Australia
October 17, 2016

Gene technology is a rapidly developing field of science and the OGTR is aware of differences of opinion among regulated stakeholders as to whether organisms modified using some new technologies are subject to regulation as GMOs, for example:

• oligonucleotide-directed mutagenesis
• some RNA interference applications
• some site-directed nuclease techniques, including zinc finger nucleases, CRISPR/Cas9, TALENs and meganucleases.

Section 3 of the Gene Technology Act 2000 (the Act) sets out the object of the Act which is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs.

Section 10 of the Act contains a broad definition of ‘gene technology’ and thus also a broad definition of ‘genetically modified organism’ (GMO). The Gene Technology Regulations 2001 (the Regulations) provide some exclusions to the definitions, some of which have not been changed since 2001. Although there are challenges in applying the current definitions to some new technologies, the Regulator is obliged to perform the functions required by the Act and apply the legislation as it stands today.

Please continue to discuss your particular queries about regulatory coverage with OGTR. You may also seek your own legal advice. The Regulator can only provide advice on a case-by-case basis and on the understanding of the technology as presented and the legislation in its current form. When considering new technologies the Regulator must take a conservative approach, consistent with promoting the object of the Act, and the broad scope of the definition of GMO contained in Section 10 of the Act.

The Regulator is currently conducting a technical review of the Regulations to ensure the level of regulation of activities with GMOs remains commensurate with risk according to current science. The review aims to provide clarity regarding regulatory capture of new technologies. Public consultation on a discussion paper on options for regulating new technologies is open until 2 December.

Should the Regulator decide to propose amendments to the Regulations, broad consultation with the public, states and territories, regulated stakeholders, industry and scientific experts will be undertaken before any amendment proposals are finalised. If you would like to ensure you are notified of any public consultation for the review of the Regulations, please subscribe to OGTR News.

Website: http://www.ogtr.gov.au

Published: October 17, 2016