Commonwealth Numbered Regulations

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Dealings exempt from licensing

(regulation 6)

Subregulation 6 (1) sets out other requirements for exempt dealings.

Part 1 Exempt dealings


Description of dealing


Any dealing with gene-knockout mice (that is, mice whose genetic modification involves deletion or inactivation of a specific gene), if no advantage is conferred on the adult animal:

(a) by the deletion or inactivation of the gene concerned; or
(b) for mice that also carry a selectable marker gene — by the selectable marker gene.


Any dealing with a whole animal, if:

(a) naked recombinant nucleic acid has been introduced into its somatic cells; and
(b) the introduced nucleic acid is incapable of giving rise to infectious agents.


Any dealing with an animal into which genetically modified somatic cells have been introduced, unless the cells:

(a) are capable of giving rise to recombinant infectious agents; or
(b) contain viral sequences that could recombine with, or be complemented by, genomes of introduced superinfecting viruses.


Any dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 10 litres of GMO culture , if:

(a) the donor DNA:
(i) is not derived from micro-organisms capable of causing disease in human beings, other animals, plants or fungi, or is fully characterised and will not increase the virulence or host range of the host or vector; and
(ii) is not an oncogene; and

(iii) does not code for a toxin for vertebrates with an LD50 of less than 100 µg/kg; and
(iv) does not code for a toxin for vertebrates with an LD50 of 100 µg/kg or more, if the intention is to express the toxin at high levels; and
(v) is not uncharacterised DNA from a micro-organism that produces toxins with an LD50 of 100 µg/kg or less; or

(b) the donor DNA includes a viral sequence or viral sequences, but:
(i) is missing at least 1 gene essential for viral multiplication that is not available in the cell into which the DNA is introduced and that will not become available through subsequent breeding; and
(ii) is incapable of complementing a defect in the host/vector system.


Any dealing involving shot-gun cloning of mammalian DNA in a host/vector system mentioned in Part 2 of this Schedule.

Part 2 Host/vector systems for exempt dealings







Escherichia coli K12 or E coli  B - any derivative that does not contain:

(a) conjugative or generalised transducing phages; or
(b) genes able to complement the conjugation defect in a non-conjugative plasmid

1. Non-conjugative plasmids
2. Bacteriophage

(a) lambda
(b) lambdoid
(c) Fd or F1 (eg M13)


Bacillus subtilis or B licheniformis - an asporogenic strain with a reversion frequency of less than 10 -7

Plasmids and phages whose host range does not include B . cereus , B. anthracis or any other pathogenic strain of bacillus


Pseudomonas putida - strain KT 2440

Certified plasmids: pKT 262, pKT 263, pKT 264


Streptomyces - specified species:

(a) S. coelicolor
(b) S. lividans
(c) S. parvulus
(d) S. griseus

1. Certified plasmids: SCP2, SLP1, SLP2, PIJ101 and derivatives
2. Actinophage phi C31 and derivatives


Neurospora crassa - laboratory strains

All vectors

Pichia pastoris

All vectors

Saccharomyces cerevisiae

All vectors

Schizosaccharomyces pombe

All vectors

Kluyveromyces lactis

All vectors

Trichoderma reesei

All vectors

Slime moulds

Dictyostelium species

Dictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2

Tissue culture

Mammalian (including human) cells and cells of aquatic organisms

Non-viral vectors or defective viral vectors (including retrovirus or retroviral-helper combinations that cannot infect human cells)

Avian cells

Avipoxvirus vectors (attenuated vaccine strains)

Plant cell cultures

Non-tumorigenic disarmed Ti plasmid vectors in Agrobacterium tumefaciens and non-pathogenic viral vectors

Insect cell cultures, such as Spodoptera frugiperda , if the recombinants are also inclusion-negative (eg polyhedrin minus)

Baculovirus ( Autographa californica nuclear polyhedrosis virus), polyhedrin minus


Any host mentioned, or of a kind mentioned, in any of items 1 to 4

Any non-biological vector (for example, electrocorporation or particle bombardment)

Part 3 Definitions
In this Schedule:

"advantage", in relation to an adult animal that is genetically modified, means a superior ability in its modified form, relative to the unmodified parental organism, to survive, reproduce or otherwise contribute to the gene pool.

"characterised", in relation to DNA, means that the DNA has been sequenced and that there is an understanding of potential gene products of the DNA.

"code for", in relation to a toxin, means to specify the amino acid sequence of the toxin.

"inclusion-negative", in relation to a recombinant of insect cell cultures, means the vector baculovirus used is in a mutant form that is unable to make polyhedrin (a material surrounding a virus and protecting it from adverse environmental effects such as UV radiation).

"recombinant", in relation to matter that is a sequence or an organism, means matter of that kind containing recombinant DNA (that is, DNA formed by joining, in vitro , segments of DNA from different organisms).

"shot-gun cloning", in relation to mammalian DNA, means the production of a large random collection of cloned fragments of the DNA from which genes of interest can later be selected.

"toxin producing organism" means an organism producing toxin with an LD50 of less than 100 µg/kg.

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