One type of gene editing de-regulated while the rest are regulated as GMOs, requiring pre-market approval.
The Australian government will not regulate the use of gene-editing techniques in plants, animals and human cell lines that do not introduce new genetic material. The April 2019 ruling is considered a “middle ground” between more lenient gene-editing rules in the United States, Brazil and Argentina, which regulates biotechnology based on the product versus the tightly restrictive measures in the European Union, which regulates based on the process.
Gene edited animals 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, Genus, a UK biotechnology company, and researchers at the University of Missouri developed a pig that is resistant to a deadly virus by deleting just a small section of a gene in the pig’s DNA, which disrupts the virus’ ability to attack the pig’s cells.
This is in contrast to other gene editing techniques that do specify exactly what gene sequences will be inserted. For example, the American company Recombinetics is conducting tests in Australia of a gene edited, hornless cow that was created by cutting the genome at a specific location and then inserting a specific gene sequence (from a breed of cow that is naturally hornless) into the cut genome, to produce a cow without horns. These types of techniques are regulated under existing gene technology legislation, which requires a license. This positions Australia as more restrictive to gene technology than the United States, but less restrictive than the EU. No gene edited animals have been approved in Australia.
- Non-poisonous toad: University of Melbourne developed a cane toad without its lethal toxin.
- Daughterless carp: Commonwealth Scientific and Industrial Research Organisation (CSIRO) used CRISPR to safely control carp (an invasive fish species) by removing females from populations.
- Hornless cattle: The US company Recombinetics conducted tests of gene edited, hornless dairy cattle.
- Heat-resistant cattle: Recombinetics conducted tests of gene edited cattle that can withstand hotter temperatures.
- Sexed chickens: To avoid culling male chicks, CSIRO used CRISPR to make a marker gene that allows chickens to be separated at the embryo stage so that only females are incubated and grow into chicks.
- Chicken eggs without allergens: CSIRO and Deakin University investigated gene editing as a means of removing the allergenic properties in egg whites.
- Daughterless mice: CSIRO developed mice that only have male offspring, to help control the invasive mouse population.
2019: 2019 Amendments to the Gene Technology Regulations 2001 go into effect, with all gene edited animals regulated except those developed using SDN-1 techniques.
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.
Environmental advocacy groups including Greenpeace, Center for Food Safety, Environmental Working Group and Friends of the Earth Australia, have taken the stance that gene editing is the newest version of transgenic modification (GMO 2.0), arguing that it has not been tested enough for safety and should be tightly regulated because it could lead to unintended side effects.
- Genetic Literacy Project’s FAQ on gene editing