Commonwealth-State Regulation Impact Statement – Department of Health
On 20 July 2021, the Gene Technology Ministers’ Meeting (GTMM), considered a Decision Regulation Impact Statement (Decision RIS) and endorsed the preferred option to address key recommendations of the Third Review of the National Gene Technology Scheme.
The RIS assessed options for delivering a more flexible, streamlined and risk-based regulatory process that future-proofs the Scheme, enables efficiencies, and relieves regulatory burden.
Three potential regulatory options for improving the authorisation pathways for dealing with Genetically Modified Organisms (GMOs) were considered:
- Option A: Status Quo. The current authorisation pathways depend on whether the GMO dealings are “contained” or involve “intentional release of the GMO into the environment”, with the latter having higher oversight.
- Option B: Risk tiering model. The level of oversight is determined entirely by the level of indicative risk, taking into account matters such as the characteristics of the GMO, the type of dealings and whether effective risk management measures are known.
- Option C: Matrix model. The categorisation of GMO dealings in authorisation pathways depends firstly on the nature of the dealing (whether it is “contained”, involves “intentional release of the GMO into the environment”, or involves “clinical trials / medical applications”). After this first categorisation, dealings with GMOs are then classified in different authorisation pathways according to the level of indicative risk.
Option B was the recommended option.
The RIS was assessed by the Office of Best Practice Regulation as compliant with COAG Best Practice Regulation requirements.