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.

Recent consultation on proposed amendments and next steps

From 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 is now considering the issues raised in submissions and finalising the draft amendments. The Regulator will then propose the amendments to the Commonwealth and State and Territory governments for their agreement. If there is agreement, the OGTR will commence the Commonwealth regulation-making process which requires approval from the Governor-General and tabling in Parliament.

Additional information about the proposed amendments is available on the Regulations Review Proposed Amendments page.

Submissions received by the Regulator are available on the Regulations Review Amendment Proposals Submissions page.

If you 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.

Review of the National Gene Technology Scheme

The 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 Scheme Review is an alternate avenue for submitters to pursue other issues, particularly policy issues that cannot be addressed through this technical review.

Discussion Paper Consultation

The 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.

Current legislative position

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.

Any progressed amendments will not commence until the above described steps have been completed. Organisations or individuals working with GMOs are cautioned to continuing 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.

Questions & Answers on the Technical Review of the Gene Technology Regulations 2001 (PDF 74 KB)
Questions & Answers on the Technical Review of the Gene Technology Regulations 2001 (DOCX 28 KB)

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