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The objective of these Regulations is to prescribe those matters that are—
required or permitted by the Gene Technology Act 2001 to be prescribed; and
necessary or convenient to be prescribed for carrying out or giving effect to that Act.
Note
This regulation differs from regulation 1 of the Commonwealth Regulations.
These Regulations are made under section 193 of the Gene Technology Act 2001.
Note
This regulation does not appear in the Commonwealth Regulations.
These Regulations come into operation on 29 August 2021.
The following regulations are revoked—
the Gene Technology Regulations 2011[1];
the Gene Technology Amendment Regulations 2016[2];
the Gene Technology Amendment Regulations 2019[3].
Note
This regulation does not appear in the Commonwealth Regulations.
In these Regulations—
Act means the Gene Technology Act 2001;
Note
This definition differs from the definition of Act in regulation 3 of the Commonwealth Regulations.
advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool;
animal includes every kind of organism in the animal kingdom, including non-vertebrates but not including human beings;
characterised means—
in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or
in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of—
potential gene products or potential functions of the gene or genomic region; and
the likely effect of the genetic modification on the gene products or functions;
code for, for Schedule 2, has the meaning given in Part 3 of that Schedule;
Commonwealth Regulations means the Gene Technology Regulations 2001 of the Commonwealth;
Note
This definition does not appear in regulation 3 of the Commonwealth Regulations.
expert adviser means—
in Part 4—an expert adviser appointed under section 102(1) of the Commonwealth Act; and
in Part 5—an expert adviser appointed under section 112(1) of the Commonwealth Act;
genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology;
genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology;
genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology;
genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology;
host/vector system has a meaning affected by clause 2.1(3) of Schedule 2;
infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host;
inspector means a person appointed by the Regulator under section 150 of the Act as an inspector;
known means known within the scientific community;
non‑conjugative plasmid, for Schedule 2, has the meaning given in Part 3 of that Schedule;
non‑vector system has the meaning given in Part 3 of Schedule 2;
nucleic acid means either, or both, deoxyribonucleic acid (DNA), or ribonucleic acid (RNA), of any length;
oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least one of the following—
defects in DNA proofreading and repair;
defects in chromosome maintenance;
defects in cell cycle checkpoint mechanisms;
uncontrolled cell proliferation;
resistance to apoptosis;
cellular immortalisation;
packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions;
pathogenic, in relation to an organism, means having the capacity to cause disease or abnormality;
pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality;
physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities;
plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell;
shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected;
toxin means a substance that is toxic to any vertebrate;
toxin‑producing organism means an organism producing toxin with an LD50 of less than 100 micrograms per kilogram;
transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.
Note
Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example—
• accredited organisation
• deal with
• environment
• Ethics and Community Committee
• facility
• Gene Technology Technical Advisory Committee
• GMO
• Institutional Biosafety Committee
• intentional release of the GMO into the environment (see section 11)
• notifiable low risk dealing
• Regulator.
In order to maintain consistent numbering between these Regulations and the Commonwealth Regulations—
if the Commonwealth Regulations contain a regulation that is not required in these Regulations, the regulation number and heading to the regulation appearing in the Commonwealth Regulations are included in these Regulations despite the omission of the body of the regulation; and
if these Regulations contain a regulation that is not included in the Commonwealth Regulations, the regulation is numbered so as to maintain consistency in numbering between regulations common to both Regulations.
A regulation number and heading referred to in subregulation (1)(a) form part of these Regulations.
Notes
Notes do not form part of these Regulations.
Note
This regulation does not appear in the Commonwealth Regulations.
For the purposes of paragraph (c) of the definition of gene technology in section 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in section 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in section 10(1) of the Act, an organism is not a genetically modified organism if—
one or more items of Schedule 1 apply to the organism; and
the organism has not been modified by gene technology except for any modifications described in those items; and
the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 of Schedule 1; and
none of the items of Schedule 1B apply to the organism.
Note to reg. 5A substituted by S.R. No. 51/2025 reg. 4.
Note
Regulation 5A of the Commonwealth Regulations sets out the Regulator's functions of—
making inspectors available to be appointed as inspectors under the National Health Security Act 2007 of the Commonwealth; and
making inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
For the purposes of section 32(3) of the Act, a dealing, in relation to a GMO, is an exempt dealing if—
it is a dealing of a kind referred to in Part 1 of Schedule 2; and
it does not involve a genetic modification other than a modification described in Part 1 of Schedule 2; and
it does not involve an intentional release of the GMO into the environment.
For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.
Notes
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