Australian Capital Territory Numbered Regulations Australian Capital Territory Numbered Regulationssubstitute
Schedule 3 Notifiable low risk dealings in relation to a GMO
Part 3.1 Notifiable low risk dealings suitable for at least physical containment level 1
Note Because of s 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 pt 3.3.
3.1 Kinds of dealings suitable for at least physical containment level 1
The following kinds of notifiable low risk dealings must be undertaken, unless section 13 (2) (c) or 13 (3) (b) 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 a replication defective vector derived from Human adenovirus or Adeno associated virus in a host mentioned in schedule 2, part 2.2, item 4, if the donor nucleic acid—
(i) cannot restore replication competence to the vector; and
(ii) does not—
(A) confer an oncogenic modification in humans; or
(B) encode a protein with immunomodulatory activity in humans.
Part 3.2 Notifiable low risk dealings suitable for at least physical containment level 2 or 3
Note Because of s 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 3.3.
3.2 Kinds of dealings suitable for at least physical containment level 2
The following kinds of notifiable low risk dealings must be undertaken, unless section 13 (2) (c) or 13 (3) (b) 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 result of the genetic modification;
(b) a dealing involving a genetically modified plant;
(c) a dealing involving a host/vector system not mentioned in section 3.1 (c) or schedule 2, part 2.2 if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise healthy—
(i) human beings; or
(ii) animals; or
(iii) plants; or
(iv) fungi;
(d) a dealing involving a host and vector not mentioned as a host/vector system in schedule 2, part 2.2 if—
(i) the host or vector 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) the donor nucleic acid is characterised; and
(iii) the characterisation of the donor nucleic acid shows that it is unlikely to increase the capacity of the host or vector to cause harm;
Example
Donor nucleic acid would not comply with par (iii) 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.
Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).
(e) a dealing involving a host/vector system mentioned in schedule 2, part 2.2, if the donor nucleic acid—
(i) encodes a pathogenic determinant; or
(ii) is uncharacterised nucleic acid from an organism that 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;
(f) a dealing involving a host/vector system mentioned in schedule 2, part 2.2 and producing more than 25L of GMO culture in each vessel containing the resultant culture, if—
(i) the dealing is undertaken in a facility that is certified by the regulator as a large scale facility; and
(ii) the donor nucleic acid satisfies the conditions set out in schedule 2, part 2.1, item 4 (2);
(g) a dealing involving complementation of knocked-out genes, if the complementation is unlikely to increase the capacity of the GMO to cause harm compared to the capacity of the parent organism before the genes were knocked out;
Example
A dealing would not comply with par (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.
Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).
(h) a dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in schedule 2, part 2.2, item 1, if the donor nucleic acid is derived from either—
(i) a pathogen; or
(ii) a toxin-producing organism;
(i) a dealing involving the introduction of a replication defective viral vector unable to transduce human cells into a host not mentioned in schedule 2, part 2.2 if the donor nucleic acid cannot restore replication competence to the vector;
(j) a dealing involving the introduction of a replication defective non-retroviral vector able to transduce human cells, other than a dealing mentioned in section 3.1 (c), into a host mentioned in schedule 2, part 2.2 if the donor nucleic acid cannot restore replication competence to the vector;
(k) a dealing involving the introduction of a replication defective non-retroviral vector able to transduce human cells into a host not mentioned in schedule 2, part 2.2 if—
(i) the donor nucleic acid cannot restore replication competence to the vector; and
(ii) the donor nucleic acid does not—
(A) confer an oncogenic modification in humans; or
(B) encode a protein with immunomodulatory activity in humans;
(l) a dealing involving the introduction of a replication defective retroviral vector able to transduce human cells into a host mentioned in schedule 2, part 2.2 if—
(i) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble into a virion 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 the introduction of a replication defective retroviral vector able to transduce human cells into a host not mentioned in schedule 2, part 2.2, if—
(i) the donor nucleic acid does not—
(A) confer an oncogenic modification in humans; or
(B) encode a protein with immunomodulatory activity in humans; and
(ii) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble into a virion 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.
3.2A Kinds of dealings suitable for at least physical containment level 3
Any kind of dealing mentioned in this part involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 must be undertaken, unless section 13 (2) (c) or 13 (3) (b) applies, in facilities that are—
(a) certified to at least physical containment level 3; and
(b) appropriate for the dealing.
Part 3.3 Dealings that are not notifiable low risk dealings
Note 1 The following list qualifies the list in pt 3.1 and pt 3.2 and is not an exhaustive list of dealings that are not notifiable low risk dealings.
Note 2 A dealing that is not a notifiable low risk dealing, or an exempt dealing, can only be undertaken by a person who is licensed, under the Act, for the dealing (see the Act, s 32).
3.3 Kinds of dealings
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 section 3.2 (h)) involving cloning of nucleic acid encoding a toxin having an LD 50 of less than 100μg/kg;
(b) a dealing involving high level expression of toxin genes, even if the LD 50 is 100μg/kg or more;
(c) a dealing (other than a dealing mentioned in section 3.2 (h)) involving cloning of uncharacterised nucleic acid from a toxin-producing organism;
(d) a dealing involving the introduction of a replication defective viral vector into a host not mentioned in schedule 2, part 2.2 other than a dealing mentioned in section 3.2 (i), if the donor nucleic acid—
(i) confers an oncogenic modification in humans; or
(ii) encodes a protein with immunomodulatory activity in humans;
(e) a dealing involving a replication competent virus or viral vector, other than a vector mentioned in schedule 2, part 2.2 if the donor nucleic acid—
(i) confers an oncogenic modification in humans; or
(ii) encodes a protein with immunomodulatory activity 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 apply:
(A) the host/vector system is a system mentioned in schedule 2, part 2.2;
(B) the donor nucleic acid 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 section 3.2 (g);
Example
Donor nucleic acid would not comply with par (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.
Note An example is part of the regulation, is not exhaustive and may extend, but does not limit, the meaning of the provision in which it appears (see Legislation Act, s 126 and s 132).
(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 section 3.2 (g); or
(ii) the micro-organism is a host mentioned in schedule 2, part 2.2;
(h) a dealing involving the introduction into a micro-organism, other than a host mentioned in schedule 2, part 2.2 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 par (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 host species or mode of transmissibility; or
(c) increased virulence, pathogenicity or transmissibility.
(j) a dealing, other than a dealing mentioned in section 3.2 (l) or (m), with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;
(k) a dealing involving a genetically modified animal, plant or fungus that is capable of secreting or producing infectious agents as a result of the genetic modification;
(l) a dealing producing, in each vessel containing the resultant GMO culture, more than 25L of that culture, other than a dealing mentioned in section 3.2 (f);
(m) a dealing that is inconsistent with a policy principle issued by the ministerial council;
(n) a dealing involving the intentional introduction of a GMO into a human being, unless the GMO—
(i) is a human somatic cell; and
(ii) cannot secrete or produce infectious agents as a result of the genetic modification; and
(iii) if it was generated using viral vectors—
(A) has been tested for the presence of viruses likely to recombine with the genetically modified nucleic acid in the somatic cells; and
(B) the testing did not detect a virus mentioned in sub-subparagraph (A); and
(C) the viral vector used to generate the GMO as part of a previous dealing is no longer present in the somatic cells;
(o) a dealing involving a genetically modified pathogenic organism, if the practical treatment of any disease or abnormality caused by the organism would be impaired by the genetic modification;
(p) a dealing involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4.