Australian Capital Territory Consolidated Regulations

GENE TECHNOLOGY REGULATION 2004 - NOTES

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

              •     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:

              •     Commonwealth Act

              •     deal with

              •     ethics and community committee

              •     exempt dealing

              •     gene technology

              •     genetically modified organism

              •     GMO

              •     GM product

              •     institutional biosafety committee

              •     ministerial council

              •     notifiable low risk dealing

              •     regulator.

"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", in relation to nucleic acid, means nucleic acid that has been sequenced and in relation to which there is an understanding of potential gene products or potential 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).

"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.

"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.

"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.

"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 μg/kg.

"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.

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

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))

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

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

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

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

Requirements in relation to notifying regulator of notifiable low risk dealings
s 13A     ins SL2008-17 s 19
    sub SL2011-26 s 8

Requirements for institutional biosafety committees about records of assessments of notifiable low risk dealing proposals
s 13B     ins SL2011-26 s 8

Information to be kept or given to the regulator by people or accredited organisations
s 13C     ins SL2011-26 s 8

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

Record of GMO and GM product dealings
s 39     am SL2008-17 s 21; SL2011-26 s 9, s 10

Transitional
pt 8 hdg     om SL2008-17 s 22

Existing facilities—certification
s 41     om SL2008-17 s 22

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)

Techniques that are not gene technology
sch 1A     ins SL2008-17 s 23

Organisms that are not genetically modified organisms
sch 1     sub SL2008-17 s 23
    am SL2011-26 s 12

Dealings exempt from licensing
sch 2     sub SL2008-17 s 23
    am SL2011-26 ss 13-16

Notifiable low risk dealings in relation to a GMO
sch 3     sub SL2008-17 s 23; SL2011-26 s 17

Prescribed information—application for licence
sch 4     om SL2008-17 s 23

Dictionary
dict     am SL2008-17 s 24; SL2011-26 s 18
    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
    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 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
    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
    def transduce ins SL2008-17 s 37

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

© Australian Capital Territory 2011

Australian Capital Territory

SL2004-17

Republication No 7

Effective: 21 September 2011

Republication date: 21 September 2011

Last amendment made by A2011-28




Unauthorised version prepared by ACT Parliamentary Counsel's Office

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 21 September 2011

. It also includes any commencement, amendment, repeal or expiry affecting this republished law to 21 September 2011

.

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 $110 for an individual and $550 for a corporation (see Legislation Act 2001, s 133).

Australian Capital Territory

Gene Technology Regulation 2004

Part 2.1Exempt dealings30

Part 2.3Definitions—sch 237

Part 3.1Notifiable low risk dealings suitable for at least physical containment level 138

Part 3.2Notifiable low risk dealings suitable for at least physical containment level 2 or 340

Part 3.3Dealings that are not notifiable low risk dealings45

Endnotes54

Gene Technology Regulation 2004