Commonwealth Consolidated Regulations

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GENE TECHNOLOGY REGULATIONS 2001 - REG 3

Definitions

    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 LD 50 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:

ï‚·   accredited organisation

ï‚·   deal with

ï‚·   environment

ï‚·   Ethics and Community Committee

ï‚·   facility

ï‚·   Gene Technology Technical Advisory Committee

ï‚·   GMO

ï‚·   Institutional Biosafety Committee

ï‚·   intentional release of the GMO into the environment (see section   11)

ï‚·   notifiable low risk dealing

ï‚·   Regulator.

 


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