> Classes of Dealings
What are Dealings involving an Intentional Release (DIR) of a GMO into the environment?
Dealings involving an Intentional Release (DIR) of GMOs into the Australian environment are dealings with GMOs which take place outside of containment facilities.
The majority of DIR licences issued to date have been for experimental field trials (limited and controlled releases) or general/commercial releases of GM plants. A small number of DIR licences have also been issued for GM vaccines for human or veterinary use, either for trial (limited and controlled release) or general/commercial release. The release of GM animals would also require a DIR licence.
DIRs are included on the GMO Record.
You can see the list of applications and licences for DIRs
online. You can also see a list of DIR applications currently under consideration
How are DIR licence applications evaluated?
Each DIR licence application
is subject to a comprehensive, science-based, case-by-case analysis process.
The Gene Technology Act 2000
(Sections 48–67) sets out a clear process that the Gene Technology Regulator (the Regulator) must follow to:
- prepare a risk assessment and risk management plan (RARMP)
- make a decision about whether or not to issue a licence.
Each application’s prepared RARMP identifies risks to human health and safety, and to the environment, posed by the dealings with GMOs proposed in the application.
It also addresses risk management measures (that would be covered by the licence conditions) to manage any identified risks.
As the Regulator evaluates the DIR application and prepares a RARMP, the Regulator consults with:
The Regulator notifies the public of the DIR application being received.
After the draft RARMP is prepared, the Regulator invites submissions about the RARMP from the above groups as well as the public through fact sheets
and other communiqués.
This consultation process provides an opportunity for a diverse group of people, including the public, to have direct input into the decision-making process.
The Regulator provides a summary of the evaluation process:
Summary of the evaluation process for DIR licence applications
How long does it take to evaluate a DIR licence application?
The Regulator must decide whether to issue a DIR licence within 255 working days*
Some DIR applications which are principally for research and meet criteria for a ‘limited and controlled release’ application (outlined in Section 50A of the Act) may qualify for a streamlined process. The Regulator decides which applications qualify for that process on a case-by-case basis, based on the information in each one’s DIR application.
For applications identified as limited and controlled releases, the Regulator will decide within (from the Gene Technology Regulations 2001
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- 150 days for applications for which the Regulator has not identified a significant risk
- 170 days for applications for which the Regulator has identified a significant risk.