Document ID: chunk:federal_register_of_legislation:F2025C00199:reg:3:p2
Version: federal_register_of_legislation:F2025C00199
Segment Type: reg
Provision Reference: reg 3 (pt 2/2)
Character Range: 8677–10993

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 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.
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
 Ethics and Community Committee
 facility
 Gene Technology Technical Advisory Committee
 GMO
 Institutional Biosafety Committee
 intentional release of the GMO into the environment (see section 11)
 notifiable low risk dealing
 Regulator.

Part 2—Interpretation and general operation