House of Assembly Fifty-First Parliament, Third Session (51-3) 51 3 Parliament of South Australia House of Assembly published Bills Gene Technology (Miscellaneous) Amendment Bill GENE TECHNOLOGY (MISCELLANEOUS) AMENDMENT BILL Introduction and First Reading Introduction and First Reading The Hon. J.D. HILL House of Assembly Kaurna Minister for Health Minister for the Southern Suburbs Minister Assisting the Premier in the Arts The Hon. J.D. HILL (Kaurna—Minister for Health, Minister for the Southern Suburbs, Minister Assisting the Premier in the Arts) (15:54): Obtained leave and introduced a bill for an act to amend the Gene Technology Act 2001. Read a first time. Second Reading Second Reading The Hon. J.D. HILL House of Assembly Kaurna Minister for Health Minister for the Southern Suburbs Minister Assisting the Premier in the Arts The Hon. J.D. HILL (Kaurna—Minister for Health, Minister for the Southern Suburbs, Minister Assisting the Premier in the Arts) (15:54): I move: That this bill be now read a second time. I seek leave to have the second reading explanation inserted in Hansard without my reading it. Leave granted. This Bill amends the Gene Technology Act 2001 (the South Australian Act) in a manner consistent with amendments made to the Gene Technology Act 2000 of the Commonwealth (the Commonwealth Act), in order to preserve consistency with the national regulatory scheme for gene technology. The purpose of the amendments is to improve the operation of the Act without changing the underlying policy intent or overall legislative framework of the regulatory scheme. The South Australian Act is the State Government’s component of the nationally consistent regulatory scheme for gene technology. Under the Gene Technology Agreement 2001 (the Intergovernmental Agreement), all States and Territories are committed to maintaining corresponding legislation. The object of the Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs). In 2005-06, an independent review of the Commonwealth Act and the Intergovernmental Agreement was conducted. This review found that the national regulatory scheme had worked well in the 5 years following introduction, and that no major changes were required. However, it suggested a number of minor changes, aimed at improving the operation of the legislation. On 27 October 2006, the Gene Technology Ministerial Council, an intergovernmental body comprised of State, Territory and Australian Government Ministers, agreed to proposals to implement the recommendations of the Review which included amendments to the Commonwealth Act which took effect on 1 July 2007. This Bill proposes to implement the corresponding amendments in the South Australian Act. These changes include introducing emergency powers that give the Federal Minister, in consultation with the Gene Technology Ministerial Council, the ability to expedite the approval of a dealing with a GMO in an emergency. Such an emergency could be, for example, the need to allow a genetically modified vaccine to enable a timely response to a disease outbreak or use of a genetically modified organism to aid in degrading an environmental toxin. Other changes proposed in the Bill include improving the mechanisms for providing advice to the Gene Technology Regulator (the Regulator); streamlining the processes for the initial consideration of licences; reducing the compliance burden for low risk dealings; providing clarification on the circumstances in which licence variations can be made and the circumstances under which the Regulator can direct a person to comply with the South Australian Act; 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; and technical amendments to improve the operation of the South Australian Act. I commend the Bill to Members. Explanation of Clauses Explanation of Clauses Part 1—Preliminary 1—Short title 2—Commencement 3—Amendment provisions These clauses are formal. Part 2—Amendment of Gene Technology Act 2001 4—Amendment of section 8B—Notes This proposed amendment would provide that notes form part of the South Australian Act. 5—Amendment of section 10—Definitions This proposed amendment would insert a number of new definitions for the purposes of the South Australian Act and make related changes to current definitions. In particular, an emergency dealing determination is defined as a determination in force under section 72B and an inadvertent dealings application is defined as an application for a GMO licence to which Division 3 or 4 of Part 5 does not apply because of the application of section 46A or 49. A note is also to be inserted that points out that section 10 of the South Australian Act is different from section 10 of the Commonwealth Act. 6—Amendment of section 31—Simplified outline This proposed amendment adds another paragraph to make it clear that a dealing specified in an emergency dealing determination is not prohibited under the Part. 7—Amendment of section 32—Person not to deal with a GMO without a licence Current section 32(1) provides that a person commits an offence if he or she deals with a GMO in the circumstances set out in that subsection. The subsection is to be clarified and an additional circumstance added; that is, that the dealing with the GMO is not specified in an emergency dealing determination, and the person knows or is reckless as to that fact. 8—Amendment of section 33—Person not to deal with a GMO without a licence—strict liability offence 9—Amendment of section 34—Person must not breach conditions of a GMO licence Clauses 8 and 9 would insert a new paragraph (ba) into current section 34(1) and a reference to that new paragraph in current section 34(2). The effect of these amendments is to provide that it will also be a strict liability offence for a person to deal with a GMO, knowing that it is a GMO, if the dealing is not specified in an emergency dealing determination. 10—Insertion of sections 35A and 35B 35A—Person must not breach conditions of emergency dealing determination Proposed section 35A is similar to current section 34. Proposed subsection (1) creates an offence for intentionally breaching the conditions of an emergency dealing determination. Proposed subsection (2)(a) provides that the penalty for an aggravated offence is imprisonment for 5 years or a fine of $220,000, while in any other case, the penalty will be imprisonment for 2 years or a fine of $55,000. 35B—Person must not breach conditions of emergency dealing determination—strict liability offence Proposed section 35B creates a strict liability offence for breaching the conditions of an emergency dealing determination and is similar to current section 35. In order to have committed an offence under proposed subsection (1), the person must have knowledge of the conditions to which the emergency dealing determination is subject, but need not know that he or she is breaching that condition. Proposed subsection (2) provides that strict liability applies to proposed subsection (1)(a) and (c). The penalty for an offence under this proposed section is $22,000 for an aggravated offence or, in any other case, $5,500. 11—Insertion of section 40A 40A—Licences relating to inadvertent dealings New section 40A provides that 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. 12—Amendment of section 42—Regulator may require applicant to give further information The proposed amendment provides that 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. 13—Amendment of section 43—Regulator must consider applications except in certain circumstances The proposed amendment to current section 43(2) adds an additional paragraph that provides that the Regulator is not required to consider an application under Part 5 Division 2 for a licence if 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. 14—Insertion of section 46A 46A—Division does not apply to an application relating to inadvertent dealings New section 46A provides that Division 3 of Part 5 does not apply to an application for a GMO licence if the Regulator is satisfied that— 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 the applicant for the licence came into possession of the GMO inadvertently. 15—Substitution of section 49 49—Division does not apply to an application relating to inadvertent dealings Current section 48 makes provision for applications to which Division 4 of Part 5 apply. Substituted section 49 clarifies the position to provide that, despite section 48, Division 4 does not apply to an application for a GMO licence if the Regulator is satisfied that— 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 the applicant for the licence came into possession of the GMO inadvertently. 16—Amendment of section 50—Regulator must prepare risk assessment and risk management plan These proposed amendments are consequential on the insertion of proposed section 50A and allow the Regulator to prepare a risk assessment and risk management plan without consulting with the various bodies set out in current section 50(3) if new section 50A applies in relation to the application for the licence. 17—Insertion of section 50A 50A—Limited and controlled release applications Proposed section 50A(1) provides that this section applies to an application for a licence if the Regulator is satisfied that— the principal purpose of the application is to enable the licence holder, and persons covered by the licence, to conduct experiments; and the application proposes, in relation to any GMO in respect of which dealings are proposed to be authorised— controls to restrict the dissemination or persistence of the GMO and its genetic material in the environment; and limits on the proposed release of the GMO; and 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). 18—Amendment of section 51—Matters Regulator must take into account in preparing risk assessment and risk management plan The first amendment proposed to this section will remove the unnecessary reference to the matters set out in current section 49(2)(a) to (f) and insert, instead, a reference to matters prescribed by regulation. The other proposed amendments tidy up subsection (2) and are related to the amendments proposed by clauses 16 and 17. 19—Amendment of section 52—Public notification of risk assessment and risk management plan These proposed amendments set out some additional requirements relating to public notification by the Regulator of the risk assessment and risk management plan. 20—Amendment of section 56—Regulator must not issue the licence unless satisfied as to risk management These proposed amendments insert a reference to a risk assessment and risk management plan being prepared under section 47 in current subsection (1) and a note that provides that subsections (2)(a), (b) and (c) do not apply to an inadvertent dealings application. 21—Amendment of section 57—Other circumstances in which Regulator must not issue the licence This clause provides for a new subsection to be inserted in current section 57 which provides that subsection (2) does not apply to an inadvertent dealings application. 22—Amendment of section 60—Period of licence This clause provides for an additional subsection that provides that 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. 23—Amendment of section 67—Protection of persons who give information This amendment is consequential. 24—Amendment of section 71—Variation of licence The proposed amendments to this clause will allow for the Regulator to vary a licence (by notice in writing) at any time on the Regulator's own initiative, or on application by the licence holder. The power of the Regulator to vary a licence is subject to a number of exceptions or conditions to be inserted under the proposed amendments. 25—Amendment of section 72—Regulator to notify of proposed suspension, cancellation or variation The proposed amendment provides that the Regulator is not required to give written notice of a proposed variation of a licence to the licence holder if the variation is of minor significance or complexity. 26—Redesignation of section 72A It is proposed to redesignate current section 72A as section 72AA to allow for new sections to be inserted into the South Australian Act (see the following clause). 27—Insertion of Part 5A Part 5A—Emergency dealing determinations Division 1—Simplified outline 72A—Simplified outline New section 72A is a simplified outline for the new Part. It provides that the Part creates a system under which the Minister can make a determination relating to dealings with GMOs in an emergency. Division 2—Making of emergency dealing determination 72B—Minister may make emergency dealing determination New section 72B(1) gives the Minister power to make an emergency dealing determination by order published in the Gazette. The emergency dealing determination effectively authorises the specified dealings with a GMO so that the penalty provisions in Part 4 of the Act will not apply. In accordance with the nationally consistent scheme, new section 72B(2) provides that the Minister may make an emergency dealing determination only if the relevant Commonwealth Minister has already made, or is proposing to make, such a determination, known as 'a corresponding Commonwealth emergency dealing determination'. Section 72B(2) of the Commonwealth Act sets out the conditions under which the Commonwealth Minister is permitted to make an emergency dealing determination. It provides that before making an emergency dealing determination the Commonwealth Minister must— have received advice from the Commonwealth Chief Medical Officer, the Commonwealth Chief Veterinary Officer, the Commonwealth Chief Plant Protection Officer or a person specified in the regulations, that there is an actual or imminent threat to the health and safety of people or the environment and that the dealings proposed to be specified in the emergency dealing determination would, or would be likely to, adequately address the threat; and be satisfied that there is an actual or imminent threat to the health and safety of people or the environment and that the dealings proposed to be covered by the emergency dealing determination would, or would be likely to, adequately address the threat; and be satisfied that the risks posed by the proposed dealings can be managed safely, and have received advice from the Regulator to that effect. States and Territories must also have been consulted about the proposed emergency dealing determination. This means that before making a determination under new section 72B(1) of the Act, the Minister will have had input into the decision-making process leading to the 'corresponding Commonwealth emergency dealing determination'. Examples given in section 72B(3) of the Commonwealth Act of situations in which it may be appropriate to make an emergency dealing determination include— where there is a threat of disease; where there is a threat from an animal or plant (such as a pest or alien invasive species); or where there is a threat from industrial spillage. The new section makes it clear that the threat must be actual and imminent for the emergency provisions to apply. It is expected that the provisions will only be utilised if a threat is serious and immediate. New section 72B(1) restricts the Minister's power to make an emergency dealing determination to making 1 the same as any made or proposed by the Commonwealth Minister, to ensure that the exemption from all the offences in Part 4 in relation to that dealing will apply consistently to all those dealing with GMOs throughout the State. New section 72B(4) sets out the types of dealings for which the Minister will be able to make an emergency dealing determination. It makes clear that the determination may be in respect of all dealings with a GMO, a specified class of dealings, or 1 or more specified dealings and may relate to a specific GMO or a class of GMOs. This provision is drafted in similar terms to existing section 32(4) of the Act dealing with exempt GMOs. 72C—Period of effect of emergency dealing determination New section 72C(1) sets out that a determination can take effect on the day it is made or at a specified later date. In other words, the determinations cannot apply retrospectively. Subsection (2) provides that a determination ceases to have effect on a date specified in the determination, or the date on which the determination is revoked, or after 6 months, whichever occurs first; and subsection (3) provides that the Minister may extend an emergency dealing determination by order published in the Gazette. New subsection (4) provides that the Minister may extend the emergency dealing determination more than once, but only for up to 6 months at a time. New subsection (5) provides that the Minister may extend the period of effect of an emergency dealing determination if the Commonwealth Minister has extended the period of effect, or is proposing to extend the period of effect, of the corresponding Commonwealth emergency dealing determination. New subsection (6) provides that an order extending the period of effect of an emergency dealing determination takes effect at the time the original determination would have ended if not extended. Division 3—Effect and conditions of emergency dealing determination 72D—Emergency dealing determination authorises dealings, subject to conditions New section 72D(1) allows conditions to be imposed on an emergency dealing determination. Subsections (2)(a) to (v) give examples of the conditions that may be imposed. These include conditions relating to the quantity of GMO, the scope of dealings, the source of GMO, the person who may deal with the GMO, information required to be given to persons permitted to deal with a GMO, additional information that must be provided to the Regulator and the storage and security of the GMO amongst other things. Subsection (2)(w) clarifies that the conditions the Minister may impose are not limited to the matters listed in paragraphs (a) to (v) but that the Minister may impose conditions over any other matter he or she considers appropriate. Paragraphs (a) to (v) of subsection (2) correspond to the current sections 62, 63 and 64, which relate to the conditions that may be imposed on licences. Subsection (2)(f) provides that a condition may specify the person who may deal with the GMO and subsection (3) makes it clear that it is not necessary to specify a single person, that a condition can specify persons or a class of persons who may deal with the GMO. There are no restrictions on who may be included in the class of persons who may deal with the GMO, or how large the class may be. Subsection (4) is drafted in similar terms to current section 64. It provides that it is a condition of an emergency dealing determination that a person permitted to deal with a GMO under an emergency dealing determination must allow the Regulator (or delegate) to enter premises where the dealing is being undertaken, in order to conduct audits, or monitor the dealings covered by the emergency dealing determination. This allows the Regulator to undertake routine or 'on-the-spot' auditing or monitoring of dealings covered by an emergency dealing determination. Subsection (5) makes it clear that subsection (4) does not limit the conditions that may be placed on an emergency dealing determination. Division 4—Variation, suspension and revocation of emergency dealing determination 72E—Variation, suspension and revocation of emergency dealing determination New section 72E(1) provides that the Minister may, by order in the Gazette, vary the conditions of an emergency dealing determination if the relevant Commonwealth Minister has made, or is proposing to make, the same variation to the corresponding Commonwealth emergency dealing determination. This power to vary includes the power to impose new conditions. New section 72E(2) provides that the Minister may, by order in the Gazette, suspend or revoke an emergency dealing determination if the relevant Commonwealth Minister has suspended or revoked, or is proposing to suspend or revoke, the corresponding Commonwealth emergency dealing determination. The corresponding provisions of the Commonwealth Act set out the relevant circumstances for the Commonwealth Minister. Paragraph (a) of subsection (4) provides that a variation, suspension or revocation of an emergency dealing determination may take effect immediately only if the Minister states that this is necessary to prevent imminent risk of death, serious illness or serious injury or serious damage to the environment and paragraph (b) provides that, in any other case, the variation, suspension or revocation will take effect on the day specified by the Minister in the order making the variation, suspension or revocation. Subsection (5) provides that the date specified in the order under subsection (4)(b) must be 30 days or more after it is made. 28—Amendment of section 78—Regulator may include dealings with GMOs on GMO register This clause amends section 78(3) of the Act to remove the requirement that a registration of a dealing, made on the application of a licence holder, can only take effect if the licence authorising the dealing ceases to be in force. 29—Amendment of section 82—Simplified outline This clause amends the simplified outline to Part 7 of the South Australian Act to include conditions of an emergency dealing determination, along with licence conditions, as conditions that could require a facility to be certified under Division 2 of the Part, or an organisation to be accredited under Division 3 of the Part. 30—Amendment of section 83—Application for certification This clause inserts words into the note at the foot of section 83(2) to make clear that the conditions of an emergency dealing determination could require a facility to be certified under Division 2 of Part 7. 31—Amendment of section 89—Regulator to notify of proposed suspension, cancellation or variation This clause inserts subsection (7), which provides that section 89, which includes, among other things, requirements of notice of proposed variations of certification, does not apply where the proposed variation is of minor significance or complexity. 32—Insertion of section 89A 89A—Transfer of certification New section 89A(1) provides for transfers of certification by way of a joint application between the holder of the certification and the transferee; subsection (2) requires the application to be in writing and contain information prescribed by the Regulations or specified in writing by the Regulator; subsection (3) prohibits the Regulator from transferring certification unless satisfied that the conditions to which the certification is subject will continue to be met; subsection (4) requires the Regulator to give written notice of his or her decision to the applicants; and subsection (5) provides for the transfer, if approved, to take effect on the date specified in the notice, for the certification to continue in force and for the certification to be subject to the same conditions which applied before the transfer. 33—Amendment of section 91—Application for accreditation This clause replaces the note at the foot of section 91(1) with notes that make it clear that the conditions of an emergency dealing determination could require supervision by an Institutional Biosafety Committee (IBC). 34—Amendment of section 92—Regulator may accredit organisations This clause amends section 92(2)(a) to remove the obligation for the Regulator to have regard to whether or not an organisation proposes to establish an IBC for the purposes of deciding whether to accredit an organisation. The other proposed amendment substitutes paragraphs (b) and (c) of subsection (2) and inserts a new paragraph (ca). The new provisions require the Regulator, for purposes of accrediting organisations, to have regard to— whether an organisation will be able to maintain an IBC already established; whether an organisation has appropriate indemnity arrangements if the organisation has established an IBC; whether or not the organisation will be in a position to use an IBC established by another accredited organisation. 35—Amendment of section 97—Regulator to notify of proposed suspension, cancellation or variation This clause inserts a new subsection (7) which provides that section 97, which includes, among other things, requirements of notice of proposed variations of accreditation, does not apply where the proposed variation is of minor significance or complexity. 36—Substitution of heading to Part 8 It is proposed to amend the heading to Part 8 to the Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee as a result of combining the Gene Technology Ethics Committee (the Ethics Committee) and the Gene Technology Community Consultative Committee (the Consultative Committee) into 1 advisory committee. The combined committee will be known as the Gene Technology Ethics and Community Consultative Committee (the Ethics and Community Committee) and will carry out the combined functions of both committees as well as providing advice on risk communication and community consultation in relation to intentional release licence applications. The object of the amendments proposed to Part 8 is to increase efficiency by addressing the overlap between the roles of the Ethics Committee and the Consultative Committee. The new committee will also allow relevant skills to be distributed across its membership so that the committee is able to provide clear, balanced, appropriate and more coordinated advice. 37—Amendment of section 99—Simplified outline This clause amends the simplified outline of Part 8 in section 99 to replace the names of the previously existing committees with that of the new combined committee. 38—Amendment of heading to Part 8 Division 3 39—Amendment of section 106—The Gene Technology Ethics and Community Consultative Committee These proposed amendments are consequential. 40—Substitution of section 107 107—Function of Ethics and Community Committee New section 107 provides that the function of the Ethics and Community Committee will be to provide advice, at the request of the Regulator or the Ministerial Council, on— matters on which the Ethics Committee currently advises; matters on which the Consultative Committee currently advises; community consultation matters relating to intentional release licence applications; and risk communication matters relating to dealings that involve the intentional release of a GMO into the environment. Risk communication involves an interactive dialogue between risk assessors, risk managers and stakeholders. It underpins the processes of risk assessment and risk management. The new section 107 is not intended to mandate the examination of every intentional release application; instead it is intended to permit the Regulator to seek advice in relation to certain types of releases that might be precipitated by such an application. The matters on which the Ethics Committee currently advises are set out in section 112 of the current Act. These are—ethical issues relating to gene technology; the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs; and the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons. These matters have been incorporated into new section 107(a), (b) and (c). The matters on which the Consultative Committee currently advises are set out in current section 107. These are—matters of general concern identified by the Regulator in relation to applications, matters of general concern in relation to GMOs, and the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products and the conduct of such principles, guidelines and codes. These matters have been incorporated into new section 107(d), (g), and (h). 41—Amendment of section 108—Membership 42—Amendment of section 109—Remuneration 43—Amendment of section 110—Regulations 44—Repeal of section 110A 45—Repeal of heading 46—Substitution of sections 111 to 116 The amendments to clauses 41 to 46 are consequential on the proposed changes to the Gene Technology Ethics and Community Consultative Committee in Part 8. 47—Amendment of section 136A—Quarterly reports This clause inserts 2 new paragraphs into section 136A(2) to provide that quarterly reports prepared by the Regulator and given to the Minister must include information about any emergency dealing determination made by the Minister and any breaches of conditions of an emergency dealing determination that have come to the Regulator's attention during the quarter. 48—Amendment of section 138—Record of GMO and GM Product Dealings This clause inserts a new subsection (1A) into the South Australian Act providing that the Record of GMO and GM Product dealings required under Division 6 of Part 9 must include comprehensive information, except confidential commercial information, about the content of emergency dealing determinations. The clause also makes a consequential amendment to subsection (5) to ensure that this information is entered on the Record as soon as reasonably practicable. 49—Amendment of section 145—Simplified outline This clause inserts a new paragraph into the simplified outline of Part 10 of the South Australian Act. This makes clear that Part 10 enables the Regulator to give directions to a person permitted to deal with a GMO under an emergency dealing determination. 50—Amendment of section 146—Regulator may give directions This clause amends section 146(2) to provide that the Regulator may give directions to a person dealing with, or who has dealt with, a GMO specified in an emergency dealing determination in the circumstances set out in that subsection. The other amendments proposed to the section are consequential with new subsection (2A) setting out the matters to which regard must be had when deciding whether it is desirable to exercise the powers under the section. 51—Amendment of section 149—Simplified outline This clause inserts a reference to an emergency dealing determination into the simplified outline in section 149. This makes it clear that Part 11 does not limit the conditions to which an emergency dealing determination can be subject. 52—Amendment of section 152—Powers available to inspectors for monitoring compliance This clause inserts a new paragraph (d) in current subsection (2) to make it clear that an inspector may enter premises and exercise monitoring powers set out in section 153 for the purpose of finding out whether the Act or regulations have been complied with, if the occupier of the premises is a person dealing with, or who has dealt with, a GMO specified in an emergency dealing determination and entry is at a reasonable time. 53—Amendment of section 177—Part does not limit power to impose conditions This clause amends section 177 to make it clear that Part 11 is not to be taken to limit either the Regulator's power to impose licence conditions, or the Minister's power to impose conditions on an emergency dealing determination. 54—Amendment of section 179—Meaning of terms This clause inserts various new items into the table in section 179 of the South Australian Act. These make it clear that the Regulator's decision to refuse— (a)	to consider an application on the basis that the applicant is not a suitable person to hold a licence; or (b)	to transfer a licence; or (c)	to vary a licence; or (d)	to transfer a certification, is a reviewable decision, and that the eligible person can apply to the Administrative Appeals Tribunal under section 183 of the Act for review of the decision. 55—Amendment of section 182—Deadlines for making reviewable decisions This clause amends the wording of section 182(a) so as to extend the application of section 182 to all applications to the Regulator, not just applications to the Regulator to make a reviewable decision. The wording 'reviewable decision to reject the application' is to be inserted in the section, thereby removing any doubt that a deemed rejection of an application on account of elapse of time is reviewable under the Act. 56—Amendment of section 185—Regulator may declare that information is confidential commercial information This clause adds a new subsection (3B) into the section which would provide that information specified for the purposes of an application for a declaration that information is confidential commercial information (CCI), is treated as CCI until the Regulator has made a decision on the application. 57—Amendment of section 192A—Interference with dealings with GMOs This clause amends the definition of authorised GMO dealings in section 192A(2) to include a reference to dealings specified in an emergency dealing determination that are not prohibited by the determination from being undertaken. Debate adjourned on motion of Ms Chapman.