Document ID: chunk:federal_register_of_legislation:F2025C00199:schedule:3:p4
Version: federal_register_of_legislation:F2025C00199
Segment Type: schedule
Provision Reference: sch 3 (pt 4/9)
Character Range: 75293–78029

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 it cannot replicate or assemble new virions without these functions being supplied in trans; and
 (iii) 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
 (iv) 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.

2.2  Kinds of dealing suitable for at least physical containment level 3
 (1) A kind of dealing that:
 (a) is a kind mentioned in clause 2.1; and
 (b) involves a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3;
must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 3 and that are appropriate for the dealings.
 (2) For the purposes of paragraph (1)(b), a genetically modified micro‑organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro‑organism satisfies those criteria.
 (3) However, subclause (2) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).

Part 3—Dealings that are not notifiable low risk dealings
Note 1: The following list qualifies the list in Parts 1 and 2, and is not an exhaustive list of dealings that are not notifiable low risk dealings.
Note 2: If a dealing is not a notifiable low risk dealing, or an exempt dealing, as provided by these Regulations, a person undertaking the dealing must be authorised by a GMO licence unless the dealing is within one of the other exceptions to licensing provided by the Act: see section 32 of the Act.

3.1  Kinds of dealings
 (1) A dealing of any of the following kinds, or involving a dealing of the following kinds, is not a notifiable low risk dealing:
 (a) a dealing (other than a dealing mentioned in paragraph 2.1(h)) involving cloning of nucleic acid encoding a toxin having 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