As part of the 2016-17 Technical Review of the Gene Technology Regulations 2001, the OGTR prepared a Discussion Paper canvasing four options for how new technologies could be regulated, and sought submissions on the paper from 17 October to 16 December 2016.

The Discussion Paper sought stakeholder views on how two site-directed nuclease (SDN) techniques and oligo-directed mutagenesis should be regulated. The SDN techniques are:

  • SDN-1, which involves the unguided repair of a targeted double-strand break (ie no template is used)
  • SDN-2, which involves template-guided repair of a targeted double-strand break, using an oligonucleotide to guide small sequence changes
The Discussion Paper provides further information about these techniques. A third SDN technique, SDN-3, is clearly within the scope of regulation currently and this status is not open to change through this review. SDN-3 involves template-guided repair of a targeted double-strand break using a long template to insert new sequences.

The figure below compares the process and product features of organisms produced using these technologies relative to techniques that are outside the scope of the gene technology regulatory scheme (natural mutations, chemical mutagenesis and radiation mutagenesis) and techniques that result in regulated GMOs (inserting transgenes).

Site-directed nuclease (SDN) techniques and oligo-directed mutagenesis are represented according to their process and product features, relative to unregulated techniques (natural mutations and mutagenesis) and transgenesis. SDN-1 involves the random repa

Discussion Paper - Review of the Gene Technology Regulations (DOCX 176 KB)
Discussion Paper - Review of the Gene Technology Regulations (PDF 269 KB)


Gene Technology Regulator’s response to campaign submissions to the Regulations Review