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Canadian regulatory aspects of gene editing technologies.
Transgenic Research ( IF 2.7 ) Pub Date : 2019-08-01 , DOI: 10.1007/s11248-019-00153-2
Kenneth W Ellens 1 , Dylan Levac 2 , Cindy Pearson 1 , Annie Savoie 3 , Neil Strand 4 , Jim Louter 5 , Christine Tibelius 2
Affiliation  

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.

中文翻译:

基因编辑技术的加拿大监管方面。

基因编辑技术的发展,能够生产具有新的和改良的性状的动植物,正在彻底改变动植物育种世界,并迅速进入商业现实。但是,从管理的角度来看,加拿大政府将基因编辑视为另一种工具,它将与目前用于在动植物中发展理想性状的方法相结合。这是因为加拿大关注的是该性状或植物或动物产品进入加拿大环境或市场的新颖性所引起的潜在风险,而不是其创造过程或方法。加拿大食品检验局负责监管具有新特性和新型牲畜饲料的植物的环境释放,而加拿大卫生部则负责监管新型食品。加拿大环境与气候变化局与加拿大卫生部合作,监管改良动物进入环境。在所有情况下,这些新产品可能是常规育种,诱变,重组DNA技术或其他动植物育种方法(例如基因编辑)的结果。这种新颖的方法使加拿大的监管体系可以有效地适应动植物育种科学的任何新发展,并可以做出适合风险的监管决策。这种方法鼓励创新,同时保持基于科学的监管专业知识。加拿大监管机构与支持者合作,确定其基因编辑衍生产品是否符合新产品的定义,以及是否需要进行上市前评估。因此,加拿大
更新日期:2019-11-01
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