Download Word 
Download PDF Bill home page
Table Of Contents
Next Fragment
-
Bill
- Part 1—Preliminary
- Part 2—Interpretation and operation of Act
- Part 3—The Gene Technology Regulator
- Part 4—Regulation of dealings with GMOs
- Part 5—Licensing system
- Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register
- Part 7—Certification and accreditation
- Part 8—The Gene Technology Technical Advisory Committee, the Gene Technology Community Consultative Group and the Gene Technology Ethics Committee
- Part 9—Administration
- Part 10—Enforcement
- Part 11—Powers of inspection
- Part 12—Miscellaneous
1998-1999-2000
The Parliament of the
Commonwealth of Australia
HOUSE OF REPRESENTATIVES
Presented and read a first time
Gene Technology Bill 2000
No. , 2000
(Health and Aged Care)
A Bill for an Act to regulate activities involving gene technology, and for related purposes
Contents
Part 1—Preliminary 1
1............ Short title............................................................................................. 1
2............ Commencement................................................................................... 1
3............ Object of Act....................................................................................... 2
4............ Regulatory framework to achieve object............................................. 2
5............ Nationally consistent scheme.............................................................. 2
6............ Act to bind the Crown......................................................................... 2
7............ External Territories.............................................................................. 3
8............ Offences.............................................................................................. 3
Part 2—Interpretation and operation of Act 4
Division 1—Simplified outline 4
9............ Simplified outline................................................................................ 4
Division 2—Definitions 5
10.......... Definitions.......................................................................................... 5
11.......... Meaning of intentional release of a GMO into the environment ....... 10
12.......... Meaning of corresponding State law ................................................ 10
Division 3—Operation of Act 12
13.......... Operation of Act............................................................................... 12
14.......... Wind-back of reach of Act................................................................ 12
15.......... Relationship to other Commonwealth laws....................................... 13
Division 4—Provisions to facilitate a nationally consistent scheme 14
Subdivision A—General provisions 14
16.......... State laws may operate concurrently................................................. 14
17.......... Conferral of functions on Commonwealth officers and bodies......... 14
18.......... No doubling-up of liabilities............................................................. 15
19.......... Review of certain decisions............................................................... 16
20.......... Things done for multiple purposes.................................................... 16
Subdivision B—Policy principles, policy guidelines and codes of practice 16
21.......... Ministerial Council may issue policy principles................................ 16
22.......... Consultation on policy principles...................................................... 17
23.......... Ministerial Council may issue policy guidelines............................... 17
24.......... Ministerial Council may issue codes of practice................................ 18
Part 3—The Gene Technology Regulator 19
25.......... Simplified outline.............................................................................. 19
26.......... The Gene Technology Regulator....................................................... 19
27.......... Functions of the Regulator................................................................ 19
28.......... Powers of the Regulator.................................................................... 20
29.......... Delegation......................................................................................... 20
30.......... Independence of the Regulator.......................................................... 20
Part 4—Regulation of dealings with GMOs 22
Division 1—Simplified outline 22
31.......... Simplified outline.............................................................................. 22
Division 2—Dealings with GMOs must be licensed 23
32.......... Person not to deal with a GMO without a licence............................. 23
33.......... Person not to deal with a GMO without a licence—strict liability offence 24
34.......... Person must not breach conditions of a GMO licence...................... 24
35.......... Person must not breach conditions of a GMO licence—strict liability offence 25
36.......... Person must not breach conditions on GMO Register...................... 26
37.......... Offence relating to notifiable low risk dealings................................. 26
38.......... Aggravated offences—significant damage to health or safety of people or to the environment 27
Part 5—Licensing system 28
Division 1—Simplified outline 28
39.......... Simplified outline.............................................................................. 28
Division 2—Licence applications 29
40.......... Person may apply for a licence.......................................................... 29
41.......... Application may be withdrawn......................................................... 29
42.......... Regulator may require applicant to give further information............. 30
43.......... Regulator must consider applications except in certain circumstances 30
44.......... Regulator may consult with applicant................................................ 30
45.......... Regulator must not use certain information in considering licence application 31
Division 3—Initial consideration of licences for dealings not involving intentional release of a GMO into the environment 32
46.......... Applications to which this Division applies...................................... 32
47.......... What the Regulator must do in relation to application....................... 32
Division 4—Initial consideration of licences for dealings involving intentional release of a GMO into the environment 33
48.......... Applications to which this Division applies...................................... 33
49.......... Dealings that may pose significant risks to the health and safety of people or the environment 33
50.......... Regulator must prepare risk assessment and risk management plan.. 34
51.......... Matters Regulator must take into account in preparing risk assessment and risk management plan 35
52.......... Public notification of risk assessment and risk management plan..... 36
53.......... Regulator may take other actions....................................................... 37
54.......... Person may request copies of certain documents.............................. 38
Division 5—Decision on licence etc. 39
55.......... Regulator must make a decision on licence and licence conditions.... 39
56.......... Regulator must not issue the licence unless satisfied as to risk management 39
57.......... Other circumstances in which Regulator must not issue the licence.. 40
58.......... Matters to be taken into account in deciding whether a person is suitable to hold a licence 40
59.......... Notification of licence decision......................................................... 41
60.......... Period of licence................................................................................ 41
Division 6—Conditions of licences 42
61.......... Licence is subject to conditions......................................................... 42
62.......... Conditions that may be prescribed or imposed.................................. 42
63.......... Condition about informing people of obligations.............................. 43
64.......... Condition about monitoring and audits............................................. 43
65.......... Condition about additional information to be given to the Regulator. 44
66.......... Person may give information to Regulator........................................ 44
67.......... Protection of persons who give information..................................... 45
Division 7—Suspension, cancellation and variation of licences 46
68.......... Suspension and cancellation of licence.............................................. 46
69.......... Surrender of licence.......................................................................... 46
70.......... Transfer of licences........................................................................... 46
71.......... Variation of licence........................................................................... 47
72.......... Regulator to notify of proposed suspension, cancellation or variation 48
Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register 50
Division 1—Simplified outline 50
73.......... Simplified outline.............................................................................. 50
Division 2—Notifiable low risk dealings 51
74.......... Notifiable low risk dealings.............................................................. 51
75.......... Regulation of notifiable low risk dealings......................................... 51
Division 3—The GMO Register 53
76.......... GMO Register.................................................................................. 53
77.......... Contents of Register.......................................................................... 53
78.......... Regulator may include dealings with GMOs on GMO Register....... 53
79.......... Regulator not to make determination unless risks can be managed... 54
80.......... Variation of GMO Register.............................................................. 54
81.......... Inspection of Register....................................................................... 55
Part 7—Certification and accreditation 56
Division 1—Simplified outline 56
82.......... Simplified outline.............................................................................. 56
Division 2—Certification 57
83.......... Application for certification............................................................... 57
84.......... When the Regulator may certify the facility....................................... 57
85.......... Regulator may require applicant to give further information............. 57
86.......... Conditions of certification................................................................. 57
87.......... Variation of certification.................................................................... 58
88.......... Suspension or cancellation of certification........................................ 58
89.......... Regulator to notify of proposed suspension, cancellation or variation 58
90.......... Guidelines......................................................................................... 59
Division 3—Accredited organisations 60
91.......... Application for accreditation............................................................. 60
92.......... Regulator may accredit organisations................................................ 60
93.......... Regulator may require applicant to give further information............. 60
94.......... Conditions of accreditation................................................................ 61
95.......... Variation of accreditation.................................................................. 61
96.......... Suspension or cancellation of accreditation....................................... 61
97.......... Regulator to notify of proposed suspension, cancellation or variation 61
98.......... Guidelines......................................................................................... 62
Part 8—The Gene Technology Technical Advisory Committee, the Gene Technology Community Consultative Group and the Gene Technology Ethics Committee 64
Division 1—Simplified outline 64
99.......... Simplified outline.............................................................................. 64
Division 2—The Gene Technology Technical Advisory Committee 65
100........ The Gene Technology Technical Advisory Committee..................... 65
101........ Function of the Gene Technology Technical Advisory Committee... 66
102........ Expert advisers.................................................................................. 67
103........ Remuneration.................................................................................... 67
104........ Members and procedures.................................................................. 67
105........ Subcommittees.................................................................................. 68
Division 3—The Gene Technology Community Consultative Group 69
106........ The Gene Technology Community Consultative Group................... 69
107........ Function of Consultative Group........................................................ 69
108........ Membership...................................................................................... 69
109........ Remuneration.................................................................................... 70
110........ Regulations....................................................................................... 71
Division 4—The Gene Technology Ethics Committee 72
111........ The Gene Technology Ethics Committee.......................................... 72
112........ Function of the Gene Technology Ethics Committee........................ 73
113........ Expert advisers.................................................................................. 73
114........ Remuneration.................................................................................... 73
115........ Members and procedures.................................................................. 74
116........ Subcommittees.................................................................................. 75
Part 9—Administration 76
Division 1—Simplified outline 76
117........ Simplified outline.............................................................................. 76
Division 2—Appointment and conditions of Regulator 77
118........ Appointment of the Regulator........................................................... 77
119........ Termination of appointment.............................................................. 77
120........ Disclosure of interests....................................................................... 78
121........ Acting appointment........................................................................... 78
122........ Terms and conditions........................................................................ 79
123........ Outside employment......................................................................... 79
124........ Remuneration.................................................................................... 79
125........ Leave of absence............................................................................... 80
126........ Resignation....................................................................................... 80
Division 3—Money 81
127........ Regulator may charge for services.................................................... 81
128........ Notional payments by the Commonwealth........................................ 81
129........ Gene Technology Account................................................................ 81
130........ Credits to Account............................................................................ 81
131........ Recovery of amounts........................................................................ 82
132........ Purposes of Account......................................................................... 82
Division 4—Staffing 84
133........ Staff assisting the Regulator.............................................................. 84
134........ Consultants....................................................................................... 84
135........ Seconded officers.............................................................................. 84
Division 5—Reporting requirements 85
136........ Annual Report................................................................................... 85
137........ Reports to Parliament........................................................................ 85
Division 6—Record of GMO and GM Product Dealings 86
138........ Record of GMO and GM Product Dealings..................................... 86
139........ Inspection of Record......................................................................... 87
Division 7—Reviews of notifiable low risk dealings and exemptions 88
140........ Regulator may review notifiable low risk dealings............................ 88
141........ Regulator may review exemptions.................................................... 88
142........ Regulator may give notice of consideration....................................... 88
143........ What Regulator may do after consideration....................................... 89
144........ Regulator not required to review matters........................................... 90
Part 10—Enforcement 91
145........ Simplified outline.............................................................................. 91
146........ Regulator may give directions........................................................... 91
147........ Injunctions........................................................................................ 93
148........ Forfeiture.......................................................................................... 93
Part 11—Powers of inspection 95
Division 1—Simplified outline 95
149........ Simplified outline.............................................................................. 95
Division 2—Appointment of inspectors and identity cards 96
150........ Appointment of inspectors................................................................ 96
151........ Identity card...................................................................................... 96
Division 3—Monitoring powers 97
152........ Powers available to inspectors for monitoring compliance................ 97
153........ Monitoring powers........................................................................... 97
Division 4—Offence-related powers 99
154........ Searches and seizures related to offences.......................................... 99
155........ Offence-related powers of inspectors in relation to premises............ 99
156........ Use of equipment at premises......................................................... 100
Division 5—Expert assistance 102
157........ Expert assistance to operate a thing................................................. 102
Division 6—Emergency powers 103
158........ Powers available to inspectors for dealing with dangerous situations 103
Division 7—Obligations and incidental powers of inspectors 104
159........ Inspector must produce identity card on request............................. 104
160........ Consent........................................................................................... 104
161........ Details of warrant to be given to occupier etc.................................. 104
162........ Announcement before entry............................................................ 104
163........ Compensation for damage............................................................... 105
Division 8—Power to search goods, baggage etc. 106
164........ Power to search goods, baggage etc................................................ 106
165........ Seizure of goods............................................................................. 106
Division 9—General provisions relating to search and seizure 107
166........ Copies of seized things to be provided............................................ 107
167........ Occupier entitled to be present during search.................................. 107
168........ Receipts for things seized................................................................ 108
169........ Retention of seized things............................................................... 108
170........ Magistrate may permit a thing to be retained................................... 109
171........ Disposal of goods if there is no owner or owner cannot be located 109
Division 10—Warrants 110
172........ Monitoring warrants....................................................................... 110
173........ Offence-related warrants................................................................. 110
174........ Offence-related warrants by telephone, telex, fax etc...................... 111
175........ Offences relating to warrants.......................................................... 113
Division 11—Other matters 115
176........ Part not to abrogate privilege against self-incrimination.................. 115
177........ Part does not limit power to impose licence conditions................... 115
Part 12—Miscellaneous 116
Division 1—Simplified outline 116
178........ Simplified outline............................................................................ 116
Division 2—Review of decisions 117
179........ Meaning of terms............................................................................ 117
180........ Notification of decisions and review rights..................................... 118
181........ Internal review................................................................................ 118
182........ Deadlines for making reviewable decisions.................................... 119
183........ Review of decisions by Administrative Appeals Tribunal.............. 119
Division 3—Confidential commercial information 120
184........ Application for protection of confidential commercial information. 120
185........ Regulator may declare that information is confidential commercial information 120
186........ Revocation of declaration................................................................ 121
187........ Confidential commercial information must not be disclosed........... 121
Division 4—Conduct by directors, employees and agents 123
188........ Conduct by directors, employees and agents................................... 123
189........ Meaning of terms............................................................................ 124
Division 5—Transitional provisions 125
190........ Transitional provision—dealings covered by Genetic Manipulation Advisory Committee advice to proceed 125
191........ Regulations may relate to transitional matters.................................. 126
Division 6—Other 127
192........ False or misleading information or document................................. 127
193........ Regulations..................................................................................... 127
A Bill for an Act to regulate activities involving gene technology, and for related purposes
The Parliament of Australia enacts: