The Gene Technology Regulator (the Regulator) has initiated a technical review of the Gene Technology Regulations 2001 (the Technical Review) 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.
Legislative and Governance Forum on Gene Technology consideration of proposed amendmentsThe Legislative and Governance Forum on Gene Technology (the Forum) is considering amendments to the Gene Technology Regulations 2001 proposed by the Regulator. On 11 October 2018 the Forum discussed the proposed amendments and requested further advice (Forum communique available here), The amendments are substantially the same as those put forward for public consultation on 30 November 2017, with minor changes to clarify the drafting and address a possible loophole, ensuring oversight of organisms intended to be regulated as GMOs.
Next steps and current legislative positionIf the Forum agrees to the proposed amendments, the OGTR will commence the Commonwealth regulation-making process which requires approval from the Governor-General and tabling in Parliament. The amendments would be released once they are made by the Governor-General. OGTR would also notify accredited organisations, Institutional Biosafety Committees and OGTR News subscribers with details of the amendments and commencement dates.
Any progressed amendments will not commence until six months after they are made by the Governor-General. Organisations or individuals working with GMOs are cautioned to continue complying with all current requirements contained in the GT Regulations (as well as any guidance provided by the Regulator) until any amendments come into force.
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.
Review of the National Gene Technology SchemeThe Scheme Review is a broad-reaching policy review being undertaken for the Legislative and Governance Forum on Gene Technology, independently of the Regulator. The Technical Review is intended to provide an interim solution whist broader policy considerations associated with new technologies are being progressed through the Scheme Review. The Final Report is now available on the Scheme Review website.
Amendment Proposals ConsultationFrom 30 November 2017 to 21 February 2018 the Regulator invited submissions on proposed amendments to the Regulations for the Technical Review of the Regulations. The Regulator considered the issues raised in submissions in finalising the draft amendments.
Additional information about the amendments as proposed at consultation is available on the Regulations Review Proposed Amendments page.
Submissions received by the Regulator are available on the Regulations Review Amendment Proposals Submissions page.
Discussion Paper ConsultationThe Regulator 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.
Copies of the submissions received by the Regulator and a summary of submissions are available on the Regulations Review Discussion Paper Submissions page.
OGTR continues to monitor scientific developments and you can contact OGTR at any time if you would like to identify an issue for consideration in the next review. The Regulator undertakes periodic reviews of the Regulations and a commencement date for the next review has not been set.
Questions & Answers on the Technical Review of the Gene Technology Regulations 2001 - updated October (PDF 74 KB)
Questions & Answers on the Technical Review of the Gene Technology Regulations 2001 - updated October (Word 28 KB)