Schedule 1 Amendments
(regulation 3)
[1] Regulation 3, after definition of animal
insert
AS/NZS 2243.3:2010 means the Australian/New
Zealand Standard Safety in laboratories Part 3: Microbiological safety and
containment, jointly published by Standards Australia and Standards New
Zealand, as in force on 1 September 2011.
[2] Regulation 3, after definition of expert adviser
insert
genetically modified laboratory guinea pig means
a laboratory strain of guinea pig of the species Cavia porcellus that
has been modified by gene technology.
[3] Regulation 3, after definition of genetically
modified laboratory mouse
insert
genetically modified laboratory rabbit means
a laboratory strain of rabbit of the species Oryctolagus cuniculus that
has been modified by gene technology.
[4] Regulation 3, after definition of infectious
agent
insert
inspector means a person appointed by the
Regulator under section 150 of the Act as an inspector.
[5] Regulation 3, definition of oncogenic
modification
substitute
oncogenic modification means a genetic
modification capable of contributing to tumour formation, including
modifications that cause at least 1 of the following:
(a) defects in DNA proofreading and repair;
(b) defects in chromosome maintenance;
(c) defects in cell cycle checkpoint mechanisms;
(d) uncontrolled cell proliferation;
(e) resistance to apoptosis;
(f) cellular immortalisation.
[6] Regulation 5A
omit
making available inspectors appointed under section 150 of the Act
insert
making inspectors available
[7] Paragraph 6 (1) (d)
omit
environment; and
insert
environment.
[8] Paragraph 6 (1) (e)
omit
[9] Regulation 11A
substitute
11A Time limit for deciding
variation application
(1) For subsection 71 (7) of the Act, the
Regulator must vary the licence, or refuse to vary the licence, within 90 days
after the day an application for a variation of the licence is received by the
Regulator.
(2) For the period mentioned in subregulation (1),
the following days are not counted:
(a) a Saturday, a Sunday or a public holiday in
the Australian Capital Territory;
(b) a day on which the Regulator cannot proceed
with the decision-making process, or a related function, because the Regulator
is waiting for information that the applicant has been asked, in writing, to
give.
[10] Paragraph 12 (1) (a)
substitute
(a) it is a dealing of a kind mentioned in Part 1
or 2 of Schedule 3 (other than a dealing also mentioned in Part 3
of Schedule 3); and
[11] Regulation 13
substitute
13 Requirements for
undertaking notifiable low risk dealings
(1) A person may undertake a notifiable low risk
dealing only if:
(a) a person or an accredited organisation has
prepared and submitted a written proposal for an Institutional Biosafety
Committee to assess whether the dealing is a notifiable low risk dealing; and
(b) the Institutional Biosafety Committee has
assessed the dealing to be a notifiable low risk dealing mentioned in Part 1 or
2 of Schedule 3; and
(c) the dealing undertaken is the dealing described
in the Institutional Biosafety Committee’s record of assessment of the proposal;
and
(d) the dealing is only undertaken before the day
mentioned in regulation 13A for the dealing; and
(e) the person is mentioned in the
Institutional Biosafety Committee’s record of assessment as having the
appropriate training and experience to undertake the dealing; and
(f) the dealing is undertaken in facilities
mentioned in the Institutional Biosafety Committee’s record of assessment as
being appropriate for the dealing; and
(g) the person keeps or can give, on request, a
copy of the Institutional Biosafety Committee’s record of assessment to an
inspector; and
(h) the person does not compromise the
containment of a GMO involved in the dealing; and
(i) the person undertakes
the dealing in accordance with subregulations (2) and (3).
Note A person complies with paragraph (e)
if the person is in a class of persons that an Institutional Biosafety
Committee has included in the record of assessment as having the appropriate
training and experience to undertake the dealing. Similarly, a person complies
with paragraph (f) if the facility in which the person undertakes the
dealing is in a class of facilities that an Institutional Biosafety Committee
has included in the record of assessment as being appropriate for the dealing.
(2) A notifiable low risk dealing must be undertaken:
(a) for a kind of dealing mentioned in Part 1
of Schedule 3 — in a facility certified by the Regulator to at least
physical containment level 1 and that is appropriate for the dealing; or
(b) for a kind of dealing mentioned in Part 2
of Schedule 3:
(i) that is not a dealing mentioned in
subparagraph (ii) — in a facility certified by the Regulator to at
least physical containment level 2 and that is appropriate for the dealing; or
(ii) that involves a micro-organism that
satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 —
in a facility certified by the Regulator to at least physical containment level
3 and that is appropriate for the dealing; or
(c) in a facility that the Regulator has agreed
in writing is a facility in which the dealing may be undertaken.
(3) However, if a notifiable low risk dealing involves
the transportation, storage or disposal of a GMO, the transportation, storage
or disposal:
(a) may only be undertaken before the day
mentioned in regulation 13A as being the day on or before which the dealing
must stop being undertaken; and
(b) may happen outside a facility mentioned in
subregulation (2), but in that case must be conducted in accordance with:
(i) the Guidelines for the
Transport, Storage and Disposal of GMOs, as in force on 1 September 2011,
that have been issued by the Regulator for this purpose under paragraph 27 (d)
of the Act; or
(ii) transportation, storage or
disposal requirements that the Regulator has agreed in writing are appropriate
for the containment of the GMO.
(4) For paragraph (2) (c), the Regulator must
consider the capacity of a facility to contain GMOs before deciding whether to agree,
in writing, to a facility.
[12] Regulation 13A
substitute
13A Time limits for stopping notifiable
low risk dealings
For paragraph 13 (1) (d), the day on or
before which the dealing described in the record of assessment of the dealing must
stop being undertaken is:
(a) the day 5 years after the date of assessment,
if the dealing is assessed by an Institutional Biosafety Committee on or after 1 September 2011;
and
(b) 31 August 2016, if the dealing is assessed
by an Institutional Biosafety Committee in the period 31 March 2008
to 31 August 2011 (inclusive); and
(c) 31 March 2015, if the dealing is assessed
by an Institutional Biosafety Committee before 31 March 2008.
Note A person will have to apply for, and
obtain, a new assessment of the dealing as a notifiable low risk dealing from
an Institutional Biosafety Committee to continue to undertake the dealing after
the applicable day mentioned in this regulation.
13B Requirements for Institutional
Biosafety Committees about records of assessments of notifiable low risk
dealing proposals
An Institutional Biosafety Committee that has
assessed a proposal as to whether a dealing is a notifiable low risk dealing
must:
(a) make a record of its assessment, in a form
approved by the Regulator, that includes the following:
(i) the identifying name of the
dealing to be undertaken that was given to the dealing by the person or
accredited organisation proposing to undertake the dealing;
(ii) a description of the dealing to be
undertaken;
(iii) its assessment whether the dealing
is a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3;
(iv) if the Committee has assessed the
dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of
Schedule 3, the kind of notifiable low risk dealing that the dealing is, in
terms of those Parts;
(v) the date of the Committee’s assessment
of the dealing;
(vi) the persons or classes of persons
considered by the Committee to have the appropriate training and experience to
undertake the dealing;
(vii) the facilities or classes of facilities
the Committee considers to be of the appropriate physical containment level and
type for the dealing;
(viii) the name of the Committee that
assessed the proposal;
(ix) the name of the person or
accredited organisation that submitted the proposal;
(x) the name of the person or
accredited organisation proposing to undertake the dealing; and
(b) give a copy of the record of assessment to the
person or accredited organisation that submitted the proposal to the Committee.
13C Information to be kept or
given to the Regulator by persons or accredited organisations
(1) A person or an accredited organisation that has
been given a copy of a record of assessment by an Institutional Biosafety
Committee must, if the dealing has been assessed by the Committee as a
notifiable low risk dealing, give the Regulator a record of the proposed
dealing, in the form approved by the Regulator, that includes:
(a) the particulars, prescribed under regulation 39 (1)
in relation to the dealing, to be included in the Record of GMO and GM Product
Dealings; and
(b) the name of the Committee that assessed the
dealing; and
(c) the name of the person or accredited
organisation that submitted the proposal for assessment of the dealing to the
Committee.
(2) The record of the proposed dealing mentioned in
subregulation (1) must be given to the Regulator in the financial year in
which the Institutional Biosafety Committee made the assessment:
(a) by an accredited organisation — in the
annual report for the financial year to be given by the organisation to the Regulator;
or
(b) by any other person — in a report for
the financial year to be given by the person to the Regulator, in the form
approved by the Regulator.
(3) A person or accredited organisation given a copy of
a record of assessment by an Institutional Biosafety Committee must keep a copy
of the Committee’s record of assessment for 8 years after the date of the
assessment.
(4) The Regulator may at any time, by written notice,
require from the following persons or organisations further information about how
a notifiable low risk dealing is being undertaken, including information about
a GMO being dealt with:
(a) the person or accredited organisation that
submitted the proposal for assessment of the dealing;
(b) any other person involved with undertaking
the dealing.
(5) A person or organisation given a notice under
subregulation (4) must, by the end of the period mentioned in the notice,
give the Regulator the information required by the notice.
[13] Paragraph 39 (1) (b)
after
Part 1
insert
or 2
[14] Paragraph 39 (1) (d)
substitute
(d) the date of assessment by an Institutional
Biosafety Committee that the dealing is a notifiable low risk dealing.
[15] Schedule 1, item 7, subparagraph (b) (i)
omit
AS/NZS 2243.3:2002 (Safety in laboratories, Part 3:
Microbiological aspects and containment facilities) jointly published by
Standards Australia and Standards New Zealand
insert
AS/NZS 2243.3:2010
[16] Schedule 2, Part 1, after item 3
insert
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3A
|
A dealing with an animal whose somatic cells have been genetically
modified in vivo by a replication defective viral vector, if:
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(a) the in vivo
modification occurred as part of a previous dealing; and
(b) the replication defective viral vector is no longer
in the animal; and
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(c) no germ line cells have been genetically modified;
and
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(d) the somatic cells cannot give rise to infectious
agents as a result of the genetic modification; and
(e) the animal is not infected with a virus that can
recombine with the genetically modified nucleic acid in the somatic cells of
the animal.
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[17] Schedule 2, Part 1, subitem 4 (1)
omit
10
insert
25
[18] Schedule 2, Part 1, subitem 4 (2)
substitute
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(2) The
donor nucleic acid:
(a) must meet either of the following requirements:
(i) it must not be derived from organisms
implicated in, or with a history of causing, disease in otherwise healthy:
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
(ii) it must be
characterised and the information derived from its characterisation show that
it is unlikely to increase the capacity of the host or vector to cause harm;
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Example
Donor nucleic acid would not comply with subparagraph
(ii) if its characterisation shows that, 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; and
(b) must not code for a toxin
with an LD50 of
less than 100 mg/kg; and
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(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) cannot restore replication competence to the
vector.
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[19] Schedule 2, Part 2
substitute
Part 2 Host/vector systems for exempt dealings
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Item
|
Class
|
Host
|
Vector
|
|
1
|
Bacteria
|
Escherichia coli K12, E. coli B, E.
coli C or E. coli Nissle 1917 — 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)
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|
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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)
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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)
|
|
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Agrobacterium radiobacter
Agrobacterium rhizogenes —
disarmed strains
Agrobacterium tumefaciens —
disarmed strains
|
1. Non‑tumorigenic
disarmed Ti plasmid vectors, or Ri plasmid vectors
2. None (non‑vector systems)
|
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Lactobacillus
Lactococcus lactis
Oenococcus oeni syn. Leuconostoc
oeni
Pediococcus
Photobacterium angustum
Pseudoalteromonas tunicata
Rhizobium (including the
genus Allorhizobium)
Sphingopyxis alaskensis syn.
Sphingomonas alaskensis
Streptococcus thermophilus
|
1. Non‑conjugative
plasmids
2. None (non‑vector systems)
|
|
|
|
Synechococcus —
specified strains:
(a) PCC 7002
(b) PCC
7942
(c) WH
8102
Synechocystis species —
strain PCC 6803
Vibrio cholerae CVD103‑HgR
|
|
|
2
|
Fungi
|
Kluyveromyces
lactis
Neurospora
crassa — laboratory strains
Pichia
pastoris
Saccharomyces
cerevisiae
Schizosaccharomyces
pombe
Trichoderma
reesei
Yarrowia lipolytica
|
1. All vectors
2. None (non‑vector systems)
|
|
3
|
Slime moulds
|
Dictyostelium species
|
1. Dictyostelium
shuttle vectors, including those based on the endogenous plasmids Ddp1 and
Ddp2
2. None (non‑vector systems)
|
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4
|
Tissue culture
|
Any of the following if they cannot spontaneously generate
a whole animal:
(a) animal
or human cell cultures (including packaging cell lines);
(b) isolated
cells, isolated tissues or isolated organs, whether animal or human;
(c) early
non-human mammalian embryos cultured in vitro
|
1. Non‑conjugative
plasmids
2. Non‑viral vectors, or replication
defective viral vectors unable to transduce human cells
3. Baculovirus (Autographa
californica nuclear polyhedrosis virus), polyhedrin minus
4. None (non‑vector systems)
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Either of the following if they are not intended, and are
not likely without human intervention, to vegetatively propagate, flower or
regenerate into a whole plant:
(a) plant
cell cultures;
(b) isolated
plant tissues or organs
|
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)
|
[20] Schedule 2, Part 3, definition of non-vector
system
substitute
non-vector system means a system in which
donor nucleic acid is or was introduced into a host cell:
(a) in the absence of a nucleic acid-based
vector; or
(b) using a nucleic acid-based vector in the
course of a previous dealing and the vector is:
(i) no longer present; or
(ii) present but cannot be remobilised
from a host cell.
Example 1
A system mentioned in paragraph (a) might involve the
use of electroporation or particle bombardment.
Example 2
A system mentioned in paragraph (b) might involve cells
that were transduced with a replication defective retroviral vector in which no
vector particles remain.
[21] Schedule 3
substitute
Schedule 3 Notifiable low risk dealings in relation to a GMO
(regulations 12 and 13)
Part 1 Notifiable
low risk dealings suitable for at least physical containment level 1
|
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.
|
1.1 Kinds of dealings suitable for at least
physical containment level 1
The following kinds of notifiable low
risk dealings must be undertaken, unless paragraph 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 item 4 of Part 2 of Schedule 2, 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 2 Notifiable
low risk dealings suitable for at least physical containment level 2 or 3
|
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.
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2.1 Kinds of dealings
suitable for at least physical containment level 2
The following kinds of notifiable low
risk dealings must be undertaken, unless paragraph 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 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 and vector not
mentioned as a host/vector system 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 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 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) 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 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 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 viral vector unable to transduce human cells into 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 the introduction of a
replication defective non-retroviral vector able to transduce human cells,
other than a dealing mentioned in paragraph 1.1 (c), into a host mentioned
in Part 2 of Schedule 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 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:
(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 Part 2 of Schedule 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 Part 2 of Schedule 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.
2.2 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 paragraph 13 (2) (c) or (3) (b)
applies, in facilities that are:
(a) certified to at least physical containment
level 3; and
(b) appropriate for the dealing.
Part 3 Dealings
that are not notifiable low risk dealings
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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 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 Act, section
32).
|
3.1 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 2.1 (h)) 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 2.1 (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 Part 2 of
Schedule 2, other than a dealing mentioned in paragraph 2.1 (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 Part 2 of Schedule 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
sub-subparagraphs apply:
(A) the host/vector system
is a system mentioned in Part 2 of Schedule 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 paragraph 2.1 (g);
Example
Donor nucleic acid 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.