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Australian Capital Territory
Gene Technology Regulation 2004
SL2004-17
made under the
Gene Technology Act 2003
Republication No 14
Effective: 2 June 2025
Republication date: 2 June 2025
Last amendment made by A2025-16
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About this republication
The republished law
This is a republication of the Gene Technology Regulation 2004, made under the Gene
Technology Act 2003 (including any amendment made under the Legislation Act 2001, part 11.3
(Editorial changes)) as in force on 2 June 2025. It also includes any commencement, amendment,
repeal or expiry affecting this republished law to 2 June 2025.
The legislation history and amendment history of the republished law are set out in endnotes 3
and 4.
Kinds of republications
The Parliamentary Counsel’s Office prepares 2 kinds of republications of ACT laws (see the ACT
legislation register at www.legislation.act.gov.au):
• authorised republications to which the Legislation Act 2001 applies
• unauthorised republications.
The status of this republication appears on the bottom of each page.
Editorial changes
The Legislation Act 2001, part 11.3 authorises the Parliamentary Counsel to make editorial
amendments and other changes of a formal nature when preparing a law for republication.
Editorial changes do not change the effect of the law, but have effect as if they had been made by
an Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117). The
changes are made if the Parliamentary Counsel considers they are desirable to bring the law into
line, or more closely into line, with current legislative drafting practice.
This republication does not include amendments made under part 11.3 (see endnote 1).
Uncommenced provisions and amendments
If a provision of the republished law has not commenced, the symbol U appears immediately
before the provision heading. Any uncommenced amendments that affect this republished law
are accessible on the ACT legislation register (www.legislation.act.gov.au). For more
information, see the home page for this law on the register.
Modifications
If a provision of the republished law is affected by a current modification, the
symbol M appears immediately before the provision heading. The text of the modifying
provision appears in the endnotes. For the legal status of modifications, see the Legislation
Act 2001, section 95.
Penalties
At the republication date, the value of a penalty unit for an offence against this law is $160 for an
individual and $810 for a corporation (see Legislation Act 2001, s 133).
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Australian Capital Territory
Gene Technology Regulation 2004
made under the
Gene Technology Act 2003
Contents
Page
Part 1 Preliminary
1 Name of regulation 2
3 Dictionary 2
3A Numbering 2
3B Notes 3
3C Offences against regulation—application of Criminal Code etc 4
Contents
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Part 2 Interpretation and general operation
4 Techniques not constituting gene technology 5
4A Organisms that are genetically modified organisms 5
5 Organisms that are not genetically modified organisms 5
Part 3 Dealings with GMOs
Division 3.1 Licensing system
6 Dealings exempt from licensing 6
7 Application for licence—prescribed fee 6
8 Time limit for deciding an application—Act, s 43 (3) 6
9 Prescribed authorities—Act, s 50 (3) (c) and s 52 (5) (c) 9
9A Risks posed by dealings proposed to be authorised by licence—Act, s
51 (1) (a) 9
10 Risk assessment—matters to be taken into account—Act, s 51 (1) (d)
and (2) (d) 10
11 Prescribed conditions of licence 10
11A Time limit for deciding variation application—Act, s 71 (7) 10
Division 3.2 Notifiable low risk dealings
12 Notifiable low risk dealings—Act, s 74 (1) 11
13 Requirements for undertaking notifiable low risk dealings 11
13B Requirements for institutional biosafety committees about records of
assessments of notifiable low risk dealing proposals 14
13C Information to be kept or given to the regulator by people or accredited
organisations 15
Division 3.3 Certification and accreditation
14 Regulator to decide certification application within 90 days 16
15 Application for certification—failure to provide Act, s 85 information 17
16 Regulator to decide accreditation application within 90 days 17
17 Application for accreditation—failure to provide Act, s 93 information 17
Part 4 Gene technology technical advisory
committee
Division 4.1 Conditions of appointment
18 GTTAC members and advisers—term of appointment 18
Contents
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19 GTTAC members and advisers—resignation 18
20 GTTAC members—disclosure of interests 18
21 GTTAC members and advisers—termination of appointment 18
22 GTTAC members—leave of absence 18
23 Expert advisers—disclosure of interests 19
Division 4.2 Committee procedures
24 Committee procedures generally 19
25 Committee meetings 19
26 Presiding member 19
27 Quorum 19
28 Voting 19
29 Records and reports 20
Division 4.3 Subcommittees
30 Operation of subcommittees 20
Part 5 Ethics and community committee
31 Ethics and community committee—conditions of appointment 21
32 Ethics and community committee—committee procedures 21
33 Ethics and community committee—operation of subcommittees 21
Part 7 Miscellaneous
37 Reviewable State decisions 22
38 Review of decisions 22
39 Record of GMO dealings 22
40 Inspector identity card 23
41 Disapplication of Legislation Act, s 47 (5) 23
Contents
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Schedule 1A Techniques that are not gene technology 24
Schedule 1B Organisms that are genetically modified
organisms 25
Schedule 1 Organisms that are not genetically modified
organisms 26
Schedule 2 Dealings exempt from licensing 28
Part 2.1 Exempt dealings 28
Part 2.2 Host/vector systems for exempt dealings 31
2.2 Hosts and vectors 31
Part 2.3 Definitions—sch 2 36
Schedule 3 Notifiable low risk dealings in relation to a
GMO 37
Part 3.1 Notifiable low risk dealings suitable for at least
physical containment level 1 37
3.1 Kinds of dealings suitable for at least physical containment level 1 37
Part 3.2 Notifiable low risk dealings suitable for at least
physical containment level 2 or 3 39
3.2 Kinds of dealings suitable for at least physical containment level 2 39
3.2A Kinds of dealing suitable for at least physical containment level 3 44
Contents
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Part 3.3 Dealings that are not notifiable low risk dealings 46
3.3 Kinds of dealings 46
Dictionary 51
Endnotes
1 About the endnotes 56
2 Abbreviation key 56
3 Legislation history 57
4 Amendment history 59
5 Earlier republications 64
6 Expired transitional or validating provisions 66
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Australian Capital Territory
Gene Technology Regulation 2004
made under the
Gene Technology Act 2003
Part 1 Preliminary
Section 1
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Part 1 Preliminary
1 Name of regulation
This regulation is the Gene Technology Regulation 2004.
3 Dictionary
The dictionary at the end of this regulation is part of this regulation.
Note 1 The dictionary at the end of this regulation defines certain terms used in
this regulation.
Note 2 A definition in the dictionary applies to the entire regulation unless the
definition, or another provision of the regulation, provides otherwise or
the contrary intention otherwise appears (see Legislation Act, s 155 and
s 156 (1)).
3A Numbering
(1) To maintain consistent provision numbering between this regulation
and the Commonwealth regulations—
(a) if the Commonwealth regulations contain a regulation that is not
needed in this regulation—the provision number and heading to
the regulation appearing in the Commonwealth regulations are
included in this regulation despite the omission of the body of
the Commonwealth regulation; and
(b) if this regulation contains a section that is not included in the
Commonwealth regulations—the section is numbered to
maintain consistency in numbering between provisions common
to both.
(2) A provision number and heading mentioned in subsection (1) (a)
form part of this regulation.
Preliminary Part 1
Section 3B
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(3) If a provision of this regulation (other than a section) is numbered
differently from the equivalent provision of the Commonwealth
regulations, the provision of this regulation may be referred to using
the number of the equivalent provision of the Commonwealth
regulations.
(4) Also, a provision of this regulation may be referred to in the way in
which a corresponding provision may be referred to in
Commonwealth regulations.
Note 1 A note appears under each heading of a kind mentioned in s (1) (a)
describing the omitted regulation of the Commonwealth regulations.
Note 2 A note appears under each section of a kind mentioned in s (1) (b)
highlighting the non-appearance of an equivalent regulation in the
Commonwealth regulations.
Note 3 This section does not appear in the Commonwealth regulations.
3B Notes
A note included in this regulation is explanatory and is not part of this
regulation.
Note 1 See the Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.
Note 2 This section does not appear in the Commonwealth regulations.
Part 1 Preliminary
Section 3C
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3C Offences against regulation—application of Criminal
Code etc
Other legislation applies in relation to offences against this
regulation.
Note 1 Criminal Code
The Criminal Code, ch 2 applies to all offences against this regulation
(see Code, pt 2.1).
The chapter sets out the general principles of criminal responsibility
(including burdens of proof and general defences), and defines terms used
for offences to which the Code applies (eg conduct, intention,
recklessness and strict liability).
Note 2 Penalty units
The Legislation Act, s 133 deals with the meaning of offence penalties
that are expressed in penalty units.
Note 3 This section does not appear in the Commonwealth regulations.
Interpretation and general operation Part 2
Section 4
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Part 2 Interpretation and general
operation
4 Techniques not constituting gene technology
For the Act, dictionary, definition of gene technology, paragraph (c),
gene technology does not include a technique in schedule 1A.
4A Organisms that are genetically modified organisms
For the Act, dictionary, definition of genetically modified organism,
paragraph (c), an organism mentioned in schedule 1B is a genetically
modified organism.
5 Organisms that are not genetically modified organisms
For the Act, dictionary, definition of genetically modified organism,
paragraph (e), an organism is not a genetically modified organism
if—
(a) 1 or more items mentioned in schedule 1 applies to the organism;
and
(b) the organism has not been modified by gene technology, other
than any modification mentioned in schedule 1; and
(c) the organism has not inherited any traits from an organism (the
initial organism) that occurred in the initial organism because
of gene technology, other than as mentioned in schedule 1,
item 9; and
(d) none of the items mentioned in schedule 1B applies to the
organism.
Part 3 Dealings with GMOs
Division 3.1 Licensing system
Section 6
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Part 3 Dealings with GMOs
Division 3.1 Licensing system
6 Dealings exempt from licensing
(1) For the Act, dictionary, definition of exempt dealing, a dealing with
a GMO is an exempt dealing if—
(a) it is a dealing of a kind mentioned in schedule 2, part 2.1; and
(b) it does not involve a genetic modification other than a
modification described in schedule 2, part 2.1; and
(d) it does not involve an intentional release of the GMO into the
environment.
(2) To remove any doubt, an exemption under subsection (1) does not
apply to a dealing that does not comply with that subsection, whether
or not that dealing is related to a dealing that does comply.
Note 1 A dealing affected by this section could be any of the forms of dealing
mentioned in the Act, dict, def deal with.
Note 2 Exemption from provisions of the Act does not preclude the application
of other Commonwealth and State laws.
7 Application for licence—prescribed fee
Note At the commencement of the regulation, no application fee is prescribed
under the Act, s 40 (6).
8 Time limit for deciding an application—Act, s 43 (3)
(1) The period within which the regulator must issue, or refuse to issue,
a licence is—
(a) for an application to which the Act, division 5.3 applies—
90 days after the day the application is received by the regulator;
or
Dealings with GMOs Part 3
Licensing system Division 3.1
Section 8
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(b) for an application to which the Act, division 5.4 applies—
(i) for a limited and controlled release application for which
the regulator is satisfied that the dealings proposed to be
authorised by the licence do not pose significant risks to
the health and safety of people or to the environment—
150 days after the day the application is received by the
regulator; and
(ii) for a limited and controlled release application for which
the regulator is satisfied that at least 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
(iii) in any other case—255 days after the day the application is
received by the regulator.
(2) In working out the end of a period mentioned in subsection (1), the
following days are not counted:
(a) a Saturday, a Sunday or a public holiday;
(b) a day when the regulator cannot proceed with the
decision-making process, or a related function, because the
regulator is awaiting information that the applicant has been
asked, in writing, to give;
(c) if, in relation to the application, the regulator publishes notice of
a public hearing under the Act, section 53—a day in the period
that—
(i) begins on the day of publication; and
(ii) ends on the day when the public hearing ends;
Part 3 Dealings with GMOs
Division 3.1 Licensing system
Section 8
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(d) a day when the regulator cannot proceed with the
decision-making process, or a related function, because—
(i) the applicant has applied under the Act, section 184 for
information given in relation to the application to be
declared confidential commercial information for the Act;
and
(ii) the regulator is—
(A) considering the application; or
(B) waiting until any review rights under the Act,
section 181 or section 183 in relation to the
application are exhausted;
(e) if, in relation to the application, the regulator requests the ethics
and community committee to provide advice on an ethical issue,
a day in the period that—
(i) begins on the day the request is made; and
(ii) subject to subsection (3), ends on the day the advice is
given or, if the advice is not given within the period (if any)
specified under that subsection, on the last day of that
period.
(3) The regulator, when seeking advice under the Act, section 50 (3) or
section 52 (5) 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 the period, must proceed
without regard to the advice.
(4) In this section:
limited and controlled release application means an application for
a licence to which the Act, section 50A applies.
Dealings with GMOs Part 3
Licensing system Division 3.1
Section 9
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9 Prescribed authorities—Act, s 50 (3) (c) and s 52 (5) (c)
The following Commonwealth authorities and agencies are
prescribed:
(a) Food Standards Australia New Zealand;
(b) the Commonwealth department administered by the Minister
administering the Biosecurity Act 2015 (Cwlth), chapter 8,
part 1 (Biosecurity emergencies);
(d) the Director, National Industrial Chemical Notification and
Assessment Scheme under the Industrial Chemicals
(Notification and Assessment) Act 1989 (Cwlth);
(e) Australian Pesticides and Veterinary Medicines Authority;
(f) Therapeutic Goods Administration, Commonwealth
Department of Health.
9A Risks posed by dealings proposed to be authorised by
licence—Act, s 51 (1) (a)
The regulator must have regard to the following matters:
(a) the properties of the organism to which dealings proposed to be
authorised by a licence relate before it became, or will become,
a GMO;
(b) the effect, or the expected effect, of the genetic modification that
has occurred, or will occur, on the properties of the organism;
(c) provisions for limiting the dissemination or persistence of the
GMO or its genetic material in the environment;
(d) the potential for spread or persistence of the GMO or its genetic
material in the environment;
(e) the extent or scale of the proposed dealings;
(f) any likely impacts of the proposed dealings on the health and
safety of people.
Part 3 Dealings with GMOs
Division 3.1 Licensing system
Section 10
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10 Risk assessment—matters to be taken into account—Act,
s 51 (1) (d) and (2) (d)
(1) Other matters to be taken into account in relation to dealings proposed
to be authorised by a licence include—
(a) subject to the Act, section 45, any previous assessment by a
regulatory authority, in Australia or overseas, in relation to
allowing or approving dealings with the GMO; and
(b) the potential of the GMO concerned to—
(i) be harmful to other organisms; and
(ii) adversely affect any ecosystems; and
(iii) transfer genetic material to another organism; and
(iv) spread, or persist, in the environment; and
(v) have an advantage in the environment in comparison to
related organisms; and
(vi) be toxic, allergenic or pathogenic to other organisms.
(2) In taking into account a risk mentioned in the Act, section 51 (1), or
a potential capacity mentioned in subsection (1), the regulator must
consider both the short term and the long term.
11 Prescribed conditions of licence
Note At the commencement of this regulation, no conditions are prescribed
under the Act, s 61 (b).
11A Time limit for deciding variation application—Act, s 71 (7)
(1) 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.
Dealings with GMOs Part 3
Notifiable low risk dealings Division 3.2
Section 12
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(2) For the period mentioned in subsection (1), the following days are not
counted:
(a) a Saturday, a Sunday or a public holiday;
(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 3.2 Notifiable low risk dealings
12 Notifiable low risk dealings—Act, s 74 (1)
(1) A dealing with a GMO is a notifiable low risk dealing if—
(a) it is a dealing of a kind mentioned in schedule 3, part 3.1 or
part 3.2; and
(aa) it is not a dealing of a kind mentioned in schedule 3, part 3.3;
and
(b) it does not involve an intentional release of the GMO into the
environment.
(2) To remove any doubt, subsection (1) does not apply to a dealing that
does not comply with that subsection, whether or not that dealing is
related to a dealing that does comply.
Note A dealing affected by this section could be any of the forms of dealing
mentioned in the Act, dict, def deal with.
13 Requirements for undertaking notifiable low risk dealings
(1) A person may undertake a notifiable low risk dealing only if—
(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
Part 3 Dealings with GMOs
Division 3.2 Notifiable low risk dealings
Section 13
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(b) the institutional biosafety committee has assessed the dealing to
be a kind of dealing—
(i) mentioned in schedule 3, part 3.1 or part 3.2; and
(ii) not mentioned in schedule 3, part 3.3; and
(c) the dealing undertaken is the dealing described in the
institutional biosafety committee’s record of assessment of the
proposal; and
(d) the dealing is only undertaken not later than the day 5 years after
the date of the assessment; and
(e) the person is mentioned in, or is in a class of people mentioned
in, the institutional biosafety committee’s record of assessment
as having the appropriate training and experience to undertake
the dealing; and
(f) subject to subsection (3), the dealing is undertaken in facilities
that—
(i) are mentioned in, or are in a class of facilities mentioned
in, the institutional biosafety committee’s record of
assessment as being appropriate for the dealing; and
(ii) are facilities in which the dealing may be undertaken under
subsection (2); and
(g) the person keeps or can give, on request, a copy of the
institutional biosafety committee’s record of assessment to an
inspector; and
(h) the person does not compromise the containment of a GMO
involved in the dealing.
(2) A notifiable low risk dealing must be undertaken—
(a) for a kind of dealing mentioned in schedule 3, part 3.1—in a
facility certified by the regulator to at least physical containment
level 1 and that is appropriate for the dealing; or
Dealings with GMOs Part 3
Notifiable low risk dealings Division 3.2
Section 13
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(b) for a kind of dealing mentioned in schedule 3, section 3.2, but
not in section 3.2A—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 schedule 3, section 3.2A—in
a facility certified by the regulator to at least physical
containment level 3 and that is appropriate for the dealing; or
(c) in a facility that the regulator has agreed in writing is a facility
in which the dealing may be undertaken.
(3) If a notifiable low risk dealing involves the transportation, storage or
disposal of a GMO, the transportation, storage or disposal may
happen outside a facility that complies with
subsections (1) (f) and (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, issued by the regulator
under the Commonwealth Act, section 27 (d); 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.
Part 3 Dealings with GMOs
Division 3.2 Notifiable low risk dealings
Section 13B
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13B Requirements for institutional biosafety committees
about records of assessments of notifiable low risk
dealing proposals
An institutional biosafety committee that has assessed a proposal as
to whether a dealing is a notifiable low risk dealing must—
(a) make a record of its assessment, in a form approved by the
regulator, that includes the following:
(i) the identifying name of the dealing to be undertaken that
was given to the dealing by the person or accredited
organisation that submitted the proposal;
(ii) a description of the dealing to be undertaken;
(iii) its assessment whether the dealing is a kind of dealing
mentioned in schedule 3, part 3.1 or part 3.2, and not
mentioned in schedule 3, part 3.3;
(iv) if the committee has assessed the dealing to be a kind of
dealing mentioned in schedule 3, part 3.1 or part 3.2 (and
not mentioned in schedule 3, part 3.3)—which kind of
dealing in those parts that the dealing is;
(v) the date of the committee’s assessment of the dealing;
(vi) the people or classes of people 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
section 13 (2);
(viii) the name of the committee that assessed the proposal;
Dealings with GMOs Part 3
Notifiable low risk dealings Division 3.2
Section 13C
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(ix) the name of the person or accredited organisation that
submitted the proposal;
(x) the name of the person proposing to undertake the dealing;
and
(b) give a copy of the record of assessment to the person or
accredited organisation that submitted the proposal to the
committee.
13C Information to be kept or given to the regulator by people
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
section 13B (b) must, if the dealing has been assessed by the
committee as a notifiable low risk dealing, give the regulator a record
of the dealing.
(2) For subsection (1), a record of a dealing must include—
(a) the particulars, prescribed under section 39 in relation to the
dealing, to be included in the record of GMO dealings; and
(b) the name of the committee that assessed the proposal relating to
the dealing; and
(c) the name of the person or accredited organisation that submitted
the proposal to the committee for assessment.
(2A) The record must be given to the regulator—
(a) in a form approved by the regulator; and
(b) not later than 30 September in the financial year following the
financial year in which the institutional biosafety committee
made the assessment.
Part 3 Dealings with GMOs
Division 3.3 Certification and accreditation
Section 14
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(2B) An accredited organisation that is required to, as a condition of
accreditation, give an annual report to the regulator, must—
(a) include the record in the annual report for the year in which the
institutional biosafety committee made the assessment; or
(b) certify in the annual report that the record has previously been
given to the regulator.
(3) A person or accredited organisation given a copy of a record of
assessment by an institutional biosafety committee under
section 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 people or organisations more information about how a
notifiable low risk dealing is being undertaken, including information
about a GMO being dealt with:
(a) the person or accredited organisation that submitted the proposal
for assessment of the dealing;
(b) any other person involved with undertaking the dealing.
(5) A person or organisation given a notice under subsection (4) must, by
the end of the period mentioned in the notice, give the regulator the
information required by the notice.
Division 3.3 Certification and accreditation
14 Regulator to decide certification application within
90 days
Note The Commonwealth regulations, reg 14 provides the period within which
the regulator must consider and decide an application for certification of
a facility.
Dealings with GMOs Part 3
Certification and accreditation Division 3.3
Section 15
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15 Application for certification—failure to provide Act, s 85
information
If an applicant for certification of a facility fails to provide
information required under the Act, section 85 (1) within the period
stated in a notice given under the Act, section 85 (2) and gives no
reasonable explanation for the failure, the regulator may refuse to
certify the facility.
Note A refusal to certify a facility is a reviewable decision (see the Act,
div 12.2).
16 Regulator to decide accreditation application within
90 days
Note The Commonwealth regulations, reg 16 provides the period within which
the regulator must consider and decide an application for accreditation of
an organisation.
17 Application for accreditation—failure to provide Act, s 93
information
If an applicant for accreditation of an organisation fails to provide
information required under the Act, section 93 (1) within the period
stated in a notice given under the Act, section 93 (2) and gives no
reasonable explanation for the failure, the regulator may refuse to
accredit the organisation.
Note A refusal to accredit an organisation is a reviewable decision (see the Act,
div 12.2).
Part 4 Gene technology technical advisory committee
Division 4.1 Conditions of appointment
Section 18
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Part 4 Gene technology technical
advisory committee
Division 4.1 Conditions of appointment
18 GTTAC members and advisers—term of appointment
Note The Commonwealth regulations, reg 18 provides for the term of
appointment of members of the gene technology technical advisory
committee and expert advisers to the committee.
19 GTTAC members and advisers—resignation
Note The Commonwealth regulations, reg 19 provides for the resignation of
members of the gene technology technical advisory committee and expert
advisers to the committee.
20 GTTAC members—disclosure of interests
Note The Commonwealth regulations, reg 20 provides for disclosure of any
interests members of the gene technology technical advisory committee
may have in matters likely to be considered at a meeting of the committee.
21 GTTAC members and advisers—termination of
appointment
Note The Commonwealth regulations, reg 21 provides for termination of the
appointment of members of the gene technology technical advisory
committee and expert advisers to the committee.
22 GTTAC members—leave of absence
Note The Commonwealth regulations, reg 22 provides for the granting of leave
to the chairperson and members of the gene technology technical
advisory committee.
Gene technology technical advisory committee Part 4
Committee procedures Division 4.2
Section 23
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23 Expert advisers—disclosure of interests
Note The Commonwealth regulations, reg 23 provides for disclosure of any
interests expert advisers to the gene technology technical advisory
committee may have in matters likely to be considered at a meeting of
the committee.
Division 4.2 Committee procedures
24 Committee procedures generally
Note The Commonwealth regulations, reg 24—
• provides that the gene technology technical advisory committee
must act without formality; and
• provides for how the committee may obtain information.
25 Committee meetings
Note The Commonwealth regulations, reg 25 provides for when and how the
gene technology technical advisory committee may have meetings.
26 Presiding member
Note The Commonwealth regulations, reg 26 provides for who is to preside at
a meeting of the gene technology technical advisory committee.
27 Quorum
Note The Commonwealth regulations, reg 27 provides that there is a quorum
at a meeting of the gene technology technical advisory committee if half
of the appointed members are present.
28 Voting
Note The Commonwealth regulations, reg 28 provides that—
• a decision of the gene technology technical advisory committee is
made by half of the members present, and voting for the decision, at
a meeting of the committee; and
• the presiding member has a deliberative and casting vote.
Part 4 Gene technology technical advisory committee
Division 4.3 Subcommittees
Section 29
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29 Records and reports
Note The Commonwealth regulations, reg 29 provides for—
• records of proceedings and resolutions of the gene technology
technical advisory committee to be kept; and
• resolutions of the committee to be publicly available; and
• reports to be prepared about the committee’s activities.
Division 4.3 Subcommittees
30 Operation of subcommittees
Note The Commonwealth regulations, reg 30 provides for the matters covered
by the Commonwealth regulations, pt 4, div 2 for subcommittees
established under the Commonwealth Act, s 105 (1).
Ethics and community committee Part 5
Section 31
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Part 5 Ethics and community committee
31 Ethics and community committee—conditions of
appointment
Note The Commonwealth regulations, reg 31 provides for the Commonwealth
Act, pt 4, div 1 to apply to the conditions of appointment of a member of
the ethics and community committee.
32 Ethics and community committee—committee
procedures
Note The Commonwealth regulations, reg 32 provides for the Commonwealth
Act, pt 4, div 2 to apply to the procedures of the ethics and community
committee.
33 Ethics and community committee—operation of
subcommittees
Note The Commonwealth regulations, reg 33 provides for the matters covered
by the Commonwealth Act, pt 4, div 2 for subcommittees established
under the Commonwealth Act, s 111 (1).
Part 7 Miscellaneous
Section 37
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Part 7 Miscellaneous
37 Reviewable State decisions
Note At the commencement of this regulation, the Commonwealth regulations
have not declared any decisions of the regulator to be reviewable State
decisions for the Commonwealth Act, s 19.
38 Review of decisions
Note The Commonwealth regulations, reg 38 provides that a person whose
interests are affected by a decision terminating an appointment to a
committee may apply to the Commonwealth administrative review
tribunal for review of the decision.
39 Record of GMO dealings
For the Act, section 138 (2) (b), the following particulars are
prescribed for a notifiable low risk dealing notified to the regulator:
(a) the person that proposed to undertake the dealing, as recorded
by the institutional biosafety committee that assessed the dealing
as a notifiable low risk dealing;
(b) the kind of notifiable low risk dealing (described using the terms
in schedule 3, part 3.1 or part 3.2);
(c) the identifying name given to the dealing by the person or
accredited organisation that submitted the dealing to the
institutional biosafety committee for assessment;
(d) the date of assessment by the institutional biosafety committee
that the dealing is a notifiable low risk dealing.
Miscellaneous Part 7
Section 40
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40 Inspector identity card
Note The Commonwealth regulations, reg 40 prescribes the form of an
inspector’s identity card. Under the Act, s 151 the card must be in the
approved form.
41 Disapplication of Legislation Act, s 47 (5)
The Legislation Act, section 47 (5) does not apply to
AS/NZS 2243.3:2010 under this regulation.
Schedule 1A Techniques that are not gene technology
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Schedule 1A Techniques that are not gene
technology
(see s 4)
column 1
item
column 2
description of technique
1 somatic cell nuclear transfer, if the transfer does not involve genetically
modified material
2 electromagnetic radiation-induced mutagenesis
3 particle radiation-induced mutagenesis
4 chemical-induced mutagenesis
5 fusion of animal cells, or human cells, if the fused cells are unable to form a
viable whole animal or human
6 protoplast fusion, including fusion of plant protoplasts
7 embryo rescue
8 in-vitro fertilisation
9 zygote implantation
10 a natural process, if the process does not involve genetically modified material
Examples—natural processes
Conjugation, transduction, transformation and transposon mutagenesis.
11 introduction of RNA into an organism if—
(a) the RNA cannot be translated into a polypeptide; and
(b) the introduction of the RNA cannot result in an alteration of the
organism’s genome sequence; and
(c) the introduction of the RNA cannot give rise to an infectious agent
Organisms that are genetically modified organisms Schedule 1B
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Schedule 1B Organisms that are genetically
modified organisms
(see s 4A)
column 1
item
column 2
description of organism
1 an organism that has had its genome modified by oligonucleotide-directed
mutagenesis
2 an organism modified by repair of single-strand or double-strand breaks of
genomic DNA induced by a site-directed nuclease, if a nucleic acid template
was added to guide homology-directed repair
Schedule 1 Organisms that are not genetically modified organisms
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Schedule 1 Organisms that are not
genetically modified organisms
(see s 5)
column 1
item
column 2
description of organism
2 a whole animal, or a human being, modified by the introduction of naked
recombinant nucleic acid (such as a DNA vaccine) into its somatic cells, if the
introduced nucleic acid is incapable of giving rise to infectious agents
3 naked plasmid DNA that is incapable of giving rise to infectious agents when
introduced into a host cell
4 an organism modified by repair of single-strand or double-strand breaks of
genomic DNA induced by a site-directed nuclease, if a nucleic acid template
was not added to guide homology-directed repair
6 an organism that results from an exchange of DNA if—
(a) the donor species is also the host species; and
(b) the vector DNA does not contain any heterologous DNA
7 an organism that results from an exchange of DNA between the donor species
and the host species if—
(a) such exchange can occur by naturally occurring processes; and
(b) the donor species and the host species are micro-organisms that—
(i) satisfy the criteria in AS/NZS 2243.3:2010, for classification as
Risk Group 1; and
(ii) are known to exchange nucleic acid by a natural physiological
process; and
(c) the vector used in the exchange does not contain heterologous DNA
from any organism other than an organism that is involved in the
exchange
Organisms that are not genetically modified organisms Schedule 1
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column 1
item
column 2
description of organism
8 an organism that is descended from a genetically modified organism (the initial
organism) if none of the traits it has inherited from the initial organism are
traits that occurred in the initial organism because of gene technology
9 an organism that has inherited particular traits from an organism (the initial
organism) that occurred in the initial organism because of gene technology,
if—
(a) the initial organism was not a genetically modified organism (because of
the application of section 5); or
(b) all such inherited traits are traits that occurred in the initial organism as a
result of a modification mentioned in an item in this schedule
10 an organism that was modified by gene technology but in which the
modification, and any traits that occurred because of gene technology, are no
longer present
11 Agrobacterium radiobacter strain K1026
12 Pasteurella multocida strain PMP1
Schedule 2 Dealings exempt from licensing
Part 2.1 Exempt dealings
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Schedule 2 Dealings exempt from
licensing
(see s 6)
Note For this schedule, s 6 (1) sets out other requirements for exempt dealings.
Part 2.1 Exempt dealings
column 1
item
column 2
description of dealing
2 a dealing with a genetically modified Caenorhabditis elegans, unless—
(a) an advantage is conferred on the animal by the genetic modification; or
(b) as a result of the genetic modification, the animal is capable of secreting
or producing an infectious agent
3 a dealing with an animal into which genetically modified somatic cells have
been introduced, if—
(a) the somatic cells are not capable of giving rise to infectious agents as a
result of the genetic modification; and
(b) the animal is not infected with a virus that is capable of recombining
with the genetically modified nucleic acid in the somatic cells
3A a dealing with an animal whose somatic cells have been genetically modified in
vivo by a replication defective viral vector, if—
(a) the in vivo modification occurred as part of a previous dealing; and
(b) the replication defective viral vector is no longer in the animal; and
(c) no germ line cells have been genetically modified; and
(d) the somatic cells cannot give rise to infectious agents as a result of the
genetic modification; and
(e) the animal is not infected with a virus that can recombine with the
genetically modified nucleic acid in the somatic cells of the animal.
4 (1) Subject to subsection (1), a dealing involving a host/vector system
mentioned in table 2.2 and producing not more than 25L of GMO culture
in each vessel containing the resultant culture.
Dealings exempt from licensing Schedule 2
Exempt dealings Part 2.1
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column 1
item
column 2
description of dealing
(2) The donor nucleic acid—
(a) must meet either of the following requirements:
(i) the acid must not be derived from organisms implicated in, or
with a history of causing, disease in otherwise healthy—
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
(ii) the acid must be characterised and the information derived
from its characterisation show that it is unlikely to increase
the capacity of the host or vector to cause harm; and
Example
Donor nucleic acid would not comply with par (ii) if its
characterisation shows that, in relation to the capacity of the
host or vector to cause harm, it—
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility.
(b) must not code for a toxin with an LD50 of less than 100
micrograms per kilogram; and
(c) must not code for a toxin with an LD50 of 100 micrograms per
kilogram or more, if the intention is to express the toxin at high
levels; and
(d) must not be uncharacterised nucleic acid from a toxin-producing
organism; and
(e) if the donor nucleic acid includes a viral sequence—cannot give
rise to infectious agents when introduced into any potential host
species without additional non-host genes or gene products that—
(i) are not available in the host cell into which the nucleic acid is
introduced as part of the dealing; and
(ii) will not become available during the dealing; and
(f) if the donor nucleic acid includes a viral sequence—cannot restore
replication competence to the vector.
Schedule 2 Dealings exempt from licensing
Part 2.1 Exempt dealings
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column 1
item
column 2
description of dealing
5 a dealing involving shotgun cloning, or the preparation of a cDNA library, in a
host/vector system mentioned in table 2.2, items 1 to 6, if the donor nucleic acid
is not derived from either—
(a) a pathogen; or
(b) a toxin-producing organism
Dealings exempt from licensing Schedule 2
Host/vector systems for exempt dealings Part 2.2
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Part 2.2 Host/vector systems for exempt
dealings
2.2 Hosts and vectors
In this part:
host means a host mentioned in column 3 of an item in table 2.2.
host/vector system means any of the following:
(a) a system involving a host mentioned in column 3 of an item in
table 2.2 and a vector mentioned in column 4 of the item;
(b) a non-vector system involving a host mentioned in column 3 of
an item in table 2.2;
(c) a system involving a GMO mentioned as a vector in column 4
of an item in table 2.2 (other than item 7), without a host.
vector means a vector mentioned in column 4 of an item in table 2.2.
Note Column 2 of table 2.2 is included for information only.
Table 2.2
column 1
item
column 2
class
column 3
host
column 4
vector
1 bacteria Escherichia coli K12, E. coli B,
E. coli C or E. coli Nissle 1917—
any derivative that does not
contain—
(a) generalised transducing
phages; or
(b) genes able to complement
the conjugation defect in a
non-conjugative plasmid
any of the following:
(a) non-conjugative
plasmids;
(b) lambda bacteriophage;
(c) lambdoid
bacteriophage;
(d) Fd, F1 or M13
bacteriophage
Schedule 2 Dealings exempt from licensing
Part 2.2 Host/vector systems for exempt dealings
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column 1
item
column 2
class
column 3
host
column 4
vector
2 bacteria Bacillus—asporogenic strains of
the following species with a
reversion frequency of less
than 10–7:
(a) B. amyloliquefaciens;
(b) B. licheniformis;
(c) B. pumilus;
(d) B. subtilis;
(e) B. thuringiensis
any of the following:
(a) non-conjugative
plasmids;
(b) other plasmids and
phages whose host
range does not include
B. cereus, B. anthracis
or any other pathogenic
strain of Bacillus
3 bacteria Pseudomonas putida strain
KT2440
non-conjugative plasmids
4 bacteria the following Streptomyces
species:
(a) S. aureofaciens;
(b) S. coelicolor;
(c) S. cyaneus;
(d) S. griseus;
(e) S. lividans;
(f) S. parvulus;
(g) S. rimosus;
(h) S. venezuelae
any of the following:
(a) non-conjugative
plasmids;
(b) plasmids SCP2, SLP1,
SLP2, pIJ101 and
derivatives;
(c) actinophage phi C31
and derivatives
5 bacteria any of the following:
(a) Agrobacterium
radiobacter;
(b) Agrobacterium rhizogenes
(disarmed strains only);
(c) Agrobacterium tumefaciens
(disarmed strains only)
disarmed Ri or Ti plasmids
Dealings exempt from licensing Schedule 2
Host/vector systems for exempt dealings Part 2.2
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column 1
item
column 2
class
column 3
host
column 4
vector
6 bacteria any of the following:
(a) Allorhizobium species;
(b) Corynebacterium
glutamicum;
(c) Lactobacillus species;
(d) Lactococcus lactis;
(e) Oenococcus oeni syn.
Leuconostoc oeni;
(f) Pediococcus species;
(g) Photobacterium angustum;
(h) Pseudoalteromonas
tunicata;
(i) Rhizobium species;
(j) Sphingopyxis alaskensis
syn. Sphingomonas
alaskensis;
(k) Streptococcus
thermophilus;
(l) Synechococcus species
strains PCC 7002, PCC
7942 and WH 8102;
(m) Synechocystis species strain
PCC 6803;
(n) Vibrio cholerae CVD
103-HgR;
(o) Zymomonas mobilis
non-conjugative plasmids
Schedule 2 Dealings exempt from licensing
Part 2.2 Host/vector systems for exempt dealings
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column 1
item
column 2
class
column 3
host
column 4
vector
7 fungi any of the following:
(a) Kluyveromyces lactis;
(b) Neurospora crassa
(laboratory strains);
(c) Pichia pastoris;
(d) Saccharomyces cerevisiae;
(e) Schizosaccharomyces
pombe;
(f) Trichoderma reesei;
(g) Yarrowia lipolytica
all vectors
8 slime
moulds
Dictyostelium species Dictyostelium shuttle
vectors, including those
based on the endogenous
plasmids Ddp1 and Ddp2
9 tissue
culture
any of the following if they
cannot spontaneously generate a
whole animal:
(a) animal or human cell
cultures (including
packaging cell lines);
(b) isolated cells, isolated
tissues or isolated organs,
whether animal or human;
(c) early non-human
mammalian embryos
cultured in vitro
any of the following:
(a) plasmids;
(b) replication defective
viral vectors unable to
transduce human cells;
(c) polyhedron-minus
forms of the baculovirus
Autographa californica
nuclear polyhedrosis
virus (ACNPV)
Dealings exempt from licensing Schedule 2
Host/vector systems for exempt dealings Part 2.2
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column 1
item
column 2
class
column 3
host
column 4
vector
10 tissue
culture
either of the following if they are
not intended, and are not likely
without human intervention, to
vegetatively propagate, flower or
regenerate into a whole plant:
(a) plant cell cultures;
(b) isolated plant tissues or
organs
any of the following:
(a) Disarmed Ri or Ti
plasmids in
Agrobacterium
radiobacter,
Agrobacterium
rhizogenes (disarmed
strains only) or
Agrobacterium
tumefaciens (disarmed
strains only);
(b) non-pathogenic viral
vectors
Schedule 2 Dealings exempt from licensing
Part 2.3 Definitions—sch 2
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Part 2.3 Definitions—sch 2
In this schedule:
code for, in relation to a toxin, means to specify the amino acid
sequence of the toxin.
non-conjugative plasmid means a plasmid that is not
self-transmissible, and includes, but is not limited to, non-conjugative
forms of the following plasmids:
(a) bacterial artificial chromosomes (BACs);
(b) cosmids;
(c) P1 artificial chromosomes (PACs);
(d) yeast artificial chromosomes (YACs).
non-vector system means a system in which donor nucleic acid is or
was introduced into a host cell—
(a) in the absence of a nucleic acid-based vector; or
(b) using a nucleic acid-based vector in the course of a previous
dealing and the vector is—
(i) no longer present; or
(ii) present but cannot be remobilised from a host cell.
Examples
1 A system mentioned in par (a) might involve the use of electroporation or
particle bombardment.
2 A system mentioned in par (b) might involve cells that were transduced with a
replication defective retroviral vector in which no vector particles remain.
Notifiable low risk dealings in relation to a GMO Schedule 3
Notifiable low risk dealings suitable for at least physical containment level 1 Part 3.1
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Schedule 3 Notifiable low risk dealings in
relation to a GMO
(see s 12 and s 13)
Part 3.1 Notifiable low risk dealings
suitable for at least physical
containment level 1
Note Because of s 12 (1), a dealing mentioned in this part is not a notifiable
low risk dealing if it is also a dealing of a kind mentioned in pt 3.3.
3.1 Kinds of dealings suitable for at least physical
containment level 1
The following kinds of notifiable low risk dealings must be
undertaken, unless section 13 (2) (c) or 13 (3) applies, in facilities
certified to at least physical containment level 1 and that are
appropriate for the dealings:
(a) a dealing involving a genetically modified laboratory guinea
pig, a genetically modified laboratory mouse, a genetically
modified laboratory rabbit or a genetically modified laboratory
rat, unless—
(i) an advantage is conferred on the animal by the genetic
modification; or
(ii) the animal is capable of secreting or producing an
infectious agent as a result of the genetic modification;
Schedule 3 Notifiable low risk dealings in relation to a GMO
Part 3.1 Notifiable low risk dealings suitable for at least physical containment level 1
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(c) a dealing involving virions of a replication defective vector
derived from Human adenovirus or from Adeno-associated
virus, either without a host or with a host mentioned in column 3
of item 9 in schedule 2, table 2.2 if the donor nucleic acid—
(i) cannot restore replication competence to the vector; and
(ii) does not confer an oncogenic modification or
immunomodulatory effect in humans.
Notifiable low risk dealings in relation to a GMO Schedule 3
Notifiable low risk dealings suitable for at least physical containment level 2
or 3
Part 3.2
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Part 3.2 Notifiable low risk dealings
suitable for at least physical
containment level 2 or 3
Note Because of s 12 (1), a dealing mentioned in this part is not a notifiable
low risk dealing if it is also a dealing of a kind mentioned in part 3.3.
3.2 Kinds of dealings suitable for at least physical
containment level 2
The following kinds of notifiable low risk dealings must be
undertaken, unless section 13 (2) (c) or 13 (3) applies, in facilities
certified to at least physical containment level 2 and that are
appropriate for the dealings:
(a) a dealing involving whole animals (including non-vertebrates)
that—
(i) involves genetic modification of the genome of the oocyte
or zygote or early embryo by any means to produce a novel
whole organism; and
(ii) does not involve any of the following:
(A) a genetically modified laboratory guinea pig;
(B) a genetically modified laboratory mouse;
(C) a genetically modified laboratory rabbit;
(D) a genetically modified laboratory rat;
(E) a genetically modified Caenorhabditis elegans;
(aa) a dealing involving a genetically modified laboratory guinea
pig, a genetically modified laboratory mouse, a genetically
modified laboratory rabbit, a genetically modified laboratory rat
or a genetically modified Caenorhabditis elegans, if—
(i) the genetic modification confers an advantage on the
animal; and
Schedule 3 Notifiable low risk dealings in relation to a GMO
Part 3.2 Notifiable low risk dealings suitable for at least physical containment level 2
or 3
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(ii) the animal is not capable of secreting or producing an
infectious agent as a result of the genetic modification;
(b) a dealing involving a genetically modified plant;
(c) a dealing involving a host/vector system not mentioned in
section 3.1 (c) or schedule 2, table 2.2 if neither host nor vector
has been implicated in, or has a history of causing, disease in
otherwise healthy—
(i) human beings; or
(ii) animals; or
(iii) plants; or
(iv) fungi;
(d) a dealing involving a host/vector system not mentioned in
schedule 2, table 2.2 if—
(i) the host or vector has been implicated in, or has a history
of causing, disease in otherwise healthy—
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi; and
(ii) the genetic modification is characterised; and
Notifiable low risk dealings in relation to a GMO Schedule 3
Notifiable low risk dealings suitable for at least physical containment level 2
or 3
Part 3.2
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(iii) the characterisation of the genetic modification shows that
it is unlikely to increase the capacity of the host or vector
to cause harm;
Example
A genetic modification would not comply with par (iii) if, in relation to the
capacity of the host or vector to cause harm, it—
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility.
(e) a dealing involving a host/vector system mentioned in
schedule 2, table 2.2, if the donor nucleic acid—
(i) is characterised, and the characterisation shows that it may
increase the capacity of the host or vector to cause harm;
or
(ii) is uncharacterised nucleic acid from an organism that has
been implicated in, or has a history of causing, disease in
otherwise healthy—
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi;
(f) a dealing involving a host/vector system mentioned in
schedule 2, table 2.2 and producing more than 25L of GMO
culture in each vessel containing the resultant culture, if—
(i) the dealing is undertaken in a facility that is certified by the
regulator as a large scale facility; and
(ii) the donor nucleic acid satisfies the conditions set out in
schedule 2, part 2.1, item 4 (2);
Schedule 3 Notifiable low risk dealings in relation to a GMO
Part 3.2 Notifiable low risk dealings suitable for at least physical containment level 2
or 3
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(g) a dealing involving complementation of knocked-out genes, if
the complementation is unlikely to increase the capacity of the
GMO to cause harm compared to the capacity of the parent
organism before the genes were knocked out;
Example
A dealing would not comply with par (g) if it involved complementation that,
in relation to the parent organism—
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility.
(h) a dealing involving shot-gun cloning, or the preparation of a
cDNA library, in a host/vector system mentioned in schedule 2,
table 2.2, items 1 to 6, if the donor nucleic acid is derived from
either—
(i) a pathogen; or
(ii) a toxin-producing organism;
(i) a dealing involving virions of a replication defective viral vector
unable to transduce human cells and a host not mentioned in
schedule 2, table 2.2 if the donor nucleic acid cannot restore
replication competence to the vector;
(j) a dealing involving virions of a replication defective
non-retroviral vector able to transduce human cells, either
without a host or with a host mentioned in schedule 2, table 2.2,
if—
(i) the donor nucleic acid cannot restore replication
competence to the vector; and
(ii) the dealing is not a dealing mentioned in section 3.1 (c);
Notifiable low risk dealings in relation to a GMO Schedule 3
Notifiable low risk dealings suitable for at least physical containment level 2
or 3
Part 3.2
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(k) a dealing involving virions of a replication defective
non-retroviral vector able to transduce human cells and a host
not mentioned in schedule 2, table 2.2 if—
(i) the donor nucleic acid cannot restore replication
competence to the vector; and
(ii) the donor nucleic acid does not confer an oncogenic
modification or immunomodulatory effect in humans;
(l) a dealing involving virions of a replication defective retroviral
vector able to transduce human cells, either without a host or
with a host mentioned in schedule 2, table 2.2, if—
(i) all viral genes have been removed from the retroviral
vector so that it cannot replicate or assemble new virions
without these functions being supplied in trans; and
(ii) viral genes needed for virion production in the packaging
cell line are expressed from independent, unlinked loci
with minimal sequence overlap with the vector to limit or
prevent recombination; and
(iii) either—
(A) the retroviral vector includes a deletion in the Long
Terminal Repeat sequence of DNA that prevents
transcription of genomic RNA following integration
into the host cell DNA; or
(B) the packaging cell line and packaging plasmids
express only viral genes gagpol, rev and an envelope
protein gene, or a subset of these;
(m) a dealing involving virions of a replication defective retroviral
vector able to transduce human cells and a host not mentioned
in schedule 2, table 2.2 if—
(i) the donor nucleic acid does not confer an oncogenic
modification or immunomodulatory effect in humans; and
Schedule 3 Notifiable low risk dealings in relation to a GMO
Part 3.2 Notifiable low risk dealings suitable for at least physical containment level 2
or 3
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(ii) all viral genes have been removed from the retroviral
vector so that it cannot replicate or assemble new virions
without these functions being supplied in trans; and
(iii) viral genes needed for virion production in the packaging
cell line are expressed from independent, unlinked loci
with minimal sequence overlap with the vector to limit or
prevent recombination; and
(iv) either—
(A) the retroviral vector includes a deletion in the Long
Terminal Repeat sequence of DNA that prevents
transcription of genomic RNA following integration
into the host cell DNA; or
(B) the packaging cell line and packaging plasmids
express only viral genes gagpol, rev and an envelope
protein gene, or a subset of these.
3.2A Kinds of dealing suitable for at least physical
containment level 3
(1) This section applies to a kind of dealing that—
(a) is mentioned in section 3.2; and
(b) involves a micro-organism that satisfies the criteria in
AS/NZS 2243.3:2010 for classification as Risk Group 3.
(2) Unless section 13 (2) (c) or 13 (3) applies, the dealing must be
undertaken in facilities that are—
(a) certified to at least physical containment level 3; and
(b) appropriate for the dealings.
(3) For subsection (1) (b), a genetically modified micro-organism is
taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification
as Risk Group 3 if the unmodified parent micro-organism satisfies
those criteria.
Notifiable low risk dealings in relation to a GMO Schedule 3
Notifiable low risk dealings suitable for at least physical containment level 2
or 3
Part 3.2
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(4) However, subsection (3) does not apply in relation to a replication
defective retroviral vector that meets the criteria in
section 3.2 (l) or (m).
Schedule 3 Notifiable low risk dealings in relation to a GMO
Part 3.3 Dealings that are not notifiable low risk dealings
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Part 3.3 Dealings that are not notifiable
low risk dealings
Note 1 The following list qualifies the list in pt 3.1 and pt 3.2 and is not an
exhaustive list of dealings that are not notifiable low risk dealings.
Note 2 If a dealing is not a notifiable low risk dealing or an exempt dealing under
this regulation, a person undertaking the dealing must be authorised by a
GMO licence, unless the dealing is within one of the other exceptions to
licensing provided by the Act (see the Act, s 32).
3.3 Kinds of dealings
(1) A dealing of any of the following kinds, or involving a dealing of the
following kinds, is not a notifiable low risk dealing:
(a) a dealing (other than a dealing mentioned in section 3.2 (h))
involving cloning of nucleic acid encoding a toxin having an
LD50 of less than 100 micrograms per kilogram;
(b) a dealing involving high level expression of toxin genes, even if
the LD50 is 100 micrograms per kilogram or more;
(c) a dealing (other than a dealing mentioned in section 3.2 (h))
involving cloning of uncharacterised nucleic acid from a
toxin-producing organism;
(d) a dealing involving virions of a replication defective viral vector
and a host not mentioned in schedule 2, table 2.2 if—
(i) the donor nucleic acid confers an oncogenic modification
or immunomodulatory effect in humans; and
(ii) the dealing is not a dealing mentioned in section 3.2 (i);
(e) a dealing involving a replication competent virus or viral vector,
other than a vector mentioned in schedule 2, table 2.2, column 4,
if the genetic modification confers an oncogenic modification or
immunomodulatory effect in humans;
Notifiable low risk dealings in relation to a GMO Schedule 3
Dealings that are not notifiable low risk dealings Part 3.3
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(f) a dealing involving, as host or vector, a micro-organism, if—
(i) the micro-organism has been implicated in, or has a history
of causing, disease in otherwise healthy—
(A) human beings; or
(B) animals; or
(C) plants; or
(D) fungi; and
(ii) none of the following apply:
(A) the host/vector system is a system mentioned in
schedule 2, table 2.2;
(B) the genetic modification is characterised and its
characterisation shows that it is unlikely to increase
the capacity of the host or vector to cause harm;
(C) the dealing is a dealing mentioned in section 3.2 (g);
Example
A genetic modification would not comply with par (B) if, in relation
to the capacity of the host or vector to cause harm, it—
(a) provides an advantage; or
(b) adds a potential host species or mode of transmission; or
(c) increases its virulence, pathogenicity or transmissibility.
(g) a dealing involving the introduction, into a micro-organism, of
nucleic acid encoding a pathogenic determinant, unless—
(i) the dealing is a dealing mentioned in section 3.2 (g); or
(ii) the micro-organism is a host mentioned in schedule 2,
table 2.2;
(h) a dealing involving the introduction into a micro-organism,
other than a host mentioned in schedule 2, table 2.2 of genes
whose expressed products are likely to increase the capacity of
the micro-organisms to induce an autoimmune response;
Schedule 3 Notifiable low risk dealings in relation to a GMO
Part 3.3 Dealings that are not notifiable low risk dealings
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(i) a dealing involving use of a viral or viroid genome, or fragments
of a viral or viroid genome, to produce a novel replication
competent virus with an increased capacity to cause harm
compared to the capacity of the parent or donor organism;
Example
A dealing would comply with par (i) if it produces a novel replication
competent virus that has a higher capacity to cause harm to any potential host
species than the parent organism because the new virus has—
(a) an advantage; or
(b) a new potential host species or mode of transmissibility; or
(c) increased virulence, pathogenicity or transmissibility.
(j) a dealing, other than a dealing mentioned in section 3.2 (l) or
(m), with a replication defective retroviral vector (including a
lentiviral vector) able to transduce human cells;
(k) a dealing involving a genetically modified animal, plant or
fungus that is capable of secreting or producing infectious
agents as a result of the genetic modification;
(l) a dealing producing, in each vessel containing the resultant
GMO culture, more than 25L of that culture, other than a dealing
mentioned in section 3.2 (f);
(m) a dealing that is inconsistent with a policy principle issued by
the ministerial council;
(n) a dealing involving the intentional introduction of a GMO into
a human being, unless the GMO—
(i) is a human somatic cell; and
(ii) cannot secrete or produce infectious agents as a result of
the genetic modification; and
(iii) if it was generated using viral vectors—
(A) has been tested for the presence of viruses likely to
recombine with the genetically modified nucleic acid
in the somatic cells; and
Notifiable low risk dealings in relation to a GMO Schedule 3
Dealings that are not notifiable low risk dealings Part 3.3
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(B) the testing did not detect a virus mentioned in
sub-subparagraph (A); and
(C) the viral vector used to generate the GMO as part of a
previous dealing is no longer present in the somatic
cells;
(o) a dealing involving a genetically modified pathogenic organism,
if the practical treatment of any disease or abnormality caused
by the organism would be impaired by the genetic modification;
(p) a dealing involving a micro-organism that satisfies the criteria
in AS/NZS 2243.3:2010 for classification as Risk Group 4;
(q) a dealing involving a micro-organism that satisfies the criteria
in AS/NZS 2243.3:2010 for classification as Risk Group 3 and
that is not undertaken in a facility—
(i) that is certified by the regulator to at least physical
containment level 3 and that is appropriate for the dealing;
or
(ii) that the regulator has agreed, in writing, is a facility in
which the dealing may be undertaken;
(r) a dealing involving a GMO capable of sexual reproduction, the
sexual progeny of which are, as a result of the genetic
modification, more likely to inherit a particular nucleotide
sequence or set of nucleotide sequences (when compared to
inheritance from the unmodified parent organism);
(s) a dealing involving a viral vector that can modify an organism
capable of sexual reproduction, so that the sexual progeny of the
organism are more likely to inherit a particular nucleotide
sequence or set of nucleotide sequences (when compared to
inheritance from the unmodified parent organism).
Note A modification that increases the likelihood of inheritance of a nucleotide
sequence or sequences, as described in paragraphs (r) and (s), is generally
known as an engineered gene drive.
Schedule 3 Notifiable low risk dealings in relation to a GMO
Part 3.3 Dealings that are not notifiable low risk dealings
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(2) For subsection (1) (p), a genetically modified micro-organism is
taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification
as Risk Group 4 if the unmodified parent micro-organism satisfies
those criteria.
(3) For subsection (1) (q), a genetically modified micro-organism is
taken to satisfy the criteria in AS/NZS 2243.3:2010 for classification
as Risk Group 3 if the unmodified parent micro-organism satisfies
those criteria.
(4) However, subsection (3) does not apply in relation to a replication
defective retroviral vector that meets the criteria in
section 3.2 (l) or (m).
Dictionary
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Dictionary
(see s 3)
Note 1 The Legislation Act contains definitions and other provisions relevant to
this regulation.
Note 2 For example, the Legislation Act, dict, pt 1, defines the following terms:
• for
• function
• in relation to
• person (see s 160)
• public holiday
• under.
Note 3 Terms used in this regulation have the same meaning that they have in
the Gene Technology Act 2003 (see Legislation Act, s 148). For example,
the following terms are defined in the Gene Technology Act 2003, dict:
• accredited organisation
• Commonwealth Act
• deal with
• environment
• ethics and community committee
• exempt dealing
• facility
• gene technology
• gene technology technical advisory committee
• genetically modified organism
• GMO
• institutional biosafety committee
• intentional release of a GMO into the environment (see s 11)
• ministerial council
• notifiable low risk dealing
• regulator.
Dictionary
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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.
Note AS/NZS 2243.3:2010 may be purchased at www.standards.org.au.
characterised means—
(a) in relation to a nucleic acid—the nucleic acid has been
sequenced and there is an understanding of potential gene
products or potential functions of the nucleic acid; or
(b) in relation to a genetic modification—the gene or genomic
region which is modified has been sequenced and there is an
understanding of—
(i) potential gene products or potential functions of the gene
or genomic region; and
(ii) the likely effect of the genetic modification on the gene
products or functions.
code for, in relation to a toxin, for schedule 2 (Dealings exempt from
licensing)—see schedule 2, part 2.3.
Commonwealth regulations means the Gene Technology
Regulations 2001 (Cwlth).
Dictionary
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expert adviser means—
(a) for part 4 (Gene technology technical advisory committee)—an
expert adviser appointed under the Act, section 102 (1); and
(b) for part 5 (Ethics and community committee)—an expert adviser
appointed under the Act, section 112 (1).
genetically modified laboratory guinea pig means a laboratory strain
of guinea pig of the species Cavia porcellus that has been modified
by gene technology.
genetically modified laboratory mouse means a laboratory strain of
mouse of the species Mus musculus that has been modified by gene
technology.
genetically modified laboratory rabbit means a laboratory strain of
rabbit of the species Oryctolagus cuniculus that has been modified by
gene technology.
genetically modified laboratory rat means a laboratory strain of rat
of either the species Rattus rattus or Rattus norvegicus that has been
modified by gene technology.
host, for part 2.2 (Host/vector systems for exempt dealings)—
see schedule 2, section 2.2.
host/vector system, for part 2.2 (Host/vector systems for exempt
dealings)—see schedule 2, section 2.2.
infectious agent means an agent that is capable of entering, surviving
in, multiplying, and potentially causing disease in, a susceptible host.
inspector means a person appointed by the regulator under the Act,
section 150 as an inspector.
known means known within the scientific community.
non-conjugative plasmid, for schedule 2—see schedule 2, part 2.3.
non-vector system, for schedule 2—see schedule 2, part 2.3.
Dictionary
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nucleic acid means either, or both, deoxyribonucleic acid (DNA), or
ribonucleic acid (RNA), of any length.
oncogenic modification means a genetic modification capable of
contributing to tumour formation, including modifications that cause
at least 1 of the following:
(a) defects in DNA proofreading and repair;
(b) defects in chromosome maintenance;
(c) defects in cell cycle checkpoint mechanisms;
(d) uncontrolled cell proliferation;
(e) resistance to apoptosis;
(f) cellular immortalisation.
packaging cell line means an animal or human cell line that contains
a gene or genes that when expressed in trans are necessary and
sufficient to complement packaging defects of a replication defective
viral vector in order to produce packaged replication defective
virions.
pathogenic, in relation to an organism, means having the capacity to
cause disease or abnormality.
pathogenic determinant means a characteristic that has the potential
to increase the capacity of a host or vector to cause disease or
abnormality.
physical containment level, followed by a numeral, is a specified
containment level under guidelines made by the regulator under the
Act, section 90 for the certification of facilities.
plasmid means a DNA molecule capable of autonomous replication
and stable extra-chromosomal maintenance in a host cell.
shotgun cloning means the production of a large random collection
of cloned fragments of nucleic acid from which genes of interest can
later be selected.
Dictionary
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toxin means a substance that is toxic to any vertebrate.
toxin-producing organism means an organism producing toxin with
an LD50 of less than 100 micrograms per kilogram.
transduce, in relation to a viral vector or viral particle, means enter
an intact cell by interaction of the viral particle with the cell
membrane.
vector, for part 2.2 (Host/vector systems for exempt dealings)—
see schedule 2, section 2.2.
Endnotes
1 About the endnotes
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Endnotes
1 About the endnotes
Amending and modifying laws are annotated in the legislation history and the
amendment history. Current modifications are not included in the republished law
but are set out in the endnotes.
Not all editorial amendments made under the Legislation Act 2001, part 11.3 are
annotated in the amendment history. Full details of any amendments can be
obtained from the Parliamentary Counsel’s Office.
Uncommenced amending laws are not included in the republished law. The details
of these laws are underlined in the legislation history. Uncommenced expiries are
underlined in the legislation history and amendment history.
If all the provisions of the law have been renumbered, a table of renumbered
provisions gives details of previous and current numbering.
The endnotes also include a table of earlier republications.
2 Abbreviation key
A = Act NI = Notifiable instrument
AF = Approved form o = order
am = amended om = omitted/repealed
amdt = amendment ord = ordinance
AR = Assembly resolution orig = original
ch = chapter par = paragraph/subparagraph
CN = Commencement notice pres = present
def = definition prev = previous
DI = Disallowable instrument (prev...) = previously
dict = dictionary pt = part
disallowed = disallowed by the Legislative r = rule/subrule
Assembly reloc = relocated
div = division renum = renumbered
exp = expires/expired R[X] = Republication No
Gaz = gazette RI = reissue
hdg = heading s = section/subsection
IA = Interpretation Act 1967 sch = schedule
ins = inserted/added sdiv = subdivision
LA = Legislation Act 2001 SL = Subordinate law
LR = legislation register sub = substituted
LRA = Legislation (Republication) Act 1996 underlining = whole or part not commenced
mod = modified/modification or to be expired
Endnotes
Legislation history 3
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3 Legislation history
This regulation was originally the Gene Technology Regulations 2004. It was
renamed under the Legislation Act 2001.
Gene Technology Regulation 2004 SL2004-17
notified LR 4 June 2004
s 1, s 2 commenced 4 June 2004 (LA s 75 (1))
remainder commenced 5 June 2004 (s 2)
as amended by
Statute Law Amendment Act 2005 A2005-20 sch 3 pt 3.25
notified LR 12 May 2005
s 1, s 2 taken to have commenced 8 March 2005 (LA s 75 (2))
sch 3 pt 3.25 commenced 2 June 2005 (s 2 (1))
Gene Technology Amendment Regulation 2008 (No 1) SL2008-17
notified LR 17 April 2008
s 1, s 2 commenced 17 April 2008 (LA s 75 (1))
remainder commenced 1 May 2008 (s 2 and see Gene Technology
Amendment Act 2008 A2008-10, s 2 and CN2008-5)
Gene Technology Amendment Regulation 2011 (No 1) SL2011-26
notified LR 31 August 2011
s 1, s 2 commenced 31 August 2011 (LA s 75 (1))
remainder commenced 1 September 2011 (s 2)
Statute Law Amendment Act 2011 (No 2) A2011-28 sch 3 pt 3.16
notified LR 31 August 2011
s 1, s 2 commenced 31 August 2011 (LA s 75 (1))
sch 3 pt 3.16 commenced 21 September 2011 (s 2 (1))
Gene Technology Amendment Act 2017 A2017-15 pt 3
notified LR 14 June 2017
s 1, s 2 commenced 14 June 2017 (LA s 75 (1))
pt 3 commenced 15 June 2017 (s 2)
Statute Law Amendment Act 2019 A2019-42 sch 3 pt 3.12
notified LR 31 October 2019
s 1, s 2 commenced 31 October 2019 (LA s 75 (1))
sch 3 pt 3.12 commenced 14 November 2019 (s 2 (1))
Endnotes
3 Legislation history
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Gene Technology Amendment Regulation 2020 (No 1) SL2020-38
notified LR 9 September 2020
s 1, s 2 commenced 9 September 2020 (LA s 75 (1))
sch 1 commenced 8 October 2020 (s 2 (2))
remainder commenced 10 September 2020 (s 2 (1))
Health Legislation Amendment Act 2025 A2025-16 sch 1 pt 1.3
notified LR 26 May 2025
s 1, s 2 commenced 26 May 2025 (LA s 75 (1))
sch 1 pt 1.3 commenced 2 June 2025 (s 2)
Endnotes
Amendment history 4
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4 Amendment history
Name of regulation
s 1 am R2 LA
Commencement
s 2 om LA s 89 (4)
Numbering
s 3A am A2005-20 amdt 3.162
Techniques not constituting gene technology
s 4 am SL2008-17 s 4
Organisms that are genetically modified organisms
s 4A ins SL2020-38 s 4
Organisms that are not genetically modified organisms
s 5 sub SL2020-38 s 5
Dealings exempt from licensing
s 6 am SL2008-17 ss 5-7; SL2011-26 s 4
Application for licence—prescribed fee
s 7 sub SL2008-17 s 8
Time limit for deciding an application—Act, s 43 (3)
s 8 am SL2008-17 ss 9-12; A2011-28 amdt 3.122
Prescribed authorities—Act, s 50 (3) (c) and s 52 (5) (c)
s 9 am SL2008-17 s 13, s 14; A2019-42 amdt 3.17; SL2020-38
s 6
Risks posed by dealings proposed to be authorised by licence—Act,
s 51 (1) (a)
s 9A ins SL2008-17 s 15
Risk assessment—matters to be taken into account—Act, s 51 (1) (d)
and (2) (d)
s 10 am SL2008-17 s 16, s 17
Time limit for deciding variation application—Act, s 71 (7)
s 11A ins SL2008-17 s 18
sub SL2011-26 s 5
Notifiable low risk dealings—Act, s 74 (1)
s 12 am SL2011-26 s 6; SL2020-38 s 7
Requirements for undertaking notifiable low risk dealings
s 13 (5)-(7) exp 5 June 2006 (s 13 (7) (LA s 88 declaration applies))
sub SL2008-17 s 19; SL2011-26 s 7
am SL2020-38 ss 8-14
Endnotes
4 Amendment history
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Requirements in relation to notifying regulator of notifiable low risk dealings
s 13A ins SL2008-17 s 19
sub SL2011-26 s 8
om SL2020-38 s 15
Requirements for institutional biosafety committees about records of
assessments of notifiable low risk dealing proposals
s 13B ins SL2011-26 s 8
am SL2020-38 ss 16-19
Information to be kept or given to the regulator by people or accredited
organisations
s 13C ins SL2011-26 s 8
am SL2020-38 s 20, s 21
Ethics and community committee
pt 5 hdg sub SL2008-17 s 20
Ethics and community committee—conditions of appointment
s 31 sub SL2008-17 s 20
Ethics and community committee—committee procedures
s 32 sub SL2008-17 s 20
Ethics and community committee—operation of subcommittees
s 33 sub SL2008-17 s 20
Gene technology ethics committee
pt 6 hdg om SL2008-17 s 20
GTEC—conditions of appointment
s 34 om SL2008-17 s 20
GTEC—committee procedures
s 35 om SL2008-17 s 20
GTEC—operation of subcommittees
s 36 om SL2008-17 s 20
Review of decisions
s 38 am A2025-16 amdt 1.18
Record of GMO dealings
s 39 hdg sub A2017-15 s 19
s 39 am SL2008-17 s 21; SL2011-26 s 9, s 10; A2017-15 s 20
sub SL2020-38 s 22
Transitional
pt 8 hdg om SL2008-17 s 22
Disapplication of Legislation Act, s 47 (5)
s 41 om SL2008-17 s 22
ins SL2020-38 s 23
Endnotes
Amendment history 4
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Existing organisations—accreditation
s 42 exp 5 June 2006 (s 42 (4) (LA s 88 declaration applies))
Transitional—Gene Technology Amendment Regulation 2011 (No 1)
pt 9 hdg ins SL2011-26 s 11
exp 1 September 2013 (s 46)
Transitional
s 45 ins SL2011-26 s 11
exp 1 September 2013 (s 46)
Expiry—pt 9
s 46 ins SL2011-26 s 11
exp 1 September 2013 (s 46)
Transitional—Gene Technology Amendment Regulation 2020 (No 1)
pt 10 hdg ins SL2020-38 s 24
exp 10 September 2021 (s 56)
Meaning of commencement day—pt 10
s 50 ins SL2020-38 s 24
exp 10 September 2021 (s 56)
Changed requirements—former exempt dealings
s 51 ins SL2020-38 s 24
exp 10 September 2021 (s 56)
Changed requirements—former notifiable low risk dealings
s 52 ins SL2020-38 s 24
exp 10 September 2021 (s 56)
Changed requirements—notifiable low risk dealings
s 53 ins SL2020-38 s 24
exp 10 September 2021 (s 56)
Previous assessment by institutional biosafety committee
s 54 ins SL2020-38 s 24
exp 10 September 2021 (s 56)
Giving records to regulator for notifiable low risk dealings assessed in
previous financial year
s 55 ins SL2020-38 s 24
exp 10 September 2021 (s 56)
Expiry—pt 10
s 56 ins SL2020-38 s 24
exp 10 September 2021 (s 56)
Techniques that are not gene technology
sch 1A ins SL2008-17 s 23
am SL2020-38 s 25
Endnotes
4 Amendment history
page 62 Gene Technology Regulation 2004
Effective: 02/06/25
R14
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Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
Organisms that are genetically modified organisms
sch 1B ins SL2020-38 s 26
Organisms that are not genetically modified organisms
sch 1 sub SL2008-17 s 23
am SL2011-26 s 12; SL2020-38 s 27, s 28, amdt 1.1
Dealings exempt from licensing
sch 2 sub SL2008-17 s 23
am SL2011-26 ss 13-16; SL2020-38 ss 29-32, s 64
Notifiable low risk dealings in relation to a GMO
sch 3 sub SL2008-17 s 23; SL2011-26 s 17
am SL2020-38 ss 33-57, s 64
Prescribed information—application for licence
sch 4 om SL2008-17 s 23
Dictionary
dict am SL2008-17 s 24; SL2011-26 s 18; SL2020-38 s 58, s 59
def advantage sub SL2008-17 s 25
def AS/NZS 2243.3:2010 ins SL2011-26 s 19
def characterised sub SL2008-17 s 26; SL2020-38 s 60
def division 5.3 application om SL2008-17 s 27
def division 5.4 application om SL2008-17 s 27
def expert advisor sub SL2008-17 s 28
def gene-knockout mice om SL2008-17 s 29
def genetic manipulation advisory committee om
SL2008-17 s 30
def genetically modified laboratory guinea pig ins
SL2011-26 s 20
def genetically modified laboratory mouse ins SL2008-17
s 31
def genetically modified laboratory rabbit ins SL2011-26
s 20
def genetically modified laboratory rat ins SL2008-17 s 31
def host ins SL2020-38 s 61
def host/vector system ins SL2020-38 s 61
def inclusion-negative om SL2008-17 s 32
def infectious agent ins SL2008-17 s 33
def inspector ins SL2011-26 s 20
def known ins SL2008-17 s 33
def non-conjugative plasmid ins SL2008-17 s 33
def non-vector system ins SL2008-17 s 33
def nucleic acid ins SL2008-17 s 33
def oncogenic modification ins SL2008-17 s 33
sub SL2011-26 s 21
def packaging cell line ins SL2008-17 s 33
def pathogenic ins SL2008-17 s 33
Endnotes
Amendment history 4
R14
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Gene Technology Regulation 2004
Effective: 02/06/25
page 63
Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
def pathogenic determinant ins SL2008-17 s 33
def plasmid ins SL2008-17 s 34
def recombinant om SL2008-17 s 35
def shotgun cloning sub SL2008-17 s 36
def toxin ins SL2008-17 s 37
def toxin-producing organism ins SL2008-17 s 37
am SL2020-38 s 62
def transduce ins SL2008-17 s 37
def vector ins SL2020-38 s 63
Endnotes
5 Earlier republications
page 64 Gene Technology Regulation 2004
Effective: 02/06/25
R14
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Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
5 Earlier republications
Some earlier republications were not numbered. The number in column 1 refers to
the publication order.
Since 12 September 2001 every authorised republication has been published in
electronic pdf format on the ACT legislation register. A selection of authorised
republications have also been published in printed format. These republications are
marked with an asterisk (*) in column 1. Electronic and printed versions of an
authorised republication are identical.
Republication
No and date
Effective Last
amendment
made by
Republication
for
R1
5 June 2004
5 June 2004–
3 Nov 2004
not amended new regulation
R2
4 Nov 2004
4 Nov 2004–
1 June 2005
not amended editorial
amendments under
Legislation Act
R3
2 June 2005
2 June 2005–
5 June 2006
A2005-20 amendments by
A2005-20
R4
6 June 2006
6 June 2006–
30 Apr 2008
A2005-20 commenced expiry
R5
1 May 2008
1 May 2008–
31 Aug 2011
SL2008-17 amendments by
SL2008-17
R6
1 Sept 2011
1 Sept 2011–
20 Sept 2011
SL2011-26 amendments by
SL2011-26
R7
21 Sept 2011
21 Sept 2011–
1 Sept 2013
A2011-28 amendments by
A2011-28
R8
2 Sept 2013
2 Sept 2013–
14 June 2017
A2011-28 expiry of
transitional
provisions (pt 9)
R9
15 June 2017
15 June 2017–
13 Nov 2019
A2017-15 amendments by
A2017-15
R10
14 Nov 2019
14 Nov 2019–
9 Sept 2020
A2019-42 amendments by
A2019-42
R11
10 Sept 2020
10 Sept 2020–
7 Oct 2020
SL2020-38 amendments by
SL2020-38
Endnotes
Earlier republications 5
R14
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Gene Technology Regulation 2004
Effective: 02/06/25
page 65
Authorised by the ACT Parliamentary Counsel—also accessible at www.legislation.act.gov.au
Republication
No and date
Effective Last
amendment
made by
Republication
for
R12
8 Oct 2020
8 Oct 2020–
10 Sept 2021
SL2020-38 amendments by
SL2020-38
R13
11 Sept 2021
11 Sept 2021–
1 June 2025
SL2020-38 expiry of
transitional
provisions (pt 10)