基因编辑植物法律规制的困境及出路

Dilemma and Solution of the Legal Regulation of Genome Editing in Plant

新型基因编辑技术成功突破了传统育种障碍,实现快速、高效育种,强势开启了农业育种和食品领域新赛道。在世界范围内,基因编辑植物的法律规制主要依赖于转基因法律,表现为基于实质等同原则的产品监管模式、基于风险预防原则的过程监管模式和过程转向产品的单独监管模式。机械地运用这些传统监管模式忽视了基因编辑技术与转基因之间的本质不同,产生了科技乐观主义与科技悲观主义两种极端态度,从而进入技术放任主义和限制主义的误区。鉴于此,应脱离转基因法律而进行基因编辑植物的单独立法,通过转变立法观念重塑立法原则、重构法律规范,以防止基因编辑技术在农业领域的误用、乱用与滥用。

Gene editing technology has been successfully applied in traditional plant breeding,which quickly opens a new track of competition in the field of agricultural industry.In the world,regulating geneedited plants mainly relies on the GMO law,such as a product-based model according to the principle of substantial equivalence,a process-based model according to the risk precautionary principle,and a separate regulatory model from process-based to product-based.However,these traditional models ignore the essential difference between gene-edited plants and GMO,and produce two extreme attitudes,that is technological optimism and technological pessimism.In order to ensure food safety and environmental safety and prevent the misuse and abuse of gene editing technology in agriculture,the regulation related to gene-edited plants should separate from the GMO law,as well as change the legislative values,the legislative principles and the specific rules.