Applying for approval

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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 new ANU rDNA Sharepoint Site contains links to forms, guidelines, the Annual Report App, legislation, and news.

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. Fill out the relevant application form, which can be found on the rDNA Sharepoint Site
  2. Email an electronic copy. Please send the unsigned application form and attachments to rDNA Officer for assessment by the University Recombinant DNA Monitoring Committee
  3. Receive recommendations for revision or approval from the University Recombinant DNA Monitoring Committee
  4. Sign and finalise your application. You will be advised by the rDNA Officer when to provide a signed copy of your application. Electronic signatures, either via DocuSign or Adobe Acrobat e-signature, are an acceptable form of signature.

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

Please email the rDNA Officer with a description of the proposed exempt dealing, including a description of the exempt host, the exempt vector and the genetic modification. This email will be reviewed by the University Recombinant DNA Monitoring Committee and the applicant will be advised in writing that the application has been approved and that work on the project may commence.

Notifiable Low Risk Dealings (NLRDs)

Please fill out the appropriate NLRD form available on the rDNA Sharepoint Site (either Plant Research or Non-Plant Research). See the About GMOs Page for helpful information about what constitutes an NLRD and tips for completing the form. The University Recombinant DNA Monitoring Committee will advise the applicant in writing that the application has been approved and that work on the project may commence. The final document must be signed by the applicant. This original document will be held on file by the Research Ethics team.

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.

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