Document ID: chunk:federal_register_of_legislation:F2025C00199:schedule:3:p5
Version: federal_register_of_legislation:F2025C00199
Segment Type: schedule
Provision Reference: sch 3 (pt 5/9)
Character Range: 77800–80707

an LD50 of less than 100 micrograms per kilogram;
 (b) a dealing involving high level expression of toxin genes, even if the LD50 is 100 micrograms per kilogram or more;
 (c) a dealing (other than a dealing mentioned in paragraph 2.1(h)) involving cloning of uncharacterised nucleic acid from a toxin‑producing organism;
 (d) a dealing involving virions of a replication defective viral vector and a host not mentioned in Part 2 of Schedule 2, if:
 (i) the donor nucleic acid confers an oncogenic modification or immunomodulatory effect in humans; and
 (ii) the dealing is not a dealing mentioned in paragraph 2.1(i);
 (e) a dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the genetic modification confers an oncogenic modification or immunomodulatory effect in humans;
 (f) a dealing involving, as host or vector, a micro‑organism, if:
 (i) the micro‑organism has been implicated in, or has a history of causing, disease in otherwise healthy:
 (A) human beings; or
 (B) animals; or
 (C) plants; or
 (D) fungi; and
 (ii) none of the following sub‑subparagraphs apply:
 (A) the host/vector system is a system mentioned in Part 2 of Schedule 2;
 (B) the genetic modification is characterised and its characterisation shows that it is unlikely to increase the capacity of the host or vector to cause harm;
 (C) the dealing is a dealing mentioned in paragraph 2.1(g);
                       Example: A genetic modification would not comply with sub‑subparagraph (B) if, in relation to the capacity of the host or vector to cause harm, it:
                          (a) provides an advantage; or
                          (b) adds a potential host species or mode of transmission; or
                          (c) increases its virulence, pathogenicity or transmissibility.
 (g) a dealing involving the introduction, into a micro‑organism, of nucleic acid encoding a pathogenic determinant, unless:
 (i) the dealing is a dealing mentioned in paragraph 2.1(g); or
 (ii) the micro‑organism is a host mentioned in Part 2 of Schedule 2;
 (h) a dealing involving the introduction into a micro‑organism, other than a host mentioned in Part 2 of Schedule 2, of genes whose expressed products are likely to increase the capacity of the micro‑organisms to induce an autoimmune response;
 (i) a dealing involving use of a viral or viroid genome, or fragments of a viral or viroid genome, to produce a novel replication competent virus with an increased capacity to cause harm compared to the capacity of the parent or donor organism;
                Example: A dealing would comply with 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