Schedule 1 Amendments
(regulation 3)
[1] Regulation 3
substitute
3 Definitions
In these Regulations:
Act means the Gene Technology Act 2000.
advantage, in relation to an organism that is
genetically modified, means a superior ability in its modified form, relative
to the unmodified parent organism, to survive, reproduce or otherwise
contribute to the gene pool.
animal includes every kind of organism in the
animal kingdom, including non‑vertebrates but not including human beings.
characterised, in relation to nucleic acid,
means nucleic acid that has been sequenced and in respect of which there is an
understanding of potential gene products or potential functions.
code for, for Schedule 2, has the meaning
given in Part 3 of that Schedule.
expert adviser means:
(a) in Part 4 — an expert adviser appointed
under subsection 102 (1) of the Act; and
(a) in Part 6 — an expert adviser appointed
under subsection 113 (1) of the Act.
genetically modified laboratory mouse means a
laboratory strain of mouse of the species Mus musculus that has
been modified by gene technology.
genetically modified laboratory rat means a laboratory
strain of rat of either the species Rattus rattus or Rattus
norvegicus that has been modified by gene technology.
infectious agent means an agent that is capable
of entering, surviving in, multiplying, and potentially causing disease in, a
susceptible host.
known means known within the scientific
community.
non‑conjugative plasmid, for Schedule
2, has the meaning given in Part 3 of that Schedule.
non‑vector system, for Schedule 2, has
the meaning given in Part 3 of that Schedule.
nucleic acid means either, or both, deoxyribonucleic
acid (DNA), or ribonucleic acid (RNA), of any length.
oncogenic modification means a genetic
modification that is capable of inducing unregulated cell proliferation in a
vertebrate cell.
out of session, for regulation 25, has the
meaning given in subregulation 25 (4).
packaging cell line means an animal or human
cell line that contains a gene or genes that when expressed in trans are
necessary and sufficient to complement packaging defects of a replication
defective viral vector in order to produce packaged replication defective
virions.
pathogenic, in relation to an organism,
means having the capacity to cause disease or abnormality.
pathogenic determinant means a characteristic
that has the potential to increase the capacity of a host or vector to cause
disease or abnormality.
physical containment level, followed by a numeral,
is a specified containment level under guidelines made by the Regulator, under section
90 of the Act, for the certification of facilities.
plasmid means a DNA molecule capable of
autonomous replication and stable extra‑chromosomal maintenance in a host
cell.
shot‑gun cloning means the production
of a large random collection of cloned fragments of nucleic acid from which
genes of interest can later be selected.
toxin means a substance that is toxic to any vertebrate.
toxin‑producing organism means an organism
producing toxin with an LD50
of less than 100 mg/kg.
transduce, in relation to a viral vector or
viral particle, means enter an intact cell by interaction of the viral particle
with the cell membrane.
Note Several
other words and expressions used in these Regulations have the meaning given by
section 10, or another provision, of the Act. For example:
· accredited
organisation
· deal with
· environment
· facility
· Gene
Technology Technical Advisory Committee
· GMO
· GM product
· Institutional
Biosafety Committee
· intentional
release of the GMO into the environment (see section 11)
· notifiable low
risk dealing
· Regulator.
[2] Regulation 4
substitute
4 Techniques not
constituting gene technology
For paragraph (c) of the definition of gene
technology in section 10 of the Act, gene technology does not include a
technique mentioned in Schedule 1A.
[3] Paragraphs 6 (1) (c) and (d)
substitute
(c) it is conducted in accordance with
applicable technical and procedural guidelines, as in force from time to time
under paragraph 27 (d) of the Act, relating to:
(i) containment of the GMO; and
(ii) if the dealing involves
transporting the GMO — transport; and
(d) it does not involve an intentional release of
the GMO into the environment; and
(e) it does not involve a retroviral vector that
is able to transduce human cells.
[4] Regulation 7, including the notes
substitute
7 Application for
licence — prescribed fee
Note At the commencement of the
Regulations, no application fee is prescribed under subsection 40 (6) of
the Act.
[5] Paragraph 9 (a)
substitute
(a) Food Standards Australia New Zealand;
[6] Paragraphs 9 (d)
and (e)
substitute
(d) the Director, National Industrial Chemical
Notification and Assessment Scheme under the Industrial Chemical (Notification
and Assessment) Act 1989;
(e) Australian Pesticides and Veterinary
Medicines Authority;
[7] Paragraph 10 (1) (a)
substitute
(a) subject to section 45 of the Act, any
previous assessment by a regulatory authority, in Australia or overseas, in
relation to allowing or approving dealings with the GMO; and
[8] Subparagraph 10 (1) (b) (v)
omit
selective advantage
insert
an advantage
[9] Regulation 13
substitute
13 Requirements in
relation to notifiable low risk dealings
(1) A person must not undertake a notifiable low risk
dealing unless an Institutional Biosafety Committee has:
(a) notified the Regulator, in the form approved
by the Regulator, of the proposed dealing; and
(b) notified the person, and the
project supervisor for the proposed dealing, in writing, that:
(i) the proposed dealing is a dealing
of a kind mentioned in Part 1 of Schedule 3; and
(ii) it considers that the personnel to
be involved in the proposed dealing have appropriate training and experience;
and
(iii) paragraph (a) has been complied
with.
(2) A notifiable low risk dealing, when undertaken,
must comply with the following requirements:
(a) the dealing must be conducted in a facility
that:
(i) is certified by the Regulator to:
(A) at least physical
containment level 2; or
(B) any other containment
level that the Regulator considers suitable for conducting the dealing; and
(ii) is of appropriate design for the
kind of dealing being undertaken;
(b) to the extent that the dealing involves
transporting a GMO, the transporting must be conducted in accordance with applicable
technical and procedural guidelines, as in force from time to time under
paragraph 27 (d) of the Act.
(3) The Regulator may, by notice in writing, require:
(a) the Institutional Biosafety Committee that has
notified the Regulator of a proposed notifiable low risk dealing; or
(b) a person or organisation involved with the
conduct of a notifiable low risk dealing of which the Regulator has been
notified;
to give the Regulator such further information in relation to the
dealing as the Regulator requires in order to be satisfied that the dealing is
a notifiable low risk dealing.
(4) A Committee, person or organisation receiving a
notice under subregulation (3) must, by the end of the period specified in
the notice, give the Regulator the information required by the notice.
[10] Subregulation 29 (3)
omit
the Minister
insert
the Ministerial Council
[11] Subparagraph 39 (2) (c) (ii)
omit
in the GM product; and
insert
in the GMO from which the GM product is derived; and
[12] Part 8
omit
[13] Schedules 1, 2, 3 and 4
substitute
Schedule 1A Techniques that are not gene technology
(regulation 4)
|
Item
|
Description of technique
|
|
1
|
Somatic cell nuclear transfer,
if the transfer does not involve genetically modified material.
|
|
2
|
Electromagnetic radiation‑induced mutagenesis.
|
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3
|
Particle radiation‑induced
mutagenesis.
|
|
4
|
Chemical‑induced
mutagenesis.
|
|
5
|
Fusion of animal cells, or human cells, if the fused cells
are unable to form a viable whole animal or human.
|
|
6
|
Protoplast fusion, including fusion of plant protoplasts.
|
|
7
|
Embryo rescue.
|
|
8
|
In vitro fertilisation.
|
|
9
|
Zygote implantation.
|
|
10
|
A natural process, if the
process does not involve genetically modified material.
Examples
Examples of natural processes
include conjugation, transduction, transformation and transposon mutagenesis.
|
Schedule 1 Organisms that are not genetically modified organisms
(regulation 5)
|
Item
|
Description of organism
|
|
1
|
A mutant organism in which the
mutational event did not involve the introduction of any foreign nucleic acid
(that is, non‑homologous DNA, usually from another species).
|
|
2
|
A whole animal, or a human
being, modified by the introduction of naked recombinant nucleic acid (such
as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is
incapable of giving rise to infectious agents.
|
|
3
|
Naked plasmid DNA that is incapable
of giving rise to infectious agents when introduced into a host cell.
|
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6
|
An organism that results from
an exchange of DNA if:
(a) the donor species is
also the host species; and
(b) the vector DNA does not
contain any heterologous DNA.
|
|
7
|
An organism that results from
an exchange of DNA between the donor species and the host species if:
(a) such exchange can occur
by naturally occurring processes; and
(b) the donor species and
the host species are micro‑organisms that:
(i) satisfy the criteria in AS/NZS 2243.3:2002 (Safety
in laboratories, Part 3: Microbiological aspects and containment facilities)
jointly published by Standards Australia and Standards New Zealand, for
classification as Risk Group 1; and
(ii) are known to exchange nucleic acid by a
natural physiological process; and
(c) the vector used in the
exchange does not contain heterologous DNA from any organism other than an
organism that is involved in the exchange.
|
Schedule 2 Dealings exempt from licensing
(regulation 6)
|
Note Subregulation 6 (1) sets
out other requirements for exempt dealings.
|
Part 1 Exempt dealings
|
Item
|
Description of dealing
|
|
1
|
A dealing with a genetically
modified laboratory mouse or a genetically modified laboratory rat, unless:
(a) an advantage is conferred on the animal by the
genetic modification; or
(b) as a result of the genetic modification, the animal
is capable of secreting or producing an infectious agent.
|
|
2
|
A dealing with a genetically
modified Caenorhabditis elegans, unless:
(a) an advantage is conferred on the animal by
the genetic modification; or
(b) as a result of the genetic modification, the animal
is capable of secreting or producing an infectious agent.
|
|
3
|
A dealing with an animal into
which genetically modified somatic cells have been introduced, if:
(a) the somatic cells are not capable of giving rise to
infectious agents as a result of the genetic modification; and
(b) the animal is not infected with a virus that is
capable of recombining with the genetically modified nucleic acid in the
somatic cells.
|
|
4
|
(1) Subject to subitems (2) and (3), a dealing involving a
host/vector system mentioned in Part 2 of this Schedule and producing no more
than 10 litres of GMO culture in each vessel containing the resultant culture.
|
|
|
(2) The donor nucleic acid:
(a) must satisfy either of
the following requirements:
(i) it must not be derived
from organisms implicated in, or with a history of causing, disease in human
beings, animals, plants or fungi; or
(ii) it must be characterised and not known to alter
the host range or mode of transmission, or increase the virulence,
pathogenicity or transmissibility of the host or vector; and
|
|
|
(b) must not code for a
toxin with an LD50 of less
than 100 mg/kg; and
(c) must not code for a
toxin with an LD50 of 100 mg/kg or more, if the intention is to
express the toxin at high levels; and
(d) must not be uncharacterised
nucleic acid from a toxin‑producing organism; and
(e) must not include a viral
sequence unless the donor nucleic acid:
(i) is missing at
least 1 gene essential for viral multiplication that:
(A) is not available in the cell into which the
nucleic acid is introduced; and
(B) will not become available during the dealing; and
(ii) is incapable of correcting
a defect in the host/vector system leading to production of replication
competent virions.
(3) If the vector is able to transduce human cells, the donor
nucleic acid must not confer an oncogenic modification.
|
|
5
|
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 this Schedule, if the donor nucleic acid is
not derived from either:
(a) a pathogen; or
(b) a toxin‑producing
organism.
|
Part 2 Host/vector systems for exempt dealings
|
Item
|
Class
|
Host
|
Vector
|
|
1
|
Bacteria
|
Escherichia coli K12, E. coli B or
E. coli C – any derivative that does not contain:
(a) generalised transducing phages; or
(b) genes able to complement the conjugation defect in
a non‑conjugative plasmid
|
1. Non‑conjugative
plasmids
2. Bacteriophage
(a) lambda
(b) lambdoid
(c) Fd or
F1 (eg M13)
3. None
(non‑vector systems)
|
|
|
|
Bacillus – specified species –
asporogenic strains with a reversion frequency of less than 10–7:
(a) B. amyloliquefaciens
(b) B. licheniformis
(c) B. pumilus
(d) B. subtilis
(e) B. thuringiensis
|
1. Non‑conjugative
plasmids
2. Plasmids
and phages whose host range does not include B. cereus, B.
anthracis or any other pathogenic strain of Bacillus
3. None
(non‑vector systems)
|
|
|
|
Pseudomonas putida –
strain KT 2440
|
1. Non‑conjugative
plasmids including certified plasmids: pKT 262, pKT 263, pKT 264
2. None
(non‑vector systems)
|
|
|
|
Streptomyces – specified species:
(a) S. aureofaciens
(b) S. coelicolor
(c) S. cyaneus
(d) S. griseus
(e) S. lividans
(f) S. parvulus
(g) S. rimosus
(h) S. venezuelae
|
1. Non‑conjugative
plasmids
2. Certified
plasmids: SCP2, SLP1, SLP2, PIJ101 and derivatives
3. Actinophage
phi C31 and derivatives
4. None
(non‑vector systems)
|
|
|
|
Agrobacterium radiobacter
|
1. Non‑tumorigenic
disarmed Ti plasmid vectors, or Ri plasmid vectors
2. None
(non‑vector systems)
|
|
|
|
Agrobacterium rhizogenes — disarmed strains
|
|
|
|
Agrobacterium tumefaciens — disarmed strains
|
|
|
|
Lactobacillus
|
1. Non‑conjugative
plasmids
2. None
(non‑vector systems)
|
|
|
|
Oenococcus oeni syn. Leuconostoc oeni
|
|
|
|
Pediococcus
|
|
|
|
Photobacterium angustum
|
|
|
|
Pseudoalteromonas tunicate
|
|
|
|
Rhizobium (including the genus Allorhizobium)
|
|
|
|
Sphingopyxis alaskensis syn. Sphingomonas
alaskensis
|
|
|
|
Vibrio cholerae CVD103‑HgR
|
|
2
|
Fungi
|
Neurospora crassa –
laboratory strains
|
1. All vectors
2. None
(non‑vector systems)
|
|
|
|
Pichia pastoris
|
|
|
|
Saccharomyces cerevisiae
|
|
|
|
Schizosaccharomyces pombe
|
|
|
|
Kluyveromyces lactis
|
|
|
|
Trichoderma reesei
|
|
3
|
Slime moulds
|
Dictyostelium species
|
1. Dictyostelium
shuttle vectors, including those based on the endogenous plasmids Ddp1 and
Ddp2
2. None
(non‑vector systems)
|
|
4
|
Tissue culture
|
Animal or human cell cultures
(including packaging cell lines)
|
1. Non‑conjugative
plasmids
2. Non‑viral
vectors, or defective viral vectors (other than a retroviral vector that is
able to transduce human cells)
3. Avipox
vectors (attenuated vaccine strains)
4. Baculovirus
(Autographa californica nuclear polyhedrosis virus), polyhedrin minus
5. None
(non‑vector systems)
|
|
|
|
Plant cell cultures
|
1. Non‑tumorigenic
disarmed Ti plasmid vectors, or Ri plasmid vectors, in Agrobacterium
tumefaciens, Agrobacterium radiobacter or Agrobacterium rhizogenes
2. Non‑pathogenic
viral vectors
3. None
(non‑vector systems)
|
Part 3 Definitions
In this Schedule:
code for, in relation to a toxin, means to specify the amino acid sequence of
the toxin.
non‑conjugative plasmid means a
plasmid that is not self‑transmissible, and includes, but is not limited
to, non‑conjugative forms of the following plasmids:
(a) bacterial artificial chromosomes (BACs);
(b) cosmids;
(c) P1 artificial chromosomes (PACs);
(d) yeast artificial chromosomes (YACs).
non‑vector system
means a system by which donor nucleic acid is introduced (for example,
by electroporation or particle bombardment) into a host in the absence of a
nucleic acid‑based vector (for example, a plasmid, viral vector or
transposon).
Schedule 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 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 2 of this Schedule.
|
1.1 Kinds of dealings
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 Act, section
32).
|
2.1 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 paragraph 1.1 (h) of Part 1 of this Schedule) involving
cloning of nucleic acid encoding a toxin having an LD50 of less than 100 mg/kg;
(b) a dealing involving high level expression of
toxin genes, even if the LD50
is 100 mg/kg or more;
(c) a dealing (other than a dealing mentioned in
paragraph 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 paragraph 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 paragraph 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 paragraph 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 paragraph 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.
1. All legislative instruments and compilations are
registered on the Federal Register of Legislative Instruments kept under the Legislative
Instruments Act 2003. See www.frli.gov.au.