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Gene Technology

Gene technology is defined as any technique for the modification of genes or other genetic material, but does not include sexual reproduction, homologous recombination or any other techniques specified in the Gene Technology Regulations of the Gene Technology Act 2001.

Genetically modified organisms (GMOs) are organisms which have been modified by gene technology or organisms that have inherited traits that occurred in the initial organism because of gene technology. Therefore, even if you do not construct the GMO yourself, the act of propagation (i.e. growing the strain in the laboratory) falls within the definition.

You must gain approval from the Institutional Biosafety Committee (IBC) prior to commencing teaching or research involving genetically modified organisms.

Please consult the following two documents, for important information about working with viral vectors, before completing your application:

Application forms

The University's Institutional Biosafety Committee (IBC) assesses and reviews all proposals involving dealing with GMOs and, where required by the OGTR guidelines, submits them for assessment.

There are four types of dealings for GMOs. You will need to fill out the application form(s) relevant to the dealing your teaching or research intends to undertake.

  1. Exempt dealing: These are dealings that pose negligible risk as assessed over time, are contained within a facility and will not be released into the environment. The use of an exempt dealing organism does not require a licence however researchers must notify the Institutional Biosafety Committee of projects using exempt dealing GMOs.
  2. Notifiable Low Risk Dealings: These are dealings that pose low risk (as assessed over time), must be contained within a certified facility with an accredited organisation, and must be transported, stored and disposed of within OGTR guidelines for transport of GMOs.
    • Application for Exempt and Notifiable Low Risk Dealings (Word doc)
      This application form should be completed for all Exempt and Notifiable Low Risk category GMO dealings to be undertaken by University Personnel or to be undertaken by other personnel within University premises

    • Application Guiding Document (PDF - Prepared September 2013)
      Note: the Application for Exempt and Notifiable Low Risk Dealings Form was updated in October 2012, following changes to OGTR requirements and Gene Technology Regulations. This document has been prepared to assist you in completing your application.

    • Application to Modify an Approved Exempt or Notifiable Low Risk Dealing
      This application form should be completed for minor changes to approved Exempt and Notifiable Low Risk category GMO dealings.

  3. Dealings Not Involving Release: These are dealings that are neither exempt nor notifiable low risk dealings and which do not involve release of the GMO into the environment. They are GMAC Category A (large and small) projects. An individual license obtained directly from the OGTR is required prior to commencing the project, but initial approval by the IBC is also required as part of the OGTR application process.
  4. Dealings Involving Release: These are dealings that are neither exempt nor notifiable low risk dealings and which involve release of the GMO into the environment. An individual license obtained directly from the OGTR is required prior to commencing the project, but initial approval by the IBC is also required as part of the OGTR application process.
  5. Completed application forms must be submitted to: biosafety@unisa.edu.au

    Timelines

    Once you submit your application, feedback (which might include the requirement that your application be considered by a full Institutional Biosafety Committee meeting) will take a maximum of 10 working days. Please contact the IBC Executive Officer if you have not had a response within this timeframe.

    Current List of PC2 Certified Laboratories

    Current list of PC2 certified laboratories

    Virtual Accident - Online Biosafety Training

    Online training modules

    Policies and guidelines

    Refer to University policy RES 4.3 and the University of South Australia Biosafety Manual. The manual summarises the operation of the University's biosafety management system and provides links to other relevant resources. It includes useful information on working with biohazardous materials and genetically modified organisms, the approvals and physical containment facilities required for different types of dealings and the role of the Institutional Biosafety Committee (IBC) in overseeing research and teaching activities.

    The Office of the Gene Technology Regulator (OGTR) gives full information about genetically modified organisms and the regulations governing gene technology in Australia. The University of South Australia is an accredited organisation under the Act. OGTR guidelines must be adhered to.

    Reporting Unintentional Release

    Reporting Unintentional Release

    Transportation and Storage

    Any proposed transportation, storage and disposal of GMO material is considered an aspect of the dealing and requires approval as part of your application to the IBC. The Guidelines for these aspects are covered in the OGTR Guidelines for the Transport, Storage and Disposal of GMOs.

    Useful links

    Related codes and guidelines

    AS/NZS 2243.3:2010 - Safety in laboratories - Microbiological aspects and containment facilities.

    Electronic copies can be accessed via the SAI Global online public database through the UniSA Library - note you must log in to the database via the Library as a staff member or student to access this online.

     

 

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