Gene Technology Amendment Regulation 2020 (No 1) (ACT)
Gene Technology Amendment Regulation 2020 (No 1)
Subordinate Law SL2020-38
The Australian Capital Territory Executive makes the following regulation under the Gene Technology Act 2003.
Dated 8 September 2020.
Rachel Stephen-Smith
Minister
Gordon Ramsay
Minister
Gene Technology Amendment Regulation 2020 (No 1)
Subordinate Law SL2020-38
made under the
Gene Technology Act 2003
Contents
Page
1 Name of regulation 1
2 Commencement 1
3 Legislation amended 1
4 New section 4A 1
5 Section 5 2
6 Section 9 (b) 2
7 Section 12 (1) (a) 2
8 Section 13 (1) (b) 3
9 Section 13 (1) (d) 3
10 Section 13 (1) (e) 3
11 Section 13 (1) (f) 3
12 Section 13 (1) (i) and note 4
13 Section 13 (2) (b) 4
14 Section 13 (3) 4
15 Section 13A 4
16 Section 13B (a) (i) 5
17 Section 13B (a) (iii) and (iv) 5
18 Section 13B (a) (vii) 5
19 Section 13B (a) (x) 5
20 Section 13C (1) and (2) 6
21 Section 13C (3) 7
22 Section 39 7
23 New section 41 7
24 New part 10 8
25 Schedule 1A, new item 11 11
26 New schedule 1B 11
27 Schedule 1, new item 4 11
28 Schedule 1, new items 8 to 12 12
29 Schedule 2, part 2.1, item 4, column 2, subsection (2) (b) and (c) 12
30 Schedule 2, part 2.1, item 4, column 2, subsection (2) (e) 12
31 Schedule 2, part 2.1, item 5, column 2 13
32 Schedule 2, part 2.2 13
33 Schedule 3, section 3.1 17
34 Schedule 3, section 3.1 (c) 17
35 Schedule 3, section 3.2 18
36 Schedule 3, section 3.2 (d) 18
37 Schedule 3, section 3.2 (d) (ii) and (iii) 18
38 Schedule 3, section 3.2 (d), example 18
39 Schedule 3, section 3.2 (e) (i) 18
40 Schedule 3, section 3.2 (h) 19
41 Schedule 3, section 3.2 (i) 19
42 Schedule 3, section 3.2 (j) 19
43 Schedule 3, section 3.2 (k) 19
44 Schedule 3, section 3.2 (k) (ii) 20
45 Schedule 3, section 3.2 (l) 20
46 Schedule 3, section 3.2 (l) (i) 20
47 Schedule 3, section 3.2 (m) 20
48 Schedule 3, section 3.2 (m) (i) 20
49 Schedule 3, section 3.2 (m) (ii) 21
50 Schedule 3, section 3.2A 21
51 Schedule 3, part 3.3 heading, note 2 22
52 Schedule 3, section 3.3 (a) and (b) 22
53 Schedule 3, section 3.3 (d) and (e) 22
54 Schedule 3, section 3.3 (f) (ii) (B) 23
55 Schedule 3, section 3.3 (f) (ii), example 23
56 Schedule 3, new section 3.3 (q) to (s) 23
57 Schedule 3, new section 3.3 (2) to (4) 24
58 Dictionary, note 3 24
59 Dictionary, note 3 25
60 Dictionary, definition of characterised 25
61 Dictionary, new definitions 25
62 Dictionary, definition of toxin‑producing organism 26
63 Dictionary, new definition of vector 26
64 Further amendments, mentions of part 2.2 26
Schedule 1 Delayed amendment 27
Name of regulation
This regulation is the Gene Technology Amendment Regulation 2020 (No 1).
Commencement
(1)This regulation (other than schedule 1) commences on the day after its notification day.
NoteThe naming and commencement provisions automatically commence on the notification day (see Legislation Act, s 75 (1)).
(2)Schedule 1 commences on 8 October 2020.
Legislation amended
This regulation amends the Gene Technology Regulation 2004.
New section 4A
insert
4AOrganisms that are genetically modified organisms
For the Act, dictionary, definition of genetically modified organism, paragraph (c), an organism mentioned in schedule 1B is a genetically modified organism.
Section 5
substitute
Organisms that are not genetically modified organisms
For the Act, dictionary, definition of genetically modified organism, paragraph (e), an organism is not a genetically modified organism if—
(a)1 or more items mentioned in schedule 1 applies to the organism; and
(b)the organism has not been modified by gene technology, other than any modification mentioned in schedule 1; and
(c)the organism has not inherited any traits from an organism (the initial organism) that occurred in the initial organism because of gene technology, other than as mentioned in schedule 1, item 9; and
(d)none of the items mentioned in schedule 1B applies to the organism.
Section 9 (b)
substitute
(b)the Commonwealth department administered by the Minister administering the Biosecurity Act 2015 (Cwlth), chapter 8, part 1 (Biosecurity emergencies);
Section 12 (1) (a)
substitute
(a)it is a dealing of a kind mentioned in schedule 3, part 3.1 or part 3.2; and
(aa)it is not a dealing of a kind mentioned in schedule 3, part 3.3; and
Section 13 (1) (b)
substitute
(b)the institutional biosafety committee has assessed the dealing to be a kind of dealing—
(i)mentioned in schedule 3, part 3.1 or part 3.2; and
(ii)not mentioned in schedule 3, part 3.3; and
Section 13 (1) (d)
substitute
(d)the dealing is only undertaken not later than the day 5 years after the date of the assessment; and
Section 13 (1) (e)
after
the person is mentioned in
insert
, or is in a class of people mentioned in,
Section 13 (1) (f)
substitute
(f)subject to subsection (3), the dealing is undertaken in facilities that—
(i)are mentioned in, or are in a class of facilities mentioned in, the institutional biosafety committee’s record of assessment as being appropriate for the dealing; and
(ii)are facilities in which the dealing may be undertaken under subsection (2); and
Section 13 (1) (i) and note
omit
Section 13 (2) (b)
substitute
(b)for a kind of dealing mentioned in schedule 3, section 3.2, but not in section 3.2A—in a facility certified by the regulator to at least physical containment level 2 and that is appropriate for the dealing; or
(ba)for a kind of dealing mentioned in schedule 3, section 3.2A—in a facility certified by the regulator to at least physical containment level 3 and that is appropriate for the dealing; or
Section 13 (3)
substitute
(3)If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with subsections (1) (f) and (2), if it is conducted in accordance with—
(a)the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, issued by the regulator under the Commonwealth Act, section 27 (d); or
(b)transportation, storage or disposal requirements that the Regulator has agreed, in writing, are appropriate for the containment of the GMO.
Section 13A
omit
Section 13B (a) (i)
omit
proposing to undertake the dealing
substitute
that submitted the proposal
Section 13B (a) (iii) and (iv)
substitute
(iii)its assessment whether the dealing is a kind of dealing mentioned in schedule 3, part 3.1 or part 3.2, and not mentioned in schedule 3, part 3.3;
(iv)if the committee has assessed the dealing to be a kind of dealing mentioned in schedule 3, part 3.1 or part 3.2 (and not mentioned in schedule 3, part 3.3)—which kind of dealing in those parts that the dealing is;
Section 13B (a) (vii)
after
the dealing
insert
, having regard to the requirements of section 13 (2)
Section 13B (a) (x)
omit
or accredited organisation
Section 13C (1) and (2)
substitute
(1)A person or accredited organisation that has been given a copy of a record of assessment by an institutional biosafety committee under section 13B (b) must, if the dealing has been assessed by the committee as a notifiable low risk dealing, give the regulator a record of the dealing.
(2)For subsection (1), a record of a dealing must include—
(a)the particulars, prescribed under section 39 in relation to the dealing, to be included in the record of GMO dealings; and
(b)the name of the committee that assessed the proposal relating to the dealing; and
(c)the name of the person or accredited organisation that submitted the proposal to the committee for assessment.
(2A)The record must be given to the regulator—
(a)in a form approved by the regulator; and
(b)not later than 30 September in the financial year following the financial year in which the institutional biosafety committee made the assessment.
(2B)An accredited organisation that is required to, as a condition of accreditation, give an annual report to the regulator, must—
(a)include the record in the annual report for the year in which the institutional biosafety committee made the assessment; or
(b)certify in the annual report that the record has previously been given to the regulator.
Section 13C (3)
after
an institutional biosafety committee
insert
under section 13B (b)
Section 39
substitute
Record of GMO dealings
For the Act, section 138 (2) (b), the following particulars are prescribed for a notifiable low risk dealing notified to the regulator:
(a)the person that proposed to undertake the dealing, as recorded by the institutional biosafety committee that assessed the dealing as a notifiable low risk dealing;
(b)the kind of notifiable low risk dealing (described using the terms in schedule 3, part 3.1 or part 3.2);
(c)the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the institutional biosafety committee for assessment;
(d)the date of assessment by the institutional biosafety committee that the dealing is a notifiable low risk dealing.
New section 41
insert
Disapplication of Legislation Act, s 47 (5)
The Legislation Act, section 47 (5) does not apply to AS/NZS 2243.3:2010 under this regulation.
New part 10
insert
Part 10Transitional—Gene Technology Amendment Regulation 2020 (No 1)
Meaning of commencement day—pt 10
In this part:
commencement day means the day the Gene Technology Amendment Regulation 2020 (No 1), section 3 commences.
Changed requirements—former exempt dealings
(1)This section applies if—
(a)immediately before the commencement day—
(i)a person was undertaking a dealing; and
(ii)the dealing was an exempt dealing; and
(b)on or after the commencement day—the dealing is not an exempt dealing.
(2)The dealing is taken to be an exempt dealing if the dealing is undertaken by the person on or after the commencement day.
(3)This section applies until the earliest of—
(a)the day the dealing is assessed to be a notifiable low risk dealing by an institutional biosafety committee; and
(b)the day a GMO licence for the dealing is issued to the person; and
(c)12 months after the commencement day.
Changed requirements—former notifiable low risk dealings
(1)This section applies if—
(a)immediately before the commencement day—
(i)a person was undertaking a dealing; and
(ii)the dealing was a notifiable low risk dealing; and
(b)on or after the commencement day—the dealing is not—
(i)a notifiable low risk dealing; or
(ii)an exempt dealing.
(2)The dealing is taken to be a notifiable low risk dealing if the dealing is undertaken by the person on or after the commencement day.
(3)This section applies until the earlier of—
(a)the day a GMO licence for the dealing is issued to the person; and
(b)12 months after the commencement day.
Changed requirements—notifiable low risk dealings
(1)This section applies if a person was undertaking a notifiable low risk dealing immediately before the commencement day.
(2)For the Act, section 37, the dealing is taken to be undertaken in accordance with this regulation if the dealing is undertaken in accordance with this regulation as in force—
(a)immediately before the commencement day; or
(b)on or after the commencement day.
Previous assessment by institutional biosafety committee
(1)This section applies if—
(a)before the commencement day, an institutional biosafety committee assessed a dealing to be a notifiable low risk dealing mentioned in schedule 3, part 3.1 or part 3.2; and
(b)the record of the committee’s assessment does not indicate that the committee assessed whether the dealing is of a kind mentioned in schedule 3, part 3.3.
(2)The committee is taken to have assessed the dealing to be a kind of dealing that is not mentioned in schedule 3, part 3.3.
Giving records to regulator for notifiable low risk dealings assessed in previous financial year
(1)This section applies to a dealing that has been assessed by an institutional biosafety committee to be a notifiable low risk dealing—
(a)on or after 1 July 2019; but
(b)before the commencement day.
(2)Section 13C as in force on the commencement day applies in relation to the dealing.
Expiry—pt 10
This part expires 12 months after the commencement day.
NoteTransitional provisions are kept in the regulation for a limited time. A transitional provision is repealed on its expiry but continues to have effect after its repeal (see Legislation Act, s 88).
Schedule 1A, new item 11
insert
| 11 | introduction of RNA into an organism if— (a) the RNA cannot be translated into a polypeptide; and (b) the introduction of the RNA cannot result in an alteration of the organism’s genome sequence; and (c) the introduction of the RNA cannot give rise to an infectious agent |
New schedule 1B
after schedule 1A, insert
Schedule 1B Organisms that are genetically modified organisms
(see s 4A)
| column 1 item | column 2 description of organism |
| 1 | an organism that has had its genome modified by oligonucleotide‑directed mutagenesis |
| 2 | an organism modified by repair of single‑strand or double‑strand breaks of genomic DNA induced by a site‑directed nuclease, if a nucleic acid template was added to guide homology‑directed repair |
Schedule 1, new item 4
insert
| 4 | an organism modified by repair of single‑strand or double‑strand breaks of genomic DNA induced by a site‑directed nuclease, if a nucleic acid template was not added to guide homology‑directed repair |
Schedule 1, new items 8 to 12
insert
| 8 | an organism that is descended from a genetically modified organism (the initial organism) if none of the traits it has inherited from the initial organism are traits that occurred in the initial organism because of gene technology |
| 9 | an organism that has inherited particular traits from an organism (the initial organism) that occurred in the initial organism because of gene technology, if— (a) the initial organism was not a genetically modified organism (because of the application of section 5); or (b) all such inherited traits are traits that occurred in the initial organism as a result of a modification mentioned in an item in this schedule |
| 10 | an organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are no longer present |
| 11 | Agrobacterium radiobacter strain K1026 |
| 12 | Pasteurella multocida strain PMP1 |
Schedule 2, part 2.1, item 4, column 2, subsection (2) (b) and (c)
omit
100 mg/kg
substitute
100 micrograms per kilogram
Schedule 2, part 2.1, item 4, column 2, subsection (2) (e)
substitute
(e) if the donor nucleic acid includes a viral sequence—cannot give rise to infectious agents when introduced into any potential host species without additional non‑host genes or gene products that—
(i)are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and
(ii)will not become available during the dealing; and
(f) if the donor nucleic acid includes a viral sequence—cannot restore replication competence to the vector.
Schedule 2, part 2.1, item 5, column 2
omit
part 2.2, item 1
substitute
table 2.2, items 1 to 6
Schedule 2, part 2.2
substitute
Part 2.2Host/vector systems for exempt dealings
2.2Hosts and vectors
In this part:
host means a host mentioned in column 3 of an item in table 2.2.
host/vector system means any of the following:
(a)a system involving a host mentioned in column 3 of an item in table 2.2 and a vector mentioned in column 4 of the item;
(b)a non‑vector system involving a host mentioned in column 3 of an item in table 2.2;
(c)a system involving a GMO mentioned as a vector in column 4 of an item in table 2.2 (other than item 7), without a host.
vector means a vector mentioned in column 4 of an item in table 2.2.
NoteColumn 2 of table 2.2 is included for information only.
Table 2.2
| column 1 item | column 2 class | column 3 host | column 4 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 | any of the following: (a) non‑conjugative plasmids; (b) lambda bacteriophage; (c) lambdoid bacteriophage; (d) Fd, F1 or M13 bacteriophage |
| 2 | bacteria | Bacillus—asporogenic strains of the following species with a reversion frequency of less than 10–7: (a) B. amyloliquefaciens; (b) B. licheniformis; (c) B. pumilus; (d) B. subtilis; (e) B. thuringiensis | any of the following: (a) non‑conjugative plasmids; (b) other plasmids and phages whose host range does not include B. cereus, B. anthracis or any other pathogenic strain of Bacillus |
| 3 | bacteria | Pseudomonas putida strain KT2440 | non‑conjugative plasmids |
| 4 | bacteria | the following Streptomyces 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 | any of the following: (a) non‑conjugative plasmids; (b) plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives; (c) actinophage phi C31 and derivatives |
| 5 | bacteria | any of the following: (a) Agrobacterium radiobacter; (b) Agrobacterium rhizogenes (disarmed strains only); (c) Agrobacterium tumefaciens (disarmed strains only) | disarmed Ri or Ti plasmids |
| 6 | bacteria | any of the following: (a) Allorhizobium species; (b) Corynebacterium glutamicum; (c) Lactobacillus species; (d) Lactococcus lactis; (e) Oenococcus oeni syn. Leuconostoc oeni; (f) Pediococcus species; (g) Photobacterium angustum; (h) Pseudoalteromonas tunicata; (i) Rhizobium species; (j) Sphingopyxis alaskensis syn. Sphingomonas alaskensis; (k) Streptococcus thermophilus; (l) Synechococcus species strains PCC 7002, PCC 7942 and WH 8102; (m) Synechocystis species strain PCC 6803; (n) Vibrio cholerae CVD 103‑HgR; (o) Zymomonas mobilis | non‑conjugative plasmids |
| 7 | fungi | any of the following: (a) Kluyveromyces lactis; (b) Neurospora crassa (laboratory strains); (c) Pichia pastoris; (d) Saccharomyces cerevisiae; (e) Schizosaccharomyces pombe; (f) Trichoderma reesei; (g) Yarrowia lipolytica | all vectors |
| 8 | slime moulds | Dictyostelium species | Dictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2 |
| 9 | 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 | any of the following: (a) plasmids; (b) replication defective viral vectors unable to transduce human cells; (c) polyhedron-minus forms of the baculovirus Autographa californica nuclear polyhedrosis virus (ACNPV) |
| 10 | tissue culture | 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 | any of the following: (a) Disarmed Ri or Ti plasmids in Agrobacterium radiobacter, Agrobacterium rhizogenes (disarmed strains only) or Agrobacterium tumefaciens (disarmed strains only); (b) non‑pathogenic viral vectors |
Schedule 3, section 3.1
omit
or 13 (3) (b)
substitute
or 13 (3)
Schedule 3, section 3.1 (c)
substitute
(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 column 3 of item 9 in schedule 2, table 2.2 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.
Schedule 3, section 3.2
omit
or 13 (3) (b)
substitute
or 13 (3)
Schedule 3, section 3.2 (d)
omit everything before subparagraph (i), substitute
(d)a dealing involving a host/vector system not mentioned in schedule 2, table 2.2 if—
Schedule 3, section 3.2 (d) (ii) and (iii)
omit
donor nucleic acid
substitute
genetic modification
Schedule 3, section 3.2 (d), example
omit
Donor nucleic acid
substitute
A genetic modification
Schedule 3, section 3.2 (e) (i)
substitute
(i)is characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; or
Schedule 3, section 3.2 (h)
omit
part 2.2, item 1
substitute
table 2.2, items 1 to 6
Schedule 3, section 3.2 (i)
substitute
(i)a dealing involving virions of a replication defective viral vector unable to transduce human cells and a host not mentioned in schedule 2, table 2.2 if the donor nucleic acid cannot restore replication competence to the vector;
Schedule 3, section 3.2 (j)
substitute
(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 schedule 2, table 2.2, if—
(i)the donor nucleic acid cannot restore replication competence to the vector; and
(ii)the dealing is not a dealing mentioned in section 3.1 (c);
Schedule 3, section 3.2 (k)
omit everything before subparagraph (i), substitute
(k)a dealing involving virions of a replication defective non‑retroviral vector able to transduce human cells and a host not mentioned in schedule 2, table 2.2 if—
Schedule 3, section 3.2 (k) (ii)
substitute
(ii)the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;
Schedule 3, section 3.2 (l)
omit everything before subparagraph (i), substitute
(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 schedule 2, table 2.2, if—
Schedule 3, section 3.2 (l) (i)
omit
into a virion
substitute
new virions
Schedule 3, section 3.2 (m)
omit everything before subparagraph (i), substitute
(m)a dealing involving virions of a replication defective retroviral vector able to transduce human cells and a host not mentioned in schedule 2, table 2.2 if—
Schedule 3, section 3.2 (m) (i)
substitute
(i)the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans; and
Schedule 3, section 3.2 (m) (ii)
omit
into a virion
substitute
new virions
Schedule 3, section 3.2A
substitute
3.2AKinds of dealing suitable for at least physical containment level 3
(1)This section applies to a kind of dealing that—
(a)is mentioned in section 3.2; and
(b)involves a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3.
(2)Unless section 13 (2) (c) or 13 (3) applies, the dealing must be undertaken in facilities that are—
(a)certified to at least physical containment level 3; and
(b)appropriate for the dealings.
(3)For subsection (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.
(4)However, subsection (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in section 3.2 (l) or (m).
Schedule 3, part 3.3 heading, note 2
substitute
Note 2If a dealing is not a notifiable low risk dealing or an exempt dealing under this regulation, 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 Act, s 32).
Schedule 3, section 3.3 (a) and (b)
omit
100 mg/kg
substitute
100 micrograms per kilogram
Schedule 3, section 3.3 (d) and (e)
substitute
(d)a dealing involving virions of a replication defective viral vector and a host not mentioned in schedule 2, table 2.2 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 section 3.2 (i);
(e)a dealing involving a replication competent virus or viral vector, other than a vector mentioned in schedule 2, table 2.2, column 4, if the genetic modification confers an oncogenic modification or immunomodulatory effect in humans;
Schedule 3, section 3.3 (f) (ii) (B)
omit
donor nucleic acid
substitute
genetic modification
Schedule 3, section 3.3 (f) (ii), example
omit
Donor nucleic acid
substitute
A genetic modification
Schedule 3, new section 3.3 (q) to (s)
insert
(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 in a facility—
(i)that is certified by the regulator to at least physical containment level 3 and that is appropriate for the dealing; or
(ii)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).
NoteA 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.
Schedule 3, new section 3.3 (2) to (4)
insert
(2)For subsection (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 subsection (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, subsection (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in section 3.2 (l) or (m).
Dictionary, note 3
insert
· accredited organisation
· environment
· facility
· gene technology technical advisory committee
· intentional release of a GMO into the environment (see s 11)
Dictionary, note 3
omit
· GM product
Dictionary, definition of characterised
substitute
characterised means—
(a)in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or
(b)in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of—
(i)potential gene products or potential functions of the gene or genomic region; and
(ii)the likely effect of the genetic modification on the gene products or functions.
Dictionary, new definitions
insert
host, for part 2.2 (Host/vector systems for exempt dealings)—see schedule 2, section 2.2.
host/vector system, for part 2.2 (Host/vector systems for exempt dealings)—see schedule 2, section 2.2.
Dictionary, definition of toxin‑producing organism
omit
100 mg/kg
substitute
100 micrograms per kilogram
Dictionary, new definition of vector
insert
vector, for part 2.2 (Host/vector systems for exempt dealings)—see schedule 2, section 2.2.
Further amendments, mentions of part 2.2
omit
part 2.2
substitute
table 2.2
in
· schedule 2, part 2.1, item 4 (1)
· schedule 3, section 3.2 (c), (e) and (f)
· schedule 3, section 3.3 (f) (ii) (A), (g) (ii) and (h)
Schedule 1Delayed amendment
(see s 3)
[1.1]Schedule 1, item 1
omit
Endnotes
Notification
Notified under the Legislation Act on 8 September 2020.
Republications of amended laws
For the latest republication of amended laws, see align="center">© Australian Capital Territory 2020
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