Essential Elements of the Act

The Gene Technology Act (2000)

1. Establishes a Statutory Officer:

    Dr Sue Meek is the appointed Commonwealth's Gene Technology Regulator (the
    Regulator) to administer the legislative scheme.

    The Office of the Gene Technology Regulator (OGTR) is within the Commonwealth
    Department of Health and Ageing and provides administrative support to the Regulator.

2. Establishes Three Gene Technology Committees:

• The Gene Technology Technical Advisory Committee (GTTAC)
• The Gene Technology Community Consultative Committee (GTCCC)
• The Gene Technology Ethics Committee (GTEC)

3. Registers ALL dealings with GMOs into one of the following categories:

• An exempt dealing - a dealing with GMOs which poses a very low risk, e.g. contained research involving a very well understood process for creating and studying a GMO. For example, any dealing with gene-knockout mice, if no advantage is conferred on the adult animal:
   
  i)  by the deletion or inactivation of the gene concerned; or
  ii) for mice that also carry a selectable marker gene - by the selectable marker gene.

Other than listing in the Regulations, the only legislative requirement for exempt dealins is that they must not involve an intentional release of a GMO into the environment.

• Notifiable low risk dealings (NLRDs) - a dealing with GMOs which are low risk. Regulations requirements that the specified dealings be undertaken only in certified contained facilities (at least PC2 Standard), overseen by Institutional Biosafety Committees (IBCs) 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.  
  
  i)  involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and
  ii) does not involve gene-knockout mice.
   
• Register of GMOs - the regulator can initiate placement of GMOs onto the GMO register. This will occur when GMOs have been licensed for a certain period of time and their usage is considered safe without requiring a licence.
   
• Licensed Dealings - All dealings with GMOs not classified into the above categories, or on the GMO register, require a licence.
  There are two types:
  
  i)  DNIRs - dealings not involving intentional release of a GMO into the environment (typically laboratory-based research projects); and
  ii) DIRs - dealings involving intentional release of a GMO into the environment.  

4. Establishes a scheme to assess the risks to human health and the environment associated
    with various dealings.

5. Provides for monitoring and enforcement of the legislation.

6. Creates a publicly available database on GMOs and GM products in Australia, unless a
    declaration indicates that specified information is commercial confidential information
    (CCI).