{"id":"F2001B00162","name":"Gene Technology Regulations 2001","slug":"gene-technology-regulations-2001","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":"106 of 2001","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":30946,"registerId":"commonwealth-F2001B00162-current","compilationNumber":null,"startDate":"2026-04-01","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"Div 1","sectionType":"division","heading":"of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:","content":"  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## Division 1 Licensing system\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## 6 Dealings exempt from licensing\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n## 7 Application for licence—prescribed fee\n\n## 8 Time limit for deciding an application\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n## 9 Prescribed authorities\n\n## 9A Risks posed by dealings proposed to be authorised by licence\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n## 10 Risk assessment—matters to be taken into account\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n## 11 Prescribed conditions of licence\n\n## 11A Time limit for deciding variation application\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n## Division 2 Notifiable low risk dealings\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## 12 Notifiable low risk dealings\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n## 13 Requirements for undertaking notifiable low risk dealings\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n## 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n## 13C Information to be kept or given to the Regulator by persons or accredited organisations\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n## Division 3 Certification and accreditation\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## 14 Regulator to decide certification application within 90 days\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n## 15 Application for certification—failure to provide section 85 information\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n## 16 Regulator to decide accreditation application within 90 days\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n## 17 Application for accreditation—failure to provide section 93 information\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n## Part 4 Gene Technology Technical Advisory Committee\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## Division 1 Conditions of appointment\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## 18 GTTAC members and advisers—term of appointment\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n## 19 GTTAC members and advisers—resignation\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n## 20 GTTAC members—disclosure of interests\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n## 21 GTTAC members and advisers—termination of appointment\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n## 22 GTTAC members—leave of absence\n\n## 23 Expert advisers—disclosure of interests\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n## Division 2 Committee procedures\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## 24 Committee procedures generally\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n## 25 Committee meetings\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n## 26 Presiding member\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n## 27 Quorum\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n## 28 Voting\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n## 29 Records and Reports\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n## Division 3 Subcommittees\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## 30 Operation of subcommittees\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n## Part 5 Ethics and Community Committee\n\n## 31 Ethics and Community Committee—conditions of appointment\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n## 32 Ethics and Community Committee—Committee procedures\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n## 33 Ethics and Community Committee—operation of subcommittees\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n## Part 7 Miscellaneous\n\n## 37 Reviewable State decisions\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n## 38 Review of decisions\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n## 39 Record of GMO Dealings\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n## 40 Inspector identity card\n\n## Part 8 Application and transitional provisions\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## Division 1 Amendments made by the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## 41 Changed requirements for dealings\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n## 42 Previous assessment by an Institutional Biosafety Committee\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n## 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n## Division 2 Amendments made by the Gene Technology Amendment (Minor Measures) Regulations 2025\n\n> advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool.\n\n> animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings.\n\n> AS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.\n\n    (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n    (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of:\n\n> genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology.\n\n> genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology.\n\n> genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology.\n\n> genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology.\n\n> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.\n\n> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\n> packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions.\n\n> pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality.\n\n> physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities.\n\n> plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell.\n\n> shot‑gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected.\n\n> transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\n\n> Note: Several other words and expressions used in these Regulations have the meaning given by section 10, or another provision, of the Act. For example:\n\n  For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n  For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n  For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:\n    (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\n    (a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;\n    (b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\n  (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) in relation to an application to which Division 3 of Part 5 of the Act applies—90 days after the day the application is received by the Regulator; or\n    (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n    (ii) for a limited and controlled release application for which the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n    (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that:\n    (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n    (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that:\n    (ii) subject to subregulation (3)—ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n  (3) The Regulator, when seeking advice under subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\n    (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n    (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\n  (1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:\n    (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n  (2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n\n  (1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n    (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\n\n  (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\n\n> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.\n\n    (a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n    (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n    (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee’s record of assessment of the proposal; and\n    (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee’s record of assessment as having the appropriate training and experience to undertake the dealing; and\n    (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee’s record of assessment as being appropriate for the dealing; and\n    (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and\n    (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n    (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n    (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n  (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with:\n    (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n    (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n  (4) For paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n\n#### 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\n  An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must:\n    (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n    (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n    (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n    (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n    (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of subregulation 13(2);\n    (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n\n  (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n    (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n    (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n  (2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must:\n    (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n  (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.\n  (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n  (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\n\n  (1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:\n    (b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\n\n  (1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:\n    (b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.\n  (2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.\n\n  If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\n\n  (1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.\n\n  (1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.\n  (2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.\n\n  (1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n  (4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.\n\n  (1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:\n    (a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or\n    (b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or\n    (c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.\n\n> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.\n\n  (1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.\n  (2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.\n  (3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:\n\n    (b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and\n    (c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.\n\n  (1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:\n  (3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:\n\n> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.\n\n    (b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.\n  (2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.\n\n  At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.\n\n  (1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.\n  (2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.\n\n  (1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.\n  (2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.\n  (3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.\n\n  Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and\n\n    (a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and\n    (b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and\n    (c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and\n\n  (1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.\n  (3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.\n\n> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.\n\n  Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.\n\n  For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n    (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n    (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\n    (a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n  (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if:\n\n    (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n    (b) the record of the Committee’s assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n  (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n\n#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\n\n  Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## 44 Preliminary\n\n## 45 Risk assessments and risk management plans\n\n  Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:\n\n## 46 Resignation of committee member or expert adviser\n\n  The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.\n\n## 47 Disclosure of interests by committee member\n\n  The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.\n\n## 48 Techniques that are not gene technology\n\n  The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:\n\n    (a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or\n    (b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.\n\n## 49 Organisms that are not GMOs\n\n  (1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.\n\n  (2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.\n\n> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.\n\n## 1.1 Genetically modified organisms\n\n#### 1.1 Genetically modified organisms\n\n  For the purposes of regulation 4A, an organism is a genetically modified organism if an item in the following table applies to the organism.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"border-collapse:collapse\"><thead><tr><td colspan=\"2\" style=\"width:416.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Organisms that are genetically modified organisms</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:379.05pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Description of organism</span></p></td></tr></thead><tbody><tr><td style=\"width:26.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:379.05pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An organism that has had its genome modified by oligonucleotide</span><span>‑</span><span>directed mutagenesis</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:379.05pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An organism modified by repair of single</span><span>‑</span><span>strand or double</span><span>‑</span><span>strand breaks of genomic DNA induced by a site</span><span>‑</span><span>directed nuclease, if a nucleic acid template was added to guide homology</span><span>‑</span><span>directed repair</span></p></td></tr></tbody></table>\n```\n\n","sortOrder":0},{"sectionNumber":"Sch 1","sectionType":"schedule","heading":"Organisms that are not genetically modified organisms","content":"Schedule 1—Organisms that are not genetically modified organisms\n\n(regulation 5)\n\n| Item | Description of organism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |\n| ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 2    | A whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents.                                                                                                                                                                                                                                                                                                                             |\n| 3    | Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell.                                                                                                                                                                                                                                                                                                                                                                                                                                                     |\n| 4    | An organism modified by repair of single‑strand or double‑strand breaks of genomic DNA induced by a site‑directed nuclease, if a nucleic acid template was not added to guide homology‑directed repair.                                                                                                                                                                                                                                                                                                                                                       |\n| 6    | A micro‑organism that results from an exchange of DNA if:(a) the donor species is also the host species; and(b) the exchanged DNA does not contain any heterologous DNA.                                                                                                                                                                                                                                                                                                                                                                                      |\n| 7    | An organism that results from an exchange of DNA between the donor species and the host species if:(a) such exchange can occur by naturally occurring processes; and(b) the donor species and the host species are micro‑organisms that:(i) satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 1; and(ii) are known to exchange nucleic acid by a natural physiological process; and(c) the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange. |\n| 8    | An organism that is descended from a genetically modified organism (the initial organism), if none of the traits it has inherited from the initial organism are traits that occurred in the initial organism because of gene technology.                                                                                                                                                                                                                                                                                                                      |\n| 9    | 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, if:(a) the initial organism was not a genetically modified organism (because of the application of regulation 5); or(b) all such inherited traits are traits that occurred in the initial organism as a result of a modification described in an item in this Schedule.                                                                                                              |\n| 10   | An organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are either no longer present or are epigenetic.                                                                                                                                                                                                                                                                                                                                                                      |\n| 11   | Agrobacterium radiobacter strain K1026.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |\n| 12   | Pasteurella multocida strain PMP1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |\n\n","sortOrder":1},{"sectionNumber":"Sch 2","sectionType":"schedule","heading":"Dealings exempt from licensing","content":"Schedule 2—Dealings exempt from licensing\n\n(regulation 6)\n\nNote: Subregulation 6(1) sets out other requirements for exempt dealings.\n\n## Part 1 Exempt dealings\n\n## Part 1—Exempt dealings\n\n| Item | Description of dealing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |\n| ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 2    | A dealing with a genetically modified Caenorhabditis elegans, unless:(a) an advantage is conferred on the animal by the genetic modification; or(b) as a result of the genetic modification, the animal is capable of secreting or producing an infectious agent.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |\n| 3    | A dealing with an animal into which genetically modified somatic cells have been introduced, if:(a) the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and(b) the animal is not infected with a virus that is capable of recombining with the genetically modified nucleic acid in the somatic cells.                                                                                                                                                                                                                                                                                                                                                                                                                                             |\n| 3A   | A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |\n|      | (a) the in vivo modification occurred as part of a previous dealing; and(b) the replication defective viral vector is no longer in the animal; and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |\n|      | (c) no germ line cells have been genetically modified; and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |\n|      | (d) the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and(e) the animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n| 4    | (1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |\n|      | (2) The donor nucleic acid:(a) must meet either of the following requirements:(i) it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy:(A) human beings; or(B) animals; or(C) plants; or(D) fungi;(ii) it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm; and                                                                                                                                                                                                                                                                                                                                                                   |\n|      | Example: Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in relation to the capacity of the host or vector to cause harm, it:(a) provides an advantage; or(b) adds a potential host species or mode of transmission; or(c) increases its virulence, pathogenicity or transmissibility.                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n|      | (b) must not code for a toxin with an LD50 of less than 100 micrograms per kilogram; and(c) must not code for a toxin with an LD50 of 100 micrograms per kilogram or more, if the intention is to express the toxin at high levels; and(d) must not be uncharacterised nucleic acid from a toxin‑producing organism; and(e) if the donor nucleic acid includes a viral sequence—cannot give rise to infectious agents when introduced into any potential host species, without additional non‑host genes or gene products that:(i) are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and(ii) will not become available during the dealing; and(f) if the donor nucleic acid includes a viral sequence—cannot restore replication competence to the vector. |\n| 5    | A dealing involving shot‑gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of this Schedule, if the donor nucleic acid is not derived from either:(a) a pathogen; or(b) a toxin‑producing organism.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |\n\n## Part 2 Host/vector systems for exempt dealings\n\n","sortOrder":2},{"sectionNumber":"Sch 1A","sectionType":"schedule","heading":"Techniques that are not gene technology","content":"Schedule 1A—Techniques that are not gene technology\n\n(regulation 4)\n\n| Item | Description of technique                                                                                                                                                                                                                                                                                                                                                                                                              |\n| ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1    | Either of the following transfers, if the transfer does not involve genetically modified material:(a) nuclear transfer;(b) transfer of plastids or mitochondria.                                                                                                                                                                                                                                                                      |\n| 2    | Electromagnetic radiation‑induced mutagenesis.                                                                                                                                                                                                                                                                                                                                                                                        |\n| 3    | Particle radiation‑induced mutagenesis.                                                                                                                                                                                                                                                                                                                                                                                               |\n| 4    | Chemical‑induced mutagenesis.                                                                                                                                                                                                                                                                                                                                                                                                         |\n| 5    | Fusion of animal cells, or human cells, if the fused cells are unable to form a viable whole animal or human.                                                                                                                                                                                                                                                                                                                         |\n| 6    | Protoplast fusion, including fusion of plant protoplasts.                                                                                                                                                                                                                                                                                                                                                                             |\n| 7    | Embryo rescue.                                                                                                                                                                                                                                                                                                                                                                                                                        |\n| 8    | In vitro fertilisation.                                                                                                                                                                                                                                                                                                                                                                                                               |\n| 9    | Zygote implantation.                                                                                                                                                                                                                                                                                                                                                                                                                  |\n| 10   | A natural process, if the process does not involve genetically modified material.Examples: Examples of natural processes include conjugation, transduction, transformation and transposon mutagenesis.                                                                                                                                                                                                                                |\n| 11   | Introduction of nucleic acid or nucleic acid analogue into an organism, if:(a) the introduction of the nucleic acid or nucleic acid analogue does not result in an alteration of the organism’s genome sequence; and(b) the introduction of the nucleic acid or nucleic acid analogue cannot give rise to an infectious agent; and(c) in the case of nucleic acid or nucleic acid analogue that is DNA—the DNA cannot be transcribed. |\n\n","sortOrder":3},{"sectionNumber":"Sch 1B","sectionType":"schedule","heading":"Organisms that are genetically modified organisms","content":"Schedule 1B—Organisms that are genetically modified organisms\n\nNote: See regulation 4A.\n\n#### 1.1 Genetically modified organisms\n\n  For the purposes of regulation 4A, an organism is a genetically modified organism if an item in the following table applies to the organism.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"border-collapse:collapse\"><thead><tr><td colspan=\"2\" style=\"width:416.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Organisms that are genetically modified organisms</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:379.05pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Description of organism</span></p></td></tr></thead><tbody><tr><td style=\"width:26.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:379.05pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An organism that has had its genome modified by oligonucleotide</span><span>‑</span><span>directed mutagenesis</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:379.05pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>An organism modified by repair of single</span><span>‑</span><span>strand or double</span><span>‑</span><span>strand breaks of genomic DNA induced by a site</span><span>‑</span><span>directed nuclease, if a nucleic acid template was added to guide homology</span><span>‑</span><span>directed repair</span></p></td></tr></tbody></table>\n```\n\nSchedule 1—Organisms that are not genetically modified organisms\n\n(regulation 5)\n\n| Item | Description of organism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |\n| ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 2    | A whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents.                                                                                                                                                                                                                                                                                                                             |\n| 3    | Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell.                                                                                                                                                                                                                                                                                                                                                                                                                                                     |\n| 4    | An organism modified by repair of single‑strand or double‑strand breaks of genomic DNA induced by a site‑directed nuclease, if a nucleic acid template was not added to guide homology‑directed repair.                                                                                                                                                                                                                                                                                                                                                       |\n| 6    | A micro‑organism that results from an exchange of DNA if:(a) the donor species is also the host species; and(b) the exchanged DNA does not contain any heterologous DNA.                                                                                                                                                                                                                                                                                                                                                                                      |\n| 7    | An organism that results from an exchange of DNA between the donor species and the host species if:(a) such exchange can occur by naturally occurring processes; and(b) the donor species and the host species are micro‑organisms that:(i) satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 1; and(ii) are known to exchange nucleic acid by a natural physiological process; and(c) the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange. |\n| 8    | An organism that is descended from a genetically modified organism (the initial organism), if none of the traits it has inherited from the initial organism are traits that occurred in the initial organism because of gene technology.                                                                                                                                                                                                                                                                                                                      |\n| 9    | 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, if:(a) the initial organism was not a genetically modified organism (because of the application of regulation 5); or(b) all such inherited traits are traits that occurred in the initial organism as a result of a modification described in an item in this Schedule.                                                                                                              |\n| 10   | An organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are either no longer present or are epigenetic.                                                                                                                                                                                                                                                                                                                                                                      |\n| 11   | Agrobacterium radiobacter strain K1026.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       |\n| 12   | Pasteurella multocida strain PMP1.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |\n\nSchedule 2—Dealings exempt from licensing\n\n(regulation 6)\n\nNote: Subregulation 6(1) sets out other requirements for exempt dealings.\n\n## Part 1—Exempt dealings\n\n| Item | Description of dealing                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |\n| ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 2    | A dealing with a genetically modified Caenorhabditis elegans, unless:(a) an advantage is conferred on the animal by the genetic modification; or(b) as a result of the genetic modification, the animal is capable of secreting or producing an infectious agent.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             |\n| 3    | A dealing with an animal into which genetically modified somatic cells have been introduced, if:(a) the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and(b) the animal is not infected with a virus that is capable of recombining with the genetically modified nucleic acid in the somatic cells.                                                                                                                                                                                                                                                                                                                                                                                                                                             |\n| 3A   | A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if:                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |\n|      | (a) the in vivo modification occurred as part of a previous dealing; and(b) the replication defective viral vector is no longer in the animal; and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            |\n|      | (c) no germ line cells have been genetically modified; and                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    |\n|      | (d) the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and(e) the animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n| 4    | (1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                |\n|      | (2) The donor nucleic acid:(a) must meet either of the following requirements:(i) it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy:(A) human beings; or(B) animals; or(C) plants; or(D) fungi;(ii) it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm; and                                                                                                                                                                                                                                                                                                                                                                   |\n|      | Example: Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in relation to the capacity of the host or vector to cause harm, it:(a) provides an advantage; or(b) adds a potential host species or mode of transmission; or(c) increases its virulence, pathogenicity or transmissibility.                                                                                                                                                                                                                                                                                                                                                                                                                                                                         |\n|      | (b) must not code for a toxin with an LD50 of less than 100 micrograms per kilogram; and(c) must not code for a toxin with an LD50 of 100 micrograms per kilogram or more, if the intention is to express the toxin at high levels; and(d) must not be uncharacterised nucleic acid from a toxin‑producing organism; and(e) if the donor nucleic acid includes a viral sequence—cannot give rise to infectious agents when introduced into any potential host species, without additional non‑host genes or gene products that:(i) are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and(ii) will not become available during the dealing; and(f) if the donor nucleic acid includes a viral sequence—cannot restore replication competence to the vector. |\n| 5    | A dealing involving shot‑gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of this Schedule, if the donor nucleic acid is not derived from either:(a) a pathogen; or(b) a toxin‑producing organism.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 |\n\n## Part 2—Host/vector systems for exempt dealings\n\n#### 2.1 Hosts and vectors\n\n  (1) A reference to a host mentioned in this Part is a reference to a host mentioned in column 2 of an item of the table in this clause.\n  (2) A reference to a vector mentioned in this Part is a reference to a vector mentioned in column 3 of an item of the table in this clause.\n  (3) A reference to a host/vector system mentioned in this Part is a reference to any of the following:\n    (a) a system involving a host mentioned in column 2 of an item of the table in this clause and a vector mentioned in column 3 of the same item;\n    (b) a non‑vector system involving a host mentioned in column 2 of an item of the table;\n    (c) a system involving a GMO mentioned as a vector in column 3 of an item of the table (except item 7), without a host.\n\n> Note: Column 1 of the table is included for information only.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:428.35pt; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"width:417.55pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Hosts and vectors</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span><br><span>Host class</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span><br><span>Hosts</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span><br><span>Vectors</span></p></td></tr></thead><tbody><tr><td style=\"width:26.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:43.8pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Escherichia coli </span><span>K12, </span><span style=\"font-style:italic\">E. coli </span><span>B, </span><span style=\"font-style:italic\">E. coli </span><span>C or </span><span style=\"font-style:italic\">E. coli </span><span>Nissle 1917—any derivative that does not contain:</span></p><p class=\"Tablea\"><span>(a) generalised transducing phages; or</span></p><p class=\"Tablea\"><span>(b) genes able to complement the conjugation defect in a non</span><span>‑</span><span>conjugative plasmid</span></p></td><td style=\"width:134.8pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>conjugative plasmids;</span></p><p class=\"Tablea\"><span>(b) lambda bacteriophage;</span></p><p class=\"Tablea\"><span>(c) lambdoid bacteriophage;</span></p><p class=\"Tablea\"><span>(d) Fd, F1 or M13 bacteriophage</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Bacillus—</span><span>asporogenic strains of the following species with a reversion frequency of less than 10</span><span style=\"font-size:6.67pt; vertical-align:super\">–7</span><span>:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">B. amyloliquefaciens</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">B. licheniformis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">B. pumilus</span><span>;</span></p><p class=\"Tablea\"><span>(d) </span><span style=\"font-style:italic\">B. subtilis</span><span>;</span></p><p class=\"Tablea\"><span>(e) </span><span style=\"font-style:italic\">B. thuringiensis</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>conjugative plasmids;</span></p><p class=\"Tablea\"><span>(b) other plasmids and phages whose host range does not include </span><span style=\"font-style:italic\">B. cereus</span><span>, </span><span style=\"font-style:italic\">B. anthracis</span><span style=\"font-weight:bold\"> </span><span>or any other pathogenic strain of </span><span style=\"font-style:italic\">Bacillus</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Pseudomonas putida</span><span> strain KT2440</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Non</span><span>‑</span><span>conjugative plasmids</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The following </span><span style=\"font-style:italic\">Streptomyces</span><span> species:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">S. aureofaciens</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">S. coelicolor</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">S. cyaneus</span><span>;</span></p><p class=\"Tablea\"><span>(d) </span><span style=\"font-style:italic\">S. griseus</span><span>;</span></p><p class=\"Tablea\"><span>(e) </span><span style=\"font-style:italic\">S. lividans</span><span>;</span></p><p class=\"Tablea\"><span>(f) </span><span style=\"font-style:italic\">S. parvulus</span><span>;</span></p><p class=\"Tablea\"><span>(g) </span><span style=\"font-style:italic\">S. rimosus</span><span>;</span></p><p class=\"Tablea\"><span>(h) </span><span style=\"font-style:italic\">S. venezuelae</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>conjugative plasmids;</span></p><p class=\"Tablea\"><span>(b) plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives;</span></p><p class=\"Tablea\"><span>(c) actinophage phi C31 and derivatives</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">Agrobacterium radiobacter</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">Agrobacterium rhizogenes</span><span> (disarmed strains only);</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">Agrobacterium tumefaciens</span><span> (disarmed strains only)</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Disarmed Ri or Ti plasmids</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">Allorhizobium</span><span style=\"font-weight:bold\"> </span><span>species;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">Corynebacterium glutamicum</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">Lactobacillus</span><span style=\"font-weight:bold\"> </span><span>species;</span></p><p class=\"Tablea\"><span>(d) </span><span style=\"font-style:italic\">Lactococcus lactis</span><span>;</span></p><p class=\"Tablea\"><span>(e) </span><span style=\"font-style:italic\">Oenococcus oeni </span><span>syn. </span><span style=\"font-style:italic\">Leuconostoc oeni</span><span>;</span></p><p class=\"Tablea\"><span>(f) </span><span style=\"font-style:italic\">Pediococcus</span><span> species;</span></p><p class=\"Tablea\"><span>(g) </span><span style=\"font-style:italic\">Photobacterium angustum</span><span>;</span></p><p class=\"Tablea\"><span>(h) </span><span style=\"font-style:italic\">Pseudoalteromonas tunicata</span><span>;</span></p><p class=\"Tablea\"><span>(i) </span><span style=\"font-style:italic\">Rhizobium </span><span>species;</span></p><p class=\"Tablea\"><span>(j) </span><span style=\"font-style:italic\">Sphingopyxis alaskensis </span><span>syn. </span><span style=\"font-style:italic\">Sphingomonas alaskensis</span><span>;</span></p><p class=\"Tablea\"><span>(k) </span><span style=\"font-style:italic\">Streptococcus thermophilus</span><span>;</span></p><p class=\"Tablea\"><span>(l) </span><span style=\"font-style:italic\">Synechococcus</span><span> species strains PCC 7002, PCC 7942 and WH 8102;</span></p><p class=\"Tablea\"><span>(m) </span><span style=\"font-style:italic\">Synechocystis </span><span>species strain PCC 6803;</span></p><p class=\"Tablea\"><span>(n) </span><span style=\"font-style:italic\">Vibrio cholerae </span><span>CVD103</span><span>‑</span><span>HgR;</span></p><p class=\"Tablea\"><span>(o) </span><span style=\"font-style:italic\">Zymomonas mobilis</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Non</span><span>‑</span><span>conjugative plasmids</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Fungi</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">Kluyveromyces lactis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">Neurospora crassa </span><span>(laboratory strains);</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">Pichia pastoris</span><span>;</span></p><p class=\"Tablea\"><span>(d) </span><span style=\"font-style:italic\">Saccharomyces cerevisiae</span><span>;</span></p><p class=\"Tablea\"><span>(e) </span><span style=\"font-style:italic\">Schizosaccharomyces pombe</span><span>;</span></p><p class=\"Tablea\"><span>(f) </span><span style=\"font-style:italic\">Trichoderma reesei</span><span>;</span></p><p class=\"Tablea\"><span>(g) </span><span style=\"font-style:italic\">Yarrowia lipolytica</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>All vectors</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Slime moulds</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Dictyostelium </span><span>species</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Dictyostelium </span><span>shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>9</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Tissue culture</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following if they cannot spontaneously generate a whole animal:</span></p><p class=\"Tablea\"><span>(a) animal or human cell cultures (including packaging cell lines);</span></p><p class=\"Tablea\"><span>(b) isolated cells, isolated tissues or isolated organs, whether animal or human;</span></p><p class=\"Tablea\"><span>(c) early non</span><span>‑</span><span>human mammalian embryos cultured </span><span style=\"font-style:italic\">in vitro</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) plasmids;</span></p><p class=\"Tablea\"><span>(b) replication defective viral vectors unable to transduce human cells;</span></p><p class=\"Tablea\"><span>(c) polyhedrin minus forms of the baculovirus </span><span style=\"font-style:italic\">Autographa californica</span><span> nuclear polyhedrosis virus (ACNPV)</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Tissue culture</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following if they are not intended, and are not likely without human intervention, to vegetatively propagate, flower or regenerate into a whole plant:</span></p><p class=\"Tablea\"><span>(a) plant cell cultures;</span></p><p class=\"Tablea\"><span>(b) isolated plant tissues or organs</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) Disarmed Ri or Ti plasmids in </span><span style=\"font-style:italic\">Agrobacterium radiobacter</span><span>, </span><span style=\"font-style:italic\">Agrobacterium rhizogenes</span><span> (disarmed strains only) or </span><span style=\"font-style:italic\">Agrobacterium tumefaciens </span><span>(disarmed strains only);</span></p><p class=\"Tablea\"><span>(b) non</span><span>‑</span><span>pathogenic viral vectors</span></p></td></tr></tbody></table>\n```\n\n## Part 3—Definitions\n\n  In this Schedule:\n\n> code for, in relation to a toxin, means to specify the amino acid sequence of the toxin.\n\n> non‑conjugative plasmid means a plasmid that is not self‑transmissible, and includes, but is not limited to, non‑conjugative forms of the following plasmids:\n\n    (a) bacterial artificial chromosomes (BACs);\n    (b) cosmids;\n    (c) P1 artificial chromosomes (PACs);\n    (d) yeast artificial chromosomes (YACs).\n\n> non‑vector system means a system in which donor nucleic acid is or was introduced into a host cell:\n\n    (a) in the absence of a nucleic acid‑based vector; or\n    (b) using a nucleic acid‑based vector in the course of a previous dealing and the vector is:\n    (i) no longer present; or\n    (ii) present but cannot be remobilised from a host cell.\n\n> Note: Example 1: A system mentioned in paragraph (a) might involve the use of electroporation or particle bombardment.\n\n> Note: Example 2: A system mentioned in paragraph (b) might involve cells that were transduced with a replication defective retroviral vector in which no vector particles remain.\n\n","sortOrder":4},{"sectionNumber":"Sch 3","sectionType":"schedule","heading":"Notifiable low risk dealings in relation to a GMO","content":"Schedule 3—Notifiable low risk dealings in relation to a GMO\n\n(regulations 12 and 13)\n\n## Part 1—Notifiable low risk dealings suitable for at least physical containment level 1\n\nNote: Because of subregulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.\n\n#### 1.1 Kinds of dealings suitable for at least physical containment level 1\n\n  The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 1 and that are appropriate for the dealings:\n    (a) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit or a genetically modified laboratory rat, unless:\n    (i) an advantage is conferred on the animal by the genetic modification; or\n    (ii) the animal is capable of secreting or producing an infectious agent as a result of the genetic modification;\n    (c) a dealing involving virions of a replication defective vector derived from Human adenovirus or from Adeno‑associated virus, either without a host or with a host mentioned in item 9 of Part 2 of Schedule 2, if the donor nucleic acid:\n    (i) cannot restore replication competence to the vector; and\n    (ii) does not confer an oncogenic modification or immunomodulatory effect in humans.\n\n## Part 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3\n\nNote: Because of subregulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.\n\n#### 2.1 Kinds of dealings suitable for at least physical containment level 2\n\n  The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 2 and that are appropriate for the dealings:\n    (a) a dealing involving whole animals (including non‑vertebrates) that:\n    (i) involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and\n    (ii) does not involve any of the following:\n    (A) a genetically modified laboratory guinea pig;\n    (B) a genetically modified laboratory mouse;\n    (C) a genetically modified laboratory rabbit;\n    (D) a genetically modified laboratory rat;\n    (E) a genetically modified Caenorhabditis elegans;\n    (aa) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat or a genetically modified Caenorhabditis elegans, if:\n    (i) the genetic modification confers an advantage on the animal; and\n    (ii) the animal is not capable of secreting or producing an infectious agent as a result of the genetic modification;\n    (b) a dealing involving a genetically modified plant;\n    (c) a dealing involving a host/vector system not mentioned in paragraph 1.1(c) or Part 2 of Schedule 2, if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise healthy:\n    (i) human beings; or\n    (ii) animals; or\n    (iii) plants; or\n    (iv) fungi;\n    (d) a dealing involving a host/vector system not mentioned in Part 2 of Schedule 2, if:\n    (i) the host or vector has been implicated in, or has a history of causing, disease in otherwise healthy:\n    (ii) the genetic modification is characterised; and\n    (iii) the characterisation of the genetic modification shows that it is unlikely to increase the capacity of the host or vector to cause harm;\n    Example: A genetic modification would not comply with subparagraph (iii) if, in relation to the capacity of the host or vector to cause harm, it:\n\n(a) provides an advantage; or\n\n(b) adds a potential host species or mode of transmission; or\n\n(c) increases its virulence, pathogenicity or transmissibility.\n\n    (e) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid:\n    (i) is characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; or\n    (ii) is uncharacterised nucleic acid from an organism that has been implicated in, or has a history of causing, disease in otherwise healthy:\n    (D) fungi;\n    (f) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and producing more than 25 litres of GMO culture in each vessel containing the resultant culture, if:\n    (i) the dealing is undertaken in a facility that is certified by the Regulator as a large scale facility; and\n    (ii) the donor nucleic acid satisfies the conditions set out in subitem 4(2) of Part 1 of Schedule 2;\n    (g) a dealing involving complementation of knocked‑out genes, if the complementation is unlikely to increase the capacity of the GMO to cause harm compared to the capacity of the parent organism before the genes were knocked out;\n\n> Note: Example: A dealing would not comply with paragraph (g) if it involved complementation that, in relation to the parent organism:\n\n    (h) a dealing involving shot‑gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of Schedule 2, if the donor nucleic acid is derived from either:\n    (i) a pathogen; or\n    (ii) a toxin‑producing organism;\n    (i) a dealing involving virions of a replication defective viral vector unable to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;\n    (j) a dealing involving virions of a replication defective non‑retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:\n    (ii) the dealing is not a dealing mentioned in paragraph 1.1(c);\n    (k) a dealing involving virions of a replication defective non‑retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if:\n    (ii) the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;\n    (l) a dealing involving virions of a replication defective retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:\n    (i) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and\n    (ii) viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and\n    (iii) either:\n    (A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or\n    (B) the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these;\n    (m) a dealing involving virions of a replication defective retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if:\n    (i) the donor nucleic acids does not confer an oncogenic modification or immunomodulatory effect in humans; and\n    (ii) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and\n    (iii) viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and\n    (iv) either:\n    (A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or\n    (B) the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these.\n\n#### 2.2 Kinds of dealing suitable for at least physical containment level 3\n\n  (1) A kind of dealing that:\n    (a) is a kind mentioned in clause 2.1; and\n    (b) involves a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3;\n  must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 3 and that are appropriate for the dealings.\n  (2) For the purposes of paragraph (1)(b), a genetically modified micro‑organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro‑organism satisfies those criteria.\n  (3) However, subclause (2) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).\n\n## Part 3—Dealings that are not notifiable low risk dealings\n\nNote 1: The following list qualifies the list in Parts 1 and 2, and is not an exhaustive list of dealings that are not notifiable low risk dealings.\n\nNote 2: If a dealing is not a notifiable low risk dealing, or an exempt dealing, as provided by these Regulations, a person undertaking the dealing must be authorised by a GMO licence unless the dealing is within one of the other exceptions to licensing provided by the Act: see section 32 of the Act.\n\n#### 3.1 Kinds of dealings\n\n  (1) A dealing of any of the following kinds, or involving a dealing of the following kinds, is not a notifiable low risk dealing:\n    (a) a dealing (other than a dealing mentioned in paragraph 2.1(h)) involving cloning of nucleic acid encoding a toxin having an LD50 of less than 100 micrograms per kilogram;\n    (b) a dealing involving high level expression of toxin genes, even if the LD50 is 100 micrograms per kilogram or more;\n    (c) a dealing (other than a dealing mentioned in paragraph 2.1(h)) involving cloning of uncharacterised nucleic acid from a toxin‑producing organism;\n    (d) a dealing involving virions of a replication defective viral vector and a host not mentioned in Part 2 of Schedule 2, if:\n    (i) the donor nucleic acid confers an oncogenic modification or immunomodulatory effect in humans; and\n    (ii) the dealing is not a dealing mentioned in paragraph 2.1(i);\n    (e) a dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the genetic modification confers an oncogenic modification or immunomodulatory effect in humans;\n    (f) a dealing involving, as host or vector, a micro‑organism, if:\n    (i) the micro‑organism has been implicated in, or has a history of causing, disease in otherwise healthy:\n    (ii) none of the following sub‑subparagraphs apply:\n    (A) the host/vector system is a system mentioned in Part 2 of Schedule 2;\n    (B) the genetic modification is characterised and its characterisation shows that it is unlikely to increase the capacity of the host or vector to cause harm;\n    (C) the dealing is a dealing mentioned in paragraph 2.1(g);\n\n> Note: Example: A genetic modification would not comply with sub‑subparagraph (B) if, in relation to the capacity of the host or vector to cause harm, it:\n\n    (g) a dealing involving the introduction, into a micro‑organism, of nucleic acid encoding a pathogenic determinant, unless:\n    (i) the dealing is a dealing mentioned in paragraph 2.1(g); or\n    (ii) the micro‑organism is a host mentioned in Part 2 of Schedule 2;\n    (h) a dealing involving the introduction into a micro‑organism, other than a host mentioned in Part 2 of Schedule 2, of genes whose expressed products are likely to increase the capacity of the micro‑organisms to induce an autoimmune response;\n    (i) a dealing involving use of a viral or viroid genome, or fragments of a viral or viroid genome, to produce a novel replication competent virus with an increased capacity to cause harm compared to the capacity of the parent or donor organism;\n\n> Note: Example: A dealing would comply with paragraph (i) if it produces a novel replication competent virus that has a higher capacity to cause harm to any potential host species than the parent organism because the new virus has:\n\n> Note: (a) an advantage; or\n\n> Note: (b) a new potential host species or mode of transmissibility; or\n\n> Note: (c) increased virulence, pathogenicity or transmissibility.\n\n    (j) a dealing, other than a dealing mentioned in paragraph 2.1(l) or (m), with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;\n    (k) a dealing involving a genetically modified animal, plant or fungus that is capable of secreting or producing infectious agents as a result of the genetic modification;\n    (l) a dealing producing, in each vessel containing the resultant GMO culture, more than 25 litres of that culture, other than a dealing mentioned in paragraph 2.1(f);\n    (m) a dealing that is inconsistent with a policy principle issued by the Ministerial Council;\n    (n) a dealing involving the intentional introduction of a GMO into a human being, unless the GMO:\n    (i) is a human somatic cell; and\n    (ii) cannot secrete or produce infectious agents as a result of the genetic modification; and\n    (iii) if it was generated using viral vectors:\n    (A) has been tested for the presence of viruses likely to recombine with the genetically modified nucleic acid in the somatic cells; and\n    (B) the testing did not detect a virus mentioned in sub‑subparagraph (A); and\n    (C) the viral vector used to generate the GMO as part of a previous dealing is no longer present in the somatic cells;\n    (o) a dealing involving a genetically modified pathogenic organism, if the practical treatment of any disease or abnormality caused by the organism would be impaired by the genetic modification;\n    (p) a dealing involving a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4;\n    (q) a dealing involving a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 and that is not undertaken:\n    (i) in a facility that is certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n    (ii) in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken;\n    (r) a dealing involving a GMO capable of sexual reproduction, the sexual progeny of which are, as a result of the genetic modification, more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism);\n    (s) a dealing involving a viral vector that can modify an organism capable of sexual reproduction, so that the sexual progeny of the organism are more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism).\n\n> Note: A modification that increases the likelihood of inheritance of a nucleotide sequence or sequences, as described in paragraphs (r) and (s), is generally known as an engineered gene drive.\n\n  (2) For the purposes of paragraph (1)(p), a genetically modified micro‑organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4 if the unmodified parent micro‑organism satisfies those criteria.\n  (3) For the purposes of paragraph (1)(q), a genetically modified micro‑organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro‑organism satisfies those criteria.\n  (4) However, subclause (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).\n\n## 2.1 Hosts and vectors\n\n#### 2.1 Hosts and vectors\n\n  (1) A reference to a host mentioned in this Part is a reference to a host mentioned in column 2 of an item of the table in this clause.\n  (2) A reference to a vector mentioned in this Part is a reference to a vector mentioned in column 3 of an item of the table in this clause.\n  (3) A reference to a host/vector system mentioned in this Part is a reference to any of the following:\n    (a) a system involving a host mentioned in column 2 of an item of the table in this clause and a vector mentioned in column 3 of the same item;\n    (b) a non‑vector system involving a host mentioned in column 2 of an item of the table;\n    (c) a system involving a GMO mentioned as a vector in column 3 of an item of the table (except item 7), without a host.\n\n> Note: Column 1 of the table is included for information only.\n\n<table cellspacing=\"0\" cellpadding=\"0\" style=\"width:428.35pt; border-collapse:collapse\"><thead><tr><td colspan=\"4\" style=\"width:417.55pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Hosts and vectors</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Item</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 1</span><br><span>Host class</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 2</span><br><span>Hosts</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"TableHeading\"><span>Column 3</span><br><span>Vectors</span></p></td></tr></thead><tbody><tr><td style=\"width:26.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>1</span></p></td><td style=\"width:43.8pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Escherichia coli </span><span>K12, </span><span style=\"font-style:italic\">E. coli </span><span>B, </span><span style=\"font-style:italic\">E. coli </span><span>C or </span><span style=\"font-style:italic\">E. coli </span><span>Nissle 1917—any derivative that does not contain:</span></p><p class=\"Tablea\"><span>(a) generalised transducing phages; or</span></p><p class=\"Tablea\"><span>(b) genes able to complement the conjugation defect in a non</span><span>‑</span><span>conjugative plasmid</span></p></td><td style=\"width:134.8pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>conjugative plasmids;</span></p><p class=\"Tablea\"><span>(b) lambda bacteriophage;</span></p><p class=\"Tablea\"><span>(c) lambdoid bacteriophage;</span></p><p class=\"Tablea\"><span>(d) Fd, F1 or M13 bacteriophage</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>2</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Bacillus—</span><span>asporogenic strains of the following species with a reversion frequency of less than 10</span><span style=\"font-size:6.67pt; vertical-align:super\">–7</span><span>:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">B. amyloliquefaciens</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">B. licheniformis</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">B. pumilus</span><span>;</span></p><p class=\"Tablea\"><span>(d) </span><span style=\"font-style:italic\">B. subtilis</span><span>;</span></p><p class=\"Tablea\"><span>(e) </span><span style=\"font-style:italic\">B. thuringiensis</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>conjugative plasmids;</span></p><p class=\"Tablea\"><span>(b) other plasmids and phages whose host range does not include </span><span style=\"font-style:italic\">B. cereus</span><span>, </span><span style=\"font-style:italic\">B. anthracis</span><span style=\"font-weight:bold\"> </span><span>or any other pathogenic strain of </span><span style=\"font-style:italic\">Bacillus</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>3</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Pseudomonas putida</span><span> strain KT2440</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Non</span><span>‑</span><span>conjugative plasmids</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>4</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>The following </span><span style=\"font-style:italic\">Streptomyces</span><span> species:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">S. aureofaciens</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">S. coelicolor</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">S. cyaneus</span><span>;</span></p><p class=\"Tablea\"><span>(d) </span><span style=\"font-style:italic\">S. griseus</span><span>;</span></p><p class=\"Tablea\"><span>(e) </span><span style=\"font-style:italic\">S. lividans</span><span>;</span></p><p class=\"Tablea\"><span>(f) </span><span style=\"font-style:italic\">S. parvulus</span><span>;</span></p><p class=\"Tablea\"><span>(g) </span><span style=\"font-style:italic\">S. rimosus</span><span>;</span></p><p class=\"Tablea\"><span>(h) </span><span style=\"font-style:italic\">S. venezuelae</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) non</span><span>‑</span><span>conjugative plasmids;</span></p><p class=\"Tablea\"><span>(b) plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives;</span></p><p class=\"Tablea\"><span>(c) actinophage phi C31 and derivatives</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>5</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">Agrobacterium radiobacter</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">Agrobacterium rhizogenes</span><span> (disarmed strains only);</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">Agrobacterium tumefaciens</span><span> (disarmed strains only)</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Disarmed Ri or Ti plasmids</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>6</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Bacteria</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">Allorhizobium</span><span style=\"font-weight:bold\"> </span><span>species;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">Corynebacterium glutamicum</span><span>;</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">Lactobacillus</span><span style=\"font-weight:bold\"> </span><span>species;</span></p><p class=\"Tablea\"><span>(d) </span><span style=\"font-style:italic\">Lactococcus lactis</span><span>;</span></p><p class=\"Tablea\"><span>(e) </span><span style=\"font-style:italic\">Oenococcus oeni </span><span>syn. </span><span style=\"font-style:italic\">Leuconostoc oeni</span><span>;</span></p><p class=\"Tablea\"><span>(f) </span><span style=\"font-style:italic\">Pediococcus</span><span> species;</span></p><p class=\"Tablea\"><span>(g) </span><span style=\"font-style:italic\">Photobacterium angustum</span><span>;</span></p><p class=\"Tablea\"><span>(h) </span><span style=\"font-style:italic\">Pseudoalteromonas tunicata</span><span>;</span></p><p class=\"Tablea\"><span>(i) </span><span style=\"font-style:italic\">Rhizobium </span><span>species;</span></p><p class=\"Tablea\"><span>(j) </span><span style=\"font-style:italic\">Sphingopyxis alaskensis </span><span>syn. </span><span style=\"font-style:italic\">Sphingomonas alaskensis</span><span>;</span></p><p class=\"Tablea\"><span>(k) </span><span style=\"font-style:italic\">Streptococcus thermophilus</span><span>;</span></p><p class=\"Tablea\"><span>(l) </span><span style=\"font-style:italic\">Synechococcus</span><span> species strains PCC 7002, PCC 7942 and WH 8102;</span></p><p class=\"Tablea\"><span>(m) </span><span style=\"font-style:italic\">Synechocystis </span><span>species strain PCC 6803;</span></p><p class=\"Tablea\"><span>(n) </span><span style=\"font-style:italic\">Vibrio cholerae </span><span>CVD103</span><span>‑</span><span>HgR;</span></p><p class=\"Tablea\"><span>(o) </span><span style=\"font-style:italic\">Zymomonas mobilis</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Non</span><span>‑</span><span>conjugative plasmids</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>7</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Fungi</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) </span><span style=\"font-style:italic\">Kluyveromyces lactis</span><span>;</span></p><p class=\"Tablea\"><span>(b) </span><span style=\"font-style:italic\">Neurospora crassa </span><span>(laboratory strains);</span></p><p class=\"Tablea\"><span>(c) </span><span style=\"font-style:italic\">Pichia pastoris</span><span>;</span></p><p class=\"Tablea\"><span>(d) </span><span style=\"font-style:italic\">Saccharomyces cerevisiae</span><span>;</span></p><p class=\"Tablea\"><span>(e) </span><span style=\"font-style:italic\">Schizosaccharomyces pombe</span><span>;</span></p><p class=\"Tablea\"><span>(f) </span><span style=\"font-style:italic\">Trichoderma reesei</span><span>;</span></p><p class=\"Tablea\"><span>(g) </span><span style=\"font-style:italic\">Yarrowia lipolytica</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>All vectors</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>8</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Slime moulds</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Dictyostelium </span><span>species</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span style=\"font-style:italic\">Dictyostelium </span><span>shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\" style=\"page-break-after:avoid\"><span>9</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Tissue culture</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following if they cannot spontaneously generate a whole animal:</span></p><p class=\"Tablea\"><span>(a) animal or human cell cultures (including packaging cell lines);</span></p><p class=\"Tablea\"><span>(b) isolated cells, isolated tissues or isolated organs, whether animal or human;</span></p><p class=\"Tablea\"><span>(c) early non</span><span>‑</span><span>human mammalian embryos cultured </span><span style=\"font-style:italic\">in vitro</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) plasmids;</span></p><p class=\"Tablea\"><span>(b) replication defective viral vectors unable to transduce human cells;</span></p><p class=\"Tablea\"><span>(c) polyhedrin minus forms of the baculovirus </span><span style=\"font-style:italic\">Autographa californica</span><span> nuclear polyhedrosis virus (ACNPV)</span></p></td></tr><tr><td style=\"width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>10</span></p></td><td style=\"width:43.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Tissue culture</span></p></td><td style=\"width:180.25pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Either of the following if they are not intended, and are not likely without human intervention, to vegetatively propagate, flower or regenerate into a whole plant:</span></p><p class=\"Tablea\"><span>(a) plant cell cultures;</span></p><p class=\"Tablea\"><span>(b) isolated plant tissues or organs</span></p></td><td style=\"width:134.8pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top\"><p class=\"Tabletext\"><span>Any of the following:</span></p><p class=\"Tablea\"><span>(a) Disarmed Ri or Ti plasmids in </span><span style=\"font-style:italic\">Agrobacterium radiobacter</span><span>, </span><span style=\"font-style:italic\">Agrobacterium rhizogenes</span><span> (disarmed strains only) or </span><span style=\"font-style:italic\">Agrobacterium tumefaciens </span><span>(disarmed strains only);</span></p><p class=\"Tablea\"><span>(b) non</span><span>‑</span><span>pathogenic viral vectors</span></p></td></tr></tbody></table>\n```\n\n## Part 3 Definitions\n\n## Part 3—Definitions\n\n  In this Schedule:\n\n> code for, in relation to a toxin, means to specify the amino acid sequence of the toxin.\n\n> non‑conjugative plasmid means a plasmid that is not self‑transmissible, and includes, but is not limited to, non‑conjugative forms of the following plasmids:\n\n    (a) bacterial artificial chromosomes (BACs);\n    (b) cosmids;\n    (c) P1 artificial chromosomes (PACs);\n    (d) yeast artificial chromosomes (YACs).\n\n> non‑vector system means a system in which donor nucleic acid is or was introduced into a host cell:\n\n    (a) in the absence of a nucleic acid‑based vector; or\n    (b) using a nucleic acid‑based vector in the course of a previous dealing and the vector is:\n    (i) no longer present; or\n    (ii) present but cannot be remobilised from a host cell.\n\n> Note: Example 1: A system mentioned in paragraph (a) might involve the use of electroporation or particle bombardment.\n\n> Note: Example 2: A system mentioned in paragraph (b) might involve cells that were transduced with a replication defective retroviral vector in which no vector particles remain.\n\nSchedule 3—Notifiable low risk dealings in relation to a GMO\n\n(regulations 12 and 13)\n\n## Part 1 Notifiable low risk dealings suitable for at least physical containment level 1\n\n## Part 1—Notifiable low risk dealings suitable for at least physical containment level 1\n\nNote: Because of subregulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.\n\n## 1.1 Kinds of dealings suitable for at least physical containment level 1\n\n#### 1.1 Kinds of dealings suitable for at least physical containment level 1\n\n  The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 1 and that are appropriate for the dealings:\n    (a) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit or a genetically modified laboratory rat, unless:\n    (i) an advantage is conferred on the animal by the genetic modification; or\n    (ii) the animal is capable of secreting or producing an infectious agent as a result of the genetic modification;\n    (c) a dealing involving virions of a replication defective vector derived from Human adenovirus or from Adeno‑associated virus, either without a host or with a host mentioned in item 9 of Part 2 of Schedule 2, if the donor nucleic acid:\n    (i) cannot restore replication competence to the vector; and\n    (ii) does not confer an oncogenic modification or immunomodulatory effect in humans.\n\n## Part 2 Notifiable low risk dealings suitable for at least physical containment level 2 or 3\n\n## Part 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3\n\nNote: Because of subregulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3.\n\n## 2.1 Kinds of dealings suitable for at least physical containment level 2\n\n#### 2.1 Kinds of dealings suitable for at least physical containment level 2\n\n  The following kinds of notifiable low risk dealings must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 2 and that are appropriate for the dealings:\n    (a) a dealing involving whole animals (including non‑vertebrates) that:\n    (i) involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and\n    (ii) does not involve any of the following:\n    (A) a genetically modified laboratory guinea pig;\n    (B) a genetically modified laboratory mouse;\n    (C) a genetically modified laboratory rabbit;\n    (D) a genetically modified laboratory rat;\n    (E) a genetically modified Caenorhabditis elegans;\n    (aa) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat or a genetically modified Caenorhabditis elegans, if:\n    (i) the genetic modification confers an advantage on the animal; and\n    (ii) the animal is not capable of secreting or producing an infectious agent as a result of the genetic modification;\n    (b) a dealing involving a genetically modified plant;\n    (c) a dealing involving a host/vector system not mentioned in paragraph 1.1(c) or Part 2 of Schedule 2, if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise healthy:\n    (i) human beings; or\n    (ii) animals; or\n    (iii) plants; or\n    (iv) fungi;\n    (d) a dealing involving a host/vector system not mentioned in Part 2 of Schedule 2, if:\n    (i) the host or vector has been implicated in, or has a history of causing, disease in otherwise healthy:\n    (ii) the genetic modification is characterised; and\n    (iii) the characterisation of the genetic modification shows that it is unlikely to increase the capacity of the host or vector to cause harm;\n    Example: A genetic modification would not comply with subparagraph (iii) if, in relation to the capacity of the host or vector to cause harm, it:\n\n(a) provides an advantage; or\n\n(b) adds a potential host species or mode of transmission; or\n\n(c) increases its virulence, pathogenicity or transmissibility.\n\n    (e) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid:\n    (i) is characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; or\n    (ii) is uncharacterised nucleic acid from an organism that has been implicated in, or has a history of causing, disease in otherwise healthy:\n    (D) fungi;\n    (f) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and producing more than 25 litres of GMO culture in each vessel containing the resultant culture, if:\n    (i) the dealing is undertaken in a facility that is certified by the Regulator as a large scale facility; and\n    (ii) the donor nucleic acid satisfies the conditions set out in subitem 4(2) of Part 1 of Schedule 2;\n    (g) a dealing involving complementation of knocked‑out genes, if the complementation is unlikely to increase the capacity of the GMO to cause harm compared to the capacity of the parent organism before the genes were knocked out;\n\n> Note: Example: A dealing would not comply with paragraph (g) if it involved complementation that, in relation to the parent organism:\n\n    (h) a dealing involving shot‑gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of Schedule 2, if the donor nucleic acid is derived from either:\n    (i) a pathogen; or\n    (ii) a toxin‑producing organism;\n    (i) a dealing involving virions of a replication defective viral vector unable to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;\n    (j) a dealing involving virions of a replication defective non‑retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:\n    (ii) the dealing is not a dealing mentioned in paragraph 1.1(c);\n    (k) a dealing involving virions of a replication defective non‑retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if:\n    (ii) the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;\n    (l) a dealing involving virions of a replication defective retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if:\n    (i) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and\n    (ii) viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and\n    (iii) either:\n    (A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or\n    (B) the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these;\n    (m) a dealing involving virions of a replication defective retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if:\n    (i) the donor nucleic acids does not confer an oncogenic modification or immunomodulatory effect in humans; and\n    (ii) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and\n    (iii) viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and\n    (iv) either:\n    (A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or\n    (B) the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these.\n\n## 2.2 Kinds of dealing suitable for at least physical containment level 3\n\n#### 2.2 Kinds of dealing suitable for at least physical containment level 3\n\n  (1) A kind of dealing that:\n    (a) is a kind mentioned in clause 2.1; and\n    (b) involves a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3;\n  must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 3 and that are appropriate for the dealings.\n  (2) For the purposes of paragraph (1)(b), a genetically modified micro‑organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro‑organism satisfies those criteria.\n  (3) However, subclause (2) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).\n\n## Part 3 Dealings that are not notifiable low risk dealings\n\n## Part 3—Dealings that are not notifiable low risk dealings\n\nNote 1: The following list qualifies the list in Parts 1 and 2, and is not an exhaustive list of dealings that are not notifiable low risk dealings.\n\nNote 2: If a dealing is not a notifiable low risk dealing, or an exempt dealing, as provided by these Regulations, a person undertaking the dealing must be authorised by a GMO licence unless the dealing is within one of the other exceptions to licensing provided by the Act: see section 32 of the Act.\n\n## 3.1 Kinds of dealings\n\n#### 3.1 Kinds of dealings\n\n  (1) A dealing of any of the following kinds, or involving a dealing of the following kinds, is not a notifiable low risk dealing:\n    (a) a dealing (other than a dealing mentioned in paragraph 2.1(h)) involving cloning of nucleic acid encoding a toxin having an LD50 of less than 100 micrograms per kilogram;\n    (b) a dealing involving high level expression of toxin genes, even if the LD50 is 100 micrograms per kilogram or more;\n    (c) a dealing (other than a dealing mentioned in paragraph 2.1(h)) involving cloning of uncharacterised nucleic acid from a toxin‑producing organism;\n    (d) a dealing involving virions of a replication defective viral vector and a host not mentioned in Part 2 of Schedule 2, if:\n    (i) the donor nucleic acid confers an oncogenic modification or immunomodulatory effect in humans; and\n    (ii) the dealing is not a dealing mentioned in paragraph 2.1(i);\n    (e) a dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the genetic modification confers an oncogenic modification or immunomodulatory effect in humans;\n    (f) a dealing involving, as host or vector, a micro‑organism, if:\n    (i) the micro‑organism has been implicated in, or has a history of causing, disease in otherwise healthy:\n    (ii) none of the following sub‑subparagraphs apply:\n    (A) the host/vector system is a system mentioned in Part 2 of Schedule 2;\n    (B) the genetic modification is characterised and its characterisation shows that it is unlikely to increase the capacity of the host or vector to cause harm;\n    (C) the dealing is a dealing mentioned in paragraph 2.1(g);\n\n> Note: Example: A genetic modification would not comply with sub‑subparagraph (B) if, in relation to the capacity of the host or vector to cause harm, it:\n\n    (g) a dealing involving the introduction, into a micro‑organism, of nucleic acid encoding a pathogenic determinant, unless:\n    (i) the dealing is a dealing mentioned in paragraph 2.1(g); or\n    (ii) the micro‑organism is a host mentioned in Part 2 of Schedule 2;\n    (h) a dealing involving the introduction into a micro‑organism, other than a host mentioned in Part 2 of Schedule 2, of genes whose expressed products are likely to increase the capacity of the micro‑organisms to induce an autoimmune response;\n    (i) a dealing involving use of a viral or viroid genome, or fragments of a viral or viroid genome, to produce a novel replication competent virus with an increased capacity to cause harm compared to the capacity of the parent or donor organism;\n\n> Note: Example: A dealing would comply with paragraph (i) if it produces a novel replication competent virus that has a higher capacity to cause harm to any potential host species than the parent organism because the new virus has:\n\n> Note: (a) an advantage; or\n\n> Note: (b) a new potential host species or mode of transmissibility; or\n\n> Note: (c) increased virulence, pathogenicity or transmissibility.\n\n    (j) a dealing, other than a dealing mentioned in paragraph 2.1(l) or (m), with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;\n    (k) a dealing involving a genetically modified animal, plant or fungus that is capable of secreting or producing infectious agents as a result of the genetic modification;\n    (l) a dealing producing, in each vessel containing the resultant GMO culture, more than 25 litres of that culture, other than a dealing mentioned in paragraph 2.1(f);\n    (m) a dealing that is inconsistent with a policy principle issued by the Ministerial Council;\n    (n) a dealing involving the intentional introduction of a GMO into a human being, unless the GMO:\n    (i) is a human somatic cell; and\n    (ii) cannot secrete or produce infectious agents as a result of the genetic modification; and\n    (iii) if it was generated using viral vectors:\n    (A) has been tested for the presence of viruses likely to recombine with the genetically modified nucleic acid in the somatic cells; and\n    (B) the testing did not detect a virus mentioned in sub‑subparagraph (A); and\n    (C) the viral vector used to generate the GMO as part of a previous dealing is no longer present in the somatic cells;\n    (o) a dealing involving a genetically modified pathogenic organism, if the practical treatment of any disease or abnormality caused by the organism would be impaired by the genetic modification;\n    (p) a dealing involving a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4;\n    (q) a dealing involving a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 and that is not undertaken:\n    (i) in a facility that is certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n    (ii) in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken;\n    (r) a dealing involving a GMO capable of sexual reproduction, the sexual progeny of which are, as a result of the genetic modification, more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism);\n    (s) a dealing involving a viral vector that can modify an organism capable of sexual reproduction, so that the sexual progeny of the organism are more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism).\n\n> Note: A modification that increases the likelihood of inheritance of a nucleotide sequence or sequences, as described in paragraphs (r) and (s), is generally known as an engineered gene drive.\n\n  (2) For the purposes of paragraph (1)(p), a genetically modified micro‑organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4 if the unmodified parent micro‑organism satisfies those criteria.\n  (3) For the purposes of paragraph (1)(q), a genetically modified micro‑organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro‑organism satisfies those criteria.\n  (4) However, subclause (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).","sortOrder":5}],"analysis":{"flash_summary":{"complexity_score":9,"scope_assessment":{"changed":true,"description":"The Regulations have been amended over time (notably by the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 and the Gene Technology Amendment (Minor Measures) Regulations 2025) in ways that materially change scope and operation. Key scope changes: (a) the insertion and refinement of Schedules that carve out specific techniques and organisms from the definition of gene technology/GMO (Schedule 1A/1B and Schedule 1 items), meaning some techniques that were previously regulated may now be excluded; (b) formalisation of a three‑tier risk approach (exempt, notifiable low risk, licensable) with detailed technical thresholds, which reallocates regulatory burden away from some routine laboratory work and towards larger‑scale, novel or higher‑risk activities (regs 6, 12–13 and Schedule 3); (c) added transitional rules and grandfathering (reg 41) that protect some existing activities from immediate reclassification on amendment but only for limited periods; and (d) amendments that expand administrative duties of the Regulator (e.g. functions relating to poliovirus containment inspections reg 5A) and change committee/appointment procedures (regs 19, 20, Division 2 (2025) amendments). Collectively these changes shift the practical perimeter of regulation — narrowing it in some technical areas (by excluding particular techniques or organisms) while widening it procedurally by adding notification, record‑keeping and characterisation obligations and by creating new decision nodes and timelines. The result is a regulatory architecture that has grown from a simpler licensing scheme into a detailed, technical, risk‑tiered regime with significant implementation complexity."},"complexity_factors":["Large number of defined terms in reg 3 and throughout (many technical definitions such as 'characterised', 'physical containment level', 'non‑conjugative plasmid').","Multiple Schedules (1, 1A, 1B, 2, 3) containing species lists, host/vector tables, and multi‑condition rules that cross‑reference core regs.","Nested conditional logic and exceptions: e.g. an activity can be exempt only if numerous cumulative criteria are met (reg 6; Schedule 2 subitem 4(2)), and Schedule 3 contains \"notifiable\" parts with carve‑outs (reg 12, Schedule 3 Part 3).","Extensive cross‑references to the Gene Technology Act and to external standards (AS/NZS 2243.3:2010), creating interpretive dependencies.","Technical, domain‑specific thresholds and tests (toxin LD50 <100 μg/kg; 25 L culture threshold) that require scientific input to apply (Schedule 2, Schedule 3).","Multiple administrative timelines with excluded days and stop‑the‑clock events (reg 8(2); 11A), and differing timeframes for variation and certification (regs 11A, 14–16).","Detailed governance procedures for two advisory committees (Divisions for GTTAC and Ethics & Community Committee) including conflict disclosure, quorum rules and minutes (regs 18–30).","Transitional and amendment provisions that apply differently depending on commencement day and prior activities (regs 41–49; Division 2 amendments 2025), creating retroactive/prospective complexity.","Long lists of precise host/vector pairings and permitted vectors (Schedule 2 Part 2 host/vector table) requiring species‑level checking.","Record‑keeping and reporting requirements with deadlines and multiple addressees (IBCs, Regulator) (regs 13B, 13C, reg 39)."],"plain_english_summary":"**What these Regulations do (mechanics)\n\n- Define key terms used under the Gene Technology Act 2000 (for example \"GMO\", \"nucleic acid\", \"physical containment level\", \"host/vector system\") and adopt external lab safety standards (reg 3; AS/NZS reference).  \n- Set out which laboratory and field activities are regulated and which are not, by tiering activities into: exempt dealings (no licence needed) (reg 6; Schedule 2), notifiable low risk dealings (must be assessed and recorded by an Institutional Biosafety Committee and notified to the Regulator) (regs 12–13, Schedule 3), and licensed dealings (requires a GMO licence under the Act).  \n- Specify detailed technical thresholds and lists that determine classification: (a) techniques that are not \"gene technology\" (Schedule 1A); (b) organisms that are GMOs (Schedule 1B); and (c) organisms that are not GMOs (Schedule 1). These Schedules contain species lists, host/vector tables and conditions (Schedules 1, 1A, 1B, 2, 3).  \n- Prescribe procedural and administrative rules for the Regulator and advisory bodies: time limits for decisions on licence, certification and accreditation applications (regs 8, 14–16, 11A); consultation and who must be asked for advice (reg 9); the Regulator’s additional functions (reg 5A); inspector identity card requirements (reg 40); and record‑keeping and reporting obligations for notifiable low risk dealings (reg 13C, reg 39).  \n- Set governance rules for the technical and ethics advisory committees (Gene Technology Technical Advisory Committee and Ethics and Community Committee): appointment terms, disclosure of interests, meeting procedures, quorums, voting and records (regs 18–30 and parts 4–5).  \n- Provide transitional/grandfathering rules for past activities when the Regulations are amended (reg 41 and Division 2: regs 42–49). These say, for example, when an activity that was previously exempt or notifiable continues to be treated as such for a limited time and set out when organisms may cease to be GMOs or become GMOs after an amendment.\n\n**Who this affects and who makes the decisions\n\n- Who decides: The Gene Technology Regulator makes certification, accreditation and licensing decisions, and refers ethical issues to the Ethics and Community Committee; the Minister oversees appointments and can terminate committee members (regs 5A, 8, 14–16, 18–23, 21). Institutional Biosafety Committees (IBCs) at organisations assess and record notifiable low risk dealings and must notify the Regulator (regs 13, 13B, 13C).  \n- Who pays / bears compliance costs: applicants for licences/certification/accreditation and organisations undertaking GMO work (laboratories, biotech companies, universities) bear costs of complying with containment certification, IBC assessment, record keeping, testing/characterisation of donor nucleic acid, and any facility upgrades to meet required physical containment levels (regs 13(2), Schedule 2, Schedule 3).  \n- What behaviour changes: regulated parties will (a) choose techniques, hosts or vectors that fall outside the regulated definitions where that is feasible; (b) submit proposals to IBCs and keep records for notifiable low risk dealings (reg 13, 13B, 13C); (c) apply for certification/accreditation or licences where required (regs 14–17); and (d) adjust lab practice to meet containment levels specified in Schedule 3.\n\n**Stated purpose and how it is implemented (official claim, then mechanical test)\n\nOfficial purpose-claim: The instrument implements a risk‑tiered, technical framework to regulate dealings with genetically modified organisms — concentrating regulation on higher‑risk activities and creating streamlined paths for low‑risk work (see regs 6, 12–13 and Schedules 1–3).  \nHow that works practically and the trade‑offs:  \n- Risk‑sizing: The Regulations implement an explicit triage: exempt (Schedule 2), notifiable low risk (Schedule 3 Parts 1–2), and licensed or higher‑risk dealings (Schedule 3 Part 3). This reduces regulatory friction for many routine lab tasks (mechanism: lists/tables and defined thresholds — e.g. toxin LD50 thresholds, 25‑litre culture limit) but requires detailed technical characterisation to rely on an exemption or low‑risk pathway (Schedule 2 subitem 4(2); Schedule 3).  \n- Compliance burden and costs: The requirement to characterise donor nucleic acid, keep eight‑year records, and satisfy physical containment levels shifts upfront costs onto labs and small businesses (regs 13B, 13C, Schedule 2(4), Schedule 3). Certification/accreditation timeframes (90 days) impose predictable but non‑trivial administrative delays (regs 14, 16).  \n- Incentives and substitution effects: Because the Regulations list techniques and organisms that are excluded from regulation (Schedule 1A; items such as certain mutagenesis, cell fusion, natural processes), firms and researchers have an incentive to design work so it falls into an excluded category. That creates an operational incentive to adopt or claim particular methods or hosts that avoid licensing.  \n- Concentration of decision power and discretion: The Regulator has significant discretion in certification, facility approvals and deciding timeframes (regs 8, 14, 16, 13C(4)). The ethical committee review routes (reg 9; regs 50 references) add additional decision nodes. These combine to centralise decision‑making while relying on scientific characterisation supplied by applicants.  \n- Implementation risk: The Regulations depend on technical judgments (\"characterised\", whether donor nucleic acid confers an advantage, LD50 thresholds, host pathogenicity classification per AS/NZS 2243.3:2010). That raises operational risk: inconsistent characterisation or differing international assessments can create uncertainty about whether an activity is exempt, notifiable or licensable (regs 3, 9A, Schedule 2(4)).  \n- Opportunity costs: Activities that cross into the licensable category face long review cycles (up to 255 days for some licences — reg 8), which can delay product development. The transitional provisions (reg 41 and Div 2 regs 45–49) soften shocks for those already undertaking activities before amendments, but only for specified periods.  \n- Effects on markets and private choice: The tiered approach preserves space for small‑scale academic and industrial research under lower containment or notification pathways, while concentrating regulatory cost on larger‑scale or higher‑risk commercial dealings (e.g. >25 L cultures, gene drives, vectors able to modify sexually reproducing organisms; Schedule 3 Part 3). That changes the marginal cost of scaling up and may favour larger organisations that can afford certification and compliance.\n\n**Top practical takeaways for an organisation**\n- Check whether a technique or organism in your workflow appears in Schedule 1A/1/1B, Schedule 2 or Schedule 3 — that classification determines if you need only an IBC record, a Regulator‑issued licence, or neither (regs 4, 4A, 5, 6, 12–13; Schedules 1–3).  \n- If you rely on an exemption or notifiable low risk pathway, you must document IBC assessment in the Regulator’s approved form and give required records by the prescribed deadlines (reg 13B, reg 13C).  \n- Expect administrative timelines (90–255 days for licences; 90 days for certification/accreditation) and plan project schedules accordingly (regs 8, 14–16).  \n- Transitional/amendment rules can change an activity’s regulatory status; the 2019 and 2025 amendment provisions include grandfathering and delayed commencement rules — review those if you were operating before an amendment (reg 41; Division 2 regs 44–49)."},"kimi_summary":{"_metrics":{"completionTokens":764},"content_quality":"ok","complexity_score":8,"scope_assessment":{"changed":true,"description":"The regulations have expanded significantly beyond their original 2001 scope through multiple amendment instruments. The 2019 amendments introduced new notification requirements and transitional arrangements for existing dealings. The 2025 \"Minor Measures\" amendments (Division 2 of Part 8) further expanded scope by: (1) retrospectively reclassifying techniques that were previously gene technology, potentially making formerly regulated GMOs unregulated; (2) creating staggered commencement dates (immediate vs 12-month delays) for different organism classifications; and (3) adding poliovirus containment inspections as a new function of the Regulator under the National Health Security Act 2007. The cumulative effect is a regulatory framework that now manages not just gene technology but also overlaps with biosecurity and health security regimes."},"complexity_factors":["Extensive cross-referencing to the Gene Technology Act 2000 and multiple schedules not included in the provided text","Nested conditional logic throughout — e.g., regulation 5 has four cumulative conditions for excluding organisms from GMO status","Multiple interacting timelines for decision-making with excluded days (regulation 8 has five categories of non-counted days)","Duplicative structure with Parts 4 and 5 mirroring each other via \"as if\" references requiring mental substitution","Technical scientific definitions (e.g., \"oncogenic modification,\" \"packaging cell line,\" \"transduce\") that assume specialist knowledge","Transitional provisions in Part 8 create parallel regulatory regimes with different commencement dates and grandfathering rules","Regulation 13C contains four subregulations with multiple paragraphs and sub-paragraphs creating dense notification requirements","Committee procedures in regulations 24-30 include recursive application to subcommittees with modified quorum rules"],"plain_english_summary":"These regulations set out the detailed rules for how genetically modified organisms (GMOs) are handled in Australia. They work alongside the Gene Technology Act 2000 to create a comprehensive safety framework.\n\n**What this legislation does:**\n\n- **Defines what counts as \"gene technology\" and what doesn't** — Some techniques are excluded from regulation (listed in Schedule 1A), and certain organisms are either explicitly included or excluded from being classified as GMOs\n\n- **Establishes a three-tier system for dealing with GMOs:**\n  - **Exempt dealings** — Low-risk activities that don't need a licence (must be listed in Schedule 2, involve no intentional release, and stay within containment)\n  - **Notifiable low-risk dealings** — Medium-risk activities that need assessment by an Institutional Biosafety Committee but not a full licence; must be reported to the Regulator\n  - **Licensed dealings** — Higher-risk activities requiring a formal GMO licence from the Gene Technology Regulator\n\n- **Sets up the rules for two key advisory committees:**\n  - The **Gene Technology Technical Advisory Committee** — provides scientific and technical advice\n  - The **Ethics and Community Committee** — provides ethical and community perspectives\n\n- **Details how facilities and organisations get certified** — Physical containment levels (1-4) must be approved for different risk categories\n\n- **Creates extensive record-keeping requirements** — Institutional Biosafety Committees must document assessments, and these records must be kept for 8 years\n\n**Who it affects:**\n- Research institutions and universities doing genetic modification work\n- Biotechnology companies\n- Agricultural businesses developing GMO crops\n- Anyone importing, exporting, or releasing GMOs\n\n**Why it matters:**\nThis is Australia's primary mechanism for ensuring GMO research and commercial activities don't harm people or the environment, while still allowing innovation to proceed through clear regulatory pathways."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/gene-technology-regulations-2001","history":"/api/acts/gene-technology-regulations-2001/history","analysis":"/api/acts/gene-technology-regulations-2001/analysis","conflicts":"/api/acts/gene-technology-regulations-2001/conflicts","importantCases":"/api/acts/gene-technology-regulations-2001/important-cases","documents":"/api/acts/gene-technology-regulations-2001/documents"}}