Gene drive organisms are a recent development created by using methods of genetic engineering; they inherit genetic constructs that are passed on to future generations with a higher probability than with Mendelian inheritance. There are some specific challenges inherent to the environmental risk assessment (ERA) of genetically engineered (GE) gene drive organisms because subsequent generations of these GE organisms might show effects that were not observed or intended in the former generations. Unintended effects can emerge from interaction of the gene drive construct with the heterogeneous genetic background of natural populations and/or be triggered by changing environmental conditions. This is especially relevant in the case of gene drives with invasive characteristics and typically takes dozens of generations to render the desired effect. Under these circumstances, “next generation effects” can substantially increase the spatial and temporal complexity associated with a high level of uncertainty in ERA. To deal with these problems, we suggest the introduction of a new additional step in the ERA of GE gene drive organisms that takes 3 criteria into account: the biology of the target organisms, their naturally occurring interactions with the environment (biotic and abiotic), and their intended biological characteristics introduced by genetic engineering. These 3 criteria are merged to form an additional step in ERA, combining specific “knowns” and integrating areas of “known unknowns” and uncertainties, with the aim of assessing the spatiotemporal controllability of GE gene drive organisms. The establishment of assessing spatiotemporal controllability can be used to define so‐called “cut‐off criteria” in the risk analysis of GE gene drive organisms: If it is likely that GE gene drive organisms escape spatiotemporal controllability, the risk assessment cannot be sufficiently reliable because it is not conclusive. Under such circumstances, the environmental release of the GE gene drive organisms would not be compatible with the precautionary principle (PP). Integr Environ Assess Manag 2020;16:555–568. © 2020 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC)

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从欧盟转基因生物法规的角度来看，基因工程基因驱动生物的时空可控性和环境风险评估。

基因驱动生物是利用基因工程方法创造的最新发展。他们继承的遗传结构比孟德尔遗传的可能性更高。基因工程（GE）基因驱动生物的环境风险评估（ERA）固有固有的一些挑战，因为这些GE生物的后代可能显示出前几代未曾观察到或未预期到的效果。基因驱动构建体与自然种群的异质遗传背景之间的相互作用会产生意想不到的影响，并且/或者会因环境条件的变化而被触发。这在具有侵袭性特征的基因驱动的情况下尤其重要，通常需要数十代才能产生所需的效果。在这种情况下，“下一代效应”会大大增加与ERA中高度不确定性相关的空间和时间复杂性。为解决这些问题，我们建议在GE基因驱动生物的ERA中引入一个新的附加步骤，该步骤应考虑3个标准：目标生物的生物学特性，它们与环境（生物和非生物）的自然相互作用，及其通过基因工程引入的预期生物学特性。合并这3个标准以形成ERA的附加步骤，将特定的“已知”组合在一起，并合并“已知未知”和不确定性区域，以评估GE基因驱动生物的时空可控性。评估时空可控性的方法可用于在GE基因驱动生物的风险分析中定义所谓的“临界标准”：如果GE基因驱动生物有可能逃脱时空可控制性，则风险评估不能足够可靠因为它不是决定性的。在这种情况下，GE基因驱动生物的环境释放将与预防原则（PP）不兼容。Integr环境评估管理2020； 16：555–568。©2020作者。Wiley Periodicals，Inc.代表环境毒理化学协会（SETAC）出版的《综合环境评估与管理》