Gene Technology Amendment Regulations 2019 (Vic)
Gene Technology Amendment Regulations 2019
S.R. No. 91/2019
TABLE OF PROVISIONS
Regulation Page
Part 1—Preliminary
1Objective
2Authorising provision
3Commencement
4Principal Regulations
Part 2—Amendments commencing 8 October 2019
5Definitions
6Techniques not constituting gene technology
7New regulation 4A inserted
8Regulation 5 substituted
9Prescribed authorities
10Notifiable low risk dealings
11Requirements for undertaking notifiable low risk dealings
12Regulation 13A revoked
13New Division 1 heading in Part 8 inserted
14Definition in Division 1 of Part 8
15New Division 2 of Part 8 inserted
16Schedule 1A—Techniques that are not gene technology
17New Schedule 1B inserted
18Schedule 1—Organisms that are not genetically modified organisms
19Schedule 2—Dealings exempt from licensing
20Schedule 3—Notifiable low risk dealings in relation to a GMO
Part 3—Amendments commencing 1 July 2020
21Requirements for undertaking notifiable low risk dealings
22Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals
23Information to be kept or given to the Regulator by persons or accredited organisations
24Regulation 39 substituted
25New regulations 49 and 50 inserted
Part 4—Amendments commencing 8 October 2020
26Schedule 1—Organisms that are not genetically modified organisms
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Endnotes
STATUTORY RULES 2019
S.R. No. 91/2019
Gene Technology Act 2001
Gene Technology Amendment Regulations 2019
The Lieutenant-Governor as the Governor's deputy, with the advice of the Executive Council, makes the following Regulations:
Dated: 8 October 2019
Responsible Minister:
JENNY MIKAKOS
Minister for HealthPIETA TAVROU
Clerk of the Executive Council
Part 1—Preliminary
1Objective
The objective of these Regulations is to amend the Gene Technology Regulations 2011—
(a)to clarify the scope of the Gene Technology Regulations 2011 by identifying types of scientific techniques that constitute gene technology for the purposes of the Gene Technology Act 2001; and
(b)to specify certain types of organisms that are not genetically modified organisms; and
(c)to specify certain types of organisms that are genetically modified organisms; and
(d)to clarify requirements for undertaking notifiable low risk dealings and the scope of exempt dealings; and
(e)to clarify record-keeping requirements and procedures for assessments of notifiable low risk dealing proposals.
2Authorising provision
These Regulations are made under section 193 of the Gene Technology Act 2001.
3Commencement
(1)These Regulations, except Parts 3 and 4, come into operation on 8 October 2019.
(2)Part 3 comes into operation on 1 July 2020.
(3)Part 4 comes into operation on 8 October 2020.
4Principal Regulations
In these Regulations, the Gene Technology Regulations 2011[1] are called the Principal Regulations.
Part 2—Amendments commencing 8 October 2019
5Definitions
(1)In regulation 3 of the Principal Regulations, for the 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;".
(2)In regulation 3 of the Principal Regulations insert the following definition—
"host/vector system has a meaning affected by clause 2.1(3) of Schedule 2;".
(3)In regulation 3 of the Principal Regulations, for the definition of non‑vector system substitute—
"non‑vector system has the meaning given in Part 3 of Schedule 2;".
(4)In regulation 3 of the Principal Regulations, in the definition of toxin producing organism, for "100 mg/kg" substitute "100 micrograms per kilogram".
6Techniques not constituting gene technology
In regulation 4 of the Principal Regulations, for "section 10" substitute "section 10(1)".
7New regulation 4A inserted
After regulation 4 of the Principal Regulations insert—
4AOrganisms that are genetically modified organisms"
For the purposes of paragraph (c) of the definition of genetically modified organism in section 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.".
8Regulation 5 substituted
For regulation 5 of the Principal Regulations substitute—
5Organisms that are not genetically modified organisms"
For the purposes of paragraph (e) of the definition of genetically modified organism in section 10(1) of the Act, an organism is not a genetically modified organism if—
(a)one or more items in Schedule 1 applies to the organism; and
(b)the organism has not been modified by gene technology except for any modifications described in those items; and
(c)the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and
(d)none of the items in Schedule 1B applies to the organism.".
9Prescribed authorities
For regulation 9(f) of the Principal Regulations substitute—
"(f)that part of the Department of Health of the Commonwealth known as the Therapeutic Goods Administration.".
10Notifiable low risk dealings
For regulation 12(1)(a) of the Principal Regulations substitute—
"(a)it is a dealing of a kind mentioned in Part 1 or 2 of Schedule 3; and
(ab)it is not a dealing of a kind mentioned in Part 3 of Schedule 3; and".
11Requirements for undertaking notifiable low risk dealings
(1)For regulation 13(1)(d) of the Principal Regulations substitute—
"(d)the dealing is only undertaken no later than the day 5 years after the date of the assessment; and".
(2)In regulation 13(1)(e) of the Principal Regulations, after "is mentioned in" insert ", or is in a class of persons mentioned in,".
(3)For regulation 13(1)(f) of the Principal Regulations substitute—
"(f)subject to subregulation (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 subregulation (2) permits the dealing to be undertaken; and".
(4)In regulation 13(1)(h) of the Principal Regulations, for "dealing; and" substitute "dealing.".
(5)Regulation 13(1)(i) of the Principal Regulations is revoked.
(6)The note at the foot of regulation 13(1) of the Principal Regulations is revoked.
(7)For regulation 13(2)(b) of the Principal Regulations substitute—
"(b)for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—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 clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or".
(8)For regulation 13(3) of the Principal Regulations 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 paragraph (1)(f) and subregulation (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, that have been issued by the Regulator under paragraph 27(d) of the Act; or
(b)transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.".
12Regulation 13A revoked
Regulation 13A of the Principal Regulations is revoked.
13New Division 1 heading in Part 8 inserted
Before regulation 41 of the Principal Regulations insert—
"Division 1—Gene Technology Regulations 2001".
14Definition in Division 1 of Part 8
In regulation 41 of the Principal Regulations, for "Part" substitute "Division".
15New Division 2 of Part 8 inserted
After regulation 44 of the Principal Regulations insert—
"Division 2—Gene Technology Amendment Regulations 2019
45Definitions
In this Division—
amending Regulations means the Gene Technology Amendment Regulations 2019;
former Regulations means these Regulations as in force immediately before 8 October 2019;
new Regulations means these Regulations as amended by the amending Regulations.
Note
This regulation differs from the equivalent transitional provision in the Commonwealth Regulations.
46Former exempt dealings
(1)If—
(a)a person was undertaking a dealing before 8 October 2019; and
(b)the dealing was an exempt dealing under the former Regulations; and
(c)the dealing is not (apart from under this regulation) an exempt dealing under the new Regulations—
then, despite the amendments by the amending Regulations, the dealing is a notifiable low risk dealing when undertaken by the person.
(2)Subregulation (1) ceases to apply on the earliest of the following—
(a)the dealing being assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee;
(b)the person being issued a GMO licence for the dealing;
(c)8 October 2020.
Note
This regulation differs from the equivalent transitional provision in the Commonwealth Regulations.
47Former notifiable low risk dealings
(1)If—
(a)a person was undertaking a dealing before 8 October 2019; and
(b)the dealing was a notifiable low risk dealing under the former Regulations; and
(c)the dealing—
(i)is not (apart from under this regulation) a notifiable low risk dealing under the new Regulations; and
(ii)is not an exempt dealing—
then, despite the amendments by the amending Regulations, the dealing is a notifiable low risk dealing when undertaken by the person.
(2)Subregulation (1) ceases to apply on the earliest of the following occurring—
(a)the person being issued a GMO licence for the dealing;
(b)8 October 2020.
Note
This regulation differs from the equivalent transitional provision in the Commonwealth Regulations.
48Changed requirements for notifiable low risk dealings
(1)If a person was undertaking a notifiable low risk dealing before 8 October 2019, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if—
(a)it is undertaken in accordance with the former Regulations; or
(b)it is undertaken in accordance with the new Regulations.
(2)Subregulation (1) ceases to apply on 8 October 2020.".
16Schedule 1A—Techniques that are not gene technology
In the table in Schedule 1A to the Principal Regulations, after item 10 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.".
17New Schedule 1B inserted
After Schedule 1A to the Principal Regulations insert—
"Schedule 1B—Organisms that are genetically modified organisms
Regulation 4A
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.
".
18Schedule 1—Organisms that are not genetically modified organisms
(1)In the table in Schedule 1 to the Principal Regulations, after 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.". (2)In the table in Schedule 1 to the Principal Regulations, after item 7 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), 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.".
19Schedule 2—Dealings exempt from licensing
(1)In the table in Part 1 of Schedule 2 to the Principal Regulations—
(a)in item 4(2)(a)(ii), for "harm;" substitute "harm; and";
(b)in the example at the foot of item 4(2)(a)(ii), for "transmissibility; and" substitute "transmissibility.";
(c)in item 4(2)(b) and (c), for "100 mg/kg" substitute "100 micrograms per kilogram";
(d)for item 4(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.";
(e)in item 5, for "item 1 of" substitute "items 1 to 6 of the table in".
(2)For Part 2 of Schedule 2 to the Principal Regulations substitute—
"Part 2—Host/vector systems for exempt dealings
2.1Hosts and vectors
(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 Host class | Column 2 Hosts | Column 3 Vectors |
| 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; | Any of the following— (a) non‑conjugative plasmids; |
| (c) S. cyaneus; (d) S. griseus; (e) S. lividans; (f) S. parvulus; (g) S. rimosus; (h) S. venezuelae | (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; | Non‑conjugative plasmids |
| (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 | |||
| 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 |
".
20Schedule 3—Notifiable low risk dealings in relation to a GMO
(1)In clause 1.1 of Part 1 of Schedule 3 to the Principal Regulations—
(a)for "13(3)(b)" substitute "subregulation 13(3)";
(b)for paragraph (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 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.".
(2)In clause 2.1 of Part 2 of Schedule 3 to the Principal Regulations—
(a)for "13(3)(b)" substitute "subregulation 13(3)";
(b)in paragraph (d), for "host and vector not mentioned as a host/vector system" substitute "host/vector system not mentioned";
(c)in paragraph (d)(ii) and (iii), for "donor nucleic acid" substitute "genetic modification";
(d)in the example at the foot of paragraph (d)(iii), for "Donor nucleic acid" substitute "A genetic modification";
(e)for paragraph (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";
(f)in paragraph (h), for "item 1 of" substitute "items 1 to 6 of the table in";
(g)in paragraph (i), for "the introduction of a replication defective viral vector unable to transduce human cells into" substitute "virions of a replication defective viral vector unable to transduce human cells and";
(h)for paragraph (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 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) of Part 1;";
(i)in paragraph (k), for "the introduction of a replication defective non-retroviral vector able to transduce human cells into" substitute "virions of a replication defective non-retroviral vector able to transduce human cells and";
(j)for paragraph (k)(ii) substitute—
"(ii)the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;";
(k)in paragraph (l), for "the introduction of a replication defective retroviral vector able to transduce human cells into" substitute "virions of a replication defective retroviral vector able to transduce human cells, either without a host or with";
(l)in paragraph (l)(i), for "into a virion" substitute "new virions";
(m)in paragraph (m), for "the introduction of a replication defective retroviral vector able to transduce human cells into" substitute "virions of a replication defective retroviral vector able to transduce human cells and";
(n)for paragraph (m)(i) substitute—
"(i)the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans; and";
(o)in paragraph (m)(ii), for "into a virion" substitute "new virions".
(3)For clause 2.2 of Part 2 of Schedule 3 to the Principal Regulations substitute—
2.2Kinds 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 of a class of micro-organism referred to in clause 2.2(1)(b) in Part 2 of Schedule 3 to the Commonwealth Regulations—
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 referred to in clause 2.2(1)(b) in Part 2 of Schedule 3 to the Commonwealth Regulations 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).".
(4)For Note 2 to Part 3 of Schedule 3 to the Principal Regulations substitute—
"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.". (5)In clause 3.1 of Part 3 of Schedule 3 to the Principal Regulations—
(a)in paragraphs (a) and (b), for "100 mg/kg" substitute "100 micrograms per kilogram";
(b)for paragraphs (d) and (e) 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);
(e)a dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the genetic modification confers an oncogenic modification or immunomodulatory effect in humans;";
(c)in paragraph (f)(ii)(B), for "donor nucleic acid" substitute "genetic modification";
(d)in the example at the foot of paragraph (f)(ii)(C) for "Donor nucleic acid" substitute "A genetic modification";
(e)in paragraph (p), for "clause 3.1(p) in Part 3 of Schedule 3 to the Commonwealth Regulations." substitute "clause 3.1(1)(p) in Part 3 of Schedule 3 to the Commonwealth Regulations;";
(f)after paragraph (p) insert—
"(q)a dealing involving a micro‑organism that is of a class of micro-organism referred to in clause 3.1(1)(p) in Part 3 of Schedule 3 to the Commonwealth Regulations 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.".
(6)Before the note at the foot of clause 3.1 of Part 3 of Schedule 3 to the Principal Regulations insert—
"(2)For the purposes of paragraph (1)(p), a genetically modified micro‑organism is taken to satisfy the criteria referred to in clause 3.1(2) in Part 3 of Schedule 3 to the Commonwealth Regulations 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 referred to in clause 3.1(3) in Part 3 of Schedule 3 to the Commonwealth Regulations 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).".
Part 3—Amendments commencing 1 July 2020
21Requirements for undertaking notifiable low risk dealings
For regulation 13(1)(b) of the Principal Regulations 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".
22Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals
In regulation 13B(a) of the Principal Regulations—
(a)in subparagraph (i), for "proposing to undertake the dealing" substitute "that submitted the proposal";
(b)for subparagraphs (iii) and (iv) 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;";
(c)in subparagraph (vii), after "dealing" insert ", having regard to the requirements of regulation 13(2)";
(d)in subparagraph (x), for "the name of the person or accredited organisation" substitute "the person or persons".
23Information to be kept or given to the Regulator by persons or accredited organisations
(1)For regulation 13C(1) and (2) of the Principal Regulations substitute—
"(1)A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under regulation 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.".
(2)In regulation 13C(3) of the Principal Regulations, after "Institutional Biosafety Committee" insert "under regulation 13B(b)".
24Regulation 39 substituted
For regulation 39 of the Principal Regulations substitute—
39Record of GMO Dealings"
For the purposes of section 138(2) 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.".
25New regulations 49 and 50 inserted
After regulation 48 of the Principal Regulations insert—
"49 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.
50New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year
On and from the commencement of regulation 23 of the amending Regulations, regulation 13C as amended by regulation 23 of the amending Regulations 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.
Note
This regulation differs from the equivalent transitional provision in the Commonwealth Regulations.".
Part 4—Amendments commencing 8 October 2020
26Schedule 1—Organisms that are not genetically modified organisms
Item 1 in the table in Schedule 1 to the Principal Regulations is revoked.
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Endnotes
[1] Reg. 4: S.R. No. 91/2011 as amended by S.R. No. 130/2016.
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