Eckerstorfer Michael F, Dolezel Marion, Heissenberger Andreas, Miklau Marianne, Reichenbecher Wolfram, Steinbrecher Ricarda A, Waßmann Friedrich
Department Landuse & Biosafety, Environment Agency Austria, Vienna, Austria.
Department GMO Regulation, Biosafety, Federal Agency for Nature Conservation, Bonn, Germany.
Front Bioeng Biotechnol. 2019 Mar 5;7:31. doi: 10.3389/fbioe.2019.00031. eCollection 2019.
The question whether new genetic modification techniques (nGM) in plant development might result in non-negligible negative effects for the environment and/or health is significant for the discussion concerning their regulation. However, current knowledge to address this issue is limited for most nGMs, particularly for recently developed nGMs, like genome editing, and their newly emerging variations, e.g., base editing. This leads to uncertainties regarding the risk/safety-status of plants which are developed with a broad range of different nGMs, especially genome editing, and other nGMs such as cisgenesis, transgrafting, haploid induction or reverse breeding. A literature survey was conducted to identify plants developed by nGMs which are relevant for future agricultural use. Such nGM plants were analyzed for hazards associated either (i) with their developed traits and their use or (ii) with unintended changes resulting from the nGMs or other methods applied during breeding. Several traits are likely to become particularly relevant in the future for nGM plants, namely herbicide resistance (HR), resistance to different plant pathogens as well as modified composition, morphology, fitness (e.g., increased resistance to cold/frost, drought, or salinity) or modified reproductive characteristics. Some traits such as resistance to certain herbicides are already known from existing GM crops and their previous assessments identified issues of concern and/or risks, such as the development of herbicide resistant weeds. Other traits in nGM plants are novel; meaning they are not present in agricultural plants currently cultivated with a history of safe use, and their underlying physiological mechanisms are not yet sufficiently elucidated. Characteristics of some genome editing applications, e.g., the small extent of genomic sequence change and their higher targeting efficiency, i.e., precision, cannot be considered an indication of safety , especially in relation to novel traits created by such modifications. All nGMs considered here can result in unintended changes of different types and frequencies. However, the rapid development of nGM plants can compromise the detection and elimination of unintended effects. Thus, a case-specific premarket risk assessment should be conducted for nGM plants, including an appropriate molecular characterization to identify unintended changes and/or confirm the absence of unwanted transgenic sequences.
植物发育中的新型基因改造技术（nGM）是否会对环境和/或健康产生不可忽视的负面影响，这一问题对于其监管讨论意义重大。然而，目前针对大多数nGM的相关知识有限，特别是对于最近开发的nGM，如基因组编辑及其新出现的变体，例如碱基编辑。这导致了使用广泛不同nGM（特别是基因组编辑）以及其他nGM（如顺基因技术、转基因嫁接、单倍体诱导或反向育种）培育的植物在风险/安全状况方面存在不确定性。开展了一项文献调查，以确定由nGM培育的、与未来农业用途相关的植物。对这类nGM植物进行了分析，以确定其相关危害，这些危害要么（i）与其培育出的性状及其用途有关，要么（ii）与nGM或育种过程中应用的其他方法导致的意外变化有关。未来，几种性状可能对nGM植物尤为重要，即抗除草剂性（HR）、对不同植物病原体的抗性以及改良的成分、形态、适应性（例如增强对寒冷/霜冻、干旱或盐度的抗性）或改良的生殖特性。某些性状，如对某些除草剂的抗性，已在现有的转基因作物中出现，其先前的评估确定了一些令人关注的问题和/或风险，如抗除草剂杂草的出现。nGM植物中的其他性状是新颖的；这意味着它们不存在于目前具有安全使用历史的栽培农作物中，其潜在的生理机制尚未得到充分阐明。一些基因组编辑应用的特点，例如基因组序列变化程度小以及靶向效率更高，即精准度高，不能被视为安全的指标，特别是对于由此类修饰产生的新性状而言。这里考虑的所有nGM都可能导致不同类型和频率的意外变化。然而，nGM植物的快速发展可能会影响对意外效应的检测和消除。因此，应对nGM植物进行具体案例的上市前风险评估，包括进行适当的分子特征分析，以识别意外变化和/或确认不存在不需要的转基因序列。
