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These Regulations set out technical definitions, containment standards and administrative procedures for handling genetically modified organisms (GMOs) under the Gene Technology Act 2000. They tell laboratories, accredited organisations, Institutional Biosafety Committees (IBCs) and the Regulator which techniques and dealings are exempt, which are “notifiable low risk”, and what physical containment, record‑keeping and reporting steps are required. Mechanically they also fix decision timeframes, IBC reporting obligations and points where the Regulator may agree alternative arrangements (regs 6, 8, 13, Schedule 2).
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Direct links to the current provisions in Gene Technology Regulations 2001.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
These Regulations are the Gene Technology Regulations 2001.
In these Regulations:
Act means the Gene Technology Act 2000.
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.
AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
characterised means:
(a) 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
(b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:
(i) potential gene products or potential functions of the gene or genomic region; and
(ii) 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.
expert adviser means:
(a) in Part 4—an expert adviser appointed under subsection 102(1) of the Act; and
(b) in Part 5—an expert adviser appointed under subsection 112(1) of the 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 subclause 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 1 of the following:
(a) defects in DNA proofreading and repair;
(b) defects in chromosome maintenance;
(c) defects in cell cycle checkpoint mechanisms;
(d) uncontrolled cell proliferation;
(e) resistance to apoptosis;
(f) cellular immortalisation.
out of session, for regulation 25, has the meaning given in subregulation 25(4).
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.
For paragraph (c) of the definition of gene technology in subsection 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 subsection 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 subsection 10(1) of the Act, an organism is not a genetically modified organism if: (a) one or more items in Schedule 1 applies to the organism; and (b) the organism has not been modified by gene technology except for any modifications described in those items; and (c) 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 in Schedule 1; and (d) none of the items in Schedule 1B applies to the organism.
For the purposes of paragraph 27(l) of the Act, the Regulator has the following functions: (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007; (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
These Regulations are the Gene Technology Regulations 2001.
In these Regulations:
Act means the Gene Technology Act 2000.
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.
AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
characterised means:
(a) 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
(b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:
(i) potential gene products or potential functions of the gene or genomic region; and
(ii) 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.
expert adviser means:
(a) in Part 4—an expert adviser appointed under subsection 102(1) of the Act; and
(b) in Part 5—an expert adviser appointed under subsection 112(1) of the 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 subclause 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 1 of the following:
(a) defects in DNA proofreading and repair;
(b) defects in chromosome maintenance;
(c) defects in cell cycle checkpoint mechanisms;
(d) uncontrolled cell proliferation;
(e) resistance to apoptosis;
(f) cellular immortalisation.
out of session, for regulation 25, has the meaning given in subregulation 25(4).
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.
For paragraph (c) of the definition of gene technology in subsection 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 subsection 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 subsection 10(1) of the Act, an organism is not a genetically modified organism if: (a) one or more items in Schedule 1 applies to the organism; and (b) the organism has not been modified by gene technology except for any modifications described in those items; and (c) 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 in Schedule 1; and (d) none of the items in Schedule 1B applies to the organism.
For the purposes of paragraph 27(l) of the Act, the Regulator has the following functions: (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007; (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(1) For subsection 32(3) of the Act, a dealing, in relation to a GMO, is an exempt dealing if: (a) it is a dealing of a kind mentioned in Part 1 of Schedule 2; and (b) it does not involve a genetic modification other than a modification described in Part 1 of Schedule 2; and (d) it does not involve an intentional release of the GMO into the environment. (2) 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.
Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
Note 2: Exemption from provisions of the Act does not preclude the application of other Commonwealth and State laws.
Note: At the commencement of the Regulations, no application fee is prescribed under subsection 40(6) of the Act.
(1) For subsection 43(3) of the Act, the period within which the Regulator must issue, or refuse to issue, a licence is: (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or (b) for an application to which Division 4 of Part 5 of the Act applies: (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety o
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