Abstract
Australia has a well-developed system for the regulation of genetically manipulated (GM) and gene-edited (GEd) organisms, including grains and horticultural crop plants. The aim is to protect the health and safety of people and the environment by identifying any risks posed by gene technology. It is based on two Commonwealth legislative acts, the Gene Technology (GT) Act 2000 and the Gene Technology Regulations 2001, with corresponding State and Territory laws. The GT Act included establishing the Office of the Gene Technology Regulator (OGTR), which is overseen by the Gene Technology Regulator, who takes advice and consults with a range of bodies, and is responsible for ensuring the monitoring and compliance of the GT legislation. There have been a series of reviews of the National Gene Technology Scheme to modernize and future-proof it in response to new scientific developments. Following a consultative review process (2016–2019), to address national policy on the products of various new GEd technologies (including site-directed nucleases: SDN-1, SDN-2, SDN-3 and olignucleotide-directed mutagenesis—ODM), in October 2019 the decision was released to deregulate SDN-1 products not generated via transgenic approaches, but not those which used SDN-2, ODM or SDN-3 technologies, which remain captured as GMOs. Thus only products of SDN-1 technology which do not contain any externally introduced DNA bases can be grown in the same way as products of conventional breeding activities.
In New Zealand, GM and GEd organisms are regulated by the Hazardous Substances and New Organisms (HSNO) Act 1996 administered by the Environmental Protection Agency (EPA). In an initial determination in 2012, the EPA determined that organisms produced using GEd methods, where no foreign DNA remained in the edited plant, were not GMOs. However, in 2014, following an appeal to this decision by the Sustainability Council of New Zealand Trust (Sustainability Council) in the High Court, the determination of the presiding judge was to overturn the EPA’s decision. Thus the current status of all GEd products in New Zealand is that they are regulated as GMOs.
Nonliving food products of GM or GEd technology are overseen by Food Standards Australia New Zealand (FSANZ); the Australia New Zealand Food Standards Code applies to GM and GEd foods. FSANZ is currently reviewing its position on GEd foods, and at present considers applications for GEd food on a case-by-case basis.