Regulatory approaches to gene editing are broadly divided into those that focus on the final product and those that are more concerned with the process. Like Europe, Australia had regulated all genetically engineered crops, including both transgenic and cisgenic/ gene-edited plants, based on the process used to develop gene-edited products, instead of the characteristics of the product itself. Three GM crops (canola, cotton and safflower) are approved for growing in Australia. Multiple lines of color-modified GM carnations are available for sale.
Gene-edited plants are regulated by the Gene Technology Regulator (GTR) under the Gene Technology Regulations 2001. While the GTR is in charge of laws, it authorizes Food Standards Australia New Zealand (FSANZ) to regulate food in Australia under a joint system with New Zealand. FSANZ develops and sets pre-market regulations and labeling standards for gene-edited food.
In 2018, Australia and 12 other nations, including Argentina, Canada, Brazil and the US, issued a joint statement to the World Trade Organization supporting relaxed regulations for gene editing, stating that governments should “avoid arbitrary and unjustifiable distinctions” between crops developed through gene editing and crops developed through conventional breeding. In October 2019, CRISPR-edited plants, classified as SDN-1 organisms (SDN: site-directed nuclease), were given a green light with regulatory bodies indicating they are no longer classified as a genetically modified organism (GMO) if no “foreign” DNA is present in an edited plant. No gene-edited crops have yet been approved under these relaxed regulations.
This change brings Australia in line with evolving regulations in the USA, Brazil, Argentina, India, China and the UK where, if no foreign DNA (genes or genetic material) is present in a genome-edited variety, that variety will not be subject to the regulatory oversight applied to a transgenic crop. That could mean more rapid development of new varieties and products in Australia, and could open the door to export markets.
In 2022, the FSANZ released two reports regarding Proposal P1055: a survey of consumer attitudes towards genetically modified foods and NBTs; and a stakeholder feedback summary report which summarizes the views and comments expressed by submitters.
Products/Research (Partial list as many products are in development)
- Approved High-energy ryegrass, 2020: DairyBio developed gene-edited ryegrass to increase digestibility.
- Approved High-protein grain: Researchers from the University of Queensland developed sorghum that is larger and has extra protein. Field trials have begun in Queensland.
- Research Non-browning potatoes, 2023: Researchers at Murdoch University used CRISPR to develop potatoes with reduced browning and reduced acrylamide (a carcinogen).
- Research Disease-resistant rice, 2019: Researchers at Queensland University and in India used CRISPR to develop rice resistant to the main pathogen that causes rice blight.
- Research Fungus-resistant wheat, 2017: Researchers from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) used CRISPR and TALENs to study wheat rust, a common fungus that destroys wheat crops.
- Research Low trans-fat oil, 2017: CSIRO used RNAi to develop a cottonseed oil (used in margarine and cooking oils) without trans-fatty acids, making it a healthier oil for human consumption.
- Research Sticky rice, 2017: Researchers from the University of Queensland and others used CRISPR to develop sticky rice, a type of rice widely consumed across Asia.
- Research Improved canola, 2013: Researchers at the University of Sydney developed canola with better drought tolerance, photosynthetic capacity and seed oil content.
Regulatory Timeline
2022: FSANZ releases two reports on Proposal P1055 to commend the Final report into the Code.
2019: 2019 Amendments to the Gene Technology Regulations 2001 go into effect, deregulating gene-edited crops using SDN-1 techniques.
2019: Gene Technology Regulator conducts a technical review of the Gene Technology Regulations 2001 clarifying the regulatory status of plants developed using new breeding techniques.
2018: Australia and 12 other nations, including Argentina, Canada, Brazil and the US, issue a joint statement supporting agricultural applications of precision biotechnology, stating that governments should “avoid arbitrary and unjustifiable distinctions between end products (crop traits) derived from precision biotechnology and similar end products, obtained through other production methods.”
2018: FSANZ releases a preliminary report summarizing the various views and possible outcomes for how the Food Standards Code should apply to food derived using New Breeding Techniques (NBTs).
2001: Gene Technology Agreement goes into effect. The Agreement is an inter-governmental agreement regarding the establishment of a nationally consistent regulatory system for gene technology.
2001: Gene Technology Act 2000 begins. The Act is a plan for the regulation of GMOs in Australia and includes the Gene Technology Regulations 2001. The Act defines gene technology as any technique for the modification of genes or other genetic material.
1999: Standard 1.5.2: “Food produced using gene technology” is adopted as a new standard within Food Standards Australia New Zealand.
1991: The Food Standards Australia New Zealand 1991 is developed as a new section of the Australia New Zealand Food Standards Code.
NGO Reaction
Environmental advocacy groups including Gene Ethics, a non-profit against GM technology, have argued that the 2019 amendments to the Gene Technology Regulations are “irresponsible and would lead to a ‘free-for-all’ without appropriate boundaries”.
The European Network of Scientists for Social and Environmental Responsibility (ENSSER) wrote to Australian senators urging them to disallow the amendments.
The Greens Party, an Australian political party, filed the disallowance motion in November 2019 an attempt to overturn the 2019 amendments, but the motion failed, not receiving enough support.
Additional Resources
- Regulation of Genome Editing in Plant Biotechnology
- USDA Biotechnology Annual 2022: Australia
- Current status and prospects of plant genome editing in Australia, 2021
- 20 Years of Legislation – How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic
- How we regulate genetically modified organisms (GMOs)
Updated: 08/25/2023
