Annex: Gene Technology Regulations 2001. 

Title: Gene Technology Regulations, 2001
Authors: Office of the Gene Technology Regulator (OGTR)
Publisher: Commonwealth of Australia
Publication details: May 2001. 78p.
Further information: Available on the Office of the Gene Technology Regulator website: http://www.ogtr.gov.au

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Contents

Part 1 Preliminary

1 Name of Regulations 5
2 Commencement 5
3 Definitions 5

Part 2 Interpretation and general operation

4 Techniques not constituting gene technology 7
5 Organisms that are not genetically modified organisms 7

Part 3 Dealings with GMOs

Division 1 Licensing system 7 Application for licence — prescribed information 8
8 Time limit for deciding an application 9
9 Prescribed authorities 11
10 Risk assessment — matters to be taken into account 11
11 Prescribed conditions of licence 12

Division 2 Notifiable low risk dealings
12 Notifiable low risk dealings 12
13 Requirements in relation to notifiable low risk dealings 12

Division 3 Certification and accreditation
14 Regulator to decide certification application within 90 days 14
15 Application for certification — failure to provide section 85 information 14
16 Regulator to decide accreditation application within 90 days 15
17 Application for accreditation — failure to provide section 93 information 15

Part 4 Gene Technology Technical Advisory Committee

Division 1 Conditions of appointment
18 GTTAC members and advisers — term of appointment 16
19 GTTAC members and advisers — resignation 16
20 GTTAC members — disclosure of interests 16
21 GTTAC members and advisers — termination of appointment 17
22 GTTAC members — leave of absence 18
23 Expert advisers — disclosure of interests 18

Division 2 Committee procedures
24 Committee procedures generally 19
25 Committee meetings 19
26 Presiding member 20
27 Quorum 20
28 Voting 20
29 Records and Reports 21

Division 3 Subcommittees
30 Operation of subcommittees 21

Part 5 Gene Technology Community

Consultative Committee
31 GTCCC — conditions of appointment 22
32 GTCCC — Consultative Committee procedures 22
33 GTCCC — operation of subcommittees 23

Part 6 Gene Technology Ethics Committee

34 GTEC — Conditions of appointment 24
35 GTEC — Committee procedures 24
36 GTEC — operation of subcommittees 25

Part 7 Miscellaneous

37 Reviewable State decisions 26
38 Review of decisions 26
39 Record of GMO and GM Product Dealings 26
40 Inspector identity card 27

Part 8 Transitional

41 Existing facilities — certification 28
42 Existing organisations — accreditation 29

Schedule 1 Organisms that are not genetically modified organisms 30
Part 1 Organisms 30
Part 2 Species known to exchange DNA by a known physiological process 31

Schedule 2 Dealings exempt from licensing 33
Part 1 Exempt dealings 33
Part 2 Host/vector systems for exempt dealings 34
Part 3 Definitions 36

Schedule 3 Notifiable low risk dealings in relation to a GMO 37
Part 1 Dealings that are notifiable low risk dealings 37
Part 2 Dealings (higher risk) that are not notifiable low risk dealings 39
Part 3 Prescribed information — notification of proposed notifiable low risk dealing 40

Schedule 4 Prescribed information — application for a licence 44
Part 1 Dealings not involving an intentional release of a GMO into the environment (Division 3 of Part 5 of the Act) 44
Part 2 Dealings involving an intentional release of a GMO into the environment (Division 4 of Part 5 of the Act) 52

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