Gene Technology Amendment Act 2007

Gene Technology Amendment Act 2007 No. 43 of 2007 TABLE OF PROVISIONS Section Page PART 1—PRELIMINARY 1 1 Purpose 1 2 Commencement 2 3 Principal Act 3 4 Notes 3 PART 2—EMERGENCY DEALING DETERMINATIONS 4 5 Definitions 4 6 Simplified outline (Part 4) 4 7 Person not to deal with a GMO without a licence 5 8 Person not to deal with a GMO without a licence—strict liability offence 5 9 Person must not breach conditions of a GMO licence 6 10 New sections 35A and 35B inserted 6 35A Person must not breach conditions of emergency dealing determination 6 35B Person must not breach conditions of emergency dealing determination—strict liability offence 7 11 Protection of persons who give information 8 12 Renumbering of section 72A 8 13 New Part 5A inserted 8 PART 5A—EMERGENCY DEALING DETERMINATIONS 8 Division 1—Simplified outline 8 72A Simplified outline 8 Division 2—Making of emergency dealing determination 9 72B Minister may make emergency dealing determination 9 72C Period of effect of emergency dealing determination 10 Division 3—Effect and conditions of emergency dealing determination 11 72D Emergency dealing determination authorises dealings, subject to conditions 11 i -- 1 of 47 -- Section Page Division 4—Variation, suspension and revocation of emergency dealing determination 14 72E Variation, suspension and revocation of emergency dealing determination 14 14 Simplified outline (Part 7) 15 15 Application for certification 16 16 Application for accreditation 16 17 Quarterly reports 16 18 Record of GMO and GM Product Dealings 16 19 Simplified outline (Part 10) 17 20 Regulator may give directions 17 21 Simplified outline (Part 11) 18 22 Powers available to inspectors for monitoring compliance 18 23 Part does not limit power to impose conditions 18 24 Interference with dealings with GMOs 18 PART 3—GENE TECHNOLOGY ETHICS AND COMMUNITY CONSULTATIVE COMMITTEE 20 25 Definitions 20 26 Heading to Part 8 20 27 Simplified outline (Part 8) 20 28 The Gene Technology Ethics and Community Consultative Committee 20 29 New section 107 substituted 21 107 Function of Ethics and Community Committee 21 30 New sections 111 and 112 inserted 22 111 Subcommittees 22 112 Expert advisers 22 PART 4—ASSESSMENT OF APPLICATIONS: LIMITED AND CONTROLLED RELEASE AND CONSULTATION ON SIGNIFICANT RISK 23 31 Repeal of section 49 23 32 Regulator must prepare risk assessment and risk management plan 23 33 New section 50A inserted 23 50A Limited and controlled release applications 23 34 Matters Regulator must take into account in preparing risk assessment and risk management plan 26 35 Public notification of risk assessment and risk management plan 26 ii -- 2 of 47 -- Section Page PART 5—PROVISIONS RELATING TO VARIATION 27 36 Variation of licence 27 37 Review of decisions 29 PART 6—REGULATOR'S POWER TO DIRECT 30 38 Simplified outline (Part 10) 30 39 Regulator may give directions 30 PART 7—INADVERTENT DEALINGS 33 40 Definition 33 41 New section 40A inserted 33 40A Licences relating to inadvertent dealings 33 42 New section 46A inserted 34 46A Division does not apply to an application relating to inadvertent dealings 34 43 New section 49 inserted 34 49 Division does not apply to an application relating to inadvertent dealings 34 44 Regulator must not issue the licence unless satisfied as to risk management 35 45 Other circumstances in which Regulator must not issue the licence 35 46 Period of licence 35 PART 8—TECHNICAL AMENDMENTS 36 47 Definitions 36 48 Regulator may require applicant to give further information 36 49 Regulator must consider applications except in certain circumstances 37 50 Regulator must not issue the licence unless satisfied as to risk management 37 51 Regulator to notify of proposed suspension, cancellation or variation 37 52 Regulator may include dealings with GMOs on GMO register 37 53 Regulator to notify of proposed suspension, cancellation or variation 38 54 New section 89A inserted 38 89A Transfer of certification 38 55 Regulator may accredit organisations 39 56 Regulator to notify of proposed suspension, cancellation or variation 39 57 Review of decisions 40 58 Deadlines for making reviewable decisions 40 59 Regulator may declare that information is confidential commercial information 41 iii -- 3 of 47 -- Section Page PART 9—REPEAL OF AMENDING ACT 42 60 Repeal of amending Act 42 ═══════════════ ENDNOTES 43 iv -- 4 of 47 -- Victoria Gene Technology Amendment Act 2007† No. 43 of 2007 [Assented to 25 September 2007] The Parliament of Victoria enacts: PART 1—PRELIMINARY 1 Purpose The purpose of this Act is to improve the operation of the regulatory scheme for gene technology by making nationally agreed amendments to the legislative framework of the scheme (set out for Victoria in the Gene Technology Act 2001) including— (a) introducing emergency powers giving the Minister the ability to expedite the approval of a dealing with a GMO in an emergency (Part 2); 1 -- 5 of 47 -- Part 1—Preliminary Gene Technology Amendment Act 2007 No. 43 of 2007 s. 2 (b) improving the mechanism for providing advice to the Gene Technology Regulator and the Gene Technology Ministerial Council on ethics and community consultations (Part 3); (c) streamlining the process for the initial consideration of licences and reducing the regulatory burden for low risk dealings (Part 4); (d) providing clarification on the circumstances in which licence variations can be made (Part 5); (e) clarifying the circumstances under which the Regulator can direct a person to comply with the Act (Part 6); (f) providing the Regulator with the power to issue a licence to persons who find themselves inadvertently dealing with an unlicensed GMO, for the purpose of disposing of that organism (Part 7); (g) making technical amendments to improve the operation of the Act (Part 8). 2 Commencement (1) Subject to subsection (3), this Act (other than section 43) comes into operation on a day or days to be proclaimed. (2) Section 43 comes into operation immediately after section 31 comes into operation. (3) If a provision of this Act to which subsection (1) applies does not come into operation before 1 January 2008, it comes into operation on that day. 2 -- 6 of 47 -- Part 1—Preliminary Gene Technology Amendment Act 2007 No. 43 of 2007 s. 3 3 Principal Act In this Act, the Gene Technology Act 2001 is called the Principal Act. See: Act No. 67/2001 and amending Act Nos 11/2003 and 108/2004. LawToday: www. legislation. vic.gov.au 4 Notes Section 8B of the Principal Act is repealed. __________________ 3 -- 7 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 5 PART 2—EMERGENCY DEALING DETERMINATIONS 5 Definitions (1) Insert the following definitions in section 10(1) of the Principal Act— "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; emergency dealing determination means a determination in force under section 72B;". (2) Insert the following note at the foot of section 10 of the Principal Act— "Note This section differs from section 10 of the Commonwealth Act.". 6 Simplified outline (Part 4) In section 31 of the Principal Act after "GMO licence; or" insert— "– the dealing is specified in an emergency dealing determination; or". 4 -- 8 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 7 7 Person not to deal with a GMO without a licence For section 32(1) of the Principal Act substitute— "(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.". 8 Person not to deal with a GMO without a licence— strict liability offence (1) After section 33(1)(b) of the Principal Act insert— "(ba) the dealing with the GMO is not specified in an emergency dealing determination; and". (2) In section 33(2) of the Principal Act after "(1)(b)," insert "(ba),". 5 -- 9 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 9 9 Person must not breach conditions of a GMO licence (1) For section 34(1) of the Principal Act substitute— "(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) For section 34(2)(b) and (c) of the Principal Act substitute— "(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.". 10 New sections 35A and 35B inserted After section 35 of the Principal Act insert— "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. 6 -- 10 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 10 (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; 7 -- 11 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 11 (b) in any other case—$5500. Notes 1 Section 38 defines aggravated offence. 2 This section differs from section 35B of the Commonwealth Act.". 11 Protection of persons who give information In section 67 of the Principal Act for "or 66" substitute ", 66 or 72D(2)(h)". 12 Renumbering of section 72A For the provision number at the beginning of section 72A of the Principal Act substitute "72AA". 13 New Part 5A inserted After Part 5 of the Principal Act insert— "PART 5A—EMERGENCY DEALING DETERMINATIONS Division 1—Simplified outline 72A Simplified outline In outline, this Part provides a system under which the Minister can make determinations relating to dealings with GMOs in emergencies. Note This section differs from section 72A of the Commonwealth Act. 8 -- 12 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 13 Division 2—Making of emergency dealing determination 72B Minister may make emergency dealing determination (1) The Minister may, by Order published in the Government Gazette (an emergency dealing determination), specify dealings with a GMO for the purposes of this Part. (2) The Minister may make an emergency dealing determination only if the Minister administering section 72B of the Commonwealth Act has made, or is proposing to make, a corresponding Commonwealth emergency dealing determination. Note Section 72B of the Commonwealth Act includes a subsection (3) dealing with threats of a kind mentioned in subsection (2) of that section. (4) The dealings in respect of which the Minister may make an emergency dealing determination 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. Note This section differs from section 72B of the Commonwealth Act. 9 -- 13 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 13 72C Period of effect of emergency dealing determination (1) An emergency dealing determination takes effect— (a) on the day on which the emergency dealing determination is made; or (b) on a later day that is specified in the emergency dealing determination. (2) An emergency dealing determination ceases to have effect— (a) subject to subsection (3), at the end of the period of 6 months starting when the emergency dealing determination takes effect; or (b) at the end of the period specified by the Minister in the emergency dealing determination; or (c) when the emergency dealing determination is revoked— whichever occurs first. (3) The Minister may, by Order published in the Government Gazette, extend the period of effect of an emergency dealing determination. (4) The Minister may extend the period of effect of an emergency dealing determination under subsection (3) more than once, but each single such extension must not exceed 6 months. (5) The Minister may extend the period of effect of an emergency dealing determination only if the Minister administering section 72C of the Commonwealth Act has under that section extended, or is proposing to extend 10 -- 14 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 13 under that section, the period of effect of the corresponding Commonwealth emergency dealing determination. (6) An Order extending the period of effect of an emergency dealing determination takes effect at the time when the determination would have ceased to have effect but for the extension. Note This section differs from section 72C of the Commonwealth Act. Division 3—Effect and conditions of emergency dealing determination 72D Emergency dealing determination authorises dealings, subject to conditions (1) If an emergency dealing determination is in force in respect of dealings with a GMO, those dealings are authorised, subject to the conditions (if any) specified in the emergency dealing determination. (2) Conditions may relate to, but are not limited to, the following— (a) the quantity of GMO in relation to which dealings are covered; (b) the scope of the dealings covered; (c) the purposes for which the dealings may be undertaken; (d) variations to the scope or purposes of the dealings; (e) the source of the GMO; (f) the persons who may deal with the GMO; 11 -- 15 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 13 (g) the information that is required to be given by a person and the person to whom that information is to be given; (h) obligations about informing the Regulator if— (i) a person becomes aware of additional information as to any risks to the health and safety of people, or to the environment, associated with the dealings specified in the emergency dealing determination; or (ii) a person becomes aware of any contraventions of the conditions to which the emergency dealing determination is subject by any person; or (iii) a person becomes aware of any unintended effects of the dealings specified in the emergency dealing determination; (i) the storage and security of the GMO; (j) the required level of containment in respect of the dealings, including requirements relating to the certification of facilities to specified containment levels; (k) waste disposal requirements; (l) the manner in which any quantity of the GMO is to be dealt with if a condition of the emergency dealing determination is breached; (m) measures to manage risks posed to the health and safety of people, or to the environment; 12 -- 16 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 13 (n) data collection, including studies to be conducted; (o) auditing and reporting; (p) the keeping and disclosure of, and access to, records about the GMO; (q) actions to be taken in case of the release of the GMO from a contained environment; (r) the geographic area in which the dealings specified in the emergency dealing determination may occur; (s) requirements for compliance with a code of practice issued under section 24, or a technical or procedural guideline issued under section 27; (t) supervision by, and monitoring by, Institutional Biosafety Committees; (u) contingency planning in respect of unintended effects of the dealings specified in the emergency dealing determination; (v) limiting the dissemination or persistence of the GMO or its genetic material in the environment; (w) any other matters that the Minister thinks appropriate. (3) A condition under subsection (2)(f) may permit dealings with a GMO by, or may impose obligations upon— (a) a specified person or persons; or (b) a specified class of person. 13 -- 17 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 13 (4) It is a condition of an emergency dealing determination that if— (a) a dealing with a GMO is specified in the emergency dealing determination; and (b) a particular condition of the emergency dealing determination applies to the dealing by a person— the person must allow the Regulator, or a person authorised by the Regulator, to enter premises where the dealing is being undertaken, for the purposes of auditing or monitoring the dealing. (5) Subsection (4) does not limit the conditions that may be specified in an emergency dealing determination. Division 4—Variation, suspension and revocation of emergency dealing determination 72E Variation, suspension and revocation of emergency dealing determination (1) The Minister may, by Order published in the Government Gazette, vary the conditions to which an emergency dealing determination is subject, including by imposing new conditions, if the Minister administering section 72E of the Commonwealth Act has made, or is proposing to make, the same variation to the corresponding Commonwealth emergency dealing determination. (2) The Minister may, by Order published in the Government Gazette, suspend or revoke an emergency dealing determination if the Minister administering section 72E of the Commonwealth Act has suspended or 14 -- 18 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 14 revoked, or is proposing to suspend or revoke, (as the case requires) the corresponding Commonwealth emergency dealing determination. Note Section 72E of the Commonwealth Act includes a subsection (3) dealing with consultation with the States in relation to the variation, suspension or revocation of an emergency dealing determination. (4) A variation, suspension or revocation of an emergency dealing determination takes effect— (a) if the Minister states in the variation, suspension or revocation that the variation, suspension or revocation is necessary to prevent imminent risk of death, serious illness, serious injury or serious environmental damage—on the day on which the variation, suspension or revocation is made; or (b) in any other case—on the day specified by the Minister in the variation, suspension or revocation. (5) The day specified as mentioned in subsection (4)(b) must not be earlier than 30 days after the day on which the variation, suspension or revocation is made. Note This section differs from section 72E of the Commonwealth Act.". 14 Simplified outline (Part 7) In section 82 of the Principal Act after "Licence conditions" (where twice occurring) insert ", or conditions to which an emergency dealing determination is subject,". 15 -- 19 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 15 15 Application for certification In the note at the foot of section 83(2) of the Principal Act after "licence" insert ", or conditions to which an emergency dealing determination is subject,". 16 Application for accreditation For the note at the foot of section 91(1) of the Principal Act substitute— Notes 1 The conditions of a licence may require supervision of dealings by an Institutional Biosafety Committee (see section 62(2)(m)), and the regulations may require such supervision of notifiable low risk dealings (see section 75(2)(c)). 2 The conditions to which an emergency dealing determination is subject may require supervision of dealings by an Institutional Biosafety Committee (see section 72D(2)(t)).". 17 Quarterly reports After section 136A(2)(b) of the Principal Act insert— "(ba) emergency dealing determinations made by the Minister during the quarter; (bb) any breaches of conditions of an emergency dealing determination that have come to the Regulator's attention during the quarter;". 18 Record of GMO and GM Product Dealings (1) After section 138(1) of the Principal Act insert— "(1A) The Record must contain the following information, other than confidential commercial information, in relation to each emergency dealing determination made under section 72B— 16 -- 20 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 19 (a) the dealings specified in the emergency dealing determination and the GMO to which those dealings relate; (b) any conditions to which the emergency dealing determination is subject; (c) the date on which the emergency dealing determination takes effect; (d) the date on which the emergency dealing determination will cease to have effect.". (2) In section 138(5) of the Principal Act after "(1)," insert "(1A),". 19 Simplified outline (Part 10) In section 145 of the Principal Act after "protect the environment;" insert— "• enables the Regulator to give directions to a person permitted by an emergency dealing determination to deal with a GMO if— – the Regulator believes that the person is not complying with this Act or the regulations; and – the Regulator believes that it is necessary to do so in order to protect the health and safety of people or to protect the environment or for certain other reasons;". 20 Regulator may give directions For section 146(2)(a) of the Principal Act substitute— "(a) one of the following kinds of persons is not complying with this Act or the regulations in respect of a thing— (i) a person covered by a GMO licence; 17 -- 21 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 21 (ii) a person dealing with, or who has dealt with, a GMO specified in an emergency dealing determination; and". 21 Simplified outline (Part 11) In section 149 of the Principal Act after "a licence" insert "or an emergency dealing determination". 22 Powers available to inspectors for monitoring compliance (1) In section 152(2)(c) of the Principal Act for "time." substitute "time; or". (2) After section 152(2)(c) of the Principal Act insert— "(d) the occupier of the premises is a person dealing with, or who has dealt with, a GMO specified in an emergency dealing determination, and the entry is at a reasonable time.". 23 Part does not limit power to impose conditions (1) In the heading to section 177 of the Principal Act omit "licence". (2) In section 177 of the Principal Act after "conditions" insert "or the Minister's power to impose conditions on an emergency dealing determination". 24 Interference with dealings with GMOs (1) In section 192A(2) of the Principal Act after paragraph (a) of the definition of authorised GMO dealings insert— "(aa) that are specified in an emergency dealing determination and are not prohibited from being undertaken at the premises or facility by a condition of the determination; or". 18 -- 22 of 47 -- Part 2—Emergency Dealing Determinations Gene Technology Amendment Act 2007 No. 43 of 2007 s. 24 (2) In section 192A(2) of the Principal Act in paragraph (d) of the definition of authorised GMO dealings after "are" insert "dealings". __________________ 19 -- 23 of 47 -- Part 3—Gene Technology Ethics and Community Consultative Committee Gene Technology Amendment Act 2007 No. 43 of 2007 s. 25 PART 3—GENE TECHNOLOGY ETHICS AND COMMUNITY CONSULTATIVE COMMITTEE 25 Definitions (1) In section 10(1) of the Principal Act omit the definitions of Consultative Committee and Ethics Committee. (2) Insert the following definition in section 10(1) of the Principal Act— "Ethics and Community Committee means the Gene Technology Ethics and Community Consultative Committee established by section 106 of the Commonwealth Act;". 26 Heading to Part 8 For the heading to Part 8 of the Principal Act substitute— "PART 8—THE GENE TECHNOLOGY TECHNICAL ADVISORY COMMITTEE AND THE GENE TECHNOLOGY ETHICS AND COMMUNITY CONSULTATIVE COMMITTEE". 27 Simplified outline (Part 8) In section 99 of the Principal Act for ", the Gene Technology Community Consultative Committee and the Gene Technology Ethics Committee" substitute "and the Gene Technology Ethics and Community Consultative Committee". 28 The Gene Technology Ethics and Community Consultative Committee (1) In the heading to Division 3 of Part 8 of the Principal Act after "Technology" insert "Ethics and". 20 -- 24 of 47 -- Part 3—Gene Technology Ethics and Community Consultative Committee Gene Technology Amendment Act 2007 No. 43 of 2007 s. 29 (2) In the heading to section 106 of the Principal Act after "Technology" insert "Ethics and". (3) In the note at the foot of section 106 of the Principal Act after "Technology" insert "Ethics and". (4) In the note at the foot of sections 108, 109 and 110 of the Principal Act for "Consultative Committee" substitute "Ethics and Community Committee". (5) In the note at the foot of section 110 of the Principal Act for "operation" substitute "procedures". (6) Section 110A of the Principal Act is repealed. (7) Division 4 of Part 8 of the Principal Act is repealed. 29 New section 107 substituted For section 107 of the Principal Act substitute— "107 Function of Ethics and Community Committee The function of the Ethics and Community Committee under this Act is to provide advice, on the request of the Regulator or the Ministerial Council, on the following— (a) ethical issues relating to gene technology; (b) the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs; (c) the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons; 21 -- 25 of 47 -- Part 3—Gene Technology Ethics and Community Consultative Committee Gene Technology Amendment Act 2007 No. 43 of 2007 s. 30 (d) the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products and the content of such principles, guidelines and codes; (e) community consultation in respect of the process for applications for licences covering dealings that involve the intentional release of a GMO into the environment; (f) risk communication matters in relation to dealings that involve the intentional release of a GMO into the environment; (g) matters of general concern identified by the Regulator in relation to applications made under this Act; (h) matters of general concern in relation to GMOs.". 30 New sections 111 and 112 inserted After section 110 of the Principal Act insert— "111 Subcommittees Note Section 111 of the Commonwealth Act deals with the establishment of subcommittees by the Ethics and Community Committee. 112 Expert advisers Note Section 112 of the Commonwealth Act provides for the appointment of expert advisers to the Ethics and Community Committee.". __________________ 22 -- 26 of 47 -- Part 4—Assessment of Applications: Limited and Controlled Release and Consultation on Significant Risk Gene Technology Amendment Act 2007 No. 43 of 2007 s. 31 PART 4—ASSESSMENT OF APPLICATIONS: LIMITED AND CONTROLLED RELEASE AND CONSULTATION ON SIGNIFICANT RISK 31 Repeal of section 49 Section 49 of the Principal Act is repealed. 32 Regulator must prepare risk assessment and risk management plan (1) Section 50(2) of the Principal Act is repealed. (2) In section 50(3) of the Principal Act for "The" substitute "Unless section 50A applies in relation to the application for the licence, the". 33 New section 50A inserted After section 50 of the Principal Act insert— "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 23 -- 27 of 47 -- Part 4—Assessment of Applications: Limited and Controlled Release and Consultation on Significant Risk Gene Technology Amendment Act 2007 No. 43 of 2007 s. 33 (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— 24 -- 28 of 47 -- Part 4—Assessment of Applications: Limited and Controlled Release and Consultation on Significant Risk Gene Technology Amendment Act 2007 No. 43 of 2007 s. 33 (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.". 25 -- 29 of 47 -- Part 4—Assessment of Applications: Limited and Controlled Release and Consultation on Significant Risk Gene Technology Amendment Act 2007 No. 43 of 2007 s. 34 34 Matters Regulator must take into account in preparing risk assessment and risk management plan (1) In section 51(1)(a) of the Principal Act for "mentioned in section 49(2)(a) to (f)" substitute "prescribed by the regulations". (2) Section 51(1)(b) of the Principal Act is repealed. (3) Section 51(2)(b) of the Principal Act is repealed. 35 Public notification of risk assessment and risk management plan (1) In section 52(1) of the Principal Act omit "49 (if applicable),". (2) After section 52(2)(b) of the Principal Act insert— "(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". (3) In section 52(2)(d) of the Principal Act for "than 30 days after the date on which the notice was published." substitute— "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.". __________________ 26 -- 30 of 47 -- Part 5—Provisions Relating to Variation Gene Technology Amendment Act 2007 No. 43 of 2007 s. 36 PART 5—PROVISIONS RELATING TO VARIATION 36 Variation of licence (1) For section 71(1) of the Principal Act substitute— "(1) The Regulator may vary a licence, by notice in writing given to the licence holder— (a) at any time, on the Regulator's own initiative; or (b) on application by the licence holder. (1A) An application for a variation 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.". (2) In section 71(2) of the Principal Act for "However, the" substitute "The". (3) After section 71(2) of the Principal Act insert— "(2A) The Regulator must not vary a licence if the original application for the licence was an application to which section 50A applied, unless— (a) the Regulator is satisfied that the principal purpose of the licence as proposed to be varied is to enable the licence holder, and persons covered by the licence, to conduct experiments; and (b) the application for variation proposes, in relation to any GMO in respect of which dealings are proposed to be authorised as a result of the variation— 27 -- 31 of 47 -- Part 5—Provisions Relating to Variation Gene Technology Amendment Act 2007 No. 43 of 2007 s. 36 (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). Note Section 50A applies to an application that proposes controls and limits on the dissemination, persistence and release of the GMO concerned and is for the purpose of conducting experiments. (2B) The Regulator must not vary a licence if the Regulator is satisfied that the risk assessment and the risk management plan in respect of the original application for the licence did not cover the risks posed by the dealings proposed to be authorised by the licence as varied.". (4) In section 71(4) of the Principal Act for "However, the Regulator must not vary the" substitute "The Regulator must not vary a". (5) After section 71(4) of the Principal Act insert— "(5) The Regulator must not vary a licence unless any local council that the Regulator considers appropriate has been consulted on the proposed variation. (6) The Regulator must not vary a licence in the circumstances (if any) prescribed by the regulations. 28 -- 32 of 47 -- Part 5—Provisions Relating to Variation Gene Technology Amendment Act 2007 No. 43 of 2007 s. 37 (7) If an application has been made for variation of a licence, the Regulator must vary the licence, or refuse to vary the licence, within the period (if any) prescribed by the regulations. (8) For the purposes of subsection (2A)— controls has the same meaning as in section 50A(2); limits has the same meaning as in section 50A(3).". 37 Review of decisions After item 4 in the table in section 179 of the Principal Act insert— "4A To refuse to vary a licence section 71 the licence holder". __________________ 29 -- 33 of 47 -- Part 6—Regulator's Power to Direct Gene Technology Amendment Act 2007 No. 43 of 2007 s. 38 PART 6—REGULATOR'S POWER TO DIRECT 38 Simplified outline (Part 10) In section 145 of the Principal Act after "environment" insert ", or for certain other reasons". 39 Regulator may give directions (1) For section 146(1)(b) of the Principal Act substitute— "(b) either of the following applies— (i) it is necessary to exercise powers under this section in order to protect the health and safety of people or to protect the environment; (ii) it is desirable in the public interest, having regard to the matters specified in subsection (2A), for the Regulator to exercise powers under this section—". (2) For section 146(2)(b) of the Principal Act substitute— "(b) either of the following applies— (i) it is necessary to exercise powers under this section in order to protect the health and safety of people or to protect the environment; (ii) it is desirable in the public interest, having regard to the matters specified in subsection (2A), for the Regulator to exercise powers under this section—". 30 -- 34 of 47 -- Part 6—Regulator's Power to Direct Gene Technology Amendment Act 2007 No. 43 of 2007 s. 39 (3) After section 146(2) of the Principal Act insert— "(2A) For the purposes of deciding under subsection (1)(b)(ii) or (2)(b)(ii) whether it is desirable to exercise powers under this section to give directions to a licence holder or another person, the Regulator must have regard to the following— (a) the types of dealings with GMOs authorised by the licence or specified in the emergency dealing determination concerned, and, in particular, whether the dealings are ongoing; (b) whether measures have been, or are being, taken to address the non-compliance with this Act or the regulations that the Regulator believes is occurring (the suspected non-compliance); (c) the likelihood of the licence holder or other person not complying with this Act or the regulations at a future time; (d) the severity of the suspected non-compliance; (e) whether, on one or more occasions, the licence holder or the other person— (i) has been charged with or convicted of an offence against this Act; or (ii) has been given a direction under this section; (f) other means available to the Regulator to address the suspected non-compliance (including, but not limited to, by cancelling, varying or 31 -- 35 of 47 -- Part 6—Regulator's Power to Direct Gene Technology Amendment Act 2007 No. 43 of 2007 s. 39 suspending a licence, accreditation or certification); (g) whether, in the Regulator's opinion, the suspected non-compliance was deliberate; (h) the desirability of deterring future non-compliance with this Act or the regulations.". __________________ 32 -- 36 of 47 -- Part 7—Inadvertent Dealings Gene Technology Amendment Act 2007 No. 43 of 2007 s. 40 PART 7—INADVERTENT DEALINGS 40 Definition Insert the following definition in section 10(1) of the Principal Act— "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;". 41 New section 40A inserted After section 40 of the Principal Act insert— "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.". 33 -- 37 of 47 -- Part 7—Inadvertent Dealings Gene Technology Amendment Act 2007 No. 43 of 2007 s. 42 42 New section 46A inserted After section 46 of the Principal Act insert— "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 dealings to be undertaken for the purposes of, or for purposes relating to, disposing of a GMO; and (b) the applicant for the licence came into possession of the GMO inadvertently.". 43 New section 49 inserted After section 48 of the Principal Act insert— "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 dealings to be undertaken for the purposes of, or for purposes relating to, disposing of a GMO; and (b) the applicant for the licence came into possession of the GMO inadvertently.". 34 -- 38 of 47 -- Part 7—Inadvertent Dealings Gene Technology Amendment Act 2007 No. 43 of 2007 s. 44 44 Regulator must not issue the licence unless satisfied as to risk management At the foot of section 56 of the Principal Act insert— "Note Subsections (2)(a), (2)(b) and (2)(c) do not apply to an inadvertent dealings application.". 45 Other circumstances in which Regulator must not issue the licence After section 57(2) of the Principal Act insert— "(3) Subsection (2) does not apply to an inadvertent dealings application.". 46 Period of licence After section 60(2) of the Principal Act insert— "(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.". __________________ 35 -- 39 of 47 -- Part 8—Technical Amendments Gene Technology Amendment Act 2007 No. 43 of 2007 s. 47 PART 8—TECHNICAL AMENDMENTS 47 Definitions (1) In the definition of deal with in section 10(1) of the Principal Act— (a) for paragraph (g) substitute— "(g) import the GMO; (h) transport the GMO; (i) dispose of the GMO—"; (b) for the expression commencing "and includes" and ending at the end of the definition substitute— "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);". (2) In the definition of Institutional Biosafety Committee in section 10(1) of the Principal Act for "by an accredited organisation as an Institutional Biosafety Committee" substitute "as an Institutional Biosafety Committee in accordance with written guidelines issued by the Regulator under section 98". 48 Regulator may require applicant to give further information After section 42(2) of the Principal Act insert— "(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.". 36 -- 40 of 47 -- Part 8—Technical Amendments Gene Technology Amendment Act 2007 No. 43 of 2007 s. 49 49 Regulator must consider applications except in certain circumstances (1) In section 43(2) of the Principal Act after "application" (where first occurring) insert ", or may cease considering the application,". (2) In section 43(2)(e) of the Principal Act for "21." substitute "21; or". (3) After section 43(2)(e) of the Principal Act insert— "(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.". 50 Regulator must not issue the licence unless satisfied as to risk management For section 56(2)(a) and (b) of the Principal Act substitute— "(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;". 51 Regulator to notify of proposed suspension, cancellation or variation After section 72(6) of the Principal Act insert— "(7) This section does not apply to a variation of a licence if the Regulator is satisfied that the variation is of minor significance or complexity.". 52 Regulator may include dealings with GMOs on GMO register In section 78(3) of the Principal Act omit the second sentence. 37 -- 41 of 47 -- Part 8—Technical Amendments Gene Technology Amendment Act 2007 No. 43 of 2007 s. 53 53 Regulator to notify of proposed suspension, cancellation or variation After section 89(6) of the Principal Act insert— "(7) This section does not apply to a variation of a licence if the Regulator is satisfied that the variation is of minor significance or complexity.". 54 New section 89A inserted After section 89 of the Principal Act insert— "89A Transfer of certification (1) The holder of a certification and another person (the transferee) may jointly apply to the Regulator for the certification to be transferred from the holder of the certification to the transferee. (2) The application must be in writing, and must contain— (a) such information as is prescribed by the regulations (if any); and (b) such information as is specified in writing by the Regulator. (3) The Regulator must not transfer the certification unless the Regulator is satisfied that, if the certification is transferred, any conditions to which the certification is subject will continue to be met. (4) The Regulator must give written notice of his or her decision on the application to the holder of the certification and the transferee. (5) If the Regulator decides to transfer the certification— (a) the transfer takes effect on the date specified in the notice; and 38 -- 42 of 47 -- Part 8—Technical Amendments Gene Technology Amendment Act 2007 No. 43 of 2007 s. 55 (b) the certification continues in force; and (c) the certification is subject to the same conditions as those in force immediately before the transfer.". 55 Regulator may accredit organisations (1) In section 92(2)(a) of the Principal Act omit ", or proposes to establish,". (2) For section 92(2)(b) and (c) of the Principal Act substitute— "(b) if the organisation has established an Institutional Biosafety Committee—whether the organisation will be able to maintain the Institutional Biosafety Committee in accordance with such guidelines; and (c) if the organisation has established an Institutional Biosafety Committee—whether the organisation has appropriate indemnity arrangements for its Institutional Biosafety Committee members; and (ca) if the organisation has not established an Institutional Biosafety Committee as mentioned in paragraph (a)—whether the organisation will be in a position to use an Institutional Biosafety Committee established by an accredited organisation; and". 56 Regulator to notify of proposed suspension, cancellation or variation After section 97(6) of the Principal Act insert— "(7) This section does not apply to a variation of an accreditation if the Regulator is satisfied that the variation is of minor significance or complexity.". 39 -- 43 of 47 -- Part 8—Technical Amendments Gene Technology Amendment Act 2007 No. 43 of 2007 s. 57 57 Review of decisions (1) Before item 1 in the table in section 179 of the Principal Act insert— "1A To refuse to consider an application on the basis that the applicant is not a suitable person to hold a licence section 43(2)(f) the applicant". (2) After item 3 in the table in section 179 of the Principal Act insert— "3A To refuse to transfer a licence section 70 an applicant for the transfer". (3) After item 7 in the table in section 179 of the Principal Act insert— "7A To refuse to transfer a certification section 89A an applicant for the transfer". 58 Deadlines for making reviewable decisions (1) For section 182(a) of the Principal Act substitute— "(a) this Act provides for a person to make an application of any kind to the Regulator; and". (2) In section 182 of the Principal Act for "decision to reject the application" substitute "reviewable decision to reject the application, and the person may seek internal review of the reviewable decision under section 181". 40 -- 44 of 47 -- Part 8—Technical Amendments Gene Technology Amendment Act 2007 No. 43 of 2007 s. 59 59 Regulator may declare that information is confidential commercial information After section 185(3A) of the Principal Act insert— "(3B) If— (a) a person has made an application under section 184 for a declaration that specified information is confidential commercial information; and (b) the Regulator has not yet made a decision on the application— the information is to be treated as confidential commercial information until the Regulator makes a decision on the application.". __________________ 41 -- 45 of 47 -- Part 9—Repeal of Amending Act Gene Technology Amendment Act 2007 No. 43 of 2007 s. 60 PART 9—REPEAL OF AMENDING ACT 60 Repeal of amending Act This Act is repealed on 1 January 2009. ═══════════════ 42 -- 46 of 47 -- Gene Technology Amendment Act 2007 No. 43 of 2007 Endnotes ENDNOTES † Minister's second reading speech— Legislative Assembly: 19 July 2007 Legislative Council: 23 August 2007 The long title for the Bill for this Act was "A Bill for an Act to amend the Gene Technology Act 2001 and for other purposes." 43 -- 47 of 47 --