Source: https://www.legislation.gov.au/Details/F2007C00469
Timestamp: 2020-02-25 13:54:37
Document Index: 461578605

Matched Legal Cases: ['art 1', 'art 2', 'art 1', 'art 2', 'art 3', 'art 1', 'art 2', 'art 2', 'art 1', 'art 3', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 1', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'arts 5', 'art 6']

Details: F2007C00469
- F2007C00469
SR 2001 No. 106 Regulations as amended, taking into account amendments up to SLI 2007 No. 128
End Date 31 Dec 2007
F2007C00469
taking into account amendments up to SLI 2007 No. 128
9A Risks posed by dealings proposed to be authorised by licence 12
10 Risk assessment — matters to be taken into account 12
11 Prescribed conditions of licence 13
11A Time limit for deciding variation application 13
12 Notifiable low risk dealings 13
13 Requirements in relation to undertaking notifiable low risk dealings 14
13A Requirements in relation to notifying Regulator of notifiable low risk dealings 15
14 Regulator to decide certification application within 90 days 16
15 Application for certification — failure to provide section 85 information 16
16 Regulator to decide accreditation application within 90 days 17
17 Application for accreditation — failure to provide section 93 information 17
18 GTTAC members and advisers — term of appointment 18
19 GTTAC members and advisers — resignation 18
20 GTTAC members — disclosure of interests 18
21 GTTAC members and advisers — termination of appointment 19
22 GTTAC members — leave of absence 20
23 Expert advisers — disclosure of interests 20
24 Committee procedures generally 21
25 Committee meetings 21
26 Presiding member 22
27 Quorum 22
28 Voting 22
29 Records and Reports 23
30 Operation of subcommittees 23
31 GTCCC — conditions of appointment 24
32 GTCCC — Consultative Committee procedures 24
33 GTCCC — operation of subcommittees 25
34 GTEC — Conditions of appointment 26
35 GTEC — Committee procedures 26
36 GTEC — operation of subcommittees 27
37 Reviewable State decisions 28
38 Review of decisions 28
39 Record of GMO and GM Product Dealings 28
40 Inspector identity card 29
Schedule 1A Techniques that are not gene technology 30
Schedule 1 Organisms that are not genetically modified organisms 31
Schedule 2 Dealings exempt from licensing 32
Part 1 Exempt dealings 32
Part 2 Host/vector systems for exempt dealings 33
Schedule 3 Notifiable low risk dealings in relation to a GMO 38
Part 1 Notifiable low risk dealings suitable for physical containment level 1 38
Part 2 Notifiable low risk dealings suitable for physical containment level 2 39
Part 3 Dealings that are not notifiable low risk dealings 42
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.
13 Requirements in relation to undertaking notifiable low risk dealings
(a) a person or an accredited organisation has requested an Institutional Biosafety Committee to assess whether the proposed dealing is a notifiable low risk dealing; and
(b) the Committee has assessed the proposed dealing to be a notifiable low risk dealing; and
(c) the person who proposes to undertake the proposed dealing and the project supervisor for the proposed dealing have been notified that the Committee:
(i) has assessed the proposed dealing to be a notifiable low risk dealing; and
(ii) considers that the personnel to be involved in the proposed dealing have appropriate training and experience.
(2) A notifiable low risk dealing must comply with the following requirements:
(a) the dealing must be conducted:
(i) for a kind of dealing mentioned in Part 1 of Schedule 3 — in a facility that is certified by the Regulator to at least physical containment level 1 and is of appropriate design for the kind of dealing being undertaken; or
(ii) for a kind of dealing mentioned in Part 2 of Schedule 3 — in a facility that is certified by the Regulator to at least physical containment level 2 and is of appropriate design for the kind of dealing being undertaken; or
(iii) in another facility in accordance with any technical and procedural guidelines relating to containment of GMOs, as in force from time to time under paragraph 27 (d) of the Act, that the Regulator has determined in writing are appropriate for conducting the dealing; and
13A Requirements in relation to notifying Regulator of notifiable low risk dealings
(1) An Institutional Biosafety Committee that has assessed a proposed dealing to be a notifiable low risk dealing must:
(a) make a record of the proposed dealing in a form approved by the Regulator; and
(b) if the Regulator, by written notice given to the Committee, requests a copy of the record — give a copy of the record to the Regulator by the end of the period mentioned in the notice; and
(c) give a copy of the record to:
(i) the person or accredited organisation that requested the Committee to assess the proposed dealing; and
(ii) the project supervisor for the proposed dealing.
(2) The person or accredited organisation must:
(a) for the financial year in which the Committee assessed the proposed dealing, include a copy of the Committee’s record:
(i) for an accredited organisation — in the annual report given to the Regulator by the organisation for the financial year; or
(ii) in any other case — in a report given to the Regulator, in the form approved by the Regulator, by the person for the financial year; and
(b) retain a copy of the Committee’s record for 3 years after the date that the person or accredited organisation ceased to be involved with the conduct of the dealing.
(3) The Regulator may, by written notice, require:
(b) the person or accredited organisation; or
(c) any other person involved with the conduct of the proposed dealing;
to give the Regulator any further information about the dealing that the Regulator requires in order to be satisfied that the dealing is a notifiable low risk dealing.
(4) A Committee, person or accredited organisation receiving a notice under subregulation (3) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.
(1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 10 litres of GMO culture in each vessel containing the resultant culture.
(ii) is incapable of correcting a defect in the host/vector system leading to production of replication competent virions; and
(f) must not confer an oncogenic modification.
2. Non‑viral vectors, or defective viral vectors unable to transduce human cells
Part 1 Notifiable low risk dealings suitable for 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 of this Schedule.
The following kinds of notifiable low risk dealings may be conducted in physical containment level 1 facilities:
(a) a dealing involving a genetically modified laboratory mouse or a genetically modified laboratory rat, unless:
(ii) because of the genetic modification, the animal is capable of secreting or producing an infectious agent;
(b) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid confers an oncogenic modification;
(c) a dealing involving a defective viral vector able to transduce human cells in a host mentioned in item 4 of Part 2 of Schedule 2 (animal or human cell culture), unless:
(ii) the donor nucleic acid confers an oncogenic modification.
Part 2 Notifiable low risk dealings suitable for physical containment level 2
The following kinds of notifiable low risk dealings may be conducted in physical containment level 2 facilities:
(ii) is uncharacterised nucleic acid from an organism that has been implicated in, or has a history of causing, disease in human beings, animals, plants or fungi;
(i) a dealing involving the introduction of a replication defective viral vector able to transduce human cells into a host mentioned in Part 2 of Schedule 2 if:
(i) the donor nucleic acid is incapable of correcting a defect in the vector leading to production of replication competent virions; and
(a) a dealing (other than a dealing mentioned in paragraph 2.1 (h) of Part 2 of this Schedule) involving cloning of nucleic acid encoding a toxin having an LD50 of less than 100 mg/kg;
(c) a dealing (other than a dealing mentioned in paragraph 2.1 (h) of Part 2 of this Schedule) involving cloning of uncharacterised nucleic acid from a toxin‑producing organism;
(d) unless the viral vector is part of a host/vector system mentioned in Part 2 of Schedule 2 or in paragraph 1.1 (c) of Part 1 or 2.1 (i) of Part 2 of this Schedule — a dealing involving donor nucleic acid in a viral vector if the donor nucleic acid:
(iii) the dealing is a dealing mentioned in paragraph 2.1 (g) of Part 2 of this Schedule;
(i) the dealing is a dealing mentioned in paragraph 2.1 (g) of Part 2 of this Schedule; or
(i) a dealing involving a lentiviral vector unless:
(k) a dealing producing, in each vessel containing the resultant GMO culture, more than 10 litres of that culture, other than a dealing mentioned in paragraph 2.1 (f) of Part 2 of this Schedule;
Schedule 3: (see r. 2 (c) and Note 2)
(b) immediately after the commencement of Schedule 1 — Schedule 2;
rs. 2006 No. 314; 2007 No. 128
Gene Technology Amendment Regulations 2007 (No. 1) (2007 No. 128)
The following amendments commence on 1 January 2008 unless Part 2 of Schedule 1 to the Gene Technology Amendment Act 2007 is proclaimed earlier:
[1] Regulation 3, definition of expert adviser
[2] Regulation 3, note
[3] Paragraph 8 (2) (e)
Gene Technology Ethics Committee
[4] Subregulation 8 (3)
Gene Technology Ethics Committee,
Ethics and Community Committee,
[5] Parts 5 and 6
[6] Regulation 38
or Part 6
As at 1 July 2007 the amendments are not incorporated in this compilation.