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Gene Technology Regulations 2001
Div 1of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
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Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## Division 1 Licensing system
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## 6 Dealings exempt from licensing
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
## 7 Application for licence—prescribed fee
## 8 Time limit for deciding an application
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
## 9 Prescribed authorities
## 9A Risks posed by dealings proposed to be authorised by licence
(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;
## 10 Risk assessment—matters to be taken into account
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
## 11 Prescribed conditions of licence
## 11A Time limit for deciding variation application
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
## Division 2 Notifiable low risk dealings
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## 12 Notifiable low risk dealings
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
## 13 Requirements for undertaking notifiable low risk dealings
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
## 13B Requirements for Institutional Biosafety Committees about records of assessments of notifiable low risk dealing proposals
#### 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:
(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;
(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;
(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 subregulation 13(2);
(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 paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## 14 Regulator to decide certification application within 90 days
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
## 15 Application for certification—failure to provide section 85 information
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
## 16 Regulator to decide accreditation application within 90 days
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
## 17 Application for accreditation—failure to provide section 93 information
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
## Part 4 Gene Technology Technical Advisory Committee
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## Division 1 Conditions of appointment
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## 18 GTTAC members and advisers—term of appointment
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
## 19 GTTAC members and advisers—resignation
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
## 20 GTTAC members—disclosure of interests
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
## 21 GTTAC members and advisers—termination of appointment
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
## 22 GTTAC members—leave of absence
## 23 Expert advisers—disclosure of interests
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
## Division 2 Committee procedures
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## 24 Committee procedures generally
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
## 25 Committee meetings
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
## 26 Presiding member
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
## 27 Quorum
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
## 28 Voting
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
## 29 Records and Reports
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
## Division 3 Subcommittees
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## 30 Operation of subcommittees
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
## Part 5 Ethics and Community Committee
## 31 Ethics and Community Committee—conditions of appointment
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
## 32 Ethics and Community Committee—Committee procedures
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
## 33 Ethics and Community Committee—operation of subcommittees
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
## Part 7 Miscellaneous
## 37 Reviewable State decisions
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
## 38 Review of decisions
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
## 39 Record of GMO Dealings
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
## 40 Inspector identity card
## Part 8 Application and transitional provisions
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## Division 1 Amendments made by the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## 41 Changed requirements for dealings
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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:
## 42 Previous assessment by an Institutional Biosafety Committee
(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
#### 43 New requirements for giving records to Regulator apply to notifiable low risk dealing assessed in previous financial year
Regulation 13C as amended by Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
## Division 2 Amendments made by the Gene Technology Amendment (Minor Measures) Regulations 2025
> 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, jointly published by Standards Australia and Standards New Zealand, as in force on 1 September 2011.
(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:
> 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.
> infectious agent means an agent that is capable of entering, surviving in, multiplying, and potentially causing disease in, a susceptible host.
> oncogenic modification means a genetic modification capable of contributing to tumour formation, including modifications that cause at least 1 of the following:
> 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 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.
> 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:
For paragraph (c) of the definition of gene technology in subsection 10(1) of the Act, gene technology does not include a technique mentioned in Schedule 1A.
For the purposes of paragraph (c) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is a genetically modified organism if an item in Schedule 1B applies to the organism.
For the purposes of paragraph (e) of the definition of genetically modified organism in subsection 10(1) of the Act, an organism is not a genetically modified organism if:
(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
(a) to make inspectors available to be appointed as inspectors under Division 7 of Part 3 of the National Health Security Act 2007;
(b) to make inspectors available to undertake inspections and audits, in relation to the containment of poliovirus, of laboratories in Australia that hold poliovirus.
(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.
> Note 1: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(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
(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 one of the dealings proposed to be authorised by the licence may pose significant risks to the health and safety of people or to the environment—170 days after the day the application is received by the Regulator; and
(2) For the purpose of determining the end of a period mentioned in subregulation (1), the following days are not counted:
(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) 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
(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:
(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 subsection 50(3) or 52(3) of the Act, or from the Ethics and Community Committee, may specify a reasonable period within which the advice must be received, and, if the advice is not received within that period, must proceed without regard to that advice.
(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;
(1) For paragraphs 51(1)(g) and 51(2)(g) of the Act, other matters to be taken into account in relation to dealings proposed to be authorised by a licence include:
(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
(2) In taking into account a risk mentioned in subsection 51(1) of the Act, or a potential capacity mentioned in subregulation (1), the Regulator must consider both the short term and the long term.
(1) For subsection 71(7) of the Act, the Regulator must vary the licence, or refuse to vary the licence, within 90 days after the day an application for a variation of the licence is received by the Regulator.
(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.
(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.
> Note: A dealing affected by this regulation could be any of the forms of dealing mentioned in the definition of deal with in subsection 10(1) of the Act.
(a) a person or an accredited organisation has prepared and submitted a written proposal for an Institutional Biosafety Committee to assess whether the dealing is a notifiable low risk dealing; and
(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
(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
(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
(g) the person keeps or can give, on request, a copy of the Institutional Biosafety Committee’s record of assessment to an inspector; and
(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
(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 paragraph (2)(c), the Regulator must consider the capacity of a facility to contain GMOs before deciding whether to agree, in writing, to a facility.
#### 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:
(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;
(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;
(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 subregulation 13(2);
(b) give a copy of the record of assessment to the person or accredited organisation that submitted the proposal to the Committee.
(1) A person or accredited organisation that has been given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must, if the dealing has been assessed by the Committee as a notifiable low risk dealing, give the Regulator a record of the dealing.
(a) the particulars, prescribed under regulation 39 in relation to the dealing, to be included in the Record of GMO Dealings; 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
(3) A person or accredited organisation given a copy of a record of assessment by an Institutional Biosafety Committee under paragraph 13B(b) must keep a copy of the Committee’s record of assessment for 8 years after the date of the assessment.
(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:
(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.
(1) For section 84 of the Act, the period within which the Regulator must consider, and decide, an application for certification of a facility is:
(b) if the Regulator has given the applicant a notice under subsection 85(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for certification fails to provide information required under subsection 85(1) of the Act within the period specified in a notice given under subsection 85(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to certify the facility that is the subject of the application.
(1) For subsection 92(1) of the Act, the period within which the Regulator must consider, and decide, an application for accreditation of an organisation is:
(b) if the Regulator has given the applicant a notice under subsection 93(1) of the Act, 90 days plus the period beginning on the day the notice is given and ending when the required information is given to the Regulator.
(2) For the purpose of determining the end of a period mentioned in subregulation (1), Saturdays, Sundays and public holidays in the Australian Capital Territory are not counted.
If an applicant for accreditation fails to provide information required under subsection 93(1) of the Act within the period specified in a notice given under subsection 93(2) of the Act, and gives no reasonable explanation for the failure, the Regulator may refuse to accredit the organisation that is the subject of the application.
(1) The term of appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, is 3 years, or a lesser period specified in the instrument of appointment of the member or adviser.
(1) A member of the Gene Technology Technical Advisory Committee, or an expert adviser, may resign by giving the Minister written notice of resignation.
(2) The resignation takes effect on the day the notice is received by the Minister or, if a later day is specified in the notice, on that later day.
(1) Before the Minister appoints a person as a member of the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) A member of the Gene Technology Technical Advisory Committee who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(4) A disclosure in relation to a matter by a member of the Committee under subregulation (2) must be recorded in the minutes of the meeting referred to in that subregulation.
(1) The Minister may terminate the appointment of a member of the Gene Technology Technical Advisory Committee, or an expert adviser, for misbehaviour (including failure to disclose an interest) or physical or mental incapacity:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to fulfil his or her obligations, as a member, in enabling the Committee to comply with section 101 of the Act; or
(c) fails to attend for 3 consecutive attendance days of the Committee, except with leave of absence granted under regulation 22.
> Note: Section 266 of the Administrative Review Tribunal Act 2024 requires the decision‑maker to notify persons whose interests are affected by the decision of the making of the decision and their right to have the decision reviewed. In so notifying, the decision‑maker must have regard to any matters prescribed by rules made for the purposes of section 267 of that Act.
(1) Before the Minister appoints a person as an expert adviser to the Gene Technology Technical Advisory Committee, the Minister must obtain from the person a declaration setting out all direct or indirect interests, pecuniary or otherwise, that the person is aware of having in a matter of a kind likely to be considered at a meeting of the Committee.
(2) An expert adviser who is aware of having a direct or indirect interest, pecuniary or otherwise, in a matter being considered, or about to be considered, at a meeting of the Committee for which he or she is providing advice must, without delay, disclose the nature of the interest at, or before, the meeting of the Committee.
(3) Disclosure must include interests that could be perceived to represent a possible conflict of interest in relation to:
(b) must act with as little formality and as quickly as the requirements of these Regulations, and a proper consideration of the issues before the Committee, allow; and
(c) may obtain information about an issue in any way it considers appropriate, subject to any direction in a request from the Regulator or Ministerial Council about the extent to which, or manner in which, information is to be obtained.
(1) The Chairperson of the Gene Technology Technical Advisory Committee may, by written notice to the Committee, direct the Committee to hold a meeting:
(3) If the Chairperson of the Committee considers it appropriate and efficient in the circumstances, the Committee may be directed:
> out of session, in relation to a meeting, means a meeting in which the members take part by correspondence, electronic mail, telephone or in any other way that does not involve formal simultaneous meeting and voting.
(b) nominate, in writing, a member of the Committee (other than a member who is also a member of the Ethics and Community Committee) to preside.
(2) If the Chairperson is temporarily absent from a meeting, the members present must choose a member to preside in the Chairperson’s absence.
At a meeting of the Gene Technology Technical Advisory Committee, a quorum exists if half of the members appointed under subsection 100(2) of the Act are present.
(1) A decision of the Gene Technology Technical Advisory Committee is made by a majority of the members present, and voting for the decision, at a Committee meeting.
(2) The member presiding at a Committee meeting has a deliberative vote and also has a casting vote in the event of an equality of votes by members present.
(1) The Gene Technology Technical Advisory Committee must keep a record of its proceedings, and must give to the Regulator a copy of each resolution passed by the Committee.
(2) Copies of resolutions are to be maintained by the Regulator in a form accessible to the public, except to the extent that information in a resolution is considered by the Regulator to be confidential commercial information.
(3) The Committee must prepare any other report about its activities that is requested by the Ministerial Council or the Regulator.
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 105(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Gene Technology Technical Advisory Committee a copy of each resolution passed by the subcommittee.
Division 1 of Part 4 applies to the conditions of appointment of a member of the Ethics and Community Committee, or an expert adviser, as if:
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member of the Gene Technology Technical Advisory Committee were a reference to a member of the Ethics and Community Committee; and
(a) a reference to the Gene Technology Technical Advisory Committee were a reference to the Ethics and Community Committee; and
(b) a reference to a member or Chairperson of the Gene Technology Technical Advisory Committee were a reference to a member or Chairperson of the Ethics and Community Committee; and
(c) the reference in paragraph 26(1)(b) to the Ethics and Community Committee were a reference to the Gene Technology Technical Advisory Committee or the Australian Health Ethics Committee; and
(1) Regulations 24, 25, 26 and 28 apply to a subcommittee established under subsection 111(1) of the Act as if a reference in those regulations to the Gene Technology Technical Advisory Committee were a reference to the subcommittee.
(3) A subcommittee must keep a record of its proceedings, and must give to the Ethics and Community Committee a copy of each resolution passed by the subcommittee.
> Note: At the commencement of these Regulations, no decisions of the Regulator are reviewable State decisions under section 19 of the Act.
Subject to the Administrative Review Tribunal Act 2024, a person whose interests are affected by a decision of the Minister under regulation 21, or that regulation as applied to Part 5 of these Regulations, may apply to the Administrative Review Tribunal for review of the decision.
For the purposes of subsection 138(4) of the Act, the following particulars are prescribed in relation to a notifiable low risk dealing that is notified to the Regulator:
(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;
(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;
(a) the dealing is assessed, under the new Regulations, as a notifiable low risk dealing by an Institutional Biosafety Committee; or
(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) 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 Schedule 2 to the Gene Technology Amendment (2019 Measures No. 1) Regulations 2019 applies in relation to a dealing that has been assessed by an Institutional Biosafety Committee as a notifiable low risk dealing on or after 1 July 2019.
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## 44 Preliminary
## 45 Risk assessments and risk management plans
Paragraph 9(d), as substituted by the amending regulations, applies in relation to the seeking of advice on or after the commencement day:
## 46 Resignation of committee member or expert adviser
The amendments of regulation 19 made by the amending regulations apply in relation to a notice of resignation given to the Minister on or after the commencement day.
## 47 Disclosure of interests by committee member
The amendment of regulation 20 made by the amending regulations applies in relation to a committee meeting held on or after the commencement day, regardless of whether the disclosure of interests, by a member of the committee in relation to a matter to be considered at that meeting, was made before, on or after the commencement day.
## 48 Techniques that are not gene technology
The amendments of Schedule 1A made by the amending regulations apply in relation to a technique on or after the commencement day, regardless of whether the technique was applied before, on or after that day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendments commence, even if:
(a) a technique applied to modify the organism before the commencement day was gene technology at the time it was applied; or
(b) the organism inherited a trait, from another organism, that occurred in that other organism because of a technique that was gene technology at the time it was applied.
## 49 Organisms that are not GMOs
(1) The amendments of item 6 of Schedule 1 made by the amending regulations apply in relation to an organism on or after the day that is 12 months after the commencement day.
> Note: The effect of this regulation includes that an organism that is not a GMO immediately before the day that is 12 months after the commencement day may start to be a GMO from 12 months after the amendments commence.
(2) The amendment of item 10 of Schedule 1 made by the amending regulations applies in relation to an organism on or after the commencement day.
> Note: The effect of this regulation includes that an organism that was a GMO immediately before the commencement day may cease to be a GMO from when the amendment commences.
## 1.1 Genetically modified organisms
#### 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.
<table cellspacing="0" cellpadding="0" style="border-collapse:collapse"><thead><tr><td colspan="2" style="width:416.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Organisms that are genetically modified organisms</span></p></td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:379.05pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Description of organism</span></p></td></tr></thead><tbody><tr><td style="width:26.3pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:379.05pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>An organism that has had its genome modified by oligonucleotide</span><span>‑</span><span>directed mutagenesis</span></p></td></tr><tr><td style="width:26.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:379.05pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>An organism modified by repair of single</span><span>‑</span><span>strand or double</span><span>‑</span><span>strand breaks of genomic DNA induced by a site</span><span>‑</span><span>directed nuclease, if a nucleic acid template was added to guide homology</span><span>‑</span><span>directed repair</span></p></td></tr></tbody></table>
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