{"id":"sl-2004-17","name":"Gene Technology Regulation 2004","slug":"gene-technology-regulation-2004","collection":"regulation","jurisdiction":"act","status":"in_force","isInForce":true,"actNumber":"17 of 2004","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":173386,"registerId":"act-sl-2004-17-current","compilationNumber":null,"startDate":"2026-04-05","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Gene Technology Regulation 2004","content":"Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nAustralian Capital Territory\nGene Technology Regulation 2004\nSL2004-17\nmade under the\nGene Technology Act 2003\nRepublication No 14\nEffective: 2 June 2025\nRepublication date: 2 June 2025\nLast amendment made by A2025-16\n\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nAbout this republication\nThe republished law\nThis is a republication of the Gene Technology Regulation 2004, made under the Gene\nTechnology Act 2003 (including any amendment made under the Legislation Act 2001, part 11.3\n(Editorial changes)) as in force on 2 June 2025. It also includes any commencement, amendment,\nrepeal or expiry affecting this republished law to 2 June 2025.\nThe legislation history and amendment history of the republished law are set out in endnotes 3\nand 4.\nKinds of republications\nThe Parliamentary Counsel’s Office prepares 2 kinds of republications of ACT laws (see the ACT\nlegislation register at www.legislation.act.gov.au):\n• authorised republications to which the Legislation Act 2001 applies\n• unauthorised republications.\nThe status of this republication appears on the bottom of each page.\nEditorial changes\nThe Legislation Act 2001, part 11.3 authorises the Parliamentary Counsel to make editorial\namendments and other changes of a formal nature when preparing a law for republication.\nEditorial changes do not change the effect of the law, but have effect as if they had been made by\nan Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117). The\nchanges are made if the Parliamentary Counsel considers they are desirable to bring the law into\nline, or more closely into line, with current legislative drafting practice.\nThis republication does not include amendments made under part 11.3 (see endnote 1).\nUncommenced provisions and amendments\nIf a provision of the republished law has not commenced, the symbol U appears immediately\nbefore the provision heading. Any uncommenced amendments that affect this republished law\nare accessible on the ACT legislation register (www.legislation.act.gov.au). For more\ninformation, see the home page for this law on the register.\nModifications\nIf a provision of the republished law is affected by a current modification, the\nsymbol M appears immediately before the provision heading. The text of the modifying\nprovision appears in the endnotes. For the legal status of modifications, see the Legislation\nAct 2001, section 95.\nPenalties\nAt the republication date, the value of a penalty unit for an offence against this law is $160 for an\nindividual and $810 for a corporation (see Legislation Act 2001, s 133).\n\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\ncontents 1\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nAustralian Capital Territory\nGene Technology Regulation 2004\nmade under the\nGene Technology Act 2003\nContents\nPage\nPart 1 Preliminary\n1 Name of regulation 2\n3 Dictionary 2\n3A Numbering 2\n3B Notes 3\n3C Offences against regulation—application of Criminal Code etc 4\n\nContents\nPage\ncontents 2 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 2 Interpretation and general operation\n4 Techniques not constituting gene technology 5\n4A Organisms that are genetically modified organisms 5\n5 Organisms that are not genetically modified organisms 5\nPart 3 Dealings with GMOs\nDivision 3.1 Licensing system\n6 Dealings exempt from licensing 6\n7 Application for licence—prescribed fee 6\n8 Time limit for deciding an application—Act, s 43 (3) 6\n9 Prescribed authorities—Act, s 50 (3) (c) and s 52 (5) (c) 9\n9A Risks posed by dealings proposed to be authorised by licence—Act, s\n51 (1) (a) 9\n10 Risk assessment—matters to be taken into account—Act, s 51 (1) (d)\nand (2) (d) 10\n11 Prescribed conditions of licence 10\n11A Time limit for deciding variation application—Act, s 71 (7) 10\nDivision 3.2 Notifiable low risk dealings\n12 Notifiable low risk dealings—Act, s 74 (1) 11\n13 Requirements for undertaking notifiable low risk dealings 11\n13B Requirements for institutional biosafety committees about records of\nassessments of notifiable low risk dealing proposals 14\n13C Information to be kept or given to the regulator by people or accredited\norganisations 15\nDivision 3.3 Certification and accreditation\n14 Regulator to decide certification application within 90 days 16\n15 Application for certification—failure to provide Act, s 85 information 17\n16 Regulator to decide accreditation application within 90 days 17\n17 Application for accreditation—failure to provide Act, s 93 information 17\nPart 4 Gene technology technical advisory\ncommittee\nDivision 4.1 Conditions of appointment\n18 GTTAC members and advisers—term of appointment 18\n\nContents\nPage\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\ncontents 3\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n19 GTTAC members and advisers—resignation 18\n20 GTTAC members—disclosure of interests 18\n21 GTTAC members and advisers—termination of appointment 18\n22 GTTAC members—leave of absence 18\n23 Expert advisers—disclosure of interests 19\nDivision 4.2 Committee procedures\n24 Committee procedures generally 19\n25 Committee meetings 19\n26 Presiding member 19\n27 Quorum 19\n28 Voting 19\n29 Records and reports 20\nDivision 4.3 Subcommittees\n30 Operation of subcommittees 20\nPart 5 Ethics and community committee\n31 Ethics and community committee—conditions of appointment 21\n32 Ethics and community committee—committee procedures 21\n33 Ethics and community committee—operation of subcommittees 21\nPart 7 Miscellaneous\n37 Reviewable State decisions 22\n38 Review of decisions 22\n39 Record of GMO dealings 22\n40 Inspector identity card 23\n41 Disapplication of Legislation Act, s 47 (5) 23\n\nContents\nPage\ncontents 4 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nSchedule 1A Techniques that are not gene technology 24\nSchedule 1B Organisms that are genetically modified\norganisms 25\nSchedule 1 Organisms that are not genetically modified\norganisms 26\nSchedule 2 Dealings exempt from licensing 28\nPart 2.1 Exempt dealings 28\nPart 2.2 Host/vector systems for exempt dealings 31\n2.2 Hosts and vectors 31\nPart 2.3 Definitions—sch 2 36\nSchedule 3 Notifiable low risk dealings in relation to a\nGMO 37\nPart 3.1 Notifiable low risk dealings suitable for at least\nphysical containment level 1 37\n3.1 Kinds of dealings suitable for at least physical containment level 1 37\nPart 3.2 Notifiable low risk dealings suitable for at least\nphysical containment level 2 or 3 39\n3.2 Kinds of dealings suitable for at least physical containment level 2 39\n3.2A Kinds of dealing suitable for at least physical containment level 3 44\n\nContents\nPage\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\ncontents 5\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 3.3 Dealings that are not notifiable low risk dealings 46\n3.3 Kinds of dealings 46\nDictionary 51\nEndnotes\n1 About the endnotes 56\n2 Abbreviation key 56\n3 Legislation history 57\n4 Amendment history 59\n5 Earlier republications 64\n6 Expired transitional or validating provisions 66\n\n\n\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 1\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nAustralian Capital Territory\nGene Technology Regulation 2004\nmade under the\nGene Technology Act 2003\n\nPart 1 Preliminary\nSection 1\npage 2 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 1 Preliminary\n1 Name of regulation\nThis regulation is the Gene Technology Regulation 2004.\n3 Dictionary\nThe dictionary at the end of this regulation is part of this regulation.\nNote 1 The dictionary at the end of this regulation defines certain terms used in\nthis regulation.\nNote 2 A definition in the dictionary applies to the entire regulation unless the\ndefinition, or another provision of the regulation, provides otherwise or\nthe contrary intention otherwise appears (see Legislation Act, s 155 and\ns 156 (1)).\n3A Numbering\n(1) To maintain consistent provision numbering between this regulation\nand the Commonwealth regulations—\n(a) if the Commonwealth regulations contain a regulation that is not\nneeded in this regulation—the provision number and heading to\nthe regulation appearing in the Commonwealth regulations are\nincluded in this regulation despite the omission of the body of\nthe Commonwealth regulation; and\n(b) if this regulation contains a section that is not included in the\nCommonwealth regulations—the section is numbered to\nmaintain consistency in numbering between provisions common\nto both.\n(2) A provision number and heading mentioned in subsection (1) (a)\nform part of this regulation.\n\nPreliminary Part 1\nSection 3B\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 3\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(3) If a provision of this regulation (other than a section) is numbered\ndifferently from the equivalent provision of the Commonwealth\nregulations, the provision of this regulation may be referred to using\nthe number of the equivalent provision of the Commonwealth\nregulations.\n(4) Also, a provision of this regulation may be referred to in the way in\nwhich a corresponding provision may be referred to in\nCommonwealth regulations.\nNote 1 A note appears under each heading of a kind mentioned in s (1) (a)\ndescribing the omitted regulation of the Commonwealth regulations.\nNote 2 A note appears under each section of a kind mentioned in s (1) (b)\nhighlighting the non-appearance of an equivalent regulation in the\nCommonwealth regulations.\nNote 3 This section does not appear in the Commonwealth regulations.\n3B Notes\nA note included in this regulation is explanatory and is not part of this\nregulation.\nNote 1 See the Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.\nNote 2 This section does not appear in the Commonwealth regulations.\n\nPart 1 Preliminary\nSection 3C\npage 4 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n3C Offences against regulation—application of Criminal\nCode etc\nOther legislation applies in relation to offences against this\nregulation.\nNote 1 Criminal Code\nThe Criminal Code, ch 2 applies to all offences against this regulation\n(see Code, pt 2.1).\nThe chapter sets out the general principles of criminal responsibility\n(including burdens of proof and general defences), and defines terms used\nfor offences to which the Code applies (eg conduct, intention,\nrecklessness and strict liability).\nNote 2 Penalty units\nThe Legislation Act, s 133 deals with the meaning of offence penalties\nthat are expressed in penalty units.\nNote 3 This section does not appear in the Commonwealth regulations.\n\nInterpretation and general operation Part 2\nSection 4\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 5\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 2 Interpretation and general\noperation\n4 Techniques not constituting gene technology\nFor the Act, dictionary, definition of gene technology, paragraph (c),\ngene technology does not include a technique in schedule 1A.\n4A Organisms that are genetically modified organisms\nFor the Act, dictionary, definition of genetically modified organism,\nparagraph (c), an organism mentioned in schedule 1B is a genetically\nmodified organism.\n5 Organisms that are not genetically modified organisms\nFor the Act, dictionary, definition of genetically modified organism,\nparagraph (e), an organism is not a genetically modified organism\nif—\n(a) 1 or more items mentioned in schedule 1 applies to the organism;\nand\n(b) the organism has not been modified by gene technology, other\nthan any modification mentioned in schedule 1; and\n(c) the organism has not inherited any traits from an organism (the\ninitial organism) that occurred in the initial organism because\nof gene technology, other than as mentioned in schedule 1,\nitem 9; and\n(d) none of the items mentioned in schedule 1B applies to the\norganism.\n\nPart 3 Dealings with GMOs\nDivision 3.1 Licensing system\nSection 6\npage 6 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 3 Dealings with GMOs\nDivision 3.1 Licensing system\n6 Dealings exempt from licensing\n(1) For the Act, dictionary, definition of exempt dealing, a dealing with\na GMO is an exempt dealing if—\n(a) it is a dealing of a kind mentioned in schedule 2, part 2.1; and\n(b) it does not involve a genetic modification other than a\nmodification described in schedule 2, part 2.1; and\n(d) it does not involve an intentional release of the GMO into the\nenvironment.\n(2) To remove any doubt, an exemption under subsection (1) does not\napply to a dealing that does not comply with that subsection, whether\nor not that dealing is related to a dealing that does comply.\nNote 1 A dealing affected by this section could be any of the forms of dealing\nmentioned in the Act, dict, def deal with.\nNote 2 Exemption from provisions of the Act does not preclude the application\nof other Commonwealth and State laws.\n7 Application for licence—prescribed fee\nNote At the commencement of the regulation, no application fee is prescribed\nunder the Act, s 40 (6).\n8 Time limit for deciding an application—Act, s 43 (3)\n(1) The period within which the regulator must issue, or refuse to issue,\na licence is—\n(a) for an application to which the Act, division 5.3 applies—\n90 days after the day the application is received by the regulator;\nor\n\nDealings with GMOs Part 3\nLicensing system Division 3.1\nSection 8\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 7\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(b) for an application to which the Act, division 5.4 applies—\n(i) for a limited and controlled release application for which\nthe regulator is satisfied that the dealings proposed to be\nauthorised by the licence do not pose significant risks to\nthe health and safety of people or to the environment—\n150 days after the day the application is received by the\nregulator; and\n(ii) for a limited and controlled release application for which\nthe regulator is satisfied that at least one of the dealings\nproposed to be authorised by the licence may pose\nsignificant risks to the health and safety of people or to the\nenvironment—170 days after the day the application is\nreceived by the regulator; and\n(iii) in any other case—255 days after the day the application is\nreceived by the regulator.\n(2) In working out the end of a period mentioned in subsection (1), the\nfollowing days are not counted:\n(a) a Saturday, a Sunday or a public holiday;\n(b) a day when the regulator cannot proceed with the\ndecision-making process, or a related function, because the\nregulator is awaiting information that the applicant has been\nasked, in writing, to give;\n(c) if, in relation to the application, the regulator publishes notice of\na public hearing under the Act, section 53—a day in the period\nthat—\n(i) begins on the day of publication; and\n(ii) ends on the day when the public hearing ends;\n\nPart 3 Dealings with GMOs\nDivision 3.1 Licensing system\nSection 8\npage 8 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(d) a day when the regulator cannot proceed with the\ndecision-making process, or a related function, because—\n(i) the applicant has applied under the Act, section 184 for\ninformation given in relation to the application to be\ndeclared confidential commercial information for the Act;\nand\n(ii) the regulator is—\n(A) considering the application; or\n(B) waiting until any review rights under the Act,\nsection 181 or section 183 in relation to the\napplication are exhausted;\n(e) if, in relation to the application, the regulator requests the ethics\nand community committee to provide advice on an ethical issue,\na day in the period that—\n(i) begins on the day the request is made; and\n(ii) subject to subsection (3), ends on the day the advice is\ngiven or, if the advice is not given within the period (if any)\nspecified under that subsection, on the last day of that\nperiod.\n(3) The regulator, when seeking advice under the Act, section 50 (3) or\nsection 52 (5) or from the ethics and community committee, may\nspecify a reasonable period within which the advice must be received,\nand, if the advice is not received within the period, must proceed\nwithout regard to the advice.\n(4) In this section:\nlimited and controlled release application means an application for\na licence to which the Act, section 50A applies.\n\nDealings with GMOs Part 3\nLicensing system Division 3.1\nSection 9\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 9\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n9 Prescribed authorities—Act, s 50 (3) (c) and s 52 (5) (c)\nThe following Commonwealth authorities and agencies are\nprescribed:\n(a) Food Standards Australia New Zealand;\n(b) the Commonwealth department administered by the Minister\nadministering the Biosecurity Act 2015 (Cwlth), chapter 8,\npart 1 (Biosecurity emergencies);\n(d) the Director, National Industrial Chemical Notification and\nAssessment Scheme under the Industrial Chemicals\n(Notification and Assessment) Act 1989 (Cwlth);\n(e) Australian Pesticides and Veterinary Medicines Authority;\n(f) Therapeutic Goods Administration, Commonwealth\nDepartment of Health.\n9A Risks posed by dealings proposed to be authorised by\nlicence—Act, s 51 (1) (a)\nThe regulator must have regard to the following matters:\n(a) the properties of the organism to which dealings proposed to be\nauthorised by a licence relate before it became, or will become,\na GMO;\n(b) the effect, or the expected effect, of the genetic modification that\nhas occurred, or will occur, on the properties of the organism;\n(c) provisions for limiting the dissemination or persistence of the\nGMO or its genetic material in the environment;\n(d) the potential for spread or persistence of the GMO or its genetic\nmaterial in the environment;\n(e) the extent or scale of the proposed dealings;\n(f) any likely impacts of the proposed dealings on the health and\nsafety of people.\n\nPart 3 Dealings with GMOs\nDivision 3.1 Licensing system\nSection 10\npage 10 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n10 Risk assessment—matters to be taken into account—Act,\ns 51 (1) (d) and (2) (d)\n(1) Other matters to be taken into account in relation to dealings proposed\nto be authorised by a licence include—\n(a) subject to the Act, section 45, any previous assessment by a\nregulatory authority, in Australia or overseas, in relation to\nallowing or approving dealings with the GMO; and\n(b) the potential of the GMO concerned to—\n(i) be harmful to other organisms; and\n(ii) adversely affect any ecosystems; and\n(iii) transfer genetic material to another organism; and\n(iv) spread, or persist, in the environment; and\n(v) have an advantage in the environment in comparison to\nrelated organisms; and\n(vi) be toxic, allergenic or pathogenic to other organisms.\n(2) In taking into account a risk mentioned in the Act, section 51 (1), or\na potential capacity mentioned in subsection (1), the regulator must\nconsider both the short term and the long term.\n11 Prescribed conditions of licence\nNote At the commencement of this regulation, no conditions are prescribed\nunder the Act, s 61 (b).\n11A Time limit for deciding variation application—Act, s 71 (7)\n(1) The regulator must vary the licence, or refuse to vary the licence,\nwithin 90 days after the day an application for a variation of the\nlicence is received by the regulator.\n\nDealings with GMOs Part 3\nNotifiable low risk dealings Division 3.2\nSection 12\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 11\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(2) For the period mentioned in subsection (1), the following days are not\ncounted:\n(a) a Saturday, a Sunday or a public holiday;\n(b) a day on which the regulator cannot proceed with the\ndecision-making process, or a related function, because the\nregulator is waiting for information that the applicant has been\nasked, in writing, to give.\nDivision 3.2 Notifiable low risk dealings\n12 Notifiable low risk dealings—Act, s 74 (1)\n(1) A dealing with a GMO is a notifiable low risk dealing if—\n(a) it is a dealing of a kind mentioned in schedule 3, part 3.1 or\npart 3.2; and\n(aa) it is not a dealing of a kind mentioned in schedule 3, part 3.3;\nand\n(b) it does not involve an intentional release of the GMO into the\nenvironment.\n(2) To remove any doubt, subsection (1) does not apply to a dealing that\ndoes not comply with that subsection, whether or not that dealing is\nrelated to a dealing that does comply.\nNote A dealing affected by this section could be any of the forms of dealing\nmentioned in the Act, dict, def deal with.\n13 Requirements for undertaking notifiable low risk dealings\n(1) A person may undertake a notifiable low risk dealing only if—\n(a) a person or an accredited organisation has prepared and\nsubmitted a written proposal for an institutional biosafety\ncommittee to assess whether the dealing is a notifiable low risk\ndealing; and\n\nPart 3 Dealings with GMOs\nDivision 3.2 Notifiable low risk dealings\nSection 13\npage 12 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(b) the institutional biosafety committee has assessed the dealing to\nbe a kind of dealing—\n(i) mentioned in schedule 3, part 3.1 or part 3.2; and\n(ii) not mentioned in schedule 3, part 3.3; and\n(c) the dealing undertaken is the dealing described in the\ninstitutional biosafety committee’s record of assessment of the\nproposal; and\n(d) the dealing is only undertaken not later than the day 5 years after\nthe date of the assessment; and\n(e) the person is mentioned in, or is in a class of people mentioned\nin, the institutional biosafety committee’s record of assessment\nas having the appropriate training and experience to undertake\nthe dealing; and\n(f) subject to subsection (3), the dealing is undertaken in facilities\nthat—\n(i) are mentioned in, or are in a class of facilities mentioned\nin, the institutional biosafety committee’s record of\nassessment as being appropriate for the dealing; and\n(ii) are facilities in which the dealing may be undertaken under\nsubsection (2); and\n(g) the person keeps or can give, on request, a copy of the\ninstitutional biosafety committee’s record of assessment to an\ninspector; and\n(h) the person does not compromise the containment of a GMO\ninvolved in the dealing.\n(2) A notifiable low risk dealing must be undertaken—\n(a) for a kind of dealing mentioned in schedule 3, part 3.1—in a\nfacility certified by the regulator to at least physical containment\nlevel 1 and that is appropriate for the dealing; or\n\nDealings with GMOs Part 3\nNotifiable low risk dealings Division 3.2\nSection 13\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 13\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(b) for a kind of dealing mentioned in schedule 3, section 3.2, but\nnot in section 3.2A—in a facility certified by the regulator to at\nleast physical containment level 2 and that is appropriate for the\ndealing; or\n(ba) for a kind of dealing mentioned in schedule 3, section 3.2A—in\na facility certified by the regulator to at least physical\ncontainment level 3 and that is appropriate for the dealing; or\n(c) in a facility that the regulator has agreed in writing is a facility\nin which the dealing may be undertaken.\n(3) If a notifiable low risk dealing involves the transportation, storage or\ndisposal of a GMO, the transportation, storage or disposal may\nhappen outside a facility that complies with\nsubsections (1) (f) and (2), if it is conducted in accordance with—\n(a) the Guidelines for the Transport, Storage and Disposal of\nGMOs, as in force from time to time, issued by the regulator\nunder the Commonwealth Act, section 27 (d); or\n(b) transportation, storage or disposal requirements that the\nRegulator has agreed, in writing, are appropriate for the\ncontainment of the GMO.\n(4) For paragraph (2) (c), the regulator must consider the capacity of a\nfacility to contain GMOs before deciding whether to agree, in writing,\nto a facility.\n\nPart 3 Dealings with GMOs\nDivision 3.2 Notifiable low risk dealings\nSection 13B\npage 14 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n13B Requirements for institutional biosafety committees\nabout records of assessments of notifiable low risk\ndealing proposals\nAn institutional biosafety committee that has assessed a proposal as\nto whether a dealing is a notifiable low risk dealing must—\n(a) make a record of its assessment, in a form approved by the\nregulator, that includes the following:\n(i) the identifying name of the dealing to be undertaken that\nwas given to the dealing by the person or accredited\norganisation that submitted the proposal;\n(ii) a description of the dealing to be undertaken;\n(iii) its assessment whether the dealing is a kind of dealing\nmentioned in schedule 3, part 3.1 or part 3.2, and not\nmentioned in schedule 3, part 3.3;\n(iv) if the committee has assessed the dealing to be a kind of\ndealing mentioned in schedule 3, part 3.1 or part 3.2 (and\nnot mentioned in schedule 3, part 3.3)—which kind of\ndealing in those parts that the dealing is;\n(v) the date of the committee’s assessment of the dealing;\n(vi) the people or classes of people considered by the\ncommittee to have the appropriate training and experience\nto undertake the dealing;\n(vii) the facilities or classes of facilities the committee considers\nto be of the appropriate physical containment level and\ntype for the dealing, having regard to the requirements of\nsection 13 (2);\n(viii) the name of the committee that assessed the proposal;\n\nDealings with GMOs Part 3\nNotifiable low risk dealings Division 3.2\nSection 13C\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 15\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(ix) the name of the person or accredited organisation that\nsubmitted the proposal;\n(x) the name of the person proposing to undertake the dealing;\nand\n(b) give a copy of the record of assessment to the person or\naccredited organisation that submitted the proposal to the\ncommittee.\n13C Information to be kept or given to the regulator by people\nor accredited organisations\n(1) A person or accredited organisation that has been given a copy of a\nrecord of assessment by an institutional biosafety committee under\nsection 13B (b) must, if the dealing has been assessed by the\ncommittee as a notifiable low risk dealing, give the regulator a record\nof the dealing.\n(2) For subsection (1), a record of a dealing must include—\n(a) the particulars, prescribed under section 39 in relation to the\ndealing, to be included in the record of GMO dealings; and\n(b) the name of the committee that assessed the proposal relating to\nthe dealing; and\n(c) the name of the person or accredited organisation that submitted\nthe proposal to the committee for assessment.\n(2A) The record must be given to the regulator—\n(a) in a form approved by the regulator; and\n(b) not later than 30 September in the financial year following the\nfinancial year in which the institutional biosafety committee\nmade the assessment.\n\nPart 3 Dealings with GMOs\nDivision 3.3 Certification and accreditation\nSection 14\npage 16 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(2B) An accredited organisation that is required to, as a condition of\naccreditation, give an annual report to the regulator, must—\n(a) include the record in the annual report for the year in which the\ninstitutional biosafety committee made the assessment; or\n(b) certify in the annual report that the record has previously been\ngiven to the regulator.\n(3) A person or accredited organisation given a copy of a record of\nassessment by an institutional biosafety committee under\nsection 13B (b) must keep a copy of the committee’s record of\nassessment for 8 years after the date of the assessment.\n(4) The regulator may at any time, by written notice, require from the\nfollowing people or organisations more information about how a\nnotifiable low risk dealing is being undertaken, including information\nabout a GMO being dealt with:\n(a) the person or accredited organisation that submitted the proposal\nfor assessment of the dealing;\n(b) any other person involved with undertaking the dealing.\n(5) A person or organisation given a notice under subsection (4) must, by\nthe end of the period mentioned in the notice, give the regulator the\ninformation required by the notice.\nDivision 3.3 Certification and accreditation\n14 Regulator to decide certification application within\n90 days\nNote The Commonwealth regulations, reg 14 provides the period within which\nthe regulator must consider and decide an application for certification of\na facility.\n\nDealings with GMOs Part 3\nCertification and accreditation Division 3.3\nSection 15\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 17\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n15 Application for certification—failure to provide Act, s 85\ninformation\nIf an applicant for certification of a facility fails to provide\ninformation required under the Act, section 85 (1) within the period\nstated in a notice given under the Act, section 85 (2) and gives no\nreasonable explanation for the failure, the regulator may refuse to\ncertify the facility.\nNote A refusal to certify a facility is a reviewable decision (see the Act,\ndiv 12.2).\n16 Regulator to decide accreditation application within\n90 days\nNote The Commonwealth regulations, reg 16 provides the period within which\nthe regulator must consider and decide an application for accreditation of\nan organisation.\n17 Application for accreditation—failure to provide Act, s 93\ninformation\nIf an applicant for accreditation of an organisation fails to provide\ninformation required under the Act, section 93 (1) within the period\nstated in a notice given under the Act, section 93 (2) and gives no\nreasonable explanation for the failure, the regulator may refuse to\naccredit the organisation.\nNote A refusal to accredit an organisation is a reviewable decision (see the Act,\ndiv 12.2).\n\nPart 4 Gene technology technical advisory committee\nDivision 4.1 Conditions of appointment\nSection 18\npage 18 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 4 Gene technology technical\nadvisory committee\nDivision 4.1 Conditions of appointment\n18 GTTAC members and advisers—term of appointment\nNote The Commonwealth regulations, reg 18 provides for the term of\nappointment of members of the gene technology technical advisory\ncommittee and expert advisers to the committee.\n19 GTTAC members and advisers—resignation\nNote The Commonwealth regulations, reg 19 provides for the resignation of\nmembers of the gene technology technical advisory committee and expert\nadvisers to the committee.\n20 GTTAC members—disclosure of interests\nNote The Commonwealth regulations, reg 20 provides for disclosure of any\ninterests members of the gene technology technical advisory committee\nmay have in matters likely to be considered at a meeting of the committee.\n21 GTTAC members and advisers—termination of\nappointment\nNote The Commonwealth regulations, reg 21 provides for termination of the\nappointment of members of the gene technology technical advisory\ncommittee and expert advisers to the committee.\n22 GTTAC members—leave of absence\nNote The Commonwealth regulations, reg 22 provides for the granting of leave\nto the chairperson and members of the gene technology technical\nadvisory committee.\n\nGene technology technical advisory committee Part 4\nCommittee procedures Division 4.2\nSection 23\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 19\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n23 Expert advisers—disclosure of interests\nNote The Commonwealth regulations, reg 23 provides for disclosure of any\ninterests expert advisers to the gene technology technical advisory\ncommittee may have in matters likely to be considered at a meeting of\nthe committee.\nDivision 4.2 Committee procedures\n24 Committee procedures generally\nNote The Commonwealth regulations, reg 24—\n• provides that the gene technology technical advisory committee\nmust act without formality; and\n• provides for how the committee may obtain information.\n25 Committee meetings\nNote The Commonwealth regulations, reg 25 provides for when and how the\ngene technology technical advisory committee may have meetings.\n26 Presiding member\nNote The Commonwealth regulations, reg 26 provides for who is to preside at\na meeting of the gene technology technical advisory committee.\n27 Quorum\nNote The Commonwealth regulations, reg 27 provides that there is a quorum\nat a meeting of the gene technology technical advisory committee if half\nof the appointed members are present.\n28 Voting\nNote The Commonwealth regulations, reg 28 provides that—\n• a decision of the gene technology technical advisory committee is\nmade by half of the members present, and voting for the decision, at\na meeting of the committee; and\n• the presiding member has a deliberative and casting vote.\n\nPart 4 Gene technology technical advisory committee\nDivision 4.3 Subcommittees\nSection 29\npage 20 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n29 Records and reports\nNote The Commonwealth regulations, reg 29 provides for—\n• records of proceedings and resolutions of the gene technology\ntechnical advisory committee to be kept; and\n• resolutions of the committee to be publicly available; and\n• reports to be prepared about the committee’s activities.\nDivision 4.3 Subcommittees\n30 Operation of subcommittees\nNote The Commonwealth regulations, reg 30 provides for the matters covered\nby the Commonwealth regulations, pt 4, div 2 for subcommittees\nestablished under the Commonwealth Act, s 105 (1).\n\nEthics and community committee Part 5\nSection 31\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 21\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 5 Ethics and community committee\n31 Ethics and community committee—conditions of\nappointment\nNote The Commonwealth regulations, reg 31 provides for the Commonwealth\nAct, pt 4, div 1 to apply to the conditions of appointment of a member of\nthe ethics and community committee.\n32 Ethics and community committee—committee\nprocedures\nNote The Commonwealth regulations, reg 32 provides for the Commonwealth\nAct, pt 4, div 2 to apply to the procedures of the ethics and community\ncommittee.\n33 Ethics and community committee—operation of\nsubcommittees\nNote The Commonwealth regulations, reg 33 provides for the matters covered\nby the Commonwealth Act, pt 4, div 2 for subcommittees established\nunder the Commonwealth Act, s 111 (1).\n\nPart 7 Miscellaneous\nSection 37\npage 22 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 7 Miscellaneous\n37 Reviewable State decisions\nNote At the commencement of this regulation, the Commonwealth regulations\nhave not declared any decisions of the regulator to be reviewable State\ndecisions for the Commonwealth Act, s 19.\n38 Review of decisions\nNote The Commonwealth regulations, reg 38 provides that a person whose\ninterests are affected by a decision terminating an appointment to a\ncommittee may apply to the Commonwealth administrative review\ntribunal for review of the decision.\n39 Record of GMO dealings\nFor the Act, section 138 (2) (b), the following particulars are\nprescribed for a notifiable low risk dealing notified to the regulator:\n(a) the person that proposed to undertake the dealing, as recorded\nby the institutional biosafety committee that assessed the dealing\nas a notifiable low risk dealing;\n(b) the kind of notifiable low risk dealing (described using the terms\nin schedule 3, part 3.1 or part 3.2);\n(c) the identifying name given to the dealing by the person or\naccredited organisation that submitted the dealing to the\ninstitutional biosafety committee for assessment;\n(d) the date of assessment by the institutional biosafety committee\nthat the dealing is a notifiable low risk dealing.\n\nMiscellaneous Part 7\nSection 40\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 23\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n40 Inspector identity card\nNote The Commonwealth regulations, reg 40 prescribes the form of an\ninspector’s identity card. Under the Act, s 151 the card must be in the\napproved form.\n41 Disapplication of Legislation Act, s 47 (5)\nThe Legislation Act, section 47 (5) does not apply to\nAS/NZS 2243.3:2010 under this regulation.\n\nSchedule 1A Techniques that are not gene technology\npage 24 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nSchedule 1A Techniques that are not gene\ntechnology\n(see s 4)\ncolumn 1\nitem\ncolumn 2\ndescription of technique\n1 somatic cell nuclear transfer, if the transfer does not involve genetically\nmodified material\n2 electromagnetic radiation-induced mutagenesis\n3 particle radiation-induced mutagenesis\n4 chemical-induced mutagenesis\n5 fusion of animal cells, or human cells, if the fused cells are unable to form a\nviable whole animal or human\n6 protoplast fusion, including fusion of plant protoplasts\n7 embryo rescue\n8 in-vitro fertilisation\n9 zygote implantation\n10 a natural process, if the process does not involve genetically modified material\nExamples—natural processes\nConjugation, transduction, transformation and transposon mutagenesis.\n11 introduction of RNA into an organism if—\n(a) the RNA cannot be translated into a polypeptide; and\n(b) the introduction of the RNA cannot result in an alteration of the\norganism’s genome sequence; and\n(c) the introduction of the RNA cannot give rise to an infectious agent\n\nOrganisms that are genetically modified organisms Schedule 1B\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nSchedule 1B Organisms that are genetically\nmodified organisms\n(see s 4A)\ncolumn 1\nitem\ncolumn 2\ndescription of organism\n1 an organism that has had its genome modified by oligonucleotide-directed\nmutagenesis\n2 an organism modified by repair of single-strand or double-strand breaks of\ngenomic DNA induced by a site-directed nuclease, if a nucleic acid template\nwas added to guide homology-directed repair\n\nSchedule 1 Organisms that are not genetically modified organisms\npage 26 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nSchedule 1 Organisms that are not\ngenetically modified organisms\n(see s 5)\ncolumn 1\nitem\ncolumn 2\ndescription of organism\n2 a whole animal, or a human being, modified by the introduction of naked\nrecombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the\nintroduced nucleic acid is incapable of giving rise to infectious agents\n3 naked plasmid DNA that is incapable of giving rise to infectious agents when\nintroduced into a host cell\n4 an organism modified by repair of single-strand or double-strand breaks of\ngenomic DNA induced by a site-directed nuclease, if a nucleic acid template\nwas not added to guide homology-directed repair\n6 an organism that results from an exchange of DNA if—\n(a) the donor species is also the host species; and\n(b) the vector DNA does not contain any heterologous DNA\n7 an organism that results from an exchange of DNA between the donor species\nand the host species if—\n(a) such exchange can occur by naturally occurring processes; and\n(b) the donor species and the host species are micro-organisms that—\n(i) satisfy the criteria in AS/NZS 2243.3:2010, for classification as\nRisk Group 1; and\n(ii) are known to exchange nucleic acid by a natural physiological\nprocess; and\n(c) the vector used in the exchange does not contain heterologous DNA\nfrom any organism other than an organism that is involved in the\nexchange\n\nOrganisms that are not genetically modified organisms Schedule 1\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 27\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ncolumn 1\nitem\ncolumn 2\ndescription of organism\n8 an organism that is descended from a genetically modified organism (the initial\norganism) if none of the traits it has inherited from the initial organism are\ntraits that occurred in the initial organism because of gene technology\n9 an organism that has inherited particular traits from an organism (the initial\norganism) that occurred in the initial organism because of gene technology,\nif—\n(a) the initial organism was not a genetically modified organism (because of\nthe application of section 5); or\n(b) all such inherited traits are traits that occurred in the initial organism as a\nresult of a modification mentioned in an item in this schedule\n10 an organism that was modified by gene technology but in which the\nmodification, and any traits that occurred because of gene technology, are no\nlonger present\n11 Agrobacterium radiobacter strain K1026\n12 Pasteurella multocida strain PMP1\n\nSchedule 2 Dealings exempt from licensing\nPart 2.1 Exempt dealings\npage 28 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nSchedule 2 Dealings exempt from\nlicensing\n(see s 6)\nNote For this schedule, s 6 (1) sets out other requirements for exempt dealings.\nPart 2.1 Exempt dealings\ncolumn 1\nitem\ncolumn 2\ndescription of dealing\n2 a dealing with a genetically modified Caenorhabditis elegans, unless—\n(a) an advantage is conferred on the animal by the genetic modification; or\n(b) as a result of the genetic modification, the animal is capable of secreting\nor producing an infectious agent\n3 a dealing with an animal into which genetically modified somatic cells have\nbeen introduced, if—\n(a) the somatic cells are not capable of giving rise to infectious agents as a\nresult of the genetic modification; and\n(b) the animal is not infected with a virus that is capable of recombining\nwith the genetically modified nucleic acid in the somatic cells\n3A a dealing with an animal whose somatic cells have been genetically modified in\nvivo by a replication defective viral vector, if—\n(a) the in vivo modification occurred as part of a previous dealing; and\n(b) the replication defective viral vector is no longer in the animal; and\n(c) no germ line cells have been genetically modified; and\n(d) the somatic cells cannot give rise to infectious agents as a result of the\ngenetic modification; and\n(e) the animal is not infected with a virus that can recombine with the\ngenetically modified nucleic acid in the somatic cells of the animal.\n4 (1) Subject to subsection (1), a dealing involving a host/vector system\nmentioned in table 2.2 and producing not more than 25L of GMO culture\nin each vessel containing the resultant culture.\n\nDealings exempt from licensing Schedule 2\nExempt dealings Part 2.1\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 29\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ncolumn 1\nitem\ncolumn 2\ndescription of dealing\n(2) The donor nucleic acid—\n(a) must meet either of the following requirements:\n(i) the acid must not be derived from organisms implicated in, or\nwith a history of causing, disease in otherwise healthy—\n(A) human beings; or\n(B) animals; or\n(C) plants; or\n(D) fungi;\n(ii) the acid must be characterised and the information derived\nfrom its characterisation show that it is unlikely to increase\nthe capacity of the host or vector to cause harm; and\nExample\nDonor nucleic acid would not comply with par (ii) if its\ncharacterisation shows that, in relation to the capacity of the\nhost or vector to cause harm, it—\n(a) provides an advantage; or\n(b) adds a potential host species or mode of transmission; or\n(c) increases its virulence, pathogenicity or transmissibility.\n(b) must not code for a toxin with an LD50 of less than 100\nmicrograms per kilogram; and\n(c) must not code for a toxin with an LD50 of 100 micrograms per\nkilogram or more, if the intention is to express the toxin at high\nlevels; and\n(d) must not be uncharacterised nucleic acid from a toxin-producing\norganism; and\n(e) if the donor nucleic acid includes a viral sequence—cannot give\nrise to infectious agents when introduced into any potential host\nspecies without additional non-host genes or gene products that—\n(i) are not available in the host cell into which the nucleic acid is\nintroduced as part of the dealing; and\n(ii) will not become available during the dealing; and\n(f) if the donor nucleic acid includes a viral sequence—cannot restore\nreplication competence to the vector.\n\nSchedule 2 Dealings exempt from licensing\nPart 2.1 Exempt dealings\npage 30 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ncolumn 1\nitem\ncolumn 2\ndescription of dealing\n5 a dealing involving shotgun cloning, or the preparation of a cDNA library, in a\nhost/vector system mentioned in table 2.2, items 1 to 6, if the donor nucleic acid\nis not derived from either—\n(a) a pathogen; or\n(b) a toxin-producing organism\n\nDealings exempt from licensing Schedule 2\nHost/vector systems for exempt dealings Part 2.2\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 31\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 2.2 Host/vector systems for exempt\ndealings\n2.2 Hosts and vectors\nIn this part:\nhost means a host mentioned in column 3 of an item in table 2.2.\nhost/vector system means any of the following:\n(a) a system involving a host mentioned in column 3 of an item in\ntable 2.2 and a vector mentioned in column 4 of the item;\n(b) a non-vector system involving a host mentioned in column 3 of\nan item in table 2.2;\n(c) a system involving a GMO mentioned as a vector in column 4\nof an item in table 2.2 (other than item 7), without a host.\nvector means a vector mentioned in column 4 of an item in table 2.2.\nNote Column 2 of table 2.2 is included for information only.\nTable 2.2\ncolumn 1\nitem\ncolumn 2\nclass\ncolumn 3\nhost\ncolumn 4\nvector\n1 bacteria Escherichia coli K12, E. coli B,\nE. coli C or E. coli Nissle 1917—\nany derivative that does not\ncontain—\n(a) generalised transducing\nphages; or\n(b) genes able to complement\nthe conjugation defect in a\nnon-conjugative plasmid\nany of the following:\n(a) non-conjugative\nplasmids;\n(b) lambda bacteriophage;\n(c) lambdoid\nbacteriophage;\n(d) Fd, F1 or M13\nbacteriophage\n\nSchedule 2 Dealings exempt from licensing\nPart 2.2 Host/vector systems for exempt dealings\npage 32 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ncolumn 1\nitem\ncolumn 2\nclass\ncolumn 3\nhost\ncolumn 4\nvector\n2 bacteria Bacillus—asporogenic strains of\nthe following species with a\nreversion frequency of less\nthan 10–7:\n(a) B. amyloliquefaciens;\n(b) B. licheniformis;\n(c) B. pumilus;\n(d) B. subtilis;\n(e) B. thuringiensis\nany of the following:\n(a) non-conjugative\nplasmids;\n(b) other plasmids and\nphages whose host\nrange does not include\nB. cereus, B. anthracis\nor any other pathogenic\nstrain of Bacillus\n3 bacteria Pseudomonas putida strain\nKT2440\nnon-conjugative plasmids\n4 bacteria the following Streptomyces\nspecies:\n(a) S. aureofaciens;\n(b) S. coelicolor;\n(c) S. cyaneus;\n(d) S. griseus;\n(e) S. lividans;\n(f) S. parvulus;\n(g) S. rimosus;\n(h) S. venezuelae\nany of the following:\n(a) non-conjugative\nplasmids;\n(b) plasmids SCP2, SLP1,\nSLP2, pIJ101 and\nderivatives;\n(c) actinophage phi C31\nand derivatives\n5 bacteria any of the following:\n(a) Agrobacterium\nradiobacter;\n(b) Agrobacterium rhizogenes\n(disarmed strains only);\n(c) Agrobacterium tumefaciens\n(disarmed strains only)\ndisarmed Ri or Ti plasmids\n\nDealings exempt from licensing Schedule 2\nHost/vector systems for exempt dealings Part 2.2\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 33\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ncolumn 1\nitem\ncolumn 2\nclass\ncolumn 3\nhost\ncolumn 4\nvector\n6 bacteria any of the following:\n(a) Allorhizobium species;\n(b) Corynebacterium\nglutamicum;\n(c) Lactobacillus species;\n(d) Lactococcus lactis;\n(e) Oenococcus oeni syn.\nLeuconostoc oeni;\n(f) Pediococcus species;\n(g) Photobacterium angustum;\n(h) Pseudoalteromonas\ntunicata;\n(i) Rhizobium species;\n(j) Sphingopyxis alaskensis\nsyn. Sphingomonas\nalaskensis;\n(k) Streptococcus\nthermophilus;\n(l) Synechococcus species\nstrains PCC 7002, PCC\n7942 and WH 8102;\n(m) Synechocystis species strain\nPCC 6803;\n(n) Vibrio cholerae CVD\n103-HgR;\n(o) Zymomonas mobilis\nnon-conjugative plasmids\n\nSchedule 2 Dealings exempt from licensing\nPart 2.2 Host/vector systems for exempt dealings\npage 34 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ncolumn 1\nitem\ncolumn 2\nclass\ncolumn 3\nhost\ncolumn 4\nvector\n7 fungi any of the following:\n(a) Kluyveromyces lactis;\n(b) Neurospora crassa\n(laboratory strains);\n(c) Pichia pastoris;\n(d) Saccharomyces cerevisiae;\n(e) Schizosaccharomyces\npombe;\n(f) Trichoderma reesei;\n(g) Yarrowia lipolytica\nall vectors\n8 slime\nmoulds\nDictyostelium species Dictyostelium shuttle\nvectors, including those\nbased on the endogenous\nplasmids Ddp1 and Ddp2\n9 tissue\nculture\nany of the following if they\ncannot spontaneously generate a\nwhole animal:\n(a) animal or human cell\ncultures (including\npackaging cell lines);\n(b) isolated cells, isolated\ntissues or isolated organs,\nwhether animal or human;\n(c) early non-human\nmammalian embryos\ncultured in vitro\nany of the following:\n(a) plasmids;\n(b) replication defective\nviral vectors unable to\ntransduce human cells;\n(c) polyhedron-minus\nforms of the baculovirus\nAutographa californica\nnuclear polyhedrosis\nvirus (ACNPV)\n\nDealings exempt from licensing Schedule 2\nHost/vector systems for exempt dealings Part 2.2\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 35\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ncolumn 1\nitem\ncolumn 2\nclass\ncolumn 3\nhost\ncolumn 4\nvector\n10 tissue\nculture\neither of the following if they are\nnot intended, and are not likely\nwithout human intervention, to\nvegetatively propagate, flower or\nregenerate into a whole plant:\n(a) plant cell cultures;\n(b) isolated plant tissues or\norgans\nany of the following:\n(a) Disarmed Ri or Ti\nplasmids in\nAgrobacterium\nradiobacter,\nAgrobacterium\nrhizogenes (disarmed\nstrains only) or\nAgrobacterium\ntumefaciens (disarmed\nstrains only);\n(b) non-pathogenic viral\nvectors\n\nSchedule 2 Dealings exempt from licensing\nPart 2.3 Definitions—sch 2\npage 36 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 2.3 Definitions—sch 2\nIn this schedule:\ncode for, in relation to a toxin, means to specify the amino acid\nsequence of the toxin.\nnon-conjugative plasmid means a plasmid that is not\nself-transmissible, and includes, but is not limited to, non-conjugative\nforms of the following plasmids:\n(a) bacterial artificial chromosomes (BACs);\n(b) cosmids;\n(c) P1 artificial chromosomes (PACs);\n(d) yeast artificial chromosomes (YACs).\nnon-vector system means a system in which donor nucleic acid is or\nwas introduced into a host cell—\n(a) in the absence of a nucleic acid-based vector; or\n(b) using a nucleic acid-based vector in the course of a previous\ndealing and the vector is—\n(i) no longer present; or\n(ii) present but cannot be remobilised from a host cell.\nExamples\n1 A system mentioned in par (a) might involve the use of electroporation or\nparticle bombardment.\n2 A system mentioned in par (b) might involve cells that were transduced with a\nreplication defective retroviral vector in which no vector particles remain.\n\nNotifiable low risk dealings in relation to a GMO Schedule 3\nNotifiable low risk dealings suitable for at least physical containment level 1 Part 3.1\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 37\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nSchedule 3 Notifiable low risk dealings in\nrelation to a GMO\n(see s 12 and s 13)\nPart 3.1 Notifiable low risk dealings\nsuitable for at least physical\ncontainment level 1\nNote Because of s 12 (1), a dealing mentioned in this part is not a notifiable\nlow risk dealing if it is also a dealing of a kind mentioned in pt 3.3.\n3.1 Kinds of dealings suitable for at least physical\ncontainment level 1\nThe following kinds of notifiable low risk dealings must be\nundertaken, unless section 13 (2) (c) or 13 (3) applies, in facilities\ncertified to at least physical containment level 1 and that are\nappropriate for the dealings:\n(a) a dealing involving a genetically modified laboratory guinea\npig, a genetically modified laboratory mouse, a genetically\nmodified laboratory rabbit or a genetically modified laboratory\nrat, unless—\n(i) an advantage is conferred on the animal by the genetic\nmodification; or\n(ii) the animal is capable of secreting or producing an\ninfectious agent as a result of the genetic modification;\n\nSchedule 3 Notifiable low risk dealings in relation to a GMO\nPart 3.1 Notifiable low risk dealings suitable for at least physical containment level 1\npage 38 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(c) a dealing involving virions of a replication defective vector\nderived from Human adenovirus or from Adeno-associated\nvirus, either without a host or with a host mentioned in column 3\nof item 9 in schedule 2, table 2.2 if the donor nucleic acid—\n(i) cannot restore replication competence to the vector; and\n(ii) does not confer an oncogenic modification or\nimmunomodulatory effect in humans.\n\nNotifiable low risk dealings in relation to a GMO Schedule 3\nNotifiable low risk dealings suitable for at least physical containment level 2\nor 3\nPart 3.2\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 39\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 3.2 Notifiable low risk dealings\nsuitable for at least physical\ncontainment level 2 or 3\nNote Because of s 12 (1), a dealing mentioned in this part is not a notifiable\nlow risk dealing if it is also a dealing of a kind mentioned in part 3.3.\n3.2 Kinds of dealings suitable for at least physical\ncontainment level 2\nThe following kinds of notifiable low risk dealings must be\nundertaken, unless section 13 (2) (c) or 13 (3) applies, in facilities\ncertified to at least physical containment level 2 and that are\nappropriate for the dealings:\n(a) a dealing involving whole animals (including non-vertebrates)\nthat—\n(i) involves genetic modification of the genome of the oocyte\nor zygote or early embryo by any means to produce a novel\nwhole organism; and\n(ii) does not involve any of the following:\n(A) a genetically modified laboratory guinea pig;\n(B) a genetically modified laboratory mouse;\n(C) a genetically modified laboratory rabbit;\n(D) a genetically modified laboratory rat;\n(E) a genetically modified Caenorhabditis elegans;\n(aa) a dealing involving a genetically modified laboratory guinea\npig, a genetically modified laboratory mouse, a genetically\nmodified laboratory rabbit, a genetically modified laboratory rat\nor a genetically modified Caenorhabditis elegans, if—\n(i) the genetic modification confers an advantage on the\nanimal; and\n\nSchedule 3 Notifiable low risk dealings in relation to a GMO\nPart 3.2 Notifiable low risk dealings suitable for at least physical containment level 2\nor 3\npage 40 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(ii) the animal is not capable of secreting or producing an\ninfectious agent as a result of the genetic modification;\n(b) a dealing involving a genetically modified plant;\n(c) a dealing involving a host/vector system not mentioned in\nsection 3.1 (c) or schedule 2, table 2.2 if neither host nor vector\nhas been implicated in, or has a history of causing, disease in\notherwise healthy—\n(i) human beings; or\n(ii) animals; or\n(iii) plants; or\n(iv) fungi;\n(d) a dealing involving a host/vector system not mentioned in\nschedule 2, table 2.2 if—\n(i) the host or vector has been implicated in, or has a history\nof causing, disease in otherwise healthy—\n(A) human beings; or\n(B) animals; or\n(C) plants; or\n(D) fungi; and\n(ii) the genetic modification is characterised; and\n\nNotifiable low risk dealings in relation to a GMO Schedule 3\nNotifiable low risk dealings suitable for at least physical containment level 2\nor 3\nPart 3.2\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 41\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(iii) the characterisation of the genetic modification shows that\nit is unlikely to increase the capacity of the host or vector\nto cause harm;\nExample\nA genetic modification would not comply with par (iii) if, in relation to the\ncapacity of the host or vector to cause harm, it—\n(a) provides an advantage; or\n(b) adds a potential host species or mode of transmission; or\n(c) increases its virulence, pathogenicity or transmissibility.\n(e) a dealing involving a host/vector system mentioned in\nschedule 2, table 2.2, if the donor nucleic acid—\n(i) is characterised, and the characterisation shows that it may\nincrease the capacity of the host or vector to cause harm;\nor\n(ii) is uncharacterised nucleic acid from an organism that has\nbeen implicated in, or has a history of causing, disease in\notherwise healthy—\n(A) human beings; or\n(B) animals; or\n(C) plants; or\n(D) fungi;\n(f) a dealing involving a host/vector system mentioned in\nschedule 2, table 2.2 and producing more than 25L of GMO\nculture in each vessel containing the resultant culture, if—\n(i) the dealing is undertaken in a facility that is certified by the\nregulator as a large scale facility; and\n(ii) the donor nucleic acid satisfies the conditions set out in\nschedule 2, part 2.1, item 4 (2);\n\nSchedule 3 Notifiable low risk dealings in relation to a GMO\nPart 3.2 Notifiable low risk dealings suitable for at least physical containment level 2\nor 3\npage 42 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(g) a dealing involving complementation of knocked-out genes, if\nthe complementation is unlikely to increase the capacity of the\nGMO to cause harm compared to the capacity of the parent\norganism before the genes were knocked out;\nExample\nA dealing would not comply with par (g) if it involved complementation that,\nin relation to the parent organism—\n(a) provides an advantage; or\n(b) adds a potential host species or mode of transmission; or\n(c) increases its virulence, pathogenicity or transmissibility.\n(h) a dealing involving shot-gun cloning, or the preparation of a\ncDNA library, in a host/vector system mentioned in schedule 2,\ntable 2.2, items 1 to 6, if the donor nucleic acid is derived from\neither—\n(i) a pathogen; or\n(ii) a toxin-producing organism;\n(i) a dealing involving virions of a replication defective viral vector\nunable to transduce human cells and a host not mentioned in\nschedule 2, table 2.2 if the donor nucleic acid cannot restore\nreplication competence to the vector;\n(j) a dealing involving virions of a replication defective\nnon-retroviral vector able to transduce human cells, either\nwithout a host or with a host mentioned in schedule 2, table 2.2,\nif—\n(i) the donor nucleic acid cannot restore replication\ncompetence to the vector; and\n(ii) the dealing is not a dealing mentioned in section 3.1 (c);\n\nNotifiable low risk dealings in relation to a GMO Schedule 3\nNotifiable low risk dealings suitable for at least physical containment level 2\nor 3\nPart 3.2\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 43\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(k) a dealing involving virions of a replication defective\nnon-retroviral vector able to transduce human cells and a host\nnot mentioned in schedule 2, table 2.2 if—\n(i) the donor nucleic acid cannot restore replication\ncompetence to the vector; and\n(ii) the donor nucleic acid does not confer an oncogenic\nmodification or immunomodulatory effect in humans;\n(l) a dealing involving virions of a replication defective retroviral\nvector able to transduce human cells, either without a host or\nwith a host mentioned in schedule 2, table 2.2, if—\n(i) all viral genes have been removed from the retroviral\nvector so that it cannot replicate or assemble new virions\nwithout these functions being supplied in trans; and\n(ii) viral genes needed for virion production in the packaging\ncell line are expressed from independent, unlinked loci\nwith minimal sequence overlap with the vector to limit or\nprevent recombination; and\n(iii) either—\n(A) the retroviral vector includes a deletion in the Long\nTerminal Repeat sequence of DNA that prevents\ntranscription of genomic RNA following integration\ninto the host cell DNA; or\n(B) the packaging cell line and packaging plasmids\nexpress only viral genes gagpol, rev and an envelope\nprotein gene, or a subset of these;\n(m) a dealing involving virions of a replication defective retroviral\nvector able to transduce human cells and a host not mentioned\nin schedule 2, table 2.2 if—\n(i) the donor nucleic acid does not confer an oncogenic\nmodification or immunomodulatory effect in humans; and\n\nSchedule 3 Notifiable low risk dealings in relation to a GMO\nPart 3.2 Notifiable low risk dealings suitable for at least physical containment level 2\nor 3\npage 44 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(ii) all viral genes have been removed from the retroviral\nvector so that it cannot replicate or assemble new virions\nwithout these functions being supplied in trans; and\n(iii) viral genes needed for virion production in the packaging\ncell line are expressed from independent, unlinked loci\nwith minimal sequence overlap with the vector to limit or\nprevent recombination; and\n(iv) either—\n(A) the retroviral vector includes a deletion in the Long\nTerminal Repeat sequence of DNA that prevents\ntranscription of genomic RNA following integration\ninto the host cell DNA; or\n(B) the packaging cell line and packaging plasmids\nexpress only viral genes gagpol, rev and an envelope\nprotein gene, or a subset of these.\n3.2A Kinds of dealing suitable for at least physical\ncontainment level 3\n(1) This section applies to a kind of dealing that—\n(a) is mentioned in section 3.2; and\n(b) involves a micro-organism that satisfies the criteria in\nAS/NZS 2243.3:2010 for classification as Risk Group 3.\n(2) Unless section 13 (2) (c) or 13 (3) applies, the dealing must be\nundertaken in facilities that are—\n(a) certified to at least physical containment level 3; and\n(b) appropriate for the dealings.\n(3) For subsection (1) (b), a genetically modified micro-organism is\ntaken to satisfy the criteria in AS/NZS 2243.3:2010 for classification\nas Risk Group 3 if the unmodified parent micro-organism satisfies\nthose criteria.\n\nNotifiable low risk dealings in relation to a GMO Schedule 3\nNotifiable low risk dealings suitable for at least physical containment level 2\nor 3\nPart 3.2\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 45\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(4) However, subsection (3) does not apply in relation to a replication\ndefective retroviral vector that meets the criteria in\nsection 3.2 (l) or (m).\n\nSchedule 3 Notifiable low risk dealings in relation to a GMO\nPart 3.3 Dealings that are not notifiable low risk dealings\npage 46 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nPart 3.3 Dealings that are not notifiable\nlow risk dealings\nNote 1 The following list qualifies the list in pt 3.1 and pt 3.2 and is not an\nexhaustive list of dealings that are not notifiable low risk dealings.\nNote 2 If a dealing is not a notifiable low risk dealing or an exempt dealing under\nthis regulation, a person undertaking the dealing must be authorised by a\nGMO licence, unless the dealing is within one of the other exceptions to\nlicensing provided by the Act (see the Act, s 32).\n3.3 Kinds of dealings\n(1) A dealing of any of the following kinds, or involving a dealing of the\nfollowing kinds, is not a notifiable low risk dealing:\n(a) a dealing (other than a dealing mentioned in section 3.2 (h))\ninvolving cloning of nucleic acid encoding a toxin having an\nLD50 of less than 100 micrograms per kilogram;\n(b) a dealing involving high level expression of toxin genes, even if\nthe LD50 is 100 micrograms per kilogram or more;\n(c) a dealing (other than a dealing mentioned in section 3.2 (h))\ninvolving cloning of uncharacterised nucleic acid from a\ntoxin-producing organism;\n(d) a dealing involving virions of a replication defective viral vector\nand a host not mentioned in schedule 2, table 2.2 if—\n(i) the donor nucleic acid confers an oncogenic modification\nor immunomodulatory effect in humans; and\n(ii) the dealing is not a dealing mentioned in section 3.2 (i);\n(e) a dealing involving a replication competent virus or viral vector,\nother than a vector mentioned in schedule 2, table 2.2, column 4,\nif the genetic modification confers an oncogenic modification or\nimmunomodulatory effect in humans;\n\nNotifiable low risk dealings in relation to a GMO Schedule 3\nDealings that are not notifiable low risk dealings Part 3.3\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 47\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(f) a dealing involving, as host or vector, a micro-organism, if—\n(i) the micro-organism has been implicated in, or has a history\nof causing, disease in otherwise healthy—\n(A) human beings; or\n(B) animals; or\n(C) plants; or\n(D) fungi; and\n(ii) none of the following apply:\n(A) the host/vector system is a system mentioned in\nschedule 2, table 2.2;\n(B) the genetic modification is characterised and its\ncharacterisation shows that it is unlikely to increase\nthe capacity of the host or vector to cause harm;\n(C) the dealing is a dealing mentioned in section 3.2 (g);\nExample\nA genetic modification would not comply with par (B) if, in relation\nto the capacity of the host or vector to cause harm, it—\n(a) provides an advantage; or\n(b) adds a potential host species or mode of transmission; or\n(c) increases its virulence, pathogenicity or transmissibility.\n(g) a dealing involving the introduction, into a micro-organism, of\nnucleic acid encoding a pathogenic determinant, unless—\n(i) the dealing is a dealing mentioned in section 3.2 (g); or\n(ii) the micro-organism is a host mentioned in schedule 2,\ntable 2.2;\n(h) a dealing involving the introduction into a micro-organism,\nother than a host mentioned in schedule 2, table 2.2 of genes\nwhose expressed products are likely to increase the capacity of\nthe micro-organisms to induce an autoimmune response;\n\nSchedule 3 Notifiable low risk dealings in relation to a GMO\nPart 3.3 Dealings that are not notifiable low risk dealings\npage 48 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(i) a dealing involving use of a viral or viroid genome, or fragments\nof a viral or viroid genome, to produce a novel replication\ncompetent virus with an increased capacity to cause harm\ncompared to the capacity of the parent or donor organism;\nExample\nA dealing would comply with par (i) if it produces a novel replication\ncompetent virus that has a higher capacity to cause harm to any potential host\nspecies than the parent organism because the new virus has—\n(a) an advantage; or\n(b) a new potential host species or mode of transmissibility; or\n(c) increased virulence, pathogenicity or transmissibility.\n(j) a dealing, other than a dealing mentioned in section 3.2 (l) or\n(m), with a replication defective retroviral vector (including a\nlentiviral vector) able to transduce human cells;\n(k) a dealing involving a genetically modified animal, plant or\nfungus that is capable of secreting or producing infectious\nagents as a result of the genetic modification;\n(l) a dealing producing, in each vessel containing the resultant\nGMO culture, more than 25L of that culture, other than a dealing\nmentioned in section 3.2 (f);\n(m) a dealing that is inconsistent with a policy principle issued by\nthe ministerial council;\n(n) a dealing involving the intentional introduction of a GMO into\na human being, unless the GMO—\n(i) is a human somatic cell; and\n(ii) cannot secrete or produce infectious agents as a result of\nthe genetic modification; and\n(iii) if it was generated using viral vectors—\n(A) has been tested for the presence of viruses likely to\nrecombine with the genetically modified nucleic acid\nin the somatic cells; and\n\nNotifiable low risk dealings in relation to a GMO Schedule 3\nDealings that are not notifiable low risk dealings Part 3.3\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 49\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(B) the testing did not detect a virus mentioned in\nsub-subparagraph (A); and\n(C) the viral vector used to generate the GMO as part of a\nprevious dealing is no longer present in the somatic\ncells;\n(o) a dealing involving a genetically modified pathogenic organism,\nif the practical treatment of any disease or abnormality caused\nby the organism would be impaired by the genetic modification;\n(p) a dealing involving a micro-organism that satisfies the criteria\nin AS/NZS 2243.3:2010 for classification as Risk Group 4;\n(q) a dealing involving a micro-organism that satisfies the criteria\nin AS/NZS 2243.3:2010 for classification as Risk Group 3 and\nthat is not undertaken in a facility—\n(i) that is certified by the regulator to at least physical\ncontainment level 3 and that is appropriate for the dealing;\nor\n(ii) that the regulator has agreed, in writing, is a facility in\nwhich the dealing may be undertaken;\n(r) a dealing involving a GMO capable of sexual reproduction, the\nsexual progeny of which are, as a result of the genetic\nmodification, more likely to inherit a particular nucleotide\nsequence or set of nucleotide sequences (when compared to\ninheritance from the unmodified parent organism);\n(s) a dealing involving a viral vector that can modify an organism\ncapable of sexual reproduction, so that the sexual progeny of the\norganism are more likely to inherit a particular nucleotide\nsequence or set of nucleotide sequences (when compared to\ninheritance from the unmodified parent organism).\nNote A modification that increases the likelihood of inheritance of a nucleotide\nsequence or sequences, as described in paragraphs (r) and (s), is generally\nknown as an engineered gene drive.\n\nSchedule 3 Notifiable low risk dealings in relation to a GMO\nPart 3.3 Dealings that are not notifiable low risk dealings\npage 50 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n(2) For subsection (1) (p), a genetically modified micro-organism is\ntaken to satisfy the criteria in AS/NZS 2243.3:2010 for classification\nas Risk Group 4 if the unmodified parent micro-organism satisfies\nthose criteria.\n(3) For subsection (1) (q), a genetically modified micro-organism is\ntaken to satisfy the criteria in AS/NZS 2243.3:2010 for classification\nas Risk Group 3 if the unmodified parent micro-organism satisfies\nthose criteria.\n(4) However, subsection (3) does not apply in relation to a replication\ndefective retroviral vector that meets the criteria in\nsection 3.2 (l) or (m).\n\nDictionary\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 51\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nDictionary\n(see s 3)\nNote 1 The Legislation Act contains definitions and other provisions relevant to\nthis regulation.\nNote 2 For example, the Legislation Act, dict, pt 1, defines the following terms:\n• for\n• function\n• in relation to\n• person (see s 160)\n• public holiday\n• under.\nNote 3 Terms used in this regulation have the same meaning that they have in\nthe Gene Technology Act 2003 (see Legislation Act, s 148). For example,\nthe following terms are defined in the Gene Technology Act 2003, dict:\n• accredited organisation\n• Commonwealth Act\n• deal with\n• environment\n• ethics and community committee\n• exempt dealing\n• facility\n• gene technology\n• gene technology technical advisory committee\n• genetically modified organism\n• GMO\n• institutional biosafety committee\n• intentional release of a GMO into the environment (see s 11)\n• ministerial council\n• notifiable low risk dealing\n• regulator.\n\nDictionary\npage 52 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nadvantage, in relation to an organism that is genetically modified,\nmeans a superior ability in its modified form, relative to the\nunmodified parent organism, to survive, reproduce or otherwise\ncontribute to the gene pool.\nanimal includes every kind of organism in the animal kingdom,\nincluding non-vertebrates but not including human beings.\nAS/NZS 2243.3:2010 means the Australian/New Zealand Standard\nSafety in laboratories Part 3: Microbiological safety and\ncontainment, jointly published by Standards Australia and Standards\nNew Zealand, as in force on 1 September 2011.\nNote AS/NZS 2243.3:2010 may be purchased at www.standards.org.au.\ncharacterised means—\n(a) in relation to a nucleic acid—the nucleic acid has been\nsequenced and there is an understanding of potential gene\nproducts or potential functions of the nucleic acid; or\n(b) in relation to a genetic modification—the gene or genomic\nregion which is modified has been sequenced and there is an\nunderstanding of—\n(i) potential gene products or potential functions of the gene\nor genomic region; and\n(ii) the likely effect of the genetic modification on the gene\nproducts or functions.\ncode for, in relation to a toxin, for schedule 2 (Dealings exempt from\nlicensing)—see schedule 2, part 2.3.\nCommonwealth regulations means the Gene Technology\nRegulations 2001 (Cwlth).\n\nDictionary\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 53\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nexpert adviser means—\n(a) for part 4 (Gene technology technical advisory committee)—an\nexpert adviser appointed under the Act, section 102 (1); and\n(b) for part 5 (Ethics and community committee)—an expert adviser\nappointed under the Act, section 112 (1).\ngenetically modified laboratory guinea pig means a laboratory strain\nof guinea pig of the species Cavia porcellus that has been modified\nby gene technology.\ngenetically modified laboratory mouse means a laboratory strain of\nmouse of the species Mus musculus that has been modified by gene\ntechnology.\ngenetically modified laboratory rabbit means a laboratory strain of\nrabbit of the species Oryctolagus cuniculus that has been modified by\ngene technology.\ngenetically modified laboratory rat means a laboratory strain of rat\nof either the species Rattus rattus or Rattus norvegicus that has been\nmodified by gene technology.\nhost, for part 2.2 (Host/vector systems for exempt dealings)—\nsee schedule 2, section 2.2.\nhost/vector system, for part 2.2 (Host/vector systems for exempt\ndealings)—see schedule 2, section 2.2.\ninfectious agent means an agent that is capable of entering, surviving\nin, multiplying, and potentially causing disease in, a susceptible host.\ninspector means a person appointed by the regulator under the Act,\nsection 150 as an inspector.\nknown means known within the scientific community.\nnon-conjugative plasmid, for schedule 2—see schedule 2, part 2.3.\nnon-vector system, for schedule 2—see schedule 2, part 2.3.\n\nDictionary\npage 54 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nnucleic acid means either, or both, deoxyribonucleic acid (DNA), or\nribonucleic acid (RNA), of any length.\noncogenic modification means a genetic modification capable of\ncontributing to tumour formation, including modifications that cause\nat least 1 of the following:\n(a) defects in DNA proofreading and repair;\n(b) defects in chromosome maintenance;\n(c) defects in cell cycle checkpoint mechanisms;\n(d) uncontrolled cell proliferation;\n(e) resistance to apoptosis;\n(f) cellular immortalisation.\npackaging cell line means an animal or human cell line that contains\na gene or genes that when expressed in trans are necessary and\nsufficient to complement packaging defects of a replication defective\nviral vector in order to produce packaged replication defective\nvirions.\npathogenic, in relation to an organism, means having the capacity to\ncause disease or abnormality.\npathogenic determinant means a characteristic that has the potential\nto increase the capacity of a host or vector to cause disease or\nabnormality.\nphysical containment level, followed by a numeral, is a specified\ncontainment level under guidelines made by the regulator under the\nAct, section 90 for the certification of facilities.\nplasmid means a DNA molecule capable of autonomous replication\nand stable extra-chromosomal maintenance in a host cell.\nshotgun cloning means the production of a large random collection\nof cloned fragments of nucleic acid from which genes of interest can\nlater be selected.\n\nDictionary\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 55\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ntoxin means a substance that is toxic to any vertebrate.\ntoxin-producing organism means an organism producing toxin with\nan LD50 of less than 100 micrograms per kilogram.\ntransduce, in relation to a viral vector or viral particle, means enter\nan intact cell by interaction of the viral particle with the cell\nmembrane.\nvector, for part 2.2 (Host/vector systems for exempt dealings)—\nsee schedule 2, section 2.2.\n\nEndnotes\n1 About the endnotes\npage 56 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nEndnotes\n1 About the endnotes\nAmending and modifying laws are annotated in the legislation history and the\namendment history. Current modifications are not included in the republished law\nbut are set out in the endnotes.\nNot all editorial amendments made under the Legislation Act 2001, part 11.3 are\nannotated in the amendment history. Full details of any amendments can be\nobtained from the Parliamentary Counsel’s Office.\nUncommenced amending laws are not included in the republished law. The details\nof these laws are underlined in the legislation history. Uncommenced expiries are\nunderlined in the legislation history and amendment history.\nIf all the provisions of the law have been renumbered, a table of renumbered\nprovisions gives details of previous and current numbering.\nThe endnotes also include a table of earlier republications.\n2 Abbreviation key\nA = Act NI = Notifiable instrument\nAF = Approved form o = order\nam = amended om = omitted/repealed\namdt = amendment ord = ordinance\nAR = Assembly resolution orig = original\nch = chapter par = paragraph/subparagraph\nCN = Commencement notice pres = present\ndef = definition prev = previous\nDI = Disallowable instrument (prev...) = previously\ndict = dictionary pt = part\ndisallowed = disallowed by the Legislative r = rule/subrule\nAssembly reloc = relocated\ndiv = division renum = renumbered\nexp = expires/expired R[X] = Republication No\nGaz = gazette RI = reissue\nhdg = heading s = section/subsection\nIA = Interpretation Act 1967 sch = schedule\nins = inserted/added sdiv = subdivision\nLA = Legislation Act 2001 SL = Subordinate law\nLR = legislation register sub = substituted\nLRA = Legislation (Republication) Act 1996 underlining = whole or part not commenced\nmod = modified/modification or to be expired\n\nEndnotes\nLegislation history 3\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 57\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n3 Legislation history\nThis regulation was originally the Gene Technology Regulations 2004. It was\nrenamed under the Legislation Act 2001.\nGene Technology Regulation 2004 SL2004-17\nnotified LR 4 June 2004\ns 1, s 2 commenced 4 June 2004 (LA s 75 (1))\nremainder commenced 5 June 2004 (s 2)\nas amended by\nStatute Law Amendment Act 2005 A2005-20 sch 3 pt 3.25\nnotified LR 12 May 2005\ns 1, s 2 taken to have commenced 8 March 2005 (LA s 75 (2))\nsch 3 pt 3.25 commenced 2 June 2005 (s 2 (1))\nGene Technology Amendment Regulation 2008 (No 1) SL2008-17\nnotified LR 17 April 2008\ns 1, s 2 commenced 17 April 2008 (LA s 75 (1))\nremainder commenced 1 May 2008 (s 2 and see Gene Technology\nAmendment Act 2008 A2008-10, s 2 and CN2008-5)\nGene Technology Amendment Regulation 2011 (No 1) SL2011-26\nnotified LR 31 August 2011\ns 1, s 2 commenced 31 August 2011 (LA s 75 (1))\nremainder commenced 1 September 2011 (s 2)\nStatute Law Amendment Act 2011 (No 2) A2011-28 sch 3 pt 3.16\nnotified LR 31 August 2011\ns 1, s 2 commenced 31 August 2011 (LA s 75 (1))\nsch 3 pt 3.16 commenced 21 September 2011 (s 2 (1))\nGene Technology Amendment Act 2017 A2017-15 pt 3\nnotified LR 14 June 2017\ns 1, s 2 commenced 14 June 2017 (LA s 75 (1))\npt 3 commenced 15 June 2017 (s 2)\nStatute Law Amendment Act 2019 A2019-42 sch 3 pt 3.12\nnotified LR 31 October 2019\ns 1, s 2 commenced 31 October 2019 (LA s 75 (1))\nsch 3 pt 3.12 commenced 14 November 2019 (s 2 (1))\n\nEndnotes\n3 Legislation history\npage 58 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nGene Technology Amendment Regulation 2020 (No 1) SL2020-38\nnotified LR 9 September 2020\ns 1, s 2 commenced 9 September 2020 (LA s 75 (1))\nsch 1 commenced 8 October 2020 (s 2 (2))\nremainder commenced 10 September 2020 (s 2 (1))\nHealth Legislation Amendment Act 2025 A2025-16 sch 1 pt 1.3\nnotified LR 26 May 2025\ns 1, s 2 commenced 26 May 2025 (LA s 75 (1))\nsch 1 pt 1.3 commenced 2 June 2025 (s 2)\n\nEndnotes\nAmendment history 4\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 59\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n4 Amendment history\nName of regulation\ns 1 am R2 LA\nCommencement\ns 2 om LA s 89 (4)\nNumbering\ns 3A am A2005-20 amdt 3.162\nTechniques not constituting gene technology\ns 4 am SL2008-17 s 4\nOrganisms that are genetically modified organisms\ns 4A ins SL2020-38 s 4\nOrganisms that are not genetically modified organisms\ns 5 sub SL2020-38 s 5\nDealings exempt from licensing\ns 6 am SL2008-17 ss 5-7; SL2011-26 s 4\nApplication for licence—prescribed fee\ns 7 sub SL2008-17 s 8\nTime limit for deciding an application—Act, s 43 (3)\ns 8 am SL2008-17 ss 9-12; A2011-28 amdt 3.122\nPrescribed authorities—Act, s 50 (3) (c) and s 52 (5) (c)\ns 9 am SL2008-17 s 13, s 14; A2019-42 amdt 3.17; SL2020-38\ns 6\nRisks posed by dealings proposed to be authorised by licence—Act,\ns 51 (1) (a)\ns 9A ins SL2008-17 s 15\nRisk assessment—matters to be taken into account—Act, s 51 (1) (d)\nand (2) (d)\ns 10 am SL2008-17 s 16, s 17\nTime limit for deciding variation application—Act, s 71 (7)\ns 11A ins SL2008-17 s 18\nsub SL2011-26 s 5\nNotifiable low risk dealings—Act, s 74 (1)\ns 12 am SL2011-26 s 6; SL2020-38 s 7\nRequirements for undertaking notifiable low risk dealings\ns 13 (5)-(7) exp 5 June 2006 (s 13 (7) (LA s 88 declaration applies))\nsub SL2008-17 s 19; SL2011-26 s 7\nam SL2020-38 ss 8-14\n\nEndnotes\n4 Amendment history\npage 60 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nRequirements in relation to notifying regulator of notifiable low risk dealings\ns 13A ins SL2008-17 s 19\nsub SL2011-26 s 8\nom SL2020-38 s 15\nRequirements for institutional biosafety committees about records of\nassessments of notifiable low risk dealing proposals\ns 13B ins SL2011-26 s 8\nam SL2020-38 ss 16-19\nInformation to be kept or given to the regulator by people or accredited\norganisations\ns 13C ins SL2011-26 s 8\nam SL2020-38 s 20, s 21\nEthics and community committee\npt 5 hdg sub SL2008-17 s 20\nEthics and community committee—conditions of appointment\ns 31 sub SL2008-17 s 20\nEthics and community committee—committee procedures\ns 32 sub SL2008-17 s 20\nEthics and community committee—operation of subcommittees\ns 33 sub SL2008-17 s 20\nGene technology ethics committee\npt 6 hdg om SL2008-17 s 20\nGTEC—conditions of appointment\ns 34 om SL2008-17 s 20\nGTEC—committee procedures\ns 35 om SL2008-17 s 20\nGTEC—operation of subcommittees\ns 36 om SL2008-17 s 20\nReview of decisions\ns 38 am A2025-16 amdt 1.18\nRecord of GMO dealings\ns 39 hdg sub A2017-15 s 19\ns 39 am SL2008-17 s 21; SL2011-26 s 9, s 10; A2017-15 s 20\nsub SL2020-38 s 22\nTransitional\npt 8 hdg om SL2008-17 s 22\nDisapplication of Legislation Act, s 47 (5)\ns 41 om SL2008-17 s 22\nins SL2020-38 s 23\n\nEndnotes\nAmendment history 4\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 61\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nExisting organisations—accreditation\ns 42 exp 5 June 2006 (s 42 (4) (LA s 88 declaration applies))\nTransitional—Gene Technology Amendment Regulation 2011 (No 1)\npt 9 hdg ins SL2011-26 s 11\nexp 1 September 2013 (s 46)\nTransitional\ns 45 ins SL2011-26 s 11\nexp 1 September 2013 (s 46)\nExpiry—pt 9\ns 46 ins SL2011-26 s 11\nexp 1 September 2013 (s 46)\nTransitional—Gene Technology Amendment Regulation 2020 (No 1)\npt 10 hdg ins SL2020-38 s 24\nexp 10 September 2021 (s 56)\nMeaning of commencement day—pt 10\ns 50 ins SL2020-38 s 24\nexp 10 September 2021 (s 56)\nChanged requirements—former exempt dealings\ns 51 ins SL2020-38 s 24\nexp 10 September 2021 (s 56)\nChanged requirements—former notifiable low risk dealings\ns 52 ins SL2020-38 s 24\nexp 10 September 2021 (s 56)\nChanged requirements—notifiable low risk dealings\ns 53 ins SL2020-38 s 24\nexp 10 September 2021 (s 56)\nPrevious assessment by institutional biosafety committee\ns 54 ins SL2020-38 s 24\nexp 10 September 2021 (s 56)\nGiving records to regulator for notifiable low risk dealings assessed in\nprevious financial year\ns 55 ins SL2020-38 s 24\nexp 10 September 2021 (s 56)\nExpiry—pt 10\ns 56 ins SL2020-38 s 24\nexp 10 September 2021 (s 56)\nTechniques that are not gene technology\nsch 1A ins SL2008-17 s 23\nam SL2020-38 s 25\n\nEndnotes\n4 Amendment history\npage 62 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nOrganisms that are genetically modified organisms\nsch 1B ins SL2020-38 s 26\nOrganisms that are not genetically modified organisms\nsch 1 sub SL2008-17 s 23\nam SL2011-26 s 12; SL2020-38 s 27, s 28, amdt 1.1\nDealings exempt from licensing\nsch 2 sub SL2008-17 s 23\nam SL2011-26 ss 13-16; SL2020-38 ss 29-32, s 64\nNotifiable low risk dealings in relation to a GMO\nsch 3 sub SL2008-17 s 23; SL2011-26 s 17\nam SL2020-38 ss 33-57, s 64\nPrescribed information—application for licence\nsch 4 om SL2008-17 s 23\nDictionary\ndict am SL2008-17 s 24; SL2011-26 s 18; SL2020-38 s 58, s 59\ndef advantage sub SL2008-17 s 25\ndef AS/NZS 2243.3:2010 ins SL2011-26 s 19\ndef characterised sub SL2008-17 s 26; SL2020-38 s 60\ndef division 5.3 application om SL2008-17 s 27\ndef division 5.4 application om SL2008-17 s 27\ndef expert advisor sub SL2008-17 s 28\ndef gene-knockout mice om SL2008-17 s 29\ndef genetic manipulation advisory committee om\nSL2008-17 s 30\ndef genetically modified laboratory guinea pig ins\nSL2011-26 s 20\ndef genetically modified laboratory mouse ins SL2008-17\ns 31\ndef genetically modified laboratory rabbit ins SL2011-26\ns 20\ndef genetically modified laboratory rat ins SL2008-17 s 31\ndef host ins SL2020-38 s 61\ndef host/vector system ins SL2020-38 s 61\ndef inclusion-negative om SL2008-17 s 32\ndef infectious agent ins SL2008-17 s 33\ndef inspector ins SL2011-26 s 20\ndef known ins SL2008-17 s 33\ndef non-conjugative plasmid ins SL2008-17 s 33\ndef non-vector system ins SL2008-17 s 33\ndef nucleic acid ins SL2008-17 s 33\ndef oncogenic modification ins SL2008-17 s 33\nsub SL2011-26 s 21\ndef packaging cell line ins SL2008-17 s 33\ndef pathogenic ins SL2008-17 s 33\n\nEndnotes\nAmendment history 4\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 63\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\ndef pathogenic determinant ins SL2008-17 s 33\ndef plasmid ins SL2008-17 s 34\ndef recombinant om SL2008-17 s 35\ndef shotgun cloning sub SL2008-17 s 36\ndef toxin ins SL2008-17 s 37\ndef toxin-producing organism ins SL2008-17 s 37\nam SL2020-38 s 62\ndef transduce ins SL2008-17 s 37\ndef vector ins SL2020-38 s 63\n\nEndnotes\n5 Earlier republications\npage 64 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n5 Earlier republications\nSome earlier republications were not numbered. The number in column 1 refers to\nthe publication order.\nSince 12 September 2001 every authorised republication has been published in\nelectronic pdf format on the ACT legislation register. A selection of authorised\nrepublications have also been published in printed format. These republications are\nmarked with an asterisk (*) in column 1. Electronic and printed versions of an\nauthorised republication are identical.\nRepublication\nNo and date\nEffective Last\namendment\nmade by\nRepublication\nfor\nR1\n5 June 2004\n5 June 2004–\n3 Nov 2004\nnot amended new regulation\nR2\n4 Nov 2004\n4 Nov 2004–\n1 June 2005\nnot amended editorial\namendments under\nLegislation Act\nR3\n2 June 2005\n2 June 2005–\n5 June 2006\nA2005-20 amendments by\nA2005-20\nR4\n6 June 2006\n6 June 2006–\n30 Apr 2008\nA2005-20 commenced expiry\nR5\n1 May 2008\n1 May 2008–\n31 Aug 2011\nSL2008-17 amendments by\nSL2008-17\nR6\n1 Sept 2011\n1 Sept 2011–\n20 Sept 2011\nSL2011-26 amendments by\nSL2011-26\nR7\n21 Sept 2011\n21 Sept 2011–\n1 Sept 2013\nA2011-28 amendments by\nA2011-28\nR8\n2 Sept 2013\n2 Sept 2013–\n14 June 2017\nA2011-28 expiry of\ntransitional\nprovisions (pt 9)\nR9\n15 June 2017\n15 June 2017–\n13 Nov 2019\nA2017-15 amendments by\nA2017-15\nR10\n14 Nov 2019\n14 Nov 2019–\n9 Sept 2020\nA2019-42 amendments by\nA2019-42\nR11\n10 Sept 2020\n10 Sept 2020–\n7 Oct 2020\nSL2020-38 amendments by\nSL2020-38\n\nEndnotes\nEarlier republications 5\nR14\n02/06/25\nGene Technology Regulation 2004\nEffective: 02/06/25\npage 65\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\nRepublication\nNo and date\nEffective Last\namendment\nmade by\nRepublication\nfor\nR12\n8 Oct 2020\n8 Oct 2020–\n10 Sept 2021\nSL2020-38 amendments by\nSL2020-38\nR13\n11 Sept 2021\n11 Sept 2021–\n1 June 2025\nSL2020-38 expiry of\ntransitional\nprovisions (pt 10)\n\nEndnotes\n6 Expired transitional or validating provisions\npage 66 Gene Technology Regulation 2004\nEffective: 02/06/25\nR14\n02/06/25\nAuthorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au\n6 Expired transitional or validating provisions\nThis Act may be affected by transitional or validating provisions that have expired.\nThe expiry does not affect any continuing operation of the provisions (see\nLegislation Act 2001, s 88 (1)).\nExpired provisions are removed from the republished law when the expiry takes\neffect and are listed in the amendment history using the abbreviation ‘exp’ followed\nby the date of the expiry.\nTo find the expired provisions see the version of this Act before the expiry took\neffect. The ACT legislation register has point-in-time versions of this Act.\n© Australian Capital Territory 2025","sortOrder":0}],"analysis":{"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":false,"description":"The regulation continues to implement the original regulatory purpose: to classify, manage and control dealings with GMOs under the Gene Technology Act. Recent amendments refine technical definitions (techniques excluded, specific organisms captured in schedules), add and reorganise lists of host/vector systems and notifiable dealings, and update procedural timeframes and reporting rules (see amendment history entries for 2008, 2011, 2020 and 2025). These are detailed expansions and clarifications of scope within the original regulatory framework rather than a change of purpose: they tighten which activities fall into exempt, notifiable or licenced classes and adjust administrative mechanics, but do not repurpose the regime beyond managing gene‑technology risks."},"complexity_factors":["Extensive schedules with granular lists (Schedule 2 host/vector table 2.2 plus Schedule 3 parts 3.1–3.3)","Multiple defined terms in the Dictionary (approximately 40–50 defined or cross-referenced terms)","Numerous cross-references to the Gene Technology Act and Commonwealth regulations (20+ explicit cross-references such as ss 43, 50, 51, 61, 71, 74, 85, 93, 138, 150)","Nested conditional logic and exceptions (e.g. schedule 3 contains many sub-paragraphs that carve in or out specific dealings; s 13 contains multiple containment and time conditions)","Stop‑the‑clock decision rules with multiple distinct pause triggers (s 8(2)(b)–(e))","Different regulatory pathways with different procedural rules (exempt dealings, notifiable low risk dealings, licence system, certification/accreditation)","Record-keeping and reporting requirements with specified forms and multi-year retention (ss 13B–13C, s 39)","Interplay between multiple decision-makers (institutional biosafety committees, the regulator, advisory committees, ethics/community committee)","Containment-level technical standards tied to an external standard (AS/NZS 2243.3:2010) and discretion to the regulator on facility suitability (s 41; ss 13(2), 13(3))","Historical amendments and transitional provisions that change definitions and lists over time (multiple amendment entries including 2008, 2011, 2020, 2025)"],"plain_english_summary":"**What this regulation does (mechanics)**\n\n- Sets detailed rules under the Gene Technology Act 2003 for how dealings with genetically modified organisms (GMOs) are classified, authorised, recorded and overseen. Key operational elements are:\n  - Lists specific laboratory techniques that are not treated as \"gene technology\" (schedule 1A) (see s 4).\n  - Identifies particular organisms that are treated as GMOs and lists organisms that are not GMOs for the Act’s purposes (s 4A, s 5; schedules 1B and 1).\n  - Creates three operational pathways for dealing with GMOs:\n    - Exempt dealings (no licence required) where conditions in schedule 2 are met (s 6; sch 2).\n    - Notifiable low risk dealings that require an institutional biosafety committee assessment and notification to the regulator, plus specified containment and record-keeping (s 12–13C; sch 3).\n    - Other dealings that require a formal GMO licence from the regulator, with statutory time limits for decisions (s 8; s 11A).\n  - Prescribes time limits and \"stop‑the‑clock\" rules for regulator decisions and for licence variations (s 8; s 11A).\n  - Specifies matters the regulator must consider in risk assessments and the Commonwealth authorities to consult (s 9, s 9A, s 10).\n  - Sets requirements for facility certification and organisational accreditation processes and time limits (ss 14–17).\n  - Requires institutional biosafety committees to make and keep approved assessment records and to supply records and certain summaries to the regulator (ss 13B–13C; s 39).\n  - Provides procedural notes about advisory committees, inspector identity cards and standards to be applied (parts 4–5; s 40; s 41).\n\n**Who this affects**\n\n- Researchers and laboratory managers working with genetic modification (academic, commercial, clinical) — they must classify dealings, obtain certification/accreditation, keep records, and engage institutional biosafety committees (ss 13–13C; schs 2–3).\n- Organisations that run containment facilities (must seek certification and may be accredited) (ss 14–17).\n- Applicants for GMO licences (companies, research institutions) — the regulator has formal decision timelines and consultative duties (s 8; s 9).\n- Institutional biosafety committees (IBCs) — they must assess notifiable low risk proposals, keep a specified record in an approved form and provide records to applicants and the regulator (ss 13B, 13C).\n- The regulator and specialist advisory bodies (Gene Technology Technical Advisory Committee, Ethics and Community Committee) — they make risk and ethical assessments and set containment standards (parts 4–5; s 9A).\n- Inspectors — have identity-card and enforcement roles (s 40; definition of inspector).\n\n**Why it matters (official rationale, followed by a practical test of effects)**\n\nOfficial rationale (stated by the regulatory framework):\n- To manage health, safety and environmental risks from gene technology by distinguishing low-risk activities that can proceed with internal oversight from higher-risk activities that need regulator licences and external review (see s 6; s 12; schs 2–3).\n\nHow that operates in practice and what it costs or changes:\n- Compliance burden and administration: many dealings require an IBC assessment, written records in an approved form, and (for notifiable low risk dealings) annual reporting to the regulator (ss 13, 13B–13C). That creates recurring administrative costs for labs and organisations (time, record systems, IBC staffing/training).\n- Who pays: applicants and accredited organisations bear the costs of certification, accreditation, IBC processes and record-keeping. The regulator and advisory committees bear assessment and oversight costs funded by government (ss 14–17; parts 4–5). At the time of this regulation no application fee is prescribed for some licences (s 7 note), but other user costs (facility upgrades, containment certification) are likely to fall on organisations.\n- Decision speed and regulatory certainty: the regulation prescribes decision timelines (90–255 days depending on application type) but also multiple “stop‑the‑clock” conditions (s 8(2))—for example, when the regulator is awaiting information from the applicant, when confidentiality claims are under review, when public hearings occur, or when ethics advice is requested (s 8(2)(b)–(e)). That combination allows predictability but also introduces potential delays and discretionary pausing points.\n- Division of decision-making: institutional biosafety committees make the first-line technical assessment for notifiable low risk dealings (s 13); the regulator retains the power to certify facilities, accredit organisations, decide licences and request further information or proceed without committee/ethics advice if responses are late (ss 13(2)(c), 14–17, s 8(3)). This structure preserves local scientific oversight while centralising final authorisation.\n- Technical specificity reduces ambiguity but increases administrative complexity: schedules 2 and 3 list host/vector systems, containment levels and granular exclusions (e.g., engineered gene drives are treated as non-notifiable; see sch 3, pt 3.3 pars (r)–(s)). That specificity helps practitioners classify work (reducing legal uncertainty) but requires users to map their protocols carefully to long schedules.\n- Effects on private enterprise and research choices: the regulation lowers regulatory friction for certain low-risk lab work by enabling internal IBC sign‑off rather than a licence (ss 12–13), which may speed bench-level research. Conversely, activities excluded from the low‑risk pathway (sch 3, pt 3.3) will face higher cost and delay because they require licences and possibly higher containment standards, which can raise the entry bar for commercial development in those areas.\n- Concentrated vs diffuse impacts: technical suppliers and containment facility builders may see concentrated demand for upgrades and certification work (costs borne by research organisations). Small labs and startups may face relatively higher marginal compliance costs than large institutions that can spread fixed compliance investments.\n- Implementation and enforcement risk: the regime depends on effective functioning of institutional biosafety committees, timely regulator assessments, and consistent application of containment standards (AS/NZS 2243.3:2010) (ss 13B–13C; s 41). Weak IBCs or inconsistent regulator interpretation create risk of under- or over-regulation.\n\n**Key operational highlights to watch**\n- Which specific techniques and organisms are captured or excluded (s 4; s 4A; schs 1A, 1, 1B).\n- The detailed lists in schedule 2 (exempt dealings and host/vector table 2.2) and schedule 3 (notifiable low risk dealings and exclusions) — they determine whether a project needs only IBC oversight, facility certification, or a full licence.\n- Record-keeping and reporting windows: IBC records must be kept for 8 years and certain summaries must be provided to the regulator by 30 September after the financial year of assessment (ss 13B(3); 13C(2A)).\n\nSections cited on key points: Exempt/Notifiable definitions and duties (ss 6, 12–13, schs 2–3); risk assessment and consultation (ss 9, 9A, 10); decision timelines and pausing rules (s 8); certification/accreditation time limits and refusal powers (ss 14–17); record-keeping (ss 13B–13C; s 39)."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"kimi_summary":{"content_quality":"ok","complexity_score":7,"scope_assessment":{"changed":false,"description":"The regulation maintains its original scope as a technical implementation instrument for the Gene Technology Act 2003. While it has been amended multiple times (14 republications since 2004) to incorporate new scientific developments like CRISPR gene editing and updated containment standards, these changes represent natural evolution within the original regulatory framework rather than scope creep. The core purpose—defining exempt and notifiable low-risk dealings, setting containment requirements, and establishing administrative procedures—remains consistent with the 2004 intent."},"complexity_factors":["Extensive cross-referencing to the Commonwealth Gene Technology Regulations 2001 and the Gene Technology Act 2003, with many provisions consisting entirely of notes pointing to Commonwealth equivalents","Multiple schedules containing detailed technical specifications (Schedules 1A, 1B, 1, 2, and 3) with complex conditional logic and nested exceptions","Highly technical definitions requiring scientific expertise to interpret (e.g., 'replication defective viral vector', 'homology-directed repair', 'packaging cell line', 'transduce')","Layered exemption structures – for example, Schedule 3 Part 3.3 contains 19 specific exclusions that override the general notifiable low risk dealing categories in Parts 3.1 and 3.2","Incorporation of external standards by reference (AS/NZS 2243.3:2010 for microbiological safety and containment)","Complex timing provisions for licence applications with multiple calculation rules excluding weekends, public holidays, and waiting periods for information","Dual numbering system maintained for consistency with Commonwealth regulations (Section 3A), creating potential confusion about which provisions are ACT-specific versus Commonwealth-aligned","Detailed record-keeping and reporting requirements with specific timeframes (e.g., 8-year retention of assessment records, 30 September annual reporting deadline)"],"plain_english_summary":"This regulation implements the Gene Technology Act 2003 in the ACT by setting out how genetically modified organisms are classified, handled and overseen. It creates a tiered system (exempt, notifiable low‑risk, and licensed dealings), requires appropriate containment for different risks, and establishes processes for licences, facility certification and institutional oversight. \n\nIt affects researchers, universities, biotech firms, biosafety committees and the Gene Technology Regulator, ensuring safe, proportionate governance of genetic research to protect health and the environment."}},"importantCases":[],"_links":{"self":"/api/acts/gene-technology-regulation-2004","history":"/api/acts/gene-technology-regulation-2004/history","analysis":"/api/acts/gene-technology-regulation-2004/analysis","conflicts":"/api/acts/gene-technology-regulation-2004/conflicts","importantCases":"/api/acts/gene-technology-regulation-2004/important-cases","documents":"/api/acts/gene-technology-regulation-2004/documents"}}