Australia Updates Gene Technology Regulations; Will Not Regulate Gene Editing in Plants Without New Genetic Material
The Australian government has released a decision that says it will not
regulate the use of gene editing techniques in plants, animals, and human
cells that do not introduce new genetic material. The decision comes from a
review of the country's gene technology regulations and changes will take
effect on October 8, 2019.
Previously, the use of such technologies, including CRISPR-Cas9 for research
was restricted in practice because such 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
The Australian regulator states 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 genetic material into
the cell, will continue to be regulated by the OGTR.
Australia's regulations have not been reviewed since 2011, before gene
editing technologies became widespread. However, the updated regulations do
not apply to the use of gene editing in human embryos for reproduction,
which is banned. The amendments also increase monitoring of gene drive
experiments, but separate laws cover genetically modified food products.