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 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. The Regulator is now consulting on amendment proposals, further information about the review and the current consultation is available on the Regulations review page.