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 decision, announced on 10 April, is the result of a review of the country's gene technology regulations.
Previously, the use of such technologies, including CRISPR–Cas9, for research was restricted in practice because the techniques were governed by the same rules as conventional genetic modifications, which require approval from a biosafety committee accredited by the Office of the Gene Technology Regulator (OGTR).
The amended rules remove that requirement for the use of tools in which proteins cut DNA at a specific target site — as long as the tools allow the host cell to repair the break naturally, rather than using a template containing genetic material to direct the repair process.
The Australian ruling is a “middle ground” between more lenient gene-editing rules in the United States, Brazil and Argentina, and tougher measures in the European Union, say geneticists James Hereward and Caitlin Curtis of the University of Queensland in Brisbane, Australia.
In March 2018, the US Department of Agriculture excluded genome-edited plants from regulatory oversight altogether. By contrast, the Court of Justice of the European Union ruled in July last year that it would treat gene-edited crops as genetically modified organisms, subject to stringent regulation.
The Australian regulator says that genetic edits made without templates are no different from changes that occur in nature, and therefore do not pose an additional risk to the environment and human health. Gene-editing technologies that do use a template, or that insert other genetic material into the cell, will continue to be regulated by the OGTR.
“This is an excellent and logical decision,” says Gaetan Burgio, a geneticist at the Australian National University in Canberra. Previously, plant and biomedical scientists did not know whether gene editing using CRISPR–Cas9 was classified as genetic modification, says Burgio. There is less room for confusion now, he says.
Before the update, the rules had not been reviewed since 2011, before gene-editing technologies became widespread. But the updated regulations do not apply to the use of gene editing in human embryos for reproduction, which is banned. And separate laws cover genetically modified food products.
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. Researchers working on the technology in contained settings will now need to obtain a licence from the OGTR.
The Australian changes will take effect on 8 October.