How each application is assessed
The comprehensive and highly consultative processes undertaken by the Gene Technology Regulator (the Regulator) to decide whether or not to issue a licence to deal with a genetically modified organism (GMO) are governed by:
- the Gene Technology Act 2000 (the Act)
- the Gene Technology Regulations 2001 (the Regulations)
- corresponding state and territory law.
General steps for Dealings NOT involving Intentional Release (DNIR) and Dealings involving Intentional Release (DIR) licensing processes are shown below.
1. Application form must be filled out. You can access DIR and DNIR application forms online.
2. Application reviewed/supported by an Institutional Biosafety Committee. In addition to the review by the Institutional Biosafety Committee, supporting information will be provided by the committee and forwarded to the Regulator.
3. Application identification number assigned. Once the application is received by the Regulator, it is acknowledged and a DNIR or DIR identification number assigned.
Time frames for a decision. The Regulations prescribe how many working days the Regulator has to make a decision to issue, or refuse to issue, a licence for the dealings proposed in the application:
- For DNIR applications: 90 working days*.
- For DIR applications which are not limited and controlled release applications: 255 working days*
- For limited and controlled release DIR applications: 150 working days* (or 170 working days* if a significant risk is identified).
4. Consultation with experts, agencies or authorities. The Regulator may consult experts, agencies or authorities about the application.
5. Preparation of a risk assessment and risk management plan (RARMP). A RARMP is prepared for the application.
6. Consultation about RARMP. The Regulator must consult the Gene Technology Technical Advisory Committee, prescribed agencies and authorities, and the public on all RARMPs prepared for DIR applications.The Regulator provides a summary of the evaluation process for DIRs.
7. Decision on licence. The Regulator makes a decision to issue, or refuse to issue, a licence.
8. Decision is recorded on the public GMO record. The decision on the licence application is recorded in the GMO Record on the Office of the Gene Technology Regulator (OGTR) website. For DIR licences, you can download the RARMP, the licence conditions and other supporting information.
Typical licence conditions for DNIRs are also provided online.You can see an up-to-date list of applications and licences for DIRs, or applications and licences for DNIRs, online. You can also see a list of DIR applications currently under consideration. If you would like more information about applications to deal with GMOs, please contact the OGTR.
What is a GMO licence?A GMO licence is a legal instrument issued by the Regulator under the Act that sets out the conditions under which specified dealings with GMOs must be undertaken.There are three main types of licences—for Dealings Not involving Intentional Releases (DNIRs), Dealings involving Intentional Releases (DIRs) or inadvertent dealings.
A person who deals with a GMO without a licence is guilty of an offence (punishable under Section 32 of the Act) if:
- the person deals with a GMO, knowing that it is a GMO
- the dealing with the GMO by the person is not authorised by a GMO licence, and the person knows or is reckless as to that fact
- the dealing with the GMO is not specified in an Emergency Dealing Determination, and the person knows or is reckless as to that fact
- the dealing is not a Notifiable Low Risk Dealing, and the person knows or is reckless as to that fact
- the dealing is not an Exempt Dealing, and the person knows or is reckless as to that fact and
- the dealing is not included on the GMO Register, and the person knows or is reckless as to that fact.
*Note about ‘working days’: These periods do not include weekends or public holidays in the Australian Capital Territory, nor do they include days during which the Regulator is formally seeking further information from the applicant about the application.