Techniques and organisms listed in Schedule I, IA and 1B

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 or IBC approval is not required if your technique or organism is listed.

Schedule 1A: Techniques that are not gene technology

1. Somatic cell nuclear transfer, if the transfer does not involve genetically modified material
2. Electromagnetic radiation-induced mutagenesis
3. Particle radiation-induced mutagenesis
4. Chemical-induced mutagenesis
5. Fusion of animal cells, or human cells, if the fused cells are unable to form a viable whole animal or human
6. Protoplast fusion, including fusion of plant protoplasts
7. Embryo rescue
8. In vitro fertilisation
9. Zygote implantation
10. A natural process, if the process does not involve genetically modified material (Examples of natural processes include conjugation, transduction, transformation and transposon mutagenesis.)
11. Introduction of RNA into an organism, if:
    1. the RNA cannot be translated into a polypeptide; and
    2. the introduction of the RNA cannot result in an alteration of the organism's genome sequence; and
    3. the introduction of the RNA cannot give rise to an infectious agent

Schedule 1B: Organisms that are genetically modified organisms

An organism is a genetically modified organism if an item listed below applies to the organism.

1. An organism that has had its genome modified by oligonucleotide-directed mutagenesis
2. 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

Schedule 1: Organisms that are not genetically modified organisms

1. 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).
2. 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.
3. Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell.
4. An organism modified by repair of single-strand or double-strand of genomic DNA induced by a site-directed nuclease, if a nucleic acid template was added to guide homology-directed repair
5. there is no item 5
6. An organism that results from an exchange of DNA if:
   1. the donor species is also the host species; and
   2. the vector DNA does not contain any heterologous DNA.
7. An organism that results from an exchange of DNA between the donor species and the host species if:
   1. such an exchange can occur by naturally occurring processes; and
   2. the donor species and the host species are micro-organisms that:
      1. satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 1; and
      2. are known to exchange nucleic acid by a natural physiological process; and
   3. the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange.
8. 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.
9. 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:
   1. the initial organism was not a genetically modified organism (because of the application of an item listed in this Schedule); or
   2. all such inherited traits are traits that occurred in the initial organism as a result of a modificaiton described in an item in this Schedule.
10. 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.
11. Agrobacterium radiobacter strain K1026.
12. Pasteurella multocida strain PMP1.

Contact OREI if you require further advice about the classification of your work.