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.

Next Steps

The Technical Review is progressing towards consultation on draft amendment regulations. We are now informing stakeholders of the direction of the Technical Review, so that they can take part in the approaching consultation for the Review of the National Gene Technology Scheme (the Scheme Review). The Technical Review is intended to provide an interim solution whilst broader policy considerations associated with new technologies are being progressed through the Scheme Review.

In October-December 2016 the Office of the Gene Technology Regulator consulted on four options for how particular new technologies could be regulated. The Regulator has considered issues raised in submissions, scientific understanding, potential risks, regulatory burden implications, whether regulatory burden would be commensurate with risk, and the policy intent of the GT Act in arriving at the following draft proposals:
      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 (ie SDN-1) would not be regulated as GMOs. Currently, if a template is used to guide genome repair (ie 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.
In summary the key considerations were:
  • the extent of modifications possible through SDN-1 are the same as that possible with currently excluded techniques (natural mutations, chemical mutagenesis and radiation mutagenesis) which rely on the same natural cellular repair mechanisms
  • there are practical considerations for regulatory compliance as it is not possible to distinguish products of SDN-1 from naturally occurring mutation
  • Option 3 would maintain the policy settings of the gene technology scheme by reflecting the concepts guiding the scope of the regulatory scheme at its inception.

Consultation on draft amendments

The OGTR anticipates opening consultation on draft amendments from November 2017 until late January 2018. This timeline aims to provide interested parties with the draft amendments as soon as possible to inform their input to the Review of the National Gene Technology Scheme (the Scheme Review, see below), with the extended consultation allowing involvement in the upcoming Scheme Review consultations.

Details of the Technical Review proposals, including a consultation regulation impact statement and an exposure draft of proposed amendments, will be published. Minor technical amendments in response to submitter proposals and based upon OGTR’s operational experience will also be included.

Please subscribe to OGTR News if you wish to receive notification when consultation commences, and contact OGTR if you require further information (ph: 1800 181 030, email: ogtr@health.gov.au).

Scheme Review

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 Scheme Review is an alternate avenue for submitters to pursue other issues, particularly policy issues that cannot be addressed through the new technologies options.

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.

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 are available on the Regulations Review 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.

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.

Questions and Answers on the Regulations Review (PDF 101 KB)
Questions and Answers on the Regulations Review (DOCX 26 KB)

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