Naegeli Hanspeter, Bresson Jean-Louis, Dalmay Tamas, Dewhurst Ian C, Epstein Michelle M, Guerche Philippe, Hejatko Jan, Moreno Francisco J, Mullins Ewen, Nogué Fabien, Rostoks Nils, Sánchez Serrano Jose J, Savoini Giovanni, Veromann Eve, Veronesi Fabio, Bonsall Michael B, Mumford John, Wimmer Ernst A, Devos Yann, Paraskevopoulos Konstantinos, Firbank Leslie G
EFSA J. 2020 Nov 12;18(11):e06297. doi: 10.2903/j.efsa.2020.6297. eCollection 2020 Nov.
Advances in molecular and synthetic biology are enabling the engineering of gene drives in insects for disease vector/pest control. Engineered gene drives (that bias their own inheritance) can be designed either to suppress interbreeding target populations or modify them with a new genotype. Depending on the engineered gene drive system, theoretically, a genetic modification of interest could spread through target populations and persist indefinitely, or be restricted in its spread or persistence. While research on engineered gene drives and their applications in insects is advancing at a fast pace, it will take several years for technological developments to move to practical applications for deliberate release into the environment. Some gene drive modified insects (GDMIs) have been tested experimentally in the laboratory, but none has been assessed in small-scale confined field trials or in open release trials as yet. There is concern that the deliberate release of GDMIs in the environment may have possible irreversible and unintended consequences. As a proactive measure, the European Food Safety Authority (EFSA) has been requested by the European Commission to review whether its previously published guidelines for the risk assessment of genetically modified animals (EFSA, 2012 and 2013), including insects (GMIs), are adequate and sufficient for GDMIs, primarily disease vectors, agricultural pests and invasive species, for deliberate release into the environment. Under this mandate, EFSA was not requested to develop risk assessment guidelines for GDMIs. In this Scientific Opinion, the Panel on Genetically Modified Organisms (GMO) concludes that EFSA's guidelines are adequate, but insufficient for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of GDMIs. While the MC,ERA and PMEM of GDMIs can build on the existing risk assessment framework for GMIs that do not contain engineered gene drives, there are specific areas where further guidance is needed for GDMIs.
分子生物学和合成生物学的进展使得通过基因驱动对昆虫进行工程改造以控制病媒/害虫成为可能。经过工程改造的基因驱动（即偏向自身遗传的基因驱动）可以设计用于抑制杂交目标种群，或用新的基因型对其进行改造。根据工程基因驱动系统的不同，从理论上讲，感兴趣的基因改造可以在目标种群中传播并无限期持续存在，或者其传播或持续性受到限制。虽然关于工程基因驱动及其在昆虫中的应用研究进展迅速，但技术发展要应用于有意释放到环境中的实际应用还需要数年时间。一些基因驱动改造昆虫（GDMI）已在实验室进行了实验测试，但尚未在小规模的封闭田间试验或开放释放试验中进行评估。人们担心在环境中有意释放GDMI可能会产生不可逆转的意外后果。作为一项积极措施，欧盟委员会要求欧洲食品安全局（EFSA）审查其先前发布的关于转基因动物（包括昆虫（GMI））风险评估的指南（EFSA，2012年和2013年）是否足以用于主要作为病媒、农业害虫和入侵物种的GDMI有意释放到环境中。根据这项任务要求，并未要求EFSA制定GDMI的风险评估指南。在本科学意见中，转基因生物（GMO）专家组得出结论，EFSA的指南是充分的，但对于GDMI的分子特征描述（MC）、环境风险评估（ERA）和上市后环境监测（PMEM）而言并不足够。虽然GDMI的MC、ERA和PMEM可以基于不包含工程基因驱动的GMI的现有风险评估框架，但在一些特定领域，GDMI还需要进一步的指导。
