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1

Either of the following transfers, if the transfer does not involve genetically modified material:

a) nuclear transfer

b) transfer of plastids or mitochondria

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 vitroÌýfertilisation.

9

Zygote implantation.

10

A natural process, if the process does not involve genetically modified material.

Examples
Examples of natural processes include conjugation, transduction, transformation and transposon mutagenesis.

11

Introduction of nucleic acid or nucleic acid analogue does not result in an alteration of the organism's genome sequence; and if:
Ìýa.Ìýthe introduction of the nucleic acid or nucleic acid analogue does not result in an alteration of the organism’s genome sequence; and
Ìýb.ÌýÌýthe introduction of the nucleic acid or nucleic acid analogue cannot give rise to an infectious agent; and
Ìýc.Ìýin the case of nucleic acid or nucleic acid analogue that is DNA – the DNA cannot be transcribed.

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.

1

(Item 1 repealed 8 October 2020)

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 breaks of genomic DNA induced by a site-directed nuclease, if a nucleic acid template was not added to guide homology-directed repair.

6

7

An organism that results from an exchange of DNA between the donor species and the host species if:
Ìýa.Ìýsuch exchange can occur by naturally occurring processes; and
Ìýb.Ìýthe donor species and the host species are micro-organisms that:
Ìý Ìý Ìýi.Ìýsatisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 1; and
Ìý Ìý ii.Ìýare known to exchange nucleic acid by a natural physiological process; and
Ìýc.Ìýthe 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 (theÌýinitial 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

10

An organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are either no longer present or are epigenetic.

11

Agrobacterium radiobacterÌýstrain K1026.

12

Pasteurella multocidaÌýstrain PMP1.

2

3

3A

4

(1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture.

(2) The donor nucleic acid:
Ìýa.Ìýmust meet either of the following requirements:
Ìý Ìý Ìýi.Ìýit must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy:
Ìý Ìý Ìý Ìý A.Ìýhuman beings;
Ìý Ìý Ìý Ìý B.Ìýanimals;
Ìý Ìý Ìý Ìý C.Ìýplants; or
Ìý Ìý Ìý Ìý D.Ìýfungi

Ìý Ìý ii. it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm*; and

Ìýb.Ìýmust not code for a toxin with an LD50 of less than 100 micrograms/kg; and
Ìýc.Ìýmust not code for a toxin with an LD50 of 100 micrograms/kg or more, if the intention is to express the toxin at high levels; and
Ìýd.Ìýmust not be uncharacterised nucleic acid from a toxin-producing organism; and
Ìýe.Ìýif the donor nucleic acid includes a viral sequence - cannot give rise to infectious agents when introduced into any potential host species, without additional non-host genes or gene products that:
Ìý Ìý i.Ìýare not available in the host cell into which the nucleic acid is introduced as part of the dealing; and
Ìý Ìýii.Ìýwill not become available during the dealing; and

Ìýf.Ìýif the donor nucleic acid includes a viral sequence - cannot restore replication competence to the vector.

* Example
Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in relation to the capacity of the host or vector to cause harm, it:
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility.

5

1

Bacteria

Ìý

2

Bacteria

Ìý

3

Bacteria

Pseudomonas putidaÌýstrain KT2440

Non-conjugative plasmids

4

Bacteria

Ìý

5

Bacteria

Disarmed Ri or Ti plasmids

6

Bacteria

Ìý

Non-conjugative plasmids

7

Fungi

Ìý

All vectors

8

Slime moulds

DictyosteliumÌýspecies

DictyosteliumÌýshuttle vectors, including those based on the endogenous plasmids Ddp1 & Ddp2

9

Tissue Culture

Any of the following if they cannot spontaneously generate a whole animal:
Ìýa.Ìýanimal or human cell cultures (including packaging cell lines)
Ìýb.Ìýisolated cells, isolated tissues or isolated organs, whether animal or human
Ìýc.Ìýearly non-human mammalian embryos culturedÌýin vitro

10

Tissue Culture

(a)

a dealing involving a genetically modified plant

a dealing involving a host/vector system not mentioned in paragraph 1.1(c) or Part 2 of Schedule 2, if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise healthy:
Ìý Ìýi.Ìýhuman beings; or
Ìý ii.Ìýanimals; or
Ìýiii.Ìýplants; or
Ìýiv.Ìýfungi;

a dealing involving a host/vector system not mentioned in Part 2 of Schedule 2, if:
Ìý Ìýi. the host or vector has been implicated in, or has a history of causing, disease in otherwise healthy:
Ìý Ìý ÌýA.Ìýhuman beings; or
Ìý Ìý ÌýB.Ìýanimals; or
Ìý Ìý ÌýC.Ìýplants; or
Ìý Ìý ÌýD. fungi; and

Ìý ii.Ìýthe genetic modification is characterised; and
Ìýiii.Ìýthe characterisation of the genetic modification shows that it is unlikely to increase the capacity of the host or vector to cause harm;

• provides an advantage; or
• adds a potential host species or mode of transmission; or
• increases its virulence, pathogenicity or transmissibility.

a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid:
Ìý Ìýi.Ìýis characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; or
Ìý ii.Ìýis uncharacterised nucleic acid from an organism that has been implicated in, or has a history of causing, disease in otherwise
Ìý Ìý ÌýA.Ìýhuman beings; or
Ìý Ìý ÌýB.Ìýanimals; or
Ìý Ìý ÌýC.Ìýplants; or
Ìý Ìý ÌýD.Ìýfungi;

a dealing involving complementation of knocked-out genes, if the complementation is unlikely to increase the capacity of the GMO to cause harm compared to the capacity of the parent organism before the genes were knocked out;

• provides an advantage; or
• adds a potential host species or mode of transmission; or
• increases its virulence, pathogenicity or transmissibility.

a dealing involving virions of a replication defective viral vector unable to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;

A kind of dealing that:
Ìýa.Ìýis a kind mentioned in clause 2.1; and
Ìýb.Ìýinvolves a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3

​â¶Ä‹â¶Ä‹must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 3 and that are appropriate for the dealings.

For the purposes of paragraph (1)(b), a genetically modified micro-organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro-organism satisfies those criteria.

However, subclause (2) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).

a dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the genetic modification confers an oncogenic modification or immunomodulatory effect in humans;

a dealing involving, as host or vector, a micro-organism, if:
Ìý Ìýi.Ìýthe micro-organism has been implicated in, or has a history of causing, disease in otherwise healthy:
Ìý Ìý Ìý A.Ìýhuman beings; or
Ìý Ìý Ìý B.Ìýanimals; or
Ìý Ìý Ìý C.Ìýplants; or
Ìý Ìý Ìý D.Ìýfungi; and

Ìý ii.Ìýnone of the following sub-subparagraphs apply:
Ìý Ìý Ìý A.Ìýthe host/vector system is a system mentioned in Part 2 of Schedule 2;
Ìý Ìý Ìý B.Ìýthe genetic modification is characterised and its characterisation shows that it is unlikely to increase the capacity of the host or vector to cause harm;
Ìý Ìý Ìý C.Ìýthe dealing is a dealing mentioned in paragraph 2.1 (g);

• provides an advantage; or
• adds a potential host species or mode of transmission; or
• increases its virulence, pathogenicity or transmissibility.

a dealing involving the introduction into a micro-organism, other than a host mentioned in Part 2 of Schedule 2, of genes whose expressed products are likely to increase the capacity of the micro-organisms to induce an autoimmune response;

a dealing involving use of a viral or viroid genome, or fragments of a viral or viroid genome, to produce a novel replication competent virus with an increased capacity to cause harm compared to the capacity of the parent or donor organism;

• an advantage; or
• a new potential host species or mode of transmissibility; or
• increased virulence, pathogenicity or transmissibility.

a dealing, other than a dealing mentioned in paragraph 2.1 (l) or (m), with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;

a dealing producing, in each vessel containing the resultant GMO culture, more than 25 litres of that culture, other than a dealing mentioned in paragraph 2.1 (f);

Ìý

a dealing involving a genetically modified pathogenic organism, if the practical treatment of any disease or abnormality caused by the organism would be impaired by the genetic modification;

a dealing involving a viral vector that can modify an organism capable of sexual reproduction, so that the sexual progeny of the organism are more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism).

Note: A modification that increases the likelihood of inheritance of a nucleotide sequence or sequences, as described in paragraphs (r) and (s), is generally known as an engineered gene drive.