Australia has de-regulated one type of gene-edited crops. Like Europe, Australia regulates based on the process used to develop gene-edited products, instead of the characteristics of the product itself. Gene-edited plants are regulated by the Gene Technology Regulator (GTR) under the Gene Technology Regulations 2001. The GTR’s 2019 Amendments state that New Breeding Techniques (NBTs) that cut the genome at a specific location, but do not control or specify what DNA sequence is inserted into the cut (known as SDN-1 techniques) are not regulated because they are more like traditional mutagenesis techniques. For example, Yield10 Biosciences in the US gene-edited camelina (a plant in the mustard family that is used for vegetable oil and animal feed) with enhanced omega-3 oil. They did this by cutting a specific gene in the plant, which inactivated the gene and increased the omega-3 content.
This is in contrast to other gene editing techniques that do specify exactly what gene sequences will be inserted (known as SDN-2 and SDN-3 techniques). For example, researchers in the US developed an herbicide-resistant potato by cutting a specific gene of the potato and then inserting a specific sequence of DNA that decreased the herbicide’s effect on the potato. These types of techniques are regulated under existing gene technology legislation, which requires a license. Geneticists James Hereward and Caitlin Curtis of the University of Queensland in Brisbane, describe the Australian ruling as a “‘middle ground‘ between more lenient gene-editing rules in the United States, Brazil and Argentina, and tougher measures in the European Union.”
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.
No gene-edited crops have been approved in Australia.
While the Gene Technology Regulator is in charge of laws to protect people and the environment from risks posed by genetically engineered organisms, food is regulated in Australia under a joint system with New Zealand. Food Standards Australia New Zealand (FSANZ) develops and sets pre-market regulations and labeling standards gene-edited food. In December 2019, FSAN released its Final Report, which made three recommendations detailing how NBTs will be regulated and whether they will require pre-market approval: (1) Revise and modernize the definitions in the Code to accommodate existing and emerging biotechnologies; (2) give consideration to process and non-process based definitions and the need to ensure that NBT foods are regulated in a manner that is commensurate with the risk they pose; and (3) ensure transparency and raise awareness about GM and NBT foods. The evaluation process is expected to be completed during 2020. A new Proposal to amend the definitions in the Code commenced in February 2020. FSANZ anticipates that a first call for submissions will be released for public consultation in mid-2020.
Products/Research
- High-protein grain: Researchers from the University of Queensland developed sorghum that is larger and has extra protein.
- Fungus-resistant wheat: 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.
- High-yield wheat: CSIRO used a New Breeding Technique (NBT) called RNAi to develop wheat with increased yields, as well as improved quality and tolerance to environmental stressors like heat, cold and drought.
- Virus-resistant barley: CSIRO used RNAi to develop barley resistant to Barley Yellow Dwarf Virus.
- Low trans-fat oil: 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.
- Improved canola: Researchers at the University of Sydney developed canola with better drought tolerance, photosynthetic capacity and seed oil content.
- Low-gluten potatoes: Researchers from Murdoch University developed a low gluten index (GI) potato using CRISPR.
- Sticky rice: Researchers from the University of Queensland used CRISPR to develop sticky rice, a type of rice widely consumed across Asia.
Regulatory Timeline
2019: 2019 Amendments to the Gene Technology Regulations 2001 go into effect, with all gene-edited crops regulated except those developed using SDN-1 techniques.
2019: Gene Technology Regulator conducts a technical review of the Gene Technology Regulations 2001 clarifying the regulatory status of organisms developed using a range of NBTs.
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, argued that the 2019 amendments to the Gene Technology Regulations were “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 of 2019 an attempt to overturn the 2019 amendments, but the motion failed, not receiving enough support.
Additional Resources
- Genes and Science’s FAQ on gene editing
- Regulation of Genome Editing in Plant Biotechnology
- USDA Biotechnology Annual 2020: Australia
