Gene Technology Regulations 2021

A dealing of any of the following kinds, or involving a dealing of the following kinds, is not a notifiable low risk dealing—

a dealing (other than a dealing mentioned in clause 2.1(h)) involving cloning of nucleic acid encoding a toxin having an LD₅₀ of less than 100 micrograms per kilogram;

a dealing involving high level expression of toxin genes, even if the LD₅₀ is 100 micrograms per kilogram or more;

a dealing (other than a dealing mentioned in clause 2.1(h)) involving cloning of uncharacterised nucleic acid from a toxin‑producing organism;

a dealing involving virions of a replication defective viral vector and a host not mentioned in Part 2 of Schedule 2, if—

the donor nucleic acid confers an oncogenic modification or immunomodulatory effect in humans; and

the dealing is not a dealing mentioned in clause 2.1(i);

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;

a dealing involving, as host or vector, a micro-organism, if—

the micro-organism has been implicated in, or has a history of causing, disease in otherwise healthy—

human beings; or

animals; or

plants; or

fungi; and

none of the following sub‑subparagraphs apply—

the host/vector system is a system mentioned in Part 2 of Schedule 2;

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;

the dealing is a dealing mentioned in clause 2.1(g);

provides an advantage; or

adds a potential host species or mode of transmission; or

increases its virulence, pathogenicity or transmissibility.

a dealing involving the introduction, into a micro-organism, of nucleic acid encoding a pathogenic determinant, unless—

the dealing is a dealing mentioned in clause 2.1(g); or

the micro-organism is a host mentioned in Part 2 of Schedule 2;

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;

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;

an advantage; or

a new potential host species or mode of transmissibility; or

increased virulence, pathogenicity or transmissibility.

a dealing, other than a dealing mentioned in clause 2.1(l) or (m), with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;

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;

a dealing producing, in each vessel containing the resultant GMO culture, more than 25 litres of that culture, other than a dealing mentioned in clause 2.1(f);

a dealing that is inconsistent with a policy principle issued by the Ministerial Council;

a dealing involving the intentional introduction of a GMO into a human being, unless the GMO—

is a human somatic cell; and

cannot secrete or produce infectious agents as a result of the genetic modification; and

if it was generated using viral vectors—

has been tested for the presence of viruses likely to recombine with the genetically modified nucleic acid in the somatic cells; and

the testing did not detect a virus mentioned in sub‑subparagraph (A); and

the viral vector used to generate the GMO as part of a previous dealing is no longer present in the somatic cells;

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;

a dealing involving a micro-organism that is of a class of micro-organism referred to in clause 3.1(1)(p) in Part 3 of Schedule 3 to the Commonwealth Regulations;

a dealing involving a micro‑organism that is of a class of micro-organism referred to in clause 3.1(1)(p) in Part 3 of Schedule 3 to the Commonwealth Regulations and that is not undertaken—

in a facility that is certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or

in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken;

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);

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).

For the purposes of subclause (1)(p), a genetically modified micro‑organism is taken to satisfy the criteria referred to in clause 3.1(2) in Part 3 of Schedule 3 to the Commonwealth Regulations if the unmodified parent micro‑organism satisfies those criteria.

For the purposes of subclause (1)(q), a genetically modified micro‑organism is taken to satisfy the criteria referred to in clause 3.1(3) in Part 3 of Schedule 3 to the Commonwealth Regulations if the unmodified parent micro‑organism satisfies those criteria.

However, subclause (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in clause 2.1(l) or (m).