As part of the Technical Review of the Gene Technology Regulations 2001, OGTR developed amendment proposals following consultation on a discussion paper in October-December 2016 describing four options for how particular new technologies could be regulated. The Regulator considered issues raised in submissions on the discussion paper, current scientific understanding, potential risks, regulatory burden implications, whether regulatory burden would be commensurate with risk, and the policy intent of the GT Act.
From 30 November 2017 to 21 February 2018 the Regulator invited comments on the proposed amendments, as detailed in the Consultation Regulation Impact Statement and summarised in the Consultation Quick Guide, both linked below.
The key proposals were:
- 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 was 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 was 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 Quick Guide - PDF 80 KB
Consultation Quick Guide - DOCX 90 KB
Consultation Regulation Impact Statement - PDF 364 KB
Consultation Regulation Impact Statement - Word 690 KB
The proposed amendments should be read with the Regulations, and for ease of reading a future law compilation of the draft amendments and 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 290 KB
Future Law compilation of the Gene Technology Regulations 2001 - PDF 315 KB
Future Law compilation of the Gene Technology Regulations 2001- DOCX 210 KB