La Trobe University > Researchers > Research Office > Ethics, Biosafety and Integrity > Biosafety, biosecurity and gene technology research

Biosafety, biosecurity and gene technology research

How to apply

Download and complete the Application Form for Exempt and Notifiable Low Risk Dealings

Committee meeting dates


Application deadline		Meeting date
Thursday 07 February 2019Thursday 21 February 2019
Thursday 07 March 2019Thursday 21 March 2019
Thursday 04 April 2019Thursday 18 April 2019
Thursday 02 May 2019Thursday 16 May 2019
Thursday 06 June 2019Thursday 20 June 2019

Post approval requirements

  • 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.
  • Progress reports are not required for NLRDs and Exempt Dealings, you are required to submit a final report within 3 months of expiry. Download final report.

Please contact the Senior Biosafety Officer at biosafety@latrobe.edu.au for any questions regarding risk group levels, containment, import and export, legislative requirements.

DNIR (Dealings involving Non-Intentional Release)

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

· Comparison between 2011 and 2007 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.

DIR (Dealings involving Intentional Release)

Dealings with GMOs outside contained facilities and involving an intentional release into the environment are classified as DIR.

DIRs must be licensed by the Regulator and are included on the GMO Record. The evaluation process of DIR licence applications is comprehensive and involves the preparation of a risk assessment and risk management plan (RARMP).

Application process

  1. Read the Licence Application & Assessment Process information provided by the OGTR.
  2. Download an OGTR Application Form - Dealings involving Intentional Release (DIR) and save a copy to your computer.
  3. 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.
  4. DIR 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 255 working days. Work cannot commence the Regulator has issued a licence.

Internal facility certification

Legislation requires certain dealings with GMOs must be conducted within physical containment facilities.

For research involving or potentially involving Risk Group 1 or Risk Group 2 organisms that do not include genetically modified organisms, the LTIBC oversees an internal certification program that verifies our laboratories comply with Australian New Zealand Standards, 2982:2010 and 2243:3:2010.

Please contact the Senior Biosafety Officer at biosafety@latrobe.edu.au for any questions regarding La Trobe's internal certification or external OGTR certification.

Do you require explanatory information on the OGTR Guidelines for Certification of Physical Containment Facilities

Training

To access the ‘Working with recombinant DNA’ training module on the LMS:

  1. Log in to Ethics Online
  2. Enter your details under the 'Course  registration' tab
  3. Your username and password will be emailed to you automatically. Activate your account  Once your account before logging in to the Ethics Online.
  4. Training will appear as 'Working with Recombinant DNA' training module 4.
  5. When you have completed the training, you will receive a completion certificate, please email this to your supervisor, Lab Manager and the Biosafety Team.

Feedback and Complaints

If you wish to provide feedback or make a complaint please email biosafety@latrobe.edu.au or call the Senior Biosafety Officer on (03) 9479 1443