Document ID: chunk:federal_register_of_legislation:F2025C00199:schedule:3:p1
Version: federal_register_of_legislation:F2025C00199
Segment Type: schedule
Provision Reference: sch 3 (pt 1/9)
Character Range: 67527–70428

Schedule 3—Notifiable low risk dealings in relation to a GMO
(regulations 12 and 13)

Part 1—Notifiable low risk dealings suitable for at least physical containment level 1
Note: Because of subregulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.

1.1  Kinds of dealings suitable for at least physical containment level 1
  The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 1 and that are appropriate for the dealings:
 (a) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit or a genetically modified laboratory rat, unless:
 (i) an advantage is conferred on the animal by the genetic modification; or
 (ii) the animal is capable of secreting or producing an infectious agent as a result of the genetic modification;
 (c) a dealing involving virions of a replication defective vector derived from Human adenovirus or from Adeno‑associated virus, either without a host or with a host mentioned in item 9 of Part 2 of Schedule 2, if the donor nucleic acid:
 (i) cannot restore replication competence to the vector; and
 (ii) does not confer an oncogenic modification or immunomodulatory effect in humans.

Part 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3
Note: Because of subregulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.

2.1  Kinds of dealings suitable for at least physical containment level 2
  The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 2 and that are appropriate for the dealings:
 (a) a dealing involving whole animals (including non‑vertebrates) that:
 (i) involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and
 (ii) does not involve any of the following:
 (A) a genetically modified laboratory guinea pig;
 (B) a genetically modified laboratory mouse;
 (C) a genetically modified laboratory rabbit;
 (D) a genetically modified laboratory rat;
 (E) a genetically modified Caenorhabditis elegans;
 (aa) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat or a genetically modified Caenorhabditis elegans, if:
 (i) the genetic modification confers an advantage on the animal; and
 (ii) the animal is not capable of secreting or producing an infectious agent as a