unintended effects such as off-target effects, unintended on-target effects and other unintended consequences arising from genome editing, summarised under the term genomic irregularities. Despite this, the searching for genomic irregularities is far from routine in these studies and protocols vary widely, particularly for off-target effects, leading to differences in the efficacy of detection of off-target effects. Here, we describe the range of specific unintended effects associated with genome editing. We examine the considerable possibilities to change the genome of plants and animals with SDN-1 and SDN-2 genome editing (i.e. without the insertion of genes conferring the novel trait) and show that genome editing techniques are able to produce a broad spectrum of novel traits that, thus far, were not possible to be obtained using conventional breeding techniques. We consider that the current EU risk assessment guidance for GMOs requires revision and broadening to capture all potential genomic irregularities arising from genome editing and suggest additional tools to assist the risk assessment of genome-edited plants and animals for the environment and food/animal feed in the EU.

中文翻译：

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扩大欧盟针对农业基因组编辑技术的转基因生物风险评估

基因组编辑技术，特别是CRISPR / Cas技术，增加了改变生物体遗传物质的可能性和速度。越来越多地使用所谓的基因组编辑来在植物和动物中实现与农业相关的新颖性状和/或遗传组合，尽管主要是作为概念研究的证据，到目前为止，商业发展或养殖仅限于美国和加拿大。但是，有许多关于意外影响的报道，例如脱靶效应，意外靶点效应以及其他由于基因组编辑而产生的意外后果，均归因于基因组不规则现象。尽管如此，在这些研究中寻找基因组不规则性仍非常规操作，而且方案差异很大，尤其是脱靶效应，导致脱靶效应检测功效的差异。在这里，我们描述了与基因组编辑相关的特定意外影响的范围。我们研究了使用SDN-1和SDN-2基因组编辑来改变动植物基因组的巨大可能性（即，不插入赋予新颖性状的基因），并证明了基因组编辑技术能够产生广泛的新颖性迄今为止，使用常规育种技术无法获得的性状。我们认为，当前的欧盟关于转基因生物的风险评估指南需要修订和扩展，以捕获由基因组编辑引起的所有潜在的基因组不规则现象，并建议使用其他工具来协助基因组编辑的动植物对环境和食品/动物饲料进行风险评估。欧盟。