Worldwide, gene drive regulations are in flux. Gene drives are being developed using transgenic technology (GMOs) that contain foreign genes, as well as gene editing, including CRISPR (synthetic gene drives), which do not, complicating regulatory oversight as gene editing and GMOs are often regulated differently.
In Australia, all gene drives are considered GMOs and subject to GMO regulations. Each gene drive is evaluated on a case-by-case basis. Gene drives are also regulated through the 2019 Amendments to the Gene Technology Regulations 2001 and require a license issued through the Gene Technology Regulator. The amendments also increase monitoring of gene-drive experiments, in which genetic modifications are propagated through an entire population, for example to produce sterile mosquitoes.
Other organizations responsible for overseeing issues related to gene drives include the Department of Agriculture and Water Resources, which manages biological diseases and pests; the Australian Pesticides and Veterinary Medicines Authority, which regulates pesticides; and the Therapeutic Goods Administration, which oversees medicines. These organizations have not yet published regulations addressing gene drives.
Because of the ability for gene drives to cross borders, some Australian scientists are requesting a national debate and decision-making to help in the development of clearer, overarching gene drive regulation.
- Less harmful fungus: Researchers from the Commonwealth Scientific and Industrial Research Organisation (CSIRO) developed a gene drive to control a fungus that causes wheat scab, which destroys wheat harvests. This is the first use of a gene drive to control a pathogen in plants. For research purposes only at this stage.
- Daughterless cats: CSIRO developed cats that only have male offspring to control the invasive feral cats that kill native species.
- Daughterless mice: CSIRO developed mice that only have male offspring to help control the invasive mouse population.
- Daughterless carp: CSIRO used CRISPR to safely control carp (an invasive fish species) by removing females from populations.
2019: 2019 Amendments to the Gene Technology Regulations 2001 commence, including the requirement of a license for all gene drives to ensure case-by-case evaluation of risks and tailored risk management.
2001: Gene Technology Act 2000 and the Gene Technology Regulations 2001 regulate GMOs in Australia. The Act defines gene technology as any technique for the modification of genes or other genetic material.
Gene drives face fierce opposition from certain environmental advocacy groups, which claim that modified creatures might spread across borders and adversely impact the environment in unseen ways—claims most scientists say are overblown. The Canadian-based, international organization ETC Group and more than 200 global anti-GMO activists and NGOs published an open letter in 2016 opposing gene drives and called for a global moratorium. During the 2016 World Conservation Congress, a select group of NGOs, environmental activists and some scientists voted to adopt a moratorium on supporting research into gene drives. The moratorium call was rejected at the 2016 United Nations Convention on Biodiversity (CBD). Counter NGO groups, including Target Malaria, Island Conservation and Genetic Biocontrol of Invasive Rodents Program, have adopted the opposite position, stating that “gene drive is vital to the future of restoration and critical in preventing extinctions”.
- Genetic Literacy Project’s FAQ on gene editing
- Outreach Network for Gene Drive Research
- Gene drive research: Why it matters