{"id":"gene-technology-regulations-2017","name":"Gene Technology Regulations 2017","slug":"gene-technology-regulations-2017","collection":"regulation","jurisdiction":"sa","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":235592,"registerId":"sa-gene-technology-regulations-2017-current","compilationNumber":null,"startDate":"2026-04-06","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Gene Technology Regulations 2017","content":"South Australia\nGene Technology Regulations 2017\nunder the Gene Technology Act 2001\n\nContents\nPart 1—Preliminary\n1\tShort title\n3\tDefinitions\n3A\tNumbering\nPart 2—Interpretation and general operation\n4\tTechniques not constituting gene technology\n4A\tOrganisms that are genetically modified organisms\n5\tOrganisms that are not genetically modified organisms\nPart 3—Dealings with GMOs\nDivision 1—Licensing system\n6\tDealings exempt from licensing\n7\tApplication for licence—prescribed fee\n8\tTime limit for deciding an application\n9\tPrescribed authorities\n9A\tRisks posed by dealings proposed to be authorised by licence\n10\tRisk assessment—matters to be taken into account\n11\tPrescribed conditions of licence\n11A\tTime limit for deciding variation application\nDivision 2—Notifiable low risk dealings\n12\tNotifiable low risk dealings\n13\tRequirements for undertaking notifiable low risk dealings\n13B\tRequirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\n13C\tInformation to be kept or given to the Regulator by persons or accredited organisations\nDivision 3—Certification and accreditation\n14\tRegulator to decide certification application within 90 days\n15\tApplication for certification—failure to provide section 85 information\n16\tRegulator to decide accreditation application within 90 days\n17\tApplication for accreditation—failure to provide section 93 information\nPart 4—Gene Technology Technical Advisory Committee\nDivision 1—Conditions of appointment\n18\tGTTAC members and advisers—term of appointment\n19\tGTTAC members and advisers—resignation\n20\tGTTAC members—disclosure of interests\n21\tGTTAC members and advisers—termination of appointment\n22\tGTTAC members—leave of absence\n23\tExpert advisers—disclosure of interests\nDivision 2—Committee procedures\n24\tCommittee procedures generally\n25\tCommittee meetings\n26\tPresiding member\n27\tQuorum\n28\tVoting\n29\tRecords and Reports\nDivision 3—Subcommittees\n30\tOperation of subcommittees\nPart 5—Ethics and Community Committee\n31\tEthics and Community Committee—conditions of appointment\n32\tEthics and Community Committee—Committee procedures\n33\tEthics and Community Committee—operation of subcommittees\nPart 7—Miscellaneous\n37\tReviewable State decisions\n38\tReview of decisions\n39\tRecord of GMO Dealings\n40\tInspector identity card\nPart 8—Application and transitional provisions\nDivision 1—Amendments made by the Gene Technology Variation Regulations 2019\n41\tChanged requirements for dealings\n42\tPrevious assessment by an Institutional Biosafety Committee\n43\tNew requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\nSchedule 1A—Techniques that are not gene technology\nSchedule 1B—Organisms that are genetically modified organisms\n1.1\tGenetically modified organisms\nSchedule 1—Organisms that are not genetically modified organisms\nSchedule 2—Dealings exempt from licensing\nPart 1—Exempt dealings\nPart 2—Host/vector systems for exempt dealings\n2.1\tHosts and vectors\nPart 3—Definitions\nSchedule 3—Notifiable low risk dealings in relation to a GMO\nPart 1—Notifiable low risk dealings suitable for at least physical containment level 1\n1.1\tKinds of dealings suitable for at least physical containment level 1\nPart 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3\n2.1\tKinds of dealings suitable for at least physical containment level 2\n2.2\tKinds of dealing suitable for at least physical containment level 3\nPart 3—Dealings that are not notifiable low risk dealings\n3.1\tKinds of dealings\nLegislative history\n\nPart 1—Preliminary\n1—Short title\n\t(1)\tThese regulations may be cited as the Gene Technology Regulations 2017.\n\t(2)\tThese regulations may also be referred to as the Gene Technology Regulations.\n3—Definitions\nIn these regulations—\nAct means the Gene Technology Act 2001;\nadvantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool;\nanimal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings;\nAS/NZS 2243.3:2010 means the Australian/New Zealand Standard Safety in laboratories Part 3: Microbiological safety and containment, as in force on 1 September 2011;\ncharacterised means—\n\t(a)\tin relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or\n\t(b)\tin relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of—\n\t(i)\tpotential gene products or potential functions of the gene or genomic region; and\n\t(ii)\tthe likely effect of the genetic modification on the gene products or functions;\nCommonwealth regulations means the Gene Technology Regulations 2001 of the Commonwealth;\nexpert adviser means—\n\t(a)\tin Part 4—an expert adviser appointed under section 102(1) of the Commonwealth Act; and\n\t(b)\tin Part 5—an expert adviser appointed under section 112(1) of the Commonwealth Act;\ngenetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology;\ngenetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology;\ngenetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology;\ngenetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology;\nhost/vector system has a meaning affected by subclause 2.1(3) of Schedule 2;\ninfectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host;\ninspector means a person appointed by the Regulator under section 150 of the Act as an inspector;\nknown means known within the scientific community;\nnon-conjugative plasmid, for Schedule 2, has the meaning given in Part 3 of that Schedule;\nnon‑vector system has the meaning given in Part 3 of Schedule 2;\nnucleic acid means either, or both, deoxyribonucleic acid (DNA), or ribonucleic acid (RNA), of any length;\noncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:\n\t(a)\tdefects in DNA proofreading and repair;\n\t(b)\tdefects in chromosome maintenance;\n\t(c)\tdefects in cell cycle checkpoint mechanisms;\n\t(d)\tuncontrolled cell proliferation;\n\t(e)\tresistance to apoptosis;\n\t(f)\tcellular immortalisation;\npackaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions;\npathogenic, in relation to an organism, means having the capacity to cause disease or abnormality;\npathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality;\nphysical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities;\nplasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell;\nshot-gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected;\ntoxin means a substance that is toxic to any vertebrate;\ntoxin-producing organism means an organism producing toxin with an LD50 of less than 100 micrograms per kilogram;\ntransduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane.\nNote—\nSeveral other words and expressions used in these regulations have the meaning given by section 10, or another provision, of the Act. For example—\n\t•\taccredited organisation\n\t•\tdeal with\n\t•\tenvironment\n\t•\tfacility\n\t•\tGene Technology Technical Advisory Committee\n\t•\tGMO\n\t•\tInstitutional Biosafety Committee\n\t•\tintentional release of the GMO into the environment (see section 11)\n\t•\tnotifiable low risk dealing\n\t•\tRegulator.\n3A—Numbering\n\t(1)\tIn order to maintain consistent numbering between these regulations and the Commonwealth Regulations—\n\t(a)\tif the Commonwealth Regulations contain a regulation that is not required in these regulations, the provision number and heading to the regulation appearing in the Commonwealth Regulations are included in these regulations despite the omission of the body of the regulation; and\n\t(b)\tif these regulations contain a regulation that is not included in the Commonwealth Regulations, the regulation is numbered so as to maintain consistency in numbering between regulations common to both regulations.\n\t(2)\tA provision number and heading referred to in subregulation (1)(a) form part of these regulations.\nNotes—\n1\tA note appears under each heading of a kind referred to in subregulation (1)(a) describing the omitted regulation of the Commonwealth Regulations.\n2\tA note appears under each regulation of a kind referred to in subregulation (1)(b) highlighting the non‑appearance of an equivalent regulation in the Commonwealth Regulations.\n3\tThis regulation does not appear in the Commonwealth Regulations.\nPart 2—Interpretation and general operation\n4—Techniques not constituting gene technology\nFor the purposes of paragraph (c) of the definition of gene technology in section 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.\n4A—Organisms that are genetically modified organisms\nFor the purposes of paragraph (c) of the definition of genetically modified organism in section 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.\n5—Organisms that are not genetically modified organisms\nFor the purposes of paragraph (e) of the definition of genetically modified organism in section 10(1) of the Act, an organism is not a genetically modified organism if—\n\t(a)\tone or more items in Schedule 1 applies to the organism; and\n\t(b)\tthe organism has not been modified by gene technology except for any modifications described in those items; and\n\t(c)\tthe organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and\n\t(d)\tnone of the items in Schedule 1B applies to the organism.\nPart 3—Dealings with GMOs\nDivision 1—Licensing system\n6—Dealings exempt from licensing\n\t(1)\tFor the purposes of section 32(3) of the Act, a dealing, in relation to a GMO, is an exempt dealing if—\n\t(a)\tit is a dealing of a kind referred to in Part 1 of Schedule 2; and\n\t(b)\tit does not involve a genetic modification other than a modification described in Part 1 of Schedule 2; and\n\t(d)\tit does not involve an intentional release of the GMO into the environment.\n\t(2)\tFor the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\nNotes—\n1\tA dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in section 10(1) of the Act.\n2\tExemption from provisions of the Act does not preclude the application of other Commonwealth and State laws.\n3\tIntentional release of the GMO into the environment is defined in section 11 of the Act.\n7—Application for licence—prescribed fee\nNote—\nAt the commencement of this regulation, no application fee is prescribed under section 40(6) of the Act.\n8—Time limit for deciding an application\n\t(1)\tFor the purposes of section 43(3) of the Act, the period within which the Regulator must issue, or refuse to issue, a licence is—\n\t(a)\tin relation to an application to which Division 3 of Part 5 of the Act applies, 90 days after the day the application is received by the Regulator; or\n\t(b)\tin relation to an application to which Division 4 of Part 5 of the Act applies—\n\t(i)\tfor a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and\n\t(ii)\tfor a limited and controlled release application for which the Regulator is satisfied that at least 1 of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and\n\t(iii)\tin any other case—255 days after the day the application is received by the Regulator.\n\t(2)\tFor the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:\n\t(a)\ta Saturday, a Sunday or a public holiday in the Australian Capital Territory;\n\t(b)\ta day on which the Regulator cannot proceed with the decision-making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give;\n\t(c)\tif, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that—\n\t(i)\tbegins on the day of publication; and\n\t(ii)\tends on the day when the public hearing ends;\n\t(d)\ta day on which the Regulator cannot proceed with the decision-making process, or a related function, because—\n\t(i)\tthe applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and\n\t(ii)\tthe Regulator is—\n\t(A)\tconsidering the application; or\n\t(B)\twaiting until any review rights under section 181 or 183 of the Act, in relation to the application, are exhausted;\n\t(e)\tif, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that—\n\t(i)\tbegins on the day the request is made; and\n\t(ii)\tsubject to subregulation (3), ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period.\n\t(3)\tThe Regulator, when seeking advice under section 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.\n\t(4)\tIn subregulation (1)—\nlimited and controlled release application means an application for a licence to which section 50A of the Act applies.\n9—Prescribed authorities\n\t(1)\tFor the purposes of sections 50(3)(c) and 52(3)(c) of the Act, the following Commonwealth authorities and agencies are prescribed:\n\t(a)\tFood Standards Australia New Zealand;\n\t(b)\tAustralian Quarantine and Inspection Service;\n\t(d)\tthat part of the Department known as the Australian Industrial Chemicals Introduction Scheme;\n\t(e)\tAustralian Pesticides and Veterinary Medicines Authority;\n\t(f)\tthat part of the Department known as the Therapeutic Goods Administration.\n\t(2)\tIn this regulation—\nDepartment has the same meaning as in the Commonwealth Act. \n9A—Risks posed by dealings proposed to be authorised by licence\nFor the purposes of section 51(1)(a) of the Act, the Regulator must have regard to the following matters:\n\t(a)\tthe properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO;\n\t(b)\tthe effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism;\n\t(c)\tprovisions for limiting the dissemination or persistence of the GMO or its genetic material in the environment;\n\t(d)\tthe potential for spread or persistence of the GMO or its genetic material in the environment;\n\t(e)\tthe extent or scale of the proposed dealings;\n\t(f)\tany likely impacts of the proposed dealings on the health and safety of people.\n10—Risk assessment—matters to be taken into account\n\t(1)\tFor the purposes of sections 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include—\n\t(a)\tsubject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and\n\t(b)\tthe potential of the GMO concerned to—\n\t(i)\tbe harmful to other organisms; and\n\t(ii)\tadversely affect any ecosystems; and\n\t(iii)\ttransfer genetic material to another organism; and\n\t(iv)\tspread, or persist, in the environment; and\n\t(v)\thave, in comparison to related organisms, an advantage in the environment; and\n\t(vi)\tbe toxic, allergenic or pathogenic to other organisms.\n\t(2)\tIn taking into account a risk mentioned in section 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.\n11—Prescribed conditions of licence\nNote—\nAt the commencement of these regulations, no conditions are prescribed under section 61(b) of the Act.\n11A—Time limit for deciding variation application\n\t(1)\tFor section 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.\n\t(2)\tFor the period mentioned in subregulation (1), the following days are not counted:\n\t(a)\ta Saturday or a public holiday in South Australia;\n\t(b)\ta day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give.\nNote—\nThis subregulation differs from regulation 11A(2) of the Commonwealth regulations.\nDivision 2—Notifiable low risk dealings\n12—Notifiable low risk dealings\n\t(1)\tFor the purposes of section 74(1) of the Act, a dealing with a GMO is a notifiable low risk dealing if—\n\t(a)\tit is a dealing of a kind mentioned in Part 1 or 2 of Schedule 3; and\n\t(aa)\tit is not a dealing of a kind mentioned in Part 3 of Schedule 3; and\n\t(b)\tit does not involve an intentional release of the GMO into the environment.\n\t(2)\tFor the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply.\nNotes—\n1\tA dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in section 10(1) of the Act.\n2\tIntentional release of the GMO into the environment is defined in section 11 of the Act.\n13—Requirements for undertaking notifiable low risk dealings\n\t(1)\tA person may undertake a notifiable low risk dealing only if—\n\t(a)\tthe person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and\n\t(b)\tthe Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and\n\t(c)\tthe dealing undertaken is the dealing described in the Institutional Biosafety Committee's record of assessment of the proposal; and\n\t(d)\tthe dealing is only undertaken no later than the day 5 years after the date of the assessment; and\n\t(e)\tthe person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee's record of assessment as having the appropriate training and experience to undertake the dealing; and\n\t(f)\tsubject to subregulation (3), the dealing is undertaken in facilities that—\n\t(i)\tare mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee's record of assessment as being appropriate for the dealing; and\n\t(ii)\tare facilities in which subregulation (2) permits the dealing to be undertaken; and\n\t(g)\tthe person keeps or can give, on request, a copy of the Institutional Biosafety Committee's record of assessment to an inspector; and\n\t(h)\tthe person does not compromise the containment of a GMO involved in the dealing.\n\t(2)\tA notifiable low risk dealing must be undertaken—\n\t(a)\tfor a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or\n\t(b)\tfor a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or\n\t(ba)\tfor a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n\t(c)\tin a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken.\n\t(3)\tIf a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with—\n\t(a)\tthe Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or\n\t(b)\ttransportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO.\n\t(4)\tFor subregulation (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.\n13B—Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals\nAn Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must—\n\t(a)\tmake a record of its assessment, in a form approved by the Regulator, that includes the following:\n\t(i)\tthe identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal;\n\t(ii)\ta description of the dealing to be undertaken;\n\t(iii)\tits assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3;\n\t(iv)\tif the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is;\n\t(v)\tthe date of the Committee's assessment of the dealing;\n\t(vi)\tthe persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing;\n\t(vii)\tthe facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of regulation 13(2);\n\t(viii)\tthe name of the Committee that assessed the proposal;\n\t(ix)\tthe name of the person or accredited organisation that submitted the proposal;\n\t(x)\tthe person or persons proposing to undertake the dealing; and\n\t(b)\tgive a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.\n13C—Information to be kept or given to the Regulator by persons or accredited organisations\n\t(1)\tA person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under regulation 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.\n\t(2)\tA record of a dealing for the purposes of subregulation (1) must include—\n\t(a)\tthe particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and\n\t(b)\tthe name of the Committee that assessed the proposal relating to the dealing; and\n\t(c)\tthe name of the person or accredited organisation that submitted the proposal to the Committee for assessment.\n\t(2a)\tThe record must be given to the Regulator—\n\t(a)\tin a form approved by the Regulator; and\n\t(b)\tno later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment.\n\t(2b)\tAn accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must—\n\t(a)\tinclude the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or\n\t(b)\tcertify in the annual report that the record has previously been given to the Regulator.\n\t(3)\tA person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under regulation 13B(b) must keep a copy of the Committee's record of assessment for 8 years after the date of the assessment.\n\t(4)\tThe Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with:\n\t(a)\tthe person or accredited organisation that submitted the proposal for assessment of the dealing;\n\t(b)\tany other person involved with undertaking the dealing. \n\t(5)\tA person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice.\nDivision 3—Certification and accreditation\n14—Regulator to decide certification application within 90 days\nNote—\nThe Commonwealth Regulations provide the period within which the Regulator must consider and decide an application for certification of a facility.\n15—Application for certification—failure to provide section 85 information\nIf an applicant for certification fails to provide information required under section 85(1) of the Act within the period specified in a notice given under section 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.\nNote—\nA refusal to certify a facility is a reviewable decision (see Division 2 of Part 12 of the Act).\n16—Regulator to decide accreditation application within 90 days\nNote—\nThe Commonwealth Regulations provide the period within which the Regulator must consider and decide an application for accreditation of an organisation.\n17—Application for accreditation—failure to provide section 93 information\nIf an applicant for accreditation fails to provide information required under section 93(1) of the Act within the period specified in a notice given under section 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.\nNote—\nA refusal to accredit an organisation is a reviewable decision (see Division 2 of Part 12 of the Act).\nPart 4—Gene Technology Technical Advisory Committee\nDivision 1—Conditions of appointment\n18—GTTAC members and advisers—term of appointment\nNote—\nRegulation 18 of the Commonwealth Regulations provides for the term of appointment of members of the Gene Technology Technical Advisory Committee and expert advisers to the GTTAC.\n19—GTTAC members and advisers—resignation\nNote—\nRegulation 19 of the Commonwealth Regulations provides for the resignation of members of the Gene Technology Technical Advisory Committee and expert advisers to the GTTAC.\n20—GTTAC members—disclosure of interests\nNote—\nRegulation 20 of the Commonwealth Regulations sets out when and how members of the Gene Technology Technical Advisory Committee must disclose any interests of a kind likely to be considered at a meeting of the GTTAC.\n21—GTTAC members and advisers—termination of appointment\nNote—\nRegulation 21 of the Commonwealth Regulations sets out the circumstances of terminating the appointment of members of the Gene Technology Technical Advisory Committee and expert advisers to the GTTAC.\n22—GTTAC members—leave of absence\nNote—\nRegulation 22 of the Commonwealth Regulations provides when the Chairperson and members of the Gene Technology Technical Advisory Committee may be granted leave.\n23—Expert advisers—disclosure of interests\nNote—\nRegulation 23 of the Commonwealth Regulations sets out when and how expert advisers to the Gene Technology Technical Advisory Committee must disclose any interests of a kind likely to be considered at a meeting of the GTTAC.\nDivision 2—Committee procedures\n24—Committee procedures generally\nNote—\nRegulation 24 of the Commonwealth Regulations provides that the Gene Technology Technical Advisory Committee must perform its functions as informally as the Commonwealth Regulations allow and how the GTTAC may obtain information.\n25—Committee meetings\nNote—\nRegulation 25 of the Commonwealth Regulations provides when the Gene Technology Technical Advisory Committee may have meetings and provides that in certain circumstances meetings may be by videoconference or teleconference.\n26—Presiding member\nNote—\nRegulation 26 of the Commonwealth Regulations provides that the Chairperson of the Gene Technology Technical Advisory Committee presides at its meetings and who presides in the Chairperson's absence.\n27—Quorum\nNote—\nRegulation 27 of the Commonwealth Regulations provides that half the members of the Gene Technology Technical Advisory Committee comprises the GTTAC's quorum.\n28—Voting\nNote—\nRegulation 28 of the Commonwealth Regulations provides that decisions of the Gene Technology Technical Advisory Committee must be made by a majority of members present and voting and that the Chairperson has a deliberative and casting vote.\n29—Records and Reports\nNote—\nRegulation 29 of the Commonwealth Regulations provides that records must be kept of the Gene Technology Technical Advisory Committee's proceedings and when reports must be prepared.\nDivision 3—Subcommittees\n30—Operation of subcommittees\nNote—\nRegulation 30 of the Commonwealth Regulations states that regulations 24, 25, 26 and 28 of those regulations apply to a subcommittee established under section 105(1) of the Commonwealth Act.\nPart 5—Ethics and Community Committee\n31—Ethics and Community Committee—conditions of appointment\nNote—\nRegulation 31 of the Commonwealth Regulations provides that Division 1 of Part 4 of the Commonwealth Regulations applies to the conditions of appointment of members of the Ethics and Community Committee.\n32—Ethics and Community Committee—Committee procedures\nNote—\nRegulation 32 of the Commonwealth Regulations provides that Division 2 of Part 4 of the Commonwealth Regulations applies to the procedures of members of the Ethics and Community Committee.\n33—Ethics and Community Committee—operation of subcommittees\nNote—\nRegulation 33 of the Commonwealth Regulations provides that regulations 24, 25, 26 and 28 of the Commonwealth Regulations apply to a subcommittee established under subsection 111(1) of the Commonwealth Act.\nPart 7—Miscellaneous\n37—Reviewable State decisions\nNote—\nThe scheme for reviewable State decisions under the Commonwealth Act does not apply under the South Australian legislation.\n38—Review of decisions\nNote—\nRegulation 38 of the Commonwealth Regulations provides that a person whose interests are affected by a decision in relation to the termination of the appointment of a member to a committee under those regulations may apply to the Administrative Appeals Tribunal for review of the decision.\n39—Record of GMO Dealings\nFor the purposes of section 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:\n\t(a)\tthe person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing;\n\t(b)\tthe kind of notifiable low risk dealing, in terms of Part 1 or 2 of Schedule 3;\n\t(c)\tthe identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment;\n\t(d)\tthe date of assessment by the Institutional Biosafety Committee that the dealing is a notifiable low risk dealing.\n40—Inspector identity card\nFor the purposes of section 151(2)(a) of the Act, an inspector's identity card must—\n\t(a)\tdisplay a recent photograph of the inspector's face; and\n\t(b)\tstate the date of issue; and\n\t(c)\tstate the period of its validity.\nPart 8—Application and transitional provisions\nDivision 1—Amendments made by the Gene Technology Variation Regulations 2019\n41—Changed requirements for dealings\n\t\tFormer exempt dealings\n\t(1)\tIf—\n\t(a)\ta person was undertaking a dealing before the amending day; and\n\t(b)\tthe dealing was an exempt dealing under the old regulations; and\n\t(c)\tthe dealing is not (apart from this provision) an exempt dealing under the new regulations,\nthen, despite the amendments, the dealing is an exempt dealing when undertaken by the person.\n\t(2)\tSubregulation (1) applies until—\n\t(a)\tthe dealing is assessed, under the new regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or\n\t(b)\tthe person is issued a GMO licence for the dealing; or\n\t(c)\t1 year after the amending day if neither of the events in paragraphs (a) and (b) occurs before then.\n\t\tFormer notifiable low risk dealings\n\t(3)\tIf—\n\t(a)\ta person was undertaking a dealing before the amending day; and\n\t(b)\tthe dealing was a notifiable low risk dealing under the old regulations; and\n\t(c)\tthe dealing—\n\t(i)\tis not (apart from this provision) a notifiable low risk dealing under the new regulations; and\n\t(ii)\tis not an exempt dealing,\nthen, despite the amendments, the dealing is a notifiable low risk dealing when undertaken by the person.\n\t(4)\tSubregulation (3) applies until—\n\t(a)\tthe person is issued a GMO licence for the dealing; or\n\t(b)\t1 year after the amending day if the person is not issued a GMO licence before then.\n\t\tChanged requirements for notifiable low risk dealings\n\t(5)\tIf a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if—\n\t(a)\tit is undertaken in accordance with the old regulations; or\n\t(b)\tit is undertaken in accordance with the new regulations.\n\t(6)\tSubregulation (5) ceases to be in force 1 year after the amending day.\n\t\tDefinitions\n\t(7)\tIn this regulation—\namending day means the day that Part 2 of the amending regulations commences;\namending regulations means the Gene Technology Variation Regulations 2019;\nnew regulations means these regulations as amended by the amending regulations;\nold regulations means these regulations as in force immediately before the amending day.\n42—Previous assessment by an Institutional Biosafety Committee\n\t(1)\tThis regulation applies if—\n\t(a)\tbefore 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and\n\t(b)\tthe record of the Committee's assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3.\n\t(2)\tThe Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3.\n43—New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year\nRegulation 13C as amended by the Gene Technology Variation Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.\nSchedule 1A—Techniques that are not gene technology\n(regulation 4)\n\nItem\nDescription of technique\n1\nEither of the following transfers, if the transfer does not involve genetically modified material:\n\t(a)\tnuclear transfer;\n\t(b)\ttransfer of plastids or mitochondria.\n2\nElectromagnetic radiation-induced mutagenesis.\n3\nParticle radiation-induced mutagenesis.\n4\nChemical-induced mutagenesis.\n5\nFusion of animal cells, or human cells, if the fused cells are unable to form a viable whole animal or human.\n6\nProtoplast fusion, including fusion of plant protoplasts.\n7\nEmbryo rescue.\n8\nIn vitro fertilisation.\n9\nZygote implantation.\n10\nA natural process, if the process does not involve genetically modified material.\nExamples—\nExamples of natural processes include conjugation, transduction, transformation and transposon mutagenesis.\n11\nIntroduction of nucleic acid or nucleic acid analogue into an organism, if—\n\t(a)\tthe introduction of the nucleic acid or nucleic acid analogue does not result in an alteration of the organism's genome sequence; and\n\t(b)\tthe introduction of the nucleic acid or nucleic acid analogue cannot give rise to an infectious agent; and\n\t(c)\tin the case of nucleic acid or nucleic acid analogue that is DNA—the DNA cannot be transcribed.\nSchedule 1B—Organisms that are genetically modified organisms\nNote—\nSee regulation 4A.\n1.1—Genetically modified organisms\nFor the purposes of regulation 4A, an organism is a genetically modified organism if an item in the following table applies to the organism.\n\nItem\nDescription of organism\n1\nAn organism that has had its genome modified by oligonucleotide‑directed mutagenesis.\n2\nAn organism modified by repair of single‑strand or double‑strand breaks of genomic DNA induced by a site‑directed nuclease, if a nucleic acid template was added to guide homology‑directed repair.\nSchedule 1—Organisms that are not genetically modified organisms\n(regulation 5)\n\nItem\nDescription of organism\n2\nA whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents.\n3\nNaked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell.\n4\nAn organism modified by repair of single‑strand or double‑strand breaks of genomic DNA induced by a site‑directed nuclease, if a nucleic acid template was not added to guide homology‑directed repair.\n6\nA micro‑organism that results from an exchange of DNA if—\n\n\t(a)\tthe donor species is also the host species; and\n\n\t(b)\tthe exchanged DNA does not contain any heterologous DNA.\n7\nAn organism that results from an exchange of DNA between the donor species and the host species if—\n\n\t(a)\tsuch exchange can occur by naturally occurring processes; and\n\n\t(b)\tthe donor species and the host species are micro-organisms that—\n\n\t(i)\tsatisfy the criteria in AS/NZS 2243.3:2010, for classification as Risk Group 1; and\n\n\t(ii)\tare known to exchange nucleic acid by a natural physiological process; and\n\n\t(c)\tthe vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange.\n8\nAn organism that is descended from a genetically modified organism (the initial organism), if none of the traits it has inherited from the initial organism are traits that occurred in the initial organism because of gene technology.\n9\nAn organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, if—\n\n\t(a)\tthe initial organism was not a genetically modified organism (because of the application of regulation 5); or\n\n\t(b)\tall such inherited traits are traits that occurred in the initial organism as a result of a modification described in an item in this Schedule.\n10\nAn organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are either no longer present or are epigenetic.\n11\nAgrobacterium radiobacter strain K1026.\n12\nPasteurella multocida strain PMP1.\nSchedule 2—Dealings exempt from licensing\n(regulation 6)\nNote—\nRegulation 6(1) sets out other requirements for exempt dealings.\nPart 1—Exempt dealings\n\nItem\n\nDescription of dealing\n2\n\nA dealing with a genetically modified Caenorhabditis elegans, unless—\n\n\n\t(a)\tan advantage is conferred on the animal by the genetic modification; or\n\n\n\t(b)\tas a result of the genetic modification, the animal is capable of secreting or producing an infectious agent.\n3\n\nA dealing with an animal into which genetically modified somatic cells have been introduced, if—\n\n\n\t(a)\tthe somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and\n\n\n\t(b)\tthe animal is not infected with a virus that is capable of recombining with the genetically modified nucleic acid in the somatic cells.\n3A\n\nA dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if—\n\n\n\t(a)\tthe in vivo modification occurred as part of a previous dealing; and\n\n\n\t(b)\tthe replication defective viral vector is no longer in the animal; and\n\n\n\t(c)\tno germ line cells have been genetically modified; and\n\n\n\t(d)\tthe somatic cells cannot give rise to infectious agents as a result of the genetic modification; and\n\n\n\t(e)\tthe animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal.\n4\n(1)\nSubject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture.\n\n(2)\nThe donor nucleic acid—\n\n\n\t(a)\tmust meet either of the following requirements:\n\n\n\t(i)\tit must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy—\n\t(A)\thuman beings; or\n\t(B)\tanimals; or\n\t(C)\tplants; or\n\t(D)\tfungi;\n\n\n\t(ii)\tit must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm; and\nExample—\nDonor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in relation to the capacity of the host or vector to cause harm, it—\n\t(a)\tprovides an advantage; or\n\t(b)\tadds a potential host species or mode of transmission; or\n\t(c)\tincreases its virulence, pathogenicity or transmissibility.\n\n\n\t(b)\tmust not code for a toxin with an LD50 of less than 100 micrograms per kilogram; and\n\n\n\t(c)\tmust not code for a toxin with an LD50 of 100 micrograms per kilogram or more, if the intention is to express the toxin at high levels; and\n\n\n\t(d)\tmust not be uncharacterised nucleic acid from a toxin‑producing organism; and\n\n\n\t(e)\tif the donor nucleic acid includes a viral sequence—cannot give rise to infectious agents when introduced into any potential host species, without additional non-host genes or gene products that—\n\n\n\t(i)\tare not available in the host cell into which the nucleic acid is introduced as part of the dealing; and\n\n\n\t(ii)\twill not become available during the dealing; and\n\n\n\t(f)\tif the donor nucleic acid includes a viral sequence—cannot restore replication competence to the vector.\n5\n\nA dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of this Schedule, if the donor nucleic acid is not derived from either—\n\n\n\t(a)\ta pathogen; or\n\n\n\t(b)\ta toxin-producing organism.\nPart 2—Host/vector systems for exempt dealings\n2.1—Hosts and vectors\n\t(1)\tA reference to a host mentioned in this Part is a reference to a host mentioned in column 2 of an item of the table in this clause.\n\t(2)\tA reference to a vector mentioned in this Part is a reference to a vector mentioned in column 3 of an item of the table in this clause.\n\t(3)\tA reference to a host/vector system mentioned in this Part is a reference to any of the following:\n\t(a)\ta system involving a host mentioned in column 2 of an item of the table in this clause and a vector mentioned in column 3 of the same item;\n\t(b)\ta non‑vector system involving a host mentioned in column 2 of an item of the table;\n\t(c)\ta system involving a GMO mentioned as a vector in column 3 of an item of the table (except item 7), without a host.\nNote—\nColumn 1 of the table is included for information only.\n\nItem\nColumn 1\nHost class\nColumn 2\nHosts\nColumn 3\nVectors\n1\nBacteria\nEscherichia coli K12, E. coli B, E. coli C or E. coli Nissle 1917—any derivative that does not contain—\nAny of the following:\n\n\n\t(a)\tgeneralised transducing phages; or\n\t(a)\tnon-conjugative plasmids;\n\n\n\t(b)\tgenes able to complement the conjugation defect in a non‑conjugative plasmid.\n\t(b)\tlambda bacteriophage;\n\n\n\n\t(c)\tlambdoid bacteriophage;\n\n\n\n\t(d)\tFd, F1 or M13 bacteriophage.\n2\nBacteria\nBacillus—asporogenic strains of the following species with a reversion frequency of less than 10—7:\nAny of the following:\n\n\n\t(a)\tB. amyloliquefaciens;\n\t(a)\tnon-conjugative plasmids;\n\n\n\t(b)\tB. licheniformis;\n\t(b)\tother plasmids and phages whose host range does not include B. cereus, B. anthracis or any other pathogenic strain of Bacillus.\n\n\n\t(c)\tB. pumilus;\n\n\n\n\t(d)\tB. subtilis;\n\n\n\n\t(e)\tB. thuringiensis.\n\n3\nBacteria\nPseudomonas putida strain KT 2440.\nNon‑conjugative plasmids.\n4\nBacteria\nThe following Streptomyces species:\nAny of the following:\n\n\n\t(a)\tS. aureofaciens;\n\t(a)\tnon-conjugative plasmids;\n\n\n\t(b)\tS. coelicolor;\n\t(b)\tplasmids SCP2, SLP1, SLP2, pIJ101 and derivatives;\n\n\n\t(c)\tS. cyaneus;\n\t(c)\tactinophage phi C31 and derivatives.\n\n\n\t(d)\tS. griseus;\n\n\n\n\t(e)\tS. lividans;\n\n\n\n\t(f)\tS. parvulus;\n\n\n\n\t(g)\tS. rimosus;\n\n\n\n\t(h)\tS. venezuelae.\n\n5\nBacteria\nAny of the following:\nDisarmed Ri or Ti plasmids.\n\n\n\t(a)\tAgrobacterium radiobacter;\n\n\n\n\t(b)\tAgrobacterium rhizogenes (disarmed strains only);\n\n\n\n\t(c)\tAgrobacterium tumefaciens (disarmed strains only).\n\n6\nBacteria\nAny of the following:\nNon‑conjugative plasmids.\n\n\n\t(a)\tAllorhizobium species;\n\n\n\n\t(b)\tCorynebacterium glutamicum;\n\n\n\n\t(c)\tLactobacillus species;\n\n\n\n\t(d)\tLactococcus lactis;\n\n\n\n\t(e)\tOenococcus oeni syn. Leuconostoc oeni;\n\n\n\n\t(f)\tPediococcus species;\n\n\n\n\t(g)\tPhotobacterium angustum;\n\n\n\n\t(h)\tPseudoalteromonas tunicata;\n\n\n\n\t(i)\tRhizobium species;\n\n\n\n\t(j)\tSphingopyxis alaskensis syn. Sphingomonas alaskensis;\n\n\n\n\t(k)\tStreptococcus thermophilus;\n\n\n\n\t(l)\tSynechococcus species strains PCC 7002, PCC 7942 and WH 8102;\n\n\n\n\t(m)\tSynechocystis species strain PCC 6803;\n\n\n\n\t(n)\tVibrio cholerae CVD103-HgR;\n\n\n\n\t(o)\tZymomonas mobilis.\n\n7\nFungi\nAny of the following:\nAll vectors.\n\n\n\t(a)\tKluyveromyces lactis;\n\n\n\n\t(b)\tNeurospora crassa (laboratory strains);\n\n\n\n\t(c)\tPichia pastoris;\n\n\n\n\t(d)\tSaccharomyces cerevisiae;\n\n\n\n\t(e)\tSchizosaccharomyces pombe;\n\n\n\n\t(f)\tTrichoderma reesei;\n\n\n\n\t(g)\tYarrowia lipolytica.\n\n8\nSlime moulds\nDictyostelium species.\nDictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2.\n9\nTissue culture\nAny of the following if they cannot spontaneously generate a whole animal:\nAny of the following:\n\n\n\t(a)\tanimal or human cell cultures (including packaging cell lines);\n\t(a)\tplasmids;\n\n\n\t(b)\tisolated cells, isolated tissues or isolated organs, whether animal or human;\n\t(b)\treplication defective viral vectors unable to transduce human cells;\n\n\n\t(c)\tearly non‑human mammalian embryos cultured in vitro.\n\t(c)\tpolyhedrin minus forms of the baculovirus Autographa californica nuclear polyhedrosis virus (ACNPV).\n10\nTissue culture\nEither of the following if they are not intended, and are not likely without human intervention, to vegetatively propagate, flower or regenerate into a whole plant:\nAny of the following:\n\n\n\t(a)\tplant cell cultures;\n\t(a)\tDisarmed Ri or Ti plasmids in Agrobacterium radiobacter, Agrobacterium rhizogenes (disarmed strains only) or Agrobacterium tumefaciens (disarmed strains only);\n\n\n\t(b)\tisolated plant tissues or organs.\n\t(b)\tnon‑pathogenic viral vectors.\nPart 3—Definitions\nIn this Schedule—\ncode for, in relation to a toxin, means to specify the amino acid sequence of the toxin;\nnon-conjugative plasmid means a plasmid that is not self-transmissible, and includes, but is not limited to, non-conjugative forms of the following plasmids:\n\t(a)\tbacterial artificial chromosomes (BACs);\n\t(b)\tcosmids;\n\t(c)\tP1 artificial chromosomes (PACs);\n\t(d)\tyeast artificial chromosomes (YACs);\nnon‑vector system means a system in which donor nucleic acid is or was introduced into a host cell—\n\t(a)\tin the absence of a nucleic acid‑based vector; or\n\t(b)\tusing a nucleic acid‑based vector in the course of a previous dealing and the vector is—\n\t(i)\tno longer present; or\n\t(ii)\tpresent but cannot be remobilised from a host cell.\nExample 1—\nA system mentioned in paragraph (a) might involve the use of electroporation or particle bombardment.\nExample 2—\nA system mentioned in paragraph (b) might involve cells that were transduced with a replication defective retroviral vector in which no vector particles remain.\nSchedule 3—Notifiable low risk dealings in relation to a GMO\n(Regulations 12 and 13)\nPart 1—Notifiable low risk dealings suitable for at least physical containment level 1\nNote—\nBecause of regulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3 of this Schedule.\n1.1—Kinds of dealings suitable for at least physical containment level 1\nThe following kinds of notifiable low risk dealings must be undertaken, unless regulation 13(2)(c) or 13(3) applies, in facilities certified to at least physical containment level 1 and that are appropriate for the dealings:\n\t(a)\ta dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit or a genetically modified laboratory rat, unless—\n\t(i)\tan advantage is conferred on the animal by the genetic modification; or\n\t(ii)\tthe animal is capable of secreting or producing an infectious agent as a result of the genetic modification;\n\t(c)\ta dealing involving virions of a replication defective vector derived from Human adenovirus or from Adeno-associated virus, either without a host or with a host mentioned in item 9 of Part 2 of Schedule 2, if the donor nucleic acid—\n\t(i)\tcannot restore replication competence to the vector; and\n\t(ii)\tdoes not confer an oncogenic modification or immunomodulatory effect in humans.\nPart 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3\nNote—\nBecause of regulation 12(1), a dealing mentioned in this Part is not a notifiable low risk dealing if it is also a dealing of a kind mentioned in Part 3 of this Schedule.\n2.1—Kinds of dealings suitable for at least physical containment level 2\nThe following kinds of notifiable low risk dealings must be undertaken, unless regulation 13(2)(c) or 13(3) applies, in facilities certified to at least physical containment level 2 and that are appropriate for the dealings:\n\t(a)\ta dealing involving whole animals (including non‑vertebrates) that—\n\t(i)\tinvolves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and\n\t(ii)\tdoes not involve any of the following:\n\t(A)\ta genetically modified laboratory guinea pig;\n\t(B)\ta genetically modified laboratory mouse;\n\t(C)\ta genetically modified laboratory rabbit;\n\t(D)\ta genetically modified laboratory rat;\n\t(E)\ta genetically modified Caenorhabditis elegans;\n\t(aa)\ta dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat or a genetically modified Caenorhabditis elegans, if—\n\t(i)\tthe genetic modification confers an advantage on the animal; and\n\t(ii)\tthe animal is not capable of secreting or producing an infectious agent as a result of the genetic modification;\n\t(b)\ta dealing involving a genetically modified plant;\n\t(c)\ta dealing involving a host/vector system not mentioned in clause 1.1(c) of Part 1 of this Schedule or Part 2 of Schedule 2, if neither host nor vector has been implicated in, or has a history of causing, disease in otherwise healthy—\n\t(i)\thuman beings; or\n\t(ii)\tanimals; or\n\t(iii)\tplants; or\n\t(iv)\tfungi;\n\t(d)\ta dealing involving a host/vector system not mentioned in Part 2 of Schedule 2, if—\n\t(i)\tthe host or vector has been implicated in, or has a history of causing, disease in otherwise healthy—\n\t(A)\thuman beings; or\n\t(B)\tanimals; or\n\t(C)\tplants; or\n\t(D)\tfungi; and\n\t(ii)\tthe genetic modification is characterised; and\n\t(iii)\tthe characterisation of the genetic modification shows that it is unlikely to increase the capacity of the host or vector to cause harm;\nExample—\nA genetic modification would not comply with subparagraph (iii) if, in relation to the capacity of the host or vector to cause harm, it—\n\t(a)\tprovides an advantage; or\n\t(b)\tadds a potential host species or mode of transmission; or\n\t(c)\tincreases its virulence, pathogenicity or transmissibility. \n\t(e)\ta dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid—\n\t(i)\tis characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; or\n\t(ii)\tis uncharacterised nucleic acid from an organism that has been implicated in, or has a history of causing, disease in otherwise healthy—\n\t(A)\thuman beings; or\n\t(B)\tanimals; or\n\t(C)\tplants; or\n\t(D)\tfungi;\n\t(f)\ta dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and producing more than 25 litres of GMO culture in each vessel containing the resultant culture, if—\n\t(i)\tthe dealing is undertaken in a facility that is certified by the Regulator as a large scale facility; and\n\t(ii)\tthe donor nucleic acid satisfies the conditions set out in item 4(2) of Part 1 of Schedule 2;\n\t(g)\ta dealing involving complementation of knocked‑out genes, if the complementation is unlikely to increase the capacity of the GMO to cause harm compared to the capacity of the parent organism before the genes were knocked out;\nExample—\nA dealing would not comply with paragraph (g) if it involved complementation that, in relation to the parent organism—\n\t(a)\tprovides an advantage; or\n\t(b)\tadds a potential host species or mode of transmission; or\n\t(c)\tincreases its virulence, pathogenicity or transmissibility.\n\t(h)\ta dealing involving shot‑gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of Schedule 2, if the donor nucleic acid is derived from either—\n\t(i)\ta pathogen; or\n\t(ii)\ta toxin‑producing organism;\n\t(i)\ta dealing involving virions of a replication defective viral vector unable to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector;\n\t(j)\ta dealing involving virions of a replication defective non-retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if—\n\t(i)\tthe donor nucleic acid cannot restore replication competence to the vector; and\n\t(ii)\tthe dealing is not a dealing mentioned in paragraph 1.1(c);\n\t(k)\ta dealing involving virions of a replication defective non‑retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if—\n\t(i)\tthe donor nucleic acid cannot restore replication competence to the vector; and\n\t(ii)\tthe donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans;\n\t(l)\ta dealing involving virions of a replication defective retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if—\n\t(i)\tall viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and\n\t(ii)\tviral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and\n\t(iii)\teither—\n\t(A)\tthe retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or\n\t(B)\tthe packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these;\n\t(m)\ta dealing involving virions of a replication defective retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if—\n\t(i)\tthe donor nucleic acids does not confer an oncogenic modification or immunomodulatory effect in humans; and\n\t(ii)\tall viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and\n\t(iii)\tviral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and\n\t(iv)\teither—\n\t(A)\tthe retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or\n\t(B)\tthe packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these.\n2.2—Kinds of dealing suitable for at least physical containment level 3\n\t(1)\tA kind of dealing that—\n\t(a)\tis a kind mentioned in clause 2.1; and\n\t(b)\tinvolves a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3,\nmust be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 3 and that are appropriate for the dealings.\n\t(2)\tFor the purposes of paragraph (1)(b), a genetically modified micro‑organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro‑organism satisfies those criteria.\n\t(3)\tHowever, subclause (2) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).\nPart 3—Dealings that are not notifiable low risk dealings\nNote 1—\nThe following list qualifies the list in Part 1 and Part 2, and is not an exhaustive list of dealings that are not notifiable low risk dealings.\nNote 2—\nIf a dealing is not a notifiable low risk dealing, or an exempt dealing, as provided by these Regulations, a person undertaking the dealing must be authorised by a GMO licence unless the dealing is within one of the other exceptions to licensing provided by the Act: see section 32 of the Act. \n3.1—Kinds of dealings\n\t(1)\tA dealing of any of the following kinds, or involving a dealing of the following kinds, is not a notifiable low risk dealing:\n\t(a)\ta dealing (other than a dealing mentioned in clause 2.1(h) of Part 2 of this Schedule) involving cloning of nucleic acid encoding a toxin having an LD50 of less than 100 micrograms per kilogram;\n\t(b)\ta dealing involving high level expression of toxin genes, even if the LD50 is 100 micrograms per kilogram or more;\n\t(c)\ta dealing (other than a dealing mentioned in clause 2.1(h) of Part 2 of this Schedule) involving cloning of uncharacterised nucleic acid from a toxin‑producing organism;\n\t(d)\ta dealing involving virions of a replication defective viral vector and a host not mentioned in Part 2 of Schedule 2, if—\n\t(i)\tthe donor nucleic acid confers an oncogenic modification or immunomodulatory effect in humans; and\n\t(ii)\tthe dealing is not a dealing mentioned in paragraph 2.1(i);\n\t(e)\ta dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the genetic modification confers an oncogenic modification or immunomodulatory effect in humans;\n\t(f)\ta dealing involving, as host or vector, a micro‑organism, if—\n\t(i)\tthe micro‑organism has been implicated in, or has a history of causing, disease in otherwise healthy—\n\t(A)\thumans; or\n\t(B)\tanimals; or\n\t(C)\tplants; or\n\t(D)\tfungi; and\n\t(ii)\tnone of the following subsubparagraphs apply:\n\t(A)\tthe host/vector system is a system mentioned in Part 2 of Schedule 2;\n\t(B)\tthe genetic modification is characterised and its characterisation shows that it is unlikely to increase the capacity of the host or vector to cause harm;\n\t(C)\tthe dealing is a dealing mentioned in clause 2.1(g) of Part 2 of this Schedule;\nExample—\nA genetic modification would not comply with subsubparagraph (B) if, in relation to the capacity of the host or vector to cause harm, it—\n\t(a)\tprovides an advantage; or\n\t(b)\tadds a potential host species or mode of transmission; or\n\t(c)\tincreases its virulence, pathogenicity or transmissibility.\n\t(g)\ta dealing involving the introduction, into a micro‑organism, of nucleic acid encoding a pathogenic determinant, unless—\n\t(i)\tthe dealing is a dealing mentioned in clause 2.1(g) of Part 2 of this Schedule; or\n\t(ii)\tthe micro‑organism is a host mentioned in Part 2 of Schedule 2;\n\t(h)\ta dealing involving the introduction into a micro‑organism (other than a host mentioned in Part 2 of Schedule 2) of genes whose expressed products are likely to increase the capacity of the micro‑organisms to induce an autoimmune response;\n\t(i)\ta dealing involving use of a viral or viroid genome, or fragments of a viral or viroid genome, to produce a novel replication competent virus with an increased capacity to cause harm compared to the capacity of the parent or donor organism;\nExample—\nA dealing would comply with paragraph (i) if it produces a novel replication competent virus that has a higher capacity to cause harm to any potential host species than the parent organism because the new virus has—\n\t(a)\tan advantage; or\n\t(b)\ta new potential host species or mode of transmissibility; or\n\t(c)\tincreased virulence, pathogenicity or transmissibility. \n\t(j)\ta dealing, other than a dealing mentioned in clause 2.1(l) or (m) of Part 2 of this Schedule, with a replication defective retroviral vector (including a lentiviral vector) able to transduce human cells;\n\t(k)\ta dealing involving a genetically modified animal, plant or fungus that is capable of secreting or producing infectious agents as a result of the genetic modification;\n\t(l)\ta dealing producing, in each vessel containing the resultant GMO culture, more than 25 litres of that culture, other than a dealing mentioned in clause 2.1(f) of Part 2 of this Schedule;\n\t(m)\ta dealing that is inconsistent with a policy principle issued by the Ministerial Council;\n\t(n)\ta dealing involving the intentional introduction of a GMO into a human being, unless the GMO—\n\t(i)\tis a human somatic cell; and\n\t(ii)\tcannot secrete or produce infectious agents as a result of the genetic modification; and\n\t(iii)\tif it was generated using viral vectors—\n\t(A)\thas been tested for the presence of viruses likely to recombine with the genetically modified nucleic acid in the somatic cells; and\n\t(B)\tthe testing did not detect a virus mentioned in subsubparagraph (A); and\n\t(C)\tthe viral vector used to generate the GMO as part of a previous dealing is no longer present in the somatic cells;\n\t(o)\ta dealing involving a genetically modified pathogenic organism, if the practical treatment of any disease or abnormality caused by the organism would be impaired by the genetic modification;\n\t(p)\ta dealing involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4;\n\t(q)\ta dealing involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 and that is not undertaken—\n\t(i)\tin a facility that is certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or\n\t(ii)\tin a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken;\n\t(r)\ta dealing involving a GMO capable of sexual reproduction, the sexual progeny of which are, as a result of the genetic modification, more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism);\n\t(s)\ta dealing involving a viral vector that can modify an organism capable of sexual reproduction, so that the sexual progeny of the organism are more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism).\nNote—\nA modification that increases the likelihood of inheritance of a nucleotide sequence or sequences, as described in paragraphs (r) and (s), is generally known as an engineered gene drive.\n\t(2)\tFor the purposes of paragraph (1)(p), a genetically modified micro-organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4 if the unmodified parent micro-organism satisfies those criteria.\n\t(3)\tFor the purposes of paragraph (1)(q), a genetically modified micro-organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro-organism satisfies those criteria.\n\t(4)\tHowever, subclause (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m).\nLegislative history\nNotes\n\t•\tPlease note—References in the legislation to other legislation or instruments or to titles of bodies or offices are not automatically updated as part of the program for the revision and publication of legislation and therefore may be obsolete.\n\t•\tEarlier versions of these regulations (historical versions) are listed at the end of the legislative history.\n\t•\tFor further information relating to the Act and subordinate legislation made under the Act see the Index of South Australian Statutes or www.legislation.sa.gov.au.\nLegislation revoked by principal regulations\nThe Gene Technology Regulations 2017 revoked the following:\nGene Technology Regulations 2002\nPrincipal regulations and variations\nNew entries appear in bold.\nYear\nNo\nReference\nCommencement\n2017\n196\nGazette 4.7.2017 p2763 \n1.8.2017: r 2\n2019\n216\nGazette 3.10.2019 p3399\n8.10.2019 except Pt 3—1.7.2020 and except Pt 4—8.10.2020: r 2\n2025\n81\nGazette 7.8.2025 p3013\n7.8.2025: r 2\nProvisions varied\nNew entries appear in bold.\nEntries that relate to provisions that have been deleted appear in italics.\nProvision\nHow varied\nCommencement\nPt  1\n\n\nr 2\nomitted under Legislation Revision and Publication Act 2002\n8.10.2019\nr 3\n\n\ncharacterised\nsubstituted by 216/2019 r 4(1)\n8.10.2019\nhost/vector system\ninserted by 216/2019 r 4(2)\n8.10.2019\nnon‑vector system\nsubstituted by 216/2019 r 4(3)\n8.10.2019\ntoxin‑producing organism\nvaried by 216/2019 r 4(4)\n8.10.2019\nnote\nvaried by 216/2019 r 4(5)\n8.10.2019\nr 3B\ndeleted by 216/2019 r 5\n8.10.2019\nPt 2\n\n\nr 4\nvaried by 216/2019 r 6\n8.10.2019\nr 4A\ninserted by 216/2019 r 7\n8.10.2019\nr 5\nsubstituted by 216/2019 r 8\n8.10.2019\nPt 3\n\n\nr 9\nvaried by 216/2019 r 9\n8.10.2019\nr 9(1)\nr 9 amended and redesignated as r 9(1) by 81/2025 r 3(1), (2)\n7.8.2025\nr 9(2)\ninserted by 81/2025 r 3(2)\n7.8.2025\nr 11A\n\n\nr 11A(2)\nvaried by 216/2019 r 10\n8.10.2019\nr 12\n\n\nr 12(1)\nvaried by 216/2019 r 11\n8.10.2019\nr 13\n\n\nr 13(1)\nvaried by 216/2019 r 12(1)—(4)\n8.10.2019\n\n(i) deleted by 216/2019 r 12(5)\n8.10.2019\n\nnote deleted by 216/2019 r 12(6)\n8.10.2019\n\nvaried by 216/2019 r 20\n1.7.2020\nr 13(2)\nvaried by 216/2019 r 12(7)\n8.10.2019\nr 13(3)\nsubstituted by 216/2019 r 12(8)\n8.10.2019\nr 13A\ndeleted by 216/2019 r 13\n8.10.2019\nr 13B\nvaried by 216/2019 r 21(1)—(4)\n1.7.2020\nr 13C\n\n\nr 13C(1) and (2)\nsubstituted by 216/2019 r 22(1)\n1.7.2020\nr 13C(2a) and (2b)\ninserted by 216/2019 r 22(1)\n1.7.2020\nr 13C(3)\nvaried by 216/2019 r 22(2)\n1.7.2020\nPt 7\n\n\nr 39\nsubstituted by 216/2019 r 23\n1.7.2020\nPt 8\ninserted by 216/2019 r 14\n8.10.2019\nrr 42 and 43\ninserted by 216/2019 r 24\n1.7.2020\nSch 1A\nvaried by 216/2019 r 15\n8.10.2019\n\namended by 81/2025 r 4(1), (2)\n7.8.2025\nSch 1B\ninserted by 216/2019 r 16\n8.10.2019\nSch 1\nvaried by 216/2019 r 17\n8.10.2019\n\nvaried by 216/2019 r 25\n8.10.2020\n\namended by 81/2025 r 5(1)—(3)\n7.8.2025\nSch 2\n\n\nPts 1 and 2\nsubstituted by 216/2019 r 18\n8.10.2019\nSch 3\n\n\nPt 1\n\n\ncl 1.1\nvaried by 216/2019 r 19(1), (2)\n8.10.2019\nPt 2\n\n\ncl 2.1\nvaried by 216/2019 r 19(3)—(21)\n8.10.2019\ncl 2.2\nsubstituted by 216/2019 r 19(22)\n8.10.2019\nPt 3\n\n\nheading\n\n\nnote 2\nsubstituted by 216/2019 r 19(23)\n8.10.2019\ncl 3.1\n\n\ncl 3.1(1)\ncl 3.1 varied and redesignated as cl 3.1(1) by 216/2019 r 19(24)—(30)\n8.10.2019\ncl 3.1(2)—(4)\ninserted by 216/2019 r 19(30)\n8.10.2019\nSch 4\nomitted under Legislation Revision and Publication Act 2002\n8.10.2019\nHistorical versions\n8.10.2019\n\n1.7.2020\n\n8.10.2020\n\n","sortOrder":0}],"analysis":{"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":8,"scope_assessment":{"changed":true,"description":"The legislation has grown significantly beyond simple licensing rules. Originally likely focused on basic exempt/licensed distinctions, it now includes: detailed categorisation of modern gene editing techniques (CRISPR/Cas9 addressed in Schedule 1B); explicit regulation of gene drive technology (Schedule 3, Part 3, paragraphs 3.1(1)(r) and (s)); complex transitional arrangements for regulatory changes (Part 8); and extensive record-keeping and reporting requirements for notifiable low risk dealings (regulations 13B and 13C). The 2019 amendments substantially expanded the scope to capture newer biotechnologies and strengthen oversight of previously exempt activities."},"complexity_factors":["Extensive cross-referencing between South Australian and Commonwealth regulations (mirror numbering system in regulation 3A)","Multiple nested conditional exceptions (e.g., regulation 5 has 4 cumulative conditions for organisms not being GMOs; Schedule 2 item 4 has 6 sub-conditions for donor nucleic acid)","47+ defined terms in regulation 3 alone, plus terms imported from the Act","Complex scheduling structure with 3 main schedules containing multiple parts, clauses, and subclauses (Schedule 2 has 3 parts; Schedule 3 has 3 parts with 19 separate dealing categories)","Technical scientific definitions requiring specialist knowledge (e.g., 'non-conjugative plasmid', 'replication defective viral vector', 'homology-directed repair')","Multiple overlapping exemptions and inclusions (Schedule 1A excludes techniques; Schedule 1B includes certain organisms as GMOs; Schedule 1 excludes certain organisms)","Conditional time limits with extensive exclusion periods (regulation 8 has 5 categories of non-countable days)","Transitional provisions with multiple cascading conditions (regulation 41 has 6 subsections with complex grandfathering arrangements)"],"plain_english_summary":"**What this legislation does:**\n\nThese regulations set the detailed rules for how genetically modified organisms (GMOs) are handled in South Australia under the *Gene Technology Act 2001*. They classify different types of genetic work into three main categories based on risk:\n\n- **Exempt dealings** – Low-risk work that doesn't need a licence (like working with certain harmless bacteria or standard lab animals under specific conditions)\n- **Notifiable low risk dealings** – Medium-risk work that doesn't need a licence but must be assessed by an Institutional Biosafety Committee and reported to the Regulator\n- **Licensed dealings** – Higher-risk work that requires a formal licence from the Gene Technology Regulator\n\n**Who it affects:**\n\n- **Scientists and researchers** working with GMOs in universities, hospitals, and private labs\n- **Biotech companies** developing genetically modified products\n- **Institutional Biosafety Committees** – internal committees that assess research proposals\n- **The Gene Technology Regulator** – the federal official who oversees the system\n- **Facility operators** who need certification to handle GMOs at different containment levels (PC1, PC2, PC3)\n\n**Key practical requirements:**\n\n- **Containment levels**: Work must happen in certified facilities matching the risk level (Level 1 for low risk, up to Level 3 for riskier organisms)\n- **Record keeping**: Detailed records must be kept for 8 years and submitted annually to the Regulator\n- **Time limits**: The Regulator must decide on licence applications within specific timeframes (90–255 days depending on risk level)\n- **Prohibited activities**: The regulations ban certain high-risk activities outright, including gene drives (techniques that force genetic traits through populations) and work with the most dangerous pathogens (Risk Group 4)\n\n**Why it matters:**\n\nThese regulations balance scientific innovation with safety. They allow routine genetic research to proceed with minimal bureaucracy while ensuring dangerous experiments get proper scrutiny. The rules protect public health, the environment, and agricultural industries from potential harms of escaped GMOs or accidental releases of dangerous organisms.\n\n**Notable features:**\n\n- **Mirror legislation**: South Australia deliberately keeps numbering consistent with Commonwealth regulations to make cross-referencing easier\n- **Updated for modern science**: Recent amendments added rules for newer techniques like CRISPR gene editing and explicitly addressed gene drive technology\n- **Exclusions**: Certain techniques (like traditional breeding, mutagenesis, and some forms of gene editing) are explicitly excluded from being regulated as \"gene technology\""},"issue_detection":{"absurdities":[],"contradictions":[]},"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":true,"description":"The regulations, as amended (notably by the 2019–2020 variations and later tweaks), materially adjusted the scope compared with earlier versions. Key scope changes include:\n\n- Explicitly treating some outcomes of modern genome‑editing techniques as GMOs (regulation 4A and Schedule 1B—eg. oligonucleotide‑directed mutagenesis and site‑directed nuclease repair where a template was added). That brings certain gene‑editing outcomes under licensing/notification that might previously have been treated differently.\n\n- Reworking exempt dealings and host/vector system lists (Schedule 2) and introducing clear scale limits (25 litres) and donor nucleic acid characterisation tests, which narrows the range of truly exempt activities and raises compliance obligations for many routine molecular biology projects (see Schedule 2, item 4 and related donor nucleic acid conditions).\n\n- Creating new and stricter requirements for notifiable low risk dealings (detailed IBC records, approved forms, 8‑year retention and deadline for providing records to the Regulator—regulations 13B and 13C) and establishing transitional grandfathering rules to manage the change (regulation 41). These changes increase administrative oversight and reporting.\n\nOverall, the amendments have broadened regulatory capture of some contemporary gene editing techniques and increased the administrative and facility compliance burden for activities that remain outside full licensing; they also added transitional protections for pre‑existing activities while moving the long‑term equilibrium toward greater centralised oversight (regulations 4A, 13B, 13C, Schedule 2, Schedule 3 and Part 8)."},"complexity_factors":["Extensive cross‑references to the Gene Technology Act 2001 and the Commonwealth Regulations (many procedural provisions applied by reference).","Large number of defined technical terms in regulation 3 and in Schedules (around 30–40 specific defined terms and technical phrases such as \"characterised\", \"host/vector system\", \"non‑vector system\").","Multiple Schedules with detailed, technical lists and tables: Schedule 1A (11 technique items), Schedule 1B (2 explicit GMO categories), Schedule 1 (around 12 items), Schedule 2 (host/vector tables with 10 table items) and Schedule 3 (detailed multi‑part containment rules).","Nested conditional logic and exceptions: e.g. Schedule 3 contains paragraphs that exclude particular dealings from being notifiable low risk depending on characterisation, donor nucleic acid origin, and containment level; Schedule 2 contains multi‑part conditions (item 4(2)).","Time limits with numerous suspensions and different periods depending on risk and procedure (regulation 8(1)–(3) and regulation 11A(1)–(2)).","Transitional provisions and grandfathering rules with multiple triggering events and time limits (regulation 41 and regulations 42–43).","Recordkeeping and reporting obligations with multiple deadlines and approved forms (regulation 13B and regulation 13C)—administrative complexity for regulated parties.","Containment categorisation by physical containment levels (1–3) tied to specific technical criteria and Risk Group classifications (AS/NZS 2243.3:2010), adding facility certification complexity (Schedule 3 and regulation 13(2))."],"plain_english_summary":"**What these Regulations do (mechanics first)**\n\n- They set out detailed rules about which laboratory and other activities involving genetically modified organisms (GMOs) are: exempt from licence, `notifiable low risk` (can be done after local committee review and record-keeping), or require a formal GMO licence from the Regulator. (See regulation 6, regulation 12 and Schedules 2 and 3.)\n\n- They define important technical terms and list specific techniques and organisms that are or are not treated as gene technology or GMOs. This includes a schedule of techniques that are excluded from the statutory definition of \"gene technology\" (Schedule 1A), lists of organisms that are explicitly GMOs (Schedule 1B), and lists of organisms treated as not GMOs (Schedule 1). (See regulations 3, 4, 4A, 5 and Schedules 1A, 1B and 1.)\n\n- They prescribe the allowed host/vector systems and the limits on small-scale laboratory work that can be carried out without a licence (for example, specific bacterial, fungal and tissue-culture systems and a 25‑litre per vessel limit for some exempt culture work). (See Schedule 2 and regulation 6.)\n\n- They establish the category of \"notifiable low risk dealings\": those activities that do not need a licence but must be assessed and recorded by an Institutional Biosafety Committee (IBC) and reported to the Regulator in an approved form and timeframe. The rules set who may carry out the dealing, where it must be done (physical containment levels 1–3), that the IBC must keep an approved form of record, and that records must be retained for 8 years. (See regulations 12, 13, 13B and 13C and Schedule 3.)\n\n- They set timeframes and procedural rules for the Regulator’s decisions on licence, certification and accreditation applications (for example, decision periods of 90, 150, 170 or 255 days depending on the application type and risk assessment triggers). They also list Commonwealth authorities the Regulator must consider when seeking advice. (See regulations 8, 9, 11A, 14, 16.)\n\n- They prescribe matters the Regulator must have regard to when assessing risks and deciding whether to authorise dealings, and list additional matters to be considered in risk assessments (including potential for spread, persistence, ecological impacts, toxicity and long-term risks). (See regulations 9A and 10.)\n\n- They make procedural and administrative provisions about advisory committees (Gene Technology Technical Advisory Committee and Ethics and Community Committee), inspector identity cards and the particulars to be included in the Regulator’s Record of GMO Dealings. Many committee procedures are applied by reference to the Commonwealth Regulations. (See Parts 4, 5, regulation 39 and regulation 40.)\n\n- Transitional provisions preserve existing permissions for a limited period where the 2019–2020 amendments changed whether an activity is exempt, notifiable low risk or licence‑required; they also clarify how previously assessed notifiable low risk dealings are treated under the new rules. (See Part 8, regulations 41–43.)\n\n\n**Who this affects**\n\n- Researchers and laboratory staff in universities, hospitals and industry, including principal investigators, lab managers and technical staff who carry out genetic modification work.\n- Institutional Biosafety Committees (IBCs) that assess and record notifiable low risk dealings, and accredited organisations that host GMO work.\n- Facilities that handle GMOs (they may need certification to specified physical containment levels and may face limits on scale of culture work).\n- Biotech and contract research organisations that move from exempt to notifiable or licensed categories.\n- The Regulator, advisory committees and inspectors, who administer, assess and enforce the rules.\n\n\n**Who pays / who bears the burden**\n\n- Regulated entities bear the direct compliance costs: preparing IBC proposals and records, retaining records for 8 years (regulation 13B(1)(a) and regulation 13C(3)), meeting containment/certification requirements for facilities (Schedule 3 and regulation 13(2)), potential testing to show vectors cannot restore replication competence (various clauses in Schedule 3), and administrative time to respond to Regulator notices (regulation 13C(4)–(5)).\n- Costs of certification/accreditation of facilities and organisations are on the applicant side (regulations 14–17 and related parts of the Act); licence application fees are left to the Regulator/Act (regulation 7 notes no fee prescribed at commencement).\n\n\n**Who decides**\n\n- Institutional Biosafety Committees decide whether a proposed activity qualifies as a notifiable low risk dealing and must record that assessment (regulation 13 and regulation 13B).\n- The Regulator decides on licences, facility certification and accreditation, whether to agree in writing that a non‑standard facility is acceptable, and may request information from persons undertaking notifiable low risk dealings (regulations 8, 13(2)(c), 13(4) and regulation 13C(4)).\n- Advisory bodies (GTTAC and the Ethics & Community Committee) can be asked to give advice that may be taken into account by the Regulator (regulation 8(1)(e), Parts 4 and 5).\n\n\n**What behaviour changes the Regulations impose**\n\n- Some laboratory procedures that were previously treated as exempt may now be classed as notifiable low risk or licence‑required (see transitional rules in regulation 41). That requires researchers to: obtain an IBC assessment, keep a formal record, and, for many activities, run work in certified facilities at particular containment levels (Schedule 3 and regulation 13(2)).\n- Work that remains exempt is constrained by host/vector lists, donor nucleic acid characterisation requirements and scale limits (Schedule 2 and item 4 of Part 1 of Schedule 2).\n- Laboratories and organisations must maintain and supply records to the Regulator and respond to information notices (regulation 13C); failure to supply required information may lead to refusal of certification or accreditation (regulations 15 and 17).\n\n\n**Official purpose-claims and an analytical check**\n\nThe instrument’s stated or apparent purpose is to provide a risk‑proportionate, technically specific regulatory framework for gene technology consistent with the Gene Technology Act 2001 and Commonwealth Regulations: it classifies activities by risk, prescribes containment levels and requires oversight proportionate to assessed risks (see regulation 12, Schedule 3, regulations 9A and 10). In practice: \n\n- Costs and compliance burden: The rules increase administrative and recordkeeping obligations (IBC records in an approved form, 8‑year retention, annual reporting/records to the Regulator — regulations 13B, 13C), and impose capital/operational costs to maintain or certify facilities to specified containment levels (Schedule 3 and regulation 13(2)). Those are concentrated costs on small labs and start‑ups that cannot easily absorb facility certification expenses.\n\n- Incentives and substitution effects: By explicitly listing some genome editing outcomes as GMOs (Schedule 1B — e.g., oligonucleotide‑directed mutagenesis and site‑directed nuclease edits with a repair template) while treating other edits as not GMOs (Schedule 1 items), the framework changes the incentive to use certain techniques over others. That may shift research toward techniques that escape the GMO classification (subject to the definitions), or push higher‑risk work to licensed facilities or outside the jurisdiction.\n\n- Bureaucratic discretion and delay risk: The Regulator has discretionary powers (for example, to agree in writing to use alternative facilities — regulation 13(2)(c); to request information and pause time limits — regulation 8(2)(b),(d),(e)). Those powers are necessary for risk management but create potential delays and uncertainty for applicants (the decision timeframes in regulation 8 contain multiple suspensions and different time limits depending on risk). \n\n- Trade‑offs and opportunity costs: The Regulations trade simpler permissive access for more targeted risk control. The opportunity cost is researcher time and capital diverted to compliance and facility upgrades rather than research, or commercial investment decisions made on the basis of regulatory overhead.\n\n- Implementation risk: Effective application depends on consistent IBC assessments (regulation 13B) and clear laboratory guidance (Regulator’s guidelines are referenced). Variability across IBCs and uncertain interpretation of terms such as “characterised” (defined but fact‑sensitive) could cause inconsistent outcomes and enforcement burden.\n\n\n**Concrete statutory hooks to the key impacts**\n\n- IBC assessment and records: regulation 13, regulation 13B, regulation 13C.  \n- Containment levels and which activities fit each level: Schedule 3 (Parts 1–3).  \n- Exempt host/vector systems and scale limits: Schedule 2 (Part 1 and Part 2, item 4).  \n- Techniques explicitly treated as GMOs: regulation 4A and Schedule 1B.  \n- Techniques not treated as gene technology: regulation 4 and Schedule 1A.  \n- Time limits and procedural suspensions for Regulator decisions: regulation 8(1)–(3).  \n- Transitional grandfathering and changed scope handling: regulations 41–43.\n\n\n**Bottom line (neutral, practical)**\n\nThese Regulations map many specific laboratory techniques and organisms onto three compliance pathways (exempt, notifiable low risk, licence) and attach procedural, containment and recordkeeping obligations to each pathway. They are detailed and technical by design: the effect is to move many routine research activities into a framework of formal local oversight (IBC assessment, recordkeeping, facility certification) while reserving licensing for higher‑risk activities. That produces clearer regulatory boundaries for some activities but raises compliance, facility and administrative costs for researchers and organisations who handle GMOs (see regulation 13, Schedule 2 and Schedule 3)."},"summary":{"complexity_score":1,"scope_assessment":{"changed":false,"description":"No legislative content was available to assess whether scope changed from any original intent. The submission contained only a 404 error page from the South Australian legislation website."},"complexity_factors":["No legislative text was retrievable — only a website error page was provided","There is nothing substantive to assess for legal complexity","Score of 1 reflects absence of content, not simplicity of any actual law"],"plain_english_summary":"**Nothing to analyse here — the page didn't load.**\n\nThe link provided for the *Gene Technology Regulations 2017* (South Australian legislation) returned a **404 Page Not Found** error. The actual text of the legislation was not retrieved — only an error message from the South Australian legislation website.\n\n**What this means for you:** No legal content could be examined. If you need to read or understand these Regulations, try:\n- Visiting [legislation.sa.gov.au](https://www.legislation.sa.gov.au) directly and searching for the Gene Technology Regulations 2017\n- Checking the **Federal Register of Legislation** at [legislation.gov.au](https://www.legislation.gov.au), as gene technology is primarily regulated at the Commonwealth (national) level under the *Gene Technology Act 2000* (Cth)\n- Contacting the South Australian Office of Parliamentary Counsel at OPCWeb@sa.gov.au\n\n**Note:** The website advises that bookmarks or hyperlinks created before 24 March 2026 may no longer work due to a site update."}},"importantCases":[],"_links":{"self":"/api/acts/gene-technology-regulations-2017","history":"/api/acts/gene-technology-regulations-2017/history","analysis":"/api/acts/gene-technology-regulations-2017/analysis","conflicts":"/api/acts/gene-technology-regulations-2017/conflicts","importantCases":"/api/acts/gene-technology-regulations-2017/important-cases","documents":"/api/acts/gene-technology-regulations-2017/documents"}}