Regulation of genome edited organisms in Australia.

Abstract

Whether organisms developed with the use of genome editing techniques, or food derived from such organisms, are, or should be, regulated as genetically modified organisms (GMOs) or genetically modified (GM) food, respectively, remains a subject of debate globally. Much of the discussion has been scientific and focussed on the similar genetic outcomes of some genome editing techniques and 'conventional' or natural mutagenesis. Many jurisdictions, including Australia, have considered, or are considering, how their regulatory frameworks will deal with such organisms and products. In Australia, organisms developed with site directed nuclease 1 (SDN-1, with no added template to guide homology-directed repair) are not regulated as GMOs, pursuant to exclusions in the Gene Technology Regulations 2001. The exclusion of SDN-1 organisms from regulation in Australia is sometimes misrepresented, including in scientific peer reviewed publications, as extending to all genome edited organisms. This highlights the importance for researchers, developers and other stakeholders to understand that whether genome edited organisms are, or are not, subject to regulation as GMOs in a particular jurisdiction may quintessentially be a legal question, not a scientific one.