South Australia: Gene Technology Act 2001 (SA)

South Australia Gene Technology Act 2001 An Act to regulate activities involving gene technology; and for other purposes. Contents Part 1—Preliminary 1 Short title 3 Object of Act 4 Regulatory framework to achieve object 5 Nationally consistent scheme 5A Amendments to Act to maintain national consistency 6 Act to bind the Crown 7 External Territories 8 Offences 8A Numbering 8B Notes 8C Outlines 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 State laws Division 4—Provisions to facilitate a nationally consistent scheme Subdivision 1—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 2—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—Regulations 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 Division 8—Annual charge 72AA GMO licence—annual charge 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 Regulations 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 State 129 Gene Technology Account 130 Credits to Gene Technology 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 Magistrates Court 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 South Australian Civil and Administrative Tribunal 183A Extended standing for judicial review 183B Interaction with Commonwealth law 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 192E Attempts to commit offences against Act 193 Regulations 194 Review of operation of Act Legislative history The Parliament of South Australia enacts as follows: Part 1—Preliminary 1—Short title (1) This Act may be cited as the Gene Technology Act 2001. (2) This Act may also be referred to as— (a) the Gene Technology Law of South Australia; or (b) the Gene Technology Law. 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 GMO products. Note— Examples of the schemes mentioned in paragraph (b) are those that regulate food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods or substances. 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. 5A—Amendments to Act to maintain national consistency (1) If— (a) the Parliament of the Commonwealth enacts an amendment to the Commonwealth Act (the Commonwealth amendment); and (b) the Governor is satisfied that an amendment that corresponds, or substantially corresponds, to the Commonwealth amendment should be made to this Act, the Governor may, by regulation, amend this Act to give effect to the Commonwealth amendment as a law of South Australia. (2) The Governor may, as part of any regulation made under subsection (1) in respect of a Commonwealth amendment, make any additional provision (including so as to modify the terms of the Commonwealth amendment or to provide for related or transitional matters) considered by the Governor to be necessary to ensure that the Commonwealth amendment has proper effect under the law of South Australia. (3) A regulation made under this section in respect of a Commonwealth amendment may, if the regulation so provides, take effect from the day of the commencement of the Commonwealth amendment (including a day that is earlier than the day of the regulation's publication in the Gazette). 6—Act to bind the Crown (1) This Act binds the Crown in right of South 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— The Commonwealth Act includes a provision extending that Act to every external Territory other than Norfolk Island. 8—Offences Note— The Commonwealth Act includes a provision applying Chapter 2 of the Criminal Code to offences against that Act and construing penalty provisions in that Act. 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— 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 form part of this Act. Note— This section does not appear in the Commonwealth Act. 8C—Outlines The provisions appearing at the beginning of Parts 2 to 12 outlining the Part are intended only as a guide to readers as to the general scheme and effect of that Part. Note— This section does not appear in the Commonwealth Act. Part 2—Interpretation and operation of Act Division 1—Simplified outline 9—Simplified outline In outline, this Part— (a) contains the definitions used in this Act; (b) contains provisions to facilitate a nationally consistent regulatory scheme; (c) enables the Ministerial Council to issue policy principles, policy guidelines and codes of practice. Note— This section differs from section 9 of the Commonwealth Act. Division 2—Definitions 10—Definitions (1) In this Act, unless the contrary intention appears— accredited organisation means an organisation accredited under Division 3 of Part 7; 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; (b) a company in which a controlling interest is held by any one of the following persons, or by two 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 Commonwealth emergency dealing determination, in relation to an emergency dealing determination under this Act, means a determination under section 72B of the Commonwealth Act that specifies the same kind of dealings as those proposed to be specified in, or specified in, the emergency dealing determination under this Act; 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 Australia means— (a) the Commonwealth department of that name; or (b) if there is no Commonwealth department of that name—a department or agency prescribed by the regulations for the purposes of this definition; Ethics and Community Committee means the Gene Technology Ethics and Community Consultative Committee established by section 106 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; or (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 Agreement made for the purposes of this Act between the Commonwealth and at least four 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; 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 of the Commonwealth Act; GM product means a thing (other than a GMO) derived or produced from a GMO; 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) a State; or (b) the Commonwealth; licence holder means the holder of a GMO licence; local council means a council within the meaning of the Local Government Act 1999; 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; or (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; 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 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 the following: (a) the Crown in right of South Australia; (b) a Minister of the Crown in right of South Australia; (c) an administrative unit of the Public Service; (d) an instrumentality of the State of South Australia, including a body corporate established for a public purpose by or under a law of the State of South Australia; (e) a company in which a controlling interest is held by any one of the following persons, or by two or more of the following persons together: (i) the Crown in right of South Australia; (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; Tribunal means the South Australian Civil and Administrative Tribunal established under the South Australian Civil and Administrative Tribunal Act 2013. (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. Note— This section differs from section 10 of the Commonwealth Act. 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— The Commonwealth Act includes a provision defining corresponding State law for the purposes of that Act. Division 3—Operation of Act 13—Operation of Act Note— The Commonwealth Act includes a provision about the application of that Act. 14—Wind-back of reach of Act Note— The Commonwealth Act includes a provision about the giving of wind-back notices by a State. 15—Relationship to other State laws The provisions of this Act are in addition to, and not in substitution for, the requirements of any other law of the State of South Australia (whether passed or made before or after the commencement of this section). Note— The equivalent section in the Commonwealth Act deals with the relationship of that Act to other Commonwealth laws. Division 4—Provisions to facilitate a nationally consistent scheme Subdivision 1—General provisions 16—State laws may operate concurrently Note— The Commonwealth Act includes a provision allowing State laws (apart from State laws prescribed for the purposes of the provision) to operate concurrently with that Act. 17—Conferral of functions on Commonwealth officers and bodies Note— The Commonwealth Act includes a provision allowing corresponding State laws to confer functions, powers and duties on certain Commonwealth officers and bodies. 18—No doubling-up of liabilities (1) If— (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 Note— Section 19 of the Commonwealth Act provides that an application may be made to the Administrative Appeals Tribunal for review of a reviewable State decision within the meaning of that section. Part 12 of this Act provides that a person may apply for review of a reviewable decision under this Act to the Tribunal. 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 2—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 South 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. Note— Section 57 provides that the Regulator must not issue a licence if to do so would be inconsistent with a policy principle. (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— This section differs from section 21 of the Commonwealth Act. 22—Consultation on policy principles Note— The Commonwealth Act includes a provision about how policy principles are to be developed. 23—Ministerial Council may issue policy guidelines The Ministerial Council may issue policy guidelines in relation to matters relevant to the functions of the Regulator under this Act or the regulations. Note— 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. 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. Note— 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— This section differs from section 25 of the Commonwealth Act. 26—The Gene Technology Regulator Note— Section 26 of the Commonwealth Act creates the office of Gene Technology Regulator. 27—Functions of the Regulator 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 South 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 employee; (b) an officer or employee of a State agency, if the functions of the State agency relate, whether directly or indirectly, to GMOs or GM products; (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) A delegation may be made to— (a) a specified officer or employee; or (b) an officer or employee holding a specified office or position. (3) In exercising powers or performing functions under a delegation, the delegate must comply with any directions of the Regulator. (4) A delegation is revocable at will and does not derogate from the power of the Regulator to act in a matter. Note— 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 South 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 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—Regulations of dealings with GMOs Division 1—Simplified outline 31—Simplified outline In outline, this Part— (a) deals with the regulation of dealings with GMOs; (b) prohibits dealings with GMOs unless— (i) the person undertaking the dealing is authorised to do so by a GMO licence; or (ia) the dealing is specified in an emergency dealing determination; or (ii) the dealing is a notifiable low risk dealing (see Division 2 of Part 6); or (iii) the dealing is an exempt dealing; or (iv) the dealing is included in the GMO Register (see Division 3 of Part 6); (c) 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 is guilty of 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. (2) An offence under subsection (1) is punishable by whichever of the following applies: (a) in the case of an aggravated offence—imprisonment for a term not exceeding 5 years or a fine not exceeding $220 000; or (b) in any other case—imprisonment for a term not exceeding 2 years or a fine not exceeding $55 000. 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. Note— 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 is guilty of 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. (2) Strict liability applies to subsection (1)(b), (ba), (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— Section 38 defines aggravated offence. (4) In this section— exempt dealing has the same meaning as in section 32. Note— This section differs from section 33 of the Commonwealth Act. 34—Person must not breach conditions of a GMO licence (1) The holder of a GMO licence is guilty of 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. (2) A person covered by a GMO licence is guilty of an offence if— (a) the person intentionally takes an action or omits to take an action; and (b) the person 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. (3) An offence under subsection (1) or (2) is punishable by whichever of the following applies: (a) in the case of an aggravated offence—imprisonment for a term not exceeding 5 years or a fine not exceeding $220 000 plus an additional fine not exceeding $22 000 for every day during which the offence continues; (b) in any other case—imprisonment for a term not exceeding 2 years or a fine not exceeding $55 000 plus an additional fine not exceeding $5 500 for every day during which the offence continues. Note— Section 38 defines aggravated offence. Note— 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 is guilty of an offence if the holder— (a) takes an action or omits to take an action; and (b) the action or omission contravenes the licence. (2) A person covered by a GMO licence is guilty of 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. (3) Strict liability applies to subsections (1)(a)and (b) and (2)(a) and (b). (4) 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— Section 38 defines aggravated offence. 35A—Person must not breach conditions of emergency dealing determination (1) A person is guilty of 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. (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 a term not exceeding 5 years or a fine not exceeding $220 000; (b) in any other case—imprisonment for a term not exceeding 2 years or a fine not exceeding $55 000. Notes— 1 Section 38 defines aggravated offence. 2 This section differs from section 35A of the Commonwealth Act. 35B—Person must not breach conditions of emergency dealing determination—strict liability offence (1) A person is guilty of 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. (2) Strict liability applies to subsection (1)(a) and (c). (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—$22 000; (b) in any other case—$5 500. Notes— 1 Section 38 defines aggravated offence. 2 This section differs from section 35B of the Commonwealth Act. 36—Person must not breach conditions on GMO Register (1) A person is guilty of an offence if the person— (a) deals with a GMO, knowing that it is a GMO; and (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. (2) Strict liability applies to subsection (1)(b) and (c). (3) An offence against subsection (1) is punishable by a fine of not more than $5 500. 37—Offence relating to notifiable low risk dealings (1) A person is guilty of an offence if— (a) the person deals with a GMO, knowing that it is a GMO; and (b) the dealing is a notifiable low risk dealing; and (c) the dealing by the person was not undertaken in accordance with the regulations. Note— Notifiable low risk dealings are specified in the regulations—see Part 6. (2) Strict liability applies to subsection (1)(b) and (c). (3) An offence against subsection (1) is punishable by a fine of not more than $5 500. 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— (a) provides a licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs; (b) sets out the processes to be followed by the Regulator in relation to applications involving two kinds of dealings— (i) those that involve the intentional release of a GMO into the environment; and (ii) those that do not involve the intentional release of a GMO into the environment; (c) 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; 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 this Division 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 section 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 1 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 1 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) Environment Australia; 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 section 50(3). (2) For the purposes of subsection (1)— controls, in relation to restricting the dissemination or persistence of a GMO and its genetic material in the environment, include the following: (a) specified methods for disposal of the GMO or its genetic material; (b) data collection requirements, including studies to be conducted about the GMO or its genetic material; (c) a restricted geographic area in which the proposed dealings with the GMO or its genetic material may occur; (d) 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. Note— This section differs from section 50A of the Commonwealth Act. 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 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 Environment Australia 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; (c) any advice in relation to the risk management plan provided by a State or a local council in response to a request under section 50(3); (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 Environment Australia 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) 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 1 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 1 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) Environment Australia; 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: $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— 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) the risk assessment prepared under section 47 or 50 in relation to the dealings; (b) the risk management plan prepared under section 47 or 50 in relation to the dealings; (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. Note— Paragraphs (a), (b) and (c) of subsection (2) do not apply to an inadvertent dealings application. 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. (3) Subsection (2) does not apply to an inadvertent dealings application. 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; and (b) any revocation or suspension of a licence or permit (however described) held by the person under a law of South Australia, the Commonwealth, another State or a foreign country, being a law 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; and (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; and (c) any revocation or suspension of a licence or permit (however described) held by the body corporate under a law of South Australia, the Commonwealth, another State or a foreign country, being a law 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 South 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. Note— 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. (3) A licence issued as a result of an inadvertent dealings application must not be expressed to be in force for a period of longer than 12 months. Division 6—Conditions of licences 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