Document ID: chunk:federal_register_of_legislation:F2025C00199:schedule:3:p6
Version: federal_register_of_legislation:F2025C00199
Segment Type: schedule
Provision Reference: sch 3 (pt 6/9)
Character Range: 80447–83270

paragraph (i) if it produces a novel replication competent virus that has a higher capacity to cause harm to any potential host species than the parent organism because the new virus has:
                (a) an advantage; or
                (b) a new potential host species or mode of transmissibility; or
                (c) increased virulence, pathogenicity or transmissibility.
 (j) a dealing, other than a dealing mentioned in paragraph 2.1(l) or (m), with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;
 (k) a dealing involving a genetically modified animal, plant or fungus that is capable of secreting or producing infectious agents as a result of the genetic modification;
 (l) a dealing producing, in each vessel containing the resultant GMO culture, more than 25 litres of that culture, other than a dealing mentioned in paragraph 2.1(f);
 (m) a dealing that is inconsistent with a policy principle issued by the Ministerial Council;
 (n) a dealing involving the intentional introduction of a GMO into a human being, unless the GMO:
 (i) is a human somatic cell; and
 (ii) cannot secrete or produce infectious agents as a result of the genetic modification; and
 (iii) if it was generated using viral vectors:
 (A) has been tested for the presence of viruses likely to recombine with the genetically modified nucleic acid in the somatic cells; and
 (B) the testing did not detect a virus mentioned in sub‑subparagraph (A); and
 (C) the viral vector used to generate the GMO as part of a previous dealing is no longer present in the somatic cells;
 (o) a dealing involving a genetically modified pathogenic organism, if the practical treatment of any disease or abnormality caused by the organism would be impaired by the genetic modification;
 (p) a dealing involving a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4;
 (q) a dealing involving a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 and that is not undertaken:
 (i) in a facility that is certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or
 (ii) in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken;
 (r) a dealing involving a GMO capable of sexual reproduction, the sexual progeny of which are, as a result of the genetic modification, more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism);
 (s) a dealing involving a viral vector that can modify an organism capable of sexual reproduction, so that the sexual progeny of the organism are more likely to inherit a particular