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Crop Biotech Update

Australia Updates Gene Technology Regulations; Will Not Regulate Gene Editing in Plants Without New Genetic Material

May 2, 2019

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 Regulator (OGTR).

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.

For more details, read the news article in Nature. Information on the current Technical Review of the Gene Technology Regulations is available in the OGTR website.