The following information is taken from the Gene Technology Regulations 2001
(as amended 8 October 2019).
The following do not fall under the Gene Technology Regulations and OGTR approval is not required.
Schedule 1A: techniques that are not gene technology
There are some simple steps that you can follow to find out the type of approval you need for your work with a genetically modified organism (GMO):
- Somatic cell nuclear transfer, if the transfer does not involve genetically modified material
- Electromagnetic radiation-induced mutagenesis
- Particle radiation-induced mutagenesis
- Chemical-induced mutagenesis
- Fusion of animal cells, or human cells, if the fused cells are unable to form a viable whole animal or human
- Protoplast fusion, including fusion of plant protoplasts
- Embryo rescue
- In vitro fertilisation
- Zygote implantation
- A natural process, if the process does not involve genetically modified material. Examples of natural processes include conjugation, transduction, transformation and transposon mutagenesis.
- Introduction of RNA into an organism, if:
- the RNA cannot be translated into a polypeptide; and
- the introduction of the RNA cannot result in an alteration of the organism's genome sequence; and
- the introduction of the RNA cannot give rise to an infectious agent.
Schedule 1: organisms that are not GMOs
- A mutant organism in which the mutational event did not involve the introduction of any foreign nucleic acid (that is, non-homologous DNA, usually from another species).
- A whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents.
- Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell.
- An organism modified by repair of single-strand or double-strand breaks of genomic DNA induced by a site-directed nuclease, if a nucleic acid template was not added to guide homology-directed repair.
- there is no item 5
- An organism that results from the exchange of DNA if:
- the donor species is also the host species; and
- the vector DNA does not contain any heterologous DNA.
- An organism that results from an exchange of DNA between the donor species and the host species if:
- such an exchange can occur by naturally occurring processes; and
- the donor species and the host species are micro-organisms that:
- satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 1; and
- are known to exchange nucleic acid by a natural physiological process; and
- the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange.
- An organism that is descended from a genetically modified organism (the initial organism), if none of the traits it has inherited from the initial organism are traits that occurred in the initial organism because of gene technology.
- An organism that has inherited particular traits from an organism (the initial organism) being traits that occurred in the initial organism because of gene technology, if:
- The initial organism was not a genetically modified organism (because of the application of regulation 5), or
- all such inherited traits are traits that occurred in the initial organism as a result of a modification described in an item in this Schedule.
- An organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are no longer present.
- Agrobacterium radiobacter stain K1026.
- Pasteurella multocida stain PMP1.
Schedule 1B: organisms that are GMOs
- An organism that has had its genome modified by oligonucleotide directed mutagenesis
- An organism modified by repair of single strand or double strand breaks of genomic DNA induced by a site directed nuclease, if a nucleic acid template was added to guide homology directed repair