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加拿大基因编辑技术的监管方面。

Canadian regulatory aspects of gene editing technologies.

机构信息

Plant Biosafety Office, Canadian Food Inspection Agency, 59 Camelot Drive, Ottawa, ON, K1A 0Y9, Canada.

Plant Health Science Division, Canadian Food Inspection Agency, 1400 Merivale Road, Ottawa, ON, K1A 0Y9, Canada.

出版信息

Transgenic Res. 2019 Aug;28(Suppl 2):165-168. doi: 10.1007/s11248-019-00153-2.

Abstract

The development of gene editing techniques, capable of producing plants and animals with new and improved traits, is revolutionizing the world of plant and animal breeding and rapidly advancing to commercial reality. However, from a regulatory standpoint the Government of Canada views gene editing as another tool that will join current methods used to develop desirable traits in plants and animals. This is because Canada focusses on the potential risk resulting from the novelty of the trait, or plant or animal product entering the Canadian environment or market place, rather than the process or method by which it was created. The Canadian Food Inspection Agency is responsible for the regulation of the environmental release of plants with novel traits, and novel livestock feeds, while Health Canada is responsible for the regulation of novel foods. Environment and Climate Change Canada, in partnership with Health Canada, regulates modified animals for entry into the environment. In all cases, these novel products may be the result of conventional breeding, mutagenesis, recombinant DNA techniques or other methods of plant or animal breeding such as gene editing. This novelty approach allows the Canadian regulatory system to efficiently adjust to any new developments in the science of plant and animal breeding and allows for risk-appropriate regulatory decisions. This approach encourages innovation while maintaining science-based regulatory expertise. Canadian regulators work cooperatively with proponents to determine if their gene editing-derived product meets the definition of a novel product, and whether it would be subject to a pre-market assessment. Therefore, Canada's existing regulatory system is well positioned to accommodate any new innovations or technologies in plant or animal breeding, including gene editing.

摘要

基因编辑技术的发展能够培育出具有新特性和改进特性的动植物,正在彻底改变动植物的育种领域,并迅速向商业化现实迈进。然而,从监管角度来看,加拿大政府认为基因编辑是另一种工具,将与目前用于开发动植物理想特性的方法一起使用。这是因为加拿大专注于新特性、进入加拿大环境或市场的动植物产品所带来的潜在风险,而不是其产生的过程或方法。加拿大食品检验署负责监管具有新特性的植物和新型动物饲料的环境释放,而加拿大卫生部负责监管新型食品。环境和气候变化部与加拿大卫生部合作,负责监管进入环境的改良动物。在所有情况下,这些新型产品可能是常规育种、诱变、重组 DNA 技术或其他植物或动物育种方法(如基因编辑)的结果。这种新颖的方法使加拿大监管系统能够有效地适应动植物育种科学的任何新发展,并做出适当风险的监管决策。这种方法鼓励创新,同时保持基于科学的监管专业知识。加拿大监管机构与提案人合作,确定他们的基因编辑衍生产品是否符合新型产品的定义,以及是否需要进行上市前评估。因此,加拿大现有的监管系统能够很好地适应动植物育种方面的任何新创新或技术,包括基因编辑。

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