The Gene Technology Regulator (the Regulator) has initiated a technical review of the Gene Technology Regulations 2001 (the Regulations) to provide clarity about whether organisms developed using a range of new technologies are subject to regulation as genetically modified organisms (GMOs) and ensure that new technologies are regulated in a manner commensurate with the risks they pose.
The Legislative and Governance Forum on Gene Technology has commenced the third review of Australia’s Gene Technology Scheme. While the technical review of the Regulations is limited to the current policy settings of the regulatory scheme, issues outside this scope may be considered through the review of the Gene Technology Scheme. More information is available on the Department of Health’s Review of the National Gene Technology Scheme 2017 web page.
OGTR is working toward publicising outcomes of the technical review of the Regulations in time for future stages of consultation for the Review of the National Gene Technology Scheme.
Discussion Paper ConsultationThe Regulator has consulted the public on a discussion paper detailing four options for how new technologies could be regulated, seeking submissions on the paper from 17 October to 16 December 2016.
Additional information on the content of the discussion paper is available on the Regulations Review Discussion Paper page.
Discussion Paper SubmissionsCopies of the submissions received by the Regulator are available on the Regulations Review Submissions page.
The Regulator is now considering the issues raised in submissions and will decide which option supports the effectiveness of the legislative framework. The Regulator is also considering scientific understanding, potential risks, the regulatory burden implications for stakeholders, whether regulatory burden would be commensurate with risks, and the policy intent of the GT Act.
Next steps in the reviewIf amendments to the Regulations are recommended, the Regulator will publicly consult on any amendments before they are finalised. If you want to ensure you are informed of any future consultations, please subscribe to OGTR News.
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 see the Regulator’s general advice on regulatory coverage of new technologies.
During the discussion paper consultation the OGTR learned that some stakeholders are not aware that organisms genetically modified to contain gene drives are GMOs. The Regulator has now issued guidance for Institutional Biosafety Committees and researchers on the regulatory requirements for organisms containing engineered gene drives.
If you have missed the consultation period and would like to identify an issue for consideration in the next review you can contact OGTR at any time. The Regulator undertakes periodic reviews of the Regulations, and a commencement date for the next review has not been set.
Questions and Answers on the Regulations Review (PDF 100 KB)
Questions and Answers on the Regulations Review (DOCX 25 KB)