To include a dealing with a genetically modified organism (GMO) on the Register, the Gene Technology Regulator must:
- clearly define the dealing with the GMO
- clearly describe any condition that relates to the dealing
- be satisfied that any risks posed by the dealing are minimal.
Importantly, the Regulator must be satisfied that the dealings are safe enough to be undertaken by anyone without the need for a licence.
The only eligible dealings are those that:
- have been authorised by a GMO licence, or
- involve a genetically modified product declared to be a GMO under the Regulations.
Requirements for the GMO Register are detailed in sections 76 to 79 of the Gene Technology Act 2000.
Process for adding a dealing with a GMO to the GMO Register
If you want to add your dealings to the GMO Register, contact us to discuss what information you need to provide.
- Application submitted or process initiated by the Regulator.
- Confirm dealing authorised under a GMO licence or a GM product declared a GMO.
- Prepare Risk Assessment & Risk Management Plan (RARMP).
- Public notification of application, consult on RARMP.
- Prepare final RARMP.
- Regulator assesses if risk is minimal (does not require a licence to protect health and environment).
- Dealing included on the GMO Register.
- Licence holder may apply to surrender licence.
Assessing the level of risk
The Regulator looks at a range of information to decide whether they are satisfied that the dealings pose minimal risk, including:
- any available reports of adverse effects from the dealing
- 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.
We prepare a Risk Assessment and Risk Management Plan (RARMP) that considers all of the above. We gather information for the RARMP 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
- any information about adverse effects provided by any other person
- information provided by the applicant (licence holder) 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 other regulators, locally or globally
- information from scientific papers and databases about any adverse effects of the GMO, or its parent species, on people or the environment.
If the risk estimates for identified risks are low or negligible, that may satisfy the Regulator.
Consulting on the risk
The Regulator makes the RARMP available online, and invites comments from:
- the general public
- relevant government agencies
- state and territory governments
- the Gene Technology Technical Advisory Committee
- other experts.
When preparing the final RARMP, the Regulator considers any relevant information received. The Regulator uses the RARMP to decide whether the dealing is safe enough for anyone to conduct without a licence, and to include it on the register.
Making a determination
The Regulator’s decision to include a dealing with a GMO on the GMO Register is known as a determination.
Once the dealing is included on the register, no licence is required to conduct the dealing. The licence holder can then apply to the Regulator to surrender the GMO licence.
If the Regulator does not make a determination, then the dealing is not included on the register. This is usually because the Regulator decides that the dealing:
- poses more than a minimal risk
- requires a licence in order to manage the risk.
When there is no determination, any licence authorising the dealing remains in force and only people authorised under the licence can conduct the dealing.
There is no statutory time frame for making a decision.