Western Australian Consolidated Regulations

GENE TECHNOLOGY REGULATIONS 2007 - REG 3

3 .         Definitions

                In these regulations —

        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;

        code for , for Schedule 2, has the meaning given in Schedule 2 Part 3;

        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‑conjunctive plasmid , for Schedule 2, has the meaning given in Schedule 2 Part 3;

        non‑vector system , for Schedule 2, has the meaning given in Schedule 2 Part 3;

        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 a LD ₅₀ of less than 100μg/kg;

        transduce , in relation to a viral vector or viral particle, means enter an intact cell by interaction of the vital 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

•         Commonwealth Act

•         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