为了确保安全使用转基因生物(GMOs),1993年以来,我国大力建立和完善转基因生物的安全监管体系。这里,我们总结和分析了农业转基因生物的监管框架,以及中国转基因作物监管审批的进展。总的来说,转基因生物安全法规的制定经历了四个阶段:探索(1993-2000),发展(2001-2010),改善(2011-2020年)和当前(2021年至今)阶段。第一部正式条例于1993年颁布,为条例的进一步发展提供了依据,在勘探阶段,当抗虫转基因棉花,表达苏云金芽孢杆菌(Bt)的基因,被批准种植。在发展阶段,中国政府出台了一系列行政措施,基本监管体系建立时,几乎涵盖了与GMO安全相关的所有领域。除了关于转基因生物安全的争议,条例更进一步,并大大改善,在改进阶段。从2021年开始,进行了一些额外的修订,同时,随着生物技术的发展,对基因编辑作物的新规定被引入,形成了中国相对完整的法规和法律体系。完善的转基因法规为在中国安全使用转基因作物奠定了坚实的基础。目前,转基因棉花和转基因木瓜在我国大规模种植,带来了巨大的经济和生态效益。此外,12个玉米事件,3大豆事件,还有两次水稻活动也获得了生物安全认证,但目前,这些生产线尚未进入商业生产。然而,几个转基因大豆和玉米事件已经进入试点产业化,并有望很快在中国实现商业化。除了种植,六种转基因作物,包括大豆,玉米,棉花,卡诺拉,木瓜和甜菜,总共有64个事件,已被批准在中国进口加工原料。
To ensure safe use of genetically modified organisms (GMOs), since 1993,
China has made great efforts to establish and improve the safety regulatory system for GMOs. Here, we summarize and analyze the regulatory framework of agricultural GMOs, and the progress in regulatory approval of GM crops in
China. In general, the development of GMO safety regulations underwent four stages: exploration (1993-2000), development (2001-2010), improvement (2011-2020) and current (2021-present) stage. The first formal regulation was promulgated in 1993, which provided a basis for further development of the regulations, during the exploration stage, when insect-resistant GM cotton, expressing genes from Bacillus thuringiensis (Bt), was approved for cultivation. During the development stage, the Chinese government issued a series of administrative measures, which covered almost all the fields relative to GMO safety when the basic regulatory system was established. Along with the controversy over GMO safety, the regulations have been further, and greatly improved, during improvement stage. From 2021, a few additional revisions have been made, and meanwhile, the new regulation on gene-edited crops was introduced with the development of biotechnology, forming a relative complete regulation and law system for China. The well-developed GMO regulations establishes a firm basis for safe use of GM crops in
China. Currently, GM cotton and GM papaya have been widely grown on a large scale in
China that have brought great economic and ecological benefits. In addition, 12 corn events, 3 soybean events, and 2 rice events have also obtained biosafety certification, but presently, these lines have yet to enter commercial production. However, several GM soybean and corn events have entered pilot industrialization, and can soon be expected to be commercially grown in China. In addition to planting, six GM crops, including soybean, corn, cotton, canola, papaya and sugar beet, with a total of 64 events, have been approved for import as processing material in
China.