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.
Call for submissions on proposed amendmentsThe Regulator is inviting submissions on proposed amendments to the Regulations in this public consultation for the Technical Review of the Regulations. These proposals were developed following consultation in October-December 2016 on four options for how particular new technologies could be regulated. The Regulator has considered issues raised in submissions, current scientific understanding, potential risks, regulatory burden implications, whether regulatory burden would be commensurate with risk, and the policy intent of the GT Act.
The key proposals are:
- Regarding new technologies, option 3 best supports the effectiveness of the legislative framework at this time. Under option 3 organisms modified using site-directed nucleases without templates to guide genome repair (i.e. SDN-1) would not be regulated as GMOs. Currently, if a template is used to guide genome repair (i.e. SDN-2 and SDN-3), the resulting organisms are GMOs, as are organisms modified using oligonucleotide-directed mutagenesis. These would continue to be regulated under this option.
Regarding RNAi, it will be proposed to list the application of RNA molecules to induce RNAi as a technique that is not gene technology provided the RNA cannot give rise to changes to genomic sequence and cannot be translated into proteins. RNAi techniques which involve inserting sequences into the genome or use of viral vectors would continue to result in GMOs which are subject to regulation.
Regarding gene drives, it will be proposed to require a licence for all contained dealings with gene drive GMOs. Advice on the current regulatory status of gene drive GMOs was published on the OGTR website in December 2016.
Consultation documentsThe Regulator is inviting your comments on proposed amendments to the Regulations, as detailed in the Consultation Regulation Impact Statement and summarised in the Consultation Quick Guide, both linked below. Comments and submissions that address any or all of the options and consultation questions described in the Consultation Regulation Impact Statement are welcome. Submitters are not required to address all options in the Consultation Regulation Impact Statement; however, submitters should address the questions for your preferred options.
Consultation Quick Guide (PDF 80 KB)
Consultation Quick Guide (DOCX 90 KB)
Consultation Regulation Impact Statement (PDF 364 KB)
Consultation Regulation Impact Statement (Word 1007 KB)
The proposed amendments should be read with the Regulations, and for ease of reading a future law compilation of the draft amendments and the Regulations is also available.
Gene Technology Amendment (2017 Measures No.1) Regulations 2017 (PDF 473 KB)
Gene Technology Amendment (2017 Measures No.1) Regulations 2017 (Word 289 KB)
Future Law compilation of the Gene Technology Regulations 2001 (PDF 315 KB)
Future Law compilation of the Gene Technology Regulations 2001 (DOCX 217 KB)
How can you participate in this consultation?Please email your submission to OGTR@health.gov.au or mail it to: The Regulations Review, The Office of the Gene Technology Regulator (MDP 54); GPO Box 9848, Canberra ACT 2601.
Submissions must be received by 21 February 2018.
Submissions will be published on the OGTR website after the consultation period closes, however, OGTR can treat information of a confidential nature as such. Please ensure that material supplied in confidence is clearly marked ‘IN CONFIDENCE’ and is in a separate attachment to non-confidential material.
For privacy reasons, all personal details (e.g. signatures, phone, mobile and fax numbers) will be removed from your submission before they are published on the website. Please do not include these details in your submission unless necessary.
Next stepsIssues raised in submissions will be considered in 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.
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 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 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.
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.
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 Submissions page.
Current legislative positionAlthough 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 73 KB)
Questions & Answers on the Technical Review of the Gene Technology Regulations 2001 (DOCX 28 KB)