How the legislation is used to regulate GMO dealings
The legislation regulates all dealings (for example: research, manufacture, production, transport, destruction, commercial release or import) with live and viable organisms that have been modified by gene technology.
This includes the progeny (or descendants) of GMOs which also share a genetically modified trait.
The legislation revolves around a system of, and process for, prohibitions and approvals.
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).
Here is more information about different types of approvals:
- Licences. All dealings with GMOs (that are not exempt, NLRDs or on the GMO Register) need to be licensed by the Regulator. The licensing system is based on rigorous scientific risk assessment and extensive consultation with expert advisory committees and government agencies—and for intentional releases of GMOs into the environment, the public.
- Exempt dealings. Certain types of dealings with GMOs involve a very low risk (i.e. contained research involving very well understood organisms and processes for creating and studying GMOs). Other than listing in the Regulations, the only legislative requirement for exempt dealings is that they must not involve an intentional release of a GMO into the environment.
- Notifiable Low Risk Dealings. The Regulations also set out categories of dealings with GMOs which are low risk and may proceed if certain conditions are observed, such as specified dealings only being undertaken in certified contained facilities, overseen by Institutional Biosafety Committees and notified annually to the Regulator. The conditions under which such dealings must be conducted are clearly set out in the regulations. An NLRD must not involve the intentional release of a GMO into the environment.
- GMO Register. Dealings with GMOs may be entered on the GMO Register once they have been licensed for a certain period of time. Dealings will not be entered onto the Register until the Regulator is satisfied that the dealings are safe enough that they can be undertaken by anyone, and that safety does not depend on oversight by a licence holder.
- Emergency Dealing Determination. The Minister may make an EDD authorising dealings with GMOs for a limited time in an emergency. The Minister must be satisfied that (a) there is an actual or imminent threat to people or the environment, (b) that the EDD would adequately address the threat and (c) that the risks posed are able to be managed to protect people and the environment. The Minister must receive advice from the Regulator about managing these risks.