South Australian Consolidated Regulations

GENE TECHNOLOGY REGULATIONS 2002 - REG 3

3—Definitions

In these regulations—

"Act" means the Gene Technology Act 2001;

"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", 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;

"Commonwealth regulations" means the Gene Technology Regulations 2001 of the Commonwealth;

"expert adviser" means—

            (a)         in Part 4—an expert adviser appointed under section 102(1) of the Commonwealth Act; and

            (b)         in Part 6—an expert adviser appointed under section 113(1) of the Commonwealth Act;

"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 rat" means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology;

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

"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", for Schedule 2, has the meaning given in Part 3 of that Schedule;

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

"oncogenic modification" means a genetic modification that is capable of inducing unregulated cell proliferation in a vertebrate cell;

"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 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.

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

        •         facility

        •         Gene Technology Technical Advisory Committee

        •         GMO

        •         GM product

        •         Institutional Biosafety Committee

        •         intentional release of the GMO into the environment (see section 11)

        •         notifiable low risk dealing

        •         Regulator.