{"id":"sr:gene-technology-regulations-2021","name":"Gene Technology Regulations 2021","slug":"gene-technology-regulations-2021","collection":"regulation","jurisdiction":"vic","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":181559,"registerId":"vic-sr:gene-technology-regulations-2021-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Gene Technology Regulations 2021","content":"Version No. 002\n\n**Gene Technology Regulations 2021**\n\n**S.R. No. 94/2021**\n\nVersion incorporating amendments as at  \n17 June 2025\n\n**TABLE OF PROVISIONS**\n\n*Regulation Page*\n\nPart 1—Preliminary 1\n\n1 Objective 1\n\n1A Authorising provision 1\n\n2 Commencement 1\n\n2A Revocations 2\n\n3 Definitions 2\n\n3A Numbering 6\n\n3B Notes 7\n\nPart 2—Interpretation and general operation 8\n\n4 Techniques not constituting gene technology 8\n\n4A Organisms that are genetically modified organisms 8\n\n5 Organisms that are not genetically modified organisms 8\n\nPart 2A—Gene Technology Regulator 9\n\n5A Functions of the Regulator 9\n\nPart 3—Dealings with GMOs 10\n\nDivision 1—Licensing system 10\n\n6 Dealings exempt from licensing 10\n\n7 Application for licence—prescribed fee 10\n\n8 Time limit for deciding an application 10\n\n9 Prescribed authorities 13\n\n9A Risks posed by dealings proposed to be authorised by licence 14\n\n10 Risk assessment—matters to be taken into account 14\n\n11 Prescribed conditions of licence 15\n\n11A Time limit for deciding variation application 15\n\nDivision 2—Notifiable low risk dealings 16\n\n12 Notifiable low risk dealings 16\n\n13 Requirements for undertaking notifiable low risk dealings 16\n\n13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals 19\n\n13C Information to be kept or given to the Regulator by persons or accredited organisations 20\n\nDivision 3—Certification and accreditation 22\n\n14 Regulator to decide certification application within 90 days 22\n\n15 Application for certification—failure to provide section 85 information 22\n\n16 Regulator to decide accreditation application within 90 days 22\n\n17 Application for accreditation—failure to provide section 93 information 23\n\nPart 4—Gene Technology Technical Advisory Committee 24\n\nDivision 1—Conditions of appointment 24\n\n18 GTTAC members and advisers—term of appointment 24\n\n19 GTTAC members and advisers—resignation 24\n\n20 GTTAC members—disclosure of interests 24\n\n21 GTTAC members and advisers—termination of appointment 24\n\n22 GTTAC members—leave of absence 24\n\n23 Expert advisers—disclosure of interests 25\n\nDivision 2—Committee procedures 25\n\n24 Committee procedures generally 25\n\n25 Committee meetings 25\n\n26 Presiding member 25\n\n27 Quorum 25\n\n28 Voting 26\n\n29 Records and Reports 26\n\nDivision 3—Subcommittees 26\n\n30 Operation of subcommittees 26\n\nPart 5—Ethics and Community Committee 27\n\n31 Ethics and Community Committee—conditions of appointment 27\n\n32 Ethics and Community Committee—Committee procedures 27\n\n33 Ethics and Community Committee—operation of subcommittees 27\n\nPart 7—Miscellaneous 28\n\n37 Reviewable State decisions 28\n\n38 Review of decisions 28\n\n39 Record of GMO Dealings 28\n\n40 Inspector identity card 29\n\nSchedule 1A—Techniques that are not gene technology 30\n\nSchedule 1B—Organisms that are genetically modified organisms 31\n\nSchedule 1—Organisms that are not genetically modified organisms 32\n\nSchedule 2—Dealings exempt from licensing 34\n\nSchedule 3—Notifiable low risk dealings in relation to a GMO 42\n\n═════════════\n\nEndnotes 56\n\n1 General information 56\n\n2 Table of Amendments 58\n\n3 Explanatory details 59\n\n**Version No.** **002**\n\n**Gene Technology Regulations 2021**\n\n**S.R. No. 94/2021**\n\nVersion incorporating amendments as at  \n17 June 2025\n\nPart 1—Preliminary\n\n\t1 Objective\n\nThe objective of these Regulations is to prescribe those matters that are—\n\n(a) required or permitted by the **Gene Technology Act 2001** to be prescribed; and\n\n(b) necessary or convenient to be prescribed for carrying out or giving effect to that Act.\n\n**Note**\n\nThis regulation differs from regulation 1 of the Commonwealth Regulations.\n\n\t1A Authorising provision\n\nThese Regulations are made under section 193 of the **Gene Technology Act 2001**.\n\n**Note**\n\nThis regulation does not appear in the Commonwealth Regulations.\n\n\t2 Commencement\n\nThese Regulations come into operation on 29 August 2021.\n\n\t2A Revocations\n\nThe following regulations are **revoked**—\n\n(a) the Gene Technology Regulations 2011[[1]](#endnote-1);\n\n(b) the Gene Technology Amendment Regulations 2016[[2]](#endnote-2);\n\n(c) the Gene Technology Amendment Regulations 2019[[3]](#endnote-3).\n\n**Note**\n\nThis regulation does not appear in the Commonwealth Regulations.\n\n\t3 Definitions\n\nIn these Regulations—\n\n***Act*** means the **Gene Technology Act 2001**;\n\n**Note**\n\nThis definition differs from the definition of ***Act*** in regulation 3 of the Commonwealth Regulations.\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***characterised*** means—\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\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(i) potential gene products or potential functions of the gene or genomic region; and\n\n(ii) the likely effect of the genetic modification on the gene products or functions;\n\n***code for***, for Schedule 2, has the meaning given in Part 3 of that Schedule;\n\n***Commonwealth Regulations***  means the Gene Technology Regulations 2001 of the Commonwealth;\n\n**Note**\n\nThis definition does not appear in regulation 3 of the Commonwealth Regulations.\n\n***expert adviser*** means—\n\n(a) in Part 4—an expert adviser appointed under section 102(1) of the Commonwealth Act; and\n\n(b) in Part 5—an expert adviser appointed under section 112(1) of the Commonwealth Act;\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***host/vector system*** has a meaning affected by clause 2.1(3) of Schedule 2;\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***inspector*** means a person appointed by the Regulator under section 150 of the Act as an inspector;\n\n***known*** means known within the scientific community;\n\n***non‑conjugative plasmid***, for Schedule 2, has the meaning given in Part 3 of that Schedule;\n\n***non‑vector system*** has the meaning given in Part 3 of Schedule 2;\n\n***nucleic acid*** means either, or both, deoxyribonucleic acid (DNA), or ribonucleic acid (RNA), of any length;\n\n***oncogenic modification*** means a genetic modification capable of contributing to tumour formation, including modifications that cause at least one of the following—\n\n(a) defects in DNA proofreading and repair;\n\n(b) defects in chromosome maintenance;\n\n(c) defects in cell cycle checkpoint mechanisms;\n\n(d) uncontrolled cell proliferation;\n\n(e) resistance to apoptosis;\n\n(f) cellular immortalisation;\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***, in relation to an organism,  means having the capacity to cause disease or abnormality;\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***toxin*** means a substance that is toxic to any vertebrate;\n\n***toxin‑producing organism*** means an organism producing toxin with an LD50 of less than 100 micrograms per kilogram;\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**\n\nSeveral 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• accredited organisation\n\n• deal with\n\n• environment\n\n• Ethics and Community Committee\n\n• facility\n\n• Gene Technology Technical Advisory Committee\n\n• GMO\n\n• Institutional Biosafety Committee\n\n• intentional release of the GMO into the environment (see section 11)\n\n• notifiable low risk dealing\n\n• Regulator.\n\n\t3A Numbering\n\n(1) In order to maintain consistent numbering between these Regulations and the Commonwealth Regulations—\n\n(a) if the Commonwealth Regulations contain a regulation that is not required in these Regulations, the regulation number and heading to the regulation appearing in the Commonwealth Regulations are included in these Regulations despite the omission of the body of the regulation; and\n\n(b) if these Regulations contain a regulation that is not included in the Commonwealth Regulations, the regulation is numbered so as to maintain consistency in numbering between regulations common to both Regulations.\n\n(2) A regulation number and heading referred to in subregulation (1)(a) form part of these Regulations.\n\n**Notes**\n\n1 A note appears under each heading of a kind referred to in subregulation (1)(a) describing the omitted regulation of the Commonwealth Regulations.\n\n2 A note appears under each regulation of a kind referred to in subregulation (1)(b) highlighting the non‑appearance of an equivalent regulation in the Commonwealth Regulations.\n\n3 This regulation does not appear in the Commonwealth Regulations.\n\n\t3B Notes\n\nNotes do not form part of these Regulations.\n\n**Note**\n\nThis regulation does not appear in the Commonwealth Regulations.\n\nPart 2—Interpretation and general operation\n\n\t4 Techniques not constituting gene technology\n\nFor the purposes of paragraph (c) of the definition of ***gene technology*** in section 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n\n\t4A Organisms that are genetically modified organisms\n\nFor the purposes of paragraph (c) of the definition of ***genetically modified organism*** in section 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n\n\t5 Organisms that are not genetically modified organisms\n\nFor the purposes of paragraph (e) of the definition of ***genetically modified organism*** in section 10(1) of the Act, an organism is not a genetically modified organism if—\n\n(a) one or more items of Schedule 1 apply to the organism; and\n\n(b) the organism has not been modified by gene technology except for any modifications described in those items; and\n\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 of Schedule 1; and\n\n(d) none of the items of Schedule 1B apply to the organism.\n\nPart 2A—Gene Technology Regulator\n\n\t5A Functions of the Regulator\n\nNote to reg. 5A substituted by S.R. No. 51/2025 reg. 4.\n\n**Note**\n\nRegulation 5A of the Commonwealth Regulations sets out the Regulator's functions of—\n\n(a) making inspectors available to be appointed as inspectors under the National Health Security Act 2007 of the Commonwealth; and\n\n(b) making inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.\n\nPart 3—Dealings with GMOs\n\nDivision 1—Licensing system\n\n\t6 Dealings exempt from licensing\n\n(1) For the purposes of section 32(3) of the Act, a dealing, in relation to a GMO, is an exempt dealing if—\n\n(a) it is a dealing of a kind referred to in Part 1 of Schedule 2; and\n\n(b) it does not involve a genetic modification other than a modification described in Part 1 of Schedule 2; and\n\n(d) it does not involve an intentional release of the GMO into the environment.\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**Notes**\n\n1 A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of ***deal with*** in section 10(1) of the Act.\n\n2 Exemption from provisions of the Act does not preclude the application of other Commonwealth and State laws.\n\n\t7 Application for licence—prescribed fee\n\n**Note**\n\nAt the commencement of these Regulations, no application fee is prescribed under section 40(6) of the Act.\n\n\t8 Time limit for deciding an application\n\n(1) For the purposes of section 43(3) of the Act, the period within which the Regulator must issue, or refuse to issue, a licence is—\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\n(b) in relation to an application to which Division 4 of Part 5 of the Act applies—\n\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\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\n(iii) in any other case—255 days after the day the application is received by the Regulator.\n\n(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted—\n\n(a) a Saturday, a Sunday or a public holiday in the Australian Capital Territory;\n\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\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\n(i) begins on the day of publication; and\n\n(ii) ends on the day when the public hearing ends;\n\n(d) a day on which the Regulator cannot proceed with the decision-making process, or a related function, because—\n\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\n(ii) the Regulator is—\n\n(A) considering the application; or\n\n(B) waiting until any review rights under section 181 or 183 of the Act, in relation to the application, are exhausted;\n\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\n(i) begins on the day the request is made; and\n\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\n(3) The Regulator, when seeking advice under section 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(4) In subregulation (1)—\n\n***limited and controlled release application*** means an application for a licence to which section 50A of the Act applies.\n\n\t9 Prescribed authorities\n\nFor the purposes of sections 50(3)(c) and 52(3)(c) of the Act, the following Commonwealth authorities and agencies are prescribed—\n\n(a) Food Standards Australia New Zealand;\n\n(b) the Department administered by the Minister administering Part 1 of Chapter 8 of the Biosecurity Act 2015 of the Commonwealth;\n\nReg. 9(d) substituted by S.R. No. 51/2025 reg. 5(a).\n\n(d) that part of the Department of Health and Aged Care of the Commonwealth known as the Australian Industrial Chemicals Introduction Scheme;\n\n(e) Australian Pesticides and Veterinary Medicines Authority;\n\nReg. 9(f) amended by S.R. No. 51/2025 reg. 5(b).\n\n(f) that part of the Department of Health and Aged Care of the Commonwealth known as the Therapeutic Goods Administration.\n\n**Notes**\n\n1 Paragraph (c) is omitted in these Regulations and the Commonwealth Regulations.\n\n2 This regulation differs from regulation 9 of the Commonwealth Regulations.\n\n\t9A Risks posed by dealings proposed to be authorised by licence\n\nFor the purpose of section 51(1)(a) of the Act, the Regulator must have regard to the following matters—\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\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(c) provisions for limiting the dissemination or persistence of the GMO or its genetic material in the environment;\n\n(d) the potential for spread or persistence of the GMO or its genetic material in the environment;\n\n(e) the extent or scale of the proposed dealings;\n\n(f) any likely impacts of the proposed dealings on the health and safety of people.\n\n\t10 Risk assessment—matters to be taken into account\n\n(1) For the purposes of section 51(1)(g) and (2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence are—\n\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\n(b) the potential of the GMO concerned to—\n\n(i) be harmful to other organisms; and\n\n(ii) adversely affect any ecosystems; and\n\n(iii) transfer genetic material to another organism; and\n\n(iv) spread, or persist, in the environment; and\n\n(v) have, in comparison to related organisms, an advantage in the environment; and\n\n(vi) be toxic, allergenic or pathogenic to other organisms.\n\n(2) In taking into account a risk mentioned in section 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\t11 Prescribed conditions of licence\n\n**Note**\n\nAt the commencement of these Regulations, no conditions are prescribed under section 61(b) of the Act.\n\n\t11A Time limit for deciding variation application\n\n(1) For the purposes of section 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\n(2) For the period mentioned in subregulation (1), the following days are not counted—\n\n(a) a Saturday, a Sunday or a public holiday in the Australian Capital Territory;\n\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\nDivision 2—Notifiable low risk dealings\n\n\t12 Notifiable low risk dealings\n\n(1) For the purposes of section 74(1) of the Act, a dealing with a GMO is a notifiable low risk dealing if—\n\n(a) it is a dealing of a kind mentioned in Part 1 or 2 of Schedule 3; and\n\n(ab) it is not a dealing of a kind mentioned in Part 3 of Schedule 3; and\n\n(b) it does not involve an intentional release of the GMO into the environment.\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**\n\nA dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of ***deal with*** in section 10(1) of the Act.\n\n\t13 Requirements for undertaking notifiable low risk dealings\n\n(1) A person may undertake a notifiable low risk dealing only if—\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\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\n(c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee's record of assessment of the proposal; and\n\n(d) the dealing is only undertaken no later than the day 5 years after the date of the assessment; and\n\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\n(f) subject to subregulation (3), the dealing is undertaken in facilities that—\n\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\n(ii) are facilities in which subregulation (2) permits the dealing to be undertaken; and\n\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\n(h) the person does not compromise the containment of a GMO involved in the dealing.\n\n(2) A notifiable low risk dealing must be undertaken—\n\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\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\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\n(c) in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken.\n\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 subregulations (1)(f) and (2), if it is conducted in accordance with—\n\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 section 27(d) of the Act; or\n\n(b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n\n(4) For subregulation (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**Note**\n\nThis regulation differs from regulation 13 of the Commonwealth Regulations.\n\n\t13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n\nAn Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must—\n\n(a) make a record of its assessment, in a form approved by the Regulator, that includes the following—\n\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\n(ii) a description of the dealing to be undertaken;\n\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\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\n(v) the date of the Committee's assessment of the dealing;\n\n(vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n\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 regulation 13(2);\n\n(viii) the name of the Committee that assessed the proposal;\n\n(ix) the name of the person or accredited organisation that submitted the proposal;\n\n(x) the person or persons proposing to undertake the dealing; and\n\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\t13C 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 regulation 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\n(2) A record of a dealing for the purposes of subregulation (1) must include—\n\n(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n\n(b) the name of the Committee that assessed the proposal relating to the dealing; and\n\n(c) the name of the person or accredited organisation that submitted the proposal to the Committee for assessment.\n\n(2A) The record must be given to the Regulator—\n\n(a) in a form approved by the Regulator; and\n\n(b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n\n(2B) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must—\n\n(a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n\n(b) certify in the annual report that the record has previously been given to the Regulator.\n\n(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under regulation 13B(b) must keep a copy of the Committee's record of assessment for 8 years after the date of the assessment.\n\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\n(a) the person or accredited organisation that submitted the proposal for assessment of the dealing;\n\n(b) any other person involved with undertaking the dealing.\n\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\nDivision 3—Certification and accreditation\n\n\t14 Regulator to decide certification application within 90 days\n\n**Note**\n\nRegulation 14 of the Commonwealth Regulations provides the period within which the Regulator must consider and decide an application for certification of a facility.\n\n\t15 Application for certification—failure to provide section 85 information\n\nIf an applicant for certification fails to provide information required under section 85(1) of the Act within the period specified in a notice given under section 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**Note**\n\nA refusal to certify a facility is a reviewable decision (see Division 2 of Part 12 of the Act).\n\n\t16 Regulator to decide accreditation application within 90 days\n\n**Note**\n\nRegulation 16 of the Commonwealth Regulations provides the period within which the Regulator must consider and decide an application for accreditation of an organisation.\n\n\t17 Application for accreditation—failure to provide section 93 information\n\nIf an applicant for accreditation fails to provide information required under section 93(1) of the Act within the period specified in a notice given under section 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**Note**\n\nA refusal to accredit an organisation is a reviewable decision (see Division 2 of Part 12 of the Act).\n\nPart 4—Gene Technology Technical Advisory Committee\n\nDivision 1—Conditions of appointment\n\n\t18 GTTAC members and advisers—term of appointment\n\n**Note**\n\nRegulation 18 of the Commonwealth Regulations provides for the term of appointment of members of the Gene Technology Technical Advisory Committee and expert advisers to the Gene Technology Technical Advisory Committee.\n\n\t19 GTTAC members and advisers—resignation\n\n**Note**\n\nRegulation 19 of the Commonwealth Regulations provides for the resignation of members of the Gene Technology Technical Advisory Committee and expert advisers to the Gene Technology Technical Advisory Committee.\n\n\t20 GTTAC members—disclosure of interests\n\n**Note**\n\nRegulation 20 of the Commonwealth Regulations sets out when and how members of the Gene Technology Technical Advisory Committee must disclose any interests of a kind likely to be considered at a meeting of the Gene Technology Technical Advisory Committee.\n\n\t21 GTTAC members and advisers—termination of appointment\n\n**Note**\n\nRegulation 21 of the Commonwealth Regulations sets out the circumstances of terminating the appointment of members of the Gene Technology Technical Advisory Committee and expert advisers to the Gene Technology Technical Advisory Committee.\n\n\t22 GTTAC members—leave of absence\n\n**Note**\n\nRegulation 22 of the Commonwealth Regulations provides when the Chairperson and members of the Gene Technology Technical Advisory Committee may be granted leave.\n\n\t23 Expert advisers—disclosure of interests\n\n**Note**\n\nRegulation 23 of the Commonwealth Regulations sets out when and how expert advisers to the Gene Technology Technical Advisory Committee must disclose any interests of a kind likely to be considered at a meeting of the Gene Technology Technical Advisory Committee.\n\nDivision 2—Committee procedures\n\n\t24 Committee procedures generally\n\n**Note**\n\nRegulation 24 of the Commonwealth Regulations provides that the Gene Technology Technical Advisory Committee must perform its functions as informally as the Commonwealth Regulations allow and provides how the Gene Technology Technical Advisory Committee may obtain information.\n\n\t25 Committee meetings\n\n**Note**\n\nRegulation 25 of the Commonwealth Regulations provides when the Gene Technology Technical Advisory Committee may have meetings and provides that in certain circumstances meetings may be by videoconference or teleconference.\n\n\t26 Presiding member\n\n**Note**\n\nRegulation 26 of the Commonwealth Regulations provides that the Chairperson of the Gene Technology Technical Advisory Committee presides at Gene Technology Technical Advisory Committee meetings and provides who presides in the Chairperson's absence.\n\n\t27 Quorum\n\n**Note**\n\nRegulation 27 of the Commonwealth Regulations provides that half the members of the Gene Technology Technical Advisory Committee comprises the Gene Technology Technical Advisory Committee's quorum.\n\n\t28 Voting\n\n**Note**\n\nRegulation 28 of the Commonwealth Regulations provides that decisions of the Gene Technology Technical Advisory Committee must be made by a majority of members present and voting and that the Chairperson has a deliberative and casting vote.\n\n\t29 Records and Reports\n\n**Note**\n\nRegulation 29 of the Commonwealth Regulations provides that records must be kept of the Gene Technology Technical Advisory Committee's proceedings and provides when reports must be prepared.\n\nDivision 3—Subcommittees\n\n\t30 Operation of subcommittees\n\n**Note**\n\nRegulation 30 of the Commonwealth Regulations states that regulations 24, 25, 26 and 28 of those Regulations apply to a subcommittee established under section 105(1) of the Commonwealth Act. It also provides for a quorum for meetings of a subcommittee, for records of its proceedings and for a copy of each of its resolutions to be given to the Gene Technology Technical Advisory Committee.\n\nPart 5—Ethics and Community Committee\n\n\t31 Ethics and Community Committee—conditions of appointment\n\n**Note**\n\nRegulation 31 of the Commonwealth Regulations provides that Division 1 of Part 4 of the Commonwealth Regulations applies to the conditions of appointment of members of the Ethics and Community Committee.\n\n\t32 Ethics and Community Committee—Committee procedures\n\n**Note**\n\nRegulation 32 of the Commonwealth Regulations provides that Division 2 of Part 4 of the Commonwealth Regulations applies to the procedures of members of the Ethics and Community Committee.\n\n\t33 Ethics and Community Committee—operation of subcommittees\n\n**Note**\n\nRegulation 33 of the Commonwealth Regulations provides that regulations 24, 25, 26 and 28 of the Commonwealth Regulations apply to a subcommittee established under section 111(1) of the Commonwealth Act. It also provides for a quorum for meetings of a subcommittee, for records of its proceedings and for a copy of each of its resolutions to be given to the Ethics and Community Committee.\n\nPart 7—Miscellaneous\n\n**Note**\n\nThe Commonwealth Regulations or these Regulation do not contain a Part 6.\n\n\t37 Reviewable State decisions\n\n**Note**\n\nAt the commencement of these Regulations, no decision has been declared by the Commonwealth Regulations to be a reviewable State decision for the purposes of section 19 of the Commonwealth Act.\n\n\t38 Review of decisions\n\nNote to reg. 38 amended by S.R. No. 51/2025 reg. 6.\n\n**Note**\n\nRegulation 38 of the Commonwealth Regulations provides that a person whose interests are affected by a decision in relation to the appointment of a member to a committee under those Regulations may apply to the Administrative Review Tribunal for review of the decision.\n\n\t39 Record of GMO Dealings\n\nFor the purposes of section 138(2) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator—\n\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\n(b) the kind of notifiable low risk dealing, in terms of Part 1 or 2 of Schedule 3;\n\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(d) the date of assessment by the Institutional Biosafety Committee that the dealing is a notifiable low risk dealing.\n\n\t40 Inspector identity card\n\nFor the purposes of section 151(2)(a) of the Act, an inspector's identity card must—\n\n(a) display a recent photograph of the inspector's face; and\n\n(b) state the date of issue; and\n\n(c) state the period of its validity.\n\nSch. 1A amended by S.R. No. 51/2025 reg. 7.\n\nSchedule 1A—Techniques that are not gene technology\n\nRegulation 4\n\n| *Item* | *Description of technique* |\n| --- | --- |\n| 1 | Either of the following transfers, if the transfer does not involve genetically modified material—<br> (a) nuclear transfer;<br> (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.<br>**Examples**<br>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—<br> (a) the introduction of the nucleic acid or nucleic acid analogue does not result in an alteration of the organism's genome sequence; and<br> (b) the introduction of the nucleic acid or nucleic acid analogue cannot give rise to an infectious agent; and<br> (c) in the case of nucleic acid or nucleic acid analogue that is DNA—the DNA cannot be transcribed. |\n\n\nSchedule 1B—Organisms that are genetically modified organisms\n\nRegulation 4A\n\n| *Item* | *Description of organism* |\n| --- | --- |\n| 1 | An organism that has had its genome modified by oligonucleotide‑directed mutagenesis. |\n| 2 | 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 added to guide homology‑directed repair. |\n\n\nSch. 1 amended by S.R. No. 51/2025 reg. 8.\n\nSchedule 1—Organisms that are not genetically modified organisms\n\nRegulation 5\n\n| *Item* | *Description of organism* |\n| --- | --- |\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—<br> (a) the donor species is also the host species; and<br> (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—<br> (a) such exchange can occur by naturally occurring processes; and<br> (b) the donor species and the host species are micro‑organisms that—<br> (i) are of a class of micro-organism referred to in item 7 of Schedule 1 to the Commonwealth Regulations; and<br> (ii) are known to exchange nucleic acid by a natural physiological process; and<br> (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— |\n|  | (a) the initial organism was not a genetically modified organism (because of the application of regulation 5); or<br> (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\nSchedule 2—Dealings exempt from licensing\n\nRegulation 6\n\n**Note**\n\nRegulation 6(1) sets out other requirements for exempt dealings.\n\nPart 1—Exempt dealings\n\n| *Item* | *Description of dealing* |\n| --- | --- |\n| 2 | A dealing with a genetically modified *Caenorhabditis elegans*, unless—<br> (a) an advantage is conferred on the animal by the genetic modification; or<br> (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—<br> (a) the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and<br> (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—<br> (a) the *in vivo* modification occurred as part of a previous dealing; and<br> (b) the replication defective viral vector is no longer in the animal; and<br> (c) no germ line cells have been genetically modified; and<br> (d) the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and<br> (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|  |  |\n|  | (2) The donor nucleic acid—<br> (a) must meet either of the following requirements—<br> (i) it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy—<br>(A) human beings; or<br>(B) animals; or<br>(C) plants; or<br>(D) fungi;<br> (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<br>**Example**<br>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—<br>(a) provides an advantage; or<br>(b) adds a potential host species or mode of transmission; or<br>(c) increases its virulence, pathogenicity or transmissibility.<br> (b) must not code for a toxin with an LD50 of less than 100 micrograms per kilogram; and<br> (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<br> (d) must not be uncharacterised nucleic acid from a toxin‑producing organism; and<br> (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—<br> (i) are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and<br> (ii) will not become available during the dealing; and |\n|  | (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—<br> (a) a pathogen; or<br> (b) a toxin‑producing organism. |\n\n\nPart 2—Host/vector systems for exempt dealings\n\n\t2.1 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\n(2) A reference to a vector mentioned in this Part is a reference to a vector mentioned in column 3 of an item in the table in this clause.\n\n(3) A reference to a ***host/vector system*** mentioned in this Part is a reference to any of the following—\n\n(a) a system involving a host mentioned in column 2 of an item in the table in this clause and a vector mentioned in column 3 of the same item;\n\n(b) a non‑vector system involving a host mentioned in column 2 of an item in the table;\n\n(c) a system involving a GMO mentioned as a vector in column 3 of an item in the table (except item 7), without a host.\n\n**Note**\n\nColumn 1 of the table is included for information only.\n\n**Hosts and vectors**\n\n| *Item* | *Column 1   Host class* | *Column 2   Hosts* | *Column 3   Vectors* |\n| --- | --- | --- | --- |\n| 1 | Bacteria | *Escherichia coli* K12,    *E. coli* B, *E. coli* C or *E. coli* Nissle 1917—any derivative that does not contain—<br> (a) generalised transducing phages; or<br> (b) genes able to complement the conjugation defect in a non-conjugative plasmid | Any of the following—<br> (a) non‑conjugative plasmids;<br> (b) lambda bacteriophage;<br> (c) lambdoid bacteriophage;<br> (d) Fd, F1 or M13 bacteriophage |\n| 2 | Bacteria | *Bacillus—*asporogenic strains of the following species with a reversion frequency of less than 10–7—<br> (a) *B. amyloliquefaciens*;<br> (b) *B. licheniformis*;<br> (c) *B. pumilus*;<br> (d) *B. subtilis*;<br> (e) *B. thuringiensis* | Any of the following—<br> (a) non‑conjugative plasmids;<br> (b) other plasmids and phages whose host range does not include *B. cereus*, *B. anthracis*  or any other pathogenic strain of *Bacillus* |\n| 3 | Bacteria | *Pseudomonas putida* strain KT2440 | Non‑conjugative plasmids |\n| 4 | Bacteria | The following *Streptomyces* species—<br> (a) *S. aureofaciens*;<br> (b) *S. coelicolor*;<br> (c) *S. cyaneus*;<br> (d) *S. griseus*;<br> (e) *S. lividans*;<br> (f) *S. parvulus*;<br> (g) *S. rimosus*;<br> (h) *S. venezuelae* | Any of the following—<br> (a) non‑conjugative plasmids;<br> (b) plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives;<br> (c) actinophage phi C31 and derivatives |\n| 5 | Bacteria | Any of the following—<br> (a) *Agrobacterium radiobacter*;<br> (b) *Agrobacterium rhizogenes* (disarmed strains only);<br> (c) *Agrobacterium tumefaciens* (disarmed strains only) | Disarmed Ri or Ti plasmids |\n| 6 | Bacteria | Any of the following—<br> (a) *Allorhizobium*  species;<br> (b) *Corynebacterium glutamicum*;<br> (c) *Lactobacillus*  species;<br> (d) *Lactococcus lactis*;<br> (e) *Oenococcus oeni* syn. *Leuconostoc oeni*;<br> (f) *Pediococcus* species;<br> (g) *Photobacterium angustum*;<br> (h) *Pseudoalteromonas tunicata*;<br> (i) *Rhizobium* species;<br> (j) *Sphingopyxis alaskensis* syn. *Sphingomonas alaskensis*;<br> (k) S*treptococcus thermophilus*;<br> (l) *Synechococcus* species strains PCC 7002, PCC 7942 and WH 8102;<br> (m) *Synechocystis* species strain PCC 6803;<br> (n) *Vibrio cholerae* CVD103‑HgR;<br> (o) *Zymomonas mobilis* | Non‑conjugative plasmids |\n| 7 | Fungi | Any of the following—<br> (a) *Kluyveromyces lactis*;<br> (b) *Neurospora crassa* (laboratory strains);<br> (c) *Pichia pastoris*;<br> (d) *Saccharomyces cerevisiae*;<br> (e) *Schizosaccharomyces pombe*;<br> (f) *Trichoderma reesei*;<br> (g) *Yarrowia lipolytica* | All vectors |\n| 8 | Slime moulds | *Dictyostelium* species | *Dictyostelium* shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2 |\n| 9 | Tissue culture | Any of the following if they cannot spontaneously generate a whole animal—<br> (a) animal or human cell cultures (including packaging cell lines);<br> (b) isolated cells, isolated tissues or isolated organs, whether animal or human;<br> (c) early non‑human mammalian embryos cultured *in vitro* | Any of the following—<br> (a) plasmids;<br> (b) replication defective viral vectors unable to transduce human cells;<br> (c) polyhedrin minus forms of the baculovirus *Autographa californica* nuclear polyhedrosis virus (ACNPV) |\n|  |  |  |  |\n|  |  |  |  |\n| 10 | Tissue culture | 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— | Any of the following—<br> (a) Disarmed Ri or Ti plasmids in *Agrobacterium radiobacter*, |\n|  |  | (a) plant cell cultures;<br> (b) isolated plant tissues or organs | *Agrobacterium rhizogenes* (disarmed strains only) or *Agrobacterium tumefaciens* (disarmed strains only);<br> (b) non-pathogenic viral vectors |\n\n\nPart 3—Definitions\n\nIn 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\n(b) cosmids;\n\n(c) P1 artificial chromosomes (PACs);\n\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\n(b) using a nucleic acid-based vector in the course of a previous dealing and the vector is—\n\n(i) no longer present; or\n\n(ii) present but cannot be remobilised from a host cell.\n\n**Examples**\n\n1 A system mentioned in paragraph (a) might involve the use of electroporation or particle bombardment.\n\n2 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\nRegulations 12 and 13\n\nPart 1—Notifiable low risk dealings suitable for at least physical containment level 1\n\n**Note**\n\nBecause of regulation 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\t1.1 Kinds of dealings suitable for at least physical containment level 1\n\nThe following kinds of notifiable low risk dealings must be undertaken, unless regulation 13(2)(c) or (3) applies, in facilities certified to at least physical containment level 1 and that are appropriate for the dealings—\n\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\n(i) an advantage is conferred on the animal by the genetic modification; or\n\n(ii) the animal is capable of secreting or producing an infectious agent as a result of the genetic modification;\n\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 the table in Part 2 of Schedule 2, if the donor nucleic acid—\n\n(i) cannot restore replication competence to the vector; and\n\n(ii) does not confer an oncogenic modification or immunomodulatory effect in humans.\n\nPart 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3\n\n**Note**\n\nBecause of regulation 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\t2.1 Kinds of dealings suitable for at least physical containment level 2\n\nThe following kinds of notifiable low risk dealings must be undertaken, unless regulation 13(2)(c) or (3) applies, in facilities certified to at least physical containment level 2 and that are appropriate for the dealings—\n\n(a) a dealing involving whole animals (including non-vertebrates) that—\n\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\n(ii) does not involve any of the following—\n\n(A) a genetically modified laboratory guinea pig;\n\n(B) a genetically modified laboratory mouse;\n\n(C) a genetically modified laboratory rabbit;\n\n(D) a genetically modified laboratory rat;\n\n(E) a genetically modified *Caenorhabditis elegans*;\n\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\n(i) the genetic modification confers an advantage on the animal; and\n\n(ii) the animal is not capable of secreting or producing an infectious agent as a result of the genetic modification;\n\n(b) a dealing involving a genetically modified plant;\n\n(c) a dealing involving a host/vector system not mentioned in clause 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\n(i) human beings; or\n\n(ii) animals; or\n\n(iii) plants; or\n\n(iv) fungi;\n\n(d) a dealing involving a host/vector system not mentioned in Part 2 of Schedule 2, if—\n\n(i) the host or vector has been implicated in, or has a history of causing, disease in otherwise healthy—\n\n(A) human beings; or\n\n(B) animals; or\n\n(C) plants; or\n\n(D) fungi; and\n\n(ii) the genetic modification is characterised; and\n\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\n**Example**\n\nA 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\n(i) is characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; or\n\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\n(A) human beings; or\n\n(B) animals; or\n\n(C) plants; or\n\n(D) fungi;\n\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\n(i) the dealing is undertaken in a facility that is certified by the Regulator as a large scale facility; and\n\n(ii) the donor nucleic acid satisfies the conditions set out in item 4(2) of the table in Part 1 of Schedule 2;\n\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**Example**\n\nA dealing would not comply with paragraph (g) if it involved complementation that, in relation to the parent organism—\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(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 in the table in Part 2 of Schedule 2, if the donor nucleic acid is derived from either—\n\n(i) a pathogen; or\n\n(ii) a toxin-producing organism;\n\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\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\n(i) the donor nucleic acid cannot restore replication competence to the vector; and\n\n(ii) the dealing is not a dealing mentioned in clause 1.1(c);\n\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\n(i) the donor nucleic acid cannot restore replication competence to the vector; and\n\n(ii) the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;\n\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\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\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\n(iii) either—\n\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\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(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\n(i) the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans; and\n\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\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\n(iv) either—\n\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\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\t2.2 Kinds of dealing suitable for at least physical containment level 3\n\n(1) A kind of dealing that—\n\n(a) is a kind mentioned in clause 2.1; and\n\n(b) involves a micro-organism of a class of micro-organism referred to in clause 2.2(1)(b) in Part 2 of Schedule 3 to the Commonwealth Regulations—\n\nmust be undertaken, unless regulation 13(2)(c) or (3) applies, in facilities certified to at least physical containment level 3 and that are appropriate for the dealings.\n\n(2) For the purposes of subclause (1)(b), a genetically modified micro‑organism is taken to satisfy the criteria referred to in clause 2.2(1)(b) in Part 2 of Schedule 3 to the Commonwealth Regulations if the unmodified parent micro‑organism satisfies those criteria.\n\n(3) However, subclause (2) does not apply in relation to a replication defective retroviral vector that meets the criteria in clause 2.1(l) or (m).\n\nPart 3—Dealings that are not notifiable low risk dealings\n\n**Notes**\n\n1 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\n2 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\t3.1 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\n(a) a dealing (other than a dealing mentioned in clause 2.1(h)) involving cloning of nucleic acid encoding a toxin having an LD50 of less than 100 micrograms per kilogram;\n\n(b) a dealing involving high level expression of toxin genes, even if the LD50 is 100 micrograms per kilogram or more;\n\n(c) a dealing (other than a dealing mentioned in clause 2.1(h)) involving cloning of uncharacterised nucleic acid from a toxin‑producing organism;\n\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\n(i) the donor nucleic acid confers an oncogenic modification or immunomodulatory effect in humans; and\n\n(ii) the dealing is not a dealing mentioned in clause 2.1(i);\n\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\n(f) a dealing involving, as host or vector, a micro-organism, if—\n\n(i) the micro-organism has been implicated in, or has a history of causing, disease in otherwise healthy—\n\n(A) human beings; or\n\n(B) animals; or\n\n(C) plants; or\n\n(D) fungi; and\n\n(ii) none of the following sub‑subparagraphs apply—\n\n(A) the host/vector system is a system mentioned in Part 2 of Schedule 2;\n\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\n(C) the dealing is a dealing mentioned in clause 2.1(g);\n\n**Example**\n\nA 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(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(g) a dealing involving the introduction, into a micro-organism, of nucleic acid encoding a pathogenic determinant, unless—\n\n(i) the dealing is a dealing mentioned in clause 2.1(g); or\n\n(ii) the micro-organism is a host mentioned in Part 2 of Schedule 2;\n\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\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**Example**\n\nA 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(a) an advantage; or\n\n(b) a new potential host species or mode of transmissibility; or\n\n(c) increased virulence, pathogenicity or transmissibility.\n\n(j) a dealing, other than a dealing mentioned in clause 2.1(l) or (m), with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;\n\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\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 clause 2.1(f);\n\n(m) a dealing that is inconsistent with a policy principle issued by the Ministerial Council;\n\n(n) a dealing involving the intentional introduction of a GMO into a human being, unless the GMO—\n\n(i) is a human somatic cell; and\n\n(ii) cannot secrete or produce infectious agents as a result of the genetic modification; and\n\n(iii) if it was generated using viral vectors—\n\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\n(B) the testing did not detect a virus mentioned in sub‑subparagraph (A); and\n\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\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\n(p) a dealing involving a micro-organism that is of a class of micro-organism referred to in clause 3.1(1)(p) in Part 3 of Schedule 3 to the Commonwealth Regulations;\n\n**Note**\n\nThis paragraph differs from clause 3.1(p) of Part 3 of Schedule 3 to the Commonwealth Regulations.\n\n(q) a dealing involving a micro‑organism that is of a class of micro-organism referred to in clause 3.1(1)(p) in Part 3 of Schedule 3 to the Commonwealth Regulations and that is not undertaken—\n\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\n(ii) in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken;\n\n**Note**\n\nThis paragraph differs from clause 3.1(q) of Part 3 of Schedule 3 to the Commonwealth Regulations.\n\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\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**\n\nA 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 subclause (1)(p), a genetically modified micro‑organism is taken to satisfy the criteria referred to in clause 3.1(2) in Part 3 of Schedule 3 to the Commonwealth Regulations if the unmodified parent micro‑organism satisfies those criteria.\n\n(3) For the purposes of subclause (1)(q), a genetically modified micro‑organism is taken to satisfy the criteria referred to in clause 3.1(3) in Part 3 of Schedule 3 to the Commonwealth Regulations if the unmodified parent micro‑organism satisfies those criteria.\n\n(4) However, subclause (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in clause 2.1(l) or (m).\n\n**Note**\n\nClause 3.1(2)–(4) differs from clause 3.1(2)–(4) of Part 3 of Schedule 3 to the Commonwealth Regulations.\n\n═════════════\n\nEndnotes\n\n1 General information\n\nSee [www.legislation.vic.gov.au](http://www.legislation.vic.gov.au) for Victorian Bills, Acts and current Versions of legislation and up-to-date legislative information.\n\nThe Gene Technology Regulations 2021, S.R. No. 94/2021 were made on 3 August 2021 by the Governor in Council under section 193 of the **Gene Technology Act 2001**, No. 67/2001 and came into operation on 29 August 2021: regulation 2.\n\nThe Gene Technology Regulations 2021 will sunset 10 years after the day of making on 3 August 2031 (see section 5 of the **Subordinate Legislation Act 1994**).\n\nINTERPRETATION OF LEGISLATION ACT 1984 (ILA)\n\nStyle changes\n\nSection 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act.\n\nReferences to ILA s. 39B\n\nSidenotes which cite ILA s. 39B refer to section 39B of the ILA which provides that where an undivided regulation, rule or clause of a Schedule is amended by the insertion of one or more subregulations, subrules or subclauses the original regulation, rule or clause becomes subregulation, subrule or subclause (1) and is amended by the insertion of the expression \"(1)\" at the beginning of the original regulation, rule or clause.\n\nInterpretation\n\nAs from 1 January 2001, amendments to section 36 of the ILA have the following effects:\n\n• Headings\n\nAll headings included in a Statutory Rule which is made on or after  \n1 January 2001 form part of that Statutory Rule. Any heading inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.  \nThis includes headings to Parts, Divisions or Subdivisions in a Schedule; Orders; Parts into which an Order is divided; clauses; regulations; rules; items; tables; columns; examples; diagrams; notes or forms.  \nSee section 36(1A)(2A)(2B).\n\n• Examples, diagrams or notes\n\nAll examples, diagrams or notes included in a Statutory Rule which is made on or after 1 January 2001 form part of that Statutory Rule. Any examples, diagrams or notes inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, form part of that Statutory Rule. See section 36(3A).\n\n• Punctuation\n\nAll punctuation included in a Statutory Rule which is made on or after  \n1 January 2001 forms part of that Statutory Rule. Any punctuation inserted in a Statutory Rule which was made before 1 January 2001, by a Statutory Rule made on or after 1 January 2001, forms part of that Statutory Rule.  \nSee section 36(3B).\n\n• Provision numbers\n\nAll provision numbers included in a Statutory Rule form part of that Statutory Rule, whether inserted in the Statutory Rule before, on or after  \n1 January 2001. Provision numbers include regulation numbers, rule numbers, subregulation numbers, subrule numbers, paragraphs and subparagraphs. See section 36(3C).\n\n• Location of \"legislative items\"\n\nA \"legislative item\" is a penalty, an example or a note. As from 13 October 2004, a legislative item relating to a provision of a Statutory Rule is taken to be at the foot of that provision even if it is preceded or followed by another legislative item that relates to that provision. For example, if a penalty at the foot of a provision is followed by a note, both of these legislative items will be regarded as being at the foot of that provision. See section 36B.\n\n• Other material\n\nAny explanatory memorandum, table of provisions, endnotes, index and other material printed after the Endnotes does not form part of a Statutory Rule. See section 36(3)(3D)(3E).\n\n2 Table of Amendments\n\nThis publication incorporates amendments made to the Gene Technology Regulations 2021 by statutory rules, subordinate instruments and Acts.\n\n–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––\n\nGene Technology Amendment Regulations 2025, S.R. No. 51/2025\n\n| *Date of Making:* | 17.6.25 |\n| --- | --- |\n| *Date of Commencement:* | 17.6.25 |\n\n\n–––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––\n\n3 Explanatory details\n\n1. Reg. 2A(a): S.R. No. 91/2011 as amended by S.R. Nos 130/2016 and 91/2019. [↑](#endnote-ref-1)\n\n2. Reg. 2A(b): S.R. No. 130/2016. [↑](#endnote-ref-2)\n\n3. Reg. 2A(c): S.R. No. 91/2019. [↑](#endnote-ref-3)","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":true,"description":"This version incorporates substantive technical changes that expand and clarify the regulatory scope compared with the simpler statutory lists used previously. Notably, Schedule 1B now lists specific gene‑editing outcomes (oligonucleotide‑directed mutagenesis and site‑directed nuclease repair with an added template) as making an organism a GMO (reg 4A and Schedule 1B). At the same time Schedule 1 retains carve‑outs for some repair events without a template. Those additions are a material scope change: they bring particular modern gene‑editing outcomes expressly within the regulatory definition of GMO, shifting certain activities from the ‘not regulated’ or ‘exempt’ side into regulated territory. Other amendments update prescribed authorities and procedural notes (e.g. reg 9), and add or amend administrative details (inspector/committee notes). Overall the instrument has grown beyond mere housekeeping: it updates substantive technical coverage to capture newer techniques and clarifies decision and recordkeeping mechanics, thereby widening the range of activities that may require oversight or notification."},"complexity_factors":["Multiple cross‑references to the Gene Technology Act 2001 and to Commonwealth Regulations (frequent disapplication and difference notes throughout)","Five separate Schedules (1A, 1B, 1, 2, 3) containing long lists and tables that determine regulatory scope","Large number of defined terms in regulation 3 (dozens of technical definitions such as \"characterised\", \"host/vector system\", \"oncogenic modification\")","Extensive nested conditional logic and \"exceptions to exceptions\" (e.g. reg 12(1) referencing Parts 1–3 of Schedule 3; Schedule 3 contains many carve‑outs and cross‑clauses)","Detailed host/vector tables with 10 items and many sub‑conditions in Schedule 2 Part 2 (complex biological taxonomies and vector constraints)","Multiple decision timeframes with suspendable counting and discretionary pauses (reg 8: 90/150/170/255 days; reg 11A: 90 days)","Numerous procedural and recordkeeping obligations: IBC approved form, 8‑year retention, annual submission deadlines (reg 13B, 13C)","Discretionary powers and approvals by the Regulator (agreeing in writing that a facility is suitable, setting guidelines that affect permitted transport/disposal), creating interpretive dependence on guidance documents (reg 13(2)(c), reg 13C(4))","Amendments incorporated (2025) that alter technical scope (e.g. new Schedule 1B items) increasing substantive content to track newer gene editing methods","Cross‑references to external regulatory schemes and agencies (Biosecurity Act, TGA, Australian Industrial Chemicals Introduction Scheme, APVMA) increasing compliance intersections (reg 9 and notes)"],"plain_english_summary":"**What this instrument does (mechanics)**\n\n- Sets out detailed rules implementing the Gene Technology Act 2001 for how genetically modified organisms (GMOs) and gene technology activities are identified, regulated and recorded in the relevant State jurisdiction. (See reg 1 and reg 1A.)\n\n- Defines key terms and techniques so it is clear which laboratory methods and organisms fall inside or outside the statutory definition of “gene technology” and “genetically modified organism” (GMO). Important lists are in Schedule 1A (techniques that are not gene technology), Schedule 1B (organisms that are GMOs), and Schedule 1 (organisms that are not GMOs). (See regs 3, 4, 4A, 5 and Schedules 1A–1B–1.)\n\n- Establishes the licensing framework and administrative rules: which dealings require licences, which are exempt, and which are “notifiable low risk dealings” that can be carried out after an Institutional Biosafety Committee (IBC) assessment rather than an individual licence. Schedules 2 and 3 contain exhaustive lists of exempt dealings and notifiable low risk dealings and the host/vector systems they relate to. (See regs 6, 12 and Schedules 2–3.)\n\n- Sets procedural time limits and process rules for the Regulator’s decisions: standard decision periods for licence applications (90, 150, 170 or 255 days depending on the application type and identified risks) and for licence variations (90 days). The Regulator may pause counting when awaiting requested information, during public hearings, or while awaiting specified advice. (See reg 8 and reg 11A.)\n\n- Specifies administrative requirements for notifiable low risk dealings: an IBC must assess and record the proposal in a Regulator‑approved form; persons undertaking the dealing must keep a copy of the IBC assessment and must provide a record to the Regulator (in a form approved) by 30 September following the financial year of the IBC assessment. IBC assessment records must be kept for 8 years. The Regulator can request further information at any time. (See regs 13, 13B, 13C.)\n\n- Sets facility and containment requirements: notifiable low risk dealings are tied to minimum physical containment levels (PC1, PC2 or PC3) set by the Regulator’s certification rules and guidelines; transportation, storage and disposal may occur outside certified facilities only if done under Regulator guidance or agreed arrangements. (See reg 13(2)–(3) and Schedule 3.)\n\n- Deals with certification and accreditation procedures for facilities and organisations, including time limits for decisions and the grounds for refusing when required information is not provided. (See regs 14–17.)\n\n- Provides governance detail for advisory committees (Gene Technology Technical Advisory Committee and Ethics and Community Committee): appointment, disclosure of interests, procedure and subcommittee operation, largely by cross‑reference to Commonwealth Regulations. (See Part 4 and Part 5 notes.)\n\n- Prescribes operational details such as what particulars must be recorded for notifiable low risk dealings, and requirements for inspector identity cards. (See regs 39–40.)\n\n\n**Who this affects**\n\n- Researchers, laboratory managers, institutions and companies that work with gene technology (academia, biotech start‑ups, contract research organisations, clinical research groups). (See regs 6, 12, Schedules 2–3.)\n\n- Institutional Biosafety Committees (IBCs): must assess proposals, keep specified records in an approved form and give copies to proposers. (See regs 13, 13B.)\n\n- Accredited organisations and facility operators: must be certified to the Regulator’s physical containment levels to host particular types of dealings; accreditation and certification applications are subject to specific timeframes and disclosure requirements. (See regs 13(2), 14–17.)\n\n- The Gene Technology Regulator: has decision‑making responsibilities and discretion (for example, to agree in writing that a particular facility is appropriate, to specify timeframes for committee advice, and to request further information). (See regs 8(3), 13(2)(c), 13C(4).)\n\n- Inspections and enforcement: inspectors appointed by the Regulator carry powers subject to identity card rules. (See reg 40.)\n\n\n**Why it matters (purpose claims and practical effects)**\n\nThe Regulations state their purpose is to prescribe matters required or permitted under the Gene Technology Act and to provide practical rules to give effect to the Act (reg 1). The functional effects are:\n\n- Clarification of scope: the Schedules draw detailed bright lines about which techniques and organisms are regulated as GMOs and which are excluded (e.g. some gene‑editing outcomes are classified as GMOs; some repair events without a template are carved out). This changes legal classification of certain laboratory activities and therefore whether licensing or notification is required (regs 4, 4A, 5; Schedules 1A, 1B, 1).\n\n- Regulatory pathing and administrative burden: many lower‑risk activities are channelled into an IBC + notification route rather than an individual licence (reg 12–13 and Schedule 3). That reduces licensing load but creates compliance tasks for institutions (IBC records, annual reporting/filing deadlines, 8‑year retention) and gives the Regulator oversight via records and information notices (reg 13C(1)–(5)).\n\n- Time and cost trade‑offs for applicants: the Regulator’s statutory decision periods (reg 8 and regs 14–17) provide predictability, but are long enough (up to 255 days for some release applications) to affect project timelines, investment decisions and commercialisation schedules. The ability to pause timeframes while waiting for information or advice shifts some costs and delay incentives to applicants and advisory committees (reg 8(2)).\n\n- Discretion and uncertainty: the Regulator retains discretion to agree in writing to alternative facility arrangements, to set guidelines that determine containment and transport requirements, and to request further information (reg 13(2)(c), reg 13C(4)–(5)). That permits case‑by‑case flexibility but also introduces implementation risk and uncertainty about what will be accepted in practice.\n\n\n**Costs, incentives and trade‑offs**\n\n- Who pays: institutions and applicants bear the compliance costs — IBC assessment time, recordkeeping (8 years), facility certification or upgrades to meet physical containment levels, and possible delays from required Regulator or committee advice (regs 13, 13B, 13C, Schedule 3; regs 14–17; reg 8). At commencement no application fee was prescribed (reg 7), but fees could be introduced in future.\n\n- Incentives: the notifiable low risk pathway reduces the need for individual licences for many routine laboratory activities, so institutions are incentivised to maintain functioning IBCs and accredited facilities rather than seek individual licences (regs 12–13, Part 3 Div 2). Conversely, the detailed listings and some expansions of what counts as a GMO (Schedule 1B) create an incentive to treat borderline techniques conservatively and use licensed routes when doubt exists.\n\n- Opportunity costs: resources spent on compliance reduce resources for R&D; long decision periods may make small entities defer or relocate activities.\n\n- Implementation risk and capture: the Regulator’s powers to set guidelines and to accept alternative facility arrangements concentrates discretion in the regulator’s processes (reg 13(2)(c), reg 13C(4)). This improves adaptability but may produce uneven outcomes across applicants if administrative guidance is not highly prescriptive.\n\n\n**Concrete mechanisms to watch (selected citations)**\n\n- Timeframes for regulator decisions: reg 8 (90 / 150 / 170 / 255 days depending on application type and risk).  \n- Notifiable low risk route: definition and scope in reg 12 and the detailed lists in Schedule 3; IBC assessment and records in regs 13 and 13B; record submission to Regulator by 30 September next financial year (reg 13C(2A)).  \n- Facility levels: prescribed minimum physical containment levels (PC1/PC2/PC3) tied to categories in Schedule 3 (reg 13(2) and Schedule 3 Parts 1–2).  \n- Exempt dealings and small‑scale culture thresholds: Schedule 2 item 4 limits certain exempt host/vector work to 25 litres per vessel, with characterisation requirements for donor nucleic acid (Schedule 2 item 4(2)).  \n- Definition changes affecting scope: Schedule 1B item 1 (oligonucleotide‑directed mutagenesis) and item 2 (homology‑directed repair with an added nucleic acid template) are treated as making organisms GMOs (reg 4A and Schedule 1B); by contrast Schedule 1 item 4 exempts repair without added template (reg 5 and Schedule 1 item 4).\n\n\n**Practical takeaways for regulated actors**\n\n- Check whether your technique or organism is listed in Schedules 1A–1B–1 and 2–3; classification determines whether you need a licence, can use the IBC notifiable route, or are exempt (regs 4, 4A, 5, 6, 12; Schedules 1A–3).  \n- Maintain functioning IBC processes and recordkeeping systems (approved forms, 8‑year retention) and be prepared to submit annual records to the Regulator by 30 September (regs 13, 13B, 13C).  \n- Factor Regulator decision timeframes and potential pauses into project timelines and budgets; consider the facility certification requirements and whether the Regulator’s written agreement is required for non‑standard facilities (reg 8; regs 13(2), 14–17)."},"issue_detection":{"absurdities":[],"contradictions":[]},"summary":{"complexity_score":7,"scope_assessment":{"changed":false,"description":"Based on available information, the 2021 regulations appear to consolidate and update the existing gene technology regulatory framework rather than expand or narrow its scope. The core purpose — licensing and oversight of GMO research and commercialisation — remains consistent with the original Gene Technology Act 2000 intent. However, the insufficient legislative text provided prevents a definitive assessment of any specific scope changes introduced in this version."},"complexity_factors":["Operates within a layered regulatory framework — must be read alongside the Gene Technology Act 2000 and state/territory mirror legislation","Highly technical subject matter requiring scientific literacy (molecular biology, containment levels, risk assessment concepts)","Multiple categories of GMO dealings with different regulatory pathways (exempt, notifiable, licensed)","Intersects with other regulatory regimes including food standards (FSANZ), therapeutic goods (TGA), and agricultural chemicals (APVMA)","Frequent amendments required to keep pace with rapidly evolving biotechnology — version history indicates ongoing changes","Significant definitional complexity around what constitutes a 'GMO' or 'gene technology' as new techniques (e.g., CRISPR) emerge","Compliance obligations differ significantly depending on whether work is contained or involves environmental release"],"plain_english_summary":"These regulations set the practical rules for how genetically modified organisms (GMOs) are researched, developed, used and regulated in Australia, directing the Gene Technology Regulator’s approval, licensing, oversight, fees and timeframes. They affect scientists, universities, biotech and agricultural companies, importers, sellers and farmers — and by extension the public — because they determine which gene technologies can be used, which are exempted, and how risks to health and the environment are managed."},"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"},"kimi_summary":{"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":false,"description":"The regulations appear to maintain their original scope as delegated legislation supporting the Gene Technology Act 2001. While they incorporate amendments (notably the 2025 update adding gene drive provisions and refining CRISPR-related definitions), these changes reflect evolving scientific understanding and national harmonisation rather than mission creep. The core framework — three-tier regulation of GMO dealings with prescribed authorities, containment levels, and committee procedures — remains consistent with the original 2021 intent."},"complexity_factors":["Extensive cross-referencing between the Act, Commonwealth Regulations, and these Victorian Regulations — many provisions are 'notes' referring to Commonwealth rules rather than standalone text","Multiple nested conditional tests for categorising dealings (exempt vs notifiable low risk vs licensed) with numerous exceptions and qualifications","Highly technical scientific definitions (e.g., 'replication defective viral vector', 'homology-directed repair', 'packaging cell line', 'non-conjugative plasmid')","Four detailed schedules containing tabulated technical criteria for host/vector systems, containment levels, and prohibited dealings","Complex temporal calculations for licence decision timeframes with multiple exclusion periods (public holidays, waiting for information, public hearings, confidentiality requests)","Dual-layer structure where Victorian regulations intentionally mirror Commonwealth numbering but omit or modify specific provisions, requiring readers to check both sets","Specific LD50 thresholds (100 micrograms per kilogram) and volume limits (25 litres) triggering different regulatory treatments","Conditional logic for gene drive technologies and oncogenic modifications requiring careful parsing of sub-clauses"],"plain_english_summary":"These regulations set the rules for how genetically modified organisms (GMOs) are handled in Victoria. They work alongside the Gene Technology Act 2001 to create a licensing and notification system for anyone working with GMOs.\n\n**What the regulations do:**\n\n*   **Define what counts as 'gene technology' and what doesn't** — Schedule 1A lists techniques that are excluded (like traditional breeding, embryo rescue, and some forms of mutagenesis), while Schedule 1B specifically captures newer techniques like gene editing when a template is used.\n*   **Create three tiers of regulation:**\n    *   **Exempt dealings** (Schedule 2): Low-risk work that doesn't need a licence — for example, working with certain lab animals like modified mice or rabbits, or using approved bacterial strains in small volumes.\n    *   **Notifiable low risk dealings** (Schedule 3): Medium-risk work that doesn't need a licence but must be assessed by an Institutional Biosafety Committee and reported to the Regulator — this includes work with certain viruses, plants, or larger volumes of GMOs.\n    *   **Licensed dealings**: Everything else requires a formal licence from the Gene Technology Regulator.\n*   **Set safety standards** — Physical containment levels (1, 2, or 3) are specified for different types of work, essentially how secure the lab needs to be.\n*   **Establish committees and procedures** — Rules for the Gene Technology Technical Advisory Committee (GTTAC) and Ethics and Community Committee, including how they meet, disclose conflicts of interest, and make decisions.\n*   **Set timeframes** — The Regulator has specific deadlines (90, 150, or 255 days depending on risk) to decide on licence applications.\n\n**Who it affects:**\n\n*   Scientists and researchers working with GMOs in universities, hospitals, and private labs\n*   Biotech companies developing genetically modified products\n*   Institutional Biosafety Committees that assess research proposals\n*   The Gene Technology Regulator and inspectors who enforce the rules\n\n**Why it matters:**\n\nThese regulations balance scientific innovation with public safety. They ensure that potentially risky genetic research is properly contained and assessed, while allowing straightforward, low-risk research to proceed without excessive red tape. The rules are designed to align with national (Commonwealth) standards while being specific to Victorian law."}},"importantCases":[],"_links":{"self":"/api/acts/gene-technology-regulations-2021","history":"/api/acts/gene-technology-regulations-2021/history","analysis":"/api/acts/gene-technology-regulations-2021/analysis","conflicts":"/api/acts/gene-technology-regulations-2021/conflicts","importantCases":"/api/acts/gene-technology-regulations-2021/important-cases","documents":"/api/acts/gene-technology-regulations-2021/documents"}}