Institute for Biosafety in Plant Biotechnology, Julius Kühn-Institut, Federal Research Centre for Cultivated Plants, 06484 Quedlinburg, Germany; email:
Research Division Agroecology and Environment, Agroscope, 8046 Zurich, Switzerland.
Annu Rev Plant Biol. 2019 Apr 29;70:699-726. doi: 10.1146/annurev-arplant-050718-100025. Epub 2019 Mar 1.
This review describes the current status and future challenges of risk assessment and regulation of plants modified by modern biotechniques, namely genetic engineering and genome editing. It provides a general overview of the biosafety and regulation of genetically modified plants and details different regulatory frameworks with a focus on the European situation. The environmental risk and safety assessment of genetically modified plants is explained, and aspects of toxicological assessments are discussed, especially the controversial debate in Europe on the added scientific value of untargeted animal feeding studies. Because RNA interference (RNAi) is increasingly explored for commercial applications, the risk and safety assessment of RNAi-based genetically modified plants is also elucidated. The production, detection, and identification of genome-edited plants are described. Recent applications of modern biotechniques, namely synthetic biology and gene drives, are discussed, and a short outlook on the future follows.
本文综述了采用现代生物技术（即基因工程和基因组编辑）改良的植物的风险评估和监管的现状和未来挑战。文中概述了转基因植物的生物安全性和监管，并详细介绍了不同的监管框架，重点关注了欧洲的情况。解释了转基因植物的环境风险和安全性评估，并讨论了毒理学评估的各个方面，特别是欧洲关于非靶向动物喂养研究附加科学价值的争议性辩论。由于 RNA 干扰 (RNAi) 越来越多地被用于商业应用，因此还阐明了基于 RNAi 的转基因植物的风险和安全性评估。描述了基因组编辑植物的生产、检测和鉴定。讨论了现代生物技术（即合成生物学和基因驱动）的最新应用，并展望了未来。
