Australia’s response to genome edited plants and their products builds on regulatory frameworks created for GMOs. All dealings with GMOs and the sale of GM food must be authorised, the form of authorisation corresponding with potential risks. In summary, recent amendments clarify that organisms and products produced using SDN1 are not regulated as GMOs although they may be regulated by other agencies such as that for food or therapeutic products. Similarly, the food regulator has determined that food from plants with no new DNA present in their genome, even if the genome has been changed, are not regulated under the current GM standard. ^[1] Additional modernisation of these two regulatory frameworks is underway to ensure that regulation remains proportionate to potential risk.

More specifically, the question whether GMO and/or food regulations apply to genome edited plants and their products is determined by the use of ‘gene technology’, although the meaning of gene technology differs between GMO regulation and food regulation.

For the regulatory framework around GMOs,^[2] gene technology is defined very broadly to mean “any technique for the modification of genes, or other genetic material” and it is irrelevant whether the modification produces a novel combination of DNA or not. Genome editing is unsurprisingly included as gene technology given it modifies the plant’s genetic material. Because regulations prohibit all dealings with organisms produced using gene technology (that is, a ‘GMO’) unless authorised by the independent regulator created by the framework, genome editing of plants requires authorisation. That authorisation may require only approval by an institution’s internal biosafety committee or further steps including case-by-case assessment by the regulator. These regulations apply to all stages of research and development, importation into Australia, laboratory work, field trials and commercial release and are intended to manage risks to human health and safety and to the environment in light of the proposed use of the GMO.

In September 2019, following extensive review, the regulations were updated to address genome editing. Importantly, although genome editing is gene technology, the final plant may not be a GMO. If a plant is not a GMO, use of it will not require further authorisation. When the regulations were created, organisms produced using conventional breeding (such as selective or protoplast breeding) or mutagenesis, and the processes themselves, were expressly excluded from regulation because they are considered to pose little risk. Following the review, these exceptions were replaced to exclude organisms where the mutational event does not involve introduction of foreign nucleic acid and also organisms modified by repair of single or double stranded breaks induced by a site directed nuclease provided that no nucleic acid repair template was used.  However, other amendments mean plants produced using a nucleic acid repair template are now expressly included as GMOs. As the regulator has observed in regards to plants produced using SDN2 or SDN3, ‘The number of resulting nucleotide changes, whether insertions or deletions, or whether the resulting nucleotide sequence may be found in sexually compatible species, is not a deciding factor’ (Australian Government, 2021).

Despite the amendments referred to above, a parallel review of Australia’s broader policy around GMO regulation has found that some genome edited plants continue to be regulated despite them being of no greater risk than plants produced using random and unregulated mutagenesis or being identical to natural variants. This parallel review, begun in 2017, has confirmed that while the use of the process trigger will continue, further regulatory changes will be made to modernise and future proof the regulations. This is likely to include a risk tiering model, but in any case is intended to allow streamlining of low risk dealings with GMOs or dealings that are under the remit of other agencies, such as vaccines, as well as the creation of new authorisation categories (Commonweath of Australia, 2020). Legislative definitions of ‘gene technology’, ‘GMO’ and ‘deal with’ are also to be updated to enable a faster response to the changing science. These changes are intended to be implemented by 2023.

Like the GMO regulatory framework, Australia’s food regulations have also been reviewed in response to genome edited plants. While Australia and New Zealand have separate regulations for GMOs, the two countries share a Food Standards Code under the arrangements of a bi-national food system. In 1999, a new Standard on ‘Food produced using gene technology’, was included in the Code. This standard establishes a pre-market safety assessment and approval system for food produced using gene technology and mandatory labelling requirements for some of that food. Like the GMO regulatory framework, a process trigger is used such that the use of gene technology in the production of food causes the Standard to apply. In such cases, the food undergoes a formal risk assessment to obtain pre-market approval prior to sale.

However, the Standard predates the GMO framework and thus uses a different definition of gene technology. The definition in the Food Standards Code is limited to ‘recombinant DNA techniques’, which the food regulator Food Standards Australia New Zealand (FSANZ) has explained as being the joining of DNA from two or more sources (including from the same species) and then insertion into an organism. The trigger is therefore the inclusion of ‘new’ DNA, with new in this context meaning in terms of its nucleotide sequence, genome location or orientation of insertion (Food Standards Australia New Zealand, Consultation Paper, 2018). Conventional breeding techniques (for example, cross-breeding and selection, mutation breeding of plants, cell culture techniques), which have a presumption of safety based on their history of safe use are not regulated under this standard.

Because of the ambiguity of the place of genome edited plants and their products within the scope of the Standard, FSANZ initiated a review in June 2017. The final report, delivered in December 2019, found that the definitions used in the Standard are outdated and unclear and no longer fit for purposes. Whether food from genome edited plants is included within the Standard or not, the report recommended consideration of whether pre-market safety assessment is justified based on the risks posed either by the modification of the genome or changes to a food’s characteristics (Food Standards Australia New Zealand, 2019). FSANZ is now considering how to modernise the definitions in the Code to make them clearer and ensure they better reflect existing and emerging genetic technologies.^[3] Public consultation is still to be sought on this (expected in mid 2021) followed by another round of public consultation (expected in 2022) once draft changes are released.

At present then, food from plants with no new DNA present in the genome, even if the genome has been changed, is not considered to be food produced using gene technology and is therefore not regulated under the standard, although general principles of food safety apply.^[1] Where a plant’s genome does contain new DNA, such as where transgenesis, cisgenesis or intragenesis have been used, food from these plants is regulated as ‘food produced using gene technology’.

[1] Website: FSANZ – ‘Foods Derived using new breeding techniques – review’ (accessed 22^nd May 2023)

[2] That framework comprises the Gene Technology Act 2000 (GT Act) and its accompanying regulations (Gene Technology Regulations 2001) as well as an inter-governmental between the Australian Federal, State and Territory governments. Website: Office of the Gene Technology Regulator (accessed: 15^th March 2023).

[3] Website: Food Standards Australia New Zealand: Proposal P1055 – Definitions for gene technology and new breeding techniques (accessed: 15^th March 2023)