Commonwealth Numbered Regulations Commonwealth Numbered Regulations
1.1 Genetically modified organisms
For the purposes of regulation 4A, an organism is a genetically modified organism if an item in the following table applies to the organism.
Organisms that are genetically modified organisms | |
| Item | 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 |
26 Schedule 1 (after table item 3)
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. |
27 Schedule 1 (at the end of the table)
Add:
| 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 ), being traits 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 regulation 5); or (b) all such inherited traits are traits that occurred in the initial organism as a result of a modification described 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. |
28 Part 1 of Schedule 2 (table item 4, column headed "Description of dealing", subparagraph (2)(a)(ii))
Omit "harm;", substitute "harm; and".
29 Part 1 of Schedule 2 (table item 4, column headed "Description of dealing", example)
Omit "transmissibility; and", substitute "transmissibility.".
30 Part 1 of Schedule 2 (table item 4, column headed "Description of dealing", paragraphs (2)(b) and (c))
Omit "100 m g/kg", substitute "100 micrograms per kilogram".
31 Part 1 of Schedule 2 (table item 4, column headed "Description of dealing", paragraph (2)(e))
Repeal the paragraph, 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.
32 Part 1 of Schedule 2 (table item 5, column headed "Description of dealing")
Omit "item 1 of", substitute "items 1 to 6 of the table in".
33 Part 2 of Schedule 2
Repeal the Part, substitute:
Part 2 -- Host/vector systems for exempt dealings
(1) A reference to a host mentioned in this Part is a reference to a host mentioned in column 2 of an item of the table in this clause.
(2) A reference to a vector mentioned in this Part is a reference to a vector mentioned in column 3 of an item of the table in this clause.
(3) A reference to a host/vector system mentioned in this Part is a reference to any of the following:
(a) a system involving a host mentioned in column 2 of an item of the table in this clause and a vector mentioned in column 3 of the same item;
(b) a non-vector system involving a host mentioned in column 2 of an item of the table;
(c) a system involving a GMO mentioned as a vector in column 3 of an item of the table (except item 7), without a host.
Note: Column 1 of the table is included for information only.
| Hosts and vectors | |||
|
Item | Column 1 | Column 2 | Column 3 |
|
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 CVD103-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) polyhedrin 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 |
34 Clause 1.1 of Schedule 3
Omit "13(3)(b)", substitute "subregulation 13(3)".
35 Paragraph 1.1(c) of Schedule 3
Repeal the paragraph, 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 item 9 of Part 2 of Schedule 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.
36 Clause 2.1 of Schedule 3
Omit "13(3)(b)", substitute "subregulation 13(3)".
37 Paragraph 2.1(d) of Schedule 3
Omit "host and vector not mentioned as a host/vector system", substitute "host/vector system not mentioned".
38 Subparagraphs 2.1(d)(ii) and (iii) of Schedule 3
Omit "donor nucleic acid", substitute "genetic modification".
39 Paragraph 2.1(d) of Schedule 3 (example)
Omit "Donor nucleic acid", substitute "A genetic modification".
40 Subparagraph 2.1(e)(i) of Schedule 3
Repeal the subparagraph, substitute:
(i) is characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; or
41 Paragraph 2.1(h) of Schedule 3
Omit "item 1 of", substitute "items 1 to 6 of the table in".
42 Paragraph 2.1(i) of Schedule 3
Omit "the introduction", substitute "virions".
43 Paragraph 2.1(i) of Schedule 3
Omit "into", substitute "and".
44 Paragraph 2.1(j) of Schedule 3
Repeal the paragraph, 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 Part 2 of Schedule 2, if:
(i) the donor nucleic acid cannot restore replication competence to the vector; and
(ii) the dealing is not a dealing mentioned in paragraph 1.1(c);
45 Paragraph 2.1(k) of Schedule 3
Omit "the introduction", substitute "virions".
46 Paragraph 2.1(k) of Schedule 3
Omit "into", substitute "and".
47 Subparagraph 2.1(k)(ii) of Schedule 3
Repeal the subparagraph, substitute:
(ii) the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;
48 Paragraph 2.1(l) of Schedule 3
Omit all the words 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 Part 2 of Schedule 2, if:
49 Subparagraph 2.1(l)(i) of Schedule 3
Omit "into a virion", substitute "new virions".
50 Paragraph 2.1(m) of Schedule 3
Omit "the introduction", substitute "virions".
51 Paragraph 2.1(m) of Schedule 3
Omit "into a host", substitute "and a host".
52 Subparagraph 2.1(m)(i) of Schedule 3
Repeal the subparagraph, substitute:
(i) the donor nucleic acids does not confer an oncogenic modification or immunomodulatory effect in humans; and
53 Subparagraph 2.1(m)(ii) of Schedule 3
Omit "into a virion", substitute "new virions".
54 Clause 2.2 of Schedule 3
Repeal the clause, substitute:
2.2 Kinds of dealing suitable for at least physical containment level 3
(1) A kind of dealing that:
(a) is a kind mentioned in clause 2.1; and
(b) involves 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 subregulation 13(3) applies, in facilities certified to at least physical containment level 3 and that are appropriate for the dealings.
(2) For the purposes of paragraph (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.
(3) However, subclause (2) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).
55 Part 3 of Schedule 3 (note 2 to Part heading)
Repeal the note, substitute:
Note 2: If a dealing is not a notifiable low risk dealing, or an exempt dealing, as provided by these Regulations, 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 section 32 of the Act.
56 Clause 3.1 of Schedule 3
Before "A dealing", insert "(1)".
57 Paragraphs 3.1(a) and (b) of Schedule 3
Omit "100 m g/kg", substitute "100 micrograms per kilogram".
58 Paragraph 3.1(d) of Schedule 3
Repeal the paragraph, substitute:
(d) a dealing involving virions of a replication defective viral vector and a host not mentioned in Part 2 of Schedule 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 paragraph 2.1(i);
59 Paragraph 3.1(e) of Schedule 3
Omit all the words after "if the", substitute "genetic modification confers an oncogenic modification or immunomodulatory effect in humans;".
60 Sub-subparagraph 3.1(f)(ii)(B) of Schedule 3
Omit "donor nucleic acid", substitute "genetic modification".
61 Subparagraph 3.1(f)(ii) of Schedule 3 (example)
Omit "Donor nucleic acid", substitute "A genetic modification".
62 At the end of clause 3.1 of Schedule 3
Add:
; (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:
(i) in a facility that is certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or
(ii) in a facility 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).
Note: A 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.
(2) For the purposes of paragraph (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 the purposes of paragraph (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, subclause (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).
Schedule 2 -- Amendments commencing 1 July 2020
Gene Technology Regulations 2001
1 Paragraph 13(1)(b)
Repeal the paragraph, substitute:
(b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and
2 Subparagraph 13B(a)(i)
Omit "proposing to undertake the dealing", substitute "that submitted the proposal".
3 Subparagraphs 13B(a)(iii) and (iv)
Repeal the subparagraphs, substitute:
(iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;
(iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)--which kind of dealing in those Parts that the dealing is;
4 Subparagraph 13B(a)(vii)
After "dealing", insert ", having regard to the requirements of subregulation 13(2)".
5 Subparagraph 13B(a)(x)
Omit "the name of the person or accredited organisation", substitute "the person or persons".
6 Subregulations 13C(1) and (2)
Repeal the subregulations, substitute:
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 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) A record of a dealing for the purposes of subregulation (1) must include:
(a) the particulars, prescribed under regulation 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) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.
(2B) An accredited organisation that is required, as a condition of accreditation, to 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.
7 Subregulation 13C(3)
After "Institutional Biosafety Committee", insert "under paragraph 13B(b)".
8 Regulation 39
Repeal the regulation, substitute:
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(a) the person or persons 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, in terms of Part 1 or 2 of Schedule 3;
(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.
9 At the end of Division 1 of Part 8
Add:
42 Previous assessment by an Institutional Biosafety Committee
(1) This regulation applies if:
(a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; 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 Part 3 of Schedule 3.
(2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.
Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Schedule 3 -- Amendments commencing 18 months after registration
Gene Technology Regulations 2001
1 Schedule 1 (table item 1)
Repeal the item.