Definitions

A

accredited organisation
means an organisation accredited in accordance with the Accreditation Guidelines issued by the Regulator

Act
means the Gene Technology Act 2000.
That is, Act No. 169 of 2000 as amended; the compilation prepared on 15 July 2011 taking into account amendments up to Act No. 58 of 2011.

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

ASNZS 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.

C

certify
if a facility meets the containment requirements specified in guidelines issued by the Regulator, the Regulator may certify the facility to a specified containment level

characterised
in relation to nucleic acid, means nucleic acid that has been sequenced and in respect of which there is an understanding of potential gene products or potential functions

code for
for Schedule 2, has the meaning given in Part 3 of that Schedule: in relation to a toxin, means to specify the amino acid sequence of the toxin

confidential commercial information
means information declared by the Regulator to be confidential commercial information. A person may apply to the Regulator for a declaration that specified information is confidential commercial information for the purposes of the Act.

containment level
in relation to a facility, means the degree of physical confinement of GMOs provided by the facility, having regard to the design of the facility, the equipment located or installed in the facility and the procedures generally used within the facility

controls
in relation to restricting the dissemination or persistence of a GMO and its genetic material in the environment, and includes the following:

1. methods to restrict the dissemination or persistence of the GMO or its genetic material in the environment;
2. methods for disposal of the GMO or its genetic material;
3. data collection, including studies to be conducted about the GMO or its genetic material;
4. the geographic area in which the proposed dealings with the GMO or its genetic material may occur;
5. compliance, in relation to dealings with the GMO or its genetic material, with:
   (i) a code of practice issued under section 24; or
   (ii) a technical or procedural guideline issued under section 27

D

deal with
in relation to a GMO, is defined in the Act to mean;

1. conduct experiments with the GMO
2. make, develop, produce or manufacture the GMO;
3. breed the GMO;
4. propagate the GMO;
5. use the GMO in the course of manufacture of a thing that is not the GMO;
6. grow, raise or culture the GMO;
7. import the GMO;
8. transport the GMO;
9. dispose of the GMO;

and includes the possession, supply or use of the GMO, for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i).

E

emergency dealing determination
provides a system, by legislative instrument, under which the Minister can make determinations relating to dealings with GMOs in emergencies

environment
as defined in the Act includes:

1. ecosystems and their constituent parts; and
2. natural and physical resources; and
3. the qualities and characteristics of locations, places and areas.

Ethics and Community Committee
means the Gene Technology Ethics and Community Consultative Committee which will be established on 1 January 2008 unless proclaimed earlier and which will replace the current Gene Technology Ethics Committee and the Gene Technology Community Consultative Committee.
The function of the Ethics and Community Committee is to provide advice, on the request of the Regulator or the Ministerial Council, on the following:

1. ethical issues relating to gene technology;
2. the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs;
3. the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons;
4. the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products and the content of such principles, guidelines and codes;
5. community consultation in respect of the process for applications for licences covering dealings that involve the intentional release of a GMO into the environment;
6. risk communication matters in relation to dealings that involve the intentional release of a GMO into the environment;
7. matters of general concern identified by the Regulator in relation to applications made under this Act;
8. matters of general concern in relation to GMOs.

exempt dealing
means a dealing specified by the Regulations to be an exempt dealing

expert adviser means:

1. in Part 4 – an expert adviser appointed under subsection 102 (1) of the Act; and
2. in Part 5 – an expert adviser appointed under subsection 112 (1) of the Act.

F

facility
includes, but is not limited to, the following:

1. a building or part of a building;
2. a laboratory;
3. an aviary;
4. a glasshouse;
5. an insectary;
6. an animal house;
7. an aquarium or tank.

G

gene technology
means any technique for the modification of genes or other genetic material, but does not include:

1. sexual reproduction; or
2. homologous recombination; or
3. any other technique specified in the regulations for the purposes of this paragraph.

Gene Technology Community Consultative Committee (GTCCC)
The function of the Consultative Committee is to provide advice, on the request of the Regulator or the Ministerial Council, on the following:

1. matters of general concern identified by the Regulator in relation to applications made under this Act;
2. matters of general concern in relation to GMOs;
3. the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products and the content of such principles, guidelines and codes.

Gene Technology Ethics Committee (GTEC)
The function of the Ethics Committee is to provide advice, on the request of the Regulator or the Ministerial Council, on the following:

1. ethical issues relating to gene technology;
2. the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs;
3. the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons.

Gene Technology Technical Advisory Committee (GTTAC)
The function of the Gene Technology Technical Advisory Committee is to provide scientific and technical advice, on the request of the Regulator or the Ministerial Council, on the following:

1. gene technology, GMOs and GM products;
2. applications made under the Act;
3. the biosafety aspects of gene technology;
4. the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products, and the content of such principles, guidelines and codes.

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

genetically modified organism
means:

1. an organism that has been modified by gene technology; or
2. 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; or
3. anything declared by the Regulations to be a genetically modified organism, or that belongs to a class of things declared by the Regulations to be genetically modified organisms;
   
   but does not include:
4. a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
5. an organism declared by the Regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the Regulations not to be genetically modified organisms.

GMO
means a genetically modified organism

GMO licence
means a licence issued under the Act

GMO Record and GM Product Dealings
The purpose of the Record is to maintain a comprehensive record of all dealings in Australia that involve GMOs or GM products

GMO Register
means the GMO Register established under the Act
The Regulator may determine that certain dealings previously authorised by a licence be included on the GMO Register. If a dealing is included on the GMO Register, anyone may undertake the dealing, subject to any specified conditions.

GM product
means a thing (other than a GMO) derived or produced from a GMO

I

infectious agent
means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host

Institutional Biosafety Committee (IBC)
means a committee established as an Institutional Biosafety Committee in accordance with written guidelines issued by the Regulator under the Act

inspector
means a person appointed by the Regulator under section 150 of the Act as an inspector

intentional release
in relation to a GMO into the environment, for the purposes of the Act, means a dealing with a GMO involves the intentional release of the GMO into the environment if the GMO is intentionally released into the open environment, whether or not it is released with provision for limiting the dissemination or persistence of the GMO or its genetic material in the environment.

K

known
for the purposes of the Act, means known within the scientific community

L

licence holder
means the holder of a GMO licence - generally the holder of a licence is an Accredited Organisation. A licence can cover dealings by persons other than the licence holder. The licence holder is required to inform such persons of any conditions of the licence that apply to them.

limited and controlled release application
means an application for a licence for a dealing involving intentional release of a GMO into the environment under Section 50A of the Act

limits
in relation to the release of a GMO that is proposed to be authorised by a licence, includes limits on any of the following:

1. the scope of the dealings with the GMO;
2. the scale of the dealings with the GMO;
3. the locations of the dealings with the GMO;
4. the duration of the dealings with the GMO;
5. the persons who are to be permitted to conduct the dealings with the GMO.

N

non-conjugative plasmid
for Schedule 2, has the meaning given in Part 3 of that Schedule: means a plasmid that is not self-transmissible, and includes, but is not limited to, non-conjugative forms of the following plasmids:

1. bacterial artificial chromosomes (BACs);
2. cosmids;
3. P1 artificial chromosomes (PACs);
4. yeast artificial chromosomes (YACs).

non-vector system
for Schedule 2, has the meaning given in Part 3 of that Schedule: means a system in which donor nucleic acid is or was introduced into a host cell:

1. in the absence of a nucleic acid-based vector; or
2. using a nucleic acid-based vector in the course of a previous dealing and the vector is:
   1. no longer present; or
   2. present but cannot be remobilised from a host cell.

Example 1
A system mentioned in paragraph (a) might involve the use of electroporation or particle bombardment.

Example 2
A system mentioned in paragraph (b) might involve cells that were transduced with a replication defective retroviral vector in which no vector particles remain.

Notifiable Low Risk Dealing (NLRD)
a dealing with a GMO is a notifiable low risk dealing if:

1. it is a dealing of a kind mentioned in Part 1 of Schedule 3 or Part 2 of Schedule 3;
2. is not also a dealing of a kind mentioned in Part 3 of Schedule 3; and
3. it does not involve an intentional release of the GMO into the environment.

nucleic acid
means either, or both, deoxyribonucleic acid (DNA), or ribonucleic acid (RNA), of any length

O

OGTR
means the Office of the Gene Technology Regulator

oncogenic modification
means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:

1. defects in DNA proofreading and repair;
2. defects in chromosome maintenance;
3. defects in cell cycle checkpoint mechanisms;
4. uncontrolled cell proliferation;
5. resistance to apoptosis;
6. cellular immortalisation.

organism
means any biological entity that is:

1. viable; or
2. capable of reproduction; or
3. capable of transferring genetic material

out of session
for regulation 25, has the meaning given in subregulation 25 (4).

P

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

person covered by a GMO licence
means a person authorised by a GMO licence to deal with a GMO

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

premises
for the purposes of the Act includes the following:

1. a building;
2. a place (including an area of land);
3. a vehicle;
4. a vessel;
5. an aircraft;
6. a facility;
7. any part of premises (including premises referred to in paragraphs (a) to (f)).

R

Record
means the Record of GMO and GM Product Dealings

Regulations
means the Gene Technology Regulations 2001. Statutory Rules 2001 No. 106 as amended made under the Gene Technology Act 2000. The compilation prepared on 1 September 2011 taking into account amendments up to SLI 2011 No. 73.

Regulation
in relation to dealings with GMOs, means the prohibition of dealings with GMOs unless:

1. the person undertaking the dealing is authorised to do so by a GMO licence; or
2. the dealing is specified in an emergency dealing determination; or
3. the dealing is a notifiable low risk dealing; or
4. the dealing is an exempt dealing; or
5. the dealing is included in the GMO Register.

Regulator
means the Gene Technology Regulator

Risk Assessment and Risk Management Plan (RARMP)
The risk assessment undertaken by the OGTR in relation to the dealings proposed to be authorised by a licence. The RARMP, which is an extensive process, takes into account any risks to the health and safety of people or risks to the environment and the means for managing any risks posed by the dealing, with regard to the matters prescribed by the Regulations.

S

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

T

thing
includes a substance, and a thing in electronic or magnetic form

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 μg/kg

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