Gene Technology Act 2003 (ACT)

Case

Gene Technology Act 2003   

A2003-57

Republication No 15

Effective:  16 November 2025

Republication date: 16 November 2025

Last amendment made by A2025‑29

About this republication

The republished law

This is a republication of the Gene Technology Act 2003 (including any amendment made under the Legislation Act 2001, part 11.3 (Editorial changes)) as in force on 16 November 2025It also includes any commencement, amendment, repeal or expiry affecting this republished law to 16 November 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 type="disc">

  • 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 includes 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 ( 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).

    Gene Technology Act 2003

    Contents

    Page

    Part 1      Preliminary

    1            Name of Act etc  2

    3            Object of Act  2

    4            Regulatory framework to achieve object  2

    5            Nationally consistent scheme  3

    6            Act to bind the Crown  3

    7           External Territories  3

    8Offences against Act—application of Criminal Code etc 3

    8A          Numbering  4

    8B          Notes  4

    8C          Outlines  5

    Part 2      Interpretation and operation of Act

    Division 2.1              Simplified outline of pt 2

    9            Simplified outline—pt 2  6

    Division 2.2              Interpretation

    10          Dictionary etc  6

    11          Meaning of intentional release of a GMO into the environment              7

    12          Meaning of corresponding State law  7

    Division 2.3              Operation of Act

    13          Operation of Act  7

    14          Wind-back of reach of Act  7

    15          Relationship to other territory laws  7

    Division 2.4              Provisions to facilitate a nationally consistent scheme

    Subdivision 2.4.1     General provisions

    16          State laws may operate concurrently  8

    17          Conferral of functions on Commonwealth officers and bodies               8

    18          No doubling-up of liabilities  8

    19          Review of certain decisions  8

    20          Things done for multiple purposes  9

    Subdivision 2.4.2     Policy principles, policy guidelines and codes of practice

    21          Ministerial council may issue policy principles  9

    22          Consultation on policy principles  10

    23          Ministerial council may issue policy guidelines  10

    24          Ministerial council may issue codes of practice  10

    Part 3      Gene technology regulator

    25          Simplified outline—pt 3  11

    26          Gene technology regulator  11

    27          Functions of regulator  11

    28          Powers of regulator  12

    29          Delegation  12

    30          Independence of regulator  13

    Part 4      Regulation of dealings with GMOs

    Division 4.1              Simplified outline of pt 4

    31          Simplified outline—pt 4  14

    Division 4.2              Dealings with GMOs must be licensed

    32          Person not to deal with GMO without licence  15

    33          Person not to deal with GMO without licence—strict liability offence       16

    34          Person must not breach conditions of GMO licence  16

    35          Person must not breach conditions of GMO licence—strict liability offence 17

    35A         Person must not breach conditions of emergency dealing determination  18

    35B         Person must not breach conditions of emergency dealing determination—strict liability offence 19

    36          Person must not breach conditions on GMO register  19

    37          Offence relating to notifiable low risk dealings  20

    38          Aggravated offences—significant damage to health or safety of people or to environment       20

    Part 5      Licensing system

    Division 5.1              Simplified outline of pt 5

    39          Simplified outline—pt 5  21

    Division 5.2              Licence applications

    40          Person may apply for a licence  21

    40A         Licences relating to inadvertent dealings  22

    41          Application may be withdrawn  23

    42          Regulator may require applicant to give further information                 23

    43          Regulator must consider applications except in certain circumstances    23

    44          Regulator may consult with applicant  24

    45          Regulator must not use certain information in considering licence application   24

    Division 5.3              Initial consideration of licences for dealings not involving intentional release of GMO into environment

    46          Applications to which div 5.3 applies  25

    46A         Division does not apply to an application relating to inadvertent dealings  25

    47          What regulator must do in relation to application  25

    Division 5.4              Initial consideration of licences for dealings involving intentional release of GMO into environment

    48          Applications to which div 5.4 applies  26

    49          Division does not apply to an application relating to inadvertent dealings  27

    50          Regulator must prepare risk assessment and risk management plan      27

    50A         Limited and controlled release applications  28

    51          Matters regulator must take into account in preparing risk assessment and risk management plan  30

    52          Public notification of risk assessment and risk management plan          31

    53          Regulator may take other actions  32

    54          Person may request copies of certain documents  33

    Division 5.5              Decision on licence application

    55          Regulator must make a decision on licence and licence conditions       34

    56          Regulator must not issue the licence unless satisfied as to risk management    34

    57          Other circumstances in which regulator must not issue the licence        35

    58          Matters to be taken into account in deciding whether person is suitable to hold licence 35

    59          Notification of licence decision  36

    60          Period of licence  37

    Division 5.6              Conditions of licences

    61          Licence is subject to conditions  37

    62          Conditions that may be prescribed or imposed  37

    63          Condition about telling people of obligations  39

    64          Condition about monitoring and audits  39

    65          Condition about additional information to be given to regulator             40

    66          Person may give information to regulator  40

    67          Protection of persons who give information  41

    Division 5.7              Suspension, cancellation and variation of licences

    68          Suspension and cancellation of licence  41

    69          Surrender of licence  42

    70          Transfer of licences  42

    71          Variation of licence  43

    72          Regulator to notify of proposed suspension, cancellation or variation     45

    Division 5.8              Annual charge

    72AA        GMO licence—annual charge  46

    Part 5A    Emergency dealing determinations

    72A         Application of Commonwealth emergency dealing determinations         47

    72B         Minister may make emergency dealing determination  47

    72C         Period of effect of emergency dealing determination  47

    72D         Emergency dealing determination authorises dealings, subject to conditions    47

    72E         Variation, suspension and revocation of emergency dealing determination 48

    Part 6      Regulation of notifiable low risk dealings on GMO register

    Division 6.1              Simplified outline of pt 6

    73          Simplified outline—pt 6  49

    Division 6.2              Notifiable low risk dealings

    74          Notifiable low risk dealings  49

    75          Regulation of notifiable low risk dealings  50

    Division 6.3              GMO register

    76          GMO register  51

    77          Contents of register  51

    78          Regulator may include dealings with GMOs on GMO register              51

    79          Regulator not to make determination unless risks can be managed       52

    80          Variation of GMO register  53

    81          Inspection of register  53

    Part 7      Certification and accreditation

    Division 7.1              Simplified outline of pt 7

    82          Simplified outline—pt 7  54

    Division 7.2              Certification

    83          Application for certification  54

    84          When regulator may certify facility  55

    85          Regulator may require applicant to give further information                 55

    86          Conditions of certification  55

    87          Variation of certification  55

    88          Suspension or cancellation of certification  56

    89          Regulator to notify of proposed suspension, cancellation or variation     56

    89A         Transfer of certification  57

    90          Guidelines  58

    Division 7.3              Accredited organisations

    91          Application for accreditation  58

    92          Regulator may accredit organisations  58

    93          Regulator may require applicant to give further information                 59

    94          Conditions of accreditation  59

    95          Variation of accreditation  60

    96          Suspension or cancellation of accreditation  60

    97          Regulator to notify of proposed suspension, cancellation or variation     60

    98          Guidelines  61

    Part 8      Gene technology technical advisory committee and gene technology ethics and community consultative committee

    Division 8.1              Simplified outline of pt 8

    99          Simplified outline—pt 8  62

    Division 8.2              Gene technology technical advisory committee

    100         Gene technology technical advisory committee  62

    101         Function of gene technology technical advisory committee                 62

    102         Expert advisers  63

    103         Remuneration  63

    104         Members and procedures  63

    105         Subcommittees  63

    Division 8.3              Gene technology ethics and community consultative committee

    106         Gene technology ethics and community consultative committee           63

    107         Function of ethics and community committee  64

    108         Membership  64

    109         Remuneration  64

    110         Regulations  65

    111         Subcommittees  65

    112         Expert advisers  65

    Part 9      Administration

    Division 9.1              Simplified outline of pt 9

    117         Simplified outline—pt 9  66

    Division 9.2              Appointment and conditions of regulator

    118         Appointment of regulator  66

    119         Termination of appointment  66

    120         Disclosure of interests  66

    121         Acting appointment  67

    122         Terms and conditions  67

    123         Outside employment  67

    124         Remuneration  67

    125         Leave of absence  67

    126         Resignation  67

    Division 9.3              Money

    127         Regulator may charge for services  67

    128         Notional payments  68

    129         Gene technology account  68

    130         Credits to gene technology account  68

    131         Recovery of amounts  68

    132         Purposes of account  69

    Division 9.4              Staffing

    133         Staff assisting regulator  69

    134         Consultants  69

    135         Seconded officers  69

    Division 9.5              Reporting requirements

    136         Annual report  69

    137         Reports to Legislative Assembly  70

    Division 9.6              Record of GMO dealings

    138         Record of GMO dealings  70

    139         Inspection of record  72

    Division 9.7              Reviews of notifiable low risk dealings and exemptions

    140         Regulator may review notifiable low risk dealings  72

    141         Regulator may review exemptions  72

    142         Regulator may give notice of consideration  73

    143         What regulator may do after consideration  73

    144         Regulator not required to review matters  74

    Part 10     Enforcement

    145         Simplified outline—pt 10  75

    146         Regulator may give directions  76

    147         Injunctions  78

    148         Forfeiture  79

    Part 11     Powers of inspection

    Division 11.1            Simplified outline of pt 11

    149         Simplified outline—pt 11  80

    Division 11.2            Appointment of inspectors and identity cards

    150         Appointment of inspectors  80

    151         Identity card  81

    Division 11.3            Monitoring powers

    152         Powers available to inspectors for monitoring compliance                   81

    153         Monitoring powers  82

    Division 11.4            Offence-related powers

    154         Searches and seizures related to offences  84

    155         Offence-related powers of inspectors for premises  85

    156         Use of equipment at premises  85

    Division 11.5            Expert assistance

    157         Expert assistance to operate thing  86

    Division 11.6            Emergency powers

    158         Powers available to inspectors for dealing with dangerous situations      87

    Division 11.7            Obligations and incidental powers of inspectors

    159         Inspector must produce identity card on request  88

    160         Consent  88

    161         Details of warrant to be given to occupier etc  90

    162         Announcement before entry  90

    163         Compensation for damage  90

    Division 11.8            Power to search goods, baggage and containers and seize goods

    164         Power to search goods, baggage etc  91

    165         Seizure of goods  92

    Division 11.9            General provisions relating to search and seizure

    166         Copies of seized things to be provided  92

    167         Occupier entitled to be present during search  93

    168         Receipts for things seized  93

    169         Keeping seized things  93

    170         Magistrates Court may permit thing to be kept  94

    171         Disposal of goods if there is no owner or owner cannot be located        95

    Division 11.10          Warrants

    172         Monitoring warrants  95

    173         Offence-related warrants  96

    174         Offence-related warrants by telephone, fax etc  97

    175         Offences relating to warrants  99

    Division 11.11          Other matters

    176         Pt 11 not to abrogate privilege against self-incrimination                   100

    176A        Damage etc to be minimised  100

    176B        Compensation to be paid in certain circumstances  101

    177         Pt 11 does not limit power to impose conditions  101

    Part 12     Miscellaneous

    Division 12.1            Simplified outline of pt 12

    178         Simplified outline—pt 12  102

    Division 12.2            Review of decisions

    179         Meaning of reviewable decision and eligible person  102

    180         Notification of decisions and review rights  104

    181         Internal review  104

    182         Deadlines for making reviewable decisions  105

    183         Review of decisions by Commonwealth administrative review tribunal    105

    183A        Extended standing for judicial review  106

    Division 12.3            Confidential commercial information

    184         Application for protection of confidential commercial information         106

    185         Regulator may declare information is confidential commercial information 106

    186         Revocation of declaration  108

    187         Confidential commercial information must not be disclosed               109

    Division 12.4            Acts and omissions of representatives

    188         Acts and omissions of representatives  110

    Division 12.6            Other provisions

    192         False or misleading information or document  111

    192A        Interference with dealings with GMOs  112

    192E        Approved forms  113

    193         Regulation-making power  114

    Dictionary115

    Endnotes

    1            About the endnotes  122

    2            Abbreviation key  122

    3            Legislation history  123

    4            Amendment history  126

    5            Earlier republications  133

    6            Expired transitional or validating provisions  134

    Gene Technology Act 2003

    An Act to regulate activities involving gene technology, and for related purposes

    Part 1Preliminary

    1. Name of Act etc

      (1)This Act is the Gene Technology Act 2003.

      (2)This Act may also be referred to as the Gene Technology Law of the ACT or simply as the Gene Technology Law.

      NoteThis section differs from the Commonwealth Act, s 1.

    2. Object of Act

      The object of this Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with GMOs.

    3. Regulatory framework to achieve object

      The object of this Act is to be achieved through a regulatory framework that—

      (a)provides that where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation; and

      (b)provides an efficient and effective system for the application of gene technologies; and

      (c)operates in conjunction with other Commonwealth and State regulatory schemes relevant to GMOs and GM products.

      NoteExamples of the schemes mentioned in par (c) are those that regulate food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods.

    4. Nationally consistent scheme

      It is the intention of the Legislative Assembly that this Act form a component of a nationally consistent scheme for the regulation of certain dealings with GMOs by the Commonwealth and the States.

    5. Act to bind the Crown

      NoteThe Commonwealth Act includes a provision binding the Crown. The provision is unnecessary in the ACT (see Legislation Act, s 121).

    6. External Territories

      NoteThe Commonwealth Act includes a provision extending that Act to every external territory.

    7. Offences against Act—application of Criminal Code etc

      Other legislation applies to offences against this Act.

      Note 1Criminal Code

      The Criminal Code, ch 2 applies to all offences against this Act (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 2Penalty units

      The Legislation Act, s 133 deals with the meaning of offence penalties that are expressed in penalty units.

      Note 3This section differs from the Commonwealth Act, s 8.

    8ANumbering

    (1)To maintain consistent section numbering between this Act and the Commonwealth Act—

    (a)if the Commonwealth Act contains a section that is not needed in this Act—the provision number and heading to the section appearing in the Commonwealth Act are included in this Act despite the omission of the body of the section; and

    (b)if this Act contains a section that is not included in the Commonwealth Act—the section is numbered so as to maintain consistency in numbering between sections common to both Acts.

    (2)A provision number and heading mentioned in subsection (1) (a) form part of this Act.

    (3)If a provision of this Act (other than a section) is numbered differently from the equivalent provision of the Commonwealth Act, the provision of this Act may be referred to using the number of the equivalent provision of the Commonwealth Act.

    Note 1A note appears under each heading of a kind mentioned in s (1) (a) describing the omitted section of the Commonwealth Act.

    Note 2A note appears under each section of a kind mentioned in s (1) (b) highlighting the non-appearance of an equivalent section in the Commonwealth Act.

    Note 3This section does not appear in the Commonwealth Act.

    8BNotes

    A note included in this Act is explanatory and is not part of this Act.

    Note 1See the Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.

    Note 2This section does not appear in the Commonwealth Act.

    8COutlines

    The provisions appearing at the beginning of parts 2 to 12, outlining the part (simplified outlines), are intended only as a guide to readers about the general scheme and effect of the parts.

    NoteThis section does not appear in the Commonwealth Act.

    Part 2Interpretation and operation of Act

    Division 2.1               Simplified outline of pt 2

    1. Simplified outline—pt 2

      In outline, this part—

      (a)provides for the definitions used in this Act; and

      (b)contains provisions to facilitate a nationally consistent regulatory scheme; and

      (c)enables the ministerial council to issue policy principles, policy guidelines and codes of practice.

      NoteThis section differs from the Commonwealth Act, s 9.

    Division 2.2               Interpretation

    1. Dictionary etc

      (1)The dictionary at the end of this Act is part of this Act.

      Note 1The dictionary at the end of this Act defines certain terms used in this Act, and includes references (signpost definitions) to other terms defined elsewhere in this Act.

      For example, the signpost definition ‘aggravated offence—see section 38 (1).’ means that the term ‘aggravated offence’ is defined in that subsection.

      Note 2A definition in the dictionary (including a signpost definition) applies to the entire Act unless the definition, or another provision of the Act, provides otherwise or the contrary intention otherwise appears (see Legislation Act, s 155 and s 156 (1)).

      (2)If this Act requires or permits the ministerial council to do something, the ministerial council must do it in accordance with the gene technology agreement.

      NoteSubsection (1) differs from the Commonwealth Act, s 10 (1).

    2. Meaning of intentional release of a GMO into the environment

      A dealing with a GMO involves the intentional release of the GMO into the environment if the GMO is intentionally released into the open environment, whether or not it is released with provision for limiting the dissemination or persistence of the GMO or its genetic material in the environment.

    3. Meaning of corresponding State law

      NoteThe Commonwealth Act includes a provision defining ‘corresponding State law’ for that Act.

    Division 2.3               Operation of Act

    1. Operation of Act

      NoteThe Commonwealth Act includes a provision about the application of that Act.

    2. Wind-back of reach of Act

      NoteThe Commonwealth Act includes a provision about the giving of wind-back notices to a State.

    3. Relationship to other territory laws

      This Act is in addition to, and not in substitution for, the requirements of any other territory law, whether passed or made before or after the commencement of this section.

      NoteThe equivalent section in the Commonwealth Act deals with the relationship of that Act to other Commonwealth laws.

    Division 2.4               Provisions to facilitate a nationally consistent scheme

    Subdivision 2.4.1       General provisions

    1. State laws may operate concurrently

      NoteThe Commonwealth Act includes a provision allowing State laws, other than State laws prescribed for the provision, to operate concurrently with that Act.

    2. Conferral of functions on Commonwealth officers and bodies

      NoteThe Commonwealth Act includes a provision allowing corresponding State laws to give functions, powers and duties to certain Commonwealth officers and bodies.

    3. No doubling-up of liabilities

      If a person has been ordered to pay a pecuniary penalty under the Commonwealth Act, the person is not liable to a pecuniary penalty under this Act in relation to the same conduct.

      NoteThe Commonwealth Act, s 18 also includes a provision preventing a person being punished for an offence against this Act and the Commonwealth Act. The provision is unnecessary in the ACT (see Legislation Act, s 191).

    4. Review of certain decisions

      (1)Application may be made to the Commonwealth administrative review tribunal for review of a reviewable State decision.

      (2)A decision made by the regulator in the exercise of a function under this Act is a reviewable State decision if—

      (a)this Act provides for review of the decision by the Commonwealth administrative review tribunal; and

      (b)the decision is declared by regulations made under the Commonwealth Act to be a reviewable State decision for the Commonwealth Act, section 19.

      (3)The Administrative Review Tribunal Act 2024 (Cwlth) (other than part 7) applies as a territory law in relation to reviewable State decisions.

      (4)For this section, a reference in a provision of the Administrative Review Tribunal Act 2024 (Cwlth) (as that provision applies as a territory law) to all or any part of that Act, part 7 is taken to be a reference to all or any part of that part as it has effect as a law of the Commonwealth.

      Note 1A reference to the Administrative Review Tribunal Act 2024 (Cwlth) includes a reference to the regulations in force under that Act from time to time (see Legislation Act, s 102 and s 104).

      Note 2This section differs from the Commonwealth Act, s 19.

    5. Things done for multiple purposes

      The validity of a licence, certificate or other thing issued, given or done for this Act is not affected only because it was issued, given or done also for the Commonwealth Act.

    Subdivision 2.4.2       Policy principles, policy guidelines and codes of practice

    1. Ministerial council may issue policy principles

      (1)The ministerial council may issue policy principles in relation to the following:

      (a)ethical issues relating to dealings with GMOs;

      (b)recognising areas (if any) designated under a territory law for the purpose of preserving the identity of 1 or both of the following for marketing purposes:

      (i)GM crops;

      (ii)non-GM crops;

      (c)matters relating to dealings with GMOs prescribed by regulation for this paragraph.

      NoteSection 57 provides that the regulator must not issue a licence if to do so would be inconsistent with a policy principle.

      (2)Before issuing a policy principle, the ministerial council must be satisfied that the policy principle was developed in accordance with the Commonwealth Act, section 22.

      (3)A regulation for subsection (1) (c) may relate to matters other than the health and safety of people or the environment, but must not derogate from the health and safety of people or the environment.

      NoteThis section differs from the Commonwealth Act, s 21.

    2. Consultation on policy principles

      NoteThe Commonwealth Act includes a provision about how policy principles are to be developed.

    3. Ministerial council may issue policy guidelines

      The ministerial council may issue policy guidelines in relation to matters relevant to the functions of the regulator under this Act.

      NoteSection 56, among other things, requires the regulator to have regard to policy guidelines when deciding an application for a GMO licence. Section 30 provides that the regulator is not subject to direction in relation to individual decisions.

    4. Ministerial council may issue codes of practice

      The ministerial council may issue codes of practice, developed under the Commonwealth Act, section 24 (2) in relation to gene technology.

      NoteThe Commonwealth Act, s 24 includes provisions about how codes of practice are to be developed and making them disallowable instruments.

    Part 3Gene technology regulator

    1. Simplified outline—pt 3

      In outline, this part provides the functions and powers of the gene technology regulator under this Act.

      NoteThis section differs from the Commonwealth Act, s 25.

    2. Gene technology regulator

      NoteThe Commonwealth Act, s 26 creates the office of gene technology regulator.

    3. Functions of regulator

      The regulator has the following functions:

      (a)to exercise functions relating to GMO licences under part 5;

      (b)to develop draft policy principles and policy guidelines, as requested by the ministerial council;

      (c)to develop codes of practice;

      (d)to issue technical and procedural guidelines about GMOs;

      (e)to provide information and advice to other regulatory agencies about GMOs and GM products;

      (f)to provide information and advice to the public about the regulation of GMOs;

      (g)to provide advice to the ministerial council about—

      (i)the operations of the regulator and the gene technology technical advisory committee; and

      (ii)the effectiveness of the legislative framework for the regulation of GMOs, including about possible amendments of relevant legislation;

      (h)to undertake or commission research about risk assessment and the biosafety of GMOs;

      (i)to promote the harmonisation of risk assessments for GMOs and GM products by regulatory agencies;

      (j)to monitor international practice for regulating GMOs;

      (k)to maintain links with international organisations dealing with the regulation of gene technology and with agencies regulating GMOs in places outside the ACT;

      (l)to exercise other functions given to the regulator under this Act or any other law.

    4. Powers of regulator

      NoteThe Commonwealth Act, s 28 gives the regulator powers. The provision is unnecessary in the ACT (see Legislation Act, s 196).

    5. Delegation

      (1)The regulator may delegate the regulator’s functions under this Act to any of the following:

      (a)a public servant;

      (b)an officer or employee of a territory agency, if the functions of the territory agency relate, directly or indirectly, to GMOs or GM products;

      (c)an employee of a Commonwealth authority, if the functions of the Commonwealth authority relate, directly or indirectly, to GMOs or GM products.

      NoteFor the making of delegations and the exercise of delegated functions, see Legislation Act, pt 19.4.

      (2)In exercising a function under a delegation, the delegate must comply with any directions of the regulator.

      NoteThis section differs from the Commonwealth Act, s 29.

    6. Independence of regulator

      (1)The regulator has discretion in the exercise of the regulator’s functions under this Act. 

      (2)In particular, the regulator is not subject to direction from anyone about—

      (a)whether a GMO licence is issued or refused in relation to a particular application; or

      (b)the conditions to which a particular GMO licence is subject.

    Part 4Regulation of dealings with GMOs

    Division 4.1               Simplified outline of pt 4

    1. Simplified outline—pt 4

      In outline, this part—

      (a)deals with the regulation of dealings with GMOs; and

      (b)prohibits dealings with GMOs unless—

      (i)the person undertaking the dealing is authorised to do so by a GMO licence; or

      (ia)the dealing is specified in an emergency dealing determination; or

      (ii)the dealing is a notifiable low risk dealing (see division 6.2); or

      (iii)the dealing is an exempt dealing; or

      (iv)the dealing is included in the GMO register (see division 6.3); and

      (c)imposes heavier penalties on unlawful dealings that cause, or are likely to cause, significant damage to the health and safety of people or to the environment.

    Division 4.2               Dealings with GMOs must be licensed

    1. Person not to deal with GMO without licence

      A person commits an offence if—

      (a)the person deals with a  GMO, knowing that it is a GMO; and

      (b)the dealing with the GMO by the person is not authorised by a GMO licence, and the person knows or is reckless about that fact; and

      (c)the dealing with the GMO is not specified in an emergency dealing determination, and the person knows or is reckless about that fact; and

      (d)the dealing is not a notifiable low risk dealing, and the person knows or is reckless about that fact; and

      (e)the dealing is not an exempt dealing and the person knows or is reckless about that fact; and

      (f)the dealing is not included on the GMO Register, and the person knows or is reckless about that fact.

      Maximum penalty:

      (a)for an aggravated offence—2 000 penalty units, imprisonment for 5 years or both; or

      (b)in any other case—500 penalty units, imprisonment for 2 years or both.

      Note 1Aggravated offence is defined in s 38.

      Note 2For provisions corresponding to the Commonwealth Act, s 32 (4), see the Legislation Act, s 48.

    2. Person not to deal with GMO without licence—strict liability offence

      (1)A person commits an offence if—

      (a)the person deals with a GMO, knowing that it is a GMO; and

      (b)the dealing with the GMO by the person is not authorised by a GMO licence; and

      (ba)the dealing with the GMO is not specified in an emergency dealing determination; and

      (c)the dealing is not a notifiable low risk dealing; and

      (d)the dealing is not an exempt dealing; and

      (e)the dealing is not included on the GMO register.

      Maximum penalty:

      (a)for an aggravated offence—200 penalty units; or

      (b)in any other case—50 penalty units.

      (2)Strict liability applies to subsection (1) (b), (ba), (c), (d) and (e).

      NoteThis section differs from the Commonwealth Act, s 33.

    3. Person must not breach conditions of GMO licence

      (1)The holder of a GMO licence commits an offence if—

      (a)the holder intentionally takes an action or omits to take an action; and

      (b)the action or omission contravenes the licence, and the holder knows or is reckless about that fact.

      Maximum penalty:

      (a)for an aggravated offence—2 000 penalty units, imprisonment for 5 years or both; or

      (b)in any other case—500 penalty units, imprisonment for 2 years or both.

      (2)A person covered by a GMO licence commits an offence if the person—

      (a)intentionally takes an action or omits to take an action; and

      (b)the person has knowledge of the conditions of the licence; and

      (c)the action or omission contravenes a condition of the licence, and the person knows or is reckless about that fact.

      Maximum penalty:

      (a)for an aggravated offence—2 000 penalty units, imprisonment for 5 years or both ; or

      (b)in any other case—500 penalty units, imprisonment for 2 years or both.

      (3)A person who contravenes subsection (1) or (2) commits a separate offence for each day (after the first day) during any part of which the contravention continues.

      Maximum penalty (for each day):

      (a)for an aggravated offence—200 penalty units ; or

      (b)in any other case—50 penalty units.

    4. Person must not breach conditions of GMO licence—strict liability offence

      (1)The holder of a GMO licence commits an offence if the holder—

      (a)takes an action or omits to take an action; and

      (b)the action or omission contravenes the licence.

      Maximum penalty:

      (a)for an aggravated offence—200 penalty units; or

      (b)in any other case—50 penalty units.

      (2)A person covered by a GMO licence commits an offence if—

      (a)the person takes an action or omits to take an action; and

      (b)the action or omission contravenes the licence; and

      (c)the person has knowledge of the conditions of the licence.

      Maximum penalty:

      (a)for an aggravated offence—200 penalty units; or

      (b)in any other case—50 penalty units.

      (3)Strict liability applies to subsection (1) (a) and (b) and subsection (2) (a) and (b).

    35APerson must not breach conditions of emergency dealing determination

    A person commits an offence if—

    (a)the person intentionally takes an action or omits to take an action; and

    (b)the person has knowledge of the conditions to which an emergency dealing determination is subject; and

    (c)the action or omission contravenes such a condition, and the person knows or is reckless about that fact.

    Maximum penalty:

    (a)for an aggravated offence—2 000 penalty units, imprisonment for 5 years or both; or

    (b)in any other case—500 penalty units, imprisonment for 2 years or both.

    NoteThis section differs from the Commonwealth Act, s 35A.

    35BPerson must not breach conditions of emergency dealing determination—strict liability offence

    (1)A person commits an offence if—

    (a)the person takes an action or omits to take an action; and

    (b)the person has knowledge of the conditions to which an emergency dealing determination is subject; and

    (c)the action or omission by the person contravenes such a condition.

    Maximum penalty:

    (a)for an aggravated offence—200 penalty units; or

    (b)in any other case—50 penalty units.

    (2)Strict liability applies to subsection (1) (a) and (c).

    Note This section differs from the Commonwealth Act, s 35B.

    1. Person must not breach conditions on GMO register

      (1)A person commits an offence if the person—

      (a)deals with a GMO, knowing that it is a GMO; and

      (b)the dealing is on the GMO register; and

      (c)the dealing contravenes a condition about the dealing that is stated in the GMO register.

      Maximum penalty:  50 penalty units.

      (2)Strict liability applies to subsection (1) (b) and (c).

    2. Offence relating to notifiable low risk dealings

      (1)A person commits an offence if—

      (a)the person deals with a GMO, knowing that it is a GMO; and

      (b)the dealing is a notifiable low risk dealing; and

      (c)the dealing by the person was not undertaken in accordance with the regulations.

      Maximum penalty:  50 penalty units.

      (2)Strict liability applies to subsection (1) (b) and (c).

    3. Aggravated offences—significant damage to health or safety of people or to environment

      (1)An offence is an aggravated offence if the commission of the offence causes significant damage, or is likely to cause significant damage, to the health and safety of people or to the environment.

      (2)To prove an aggravated offence, the prosecution must prove that the person who committed the offence—

      (a)intended his or her conduct to cause significant damage to the health and safety of people or to the environment; or

      (b)was reckless about whether his or her conduct would cause significant damage to the health and safety of people or to the environment.

    Part 5Licensing system

    Division 5.1               Simplified outline of pt 5

    1. Simplified outline—pt 5

      In outline, this part—

      (a)provides a licensing system under which a person can apply to the regulator for a licence authorising dealings with GMOs; and

      (b)sets out the processes the regulator must follow for applications involving the following kinds of dealings:

      (i)those that involve the intentional release of a GMO into the environment;

      (ii)those that do not involve the intentional release of a GMO into the environment; and

      (c)provides that a licence can cover dealings by people other than the licence holder and requires the licence holder to tell them of any conditions of the licence that apply to them.

    Division 5.2               Licence applications

    1. Person may apply for a licence

      (1)A person may apply to the regulator for a licence authorising stated dealings with 1 or more stated GMOs.

      (2)The application must be in writing, and must contain—

      (a)the information (if any) prescribed by regulation; and

      (b)the information specified in writing by the regulator.

      (3)The application must state whether any of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment.

      (4)The dealings for which a person may apply for a licence may be—

      (a)all dealings with a GMO, or with a stated class of GMOs; or

      (b)a stated class of dealings with a GMO, or with a stated class of GMOs; or

      (c)1 or more stated dealings with a GMO, or with a stated class of GMOs.

      (5)The applicant may apply for a licence authorising the dealings by—

      (a)a stated person or stated people; or

      (b)a stated class of people; or

      (c)all people.

      (6)The application must be accompanied by the application fee (if any) prescribed by regulation.

    40ALicences relating to inadvertent dealings

    (1)If the regulator is satisfied that a person has come into possession of a GMO inadvertently the regulator may, with the agreement of the person, treat the person as having made an inadvertent dealings application.

    (2)To remove any doubt, subsection (1) does not prevent a person from making an application under section 40 in relation to a GMO that has inadvertently come into the person’s possession.

    NoteSection 46A and s 49 have the effect that the regulator may expedite consideration of an application to dispose of a GMO that has come into a person’s possession inadvertently. These sections have effect whether the application is made under s 40, or is taken to have been made under this section.

    1. Application may be withdrawn

      (1)The applicant may withdraw the application at any time before the licence is issued.

      (2)The application fee is not refundable if the applicant withdraws the application.

    2. Regulator may require applicant to give further information

      (1)The regulator may, by written notice, require the applicant to give the regulator any further information about the application the regulator requires.

      (2)The notice may state the period within which the information must be given.

      (3)The regulator may require information to be given under this section at any time before the regulator decides the application, whether before or after the regulator has begun to consider the application.

    3. Regulator must consider applications except in certain circumstances

      (1)The regulator must consider the application in accordance with this part.

      (2)However, the regulator is not required to consider the application, or may cease considering the application, if—

      (a)the application does not contain the information specified by the regulator or prescribed by regulation; or

      (b)the application does not satisfy section 40 (3); or

      (c)the application is not accompanied by the application fee (if any) prescribed by regulation; or

      (d)the applicant did not provide further information required by the regulator by notice under section 42 within the period stated in the notice; or

      (e)the regulator is satisfied that to issue the licence would be inconsistent with a policy principle in force under section 21; and

      (f)the regulator is satisfied (having regard to the matters mentioned in section 58) that the applicant is not a suitable person to hold a licence.

      (3)The regulator must issue the licence, or refuse to issue the licence, within the period (if any) prescribed by regulation.

    4. Regulator may consult with applicant

      Before considering the application, the regulator may consult the applicant, or another regulatory agency, on any aspect of the application.

    5. Regulator must not use certain information in considering licence application

      If—

      (a)a person (the first person) applies for a GMO licence; and

      (b)the first person gives information to the regulator for the regulator’s consideration of the application; and

      (c)the information is confidential commercial information;

      the regulator must not take that information into account in considering an application by someone else for a GMO licence, unless the first person has given written consent for the information to be so taken into account.

    Division 5.3               Initial consideration of licences for dealings not involving intentional release of GMO into environment

    1. Applications to which div 5.3 applies

      This division applies to an application for a GMO licence if the regulator is satisfied that none of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment.

    46ADivision does not apply to an application relating to inadvertent dealings

    Despite section 46, this division does not apply to an application for a GMO licence if the regulator is satisfied that—

    (a)the dealings proposed to be authorised by the licence are limited to 1 or more of the following for purposes relating to disposing of a GMO:

    (i)conducting experiments with the GMO;

    (ii)propagating the GMO;

    (iii)growing, raising or culturing the GMO;

    (iv)transporting the GMO;

    (v)any other dealings to be undertaken for the purposes of, or for purposes relating to, disposing of the GMO; and

    (b)the applicant for the licence came into possession of the GMO inadvertently.

    1. What regulator must do in relation to application

      (1)Before issuing the licence, the regulator must prepare a risk assessment and a risk management plan in relation to the dealings proposed to be authorised by the licence (the proposed dealings).

      (2)In preparing the risk assessment, the regulator must take into account the risks posed by the proposed dealings, including any risks to the health and safety of people and any risks to the environment.

      (3)In preparing the risk management plan, the regulator must take into account the ways of managing any risks posed by the proposed dealings that protect—

      (a)the health and safety of people; and

      (b)the environment.

      (4)The regulator may consult any of the following on any aspect of the application:

      (a)the States;

      (b)the gene technology technical advisory committee;

      (c)relevant Commonwealth authorities or agencies;

      (d)any local council the regulator considers appropriate;

      (e)anyone else the regulator considers appropriate.

    Division 5.4               Initial consideration of licences for dealings involving intentional release of GMO into environment

    1. Applications to which div 5.4 applies

      This division applies to an application for a GMO licence if the regulator is satisfied that at least 1 of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment.

    2. Division does not apply to an application relating to inadvertent dealings

      Despite section 48, this division does not apply to an application for a GMO licence if the regulator is satisfied that—

      (a)the dealings proposed to be authorised by the licence are limited to 1 or more of the following for purposes relating to disposing of a GMO:

      (i)conducting experiments with the GMO;

      (ii)propagating the GMO;

      (iii)growing, raising or culturing the GMO;

      (iv)transporting the GMO;

      (v)any other dealings to be undertaken for the purposes of, or for purposes relating to, disposing of the GMO; and

      (b)the applicant for the licence came into possession of the GMO inadvertently.

    3. Regulator must prepare risk assessment and risk management plan

      (1)Before issuing the licence, the regulator must prepare a risk assessment and a risk management plan in relation to the dealings proposed to be authorised by the licence.

      (3)Unless section 50A applies in relation to the application for the licence, the regulator must seek advice on matters relevant to the preparation of the risk assessment and the risk management plan from—

      (a)the States; and

      (b)the gene technology technical advisory committee; and

      (c)each Commonwealth authority or agency prescribed by regulation for this paragraph; and

      (d)the Commonwealth Environment Minister; and

      (e)any local council that the regulator considers appropriate.

    50ALimited and controlled release applications

    (1)This section applies to an application for a licence if the regulator is satisfied that—

    (a)the principal purpose of the application is to enable the licence holder, and people covered by the licence, to conduct experiments; and

    (b)the application proposes in relation to any GMO for which dealings are proposed to be authorised—

    (i)controls to restrict the dissemination or persistence of the GMO and its genetic material in the environment; and

    (ii)limits on the proposed release of the GMO; and

    (c)the regulator is satisfied that the controls and limits are of such a kind that it is appropriate for the regulator not to seek the advice mentioned in section 50 (3).

    (2)In deciding whether the principal purpose of an application is to enable the licence holder, and people covered by the licence, to conduct experiments, the regulator—

    (a)must have regard to whether the applicant proposes that any or all of the following be authorised by, and done under, the licence:

    (i)testing hypotheses;

    (ii)gaining scientific or technical knowledge;

    (iii)gaining data for regulatory purposes, or for product development or marketing; and

    (b)may have regard to anything else the regulator considers to be relevant.

    (3)In this section:

    controls, in relation to restricting the dissemination or persistence of a GMO and its genetic material in the environment, include the following:

    (a)stated methods for disposal of the GMO or its genetic material;

    (b)data collection requirements, including studies to be conducted about the GMO or its genetic material;

    (c)a restricted geographic area in which the proposed dealings with the GMO or its genetic material may occur;

    (d)compliance, in relation to dealings with the GMO or its genetic material, with—

    (i)a code of practice issued under section 24; or

    (ii)a technical or procedural guideline issued under section 27.

    limits, in relation to the release of a GMO that is proposed to be authorised by a licence, includes limits on any of the following:

    (a)the scope of the dealings with the GMO;

    (b)the scale of the dealings with the GMO;

    (c)the locations of the dealings with the GMO;

    (d)the duration of the dealings with the GMO;

    (e)the people who are to be permitted to conduct of the dealings with the GMO.

    NoteThis section differs from the Commonwealth Act, s 50A.

    1. Matters regulator must take into account in preparing risk assessment and risk management plan

      (1)In preparing the risk assessment in relation to the dealings proposed to be authorised by the licence (the proposed dealings), the regulator must take into account the following:

      (a)the risks posed by the proposed dealings, including any risks to the health and safety of people or risks to the environment, having regard to the matters prescribed by regulation;

      (c)any advice about the risk assessment given by the following in response to a request under section 50 (3):

      (i)a State;

      (ii)the gene technology technical advisory committee;

      (iii)a Commonwealth authority or agency;

      (iv)the Commonwealth Environment Minister;

      (v)a local council;

      (d)anything else prescribed by regulation for this paragraph.

      (2)In preparing the risk management plan, the regulator must take into account the following:

      (a)the ways of managing any risks posed by the proposed dealings that protect—

      (i)the health and safety of people; and

      (ii)the environment;

      (c)any advice about the risk management plan given by the following in response to a request under section 50 (3):

      (i)a State;

      (ii)the gene technology technical advisory committee;

      (iii)a Commonwealth authority or agency;

      (iv)the Commonwealth Environment Minister;

      (v)a local council;

      (d)anything else prescribed by regulation for this paragraph.

      (3)To remove any doubt, in taking into account the ways of managing risks mentioned in subsection (2) (a), the regulator—

      (a)is not limited to considering advice mentioned in subsection (2) (c); and

      (b)subject to section 45, may take into account other information, including, for example, relevant independent research.

    2. Public notification of risk assessment and risk management plan

      (1)After taking the steps mentioned in section 50 and section 51, the regulator must prepare a written notice in accordance with subsection (2).

      (2)The notice must—

      (a)state that a risk assessment and a risk management plan have been prepared for dealings proposed to be authorised by the licence; and

      (b)state that a person may ask for a copy of information about the risk assessment and the risk management plan under section 54; and

      (ba)if the regulator is satisfied that 1 or more dealings proposed to be authorised by the licence may pose a significant risk to the health and safety of people or to the environment—state that the regulator is so satisfied; and

      (c)invite written submissions about the risk assessment and the risk management plan; and

      (d)state the closing date for submissions, which must not be earlier than—

      (i)if the notice states that the regulator is satisfied that the dealings proposed to be authorised by the licence may pose a significant risk to the health and safety of people or to the environment—50 days after the date on which the notice was published; or

      (ii)in any other case—30 days after the date on which the notice was published.

      (3)The notice is a notifiable instrument.

      (4)The regulator must give additional public notice of the notice.

      NotePublic notice means notice on an ACT government website or in a daily newspaper circulating in the ACT (see Legislation Act, dict, pt 1). The requirement in s (4) is in addition to the requirement for notification on the legislation register as a notifiable instrument.

      (5)The regulator must also seek advice on the risk assessment and the risk management plan from—

      (a)the States; and

      (b)the gene technology technical advisory committee; and

      (c)each Commonwealth authority or agency prescribed by regulation for this paragraph; and

      (d)the Commonwealth Environment Minister; and

      (e)any local council that the regulator considers appropriate.

      NoteThis section differs from the Commonwealth Act, s 52.

    3. Regulator may take other actions

      (1)In addition to satisfying the requirements of this division, the regulator may take any other action the regulator considers appropriate for deciding the application, including holding a public hearing.

      (2)If the regulator holds a public hearing, the regulator may, having regard to the requirements of this Act about confidential commercial information, direct that any part of the hearing be held in private, and may decide who can attend.

      (3)The regulator may give directions prohibiting or restricting the publication of evidence given, or material contained in documents produced, at a public hearing.

      (4)A person must not contravene a direction under subsection (3).

      Maximum penalty:  30 penalty units.

      (5)An offence against subsection (4) is a strict liability offence.

      NoteFor strict liability offences, see the Criminal Code, s 23.

    4. Person may request copies of certain documents

      (1)A person may ask the regulator for a copy of the following documents:

      (a)an application to which this division applies;

      (b)a risk assessment or a risk management plan prepared under section 50.

      (2)If a person makes a request under subsection (1), the regulator must give the person a copy of the documents, other than—

      (a)any confidential commercial information contained in the documents; and

      (b)any information contained in the documents about relevant convictions of the applicant for the licence.

      NoteFor information to be confidential commercial information, it must be covered by a declaration under s 185.

      (3)In this section:

      relevant conviction—see section 58 (4).

    Division 5.5               Decision on licence application

    1. Regulator must make a decision on licence and licence conditions

      After taking any steps required by division 5.3 or division 5.4 for an application for a GMO licence, the regulator—

      (a)must decide whether to issue or refuse to issue the licence; and

      (b)if the regulator decides to issue the licence—may impose conditions on it.

    2. Regulator must not issue the licence unless satisfied as to risk management

      (1)The regulator must not issue the licence unless the regulator is satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in a way that protects—

      (a)the health and safety of people; and

      (b)the environment.

      (2)For subsection (1), the regulator must have regard to the following:

      (a)the risk assessment prepared under section 47 or section 50 in relation to the dealings;

      (b)the risk management plan prepared under section 47 or section 50 in relation to the dealings;

      (c)any submissions received under section 52 about the licence;

      (d)any policy guidelines in force under section 23 about—

      (i)risks that may be posed by the dealings; or

      (ii)ways of managing the risks that protect the health and safety of people and protect the environment.

      NoteSubsections (2) (a) to (c) do not apply to an inadvertent dealings application.

    3. Other circumstances in which regulator must not issue the licence

      (1)The regulator must not issue the licence if the regulator is satisfied that issuing the licence would be inconsistent with a policy principle in force under section 21.

      (2)The regulator must not issue the licence unless the regulator is satisfied that the applicant is a suitable person to hold the licence.

      (3)Subsection (2) does not apply to an inadvertent dealings application.

    4. Matters to be taken into account in deciding whether person is suitable to hold licence

      (1)Without limiting the matters to which the regulator may have regard in deciding whether an individual is a suitable person to hold a licence, the regulator must have regard to—

      (a)any relevant conviction of the individual; and

      (b)any revocation or suspension of a licence or permit (however described) held by the individual under a law of the Territory, the Commonwealth, a State or a foreign country about the health and safety of people or the environment; and

      (c)the capacity of the individual to meet the conditions of the licence.

      (2)Without limiting the matters to which the regulator may have regard in deciding whether a corporation is a suitable person to hold a licence, the regulator must have regard to—

      (a)any relevant conviction of the corporation; and

      (b)if there is a relevant conviction of the corporation—

      (i)whether the offence concerned was committed when anyone who is presently a director of the corporation was a director; and

      (ii)whether that offence was committed when any officer or shareholder of the corporation who is presently in a position to influence the management of the corporation was an officer or shareholder of the corporation; and

      (c)any revocation or suspension of a licence or permit (however described) held by the corporation under a law of the Territory, the Commonwealth, a State or a foreign country about the health and safety of people or the environment; and

      (d)the capacity of the corporation to meet the conditions of the licence.

      (3)This section does not affect the Spent Convictions Act 2000.

      (4)In this section:

      relevant conviction, for an applicant for a licence, means a conviction for an offence against a law of the Territory, the Commonwealth, a State or a foreign country, about the health and safety of people or the environment, if—

      (a)the offence was committed within 10 years immediately before the making of the application for the licence; and

      (b)the offence was punishable by a fine of $5 000 or more, or by imprisonment for 1 year or more.

      NoteThis section differs from the Commonwealth Act, s 58.

    1. Notification of licence decision

      The regulator must notify the applicant in writing of the regulator’s decision, including any conditions imposed by the regulator.

    2. Period of licence

      (1)A licence continues in force—

      (a)if the licence is expressed to be in force for a particular period—until the end of the period; or

      (b)otherwise—until it is cancelled or surrendered.

      (2)A licence is not in force during a period of suspension.

      (3)A licence issued as a result of an inadvertent dealings application must not be expressed to be in force for a period of longer than 12 months.

    Division 5.6               Conditions of licences

    1. Licence is subject to conditions

      A GMO licence is subject to the following conditions:

      (a)the conditions stated in section 63, section 64 and section 65;

      (b)any conditions prescribed by regulation;

      (c)any conditions imposed by the regulator when issuing the licence;

      (d)any conditions imposed by the regulator under section 71 after the licence is issued.

    2. Conditions that may be prescribed or imposed

      (1)Licence conditions may include conditions that impose obligations about GM products derived from a GMO for which particular dealings are licensed.

      (2)Licence conditions may relate to, for example, the following:

      (a)the scope of the dealings authorised by the licence;

      (b)the purposes for which the dealings may be undertaken;

      (c)variations to the scope or purposes of the dealings;

      (d)documentation and record-keeping requirements;

      (e)the required level of containment for the dealings, including requirements about the certification of facilities to stated containment levels;

      (f)waste disposal requirements;

      (g)measures to manage risks posed to the health and safety of people or to the environment;

      (h)data collection, including studies to be conducted;

      (i)auditing and reporting;

      (j)actions to be taken if a GMO is released from a contained environment;

      (k)the geographic area where the dealings authorised by the licence may happen;

      (l)requiring compliance with a code of practice issued under section 24, or a technical or procedural guideline issued under section 27;

      (m)supervision by, and monitoring by, institutional biosafety committees;

      (n)contingency planning for unintended effects of the dealings authorised by the licence;

      (o)limiting the dissemination or persistence of the GMO or its genetic material in the environment.

      (3)Licence conditions may also include conditions requiring the licence holder to be adequately insured against any loss, damage or injury that may be caused to human health, property or the environment by the dealings authorised by the licence.

    3. Condition about telling people of obligations

      (1)It is a condition of a licence that the licence holder tell anyone covered by the licence, to whom a particular condition of the licence applies, of the following:

      (a)the particular condition, including any variations of it;

      (b)the cancellation or suspension of the licence;

      (c)the surrender of the licence.

      (2)Requirements about how information is given under subsection (1) may be—

      (a)prescribed by regulation; or

      (b)specified by the regulator.

      (3)The requirements may include, for example, measures about labelling, packaging, conducting training and giving information.

      (4)If requirements are prescribed or specified, it is a condition of a licence that the licence holder comply with the requirements.

    4. Condition about monitoring and audits

      (1)It is a condition of a licence that if—

      (a)a person is authorised by the licence to deal with a GMO; and

      (b)a particular condition of the licence applies to the dealing by the person—

      the person must allow the regulator, or a person authorised by the regulator, to enter premises where the dealing is being undertaken, for auditing or monitoring the dealing.

      (2)Subsection (1) does not limit the conditions that may be imposed by the regulator or prescribed by regulation.

    5. Condition about additional information to be given to regulator

      (1)It is a condition of a licence that the licence holder tell the regulator if the licence holder becomes aware of—

      (a)additional information about any risks to the health and safety of people, or to the environment, associated with the dealings authorised by the licence; or

      (b)any contraventions of the licence by a person covered by the licence; or

      (c)any unintended effects of the dealings authorised by the licence.

      (2)For subsection (1)—

      (a)the licence holder is taken to have become aware of additional information of a kind mentioned in subsection (1) if the licence holder was reckless about whether the information existed; and

      (b)the licence holder is taken to have become aware of contraventions, or unintended effects, of a kind mentioned in subsection (1) if the licence holder was reckless about whether the contraventions had happened, or the unintended effects existed.

    6. Person may give information to regulator

      A person covered by a licence may tell the regulator if the person becomes aware of any of the following:

      (a)additional information about any risks to the health and safety of people, or to the environment, associated with the dealings authorised by the licence;

      (b)any contraventions of the licence by a person covered by the licence;

      (c)any unintended effects of the dealings authorised by the licence.

    7. Protection of persons who give information

      A person does not incur any civil liability for loss, damage or injury of any kind suffered by someone else because the first person gave information to the regulator under section 65, section 66 or the Commonwealth Act, section 72D (2) (h).

    Division 5.7               Suspension, cancellation and variation of licences

    1. Suspension and cancellation of licence

      The regulator may, by written notice given to the holder of a GMO licence, suspend or cancel the licence if—

      (a)the regulator believes on reasonable grounds that a condition of the licence has been breached, whether by the licence holder or a person covered by the licence; or

      (b)the regulator believes on reasonable grounds that the licence holder, or a person covered by the licence, has committed an offence against this Act; or

      (c)any annual charge payable for the licence remains unpaid after the due date; or

      (d)the licence was obtained improperly; or

      (e)the regulator becomes aware of risks associated with the continuation of the dealings authorised by the licence, and is satisfied that the licence holder has not proposed, or is not in a position to implement, adequate measures to deal with the risks; or

      (f)the regulator is satisfied that the licence holder is no longer a suitable person to hold the licence.

    2. Surrender of licence

      A licence holder may surrender the licence with the regulator’s consent.

    3. Transfer of licences

      (1)The licence holder and someone else (the transferee) may jointly apply to the regulator for the licence to be transferred from the licence holder to the transferee.

      (2)The application must be in writing, and must contain—

      (a)the information (if any) prescribed by regulation; and

      (b)the information specified in writing by the regulator.

      (3)The regulator must not transfer the licence unless the regulator is satisfied that, if the licence is transferred, any risks posed by the dealings authorised by the licence will continue to be able to be managed in a way that protects—

      (a)the health and safety of people; and

      (b)the environment.

      (4)The regulator must not transfer the licence unless the regulator is satisfied that the transferee is a suitable person to hold the licence.

      (5)The regulator must give written notice of his or her decision on the application to the licence holder and the transferee.

      (6)If the regulator decides to transfer the licence—

      (a)the transfer takes effect on the date stated in the notice; and

      (b)the licence continues in force as mentioned in section 60; and

      (c)the licence is subject to the same conditions as the conditions in force immediately before the transfer.

    4. Variation of licence

      (1)The regulator may vary a licence, by written notice given to the licence holder—

      (a)at any time, on the regulator’s own initiative; or

      (b)on application by the licence holder.

      (1A)An application for a variation must be in writing, and must contain—

      (a)any information prescribed by regulation; and

      (b)any information specified in writing by the regulator.

      (2)The regulator must not vary a licence to authorise dealings involving the intentional release of a GMO into the environment if the application for the licence was originally considered under division 5.3.

      NoteApplications may only be considered under div 5.3 if none of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment.

      (2A)The regulator must not vary a licence if the original application for the licence was an application to which section 50A applied, unless—

      (a)the regulator is satisfied that the principal purpose of the licence as proposed to be varied is to enable the licence holder, and people covered by the licence, to conduct experiments; and

      (b)the application for variation proposes, in relation to any GMO for which dealings are proposed to be authorised as a result of the variation—

      (i)controls to restrict the dissemination or persistence of the GMO and its genetic material in the environment; and

      (ii)limits on the proposed release of the GMO; and

      (c)the regulator is satisfied that the controls and limits are of such a kind that it is appropriate for the regulator not to seek the advice mentioned in section 50 (3).

      NoteSection 50A applies to an application that proposes controls and limits on the dissemination, persistence and release of the GMO concerned and is for the purpose of conducting experiments.

      (2B)If an application has been made for variation of a licence, the regulator must not vary the licence unless the regulator is satisfied that the risks posed by the dealings proposed to be authorised by the licence as varied are covered by—

      (a)the risk assessment and the risk management plan in relation to the original application for the licence; or

      (b)the risk assessment and the risk management plan in relation to an application for another licence, but only if that other licence was issued.

      (3)Without limiting subsection (1), the regulator may—

      (a)impose licence conditions or additional licence conditions; or

      (b)remove or vary licence conditions that were imposed by the regulator; or

      (c)extend or reduce the authority granted by the licence.

      (4)The regulator must not vary a licence unless the regulator is satisfied that any risks posed by the dealings proposed to be authorised by the licence as varied are able to be managed in a way that protects—

      (a)the health and safety of people; and

      (b)the environment.

      (5)The regulator must not vary a licence unless any local council that the regulator considers appropriate has been consulted about the proposed variation.

      (6)The regulator must not vary a licence in the circumstances (if any) prescribed by regulation.

      (7)If an application has been made for variation of a licence, the regulator must vary the licence or refuse to vary the licence, within the period (if any) prescribed by regulation.

      (8)In this section:

      controls—see section 50A (3).

      limits—see section 50A (3).

    5. Regulator to notify of proposed suspension, cancellation or variation

      (1)Before suspending, cancelling or varying a licence under this division, the regulator must give written notice of the proposed suspension, cancellation or variation to the licence holder.

      (2)The notice—

      (a)must state that the regulator proposes to suspend, cancel or vary the licence; and

      (b)may require the licence holder to give to the regulator any information of a kind stated in the notice that is relevant to the proposed suspension, cancellation or variation; and

      (c)may invite the licence holder to make a written submission to the regulator about the proposed suspension, cancellation or variation.

      (3)The notice must state a period within which the licence holder—

      (a)must give the information mentioned in subsection (2) (b); and

      (b)may make a submission under subsection (2) (c).

      (4)The period must not end earlier than 30 days after the day the notice was given.

      (5)In considering whether to suspend, cancel or vary a licence, the regulator must have regard to any submission made under subsection (2) (c).

      (6)This section does not apply to a suspension, cancellation or variation requested by the licence holder.

      (7)This section does not apply to a suspension, cancellation or variation of a licence if the regulator considers that the suspension, cancellation or variation is necessary to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment.

      (8)This section does not apply to a variation of a licence if the regulator is satisfied that the variation is of minor significance or complexity.

    Division 5.8               Annual charge

    72AAGMO licence—annual charge

    (1)A person who is the holder of a GMO licence at any time during a financial year is liable to pay a charge for the licence for the year.

    (2)The amount of the charge for a financial year is the amount prescribed by regulation.

    (3)The amount prescribed may be in the nature of a tax and not be related to the cost of providing any service.

    NoteThis section does not appear in the Commonwealth Act.  Provision is included, however, in the Gene Technology (Licence Charges) Act 2000 (Cwlth) for the imposition of an annual charge for a GMO licence.

    Part 5AEmergency dealing determinations

    Note to pt 5A

    This part differs from the Commonwealth Act, pt 5A.

    72AApplication of Commonwealth emergency dealing determinations

    An emergency dealing determination in force under the Commonwealth Act, section 72B applies, as far as applicable, as a law of the Territory.

    NoteThis section differs from the Commonwealth Act, s 72A.

    72BMinister may make emergency dealing determination

    NoteThe Commonwealth Act, s 72B permits the Commonwealth Minister to make emergency dealing determinations with a GMO for the purposes of the Commonwealth Act, part 5A.

    72CPeriod of effect of emergency dealing determination

    NoteThe Commonwealth Act, s 72C provides for when an emergency dealing determination takes effect, when it ceases to have effect and how the period of effect may be extended by the Commonwealth Minister responsible for emergency dealing determinations.

    72DEmergency dealing determination authorises dealings, subject to conditions

    NoteThe Commonwealth Act, s 72D authorises dealings with a GMO subject to conditions, including those referred to in s 72D (2).

    72EVariation, suspension and revocation of emergency dealing determination

    Note Under the Commonwealth Act, s 72E, the Commonwealth Minister responsible for emergency dealing determinations may suspend an emergency dealing determination, revoke an emergency dealing determination or vary the conditions to which an emergency dealing determination is subject.

    Part 6Regulation of notifiable low risk dealings on GMO register

    Division 6.1               Simplified outline of pt 6

    1. Simplified outline—pt 6

      In outline, this part—

      (a)establishes a mechanism for the regulations to regulate certain dealings with GMOs (notifiable low risk dealings) that do not involve the intentional release of GMOs into the environment (see division 6.2); and

      (b)provides that a regulation may, among other things, require that the regulator be notified of the dealings; and

      (c)enables the regulator to determine that certain dealings previously authorised by a licence be included on the GMO register; and

      (d)ensures that, if a dealing is included on the GMO register, anyone may undertake the dealing, subject to stated conditions.

    Division 6.2               Notifiable low risk dealings

    1. Notifiable low risk dealings

      (1)A regulation may declare a dealing with a GMO to be a notifiable low risk dealing for this Act.

      (2)Before the Executive makes a regulation declaring a dealing with a GMO to be a notifiable low risk dealing, the regulator must be satisfied that the dealing would not involve the intentional release of a GMO into the environment.

      (3)Also, before the Executive makes a regulation declaring a dealing with a GMO to be a notifiable low risk dealing, the regulator must consider—

      (a)whether the dealing with the GMO would involve any risk to the health and safety of people, or to the environment, taking into account—

      (i)the properties of the GMO as a pathogen or pest; and

      (ii)the toxicity of any proteins produced by the GMO; and

      (b)if there is such a risk—whether 1 or more of the requirements prescribed by regulation for section 75 (2) would be sufficient to manage the risk; and

      (c)any other matter the regulator considers appropriate.

      Note 1For provisions corresponding to the Commonwealth Act, s 74 (4), see the Legislation Act, s 48.

      Note 2This section differs from the Commonwealth Act, s 74.

    2. Regulation of notifiable low risk dealings

      (1)A regulation may regulate a notifiable low risk dealing for the purpose of protecting the health and safety of people or the environment.

      (2)A regulation may prescribe different requirements to be complied with in different situations or by different people, including requirements in relation to the following:

      (a)the people who may undertake notifiable low risk dealings;

      (b)notifying the regulator of notifiable low risk dealings;

      (c)supervision by institutional biosafety committees of notifiable low risk dealings;

      (d)the containment level of facilities in which notifiable low risk dealings may be undertaken.

      (3)Subsection (2) does not limit the Legislation Act, section 48 (Power to make instrument includes power to make different provision for different categories etc).

    Division 6.3               GMO register

    1. GMO register

      NoteThe Commonwealth Act, s 76 provides for the establishment and maintenance of the GMO register.

    2. Contents of register

      If the regulator determines under section 78 that a dealing with a GMO is to be included on the GMO register, the regulator must state in the GMO register—

      (a)a description of the dealing; and

      (b)any condition to which the dealing is subject.

    3. Regulator may include dealings with GMOs on GMO register

      (1)The regulator may, in writing, determine that a dealing with a GMO is to be included on the GMO register if the regulator is satisfied that—

      (a)the dealing is, or has been, authorised by a GMO licence; or

      (b)the GMO—

      (i)is a GM product; and

      (ii)is a GMO only because of a regulation made under the definition of genetically modified organism, paragraph (c).

      (2)A determination under subsection (1) may be made—

      (a)on application by the holder of a licence authorising the dealing; or

      (b)on the regulator’s own initiative.

      (3)A determination under subsection (1) commences on the day stated in the determination.


    Dictionary

    (see s 10 (1))

    Note 1The Legislation Act contains definitions and other provisions relevant to this Act.

    Note 2In particular, the Legislation Act, dict, pt 1, defines the following terms:

    ·     administrative unit

    ·     exercise

    ·     function

    ·     public servant

    ·     State.

    Note 3The definitions in this dictionary have equivalent definitions in the Commonwealth Act, s 10 (1).

    accredited organisation means an organisation accredited under division 7.3.

    aggravated offence—see section 38 (1).

    Commonwealth Act means the Gene Technology Act 2000 (Cwlth).

    Commonwealth administrative review tribunal means the Administrative Review Tribunal established under the Administrative Review Tribunal Act 2024 (Cwlth), section 8.

    Commonwealth authority means—

    (a)a corporation established for a public purpose under a Commonwealth Act; or

    (b)a company in which a controlling interest is held by any 1 of the following, or by 2 or more of the following together:

    (i)the Commonwealth;

    (ii)a corporation mentioned in paragraph (a);

    (iii)an entity mentioned in subparagraph (i) or (ii).

    Commonwealth Environment Minister means the Commonwealth Minister responsible for environment and conservation.

    confidential commercial information means information declared under section 185 to be confidential commercial information.

    containment level, for a facility, means the degree of physical confinement of GMOs provided by the facility, having regard to the design of the facility, the equipment located or installed in the facility and the procedures generally used within the facility.

    deal with a GMO means any of the following:

    (a)conduct experiments with the GMO;

    (b)make, develop, produce or manufacture the GMO;

    (c)breed the GMO;

    (d)propagate the GMO;

    (e)use the GMO in the course of manufacturing a thing that is not the GMO;

    (f)grow, raise or culture the GMO;

    (g)import the GMO;

    (h)transport the GMO;

    (i)dispose of the GMO;

    and includes the possession, supply or use of the GMO for the purposes of, or in the course of, a dealing mentioned in any of paragraphs (a) to (i).

    eligible person, for a reviewable decision—see section 179.

    environment includes—

    (a)ecosystems and their constituent parts; and

    (b)natural and physical resources; and

    (c)the qualities and characteristics of locations, places and areas.

    ethics and community committee means the gene technology ethics and community consultative committee established by the Commonwealth Act, section 106.

    evidential material means any of the following:

    (a)a thing in relation to which an offence against this Act has been committed or is suspected, on reasonable grounds, to have been committed;

    (b)a thing that there are reasonable grounds for suspecting will provide evidence about the commission of an offence mentioned in paragraph (a);

    (c)a thing that there are reasonable grounds for suspecting is intended to be used for committing an offence against this Act.

    exempt dealing means a dealing prescribed by regulation as an exempt dealing.

    facility includes, but is not limited to, the following:

    (a)a building or part of a building;

    (b)a laboratory;

    (c)an aviary;

    (d)a glasshouse;

    (e)an insectary;

    (f)an animal house;

    (g)an aquarium or tank.

    gene technology means any technique for modifying genes or other genetic material, but does not include—

    (a)sexual reproduction; or

    (b)homologous recombination; or

    (c)any other technique prescribed by regulation for this paragraph.

    gene technology account means the Gene Technology Account established under the Commonwealth Act, section 129.

    gene technology agreement means the Gene Technology Agreement made for this Act between the Commonwealth and at least 4 States, as in force from time to time.

    gene technology community consultative committee means the Gene Technology Community Consultative Committee established under the Commonwealth Act, section 106.

    gene technology ethics committee means the Gene Technology Ethics Committee established under the Commonwealth Act, section 111.

    gene technology regulator means the Gene Technology Regulator appointed under the Commonwealth Act, section 118.

    gene technology technical advisory committee means the Gene Technology Technical Advisory Committee established under the Commonwealth Act, section 100.

    genetically modified organism means—

    (a)an organism that has been modified by gene technology; or

    (b)an organism that has inherited particular traits from an organism (the initial organism), if the traits occurred in the initial organism because of gene technology; or

    (c)anything declared by regulation to be a genetically modified organism;

    but does not include—

    (d)a human being, if the human being is an organism mentioned in paragraph (a) only because the human being has undergone somatic cell gene therapy; or

    (e)an organism declared by regulation not to be a genetically modified organism.

    GMO means a genetically modified organism.

    GMO licence means a licence issued under section 55.

    GMO register means the GMO Register established under the Commonwealth Act, section 76.

    GM product means a thing (other than a GMO) derived or produced from a GMO.

    GM record means the Record of GMO Dealings mentioned in the Commonwealth Act, section 138.

    inadvertent dealings application means an application for a GMO licence to which division 5.3 or division 5.4 does not apply because of the operation of section 46A or section 49.

    institutional biosafety committee means a committee established as an institutional biosafety committee in accordance with the guidelines issued by the regulator under section 98.

    intentional release of a GMO into the environment—see section 11.

    licence holder means the holder of a GMO licence.

    ministerial council means the Ministerial Council within the meaning of the gene technology agreement.

    notifiable low risk dealing means a dealing declared to be a notifiable low risk dealing under section 74.

    officer, of the Commonwealth, includes the following:

    (a)a Commonwealth Minister;

    (b)a person who holds—

    (i)an office established under a Commonwealth Act; or

    (ii)an appointment made under a Commonwealth Act; or

    (iii)an appointment made by the Governor-General or a Commonwealth Minister other than under a Commonwealth Act;

    (c)a person who is a member or officer of a Commonwealth authority;

    (d)a person who is in the service or employment of the Commonwealth or of a Commonwealth authority, or is employed or engaged under a Commonwealth Act.

    organism means any biological entity that is—

    (a)viable; or

    (b)capable of reproduction; or

    (c)capable of transferring genetic material.

    person covered by a GMO licence means a person authorised by a GMO licence to deal with a GMO.

    premises includes the following:

    (a)a building;

    (b)a place, including an area of land;

    (c)a vehicle;

    (d)a vessel;

    (e)an aircraft;

    (f)a facility;

    (g)any part of premises, including premises mentioned in paragraphs (a) to (f).

    regulator means the gene technology regulator.

    reviewable decision—see section 179.

    State includes the Territory.

    NoteState also includes the Northern Territory (see Legislation Act, dict, pt 1).

    territory agency means—

    (a)the Territory; or

    (b)a Minister; or

    (c)an administrative unit; or

    (d)a territory instrumentality, and any other corporation established for a public purpose under a territory law; or

    (e)a company in which a controlling interest is held by any 1 of the following, or by 2 or more of the following together:

    (i)the Territory;

    (ii)a Minister;

    (iii)a corporation mentioned in paragraph (d);

    (iv)an entity mentioned in subparagraphs (i) to (iii).

    thing includes a substance, and a thing in electronic or magnetic form.

    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
    1. Legislation history

      Gene Technology Act 2003 A2003-57

      notified LR 5 December 2003
      s 1, s 2 commenced 5 December 2003 (LA s 75 (1))
      remainder commenced 5 June 2004 (s 2 and LA s 79)



      as amended by

      Criminal Code (Theft, Fraud, Bribery and Related Offences) Amendment Act 2004 A2004-15 sch 1 pt 1.20

      notified LR 26 March 2004
      s 1, s 2 commenced 26 March 2004 (LA s 75 (1))
      sch 1 pt 1.20 commenced 5 June 2004 (LA s 79A)



      Health Legislation Amendment Act 2006 (No 2) A2006-46 sch 2 pt 2.7

      notified LR 17 November 2006
      s 1, s 2 commenced 17 November 2006 (LA s 75 (1))
      sch 2 pt 2.7 commenced 18 November 2006 (s 2 (1))

      Gene Technology Amendment Act 2008 A2008-10

      notified LR 21 April 2008
      s 1, s 2 commenced 21 April 2008 (LA s 75 (1))
      remainder commenced 1 May 2008 (s 2 and CN2008-5)

      Statute Law Amendment Act 2009 A2009-20 sch 3 pt 3.35

      notified LR 1 September 2009
      s 1, s 2 commenced 1 September 2009 (LA s 75 (1))
      sch 3 pt 3.35 commenced 22 September 2009 (s 2)

      Statute Law Amendment Act 2011 (No 3) A2011-52 sch 3 pt 3.29

      notified LR 28 November 2011
      s 1, s 2 commenced 28 November 2011 (LA s 75 (1))
      sch 3 pt 3.29 commenced 12 December 2011 (s 2)

      Red Tape Reduction Legislation Amendment Act 2015 A2015-33 sch 1 pt 1.33

      notified LR 30 September 2015
      s 1, s 2 commenced 30 September 2015 (LA s 75 (1))
      sch 1 pt 1.33 commenced 14 October 2015 (s 2)

      Public Sector Management Amendment Act 2016 A2016-52 sch 1 pt 1.31

      notified LR 25 August 2016
      s 1, s 2 commenced 25 August 2016 (LA s 75 (1))
      sch 1 pt 1.31 commenced 1 September 2016 (s 2)

      Freedom of Information Act 2016 A2016-55 sch 4 pt 4.11 (as am by A2017-14 s 19)

      notified LR 26 August 2016
      s 1, s 2 commenced 26 August 2016 (LA s 75 (1))
      sch 4 pt 4.11 commenced 1 January 2018 (s 2 as am by A2017-14 s 19)

      Justice and Community Safety Legislation Amendment Act 2017 (No 2) A2017-14 s 19

      notified LR 17 May 2017
      s 1, s 2 commenced 17 May 2017 (LA s 75 (1))
      s 19 commenced 24 May 2017 (s 2 (1))

      NoteThis Act only amends the Freedom of Information Act 2016 A2016-55.

      Gene Technology Amendment Act 2017 A2017-15 pt 2

      notified LR 14 June 2017
      s 1, s 2 commenced 14 June 2017 (LA s 75 (1))
      pt 2 commenced 15 June 2017 (s 2)

      Red Tape Reduction Legislation Amendment Act 2018 A2018-33 sch 1 pt 1.18

      notified LR 25 September 2018
      s 1, s 2 commenced 25 September 2018 (LA s 75 (1))
      sch 1 pt 1.18 commenced 23 October 2018 (s 2 (4))

      Health Legislation Amendment Act 2025 A2025-16 sch 1 pt 1.1

      notified LR 26 May 2025
      s 1, s 2 commenced 26 May 2025 (LA s 75 (1))
      sch 1 pt 1.1 commenced 2 June 2025 (s 2)

      Statute Law Amendment Act 2025 A2025-29 sch 3 pt 3.45, sch 4 pt 4.85

      notified LR 6 November 2025
      s 1, s 2 commenced 6 November 2025 (LA s 75 (1))

      sch 3 pt 3.45, sch 4 pt 4.85 commenced 16 November 2025 (s 2 (1), (9))

    2. Amendment history

      Commencement

      s 2om LA s 89 (4)

      External Territories

      s 7am A2025-16 amdt 1.1

      Review of certain decisions

      s 19am A2025-16 amdts 1.2-1.6

      Ministerial council may issue policy principles

      s 21am A2025‑29 amdt 4.85

      Ministerial council may issue policy guidelines

      s 23am A2025‑29 amdt 4.85

      Ministerial council may issue codes of practice

      s 24am A2025‑29 amdt 4.85

      Independence of regulator

      s 30am A2017-15 s 4

      Simplified outline—pt 4

      s 31am A2008‑10 s 4

      Person not to deal with GMO without licence

      s 32sub A2008‑10 s 5

      Person not to deal with GMO without licence—strict liability offence

      s 33am A2008‑10 s 6, s 7

      Person must not breach conditions of GMO licence

      s 34am A2008‑10 s 8, s 9

      Person must not breach conditions of emergency dealing determination

      s 35Ains A2008‑10 s 10

      Person must not breach conditions of emergency dealing determination—strict liability offence

      s 35Bins A2008‑10 s 10

      Licences relating to inadvertent dealings

      s 40Ains A2008‑10 s 11

      Regulator may require applicant to give further information

      s 42am A2008‑10 s 12

      Regulator must consider applications except in certain circumstances

      s 43am A2008‑10 s 13, s 14

      Division does not apply to an application relating to inadvertent dealings

      s 46Ains A2008‑10 s 15

      am A2017-15 s 5

      Division does not apply to an application relating to inadvertent dealings

      s 49sub A2008‑10 s 16

      am A2017-15 s 6

      Regulator must prepare risk assessment and risk management plan

      s 50am A2008‑10 s 17, s 18

      Limited and controlled release applications

      s 50Ains A2008‑10 s 19

      Matters regulator must take into account in preparing risk assessment and risk management plan

      s 51am A2008‑10 ss 20-22

      Public notification of risk assessment and risk management plan

      s 52am A2008‑10 ss 23-25; A2015‑33 amdt 1.104; A2025‑29 amdt 4.85

      Regulator must not issue the licence unless satisfied as to risk management

      s 56am A2008‑10 s 26, s 27

      Other circumstances in which regulator must not issue the licence

      s 57am A2008‑10 s 28

      Period of licence

      s 60am A2008‑10 s 29

      Protection of persons who give information

      s 67am A2008‑10 s 30

      Variation of licence

      s 71am A2008‑10 ss 31-35; A2017-15 s 7

      Regulator to notify of proposed suspension, cancellation or variation

      s 72am A2008‑10 s 36

      GMO licence—annual charge

      s 72AA(prev s 72A) renum as s 72AA R4 LA (see A2008‑10 s 37)

      Emergency dealing determinations

      pt 5A hdgins A2008‑10 s 38

      Application of Commonwealth emergency dealing determinations

      s 72Aorig s 72A

      renum as s 72AA

      pres s 72A

      ins A2008‑10 s 38

      Minister may make emergency dealing determination

      s 72Bins A2008‑10 s 38

      Period of effect of emergency dealing determination

      s 72Cins A2008‑10 s 38

      Effect and conditions of emergency dealing determination

      div 5A.3 hdg         ins A2008‑10 s 38

      om A2009‑20 amdt 3.83

      Period of effect of emergency dealing determination

      s 72Dins A2008‑10 s 38

      Variation, suspension and revocation of emergency dealing determination

      div 5A.4 hdg         ins A2008‑10 s 38

      om A2009‑20 amdt 3.83

      Variation, suspension and revocation of emergency dealing determination

      s 72Eins A2008‑10 s 38

      Notifiable low risk dealings

      s 74am A2017-15 s 8

      Regulator may include dealings with GMOs on GMO register

      s 78am A2008‑10 s 39

      Variation of GMO register

      s 80am A2025‑29 amdt 3.152

      Simplified outline—pt 7

      s 82am A2008‑10 s 40

      Application for certification

      s 83am A2008‑10 s 41

      Regulator to notify of proposed suspension, cancellation or variation

      s 89am A2008‑10 s 42

      Transfer of certification

      s 89Ains A2008‑10 s 43

      Application for accreditation

      s 91am A2008‑12 s 44

      Regulator may accredit organisations

      s 92am A2008‑10 s 45, s 46

      Regulator to notify of proposed suspension, cancellation or variation

      s 97am A2008‑10 s 47

      Gene technology technical advisory committee and gene technology ethics and community consultative committee

      pt 8 hdgsub A2008‑10 s 48

      Simplified outline—pt 8

      s 99am A2008‑10 s 49

      Gene technology ethics and community consultative committee

      div 8.3 hdgsub A2008‑10 s 50

      Gene technology ethics and community consultative committee

      s 106 hdgsub A2008‑10 s 51

      s 106am A2008‑10 s 52

      Function of ethics and community committee

      s 107sub A2008‑10 s 53

      Membership

      s 108am A2008‑10 s 54

      Remuneration

      s 109am A2008‑10 s 54

      Regulations

      s 110am A2008‑10 s 55

      Subcommittees

      s 110Aom A2008‑10 s 56

      Subcommittees

      s 111om A2008‑10 s 58

      ins A2008‑10 s 57

      Expert advisers

      s 112om A2008‑10 s 58

      ins A2008‑10 s 57

      Gene technology ethics committee

      div 8.4 hdgom A2008‑10 s 58

      Expert advisers

      s 113om A2008‑10 s 58

      Remuneration

      s 114om A2008‑10 s 58

      Members and procedures

      s 115om A2008‑10 s 58

      Subcommittees

      s 116om A2008‑10 s 58

      Simplified outline—pt 9

      s 117am A2017-15 s 9

      Annual Report

      s 136am A2017-15 s 10

      Quarterly reports

      s 136Aam A2008‑10 s 59

      om A2017-15 s 11

      Record of GMO dealings

      div 9.6 hdgsub A2017-15 s 12

      Record of GMO dealings

      s 138 hdgsub A2017-15 s 13

      s 138am A2008‑10 s 60, s 61; A2017-15 ss 14-16

      Simplified outline—pt 10

      s 145am A2008‑10 s 62, s 63

      Regulator may give directions

      s 146am A2008‑10 ss 64-67; A2011‑52 amdt 3.103

      Simplified outline—pt 11

      s 149am A2008‑10 s 68

      Powers available to inspectors for monitoring compliance

      s 152am A2008‑10 s 69, s 70

      Powers available to inspectors for dealing with dangerous situations

      s 158am A2011‑52 amdt 3.104

      Acts and omissions of representatives

      div 12.4 hdgsub A2004‑15 amdt 1.24

      Monitoring warrants

      s 172am A2006‑46 amdt 2.22

      Offence-related warrants by telephone, fax etc

      s 174 hdgsub A2018‑33 amdt 1.33

      s 174am A2018‑33 amdt 1.34

      Pt 11 does not limit power to impose conditions

      s 177sub A2008‑10 s 71

      Meaning of reviewable decision and eligible person

      s 179am A2008‑12 ss 72-74

      Deadlines for making reviewable decisions

      s 182am A2008‑10 s 75, s 76

      Review of decisions by Commonwealth administrative review tribunal

      s 183 hdgsub A2025-16 amdt 1.7

      s 183am A2025-16 amdt 1.8, amdt 1.9

      Regulator may declare information is confidential commercial information

      s 185am A2008‑10 s 77

      Confidential commercial information must not be disclosed

      s 187am A2016-55 amdt 4.13

      Acts and omissions of representatives

      s 188sub A2004‑15 amdt 1.24

      Meaning of terms in s 188

      s 189om A2004‑15 amdt 1.24

      Transitional provisions

      div 12.5 hdgexp 5 June 2006 (s 191A (1))

      Transitional provision—dealings covered by genetic manipulation advisory committee advice to proceed

      s 190exp 5 June 2006 (s 191A (1) (LA s 88 declaration applies))

      Regulations may relate to transitional matters

      s 191exp 5 June 2006 (s 191A (1))

      Expiry of div 12.5

      s 191Aexp 5 June 2006 (s 191A (1))

      Interference with dealings with GMOs

      s 192Aam A2008‑10 s 78, s 79

      Cloning of human beings is prohibited

      s 192Bom A2025-16 amdt 1.10

      Certain experiments involving animal eggs prohibited

      s 192Com A2025-16 amdt 1.10

      Certain experiments involving putting human and animal cells into human uterus prohibited

      s 192Dom A2025-16 amdt 1.10

      Approved forms

      s 192Eam A2025-16 amdt 1.11; am R15 LA

      Regulation-making power

      s 193am A2025‑29 amdt 4.85

      Review of operation of Act

      s 194am A2006‑46 amdt 2.23, amdt 2.24; ss renum R3 LA

      exp 5 June 2009 (s 194 (6))

      Transitional—Gene Technology Amendment Act 2017

      pt 13 hdgins A2017-15 s 17

      exp 15 June 2019 (s 204)

      Meaning of commencement day—pt 13

      s 200ins A2017-15 s 17

      exp 15 June 2019 (s 204)

      Inadvertent dealings applications—s 46A (a) and s 49 (a)

      s 201ins A2017-15 s 17

      exp 15 June 2019 (s 204)

      Variation of licence applications—s 71 (2B)

      s 202ins A2017-15 s 17

      exp 15 June 2019 (s 204)

      Record of GMO dealings—s 138

      s 203ins A2017-15 s 17

      exp 15 June 2019 (s 204)

      Expiry—pt 13

      s 204ins A2017-15 s 17

      exp 15 June 2019 (s 204)

      Dictionary

      dictam A2016‑52 amdt 1.94

      def Commonwealth administrative appeals tribunal om A2025-16 amdt 1.12

      def Commonwealth Administrative Appeals Tribunal Act om A2025-16 amdt 1.12

      def Commonwealth administrative review tribunal ins A2025-16 amdt 1.13

      def consultative committee om A2008‑10 s 80

      def deal with am A2008‑10 s 81

      def ethics and community committee ins A2008‑10 s 82

      def ethics committee om A2008‑10 s 83

      def GM record am A2017-15 s 18

      def inadvertent dealings application ins A2008‑10 s 84

      def institutional biosafety committee sub A2008‑10 s 85

    1. 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–
    5 June 2006
    A2004‑15 new Act and amendments by A2004‑15
    R2
    6 June 2006
    6 June 2006–
    17 Nov 2006
    A2004‑15 commenced expiry
    R3
    18 Nov 2006
    18 Nov 2006–
    30 Apr 2008
    A2006‑46 amendments by A2006‑46
    R4
    1 May 2008
    1 May 2008–
    5 June 2009
    A2008‑10 amendments by A2008‑10
    R5
    6 June 2009
    6 June 2009–
    21 Sept 2009
    A2008‑10 commenced expiry
    R6
    22 Sept 2009
    22 Sept 2009‑
    11 Dec 2011
    A2009‑20 amendments by A2009‑20
    R7
    12 Dec 2011
    12 Dec 2011‑
    13 Oct 2015
    A2011‑52 amendments by A2011‑52
    R8
    14 Oct 2015
    14 Oct 2015‑
    31 Aug 2016
    A2015-33 amendments by A2015-33
    R9
    1 Sept 2016
    1 Sept 2016‑
    14 June 2017
    A2016-52 amendments by A2016-52
    R10
    15 June 2017
    15 June 2017‑
    31 Dec 2017
    A2017-15 amendments by A2017-15
    R11
    1 Jan 2018
    1 Jan 2018–
    22 Oct 2018
    A2017‑15 amendments by A2016-55 as amended by A2017‑14
    R12
    23 Oct 2018
    23 Oct 2018–
    15 June 2019
    A2018‑33 amendments by A2018‑33
    R13
    16 June 2019
    16 June 2019–
    1 June 2025
    A2018‑33 expiry of transitional provisions (pt 13)
    R14
    2 June 2025
    2 June 2025–
    15 Nov 2025
    A2025‑16 amendments by A2025‑16
    1. Expired transitional or validating provisions

      This Act may be affected by transitional or validating provisions that have expired.  The expiry does not affect any continuing operation of the provisions (see Legislation Act 2001, s 88 (1)).

      Expired provisions are removed from the republished law when the expiry takes effect and are listed in the amendment history using the abbreviation ‘exp’ followed by the date of the expiry.

      To find the expired provisions see the version of this Act before the expiry took effect.  The ACT legislation register has point-in-time versions of this Act.

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