The Gene Technology Act 2000 (the Act) prohibits all dealings with genetically modified organisms (GMOs) unless they are:
- an exempt dealing
- a notifiable low risk dealing (NLRD)
- included on the GMO Register
- an emergency dealing determination (EDD)
There are 3 types of GMO dealings that need a licence from the Gene Technology Regulator:
- dealings not involving intentional release (DNIR)
- dealings involving intentional release (DIR)
- inadvertent dealings.
You can view the details of approved dealings (except exempt dealings) on the GMO Record.
Exempt dealings are dealings with GMOs that pose a very low risk. They cannot involve any release of a GMO into the environment, such as field trials or commercial releases.
Schedule 2 of the Gene Technology Regulations 2001 lists dealings considered exempt. The list is updated during legislative reviews of the Regulations. Typically, this is due to a submission from an Institutional Biosecurity Committee (IBC).
Exempt dealings do not need a licence if the activity stays within specified criteria. Generally, an IBC will confirm if a dealing is exempt.
Exempt dealings are not listed on the GMO record.
Notifiable low risk dealings (NRLD)
A notifiable low risk dealing (NLRD) is an activity with GMOs that is:
- undertaken in containment, in a facility certified by the Regulator or approved in writing by the Regulator
- assessed as posing low risk to the health and safety of people and the environment provided certain risk management conditions are met.
Schedule 3 of the Gene Technology Regulations 2001 (the Regulations) specifies the types of dealings with GMOs classified as NLRDs.
An Institutional Biosafety Committee (IBC) must assess a dealing as an NLRD before it can be undertaken.
Dealings with a GMO may be entered on the GMO Register when:
- they have been licensed
- the Regulator is satisfied the dealings are sufficiently safe to be undertaken by anyone without the need for oversight by the licence holder.
Emergency dealing determination (EDD)
The Australian Government minister responsible for gene technology can expedite the approval of dealings with a GMO in an emergency.
An EDD has effect for up to 6 months unless extended by the minister.
The Gene Technology Ministers' Meeting has issued guidelines for emergency response under the Act.
Dealings not involving intentional release (DNIR)
A DNIR is a dealing not involving the intentional release of a GMO into the environment. These are dealings with GMOs in containment which do not meet the criteria for classification as exempt dealings or notifiable low risk dealings (NLRDs).
Dealings with a GMO licensed as a DNIR:
- must not involve release into the environment
- must be licensed by the Regulator.
Schedule 3, Part 3 of the Regulations describes which dealings with GMOs cannot be authorised by NLRDs. These dealings need to be authorised by DNIR licences.
DNIRs often involve genetically modified, disease-causing (pathogenic) organisms, or GMOs containing higher risk genes from pathogens or genes that:
- encode toxins
- confer a cancer-causing (oncogenic) modification or immuno-modulatory effect (changing the immune system).
Dealings involving intentional release (DIR)
A DIR is a dealing involving the intentional release of GMOs. These are dealings with GMOs which take place outside of containment. Most DIR licences issued have been for:
- experimental field trials of GM plants (limited and controlled releases)
- general/commercial releases of GM plants.
Some DIR licences have been issued for GMOs for medical or veterinary use, either for trial (limited and controlled release) or general/commercial release. The release of GM animals would also require a DIR licence.
It is possible to come into possession of a GMO without realising or intending to. If this happens, all further dealings with the GMO, including destruction, require an authorisation.
The Act provides for inadvertent dealings licences to facilitate the safe and legal disposal of a GMO.
The Regulator may treat a person as having made an inadvertent dealings application under section 40A of the Act, if:
- the Regulator is satisfied that the person came into possession of a GMO inadvertently
- the person agrees.
A person may also apply for a licence under section 40 of the Act in respect of an inadvertent dealing.
The Regulator may issue a temporary licence to the person. This is so the person can dispose of the GMO in a manner which protects the health and safety of people and the environment. Inadvertent dealings applications follow a simpler process than other application types.
The type of approval required for a trial depends on the nature of the GMO and its likely fate once introduced into the trial participant. Clinical trials where patient cells are removed, genetically modified and replaced may not need a licence if they meet specific requirements.
We have guidance for clinical trial sponsors.
If you are not sure about the appropriate category, get help from us before submitting an application.
Dealings with viral vectors can be classified in the DNIR, NLRD and Exempt categories. The Regulator has developed guidance on the classification of contained dealings with viral vectors.
The Regulator also has guidance for IBCs assessing NLRDs involving retroviral (including lentiviral) vectors, particularly in assessing whether:
- persons have the appropriate training and experience to undertake the dealings
- the facilities are appropriate for the dealings.
Gene drives are genetic elements that are favoured for inheritance. An organism that contains a gene drive due to gene technology will be a GMO. It will be subject to regulation under the Act.
Contained dealings with GMOs containing functional gene drives need a DNIR licence.
Dealings with viral vectors that can change an organism to produce an engineered gene drive also need a DNIR licence.
Containment requirements and facility certification
Some GMO dealings must not involve intentional release of GMOs into the environment. Generally, this means that they are undertaken in physical containment (PC) facilities. The Regulator may need to certify the facilities.
This table shows the containment requirements for each type of dealing.
No intentional release to the environment
PC1 or PC2 (usually)
≥ PC2 (usually) or appropriate clinical facilities, and other conditions will apply
|DIR (limited and controlled release)||Generally no containment measures, but confinement measures will be required based on size/scope of release sought by applicant; and other licence conditions will apply|
|DIR (except for limited and controlled release)||Generally no containment measures, but confinement measures may be required, determined on a case-by-case basis, and other licence conditions will apply|
|Inadvertent dealing||Containment and/or disposal measures will apply|
|GMO Register||Containment measures may be required|
|EDD||Containment and/or disposal measures may be included in EDD conditions|