Gene Technology Regulations 2007

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 —

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 LD₅₀ 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 for this regulation:

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