Enabling Trade in Gene-Edited Produce in Asia and Australasia: The Developing Regulatory Landscape and Future Perspectives

Abstract

Genome- or gene-editing (abbreviated here as ‘GEd’) presents great opportunities for crop improvement. This is especially so for the countries in the Asia-Pacific region, which is home to more than half of the world’s growing population. A brief description of the science of gene-editing is provided with examples of GEd products. For the benefits of GEd technologies to be realized, international policy and regulatory environments must be clarified, otherwise non-tariff trade barriers will result. The status of regulations that relate to GEd crop products in Asian countries and Australasia are described, together with relevant definitions and responsible regulatory bodies. The regulatory landscape is changing rapidly: in some countries, the regulations are clear, in others they are developing, and some countries have yet to develop appropriate policies. There is clearly a need for the harmonization or alignment of GEd regulations in the region: this will promote the path-to-market and enable the benefits of GEd technologies to reach the end-users.

Multiplex CRISPR-Cas9 Gene-Editing Can Deliver Potato Cultivars with Reduced Browning and Acrylamide

“…It generates non-transgenic events with site-directed nuclease 1 (SDN-1) editing, an outcome of gene editing, which results in a deletion, insertion, or substitution of a base or bases or a combination of the mutations without the introduction of foreign DNA for repair via endogenous non-homologous end-joining. SDN-1 food crops or the process of SDN-1 editing are currently not regulated as GMOs in many jurisdictions (e.g., USA, Canada, Argentina, Japan, and Australia) or are in the process of being deregulated in many other countries, where gene-edited plants and food products will likely make a vital contribution to food security [ 53 , 54 , 55 , 56 ]. Notably, the RNP approach is a relatively cheaper and quicker process of generating new varieties of plants, as it avoids the generation of plant transformation vectors and the associated cumbersome selection processes during the tissue culture of explants.…”

Are null segregants new combinations of heritable material and should they be regulated?

“…Over the past couple of years, some countries have introduced guidelines that regulate the use of null segregants in agriculture in a way similar to conventionally bred organisms, provided that inserted nucleic acids were removed ( Turnbull, Lillemo, and Hvoslef-Eide, 2021 ; Buchholzer and Frommer, 2022 ). Others have proposed to deregulate some uses of gene technology based on the number of nucleotides changed in an organism’s genome ( Bratlie et al, 2019 ; Jones et al, 2022 ). In both instances, risk has been rationalised as a property of nucleic acids rather than of technology.…”

Perspectives of gene editing for cattle farming in tropical and subtropical regions

“…On the other hand, the SDN-2 approach relies on a short ODN donor template to repair the DSB by HDR and it can be used to introduce few bases in the genome without introducing foreign DNA, being more precise than SDN-1. Brazil, Argentina and Japan can also consider gene-edited organisms generated by SDN-2 as non-GMO ( Whelan and Lema, 2015 ; Vieira et al, 2021 ; Jones et al, 2022 ). In contrast, Australia regulates organisms generated by SDN-2 approach as GMO ( Jones et al, 2022 ).…”