Western Australia: Gene Technology Act 2006 (WA)

Western Australia Gene Technology Act 2006 Western Australia Gene Technology Act 2006 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 11 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 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 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 Application may be withdrawn 27 42.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. 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 40 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 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 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 62 108. Membership 62 109. Remuneration 62 110. Regulations 62 110A. Subcommittees 62 Division 4 — The Gene Technology Ethics Committee 111. The Gene Technology Ethics Committee 63 112. Function of the Gene Technology Ethics Committee 63 113. Expert advisers 63 114. Remuneration 63 115. Members and procedures 63 116. Subcommittees 64 Part 9 — Administration Division 1 — Simplified outline 117. Simplified outline 65 Division 2 — Appointment and conditions of Regulator 118. Appointment of the Regulator 65 119. Termination of appointment 65 120. Disclosure of interests 65 121. Acting appointment 66 122. Terms and conditions 66 123. Outside employment 66 124. Remuneration 66 125. Leave of absence 66 126. Resignation 66 Division 3 — Money 127. Regulator may charge for services 66 128. Notional payments by the State 67 129. Gene Technology Account 67 130. Credits to Gene Technology Account 67 131. Recovery of amounts 68 132. Purposes of Account 68 Division 4 — Staffing 133. Staff assisting the Regulator 68 134. Consultants 68 135. Seconded officers 69 Division 5 — Reporting requirements 136. Annual report 69 136A. Quarterly reports 69 137. Reports to Parliament 70 Division 6 — Record of GMO and GM product dealings 138. Record of GMO and GM product dealings 70 139. Inspection of Record 71 Division 7 — Reviews of notifiable low risk dealings and exemptions 140. Regulator may review notifiable low risk dealings 71 141. Regulator may review exemptions 72 142. Regulator may give notice of consideration 72 143. What Regulator may do after consideration 73 144. Regulator not required to review matters 73 Part 10 — Enforcement 145. Simplified outline 74 146. Regulator may give directions 74 147. Injunctions 76 148. Forfeiture 77 Part 11 — Powers of inspection Division 1 — Simplified outline 149. Simplified outline 78 Division 2 — Appointment of inspectors and identity cards 150. Appointment of inspectors 78 151. Identity card 79 Division 3 — Monitoring powers 152. Powers available to inspectors for monitoring compliance 79 153. Monitoring powers 80 Division 4 — Offence‑related powers 154. Searches and seizures related to offences 81 155. Offence‑related powers of inspectors in relation to premises 82 156. Use of equipment at premises 83 Division 5 — Expert assistance 157. Expert assistance to operate a thing 84 Division 6 — Emergency powers 158. Powers available to inspectors for dealing with dangerous situations 85 Division 7 — Obligations and incidental powers of inspectors 159. Inspector must produce identity card on request 86 160. Consent 86 161. Details of warrant to be given to occupier etc. 86 162. Announcement before entry 87 163. Compensation for damage 87 Division 8 — Power to search goods, baggage etc. 164. Power to search goods, baggage etc. 88 165. Seizure of goods 88 Division 9 — General provisions relating to search and seizure 166. Copies of seized things to be provided 89 167. Occupier entitled to be present during search 89 168. Receipts for things seized 90 169. Retention of seized things 90 170. Magistrate may permit a thing to be retained 91 171. Disposal of goods if there is no owner or owner cannot be located 92 Division 10 — Warrants 172. Monitoring warrants 92 173. Offence‑related warrants 93 174. Offence‑related warrants by telephone, telex, fax etc. 94 175. Offences relating to warrants 96 Division 11 — Other matters 176. Part not to abrogate privilege against self‑incrimination 97 177. Part does not limit power to impose licence conditions 97 Part 12 — Miscellaneous Division 1 — Simplified outline 178. Simplified outline 98 Division 2 — Review of decisions 179. Meaning of terms 98 180. Notification of decisions and review rights 99 181. Internal review 100 182. Deadlines for making reviewable decisions 100 183. Review of decisions by Administrative Appeals Tribunal 101 183A. Extended standing for judicial review 101 Division 3 — Confidential commercial information 184. Application for protection of confidential commercial information 101 185. Regulator may declare that information is confidential commercial information 101 186. Revocation of declaration 103 187. Confidential commercial information must not be disclosed 104 Division 4 — Conduct by directors, employees and agents 188. Conduct by directors, employees and agents 106 189. Meaning of terms 107 Division 5 — Transitional provisions 190. Transitional provision — dealings covered by Genetic Manipulation Advisory Committee advice to proceed 108 191. Regulations may relate to transitional matters 109 Division 6 — Other 192. False or misleading information or document 109 192A. Interference with dealings with GMOs 110 192B. Ancillary offences (parties to offences, attempts, incitement or conspiracy) 111 193. Regulations: general 111 194. Review of operation of Act 112 Part 13 — Consequential amendments 195. Agricultural and Veterinary Chemicals (Western Australia) Act 1995 amended 113 23A. Consultation with Gene Technology Regulator 113 Notes Compilation table 115 Defined terms Western Australia Gene Technology Act 2006 An Act to regulate activities involving gene technology and for other purposes. The Parliament of Western Australia enacts as follows: Part 1 — Preliminary 1. Purpose and short title (1) This is the Gene Technology Act 2006. (2) The purpose of this Act is to regulate activities involving gene 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. Note for this section: 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. Note for this section: 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 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 — (aa) provides that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost‑effective measures to prevent environmental degradation; (a) provides an efficient and effective system for the application of gene technologies; and (b) operates in conjunction with other Commonwealth and State regulatory schemes relevant to GMOs and GMO products. Note for this section: Examples of the schemes mentioned in paragraph (b) are those that regulate food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods. 5. Nationally consistent scheme It is the intention of the Parliament that this Act form a component of a nationally consistent scheme for the regulation of certain dealings with 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 in all its other capacities. (2) Nothing in this Act renders the Crown liable to be prosecuted for an offence. 7. External Territories Note for this section: The Commonwealth Act includes a provision extending that Act to every external Territory other than Norfolk Island. 8. Offences Note for this section: The Commonwealth Act includes a provision applying Chapter 2 of The Criminal Code to offences against that Act and construing penalty provisions in that Act. 8A. 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 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 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. Notes for this section: 1. A note appears under each heading of a kind referred to in subsection (1)(a) describing the omitted section of the Commonwealth Act. 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. 3. This section does not appear in the Commonwealth Act. 8B. Notes Notes do not form part of this Act. Note for this section: This section does not appear in the Commonwealth Act. 8C. Outlines 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 for this section: This section does not appear in the Commonwealth Act. Part 2 — Interpretation and operation of Act Division 1 — Simplified outline 9. Simplified outline In outline this Part — * contains the definitions used in this Act; * contains provisions to facilitate a nationally consistent regulatory scheme; * enables the Ministerial Council to issue policy principles, policy guidelines and codes of practice. Note for this section: 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 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; 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 (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; (ii) a body covered by paragraph (a); (iii) a body covered by either of the above subparagraphs; Commonwealth Environment Minister means the Minister 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; 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, 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; (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; (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); eligible person, in relation to a reviewable decision, has the meaning given by section 179; environment includes — (a) ecosystems and their constituent parts; (b) natural and physical resources; and (c) the qualities and characteristics of locations, places 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 — (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 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; 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; (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 — (a) sexual reproduction; (b) homologous recombination; or (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 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; 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 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 (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 — (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 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; 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; Institutional Biosafety Committee means a committee established by an accredited organisation as an Institutional Biosafety Committee; jurisdiction means the following — (a) a State; or (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 section 74; officer, in relation to the Commonwealth, includes the following — (a) a Minister of the Crown in right of the Commonwealth; (b) a person who holds — (i) an office established by or under a Commonwealth Act; (ii) an appointment made under a Commonwealth Act; or (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 Commonwealth authority; (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 — (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; premises includes the following — (a) a building; (b) a place (including an area of land); (c) a vehicle; (d) a vessel; (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 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; 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 Australia; (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 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 — (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; 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 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 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 Note for this section: The Commonwealth Act includes a provision defining "corresponding State law" for the purposes of that Act. 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 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 — (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. Note for this section: This section is not required in the Commonwealth Act. Division 3 — Operation of Act 13. Operation of Act Note for this section: The Commonwealth Act includes a provision about the application of that Act. 14. Wind‑back of reach of Act Note for this section: The Commonwealth Act includes a provision about the giving of wind‑back notices by a State. 15. Relationship to other State laws The provisions of this Act are in addition to, and not in substitution for, the requirements of any other law of Western Australia (whether passed or made before or after the commencement of this section). Note for this section: The equivalent section in the Commonwealth Act deals with the relationship of that Act to other Commonwealth laws. Division 4 — Provisions to facilitate a nationally consistent scheme Subdivision A — General provisions 16. State laws may operate concurrently Note for this section: 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 Note for this section: 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 — (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 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 (1) Application may be made to the Administrative Appeals Tribunal for review of a reviewable decision. (2) A decision made by the Regulator in the performance of a function or the exercise of a power conferred by this Act is a reviewable decision for the purposes of this section if — (a) this Act provides for review by the Administrative Appeals Tribunal; and (b) the decision is declared by the regulations made under the Commonwealth Act to be a reviewable State decision for the purposes of section 19 of the Commonwealth Act. (3) The Administrative Appeals Tribunal Act 1975 of 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 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. Note for this section: 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 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 to the following — (a) ethical issues relating to dealings with GMOs; (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; (ii) non‑GM crops, for marketing purposes; (b) matters relating to dealings with GMOs prescribed by the regulations for the purposes of this paragraph. Notes for this subsection: 1. Section 57 provides that the Regulator must not issue a licence if to do so would be inconsistent with a policy principle. 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 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. Note for this section: This section differs from section 21 of the Commonwealth Act. 22. Consultation on policy principles Note for this section: The Commonwealth Act includes a provision about how policy principles are to be developed. 23. Ministerial Council may issue policy guidelines The Ministerial Council may issue policy guidelines in relation to matters relevant to the functions of the Regulator under this Act or the regulations. Notes for this section: 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 Regulator is not subject to direction in relation to individual decisions. 2. Section 43 of the Interpretation Act 1984 confers power to revoke or amend any subsidiary legislation. 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. Notes for this section: 1. Section 43 of the Interpretation Act 1984 confers power to revoke or amend any subsidiary legislation. 2. Section 24 of the Commonwealth Act includes provisions about how codes of practice are to be developed and making them disallowable instruments. 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. Note for this section: This section differs from section 25 of the Commonwealth Act. 26. The Gene Technology Regulator Note for this section: Section 26 of the Commonwealth Act creates the office of Gene Technology Regulator. 27. Functions of the Regulator The Regulator has the following functions — (a) to perform functions in relation to GMO licences as set out in Part 5; (b) to develop draft policy principles and policy guidelines, as requested by the Ministerial Council; (c) to develop codes of practice; (d) to issue technical and procedural guidelines in relation to GMOs; (e) to provide information and advice to other regulatory agencies about GMOs and GM products; (f) to provide information and advice to the 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 (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; (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 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; (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 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 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 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. (2) In exercising powers or performing functions under a delegation, the delegate must comply with any directions of the Regulator. Note for this section: This section differs from section 29 of the Commonwealth Act. 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 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. Part 4 — Regulation of dealings with GMOs Division 1 — Simplified outline 31. Simplified outline In outline this Part — * deals with the regulation of dealings with 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 (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, 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 — (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 notifiable low risk dealing or is reckless as to whether or not the dealing is a notifiable low risk dealing; (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 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. Note for this subsection: 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 (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. (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 — (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 specified class of GMOs. Note for this section: This section differs from section 32 of the Commonwealth Act. 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; (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; (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 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 for this subsection: Section 38 defines "aggravated offence" (4) In this section — exempt dealing has the same meaning as in section 32. Note for this section: 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 — (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. (1a) The offence under subsection (1) is a crime if the offence is an aggravated offence. Note for this subsection: Section 38 defines "aggravated offence" (1b) A person charged with an offence under subsection (1) may be 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; (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. (2a) The offence under subsection (2) is a crime if the offence is an aggravated offence. Note for this subsection: 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 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 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 for this section: This section differs from section 34 of the Commonwealth Act. 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 (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 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 applies — (a) in the case of an aggravated offence — $22 000; or (b) in any other case — $5 500. Notes for this section: 1. Section 38 defines "aggravated offence". 2. This section differs from section 35 of the Commonwealth Act. 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 dealing that is specified in the GMO Register. Penalty: $5 500. Note for this section: This section differs from section 36 of the Commonwealth Act. 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 (c) the dealing by the person was not undertaken in accordance with the regulations. Penalty: $5 500. Notes for this section: 1. "Notifiable low risk dealings" are specified in the regulations — see Part 6. 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 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 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. Part 5 — Licensing system Division 1 — Simplified outline 39. Simplified outline In outline this Part — * 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 — (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 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 (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 any); and (b) such information as is specified in writing by the Regulator. (3) The application must specify whether any of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment. (4) The dealings in respect of which a person may apply for a licence may be — (a) all dealings with a GMO, or with a specified 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 specified class of GMOs. (5) The applicant may apply for a licence authorising such dealings by — (a) a specified person or persons; (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 (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 (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. 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. (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; (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 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 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 application. 45. Regulator must not use certain information in considering licence application If — (a) a person (the first person) applies for a GMO licence; (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, 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 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 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. (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 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. (4) The Regulator may consult — (a) the States; (b) the Gene Technology Technical Advisory Committee; (c) relevant Commonwealth authorities or agencies; (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 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 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 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 (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 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; (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; (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; (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 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 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 (d) specify the closing date for submissions, which must not be earlier than 30 days after the date on which the notice was published. 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 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 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 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 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 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; (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 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); (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. (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 (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 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 provided by a Commonwealth authority or agency in response to a request under section 50(3); (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 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 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 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 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 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 assessment and the risk management plan; and (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 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; (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 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, 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 documents produced, at a public hearing. (4) A person must not contravene a direction given under subsection (3). Penalty: $3 300. 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; (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 — (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. Note for this section: 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 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 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 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. (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 in relation to those dealings — the risk assessment; (b) if a risk management plan has been prepared under 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 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 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 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. 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 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 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 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 — (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 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 law of Western Australia, the Commonwealth, another State or a foreign country, relating to the health and safety of people or the environment; and (d) the capacity of the body corporate to meet the conditions of the licence. (3) In this section — relevant conviction means a conviction for an offence 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 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. (4) Nothing in this section affects the operation of the Spent Convictions Act 1988. Note for this section: This section differs from section 58 of the Commonwealth Act. 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 (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. 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; (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 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. (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; (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; (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 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 issued under section 27; (m) supervision by, and monitoring by, Institutional Biosafety Committees; (n) contingency planning in respect of unintended effects of the dealings authorised by the licence; (o) limiting the dissemination or persistence of 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 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 — (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 — (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. (4) If such requirements are prescribed or specified, it is a condition of a licence that the licence holder comply with the requirements. 64. Condition about monitoring and audits (1) It is a condition of a licence that if — (a) a person is authorised by the licence to deal with a GMO; and (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. (2) Subsection (1) does not limit the conditions that may be imposed by the Regulator or prescribed by the regulations. 65. Condition about