About the approval process

GMO Register

The GMO Register is a list of activities (dealings) with approved genetically modified organisms. It contains dealings found to be safe enough to be done by anyone without the need for a licence. Find out more about the GMO Register.

The Gene Technology Act 2000 (the Act) details the requirements needed for the Gene Technology Regulator (the Regulator) to include a dealing with a genetically modified organism (GMO) on the GMO Register by legislative instrument. The Regulator's decision to include a dealing with a GMO on the GMO Register is known as a determination.

A dealing can only be included on the GMO Register if it has been authorised by a GMO licence; or it involves a GM product declared to be a GMO under the Gene Technology Regulations 2001 (the Regulations).

The Regulator must consider:

  • any data or other information about risks posed by the dealing;
  • whether there is a need for the dealing to be subject to conditions; 
  • any other information about whether the dealing should be authorised by a GMO licence.

The Regulator must be satisfied that:

  • any risks posed by the dealing are minimal; and
  • the dealings are safe enough to be undertaken by anyone without the need for a licence.

The Regulator must clearly:

  • define the dealing with the GMO and
  • describe any condition that relates to the dealing.

There is no statutory timeframe for making a determination to include a GMO dealing on the GMO Register.

Requirements for the GMO Register are detailed in sections 76 to 81 of the Act.

Adding a dealing with a GMO to the GMO Register

Contact us before applying to include a dealing on the GMO Register

  1. An application submitted by a licence holder or the process is initiated by the Regulator.
  2. Key criteria tested: was the dealing authorised under a GMO licence; or is it a GM product, but only because it was declared a GMO in the Regulations?
  3. The OGTR prepares a Risk Assessment and Risk Management Plan(RARMP) for public consultation. Information to inform the Regulator’s decision on whether the dealings pose minimal risk includes:
  • any available reports of adverse effects from the dealings
  • other information about potential risks with the dealing
  • whether there is a need for the dealing to be subject to conditions
  • whether to authorise the dealing with a GMO licence
  • any other information they consider relevant.

     Information is sourced from:

  • the RARMP prepared for any GMO licence authorising the dealing
  • any information about adverse effects provided by the licence holder (as required by their licence) or by any other person
  • information about how much of the GMO is present in Australia and overseas
  • any new information about the GMO provided by the applicant
  • any new information from various sources, including other regulators, locally or globally; and scientific papers and databases about any adverse effects of the GMO, or its parent species, on people or the environment.
  1. Public notification and consultation on the RARMP.

         The Regulator makes the RARMP available online and invites comments from the public,            relevant government agencies, state and territory governments, the Gene Technology                Technical Advisory Committee and other experts.

  1. The RARMP is finalised including incorporating any relevant information provided during consultation.
  2. Key criteria tested: the Regulator assesses if risk is minimal and a licence is not required to protect health and environment.

         If the risk estimates for identified risks are low or negligible, this may satisfy the                          Regulator.

  1. If these key criteria are not met, no determination is made to include the dealings on the GMO Register. The Regulator decides whether the dealings may continue under a licence including conditions that will manage the relevant risks. Only people covered by the licence are allowed to conduct the dealing.
  2. If there is minimal risk and no licence is needed, then the Regulator makes the determination to include the dealing on the GMO Register and notifies the Parliament.
  3. The licence may be surrendered.

Other considerations once a GMO dealing is on the Register

There is no formal review process for dealings included on the GMO Register, but the Regulator can review information about GMOs at any time. Furthermore, any person can report adverse experiences/effects resulting from any GMO to the OGTR – see the contact page on the OGTR Website for information. Any credible information would form the basis of further investigation by the Regulator.

The Regulator is able to make a variation to remove a dealing with a GMO from the Register, to revoke or vary conditions (if any) to which a dealing is subject, or to impose additional conditions to which a dealing is subject, if required.

The determination will have an OGTR identifier (Reg‑XXX), and this identifier can be cited as evidence that dealings with the GMO are currently authorised in Australia. For example, the GMO Register identifier can be used on import and export documentation.

For some GMOs, other agencies have oversight of specific aspects that are outside the scope of the Act. Examples include (but are not limited to): the Therapeutic Goods Administrator (TGA) regulates the use of GM therapeutics, Food Standards Australia New Zealand (FSANZ) sets standards for the sale of GMOs as human food, the Australian Pesticides and Veterinary Medicines Authority (APVMA) regulates GMOs with insecticidal compounds, IP Australia manages requirements for Plant Breeders Rights or patents, and the Department of Agriculture Fisheries and Forestry regulates biosecurity requirements related to import of GMOs.

 

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