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Gene Technology Act 2000
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Administered by
Department of Health, Disability and Ageing
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C2024C00451 (C14)
14 October 2024
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Part 1—Preliminary
1 Short title
2 Commencement
3 Object of Act
4 Regulatory framework to achieve object
5 Nationally consistent scheme
6 Act to bind the Crown
7 External Territories
8 Offences
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Part 2—Interpretation and operation of Act
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Division 1—Simplified outline
9 Simplified outline
Division 2—Definitions
10 Definitions
11 Meaning of intentional release of a GMO into the environment
12 Meaning of corresponding State law
Division 3—Operation of Act
13 Operation of Act
14 Wind back of reach of Act
15 Relationship to other Commonwealth laws
Division 4—Provisions to facilitate a nationally consistent scheme
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Subdivision A—General provisions
16 State laws may operate concurrently
17 Conferral of functions on Commonwealth officers and bodies
18 No doubling up of liabilities
19 Review of certain decisions
20 Things done for multiple purposes
Subdivision B—Policy principles, policy guidelines and codes of practice
21 Ministerial Council may issue policy principles
22 Consultation on policy principles
23 Ministerial Council may issue policy guidelines
24 Ministerial Council may issue codes of practice
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Part 3—The Gene Technology Regulator
25 Simplified outline
26 The Gene Technology Regulator
27 Functions of the Regulator
28 Powers of the Regulator
29 Delegation
30 Independence of the Regulator
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Part 4—Regulation of dealings with GMOs
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Division 1—Simplified outline
31 Simplified outline
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Division 2—Dealings with GMOs must be licensed
32 Person not to deal with a GMO without a licence
33 Person not to deal with a GMO without a licence—strict liability offence
34 Person must not breach conditions of a GMO licence
35 Person must not breach conditions of a GMO licence—strict liability offence
35A Person must not breach conditions of emergency dealing determination
35B Person must not breach conditions of emergency dealing determination—strict liability offence
36 Person must not breach conditions on GMO Register
37 Offence relating to notifiable low risk dealings
38 Aggravated offences—significant damage to health or safety of people or to the environment
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Part 5—Licensing system
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Division 1—Simplified outline
39 Simplified outline
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Division 2—Licence applications
40 Person may apply for a licence
40A Licences relating to inadvertent dealings
41 Application may be withdrawn
42 Regulator may require applicant to give further information
43 Regulator must consider applications except in certain circumstances
44 Regulator may consult with applicant
45 Regulator must not use certain information in considering licence application
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Division 3—Initial consideration of licences for dealings not involving intentional release of a GMO into the environment
46 Applications to which this Division applies
46A Division does not apply to an application relating to inadvertent dealings
47 What the Regulator must do in relation to application
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Division 4—Initial consideration of licences for dealings involving intentional release of a GMO into the environment
48 Applications to which this Division applies
49 Division does not apply to an application relating to inadvertent dealings
50 Regulator must prepare risk assessment and risk management plan
50A Limited and controlled release applications
51 Matters Regulator must take into account in preparing risk assessment and risk management plan
52 Public notification of risk assessment and risk management plan
53 Regulator may take other actions
54 Person may request copies of certain documents
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Division 5—Decision on licence etc.
55 Regulator must make a decision on licence and licence conditions
56 Regulator must not issue the licence unless satisfied as to risk management
57 Other circumstances in which Regulator must not issue the licence
58 Matters to be taken into account in deciding whether a person is suitable to hold a licence
59 Notification of licence decision
60 Period of licence
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Division 6—Conditions of licences
61 Licence is subject to conditions
62 Conditions that may be prescribed or imposed
63 Condition about informing people of obligations
64 Condition about monitoring and audits
65 Condition about additional information to be given to the Regulator
66 Person may give information to Regulator
67 Protection of persons who give information
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Division 7—Suspension, cancellation and variation of licences
68 Suspension and cancellation of licence
69 Surrender of licence
70 Transfer of licences
71 Variation of licence
72 Regulator to notify of proposed suspension, cancellation or variation
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Part 5A—Emergency dealing determinations
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Division 1—Simplified outline
72A Simplified outline
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Division 2—Making of emergency dealing determination
72B Minister may make emergency dealing determination
72C Period of effect of emergency dealing determination
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Division 3—Effect and conditions of emergency dealing determination
72D Emergency dealing determination authorises dealings, subject to conditions
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Division 4—Variation, suspension and revocation of emergency dealing determination
72E Variation, suspension and revocation of emergency dealing determination
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Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register
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Division 1—Simplified outline
73 Simplified outline
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Division 2—Notifiable low risk dealings
74 Notifiable low risk dealings
75 Regulation of notifiable low risk dealings
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Division 3—The GMO Register
76 GMO Register
77 Contents of Register
78 Regulator may include dealings with GMOs on GMO Register
79 Regulator not to make determination unless risks can be managed
80 Variation of GMO Register
81 Inspection of Register
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Part 7—Certification and accreditation
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Division 1—Simplified outline
82 Simplified outline
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Division 2—Certification
83 Application for certification
84 When the Regulator may certify the facility
85 Regulator may require applicant to give further information
86 Conditions of certification
87 Variation of certification
88 Suspension or cancellation of certification
89 Regulator to notify of proposed suspension, cancellation or variation
89A Transfer of certification
90 Guidelines
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Division 3—Accredited organisations
91 Application for accreditation
92 Regulator may accredit organisations
93 Regulator may require applicant to give further information
94 Conditions of accreditation
95 Variation of accreditation
96 Suspension or cancellation of accreditation
97 Regulator to notify of proposed suspension, cancellation or variation
98 Guidelines
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Part 8—The Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee
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Division 1—Simplified outline
99 Simplified outline
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Division 2—The Gene Technology Technical Advisory Committee
100 The Gene Technology Technical Advisory Committee
101 Function of the Gene Technology Technical Advisory Committee
102 Expert advisers
103 Remuneration
104 Members and procedures
105 Subcommittees
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Division 3—The Gene Technology Ethics and Community Consultative Committee
106 The Gene Technology Ethics and Community Consultative Committee
107 Function of Ethics and Community Committee
108 Membership
109 Remuneration
110 Membership and Procedures
111 Subcommittees
112 Expert advisers
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Part 9—Administration
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Division 1—Simplified outline
117 Simplified outline
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Division 2—Appointment and conditions of Regulator
118 Appointment of the Regulator
119 Termination of appointment
120 Disclosure of interests
121 Acting appointment
122 Terms and conditions
123 Outside employment
124 Remuneration
125 Leave of absence
126 Resignation
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Division 3—Money
127 Regulator may charge for services
128 Notional payments by the Commonwealth
129 Gene Technology Account
130 Credits to Account
131 Recovery of amounts
132 Purposes of Account
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Division 4—Staffing
133 Staff assisting the Regulator
134 Consultants
135 Seconded officers
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Division 5—Reporting requirements
136 Annual Report
137 Reports to Parliament
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Division 6—Record of GMO Dealings
138 Record of GMO Dealings
139 Inspection of Record
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Division 7—Reviews of notifiable low risk dealings and exemptions
140 Regulator may review notifiable low risk dealings
141 Regulator may review exemptions
142 Regulator may give notice of consideration
143 What Regulator may do after consideration
144 Regulator not required to review matters
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Part 10—Enforcement
145 Simplified outline
146 Regulator may give directions
147 Injunctions
148 Forfeiture
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Part 11—Powers of inspection
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Division 1—Simplified outline
149 Simplified outline
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Division 2—Appointment of inspectors and identity cards
150 Appointment of inspectors
151 Identity card
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Division 3—Monitoring powers
152 Powers available to inspectors for monitoring compliance
153 Monitoring powers
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Division 4—Offence related powers
154 Searches and seizures related to offences
155 Offence related powers of inspectors in relation to premises
156 Use of equipment at premises
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Division 5—Expert assistance
157 Expert assistance to operate a thing
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Division 6—Emergency powers
158 Powers available to inspectors for dealing with dangerous situations
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Division 7—Obligations and incidental powers of inspectors
159 Inspector must produce identity card on request
160 Consent
161 Details of warrant to be given to occupier etc.
162 Announcement before entry
163 Compensation for damage
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Division 8—Power to search goods, baggage etc.
164 Power to search goods, baggage etc.
165 Seizure of goods
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Division 9—General provisions relating to search and seizure
166 Copies of seized things to be provided
167 Occupier entitled to be present during search
168 Receipts for things seized
169 Retention of seized things
170 Magistrate may permit a thing to be retained
171 Disposal of goods if there is no owner or owner cannot be located
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Division 10—Warrants
172 Monitoring warrants
173 Offence related warrants
174 Offence related warrants by telephone, telex, fax etc.
175 Offences relating to warrants
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Division 11—Other matters
176 Part not to abrogate privilege against self incrimination
177 Part does not limit power to impose conditions
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Part 12—Miscellaneous
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Division 1—Simplified outline
178 Simplified outline
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Division 2—Review of decisions
179 Meaning of terms
180 Notification of decisions and review rights
181 Internal review
182 Deadlines for making reviewable decisions
183 Review of decisions by Administrative Review Tribunal
183A Extended standing for judicial review
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Division 3—Confidential commercial information
184 Application for protection of confidential commercial information
185 Regulator may declare that information is confidential commercial information
186 Revocation of declaration
187 Confidential commercial information must not be disclosed
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Division 4—Conduct by directors, employees and agents
188 Conduct by directors, employees and agents
189 Meaning of terms
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Division 5—Transitional provisions
190 Transitional provision—dealings covered by Genetic Manipulation Advisory Committee advice to proceed
191 Regulations may relate to transitional matters
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Division 6—Other
192 False or misleading information or document
192A Interference with dealings with GMOs
193 Regulations
194 Review of operation of Act
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Endnotes
Endnote 1—About the endnotes
Endnote 2—Abbreviation key
Endnote 3—Legislation history
Endnote 4—Amendment history
