South Australian Consolidated Regulations South Australian Consolidated RegulationsSchedule 3—Notifiable low risk dealings in relation to a GMO
(regulations 12 and 13)
Part 1—Dealings that are notifiable low risk dealings
Note—
Because of regulation 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 2 of this Schedule.
The following kinds of dealings are notifiable low risk 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
mouse;
(B) a genetically modified laboratory rat;
(C) a genetically modified Caenorhabditis
elegans ;
(aa) a
dealing involving a genetically modified laboratory mouse or a genetically
modified laboratory rat, 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;
(ab) a
dealing involving 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 (including a genetically
modified flowering plant), if the dealing occurs in a facility that is
designed to prevent the escape from the facility of—
(i)
pollen, seed, spores or other propagules which may be
produced in the course of the dealing; and
(ii)
invertebrates that are capable of carrying the material
mentioned in subparagraph (i);
(ba) a
dealing involving a genetically modified flowering plant, if, before
flowering, all inflorescences are wholly enclosed in bags designed to prevent
escape of viable pollen and seed;
(c) a
dealing involving a host and vector that are not mentioned as a host/vector
system in Part 2 of Schedule 2, if—
(i)
the host has not been implicated in, or had a history of
causing, disease in human beings, animals, plants or fungi; and
(ii)
the vector has not been implicated in, or had a history
of causing, disease in human beings, animals, plants or fungi;
(d) a
dealing involving a host and vector that are not mentioned as a host/vector
system in Part 2 of Schedule 2, if—
(i)
either—
(A) the host has been implicated in, or has
a history of causing, disease in human beings, animals, plants or fungi; or
(B) the vector has been implicated in, or
has a history of causing, disease in human beings, animals, plants or fungi;
and
(ii)
the donor nucleic acid is characterised and is not known
to alter the host range or mode of transmission, or increase the virulence,
pathogenicity or transmissibility of the host or vector;
(e) a
dealing involving a host/vector system mentioned in Part 2 of Schedule 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 human beings,
animals, plants or fungi; or
(iii)
where the vector is able to transduce human
cells—confers an oncogenic modification;
(f) a
dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and
producing more than 10 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—
(A) as a large scale facility; and
(B) to at least physical containment
Level 2; and
(ii)
the donor nucleic acid satisfies the conditions set out
in item 4 of Part 1 of Schedule 2;
(g) a
dealing involving complementation of knocked-out genes, if the complementation
does not alter the host range or mode of transmission, or increase the
virulence, pathogenicity, or transmissibility of the host above that of the
parent organism before the genes were knocked-out;
(h) a
dealing involving shot-gun cloning, or the preparation of a cDNA library, in a
host/vector system mentioned in item 1 of 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 the introduction of a replication
defective retroviral vector able to transduce human cells into a host
mentioned in Part 2 of Schedule 2 if the donor nucleic acid is incapable of
correcting a defect in the vector leading to production of replication
competent virions.
Part 2—Dealings that are not notifiable low risk dealings
Note 1—
The following list qualifies the list in Part 1, 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
be undertaken only by a person who is licensed, under the Act, for the dealing
(see section 32 of the Act).
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 item 1.1(h) of Part 1 of this
Schedule) involving cloning of nucleic acid encoding a toxin having an LD 50
of less than 100 µg/kg;
(b) a
dealing involving high level expression of toxin genes, even if the LD 50 is
100 µg/kg or more;
(c) a
dealing (other than a dealing mentioned in items 1.1(h) of Part 1 of this
Schedule) involving cloning of uncharacterised nucleic acid from a
toxin-producing organism;
(d)
unless the viral vector is part of a host/vector system mentioned in Part 2 of
Schedule 2 or in item 1.1(i) of Part 1 of this Schedule—a dealing
involving donor nucleic acid in a viral vector if the donor nucleic
acid—
(i)
confers an oncogenic modification; or
(ii)
encodes—
(A) immunomodulatory molecules; or
(B) cytokines; or
(C) growth factors, or components of a
signal transduction pathway, that, when expressed, may lead to cell
proliferation;
(e) a
dealing involving, as host or vector, a micro-organism that has been
implicated in, or has a history of causing, disease in humans, animals, plants
or fungi, unless—
(i)
the host/vector system is a system mentioned in Part 2 of
Schedule 2; or
(ii)
the donor nucleic acid is characterised and is not known
to alter the host range or mode of transmission, or increase the virulence,
pathogenicity or transmissibility of the host or vector; or
(iii)
the dealing is a dealing mentioned in item 1.1(g) of
Part 1 of this Schedule;
(f) 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 item 1.1(g) of
Part 1 of this Schedule; or
(ii)
the micro-organism is a host mentioned in Part 2 of
Schedule 2;
(g) 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 have a
heightened risk of inducing an autoimmune response;
(h) 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 altered
host range or mode of transmission, or increased virulence, pathogenicity or
transmissibility in relation to any parent or donor organism;
(i)
a dealing involving a lentiviral vector able to transduce
human cells unless—
(i)
all structural and accessory genes have been removed from
the vector to render it incapable of replication or assembly into a virion
without these functions being supplied in trans ; and
(ii)
the vector includes a deletion that results in a
transcriptionally inactive vector which, even when packaging functions are
supplied in trans , cannot be converted into full length viral RNA; and
(iii)
the packaging cell line and packaging plasmids used
contain only viral genes gag, pol, rev and a gene encoding an envelope
protein;
(j) 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;
(k) a
dealing producing, in each vessel containing the resultant GMO culture, more
than 10 litres of that culture, other than a dealing mentioned in
item 1.1(f) of Part 1 of this Schedule;
(l) a
dealing that is inconsistent with a policy principle issued by the Ministerial
Council;
(m) a
dealing involving the intentional introduction of a GMO into a human being;
(n) 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.