Classes of dealings involving GMOs

Any research involving a dealing with a GMO requires approval from the UNSW Gene Technology Research Committee (GTRC) before work can start.
 

What is a dealing?

Under the Gene Technology Act 2000, 'dealing' means to do the following:

  • conduct experiments with the GMO;
  • make, develop, produce or manufacture the GMO;
  • breed the GMO;
  • propagate the GMO;
  • use the GMO in the course of manufacture of a thing that is not the GMO;
  • grow, raise or culture the GMO;
  • import the GMO;
  • transport the GMO;
  • dispose of the GMO;
  • possess, supply, use a GMO for the purposes of any of the above.

 

What is a Genetically Modified Organism? 

Under the Gene Technology Act 2000, Genetically Modified Organism (GMO) means:

  • an organism that has been modified by gene technology; or
  • an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology; or
  • anything declared by the Gene Technology Regulations 2011 to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms.. Note: Under amendments to the 2011 Regulations that come into force on 8/10/2019: “organisms are genetically modified if the genomes are “edited” by a site-directed nuclease and if a template nucleic acid was added to guide homolog-directed repair of the single strand (s-s) or double strand (d-s) break/s." If the repair of s-s or d-s break/s is not homology directed by an added guide nucleic acid it is not genetically modified under the Regulations”

 

How are dealings classified?

 

Dealings with GMOs are classified into four areas as defined by the OGTR:

 

DEALING RISK LEVEL APPROVAL REQUIRED
Exempt Very low Notifcation of Exempt Dealing submitted to GTRC

NLRD - Notifiable Low Risk Dealings

Low provided required conditions are met GTRC Approval at monthly meeting
DNIR - Dealings Not involving Intentional Release into the environment Higher than NLRD OGTR Approval (lengthy process)
DIR - Dealings involving Intentional Release into the envrionment Highest OGTR Approval (lengthy process - may take up to 2 years)

 

Back to: What type of approval do I need?

 

0