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This is a Bill, not an Act. For current law, see the Acts databases.
Western Australia
Gene Technology Bill 2001
CONTENTS
Part 1 -- Preliminary
1. Purpose and short title 2
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 4
8B. Notes 4
8C. Outlines 4
Part 2 -- Interpretation and operation
of Act
Division 1 -- Simplified outline
9. Simplified outline 5
Division 2 -- Definitions
10. Definitions 5
11. Meaning of intentional release of a GMO into the
environment 11
12. Meaning of corresponding State law 11
12A. Meaning of reckless 12
Division 3 -- Operation of Act
13. Operation of Act 12
14. Wind-back of reach of Act 12
15. Relationship to other State laws 12
page i
39--2
Gene Technology Bill 2001
Contents
Division 4 -- Provisions to facilitate a nationally
consistent scheme
Subdivision A -- General provisions
16. State laws may operate concurrently 13
17. Conferral of functions on Commonwealth officers and
bodies 13
18. No doubling-up of liabilities 13
19. Review of certain decisions 13
20. Things done for multiple purposes 14
Subdivision B -- Policy principles, policy
guidelines and codes of practice
21. Ministerial Council may issue policy principles 14
22. Consultation on policy principles 15
23. Ministerial Council may issue policy guidelines 15
24. Ministerial Council may issue codes of practice 16
Part 3 -- The Gene Technology
Regulator
25. Simplified outline 17
26. The Gene Technology Regulator 17
27. Functions of the Regulator 17
28. Powers of the Regulator 18
29. Delegation 18
30. Independence of the Regulator 19
Part 4 -- Regulation of dealings with
GMOs
Division 1 -- Simplified outline
31. Simplified outline 20
Division 2 -- Dealings with GMOs must be
licensed
32. Person not to deal with a GMO without a licence 20
33. Person not to deal with a GMO without a licence --
strict liability offence 22
34. Person must not breach conditions of a GMO licence 22
35. Person must not breach conditions of a GMO
licence -- strict liability offence 24
36. Person must not breach conditions on GMO Register 24
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Gene Technology Bill 2001
Contents
37. Offence relating to notifiable low risk dealings 25
38. Aggravated offences -- significant damage to health
or safety of people or to the environment 25
Part 5 -- Licensing system
Division 1 -- Simplified outline
39. Simplified outline 26
Division 2 -- Licence applications
40. Person may apply for a licence 26
41. Application may be withdrawn 27
42. Regulator may require applicant to give further
information 27
43. Regulator must consider applications except in certain
circumstances 28
44. Regulator may consult with applicant 28
45. Regulator must not use certain information in
considering licence application 28
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 29
47. What the Regulator must do in relation to application 29
Division 4 -- Initial consideration of licences for
dealings involving intentional release of a
GMO into the environment
48. Applications to which this Division applies 30
49. Dealings that may pose significant risks to the health
and safety of people or the environment 30
50. Regulator must prepare risk assessment and risk
management plan 32
51. Matters Regulator must take into account in preparing
risk assessment and risk management plan 32
52. Public notification of risk assessment and risk
management plan 34
53. Regulator may take other actions 35
54. Person may request copies of certain documents 36
Division 5 -- Decision on licence etc.
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Gene Technology Bill 2001
Contents
55. Regulator must make a decision on licence and
licence conditions 36
56. Regulator must not issue the licence unless satisfied as
to risk management 36
57. Other circumstances in which Regulator must not
issue the licence 37
58. Matters to be taken into account in deciding whether a
person is suitable to hold a licence 38
59. Notification of licence decision 39
60. Period of licence 39
Division 6 -- Conditions of licence
61. Licence is subject to conditions 39
62. Conditions that may be prescribed or imposed 40
63. Condition about informing people of obligations 41
64. Condition about monitoring and audits 42
65. Condition about additional information to be given to
the Regulator 42
66. Person may give information to Regulator 43
67. Protection of persons who give information 43
Division 7 -- Suspension, cancellation and
variation of licences
68. Suspension and cancellation of licence 43
69. Surrender of licence 44
70. Transfer of licence 44
71. Variation of licence 45
72. Regulator to notify of proposed suspension,
cancellation or variation 46
Division 8 -- Annual charge
72A. GMO licence -- annual charge 47
Part 6 -- Regulation of notifiable low
risk dealings and dealings on the
GMO Register
Division 1 -- Simplified outline
73. Simplified outline 48
Division 2 -- Notifiable low risk dealings
74. Notifiable low risk dealings 48
75. Regulation of notifiable low risk dealings 49
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Gene Technology Bill 2001
Contents
Division 3 -- The GMO Register
76. The GMO Register 50
77. Contents of Register 50
78. Regulator may include dealings with GMOs on GMO
Register 50
79. Regulator not to make determination unless risks can
be managed 51
80. Variation of GMO Register 52
81. Inspection of Register 52
Part 7 -- Certification and
accreditation
Division 1 -- Simplified outline
82. Simplified outline 53
Division 2 -- Certification
83. Application for certification 53
84. When the Regulator may certify the facility 53
85. Regulator may require applicant to give further
information 54
86. Conditions of certification 54
87. Variation of certification 54
88. Suspension or cancellation of certification 54
89. Regulator to notify of proposed suspension,
cancellation or variation 55
90. Guidelines 56
Division 3 -- Accredited organisations
91. Application for accreditation 56
92. Regulator may accredit organisations 56
93. Regulator may require applicant to give further
information 57
94. Conditions of accreditation 57
95. Variation of accreditation 57
96. Suspension or cancellation of accreditation 58
97. Regulator to notify of proposed suspension,
cancellation or variation 58
98. Guidelines 59
Part 8 -- The Gene Technology
Technical Advisory Committee, the
page v
Gene Technology Bill 2001
Contents
Gene Technology Community
Consultative Group and the Gene
Technology Ethics Committee
Division 1 -- Simplified outline
99. Simplified outline 60
Division 2 -- The Gene Technology Technical
Advisory Committee
100. The Gene Technology Technical Advisory Committee 60
101. Function of the Gene Technology Technical Advisory
Committee 60
102. Expert advisers 61
103. Remuneration 61
104. Members and procedures 61
105. Subcommittees 61
Division 3 -- The Gene Technology Community
Consultative Committee
106. The Gene Technology Community Consultative
Committee 61
107. Function of Consultative Committee 61
108. Membership 62
109. Remuneration 62
110. Regulations 62
110A. Subcommittees 62
Division 4 -- The Gene Technology Ethics
Committee
111. The Gene Technology Ethics Committee 62
112. Function of the Gene Technology Ethics Committee 62
113. Expert advisers 63
114. Remuneration 63
115. Members and procedures 63
116. Subcommittees 63
Part 9 -- Administration
Division 1 -- Simplified outline
117. Simplified outline 64
Division 2 -- Appointment and conditions of
Regulator
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Gene Technology Bill 2001
Contents
118. Appointment of the Regulator 64
119. Termination of appointment 64
120. Disclosure of interests 64
121. Acting appointment 64
122. Terms and conditions 65
123. Outside employment 65
124. Remuneration 65
125. Leave of absence 65
126. Resignation 65
Division 3 -- Money
127. Regulator may charge for services 65
128. Notional payments by the State 65
129. Gene Technology Account 66
130. Credits to Gene Technology Account 66
131. Recovery of amounts 66
132. Purposes of Account 67
Division 4 -- Staffing
133. Staff assisting the Regulator 67
134. Consultants 67
135. Seconded officers 67
Division 5 -- Reporting requirements
136. Annual report 67
136A. Quarterly reports 68
137. Reports to Parliament 68
Division 6 -- Record of GMO and GM product
dealings
138. Record of GMO and GM product dealings 69
139. Inspection of Record 70
Division 7 -- Reviews of notifiable low risk
dealings and exemptions
140. Regulator may review notifiable low risk dealings 70
141. Regulator may review exemptions 70
142. Regulator may give notice of consideration 71
143. What Regulator may do after consideration 71
144. Regulator not required to review matters 72
Part 10 -- Enforcement
145. Simplified outline 73
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Gene Technology Bill 2001
Contents
146. Regulator may give directions 73
147. Injunctions 74
148. Forfeiture 75
Part 11 -- Powers of inspection
Division 1 -- Simplified outline
149. Simplified outline 77
Division 2 -- Appointment of inspectors and
identity cards
150. Appointment of inspectors 77
151. Identity card 78
Division 3 -- Monitoring powers
152. Powers available to inspectors for monitoring
compliance 78
153. Monitoring powers 79
Division 4 -- Offence-related powers
154. Searches and seizures related to offences 80
155. Offence-related powers of inspectors in relation to
premises 81
156. Use of equipment at premises 82
Division 5 -- Expert assistance
157. Expert assistance to operate a thing 83
Division 6 -- Emergency powers
158. Powers available to inspectors for dealing with
dangerous situations 84
Division 7 -- Obligations and incidental powers of
inspectors
159. Inspector must produce identity card on request 85
160. Consent 85
161. Details of warrant to be given to occupier etc. 85
162. Announcement before entry 86
163. Compensation for damage 86
Division 8 -- Power to search goods, baggage etc.
164. Power to search goods, baggage etc. 87
165. Seizure of goods 87
Division 9 -- General provisions relating to search
and seizure
page viii
Gene Technology Bill 2001
Contents
166. Copies of seized things to be provided 88
167. Occupier entitled to be present during search 88
168. Receipts for things seized 89
169. Retention of seized things 89
170. Magistrate may permit a thing to be retained 90
171. Disposal of goods if there is no owner or owner
cannot be located 91
Division 10 -- Warrants
172. Monitoring warrants 91
173. Offence-related warrants 92
174. Offence-related warrants by telephone, telex, fax etc. 93
175. Offences relating to warrants 95
Division 11 -- Other matters
176. Part not to abrogate privilege against
self-incrimination 96
177. Part does not limit power to impose licence conditions 96
Part 12 -- Miscellaneous
Division 1 -- Simplified outline
178. Simplified outline 97
Division 2 -- Review of decisions
179. Meaning of terms 97
180. Notification of decisions and review rights 98
181. Internal review 99
182. Deadlines for making reviewable decisions 99
183. Review of decisions by Administrative Appeals
Tribunal 100
183A. Extended standing for judicial review 100
Division 3 -- Confidential commercial information
184. Application for protection of confidential commercial
information 100
185. Regulator may declare that information is confidential
commercial information 100
186. Revocation of declaration 102
187. Confidential commercial information must not be
disclosed 103
Division 4 -- Conduct by directors, employees and
agents
page ix
Gene Technology Bill 2001
Contents
188. Conduct by directors, employees and agents 105
189. Meaning of terms 106
Division 5 -- Transitional provisions
190. Transitional provision -- dealings covered by Genetic
Manipulation Advisory Committee advice to proceed 107
191. Regulations may relate to transitional matters 108
Division 6 -- Other
192. False or misleading information or document 108
192A. Interference with dealings with GMOs 109
192B. Cloning of human beings is prohibited 110
192C. Certain experiments involving animal eggs prohibited 110
192D. Certain experiments involving putting human and
animal cells into a human uterus prohibited 110
192E. Ancillary offences (parties to offences, attempts,
incitement or conspiracy) 110
193. Regulations: general 111
194. Review of operation of Act 111
Part 13 -- Consequential amendments
195. Agriculture and Related Resources Protection Act
1976 amended 113
196. Agricultural and Veterinary Chemicals (Western
Australia) Act 1995 amended 113
page x
Western Australia
LEGISLATIVE ASSEMBLY
(As amended during consideration in detail)
Gene Technology Bill 2001
A Bill for
An Act to regulate activities involving gene technology and for other
purposes.
The Parliament of Western Australia enacts as follows:
page 1
Gene Technology Bill 2001
Part 1 Preliminary
s. 1
Part 1 -- Preliminary
1. Purpose and short title
(1) This Act may be cited as the Gene Technology Act 2001.
(2) The purpose of this Act is to regulate activities involving gene
5 technology.
(3) Without limiting subsection (1) and section 26(1) of the
Interpretation Act 1984, this Act may be referred to as the Gene
Technology Law of Western Australia or simply as the Gene
Technology Law.
10 Note: This section differs from section 1 of the Commonwealth Act.
2. Commencement
(1) This Act comes into operation on a day fixed by proclamation.
(2) Different days may be fixed under subsection (1) for different
provisions.
15 Note: This section differs from section 2 of the 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 technology, and by managing
20 those risks through regulating certain dealings with genetically
modified organisms.
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
page 2
Gene Technology Bill 2001
Preliminary Part 1
s. 5
scientific certainty should not be used as a reason for
postponing cost-effective measures to prevent
environmental degradation;
(a) provides an efficient and effective system for the
5 application of gene technologies; and
(b) operates in conjunction with other Commonwealth and
State regulatory schemes relevant to GMOs and GMO
products.
Note: Examples of the schemes mentioned in paragraph (b) are those that
10 regulate food, agricultural and veterinary chemicals, industrial chemicals and
therapeutic goods.
5. Nationally consistent scheme
It is the intention of the Parliament that this Act form a
component of a nationally consistent scheme for the regulation
15 of certain dealings with genetically modified organisms by the
Commonwealth and the States.
6. Act to bind the Crown
(1) This Act binds the Crown in right of Western Australia and, so
far as the legislative power of the Parliament permits, the Crown
20 in all its other capacities.
(2) Nothing in this Act renders the Crown liable to be prosecuted
for an offence.
7. External Territories
Note: The Commonwealth Act includes a provision extending that Act to
25 every external Territory other than Norfolk Island.
8. Offences
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.
page 3
Gene Technology Bill 2001
Part 1 Preliminary
s. 8A
8A. Numbering
(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
5 required in this Act, the provision number and heading
to the section appearing 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 included in the
10 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 subsection (1)(a)
form part of this Act.
15 Note 1: A note appears under each heading of a kind referred to in
subsection (1)(a) describing the omitted section of the Commonwealth Act.
Note 2: A note appears under each section of a kind referred to in
subsection (1)(b) highlighting the non-appearance of an equivalent section in
the Commonwealth Act.
20 Note 3: This section does not appear in the Commonwealth Act.
8B. Notes
Notes do not form part of this Act.
Note: This section does not appear in the Commonwealth Act.
8C. Outlines
25 The provisions appearing at the beginning of Parts 2 to 12
outlining that 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 Act.
page 4
Gene Technology Bill 2001
Interpretation and operation of Act Part 2
Simplified outline Division 1
s. 9
Part 2 -- Interpretation and operation of Act
Division 1 -- Simplified outline
9. Simplified outline
In outline this Part --
5 · contains the definitions used in this Act;
· contains provisions to facilitate a nationally consistent
regulatory scheme;
· enables the Ministerial Council to issue policy principles,
policy guidelines and codes of practice.
10 Note: This section differs from section 9 of the Commonwealth Act.
Division 2 -- Definitions
10. Definitions
(1) In this Act --
"accredited organisation" means an organisation accredited
15 under Part 7 Division 3;
"Administrative Appeals Tribunal" means the Administrative
Appeals Tribunal established by the Administrative
Appeals Tribunal Act 1975 of the Commonwealth;
"aggravated offence" has the meaning given by section 38;
20 "Commonwealth Act" means the Gene Technology Act 2000
of the Commonwealth;
"Commonwealth authority" means the following --
(a) a body corporate established for a public purpose by
or under a Commonwealth Act; or
25 (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 --
(i) the Commonwealth;
page 5
Gene Technology Bill 2001
Part 2 Interpretation and operation of Act
Division 2 Definitions
s. 10
(ii) a body covered by paragraph (a);
(iii) a body covered by either of the above
subparagraphs;
"Commonwealth Environment Minister" means the Minister
5 of State for the Commonwealth responsible for
environment and conservation;
"confidential commercial information" means information
declared by the Regulator to be confidential commercial
information under section 185;
10 "Consultative Committee" means the Gene Technology
Community Consultative Committee established by
section 106 of the Commonwealth Act;
"containment level", in relation to a facility, means the degree
of physical confinement of GMOs provided by the facility,
15 having regard to the design of the facility, the equipment
located or installed in the facility and the procedures
generally used within the facility;
"deal with", in relation to a GMO, means the following --
(a) conduct experiments with the GMO;
20 (b) make, develop, produce or manufacture 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 GMO;
25 (f) grow, raise or culture the GMO; or
(g) import the GMO,
and includes the possession, supply, use, transport or
disposal of the GMO for the purposes of, or in the course
of, a dealing mentioned in any of paragraphs (a) to (g);
30 "eligible person", in relation to a reviewable decision, has the
meaning given by section 179;
page 6
Gene Technology Bill 2001
Interpretation and operation of Act Part 2
Definitions Division 2
s. 10
"environment" includes --
(a) ecosystems and their constituent parts;
(b) natural and physical resources; and
(c) the qualities and characteristics of locations, places
5 and areas;
"Ethics Committee" means the Gene Technology Ethics
Committee established by section 111 of the
Commonwealth Act;
"evidential material" means any of the following --
10 (a) a thing with respect to which an offence against this
Act or the regulations has been committed or is
suspected, on reasonable grounds, to have been
committed;
(b) a thing that there are reasonable grounds for
15 suspecting will afford 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 such offence;
20 "facility" includes, but is not limited to, the following --
(a) a building or part of a building;
(b) a laboratory;
(c) an aviary;
(d) a glasshouse;
25 (e) an insectary;
(f) an animal house;
(g) an aquarium or tank;
"gene technology" means any technique for the modification of
genes or other genetic material, but does not include --
30 (a) sexual reproduction;
(b) homologous recombination; or
page 7
Gene Technology Bill 2001
Part 2 Interpretation and operation of Act
Division 2 Definitions
s. 10
(c) any other technique specified in the regulations for
the purposes of this paragraph;
"Gene Technology Account" means the Gene Technology
Account established by section 129 of the Commonwealth
5 Act;
"Gene Technology Agreement" means the Gene Technology
Intergovernmental Agreement made for the purposes of this
Act between the Commonwealth and at least 4 States, as in
force from time to time;
10 "Gene Technology Technical Advisory 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 gene
15 technology;
(b) an organism that has inherited particular traits from
an organism ("the initial organism"), being traits
that occurred in the initial organism because of gene
technology; or
20 (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
genetically modified organisms,
but does not include --
25 (d) a human being, if the human being is covered by
paragraph (a) only because the human being has
undergone somatic cell gene therapy; or
(e) an organism declared by the regulations not to be a
genetically modified organism, or that belongs to a
30 class of organisms declared by the regulations not to
be genetically modified organisms;
"GMO" means a genetically modified organism;
"GMO licence" means a licence issued under section 55;
page 8
Gene Technology Bill 2001
Interpretation and operation of Act Part 2
Definitions Division 2
s. 10
"GMO Register" means the GMO Register established by
section 76 of the Commonwealth Act;
"GM product" means a thing (other than a GMO) derived or
produced from a GMO;
5 "Institutional Biosafety Committee" means a committee
established by an accredited organisation as an Institutional
Biosafety Committee;
"jurisdiction" means the following --
(a) a State; or
10 (b) the Commonwealth;
"licence holder" means the holder of a GMO licence;
"Ministerial Council" means the Ministerial Council within
the meaning of the Gene Technology Agreement;
"notifiable low risk dealing" has the meaning given by
15 section 74;
"officer", in relation to the Commonwealth, includes the
following --
(a) a Minister of the Crown in right of the
Commonwealth;
20 (b) a person who holds --
(i) an office established by or under a
Commonwealth Act;
(ii) an appointment made under a Commonwealth
Act; or
25 (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;
(c) a person who is a member or officer of a
30 Commonwealth authority;
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Gene Technology Bill 2001
Part 2 Interpretation and operation of Act
Division 2 Definitions
s. 10
(d) a person who is in the service or employment of the
Commonwealth or of a Commonwealth authority, or
is employed or engaged under a Commonwealth Act;
"organism" means any biological entity that is --
5 (a) viable;
(b) capable of reproduction; or
(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;
10 "premises" includes the following --
(a) a building;
(b) a place (including an area of land);
(c) a vehicle;
(d) a vessel;
15 (e) an aircraft;
(f) a facility;
(g) any part of premises (including premises referred to
in paragraphs (a) to (f));
"Record" means the Record of GMO and GM Product
20 Dealings mentioned in section 138 of the Commonwealth
Act;
"Regulator" means the Gene Technology Regulator appointed
under section 118 of the Commonwealth Act;
"reviewable decision" has the meaning given by section 179;
25 "State" includes the Australian Capital Territory and the
Northern Territory;
"State agency" means --
(a) the Crown in right of Western Australia;
(b) a Minister of the Crown in right of Western
30 Australia;
page 10
Gene Technology Bill 2001
Interpretation and operation of Act Part 2
Definitions Division 2
s. 11
(c) an agency within the meaning of the Public Sector
Management Act 1994;
(d) an instrumentality of the State of Western Australia,
including a body corporate established for a public
5 purpose by or under a law of the State of Western
Australia; or
(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 --
10 (i) the Crown in right of Western Australia;
(ii) a person or body covered by paragraph (b)
or (d);
(iii) a body covered by any of the above
subparagraphs;
15 "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 must do the thing in accordance
with any requirements specified in the Gene Technology
20 Agreement.
11. Meaning of intentional release of a GMO into the
environment
For the purposes of this Act, a dealing with a GMO involves the
"intentional release of the GMO into the environment" if the
25 GMO is intentionally released into the open environment,
whether or not it is released with provision for limiting the
dissemination or persistence of the GMO or its genetic material
in the environment.
12. Meaning of corresponding State law
30 Note: The Commonwealth Act includes a provision defining "corresponding
State law" for the purposes of that Act.
page 11
Gene Technology Bill 2001
Part 2 Interpretation and operation of Act
Division 3 Operation of Act
s. 12A
12A. Meaning of reckless
(1) For the purposes of this Act a person is reckless with respect to
circumstances if --
(a) the person is aware of a substantial risk that the
5 circumstance exists or will exist; and
(b) having regard to the circumstances known to the person,
it is unjustifiable to take the risk.
(2) For the purposes of this Act a person is reckless with respect to
a result if --
10 (a) the person is aware of a substantial risk that the result
will occur; and
(b) having regard to the circumstances known to the person,
it is unjustifiable to take the risk.
(3) The question whether taking a risk is unjustifiable is one of fact.
15 Note: This section is not required in the Commonwealth Act.
Division 3 -- Operation of Act
13. Operation of Act
Note: The Commonwealth Act includes a provision about the application of
that Act.
20 14. Wind-back of reach of Act
Note: The Commonwealth Act includes a provision about the giving of
wind-back notices to a State.
15. Relationship to other State laws
The provisions of this Act are in addition to, and not in
25 substitution for, the requirements of any other law of Western
Australia (whether passed or made before or after the
commencement of this section).
Note: The equivalent section in the Commonwealth Act deals with the
relationship of that Act to other Commonwealth laws.
page 12
Gene Technology Bill 2001
Interpretation and operation of Act Part 2
Provisions to facilitate a nationally consistent scheme Division 4
s. 16
Division 4 -- Provisions to facilitate a nationally
consistent scheme
Subdivision A -- General provisions
16. State laws may operate concurrently
5 Note: The Commonwealth Act includes a provision allowing State laws (apart
from State laws prescribed for the purposes of the provision) to operate
concurrently with that Act.
17. Conferral of functions on Commonwealth officers and
bodies
10 Note: The Commonwealth Act includes a provision allowing corresponding
State laws to confer functions, powers and duties on certain Commonwealth
officers and bodies.
18. No doubling-up of liabilities
(1) If --
15 (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,
the offender is not liable to be punished for the offence under
20 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 in respect of the same conduct.
19. Review of certain decisions
25 (1) Application may be made to the Administrative Appeals
Tribunal for review of a reviewable decision.
page 13
Gene Technology Bill 2001
Part 2 Interpretation and operation of Act
Division 4 Provisions to facilitate a nationally consistent scheme
s. 20
(2) A decision made by the Regulator in the 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
5 Appeals Tribunal; and
(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.
10 (3) The Administrative Appeals Tribunal Act 1975 of the
Commonwealth (excluding Part IVA) and the regulations in
force for the time being under that Act apply as laws of Western
Australia in relation to reviewable decisions.
(4) For the purposes of this section, a reference in a provision of the
15 Administrative Appeals Tribunal Act 1975 of the
Commonwealth (as that provision applies as a law of Western
Australia) 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
has effect as a law of the Commonwealth.
20 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 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
25 Commonwealth Act.
Subdivision B -- Policy principles, policy guidelines and
codes of practice
21. Ministerial Council may issue policy principles
(1) The Ministerial Council may issue policy principles in relation
30 to the following --
(a) ethical issues relating to dealings with GMOs;
page 14
Gene Technology Bill 2001
Interpretation and operation of Act Part 2
Provisions to facilitate a nationally consistent scheme Division 4
s. 22
(aa) recognising areas, if any, designated under a law of
Western Australia for the purpose of preserving the
identity of one or both of the following --
(i) GM crops;
5 (ii) non-GM crops,
for marketing purposes;
(b) matters relating to dealings with GMOs 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
10 do so would be inconsistent with a policy principle.
Note 2: Section 43 of the Interpretation Act 1984 confers power to revoke or
amend any subsidiary legislation.
(2) Before issuing a policy principle, the Ministerial Council must
be satisfied that the policy principle was developed in
15 accordance with section 22 of the Commonwealth Act.
(3) Regulations for the purposes of subsection (1)(b) may relate to
matters other than the health and safety of people or the
environment, but must not derogate from the health and safety
of people or the environment.
20 Note: This section differs from section 21 of the Commonwealth Act.
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
25 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 policy guidelines
when deciding an application for a GMO licence. Section 30 provides that the
30 Regulator is not subject to direction in relation to individual decisions.
Note 2: Section 43 of the Interpretation Act 1984 confers power to revoke or
amend any subsidiary legislation.
page 15
Gene Technology Bill 2001
Part 2 Interpretation and operation of Act
Division 4 Provisions to facilitate a nationally consistent scheme
s. 24
24. Ministerial Council may issue codes of practice
The Ministerial Council may issue codes of practice, developed
in accordance with section 24(2) of the Commonwealth Act, in
relation to gene technology.
5 Note 1: Section 43 of the Interpretation Act 1984 confers power to revoke or
amend any subsidiary legislation.
Note 2: Section 24 of the Commonwealth Act includes provisions about how
codes of practice are to be developed and making them disallowable
instruments.
page 16
Gene Technology Bill 2001
The Gene Technology Regulator Part 3
s. 25
Part 3 -- The Gene Technology Regulator
25. Simplified outline
In outline this Part specifies the functions and powers of the
Gene Technology Regulator under this Act or the regulations.
5 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 office of Gene
Technology Regulator.
27. Functions of the Regulator
10 The Regulator has the following functions --
(a) to perform functions in relation to GMO licences as set
out in Part 5;
(b) to develop draft policy principles and policy guidelines,
as requested by the Ministerial Council;
15 (c) to develop codes of practice;
(d) to issue technical and procedural guidelines in relation
to GMOs;
(e) to provide information and advice to other regulatory
agencies about GMOs and GM products;
20 (f) to provide information and advice to the 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 Committee; and
25 (ii) the effectiveness of the legislative framework for
the regulation of GMOs, including in relation to
possible amendments of relevant legislation;
(h) to undertake or commission research in relation to risk
assessment and the biosafety of GMOs;
page 17
Gene Technology Bill 2001
Part 3 The Gene Technology Regulator
s. 28
(i) to promote the harmonisation of risk assessments
relating to GMOs and GM products by regulatory
agencies;
(j) to monitor international practice in relation to the
5 regulation of GMOs;
(k) to maintain links with international organisations that
deal with the regulation of gene technology and with
agencies that regulate GMOs in places outside Western
Australia;
10 (l) such other functions as are conferred on the Regulator
by this Act, the regulations or any other law.
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
15 performance of the Regulator's functions under this Act or the
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
20 regulations to any of the following --
(a) a public service officer;
(b) an officer of an organisation within the meaning of the
Public Sector Management Act 1994, if the functions of
the organisation relate, whether directly or indirectly, to
25 GMOs or GM products;
(c) an employee of a Commonwealth authority, if the
functions of the Commonwealth authority relate,
whether directly or indirectly, to GMOs or GM
products.
page 18
Gene Technology Bill 2001
The Gene Technology Regulator Part 3
s. 30
(2) In exercising powers or performing functions under a
delegation, the delegate must comply with any directions of the
Regulator.
Note: This section differs from section 29 of the Commonwealth Act.
5 30. Independence of the Regulator
Subject to this Act and to other laws of the State of Western
Australia, 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
10 direction 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.
page 19
Gene Technology Bill 2001
Part 4 Regulation of dealings with GMOs
Division 1 Simplified outline
s. 31
Part 4 -- Regulation of dealings with GMOs
Division 1 -- Simplified outline
31. Simplified outline
In outline this Part --
5 · deals with the regulation of dealings with GMOs;
· prohibits dealings with GMOs unless --
(a) the person undertaking the dealing is authorised
to do so by a GMO licence;
(b) the dealing is a notifiable low risk dealing
10 (see Part 6 Division 2);
(c) the dealing is an exempt dealing; or
(d) the dealing is included in the GMO Register
(see Part 6 Division 3);
· imposes heavier penalties on unlawful dealings that cause,
15 or are likely to cause, significant damage to the health and
safety of people or the environment.
Division 2 -- Dealings with GMOs must be licensed
32. Person not to deal with a GMO without a licence
(1) A person commits an offence if --
20 (a) the person deals with a GMO, knowing that it is a GMO;
(b) the person knows that the dealing with the GMO by the
person is not authorised by a GMO licence or is reckless
as to whether or not the dealing is so authorised;
(c) the person knows that the dealing with the GMO is not a
25 notifiable low risk dealing or is reckless as to whether or
not the dealing is a notifiable low risk dealing;
page 20
Gene Technology Bill 2001
Regulation of dealings with GMOs Part 4
Dealings with GMOs must be licensed Division 2
s. 32
(d) the person knows that the dealing with the GMO 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 with the GMO is not
5 included in the GMO Register or is reckless as to
whether or not the dealing is included on the GMO
Register.
(1a) The offence under subsection (1) is a crime if the offence is an
aggravated offence.
10 Note: Section 38 defines "aggravated offence".
(2) A person who commits an offence under subsection (1) is
liable --
(a) if it is a simple offence, to imprisonment for 2 years or a
fine of $55 000; or
15 (b) if it is a crime, to imprisonment for 5 years or a fine of
$220 000.
(2a) A person charged with an offence under subsection (1) may be
convicted of an offence under section 33(1), if that offence is
established by the evidence.
20 (3) In this section --
"exempt dealing" means a dealing specified by the regulations
to be an exempt dealing.
(4) Regulations made under subsection (3) may be expressed to
exempt --
25 (a) all dealings with a GMO or with a specified class of
GMOs;
(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
30 specified class of GMOs.
Note: This section differs from section 32 of the Commonwealth Act.
page 21
Gene Technology Bill 2001
Part 4 Regulation of dealings with GMOs
Division 2 Dealings with GMOs must be licensed
s. 33
33. Person not to deal with a GMO without a licence -- strict
liability offence
(1) A person commits an offence if --
(a) the person deals with a GMO, knowing that it is a GMO;
5 (b) the dealing with the GMO by the person is not
authorised by a GMO licence;
(c) the dealing with the GMO is not a notifiable low risk
dealing;
(d) the dealing with the GMO is not an exempt dealing;
10 (e) the dealing with the GMO is not included on the GMO
Register.
(2) Note: Section 33(2) of the Commonwealth Act provides that strict liability
applies to subsection (1)(b), (c), (d) and (e).
(3) An offence under this section is punishable by a fine of not
15 more than whichever of the following amounts applies --
(a) in the case of an aggravated offence -- $22 000; or
(b) in any other case -- $5 500.
Note: Section 38 defines "aggravated offence".
(4) In this section --
20 "exempt dealing" has the same meaning as in section 32.
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 commits an offence if the
holder --
25 (a) intentionally takes an action or omits to take an action;
and
(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.
page 22
Gene Technology Bill 2001
Regulation of dealings with GMOs Part 4
Dealings with GMOs must be licensed Division 2
s. 34
(1a) The offence under subsection (1) is a crime if the offence is an
aggravated offence.
Note: Section 38 defines "aggravated offence".
(1b) A person charged with an offence under subsection (1) may be
5 convicted of an offence under section 35(1), if that offence is
established by the evidence.
(2) A person covered by a GMO licence commits an offence if --
(a) the person intentionally takes an action or omits to take
an action;
10 (b) the person knows that the action or omission
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 (2a) The offence under subsection (2) is a crime if the offence is an
aggravated offence.
Note: Section 38 defines "aggravated offence".
(2b) A person charged with an offence under subsection (2) may be
convicted of an offence under section 35(2), if that offence is
20 established by the evidence.
(3) A person who commits an offence under this section is liable --
(a) if it is a simple offence, to imprisonment for 2 years or a
fine of $55 000 and an additional fine not exceeding
$5 500 for every day during which the offence
25 continues;
(b) if it is a crime, to imprisonment for 5 years or a fine of
$220 000 and an additional fine not exceeding $22 000
for every day during which the offence continues.
Note: This section differs from section 34 of the Commonwealth Act.
page 23
Gene Technology Bill 2001
Part 4 Regulation of dealings with GMOs
Division 2 Dealings with GMOs must be licensed
s. 35
35. Person must not breach conditions of a GMO licence --
strict liability offence
(1) The holder of a GMO licence commits an offence if --
(a) the holder takes an action or omits to take an action; and
5 (b) the action or omission contravenes the licence.
(2) A person covered by a GMO licence commits an offence if --
(a) the person takes an action or omits to take an action;
(b) the action or omission contravenes the licence; and
(c) the person has knowledge of the conditions of the
10 licence.
(3) Note: Section 35(3) of the Commonwealth Act provides that strict liability
applies to paragraphs (1)(a) and (b) and (2)(a) and (b).
(4) An offence under this section is punishable on conviction by a
fine of not more than whichever of the following amounts
15 applies --
(a) in the case of an aggravated offence -- $22 000; or
(b) in any other case -- $5 500.
Note 1: Section 38 defines "aggravated offence".
Note 2: This section differs from section 35 of the Commonwealth Act.
20 36. Person must not breach conditions on GMO Register
A person commits an offence if --
(a) the person deals with a GMO knowing that it is a GMO;
(b) the dealing is on the GMO Register; and
(c) the dealing contravenes a condition relating to the
25 dealing that is specified in the GMO Register.
Penalty: $5 500.
Note: This section differs from section 36 of the Commonwealth Act.
page 24
Gene Technology Bill 2001
Regulation of dealings with GMOs Part 4
Dealings with GMOs must be licensed Division 2
s. 37
37. Offence relating to notifiable low risk dealings
A person commits an offence if --
(a) the person deals with a GMO, knowing that it is a GMO;
(b) the dealing is a notifiable low risk dealing; and
5 (c) the dealing by the person was not undertaken in
accordance with the regulations.
Penalty: $5 500.
Note 1: "Notifiable low risk dealings" are specified in the regulations -- see
Part 6.
10 Note 2: This section differs from section 37 of the Commonwealth Act.
38. Aggravated offences -- significant damage to health or
safety of people or to the environment
(1) An offence is an "aggravated offence" if the commission of
the offence causes significant damage, or is likely to cause
15 significant damage, to the health and safety of people or to the
environment.
(2) In order to prove an aggravated offence, the prosecution must
prove that the person who committed the offence --
(a) intended their conduct to cause significant damage to the
20 health and safety of people or to the environment; or
(b) was reckless as to whether that conduct would cause
significant damage to the health and safety of people or
to the environment.
page 25
Gene Technology Bill 2001
Part 5 Licensing system
Division 1 Simplified outline
s. 39
Part 5 -- Licensing system
Division 1 -- Simplified outline
39. Simplified outline
In outline this Part --
5 · provides a licensing system under which a 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 2 kinds of dealings --
10 (a) those that involve the intentional release of a
GMO into the environment; and
(b) those that do not involve the intentional release of
a GMO into the environment;
· provides that a licence can cover dealings by persons other
15 than the licence holder and requires the licence holder to
inform such persons of any conditions of the licence that
apply to them.
Division 2 -- Licence applications
40. Person may apply for a licence
20 (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.
(2) The application must be in writing, and must contain --
(a) such information as is prescribed by the regulations (if
25 any); and
(b) such information as is specified in writing by the
Regulator.
page 26
Gene Technology Bill 2001
Licensing system Part 5
Licence applications Division 2
s. 41
(3) The application must specify whether any of the dealings
proposed to be authorised by the licence would involve the
intentional release of a GMO into the environment.
(4) The dealings in respect of which a person may apply for a
5 licence may be --
(a) all dealings with a GMO, or with a specified class of
GMOs;
(b) a specified class of dealings with a GMO, or with a
specified class of GMOs; or
10 (c) one or more specified dealings with a GMO, or with a
specified class of GMOs.
(5) The applicant may apply for a licence authorising such dealings
by --
(a) a specified person or persons;
15 (b) a specified class of person; or
(c) all persons.
(6) The application must be accompanied by the application fee (if
any) prescribed by the regulations.
41. Application may be withdrawn
20 (1) The applicant may withdraw the application at any time before
the licence is issued.
(2) The application fee is not refundable if the applicant withdraws
the application.
42. Regulator may require applicant to give further information
25 (1) The Regulator may, by notice in writing, require an applicant
for a licence 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.
page 27
Gene Technology Bill 2001
Part 5 Licensing system
Division 2 Licence applications
s. 43
43. Regulator must consider applications except in certain
circumstances
(1) The Regulator must consider an application under section 40 for
a licence in accordance with this Part.
5 (2) However, the Regulator is not required to consider the
application if --
(a) the application does not contain the information
specified by the Regulator or prescribed by the
regulations;
10 (b) the application does not satisfy section 40(3);
(c) the application is not accompanied by the application fee
(if any) prescribed by the regulations;
(d) the applicant did not provide further information
required by the Regulator by notice under section 42
15 within the period specified in the notice; or
(e) the Regulator is satisfied that to issue the licence would
be inconsistent with a policy principle in force under
section 21.
(3) The Regulator must issue the licence, or refuse to issue the
20 licence, within the period (if any) prescribed by the regulations.
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 agency, on any aspect of the
25 application.
45. Regulator must not use certain information in considering
licence application
If --
(a) a person (the "first person") applies for a GMO
30 licence;
page 28
Gene Technology Bill 2001
Licensing system Part 5
Initial consideration of licences for dealings not involving Division 3
intentional release of a GMO into the environment
s. 46
(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 information,
5 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
for the information to be so taken into account.
Division 3 -- Initial consideration of licences for dealings not
10 involving intentional release of a GMO into the environment
46. Applications to which this Division applies
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
15 of a GMO into the environment.
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 authorised by the licence.
20 (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 people or risks to the environment.
(3) In preparing the risk management plan, the Regulator must take
25 into account the means of managing any risks posed by the
dealings proposed to be authorised by the licence in such a way
as to protect --
(a) the health and safety of people; and
(b) the environment.
page 29
Gene Technology Bill 2001
Part 5 Licensing system
Division 4 Initial consideration of licences for dealings involving intentional
release of a GMO into the environment
s. 48
(4) The Regulator may consult --
(a) the States;
(b) the Gene Technology Technical Advisory Committee;
(c) relevant Commonwealth authorities or agencies;
5 (d) any local government that the Regulator considers
appropriate; and
(e) any other person the Regulator considers appropriate,
on any aspect of the application.
Division 4 -- Initial consideration of licences for dealings
10 involving intentional release of a GMO into the environment
48. Applications to which this Division applies
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
15 release of a GMO into the environment.
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
20 risks to the health and safety of people or the environment, the
Regulator must publish a notice in respect of the application --
(a) in the Gazette;
(b) in a newspaper circulating generally in Western
Australia; and
25 (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 the
page 30
Gene Technology Bill 2001
Licensing system Part 5
Initial consideration of licences for dealings involving Division 4
intentional release of a GMO into the environment
s. 49
environment, 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;
5 (b) the effect, or the expected effect, of genetic modification
that has occurred, or will occur, on the properties of the
organism;
(c) provisions for limiting the dissemination or persistence
of the GMO or its genetic material in the environment;
10 (d) the potential for spread or persistence of the 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;
15 (g) any other matter prescribed by the regulations for the
purposes of this paragraph.
(3) The notice mentioned in subsection (1) must --
(a) state that the application has been made;
(b) state that a person may request further information about
20 the application under section 54;
(c) invite written submissions on whether the licence should
be issued, being submissions about matters that the
Regulator is required to take into account --
(i) under section 51(1)(a) in preparing a risk
25 assessment in relation to the dealings proposed to
be authorised by the licence; and
(ii) under section 51(2)(a) in preparing a risk
management plan in relation to those dealings;
and
30 (d) specify the closing date for submissions, which must not
be earlier than 30 days after the date on which the notice
was published.
page 31
Gene Technology Bill 2001
Part 5 Licensing system
Division 4 Initial consideration of licences for dealings involving intentional
release of a GMO into the environment
s. 50
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 plan in relation to the
5 dealing 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 relation to the application under section 49.
(3) The Regulator must seek advice on matters relevant to the
10 preparation of the risk assessment and the risk management plan
from --
(a) the States;
(b) the Gene Technology Technical Advisory Committee;
(c) each Commonwealth authority or agency prescribed by
15 the regulations for the purposes of this paragraph;
(d) the Commonwealth Environment Minister; and
(e) any local government that the Regulator considers
appropriate.
51. Matters Regulator must take into account in preparing risk
20 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 --
(a) the risks posed by those dealings, including any risks to
25 the health and safety of people or risks to the
environment having regard to the matters mentioned in
section 49(2)(a) to (f);
(b) any submission made under section 49(3)(c) in relation
to such risks;
page 32
Gene Technology Bill 2001
Licensing system Part 5
Initial consideration of licences for dealings involving Division 4
intentional release of a GMO into the environment
s. 51
(c) any advice in relation to the risk assessment provided by
the State or a local government in response to a request
under section 50(3);
(d) any advice in relation to the risk assessment provided by
5 the Gene Technology Technical Advisory Committee in
response to a request under section 50(3);
(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);
10 (f) any advice in relation to the risk assessment 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 paragraph.
15 (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 --
(i) the health and safety of people; and
20 (ii) the environment;
(b) any submissions made under section 49(3)(c) in relation
to the means of managing such risks;
(c) any advice in relation to the risk management plan
provided by the State or a local government in response
25 to a request under section 50(3);
(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);
(e) any advice in relation to the risk management plan
30 provided by a Commonwealth authority or agency in
response to a request under section 50(3);
page 33
Gene Technology Bill 2001
Part 5 Licensing system
Division 4 Initial consideration of licences for dealings involving intentional
release of a GMO into the environment
s. 52
(f) any advice in relation to the risk 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
5 purposes of this paragraph.
(3) For the avoidance of doubt, in taking into account the means of
managing risks as mentioned in subsection (2)(a), the
Regulator --
(a) is not limited to considering submissions or advice
10 mentioned in subsection (2)(b), (c), (d), (e) or (f); and
(b) subject to section 45, may take into account other
information, including, but not limited to, relevant
independent research.
52. Public notification of risk assessment and risk management
15 plan
(1) After taking the steps referred to in sections 49 (if applicable),
50 and 51, the Regulator must publish a notice --
(a) in the Gazette;
(b) in a newspaper circulating generally in Western
20 Australia; and
(c) on the Regulator's website (if any).
(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
25 authorised by the licence;
(b) state that a person may request further information about
the risk assessment and the risk management plan under
section 54;
(c) invite written submissions in relation to the risk
30 assessment and the risk management plan; and
page 34
Gene Technology Bill 2001
Licensing system Part 5
Initial consideration of licences for dealings involving Division 4
intentional release of a GMO into the environment
s. 53
(d) specify the closing date for submissions, which must not
be earlier than 30 days after the date on which the notice
was published.
(3) The Regulator must also seek advice on the risk assessment and
5 the risk management plan from --
(a) the States;
(b) the Gene Technology Technical Advisory Committee;
(c) each Commonwealth authority or agency prescribed by
the regulations for the purposes of this paragraph;
10 (d) the Commonwealth Environment Minister; and
(e) any local government that the Regulator considers
appropriate.
53. Regulator may take other actions
(1) In addition to satisfying the requirements of this Division in
15 relation to an application for a licence to which this Division
applies, the Regulator may take any other action the Regulator
considers appropriate for the purpose of deciding the
application, including holding a public hearing.
(2) If the Regulator holds a public hearing, the Regulator may,
20 having regard to the requirements 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 restricting the
publication of evidence given, or material contained in
25 documents produced, at a public hearing.
(4) A person must not contravene a direction given under
subsection (3).
Penalty: $3 300.
page 35
Gene Technology Bill 2001
Part 5 Licensing system
Division 5 Decision on licence etc.
s. 54
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 --
(a) an application to which this Division applies;
5 (b) a risk assessment or a risk management plan prepared
under section 50.
(2) If a person makes a request under subsection (1), the Regulator
must provide to the person a copy of the documents, other
than --
10 (a) any confidential commercial information contained in
the documents; and
(b) any information contained in the documents about
relevant convictions (within the meaning of section 58)
of the applicant for the licence.
15 Note: In order for information to be "confidential commercial information", it
must be covered by a declaration under section 185.
Division 5 -- Decision on licence etc.
55. Regulator must make a decision on licence and licence
conditions
20 After taking any steps required by Division 3 or 4 in relation to
an application for a GMO licence, the Regulator --
(a) must decide whether to issue or refuse to issue the
licence; and
(b) if the Regulator decides to issue the licence -- may
25 impose conditions to which the licence is subject.
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
page 36
Gene Technology Bill 2001
Licensing system Part 5
Decision on licence etc. Division 5
s. 57
authorised by the licence are able to be managed in such a way
as to protect --
(a) the health and safety of people; and
(b) the environment.
5 (2) For the purposes of subsection (1), the Regulator 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 under
10 section 50 in relation to those dealings -- the risk
management plan;
(c) any submissions received under section 52 in relation to
the licence;
(d) any policy guidelines in force under section 23 that
15 relate to --
(i) risks that may be posed by the dealings proposed
to be authorised by the licence; or
(ii) ways of managing such risks so as to protect the
health and safety of people or to protect the
20 environment.
57. Other circumstances in which Regulator must not 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
25 policy principle in force under section 21.
(2) The Regulator must not issue the licence unless the Regulator is
satisfied that the applicant is a suitable person to hold the
licence.
page 37
Gene Technology Bill 2001
Part 5 Licensing system
Division 5 Decision on licence etc.
s. 58
58. Matters to be taken into account in deciding whether a
person is suitable to hold a licence
(1) Without limiting the matters to which the Regulator may have
regard in deciding whether a natural person is a suitable person
5 to hold a licence, the Regulator must have regard to --
(a) any relevant conviction of the person;
(b) any revocation or suspension of a licence or permit
(however described) held by the person under a law of
Western Australia, the Commonwealth, another State or
10 a foreign country, relating to the health and safety of
people or the environment; and
(c) the capacity of the person to meet the conditions of the
licence.
(2) Without limiting the matters to which the Regulator may have
15 regard in deciding whether a body corporate is a suitable person
to hold a licence, the Regulator must have regard to the
following --
(a) any relevant conviction of the body corporate;
(b) if there is a relevant conviction of the body corporate --
20 (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 a time
when any officer or shareholder of the body
25 corporate who is presently in a position to
influence the management of the body corporate
was such an officer or shareholder;
(c) any revocation or suspension of a licence or permit
(however described) held by the body corporate under a
30 law of Western Australia, the Commonwealth, another
State or a foreign country, relating to the health and
safety of people or the environment; and
page 38
Gene Technology Bill 2001
Licensing system Part 5
Conditions of licence Division 6
s. 59
(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 offence
5 against a law of Western Australia, 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 period of
10 years immediately before the making of the
10 application for the licence; and
(b) the offence was punishable by a fine of $5 000 or
more, or by a term of imprisonment of one year or
more.
Note: This section differs from section 58 of the Commonwealth Act.
15 59. Notification of licence decision
The Regulator must notify the applicant in writing of the
Regulator's decision (including any conditions imposed by the
Regulator, if applicable).
60. Period of licence
20 (1) A licence continues in force --
(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.
(2) A licence is not in force throughout any period of suspension.
25 Division 6 -- Conditions of licence
61. Licence is subject to conditions
A GMO licence is subject to the following conditions --
(a) the conditions set out in sections 63, 64 and 65;
page 39
Gene Technology Bill 2001
Part 5 Licensing system
Division 6 Conditions of licence
s. 62
(b) any conditions prescribed by the regulations;
(c) any conditions imposed by the Regulator at the time of
issuing the licence;
(d) any conditions imposed by the Regulator under
5 section 71 after the licence is issued.
62. Conditions that may be prescribed or imposed
(1) Licence conditions may include conditions that impose
obligations in relation to GM products that are derived from a
GMO in respect of which particular dealings are licensed.
10 (2) Licence conditions may relate to, but are not limited to, the
following --
(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 dealings;
15 (d) documentation and record-keeping requirements;
(e) the required level of containment in respect of the
dealings, including requirements relating to the
certification of facilities to specified containment levels;
(f) waste disposal requirements;
20 (g) measures to manage risks posed to the health and safety
of people, or to the environment;
(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
25 a contained environment;
(k) the geographic area in which the dealings authorised by
the licence may occur;
(l) requiring compliance with a code of practice issued
under section 24, or a technical or procedural guideline
30 issued under section 27;
page 40
Gene Technology Bill 2001
Licensing system Part 5
Conditions of licence Division 6
s. 63
(m) supervision by, and monitoring by, Institutional
Biosafety Committees;
(n) contingency planning in respect of unintended effects of
the dealings authorised by the licence;
5 (o) limiting the dissemination or persistence of 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 may be caused to human health, property or the
10 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 whom a particular condition of
the licence applies, of the following --
15 (a) the particular condition, including any variations of it;
(b) the cancellation or suspension of the licence;
(c) the surrender of the licence.
(2) Requirements in relation to the manner in which information is
provided under subsection (1) may be --
20 (a) prescribed by the regulations; or
(b) specified by the Regulator.
(3) Such requirements may include, but are not limited to, measures
relating to labelling, packaging, conducting training and
providing information.
25 (4) If such requirements are prescribed or specified, it is a condition
of a licence that the licence holder comply with the
requirements.
page 41
Gene Technology Bill 2001
Part 5 Licensing system
Division 6 Conditions of licence
s. 64
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
5 (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 purposes of auditing or monitoring the dealing.
10 (2) Subsection (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 the
Regulator
(1) It is a condition of a licence that the licence holder inform the
15 Regulator if the licence holder --
(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;
(b) becomes aware of any contraventions of the licence by a
20 person covered by the licence; or
(c) becomes aware of any unintended effects of the dealings
authorised by the licence.
(2) For the purposes of subsection (1) --
(a) the licence holder is taken to have become aware of
25 additional information of a kind mentioned in
subsection (1) if the licence 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
30 mentioned in subsection (1) if the licence holder was
reckless as to whether such contraventions had occurred,
or such unintended effects existed.
page 42
Gene Technology Bill 2001
Licensing system Part 5
Suspension, cancellation and variation of licences Division 7
s. 66
66. Person may give information to Regulator
A person covered by a licence may inform the Regulator if the
person --
(a) becomes aware of additional information as to any risks
5 to the health and safety of people, or to the environment,
associated with the dealings authorised by the licence;
(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 the dealings
10 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 the first person gave information to the
15 Regulator under section 65 or 66.
Division 7 -- Suspension, cancellation and variation of licences
68. Suspension and cancellation of licence
The Regulator may, by notice in writing given to the holder of a
GMO licence, suspend or cancel a licence if --
20 (a) the Regulator believes on reasonable grounds that a
condition of the licence has been breached, whether by
the licence holder or by a person covered by the licence;
(b) the Regulator believes on reasonable grounds that the
licence holder, or a person covered by the licence, has
25 committed an offence against this Act or the regulations;
(c) any annual charge payable in respect of the licence
remains unpaid after the due date;
(d) the licence was obtained improperly;
(e) the Regulator becomes aware of risks associated with
30 the continuation of the dealings authorised by the
page 43
Gene Technology Bill 2001
Part 5 Licensing system
Division 7 Suspension, cancellation and variation of licences
s. 69
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
(f) the Regulator is satisfied that the licence holder is no
5 longer a suitable person to hold the licence.
69. Surrender of licence
A licence holder may, with the consent of the Regulator,
surrender the licence.
70. Transfer of licence
10 (1) The licence holder and another person (the "transferee") may
jointly apply to the Regulator for the licence to be transferred
from the licence holder to the transferee.
(2) The application must be in writing, and must contain --
(a) such information as is prescribed by the regulations (if
15 any); and
(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
20 the dealings 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 the Regulator
25 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.
page 44
Gene Technology Bill 2001
Licensing system Part 5
Suspension, cancellation and variation of licences Division 7
s. 71
(6) If the Regulator decides to transfer the licence --
(a) the transfer takes effect on the date specified in the
notice;
(b) the licence continues in force as mentioned in
5 section 60; and
(c) the licence is subject to the same conditions as those in
force immediately before the transfer.
71. Variation of licence
(1) The Regulator may, at any time, by notice in writing given to
10 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 application for the licence was originally
considered under Division 3.
15 Note: Applications can only be considered under Division 3 if none of the
dealings proposed to be authorised by the licence would involve the
intentional release of a GMO into the environment.
(3) Without limiting subsection (1), the Regulator may --
(a) impose licence conditions or additional licence
20 conditions;
(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 unless the
25 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
(b) the environment.
page 45
Gene Technology Bill 2001
Part 5 Licensing system
Suspension, cancellation and variation of licences
s. 72
72. Regulator to notify of proposed suspension, cancellation or
variation
(1) Before suspending, cancelling or varying a licence under this
Division, the Regulator must give written notice of the proposed
5 suspension, cancellation or variation to the licence holder.
(2) The notice --
(a) must state that the Regulator proposes to suspend,
cancel or vary the licence;
(b) may require the licence holder to give to the Regulator
10 any information of a kind specified in the notice that is
relevant to the proposed suspension, cancellation or
variation; and
(c) may invite the licence holder to make a written
submission to the Regulator about the proposed
15 suspension, cancellation or variation.
(3) The notice must specify a period within which the licence
holder --
(a) must give the information referred to in
subsection (2)(b); and
20 (b) may make a submission under subsection (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 submission made under
25 subsection (2)(c).
(5) The section does not apply to a suspension, cancellation or
variation requested by the licence holder.
(6) This section does not apply to a suspension, cancellation or
variation of a licence if the Regulator considers that the
30 suspension, cancellation or variation is necessary in order to
avoid an imminent risk of death, serious illness, serious injury
or serious damage to the environment.
page 46
Gene Technology Bill 2001
Licensing system Part 5
Annual charge Division 8
s. 72A
Division 8 -- Annual charge
72A. GMO licence -- annual charge
(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
5 respect of that year.
(2) The amount of the charge for a financial year is such amount as
is prescribed by the regulations.
Note 1: This section does not appear in the Commonwealth Act but charges
are imposed under the Gene Technology (Licence Charges) Act 2000 of the
10 Commonwealth.
Note 2: See also the Gene Technology Amendment Act 2001.
page 47
Gene Technology Bill 2001
Part 6 Regulation of notifiable low risk dealings and dealings on the
GMO Register
Division 1 Simplified outline
s. 73
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 the environment (see Division 2);
10 · provides that the regulations may (among other things)
require that the Regulator be notified of such dealings;
· enables the Regulator to determine that certain dealings
previously authorised by a licence be included on the
GMO Register;
15 · ensures that, if a dealing is included on the GMO Register,
anyone may undertake the dealing, subject to specified
conditions.
Note: This section differs from section 73 of the Commonwealth Act.
Division 2 -- Notifiable low risk dealings
20 74. Notifiable low risk dealings
(1) The regulations may declare a dealing with a GMO to be a
notifiable low risk dealing for the purposes of this Act.
(2) Before the Governor makes regulations declaring a dealing with
a GMO to be a notifiable low risk dealing, the Regulator must
25 be satisfied that the dealing would not involve the intentional
release of a GMO into the environment.
page 48
Gene Technology Bill 2001
Regulation of notifiable low risk dealings and dealings on the Part 6
GMO Register
Notifiable low risk dealings Division 2
s. 75
(3) Before the Governor makes regulations 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
5 not able to survive or reproduce 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
10 the GMO as a 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 paragraph (b).
15 (4) Regulations under subsection (1) may be expressed to apply
to --
(a) all dealings with a GMO or with a specified class of
GMOs;
(b) a specified class of dealings with a GMO or with a
20 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
(1) The regulations may regulate --
25 (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 of people or
the environment.
page 49
Gene Technology Bill 2001
Part 6 Regulation of notifiable low risk dealings and dealings on the
GMO Register
Division 3 The GMO Register
s. 76
(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 --
(a) the class of person who may undertake notifiable low
5 risk dealings;
(b) notifying the Regulator of notifiable low risk dealings;
(c) supervision by Institutional Biosafety Committees of
notifiable low risk dealings;
(d) the containment level of facilities in which notifiable
10 low risk dealings may be undertaken.
Division 3 -- The GMO Register
76. The GMO Register
Note: Section 76 of the Commonwealth Act provides for the establishment
and maintenance of the GMO Register.
15 77. Contents of Register
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; and
20 (b) any condition to which the dealing is subject.
78. Regulator may include dealings with GMOs on GMO
Register
(1) The Regulator may, by writing, determine that the dealing with
the GMO is to be included on the GMO Register if the
25 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
page 50
Gene Technology Bill 2001
Regulation of notifiable low risk dealings and dealings on the Part 6
GMO Register
The GMO Register Division 3
s. 79
(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 subsection (1) may be made --
5 (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 subsection (1) comes into effect on the
day specified in the determination. If the determination was
10 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.
Note: Section 78(4) of the Commonwealth Act provides for determinations to
be disallowable instruments.
15 79. Regulator not to make determination unless risks can be
managed
(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 --
20 (a) that any risks posed by the dealing are 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
protect the environment.
25 (2) For the purposes of subsection (1), the Regulator must have
regard to the following --
(a) any data available to the Regulator about adverse effects
posed by the dealing;
(b) any other information as to risks associated with the
30 dealing of which the Regulator is aware, including
information provided by the Regulator by a licence
holder under section 65 or by another person under
section 66;
page 51
Gene Technology Bill 2001
Part 6 Regulation of notifiable low risk dealings and dealings on the
GMO Register
Division 3 The GMO Register
s. 80
(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 licence.
5 (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 written
determination.
10 (2) A variation may --
(a) remove a dealing from the GMO Register;
(b) revoke or vary conditions to which a dealing on the
GMO Register is subject; or
(c) impose additional conditions to which a dealing on the
15 GMO Register is subject.
Note: Section 80(3) of the Commonwealth Act provides for determinations to
be disallowable instruments.
81. Inspection of Register
Note: Section 81 of the Commonwealth Act requires the Regulator to permit
20 any person to inspect the GMO Register.
page 52
Gene Technology Bill 2001
Certification and accreditation Part 7
Simplified outline Division 1
s. 82
Part 7 -- Certification and accreditation
Division 1 -- Simplified outline
82. Simplified outline
In outline this Part --
5 · establishes a system under which the Regulator may
certify facilities to specified containment levels in
accordance with guidelines issued by the Regulator.
Licence conditions can require that facilities be certified to
specified containment levels (see Division 2);
10 · enables the Regulator to accredit organisations in
accordance with accreditation guidelines issued by the
Regulator. Licence conditions can specify that dealings
must be supervised by an Institutional Biosafety
Committee established by an accredited organisation (see
15 Division 3).
Division 2 -- Certification
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.
20 (2) The application must be in writing and must 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 application fee (if
25 any) prescribed by the regulations.
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
page 53
Gene Technology Bill 2001
Part 7 Certification and accreditation
Division 2 Certification
s. 85
containment requirements 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 an applicant
5 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.
10 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;
15 (b) any conditions imposed by the Regulator under
section 87 after certification;
(c) any conditions imposed by the regulations.
87. Variation of certification
(1) The Regulator may, at any time, by notice in writing given to
20 the holder of the certification, vary the certification of a facility.
(2) Without limiting subsection (1), the Regulator may --
(a) impose additional conditions; or
(b) remove or vary conditions that were imposed by the
Regulator.
25 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 condition of the certification has been breached.
page 54
Gene Technology Bill 2001
Certification and accreditation Part 7
Certification Division 2
s. 89
89. Regulator to notify of proposed suspension, cancellation or
variation
(1) Before suspending, cancelling or varying a certification under
this Division, the Regulator must give written notice of the
5 proposed suspension, cancellation or variation to the holder of
the certification.
(2) The notice --
(a) must state that the Regulator proposes to suspend,
cancel or vary the certification;
10 (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 variation; and
(c) may invite the holder of the certification to make a
15 written submission to the Regulator about the proposed
suspension, cancellation or variation.
(3) The notice must specify a period within which the holder of the
certification --
(a) must give the information referred to in
20 subsection (2)(b); and
(b) may make a submission under subsection (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
25 certification, the Regulator must have regard to any submission
made under subsection (2)(c).
(5) This section does not apply to a suspension, cancellation or
variation requested by the holder of the certification.
(6) This section does not apply to a suspension, cancellation or
30 variation of a certification if the Regulator considers that the
suspension, cancellation or variation is necessary in order to
page 55
Gene Technology Bill 2001
Part 7 Certification and accreditation
Division 3 Accredited organisations
s. 90
avoid an imminent risk of death, serious illness, serious injury
or serious damage to the environment.
90. Guidelines
(1) The Regulator may, by written instrument, issue technical or
5 procedural guidelines about the requirements for the
certification of facilities to specified containment levels.
(2) The Regulator may, by written instrument, vary or revoke the
guidelines.
Division 3 -- Accredited organisations
10 91. Application for accreditation
(1) A person may apply to the Regulator for accreditation of an
organisation as an accredited 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
15 (see section 62(2)(m)), and the regulations may 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.
92. Regulator may accredit organisations
20 (1) The Regulator may, by written instrument, accredit an
organisation as an accredited organisation.
(2) In deciding whether to accredit an organisation, the Regulator
must have regard to --
(a) whether the organisation has established, or proposes to
25 establish, an Institutional Biosafety Committee in
accordance with written guidelines issued by the
Regulator under section 98;
page 56
Gene Technology Bill 2001
Certification and accreditation Part 7
Accredited organisations Division 3
s. 93
(b) whether the organisation will be able to maintain an
Institutional Biosafety Committee in accordance with
such guidelines;
(c) whether the organisation has, or will have, appropriate
5 indemnity arrangements for its Institutional Biosafety
Committee members; and
(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 an applicant
10 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 the information
is to be provided.
15 94. Conditions of accreditation
The accreditation of an accredited organisation is subject to the
following conditions --
(a) any conditions imposed by the Regulator at the time of
accreditation;
20 (b) any conditions imposed by the Regulator under
section 95 after accreditation;
(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
25 accredited organisation, vary the organisation's accreditation.
(2) Without limiting subsection (1), the Regulator may --
(a) impose additional conditions; or
(b) remove or vary conditions that were imposed by the
Regulator.
page 57
Gene Technology Bill 2001
Part 7 Certification and accreditation
Division 3 Accredited organisations
s. 96
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
5 been breached.
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
10 proposed 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;
15 (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 variation; and
(c) may invite the holder of the accreditation to make a
20 written submission to the Regulator about the proposed
suspension, cancellation or variation.
(3) The notice must specify a period within which the holder of the
accreditation --
(a) must give the information referred to in
25 subsection (2)(b); and
(b) may make a submission under subsection (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
30 accreditation, the Regulator must have regard to any submission
made under subsection (2)(c).
page 58
Gene Technology Bill 2001
Certification and accreditation Part 7
Accredited organisations Division 3
s. 98
(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, cancellation or
variation of an accreditation if the Regulator considers that the
5 suspension, cancellation or variation is necessary in order to
avoid an imminent risk of death, serious illness, serious injury
or serious damage to the environment.
98. Guidelines
(1) The Regulator may, by written instrument, issue technical or
10 procedural guidelines in relation to 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 maintenance of Institutional
15 Biosafety Committees.
(3) The Regulator may, by written instrument, vary or revoke the
guidelines.
page 59
Gene Technology Bill 2001
Part 8 The Gene Technology Technical Advisory Committee, the Gene
Technology Community Consultative Group and the Gene
Technology Ethics Committee
Division 1 Simplified outline
s. 99
Part 8 -- The Gene Technology Technical Advisory
Committee, the Gene Technology Community
Consultative Group 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 Community Consultative Committee and the Gene
10 Technology Ethics Committee.
Note: This section differs from section 99 of the Commonwealth Act.
Division 2 -- The Gene Technology Technical
Advisory Committee
100. The Gene Technology Technical Advisory Committee
15 Note: Section 100 of the Commonwealth Act provides for the establishment
and membership of the Gene Technology Technical Advisory Committee.
101. Function of the Gene Technology Technical Advisory
Committee
The function of the Gene Technology Technical Advisory
20 Committee under this Act is to provide scientific and technical
advice, on the request of the Regulator or the Ministerial
Council, on the following --
(a) gene technology, GMOs and GM products;
(b) applications made under this Act;
25 (c) the biosafety aspects of gene technology;
(d) the need for policy principles, policy guidelines, codes
of practice and technical and procedural guidelines in
page 60
Gene Technology Bill 2001
The Gene Technology Technical Advisory Committee, the Part 8
Gene Technology Community Consultative Group and the
Gene Technology Ethics Committee
The Gene Technology Community Consultative Committee Division 3
s. 102
relation to GMOs and GM products and the content of
such principles, guidelines and codes.
102. Expert advisers
Note: Section 102 of the Commonwealth Act provides for the appointment of
5 expert advisers to the Gene Technology Technical Advisory Committee.
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.
10 104. 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.
105. Subcommittees
15 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
Committee
106. The Gene Technology Community Consultative Committee
20 Note: Section 106 of the Commonwealth Act establishes the Gene
Technology Community Consultative Committee.
107. Function of Consultative Committee
The function of the Consultative Committee under this Act is to
provide advice, on the request of the Regulator or the
25 Ministerial Council, on the following --
(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;
page 61
Gene Technology Bill 2001
Part 8 The Gene Technology Technical Advisory Committee, the Gene
Technology Community Consultative Group and the Gene
Technology Ethics Committee
Division 4 The Gene Technology Ethics Committee
s. 108
(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.
5 108. 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 the payment of
10 remuneration and allowances to members of the Consultative Committee.
110. Regulations
Note: Section 110 of the Commonwealth Act empowers the making of
regulations relating to the membership and operation of the Consultative
Committee.
15 110A. Subcommittees
Note: Section 110A of the Commonwealth Act deals with the establishment of
subcommittees by the Consultative Committee.
Division 4 -- The Gene Technology Ethics Committee
111. The Gene Technology Ethics Committee
20 Note: Section 111 of the Commonwealth Act provides for the establishment
and membership of the Gene Technology Ethics Committee.
112. Function of the Gene Technology Ethics Committee
The function of the Gene Technology Ethics Committee under
this Act is to provide advice, on the request of the Regulator or
25 the Ministerial Council, on the following --
(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;
page 62
Gene Technology Bill 2001
The Gene Technology Technical Advisory Committee, the Part 8
Gene Technology Community Consultative Group and the
Gene Technology Ethics Committee
The Gene Technology Ethics Committee Division 4
s. 113
(c) the need for, and content of, policy principles in relation
to dealings with GMOs that should not be conducted for
ethical reasons.
113. Expert advisers
5 Note: Section 113 of the Commonwealth Act provides for 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 members of, and expert advisers to, the
10 Ethics Committee.
115. Members and procedures
Note: Section 115 of the Commonwealth Act empowers the making of
regulations relating to the membership and operation of the Ethics
Committee.
15 116. Subcommittees
Note: Section 116 of the Commonwealth Act deals with the establishment of
subcommittees by the Ethics Committee.
page 63
Gene Technology Bill 2001
Part 9 Administration
Division 1 Simplified outline
s. 117
Part 9 -- Administration
Division 1 -- Simplified outline
117. Simplified outline
In outline this Part --
5 · provides for financial matters (see Division 3);
· sets out reporting requirements (see Division 5);
· requires the Regulator to ensure that certain information is
entered on a record of GMOs and GM products (see
Division 6);
10 · 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.
Division 2 -- Appointment and conditions of Regulator
118. Appointment of the Regulator
15 Note: Section 118 of the Commonwealth Act provides for the appointment of
the Regulator.
119. Termination of appointment
Note: Section 119 of the Commonwealth Act sets out the circumstances in
which the Regulator's appointment may be terminated.
20 120. Disclosure of interests
Note: Section 120 of the Commonwealth Act requires the 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
25 person to act as the Regulator.
page 64
Gene Technology Bill 2001
Administration Part 9
Money Division 3
s. 122
122. Terms and conditions
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 the payment of
remuneration and allowances to the Regulator.
10 125. Leave of absence
Note: Section 125 of the Commonwealth Act deals with the entitlement of the
Regulator to leave of absence.
126. Resignation
Note: Section 126 of the Commonwealth Act deals with the procedure for
15 resignation by the Regulator.
Division 3 -- Money
127. Regulator may charge for services
The Regulator may charge for services provided by, or on
behalf of, the Regulator in the performance of the Regulator's
20 functions under this Act or the regulations.
128. Notional payments by the State
(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 Western Australia and bodies representing the State.
25 (2) The Minister responsible for administering the Financial
Administration and Audit Act 1985 may give written directions
for the purpose of this section, including directions relating to
the transfer of accounts within, or between, accounts operated
by the State of Western Australia.
30 Note: This section differs from section 128 of the Commonwealth Act.
page 65
Gene Technology Bill 2001
Part 9 Administration
Division 3 Money
s. 129
129. Gene Technology Account
Note: Section 129 of the Commonwealth Act provides for the establishment of
the Gene Technology Account.
130. Credits to Gene Technology Account
5 (1) There must be paid to the Commonwealth for crediting to the
Gene Technology Account the following --
(a) amounts equal to money from time to time received by
the State of Western Australia under Part 5 Division 8;
(b) amounts equal to fees received by the State of Western
10 Australia under sections 40(6) and 83(3);
(c) amounts equal to amounts received by the State of
Western Australia in connection with the performance
of the Regulator's functions under this Act or the
regulations;
15 (d) amounts equal to amounts recovered by the State of
Western Australia 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 necessary extent
20 to enable amounts to be paid to the Commonwealth in
accordance with subsection (1).
Note: This section differs from section 130 of the Commonwealth Act.
131. Recovery of amounts
The following amounts may be recovered in a court of
25 competent jurisdiction as debts due to the State of Western
Australia --
(a) amounts payable to the State of Western Australia under
Part 5 Division 8;
(b) fees payable to the State of Western Australia under this
30 Act or the regulations;
page 66
Gene Technology Bill 2001
Administration Part 9
Staffing Division 4
s. 132
(c) amounts payable to the State of Western Australia in
connection with the performance of the Regulator's
functions under this Act or the regulations.
132. Purposes of Account
5 Note: Section 132 of the Commonwealth Act sets out the purposes for which
money in the 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
10 available to assist the Regulator.
134. Consultants
Note: Section 134 of the Commonwealth Act enables the Regulator to engage
consultants.
135. Seconded officers
15 Note: Section 135 of the Commonwealth Act provides for staff to be seconded
to the Regulator.
Division 5 -- Reporting requirements
136. Annual report
(1) As soon as practicable after the end of each financial year, the
20 Regulator must prepare and give to the Minister a report on the
operations of the Regulator under this Act and the regulations
during that year.
(2) The Minister must cause a copy of the report to be laid before
each House of Parliament within 15 sitting days of that House
25 after the Minister receives the report.
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.
page 67
Gene Technology Bill 2001
Part 9 Administration
Division 5 Reporting requirements
s. 136A
136A. Quarterly reports
(1) As soon as practicable after the end of each quarter, the
Regulator must prepare and give to the Minister a report on the
operations of the Regulator under this Act and the regulations
5 during that quarter.
(2) The report must include information about the 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;
10 (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 laid before
15 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 on 1 January,
1 April, 1 July or 1 October of any year.
20 137. Reports to Parliament
(1) The Regulator may at any time cause a report about matters
relating to the Regulator's functions under this Act or the
regulations to be laid before each House of Parliament.
(2) The Regulator must give a copy of the report to the Minister.
25 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.
page 68
Gene Technology Bill 2001
Administration Part 9
Record of GMO and GM product dealings Division 6
s. 138
Division 6 -- Record of GMO and GM product dealings
138. Record of GMO and GM product dealings
(1) The Record must contain the following information, other than
confidential commercial information, in relation to each licence
5 issued under section 55 --
(a) the name of the licence holder;
(b) the persons covered by the licence;
(c) the dealings authorised by the licence and the GMO to
which those dealings relate;
10 (d) any licence conditions;
(e) the date on which the licence was issued, and its expiry
date (if any).
(2) The Record must contain the following information, other than
confidential commercial information, in relation to each
15 notifiable low risk dealing that is notified to the Regulator in
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 purposes of this paragraph.
20 (3) The Record must contain such information as is prescribed by
the regulations, other than confidential commercial information,
in relation to GM products mentioned in designated
notifications given to the Regulator under any Act.
(4) The Record must also contain --
25 (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 mentioned in
subsection (1), (2), (3) or (4) is entered on the Record as soon as
reasonably practicable.
page 69
Gene Technology Bill 2001
Part 9 Administration
Division 7 Reviews of notifiable low risk dealings and exemptions
s. 139
(6) In this section --
"designated notification" means a notification required to be
given to the Regulator under an Act or any law applying as
a law of the State of Western Australia by force of an Act.
5 Note: This section differs from section 138 of the Commonwealth Act.
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
10 and exemptions
140. Regulator may review notifiable low risk dealings
(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 notifiable
15 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 relate to --
(a) the matters of which the Regulator must be satisfied
20 under section 74(2); or
(b) the matters the Regulator must consider under
section 74(3).
141. Regulator may review exemptions
The Regulator may, at any time, in accordance with this
25 Division, consider the following matters --
(a) whether a dealing that is an exempt dealing 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.
page 70
Gene Technology Bill 2001
Administration Part 9
Reviews of notifiable low risk dealings and exemptions Division 7
s. 142
142. Regulator may give notice of consideration
(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 --
5 (a) specify the matters to which submissions are 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.
10 (2) If the Regulator publishes a notice under subsection (1), the
Regulator must also give written notice, stating the matters
mentioned in subsection (1), to --
(a) the States;
(b) the Gene Technology Technical Advisory Committee;
15 and
(c) each Commonwealth authority or agency prescribed by
the regulations for the purposes of this paragraph.
(3) A notice under this section may relate to a single matter or to a
class of matters.
20 143. What Regulator may do after consideration
(1) If --
(a) the matter relates to whether a dealing should be a
notifiable low risk dealing;
(b) the Regulator is satisfied as mentioned in section 74(2);
25 (c) the Regulator has considered the matters 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.
page 71
Gene Technology Bill 2001
Part 9 Administration
Division 7 Reviews of notifiable low risk dealings and exemptions
s. 144
(2) If --
(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
5 section 74, the Regulator considers that the dealing
should not be a notifiable low risk dealing,
the Regulator may recommend to the Ministerial Council that
the regulations be amended accordingly.
(3) If the matter relates to whether a dealing --
10 (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.
144. Regulator not required to review matters
15 Nothing in this Division requires the Regulator to consider a
matter under section 140 or 141.
page 72
Gene Technology Bill 2001
Enforcement Part 10
s. 145
Part 10 -- Enforcement
145. Simplified outline
In outline this Part --
· enables the Regulator to give directions to a licence holder
5 or to a person covered by a licence if --
(a) the Regulator believes that the person is not
complying with this Act or the regulations; and
(b) the Regulator believes that it is necessary to do so
in order to protect the health and safety of people
10 or to protect the environment;
· empowers the Supreme Court to issue injunctions, and
contains a forfeiture provision.
Note: This section differs from section 145 of the Commonwealth Act.
146. Regulator may give directions
15 (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
(b) it is necessary to exercise powers under this section in
order to protect the health and safety of people or to
20 protect the environment,
the Regulator may give directions to the licence 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 reasonable in the circumstances for the licence holder to
25 comply with this Act or the regulations.
(2) If the Regulator believes on reasonable grounds that --
(a) a person covered by a GMO licence is not complying
with this Act or the regulations in respect of a thing; and
page 73
Gene Technology Bill 2001
Part 10 Enforcement
s. 147
(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 person, by written
5 notice, requiring the person, within the time specified in the
notice, to take such steps in 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
10 subsection (1) or (2) within the time specified in the notice.
Penalty:
(a) in the case of an aggravated offence -- $220 000;
(b) in any other case -- $55 000.
Note: Section 38 defines "aggravated offence".
15 (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 arrangements made by
20 the Regulator under subsection (4), the licence holder or the
person, as the case requires, is liable to pay to the State of
Western Australia an amount equal to the cost, and the amount
may be recovered by the State as a debt due to the State in a
court of competent jurisdiction.
25 (6) A time specified in a notice under subsection (1) or (2) must be
reasonable having regard to the 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 engage in
30 any conduct that is or would be an offence against this Act or
the regulations, the Supreme Court ("the Court") may, on the
page 74
Gene Technology Bill 2001
Enforcement Part 10
s. 148
application of the Regulator or any other aggrieved person,
grant an injunction restraining the person from engaging in the
conduct.
(2) If --
5 (a) a person has refused or failed, is refusing or failing, or is
about to refuse or fail, to do a thing; and
(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
10 aggrieved person, grant an injunction requiring the person to do
the thing.
(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
15 intends to engage, or to continue to engage, in conduct
of that kind; and
(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
20 this section.
(5) The Court may grant an interim injunction pending a
determination of an application under subsection (1).
(6) The powers granted by this section are in addition to, and not in
derogation of, any other powers of the Court.
25 Note: Section 147 of the Commonwealth Act confers a similar power to grant
injunctions on the Federal Court of Australia.
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
30 Western Australia of any thing used or otherwise involved in
the commission of the offence.
page 75
Gene Technology Bill 2001
Part 10 Enforcement
s. 148
(2) A thing ordered by a court to be forfeited under this section
becomes the property of the State of Western Australia and may
be sold or otherwise dealt with in accordance with the directions
of the Regulator.
5 (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.
page 76
Gene Technology Bill 2001
Powers of inspection Part 11
Simplified outline Division 1
s. 149
Part 11 -- Powers of inspection
Division 1 -- Simplified outline
149. Simplified outline
In outline this Part --
5 · provides for powers of inspection in relation to monitoring
and offences;
· provides for the appointment of inspectors (see
Division 2);
· deals with the powers and obligations of inspectors and
10 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 warrants and
offence-related warrants (see Division 10);
15 · does not limit the conditions to which a licence can be
subject, and section 64 imposes a condition in relation to
monitoring dealings with GMOs.
Division 2 -- Appointment of inspectors and identity cards
150. Appointment of inspectors
20 (1) The Regulator may, by instrument in writing, appoint any of the
following persons as inspectors --
(a) any employee or class of employee employed under
Part 3 of the Public Sector Management Act 1994; or
(b) a person who is appointed or employed by the
25 Commonwealth.
page 77
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 3 Monitoring powers
s. 151
(2) In exercising powers or performing functions as an inspector, an
inspector must comply with any directions of the Regulator.
Note: This section differs from section 150 of the Commonwealth Act.
151. Identity card
5 (1) The Regulator must issue an identity card to an inspector.
(2) The identity card --
(a) must be in the form prescribed by the regulations; and
(b) must contain a recent photograph of the inspector.
(3) If a person to whom an identity card has been issued ceases to
10 be an inspector, the person must return the identity card to the
Regulator as soon as practicable.
Penalty: $110.
(4) An inspector must carry his or her identity card at all times
when exercising powers or performing functions as an
15 inspector.
Division 3 -- Monitoring powers
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 --
20 (a) enter any premises; and
(b) exercise the monitoring powers set out in section 153.
(2) An inspector is not authorised to enter premises under
subsection (1) unless --
(a) the occupier of the premises has consented to the entry;
25 (b) the entry is made under a warrant under section 172; or
(c) the occupier of the premises is a licence holder, or a
person covered by a licence, and the entry is at a
reasonable time.
page 78
Gene Technology Bill 2001
Powers of inspection Part 11
Monitoring powers Division 3
s. 153
153. Monitoring powers
(1) The monitoring powers that an inspector may exercise under
section 152(1)(b) are as follows --
(a) to search the premises and any thing on the premises;
5 (b) to inspect, examine, take measurements of, conduct tests
on, or take samples of, any thing on the premises that
relates to a GMO;
(c) to take photographs, make video or audio recordings or
make sketches of the premises or any thing on the
10 premises;
(d) if the inspector was authorised to enter the premises by a
warrant under section 172 -- to require any person in or
on the premises to --
(i) answer any questions put by the inspector; and
15 (ii) produce any book, record or document requested
by the inspector;
(e) to inspect any book, record or document on the
premises;
(f) to take extracts from or make copies of any such book,
20 record or document;
(g) to take onto the premises such equipment and materials
as the inspector requires for the purpose of exercising
powers in relation to the premises;
(h) to secure a thing, until a warrant is obtained to seize it,
25 being a thing --
(i) that the inspector finds during the exercise of
monitoring powers on the premises;
(ii) that the inspector believes on reasonable grounds
is evidential material; and
30 (iii) that the inspector believes on reasonable grounds
would be lost, destroyed or tampered with before
the warrant can be obtained.
page 79
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 4 Offence-related powers
s. 154
(2) For the purposes of this Part "monitoring powers" include the
power to operate equipment at premises to see whether --
(a) the equipment; or
(b) a disk, tape or other storage device that --
5 (i) is at the premises; and
(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.
10 (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, contains information mentioned in subsection (2),
the inspector may --
(a) operate facilities at the premises to put the information
15 in documentary form and copy 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
20 (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,
operate the equipment or other facilities to copy the
information to the storage device, and remove the
25 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 grounds for
suspecting that there may be evidential material on any
30 premises.
page 80
Gene Technology Bill 2001
Powers of inspection Part 11
Offence-related powers Division 4
s. 155
(2) The inspector may --
(a) enter the premises, with the consent of the occupier or
under a warrant issued under section 173;
(b) exercise the powers set out in subsection (3) and
5 section 155; and
(c) if the entry is under a warrant -- seize the evidential
material, if the inspector finds it on the premises.
(3) If --
(a) in the course of searching, in accordance with a warrant,
10 for a particular thing, an inspector finds another thing
that the inspector believes on reasonable grounds to 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
15 concealment, loss or destruction, or its use in
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.
20 155. Offence-related powers of inspectors in relation to 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;
25 (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 or the evidential material;
(d) to take onto the premises such equipment and materials
30 as the inspector requires for the purpose of exercising
powers in relation to the premises.
page 81
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 4 Offence-related powers
s. 156
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
5 the 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 doing so, the inspector
may --
10 (a) seize the equipment and any disk, tape or other
associated device;
(b) if the material can, by using facilities at the premises, be
put in documentary form -- operate the facilities to put
the material in that form and seize the documents so
15 produced; or
(c) if the material can be transferred to a disk, tape or other
storage device that --
(i) is brought to the premises; or
(ii) is at the premises and the use of which for the
20 purpose has been agreed to in writing by the
occupier of the premises,
operate the equipment or other facilities to copy the material to
the storage device and take the storage device from the
premises.
25 (3) An inspector may seize equipment under subsection (2)(a) only
if --
(a) it is not practicable to put the material in documentary
form as mentioned in subsection (2)(b) or to copy the
material as mentioned in subsection (2)(c); or
30 (b) possession by the occupier of the equipment could
constitute an offence.
page 82
Gene Technology Bill 2001
Powers of inspection Part 11
Expert assistance Division 5
s. 157
(4) An inspector may seize equipment under subsection (2)(a) or
documents under subsection (2)(b) only if the inspector entered
the premises under a warrant.
Division 5 -- Expert assistance
5 157. Expert assistance to operate a thing
(1) If an inspector believes on reasonable grounds that --
(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
10 thing at particular premises;
(b) expert assistance is required to operate the thing; and
(c) if the inspector does not take action under this
subsection, the information or material may be
destroyed, altered or otherwise interfered with,
15 the inspector 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 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.
20 (3) The thing may be secured --
(a) for a period not exceeding 24 hours; or
(b) until the equipment has been operated by the expert,
whichever happens first.
(4) If the inspector believes on reasonable grounds that the expert
25 assistance will not be available within 24 hours, the inspector
may apply to a magistrate for an extension of that period.
(5) The inspector must give notice to the occupier of the premises
of the inspector's intention to apply for an extension, and the
occupier is entitled to be heard in relation to the application.
page 83
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 6 Emergency powers
s. 158
Division 6 -- Emergency powers
158. Powers available to inspectors for dealing with dangerous
situations
(1) This section applies if --
5 (a) an inspector has reasonable grounds for suspecting that
there may be on any premises a particular thing in
respect of which this Act or the regulations has not been
complied with; and
(b) the inspector considers that it is necessary to exercise
10 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 --
(a) enter the premises;
15 (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;
(d) if the inspector has reasonable grounds for suspecting
that a person has not complied with this Act or the
20 regulations in respect of the thing -- require the person
to take such steps that the inspector considers necessary
for the person to comply with this Act or the regulations;
(e) take such steps, or arrange for such steps to be taken, in
relation to the thing as the inspector considers
25 appropriate.
(3) The inspector may exercise the powers in subsection (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.
30 (4) If the Regulator incurs costs because of steps reasonably taken
or arranged to be taken by an inspector under subsection (2)(e),
page 84
Gene Technology Bill 2001
Powers of inspection Part 11
Obligations and incidental powers of inspectors Division 7
s. 159
the person is liable to pay to the State of Western Australia an
amount equal to the cost, and the amount may be recovered by
the State as a debt due to the State in a court of competent
jurisdiction.
5 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 --
(a) the occupier of the premises has required the inspector
10 to produce his or her identity card for inspection by the
occupier; and
(b) the inspector fails to comply with the requirement.
160. Consent
(1) Before obtaining the consent of a person for the purposes of
15 section 152(2)(a) or 154(2)(a), the inspector must inform the
person that the person may refuse consent.
(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.
20 (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
must make available to that person a copy of the warrant.
(2) The inspector must identify himself or herself to that person.
25 (3) The copy of the warrant referred to in subsection (1) need not
include the signature of the magistrate who issued the warrant.
page 85
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 7 Obligations and incidental powers of inspectors
s. 162
162. Announcement before entry
(1) An inspector must, before entering premises under a warrant --
(a) announce that the inspector is authorised to enter the
premises; and
5 (b) give any person at the premises an opportunity to allow
entry to the premises.
(2) An inspector is not required to comply with subsection (1) if the
inspector believes on reasonable grounds that immediate entry
to the premises is required --
10 (a) to ensure the safety of a person;
(b) to prevent serious damage to the environment; or
(c) to ensure that the effective execution of the warrant is
not frustrated.
163. Compensation for damage
15 (1) The owner of a thing is entitled to compensation 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
(b) the damage was caused as a result of --
20 (i) insufficient care being exercised in selecting the
person who was to operate the thing; or
(ii) insufficient care being exercised by the person
operating the thing.
(2) Compensation is payable by the Regulator.
25 (3) In determining the amount of compensation payable, regard is
to be had to whether the 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.
30 Note: Section 163(2) of the Commonwealth Act provides for compensation to
be payable out of money appropriated by Parliament.
page 86
Gene Technology Bill 2001
Powers of inspection Part 11
Power to search goods, baggage etc. Division 8
s. 164
Division 8 -- Power to search goods, baggage etc.
164. Power to search goods, baggage etc.
(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,
5 between a place outside Western Australia and a place in
Western Australia.
(2) If an inspector believes, on reasonable grounds, that goods are
goods to which this section applies, and that the goods may be,
or may contain, evidential material, the inspector may --
10 (a) examine the goods;
(b) if the goods are baggage -- open and search the
baggage; or
(c) if the goods are in a container -- open and search the
container.
15 (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 in respect of the goods.
(4) A person must not refuse or fail to answer a question put to a
20 person under subsection (3).
Penalty: $3 300.
Note: This section differs from section 164 of the Commonwealth Act.
165. Seizure of goods
An inspector may seize goods mentioned in section 164 if the
25 inspector has reasonable grounds to suspect that the goods are
evidential material.
page 87
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 9 General provisions relating to search and seizure
s. 166
Division 9 -- General provisions relating to search and seizure
166. Copies of seized things to be provided
(1) Subject to subsection (2), if an inspector seizes, under a warrant
relating to premises --
5 (a) a document, film, computer file or other thing that can
be readily copied; or
(b) a storage device, the information on which can be
readily copied,
the inspector must, if requested to do so by the occupier of the
10 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 soon as
practicable after the seizure.
(2) Subsection (1) does not apply if --
15 (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 could constitute an
offence.
20 167. 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 occupier is present at the premises, the person is
entitled to observe the search being conducted.
25 (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 the premises
being searched at the same time.
page 88
Gene Technology Bill 2001
Powers of inspection Part 11
General provisions relating to search and seizure Division 9
s. 168
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 covered in the one
5 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 --
(a) the reason for its seizure no longer exists or it is decided
10 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 or forfeitable
to the State of Western Australia.
(2) At the end of the 60 days specified in subsection (1), an
15 inspector must take reasonable steps to 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 the end of the 60 days
and have not been completed (including an appeal to a
20 court in relation to those proceedings);
(b) an inspector may retain the thing because of an order
under section 170;
(c) to return the thing could cause an imminent risk of
death, serious illness, serious injury or serious damage
25 to the environment; or
(d) an inspector is otherwise authorised (by a law, or an
order of a court, of the State of Western Australia or the
Commonwealth) to retain, destroy or dispose of the
thing.
page 89
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 9 General provisions relating to search and seizure
s. 170
(3) The thing may be returned under subsection (2) either
unconditionally or on such terms and conditions as the
Regulator sees fit.
170. Magistrate may permit a thing to be retained
5 (1) An inspector may apply to a magistrate for an order that the
inspector may retain the thing for a further period if --
(a) before the end of 60 days after the seizure; or
(b) before the end of a period previously specified in an
order by a magistrate under this section,
10 proceedings in respect of which the thing may afford evidence
have not commenced.
(2) If the magistrate is satisfied that it is necessary for an inspector
to continue to retain the thing --
(a) for the purposes of an investigation as to whether an
15 offence against this Act or the regulations has been
committed; or
(b) to enable evidence of an offence against this Act or the
regulations to be secured for the purposes of a
prosecution,
20 the magistrate may order that an inspector may retain the thing
for a period (not being a period exceeding 3 years) specified in
the order.
(3) Before making the application, the inspector must --
(a) take reasonable steps to discover who has an interest in
25 the retention of the thing; and
(b) if it is practicable to do so, notify each 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.
page 90
Gene Technology Bill 2001
Powers of inspection Part 11
Warrants Division 10
s. 171
171. Disposal of goods if there is no owner or owner cannot be
located
If --
(a) a thing is seized under this Part;
5 (b) apart from this section, the State of Western Australia is
required to return the thing to the owner; 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 manner as the
10 Regulator thinks appropriate.
Division 10 -- Warrants
172. Monitoring warrants
(1) An inspector may apply to a magistrate for a warrant under this
section in relation to premises.
15 (2) Subject to subsection (3), the magistrate may issue the warrant
if the magistrate is satisfied, by 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.
20 (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 issue of the
warrant is being sought.
25 (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 and reasonable --
(i) to enter the premises; and
page 91
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 10 Warrants
s. 173
(ii) to exercise the powers set out in section 153 in
relation to the premises;
(b) state whether the entry is authorised to be made at any
time of the day or night or during specified hours of the
5 day or night;
(c) specify the day (not more than 6 months 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.
10 173. Offence-related warrants
(1) An inspector may apply to a magistrate for a warrant under this
section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant
if the magistrate is satisfied, by evidence on oath, that there are
15 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 the inspector
or some other person has given to the magistrate, either orally or
20 by affidavit, such further information (if any) as the magistrate
requires concerning the grounds on which the issue of the
warrant is being sought.
(4) The warrant must --
(a) name one or more inspectors;
25 (b) authorise the inspectors so named, with such assistance
and by such force as is necessary and reasonable --
(i) to enter the premises;
(ii) to exercise the powers set out in sections 154(3)
and 155; and
30 (iii) to seize the evidential material;
page 92
Gene Technology Bill 2001
Powers of inspection Part 11
Warrants Division 10
s. 174
(c) 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;
(d) specify the day (not more than one week after the issue
5 of the warrant) on which the warrant ceases to have
effect; and
(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 necessary to do
10 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 voice to the
extent that it is practicable in the circumstances.
15 (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 warrant is sought.
(4) If it is necessary to do so, the inspector may apply for the
warrant before the affidavit is sworn.
20 (5) If the magistrate is satisfied --
(a) after having considered the terms of the 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.
page 93
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 10 Warrants
s. 174
(6) If the magistrate completes and signs the warrant --
(a) the magistrate must --
(i) tell the inspector what the terms of the warrant
are;
5 (ii) tell the inspector the day on which and the time
at which the warrant was signed;
(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
10 effect; and
(iv) record on the warrant the reasons for issuing the
warrant;
and
(b) the inspector must --
15 (i) complete a form of warrant in the same 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
20 warrant was 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 inspector; and
25 (b) the affidavit referred to in subsection (3) which must
have been duly sworn.
(8) When the magistrate receives those documents, the magistrate
must --
(a) attach them to the warrant that the magistrate completed
30 and signed; and
page 94
Gene Technology Bill 2001
Powers of inspection Part 11
Warrants Division 10
s. 175
(b) deal with them in the way in which the magistrate would
have dealt with the affidavit if the application had been
made under section 173.
(9) A form of warrant duly completed under subsection (6) is
5 authority for any entry, search, 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 was authorised by
10 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 proved, that the
exercise of the power was not authorised by such a warrant.
15 (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.
175. Offences relating to warrants
(1) An inspector must not make, in an application for a warrant, a
20 statement that the inspector knows to be false or misleading in a
material particular.
Penalty: Imprisonment for 2 years or $13 200.
(2) An inspector must not --
(a) state in a document that purports to be a form of warrant
25 under section 174 the name of a magistrate unless that
magistrate issued the warrant;
(b) state on a form of warrant under that section a matter
that, to the inspector's knowledge departs in a material
particular from the form authorised by the magistrate;
page 95
Gene Technology Bill 2001
Part 11 Powers of inspection
Division 11 Other matters
s. 176
(c) purport to execute, or present to another person, a
document that purports to be a form of warrant under
that section that the inspector knows --
(i) has not been approved by a magistrate under that
5 section; or
(ii) departs in a material particular from the terms
authorised by a magistrate under that section;
or
(d) give to a magistrate a form of warrant under that section
10 that is not the form of warrant that the inspector
purported to execute.
Penalty: Imprisonment for 2 years or $13 200.
Division 11 -- Other matters
176. Part not to abrogate privilege against self-incrimination
15 Nothing in this Part affects the right of a person to 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 the
person or make the person liable to a penalty.
20 177. 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.
page 96
Gene Technology Bill 2001
Miscellaneous Part 12
Simplified outline Division 1
s. 178
Part 12 -- Miscellaneous
Division 1 -- Simplified outline
178. Simplified outline
In outline this Part provides for miscellaneous matters,
5 including the following --
· review of decisions;
· provisions relating to confidential commercial
information;
· the making of regulations;
10 · transitional provisions;
· 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
Item Decision Provision Eligible person
under which in relation to
decision made decision
1 To refuse to issue a licence section 55 the applicant for
the licence
2 To impose a licence condition section 55 the licence holder
3 To suspend or cancel a licence section 68 the licence holder
4 To vary a licence section 71 the licence holder
5 To refuse to certify a facility section 84 the applicant for
certification
page 97
Gene Technology Bill 2001
Part 12 Miscellaneous
Division 2 Review of decisions
s. 180
Item Decision Provision Eligible person
under which in relation to
decision made decision
6 To specify a condition of section 86 the holder of the
certification certification
7 To vary a certification section 87 the holder of the
certification
8 To suspend or cancel a section 88 the holder of the
certification certification
9 To refuse to accredit an section 92 the applicant for
organisation accreditation
10 To specify a condition of an section 94 the holder of the
accreditation accreditation
11 To vary an accreditation section 95 the holder of the
accreditation
12 To suspend or cancel an section 96 the holder of the
accreditation accreditation
13 To refuse to declare section 185 the person who
information to be confidential made an
commercial information application under
section 184 in
relation to the
information
14 To revoke a declaration that section 186 the person who
information is confidential made an
commercial information application under
section 184 in
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 relation to the decision, containing --
5 (a) the terms of the decision;
(b) the reasons for the decision; and
page 98
Gene Technology Bill 2001
Miscellaneous Part 12
Review of decisions Division 2
s. 181
(c) a statement setting out particulars of the person's review
rights.
(2) A failure to comply with the requirements of subsection (1) in
relation to a decision does not affect the validity of the decision.
5 181. Internal review
(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
decision.
10 (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 or after the end of that period, allows.
(3) The Regulator must, on receiving an application, review the
15 reviewable decision personally.
(4) The Regulator may --
(a) make a decision affirming, varying or revoking the
reviewable decision; and
(b) if the Regulator revokes the decision, make such other
20 decision as the Regulator thinks appropriate.
182. Deadlines for making reviewable decisions
If --
(a) this Act provides for a person to apply to the Regulator
to make a reviewable decision;
25 (b) the period is specified under this Act or the 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,
the Regulator is taken, for the purposes of this Act, to have
30 made a decision to reject the application.
page 99
Gene Technology Bill 2001
Part 12 Miscellaneous
Division 3 Confidential commercial information
s. 183
183. Review of decisions by Administrative Appeals Tribunal
(1) Subject to the Administrative Appeals Tribunal Act 1975 of the
Commonwealth, an application may be made by an eligible
person in relation to --
5 (a) a reviewable decision made by the Regulator personally;
or
(b) a decision made by the Regulator under section 181
(which provides for internal review).
(2) In this section --
10 "decision" has the same meaning as in the Administrative
Appeals Tribunal Act 1975 of the Commonwealth.
183A. Extended standing for judicial review
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
15 Administrative Decisions (Judicial Review) Act 1977 of the 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
20 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.
(2) An application under subsection (1) must be in writing in the
25 form approved by the Regulator.
185. Regulator may declare that information is confidential
commercial information
(1) Subject to subsection (2), if the person satisfies the Regulator
that the information specified in the application is --
30 (a) a trade secret;
page 100
Gene Technology Bill 2001
Miscellaneous Part 12
Confidential commercial information Division 3
s. 185
(b) any other information that has a commercial or other
value that would be, or could reasonably be expected to
be, destroyed or diminished if the information were
disclosed; or
5 (c) other information that --
(i) concerns the lawful commercial or financial
affairs of a person, organisation or undertaking;
and
(ii) if it were disclosed, could unreasonably affect
10 the person, organisation or undertaking,
the Regulator must declare that the information is
confidential commercial information for the purposes of
this Act.
(2) The Regulator may refuse to declare that the information is
15 confidential commercial information if the Regulator is satisfied
that the 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 information if the information relates
20 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 environment or property would be likely to occur if
the locations were disclosed.
25 Note: This means that, in general, information about sites where dealings with
GMOs are occurring will be 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
30 Regulator's decision about the application.
(3A) If --
(a) the Regulator declares that particular information is
confidential commercial information; and
page 101
Gene Technology Bill 2001
Part 12 Miscellaneous
Division 3 Confidential commercial information
s. 186
(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 statement of
5 reasons for the making of the declaration, including, but not
limited to --
(c) the reasons why the Regulator was satisfied as
mentioned in subsection (1);
(d) the reasons why the Regulator was not satisfied under
10 subsection (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 under
subsection (2A) that significant damage to the health
15 and safety of people, the environment or property would
be likely to occur if the locations were disclosed.
(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
20 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 if the Regulator is
25 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 disclosure would cause to
30 any person.
page 102
Gene Technology Bill 2001
Miscellaneous Part 12
Confidential commercial information Division 3
s. 187
(2) A revocation by the Regulator under subsection (1) does not
take effect until any review rights under section 181 or 183 in
relation to the revocation are exhausted.
187. Confidential commercial information must not be disclosed
5 (1) A person who --
(a) has confidential commercial information;
(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
10 the meaning of the Commonwealth Act; and
(c) knows that the information is confidential commercial
information,
must not disclose the information except --
(d) to any of the following in the course of carrying out
15 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 --
(i) a State agency;
(ii) the Commonwealth or a Commonwealth
20 authority;
(iii) the Gene Technology Technical Advisory
Committee;
(e) by order of a court; or
(f) with the consent of the person who applied to have the
25 information treated as confidential commercial
information.
Penalty: Imprisonment for 2 years or $13 200.
(2) A person who --
(a) has confidential commercial information;
page 103
Gene Technology Bill 2001
Part 12 Miscellaneous
Division 3 Confidential commercial information
s. 187
(b) has it because of a disclosure under subsection (1) or
this subsection; and
(c) knows that the information is confidential commercial
information,
5 must not disclose the information except --
(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 Commonwealth Act --
10 (i) a State agency;
(ii) the Commonwealth or a Commonwealth
authority;
(iii) the Gene Technology Technical Advisory
Committee;
15 (e) by order of the 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.
20 Note: See also Schedule 1 item 14(4) of the Freedom of Information
Act 1992.
(3) In this section --
"court" includes a tribunal, authority or person having power to
require the production of documents or the answering of
25 questions;
"disclose", in relation to information, means give or
communicate in any way.
Note: This section differs from section 187 of the Commonwealth Act.
page 104
Gene Technology Bill 2001
Miscellaneous Part 12
Conduct by directors, employees and agents Division 4
s. 188
Division 4 -- Conduct by directors, employees and agents
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 relation to this Act or the
5 regulations, it is necessary to establish the state of mind of a
body corporate in relation to particular conduct, it is sufficient
to show --
(a) that the conduct was engaged in by a director, employee
or agent of the body corporate within the scope of his or
10 her actual or apparent authority; and
(b) that the director, employee or agent had the 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
15 scope of his or her actual or apparent authority is taken, for the
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.
(3) If, in proceedings for an ancillary offence relating to this Act or
25 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 --
(a) that the conduct was engaged in by an employee or
agent of the person within the scope of his or her actual
30 or apparent authority; and
(b) that the employee or agent had the state of mind.
page 105
Gene Technology Bill 2001
Part 12 Miscellaneous
Division 4 Conduct by directors, employees and agents
s. 189
(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 scope of the actual or apparent
authority of the employee or agent is taken, for the purposes of a
5 prosecution for --
(a) an offence against this Act or the regulations; or
(b) an ancillary offence relating to this Act or the
regulations,
to have been engaged in also by the first person unless the first
10 person establishes that he or she took reasonable precautions
and exercised due diligence to avoid the conduct.
(5) If --
(a) a person other than a body corporate is convicted of an
offence; and
15 (b) the person would not have been convicted of the offence
if subsections (3) and (4) had not been enacted,
the person is not liable to be punished by imprisonment for that
offence.
189. Meaning of terms
20 (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, opinion, belief or
25 purpose.
(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 Western Australia, the Commonwealth or another State.
page 106
Gene Technology Bill 2001
Miscellaneous Part 12
Transitional provisions Division 5
s. 190
(3) A reference in section 188 to engaging in conduct includes a
reference to failing or a refusing to engage in conduct.
(4) A reference in section 188 to an ancillary offence relating to this
Act or the regulations is a reference to an offence created by, or
5 that may be dealt with and punished under an ancillary criminal
law within the meaning of section 192E that relates to this Act
or the regulations.
Division 5 -- Transitional provisions
190. Transitional provision -- dealings covered by Genetic
10 Manipulation Advisory Committee advice to proceed
(1) The prohibitions in this Act apply to a dealing with a GMO by a
person at a particular time during the transition period ("the
dealing time") with the modifications set out in subsection (2)
if --
15 (a) immediately before the commencement of Part 4 of this
Act, an advice to proceed was in force in relation to the
dealing with the GMO by the person;
(b) the advice to proceed is in force at the dealing time; and
(c) the dealing is in accordance with the advice to proceed.
20 (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 purposes of this
Act to be a GMO licence;
(b) the holder of the advice to proceed is taken to be the
25 licence holder;
(c) the licence is taken to be subject to any 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 --
30 (i) the time when the advice to proceed expires;
page 107
Gene Technology Bill 2001
Part 12 Miscellaneous
Division 6 Other
s. 191
(ii) the end of the transition period;
(iii) when the licence is cancelled under section 68 or
surrendered under section 69.
(3) In this section --
5 "advice to proceed" means an advice to proceed issued by the
Genetic Manipulation Advisory Committee, in accordance
with Guidelines issued by that Committee;
"transition period" means the period, not exceeding 2 years,
prescribed for the purposes of this section.
10 Note: Section 190(3) of the Commonwealth Act defines the "transition period"
as being 2 years from the commencement of Part 4 of that Act.
191. Regulations may relate to transitional matters
Regulations may be made in relation to transitional matters
arising from the enactment of this Act.
15 Division 6 -- Other
192. False or misleading information or document
A person must not --
(a) in connection with an application made to the Regulator
under this Act or the regulations; or
20 (b) in compliance or purported compliance with this Act or
the regulations,
do either of the following --
(c) give information (whether orally or in writing) that the
person knows to be false or misleading in a material
25 particular;
(d) produce a document that the person knows to be false or
misleading in a material particular without --
(i) indicating to the person to whom the document is
produced that it is false or misleading, and the
30 respect in which it is false or misleading; and
page 108
Gene Technology Bill 2001
Miscellaneous Part 12
Other Division 6
s. 192A
(ii) providing correct information to that person, if
the person producing the document is in
possession of, or can reasonably acquire, the
correct information.
5 Penalty: Imprisonment for one year or $6 600.
192A. Interference with dealings with GMOs
(1) A person is guilty of an offence if --
(a) the person engages in conduct; and
(b) the conduct --
10 (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 interfering
with, a thing at, or removing a thing from, such
15 premises;
(c) the owner or occupier of the premises, or the owner of
the thing (as the case requires), has not consented to the
conduct;
(d) in engaging in the conduct, the person intends to prevent
20 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 matters
mentioned in paragraphs (b) and (c).
Penalty: Imprisonment for 2 years or $13 200.
25 (2) In this section --
"authorised GMO dealings", in relation to premises or a
facility, means dealings with GMOs being undertaken at
the premises or facility --
(a) that are authorised to be undertaken at the premises
30 or facility by a GMO licence;
(b) that are notifiable low risk dealings;
page 109
Gene Technology Bill 2001
Part 12 Miscellaneous
Division 6 Other
s. 192B
(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 prohibited
5 Note 1: Section 192B of the Commonwealth Act prohibits the cloning of whole
human beings.
Note 2: Section 7 of the Human Reproductive Technology Act 1991 prohibits
procedures directed at human cloning.
192C. Certain experiments involving animal eggs prohibited
10 Note 1: Section 192C of the Commonwealth Act prohibits experiments or
research involving putting human cells, or a combination of human cells and
animals cells, into animal eggs.
Note 2: Section 7 of the Human Reproductive Technology Act 1991 prohibits
procedures directed at the production of a chimaera etc.
15 192D. Certain experiments involving putting human and animal
cells into a human uterus prohibited
Note 1: Section 192D of the Commonwealth Act prohibits experiments or
research involving putting a combination of human cells, or a combination of
human cells and animal cells, into a human uterus.
20 Note 2: Section 7 of the Human Reproductive Technology Act 1991 prohibits
the placing of animal eggs or embryos in the body of a woman.
192E. Ancillary offences (parties to offences, attempts, incitement
or conspiracy)
(1) In this section --
25 "ancillary criminal laws" means section 4, Chapters II, LVII
and LVIII and section 562 of The Criminal Code.
(2) The ancillary criminal laws apply in relation to an offence
against this Act or the regulations and --
(a) section 555A of The Criminal Code so applies as if the
30 words "under this Code" in subsections (1) and (2) were
deleted; and
page 110
Gene Technology Bill 2001
Miscellaneous Part 12
Other Division 6
s. 193
(b) section 562 of The Criminal Code so applies as if the
following subsection were inserted after
subsection (2) --
"
5 (3) Any person who becomes an accessory after the fact to
a simple offence is guilty of a simple offence and is
liable to the penalty to which a person convicted of the
first-mentioned offence is liable.
".
10 (3) In this Act or the regulations, a reference to an offence against
this Act or those regulations includes a reference to a related
offence under the ancillary criminal laws.
Note: This section is not required in the Commonwealth Act.
193. Regulations: general
15 (1) The Governor may make regulations 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.
(2) Without limiting subsection (1), the regulations may require a
20 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
(1) The Minister must cause an independent review of the operation
25 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 the Minister
a written report of the review.
page 111
Gene Technology Bill 2001
Part 12 Miscellaneous
Division 6 Other
s. 194
(3) The Minister must cause a copy of the report of the review to be
laid before each House of Parliament within 12 months after the
fourth anniversary of the commencement of this Act.
(4) In this section --
5 "independent review" means a review undertaken by persons
who --
(a) in the opinion of the Minister possess appropriate
qualifications to undertake the review; and
(b) include one or more persons who are not employed
10 by the State of Western Australia, a State agency, the
Commonwealth or a Commonwealth authority.
Note: This section differs from section 194 of the Commonwealth Act.
page 112
Gene Technology Bill 2001
Consequential amendments Part 13
s. 195
Part 13 -- Consequential amendments
195. Agriculture and Related Resources Protection Act 1976
amended
After section 106A of the Agriculture and Related Resources
5 Protection Act 1976* the following section is inserted --
"
106B. Regulations -- designated area
Without limiting the generality of section 103 the
Governor may make regulations designating areas of
10 the State for the purposes of section 21(1)(aa) of the
Gene Technology Act 2001 and section 21(1)(aa) of the
Gene Technology Act 2000 of the Commonwealth.
".
[Reprinted as at 15 October 1999.
15 For subsequent amendments see 2000 Index to Legislation of
Western Australia, Table 1, p. 13.]
196. Agricultural and Veterinary Chemicals (Western Australia)
Act 1995 amended
After section 23 of the Agricultural and Veterinary Chemicals
20 (Western Australia) Act 1995* the following section is
inserted --
"
23A. Consultation with Gene Technology Regulator
(1) A duty imposed or a function or power conferred on
25 the NRA under section 8A of the Agricultural and
Veterinary Chemicals (Administration) Act in respect
of any matter arising in relation to the Code set out in
the Schedule to the Agricultural and Veterinary
Chemicals Code Act extends to any corresponding
30 matter arising in relation to the applicable provisions of
this jurisdiction, and this section applies accordingly.
page 113
Gene Technology Bill 2001
Part 13 Consequential amendments
s. 196
(2) If the NRA gives the Regulator within the 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
5 by force of subsection (1) of this section), 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.
10 (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 reference in that provision as applying by
force of subsection (1) of this section.
15 ".
[Act No. 3 of 1995.
For subsequent amendments see 2000 Index to Legislation of
Western Australia, Table 1, p. 9.]
page 114
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