Biosafety, biosecurity and gene technology research

Dealings with GMOs in contained facilities which do not meet the criteria for classification as Exempt Dealings or Notifiable Low Risk Dealings and do NOT involve an intentional release of GMOs into the environment. DNIRs are higher risk dealings than NLRDs.

DNIRs must be licensed by the Regulator. The kind of dealings classified as DNIRs are described in Schedule 3 Part 3 of the Regulations.

Contained dealings with viral vectors can be classified in the DNIR, NLRD, and exempt categories. To correctly classify dealings with viral vectors the OGTR has provided the following guides:

· Tables for the classification of contained dealings with viral vectors

· Flowchart for the classification of contained dealings with viral vectors

Application process

1. Read the Licence Application & Assessment Process information provided by the OGTR.
2. Ensure the dealing meets the classification criteria listed in Schedule 3 Part 3 of the Regulations.
3. Ensure dealings involving viral vectors meet the correct classification criteria.
4. Download an OGTR Application Form - Dealings Not involving Intentional Release (DNIR)and save a copy to your computer.
5. The completed application and all supporting documentation must be submitted electronically to biosafety@latrobe.edu.au from the Chief Investigator's La Trobe University email account.
6. DNIR licence applications must be reviewed and supported by the LTIBC. The LTIBC will forward reviewed and supported licence applications to the Regulator.

Evaluation of a licence application by the Regulator can take up to 90 working days. Work cannot commence the Regulator has issued a licence.

• Variations to Notifiable Low Risk Dealings are no longer required. Review your current Records of Assessment (LTIBC approval) to ensure that you have broad scope to undertake your teaching and research. Notify the Research Office via email of any changes in personnel associated with an approval and the LTIBC officer will email you with confirmation. If you are unsure whether a change is covered under your Records of Assessment please email the LTIBC officer. Your change will be assessed and  confirmation will be provided. If the change falls outside of your approval a new application will be required.
• How do I submit an annual/final report?
  • Download and complete the Annual Report Form (DOC 63KB) or Final Report Form (DOC 60KB)
  • Log in to  PRIME Researcher portal to lodge an annual/final report:
  • To find your IBC project click on “My Ethics Approvals” tile and select the IBC Approval Number you wish to submit an annual or final report for,
  • At the top of the IBC record click the “down” arrow and click “Create Annual Report” or “Create Final Report”
  • Upload completed annual/final report
  • In the progress bar at the top of the page, select "Review by Research Office" and then click "Mark as Current Status" to the right.

Please contact the Biosafety Team for any questions regarding risk group levels, containment, import and export, legislative requirements.