Application process for approval of dealings with GMOs

All Australian National University research involving GMOs must adhere to the Gene Technology Act 2000 and Gene Technology Regulations 2001, which are regulated by the Office of the Gene Technology Regulator (OGTR). The ANU rDNA Sharepoint Site contains links to forms, guidelines, and news. Applications for new dealings or facilities,  reporting of incidents and management of dealings can be done through the Research Ethics Management System (REMS)

If you are not using GMOs, but have an enquiry relating to biological safety, please contact the Work Environment Group (whs@anu.edu.au) or your School’s Work Health and Safety Officer.

Submitting application forms to the rDNA Committee

Applications for approval are categorised as either Exempt Dealings, Notifiable Low Risk Dealings (NLRDs), Dealings Not Involving Intentional Release (DNIRs), or Dealings Involving Intentional Release (DIRs). For more information on each category, please read the relevant section below or visit the rDNA Sharepoint Site.

The following steps outline the application process:

1. Consult the guidance material on the rDNA Sharepoint Site
2. Go to rems.anu.edu.au 
3. Create your Team, add your procedures and competencies then create new projects for submission through the REMS system

Work is not allowed to commence until written approval is obtained from the University Recombinant DNA Monitoring Committee for Exempt and Notifiable Low Risk Dealings. Licenced Dealings (DNIRs and DIRs) may not commence until OGTR approval is obtained.

If your application contains confidential commercial information please submit the declaration form available to the right of the screen.

Exempt Dealings

Submit theproposed exempt dealing, including a description of the exempt host, the exempt vector and the genetic modification through the REMS system . This will be reviewed by the University Recombinant DNA Monitoring Committee and the applicant will be advised of the outcome via the system when the project may commence.

Notifiable Low Risk Dealings (NLRDs)

See the About GMOs Page for helpful information about what constitutes an NLRD and tips for completing the form on the REMS system. The University Recombinant DNA Monitoring Committee will advise the applicant via the REMS system when the dealing has been approved and that work on the project may commence. Approved dealings may be accessed and downloaded at any time from the REMS system

Dealings Not Involving Intentional Release (DNIRs)

Please fill out the DNIR form available to the right of screen - see the About GMOs page for helpful information. The application will initially be reviewed by the University Recombinant DNA Monitoring Committee. Once the University Recombinant DNA Monitoring Committee has completed its review, the application must be signed by the applicant, the DVC of The Australian National University and the Chair of the University Recombinant DNA Monitoring Committee. The application will then be sent to the OGTR for a risk assessment and risk management process which may take 90 working days or more.

Work on the project MUST NOT commence until the application has been approved by the OGTR and a Licence to undertake the work has been received in writing by The Australian National University and the applicant. 

Dealings Involving Intentional Release (DIRs)

DIRs also need to be approved by the OGTR before commencement. If you intend to submit a DIR application, please contact the rDNA Officer for assistance.

If, after reading this information and consulting the associated Schedules, you are unsure whether or not your proposed experiments may be exempt, you should email the rDNA Officer with a description of the proposed dealing, including a description of the exempt host, the exempt vector and the genetic modification. This email should provide the University Recombinant DNA Monitoring Committee with sufficient information to evaluate whether your proposal is exempt or requires a NLRD or Licenced Dealing application. If your dealing is classified by the Committee as exempt, you will be advised in writing that the work is exempt and that you may commence experimentation. If your dealing is classified by the Committee as a NLRD or Licenced Dealing, then you will be advised that an application for a NLRD or Licenced Dealing will need to be prepared.