Commonwealth: Gene Technology Act 2000 (Cth)

Gene Technology Act 2000 No. 169, 2000 Compilation No. 14 Compilation date: 14 October 2024 Includes amendments: Act No. 39, 2024 About this compilation This compilation This is a compilation of the Gene Technology Act 2000 that shows the text of the law as amended and in force on 14 October 2024 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Editorial changes For more information about any editorial changes made in this compilation, see the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents Part 1—Preliminary 1 Short title 2 Commencement 3 Object of Act 4 Regulatory framework to achieve object 5 Nationally consistent scheme 6 Act to bind the Crown 7 External Territories 8 Offences Part 2—Interpretation and operation of Act Division 1—Simplified outline 9 Simplified outline Division 2—Definitions 10 Definitions 11 Meaning of intentional release of a GMO into the environment 12 Meaning of corresponding State law Division 3—Operation of Act 13 Operation of Act 14 Wind‑back of reach of Act 15 Relationship to other Commonwealth laws Division 4—Provisions to facilitate a nationally consistent scheme Subdivision A—General provisions 16 State laws may operate concurrently 17 Conferral of functions on Commonwealth officers and bodies 18 No doubling‑up of liabilities 19 Review of certain decisions 20 Things done for multiple purposes Subdivision B—Policy principles, policy guidelines and codes of practice 21 Ministerial Council may issue policy principles 22 Consultation on policy principles 23 Ministerial Council may issue policy guidelines 24 Ministerial Council may issue codes of practice Part 3—The Gene Technology Regulator 25 Simplified outline 26 The Gene Technology Regulator 27 Functions of the Regulator 28 Powers of the Regulator 29 Delegation 30 Independence of the Regulator Part 4—Regulation of dealings with GMOs Division 1—Simplified outline 31 Simplified outline Division 2—Dealings with GMOs must be licensed 32 Person not to deal with a GMO without a licence 33 Person not to deal with a GMO without a licence—strict liability offence 34 Person must not breach conditions of a GMO licence 35 Person must not breach conditions of a GMO licence—strict liability offence 35A Person must not breach conditions of emergency dealing determination 35B Person must not breach conditions of emergency dealing determination—strict liability offence 36 Person must not breach conditions on GMO Register 37 Offence relating to notifiable low risk dealings 38 Aggravated offences—significant damage to health or safety of people or to the environment Part 5—Licensing system Division 1—Simplified outline 39 Simplified outline Division 2—Licence applications 40 Person may apply for a licence 40A Licences relating to inadvertent dealings 41 Application may be withdrawn 42 Regulator may require applicant to give further information 43 Regulator must consider applications except in certain circumstances 44 Regulator may consult with applicant 45 Regulator must not use certain information in considering licence application Division 3—Initial consideration of licences for dealings not involving intentional release of a GMO into the environment 46 Applications to which this Division applies 46A Division does not apply to an application relating to inadvertent dealings 47 What the Regulator must do in relation to application Division 4—Initial consideration of licences for dealings involving intentional release of a GMO into the environment 48 Applications to which this Division applies 49 Division does not apply to an application relating to inadvertent dealings 50 Regulator must prepare risk assessment and risk management plan 50A Limited and controlled release applications 51 Matters Regulator must take into account in preparing risk assessment and risk management plan 52 Public notification of risk assessment and risk management plan 53 Regulator may take other actions 54 Person may request copies of certain documents Division 5—Decision on licence etc. 55 Regulator must make a decision on licence and licence conditions 56 Regulator must not issue the licence unless satisfied as to risk management 57 Other circumstances in which Regulator must not issue the licence 58 Matters to be taken into account in deciding whether a person is suitable to hold a licence 59 Notification of licence decision 60 Period of licence Division 6—Conditions of licences 61 Licence is subject to conditions 62 Conditions that may be prescribed or imposed 63 Condition about informing people of obligations 64 Condition about monitoring and audits 65 Condition about additional information to be given to the Regulator 66 Person may give information to Regulator 67 Protection of persons who give information Division 7—Suspension, cancellation and variation of licences 68 Suspension and cancellation of licence 69 Surrender of licence 70 Transfer of licences 71 Variation of licence 72 Regulator to notify of proposed suspension, cancellation or variation Part 5A—Emergency dealing determinations Division 1—Simplified outline 72A Simplified outline Division 2—Making of emergency dealing determination 72B Minister may make emergency dealing determination 72C Period of effect of emergency dealing determination Division 3—Effect and conditions of emergency dealing determination 72D Emergency dealing determination authorises dealings, subject to conditions Division 4—Variation, suspension and revocation of emergency dealing determination 72E Variation, suspension and revocation of emergency dealing determination Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register Division 1—Simplified outline 73 Simplified outline Division 2—Notifiable low risk dealings 74 Notifiable low risk dealings 75 Regulation of notifiable low risk dealings Division 3—The GMO Register 76 GMO Register 77 Contents of Register 78 Regulator may include dealings with GMOs on GMO Register 79 Regulator not to make determination unless risks can be managed 80 Variation of GMO Register 81 Inspection of Register Part 7—Certification and accreditation Division 1—Simplified outline 82 Simplified outline Division 2—Certification 83 Application for certification 84 When the Regulator may certify the facility 85 Regulator may require applicant to give further information 86 Conditions of certification 87 Variation of certification 88 Suspension or cancellation of certification 89 Regulator to notify of proposed suspension, cancellation or variation 89A Transfer of certification 90 Guidelines Division 3—Accredited organisations 91 Application for accreditation 92 Regulator may accredit organisations 93 Regulator may require applicant to give further information 94 Conditions of accreditation 95 Variation of accreditation 96 Suspension or cancellation of accreditation 97 Regulator to notify of proposed suspension, cancellation or variation 98 Guidelines Part 8—The Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee Division 1—Simplified outline 99 Simplified outline Division 2—The Gene Technology Technical Advisory Committee 100 The Gene Technology Technical Advisory Committee 101 Function of the Gene Technology Technical Advisory Committee 102 Expert advisers 103 Remuneration 104 Members and procedures 105 Subcommittees Division 3—The Gene Technology Ethics and Community Consultative Committee 106 The Gene Technology Ethics and Community Consultative Committee 107 Function of Ethics and Community Committee 108 Membership 109 Remuneration 110 Membership and Procedures 111 Subcommittees 112 Expert advisers Part 9—Administration Division 1—Simplified outline 117 Simplified outline Division 2—Appointment and conditions of Regulator 118 Appointment of the Regulator 119 Termination of appointment 120 Disclosure of interests 121 Acting appointment 122 Terms and conditions 123 Outside employment 124 Remuneration 125 Leave of absence 126 Resignation Division 3—Money 127 Regulator may charge for services 128 Notional payments by the Commonwealth 129 Gene Technology Account 130 Credits to Account 131 Recovery of amounts 132 Purposes of Account Division 4—Staffing 133 Staff assisting the Regulator 134 Consultants 135 Seconded officers Division 5—Reporting requirements 136 Annual Report 137 Reports to Parliament Division 6—Record of GMO Dealings 138 Record of GMO Dealings 139 Inspection of Record Division 7—Reviews of notifiable low risk dealings and exemptions 140 Regulator may review notifiable low risk dealings 141 Regulator may review exemptions 142 Regulator may give notice of consideration 143 What Regulator may do after consideration 144 Regulator not required to review matters Part 10—Enforcement 145 Simplified outline 146 Regulator may give directions 147 Injunctions 148 Forfeiture Part 11—Powers of inspection Division 1—Simplified outline 149 Simplified outline Division 2—Appointment of inspectors and identity cards 150 Appointment of inspectors 151 Identity card Division 3—Monitoring powers 152 Powers available to inspectors for monitoring compliance 153 Monitoring powers Division 4—Offence‑related powers 154 Searches and seizures related to offences 155 Offence‑related powers of inspectors in relation to premises 156 Use of equipment at premises Division 5—Expert assistance 157 Expert assistance to operate a thing Division 6—Emergency powers 158 Powers available to inspectors for dealing with dangerous situations Division 7—Obligations and incidental powers of inspectors 159 Inspector must produce identity card on request 160 Consent 161 Details of warrant to be given to occupier etc. 162 Announcement before entry 163 Compensation for damage Division 8—Power to search goods, baggage etc. 164 Power to search goods, baggage etc. 165 Seizure of goods Division 9—General provisions relating to search and seizure 166 Copies of seized things to be provided 167 Occupier entitled to be present during search 168 Receipts for things seized 169 Retention of seized things 170 Magistrate may permit a thing to be retained 171 Disposal of goods if there is no owner or owner cannot be located Division 10—Warrants 172 Monitoring warrants 173 Offence‑related warrants 174 Offence‑related warrants by telephone, telex, fax etc. 175 Offences relating to warrants Division 11—Other matters 176 Part not to abrogate privilege against self‑incrimination 177 Part does not limit power to impose conditions Part 12—Miscellaneous Division 1—Simplified outline 178 Simplified outline Division 2—Review of decisions 179 Meaning of terms 180 Notification of decisions and review rights 181 Internal review 182 Deadlines for making reviewable decisions 183 Review of decisions by Administrative Review Tribunal 183A Extended standing for judicial review Division 3—Confidential commercial information 184 Application for protection of confidential commercial information 185 Regulator may declare that information is confidential commercial information 186 Revocation of declaration 187 Confidential commercial information must not be disclosed Division 4—Conduct by directors, employees and agents 188 Conduct by directors, employees and agents 189 Meaning of terms Division 5—Transitional provisions 190 Transitional provision—dealings covered by Genetic Manipulation Advisory Committee advice to proceed 191 Regulations may relate to transitional matters Division 6—Other 192 False or misleading information or document 192A Interference with dealings with GMOs 193 Regulations 194 Review of operation of Act Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history An Act to regulate activities involving gene technology, and for related purposes Part 1—Preliminary 1 Short title This Act may be cited as the Gene Technology Act 2000. 2 Commencement (1) Sections 1 and 2 of this Act commence on the day on which this Act receives the Royal Assent. (2) Subject to subsection (3), the other provisions of this Act commence on a day or days to be fixed by Proclamation. (3) If a provision of this Act does not commence under subsection (2) within 6 months after the day on which this Act receives the Royal Assent, it commences on the first day after the end of that period. 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 GMOs. 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; and (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 GM products. Note: Examples of the schemes mentioned in paragraph (b) are those that regulate food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods. 5 Nationally consistent scheme It is the intention of the Parliament that this Act form a component of a nationally consistent scheme for the regulation of certain dealings with GMOs by the Commonwealth and the States. 6 Act to bind the Crown (1) This Act binds the Crown in each of its capacities. (2) Nothing in this Act renders the Crown liable to be prosecuted for an offence. 7 External Territories This Act extends to every external Territory. 8 Offences (1) Chapter 2 of the Criminal Code applies to all offences against this Act. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (2) If a maximum penalty is specified: (a) at the foot of a section of this Act (other than a section that is divided into subsections); or (b) at the foot of a subsection of this Act; then: (c) a person who contravenes the section or subsection commits an offence punishable, on conviction, by a penalty not exceeding the specified penalty; or (d) the offence referred to in the section or subsection is punishable, on conviction, by a penalty not exceeding the specified penalty. Part 2—Interpretation and operation of Act Division 1—Simplified outline 9 Simplified outline The following is a simplified outline of this Part: This Part contains the definitions used in this Act. This Part contains provisions to facilitate the conferral of functions and powers on the Regulator under State legislation, in order to facilitate a nationally consistent regulatory scheme. This Part contains provisions to enable the concurrent operation of certain State legislation in relation to GMOs, and gives the capacity for this Act to have a more limited operation when corresponding State legislation is in force. This Part also enables the Ministerial Council to issue policy principles, policy guidelines and codes of practice. Division 2—Definitions 10 Definitions (1) In this Act, unless the contrary intention appears: Account means the Gene Technology Account established by section 129. accredited organisation means an organisation accredited under Division 3 of Part 7. aggravated offence has the meaning given by section 38. Australian Health Ethics Committee means the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992. Commonwealth authority means the following: (a) a body corporate established for a public purpose by or under an Act; (b) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together: (i) the Commonwealth; (ii) a body covered by paragraph (a); (iii) a body covered by either of the above subparagraphs. confidential commercial information means information declared by the Regulator to be confidential commercial information under section 185. 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. corresponding State law has the meaning given by section 12. CSC (short for Commonwealth Superannuation Corporation) has the same meaning as in the Governance of Australian Government Superannuation Schemes Act 2011. 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; (g) import the GMO; (h) transport the GMO; (i) dispose of the GMO; and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i). eligible person, in relation to a reviewable decision, has the meaning given by section 179. emergency dealing determination means a determination in force under section 72B. environment includes: (a) ecosystems and their constituent parts; and (b) natural and physical resources; and (c) the qualities and characteristics of locations, places and areas. Environment Minister means the Minister responsible for environment and conservation. Ethics and Community Committee means the Gene Technology Ethics and Community Consultative Committee established by section 106. 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; or (b) homologous recombination; or (c) any other technique specified in the regulations for the purposes of this paragraph. Gene Technology Agreement means the Gene Technology Agreement made for the purposes of this Act between the Commonwealth and at least 4 States, as in force from time to time. Gene Technology Technical Advisory Committee means the Gene Technology Technical Advisory Committee established by section 100. genetically modified organism means: (a) an organism that has been modified by gene technology; or (b) an organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because 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. GM product means a thing (other than a GMO) derived or produced from a GMO. higher education institution means an institution within the meaning of section 4 of the Higher Education Funding Act 1988, but does not include the Australian National University. inadvertent dealings application means an application for a GMO licence to which Division 3 or 4 of Part 5 does not apply because of the operation of section 46A or 49. Institutional Biosafety Committee means a committee established as an Institutional Biosafety Committee in accordance with written guidelines issued by the Regulator under section 98. jurisdiction means the following: (a) the Commonwealth; (b) a State. 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; (b) a person who holds: (i) an office established by or under an Act; or (ii) an appointment made under an Act; or (iii) an appointment made by the Governor‑General or a Minister but not under an 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 an Act. organism means any biological entity that is: (a) viable; or (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 Dealings mentioned in section 138. Regulator means the Gene Technology Regulator appointed under section 118. reviewable decision has the meaning given by section 179. State includes the Australian Capital Territory and the Northern Territory. State agency means the following: (a) the Crown in right of a State; (b) a Minister of a State; (c) a State Government Department; (d) an instrumentality of a State, including a body corporate established for a public purpose by or under a law of a State; (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 a State; (ii) a person or body covered by paragraph (b) or (d); (iii) a person or body covered by either 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 (1) For the purposes of this Act, corresponding State law means a State law that is declared by the Minister, by notice in the Gazette, to correspond to this Act and the regulations, including such a law as amended from time to time. (2) The Minister may revoke a Gazette notice under subsection (1) in relation to a State law only if: (a) the Minister is requested by the State concerned to revoke the notice; or (b) the State law has been amended otherwise than as agreed by a majority of the members of the Ministerial Council (being a majority that includes the Commonwealth) under the Gene Technology Agreement; or (c) amendments of the State law have been agreed by a majority of the members of the Ministerial Council (being a majority that includes the Commonwealth) under the Gene Technology Agreement, and the State law has not been amended in accordance with that agreement within a reasonable period after the agreement. Division 3—Operation of Act 13 Operation of Act (1) This Act applies as follows: (a) to things done, or omitted to be done, by constitutional corporations; (b) to things done, or omitted to be done, in the course of constitutional trade or commerce; (c) to things done, or omitted to be done, by a person that may cause the spread of diseases or pests; (d) for purposes relating to the collection, compilation, analysis and dissemination of statistics; (e) to the Commonwealth and Commonwealth authorities; (f) to things authorised by the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection. (2) In this section: constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution. constitutional trade or commerce means trade or commerce: (a) between Australia and places outside Australia; or (b) among the States; or (c) by way of the supply of services to the Commonwealth or to a Commonwealth authority. 14 Wind‑back of reach of Act (1) This section applies to a State (the notifying State) at a particular time if: (a) a corresponding State law is in force in the notifying State at that time; and (b) a wind‑back notice in relation to that State is in force at that time. (2) This Act applies as a law of the Commonwealth in the notifying State with the following modifications: (a) this Act applies as if paragraph 13(1)(c) (which deals with the spread of pests and diseases) had not been enacted; (b) this Act does not apply to a dealing with a GMO undertaken: (i) by a higher education institution or a State agency; or (ii) by a person authorised to undertake the dealing by a licence held under the corresponding State law by a higher education institution or a State agency. (3) In this section: wind‑back notice, in relation to a State, means a notice given by the State to the Minister, under the Gene Technology Agreement, stating that this section is to apply to the State. 15 Relationship to other Commonwealth laws The provisions of this Act are in addition to, and not in substitution for, the requirements of any other law of the Commonwealth (whether passed or made before or after the commencement of this section). Division 4—Provisions to facilitate a nationally consistent scheme Subdivision A—General provisions 16 State laws may operate concurrently (1) This Act is not intended to exclude the operation of any State law, to the extent that the State law is capable of operating concurrently with this Act, other than a State law prescribed by the regulations for the purposes of this section. (2) The Governor‑General may prescribe a State law under subsection (1) only if: (a) there is no corresponding State law in effect in relation to that State; and (b) either: (i) the State law relates specifically to dealings with GMOs; or (ii) for the purposes of a decision under the State law as to whether or not a licence, authority or approval (however described) is granted under the State law, the State law distinguishes between dealings with GMOs and dealings with other things. 17 Conferral of functions on Commonwealth officers and bodies (1) A corresponding State law may confer functions, powers and duties on the following: (a) the Regulator or another officer of the Commonwealth; (b) a Commonwealth authority; (c) the Ethics and Community Committee; (e) the Gene Technology Technical Advisory Committee. (2) If a function, power or duty is conferred on a person or body under subsection (1), the person or body may perform the function or duty or exercise the power, as the case requires. (3) If a corresponding State law is expressed to confer on the Regulator the power to determine that dealings be included on the GMO Register, the Regulator may include the dealings on the GMO Register in accordance with the corresponding State law. (4) If a corresponding State law is expressed to confer on the Regulator the power to vary the GMO Register, the Regulator may vary the GMO Register in accordance with the corresponding State law. (5) If a corresponding State law is expressed to confer on the Regulator the power to enter information on the Record of GMO Dealings, the Regulator may enter the information on the Record in accordance with the corresponding State law. (6) The Regulator may: (a) make any notations in the GMO Register that the Regulator considers necessary to identify entries that relate to dealings included on the Register as mentioned in subsection (3) or (4); and (b) make any notations in the Record of GMO Dealings that the Regulator considers necessary to identify entries that relate to information entered on the Record as mentioned in subsection (5). 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 a corresponding State law; and (b) the offender has been punished for the offence under the corresponding State law; 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 a corresponding State law, 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 Review Tribunal for review of a reviewable State decision. (2) A decision made by the Regulator in the performance of a function or the exercise of a power conferred by a corresponding State law is a reviewable State decision for the purposes of this section if: (a) the law under which the decision was made provides for review by the Administrative Review Tribunal; and (b) the decision is declared by the regulations to be a reviewable State decision for the purposes of this section. (3) For the purposes of this section, the Administrative Review Tribunal Act 2024 has effect as if a corresponding State law were an 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 a corresponding State law. Subdivision B—Policy principles, policy guidelines and codes of practice 21 Ministerial Council may issue policy principles (1) The Ministerial Council may, by legislative instrument, issue policy principles in relation to the following: (a) ethical issues relating to dealings with GMOs; (aa) recognising areas, if any, designated under State law 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. Note 1: Section 57 provides that the Regulator must not issue a licence if to do so would be inconsistent with a policy principle. Note 2: Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act. (2) Before issuing a policy principle, the Ministerial Council must be satisfied that the policy principle was developed in accordance with section 22. (3) Regulations for the purposes of paragraph (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. 22 Consultation on policy principles (1) Policy principles are to be developed in consultation with the following: (a) the Gene Technology Technical Advisory Committee; (b) the Regulator; (c) the Ethics and Community Committee; (e) such Commonwealth and State agencies and such regulatory agencies as the Ministerial Council considers appropriate; (f) such industry groups as the Ministerial Council considers appropriate; (g) such environmental, consumer and other groups as the Ministerial Council considers appropriate. (2) Consultation under subsection (1) must be in accordance with guidelines (if any) issued by the Ministerial Council for the purposes of this section. 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. 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 Regulator is not subject to direction in relation to individual decisions. Note 2: Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act. 24 Ministerial Council may issue codes of practice (1) The Ministerial Council may, by legislative instrument, issue codes of practice in relation to gene technology. Note: Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act. (2) The Ministerial Council must not issue a code of practice unless the code of practice was developed by the Regulator in consultation with the following: (a) the Gene Technology Technical Advisory Committee; (b) the Ethics and Community Committee; (d) such Commonwealth and State agencies and such regulatory agencies as the Ministerial Council considers appropriate; (e) such industry groups as the Ministerial Council considers appropriate; (f) such environmental, consumer and other groups as the Ministerial Council considers appropriate. Part 3—The Gene Technology Regulator 25 Simplified outline The following is a simplified outline of this Part: This Part establishes the office of the Gene Technology Regulator (the Regulator), and specifies the Regulator's functions and powers. 26 The Gene Technology Regulator There is to be a 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 countries outside 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. 29 Delegation (1) The Regulator may, by instrument in writing, delegate any of the Regulator's powers or functions to any of the following: (a) an employee of the Department; (b) an employee of another Department or of a Commonwealth authority, if the functions of the other Department or Commonwealth authority relate, whether directly or indirectly, to GMOs or GM products; (c) an officer or employee of a State agency, if the functions of the State agency relate, whether directly or indirectly, to GMOs or GM products. (2) In exercising powers or functions under a delegation, the delegate must comply with any directions of the Regulator. 30 Independence of the Regulator Subject to this Act and to other laws of the Commonwealth, the Regulator has discretion in the performance or exercise of his or her functions or powers. In particular, the Regulator is not subject to direction from anyone in relation to: (a) whether a GMO licence is issued or refused in relation to a particular application; 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 The following is a simplified outline of this Part: This Part deals with the regulation of dealings with GMOs. This Part prohibits dealings with GMOs unless: (a) the person undertaking the dealing is authorised to do so by a GMO licence; or (aa) the dealing is specified in an emergency dealing determination; or (b) the dealing is a notifiable low risk dealing (see Division 2 of Part 6); or (c) the dealing is an exempt dealing; or (d) the dealing is included in the GMO Register (see Division 3 of Part 6). This Part imposes heavier penalties on unlawful dealings that cause, or are likely to cause, significant damage to the health and safety of people or to the environment. Division 2—Dealings with GMOs must be licensed 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; and (b) the dealing with the GMO by the person is not authorised by a GMO licence, and the person knows or is reckless as to that fact; and (c) the dealing with the GMO is not specified in an emergency dealing determination, and the person knows or is reckless as to that fact; and (d) the dealing is not a notifiable low risk dealing, and the person knows or is reckless as to that fact; and (e) the dealing is not an exempt dealing, and the person knows or is reckless as to that fact; and (f) the dealing is not included on the GMO Register, and the person knows or is reckless as to that fact. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (2) An offence under subsection (1) is punishable on conviction by whichever of the following applies: (a) in the case of an aggravated offence— imprisonment for 5 years or 2,000 penalty units; (b) in any other case— imprisonment for 2 years or 500 penalty units. Note: Section 38 defines aggravated offence. (3) In this section: exempt dealing means a dealing specified by the regulations to be an exempt dealing. (4) Regulations under subsection (3) may be expressed to exempt: (a) all dealings with a GMO or with a specified class of GMOs; or (b) a specified class of dealings with a GMO or with a specified class of GMOs; or (c) one or more specified dealings with a GMO or with a specified class of GMOs. 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; and (b) the dealing with the GMO by the person is not authorised by a GMO licence; and (ba) the dealing with the GMO is not specified in an emergency dealing determination; and (c) the dealing is not a notifiable low risk dealing; and (d) the dealing is not an exempt dealing; and (e) the dealing is not included on the GMO Register. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (2) Strict liability applies to paragraphs (1)(b), (ba), (c), (d) and (e). Note: For strict liability, see section 6.1 of the Criminal Code. (3) 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—200 penalty units; (b) in any other case—50 penalty units. Note: Section 38 defines aggravated offence. (4) In this section: exempt dealing has the same meaning as in section 32. 34 Person must not breach conditions of a GMO licence (1) The holder of a GMO licence commits an offence if: (a) the holder intentionally takes an action or omits to take an action; and (b) the action or omission contravenes the licence, and the holder knows or is reckless as to that fact. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (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; and (b) the person has knowledge of the conditions of the licence; and (c) the action or omission contravenes a condition of the licence, and the person knows or is reckless as to that fact. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (3) An offence under this section is punishable on conviction by whichever of the following applies: (a) in the case of an aggravated offence— imprisonment for 5 years or 2,000 penalty units; (b) in any other case— imprisonment for 2 years or 500 penalty units. Note: Section 38 defines aggravated offence. (4) A person who commits an offence under subsection (1) or (2) commits a separate offence in respect of each day (including the day of a conviction for the offence or any later day) on which the person commits the offence. 35 Person must not breach conditions of a GMO licence—strict liability offence (1) The holder of a GMO licence commits an offence if the holder: (a) takes an action or omits to take an action; and (b) the action or omission contravenes the licence. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (2) A person covered by a GMO licence commits an offence if: (a) the person takes an action or omits to take an action; and (b) the action or omission contravenes the licence; and (c) the person has knowledge of the conditions of the licence. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (3) Strict liability applies to paragraphs (1)(a) and (b) and (2)(a) and (b). Note: For strict liability, see section 6.1 of the Criminal Code. (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—200 penalty units; (b) in any other case—50 penalty units. Note: Section 38 defines aggravated offence. 35A Person must not breach conditions of emergency dealing determination (1) A person commits an offence if: (a) the person intentionally takes an action or omits to take an action; and (b) the person has knowledge of the conditions to which an emergency dealing determination is subject; and (c) the action or omission contravenes such a condition, and the person knows or is reckless as to that fact. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (2) An offence under this section is punishable on conviction by whichever of the following applies: (a) in the case of an aggravated offence—imprisonment for 5 years or 2,000 penalty units; (b) in any other case—imprisonment for 2 years or 500 penalty units. Note: Section 38 defines aggravated offence. 35B Person must not breach conditions of emergency dealing determination—strict liability offence (1) A person commits an offence if: (a) the person takes an action or omits to take an action; and (b) the person has knowledge of the conditions to which an emergency dealing determination is subject; and (c) the action or omission by the person contravenes such a condition. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (2) Strict liability applies to paragraphs (1)(a) and (c). Note: For strict liability, see section 6.1 of the Criminal Code. (3) 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—200 penalty units; (b) in any other case—50 penalty units. Note: Section 38 defines aggravated offence. 36 Person must not breach conditions on GMO Register (1) A person commits an offence if the person: (a) deals with a GMO, knowing that it is a GMO; and (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. Maximum penalty: 50 penalty units. Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (2) Strict liability applies to paragraphs (1)(b) and (c). 37 Offence relating to notifiable low risk dealings (1) A person commits an offence if: (a) the person deals with a GMO, knowing that it is a GMO; and (b) the dealing is a notifiable low risk dealing; and (c) the dealing by the person was not undertaken in accordance with the regulations. Maximum penalty: 50 penalty units. Note 1: Notifiable low risk dealings are specified in the regulations—see Part 6. Note 2: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility. (2) Strict liability applies to paragraphs (1)(b) and (c). 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 his or her 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 The following is a simplified outline of this Part: This Part provides a licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs. This Part 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. A licence can cover dealings by persons other than the licence holder. The licence holder is required 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; or (b) a specified class of dealings with a GMO, or with a specified class of GMOs; or (c) one or more specified dealings with a GMO, or with a specified class of GMOs. (5) The applicant may apply for a licence authorising such dealings by: (a) a specified person or persons; or (b) a specified class of person; or (c) all persons. (6) The application must be accompanied by the application fee (if any) prescribed by the regulations. 40A Licences relating to inadvertent dealings (1) If the Regulator is satisfied that a person has come into possession of a GMO inadvertently the Regulator may, with the agreement of the person, treat the person as having made an inadvertent dealings application. (2) To avoid doubt, subsection (1) does not prevent a person from making an application under section 40 in respect of a GMO that has inadvertently come into the person's possession. Note: Sections 46A and 49 have the effect that the Regulator may expedite consideration of an application to dispose of a GMO that has come into a person's possession inadvertently. These sections have effect whether the application is made under section 40, or is taken to have been made under this section. 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. (3) The Regulator may require information to be given under this section at any time before the Regulator decides the application, whether before or after the Regulator has begun to consider the application. 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, or may cease considering the application, if: (a) the application does not contain the information specified by the Regulator or prescribed by the regulations; or (b) the application does not satisfy subsection 40(3); or (c) the application is not accompanied by the application fee (if any) prescribed by the regulations; or (d) the applicant did not provide further 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; or (f) the Regulator is satisfied (having regard to the matters specified in section 58) that the applicant is not a suitable person to hold a licence. (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; and (b) the first person provides information to the Regulator for the purposes of the Regulator's consideration of the application; and (c) the information is confidential commercial 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. 46A Division does not apply to an application relating to inadvertent dealings Despite section 46, this Division does not apply to an application for a GMO licence if the Regulator is satisfied that: (a) the dealings proposed to be authorised by the licence are limited to one or more of the following for purposes relating to disposing of a GMO: (i) conducting experiments with the GMO; (ii) propagating the GMO; (iii) growing, raising or culturing the GMO; (iv) transporting the GMO; (v) any other dealings to be undertaken for the purposes of, or for purposes relating to, disposing of the GMO; and (b) the applicant for the licence came into possession of the GMO inadvertently. 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; and (b) the Gene Technology Technical Advisory Committee; and (c) relevant Commonwealth authorities or agencies; and (d) any local council 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 Division does not apply to an application relating to inadvertent dealings Despite section 48, this Division does not apply to an application for a GMO licence if the Regulator is satisfied that: (a) the dealings proposed to be authorised by the licence are limited to one or more of the following for purposes relating to disposing of a GMO: (i) conducting experiments with the GMO; (ii) propagating the GMO; (iii) growing, raising or culturing the GMO; (iv) transporting the GMO; (v) any other dealings to be undertaken for the purposes of, or for purposes relating to, disposing of the GMO; and (b) the applicant for the licence came into possession of the GMO inadvertently. 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 dealings proposed to be authorised by the licence. (3) Unless section 50A applies in relation to the application for the licence, the Regulator must seek advice on matters relevant to the preparation of the risk assessment and the risk management plan from: (a) the States; and (b) the Gene Technology Technical Advisory Committee; and (c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph; and (d) the Environment Minister; and (e) any local council that the Regulator considers appropriate. 50A Limited and controlled release applications (1) This section applies to an application for a licence if the Regulator is satisfied that: (a) the principal purpose of the application is to enable the licence holder, and persons covered by the licence, to conduct experiments; and (b) the application proposes, in relation to any GMO in respect of which dealings are proposed to be authorised: (i) controls to restrict the dissemination or persistence of the GMO and its genetic material in the environment; and (ii) limits on the proposed release of the GMO; and (c) the Regulator is satisfied that the controls and limits are of such a kind that it is appropriate for the Regulator not to seek the advice referred to in subsection 50(3). (2) For the purposes of subsection (1): controls, in relation to a GMO and its genetic material, include the following: (a) methods to restrict the dissemination or persistence of the GMO or its genetic material in the environment; (b) methods for disposal of the GMO or its genetic material; (c) data collection, including studies to be conducted about the GMO or its genetic material; (d) the geographic area in which the proposed dealings with the GMO or its genetic material may occur; (e) compliance, in relation to dealings with the GMO or its genetic material, with: (i) a code of practice issued under section 24; or (ii) a technical or procedural guideline issued under section 27. (3) For the purposes of subsection (1): limits, in relation to the release of a GMO that is proposed to be authorised by a licence, includes limits on any of the following: (a) the scope of the dealings with the GMO; (b) the scale of the dealings with the GMO; (c) the locations of the dealings with the GMO; (d) the duration of the dealings with the GMO; (e) the persons who are to be permitted to conduct the dealings with the GMO. (4) In deciding whether the principal purpose of an application is to enable the licence holder, and persons covered by the licence, to conduct experiments, the Regulator: (a) must have regard to whether the applicant proposes that any or all of the following be authorised by, and done under, the licence: (i) testing hypotheses; (ii) gaining scientific or technical knowledge; (iii) gaining data for regulatory purposes, or for product development or marketing; and (b) may have regard to any other matter that the Regulator considers to be relevant. 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 prescribed by the regulations; (c) any advice in relation to the risk assessment provided by a State or a local council in response to a request under subsection 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 subsection 50(3); (e) any advice in relation to the risk assessment provided by a Commonwealth authority or agency in response to a request under subsection 50(3); (f) any advice in relation to the risk assessment provided by the Environment Minister in response to a request under subsection 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; (c) any advice in relation to the risk management plan provided by a State or a local council in response to a request under subsection 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 subsection 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 subsection 50(3); (f) any advice in relation to the risk management plan provided by the Environment Minister in response to a request under subsection 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 paragraph (2)(a), the Regulator: (a) is not limited to considering submissions or advice mentioned in paragraphs (2)(b), (c), (d), (e) and (f); and (b) subject to section 45, may take into account other information, including, but not limited to, relevant independent research. 52 Public notification of risk assessment and risk management plan (1) After taking the steps referred to in sections 50 and 51, the Regulator must publish a notice: (a) in the Gazette; and (b) in one or more newspapers that the Regulator considers appropriate, having regard to the geographic area in which the dealings proposed to be authorised by the licence may occur; and (c) on the Regulator's website. (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; and (b) state that a person may request further information about the risk assessment and the risk management plan under section 54; and (ba) if the Regulator is satisfied that one or more dealings proposed to be authorised by the licence may pose a significant risk to the health and safety of people or to the environment—state that the Regulator is so satisfied; and (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: (i) if the notice states that the Regulator is satisfied that the dealings proposed to be authorised by the licence may pose a significant risk to the health and safety of people or to the environment—50 days after the date on which the notice was published; or (ii) in any other case—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; and (b) the Gene Technology Technical Advisory Committee; and (c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph; and (d) the Environment Minister; and (e) any local council that the Regulator considers appropriate. 53 Regulator may take other actions (1) In addition to satisfying the requirements of this 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). Maximum penalty: 30