Changes to the Gene Technology Regulations: effective 8 October 2019

If you are using organisms that were not Genetically Modified Organisms (GMOs) under the current Regulations, they could be GMOs under the amended Regulations. The organism may or may not be a GMO depending on how it was derived.

To ensure your research is compliant with the amended Regulations, please notify the Institutional Biosafety Committee if you are using, or intending to use, any of the organisms or techniques listed below:

  • Use of a site-directed nuclease (eg. CRISPR/Cas, TALEN, ZFN) to induce a break in genomic DNA, AND a nucleic acid template to guide the repair (homology-directed repair)
  • Oligonucleotide-directed mutagenesis
  • Introduction of RNA that involves:
    • Alteration of the organism’s genome sequence;
    • Use of viral vectors;
    • Translation of the RNA into a polypeptide; or
    • Giving rise to an infectious agent
  • Engineered gene drives (a modification that increases the likelihood of inheritance of a nucleotide sequence/sequences)
  • Dealing with a GMO where the unmodified parent organism is a pathogen classified as Risk 3 or above:
    • Includes organisms that have been modified to reduce capacity to cause harm
    • Excludes replication defective retroviral vectors as described in Schedule 3 Part 2 of the Regulations
  • A mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (e.g. introduction of a gene from the same species, or introduction of extra copies of the same organism’s DNA)
  • Genetic modification involving Corynebacterium glutamicum, or Zymomonas mobilis
  • An organism derived from a GMO, or modified by gene technology, that could be considered not a GMO for any reason (for example, if the inherited ‘traits’ were not caused by gene technology, or if the genetic modification is no longer present)
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