Report Highlights Gene Editing Regulations in Australia

Regulations surrounding organisms and food products developed using gene editing remain to be discussed among different countries and regions. Several discussions are focused on the similarities between gene editing and natural mutagenesis, and whether gene-edited products should be treated like genetically modified organisms or GM food.

Peter Thygensen from the Office of the Gene Technology Regulator (OGTR) in Australia provides a brief report on how gene-edited organisms are regulated. According to the report published in Transgenic Research, organisms developed with site-directed nuclease 1 (SDN-1, with no added template to guide homology-directed repair) are not regulated as GMOs, based on the exclusions in the Gene Technology Regulations 2001. The report highlights that this particular regulation is sometimes misrepresented, even in scientific peer-reviewed publications, indicating that the rule applies to all gene-edited products. Thus, researchers, developers, and other stakeholders need to understand whether gene-edited organisms are, or are not, subject to GMO policies in a particular jurisdiction. Thygensen concludes that such a question may quintessentially be a legal inquiry, not a scientific one.

Download the brief report from Transgenic Research.