Gene Technology Regulations 2017 (South Australia)

These regulations implement the Gene Technology Act 2001 in South Australia by setting out detailed, operational rules for identifying genetically modified organisms (GMOs), categorising types of "dealings" with GMOs, and prescribing the administrative processes that govern exemptions, notifiable low risk dealings (NLRDs), facility certification and organisational accreditation. Mechanically, the instrument:

Identifies techniques that are not "gene technology" (Schedule 1A) and defines which organisms are or are not GMOs for the purposes of the Act (regulations 4, 4A, 5; Schedules 1A, 1B, 1). Schedule 1B lists specific modifications that will be taken to make an organism a GMO (for example, oligonucleotide‑directed mutagenesis and homology‑directed repair where a template was added), while Schedule 1 identifies circumstances in which an organism is not a GMO (for example, some site‑directed nuclease repairs where no template was added).
Prescribes which deal ings are exempt from licensing (regulation 6 and Schedule 2), including defined host/vector systems, material‑ and process‑based limits (for example, donor nucleic acid characterisation and a 25‑litre per vessel limit for some exempt host/vector systems), and other categorical exclusions (Schedule 2 parts and items).
Establishes the notifiable low risk dealing framework (regulation 12, Schedule 3) that requires prior Institutional Biosafety Committee (IBC) assessment, recordkeeping, minimum containment requirements (physical containment levels 1-3 as certified by the Regulator), and time‑limited authorisation to undertake a notified dealing (regulations 13, 13B, 13C; Schedule 3).
Specifies how certification of facilities and accreditation of organisations interact with the Regulator’s processes (regulations 14-17), including refusal powers where applicants fail to provide required information (regulations 15, 17).

South Australia Gene Technology Regulations 2017 under the Gene Technology Act 2001

Contents Part 1—Preliminary 1 Short title 3 Definitions 3A Numbering Part 2—Interpretation and general operation 4 Techniques not constituting gene technology 4A Organisms that are genetically modified organisms 5 Organisms that are not genetically modified organisms Part 3—Dealings with GMOs Division 1—Licensing system 6 Dealings exempt from licensing 7 Application for licence—prescribed fee 8 Time limit for deciding an application 9 Prescribed authorities 9A Risks posed by dealings proposed to be authorised by licence 10 Risk assessment—matters to be taken into account 11 Prescribed conditions of licence 11A Time limit for deciding variation application Division 2—Notifiable low risk dealings 12 Notifiable low risk dealings 13 Requirements for undertaking notifiable low risk dealings 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals 13C Information to be kept or given to the Regulator by persons or accredited organisations Division 3—Certification and accreditation 14 Regulator to decide certification application within 90 days 15 Application for certification—failure to provide section 85 information 16 Regulator to decide accreditation application within 90 days 17 Application for accreditation—failure to provide section 93 information Part 4—Gene Technology Technical Advisory Committee Division 1—Conditions of appointment 18 GTTAC members and advisers—term of appointment 19 GTTAC members and advisers—resignation 20 GTTAC members—disclosure of interests 21 GTTAC members and advisers—termination of appointment 22 GTTAC members—leave of absence 23 Expert advisers—disclosure of interests Division 2—Committee procedures 24 Committee procedures generally 25 Committee meetings 26 Presiding member 27 Quorum 28 Voting 29 Records and Reports Division 3—Subcommittees 30 Operation of subcommittees Part 5—Ethics and Community Committee 31 Ethics and Community Committee—conditions of appointment 32 Ethics and Community Committee—Committee procedures 33 Ethics and Community Committee—operation of subcommittees Part 7—Miscellaneous 37 Reviewable State decisions 38 Review of decisions 39 Record of GMO Dealings 40 Inspector identity card Part 8—Application and transitional provisions Division 1—Amendments made by the Gene Technology Variation Regulations 2019 41 Changed requirements for dealings 42 Previous assessment by an Institutional Biosafety Committee 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year Schedule 1A—Techniques that are not gene technology Schedule 1B—Organisms that are genetically modified organisms 1.1 Genetically modified organisms Schedule 1—Organisms that are not genetically modified organisms Schedule 2—Dealings exempt from licensing Part 1—Exempt dealings Part 2—Host/vector systems for exempt dealings 2.1 Hosts and vectors Part 3—Definitions Schedule 3—Notifiable low risk dealings in relation to a GMO Part 1—Notifiable low risk dealings suitable for at least physical containment level 1 1.1 Kinds of dealings suitable for at least physical containment level 1 Part 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3 2.1 Kinds of dealings suitable for at least physical containment level 2 2.2 Kinds of dealing suitable for at least physical containment level 3 Part 3—Dealings that are not notifiable low risk dealings 3.1 Kinds of dealings Legislative history

Part 1—Preliminary 1—Short title (1) These regulations may be cited as the Gene Technology Regulations 2017. (2) These regulations may also be referred to as the Gene Technology Regulations. 3—Definitions In these regulations— Act means the Gene Technology Act 2001; advantage, in relation to an organism that is genetically modified, means a superior ability in its modified form, relative to the unmodified parent organism, to survive, reproduce or otherwise contribute to the gene pool; animal includes every kind of organism in the animal kingdom, including non‑vertebrates but not including human beings; AS/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; characterised means— (a) in relation to a nucleic acid—the nucleic acid has been sequenced and there is an understanding of potential gene products or potential functions of the nucleic acid; or (b) in relation to a genetic modification—the gene or genomic region which is modified has been sequenced and there is an understanding of— (i) potential gene products or potential functions of the gene or genomic region; and (ii) the likely effect of the genetic modification on the gene products or functions; Commonwealth regulations means the Gene Technology Regulations 2001 of the Commonwealth; expert adviser means— (a) in Part 4—an expert adviser appointed under section 102(1) of the Commonwealth Act; and (b) in Part 5—an expert adviser appointed under section 112(1) of the Commonwealth Act; genetically modified laboratory guinea pig means a laboratory strain of guinea pig of the species Cavia porcellus that has been modified by gene technology; genetically modified laboratory mouse means a laboratory strain of mouse of the species Mus musculus that has been modified by gene technology; genetically modified laboratory rabbit means a laboratory strain of rabbit of the species Oryctolagus cuniculus that has been modified by gene technology; genetically modified laboratory rat means a laboratory strain of rat of either the species Rattus rattus or Rattus norvegicus that has been modified by gene technology; host/vector system has a meaning affected by subclause 2.1(3) of Schedule 2; infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host; inspector means a person appointed by the Regulator under section 150 of the Act as an inspector; known means known within the scientific community; non-conjugative plasmid, for Schedule 2, has the meaning given in Part 3 of that Schedule; non‑vector system has the meaning given in Part 3 of Schedule 2; nucleic acid means either, or both, deoxyribonucleic acid (DNA), or ribonucleic acid (RNA), of any length; oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following: (a) defects in DNA proofreading and repair; (b) defects in chromosome maintenance; (c) defects in cell cycle checkpoint mechanisms; (d) uncontrolled cell proliferation; (e) resistance to apoptosis; (f) cellular immortalisation; packaging cell line means an animal or human cell line that contains a gene or genes that when expressed in trans are necessary and sufficient to complement packaging defects of a replication defective viral vector in order to produce packaged replication defective virions; pathogenic, in relation to an organism, means having the capacity to cause disease or abnormality; pathogenic determinant means a characteristic that has the potential to increase the capacity of a host or vector to cause disease or abnormality; physical containment level, followed by a numeral, is a specified containment level under guidelines made by the Regulator, under section 90 of the Act, for the certification of facilities; plasmid means a DNA molecule capable of autonomous replication and stable extra‑chromosomal maintenance in a host cell; shot-gun cloning means the production of a large random collection of cloned fragments of nucleic acid from which genes of interest can later be selected; toxin means a substance that is toxic to any vertebrate; toxin-producing organism means an organism producing toxin with an LD50 of less than 100 micrograms per kilogram; transduce, in relation to a viral vector or viral particle, means enter an intact cell by interaction of the viral particle with the cell membrane. Note— Several other words and expressions used in these regulations have the meaning given by section 10, or another provision, of the Act. For example— • accredited organisation • deal with • environment • facility • Gene Technology Technical Advisory Committee • GMO • Institutional Biosafety Committee • intentional release of the GMO into the environment (see section 11) • notifiable low risk dealing • Regulator. 3A—Numbering (1) In order to maintain consistent numbering between these regulations and the Commonwealth Regulations— (a) if 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 (b) if these regulations contain a regulation that is not included in the Commonwealth Regulations, the regulation is numbered so as to maintain consistency in numbering between regulations common to both regulations. (2) A provision number and heading referred to in subregulation (1)(a) form part of these regulations. Notes— 1 A note appears under each heading of a kind referred to in subregulation (1)(a) describing the omitted regulation of the Commonwealth Regulations. 2 A note appears under each regulation of a kind referred to in subregulation (1)(b) highlighting the non‑appearance of an equivalent regulation in the Commonwealth Regulations. 3 This regulation does not appear in the Commonwealth Regulations. Part 2—Interpretation and general operation 4—Techniques not constituting gene technology For 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. 4A—Organisms that are genetically modified organisms For 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. 5—Organisms that are not genetically modified organisms For 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— (a) one or more items in Schedule 1 applies to the organism; and (b) the organism has not been modified by gene technology except for any modifications described in those items; and (c) the organism has not inherited any traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, except as described in item 9 in Schedule 1; and (d) none of the items in Schedule 1B applies to the organism. Part 3—Dealings with GMOs Division 1—Licensing system 6—Dealings exempt from licensing (1) For the purposes of section 32(3) of the Act, a dealing, in relation to a GMO, is an exempt dealing if— (a) it is a dealing of a kind referred to in Part 1 of Schedule 2; and (b) it does not involve a genetic modification other than a modification described in Part 1 of Schedule 2; and (d) it does not involve an intentional release of the GMO into the environment. (2) For the avoidance of doubt, exemption under subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply. Notes— 1 A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in section 10(1) of the Act. 2 Exemption from provisions of the Act does not preclude the application of other Commonwealth and State laws. 3 Intentional release of the GMO into the environment is defined in section 11 of the Act. 7—Application for licence—prescribed fee Note— At the commencement of this regulation, no application fee is prescribed under section 40(6) of the Act. 8—Time limit for deciding an application (1) For the purposes of section 43(3) of the Act, the period within which the Regulator must issue, or refuse to issue, a licence is— (a) in relation to an application to which Division 3 of Part 5 of the Act applies, 90 days after the day the application is received by the Regulator; or (b) in relation to an application to which Division 4 of Part 5 of the Act applies— (i) for a limited and controlled release application for which the Regulator is satisfied that the dealings proposed to be authorised by the licence do not pose significant risks to the health and safety of people or to the environment—150 days after the day the application is received by the Regulator; and (ii) for 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 (iii) in any other case—255 days after the day the application is received by the Regulator. (2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted: (a) a Saturday, a Sunday or a public holiday in the Australian Capital Territory; (b) a day on which the Regulator cannot proceed with the decision-making process, or a related function, because the Regulator is awaiting information that the applicant has been requested, in writing, to give; (c) if, in relation to the application, the Regulator publishes notice of a public hearing under section 53 of the Act, a day in the period that— (i) begins on the day of publication; and (ii) ends on the day when the public hearing ends; (d) a day on which the Regulator cannot proceed with the decision-making process, or a related function, because— (i) the applicant has requested, under section 184 of the Act, that information given in relation to the application be declared confidential commercial information for the purposes of the Act; and (ii) the Regulator is— (A) considering the application; or (B) waiting until any review rights under section 181 or 183 of the Act, in relation to the application, are exhausted; (e) if, in relation to the application, the Regulator requests the Ethics and Community Committee to provide advice on an ethical issue, a day in the period that— (i) begins on the day the request is made; and (ii) subject to subregulation (3), ends on the day when the advice is given or, if the advice is not given within the period, if any, specified under subregulation (3), on the last day of that period. (3) The Regulator, when seeking advice under section 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice. (4) In subregulation (1)— limited and controlled release application means an application for a licence to which section 50A of the Act applies. 9—Prescribed authorities (1) For the purposes of sections 50(3)(c) and 52(3)(c) of the Act, the following Commonwealth authorities and agencies are prescribed: (a) Food Standards Australia New Zealand; (b) Australian Quarantine and Inspection Service; (d) that part of the Department known as the Australian Industrial Chemicals Introduction Scheme; (e) Australian Pesticides and Veterinary Medicines Authority; (f) that part of the Department known as the Therapeutic Goods Administration. (2) In this regulation— Department has the same meaning as in the Commonwealth Act. 9A—Risks posed by dealings proposed to be authorised by licence For the purposes of section 51(1)(a) of the Act, the Regulator must have regard to the following matters: (a) the properties of the organism to which dealings proposed to be authorised by a licence relate before it became, or will become, a GMO; (b) the effect, or the expected effect, of the genetic modification that has occurred, or will occur, on the properties of the organism; (c) provisions for limiting the dissemination or persistence of the GMO or its genetic material in the environment; (d) the potential for spread or persistence of the GMO or its genetic material in the environment; (e) the extent or scale of the proposed dealings; (f) any likely impacts of the proposed dealings on the health and safety of people. 10—Risk assessment—matters to be taken into account (1) For 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— (a) subject to section 45 of the Act, any previous assessment by a regulatory authority, in Australia or overseas, in relation to allowing or approving dealings with the GMO; and (b) the potential of the GMO concerned to— (i) be harmful to other organisms; and (ii) adversely affect any ecosystems; and (iii) transfer genetic material to another organism; and (iv) spread, or persist, in the environment; and (v) have, in comparison to related organisms, an advantage in the environment; and (vi) be toxic, allergenic or pathogenic to other organisms. (2) In taking into account a risk mentioned in section 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term. 11—Prescribed conditions of licence Note— At the commencement of these regulations, no conditions are prescribed under section 61(b) of the Act. 11A—Time limit for deciding variation application (1) For 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. (2) For the period mentioned in subregulation (1), the following days are not counted: (a) a Saturday or a public holiday in South Australia; (b) a day on which the Regulator cannot proceed with the decision‑making process, or a related function, because the Regulator is waiting for information that the applicant has been asked, in writing, to give. Note— This subregulation differs from regulation 11A(2) of the Commonwealth regulations. Division 2—Notifiable low risk dealings 12—Notifiable low risk dealings (1) For the purposes of section 74(1) of the Act, a dealing with a GMO is a notifiable low risk dealing if— (a) it is a dealing of a kind mentioned in Part 1 or 2 of Schedule 3; and (aa) it is not a dealing of a kind mentioned in Part 3 of Schedule 3; and (b) it does not involve an intentional release of the GMO into the environment. (2) For the avoidance of doubt, subregulation (1) does not apply to a dealing that does not comply with subregulation (1), whether or not that dealing is related to a dealing that does so comply. Notes— 1 A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in section 10(1) of the Act. 2 Intentional release of the GMO into the environment is defined in section 11 of the Act. 13—Requirements for undertaking notifiable low risk dealings (1) A person may undertake a notifiable low risk dealing only if— (a) the 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 (b) the Institutional Biosafety Committee has assessed the dealing to be a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; and (c) the dealing undertaken is the dealing described in the Institutional Biosafety Committee's record of assessment of the proposal; and (d) the dealing is only undertaken no later than the day 5 years after the date of the assessment; and (e) the person is mentioned in, or is in a class of persons mentioned in, the Institutional Biosafety Committee's record of assessment as having the appropriate training and experience to undertake the dealing; and (f) subject to subregulation (3), the dealing is undertaken in facilities that— (i) are mentioned in, or are in a class of facilities mentioned in, the Institutional Biosafety Committee's record of assessment as being appropriate for the dealing; and (ii) are facilities in which subregulation (2) permits the dealing to be undertaken; and (g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee's record of assessment to an inspector; and (h) the person does not compromise the containment of a GMO involved in the dealing. (2) A notifiable low risk dealing must be undertaken— (a) for a kind of dealing mentioned in Part 1 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 1 and that is appropriate for the dealing; or (b) for a kind of dealing mentioned in clause 2.1 of Schedule 3 (but not clause 2.2)—in a facility certified by the Regulator to at least physical containment level 2 and that is appropriate for the dealing; or (ba) for a kind of dealing mentioned in clause 2.2 of Schedule 3—in a facility certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or (c) in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken. (3) If a notifiable low risk dealing involves the transportation, storage or disposal of a GMO, the transportation, storage or disposal may happen outside a facility that complies with paragraph (1)(f) and subregulation (2), if it is conducted in accordance with— (a) the Guidelines for the Transport, Storage and Disposal of GMOs, as in force from time to time, that have been issued by the Regulator under paragraph 27(d) of the Act; or (b) transportation, storage or disposal requirements that the Regulator has agreed in writing are appropriate for the containment of the GMO. (4) For subregulation (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility. 13B—Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals An Institutional Biosafety Committee that has assessed a proposal as to whether a dealing is a notifiable low risk dealing must— (a) make a record of its assessment, in a form approved by the Regulator, that includes the following: (i) the identifying name of the dealing to be undertaken that was given to the dealing by the person or accredited organisation that submitted the proposal; (ii) a description of the dealing to be undertaken; (iii) its assessment whether the dealing is a kind of dealing mentioned in Part 1 or 2 of Schedule 3, and not mentioned in Part 3 of Schedule 3; (iv) if the Committee has assessed the dealing as being a kind of dealing mentioned in Part 1 or 2 of Schedule 3 (and not mentioned in Part 3 of Schedule 3)—which kind of dealing in those Parts that the dealing is; (v) the date of the Committee's assessment of the dealing; (vi) the persons or classes of persons considered by the Committee to have the appropriate training and experience to undertake the dealing; (vii) the facilities or classes of facilities the Committee considers to be of the appropriate physical containment level and type for the dealing, having regard to the requirements of regulation 13(2); (viii) the name of the Committee that assessed the proposal; (ix) the name of the person or accredited organisation that submitted the proposal; (x) the person or persons proposing to undertake the dealing; and (b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee. 13C—Information to be kept or given to the Regulator by persons or accredited organisations (1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under regulation 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing. (2) A record of a dealing for the purposes of subregulation (1) must include— (a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; and (b) the name of the Committee that assessed the proposal relating to the dealing; and (c) the name of the person or accredited organisation that submitted the proposal to the Committee for assessment. (2a) The record must be given to the Regulator— (a) in a form approved by the Regulator; and (b) no later than 30 September in the financial year following the one in which the Institutional Biosafety Committee made the assessment. (2b) An accredited organisation that is required, as a condition of accreditation, to give an annual report to the Regulator, must— (a) include the record in the annual report for the year in which the Institutional Biosafety Committee made the assessment; or (b) certify in the annual report that the record has previously been given to the Regulator. (3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under regulation 13B(b) must keep a copy of the Committee's record of assessment for 8 years after the date of the assessment. (4) The Regulator may at any time, by written notice, require from the following persons or organisations further information about how a notifiable low risk dealing is being undertaken, including information about a GMO being dealt with: (a) the person or accredited organisation that submitted the proposal for assessment of the dealing; (b) any other person involved with undertaking the dealing. (5) A person or organisation given a notice under subregulation (4) must, by the end of the period mentioned in the notice, give the Regulator the information required by the notice. Division 3—Certification and accreditation 14—Regulator to decide certification application within 90 days Note— The Commonwealth Regulations provide the period within which the Regulator must consider and decide an application for certification of a facility. 15—Application for certification—failure to provide section 85 information If 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. Note— A refusal to certify a facility is a reviewable decision (see Division 2 of Part 12 of the Act). 16—Regulator to decide accreditation application within 90 days Note— The Commonwealth Regulations provide the period within which the Regulator must consider and decide an application for accreditation of an organisation. 17—Application for accreditation—failure to provide section 93 information If 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. Note— A refusal to accredit an organisation is a reviewable decision (see Division 2 of Part 12 of the Act). Part 4—Gene Technology Technical Advisory Committee Division 1—Conditions of appointment 18—GTTAC members and advisers—term of appointment Note— Regulation 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. 19—GTTAC members and advisers—resignation Note— Regulation 19 of the Commonwealth Regulations provides for the resignation of members of the Gene Technology Technical Advisory Committee and expert advisers to the GTTAC. 20—GTTAC members—disclosure of interests Note— Regulation 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. 21—GTTAC members and advisers—termination of appointment Note— Regulation 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. 22—GTTAC members—leave of absence Note— Regulation 22 of the Commonwealth Regulations provides when the Chairperson and members of the Gene Technology Technical Advisory Committee may be granted leave. 23—Expert advisers—disclosure of interests Note— Regulation 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. Division 2—Committee procedures 24—Committee procedures generally Note— Regulation 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. 25—Committee meetings Note— Regulation 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. 26—Presiding member Note— Regulation 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. 27—Quorum Note— Regulation 27 of the Commonwealth Regulations provides that half the members of the Gene Technology Technical Advisory Committee comprises the GTTAC's quorum. 28—Voting Note— Regulation 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. 29—Records and Reports Note— Regulation 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. Division 3—Subcommittees 30—Operation of subcommittees Note— Regulation 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. Part 5—Ethics and Community Committee 31—Ethics and Community Committee—conditions of appointment Note— Regulation 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. 32—Ethics and Community Committee—Committee procedures Note— Regulation 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. 33—Ethics and Community Committee—operation of subcommittees Note— Regulation 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. Part 7—Miscellaneous 37—Reviewable State decisions Note— The scheme for reviewable State decisions under the Commonwealth Act does not apply under the South Australian legislation. 38—Review of decisions Note— Regulation 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. 39—Record of GMO Dealings For 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: (a) the person or persons that proposed to undertake the dealing, as recorded by the Institutional Biosafety Committee that assessed the dealing as a notifiable low risk dealing; (b) the kind of notifiable low risk dealing, in terms of Part 1 or 2 of Schedule 3; (c) the identifying name given to the dealing by the person or accredited organisation that submitted the dealing to the Institutional Biosafety Committee for assessment; (d) the date of assessment by the Institutional Biosafety Committee that the dealing is a notifiable low risk dealing. 40—Inspector identity card For the purposes of section 151(2)(a) of the Act, an inspector's identity card must— (a) display a recent photograph of the inspector's face; and (b) state the date of issue; and (c) state the period of its validity. Part 8—Application and transitional provisions Division 1—Amendments made by the Gene Technology Variation Regulations 2019 41—Changed requirements for dealings Former exempt dealings (1) If— (a) a person was undertaking a dealing before the amending day; and (b) the dealing was an exempt dealing under the old regulations; and (c) the dealing is not (apart from this provision) an exempt dealing under the new regulations, then, despite the amendments, the dealing is an exempt dealing when undertaken by the person. (2) Subregulation (1) applies until— (a) the dealing is assessed, under the new regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or (b) the person is issued a GMO licence for the dealing; or (c) 1 year after the amending day if neither of the events in paragraphs (a) and (b) occurs before then. Former notifiable low risk dealings (3) If— (a) a person was undertaking a dealing before the amending day; and (b) the dealing was a notifiable low risk dealing under the old regulations; and (c) the dealing— (i) is not (apart from this provision) a notifiable low risk dealing under the new regulations; and (ii) is not an exempt dealing, then, despite the amendments, the dealing is a notifiable low risk dealing when undertaken by the person. (4) Subregulation (3) applies until— (a) the person is issued a GMO licence for the dealing; or (b) 1 year after the amending day if the person is not issued a GMO licence before then. Changed requirements for notifiable low risk dealings (5) If a person was undertaking a notifiable low risk dealing before the amending day, the dealing is, for the purposes of section 37 of the Act, undertaken in accordance with the regulations if— (a) it is undertaken in accordance with the old regulations; or (b) it is undertaken in accordance with the new regulations. (6) Subregulation (5) ceases to be in force 1 year after the amending day. Definitions (7) In this regulation— amending day means the day that Part 2 of the amending regulations commences; amending regulations means the Gene Technology Variation Regulations 2019; new regulations means these regulations as amended by the amending regulations; old regulations means these regulations as in force immediately before the amending day. 42—Previous assessment by an Institutional Biosafety Committee (1) This regulation applies if— (a) before 1 July 2020, an Institutional Biosafety Committee assessed a dealing as being a notifiable low risk dealing mentioned in Part 1 or 2 of Schedule 3; and (b) the record of the Committee's assessment does not indicate that the Committee assessed whether the dealing is of a kind mentioned in Part 3 of Schedule 3. (2) The Committee is taken to have assessed the dealing as being a kind of dealing that is not mentioned in Part 3 of Schedule 3. 43—New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year Regulation 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. Schedule 1A—Techniques that are not gene technology (regulation 4)

Item Description of technique 1 Either of the following transfers, if the transfer does not involve genetically modified material: (a) nuclear transfer; (b) transfer of plastids or mitochondria. 2 Electromagnetic radiation-induced mutagenesis. 3 Particle radiation-induced mutagenesis. 4 Chemical-induced mutagenesis. 5 Fusion of animal cells, or human cells, if the fused cells are unable to form a viable whole animal or human. 6 Protoplast fusion, including fusion of plant protoplasts. 7 Embryo rescue. 8 In vitro fertilisation. 9 Zygote implantation. 10 A natural process, if the process does not involve genetically modified material. Examples— Examples of natural processes include conjugation, transduction, transformation and transposon mutagenesis. 11 Introduction of nucleic acid or nucleic acid analogue into an organism, if— (a) the introduction of the nucleic acid or nucleic acid analogue does not result in an alteration of the organism's genome sequence; and (b) the introduction of the nucleic acid or nucleic acid analogue cannot give rise to an infectious agent; and (c) in the case of nucleic acid or nucleic acid analogue that is DNA—the DNA cannot be transcribed. Schedule 1B—Organisms that are genetically modified organisms Note— See regulation 4A. 1.1—Genetically modified organisms For the purposes of regulation 4A, an organism is a genetically modified organism if an item in the following table applies to the organism.

Item Description of organism 1 An organism that has had its genome modified by oligonucleotide‑directed mutagenesis. 2 An organism modified by repair of single‑strand or double‑strand breaks of genomic DNA induced by a site‑directed nuclease, if a nucleic acid template was added to guide homology‑directed repair. Schedule 1—Organisms that are not genetically modified organisms (regulation 5)

Item Description of organism 2 A whole animal, or a human being, modified by the introduction of naked recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the introduced nucleic acid is incapable of giving rise to infectious agents. 3 Naked plasmid DNA that is incapable of giving rise to infectious agents when introduced into a host cell. 4 An organism modified by repair of single‑strand or double‑strand breaks of genomic DNA induced by a site‑directed nuclease, if a nucleic acid template was not added to guide homology‑directed repair. 6 A micro‑organism that results from an exchange of DNA if—

(a)	the donor species is also the host species; and

(b)	the exchanged DNA does not contain any heterologous DNA.

7 An organism that results from an exchange of DNA between the donor species and the host species if—

(a)	such exchange can occur by naturally occurring processes; and

(b)	the donor species and the host species are micro-organisms that—

(i)	satisfy the criteria in AS/NZS 2243.3:2010, for classification as Risk Group 1; and

(ii)	are known to exchange nucleic acid by a natural physiological process; and

(c)	the vector used in the exchange does not contain heterologous DNA from any organism other than an organism that is involved in the exchange.

8 An organism that is descended from a genetically modified organism (the initial organism), if none of the traits it has inherited from the initial organism are traits that occurred in the initial organism because of gene technology. 9 An organism that has inherited particular traits from an organism (the initial organism), being traits that occurred in the initial organism because of gene technology, if—

(a)	the initial organism was not a genetically modified organism (because of the application of regulation 5); or

(b)	all such inherited traits are traits that occurred in the initial organism as a result of a modification described in an item in this Schedule.

10 An organism that was modified by gene technology but in which the modification, and any traits that occurred because of gene technology, are either no longer present or are epigenetic. 11 Agrobacterium radiobacter strain K1026. 12 Pasteurella multocida strain PMP1. Schedule 2—Dealings exempt from licensing (regulation 6) Note— Regulation 6(1) sets out other requirements for exempt dealings. Part 1—Exempt dealings

Item

Description of dealing 2

A dealing with a genetically modified Caenorhabditis elegans, unless—

(a)	an advantage is conferred on the animal by the genetic modification; or


(b)	as a result of the genetic modification, the animal is capable of secreting or producing an infectious agent.

A dealing with an animal into which genetically modified somatic cells have been introduced, if—

(a)	the somatic cells are not capable of giving rise to infectious agents as a result of the genetic modification; and


(b)	the animal is not infected with a virus that is capable of recombining with the genetically modified nucleic acid in the somatic cells.

A dealing with an animal whose somatic cells have been genetically modified in vivo by a replication defective viral vector, if—

(a)	the in vivo modification occurred as part of a previous dealing; and


(b)	the replication defective viral vector is no longer in the animal; and


(c)	no germ line cells have been genetically modified; and


(d)	the somatic cells cannot give rise to infectious agents as a result of the genetic modification; and


(e)	the animal is not infected with a virus that can recombine with the genetically modified nucleic acid in the somatic cells of the animal.

4 (1) Subject to subitem (2), a dealing involving a host/vector system mentioned in Part 2 of this Schedule and producing no more than 25 litres of GMO culture in each vessel containing the resultant culture.

(2) The donor nucleic acid—

(a)	must meet either of the following requirements:


(i)	it must not be derived from organisms implicated in, or with a history of causing, disease in otherwise healthy—
(A)	human beings; or
(B)	animals; or
(C)	plants; or
(D)	fungi;


(ii)	it must be characterised and the information derived from its characterisation show that it is unlikely to increase the capacity of the host or vector to cause harm; and

Example— Donor nucleic acid would not comply with subparagraph (ii) if its characterisation shows that, in relation to the capacity of the host or vector to cause harm, it— (a) provides an advantage; or (b) adds a potential host species or mode of transmission; or (c) increases its virulence, pathogenicity or transmissibility.

(b)	must not code for a toxin with an LD50 of less than 100 micrograms per kilogram; and


(c)	must not code for a toxin with an LD50 of 100 micrograms per kilogram or more, if the intention is to express the toxin at high levels; and


(d)	must not be uncharacterised nucleic acid from a toxin‑producing organism; and


(e)	if the donor nucleic acid includes a viral sequence—cannot give rise to infectious agents when introduced into any potential host species, without additional non-host genes or gene products that—


(i)	are not available in the host cell into which the nucleic acid is introduced as part of the dealing; and


(ii)	will not become available during the dealing; and


(f)	if the donor nucleic acid includes a viral sequence—cannot restore replication competence to the vector.

A dealing involving shot-gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of this Schedule, if the donor nucleic acid is not derived from either—

(a)	a pathogen; or


(b)	a toxin-producing organism.

Part 2—Host/vector systems for exempt dealings 2.1—Hosts and vectors (1) A reference to a host mentioned in this Part is a reference to a host mentioned in column 2 of an item of the table in this clause. (2) A reference to a vector mentioned in this Part is a reference to a vector mentioned in column 3 of an item of the table in this clause. (3) A reference to a host/vector system mentioned in this Part is a reference to any of the following: (a) a system involving a host mentioned in column 2 of an item of the table in this clause and a vector mentioned in column 3 of the same item; (b) a non‑vector system involving a host mentioned in column 2 of an item of the table; (c) a system involving a GMO mentioned as a vector in column 3 of an item of the table (except item 7), without a host. Note— Column 1 of the table is included for information only.

Item Column 1 Host class Column 2 Hosts Column 3 Vectors 1 Bacteria Escherichia coli K12, E. coli B, E. coli C or E. coli Nissle 1917—any derivative that does not contain— Any of the following:

(a)	generalised transducing phages; or
(a)	non-conjugative plasmids;


(b)	genes able to complement the conjugation defect in a non‑conjugative plasmid.
(b)	lambda bacteriophage;



(c)	lambdoid bacteriophage;



(d)	Fd, F1 or M13 bacteriophage.

2 Bacteria Bacillus—asporogenic strains of the following species with a reversion frequency of less than 10—7: Any of the following:

(a)	B. amyloliquefaciens;
(a)	non-conjugative plasmids;


(b)	B. licheniformis;
(b)	other plasmids and phages whose host range does not include B. cereus, B. anthracis or any other pathogenic strain of Bacillus.


(c)	B. pumilus;



(d)	B. subtilis;



(e)	B. thuringiensis.

3 Bacteria Pseudomonas putida strain KT 2440. Non‑conjugative plasmids. 4 Bacteria The following Streptomyces species: Any of the following:

(a)	S. aureofaciens;
(a)	non-conjugative plasmids;


(b)	S. coelicolor;
(b)	plasmids SCP2, SLP1, SLP2, pIJ101 and derivatives;


(c)	S. cyaneus;
(c)	actinophage phi C31 and derivatives.


(d)	S. griseus;



(e)	S. lividans;



(f)	S. parvulus;



(g)	S. rimosus;



(h)	S. venezuelae.

5 Bacteria Any of the following: Disarmed Ri or Ti plasmids.

(a)	Agrobacterium radiobacter;



(b)	Agrobacterium rhizogenes (disarmed strains only);



(c)	Agrobacterium tumefaciens (disarmed strains only).

6 Bacteria Any of the following: Non‑conjugative plasmids.

(a)	Allorhizobium species;



(b)	Corynebacterium glutamicum;



(c)	Lactobacillus species;



(d)	Lactococcus lactis;



(e)	Oenococcus oeni syn. Leuconostoc oeni;



(f)	Pediococcus species;



(g)	Photobacterium angustum;



(h)	Pseudoalteromonas tunicata;



(i)	Rhizobium species;



(j)	Sphingopyxis alaskensis syn. Sphingomonas alaskensis;



(k)	Streptococcus thermophilus;



(l)	Synechococcus species strains PCC 7002, PCC 7942 and WH 8102;



(m)	Synechocystis species strain PCC 6803;



(n)	Vibrio cholerae CVD103-HgR;



(o)	Zymomonas mobilis.

7 Fungi Any of the following: All vectors.

(a)	Kluyveromyces lactis;



(b)	Neurospora crassa (laboratory strains);



(c)	Pichia pastoris;



(d)	Saccharomyces cerevisiae;



(e)	Schizosaccharomyces pombe;



(f)	Trichoderma reesei;



(g)	Yarrowia lipolytica.

8 Slime moulds Dictyostelium species. Dictyostelium shuttle vectors, including those based on the endogenous plasmids Ddp1 and Ddp2. 9 Tissue culture Any of the following if they cannot spontaneously generate a whole animal: Any of the following:

(a)	animal or human cell cultures (including packaging cell lines);
(a)	plasmids;


(b)	isolated cells, isolated tissues or isolated organs, whether animal or human;
(b)	replication defective viral vectors unable to transduce human cells;


(c)	early non‑human mammalian embryos cultured in vitro.
(c)	polyhedrin minus forms of the baculovirus Autographa californica nuclear polyhedrosis virus (ACNPV).

10 Tissue culture Either of the following if they are not intended, and are not likely without human intervention, to vegetatively propagate, flower or regenerate into a whole plant: Any of the following:

(a)	plant cell cultures;
(a)	Disarmed Ri or Ti plasmids in Agrobacterium radiobacter, Agrobacterium rhizogenes (disarmed strains only) or Agrobacterium tumefaciens (disarmed strains only);


(b)	isolated plant tissues or organs.
(b)	non‑pathogenic viral vectors.

Part 3—Definitions In this Schedule— code for, in relation to a toxin, means to specify the amino acid sequence of the toxin; non-conjugative plasmid means a plasmid that is not self-transmissible, and includes, but is not limited to, non-conjugative forms of the following plasmids: (a) bacterial artificial chromosomes (BACs); (b) cosmids; (c) P1 artificial chromosomes (PACs); (d) yeast artificial chromosomes (YACs); non‑vector system means a system in which donor nucleic acid is or was introduced into a host cell— (a) in the absence of a nucleic acid‑based vector; or (b) using a nucleic acid‑based vector in the course of a previous dealing and the vector is— (i) no longer present; or (ii) present but cannot be remobilised from a host cell. Example 1— A system mentioned in paragraph (a) might involve the use of electroporation or particle bombardment. Example 2— A system mentioned in paragraph (b) might involve cells that were transduced with a replication defective retroviral vector in which no vector particles remain. Schedule 3—Notifiable low risk dealings in relation to a GMO (Regulations 12 and 13) Part 1—Notifiable low risk dealings suitable for at least physical containment level 1 Note— Because 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. 1.1—Kinds of dealings suitable for at least physical containment level 1 The 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: (a) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit or a genetically modified laboratory rat, unless— (i) an advantage is conferred on the animal by the genetic modification; or (ii) the animal is capable of secreting or producing an infectious agent as a result of the genetic modification; (c) a dealing involving virions of a replication defective vector derived from Human adenovirus or from Adeno-associated virus, either without a host or with a host mentioned in item 9 of Part 2 of Schedule 2, if the donor nucleic acid— (i) cannot restore replication competence to the vector; and (ii) does not confer an oncogenic modification or immunomodulatory effect in humans. Part 2—Notifiable low risk dealings suitable for at least physical containment level 2 or 3 Note— Because 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. 2.1—Kinds of dealings suitable for at least physical containment level 2 The 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: (a) a dealing involving whole animals (including non‑vertebrates) that— (i) involves genetic modification of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism; and (ii) does not involve any of the following: (A) a genetically modified laboratory guinea pig; (B) a genetically modified laboratory mouse; (C) a genetically modified laboratory rabbit; (D) a genetically modified laboratory rat; (E) a genetically modified Caenorhabditis elegans; (aa) a dealing involving a genetically modified laboratory guinea pig, a genetically modified laboratory mouse, a genetically modified laboratory rabbit, a genetically modified laboratory rat or a genetically modified Caenorhabditis elegans, if— (i) the genetic modification confers an advantage on the animal; and (ii) the animal is not capable of secreting or producing an infectious agent as a result of the genetic modification; (b) a dealing involving a genetically modified plant; (c) a 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— (i) human beings; or (ii) animals; or (iii) plants; or (iv) fungi; (d) a dealing involving a host/vector system not mentioned in Part 2 of Schedule 2, if— (i) the host or vector has been implicated in, or has a history of causing, disease in otherwise healthy— (A) human beings; or (B) animals; or (C) plants; or (D) fungi; and (ii) the genetic modification is characterised; and (iii) the characterisation of the genetic modification shows that it is unlikely to increase the capacity of the host or vector to cause harm; Example— A genetic modification would not comply with subparagraph (iii) if, in relation to the capacity of the host or vector to cause harm, it— (a) provides an advantage; or (b) adds a potential host species or mode of transmission; or (c) increases its virulence, pathogenicity or transmissibility. (e) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2, if the donor nucleic acid— (i) is characterised, and the characterisation shows that it may increase the capacity of the host or vector to cause harm; or (ii) is uncharacterised nucleic acid from an organism that has been implicated in, or has a history of causing, disease in otherwise healthy— (A) human beings; or (B) animals; or (C) plants; or (D) fungi; (f) a dealing involving a host/vector system mentioned in Part 2 of Schedule 2 and producing more than 25 litres of GMO culture in each vessel containing the resultant culture, if— (i) the dealing is undertaken in a facility that is certified by the Regulator as a large scale facility; and (ii) the donor nucleic acid satisfies the conditions set out in item 4(2) of Part 1 of Schedule 2; (g) a dealing involving complementation of knocked‑out genes, if the complementation is unlikely to increase the capacity of the GMO to cause harm compared to the capacity of the parent organism before the genes were knocked out; Example— A dealing would not comply with paragraph (g) if it involved complementation that, in relation to the parent organism— (a) provides an advantage; or (b) adds a potential host species or mode of transmission; or (c) increases its virulence, pathogenicity or transmissibility. (h) a dealing involving shot‑gun cloning, or the preparation of a cDNA library, in a host/vector system mentioned in items 1 to 6 of the table in Part 2 of Schedule 2, if the donor nucleic acid is derived from either— (i) a pathogen; or (ii) a toxin‑producing organism; (i) a dealing involving virions of a replication defective viral vector unable to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if the donor nucleic acid cannot restore replication competence to the vector; (j) a dealing involving virions of a replication defective non-retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if— (i) the donor nucleic acid cannot restore replication competence to the vector; and (ii) the dealing is not a dealing mentioned in paragraph 1.1(c); (k) a dealing involving virions of a replication defective non‑retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if— (i) the donor nucleic acid cannot restore replication competence to the vector; and (ii) the donor nucleic acid does not confer an oncogenic modification or immunomodulatory effect in humans; (l) a dealing involving virions of a replication defective retroviral vector able to transduce human cells, either without a host or with a host mentioned in Part 2 of Schedule 2, if— (i) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and (ii) viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and (iii) either— (A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or (B) the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these; (m) a dealing involving virions of a replication defective retroviral vector able to transduce human cells and a host not mentioned in Part 2 of Schedule 2, if— (i) the donor nucleic acids does not confer an oncogenic modification or immunomodulatory effect in humans; and (ii) all viral genes have been removed from the retroviral vector so that it cannot replicate or assemble new virions without these functions being supplied in trans; and (iii) viral genes needed for virion production in the packaging cell line are expressed from independent, unlinked loci with minimal sequence overlap with the vector to limit or prevent recombination; and (iv) either— (A) the retroviral vector includes a deletion in the Long Terminal Repeat sequence of DNA that prevents transcription of genomic RNA following integration into the host cell DNA; or (B) the packaging cell line and packaging plasmids express only viral genes gagpol, rev and an envelope protein gene, or a subset of these. 2.2—Kinds of dealing suitable for at least physical containment level 3 (1) A kind of dealing that— (a) is a kind mentioned in clause 2.1; and (b) involves a micro‑organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3, must be undertaken, unless paragraph 13(2)(c) or subregulation 13(3) applies, in facilities certified to at least physical containment level 3 and that are appropriate for the dealings. (2) For the purposes of paragraph (1)(b), a genetically modified micro‑organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro‑organism satisfies those criteria. (3) However, subclause (2) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m). Part 3—Dealings that are not notifiable low risk dealings Note 1— The 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. Note 2— If a dealing is not a notifiable low risk dealing, or an exempt dealing, as provided by these Regulations, a person undertaking the dealing must be authorised by a GMO licence unless the dealing is within one of the other exceptions to licensing provided by the Act: see section 32 of the Act. 3.1—Kinds of dealings (1) A dealing of any of the following kinds, or involving a dealing of the following kinds, is not a notifiable low risk dealing: (a) a 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; (b) a dealing involving high level expression of toxin genes, even if the LD50 is 100 micrograms per kilogram or more; (c) a 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; (d) a dealing involving virions of a replication defective viral vector and a host not mentioned in Part 2 of Schedule 2, if— (i) the donor nucleic acid confers an oncogenic modification or immunomodulatory effect in humans; and (ii) the dealing is not a dealing mentioned in paragraph 2.1(i); (e) a dealing involving a replication competent virus or viral vector, other than a vector mentioned in Part 2 of Schedule 2, if the genetic modification confers an oncogenic modification or immunomodulatory effect in humans; (f) a dealing involving, as host or vector, a micro‑organism, if— (i) the micro‑organism has been implicated in, or has a history of causing, disease in otherwise healthy— (A) humans; or (B) animals; or (C) plants; or (D) fungi; and (ii) none of the following subsubparagraphs apply: (A) the host/vector system is a system mentioned in Part 2 of Schedule 2; (B) the genetic modification is characterised and its characterisation shows that it is unlikely to increase the capacity of the host or vector to cause harm; (C) the dealing is a dealing mentioned in clause 2.1(g) of Part 2 of this Schedule; Example— A genetic modification would not comply with subsubparagraph (B) if, in relation to the capacity of the host or vector to cause harm, it— (a) provides an advantage; or (b) adds a potential host species or mode of transmission; or (c) increases its virulence, pathogenicity or transmissibility. (g) a dealing involving the introduction, into a micro‑organism, of nucleic acid encoding a pathogenic determinant, unless— (i) the dealing is a dealing mentioned in clause 2.1(g) of Part 2 of this Schedule; or (ii) the micro‑organism is a host mentioned in Part 2 of Schedule 2; (h) a dealing involving the introduction into a micro‑organism (other than a host mentioned in Part 2 of Schedule 2) of genes whose expressed products are likely to increase the capacity of the micro‑organisms to induce an autoimmune response; (i) a dealing involving use of a viral or viroid genome, or fragments of a viral or viroid genome, to produce a novel replication competent virus with an increased capacity to cause harm compared to the capacity of the parent or donor organism; Example— A dealing would comply with paragraph (i) if it produces a novel replication competent virus that has a higher capacity to cause harm to any potential host species than the parent organism because the new virus has— (a) an advantage; or (b) a new potential host species or mode of transmissibility; or (c) increased virulence, pathogenicity or transmissibility. (j) a 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; (k) a dealing involving a genetically modified animal, plant or fungus that is capable of secreting or producing infectious agents as a result of the genetic modification; (l) a dealing producing, in each vessel containing the resultant GMO culture, more than 25 litres of that culture, other than a dealing mentioned in clause 2.1(f) of Part 2 of this Schedule; (m) a dealing that is inconsistent with a policy principle issued by the Ministerial Council; (n) a dealing involving the intentional introduction of a GMO into a human being, unless the GMO— (i) is a human somatic cell; and (ii) cannot secrete or produce infectious agents as a result of the genetic modification; and (iii) if it was generated using viral vectors— (A) has been tested for the presence of viruses likely to recombine with the genetically modified nucleic acid in the somatic cells; and (B) the testing did not detect a virus mentioned in subsubparagraph (A); and (C) the viral vector used to generate the GMO as part of a previous dealing is no longer present in the somatic cells; (o) a dealing involving a genetically modified pathogenic organism, if the practical treatment of any disease or abnormality caused by the organism would be impaired by the genetic modification; (p) a dealing involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4; (q) a dealing involving a micro-organism that satisfies the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 and that is not undertaken— (i) in a facility that is certified by the Regulator to at least physical containment level 3 and that is appropriate for the dealing; or (ii) in a facility that the Regulator has agreed in writing is a facility in which the dealing may be undertaken; (r) a dealing involving a GMO capable of sexual reproduction, the sexual progeny of which are, as a result of the genetic modification, more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism); (s) a dealing involving a viral vector that can modify an organism capable of sexual reproduction, so that the sexual progeny of the organism are more likely to inherit a particular nucleotide sequence or set of nucleotide sequences (when compared to inheritance from the unmodified parent organism). Note— A modification that increases the likelihood of inheritance of a nucleotide sequence or sequences, as described in paragraphs (r) and (s), is generally known as an engineered gene drive. (2) For the purposes of paragraph (1)(p), a genetically modified micro-organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 4 if the unmodified parent micro-organism satisfies those criteria. (3) For the purposes of paragraph (1)(q), a genetically modified micro-organism is taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification as Risk Group 3 if the unmodified parent micro-organism satisfies those criteria. (4) However, subclause (3) does not apply in relation to a replication defective retroviral vector that meets the criteria in paragraph 2.1(l) or (m). Legislative history Notes • Please 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. • Earlier versions of these regulations (historical versions) are listed at the end of the legislative history. • For 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. Legislation revoked by principal regulations The Gene Technology Regulations 2017 revoked the following: Gene Technology Regulations 2002 Principal regulations and variations New entries appear in bold. Year No Reference Commencement 2017 196 Gazette 4.7.2017 p2763 1.8.2017: r 2 2019 216 Gazette 3.10.2019 p3399 8.10.2019 except Pt 3—1.7.2020 and except Pt 4—8.10.2020: r 2 2025 81 Gazette 7.8.2025 p3013 7.8.2025: r 2 Provisions varied New entries appear in bold. Entries that relate to provisions that have been deleted appear in italics. Provision How varied Commencement Pt 1

r 2 omitted under Legislation Revision and Publication Act 2002 8.10.2019 r 3

characterised substituted by 216/2019 r 4(1) 8.10.2019 host/vector system inserted by 216/2019 r 4(2) 8.10.2019 non‑vector system substituted by 216/2019 r 4(3) 8.10.2019 toxin‑producing organism varied by 216/2019 r 4(4) 8.10.2019 note varied by 216/2019 r 4(5) 8.10.2019 r 3B deleted by 216/2019 r 5 8.10.2019 Pt 2

r 4 varied by 216/2019 r 6 8.10.2019 r 4A inserted by 216/2019 r 7 8.10.2019 r 5 substituted by 216/2019 r 8 8.10.2019 Pt 3

r 9 varied by 216/2019 r 9 8.10.2019 r 9(1) r 9 amended and redesignated as r 9(1) by 81/2025 r 3(1), (2) 7.8.2025 r 9(2) inserted by 81/2025 r 3(2) 7.8.2025 r 11A

r 11A(2) varied by 216/2019 r 10 8.10.2019 r 12

r 12(1) varied by 216/2019 r 11 8.10.2019 r 13

r 13(1) varied by 216/2019 r 12(1)—(4) 8.10.2019

(i) deleted by 216/2019 r 12(5) 8.10.2019

note deleted by 216/2019 r 12(6) 8.10.2019

varied by 216/2019 r 20 1.7.2020 r 13(2) varied by 216/2019 r 12(7) 8.10.2019 r 13(3) substituted by 216/2019 r 12(8) 8.10.2019 r 13A deleted by 216/2019 r 13 8.10.2019 r 13B varied by 216/2019 r 21(1)—(4) 1.7.2020 r 13C

r 13C(1) and (2) substituted by 216/2019 r 22(1) 1.7.2020 r 13C(2a) and (2b) inserted by 216/2019 r 22(1) 1.7.2020 r 13C(3) varied by 216/2019 r 22(2) 1.7.2020 Pt 7

r 39 substituted by 216/2019 r 23 1.7.2020 Pt 8 inserted by 216/2019 r 14 8.10.2019 rr 42 and 43 inserted by 216/2019 r 24 1.7.2020 Sch 1A varied by 216/2019 r 15 8.10.2019

amended by 81/2025 r 4(1), (2) 7.8.2025 Sch 1B inserted by 216/2019 r 16 8.10.2019 Sch 1 varied by 216/2019 r 17 8.10.2019

varied by 216/2019 r 25 8.10.2020

amended by 81/2025 r 5(1)—(3) 7.8.2025 Sch 2

Pts 1 and 2 substituted by 216/2019 r 18 8.10.2019 Sch 3

Pt 1

cl 1.1 varied by 216/2019 r 19(1), (2) 8.10.2019 Pt 2

cl 2.1 varied by 216/2019 r 19(3)—(21) 8.10.2019 cl 2.2 substituted by 216/2019 r 19(22) 8.10.2019 Pt 3

heading

note 2 substituted by 216/2019 r 19(23) 8.10.2019 cl 3.1

cl 3.1(1) cl 3.1 varied and redesignated as cl 3.1(1) by 216/2019 r 19(24)—(30) 8.10.2019 cl 3.1(2)—(4) inserted by 216/2019 r 19(30) 8.10.2019 Sch 4 omitted under Legislation Revision and Publication Act 2002 8.10.2019 Historical versions 8.10.2019

1.7.2020

8.10.2020

1 Gene Technology Regulations 2017

South Australia Gene Technology Regulations 2017 under the Gene Technology Act 2001

The regulations rest on a small set of interlocking technical and administrative concepts. Those concepts determine whether a particular proposed activity is a licence matter, an exempt dealing, a notifiable low risk dealing, or falls outside the regulations.

Gene technology and GMO definitions: The regulations operate against the Act’s definitions of "gene technology" and "genetically modified organism". Regulation 4 excludes specific techniques from the definition of gene technology by reference to Schedule 1A (examples include chemical or radiation‑induced mutagenesis, protoplast fusion, embryo rescue, and in vitro fertilisation). Regulation 4A makes an organism a GMO if an item in Schedule 1B applies (for example, oligonucleotide‑directed mutagenesis, and site‑directed nuclease repair where a nucleic acid template was added). Regulation 5 and Schedule 1 list organisms and circumstances that are not GMOs (for example, a site‑directed nuclease repair where no template was added, naked plasmid DNA incapable of giving rise to infectious agents, and organisms descended from a GMO that have not inherited traits attributable to gene technology).
Characterisation and "advantage": The regulations define "characterised" in regulation 3 (sequencing and understanding potential gene products/functions) and "advantage" (a superior ability to survive, reproduce or otherwise contribute to the gene pool). These definitions are operational: several Schedule and regulation tests turn on whether donor nucleic acid is characterised (for assessing whether a donor sequence is acceptable for exempt or notifiable dealings) and whether a modification confers an advantage (which can move an otherwise low‑risk animal dealing out of exemption).
Host/vector systems and non‑vector systems: Schedule 2 Part 2 lists acceptable host/vector systems for exempt dealings (for example, specified E. coli strains and non‑conjugative plasmids, certain Bacillus strains, yeast and fungi, animal and plant tissue culture systems). The schedule distinguishes "non‑vector systems" where donor nucleic acid is introduced without a nucleic acid‑based vector or in prior dealings where the vector is no longer present or remobilisable.
Donor nucleic acid and toxin thresholds: For several exemptions and NLRD categories, donor nucleic acid must meet characterisation tests and must not code for toxins below an LD50 threshold (for example, Schedule 2 item 4(b) and Schedule 3 Part 3 exclusions around toxins).
Notifiable low risk dealings (NLRDs): Regulation 12 establishes that certain dealings are "notifiable low risk" if they are the kinds listed in Schedule 3 Parts 1 or 2 and not listed in Part 3, and if they do not involve intentional environmental release. Schedule 3 then stratifies NLRDs by the minimum physical containment level (PC1, PC2 or PC3) required, technical conditions on vectors and donor nucleic acid, volume thresholds, and exclusions (for example, vector types and retroviral vector constraints in Schedule 3 clause 2.1(l)-(m)).
Physical containment levels and certification: "Physical containment level" is defined by the Regulator’s guidelines under section 90 of the Act, and Schedule 3 maps different kinds of dealings to the minimum certified containment level (PC1, PC2, PC3). Regulation 13(2) requires NLRDs to be undertaken only in facilities certified to the appropriate level by the Regulator, unless the Regulator agrees in writing otherwise.
Institutional Biosafety Committees (IBCs) and records: IBCs must assess proposals for NLRDs and make a record of the assessment in a form approved by the Regulator (regulation 13B). Persons or accredited organisations that receive a copy of the record must give a record of the dealing to the Regulator in an approved form by a specified due date (regulation 13C(2a)-(2b)) and retain the IBC’s assessment records for 8 years (13C(3)).
Process and timing: The Regulator’s timeframes for licence decisions and variations are set out (for example, 90 days for Division 3 licence applications; longer periods (150, 170 or 255 days) for limited and controlled release applications in Division 4 depending on risk), and regulation 8(2) lists days to be excluded when calculating those periods. The Regulator must also have regard to specific risk factors set out in regulation 9A and additional matters listed in regulation 10.
Interaction with Commonwealth instruments and standards: Multiple elements are intentionally left aligned with Commonwealth Regulations and standard instruments (the regulations reference the Commonwealth Regulations repeatedly and adopt AS/NZS 2243.3:2010 for risk group classification). Several committee procedural details are provided by reference to Commonwealth Regulations (Part 4 and Part 5 notes).

These concepts are the regulatory knobs: "characterised donor nucleic acid", the host/vector identity, the presence or absence of an "advantage", the containment level, and whether an IBC has recorded a dealing as NLRD determine whether an activity proceeds as exempt, notifiable, or licensed.

The regulations allocate duties, rights and process steps across identifiable actors. Practitioners should map obligations to these parties because the statutory mechanics delegate compliance tasks and decision powers to them.

Persons undertaking dealings: Any natural person who proposes to "deal with" a GMO (the Act provides the primary definition) must classify the dealing under the regulations. If the dealing is an exempt dealing under regulation 6 and Schedule 2, the person may proceed subject to the Schedule constraints. If the dealing is a notifiable low risk dealing, the person must have an IBC assessment prior to undertaking the dealing and must comply with the containment and recordkeeping rules (regulations 12, 13, 13B, 13C). If neither applies, a licence is required under the Act (regulation 6(2), 12(2) notes).
Accredited organisations and facilities: Organisations seeking accreditation or facilities seeking certification interact with the Regulator under Part 3 Division 3 (regulations 14-17). Accredited organisations have additional reporting duties: an accredited organisation required to submit an annual report must either include the record of the dealing in the annual report or certify that the record was previously given (13C(2b)). Facilities undertake certification applications and must provide required information under section 85 of the Act or face potential refusal (regulation 15).
Institutional Biosafety Committees (IBCs): IBCs are the gatekeepers for NLRDs. Regulation 13 requires that persons or accredited organisations prepare and submit a written proposal for an IBC assessment before undertaking an NLRD; regulation 13B mandates the form and content of the IBC’s record of assessment and requires the IBC to give a copy to the applicant. The IBC’s record determines who may undertake a dealing, which facilities are appropriate, and the persons or classes of persons with the appropriate training and experience (13B(a)(vi)-(vii)).
The Regulator: The Regulator certifies facilities to physical containment levels, decides licensing, accreditation and certification applications within prescribed timeframes (regulations 8, 11A, 14, 16), may request further information, may agree in writing to alternative facility arrangements (13(2)(c)), and prescribes guidelines under section 90 of the Act which define physical containment levels. The Regulator also receives the Record of GMO Dealings particulars for NLRDs (regulation 39) and may at any time require further information from persons or organisations about how an NLRD is being undertaken (13C(4)-(5)).
Advisory committees and expert advisers: The Gene Technology Technical Advisory Committee (GTTAC) and the Ethics and Community Committee are referenced; their appointment, disclosure and procedural matters are provided mainly by the Commonwealth Regulations (Part 4 and Part 5 notes). The Regulator may seek advice from the Ethics and Community Committee, and time taken while advice is sought can be excluded from the decision‑making timeframe (regulation 8(2)(e)-(3)).
Inspectors: Inspectors are appointed under s150 of the Act and have identity card requirements prescribed in regulation 40. Inspectors may request to see IBC records on the spot (regulation 13(1)(g) requires persons to keep or give a copy on request).
Prescribed Commonwealth authorities: The Regulator is required to consult particular Commonwealth authorities in licensing decisions (regulation 9 prescribes FSANZ, AQIS, Australian Industrial Chemicals Introduction Scheme, APVMA, TGA). The regulation defines "Department" consistently with the Commonwealth Act.

Concentrated duties fall on persons undertaking laboratory or other dealings (preparing proposals, satisfying IBCs, maintaining records and ensuring facility certification), on institutions (IBC operation, record submission, accreditation), and on facilities (seeking and maintaining certification at the necessary PC level). The Regulator carries concentrated decision authority and corresponding administrative burdens (timeframes, consultations and oversight). The regulations allocate information flows (IBC → person → Regulator) and set enforceable recordkeeping and reporting duties for persons and accredited organisations (regulations 13B, 13C, 39).

The regulations create clear, largely procedural duties for prospective GMO dealings, organisational actors and the Regulator, together with limited statutory rights of procedural review and information handling. The emphasis is on prior assessment, containment, and record retention.

Duties imposed on persons and organisations

IBC assessment before NLRD: A person may undertake a notifiable low risk dealing only after a written proposal has been prepared and submitted to an Institutional Biosafety Committee, and the IBC has assessed the dealing as an NLRD of the sort listed in Schedule 3 (regulation 13(1)(a)-(b)). The person may only undertake the dealing as described in the IBC's record (13(1)(c)).
Facility containment: NLRDs must be done in facilities certified by the Regulator to at least the minimum physical containment level specified in Schedule 3 unless the Regulator agrees otherwise in writing (regulation 13(2) and (4); Schedule 3 maps kinds of dealings to PC1-PC3). If transportation, storage or disposal occurs outside certified facilities, it must comply with Regulator guidelines or expressly approved requirements (13(3)).
Time limits on undertaking NLRDs: The dealing must be undertaken no later than five years after the IBC assessment (13(1)(d)).
Personnel and training: The IBC record must identify persons or classes of persons considered to have appropriate training and experience to undertake the dealing; the dealing may only be undertaken by those persons (13(1)(e); 13B(a)(vi)).
Recordkeeping and reporting: A person or accredited organisation given a copy of an IBC record must keep it for eight years (13C(3)). If the dealing is assessed as an NLRD, the person or accredited organisation must give the Regulator a record of the dealing in a form approved by the Regulator, no later than 30 September in the financial year following the assessment (13C(1), (2a)). Accredited organisations with annual report obligations must include such records or certify prior submission (13C(2b)). Regulation 39 prescribes specific particulars to be included in the Regulator’s Record of GMO Dealings for NLRDs.
Compliance with containment: Persons must not compromise the containment of a GMO involved in the dealing (13(1)(h)).
Response to Regulator notices: The Regulator may require further information about how a notifiable low risk dealing is being undertaken; persons and organisations given such notices must provide the information within the notice period (13C(4)-(5)).

Regulator duties and decision mechanics

Timeframes for licence and variation decisions: The Regulator must decide certain licence applications within legislated periods (regulation 8(1) sets 90 days for applications where Division 3 of Part 5 of the Act applies and longer periods for limited and controlled release applications under Division 4, see 8(1)(b)). Variation applications must be decided within 90 days (regulation 11A(1)), with specific days excluded from the computation (11A(2)).
Considerations in risk assessment: The Regulator must have regard to specified matters when assessing licence applications (regulation 9A) and must take into account particular matters listed in regulation 10 (for example, prior regulatory assessments in Australia or overseas, potential for harm to organisms, ecosystems, transfer of genetic material, persistence, advantage, toxicity, allergenicity or pathogenicity). Regulation 10(2) directs the Regulator to consider both short term and long term in taking these risks into account.
Certification and accreditation decisions: The Regulator has 90 days to decide certification and accreditation applications (14, 16 notes reference Commonwealth Regulations). The Regulator may refuse to certify or accredit if the applicant fails to provide required information under the relevant Act sections and gives no reasonable explanation (regulations 15, 17).
Consultation obligations: The Regulator must consult prescribed Commonwealth authorities (regulation 9 lists FSANZ, AQIS, Australian Industrial Chemicals Introduction Scheme, APVMA, TGA) where the Act requires their involvement.

Rights and reviewable decisions

Records and access: Persons undertaking NLRDs have the right to receive a copy of the IBC’s record of assessment (13B(b)). Inspectors can request to see IBC records and the person must be able to give a copy on request (13(1)(g)).
Review rights: Certain administrative decisions such as refusal to certify or accredit are reviewable decisions (regulation 15 and 17 notes state that such refusals are reviewable and point to Division 2 of Part 12 of the Act). Regulation 38 notes that persons whose interests are affected by a decision to terminate a committee appointment may apply to the Administrative Appeals Tribunal for review,this signals a route for administrative review in specified circumstances.
Time‑limited advice and proceeding without advice: When the Regulator requests advice from advisory committees, the Regulator may specify a reasonable period for advice to be returned, and if it is not, must proceed without it (regulation 8(3)). This imposes an operational limit on the extent to which committee delay can halt decision‑making.

Operational consequences

The principal operational consequence is that the persons and institutions engaged in gene technology must undertake an early, documentable triage: (1) determine whether the organism or technique is excluded from the gene technology/GMO definitions (Schedules 1A, 1B, 1); (2) test whether the dealing fits an exempt dealing in Schedule 2; (3) if not exempt, test whether it is an NLRD in Schedule 3 and if so obtain an IBC assessment and meet containment/reporting duties; and (4) if neither, prepare a licence application and factor in statutory decision timeframes and consultation requirements (regulations 4-6, 12-13, 8, 9A, 10).

The regulations embed specific documentary and facility standards into the compliance pathway and create express procedural rights and administrative duties that shape how and when persons may lawfully manipulate, culture, transport or dispose of GMOs within South Australia.

The regulations themselves largely establish procedural and administrative obligations and leave primary sanctioning powers, criminal offences and some enforcement mechanisms to the Gene Technology Act 2001 and associated Commonwealth instruments. Within the regulations there are operational enforcement levers and statutory consequences that practitioners must note.

What the regulations prescribe directly

Refusal of certification or accreditation: The Regulator may refuse to certify a facility or accredit an organisation if required information under the Act is not provided within a specified notice period and no reasonable explanation is offered (regulations 15 and 17). The notes state that such refusals are reviewable decisions (see Division 2 of Part 12 of the Act).
Information and compliance notices: Regulation 13C(4) empowers the Regulator to require further information at any time from persons or organisations about how an NLRD is being undertaken, including information about the GMO involved. Subregulation 13C(5) obliges the recipient of such a notice to provide the requested information by the end of the period mentioned in the notice. Failure to comply with a written Regulator notice is not categorised within these regulations as a specific offence, but the obligations impose an administrative compliance requirement that the Regulator can enforce under the Act.
Inspector identification and powers: Inspectors are appointed under s150 of the Act (regulation 3 defines "inspector" as such). Regulation 40 prescribes the content of an inspector’s identity card (photograph, date of issue, period of validity). Inspectors operate under the enforcement powers in the Act; these regulations ensure identification standards for inspectors who exercise those powers.

Enforcement framework anchored in the Act

The Act provides the legal basis for offences, penalties, inspection, warrant, seizure and compliance remedies; the regulations reference and implement procedures necessary for the Act to operate but do not re‑create the penal architecture. For example, licensing thresholds and offences for unauthorised dealings are principally matters of the Act (the regulations specify which dealings are exempt or NLRDs and thus do not require a licence,regulations 6 and 12,but do not themselves impose criminal sanctions).
Reviewability and administrative law remedies: The regulations identify certain reviewable decisions and refer to the Act’s review regime and the Administrative Appeals Tribunal for specified committee appointment terminations (regulations 15 note; 17 note; 38 note). These references indicate legally enforceable procedural rights and administrative remedies within the broader governance framework.

Practical enforcement levers and implementation risks

Information asymmetry and enforcement: The Regulator has the power to require further information and to refuse certification or accreditation when information is not provided. That gives the Regulator an administrative lever to compel cooperation but relies on corresponding Act powers to impose or prosecute sanctions for non‑compliance.
Recordkeeping enforcement: The requirement to keep IBC assessment records for 8 years and to submit dealing records to the Regulator by 30 September in the year following assessment (13C(3), (2a)) creates a clear compliance target. Failure to comply may trigger Regulator information requests (13C(4)) and could lead to refusal of future accreditation or certification or other Act‑based enforcement measures.
Inspector access and identity: Inspectors must be identifiable (regulation 40). The effectiveness of inspection as an enforcement tool depends on the Act’s powers that inspectors exercise and on the Regulator’s monitoring practices, both of which lie largely outside the regulations but are triggered by the recordkeeping and notification regime these regulations create.

Because the regulations primarily set process and classification rules while preserving the Act’s enforcement architecture, practitioners should map breaches of the regulations into the Act’s offence and enforcement provisions. The regulations make refusal‑of‑application and information‑request responses the immediate administrative consequences for particular failures, and they designate which dealings can be lawfully undertaken without a licence (so unauthorised dealings proceed, enforcement action under the Act may follow). The precise criminal or civil penalties for contraventions therefore require reference to the Act rather than to the regulations alone.

The regulations are explicitly drafted to operate within a network of Commonwealth regulations, standards, and the substantive Act. They preserve intergovernmental and interagency consultation, adopt external technical standards, and require compliance with other legal regimes beyond the Act itself.

Alignment and cross‑reference to Commonwealth instruments

Commonwealth Regulations and alignment: Regulation 3A directs that numbering is kept consistent with the Commonwealth Gene Technology Regulations, and many procedural and committee functions are supplied by the Commonwealth Regulations (noted throughout Part 4 and Part 5). Several regulatory provisions are notes that point users to the Commonwealth Regulations for details on terms such as committee appointment, resignation, disclosure of interests, committee procedures, meetings and recordkeeping for advisory committees.
Prescribed Commonwealth authorities: Regulation 9 prescribes specific Commonwealth authorities and agencies the Regulator must consult in licensing (Food Standards Australia New Zealand, Australian Quarantine and Inspection Service, Australian Industrial Chemicals Introduction Scheme branch, Australian Pesticides and Veterinary Medicines Authority, and the Therapeutic Goods Administration). This embeds statutory interagency consultation into licensing processes and signals overlapping responsibilities with other regulatory regimes (food, quarantine, chemicals, pesticides/therapeutics).

Interaction with standards and technical guidance

AS/NZS 2243.3:2010: The definition section references AS/NZS 2243.3:2010 (Safety in laboratories Part 3: Microbiological safety and containment) as the standard for Risk Group classifications and several Schedule 3 clauses rely on the criteria in that standard for assigning a micro‑organism to Risk Group 3 or 4 (definition in regulation 3; Schedule 3 clauses 2.2 and 3.1 discuss application).
Regulator guidelines under the Act: "Physical containment level" is defined by guidelines made by the Regulator under section 90 of the Act; several containment obligations in Schedule 3 and regulation 13 refer to facilities being certified to the Regulator’s guidelines. The guidelines themselves, issued under the Act, are therefore the technical instrument that translates statutory containment levels into facility design and operational standards.

Overlap with other Commonwealth and State laws

Exemption does not preclude other laws: Regulation 6 note (note 2) expressly states that exemption from provisions of the Act does not preclude the application of other Commonwealth and State laws. Practically, this means that activities exempt from licensing under these regulations may nonetheless be regulated under workplace health and safety, environmental protection, biosecurity and therapeutic goods laws.
Transport, storage and disposal: For NLRDs, transportation, storage or disposal outside certified facilities must comply with the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs or other transportation/storage/disposal requirements the Regulator approves in writing (13(3)). Those guidelines will interact with other transport and hazardous‑materials legal regimes and quarantine requirements.
Administrative law and tribunals: The notes to regulations 15 and 17 state that refusal outcomes are reviewable decisions (Division 2 of Part 12 of the Act). Regulation 38 references that in some committee appointment termination cases, a person may apply to the Administrative Appeals Tribunal. Those references embed administrative review avenues and potential intersection with general administrative law.

Transitional interaction and harmonisation

Transitional provisions (Part 8): The 2019 Variation Regulations and subsequent amendments adjusted which dealings are exempt or notifiable and provided transitional protections for persons who were conducting dealings under the former regulatory regime (regulation 41). Regulation 42 takes certain pre‑1 July 2020 IBC assessments to have implicitly considered Part 3 of Schedule 3 under specified conditions. The transitional rules therefore govern the interaction between older compliance regimes and the current regime and affect the obligations to reclassify or seek licences/certification.

In short, the regulations are an implementation layer: they do not supplant other regulatory regimes but channel gene technology activity into a defined administrative process while preserving interagency consultations, referencing national technical standards, and leaving substantive enforcement and certain committee procedural matters to Commonwealth instruments and the Act. Parties must therefore coordinate compliance not only with these regulations but with the Act, Commonwealth Regulations, agency guidance, and applicable State and national safety, quarantine and therapeutic law regimes.

The legislative history recorded in the regulations lists the principal instrument and subsequent variations. The practical effect for practitioners is that classification rules, NLRD thresholds, recordkeeping and facility definitions have changed over time; transitional provisions and effective dates are consequential.

Principal instrument and key variation dates

Principal regulations: Gene Technology Regulations 2017, Gazette entry 4 July 2017; principal commencement 1 August 2017 (regulation 1 and legislative history).
Gene Technology Variation Regulations 2019 (No 216): Gazetted 3 October 2019; most of the variation provisions commenced 8 October 2019, with specific parts commencing on later dates (Part 3 commenced 1 July 2020 and Part 4 on 8 October 2020 for some matters). The variations reworked substantial parts of the Schedules and inserted new material (see the detailed "Provisions varied" table).
Amendment 2025 (No 81): Gazetted 7 August 2025 and commenced 7 August 2025. The legislative history entry shows amendments by 81/2025 to particular clauses and schedules (for example, regulation 9 redesignation and insertion, Schedule 1A and Schedule 1 amendments as noted).

Substantive changes introduced by the 2019 Variation Regulations (No 216, effective 8.10.2019 and staggered dates)

New categories and exclusions: Schedule 1B (organisms that are genetically modified organisms) was inserted by the 2019 variation (regulation 4(7) inserting reg 4A and Schedule 1B). This added express examples of modifications that will be treated as making an organism a GMO (for example, oligonucleotide‑directed mutagenesis and homology‑directed repair with a template).
Reworked definitions and schedules: The 2019 variations substituted the definitions for "characterised", "host/vector system", "non‑vector system", and "toxin‑producing organism" (regulation 3 varied several definitions). Parts 1 and 2 of Schedule 2 (exempt dealings and host/vector systems) were substituted (regulation 18), altering the exempt dealing landscape.
Notifiable low risk dealing framework and recordkeeping: Regulation 12(1) was varied (regulation 11 of the 2019 variation), regulation 13(1) was varied significantly (regulation 12), and the IBC record requirements were varied and expanded by regulation 21 for 13B. Crucially, regulation 13C was substituted by 216/2019 r22(1) to create a clear obligation to give records of NLRDs to the Regulator by specified deadlines, and to require institutions to keep IBC records for eight years; those changes came into force on 1 July 2020 for some parts (regulation 22 and 24).
Transitional arrangements: Regulation 41 sets out transitional measures that provide limited grandfathering for persons undertaking dealings that were previously exempt or notifiable under the old regulations, with time limits for those transitional arrangements (one year or until a licence is issued, see regulation 41(1)-(6)). Regulation 42 addresses prior IBC assessments before 1 July 2020 where records lack a specific assessment against Part 3 of Schedule 3.
Other adjustments: Schedule 1 (organisms that are not GMOs) was substituted (regulation 17), Schedule 3 was extensively varied (regulation 19), and certain committee‑related regulatory references were realigned with Commonwealth Regulations.

Recent amendments (2025)

The legislative history records an amendment instrument 81/2025 that commenced 7 August 2025 and varied regulation 9 and parts of Schedules 1A and 1. The history table marks where those amendments affected numbering and content; practitioners must consult the consolidated text to see the precise 2025 changes as they appear in the current Schedules and regs.

Practical implications of amendment history

Role of transitional provisions: Where activities began before an amending day, regulation 41 provides that those dealings might continue under the old classification (exempt or NLRD) for a limited transitionary period, but that period lapses on licence issuance or after one year. This transitional mechanism is important for existing research programs and commercial projects that must decide whether to re‑assess, to seek an IBC determination as an NLRD, or to apply for a licence.
Need to track amendments and effective dates: Multiple provisions were varied on staggered dates, so compliance obligations changed in phases,particularly the NLRD record submission reforms (effective 1 July 2020). Practitioners must ensure that their compliance systems account for the operative date of each amendment.
Documentation of changes: The regulatory history identifies exactly which clauses were added, substituted or omitted and on which dates. Practitioners relying on long‑running projects should check whether their IBC assessments and documentation conform to the post‑variation procedural form and content requirements (regulation 13B and 13C).

In sum, the regulations have been materially reworked since 2017, with 2019/2020 changes that tightened the NLRD record regime, clarified the GMO/non‑GMO boundaries, and rewired the exempt host/vector lists. The 2025 amendment package further adjusted selected provisions. Users should rely on the consolidated text and confirm which version applied to any historical dealing (see regulation 41-43 for transitional rules).

The regulation text supplied does not cite or summarise any decided cases, judicial commentary or tribunal determinations bearing on the interpretation or application of these regulations. The “Legislative history” and other notes detail amendments and revocations, but there is no listing of litigation or judicial review outcomes in the document.

What the source does show about dispute resolution and review avenues

Reviewable decisions and administrative review: The regulations note that certain decisions (for example, refusal to certify or accredit a facility or organisation) are reviewable decisions and point to Division 2 of Part 12 of the Act for the statutory review pathway (regulations 15 and 17 notes). Regulation 38 notes the Administrative Appeals Tribunal may hear applications for review in specific circumstances concerning committee appointments.
Record of reviewable State decisions: Regulation 37 expressly notes that the scheme for reviewable State decisions under the Commonwealth Act does not apply under the South Australian legislation. That is a procedural point of interaction but not a summary of litigation outcomes.
Practical consequence: The regulations establish administrative decision points that are reviewable under the Act’s review provisions or under the Administrative Appeals Tribunal for statutorily specified matters; however the regulations themselves do not provide a litigation history or case law to indicate how tribunals or courts have interpreted these provisions.

For practitioners, the absence of a litigation history in the text means that legal argument and administrative review practice will depend on the Act, any applicable Commonwealth Regulations, and existing administrative law principles. In cases where review is available, parties should look to the Act’s review provisions and to the Administrative Appeals Tribunal jurisdiction to understand remedies and likely procedural steps. The regulations provide the administrative scaffolding that will be at issue in any tribunal or judicial review proceedings, but the supplied instrument does not narrate or identify precedent.

Practitioners and compliance officers should note several traps that arise from textual thresholds, timing rules, and classification detail in the regulations. These are concrete operational pitfalls, not normative judgments.

Narrow technical distinctions change regulatory status

Gene technology exclusions and GMO rules are highly technical: Small differences such as whether a nucleic acid template was added during site‑directed nuclease repair determine whether an organism is treated as a GMO (Schedule 1B item 2 versus Schedule 1 item 4). The definition of "characterised" requires sequencing and an understanding of potential gene products or functions (regulation 3). Misclassifying a technique or organism because of an incomplete characterisation can convert an apparently exempt or non‑GMO interaction into a notifiable dealing or a licence matter.

Exempt dealing volume and donor nucleic acid limits

Some exempt host/vector systems are subject to a 25‑litre per vessel limit (Schedule 2 Part 1 item 4). Producing more than that volume moves a dealing into Schedule 3 Part 2 territory (and possibly out of exempt status entirely). The donor nucleic acid must also meet a set of characterisation and origin tests (Schedule 2 item 4(2)). Failure to respect volume limits or to properly characterise donor sequences can invalidate an exemption.

The "advantage" test for animals

Exempt dealings for certain animals (e.g., genetically modified Caenorhabditis elegans or laboratory rodents) exclude animals where an advantage is conferred by genetic modification or where the animal can secrete/produce an infectious agent (Schedule 2 Part 1 item 2; Part 1 item 3 etc.). The statutory definition of advantage is a biological measure (superior ability to survive, reproduce or otherwise contribute to the gene pool). Determining "advantage" requires biological assessment and may not be obvious at the outset,the IBC must make a considered assessment.

IBC form, content and timing obligations are prescriptive

The IBC’s record must be in a form approved by the Regulator and include specified particulars (regulation 13B(a)(i)-(x)). Persons must keep the IBC assessment for eight years (13C(3)) and must give the Regulator a record of the dealing in an approved form no later than 30 September in the financial year following the IBC assessment (13C(2a)). Missing the 30 September deadline or failing to use an approved form creates a tangible non‑compliance risk and can trigger Regulator inquiries or refusal of accreditation.

Transitional protection is limited and time‑bound

Regulation 41 allows some dealings that were exempt or notifiable under old regulations to continue for limited periods, but those transitional protections expire on specific triggering events (IBC reassessment, licence issuance, or one year after the amending day). Projects that began under previous regulations must actively manage the transition,reassess classification, seek licences or obtain IBC determinations within the fixed windows.

Containment level mismatches and alternative facility agreements

NLRDs must be conducted in facilities certified to an appropriate physical containment level unless the Regulator has agreed in writing otherwise (13(2)(c) and 13(4)). Practically, if a facility is not yet certified, the dealing cannot proceed unless the Regulator agrees an alternative,an operational constraint that can delay research or production.

Multiple overlapping standards and versions

The regulations reference AS/NZS 2243.3:2010 "as in force on 1 September 2011" for certain risk group criteria (definition in regulation 3). A practitioner must check whether the regulations intentionally freeze the applicable standard to that version and whether subsequent updates affect classification, because the regulations do not themselves update that reference.

Non‑exhaustive “not notifiable” list

Schedule 3 Part 3 contains an illustrative but not exhaustive list of dealings that are not NLRDs. That means dealings not listed and not captured by exemption may still be licensable,practitioners cannot rely on an exhaustive checklist and must apply the schedules’ tests.

Regulator discretion and process timing

The Regulator may ask for advice from the Ethics and Community Committee,and the time while seeking such advice can be excluded from statutory timeframes (regulation 8(2)(e)-(3)). The Regulator may specify reasonable periods for advice; if advice is not received in that period, the Regulator proceeds without it (8(3)). Applicants must therefore anticipate consultation‑driven delays in some classes of licences.

Interaction with other legal regimes

Exemption under these regulations does not displace other Commonwealth or State legal duties (note to regulation 6). Practitioners must check workplace health and safety, quarantine, transport, environmental and therapeutic goods law for obligations that run concurrently with these regulations.

Taken together, these "gotchas" describe concrete sources of regulatory friction: classification thresholds determined by molecular details, strict IBC record form and timing, facility certification requirements, time‑limited transitional relief, and cross‑regime obligations that continue to apply even where the dealing is exempt under this instrument.

Compliance requires an initial legal and technical triage followed by durable documentation, facility certification planning and proactive engagement with the Regulator and Institutional Biosafety Committee(s). Below is a practical, stepwise compliance checklist grounded in the regulations.

Pre‑project classification

Determine whether the technique constitutes "gene technology" using Schedule 1A (regulation 4). If the technique is listed in Schedule 1A, it is excluded from the Act’s definition of gene technology.
Decide whether the organism is a GMO by applying Schedule 1B and Schedule 1 (regulations 4A, 5). If an item in Schedule 1B applies, the organism is a GMO; if an item in Schedule 1 applies and conditions (a)-(d) of regulation 5 are met, the organism is not a GMO.
If uncertain, prepare a written technical description of the technique and the organism’s genetic state. The regulated test turns on characterisation (see regulation 3 definition) and specific mechanics such as whether a template was added in site‑directed nuclease edits.

Triage of the dealing category

If the organism is a GMO, test whether the dealing fits an exempt dealing in Schedule 2 (regulation 6 and Schedule 2). Pay careful attention to host/vector system lists (Schedule 2 Part 2), donor nucleic acid characterisation requirements (Schedule 2 item 4(2)), toxin coding limits and the 25‑litre per vessel limit.
If not exempt, test whether the dealing is a notifiable low risk dealing in Schedule 3 (regulation 12 and Schedule 3). Map the dealing to the correct Part (PC1, PC2 or PC3) and check exclusions in Part 3 that may remove it from NLRD status even if it otherwise appears to fit.

Institutional Biosafety Committee (IBC) assessment and records

If the dealing is an NLRD, prepare a written proposal for the IBC. The IBC record must include specifics prescribed in regulation 13B (identifying name, description, assessment outcome, which kind of dealing in Schedule 3, date, persons/classes with appropriate training, appropriate facilities or classes of facilities, names of the committee and submitter, proposed persons undertaking the dealing).
Ensure the proposal enables the IBC to assess whether the dealing is listed in Schedule 3 Part 1 or Part 2 and not in Part 3. Obtain the IBC’s assessment in the form approved by the Regulator.

Containment and facility certification

Verify the minimum physical containment level required by Schedule 3 for the dealing and ensure the facility is certified by the Regulator to at least that level (regulation 13(2)). If your facility is not certified, apply for certification under the Act; note the Regulator’s refusal power if you fail to provide required information (regulation 15).
If some transportation, storage or disposal must occur outside certified facilities, ensure it complies with the Regulator’s Guideline for the Transport, Storage and Disposal of GMOs or that the Regulator has agreed in writing to alternative arrangements (regulation 13(3)-(4)).

Personnel, training and documentation

Ensure that only persons or classes of persons mentioned in the IBC’s record undertake the dealing (regulation 13(1)(e)). Document training and competence to satisfy IBC assessments and inspector requests.
Keep a copy of the IBC’s record for at least eight years after the assessment (13C(3)) and be prepared to give a copy to an inspector on request (13(1)(g)). Maintain version control to demonstrate compliance with the form the Regulator has approved.

Reporting to the Regulator

If the dealing is an NLRD, submit the required record of the dealing to the Regulator in the approved form no later than 30 September in the financial year following the IBC assessment (regulation 13C(2a)). If part of an accredited organisation with annual reporting obligations, either include the record in the annual report or certify prior submission (13C(2b)).
Ensure the record provided contains the particulars prescribed in regulation 39 (persons proposing to undertake the dealing, the kind of NLRD in terms of Schedule 3, the identifying name, and date of IBC assessment).

Licence, accreditation and certification applications

If the dealing is neither exempt nor an NLRD, prepare and submit a licence application under the Act. Account for the Regulator’s decision timeframes (regulation 8) and the list of excluded days for calculating those timeframes (8(2)). Where limited and controlled release applications are involved, identify whether the dealings pose "significant risks" so different decision timeframes apply (8(1)(b)(i)-(iii)).
For facility certification and organisational accreditation, provide the information required under sections 85 and 93 of the Act within notice periods. Failure to provide such information without reasonable explanation permits the Regulator to refuse certification or accreditation (regulations 15, 17). Build compliance workflows to track and respond to such notices promptly.

Responding to Regulator requests

Expect the Regulator to request further information at any time about how an NLRD is being undertaken (13C(4)-(5)). Put processes in place to retrieve IBC records and operational data and to meet statutory timeframes on requests.
For licence decisions, anticipate that the Regulator may request advice from advisory committees; build realistic project timelines that accommodate consultation and excluded days under regulation 8(2)(e).

Maintain compliance with non‑Act obligations

Confirm compliance obligations under other Commonwealth and State laws (workplace health and safety, quarantine, transport, environmental and therapeutic goods regulation) because exemption under these regulations does not exempt compliance with those laws (note to regulation 6).
If using materials or host/vector systems listed in Schedule 2, confirm compatibility with other statutory obligations (for example, quarantine permits or import approvals).

Audit preparedness and transitional considerations

Keep records that evidence when any dealing commenced and whether it was subject to prior regulatory regimes. Where dealings began before amending days (see regulation 41 and regulation 42), verify whether transitional relief applies and whether reassessment or licence application is required before the transitional window expires.
Prepare for inspections and audit by ensuring inspector access to IBC records and by meeting the Regulator’s approved form and content standards for submissions and Record of GMO Dealings.

In practical terms, compliance is achieved by a repeatable cycle: classify → IBC assessment where required → secure appropriate certified facilities and trained personnel → record and report to the Regulator by prescribed deadlines → retain records for the statutory period → respond promptly to Regulator notices. The regulations prescribe the timing, form and minimal content of these activities and make facility certification and IBC records the central instruments for lawful NLRD operations.

Gene Technology Regulations 2017

Plain English Summary

Deep Dive

What it does

Current sections

Gene Technology Regulations 2017

Source text: opening excerpt

1 Gene Technology Regulations 2017

Main concepts

Who it affects

Key duties and rights

Penalties and enforcement

How it interacts with other laws

Amendment history

Litigation history

Gotchas

How to comply