Current status on the modification of the scope for GMO regulation on the gene edited plants with no remnants of inserted foreign DNA fragments

Abstract

Gene edited crops can be classified as SDN-1, SDN-2 and SDN-3 group depending on their mutation's range and the usage of donor DNA. The SDN-1 and SDN-2 crops, in particular, could be developed as 100% transgenefree, which do not contain any DNA fragment of the vector or guide RNA used for gene editing such as CRISPR Cas9 system. Therefore, there are no scientific methods available for the detection of these crops and differentiation with the one produced by conventional cross breeding techniques. Additionally, it would be impossible to properly implement the existing GMO regulation law, in particular, the national legislation for "GMO labelling". In this regard, Australia has announced that SDN-1 crops will not be subjected to the existing GMO regulation. Furthermore, Argentina and Brazil have established a new policy that GE crops with no transgene (100% transgene-free crops) should be exempted from the scope of the GMO. In addition, Japan has also announced that "an organism that has no remnants of inserted nucleic acid processed extracellularly is not subjected to the Cartagena Act". It means that SDN-2 crops can also be exempted from the scope of GMO. In this trend, in South Korea, I suggested that gene edited crops with no remnants of inserted foreign DNA fragments should be excluded from the existing GMO regulation. Thus, I expect that diverse elite crop lines should be developed by using advanced gene editing technologies.

Scientific considerations for the biosafety of the off-target effects of gene editing in crops

“…따라서 최종적으로 완성된 유전자교정 작물의 유전체 내에 외래 DNA 단편이 잔존하지 않게 할 수 있다. 이렇게 제작된 유전자교정작물(site-directed nuclease, SDN-1)은 기존의 GM 작물에 대하여 잔존 하는 외래 DNA 단 편에 관한 안전성 논란은 완전히 해소한 기술이라고 할 수 있다 (Hilscher et al 2017;Lee 2019). 최근 미국 등을 중심으로 이러한 SDN-1 작물들의 상업화 승인은 빠르게 증가하는 추 세에 있다 (Lee 2018;Wolt et al 2016) (Hsu et al 2013;Mali et al 2013).…”