Document ID: chunk:federal_register_of_legislation:F2025C00199:schedule:3:p3
Version: federal_register_of_legislation:F2025C00199
Segment Type: schedule
Provision Reference: sch 3 (pt 3/9)
Character Range: 72708–75528

knocked out;
                Example: A dealing would not comply with paragraph (g) if it involved complementation that, in relation to the parent organism:
                 (a) provides an advantage; or
                 (b) adds a potential host species or mode of transmission; or
                 (c) increases its virulence, pathogenicity or transmissibility.
 (h) a dealing involving shot‑gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of Schedule 2, if the donor nucleic acid is derived from either:
 (i) a pathogen; or
 (ii) a toxin‑producing organism;
 (i) a dealing involving virions of a replication defective viral vector unable to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;
 (j) a dealing involving virions of a replication defective non‑retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:
 (i) the donor nucleic acid cannot restore replication competence to the vector; and
 (ii) the dealing is not a dealing mentioned in paragraph 1.1(c);
 (k) a dealing involving virions of a replication defective non‑retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if:
 (i) the donor nucleic acid cannot restore replication competence to the vector; and
 (ii) the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;
 (l) a dealing involving virions of a replication defective retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:
 (i) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and
 (ii) viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and
 (iii) either:
 (A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or
 (B) the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these;
 (m) a dealing involving virions of a replication defective retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if:
 (i) the donor nucleic acids does not confer an oncogenic modification or immunomodulatory effect in humans; and
 (ii) all viral genes have been removed from the retroviral vector so that