Gene Technology Resources

A

Accredited organisation
The organisation accredited in accordance with the Accreditation Guidelines issued by the Regulator.

Act
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
Relates 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
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.

B

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
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: in relation to a toxin, means to specify the amino acid sequence of the toxin.

Confidential commercial information
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, Dealings
In relation to a GMO, is defined in the Act to mean:
a. conduct experiments with the GMO;
b. make, develop, produce or manufacture the GMO;
c. breed the GMO;
d. propagate the GMO;
e. use the GMO in the course of manufacture of a thing that is not the GMO;
f. grow, raise or culture the GMO;
g. import the GMO;
h. transport the GMO;
i. 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
Defined in the Act includes:
a. ecosystems and their constituent parts; and
b. natural and physical resources; and
c. the qualities and characteristics of locations, places and areas.

Ethics and Community Committee
The Gene Technology Ethics and Community Consultative Committee 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:
a. ethical issues relating to gene technology;
b. the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs;
c. the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons;
d. 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;
e. community consultation in respect of the process for applications for licences covering dealings that involve the intentional release of a GMO into the environment;
f. risk communication matters in relation to dealings that involve the intentional release of a GMO into the environment;
g. matters of general concern identified by the Regulator in relation to applications made under this Act;
h. matters of general concern in relation to GMOs.

Exempt dealing
A dealing specified by the Regulations to be an exempt dealing.

Expert adviser
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.

F

Facility
Includes, but is not limited to, the following:
a. a building or part of a building;
b. laboratory;
c. an aviary;
d. a glasshouse;
e. an insectary;
f. an animal house;
g. an aquarium or tank.

G

Gene technology
Any technique for the modification of genes or other genetic material, but does not include:
a. sexual reproduction; or
b. homologous recombination; or
c. 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:
a. matters of general concern identified by the Regulator in relation to applications made under this Act;
b. matters of general concern in relation to GMOs;
c. 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:
a. ethical issues relating to gene technology;
b. the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs;
c. 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:
a. gene technology, GMOs and GM products;
b. applications made under the Act;
c. the biosafety aspects of gene technology;
d. 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
A laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.

Genetically modified laboratory mouse
A laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.

Genetically modified laboratory rabbit
A laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.

Genetically modified laboratory rat
A laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.

Genetically modified organism
a. an organism that has been modified by gene technology; or
b. 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
c. 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:
a. a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
b. 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
A genetically modified organism.

GMO licence
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
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.

H

Host/vector system
A reference to a host/vector system mentioned in Schedule 2 Part 2 is a reference to any of the following:
a. a system involving a host mentioned in column 2 of an item of the table in this clause and a vector mentioned in column 3 of the same item;
b. a non‑vector system involving a host mentioned in column 2 of an item of the table;
c. a system involving a GMO mentioned as a vector in column 3 of an item of the table (except item 7), without a host.

I

Infectious agent
An agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.

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

Inspector
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.

J

K

Known
For the purposes of the Act, means known within the scientific community.

L

Licence holder
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
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:
a. the scope of the dealings with the GMO;
b. the scale of the dealings with the GMO;
c. the locations of the dealings with the GMO;
d. the duration of the dealings with the GMO;
e. the persons who are to be permitted to conduct the dealings with the GMO.

M

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:
a. bacterial artificial chromosomes (BACs);
b. cosmids;
c. P1 artificial chromosomes (PACs);
d. yeast artificial chromosomes (YACs).

Non-vector system 
Has the meaning given in Part 3 of Schedule 2.

Notifiable Low Risk Dealing (NLRD)
A dealing with a GMO is a notifiable low risk dealing if:
a. it is a dealing of a kind mentioned in Part 1 of Schedule 3 or Part 2 of Schedule 3;
b. is not also a dealing of a kind mentioned in Part 3 of Schedule 3; and
c. 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
The Office of the Gene Technology Regulator.

Oncogenic modification
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.

Organism
Any biological entity that is:
a. viable; or
b. capable of reproduction; or
c. capable of transferring genetic material.

Out of session
For regulation 25, has the meaning given in subregulation 25 (4).

P

Packaging cell line
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
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
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
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:
a. a building;
b. a place (including an area of land);
c. a vehicle;
d. a vessel;
e. an aircraft;
f. a facility;
g. any part of premises (including premises referred to in paragraphs (a) to (f)).

Q

R

Record
The Record of GMO and GM Product Dealings.

Regulations
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:
a. the person undertaking the dealing is authorised to do so by a GMO licence; or
b. the dealing is specified in an emergency dealing determination; or
c. the dealing is a notifiable low risk dealing; or
d. the dealing is an exempt dealing; or
e. the dealing is included in the GMO Register.

Regulator
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
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
A substance that is toxic to any vertebrate.

Toxin-producing organism
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.

U

V

W

X

Y

Z