Dealings involving intentional release of a GMO
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.
The Regulator has issued some DIR licences 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.
Dealings not involving intentional release of a GMO
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
- 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).
The Australian Government minister responsible for gene technology can expedite the approval of dealings with a GMO in an emergency.
An Emergency Dealing Determination (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.
Human clinical trials
The type of approval required for a clinical trial depends on the nature of the GMO and its likely fate once introduced into the trial participant. Clinical trials where researchers remove patient cells, genetically modify them and replace them may not need a licence if they meet specific requirements.
Clinical trials involving any other type of GMO will need a licence. If trial participants can shed, excrete or transmit the GMO, or if the method of administration results in release of the GMO, the trial needs a DIR licence. Otherwise, the trial needs a DNIR licence. There is a single application form for both types of licence.
For more information, see our guidance for conducting clinical trials with GMOs. If you are not sure about the appropriate category, get help from us before submitting an application.
Notifiable low-risk dealings
A notifiable low risk dealing (NLRD) is an activity with GMOs that is:
- undertaken in containment, in an appropriate 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 organisation meets certain risk management conditions.
An Institutional Biosafety Committee (IBC) must assess a dealing as an NLRD before it can be undertaken.
Details of NLRDs are publicly available in the GMO record.
Conducting the dealings
You must conduct NRLDs:
- as described in the IBC Record of Assessment (RoA)
- using people with appropriate training and experience
- within a facility specified in the RoA.
You must transport, store and dispose of GMOs according to the Regulator’s guidelines. The Regulator may specifically approve alternate conditions for a particular NLRD.
An NLRD RoA is only valid for 5 years. Each dealing must be assessed every 5 years to ensure they still meet the requirements to be conducted as an NLRD.
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, need an authorisation.
The Gene Technology Act 2000 (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 for 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.
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. Parliament updates the list 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.
We do not list exempt dealings on the GMO Record.
Parliament enters dealings with a GMO 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.
We can classify dealings with viral vectors 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 editing and RNA interference
Whether or not organisms modified using gene editing or RNA interference are GMOs depends upon the specific technique used. The Regulator has developed an overview of the status of organisms modified using gene editing and other new technologies.
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.