Every dealing with a GMO needs to be licensed by the Regulator, unless the dealing is an exempt dealing, a Notifiable Low Risk Dealing (NLRD), on the GMO Register or specified in an Emergency Dealing Determination (EDD).
Section 31 of the Act prohibits dealings with GMOs unless it is:
- an exempt dealing
- a notifiable low-risk dealing (NLRD)
- authorised by a licence
- included on the GMO Register
- specified in an emergency dealing determination (EDD).
Table: Classes of GMO dealings under the Gene Technology Act 2000
|Exempt||No||No intentional release to the environment|
|NLRD||No, dealings must be assessed by IBC; notified in annual report||Yes|
PC1 or PC2 (usually)
|DNIR||Yes, applications must be reviewed by IBC; RARMP prepared and licence decision by the Regulator||Yes|
≥ PC2 (usually) and other conditions will apply
(except for limited and controlled releases)
|Yes, applications must be reviewed by IBC; consultation on application, RARMP prepared, consultation on RARMP and licence decision by the Regulator||Containment measures may be required, determined on a case-by-case basis, and other licence conditions will apply|
(limited and controlled)
|Yes, applications must be reviewed by IBC; RARMP prepared, consultation on RARMP and licence decision by the Regulator||Containment measures will be required based on size/scope of release sought by applicant; and other licence conditions will apply|
|Inadvertent dealing||Yes, licence decision by the Regulator only for the purposes of disposal of |
|Containment and/or disposal measures will apply|
|GMO Register||No, but must be previously licensed;|
review of related RARMPs
|Containment measures may be required|
|EDD||No, determination by the minister, subject to advice of threat and utility of GMO from competent authorities and risk assessment advice from the Regulator||Containment and/or disposal measures may be included in EDD conditions|
Notes: DIR = dealings involving intentional release; DNIR = dealings not involving intentional release; EDD = emergency dealing determination; GMO = genetically modified organism; IBC = Institutional Biosafety Committee; NLRD = notifiable low-risk dealing; PC = physical containment; RARMP = risk assessment and risk management plan.
Exempt dealings and NLRDs are not considered to pose risks that require direct scrutiny by the Regulator in the form of case-by-case risk assessment. These kinds of dealings are routine laboratory techniques involving GMOs that have been used safely for many years or pose minimal risks when performed in contained conditions.
The Regulator may issue three types of licences under the Act, namely:
- dealings not involving intentional release (DNIR)
- dealings involving intentional release (DIR), or
- inadvertent dealings.
The Act states that the Regulator must prepare a risk assessment and risk management plan (RARMP) for all DIR and DNIR applications, as part of the process of making a decision on whether to issue a licence (sections 47 and 50).
The Act (Part 5) allows the Regulator to grant a temporary licence to a person inadvertently dealing with an unlicensed GMO for the purpose of disposing of the GMO. This does not require preparation of an RARMP before issuing the licence (section 49).
Dealings on the GMO Register (Part 6, Division 3 of the Act) are dealings that have been authorised by a licence previously, have a history of safe use, and no longer require a licence from the Regulator to protect the health and safety of people or the environment.
The minister may issue an EDD to exempt specified dealings from the licensing requirements for a limited period, where the GMO is likely to address an actual or imminent threat to the health and safety of people or to the environment, and any risks associated with using the GMO for that purpose could be adequately managed.
A representation of the classes of dealings, outlining the predetermined management conditions (such as containment), which are based on the level of risk, is set out in the above Table.