Document ID: chunk:federal_register_of_legislation:F2025C00199:clause:2_4
Version: federal_register_of_legislation:F2025C00199
Segment Type: clause
Provision Reference: sch 2 cl 4
Character Range: 54906–56823

4     (1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture.
      (2) The donor nucleic acid:
      (a) must meet either of the following requirements:
      (i) it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy:
             (A) human beings; or
             (B) animals; or
             (C) plants; or
             (D) fungi;
      (ii) it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm; and
                Example: Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, 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.
      (b) must not code for a toxin with an LD50 of less than 100 micrograms per kilogram; and
      (c) must not code for a toxin with an LD50 of 100 micrograms per kilogram or more, if the intention is to express the toxin at high levels; and
      (d) must not be uncharacterised nucleic acid from a toxin‑producing organism; and
      (e) if the donor nucleic acid includes a viral sequence—cannot give rise to infectious agents when introduced into any potential host species, without additional non‑host genes or gene products that:
      (i) are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and
      (ii) will not become available during the dealing; and
      (f) if the donor nucleic acid includes a viral sequence—cannot restore replication competence to the vector.