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This is a Bill, not an Act. For current law, see the Acts databases.
PARLIAMENT OF VICTORIA
Gene Technology Act 2001
Act No.
TABLE OF PROVISIONS
Clause Page
PART 1--PRELIMINARY 1
1. Purpose and citation 1
2. Commencement 2
3. Object of Act 2
4. Regulatory framework to achieve object 2
5. Nationally consistent scheme 3
6. Act to bind the Crown 3
7. External Territories 3
8. Offences 3
8A. Numbering 3
8B. Notes 4
8C. Outlines 4
PART 2--INTERPRETATION AND OPERATION OF ACT 5
Division 1--Simplified outline 5
9. Simplified outline 5
Division 2--Definitions 5
10. Definitions 5
11. Meaning of intentional release of a GMO into the environment 13
12. Meaning of corresponding State law 13
Division 3--Operation of Act 13
13. Operation of Act 13
14. Wind-back of reach of Act 13
15. Relationship to other State 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 14
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19. Review of certain decisions 14
20. Things done for multiple purposes 15
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 17
PART 3--THE GENE TECHNOLOGY REGULATOR 18
25. Simplified outline 18
26. The Gene Technology Regulator 18
27. Functions of the Regulator 18
28. Powers of the Regulator 19
29. Delegation 19
30. Independence of the Regulator 20
PART 4--REGULATION OF DEALINGS WITH GMOs 21
Division 1--Simplified outline 21
31. Simplified outline 21
Division 2--Dealings with GMOs must be Licensed 21
32. Person not to deal with a GMO without a licence 21
33. Person not to deal with a GMO without a licence--strict
liability offence 23
34. Person must not breach conditions of a GMO licence 23
35. Person must not breach conditions of a GMO licence--strict
liability offence 25
36. Person must not breach conditions on GMO Register 25
37. Offence relating to notifiable low risk dealings 26
38. Aggravated offences--significant damage to health or safety
of people or to the environment 26
PART 5--LICENSING SYSTEM 28
Division 1--Simplified outline 28
39. Simplified outline 28
Division 2--Licence Applications 28
40. Person may apply for a licence 28
41. Application may be withdrawn 29
42. Regulator may require applicant to give further information 30
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43. Regulator must consider applications except in certain
circumstances 30
44. Regulator may consult with applicant 31
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 31
46. Applications to which this Division applies 31
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 35
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 37
53. Regulator may take other actions 38
54. Person may request copies of certain documents 39
Division 5--Decision on Licence etc. 40
55. Regulator must make a decision on licence and licence
conditions 40
56. Regulator must not issue the licence unless satisfied as to risk
management 40
57. Other circumstances in which Regulator must not issue the
licence 41
58. Matters to be taken into account in deciding whether a person is
suitable to hold a licence 41
59. Notification of licence decision 43
60. Period of licence 43
Division 6--Conditions of Licences 43
61. Licence is subject to conditions 43
62. Conditions that may be prescribed or imposed 44
63. Condition about informing people of obligations 45
64. Condition about monitoring and audits 46
65. Condition about additional information to be given to the
Regulator 46
66. Person may give information to Regulator 47
67. Protection of persons who give information 47
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Division 7--Suspension, Cancellation and Variation of Licences 48
68. Suspension and cancellation of licence 48
69. Surrender of licence 48
70. Transfer of licences 49
71. Variation of licence 50
72. Regulator to notify of proposed suspension, cancellation or
variation 50
Division 8--Annual Charge 52
72A. GMO licence--annual charge 52
PART 6--REGULATION OF NOTIFIABLE LOW RISK
DEALINGS AND DEALINGS ON THE GMO REGISTER 53
Division 1--Simplified outline 53
73. Simplified outline 53
Division 2--Notifiable Low Risk Dealings 53
74. Notifiable low risk dealings 53
75. Regulation of notifiable low risk dealings 54
Division 3--The GMO Register 55
76. GMO Register 55
77. Contents of Register 55
78. Regulator may include dealings with GMOs on GMO Register 56
79. Regulator not to make determination unless risks can be managed 56
80. Variation of GMO Register 57
81. Inspection of Register 58
PART 7--CERTIFICATION AND ACCREDITATION 59
Division 1--Simplified outline 59
82. Simplified outline 59
Division 2--Certification 59
83. Application for certification 59
84. When the Regulator may certify the facility 60
85. Regulator may require applicant to give further information 60
86. Conditions of certification 60
87. Variation of certification 60
88. Suspension or cancellation of certification 61
89. Regulator to notify of proposed suspension, cancellation or
variation 61
90. Guidelines 62
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Division 3--Accredited Organisations 62
91. Application for accreditation 62
92. Regulator may accredit organisations 63
93. Regulator may require applicant to give further information 63
94. Conditions of accreditation 63
95. Variation of accreditation 64
96. Suspension or cancellation of accreditation 64
97. Regulator to notify of proposed suspension, cancellation or
variation 64
98. Guidelines 65
PART 8--THE GENE TECHNOLOGY TECHNICAL ADVISORY
COMMITTEE, THE GENE TECHNOLOGY COMMUNITY
CONSULTATIVE COMMITTEE AND THE GENE
TECHNOLOGY ETHICS COMMITTEE 67
Division 1--Simplified outline 67
99. Simplified outline 67
Division 2--The Gene Technology Technical Advisory Committee 67
100. The Gene Technology Technical Advisory Committee 67
101. Function of the Gene Technology Technical Advisory
Committee 67
102. Expert advisers 68
103. Remuneration 68
104. Members and procedures 68
105. Subcommittees 68
Division 3--The Gene Technology Community Consultative
Committee 68
106. The Gene Technology Community Consultative Committee 68
107. Function of Consultative Committee 68
108. Membership 69
109. Remuneration 69
110. Regulations 69
110A. Subcommittees 69
Division 4--The Gene Technology Ethics Committee 69
111. The Gene Technology Ethics Committee 70
112. Function of the Gene Technology Ethics Committee 70
113. Expert advisers 70
114. Remuneration 70
115. Members and procedures 70
116. Subcommittees 70
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PART 9--ADMINISTRATION 72
Division 1--Simplified outline 72
117. Simplified outline 72
Division 2--Appointment and conditions of Regulator 72
118. Appointment of the Regulator 72
119. Termination of appointment 72
120. Disclosure of interests 72
121. Acting appointment 72
122. Terms and conditions 72
123. Outside employment 73
124. Remuneration 73
125. Leave of absence 73
126. Resignation 73
Division 3--Money 73
127. Regulator may charge for services 73
128. Notional payments by the State 73
129. Gene Technology Account 74
130. Credits to Gene Technology Account 74
131. Recovery of amounts 74
132. Purposes of Account 75
Division 4--Staffing 75
133. Staff assisting the Regulator 75
134. Consultants 75
135. Seconded officers 75
Division 5--Reporting Requirements 75
136. Annual report 75
136A. Quarterly reports 76
137. Reports to Parliament 76
Division 6--Record of GMO and GM Product Dealings 77
138. Record of GMO and GM Product Dealings 77
139. Inspection of Record 78
Division 7--Reviews of Notifiable Low Risk Dealings and
Exemptions 78
140. Regulator may review notifiable low risk dealings 78
141. Regulator may review exemptions 79
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142. Regulator may give notice of consideration 79
143. What Regulator may do after consideration 80
144. Regulator not required to review matters 81
PART 10--ENFORCEMENT 82
145. Simplified outline 82
146. Regulator may give directions 82
147. Injunctions 84
148. Forfeiture 85
PART 11--POWERS OF INSPECTION 86
Division 1--Simplified outline 86
149. Simplified outline 86
Division 2--Appointment of Inspectors and Identity Cards 86
150. Appointment of inspectors 86
151. Identity card 87
Division 3--Monitoring Powers 87
152. Powers available to inspectors for monitoring compliance 87
153. Monitoring powers 88
Division 4--Offence-Related Powers 90
154. Searches and seizures related to offences 90
155. Offence-related powers of inspectors in relation to premises 91
156. Use of equipment at premises 91
Division 5--Expert Assistance 93
157. Expert assistance to operate a thing 93
Division 6--Emergency powers 94
158. Powers available to inspectors for dealing with dangerous
situations 94
Division 7--Obligations and Incidental Powers of Inspectors 95
159. Inspector must produce identity card on request 95
160. Consent 95
161. Details of warrant to be given to occupier etc. 95
162. Announcement before entry 96
163. Compensation for damage 96
Division 8--Power to Search Goods, Baggage etc. 97
164. Power to search goods, baggage etc. 97
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165. Seizure of goods 98
Division 9--General Provisions relating to Search and Seizure 98
166. Copies of seized things to be provided 98
167. Occupier entitled to be present during search 99
168. Receipts for things seized 99
169. Retention of seized things 99
170. Magistrates' Court may permit a thing to be retained 100
171. Disposal of goods if there is no owner or owner cannot be
located 101
Division 10--Warrants 101
172. Monitoring warrants 101
173. Offence-related warrants 102
174. Offence-related warrants by telephone, telex, fax etc. 104
175. Offences relating to warrants 106
Division 11--Other matters 107
176. Part not to abrogate privilege against self-incrimination 107
177. Part does not limit power to impose licence conditions 107
PART 12--MISCELLANEOUS 108
Division 1--Simplified outline 108
178. Simplified outline 108
Division 2--Review of decisions 108
179. Meaning of terms 108
180. Notification of decisions and review rights 110
181. Internal review 110
182. Deadlines for making reviewable decisions 111
183. Review of decisions by Administrative Appeals Tribunal 112
183A. Extended standing for judicial review 112
Division 3--Confidential Commercial Information 112
184. Application for protection of confidential commercial
information 112
185. Regulator may declare that information is confidential
commercial information 113
186. Revocation of declaration 115
187. Confidential commercial information must not be disclosed 115
Division 4--Conduct by Directors, Employees and Agents 117
188. Conduct by directors, employees and agents 117
189. Meaning of terms 119
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Division 5--Transitional Provisions 120
190. Transitional provision--dealings covered by Genetic
Manipulation Advisory Committee advice to proceed 120
191. Regulations may relate to transitional matters 122
Division 6--Other 122
192. False or misleading information or document 122
192A. Interference with dealings with GMOs 123
192B. Cloning of human beings is prohibited 124
192C. Certain experiments involving animal eggs prohibited 124
192D. Certain experiments involving putting human and animal
cells into a human uterus prohibited 124
192E. Attempts to commit offences against Act 124
193. Regulations 125
194. Review of operation of Act 125
PART 13--CONSEQUENTIAL AMENDMENTS 127
195. New section 23A inserted in Agricultural and Veterinary
Chemicals (Victoria) Act 1994 127
23A. Consultation with Gene Technology Regulator 127
196. Amendment of Therapeutic Goods (Victoria) Act 1994 128
197. New sections 34A to 34C inserted in Therapeutic Goods
(Victoria) Act 1994 128
34A. Consultation with Gene Technology Regulator 128
34B. Secretary may seek advice about classes of GM
products 129
34C. Secretary to take advice into account 130
ENDNOTES 131
INDEX 132
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PARLIAMENT OF VICTORIA
Initiated in Assembly 22 August 2001
A BILL
to regulate activities involving gene technology, to amend the
Agricultural and Veterinary Chemicals (Victoria) Act 1994 and
the Therapeutic Goods (Victoria) Act 1994 and for other purposes.
Gene Technology Act 2001
The Parliament of Victoria enacts as follows:
PART 1--PRELIMINARY
1. Purpose and citation
(1) The purpose of this Act is to regulate activities
involving gene technology.
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541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
s. 2
Act No.
(2) Without limiting section 10(1) of the
Interpretation of Legislation Act 1984, this Act
may be referred to as the Gene Technology Law
of Victoria or simply as the Gene Technology
5 Law.
Note: This section differs from section 1 of the
Commonwealth Act.
2. Commencement
(1) Subject to sub-section (2), this Act comes into
10 operation on a day or days to be proclaimed.
(2) If a provision of this Act does not come into
operation before 1 December 2001, it comes into
operation on that day.
Note: This section differs from section 2 of the
15 Commonwealth Act.
3. Object of Act
The object of this Act is to protect the health and
safety of people, and to protect the environment,
by identifying risks posed by or as a result of gene
20 technology, and by managing those risks through
regulating certain dealings with GMOs.
4. Regulatory framework to achieve object
The object of this Act is to be achieved through a
regulatory framework which--
25 (aa) provides that where there are threats of
serious or irreversible environmental
damage, a lack of full scientific certainty
should not be used as a reason for
postponing cost-effective measures to
30 prevent environmental degradation; and
(a) provides an efficient and effective system for
the application of gene technologies; and
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Gene Technology Act 2001
s. 5
Act No.
(b) operates in conjunction with other
Commonwealth and State regulatory
schemes relevant to GMOs and GMO
products.
5 Note: Examples of the schemes mentioned in paragraph (b)
are those that regulate food, agricultural and
veterinary chemicals, industrial chemicals and
therapeutic goods.
5. Nationally consistent scheme
10 It is the intention of the Parliament that this Act
form a component of a nationally consistent
scheme for the regulation of certain dealings with
GMOs by the Commonwealth and the States.
6. Act to bind the Crown
15 (1) This Act binds the Crown in right of Victoria and,
so far as the legislative power of the Parliament
permits, the Crown in all its other capacities.
(2) Nothing in this Act renders the Crown liable to be
prosecuted for an offence.
20 7. External Territories
Note: The Commonwealth Act includes a provision
extending that Act to every external Territory other
than Norfolk Island.
8. Offences1
25 Note: The Commonwealth Act includes a provision
applying Chapter 2 of the Criminal Code to offences
against that Act and construing penalty provisions in
that Act.
8A. Numbering2
30 (1) In order to maintain consistent numbering
between this Act and the Gene Technology Act
2000 of the Commonwealth--
(a) if the Commonwealth Act contains a section
that is not required in this Act, the provision
35 number and heading to the section appearing
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Gene Technology Act 2001
s. 8B
Act No.
in the Commonwealth Act are included in
this Act despite the omission of the body of
the section; and
(b) if this Act contains a section that is not
5 included in the Commonwealth Act, the
section is numbered so as to maintain
consistency in numbering between sections
common to both Acts.
(2) A provision number and heading referred to in
10 sub-section (1)(a) form part of this Act.
Note 1: A note appears under each heading of a kind
referred to in sub-section (1)(a) describing the
omitted section of the Commonwealth Act.
Note 2: A note appears under each section of a kind
15 referred to in sub-section (1)(b) highlighting the
non-appearance of an equivalent section in the
Commonwealth Act.
Note 3: This section does not appear in the Commonwealth
Act.
8B. Notes3
20
Notes do not form part of this Act.
Note: This section does not appear in the Commonwealth
Act.
8C. Outlines4
25 The provisions appearing at the beginning of
Parts 2 to 12 outlining the Part (simplified
outlines) are intended only as a guide to readers
as to the general scheme and effect of that Part.
Note: This section does not appear in the Commonwealth
30 Act.
_______________
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Gene Technology Act 2001
s. 9
Act No.
PART 2--INTERPRETATION AND OPERATION OF ACT
Division 1--Simplified outline
9. Simplified outline
In outline, this Part--
· contains the definitions used in this Act;
5
· contains provisions to facilitate a nationally
consistent regulatory scheme;
· enables the Ministerial Council to issue policy
principles, policy guidelines and codes of
10 practice.
Note: This section differs from section 9 of the
Commonwealth Act.
Division 2--Definitions
10. Definitions
15 (1) In this Act--
"accredited organisation" means an
organisation accredited under Division 3 of
Part 7;
"Administrative Appeals Tribunal" means the
20 Administrative Appeals Tribunal established
by the Administrative Appeals Tribunal Act
1975 of the Commonwealth;
"aggravated offence" has the meaning given by
section 38;
25 "Commonwealth Act" means the Gene
Technology Act 2000 of the Commonwealth;
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Gene Technology Act 2001
s. 10
Act No.
"Commonwealth authority" means the
following--
(a) a body corporate established for a
public purpose by or under a
5 Commonwealth Act;
(b) a company in which a controlling
interest is held by any one of the
following persons, or by 2 or more of
the following persons together--
10 (i) the Commonwealth;
(ii) a body covered by paragraph (a);
(iii) a body covered by either of the
above sub-paragraphs;
"Commonwealth Environment Minister"
15 means the Minister of State for the
Commonwealth responsible for environment
and conservation;
"confidential commercial information" means
information declared by the Regulator to be
20 confidential commercial information under
section 185;
"Consultative Committee" means the Gene
Technology Community Consultative
Committee established by section 106 of the
25 Commonwealth Act;
"containment level", in relation to a facility,
means the degree of physical confinement of
GMOs provided by the facility, having
regard to the design of the facility, the
30 equipment located or installed in the facility
and the procedures generally used within the
facility;
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Gene Technology Act 2001
s. 10
Act No.
"deal with", in relation to a GMO, means the
following--
(a) conduct experiments with the GMO;
(b) make, develop, produce or manufacture
5 the GMO;
(c) breed the GMO;
(d) propagate the GMO;
(e) use the GMO in the course of
manufacture of a thing that is not the
10 GMO;
(f) grow, raise or culture the GMO;
(g) import the GMO--
and includes the possession, supply, use,
transport or disposal of the GMO for the
15 purposes of, or in the course of, a dealing
mentioned in any of paragraphs (a) to (g);
"eligible person", in relation to a reviewable
decision, has the meaning given by
section 179;
20 "environment" includes--
(a) ecosystems and their constituent parts;
and
(b) natural and physical resources; and
(c) the qualities and characteristics of
25 locations, places and areas;
"Ethics Committee" means the Gene
Technology Ethics Committee established by
section 111 of the Commonwealth Act;
7
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Gene Technology Act 2001
s. 10
Act No.
"evidential material" means any of the
following--
(a) a thing with respect to which an offence
against this Act or the regulations has
5 been committed or is suspected, on
reasonable grounds, to have been
committed;
(b) a thing that there are reasonable
grounds for suspecting will afford
10 evidence as to the commission of any
such offence;
(c) a thing that there are reasonable
grounds for suspecting is intended to be
used for the purpose of committing any
15 such offence;
"facility" includes, but is not limited to, the
following--
(a) a building or part of a building;
(b) a laboratory;
20 (c) an aviary;
(d) a glasshouse;
(e) an insectary;
(f) an animal house;
(g) an aquarium or tank;
25 "gene technology" means any technique for the
modification of genes or other genetic
material, but does not include--
(a) sexual reproduction; or
(b) homologous recombination; or
30 (c) any other technique specified in the
regulations for the purposes of this
paragraph;
8
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Gene Technology Act 2001
s. 10
Act No.
"Gene Technology Account" means the
Gene Technology Account established by
section 129 of the Commonwealth Act;
"Gene Technology Agreement" means the Gene
5 Technology Agreement made for the
purposes of this Act between the
Commonwealth and at least 4 States, as in
force from time to time;
"Gene Technology Technical Advisory
10 Committee" means the Gene Technology
Technical Advisory Committee established
by section 100 of the Commonwealth Act;
"genetically modified organism" means--
(a) an organism that has been modified by
15 gene technology; or
(b) an organism that has inherited
particular traits from an organism (the
initial organism), being traits that
occurred in the initial organism because
20 of gene technology; or
(c) anything declared by the regulations to
be a genetically modified organism, or
that belongs to a class of things
declared by the regulations to be
25 genetically modified organisms--
but does not include--
(d) a human being, if the human being is
covered by paragraph (a) only because
the human being has undergone
30 somatic cell gene therapy; or
(e) an organism declared by the regulations
not to be a genetically modified
organism, or that belongs to a class of
organisms declared by the regulations
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Gene Technology Act 2001
s. 10
Act No.
not to be genetically modified
organisms;
"GMO" means a genetically modified organism;
"GMO licence" means a licence issued under
5 section 55;
"GMO Register" means the GMO Register
established by section 76 of the
Commonwealth Act;
"GM product" means a thing (other than a
10 GMO) derived or produced from a GMO;
"Institutional Biosafety Committee" means a
committee established by an accredited
organisation as an Institutional Biosafety
Committee;
15 "jurisdiction" means the following--
(a) a State; or
(b) the Commonwealth;
"licence holder" means the holder of a GMO
licence;
20 "local council" means a Council within the
meaning of the Local Government Act
1989;
"Ministerial Council" means the Ministerial
Council within the meaning of the Gene
25 Technology Agreement;
"notifiable low risk dealing" has the meaning
given by section 74;
"officer", in relation to the Commonwealth,
includes the following--
30 (a) a Minister of the Crown in right of the
Commonwealth;
(b) a person who holds--
10
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Gene Technology Act 2001
s. 10
Act No.
(i) an office established by or under a
Commonwealth Act; or
(ii) an appointment made under a
Commonwealth Act; or
5 (iii) an appointment made by the
Governor-General or a Minister of
the Crown in right of the
Commonwealth but not under a
Commonwealth Act;
10 (c) a person who is a member or officer of
a Commonwealth authority;
(d) a person who is in the service or
employment of the Commonwealth or
of a Commonwealth authority, or is
15 employed or engaged under a
Commonwealth Act;
"organism" means any biological entity that is--
(a) viable; or
(b) capable of reproduction; or
20 (c) capable of transferring genetic material;
"person covered by a GMO licence" means a
person authorised by a GMO licence to deal
with a GMO;
"premises" includes the following--
25 (a) a building;
(b) a place (including an area of land);
(c) a vehicle;
(d) a vessel;
(e) an aircraft;
30 (f) a facility;
11
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Gene Technology Act 2001
s. 10
Act No.
(g) any part of premises (including
premises referred to in paragraphs (a)
to (f));
"Record" means the Record of GMO and GM
5 Product Dealings mentioned in section 138
of the Commonwealth Act;
"Regulator" means the Gene Technology
Regulator appointed under section 118 of the
Commonwealth Act;
10 "reviewable decision" has the meaning given by
section 179;
"State" includes the Australian Capital Territory
and the Northern Territory;
"State agency" means the following--
15 (a) the Crown in right of Victoria;
(b) a Minister of the Crown in right of
Victoria;
(c) an Agency within the meaning of the
Public Sector Management and
20 Employment Act 1998;
(d) an instrumentality of the State of
Victoria, including a body corporate
established for a public purpose by or
under a law of the State of Victoria;
25 (e) a company in which a controlling
interest is held by any one of the
following persons, or by 2 or more of
the following persons together--
(i) the Crown in right of Victoria;
30 (ii) a person or body covered by
paragraph (b) or (d);
(iii) a body covered by either of the
above sub-paragraphs;
12
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Gene Technology Act 2001
s. 11
Act No.
"thing" includes a substance, and a thing in
electronic or magnetic form.
(2) If this Act requires or permits the Ministerial
Council to do a thing, the Ministerial Council
5 must do the thing in accordance with any
requirements specified in the Gene Technology
Agreement.
11. Meaning of intentional release of a GMO into the
environment
10 For the purposes of this Act, a dealing with a
GMO involves the intentional release of the
GMO into the environment if the GMO is
intentionally released into the open environment,
whether or not it is released with provision for
15 limiting the dissemination or persistence of the
GMO or its genetic material in the environment.
12. Meaning of corresponding State law
Note: The Commonwealth Act includes a provision
defining "corresponding State law" for the purposes
20 of that Act.
Division 3--Operation of Act
13. Operation of Act
Note: The Commonwealth Act includes a provision about
the application of that Act.
25 14. Wind-back of reach of Act
Note: The Commonwealth Act includes a provision about
the giving of wind-back notices by a State.
15. Relationship to other State laws
The provisions of this Act are in addition to, and
30 not in substitution for, the requirements of any
other law of the State of Victoria (whether passed
or made before or after the commencement of this
section).
13
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Gene Technology Act 2001
s. 16
Act No.
Note: The equivalent section in the Commonwealth Act
deals with the relationship of that Act to other
Commonwealth laws.
Division 4--Provisions to Facilitate a Nationally Consistent
5 Scheme
Subdivision A--General Provisions
16. State laws may operate concurrently
Note: The Commonwealth Act includes a provision
allowing State laws (apart from State laws
10 prescribed for the purposes of the provision) to
operate concurrently with that Act.
17. Conferral of functions on Commonwealth officers
and bodies
Note: The Commonwealth Act includes a provision
15 allowing corresponding State laws to confer
functions, powers and duties on certain
Commonwealth officers and bodies.
18. No doubling-up of liabilities
(1) If--
20 (a) an act or omission is an offence against this
Act and is also an offence against the
Commonwealth Act; and
(b) the offender has been punished for the
offence under the Commonwealth Act--
25 the offender is not liable to be punished for the
offence under this Act.
(2) If a person has been ordered to pay a pecuniary
penalty under the Commonwealth Act, the person
is not liable to a pecuniary penalty under this Act
30 in respect of the same conduct.
19. Review of certain decisions
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(1) Application may be made to the Administrative
Appeals Tribunal for review of a reviewable
decision.
(2) A decision made by the Regulator in the
5 performance of a function or the exercise of a
power conferred by this Act is a reviewable
decision for the purposes of this section if--
(a) this Act provides for review by the
Administrative Appeals Tribunal; and
10 (b) the decision is declared by the regulations
made under the Commonwealth Act to be a
reviewable State decision for the purposes of
section 19 of the Commonwealth Act.
(3) The Administrative Appeals Tribunal Act 1975 of
15 the Commonwealth (excluding Part IVA) and the
regulations in force for the time being under that
Act apply as laws of Victoria in relation to
reviewable decisions.
(4) For the purposes of this section, a reference in a
20 provision of the Administrative Appeals Tribunal
Act 1975 of the Commonwealth (as that provision
applies as a law of Victoria) to the whole or any
part of Part IVA of that Act is taken to be a
reference to the whole or any part of that Part as it
25 has effect as a law of the Commonwealth.
Note: This section differs from section 19 of the
Commonwealth Act.
20. Things done for multiple purposes
The validity of a licence, certificate or other thing
30 issued, given or done for the purposes of this Act
is not affected only because it was issued, given or
done also for the purposes of the Commonwealth
Act.
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Subdivision B--Policy Principles, Policy Guidelines and
Codes of Practice
21. Ministerial Council may issue policy principles
(1) The Ministerial Council may issue policy
5 principles in relation to the following--
(a) ethical issues relating to dealings with
GMOs;
(aa) recognising areas, if any, designated under a
law of Victoria for the purpose of preserving
10 the identity of one or both of the following--
(i) GM crops;
(ii) non-GM crops--
for marketing purposes;
(b) matters relating to dealings with GMOs
15 prescribed by the regulations for the
purposes of this paragraph.
Note 1: Section 57 provides that the Regulator must not
issue a licence if to do so would be inconsistent
with a policy principle.
20 Note 2: Section 27 of the Interpretation of Legislation
Act 1984 confers power to revoke or amend an
instrument of a legislative character made under an
Act.
(2) Before issuing a policy principle, the Ministerial
25 Council must be satisfied that the policy principle
was developed in accordance with section 22 of
the Commonwealth Act.
(3) Regulations for the purposes of sub-section (1)(b)
may relate to matters other than the health and
30 safety of people or the environment, but must not
derogate from the health and safety of people or
the environment.
Note: This section differs from section 21 of the
Commonwealth Act.
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22. Consultation on policy principles
Note: The Commonwealth Act includes a provision about
how policy principles are to be developed.
23. Ministerial Council may issue policy guidelines
5 The Ministerial Council may issue policy
guidelines in relation to matters relevant to the
functions of the Regulator under this Act or the
regulations.
Note 1: Section 56 requires the Regulator to have regard to
10 policy guidelines when deciding an application for
a GMO licence. Section 30 provides that the
Regulator is not subject to direction in relation to
individual decisions.
Note 2: Section 27 of the Interpretation of Legislation
15 Act 1984 confers power to revoke or amend an
instrument of a legislative character made under an
Act.
24. Ministerial Council may issue codes of practice
The Ministerial Council may issue codes of
20 practice, developed in accordance with section
24(2) of the Commonwealth Act, in relation to
gene technology.
Note 1: Section 27 of the Interpretation of Legislation
Act 1984 confers power to revoke or amend an
25 instrument of a legislative character made under an
Act.
Note 2: Section 24 of the Commonwealth Act includes
provisions about how codes of practice are to be
developed and making them disallowable
30 instruments.
_______________
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PART 3--THE GENE TECHNOLOGY REGULATOR
25. Simplified outline
In outline, this Part specifies the functions and
powers of the Gene Technology Regulator under
5 this Act or the regulations.
Note: This section differs from section 25 of the
Commonwealth Act.
26. The Gene Technology Regulator
Note: Section 26 of the Commonwealth Act creates the
10 office of Gene Technology Regulator.
27. Functions of the Regulator
The Regulator has the following functions--
(a) to perform functions in relation to GMO
licences as set out in Part 5;
15 (b) to develop draft policy principles and policy
guidelines, as requested by the Ministerial
Council;
(c) to develop codes of practice;
(d) to issue technical and procedural guidelines
20 in relation to GMOs;
(e) to provide information and advice to other
regulatory agencies about GMOs and GM
products;
(f) to provide information and advice to the
25 public about the regulation of GMOs;
(g) to provide advice to the Ministerial Council
about--
(i) the operations of the Regulator and the
Gene Technology Technical Advisory
30 Committee; and
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(ii) the effectiveness of the legislative
framework for the regulation of GMOs,
including in relation to possible
amendments of relevant legislation;
5 (h) to undertake or commission research in
relation to risk assessment and the biosafety
of GMOs;
(i) to promote the harmonisation of risk
assessments relating to GMOs and GM
10 products by regulatory agencies;
(j) to monitor international practice in relation
to the regulation of GMOs;
(k) to maintain links with international
organisations that deal with the regulation of
15 gene technology and with agencies that
regulate GMOs in places outside Victoria;
(l) such other functions as are conferred on the
Regulator by this Act, the regulations or any
other law.
20 28. Powers of the Regulator
Subject to this Act, the Regulator has power to do
all things necessary or convenient to be done for
or in connection with the performance of the
Regulator's functions under this Act or the
25 regulations.
29. Delegation
(1) The Regulator may, by instrument in writing,
delegate any of the Regulator's powers or
functions under this Act or the regulations to any
30 of the following--
(a) an employee within the meaning of the
Public Sector Management and
Employment Act 1998;
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(b) an officer or employee of a State agency, if
the functions of the State agency relate,
whether directly or indirectly, to GMOs or
GM products;
5 (c) an employee of a Commonwealth authority,
if the functions of the Commonwealth
authority relate, whether directly or
indirectly, to GMOs or GM products.
(2) In exercising powers or functions under a
10 delegation, the delegate must comply with any
directions of the Regulator.
Note: This section differs from section 29 of the
Commonwealth Act.
30. Independence of the Regulator
15 Subject to this Act and to other laws of the State
of Victoria, the Regulator has discretion in the
performance or exercise of his or her functions or
powers under this Act or the regulations. In
particular, the Regulator is not subject to direction
20 from anyone in relation to--
(a) whether or not a particular application for a
GMO licence is issued or refused; or
(b) the conditions to which a particular GMO
licence is subject.
25 _______________
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PART 4--REGULATION OF DEALINGS WITH GMOs
Division 1--Simplified outline
31. Simplified outline
In outline, this Part--
· deals with the regulation of dealings with
5
GMOs;
· prohibits dealings with GMOs unless--
the person undertaking the dealing is
authorised to do so by a GMO licence; or
10 the dealing is a notifiable low risk dealing
(see Division 2 of Part 6); or
the dealing is an exempt dealing; or
the dealing is included in the GMO
Register (see Division 3 of Part 6);
· imposes heavier penalties on unlawful
15
dealings that cause, or are likely to cause,
significant damage to the health and safety of
people or to the environment.
Division 2--Dealings with GMOs must be Licensed
20 32. Person not to deal with a GMO without a licence
(1) A person is guilty of an offence if--
(a) the person deals with a GMO, knowing that
it is a GMO; and
(b) the person knows that the dealing with the
25 GMO by the person is not authorised by a
GMO licence or is reckless as to whether or
not the dealing is so authorised; and
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(c) the person knows that the dealing is not a
notifiable low risk dealing or is reckless as to
whether or not the dealing is a notifiable low
risk dealing; and
5 (d) the person knows that the dealing is not an
exempt dealing or is reckless as to whether
or not the dealing is an exempt dealing; and
(e) the person knows that the dealing is not
included on the GMO Register or is reckless
10 as to whether or not the dealing is included
on the GMO Register.
(2) An offence under sub-section (1) is punishable by
whichever of the following applies--
(a) in the case of an aggravated offence--
15 imprisonment for a term not exceeding
5 years or a fine not exceeding $220 000; or
(b) in any other case--imprisonment for a term
not exceeding 2 years or a fine not exceeding
$55 000.
20 Note: Section 38 defines aggravated offence.
(3) In this section--
"exempt dealing" means a dealing specified by
the regulations to be an exempt dealing.
(4) Regulations under sub-section (3) may be
25 expressed to exempt--
(a) all dealings with a GMO or with a specified
class of GMOs; or
(b) a specified class of dealings with a GMO or
with a specified class of GMOs; or
30 (c) one or more specified dealings with a GMO
or with a specified class of GMOs.
Note: This section differs from section 32 of the
Commonwealth Act.
22
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33. Person not to deal with a GMO without a licence--
strict liability offence
(1) A person is guilty of an offence if--
(a) the person deals with a GMO, knowing that
5 it is a GMO; and
(b) the dealing with the GMO by the person is
not authorised by a GMO licence; and
(c) the dealing is not a notifiable low risk
dealing; and
10 (d) the dealing is not an exempt dealing; and
(e) the dealing is not included on the GMO
Register.
(2) Strict liability applies to sub-section (1)(b), (c),
(d) and (e).
15 (3) An offence under this section is punishable by a
fine of not more than whichever of the following
amounts applies--
(a) in the case of an aggravated offence--
$22 000; or
20 (b) in any other case--$5500.
Note: Section 38 defines aggravated offence.
(4) In this section--
"exempt dealing" has the same meaning as in
section 32.
25 Note: This section differs from section 33 of the
Commonwealth Act.
34. Person must not breach conditions of a GMO licence
(1) The holder of a GMO licence is guilty of an
offence if the holder--
30 (a) intentionally takes an action or omits to take
an action; and
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(b) knows that the action or omission
contravenes the licence or is reckless as to
whether or not the action or omission
contravenes the licence.
5 (2) A person covered by a GMO licence is guilty of
an offence if--
(a) the person intentionally takes an action or
omits to take an action; and
(b) the person knows that the action or omission
10 contravenes the licence or is reckless as to
whether or not the action or omission
contravenes the licence; and
(c) the person has knowledge of the conditions
of the licence.
15 (3) An offence under sub-section (1) or (2) is
punishable by whichever of the following
applies--
(a) in the case of an aggravated offence--
imprisonment for a term not exceeding
20 5 years or a fine not exceeding $220 000
plus an additional fine not exceeding $22
000 for every day during which the offence
continues;
(b) in any other case--imprisonment for a term
25 not exceeding 2 years or a fine not exceeding
$55 000 plus an additional fine not
exceeding $5500 for every day during which
the offence continues.
Note 1: Section 38 defines aggravated offence.
30 Note 2: This section differs from section 34 of the
Commonwealth Act.
24
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35. Person must not breach conditions of a GMO
licence--strict liability offence
(1) The holder of a GMO licence is guilty of an
offence if the holder--
5 (a) takes an action or omits to take an action;
and
(b) the action or omission contravenes the
licence.
(2) A person covered by a GMO licence is guilty of
10 an offence if--
(a) the person takes an action or omits to take an
action; and
(b) the action or omission contravenes the
licence; and
15 (c) the person has knowledge of the conditions
of the licence.
(3) Strict liability applies to sub-sections (1)(a) and
(b) and (2)(a) and (b).
(4) An offence under this section is punishable by a
20 fine of not more than whichever of the following
amounts applies--
(a) in the case of an aggravated offence--
$22 000; or
(b) in any other case--$5500.
25 Note: Section 38 defines aggravated offence.
36. Person must not breach conditions on GMO Register
(1) A person is guilty of an offence if the person--
(a) deals with a GMO, knowing that it is a
GMO; and
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(b) the dealing is on the GMO Register; and
(c) the dealing contravenes a condition relating
to the dealing that is specified in the GMO
Register.
5 (2) Strict liability applies to sub-section (1)(b) and
(c).
(3) An offence against sub-section (1) is punishable
by a fine of not more than $5500.
37. Offence relating to notifiable low risk dealings
10 (1) A person is guilty of an offence if--
(a) the person deals with a GMO, knowing that
it is a GMO; and
(b) the dealing is a notifiable low risk dealing;
and
15 (c) the dealing by the person was not undertaken
in accordance with the regulations.
Note: Notifiable low risk dealings are specified in the
regulations--see Part 6.
(2) Strict liability applies to sub-section (1)(b) and
20 (c).
(3) An offence against sub-section (1) is punishable
by a fine of not more than $5500.
38. Aggravated offences--significant damage to health or
safety of people or to the environment
25 (1) An offence is an aggravated offence if the
commission of the offence causes significant
damage, or is likely to cause significant damage,
to the health and safety of people or to the
environment.
30 (2) In order to prove an aggravated offence, the
prosecution must prove that the person who
committed the offence--
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(a) intended their conduct to cause significant
damage to the health and safety of people or
to the environment; or
(b) was reckless as to whether that conduct
5 would cause significant damage to the health
and safety of people or to the environment.
_______________
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Act No.
PART 5--LICENSING SYSTEM
Division 1--Simplified outline
39. Simplified outline
In outline, this Part--
· provides a licensing system under which a
5
person can apply to the Regulator for a licence
authorising dealings with GMOs;
· sets out the processes to be followed by the
Regulator in relation to applications involving
10 2 kinds of dealings--
those that involve the intentional release of
a GMO into the environment; and
those that do not involve the intentional
release of a GMO into the environment;
· provides that a licence can cover dealings by
15
persons other than the licence holder and
requires the licence holder to inform such
persons of any conditions of the licence that
apply to them.
20 Division 2--Licence Applications
40. Person may apply for a licence
(1) A person may apply to the Regulator for a licence
authorising specified dealings with one or more
specified GMOs by a person or persons.
25 (2) The application must be in writing, and must
contain--
(a) such information as is prescribed by the
regulations (if any); and
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s. 41
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(b) such information as is specified in writing by
the Regulator.
(3) The application must specify whether any of the
dealings proposed to be authorised by the licence
5 would involve the intentional release of a GMO
into the environment.
(4) The dealings in respect of which a person may
apply for a licence may be--
(a) all dealings with a GMO, or with a specified
10 class of GMOs; or
(b) a specified class of dealings with a GMO, or
with a specified class of GMOs; or
(c) one or more specified dealings with a GMO,
or with a specified class of GMOs.
15 (5) The applicant may apply for a licence authorising
such dealings by--
(a) a specified person or persons; or
(b) a specified class of person; or
(c) all persons.
20 (6) The application must be accompanied by the
application fee (if any) prescribed by the
regulations.
41. Application may be withdrawn
(1) The applicant may withdraw the application at
25 any time before the licence is issued.
(2) The application fee is not refundable if the
applicant withdraws the application.
29
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s. 42
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42. Regulator may require applicant to give further
information
(1) The Regulator may, by notice in writing, require
an applicant for a licence to give the Regulator
5 such further information in relation to the
application as the Regulator requires.
(2) The notice may specify the period within which
the information is to be provided.
43. Regulator must consider applications except in
10 certain circumstances
(1) The Regulator must consider an application under
section 40 for a licence in accordance with this
Part.
(2) However, the Regulator is not required to consider
15 the application if--
(a) the application does not contain the
information specified by the Regulator or
prescribed by the regulations; or
(b) the application does not satisfy section
20 40(3); or
(c) the application is not accompanied by the
application fee (if any) prescribed by the
regulations; or
(d) the applicant did not provide further
25 information required by the Regulator by
notice under section 42 within the period
specified in the notice; or
(e) the Regulator is satisfied that to issue the
licence would be inconsistent with a policy
30 principle in force under section 21.
(3) The Regulator must issue the licence, or refuse to
issue the licence, within the period (if any)
prescribed by the regulations.
30
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44. Regulator may consult with applicant
Before considering an application in accordance
with the requirements of this Part, the Regulator
may consult the applicant, or another regulatory
5 agency, on any aspect of the application.
45. Regulator must not use certain information in
considering licence application
If--
(a) a person (the first person) applies for a
10 GMO licence; and
(b) the first person provides information to the
Regulator for the purposes of the Regulator's
consideration of the application; and
(c) the information is confidential commercial
15 information--
the Regulator must not take that information into
account for the purposes of considering an
application by another person for a GMO licence,
unless the first person has given written consent
20 for the information to be so taken into account.
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
25 This Division applies to an application for a GMO
licence if the Regulator is satisfied that none of
the dealings proposed to be authorised by the
licence would involve the intentional release of a
GMO into the environment.
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47. What the Regulator must do in relation to application
(1) Before issuing the licence, the Regulator must
prepare a risk assessment and a risk management
plan in relation to the dealings proposed to be
5 authorised by the licence.
(2) In preparing the risk assessment, the Regulator
must take into account the risks posed by the
dealings proposed to be authorised by the licence,
including any risks to the health and safety of
10 people or risks to the environment.
(3) In preparing the risk management plan, the
Regulator must take into account the means of
managing any risks posed by the dealings
proposed to be authorised by the licence in such a
15 way as to protect--
(a) the health and safety of people; and
(b) the environment.
(4) The Regulator may consult--
(a) the States; and
20 (b) the Gene Technology Technical Advisory
Committee; and
(c) relevant Commonwealth authorities or
agencies; and
(d) any local council that the Regulator
25 considers appropriate; and
(e) any other person the Regulator considers
appropriate--
on any aspect of the application.
32
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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
5 This Division applies to an application for a GMO
licence if the Regulator is satisfied that at least
one of the dealings proposed to be authorised by
the licence would involve the intentional release
of a GMO into the environment.
10 49. Dealings that may pose significant risks to the health
and safety of people or the environment
(1) If the Regulator is satisfied that at least one of the
dealings proposed to be authorised by the licence
may pose significant risks to the health and safety
15 of people or the environment, the Regulator must
publish a notice in respect of the application--
(a) in the Government Gazette; and
(b) in a newspaper circulating generally in
Victoria; and
20 (c) on the Regulator's website (if any).
(2) For the purpose of satisfying himself or herself as
to whether the dealings proposed to be authorised
by the licence may pose significant risks to the
health and safety of people or to the environment,
25 the Regulator must have regard to the following--
(a) the properties of the organism to which the
dealings relate before it became, or will
become, a GMO;
(b) the effect, or the expected effect, of genetic
30 modification that has occurred, or will occur,
on the properties of the organism;
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(c) provisions for limiting the dissemination or
persistence of the GMO or its genetic
material in the environment;
(d) the potential for spread or persistence of the
5 GMO or its genetic material in the
environment;
(e) the extent or scale of the proposed dealings;
(f) any likely impacts of the proposed dealings
on the health and safety of people;
10 (g) any other matter prescribed by the
regulations for the purposes of this
paragraph.
(3) The notice mentioned in sub-section (1) must--
(a) state that the application has been made; and
15 (b) state that a person may request further
information about the application under
section 54; and
(c) invite written submissions on whether the
licence should be issued, being submissions
20 about matters that the Regulator is required
to take into account--
(i) under section 51(1)(a) in preparing a
risk assessment in relation to the
dealings proposed to be authorised by
25 the licence; and
(ii) under section 51(2)(a) in preparing a
risk management plan in relation to
those dealings; and
(d) specify the closing date for submissions,
30 which must not be earlier than 30 days after
the date on which the notice was published.
34
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50. Regulator must prepare risk assessment and risk
management plan
(1) Before issuing the licence, the Regulator must
prepare a risk assessment and a risk management
5 plan in relation to the dealings proposed to be
authorised by the licence.
(2) The Regulator must prepare a risk assessment and
a risk management plan whether or not the
Regulator was required to publish a notice in
10 relation to the application under section 49.
(3) The Regulator must seek advice on matters
relevant to the preparation of the risk assessment
and the risk management plan from--
(a) the States; and
15 (b) the Gene Technology Technical Advisory
Committee; and
(c) each Commonwealth authority or agency
prescribed by the regulations for the
purposes of this paragraph; and
20 (d) the Commonwealth Environment Minister;
and
(e) any local council that the Regulator
considers appropriate.
51. Matters Regulator must take into account in
25 preparing risk assessment and risk management plan
(1) In preparing the risk assessment in relation to the
dealings proposed to be authorised by the licence,
the Regulator must take into account the
following--
30 (a) the risks posed by those dealings, including
any risks to the health and safety of people
or risks to the environment, having regard to
the matters mentioned in section 49(2)(a) to
(f);
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(b) any submission made under section 49(3)(c)
in relation to such risks;
(c) any advice in relation to the risk assessment
provided by a State or a local council in
5 response to a request under section 50(3);
(d) any advice in relation to the risk assessment
provided by the Gene Technology Technical
Advisory Committee in response to a request
under section 50(3);
10 (e) any advice in relation to the risk assessment
provided by a Commonwealth authority or
agency in response to a request under section
50(3);
(f) any advice in relation to the risk assessment
15 provided by the Commonwealth
Environment Minister in response to a
request under section 50(3);
(g) any other matter prescribed by the
regulations for the purposes of this
20 paragraph.
(2) In preparing the risk management plan, the
Regulator must take into account the following--
(a) the means of managing any risks posed by
those dealings in such a way as to protect--
25 (i) the health and safety of people; and
(ii) the environment;
(b) any submission made under section 49(3)(c)
in relation to the means of managing such
risks;
30 (c) any advice in relation to the risk
management plan provided by a State or a
local council in response to a request under
section 50(3);
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(d) any advice in relation to the risk
management plan provided by the Gene
Technology Technical Advisory Committee
in response to a request under section 50(3);
5 (e) any advice in relation to the risk
management plan provided by a
Commonwealth authority or agency in
response to a request under section 50(3);
(f) any advice in relation to the risk
10 management plan provided by the
Commonwealth Environment Minister in
response to a request under section 50(3);
(g) any other matter prescribed by the
regulations for the purposes of this
15 paragraph.
(3) For the avoidance of doubt, in taking into account
the means of managing risks as mentioned in sub-
section (2)(a), the Regulator--
(a) is not limited to considering submissions or
20 advice mentioned in sub-section (2)(b), (c),
(d), (e) and (f); and
(b) subject to section 45, may take into account
other information, including, but not limited
to, relevant independent research.
25 52. Public notification of risk assessment and risk
management plan
(1) After taking the steps referred to in sections 49 (if
applicable), 50 and 51, the Regulator must publish
a notice--
30 (a) in the Government Gazette; and
(b) in a newspaper circulating generally in
Victoria; and
(c) on the Regulator's website (if any).
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(2) The notice must--
(a) state that a risk assessment and a risk
management plan have been prepared in
respect of dealings proposed to be authorised
5 by the licence; and
(b) state that a person may request further
information about the risk assessment and
the risk management plan under section 54;
and
10 (c) invite written submissions in relation to the
risk assessment and the risk management
plan; and
(d) specify the closing date for submissions,
which must not be earlier than 30 days after
15 the date on which the notice was published.
(3) The Regulator must also seek advice on the risk
assessment and the risk management plan from--
(a) the States; and
(b) the Gene Technology Technical Advisory
20 Committee; and
(c) each Commonwealth authority or agency
prescribed by the regulations for the
purposes of this paragraph; and
(d) the Commonwealth Environment Minister;
25 and
(e) any local council that the Regulator
considers appropriate.
53. Regulator may take other actions
(1) In addition to satisfying the requirements of this
30 Division in relation to an application for a licence
to which this Division applies, the Regulator may
take any other action the Regulator considers
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appropriate for the purpose of deciding the
application, including holding a public hearing.
(2) If the Regulator holds a public hearing, the
Regulator may, having regard to the requirements
5 of this Act in relation to confidential commercial
information, direct that any part of the hearing be
held in private, and may determine who can
attend.
(3) The Regulator may give directions prohibiting or
10 restricting the publication of evidence given, or
material contained in documents produced, at a
public hearing.
(4) A person must not contravene a direction given
under sub-section (3).
15 Penalty: $3300.
54. Person may request copies of certain documents
(1) A person may request that the Regulator provide
the person with a copy of the following
documents--
20 (a) an application to which this Division applies;
(b) a risk assessment or a risk management plan
prepared under section 50.
(2) If a person makes a request under sub-section (1),
the Regulator must provide to the person a copy of
25 the documents, other than--
(a) any confidential commercial information
contained in the documents; and
(b) any information contained in the documents
about relevant convictions (within the
30 meaning of section 58) of the applicant for
the licence.
Note 1: In order for information to be confidential
commercial information, it must be covered by a
declaration under section 185.
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Note 2: The Information Privacy Act 2000 and the Health
Records Act 2001 also contain provisions relevant
to the disclosure of information.
Division 5--Decision on Licence etc.
5 55. Regulator must make a decision on licence and
licence conditions
After taking any steps required by Division 3 or 4
of this Part in relation to an application for a
GMO licence, the Regulator--
10 (a) must decide whether to issue or refuse to
issue the licence; and
(b) if the Regulator decides to issue the
licence--may impose conditions to which
the licence is subject.
15 56. Regulator must not issue the licence unless satisfied
as to risk management
(1) The Regulator must not issue the licence unless
the Regulator is satisfied that any risks posed by
the dealings proposed to be authorised by the
20 licence are able to be managed in such a way as to
protect--
(a) the health and safety of people; and
(b) the environment.
(2) For the purposes of sub-section (1), the Regulator
25 must have regard to the following--
(a) if a risk assessment has been prepared under
section 50 in relation to those dealings--the
risk assessment;
(b) if a risk management plan has been prepared
30 under section 50 in relation to those
dealings--the risk management plan;
(c) any submissions received under section 52 in
relation to the licence;
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(d) any policy guidelines in force under section
23 that relate to--
(i) risks that may be posed by the dealings
proposed to be authorised by the
5 licence; or
(ii) ways of managing such risks so as to
protect the health and safety of people
or to protect the environment.
57. Other circumstances in which Regulator must not
10 issue the licence
(1) The Regulator must not issue the licence if the
Regulator is satisfied that issuing the licence
would be inconsistent with a policy principle in
force under section 21.
15 (2) The Regulator must not issue the licence unless
the Regulator is satisfied that the applicant is a
suitable person to hold the licence.
58. Matters to be taken into account in deciding whether
a person is suitable to hold a licence
20 (1) Without limiting the matters to which the
Regulator may have regard in deciding whether a
natural person is a suitable person to hold a
licence, the Regulator must have regard to--
(a) any relevant conviction of the person; and
25 (b) any revocation or suspension of a licence or
permit (however described) held by the
person under a law of Victoria, the
Commonwealth, another State or a foreign
country, being a law relating to the health
30 and safety of people or the environment; and
(c) the capacity of the person to meet the
conditions of the licence.
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(2) Without limiting the matters to which the
Regulator may have regard in deciding whether a
body corporate is a suitable person to hold a
licence, the Regulator must have regard to the
5 following--
(a) any relevant conviction of the body
corporate; and
(b) if there is a relevant conviction of the body
corporate--
10 (i) whether the offence concerned was
committed at a time when any person
who is presently a director of the body
corporate was a director; and
(ii) whether that offence was committed at
15 a time when any officer or shareholder
of the body corporate who is presently
in a position to influence the
management of the body corporate was
such an officer or shareholder; and
20 (c) any revocation or suspension of a licence or
permit (however described) held by the body
corporate under a law of Victoria, the
Commonwealth, another State or a foreign
country, being a law relating to the health
25 and safety of people or the environment; and
(d) the capacity of the body corporate to meet
the conditions of the licence.
(3) In this section--
"relevant conviction" means a conviction for an
30 offence against a law of Victoria, the
Commonwealth, another State or a foreign
country, being a law relating to the health
and safety of people or the environment, if--
(a) the offence was committed within the
35 period of 10 years immediately before
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the making of the application for the
licence; and
(b) the offence was punishable by a fine of
$5000 or more, or by a term of
5 imprisonment of one year or more.
Note: This section differs from section 58 of the
Commonwealth Act.
59. Notification of licence decision
The Regulator must notify the applicant in writing
10 of the Regulator's decision (including any
conditions imposed by the Regulator, if
applicable).
60. Period of licence
(1) A licence continues in force--
15 (a) if the licence is expressed to be in force for a
particular period--until the end of that
period; or
(b) otherwise--until it is cancelled or
surrendered.
20 (2) A licence is not in force throughout any period of
suspension.
Division 6--Conditions of Licences
61. Licence is subject to conditions
A GMO licence is subject to the following
25 conditions--
(a) the conditions set out in sections 63, 64 and
65;
(b) any conditions prescribed by the regulations;
(c) any conditions imposed by the Regulator at
30 the time of issuing the licence;
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(d) any conditions imposed by the Regulator
under section 71 after the licence is issued.
62. Conditions that may be prescribed or imposed
(1) Licence conditions may include conditions that
5 impose obligations in relation to GM products that
are derived from a GMO in respect of which
particular dealings are licensed.
(2) Licence conditions may relate to, but are not
limited to, the following--
10 (a) the scope of the dealings authorised by the
licence;
(b) the purposes for which the dealings may be
undertaken;
(c) variations to the scope or purposes of the
15 dealings;
(d) documentation and record-keeping
requirements;
(e) the required level of containment in respect
of the dealings, including requirements
20 relating to the certification of facilities to
specified containment levels;
(f) waste disposal requirements;
(g) measures to manage risks posed to the health
and safety of people, or to the environment;
25 (h) data collection, including studies to be
conducted;
(i) auditing and reporting;
(j) actions to be taken in case of the release of a
GMO from a contained environment;
30 (k) the geographic area in which the dealings
authorised by the licence may occur;
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(l) requiring compliance with a code of practice
issued under section 24, or a technical or
procedural guideline issued under section 27;
(m) supervision by, and monitoring by,
5 Institutional Biosafety Committees;
(n) contingency planning in respect of
unintended effects of the dealings authorised
by the licence;
(o) limiting the dissemination or persistence of
10 the GMO or its genetic material in the
environment.
(3) Licence conditions may also include conditions
requiring the licence holder to be adequately
insured against any loss, damage or injury that
15 may be caused to human health, property or the
environment by the licensed dealing.
63. Condition about informing people of obligations
(1) It is a condition of a licence that the licence holder
inform any person covered by the licence, to
20 whom a particular condition of the licence applies,
of the following--
(a) the particular condition, including any
variations of it;
(b) the cancellation or suspension of the licence;
25 (c) the surrender of the licence.
(2) Requirements in relation to the manner in which
information is provided under sub-section (1) may
be--
(a) prescribed by the regulations; or
30 (b) specified by the Regulator.
(3) Such requirements may include, but are not
limited to, measures relating to labelling,
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packaging, conducting training and providing
information.
(4) If such requirements are prescribed or specified, it
is a condition of a licence that the licence holder
5 comply with the requirements.
64. Condition about monitoring and audits
(1) It is a condition of a licence that if--
(a) a person is authorised by the licence to deal
with a GMO; and
10 (b) a particular condition of the licence applies
to the dealing by the person--
the person must allow the Regulator, or a person
authorised by the Regulator, to enter premises
where the dealing is being undertaken, for the
15 purposes of auditing or monitoring the dealing.
(2) Sub-section (1) does not limit the conditions that
may be imposed by the Regulator or prescribed by
the regulations.
65. Condition about additional information to be given to
20 the Regulator
(1) It is a condition of a licence that the licence holder
inform the Regulator if the licence holder--
(a) becomes aware of additional information as
to any risks to the health and safety of
25 people, or to the environment, associated
with the dealings authorised by the licence;
or
(b) becomes aware of any contraventions of the
licence by a person covered by the licence;
30 or
(c) becomes aware of any unintended effects of
the dealings authorised by the licence.
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(2) For the purposes of sub-section (1)--
(a) the licence holder is taken to have become
aware of additional information of a kind
mentioned in sub-section (1) if the licence
5 holder was reckless as to whether such
information existed; and
(b) the licence holder is taken to have become
aware of contraventions, or unintended
effects, of a kind mentioned in sub-section
10 (1) if the licence holder was reckless as to
whether such contraventions had occurred,
or such unintended effects existed.
66. Person may give information to Regulator
A person covered by a licence may inform the
15 Regulator if the person--
(a) becomes aware of additional information as
to any risks to the health and safety of
people, or to the environment, associated
with the dealings authorised by the licence;
20 or
(b) becomes aware of any contraventions of the
licence by a person covered by the licence;
or
(c) becomes aware of any unintended effects of
25 the dealings authorised by the licence.
67. Protection of persons who give information
A person (the first person) does not incur any
civil liability in respect of loss, damage or injury
of any kind suffered by another person because
30 the first person gave information to the Regulator
under section 65 or 66.
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Division 7--Suspension, Cancellation and Variation of
Licences
68. Suspension and cancellation of licence
The Regulator may, by notice in writing given to
5 the holder of a GMO licence, suspend or cancel
the licence if--
(a) the Regulator believes on reasonable
grounds that a condition of the licence has
been breached, whether by the licence holder
10 or by a person covered by the licence; or
(b) the Regulator believes on reasonable
grounds that the licence holder, or a person
covered by the licence, has committed an
offence against this Act or the regulations; or
15 (c) any annual charge payable in respect of the
licence remains unpaid after the due date; or
(d) the licence was obtained improperly; or
(e) the Regulator becomes aware of risks
associated with the continuation of the
20 dealings authorised by the licence, and is
satisfied that the licence holder has not
proposed, or is not in a position to
implement, adequate measures to deal with
those risks; or
25 (f) the Regulator is satisfied that the licence
holder is no longer a suitable person to hold
the licence.
69. Surrender of licence
A licence holder may, with the consent of the
30 Regulator, surrender the licence.
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70. Transfer of licences
(1) The licence holder and another person (the
transferee) may jointly apply to the Regulator for
the licence to be transferred from the licence
5 holder to the transferee.
(2) The application must be in writing, and must
contain--
(a) such information as is prescribed by the
regulations (if any); and
10 (b) such information as is specified in writing by
the Regulator.
(3) The Regulator must not transfer the licence unless
the Regulator is satisfied that, if the licence is
transferred, any risks posed by the dealings
15 authorised by the licence will continue to be able
to be managed in such a way as to protect--
(a) the health and safety of people; and
(b) the environment.
(4) The Regulator must not transfer the licence unless
20 the Regulator is satisfied that the transferee is a
suitable person to hold the licence.
(5) The Regulator must give written notice of his or
her decision on the application to the licence
holder and the transferee.
25 (6) If the Regulator decides to transfer the licence--
(a) the transfer takes effect on the date specified
in the notice; and
(b) the licence continues in force as mentioned
in section 60; and
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(c) the licence is subject to the same conditions
as those in force immediately before the
transfer.
71. Variation of licence
5 (1) The Regulator may, at any time, by notice in
writing given to the licence holder, vary a licence.
(2) However, the Regulator must not vary a licence to
authorise dealings involving the intentional
release of a GMO into the environment if the
10 application for the licence was originally
considered under Division 3 of this Part.
Note: Applications can only be considered under
Division 3 if none of the dealings proposed to be
authorised by the licence would involve the
15 intentional release of a GMO into the environment.
(3) Without limiting sub-section (1), the Regulator
may--
(a) impose licence conditions or additional
licence conditions; or
20 (b) remove or vary licence conditions that were
imposed by the Regulator; or
(c) extend or reduce the authority granted by the
licence.
(4) However, the Regulator must not vary the licence
25 unless the Regulator is satisfied that any risks
posed by the dealings proposed to be authorised
by the licence as varied are able to be managed in
such a way as to protect--
(a) the health and safety of people; and
30 (b) the environment.
72. Regulator to notify of proposed suspension,
cancellation or variation5
(1) Before suspending, cancelling or varying a licence
under this Division, the Regulator must give
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written notice of the proposed suspension,
cancellation or variation to the licence holder.
(2) The notice--
(a) must state that the Regulator proposes to
5 suspend, cancel or vary the licence; and
(b) may require the licence holder to give to the
Regulator any information of a kind
specified in the notice that is relevant to the
proposed suspension, cancellation or
10 variation; and
(c) may invite the licence holder to make a
written submission to the Regulator about
the proposed suspension, cancellation or
variation.
15 (3) The notice must specify a period within which the
licence holder--
(a) must give the information referred to in sub-
section (2)(b); and
(b) may make a submission under sub-section
20 (2)(c).
The period must not end earlier than 30 days after
the day on which the notice was given.
(4) In considering whether to suspend, cancel or vary
a licence, the Regulator must have regard to any
25 submission made under sub-section (2)(c).
(5) This section does not apply to a suspension,
cancellation or variation requested by the licence
holder.
(6) This section does not apply to a suspension,
30 cancellation or variation of a licence if the
Regulator considers that the suspension,
cancellation or variation is necessary in order to
avoid an imminent risk of death, serious illness,
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serious injury or serious damage to the
environment.
Division 8--Annual Charge
72A. GMO licence--annual charge6
5 (1) A person who is the holder of a GMO licence at
any time during a financial year is liable to pay a
charge for the licence in respect of that year.
(2) The amount of the charge for a financial year is
such amount as is prescribed by the regulations.
10 (3) The amount of the charge prescribed for a
financial year may be in the nature of a tax and
not be related to the cost of providing any service.
Note: This section does not appear in the Commonwealth
Act. Provision is included, however, in the Gene
15 Technology (Licence Charges) Act 2000 of the
Commonwealth for the imposition of an annual
charge for a GMO licence.
_______________
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PART 6--REGULATION OF NOTIFIABLE LOW RISK
DEALINGS AND DEALINGS ON THE GMO REGISTER
Division 1--Simplified outline
73. Simplified outline
5 In outline, this Part--
· establishes a mechanism for the regulations to
regulate certain dealings with GMOs
(notifiable low risk dealings) that do not
involve the intentional release of GMOs into
10 the environment (see Division 2);
· provides that the regulations may (among
other things) require that the Regulator be
notified of such dealings;
· enables the Regulator to determine that certain
15 dealings previously authorised by a licence be
included on the GMO Register;
· ensures that, if a dealing is included on the
GMO Register, anyone may undertake the
dealing, subject to specified conditions.
20 Note: This section differs from section 73 of the
Commonwealth Act.
Division 2--Notifiable Low Risk Dealings
74. Notifiable low risk dealings
(1) The regulations may declare a dealing with a
25 GMO to be a notifiable low risk dealing for the
purposes of this Act.
(2) Before the Governor in Council makes regulations
declaring a dealing with a GMO to be a notifiable
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low risk dealing, the Regulator must be satisfied
that the dealing would not involve the intentional
release of a GMO into the environment.
(3) Before the Governor in Council makes regulations
5 declaring a dealing with a GMO to be a notifiable
low risk dealing, the Regulator must consider the
following matters--
(a) whether the GMO is biologically contained
so that it is not able to survive or reproduce
10 without human intervention;
(b) whether the dealing with the GMO would
involve minimal risk to the health and safety
of people and to the environment, taking into
account the properties of the GMO as a
15 pathogen or pest and the toxicity of any
proteins produced by the GMO;
(c) whether no conditions, or minimal
conditions, would be necessary to be
prescribed to manage any risk referred to in
20 paragraph (b).
(4) Regulations under sub-section (1) may be
expressed to apply to--
(a) all dealings with a GMO or with a specified
class of GMOs; or
25 (b) a specified class of dealings with a GMO or
with a specified class of GMOs; or
(c) one or more specified dealings with a GMO
or with a specified class of GMOs.
75. Regulation of notifiable low risk dealings
30 (1) The regulations may regulate--
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(a) a specified notifiable low risk dealing; or
(b) a specified class of notifiable low risk
dealings--
for the purpose of protecting the health and safety
5 of people or the environment.
(2) The regulations may prescribe different
requirements to be complied with in different
situations or by different persons, including
requirements in relation to the following--
10 (a) the class of persons who may undertake
notifiable low risk dealings;
(b) notifying the Regulator of notifiable low risk
dealings;
(c) supervision by Institutional Biosafety
15 Committees of notifiable low risk dealings;
(d) the containment level of facilities in which
notifiable low risk dealings may be
undertaken.
Division 3--The GMO Register
20 76. GMO Register
Note: Section 76 of the Commonwealth Act provides for
the establishment and maintenance of the GMO
Register.
77. Contents of Register
25 If the Regulator determines under section 78 that a
dealing with a GMO is to be included on the
GMO Register, the Regulator must specify in the
GMO Register--
(a) a description of the dealing with the GMO;
30 and
(b) any condition to which the dealing is subject.
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78. Regulator may include dealings with GMOs on GMO
Register
(1) The Regulator may, by writing, determine that a
dealing with a GMO is to be included on the
5 GMO Register if the Regulator is satisfied that--
(a) the dealing is, or has been, authorised by a
GMO licence; or
(b) the GMO concerned--
(i) is a GM product; and
10 (ii) is a genetically modified organism only
because of regulations made under
paragraph (c) of the definition of
"genetically modified organism".
(2) A determination under sub-section (1) may be
15 made--
(a) on application by the holder of a licence that
authorises the dealing; or
(b) on the initiative of the Regulator.
(3) A determination under sub-section (1) comes into
20 effect on the day specified in the determination. If
the determination was made on application by the
holder of a GMO licence that authorises the
dealing, the day must not be before the licence
ceases to be in force.
25 Note: Section 78(4) of the Commonwealth Act provides
for determinations to be disallowable instruments.
79. Regulator not to make determination unless risks can
be managed
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(1) The Regulator must not make a determination
under section 78(1) in respect of a dealing with a
GMO unless the Regulator is satisfied--
(a) that any risks posed by the dealing are
5 minimal; and
(b) that it is not necessary for persons
undertaking the dealing to hold, or be
covered by, a GMO licence, in order to
protect the health and safety of people or to
10 protect the environment.
(2) For the purposes of sub-section (1), the Regulator
must have regard to the following--
(a) any data available to the Regulator about
adverse effects posed by the dealing;
15 (b) any other information as to risks associated
with the dealing of which the Regulator is
aware, including information provided to
the Regulator by a licence holder under
section 65 or by another person under
20 section 66;
(c) whether there is a need for the dealing to be
subject to conditions;
(d) any other information in relation to whether
the dealing should be authorised by a GMO
25 licence.
(3) The Regulator may have regard to such other
matters as the Regulator considers relevant.
80. Variation of GMO Register
(1) The Regulator may vary the GMO Register by
30 written determination.
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(2) A variation may--
(a) remove a dealing from the GMO Register; or
(b) revoke or vary conditions to which a dealing
on the GMO Register is subject; or
5 (c) impose additional conditions to which a
dealing on the GMO Register is subject.
Note: Section 80(3) of the Commonwealth Act provides
for determinations to be disallowable instruments.
81. Inspection of Register
10 Note: Section 81 of the Commonwealth Act requires the
Regulator to permit any person to inspect the
GMO Register.
_______________
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PART 7--CERTIFICATION AND ACCREDITATION
Division 1--Simplified outline
82. Simplified outline
In outline, this Part--
· establishes a system under which the
5
Regulator may certify facilities to specified
containment levels in accordance with
guidelines issued by the Regulator. Licence
conditions can require that facilities be
10 certified to specified containment levels (see
Division 2);
· enables the Regulator to accredit organisations
in accordance with accreditation guidelines
issued by the Regulator. Licence conditions
15 can specify that dealings must be supervised
by an Institutional Biosafety Committee
established by an accredited organisation (see
Division 3).
Division 2--Certification
20 83. Application for certification
(1) A person may apply to the Regulator for
certification of a facility to a particular
containment level under this Division.
(2) The application must be in writing, and must
25 contain such information as the Regulator
requires.
Note: The conditions of a licence may require that a
facility be certified under this Division.
(3) The application must be accompanied by the
30 application fee (if any) prescribed by the
regulations.
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84. When the Regulator may certify the facility
The Regulator may, by written instrument, certify
the facility to a specified containment level if the
facility meets the containment requirements
5 specified in guidelines issued by the Regulator
under section 90.
85. Regulator may require applicant to give further
information
(1) The Regulator may, by notice in writing, require
10 an applicant for certification of a facility to give
the Regulator such further information in relation
to the application as the Regulator requires.
(2) The notice may specify the period within which
the information is to be provided.
15 86. Conditions of certification
The certification of a facility is subject to the
following conditions--
(a) any conditions imposed by the Regulator at
the time of certification;
20 (b) any conditions imposed by the Regulator
under section 87 after certification;
(c) any conditions prescribed by the regulations.
87. Variation of certification
(1) The Regulator may, at any time, by notice in
25 writing given to the holder of the certification,
vary the certification of a facility.
(2) Without limiting sub-section (1), the Regulator
may--
(a) impose additional conditions; or
30 (b) remove or vary conditions that were imposed
by the Regulator.
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88. Suspension or cancellation of certification
The Regulator may, by notice in writing, suspend
or cancel the certification of a facility if the
Regulator believes on reasonable grounds that a
5 condition of the certification has been breached.
89. Regulator to notify of proposed suspension,
cancellation or variation
(1) Before suspending, cancelling or varying a
certification under this Division, the Regulator
10 must give written notice of the proposed
suspension, cancellation or variation to the holder
of the certification.
(2) The notice--
(a) must state that the Regulator proposes to
15 suspend, cancel or vary the certification; and
(b) may require the holder of the certification to
give to the Regulator any information of a
kind specified in the notice that is relevant to
the proposed suspension, cancellation or
20 variation; and
(c) may invite the holder of the certification to
make a written submission to the Regulator
about the proposed suspension, cancellation
or variation.
25 (3) The notice must specify a period within which the
holder of the certification--
(a) must give the information referred to in sub-
section (2)(b); and
(b) may make a submission under sub-section
30 (2)(c).
The period must not end earlier than 30 days after
the day on which the notice was given.
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(4) In considering whether to suspend, cancel or vary
a certification, the Regulator must have regard to
any submission made under sub-section (2)(c).
(5) This section does not apply to a suspension,
5 cancellation or variation requested by the holder
of the certification.
(6) This section does not apply to a suspension,
cancellation or variation of a certification if the
Regulator considers that the suspension,
10 cancellation or variation is necessary in order to
avoid an imminent risk of death, serious illness,
serious injury or serious damage to the
environment.
90. Guidelines
15 (1) The Regulator may, by written instrument, issue
technical or procedural guidelines about the
requirements for the certification of facilities to
specified containment levels.
(2) The Regulator may, by written instrument, vary or
20 revoke the guidelines.
Division 3--Accredited Organisations
91. Application for accreditation
(1) A person may apply to the Regulator for
accreditation of an organisation as an accredited
25 organisation under this Division.
Note: The conditions of a licence may require supervision
of dealings by an Institutional Biosafety
Committee established by an accredited organisation
(see section 62(2)(m)), and the regulations may
30 require such supervision of notifiable low risk
dealings (see section 75(2)(c)).
(2) The application must be in writing, and must
contain such information as the Regulator
requires.
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92. Regulator may accredit organisations
(1) The Regulator may, by written instrument,
accredit an organisation as an accredited
organisation.
5 (2) In deciding whether to accredit an organisation,
the Regulator must have regard to--
(a) whether the organisation has established, or
proposes to establish, an Institutional
Biosafety Committee in accordance with
10 written guidelines issued by the Regulator
under section 98; and
(b) whether the organisation will be able to
maintain an Institutional Biosafety
Committee in accordance with such
15 guidelines; and
(c) whether the organisation has, or will have,
appropriate indemnity arrangements for its
Institutional Biosafety Committee members;
and
20 (d) any other matters specified in such
guidelines.
93. Regulator may require applicant to give further
information
(1) The Regulator may, by notice in writing, require
25 an applicant for accreditation of an organisation to
give the Regulator such further information in
relation to the application as the Regulator
requires.
(2) The notice may specify the period within which
30 the information is to be provided.
94. Conditions of accreditation
The accreditation of an accredited organisation is
subject to the following conditions--
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(a) any conditions imposed by the Regulator at
the time of accreditation;
(b) any conditions imposed by the Regulator
under section 95 after accreditation;
5 (c) any conditions prescribed by the regulations.
95. Variation of accreditation
(1) The Regulator may, at any time, by notice in
writing given to an accredited organisation, vary
the organisation's accreditation.
10 (2) Without limiting sub-section (1), the Regulator
may--
(a) impose additional conditions; or
(b) remove or vary conditions that were imposed
by the Regulator.
15 96. Suspension or cancellation of accreditation
The Regulator may, by notice in writing, suspend
or cancel the accreditation of an organisation if
the Regulator believes on reasonable grounds that
a condition of the accreditation has been breached.
20 97. Regulator to notify of proposed suspension,
cancellation or variation
(1) Before suspending, cancelling or varying an
accreditation under this Division, the Regulator
must give written notice of the proposed
25 suspension, cancellation or variation to the holder
of the accreditation.
(2) The notice--
(a) must state that the Regulator proposes to
suspend, cancel or vary the accreditation;
30 and
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(b) may require the holder of the accreditation to
give to the Regulator any information of a
kind specified in the notice that is relevant to
the proposed suspension, cancellation or
5 variation; and
(c) may invite the holder of the accreditation to
make a written submission to the Regulator
about the proposed suspension, cancellation
or variation.
10 (3) The notice must specify a period within which the
holder of the accreditation--
(a) must give the information referred to in sub-
section (2)(b); and
(b) may make a submission under sub-section
15 (2)(c).
The period must not end earlier than 30 days after
the day on which the notice was given.
(4) In considering whether to suspend, cancel or vary
an accreditation, the Regulator must have regard
20 to any submission made under sub-section (2)(c).
(5) This section does not apply to a suspension,
cancellation or variation requested by the holder
of the accreditation.
(6) This section does not apply to a suspension,
25 cancellation or variation of an accreditation if the
Regulator considers that the suspension,
cancellation or variation is necessary in order to
avoid an imminent risk of death, serious illness,
serious injury or serious damage to the
30 environment.
98. Guidelines
(1) The Regulator may, by written instrument, issue
technical or procedural guidelines in relation to
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requirements that must be met in order for an
organisation to be accredited under this Division.
(2) The guidelines may relate to, but are not limited
to, matters concerning the establishment and
5 maintenance of Institutional Biosafety
Committees.
(3) The Regulator may, by written instrument, vary or
revoke the guidelines.
_______________
10
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Act No.
PART 8--THE GENE TECHNOLOGY TECHNICAL
ADVISORY COMMITTEE, THE GENE TECHNOLOGY
COMMUNITY CONSULTATIVE COMMITTEE AND THE
GENE TECHNOLOGY ETHICS COMMITTEE
5 Division 1--Simplified outline
99. Simplified outline
In outline, this Part sets out the functions under
this Act of the Gene Technology Technical
Advisory Committee, the Gene Technology
10 Community Consultative Committee and the Gene
Technology Ethics Committee.
Note: This section differs from section 99 of the
Commonwealth Act.
Division 2--The Gene Technology Technical Advisory
15 Committee
100. The Gene Technology Technical Advisory Committee
Note: Section 100 of the Commonwealth Act provides for
the establishment and membership of the Gene
Technology Technical Advisory Committee.
20 101. Function of the Gene Technology Technical Advisory
Committee
The function of the Gene Technology Technical
Advisory Committee under this Act is to provide
scientific and technical advice, on the request of
25 the Regulator or the Ministerial Council, on the
following--
(a) gene technology, GMOs and GM products;
(b) applications made under this Act;
(c) the biosafety aspects of gene technology;
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(d) the need for policy principles, policy
guidelines, codes of practice and technical
and procedural guidelines in relation to
GMOs and GM products and the content of
5 such principles, guidelines and codes.
102. Expert advisers
Note: Section 102 of the Commonwealth Act provides for
the appointment of expert advisers to the Gene
Technology Technical Advisory Committee.
10 103. Remuneration
Note: Section 103 of the Commonwealth Act provides for
the payment of remuneration and allowances to
members of, and expert advisers to, the Gene
Technology Technical Advisory Committee.
15 104. Members and procedures
Note: Section 104 of the Commonwealth Act empowers
the making of regulations relating to the
membership and operation of the Gene Technology
Technical Advisory Committee.
20 105. Subcommittees
Note: Section 105 of the Commonwealth Act deals with
the establishment of subcommittees by the Gene
Technology Technical Advisory Committee.
Division 3--The Gene Technology Community Consultative
25 Committee
106. The Gene Technology Community Consultative
Committee
Note: Section 106 of the Commonwealth Act establishes
the Gene Technology Community Consultative
30 Committee.
107. Function of Consultative Committee
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The function of the Consultative Committee under
this Act is to provide advice, on the request of the
Regulator or the Ministerial Council, on the
following--
5 (aa) matters of general concern identified by the
Regulator in relation to applications made
under this Act;
(a) matters of general concern in relation to
GMOs;
10 (b) the need for policy principles, policy
guidelines, codes of practice and technical
and procedural guidelines in relation to
GMOs and GM products and the content of
such principles, guidelines and codes.
15 108. Membership
Note: Section 108 of the Commonwealth Act provides for
the membership of the Consultative Committee.
109. Remuneration
Note: Section 109 of the Commonwealth Act provides for
20 the payment of remuneration and allowances to
members of the Consultative Committee.
110. Regulations7
Note: Section 110 of the Commonwealth Act empowers
the making of regulations relating to the
25 membership and operation of the Consultative
Committee.
110A. Subcommittees8
Note: Section 110A of the Commonwealth Act deals with
the establishment of subcommittees by the
30 Consultative Committee.
Division 4--The Gene Technology Ethics Committee
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111. The Gene Technology Ethics Committee
Note: Section 111 of the Commonwealth Act provides for
the establishment and membership of the Gene
Technology Ethics Committee.
5 112. Function of the Gene Technology Ethics Committee
The function of the Ethics Committee under this
Act is to provide advice, on the request of the
Regulator or the Ministerial Council, on the
following--
10 (a) ethical issues relating to gene technology;
(b) the need for, and content of, codes of
practice in relation to ethics in respect of
conducting dealings with GMOs;
(c) the need for, and content of, policy
15 principles in relation to dealings with GMOs
that should not be conducted for ethical
reasons.
113. Expert advisers
Note: Section 113 of the Commonwealth Act provides for
20 the appointment of expert advisers to the Ethics
Committee.
114. Remuneration
Note: Section 114 of the Commonwealth Act provides for
the payment of remuneration and allowances to
25 members of, and expert advisers to, the Ethics
Committee.
115. Members and procedures
Note: Section 115 of the Commonwealth Act empowers
the making of regulations relating to the
30 membership and operation of the Ethics Committee.
116. Subcommittees
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s. 116
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Note: Section 116 of the Commonwealth Act deals with
the establishment of subcommittees by the Ethics
Committee.
_______________
5
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PART 9--ADMINISTRATION
Division 1--Simplified outline
117. Simplified outline
In outline, this Part--
· provides for financial matters (see Division 3);
5
· sets out reporting requirements (see
Division 5);
· requires the Regulator to ensure that certain
information is entered on a record of GMOs
10 and GM products (see Division 6);
· permits the Regulator to review notifiable low
risk dealings and exemptions (see Division 7).
Note: This section differs from section 117 of the
Commonwealth Act.
15 Division 2--Appointment and conditions of Regulator
118. Appointment of the Regulator
Note: Section 118 of the Commonwealth Act provides for
the appointment of the Regulator.
119. Termination of appointment
20 Note: Section 119 of the Commonwealth Act sets out the
circumstances in which the Regulator's appointment
may be terminated.
120. Disclosure of interests
Note: Section 120 of the Commonwealth Act requires the
25 Regulator to disclose his or her interests to the
Minister.
121. Acting appointment
Note: Section 121 of the Commonwealth Act deals with
the appointment of a person to act as the Regulator.
30 122. Terms and conditions
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Note: Section 122 of the Commonwealth Act deals with
the terms and conditions of appointment of the
Regulator.
123. Outside employment
5 Note: Section 123 of the Commonwealth Act prohibits the
Regulator from engaging in paid outside
employment without the approval of the Minister.
124. Remuneration
Note: Section 124 of the Commonwealth Act provides for
10 the payment of remuneration and allowances to the
Regulator.
125. Leave of absence
Note: Section 125 of the Commonwealth Act deals with
the entitlement of the Regulator to leave of absence.
15 126. Resignation
Note: Section 126 of the Commonwealth Act deals with
the procedure for resignation by the Regulator.
Division 3--Money
127. Regulator may charge for services
20 The Regulator may charge for services provided
by, or on behalf of, the Regulator in the
performance of the Regulator's functions under
this Act or the regulations.
128. Notional payments by the State
25 (1) The purpose of this section is to ensure that fees
and charges under this Act and the regulations are
notionally payable by the State of Victoria and
bodies representing the State.
(2) The Minister responsible for administering Part 7
30 of the Financial Management Act 1994 may
give written directions for the purpose of this
section, including directions relating to the
transfer of amounts within, or between, accounts
operated by the State of Victoria.
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Note: This section differs from section 128 of the
Commonwealth Act.
129. Gene Technology Account
Note: Section 129 of the Commonwealth Act provides for
5 the establishment of the Gene Technology Account.
130. Credits to Gene Technology Account
(1) There must be paid to the Commonwealth for
crediting to the Gene Technology Account the
following--
10 (a) amounts equal to money from time to time
received by the State of Victoria under
Division 8 of Part 5;
(b) amounts equal to fees received by the State
of Victoria under sections 40(6) and 83(3);
15 (c) amounts equal to amounts received by the
State of Victoria in connection with the
performance of the Regulator's functions
under this Act or the regulations;
(d) amounts equal to amounts recovered by the
20 State of Victoria under section 146(5) or
158(4), to the extent that they are referable to
costs paid out of the Gene Technology
Account.
(2) The Consolidated Fund is appropriated to the
25 necessary extent to enable amounts to be paid to
the Commonwealth in accordance with sub-
section (1).
Note: This section differs from section 130 of the
Commonwealth Act.
30 131. Recovery of amounts
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The following amounts may be recovered in a
court of competent jurisdiction as debts due to the
State of Victoria--
(a) amounts payable to the State of Victoria
5 under Division 8 of Part 5;
(b) fees payable to the State of Victoria under
this Act or the regulations;
(c) amounts payable to the State of Victoria in
connection with the performance of the
10 Regulator's functions under this Act or the
regulations.
132. Purposes of Account
Note: Section 132 of the Commonwealth Act sets out the
purposes for which money in the Gene Technology
15 Account may be expended.
Division 4--Staffing
133. Staff assisting the Regulator
Note: Section 133 of the Commonwealth Act provides for
staff to be made available to assist the Regulator.
20 134. Consultants
Note: Section 134 of the Commonwealth Act enables the
Regulator to engage consultants.
135. Seconded officers
Note: Section 135 of the Commonwealth Act provides for
25 staff to be seconded to the Regulator.
Division 5--Reporting Requirements
136. Annual report9
(1) As soon as practicable after the end of each
financial year, the Regulator must prepare and
30 give to the Minister a report on the operations of
the Regulator under this Act and the regulations
during that year.
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(2) The Minister must cause a copy of the report to be
laid before each House of the Parliament within
15 sitting days of that House after the Minister
receives the report.
5 Note: Section 136(3) of the Commonwealth Act requires
the Regulator to give a copy of his or her report
under that section to each State.
136A. Quarterly reports10
(1) As soon as practicable after the end of each
10 quarter, the Regulator must prepare and give to
the Minister a report on the operations of the
Regulator under this Act and the regulations
during that quarter.
(2) The report must include information about the
15 following--
(a) GMO licences issued during the quarter;
(b) any breaches of conditions of a GMO licence
that have come to the Regulator's attention
during the quarter;
20 (c) auditing and monitoring of dealings with
GMOs under this Act by the Regulator or an
inspector during the quarter.
Note: Auditing and monitoring may include spot checks.
(3) The Minister must cause a copy of the report to be
25 laid before each House of the Parliament within
15 sitting days of that House after the Minister
receives the report.
(4) In this section--
"quarter" means a period of 3 months beginning
30 on 1 January, 1 April, 1 July or 1 October of
any year.
137. Reports to Parliament
(1) The Regulator may at any time cause a report
about matters relating to the Regulator's functions
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under this Act or the regulations to be laid before
each House of the Parliament.
(2) The Regulator must give a copy of the report to
the Minister.
5 Note: Section 137(2) of the Commonwealth Act requires
the Regulator to give a copy of his or her report
under that section to each State.
Division 6--Record of GMO and GM Product Dealings
138. Record of GMO and GM Product Dealings
10 (1) The Record must contain the following
information, other than confidential commercial
information, in relation to each licence issued
under section 55--
(a) the name of the licence holder;
15 (b) the persons covered by the licence;
(c) the dealings authorised by the licence and
the GMO to which those dealings relate;
(d) any licence conditions;
(e) the date on which the licence was issued, and
20 its expiry date (if any).
(2) The Record must contain the following
information, other than confidential commercial
information, in relation to each notifiable low risk
dealing that is notified to the Regulator in
25 accordance with regulations under section 75--
(a) the name of the person who notified the
dealing;
(b) such particulars of the dealing as are
prescribed by the regulations for the
30 purposes of this paragraph.
(3) The Record must contain such information as is
prescribed by the regulations, other than
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confidential commercial information, in relation
to GM products mentioned in designated
notifications given to the Regulator under any
Act.
5 (4) The Record must also contain--
(a) a description of each dealing on the GMO
Register; and
(b) any condition to which the dealing is subject.
(5) The Regulator must ensure that information
10 mentioned in sub-section (1), (2), (3) or (4) is
entered on the Record as soon as reasonably
practicable.
(6) In this section--
"designated notification" means a notification
15 required to be given to the Regulator under
an Act or any law applying as a law of the
State of Victoria by force of an Act.
Note: This section differs from section 138 of the
Commonwealth Act.
20 139. Inspection of Record
Note: Section 139 of the Commonwealth Act requires the
Regulator to permit any person to inspect the
Record.
Division 7--Reviews of Notifiable Low Risk Dealings and
25 Exemptions
140. Regulator may review notifiable low risk dealings
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(1) The Regulator may, at any time, in accordance
with this Division, consider the following
matters--
(a) whether a dealing with a GMO should be a
5 notifiable low risk dealing;
(b) whether an existing notifiable low risk
dealing should no longer be a notifiable low
risk dealing.
(2) The basis of the Regulator's consideration must
10 relate to--
(a) the matters of which the Regulator must be
satisfied under section 74(2); or
(b) the matters the Regulator must consider
under section 74(3).
15 141. Regulator may review exemptions
The Regulator may, at any time, in accordance
with this Division, consider the following
matters--
(a) whether a dealing that is an exempt dealing
20 within the meaning of section 32 should not
be an exempt dealing;
(b) whether a dealing should be an exempt
dealing within the meaning of that section.
142. Regulator may give notice of consideration
25 (1) The Regulator may publish a notice inviting
written submissions in relation to any matter that
the Regulator may consider under section 140 or
141. The notice must--
(a) specify the matters to which submissions are
30 to relate; and
(b) specify the closing date for submissions,
which must not be earlier than 30 days after
the date on which the notice was published.
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(2) If the Regulator publishes a notice under sub-
section (1), the Regulator must also give written
notice, stating the matters mentioned in sub-
section (1), to--
5 (a) the States; and
(b) the Gene Technology Technical Advisory
Committee; and
(c) each Commonwealth authority or agency
prescribed by the regulations for the
10 purposes of this paragraph.
(3) A notice under this section may relate to a single
matter or to a class of matters.
143. What Regulator may do after consideration
(1) If--
15 (a) the matter relates to whether a dealing
should be a notifiable low risk dealing; and
(b) the Regulator is satisfied as mentioned in
section 74(2); and
(c) the Regulator has considered the matters
20 mentioned in section 74(3)--
the Regulator may recommend to the Ministerial
Council that the dealing be declared to be a
notifiable low risk dealing.
(2) If--
25 (a) the matter relates to whether an existing
notifiable low risk dealing be reconsidered;
and
(b) after having had regard to the matters
mentioned in section 74, the Regulator
30 considers that the dealing should not be a
notifiable low risk dealing--
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the Regulator may recommend to the Ministerial
Council that the regulations be amended
accordingly.
(3) If the matter relates to whether a dealing--
5 (a) should be an exempt dealing; or
(b) should cease to be an exempt dealing--
the Regulator may recommend to the Ministerial
Council that the regulations be amended
accordingly.
10 144. Regulator not required to review matters
Nothing in this Division requires the Regulator to
consider a matter under section 140 or 141.
_______________
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PART 10--ENFORCEMENT
145. Simplified outline
In outline, this Part--
· enables the Regulator to give directions to a
5 licence holder or to a person covered by a
licence if--
the Regulator believes that the person is not
complying with this Act or the regulations;
and
10 the Regulator believes that it is necessary to
do so in order to protect the health and
safety of people or to protect the
environment;
· empowers the Supreme Court to issue
15 injunctions, and contains a forfeiture
provision.
Note: This section differs from section 145 of the
Commonwealth Act.
146. Regulator may give directions
20 (1) If the Regulator believes, on reasonable grounds,
that--
(a) a licence holder is not complying with this
Act or the regulations in respect of a thing;
and
25 (b) it is necessary to exercise powers under this
section in order to protect the health and
safety of people or to protect the
environment--
the Regulator may give directions to the licence
30 holder, by written notice, requiring the licence
holder, within the time specified in the notice, to
take such steps in relation to the thing as are
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reasonable in the circumstances for the licence
holder to comply with this Act or the regulations.
(2) If the Regulator believes on reasonable grounds
that--
5 (a) a person covered by a GMO licence is not
complying with this Act or the regulations in
respect of a thing; and
(b) it is necessary to exercise powers under this
section in order to protect the health and
10 safety of people or to protect the
environment--
the Regulator may give directions to the person,
by written notice, requiring the person, within the
time specified in the notice, to take such steps in
15 relation to the thing as are reasonable in the
circumstances for the person to comply with this
Act or the regulations.
(3) A person must take the steps specified in a notice
under sub-section (1) or (2) within the time
20 specified in the notice.
Penalty: in the case of an aggravated offence--
$220 000;
in any other case--$55 000.
Note: Aggravated offence is defined in section 38.
25 (4) If the licence holder or the person, as the case
requires, does not take the steps specified in the
notice within the time specified in the notice, the
Regulator may arrange for those steps to be taken.
(5) If the Regulator incurs costs because of
30 arrangements made by the Regulator under sub-
section (4), the licence holder or the person, as the
case requires, is liable to pay to the State of
Victoria an amount equal to the cost, and the
amount may be recovered by the State as a debt
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due to the State in a court of competent
jurisdiction.
(6) A time specified in a notice under sub-section (1)
or (2) must be reasonable having regard to the
5 circumstances.
Note: This section differs from section 146 of the
Commonwealth Act.
147. Injunctions
(1) If a person has engaged, is engaging, or is about to
10 engage in any conduct that is or would be an
offence against this Act or the regulations, the
Supreme Court (the Court) may, on the
application of the Regulator or any other
aggrieved person, grant an injunction restraining
15 the person from engaging in the conduct.
(2) If--
(a) a person has refused or failed, is refusing or
failing, or is about to refuse or fail, to do a
thing; and
20 (b) the refusal or failure is, or would be, an
offence against this Act or the regulations--
the Court may, on the application of the Regulator
or any other aggrieved person, grant an injunction
requiring the person to do the thing.
25 (3) The power of the Court to grant an injunction may
be exercised--
(a) whether or not it appears to the Court that
the person intends to engage, or to continue
to engage, in conduct of that kind; and
30 (b) whether or not the person has previously
engaged in conduct of that kind.
(4) The Court may discharge or vary an injunction
granted under this section.
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(5) The Court may grant an interim injunction
pending a determination of an application under
sub-section (1).
(6) The powers granted by this section are in addition
5 to, and not in derogation of, any other powers of
the Court.
Note: Section 147 of the Commonwealth Act confers a
similar power to grant injunctions on the Federal
Court of Australia.
10 148. Forfeiture
(1) If a court finds a person guilty of an offence
against this Act or the regulations, the court may
order forfeiture to the State of Victoria of any
thing used or otherwise involved in the
15 commission of the offence.
(2) A thing ordered by a court to be forfeited under
this section becomes the property of the State of
Victoria and may be sold or otherwise dealt with
in accordance with the directions of the Regulator.
20 (3) Until the Regulator gives a direction, the thing
must be kept in such custody as the Regulator
directs.
Note: This section differs from section 148 of the
Commonwealth Act.
25 _______________
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PART 11--POWERS OF INSPECTION
Division 1--Simplified outline
149. Simplified outline
In outline, this Part--
· provides for powers of inspection in relation to
5
monitoring and offences;
· provides for the appointment of inspectors (see
Division 2);
· deals with the powers and obligations of
10 inspectors and the rights and responsibilities of
an occupier of premises when an inspector
seeks to exercise powers (see Divisions 3 to
9);
· sets out procedures relating to monitoring
15 warrants and offence-related warrants (see
Division 10);
· does not limit the conditions to which a
licence can be subject, and section 64 imposes
a condition in relation to monitoring dealings
20 with GMOs.
Division 2--Appointment of Inspectors and Identity Cards
150. Appointment of inspectors
(1) The Regulator may, by instrument in writing,
appoint any of the following persons as
25 inspectors--
(a) any employee or class of employee
employed under Part 3 of the Public Sector
Management and Employment Act 1998;
or
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(b) a person who is appointed or employed by
the Commonwealth.
(2) In exercising powers or performing functions as
an inspector, an inspector must comply with any
5 directions of the Regulator.
Note: This section differs from section 150 of the
Commonwealth Act.
151. Identity card
(1) The Regulator must issue an identity card to an
10 inspector.
(2) The identity card--
(a) must be in the form prescribed by the
regulations; and
(b) must contain a recent photograph of the
15 inspector.
(3) If a person to whom an identity card has been
issued ceases to be an inspector, the person must
return the identity card to the Regulator as soon as
practicable.
20 Penalty: $110.
(4) An inspector must carry his or her identity card at
all times when exercising powers or performing
functions as an inspector.
Division 3--Monitoring Powers
25 152. Powers available to inspectors for monitoring
compliance
(1) For the purpose of finding out whether this Act or
the regulations have been complied with, an
inspector may--
30 (a) enter any premises; and
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(b) exercise the monitoring powers set out in
section 153.
(2) An inspector is not authorised to enter premises
under sub-section (1) unless--
5 (a) the occupier of the premises has consented to
the entry; or
(b) the entry is made under a warrant under
section 172; or
(c) the occupier of the premises is a licence
10 holder, or a person covered by a licence, and
the entry is at a reasonable time.
153. Monitoring powers
(1) The monitoring powers that an inspector may
exercise under section 152(1)(b) are as follows--
15 (a) to search the premises and any thing on the
premises;
(b) to inspect, examine, take measurements of,
conduct tests on, or take samples of, any
thing on the premises that relates to a GMO;
20 (c) to take photographs, make video or audio
recordings or make sketches of the premises
or any thing on the premises;
(d) if the inspector was authorised to enter the
premises by a warrant under section 172, to
25 require any person in or on the premises to--
(i) answer any questions put by the
inspector; and
(ii) produce any book, record or document
requested by the inspector;
30 (e) to inspect any book, record or document on
the premises;
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(f) to take extracts from or make copies of any
such book, record or document;
(g) to take onto the premises such equipment
and materials as the inspector requires for
5 the purpose of exercising powers in relation
to the premises;
(h) to secure a thing, until a warrant is obtained
to seize it, being a thing--
(i) that the inspector finds during the
10 exercise of monitoring powers on the
premises; and
(ii) that the inspector believes on
reasonable grounds is evidential
material; and
15 (iii) that the inspector believes on
reasonable grounds would be lost,
destroyed or tampered with before the
warrant can be obtained.
(2) For the purposes of this Part, monitoring powers
20 include the power to operate equipment at
premises to see whether--
(a) the equipment; or
(b) a disk, tape or other storage device that--
(i) is at the premises; and
25 (ii) can be used with the equipment or is
associated with it--
contains information that is relevant to
determining whether there has been compliance
with this Act or the regulations.
30 (3) If the inspector, after operating equipment at the
premises, finds that the equipment, or that a tape,
disk or other storage device at the premises,
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contains information mentioned in sub-section (2),
the inspector may--
(a) operate facilities at the premises to put the
information in documentary form and copy
5 the document so produced; or
(b) if the information can be transferred to a
tape, disk or other storage device that--
(i) is brought to the premises; or
(ii) is at the premises and the use of which
10 for the purpose has been agreed to in
writing by the occupier of the
premises--
operate the equipment or other facilities to
copy the information to the storage device,
15 and remove the storage device from the
premises.
Division 4--Offence-Related Powers
154. Searches and seizures related to offences
(1) This section applies if an inspector has reasonable
20 grounds for suspecting that there may be
evidential material on any premises.
(2) The inspector may--
(a) enter the premises, with the consent of the
occupier or under a warrant issued under
25 section 173; and
(b) exercise the powers set out in sub-section (3)
and section 155; and
(c) if the entry is under a warrant--seize the
evidential material, if the inspector finds it
30 on the premises.
(3) If--
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(a) in the course of searching, in accordance
with a warrant, for a particular thing, an
inspector finds another thing that the
inspector believes on reasonable grounds to
5 be evidential material; and
(b) the inspector believes, on reasonable
grounds, that it is necessary to seize that
other thing in order to prevent its
concealment, loss or destruction, or its use in
10 committing, continuing or repeating an
offence against this Act or the regulations--
the warrant is taken to authorise the inspector to
seize that other thing.
155. Offence-related powers of inspectors in relation to
15 premises
The powers an inspector may exercise under
section 154(2)(b) are as follows--
(a) to search the premises and any thing on the
premises for the evidential material;
20 (b) to inspect, examine, take measurements of,
conduct tests on, or take samples of the
evidential material;
(c) to take photographs, make video or audio
recordings or make sketches of the premises
25 or the evidential material;
(d) to take onto the premises such equipment
and materials as the inspector requires for
the purpose of exercising powers in relation
to the premises.
30 156. Use of equipment at premises
(1) The inspector may operate equipment at the
premises to see whether evidential material is
accessible by doing so, if the inspector believes on
reasonable grounds that the operation of the
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equipment can be carried out without damage to
the equipment.
(2) If the inspector, after operating the equipment,
finds that evidential material is accessible by
5 doing so, the inspector may--
(a) seize the equipment and any disk, tape or
other associated device; or
(b) if the material can, by using facilities at the
premises, be put in documentary form--
10 operate the facilities to put the material in
that form and seize the documents so
produced; or
(c) if the material can be transferred to a disk,
tape or other storage device that--
15 (i) is brought to the premises; or
(ii) is at the premises and the use of which
for the purpose has been agreed to in
writing by the occupier of the
premises--
20 operate the equipment or other facilities to
copy the material to the storage device and
take the storage device from the premises.
(3) An inspector may seize equipment under sub-
section (2)(a) only if--
25 (a) it is not practicable to put the material in
documentary form as mentioned in sub-
section (2)(b) or to copy the material as
mentioned in sub-section (2)(c); or
(b) possession by the occupier of the equipment
30 could constitute an offence.
(4) An inspector may seize equipment under sub-
section (2)(a) or documents under sub-section
(2)(b) only if the inspector entered the premises
under a warrant.
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Division 5--Expert Assistance
157. Expert assistance to operate a thing
(1) If an inspector believes on reasonable grounds
that--
5 (a) information relevant to determining whether
there has been compliance with this Act or
the regulations, or evidential material, may
be accessible by operating a thing at
particular premises; and
10 (b) expert assistance is required to operate the
thing; and
(c) if he or she does not take action under this
sub-section, the information or material may
be destroyed, altered or otherwise interfered
15 with--
he or she may do whatever is necessary to secure
the thing, whether by locking it up, placing a
guard or otherwise.
(2) The inspector must give notice to the occupier of
20 the premises of his or her intention to secure the
thing and of the fact that the thing may be secured
for up to 24 hours.
(3) The thing may be secured--
(a) for a period not exceeding 24 hours; or
25 (b) until the thing has been operated by the
expert--
whichever happens first.
(4) If the inspector believes on reasonable grounds
that the expert assistance will not be available
30 within 24 hours, he or she may apply to the
Magistrates' Court for an extension of that period.
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(5) The inspector must give notice to the occupier of
the premises of his or her intention to apply for an
extension, and the occupier is entitled to be heard
in relation to the application.
5 Division 6--Emergency powers
158. Powers available to inspectors for dealing with
dangerous situations
(1) This section applies if--
(a) an inspector has reasonable grounds for
10 suspecting that there may be on any premises
a particular thing in respect of which this Act
or the regulations have not been complied
with; and
(b) the inspector considers that it is necessary to
15 exercise powers under this section in order to
avoid an imminent risk of death, serious
illness, serious injury, or to protect the
environment.
(2) The inspector may do any of the following--
20 (a) enter the premises;
(b) search the premises for the thing;
(c) secure the thing, if the inspector finds it on
the premises, until a warrant is obtained to
seize the thing;
25 (d) if the inspector has reasonable grounds for
suspecting that a person has not complied
with this Act or the regulations in respect of
the thing--require the person to take such
steps that the inspector considers necessary
30 for the person to comply with this Act or the
regulations;
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(e) take such steps, or arrange for such steps to
be taken, in relation to the thing as the
inspector considers appropriate.
(3) The inspector may exercise the powers in sub-
5 section (2) only to the extent that it is necessary
for the purpose of avoiding an imminent risk of
death, serious illness, serious injury or serious
damage to the environment.
(4) If the Regulator incurs costs because of steps
10 reasonably taken or arranged to be taken by an
inspector under sub-section (2)(e), the person is
liable to pay to the State of Victoria an amount
equal to the cost, and the amount may be
recovered by the State as a debt due to the State in
15 a court of competent jurisdiction.
Division 7--Obligations and Incidental Powers of Inspectors
159. Inspector must produce identity card on request
An inspector is not entitled to exercise any powers
under this Part in relation to premises if--
20 (a) the occupier of the premises has required the
inspector to produce his or her identity card
for inspection by the occupier; and
(b) the inspector fails to comply with the
requirement.
25 160. Consent
(1) Before obtaining the consent of a person for the
purposes of section 152(2)(a) or 154(2)(a), the
inspector must inform the person that he or she
may refuse consent.
30 (2) An entry of an inspector by virtue of the consent
of a person is not lawful unless the person
voluntarily consented to the entry.
161. Details of warrant to be given to occupier etc.
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(1) If a warrant in relation to premises is being
executed and the occupier of the premises or
another person who apparently represents the
occupier is present at the premises, the inspector
5 must make available to that person a copy of the
warrant.
(2) The inspector must identify himself or herself to
that person.
(3) The copy of the warrant referred to in sub-section
10 (1) need not include the signature of the
magistrate who issued the warrant.
162. Announcement before entry
(1) An inspector must, before entering premises under
a warrant--
15 (a) announce that he or she is authorised to enter
the premises; and
(b) give any person at the premises an
opportunity to allow entry to the premises.
(2) An inspector is not required to comply with sub-
20 section (1) if he or she believes on reasonable
grounds that immediate entry to the premises is
required--
(a) to ensure the safety of a person; or
(b) to prevent serious damage to the
25 environment; or
(c) to ensure that the effective execution of the
warrant is not frustrated.
163. Compensation for damage
(1) The owner of a thing is entitled to compensation
30 for damage to the thing if--
(a) the damage was caused to the thing as a
result of it being operated as mentioned in
this Part; and
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(b) the damage was caused as a result of--
(i) insufficient care being exercised in
selecting the person who was to operate
the thing; or
5 (ii) insufficient care being exercised by the
person operating the thing.
(2) Compensation is payable by the Regulator.
(3) In determining the amount of compensation
payable, regard is to be had to whether the
10 occupier of the premises and their employees and
agents, if they were available at the time, had
provided any warning or guidance as to the
operation of the thing that was appropriate in the
circumstances.
15 Note: Section 163(2) of the Commonwealth Act provides
for compensation to be payable out of money
appropriated by Parliament.
Division 8--Power to Search Goods, Baggage etc.
164. Power to search goods, baggage etc.
20 (1) This section applies to any goods that are to be,
are being, or have been, taken off a ship that
voyages, or an aircraft that flies, between a place
outside Victoria and a place in Victoria.
(2) If an inspector believes, on reasonable grounds,
25 that goods are goods to which this section applies,
and that the goods may be, or may contain,
evidential material, the inspector may--
(a) examine the goods; or
(b) if the goods are baggage--open and search
30 the baggage; or
(c) if the goods are in a container--open and
search the container.
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(3) An inspector may ask a person who owns, is
carrying or is otherwise associated with, or
appears to the inspector to be associated with,
goods to which this section applies, any question
5 in respect of the goods.
(4) A person must not refuse or fail to answer a
question put to the person under sub-section (3).
Penalty: $3300.
Note: This section differs from section 164 of the
10 Commonwealth Act.
165. Seizure of goods
An inspector may seize goods mentioned in
section 164 if the inspector has reasonable
grounds to suspect that the goods are evidential
15 material.
Division 9--General Provisions relating to Search and
Seizure
166. Copies of seized things to be provided
(1) Subject to sub-section (2), if an inspector seizes,
20 under a warrant relating to premises--
(a) a document, film, computer file or other
thing that can be readily copied; or
(b) a storage device, the information in which
can be readily copied--
25 the inspector must, if requested to do so by the
occupier of the premises, or another person who
apparently represents the occupier and who is
present when the warrant is executed, give a copy
of the thing or the information to that person as
30 soon as practicable after the seizure.
(2) Sub-section (1) does not apply if--
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(a) the thing that has been seized was seized
under section 156(2)(b) or (c); or
(b) possession by the occupier of the document,
film, computer file, thing or information
5 could constitute an offence.
167. Occupier entitled to be present during search
(1) If a warrant in relation to premises is being
executed and the occupier of the premises, or
another person who apparently represents the
10 occupier is present at the premises, the person is
entitled to observe the search being conducted.
(2) The right to observe the search being conducted
ceases if the person impedes the search.
(3) This section does not prevent 2 or more areas of
15 the premises being searched at the same time.
168. Receipts for things seized
(1) If a thing is seized under this Part, the inspector
must provide a receipt for the thing.
(2) If 2 or more things are seized, they may be
20 covered in the one receipt.
169. Retention of seized things
(1) Subject to any contrary order of a court, if an
inspector seizes a thing under this Part, the
inspector must return it if--
25 (a) the reason for its seizure no longer exists or
it is decided that it is not to be used in
evidence; or
(b) the period of 60 days after its seizure ends--
whichever first occurs, unless the thing is forfeited
30 or forfeitable to the State of Victoria.
(2) At the end of the 60 days specified in sub-section
(1), an inspector must take reasonable steps to
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return the thing to the person from whom it was
seized, unless--
(a) proceedings in respect of which the thing
may afford evidence were instituted before
5 the end of the 60 days and have not been
completed (including an appeal to a court in
relation to those proceedings); or
(b) an inspector may retain the thing because of
an order under section 170; or
10 (c) to return the thing could cause an imminent
risk of death, serious illness, serious injury
or serious damage to the environment; or
(d) an inspector is otherwise authorised (by a
law, or an order of a court, of the State of
15 Victoria or the Commonwealth) to retain,
destroy or dispose of the thing.
(3) The thing may be returned under sub-section (2)
either unconditionally or on such terms and
conditions as the Regulator sees fit.
20 170. Magistrates' Court may permit a thing to be retained
(1) An inspector may apply to the Magistrates' Court
for an order that he or she may retain the thing for
a further period if--
(a) before the end of 60 days after the seizure; or
25 (b) before the end of a period previously
specified in an order of the Magistrates'
Court under this section--
proceedings in respect of which the thing may
afford evidence have not commenced.
30 (2) If the Magistrates' Court is satisfied that it is
necessary for an inspector to continue to retain the
thing--
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(a) for the purposes of an investigation as to
whether an offence against this Act or the
regulations has been committed; or
(b) to enable evidence of an offence against this
5 Act or the regulations to be secured for the
purposes of a prosecution--
the Court may order that an inspector may retain
the thing for a period (not being a period
exceeding 3 years) specified in the order.
10 (3) Before making the application, the inspector
must--
(a) take reasonable steps to discover who has an
interest in the retention of the thing; and
(b) if it is practicable to do so, notify each
15 person whom the inspector believes to have
such an interest of the proposed application.
Note: This section differs from section 170 of the
Commonwealth Act.
171. Disposal of goods if there is no owner or owner
20 cannot be located
If--
(a) a thing is seized under this Part; and
(b) apart from this section, the State of Victoria
is required to return the thing to the owner;
25 and
(c) there is no owner or the Regulator cannot,
despite making reasonable efforts, locate the
owner--
the Regulator may dispose of the thing in such
30 manner as the Regulator thinks appropriate.
Division 10--Warrants
172. Monitoring warrants
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(1) An inspector may apply to a magistrate for a
warrant under this section in relation to premises.
(2) Subject to sub-section (3), the magistrate may
issue the warrant if the magistrate is satisfied, by
5 evidence on oath, that it is reasonably necessary
that one or more inspectors should have access to
the premises for the purposes of finding out
whether this Act or the regulations have been
complied with.
10 (3) The magistrate must not issue the warrant unless
the inspector or some other person has given to
the magistrate, either orally or by affidavit, such
further information (if any) as the magistrate
requires concerning the grounds on which the
15 issue of the warrant is being sought.
(4) The warrant must--
(a) authorise one or more inspectors (whether or
not named in the warrant), with such
assistance and by such force as is necessary
20 and reasonable--
(i) to enter the premises; and
(ii) to exercise the powers set out in
section 153 in relation to the premises;
and
25 (b) state whether the entry is authorised to be
made at any time of the day or night or
during specified hours of the day or night;
and
(c) specify the day (not more than 6 months
30 after the issue of the warrant) on which the
warrant ceases to have effect; and
(d) state the purpose for which the warrant is
issued.
173. Offence-related warrants
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(1) An inspector may apply to a magistrate for a
warrant under this section in relation to premises.
(2) Subject to sub-section (3), the magistrate may
issue the warrant if the magistrate is satisfied, by
5 evidence on oath, that there are reasonable
grounds for suspecting that there is, or there may
be within the next 72 hours, evidential material in
or on the premises.
(3) The magistrate must not issue the warrant unless
10 the inspector or some other person has given to
the magistrate, either orally or by affidavit, such
further information (if any) as the magistrate
requires concerning the grounds on which the
issue of the warrant is being sought.
15 (4) The warrant must--
(a) name one or more inspectors; and
(b) authorise the inspectors so named, with such
assistance and by such force as is necessary
and reasonable--
20 (i) to enter the premises; and
(ii) to exercise the powers set out in
sections 154(3) and 155; and
(iii) to seize the evidential material; and
(c) state whether the entry is authorised to be
25 made at any time of the day or night or
during specified hours of the day or night;
and
(d) specify the day (not more than one week
after the issue of the warrant) on which the
30 warrant ceases to have effect; and
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(e) state the purpose for which the warrant is
issued.
174. Offence-related warrants by telephone, telex, fax etc.
(1) If, in an urgent case, an inspector considers it
5 necessary to do so, the inspector may apply to a
magistrate by telephone, telex, fax or other
electronic means for a warrant under section 173
in relation to premises.
(2) The magistrate may require communication by
10 voice to the extent that it is practicable in the
circumstances.
(3) Before applying for the warrant, the inspector
must prepare an affidavit in relation to the
premises that sets out the grounds on which the
15 warrant is sought.
(4) If it is necessary to do so, the inspector may apply
for the warrant before the affidavit is sworn.
(5) If the magistrate is satisfied--
(a) after having considered the terms of the
20 affidavit; and
(b) after having received such further
information (if any) as the magistrate
requires concerning the grounds on which
the issue of the warrant is being sought--
25 that there are reasonable grounds for issuing the
warrant, the magistrate may complete and sign the
same warrant that the magistrate would issue
under section 173 if the application had been
made under that section.
30 (6) If the magistrate completes and signs the
warrant--
(a) the magistrate must--
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(i) tell the inspector what the terms of the
warrant are; and
(ii) tell the inspector the day on which and
the time at which the warrant was
5 signed; and
(iii) tell the inspector the day (not more than
one week after the magistrate
completes and signs the warrant) on
which the warrant ceases to have effect;
10 and
(iv) record on the warrant the reasons for
issuing the warrant; and
(b) the inspector must--
(i) complete a form of warrant in the same
15 terms as the warrant completed and
signed by the magistrate; and
(ii) write on the form the name of the
magistrate and the day on which and
the time at which the warrant was
20 signed.
(7) The inspector must also, not later than the day
after the day of expiry or execution of the warrant,
whichever is the earlier, send to the magistrate--
(a) the form of warrant completed by the
25 inspector; and
(b) the affidavit referred to in sub-section (3),
which must have been duly sworn.
(8) When the magistrate receives those documents,
the magistrate must--
30 (a) attach them to the warrant that the magistrate
completed and signed; and
(b) deal with them in the way in which the
magistrate would have dealt with the
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affidavit if the application had been made
under section 173.
(9) A form of warrant duly completed under sub-
section (6) is authority for any entry, search,
5 seizure or other exercise of a power that the
warrant signed by the magistrate authorises.
(10) If--
(a) it is material, in any proceedings, for a court
to be satisfied that an exercise of a power
10 was authorised by this section; and
(b) the warrant signed by the magistrate
authorising the exercise of the power is not
produced in evidence--
the court must assume, unless the contrary is
15 proved, that the exercise of the power was not
authorised by such a warrant.
(11) A reference in this Part to a warrant under
section 173 includes a reference to a warrant
signed by a magistrate under this section.
20 175. Offences relating to warrants
(1) An inspector must not make, in an application for
a warrant, a statement that the inspector knows to
be false or misleading in a material particular.
Penalty: Imprisonment for 2 years or $13 200.
25 (2) An inspector must not--
(a) state in a document that purports to be a
form of warrant under section 174 the name
of a magistrate unless that magistrate issued
the warrant; or
30 (b) state on a form of warrant under that section
a matter that, to the inspector's knowledge,
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departs in a material particular from the form
authorised by the magistrate; or
(c) purport to execute, or present to another
person, a document that purports to be a
5 form of warrant under that section that the
inspector knows--
(i) has not been approved by a magistrate
under that section; or
(ii) departs in a material particular from the
10 terms authorised by a magistrate under
that section; or
(d) give to a magistrate a form of warrant under
that section that is not the form of warrant
that the inspector purported to execute.
15 Penalty: Imprisonment for 2 years or $13 200.
Division 11--Other matters
176. Part not to abrogate privilege against self-
incrimination
Nothing in this Part affects the right of a person to
20 refuse to answer a question, give information, or
produce a document, on the ground that the
answer to the question, the information, or the
production of the document, might tend to
incriminate him or her or make him or her liable
25 to a penalty.
177. Part does not limit power to impose licence conditions
This Part is not to be taken to limit the Regulator's
power to impose licence conditions.
_______________
30
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PART 12--MISCELLANEOUS
Division 1--Simplified outline
178. Simplified outline
In outline this Part provides for miscellaneous
5 matters, including the following--
· review of decisions;
· provisions relating to confidential commercial
information;
· the making of regulations;
· transitional provisions;
10
· review of the operation of the Act.
Division 2--Review of decisions
179. Meaning of terms
The following table sets out--
15 (a) decisions that are reviewable decisions; and
(b) each eligible person in relation to a
reviewable decision:
Reviewable decisions and eligible persons
Provision
under Eligible
which person in
decision relation to
Item Decision made decision
1 To refuse to issue a section 55 the applicant
licence for the
licence
2 To impose a licence section 55 the licence
condition holder
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Reviewable decisions and eligible persons
Provision
under Eligible
which person in
decision relation to
Item Decision made decision
3 To suspend or cancel section 68 the licence
a licence holder
4 To vary a licence section 71 the licence
holder
5 To refuse to certify a section 84 the applicant
facility for
certification
6 To specify a condition section 86 the holder
of a certification of the
certification
7 To vary a certification section 87 the holder
of the
certification
8 To suspend or cancel section 88 the holder
a certification of the
certification
9 To refuse to accredit section 92 the applicant
an organisation for
accreditation
10 To specify a condition section 94 the holder
of an accreditation of the
accreditation
11 To vary an section 95 the holder
accreditation of the
accreditation
12 To suspend or cancel section 96 the holder
an accreditation of the
accreditation
Reviewable decisions and eligible persons
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Reviewable decisions and eligible persons
Provision
under Eligible
which person in
decision relation to
Item Decision made decision
13 To refuse to declare section the person
information to be 185 who made an
confidential application
commercial under section
information 184 in
relation
to the
information
14 To revoke a section the person
declaration that 186 who made an
information is application
confidential under section
commercial 184 in
information relation
to the
information
180. Notification of decisions and review rights
(1) The Regulator must, as soon as practicable after
making a reviewable decision, cause a notice in
writing to be given to each eligible person in
5 relation to the decision, containing--
(a) the terms of the decision; and
(b) the reasons for the decision; and
(c) a statement setting out particulars of the
person's review rights.
10 (2) A failure to comply with the requirements of sub-
section (1) in relation to a decision does not affect
the validity of the decision.
181. Internal review
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(1) An eligible person in relation to a reviewable
decision (other than a decision made by the
Regulator personally) may apply in writing to the
Regulator for review (internal review) of the
5 decision.
(2) An application for internal review must be made
within 30 days after the day on which the decision
first came to the notice of the applicant, or within
such period (if any) as the Regulator, either before
10 or after the end of that period, allows.
(3) The Regulator must, on receiving an application,
review the reviewable decision personally.
(4) The Regulator may--
(a) make a decision affirming, varying or
15 revoking the reviewable decision; and
(b) if the Regulator revokes the decision, make
such other decision as the Regulator thinks
appropriate.
182. Deadlines for making reviewable decisions
20 If--
(a) this Act provides for a person to apply to the
Regulator to make a reviewable decision;
and
(b) a period is specified under this Act or the
25 regulations for giving notice of the decision
to the applicant; and
(c) the Regulator has not notified the applicant
of the Regulator's decision within that
period--
30 the Regulator is taken, for the purposes of this
Act, to have made a decision to reject the
application.
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183. Review of decisions by Administrative Appeals
Tribunal11
(1) Subject to the Administrative Appeals Tribunal
Act 1975 of the Commonwealth, an application
5 may be made by an eligible person in relation to--
(a) a reviewable decision made by the Regulator
personally; or
(b) a decision made by the Regulator under
section 181 (which provides for internal
10 review).
(2) In this section--
"decision" has the same meaning as in the
Administrative Appeals Tribunal Act 1975
of the Commonwealth.
183A. Extended standing for judicial review12
15
Note: Section 183A of the Commonwealth Act requires
that a State be taken to be a person aggrieved for the
purpose of the application of the Administrative
Decisions (Judicial Review) Act 1977 of the
20 Commonwealth in relation to certain decisions,
failures or conduct under the Commonwealth Act or
regulations.
Division 3--Confidential Commercial Information
184. Application for protection of confidential commercial
25 information
(1) A person may apply to the Regulator for a
declaration that specified information to which
this Act relates is confidential commercial
information for the purposes of this Act.
30 (2) An application under sub-section (1) must be in
writing in the form approved by the Regulator.
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185. Regulator may declare that information is
confidential commercial information
(1) Subject to sub-section (2), if the person satisfies
the Regulator that the information specified in the
5 application is--
(a) a trade secret; or
(b) any other information that has a commercial
or other value that would be, or could
reasonably be expected to be, destroyed or
10 diminished if the information were
disclosed; or
(c) other information that--
(i) concerns the lawful commercial or
financial affairs of a person,
15 organisation or undertaking; and
(ii) if it were disclosed, could unreasonably
affect the person, organisation or
undertaking--
the Regulator must declare that the information is
20 confidential commercial information for the
purposes of this Act.
(2) The Regulator may refuse to declare that the
information is confidential commercial
information if the Regulator is satisfied that the
25 public interest in disclosure outweighs the
prejudice that the disclosure would cause to any
person.
(2A) The Regulator must refuse to declare that
information is confidential commercial
30 information if the information relates to one or
more locations at which field trials involving
GMOs are occurring, or are proposed to occur,
unless the Regulator is satisfied that significant
damage to the health and safety of people, the
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environment or property would be likely to occur
if the locations were disclosed.
Note: This means that, in general, information about sites
where dealings with GMOs are occurring will be
5 required to be disclosed under sections 54 and 138,
unless the Regulator is satisfied that disclosure
would involve significant risks to health and safety.
(3) The Regulator must give the applicant written
notice of the Regulator's decision about the
10 application.
(3A) If--
(a) the Regulator declares that particular
information is confidential commercial
information; and
15 (b) the information relates to one or more
locations at which field trials involving
GMOs are occurring, or are proposed to
occur--
the Regulator must make publicly available a
20 statement of reasons for the making of the
declaration, including, but not limited to--
(c) the reasons why the Regulator was satisfied
as mentioned in sub-section (1); and
(d) the reasons why the Regulator was not
25 satisfied under sub-section (2) that the public
interest in disclosure of the information
outweighed the prejudice that the disclosure
would cause; and
(e) the reasons why the Regulator was satisfied
30 under sub-section (2A) that significant
damage to the health and safety of people,
the environment or property would be likely
to occur if the locations were disclosed.
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(4) If the Regulator refuses an application under
section 184(1) in relation to information, the
information is to be treated as confidential
commercial information until any review rights
5 under section 181 or 183 in relation to the
application are exhausted.
186. Revocation of declaration
(1) The Regulator may, by written notice given to the
applicant, revoke a declaration under section 185
10 if the Regulator is satisfied--
(a) that the information concerned no longer
satisfies section 185(1)(a), (b) or (c); or
(b) that the public interest in disclosure of the
information outweighs the prejudice that
15 disclosure would cause to any person.
(2) A revocation by the Regulator under sub-section
(1) does not take effect until any review rights
under section 181 or 183 in relation to the
revocation are exhausted.
20 187. Confidential commercial information must not be
disclosed
(1) A person who--
(a) has confidential commercial information;
and
25 (b) has it only because of performing duties or
functions under this Act or the regulations or
under the Commonwealth Act or a
corresponding State law within the meaning
of the Commonwealth Act; and
30 (c) knows that the information is confidential
commercial information--
must not disclose the information except--
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(d) to any of the following in the course of
carrying out duties or functions under this
Act or the regulations or under the
Commonwealth Act or a corresponding State
5 law within the meaning of the
Commonwealth Act--
(i) a State agency;
(ii) the Commonwealth or a
Commonwealth authority;
10 (iii) the Gene Technology Technical
Advisory Committee; or
(e) by order of a court; or
(f) with the consent of the person who applied
to have the information treated as
15 confidential commercial information.
Penalty: Imprisonment for 2 years or $13 200.
(2) A person who--
(a) has confidential commercial information;
and
20 (b) has it because of a disclosure under sub-
section (1) or under this sub-section; and
(c) knows that the information is confidential
commercial information--
must not disclose the information except--
25 (d) to any of the following in the course of
carrying out duties or functions under this
Act or the regulations or under the
Commonwealth Act or a corresponding State
law within the meaning of the
30 Commonwealth Act--
(i) a State agency;
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(ii) the Commonwealth or a
Commonwealth authority;
(iii) the Gene Technology Technical
Advisory Committee; or
5 (e) by order of a court; or
(f) with the consent of the person who applied
to have the information treated as
confidential commercial information.
Penalty: Imprisonment for 2 years or $13 200.
10 (3) For the purposes of the Freedom of Information
Act 1982, information to which sub-section (1) or
(2) applies is information of a kind to which
section 38 of that Act applies.
(4) Section 50(4) of the Freedom of Information
15 Act 1982 does not apply to a document containing
information to which sub-section (1) or (2) of this
section applies.
(5) In this section--
"court" includes a tribunal, authority or person
20 having power to require the production of
documents or the answering of questions;
"disclose", in relation to information, means give
or communicate in any way.
(6) This section has effect despite anything to the
25 contrary in the Freedom of Information Act
1982.
Note: This section differs from section 187 of the
Commonwealth Act.
Division 4--Conduct by Directors, Employees and Agents
30 188. Conduct by directors, employees and agents
(1) If, in proceedings for an offence against this Act
or the regulations, or an ancillary offence in
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relation to this Act or the regulations, it is
necessary to establish the state of mind of a body
corporate in relation to particular conduct, it is
sufficient to show--
5 (a) that the conduct was engaged in by a
director, employee or agent of the body
corporate within the scope of his or her
actual or apparent authority; and
(b) that the director, employee or agent had the
10 state of mind.
(2) Any conduct engaged in on behalf of a body
corporate by a director, employee or agent of the
body corporate within the scope of his or her
actual or apparent authority is taken, for the
15 purposes of a prosecution for--
(a) an offence against this Act or the
regulations; or
(b) an ancillary offence relating to this Act or
the regulations--
20 to have been engaged in also by the body
corporate, unless the body corporate establishes
that the body corporate took reasonable
precautions and exercised due diligence to avoid
the conduct.
25 (3) If, in proceedings for an ancillary offence relating
to this Act or the regulations, it is necessary to
establish the state of mind of a person other than a
body corporate in relation to particular conduct, it
is sufficient to show--
30 (a) that the conduct was engaged in by an
employee or agent of the person within the
scope of his or her actual or apparent
authority; and
(b) that the employee or agent had the state of
35 mind.
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(4) Any conduct engaged in on behalf of a person (the
first person), other than a body corporate, by an
employee or agent of the first person, within the
5 scope of the actual or apparent authority of the
employee or agent is taken, for the purposes of a
prosecution for--
(a) an offence against this Act or the
regulations; or
10 (b) an ancillary offence relating to this Act or
the regulations--
to have been engaged in also by the first person
unless the first person establishes that he or she
took reasonable precautions and exercised due
15 diligence to avoid the conduct.
(5) If--
(a) a person other than a body corporate is
convicted of an offence; and
(b) the person would not have been convicted of
20 the offence if sub-sections (3) and (4) had
not been enacted--
the person is not liable to be punished by
imprisonment for that offence.
189. Meaning of terms
25 (1) A reference in section 188(1) or (3) to the state of
mind of a person includes a reference to--
(a) the knowledge, intention, opinion, belief or
purpose of the person; and
(b) the person's reasons for the intention,
30 opinion, belief or purpose.
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(2) A reference in section 188 to a director of a body
corporate includes a reference to a constituent
member of a body corporate incorporated for a
public purpose by a law of the State of Victoria,
5 the Commonwealth or another State.
(3) A reference in section 188 to engaging in conduct
includes a reference to failing or refusing to
engage in conduct.
(4) A reference in section 188 to an ancillary offence
10 relating to this Act or the regulations is a
reference to an offence created by, or that may be
dealt with and punished under, section 52 of the
Magistrates' Court Act 1989 or Division 10 or
11 of Part I of the Crimes Act 1958 that relates to
15 this Act or the regulations.
Division 5--Transitional Provisions
190. Transitional provision--dealings covered by Genetic
Manipulation Advisory Committee advice to proceed
(1) The prohibitions in this Act apply to a dealing
20 with a GMO by a person at a particular time
during the transition period (the dealing time)
with the modifications set out in sub-section (2)
if--
(a) immediately before the commencement of
25 Part 4 of this Act, an advice to proceed was
in force in relation to the dealing with the
GMO by the person; and
(b) the advice to proceed is in force at the
dealing time; and
30 (c) the dealing is in accordance with the advice
to proceed.
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(2) Unless the dealing is a notifiable low risk dealing,
an exempt dealing or a dealing on the GMO
Register--
(a) the advice to proceed is taken for the
5 purposes of this Act to be a GMO licence;
and
(b) the holder of the advice to proceed is taken
to be the licence holder; and
(c) the licence is taken to be subject to any
10 conditions to which the advice to proceed is
subject; and
(d) the licence is taken to remain in force for the
period ending at the earliest of the following
times--
15 (i) the time when the advice to proceed
expires;
(ii) the end of the transition period;
(iii) when the licence is cancelled under
section 68 or surrendered under
20 section 69.
(3) In this section--
"advice to proceed" means an advice to proceed
issued by the Genetic Manipulation
Advisory Committee, in accordance with
25 Guidelines issued by that Committee;
"transition period" means the period, not
exceeding 2 years, prescribed for the
purposes of this section.
Note: Section 190(3) of the Commonwealth Act defines
30 the "transition period" as being 2 years from the
commencement of Part 4 of that Act.
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191. Regulations may relate to transitional matters
Regulations may be made in relation to
transitional matters arising from the enactment of
this Act.
5 Division 6--Other
192. False or misleading information or document13
A person must not--
(a) in connection with an application made to
the Regulator under this Act or the
10 regulations; or
(b) in compliance or purported compliance with
this Act or the regulations--
do either of the following--
(c) give information (whether orally or in
15 writing) that the person knows to be false or
misleading in a material particular;
(d) produce a document that the person knows to
be false or misleading in a material particular
without--
20 (i) indicating to the person to whom the
document is produced that it is false or
misleading, and the respect in which it
is false or misleading; and
(ii) providing correct information to that
25 person, if the person producing the
document is in possession of, or can
reasonably acquire, the correct
information.
Penalty: Imprisonment for 1 year or $6600.
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192A. Interference with dealings with GMOs14
(1) A person is guilty of an offence if--
(a) the person engages in conduct; and
(b) the conduct--
5 (i) results in damage to, destruction of, or
interference with, premises at which
dealings with GMOs are being
undertaken; or
(ii) involves damaging, destroying, or
10 interfering with, a thing at, or removing
a thing from, such premises; and
(c) the owner or occupier of the premises, or the
owner of the thing (as the case requires), has
not consented to the conduct; and
15 (d) in engaging in the conduct, the person
intends to prevent or hinder authorised GMO
dealings that are being undertaken at the
premises or facility; and
(e) the person knows, or is reckless as to, the
20 matters mentioned in paragraphs (b) and (c).
Penalty: Imprisonment for 2 years or $13 200.
(2) In this section--
"authorised GMO dealings", in relation to
premises or a facility, means dealings with
25 GMOs being undertaken at the premises or
facility--
(a) that are authorised to be undertaken at
the premises or facility by a GMO
licence; or
30 (b) that are notifiable low risk dealings; or
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(c) that are exempt dealings; or
(d) that are included on the GMO Register.
Note: This section differs from section 192A of the
Commonwealth Act.
192B. Cloning of human beings is prohibited15
5
Note 1: Section 192B of the Commonwealth Act prohibits
the cloning of whole human beings.
Note 2: Section 47 of the Infertility Treatment Act 1995
prohibits cloning.
10 192C. Certain experiments involving animal eggs
prohibited16
Note 1: Section 192C of the Commonwealth Act prohibits
experiments or research involving putting human
cells, or a combination of human cells and animal
15 cells, into animal eggs.
Note 2: Section 45 of the Infertility Treatment Act 1995
prohibits mixing human and animal gametes etc.
192D. Certain experiments involving putting human and
animal cells into a human uterus prohibited17
20 Note 1: Section 192D of the Commonwealth Act prohibits
experiments or research involving putting a
combination of human cells and animal cells into a
human uterus.
Note 2: Section 45 of the Infertility Treatment Act 1995
25 prohibits mixing human and animal gametes etc.
192E. Attempts to commit offences against Act18
(1) A person who attempts to commit an offence
against this Act is guilty of the offence of
attempting to commit that offence and is liable to
30 the same penalty as is provided by this Act for
committing the offence attempted.
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(2) Sections 321N and 321Q of the Crimes Act 1958
apply to and in respect of an offence against sub-
section (1) to the same extent as they apply to and
in respect of offences against section 321M of that
5 Act.
Note: This section is not required in the Commonwealth
Act.
193. Regulations
(1) The Governor in Council may make regulations
10 prescribing matters--
(a) required or permitted by this Act to be
prescribed; or
(b) necessary or convenient to be prescribed for
carrying out or giving effect to this Act.
15 (2) Without limiting sub-section (1), the regulations
may require a person to comply with codes of
practice or guidelines issued under this Act as in
force at a particular time or from time to time.
194. Review of operation of Act
20 (1) The Minister must cause an independent review of
the operation of this Act to be undertaken as soon
as possible after the fourth anniversary of the
commencement of this Act.
(2) A person who undertakes such a review must give
25 the Minister a written report of the review.
(3) The Minister must cause a copy of the report of
the review to be laid before each House of the
Parliament within 12 months after the fourth
anniversary of the commencement of this Act.
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(4) In this section--
"independent review" means a review
undertaken by persons who--
(a) in the opinion of the Minister possess
5 appropriate qualifications to undertake
the review; and
(b) include one or more persons who are
not employed by the State of Victoria, a
State agency, the Commonwealth or a
10 Commonwealth authority.
Note: This section differs from section 194 of the
Commonwealth Act.
_______________
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Act No.
PART 13--CONSEQUENTIAL AMENDMENTS
195. New section 23A inserted in Agricultural and
See:
Act No. Veterinary Chemicals (Victoria) Act 1994
73/1994.
Reprint No. 1
After section 23 of the Agricultural and
as at
5 Veterinary Chemicals (Victoria) Act 1994
11 March
1999
insert--
and
amending
"23A. Consultation with Gene Technology
Act Nos
Regulator
22/2000,
74/2000 and
(1) A duty imposed or a function or power
39/2001.
LawToday:
10 conferred on the NRA under section 8A of
www.dms.
the Agricultural and Veterinary Chemicals
dpc.vic.
gov.au
(Administration) Act in respect of any matter
arising in relation to the Code set out in the
Schedule to the Agricultural and Veterinary
15 Chemicals Code Act extends to any
corresponding matter arising in relation to
the applicable provisions of this jurisdiction,
and that section applies accordingly.
(2) If the NRA gives the Regulator within the
20 meaning of the Gene Technology Act 2001
a notice under section 8A(3) of the
Agricultural and Veterinary Chemicals
(Administration) Act (as that section applies
by force of sub-section (1) of this section),
25 the Regulator may give written advice to the
NRA about the application, reconsideration
or issue.
(3) The advice is to be given within the period
specified in the notice.
127
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
s. 196
Act No.
(4) A reference in the Agvet Code of this
jurisdiction to a provision of section 8A of
the Agricultural and Veterinary Chemicals
(Administration) Act has effect as if it were a
5 reference to that provision as applying by
force of sub-section (1) of this section.".
Note: This section does not appear in the Commonwealth
Act but is consistent with amendments to
Commonwealth Acts made by items 1 to 7 of
10 Schedule 1 to the Gene Technology (Consequential
Amendments) Act 2000 of the Commonwealth.
See:
196. Amendment of Therapeutic Goods (Victoria) Act 1994
Act No.
79/1994.
In section 3 of the Therapeutic Goods (Victoria) Reprint No. 1
Act 1994 insert the following definitions-- as at
11 May 1999.
15 ' "Gene Technology Regulator" has the same LawToday:
www.dms.
meaning as "Regulator" in the Gene dpc.vic.
Technology Act 2001; gov.au
"GM product" has the same meaning as in the
Gene Technology Act 2001;'.
20 Note: This section does not appear in the Commonwealth
Act but is consistent with amendments to the
Therapeutic Goods Act 1989 of the Commonwealth
made by items 17 and 18 of Schedule 1 to the Gene
Technology (Consequential Amendments) Act 2000
25 of the Commonwealth.
197. New sections 34A to 34C inserted in Therapeutic
Goods (Victoria) Act 1994
In Division 2 of Part 3 of the Therapeutic Goods
(Victoria) Act 1994, after section 34 insert--
30 "34A. Consultation with Gene Technology
Regulator
(1) This section applies to an application for
listing or registration of a therapeutic good
under section 20 if the therapeutic good is, or
35 contains, a GM product.
128
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
s. 197
Act No.
(2) Subject to sub-section (5), the Secretary
must give written notice to the Gene
Technology Regulator--
(a) stating that the application has been
5 made; and
(b) requesting the Gene Technology
Regulator to give advice about the
application.
(3) If the Secretary gives the Gene Technology
10 Regulator a notice under sub-section (2), the
Gene Technology Regulator may give
written advice to the Secretary about the
application.
(4) The advice is to be given within the period
15 specified in the notice.
(5) If an advice from the Gene Technology
Regulator is in force under section 34B in
relation to a class of therapeutic goods, the
Secretary is not required to notify the
20 Regulator under this section in relation to an
application for listing or registration of a
therapeutic good belonging to that class.
34B. Secretary may seek advice about classes of
GM products
25 (1) The Secretary may request advice from the
Gene Technology Regulator in relation to
therapeutic goods that consist of, or that
contain, a GM product belonging to a class
of GM products specified in the request.
30 (2) A request for advice under sub-section (1)
must specify the matters to which the advice
is to relate.
129
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
s. 197
Act No.
(3) If the Secretary requests advice from the
Gene Technology Regulator under sub-
section (1), the Gene Technology Regulator
may provide written advice in relation to the
5 matters specified in the request.
(4) If the Gene Technology Regulator gives
advice to the Secretary under sub-section (3),
the advice remains in force until it is
withdrawn by the Gene Technology
10 Regulator by written notice given to the
Secretary.
34C. Secretary to take advice into account
If the Secretary receives advice from the
Gene Technology Regulator--
15 (a) in response to a notice under section
34A within the period specified in the
notice; or
(b) under section 34B--
the Secretary must--
20 (c) ensure that the advice is taken into
account in making a decision on the
application to which the notice relates,
or on an application to which the advice
under section 34B relates, as the case
25 requires; and
(d) inform the Gene Technology Regulator
of the decision on the application.".
Note: This section does not appear in the Commonwealth
Act but is consistent with amendments to the
30 Therapeutic Goods Act 1989 of the Commonwealth
made by item 19 of Schedule 1 to the Gene
Technology (Consequential Amendments) Act 2000
of the Commonwealth.
35
130
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
Endnotes
Act No.
ENDNOTES
1
s. 8: The next section is section 8A.
2
s. 8A: The next section is section 8B.
3
s. 8B: The next section is section 8C.
4
s. 8C: The next section is section 9.
5
s. 72: The next section is section 72A.
6
s. 72A: The next section is section 73.
7
s. 110: The next section is section 110A.
8
s. 110A: The next section is section 111.
9
s. 136: The next section is section 136A.
10
s. 136A: The next section is section 137.
11
s. 183: The next section is section 183A.
12
s. 183A: The next section is section 184.
13
s. 192: The next section is section 192A.
14
s. 192A: The next section is section 192B.
15
s. 192B: The next section is section 192C.
16
s. 192C: The next section is section 192D.
17
s. 192D: The next section is section 192E.
18
s. 192E: The next section is section 193.
By Authority. Government Printer for the State of Victoria.
131
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
Act No.
INDEX
Subject Section
Accreditation
accredited organisations (def.) 10
applications 91, 93
cancellation 9697
conditions 9495
granting of 92
guidelines regarding requirements for 98
Institutional Biosafety Committees as part of 10, 92, 98
notice of suspension, cancellation, variation 97
review rights 179183
suspension 9697
variation 95, 97
Act
as component of nationally consistent scheme 5
commencement 2
consequential amendments 195197
Crown bound by 6
notes used in 8A8B
numbering in 8A
object 3
outlines used in 8C
purpose and citation 1
regulatory framework to achieve object 4
relationship to other State laws 15
review of operation 194
transitional provisions 190191
validity of licences, certificates, things done under 20
10, 19, 183
Administrative Appeals Tribunal
Bodies corporate
offences by 188189
relevant convictions of licence applicants 54, 58
Certification
applications 83, 85
cancellation 88, 89
conditions 8687
fees 83, 130131
granting of 84
guidelines about requirements for 90
notice of suspension, cancellation, variation 89
review rights 179183
suspension 88, 89
variation 87, 89
192B
Cloning of human beings
24
Codes of practice
132
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
Act No.
Subject Section
Commonwealth Act
application 13
application to external territories 7
corresponding State law 12
definition 10
provisions facilitating nationally consistent scheme 1620
provisions in State Act not in Commonwealth Act 8A8C, 72A
provisions in State Act which are different 19, 21, 24, 25, 29,
3234, 73, 99, 117,
128, 130, 138, 146,
164, 170, 187,
192A, 194
provisions not reproduced in State Act 7, 1214, 1617,
22, 26, 76, 100,
102106, 108111,
113116, 118126,
129, 132135, 139,
183A, 192B192D
wind-back notices by States 14
10
Commonwealth authority (def.)
Confidential commercial information
declarations by Regulator 184186
definition 10
disclosure of 187
in licence applications 45, 53, 54
review rights 179183
Consultative Committee See Gene Technology
Community Consultative Committee
10, 58, 138, 190
Definitions
138
Designated notification (def.)
Entry powers
emergencies 158, 162
occupiers' consent to 152, 154, 160
relating to monitoring of compliance 152153, 172
relating to suspected offences 154, 172
warrants for 161162, 172174
10
Environment (def.)
Ethics Committee
See Gene Technology Ethics Committee
Evidential material
definition 10
inspectors' powers 153157, 164165,
173
3233, 141144
Exempt dealings
10
Facility (def.)
148
Forfeiture
10
Gene technology (def.)
129132
Gene Technology Account
10
Gene Technology Agreement (def.)
133
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
Act No.
Subject Section
Gene Technology Community Consultative
106110A
Committee
111116
Gene Technology Ethics Committee
Gene Technology Regulator
acting appointments 121
annual report 136
appointment 118
compensation payable by 163
consultants 134
costs incurred by 130, 146, 158
creation of office 26
definition of Regulator 10
delegation 29
directions by 53, 146
disclosure of interests 120
functions 27
independence 30
powers in general 28
powers regarding
accreditation 9198
certification 8390
charging for services 127
confidential commercial information 184186
disposal of things seized 171
GMO Register 7681
inspectors 150151
notifiable low risk dealings 74, 140, 142144
Record 138139
reports by 136137
resignation 126
reviews by 140144, 181
staff 133135
termination of appointment 119
terms and conditions of employment 122125
See also GMO dealings - Licences
100105
Gene Technology Technical Advisory Committee
Genetic Manipulation Advisory Committee
transitional provisions 190191
Genetically modified organisms
See headings beginning with GMO
GM products
definition 10
licence conditions regarding 62
Record of dealings with 138139
10
GMO (def.)
GMO dealings
advice to proceed 190191
auditing or monitoring of 64, 136A
134
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
Act No.
Subject Section
containment level (def.) 10
definition of deal with 10
inclusion on GMO Register 36, 7780
interference with 192A
offences 3233, 36, 37,
192A
Record of 138139
regulations 21
specific kinds of dealings
authorised dealings (def.) 192A
exempt dealings 3233, 141144
involving intentional release of GMO into
environment 11, 40, 4854, 71
not involving intentional release of GMO into
environment 4647
notifiable low risk dealings 37, 7475, 138,
140, 142144
posing significant risks 49
unauthorised, unlicensed dealings 3233
transitional provisions 190191
unintended effects of 6567
GMO dealings - Licences
additional information to be given to Regulator 6567, 79
annual charges 68, 72A, 130131
application of policy principles 43, 56, 57
applications for 4045, 54
bodies corporate as licence applicants 58
breach of conditions 3435, 65, 66, 68,
136A
cancellation 60, 63, 68, 72
conditions 55, 6165, 70, 71,
177
confidential commercial information 45, 53, 54
consultation and advice 44, 47, 50, 51, 52
dealings involving intentional release of GMO into
environment 11, 40, 4854, 71
dealings not involving intentional release of GMO
into environment 4647
dealings posing significant risks 49
directions 146
fees 40, 41, 130131
independence of Regulator 30
insurance for licence holders 62
issue 43, 5557, 136A
notification of licence holders, applicants 59, 72
period in force 60
persons covered by 10, 3435, 63,
6568, 146
public notices, hearings, access to documents 49, 5254
135
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
Act No.
Subject Section
Record information 138
refusal 43, 5557
relevant convictions of applicants 54, 58
review 179183
risk assessment and management 47, 4952, 54, 56,
68, 70, 71
submissions 49, 51, 52, 56
suitability of applicants as licence holders 57, 58, 68, 70
surrender 63, 69
suspension 60, 63, 68, 72
transfer 70
unlicensed dealings 3233
variation 7172
GMO Register
breach of conditions for dealings on 36
dealings included on 7779
definition 10
establishment and maintenance 76
inspection 81
variation 80
194
Independent review (def.)
147
Injunctions
Inspectors
appointment 150
costs incurred by 158
identity cards 151, 159
offences by 175
powers and duties regarding
emergencies 158, 162
entry 152154, 158,
160162, 172174
expert assistance 157
goods, baggage, containers 164165
monitoring of compliance 152153, 172
offences 154156, 173174
searches 153, 154, 155, 158,
164, 167, 174
securing of things 153, 157, 158
seizure 154, 156, 165, 166,
168170, 173174
use of equipment at premises 153, 156, 157, 163
warrants 161, 172175
10, 92, 98
Institutional Biosafety Committees
Liability
offences against State and Commonwealth Act 18
strict liability 33, 3537
136
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
Act No.
Subject Section
Ministerial Council
codes of practice issued by 24
definition 10
policy principles, guidelines issued by 2123
Notes
use of in Act 8A8B
Notifiable low risk dealings
offences 37
Record information 138
regulations 7475
review 140, 142144
Occupiers' rights
regarding
compensation for damage 163
copies of warrants 161
entry of premises 152, 154, 160, 162
search of premises 167
securing of things on premises 157
seizure 166, 168
Offences
against Commonwealth Act 8
aggravated offences 38
attempted offences 192E
by bodies corporate 188189
by inspectors 175
inspectors' powers regarding 154156, 173174
liability for 18, 33, 3537
relevant convictions of licence applicants 54, 58
specific offences
breach of conditions for dealings on Register 36
breach of GMO licence conditions 3435, 65, 66
contravention of Regulator's directions 53, 146
disclosing confidential commercial
information 187
giving false or misleading information 192
interference with GMO dealings 192A
unauthorised dealings with GMOs 3233
unlawful notifiable low risk dealings 37
10
Officer (def.)
10
Organism (def.)
Policy principles and guidelines
application to decisions on licences 43, 56, 57
issue of 2123
10
Premises (def.)
192B192D
Prohibited activities and research
10, 138139
Record of GMO and GM Product Dealings
137
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
Gene Technology Act 2001
Act No.
Subject Section
Regulations
making of 193
regarding
dealings with GMOs 21
exempt dealings 143
Gene Technology Committees 104, 110, 115
notifiable low risk dealings 7475, 143
transitional matters 191
Regulator See Gene Technology Regulator
54, 58
Relevant convictions
Review
by Administrative Appeals Tribunal 183
by Regulator 181
eligible persons 10, 179
exempt and notifiable low risk dealings 140144
reviewable decisions and review rights 19, 179180, 182
Seizure
general provisions regarding things seized 166, 168171
goods on ships, planes 165
warrants 154, 156, 173174
Self-incrimination
protection from 176
10
State agency (def.)
State of Victoria
money received by 130
notional payment of fees and charges by 128
recovery of money due to 131, 146, 158
Submissions
licence applications 49, 51, 52, 56
review of exempt and notifiable low risk dealings 142
suspension, cancellation, variation of accreditation 97
suspension, cancellation, variation of certification 89
suspension, cancellation, variation of licence 72
10
Thing (def.)
190191
Transitional provisions
Warrants
actions authorised by 152154, 156
copy for occupier 161
issue of 172174
offences regarding 175
138
541080B.I1-24/8/2001 BILL LA CIRCULATION 24/8/2001
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