Commonwealth Consolidated Regulations Commonwealth Consolidated RegulationsNote: 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.
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.
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.
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 result of the genetic modification;
(b) a dealing involving a genetically modified plant;
(c) a dealing involving a host/vector system not mentioned in paragraph 1.1(c) or Part 2 of Schedule 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/vector system not mentioned in Part 2 of Schedule 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 genetic modification is characterised; and
(iii) the characterisation of the genetic modification shows that it is unlikely to increase the capacity of the host or vector to cause harm;
Example: A genetic modification would not comply with subparagraph (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.
(e) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid:
(i) is characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; 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 Part 2 of Schedule 2 and producing more than 25 litres 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 subitem 4(2) of Part 1 of Schedule 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 paragraph (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.
(h) a dealing involving shot - gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of Schedule 2, if the donor nucleic acid is derived from either:
(i) a pathogen; or
(ii) a toxin - producing organism;
(i) a dealing involving virions of a replication defective viral vector unable to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;
(j) a dealing involving virions of a replication defective non - retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:
(i) the donor nucleic acid cannot restore replication competence to the vector; and
(ii) the dealing is not a dealing mentioned in paragraph 1.1(c);
(k) a dealing involving virions of a replication defective non - retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if:
(i) the donor nucleic acid cannot restore replication competence to the vector; and
(ii) the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;
(l) a dealing involving virions of a replication defective retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:
(i) 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
(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 virions of a replication defective retroviral vector able to transduce human cells and a 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.
(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).
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.
(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 LD 50 of less than 100 micrograms per kilogram;
(b) a dealing involving high level expression of toxin genes, even if the LD 50 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 host species or mode of transmissibility; or
(c) increased virulence, pathogenicity or transmissibility.
(j) a dealing, other than a dealing mentioned in paragraph 2.1(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 25 litres of that culture, other than a dealing mentioned in paragraph 2.1(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;
(q) a dealing involving a micro - organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 and that is not undertaken:
(i) in a facility that is certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or
(ii) in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken;
(r) a dealing involving a GMO capable of sexual reproduction, the sexual progeny of which are, as a result of the genetic modification, more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism);
(s) a dealing involving a viral vector that can modify an organism capable of sexual reproduction, so that the sexual progeny of the organism are more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism).
Note: A modification that increases the likelihood of inheritance of a nucleotide sequence or sequences, as described in paragraphs (r) and (s), is generally known as an engineered gene drive.
(2) For the purposes of paragraph (1)(p), a genetically modified micro - organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4 if the unmodified parent micro - organism satisfies those criteria.
(3) For the purposes of paragraph (1)(q), 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.
(4) However, subclause (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).