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 as not being gene technology in the Gene Technology Regulations of the Gene Technology Act 2001.

'All projects or teaching involving GMOs require IBC approval before work commences.'

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 falls within the definition.

Approval must be granted from the Institutional Biosafety Committee (IBC) prior to commencing teaching or research involving genetically modified organisms.

All facilities where GMOs are used need to be certified by the Office of the Gene Technology Regulator (OGTR).

COVID Note

Decontamination of Personal Protective Equipment

PPE is in short supply and many researchers are considering the best and safetest management practices.

The Therapeutic Goods Administration has tested the effectiveness of PPE after decontamination. To ensure compliance with both health and safety and legal requirements we recommend the TGA's policy on decontamination of masks and gowns be followed

Reuse of Masks in the Lab and Management of PPE Short Supply 

We recommend the TGA's guidelines should be followed.

Both the World Health Organisation and the TGA recommend that in the event of an extreme shortage of N95/P2 masks, that single use N95/P2 masks must not be stored and reused. There is a risk of self-contamination as the potentially contaminated mask is placed back on your face.

The WHO recommends that if no N95/P2 masks are available that surgical masks be used in their place.

​Definition of Site-Directed Nuclease 1 (SDN1)

SDN1 modifications are not GMOs.

SDN1 is where transduction of the organism solely involves:

No nucleic acid template being added to the cell to guide genome repair, following site-directed nuclease application such as CRISPR/Cas9, zinc finger nucleases, meganucleases and TALENs?

And

No other traits from gene technology are expressed (e.g. cas9 transgene, expressed site-directed nuclease)?

Research Leaders must still submit a GMO Dealing application to the IBC when conducting SDN1 dealings.

However, SDN1 applications are truncated to only include basic details of the dealing.

'A GMO Dealing application must still be submitted for SDN1 dealings.'

Reporting Unintentional Release

Immediate and Serious Danger

If there is an immediate and serious danger of infection, serious harm or escape of a PC1 or PC2 Genetically Modified Organism, then you should:

  • Establish an exclusion zone until the immediate danger is contained
  • Utilise the spills kit and/or spills control team
  • Dispose of waste in accordance with AS/NZS 2243.3:2010 and the OGTR Guidelines

As soon as possible notify the:

  • Senior Facility Manager
  • University Biosafety Officer and Executive Officer of the IBC: biosafety@unisa.edu.au
  • Research Leader
  • People, Talent and Culture by completing an online Incident Report form within 12 hours: Report a Hazard or Incident

Potential Breach of Compliance

Contact your manager and/or biosafety@unisa.edu.au.

Further Information

Application Forms

  1. Exempt and Notifiable Low Risk Dealings: 

     Application Form - Exempt, NLRD or DNIR 

    A guideline for classifying GM retroviral dealings and suggestions for how to complete an NRLD application form for retroviral dealings.

        Amendment Application Form

    Major modifications require a complete new application. Examples of acceptable minor modifications include changes to personnel, facilities of the same or lower containment level, storage, transport or disposal. 

  2. Dealings Not Involving Intentional 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. 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.

    Application for licence for dealings with a GMO not involving intentional release of the GMO into the environment (DNIR) (OGTR website) 

  3. Dealings Involving Intentional 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. 

    Application for licence for dealings with a GMO involving intentional release of the GMO into the environment (DIR) (OGTR website)

Before seeking signatories, submit the application forms to biosafety@unisa.edu.au for an initial review.

Timelines

If concerned about the length of time taken to approve an application, please contact biosafety@unisa.edu.au.

Transportation, Storage and Disposal

Any proposed transportation, storage and disposal of GMOs is considered an aspect of a dealing and requires approval by the IBC. The Guidelines for these aspects are covered in the OGTR Guidelines for the Transport, Storage and Disposal of GMOs.

Interstate and International Transport of GMOs

Interstate and international transport of GMOs involves air transport and as such must comply with International Air Transport Association, OGTR, Civil Aviation Safety Authority and United Nation regulations.

For further information on importing and exporting biologicals, including GMOs, see our Importing and Exporting Biologicals page.

Viral Vectors

OGTR Guidance on Viral Vector Classification (PDF)

UniSA Guidance for Viral Vector Project GM Classification (PDF)

Current List of PC2 Facilities

The list of current PC2 facilities, includes the names of signatories which are required for a GMO dealing application.

Importing GMOs

Permission to import GMOs will be granted by the IBC or the OGTR through a standard application. However, for further information see the UniSA Importing page and the OGTR website for Importation Requirements.

Policies and Guidelines

University of South Australia Biosafety Manual

The manual summarises the operation of the University's biosafety management system.

Academic Unit/Institute/Centre Specific Biosafety Guidelines

See your Research Leader or facility manager for a copy of these guidelines.

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

Electronic copies can be accessed through the UniSA Library.

Recommended way to find the Standards:

  • Go to the UniSA Library webpage and find the A-Z Databases list, Library Database T
  • Select Techstreet: Standards Australia.
  • Under 'View Online', Select “Sign In”  
  • Sign in with your UniSA staff or student username and password
  • Select Techstreet Enterprise
  • Login to the standards with your UniSA login
  • Search for AS/NZS 2243.3

Gene Technology Act

Gene Technology Act is available through the OGTR website.

The University of South Australia is an accredited organisation under the Act.

In addition to the Act, the OGTR stipulates Regulations and Guidelines which must also be adhered to.

Other Useful links

UniSA Support

  • UniSA Biosafety Officer and IBC: biosafety@unisa.edu.au (Ph. 830 23723)
  • Animal Facility Biosecurity: brigitt.hines@unisa.edu.au
  • Cell Sorting Facility Manager: Bradley.Chereda@unisa.edu.au
  • Principal Investigator of your project
  • Your Senior Facility Manager
  • Your Operations/General Manager
  • Safety and Wellness: Jenny.Hardy@unisa.edu.au

 

Biosafety Training For Working with GMOs

It is the responsibility of Research Leaders and Facility Managers to ensure they and the staff and students directly under their supervision, are adequately trained to manage GMOs.

Training should include:

  • laboratory induction,
  • online Biosafety 1 training module
  • reading and understanding the Gene Technology Guidelines for transport, storage and disposal,
  • high risk procedure, face-to-face competence confirmed training,
  • spills training,
  • attendance of the Biosafety Information Day at least once every three years,
  • reading and understanding of the Academic Unit laboratory biosafety manual
  • reading and understanding the GMO application or licence

Research & Innovation Services and the IBC offer training program support. For support and further information contact: biosafety@unisa.edu.au