Details: C2011C00539
Gene Technology Act 2000
- C2011C00539
Act No. 169 of 2000 as amended, taking into account amendments up to Superannuation Legislation (Consequential Amendments and Transitional Provisions) Act 2011
An Act to regulate activities involving gene technology, and for related purposes
Administered by: Health
Incorporated Amendments
Superannuation Legislation (Consequential Amendments and Transitional Provisions) Act 2011 - C2011A00058
sch 1 (items 90-93)
Start Date 01 Jul 2011
End Date 26 Dec 2011
C2011C00539
Part 1—Preliminary
1 Short title [see Note 1]
2 Commencement [see Note 1]
3 Object of Act
4 Regulatory framework to achieve object
5 Nationally consistent scheme
6 Act to bind the Crown
7 External Territories
8 Offences
Part 2—Interpretation and operation of Act
Part 3—The Gene Technology Regulator
Part 4—Regulation of dealings with GMOs
Part 5—Licensing system
Part 5A—Emergency dealing determinations
Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register
Part 7—Certification and accreditation
Part 8—The Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee
Part 9—Administration
Part 10—Enforcement
Part 11—Powers of inspection
Part 12—Miscellaneous
Act No. 169 of 2000 as amended
This compilation was prepared on 15 July 2011
taking into account amendments up to Act No. 58 of 2011
The text of any of those amendments not in force
on that date is appended in the Notes section
The operation of amendments that have been incorporated may be
affected by application provisions that are set out in the Notes section
Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General's Department, Canberra
Part 1—Preliminary 1
1............ Short title [see Note 1]........................................................................ 1
2............ Commencement [see Note 1].............................................................. 1
3............ Object of Act....................................................................................... 1
4............ Regulatory framework to achieve object............................................. 1
5............ Nationally consistent scheme.............................................................. 2
6............ Act to bind the Crown......................................................................... 2
7............ External Territories.............................................................................. 2
8............ Offences.............................................................................................. 2
Part 2—Interpretation and operation of Act 3
Division 1—Simplified outline 3
9............ Simplified outline................................................................................ 3
Division 2—Definitions 4
10.......... Definitions.......................................................................................... 4
11.......... Meaning of intentional release of a GMO into the environment......... 9
12.......... Meaning of corresponding State law.................................................. 9
Division 3—Operation of Act 11
13.......... Operation of Act............................................................................... 11
14.......... Wind‑back of reach of Act................................................................ 11
15.......... Relationship to other Commonwealth laws....................................... 12
Division 4—Provisions to facilitate a nationally consistent scheme 13
Subdivision A—General provisions 13
16.......... State laws may operate concurrently................................................. 13
17.......... Conferral of functions on Commonwealth officers and bodies......... 13
18.......... No doubling‑up of liabilities............................................................. 14
19.......... Review of certain decisions............................................................... 14
20.......... Things done for multiple purposes.................................................... 15
Subdivision B—Policy principles, policy guidelines and codes of practice 15
21.......... Ministerial Council may issue policy principles................................ 15
22.......... Consultation on policy principles...................................................... 16
23.......... Ministerial Council may issue policy guidelines............................... 16
24.......... Ministerial Council may issue codes of practice................................ 17
Part 3—The Gene Technology Regulator 18
25.......... Simplified outline.............................................................................. 18
26.......... The Gene Technology Regulator....................................................... 18
27.......... Functions of the Regulator................................................................ 18
28.......... Powers of the Regulator.................................................................... 19
29.......... Delegation......................................................................................... 19
30.......... Independence of the Regulator.......................................................... 20
Part 4—Regulation of dealings with GMOs 21
Division 1—Simplified outline 21
Division 2—Dealings with GMOs must be licensed 22
32.......... Person not to deal with a GMO without a licence............................. 22
33.......... Person not to deal with a GMO without a licence—strict liability offence 23
34.......... Person must not breach conditions of a GMO licence...................... 23
35.......... Person must not breach conditions of a GMO licence—strict liability offence 24
35A....... Person must not breach conditions of emergency dealing determination 25
35B....... Person must not breach conditions of emergency dealing determination—strict liability offence 25
36.......... Person must not breach conditions on GMO Register...................... 26
37.......... Offence relating to notifiable low risk dealings................................. 26
38.......... Aggravated offences—significant damage to health or safety of people or to the environment 27
Part 5—Licensing system 28
Division 2—Licence applications 29
40.......... Person may apply for a licence.......................................................... 29
40A....... Licences relating to inadvertent dealings........................................... 29
41.......... Application may be withdrawn......................................................... 30
42.......... Regulator may require applicant to give further information............. 30
43.......... Regulator must consider applications except in certain circumstances 30
44.......... Regulator may consult with applicant................................................ 31
45.......... Regulator must not use certain information in considering licence application 31
Division 3—Initial consideration of licences for dealings not involving intentional release of a GMO into the environment 32
46.......... Applications to which this Division applies...................................... 32
46A....... Division does not apply to an application relating to inadvertent dealings 32
47.......... What the Regulator must do in relation to application....................... 32
Division 4—Initial consideration of licences for dealings involving intentional release of a GMO into the environment 34
49.......... Division does not apply to an application relating to inadvertent dealings 34
50.......... Regulator must prepare risk assessment and risk management plan.. 34
50A....... Limited and controlled release applications....................................... 35
51.......... Matters Regulator must take into account in preparing risk assessment and risk management plan 36
52.......... Public notification of risk assessment and risk management plan..... 37
53.......... Regulator may take other actions....................................................... 38
54.......... Person may request copies of certain documents.............................. 39
Division 5—Decision on licence etc. 40
55.......... Regulator must make a decision on licence and licence conditions.... 40
56.......... Regulator must not issue the licence unless satisfied as to risk management 40
57.......... Other circumstances in which Regulator must not issue the licence.. 41
58.......... Matters to be taken into account in deciding whether a person is suitable to hold a licence 41
59.......... Notification of licence decision......................................................... 42
60.......... Period of licence................................................................................ 42
Division 6—Conditions of licences 44
61.......... Licence is subject to conditions......................................................... 44
62.......... Conditions that may be prescribed or imposed.................................. 44
63.......... Condition about informing people of obligations.............................. 45
64.......... Condition about monitoring and audits............................................. 45
65.......... Condition about additional information to be given to the Regulator. 46
66.......... Person may give information to Regulator........................................ 46
67.......... Protection of persons who give information..................................... 47
Division 7—Suspension, cancellation and variation of licences 48
68.......... Suspension and cancellation of licence.............................................. 48
69.......... Surrender of licence.......................................................................... 48
70.......... Transfer of licences........................................................................... 48
71.......... Variation of licence........................................................................... 49
72.......... Regulator to notify of proposed suspension, cancellation or variation 51
Part 5A—Emergency dealing determinations 53
72A....... Simplified outline.............................................................................. 53
Division 2—Making of emergency dealing determination 54
72B....... Minister may make emergency dealing determination....................... 54
72C....... Period of effect of emergency dealing determination......................... 55
Division 3—Effect and conditions of emergency dealing determination 57
72D....... Emergency dealing determination authorises dealings, subject to conditions 57
Division 4—Variation, suspension and revocation of emergency dealing determination 59
72E........ Variation, suspension and revocation of emergency dealing determination 59
Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register 61
Division 2—Notifiable low risk dealings 62
74.......... Notifiable low risk dealings.............................................................. 62
75.......... Regulation of notifiable low risk dealings......................................... 62
Division 3—The GMO Register 64
76.......... GMO Register.................................................................................. 64
77.......... Contents of Register.......................................................................... 64
78.......... Regulator may include dealings with GMOs on GMO Register....... 64
79.......... Regulator not to make determination unless risks can be managed... 65
80.......... Variation of GMO Register.............................................................. 65
81.......... Inspection of Register....................................................................... 66
Part 7—Certification and accreditation 67
Division 2—Certification 68
83.......... Application for certification............................................................... 68
84.......... When the Regulator may certify the facility....................................... 68
86.......... Conditions of certification................................................................. 68
87.......... Variation of certification.................................................................... 69
88.......... Suspension or cancellation of certification........................................ 69
89A....... Transfer of certification..................................................................... 70
90.......... Guidelines......................................................................................... 71
Division 3—Accredited organisations 72
91.......... Application for accreditation............................................................. 72
92.......... Regulator may accredit organisations................................................ 72
94.......... Conditions of accreditation................................................................ 73
95.......... Variation of accreditation.................................................................. 73
96.......... Suspension or cancellation of accreditation....................................... 73
Part 8—The Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee 76
Division 2—The Gene Technology Technical Advisory Committee 77
100........ The Gene Technology Technical Advisory Committee..................... 77
101........ Function of the Gene Technology Technical Advisory Committee... 78
102........ Expert advisers.................................................................................. 79
103........ Remuneration.................................................................................... 79
104........ Members and procedures.................................................................. 79
105........ Subcommittees.................................................................................. 80
Division 3—The Gene Technology Ethics and Community Consultative Committee 81
106........ The Gene Technology Ethics and Community Consultative Committee.. 81
107........ Function of Ethics and Community Committee................................. 81
108........ Membership...................................................................................... 81
110........ Membership and Procedures............................................................. 83
Part 9—Administration 85
117........ Simplified outline.............................................................................. 85
Division 2—Appointment and conditions of Regulator 86
118........ Appointment of the Regulator........................................................... 86
119........ Termination of appointment.............................................................. 86
120........ Disclosure of interests....................................................................... 88
121........ Acting appointment........................................................................... 88
122........ Terms and conditions........................................................................ 88
123........ Outside employment......................................................................... 88
125........ Leave of absence............................................................................... 89
126........ Resignation....................................................................................... 89
Division 3—Money 90
127........ Regulator may charge for services.................................................... 90
128........ Notional payments by the Commonwealth........................................ 90
129........ Gene Technology Account................................................................ 90
130........ Credits to Account............................................................................ 90
131........ Recovery of amounts........................................................................ 91
132........ Purposes of Account......................................................................... 91
Division 4—Staffing 93
133........ Staff assisting the Regulator.............................................................. 93
134........ Consultants....................................................................................... 93
135........ Seconded officers.............................................................................. 93
Division 5—Reporting requirements 94
136........ Annual Report................................................................................... 94
136A..... Quarterly reports............................................................................... 94
137........ Reports to Parliament........................................................................ 95
Division 6—Record of GMO and GM Product Dealings 96
138........ Record of GMO and GM Product Dealings..................................... 96
139........ Inspection of Record......................................................................... 97
Division 7—Reviews of notifiable low risk dealings and exemptions 98
140........ Regulator may review notifiable low risk dealings............................ 98
141........ Regulator may review exemptions.................................................... 98
142........ Regulator may give notice of consideration....................................... 98
143........ What Regulator may do after consideration....................................... 99
144........ Regulator not required to review matters......................................... 100
Part 10—Enforcement 101
145........ Simplified outline............................................................................ 101
146........ Regulator may give directions......................................................... 101
147........ Injunctions...................................................................................... 104
148........ Forfeiture........................................................................................ 105
Part 11—Powers of inspection 106
Division 1—Simplified outline 106
Division 2—Appointment of inspectors and identity cards 107
150........ Appointment of inspectors.............................................................. 107
151........ Identity card.................................................................................... 107
Division 3—Monitoring powers 108
152........ Powers available to inspectors for monitoring compliance.............. 108
153........ Monitoring powers......................................................................... 108
Division 4—Offence‑related powers 110
154........ Searches and seizures related to offences........................................ 110
155........ Offence‑related powers of inspectors in relation to premises.......... 110
156........ Use of equipment at premises......................................................... 111
Division 5—Expert assistance 112
157........ Expert assistance to operate a thing................................................. 112
Division 6—Emergency powers 113
158........ Powers available to inspectors for dealing with dangerous situations 113
Division 7—Obligations and incidental powers of inspectors 114
159........ Inspector must produce identity card on request............................. 114
160........ Consent........................................................................................... 114
161........ Details of warrant to be given to occupier etc.................................. 114
162........ Announcement before entry............................................................ 114
163........ Compensation for damage............................................................... 115
Division 8—Power to search goods, baggage etc. 116
164........ Power to search goods, baggage etc................................................ 116
165........ Seizure of goods............................................................................. 116
Division 9—General provisions relating to search and seizure 117
166........ Copies of seized things to be provided............................................ 117
167........ Occupier entitled to be present during search.................................. 117
168........ Receipts for things seized................................................................ 118
169........ Retention of seized things............................................................... 118
170........ Magistrate may permit a thing to be retained................................... 119
171........ Disposal of goods if there is no owner or owner cannot be located 119
Division 10—Warrants 120
172........ Monitoring warrants....................................................................... 120
173........ Offence‑related warrants................................................................. 120
174........ Offence‑related warrants by telephone, telex, fax etc...................... 121
175........ Offences relating to warrants.......................................................... 123
Division 11—Other matters 125
176........ Part not to abrogate privilege against self‑incrimination.................. 125
177........ Part does not limit power to impose conditions............................... 125
Part 12—Miscellaneous 126
Division 2—Review of decisions 127
179........ Meaning of terms............................................................................ 127
180........ Notification of decisions and review rights..................................... 128
181........ Internal review................................................................................ 128
182........ Deadlines for making reviewable decisions.................................... 129
183........ Review of decisions by Administrative Appeals Tribunal.............. 129
183A..... Extended standing for judicial review............................................. 130
Division 3—Confidential commercial information 131
184........ Application for protection of confidential commercial information. 131
185........ Regulator may declare that information is confidential commercial information 131
186........ Revocation of declaration................................................................ 133
187........ Confidential commercial information must not be disclosed........... 133
Division 4—Conduct by directors, employees and agents 135
188........ Conduct by directors, employees and agents................................... 135
Division 5—Transitional provisions 137
190........ Transitional provision—dealings covered by Genetic Manipulation Advisory Committee advice to proceed 137
191........ Regulations may relate to transitional matters.................................. 138
Division 6—Other 139
192........ False or misleading information or document................................. 139
192A..... Interference with dealings with GMOs........................................... 139
193........ Regulations..................................................................................... 140
194........ Review of operation of Act............................................................. 140
Notes 143
This Act may be cited as the Gene Technology Act 2000.
(1) Sections 1 and 2 of this Act commence on the day on which this Act receives the Royal Assent.
(2) Subject to subsection (3), the other provisions of this Act commence on a day or days to be fixed by Proclamation.
(3) If a provision of this Act does not commence under subsection (2) within 6 months after the day on which this Act receives the Royal Assent, it commences on the first day after the end of that period.
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.
The object of this Act is to be achieved through a regulatory framework which:
(aa) 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
(a) provides an efficient and effective system for the application of gene technologies; and
(b) operates in conjunction with other Commonwealth and State regulatory schemes relevant to GMOs and GM products.
Note: Examples of the schemes mentioned in paragraph (b) are those that regulate food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods.
It is the intention of the Parliament 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.
(1) This Act binds the Crown in each of its capacities.
(2) Nothing in this Act renders the Crown liable to be prosecuted for an offence.
This Act extends to every external Territory other than Norfolk Island.
(1) Chapter 2 of the Criminal Code applies to all offences against this Act.
Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.
(2) If a maximum penalty is specified:
(a) at the foot of a section of this Act (other than a section that is divided into subsections); or
(b) at the foot of a subsection of this Act;
(c) a person who contravenes the section or subsection is guilty of an offence punishable, on conviction, by a penalty not exceeding the specified penalty; or
(d) the offence referred to in the section or subsection is punishable, on conviction, by a penalty not exceeding the specified penalty.
Division 1—Simplified outline
9 Simplified outline
The following is a simplified outline of this Part:
This Part contains the definitions used in this Act.
This Part contains provisions to facilitate the conferral of functions and powers on the Regulator under State legislation, in order to facilitate a nationally consistent regulatory scheme.
This Part contains provisions to enable the concurrent operation of certain State legislation in relation to GMOs, and gives the capacity for this Act to have a more limited operation when corresponding State legislation is in force.
This Part also enables the Ministerial Council to issue policy principles, policy guidelines and codes of practice.
Division 2—Definitions
10 Definitions
(1) In this Act, unless the contrary intention appears:
Account means the Gene Technology Account established by section 129.
accredited organisation means an organisation accredited under Division 3 of Part 7.
aggravated offence has the meaning given by section 38.
Australian Health Ethics Committee means the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.
Commonwealth authority means the following:
(a) a body corporate established for a public purpose by or under an Act;
(b) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:
(i) the Commonwealth;
(ii) a body covered by paragraph (a);
(iii) a body covered by either of the above subparagraphs.
confidential commercial information means information declared by the Regulator to be confidential commercial information under section 185.
containment level, in relation to 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.
corresponding State law has the meaning given by section 12.
CSC (short for Commonwealth Superannuation Corporation) has the same meaning as in the Governance of Australian Government Superannuation Schemes Act 2011.
deal with, in relation to a GMO, means 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 manufacture of 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, in relation to a reviewable decision, has the meaning given by section 179.
emergency dealing determination means a determination in force under section 72B.
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.
Environment Minister means the Minister responsible for environment and conservation.
Ethics and Community Committee means the Gene Technology Ethics and Community Consultative Committee established by section 106.
evidential material means any of the following:
(a) a thing with respect to which an offence against this Act or the regulations has been committed or is suspected, on reasonable grounds, to have been committed;
(b) a thing that there are reasonable grounds for suspecting will afford evidence as to the commission of any such offence;
(c) a thing that there are reasonable grounds for suspecting is intended to be used for the purpose of committing any such offence.
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 the modification of genes or other genetic material, but does not include:
(a) sexual reproduction; or
(b) homologous recombination; or
(c) any other technique specified in the regulations for the purposes of this paragraph.
Gene Technology Agreement means the Gene Technology Agreement made for the purposes of this Act between the Commonwealth and at least 4 States, as in force from time to time.
Gene Technology Technical Advisory Committee means the Gene Technology Technical Advisory Committee established by 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), being traits that occurred in the initial organism because of gene technology; or
(c) anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;
but does not include:
(d) a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or
(e) an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms.
GMO means a genetically modified organism.
GMO licence means a licence issued under section 55.
GMO Register means the GMO Register established by section 76.
GM product means a thing (other than a GMO) derived or produced from a GMO.
higher education institution means an institution within the meaning of section 4 of the Higher Education Funding Act 1988, but does not include the Australian National University.
inadvertent dealings application means an application for a GMO licence to which Division 3 or 4 of Part 5 does not apply because of the operation of section 46A or 49.
Institutional Biosafety Committee means a committee established as an Institutional Biosafety Committee in accordance with written guidelines issued by the Regulator under section 98.
jurisdiction means the following:
(a) the Commonwealth;
(b) a State.
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 has the meaning given by section 74.
officer, in relation to the Commonwealth, includes the following:
(a) a Minister;
(b) a person who holds:
(i) an office established by or under an Act; or
(ii) an appointment made under an Act; or
(iii) an appointment made by the Governor‑General or a Minister but not under an 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 an 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 referred to in paragraphs (a) to (f)).
Record means the Record of GMO and GM Product Dealings mentioned in section 138.
Regulator means the Gene Technology Regulator appointed under section 118.
reviewable decision has the meaning given by section 179.
State includes the Australian Capital Territory and the Northern Territory.
State agency means the following:
(a) the Crown in right of a State;
(b) a Minister of a State;
(c) a State Government Department;
(d) an instrumentality of a State, including a body corporate established for a public purpose by or under a law of a State;
(e) a company in which a controlling interest is held by any one of the following persons, or by 2 or more of the following persons together:
(i) the Crown in right of a State;
(ii) a person or body covered by paragraph (b) or (d);
(iii) a person or body covered by either of the above subparagraphs.
thing includes a substance, and a thing in electronic or magnetic form.
(2) If this Act requires or permits the Ministerial Council to do a thing, the Ministerial Council must do the thing in accordance with any requirements specified in the Gene Technology Agreement.
11 Meaning of intentional release of a GMO into the environment
For the purposes of this Act, 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.
12 Meaning of corresponding State law
(1) For the purposes of this Act, corresponding State law means a State law that is declared by the Minister, by notice in the Gazette, to correspond to this Act and the regulations, including such a law as amended from time to time.
(2) The Minister may revoke a Gazette notice under subsection (1) in relation to a State law only if:
(a) the Minister is requested by the State concerned to revoke the notice; or
(b) the State law has been amended otherwise than as agreed by a majority of the members of the Ministerial Council (being a majority that includes the Commonwealth) under the Gene Technology Agreement; or
(c) amendments of the State law have been agreed by a majority of the members of the Ministerial Council (being a majority that includes the Commonwealth) under the Gene Technology Agreement, and the State law has not been amended in accordance with that agreement within a reasonable period after the agreement.
Division 3—Operation of Act
13 Operation of Act
(1) This Act applies as follows:
(a) to things done, or omitted to be done, by constitutional corporations;
(b) to things done, or omitted to be done, in the course of constitutional trade or commerce;
(c) to things done, or omitted to be done, by a person that may cause the spread of diseases or pests;
(d) for purposes relating to the collection, compilation, analysis and dissemination of statistics;
(e) to the Commonwealth and Commonwealth authorities;
(f) to things authorised by the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.
constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution.
constitutional trade or commerce means trade or commerce:
(a) between Australia and places outside Australia; or
(b) among the States; or
(c) by way of the supply of services to the Commonwealth or to a Commonwealth authority.
14 Wind‑back of reach of Act
(1) This section applies to a State (the notifying State) at a particular time if:
(a) a corresponding State law is in force in the notifying State at that time; and
(b) a wind‑back notice in relation to that State is in force at that time.
(2) This Act applies as a law of the Commonwealth in the notifying State with the following modifications:
(a) this Act applies as if paragraph 13(1)(c) (which deals with the spread of pests and diseases) had not been enacted;
(b) this Act does not apply to a dealing with a GMO undertaken:
(i) by a higher education institution or a State agency; or
(ii) by a person authorised to undertake the dealing by a licence held under the corresponding State law by a higher education institution or a State agency.
wind‑back notice, in relation to a State, means a notice given by the State to the Minister, under the Gene Technology Agreement, stating that this section is to apply to the State.
15 Relationship to other Commonwealth laws
The provisions of this Act are in addition to, and not in substitution for, the requirements of any other law of the Commonwealth (whether passed or made before or after the commencement of this section).
Division 4—Provisions to facilitate a nationally consistent scheme
Subdivision A—General provisions
16 State laws may operate concurrently
(1) This Act is not intended to exclude the operation of any State law, to the extent that the State law is capable of operating concurrently with this Act, other than a State law prescribed by the regulations for the purposes of this section.
(2) The Governor‑General may prescribe a State law under subsection (1) only if:
(a) there is no corresponding State law in effect in relation to that State; and
(i) the State law relates specifically to dealings with GMOs; or
(ii) for the purposes of a decision under the State law as to whether or not a licence, authority or approval (however described) is granted under the State law, the State law distinguishes between dealings with GMOs and dealings with other things.
17 Conferral of functions on Commonwealth officers and bodies
(1) A corresponding State law may confer functions, powers and duties on the following:
(a) the Regulator or another officer of the Commonwealth;
(b) a Commonwealth authority;
(c) the Ethics and Community Committee;
(e) the Gene Technology Technical Advisory Committee.
(2) If a function, power or duty is conferred on a person or body under subsection (1), the person or body may perform the function or duty or exercise the power, as the case requires.
(3) If a corresponding State law is expressed to confer on the Regulator the power to determine that dealings be included on the GMO Register, the Regulator may include the dealings on the GMO Register in accordance with the corresponding State law.
(4) If a corresponding State law is expressed to confer on the Regulator the power to vary the GMO Register, the Regulator may vary the GMO Register in accordance with the corresponding State law.
(5) If a corresponding State law is expressed to confer on the Regulator the power to enter information on the Record of GMO and GM Product Dealings, the Regulator may enter the information on the Record in accordance with the corresponding State law.
(6) The Regulator may:
(a) make any notations in the GMO Register that the Regulator considers necessary to identify entries that relate to dealings included on the Register as mentioned in subsection (3) or (4); and
(b) make any notations in the Record of GMO and GM Product Dealings that the Regulator considers necessary to identify entries that relate to information entered on the Record as mentioned in subsection (5).
18 No doubling‑up of liabilities
(a) an act or omission is an offence against this Act and is also an offence against a corresponding State law; and
(b) the offender has been punished for the offence under the corresponding State law;
the offender is not liable to be punished for the offence under this Act.
(2) If a person has been ordered to pay a pecuniary penalty under a corresponding State law, the person is not liable to a pecuniary penalty under this Act in respect of the same conduct.
19 Review of certain decisions
(1) Application may be made to the Administrative Appeals Tribunal for review of a reviewable State decision.
(2) A decision made by the Regulator in the performance of a function or the exercise of a power conferred by a corresponding State law is a reviewable State decision for the purposes of this section if:
(a) the law under which the decision was made provides for review by the Administrative Appeals Tribunal; and
(b) the decision is declared by the regulations to be a reviewable State decision for the purposes of this section.
(3) For the purposes of this section, the Administrative Appeals Tribunal Act 1975 has effect as if a corresponding State law were an enactment.
20 Things done for multiple purposes
The validity of a licence, certificate or other thing issued, given or done for the purposes of this Act is not affected only because it was issued, given or done also for the purposes of a corresponding State law.
Subdivision B—Policy principles, policy guidelines and codes of practice
21 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;
(aa) recognising areas, if any, designated under State law for the purpose of preserving the identity of one or both of the following:
(i) GM crops;
(ii) non‑GM crops;
for marketing purposes;
(b) matters relating to dealings with GMOs prescribed by the regulations for the purposes of this paragraph.
Note 1: Section 57 provides that the Regulator must not issue a licence if to do so would be inconsistent with a policy principle.
Note 2: Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act.
(2) Before issuing a policy principle, the Ministerial Council must be satisfied that the policy principle was developed in accordance with section 22.
(3) Regulations for the purposes of paragraph (1)(b) 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.
(4) Policy principles are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901.
22 Consultation on policy principles
(1) Policy principles are to be developed in consultation with the following:
(a) the Gene Technology Technical Advisory Committee;
(b) the Regulator;
(e) such Commonwealth and State agencies and such regulatory agencies as the Ministerial Council considers appropriate;
(f) such industry groups as the Ministerial Council considers appropriate;
(g) such environmental, consumer and other groups as the Ministerial Council considers appropriate.
(2) Consultation under subsection (1) must be in accordance with guidelines (if any) issued by the Ministerial Council for the purposes of this section.
23 Ministerial Council may issue policy guidelines
The Ministerial Council may issue policy guidelines in relation to matters relevant to the functions of the Regulator.
Note 1: Section 56 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.
24 Ministerial Council may issue codes of practice
(1) The Ministerial Council may issue codes of practice in relation to gene technology.
Note: Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act.
(2) The Ministerial Council must not issue a code of practice unless the code of practice was developed by the Regulator in consultation with the following:
(b) the Ethics and Community Committee;
(d) such Commonwealth and State agencies and such regulatory agencies as the Ministerial Council considers appropriate;
(e) such industry groups as the Ministerial Council considers appropriate;
(f) such environmental, consumer and other groups as the Ministerial Council considers appropriate.
(3) Codes of practice are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901.
25 Simplified outline
This Part establishes the office of the Gene Technology Regulator (the Regulator), and specifies the Regulator's functions and powers.
26 The Gene Technology Regulator
There is to be a Gene Technology Regulator.
27 Functions of the Regulator
The Regulator has the following functions:
(a) to perform functions in relation to GMO licences as set out in 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 in relation to 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 in relation to possible amendments of relevant legislation;
(h) to undertake or commission research in relation to risk assessment and the biosafety of GMOs;
(i) to promote the harmonisation of risk assessments relating to GMOs and GM products by regulatory agencies;
(j) to monitor international practice in relation to the regulation of GMOs;
(k) to maintain links with international organisations that deal with the regulation of gene technology and with agencies that regulate GMOs in countries outside Australia;
(l) such other functions as are conferred on the Regulator by this Act, the regulations or any other law.
28 Powers of the Regulator
Subject to this Act, the Regulator has power to do all things necessary or convenient to be done for or in connection with the performance of the Regulator's functions.
29 Delegation
(1) The Regulator may, by instrument in writing, delegate any of the Regulator's powers or functions to any of the following:
(a) an employee of the Department;
(b) an employee of another Department or of a Commonwealth authority, if the functions of the other Department or Commonwealth authority relate, whether directly or indirectly, to GMOs or GM products;
(c) an officer or employee of a State agency, if the functions of the State agency relate, whether directly or indirectly, to GMOs or GM products.
(2) In exercising powers or functions under a delegation, the delegate must comply with any directions of the Regulator.
30 Independence of the Regulator
Subject to this Act and to other laws of the Commonwealth, the Regulator has discretion in the performance or exercise of his or her functions or powers. In particular, the Regulator is not subject to direction from anyone in relation to:
(a) whether or not a particular application for a GMO licence is issued or refused; or
(b) the conditions to which a particular GMO licence is subject.
This Part deals with the regulation of dealings with GMOs.
This Part prohibits dealings with GMOs unless:
(a) the person undertaking the dealing is authorised to do so by a GMO licence; or
(aa) the dealing is specified in an emergency dealing determination; or
(b) the dealing is a notifiable low risk dealing (see Division 2 of Part 6); or
(c) the dealing is an exempt dealing; or
(d) the dealing is included in the GMO Register (see Division 3 of Part 6).
This Part 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 2—Dealings with GMOs must be licensed
32 Person not to deal with a GMO without a licence
(1) A person is guilty of 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 as to that fact; and
(c) the dealing with the GMO is not specified in an emergency dealing determination, and the person knows or is reckless as to that fact; and
(d) the dealing is not a notifiable low risk dealing, and the person knows or is reckless as to that fact; and
(e) the dealing is not an exempt dealing, and the person knows or is reckless as to that fact; and
(f) the dealing is not included on the GMO Register, and the person knows or is reckless as to that fact.
(2) An offence under subsection (1) is punishable on conviction by whichever of the following applies:
(a) in the case of an aggravated offence— imprisonment for 5 years or 2,000 penalty units;
(b) in any other case— imprisonment for 2 years or 500 penalty units.
Note: Section 38 defines aggravated offence.
exempt dealing means a dealing specified by the regulations to be an exempt dealing.
(4) Regulations under subsection (3) may be expressed to exempt:
(a) all dealings with a GMO or with a specified class of GMOs; or
(b) a specified class of dealings with a GMO or with a specified class of GMOs; or
(c) one or more specified dealings with a GMO or with a specified class of GMOs.
33 Person not to deal with a GMO without a licence—strict liability offence
(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.
(2) Strict liability applies to paragraphs (1)(b), (ba), (c), (d) and (e).
Note: For strict liability, see section 6.1 of the Criminal Code.
(3) An offence under this section is punishable on conviction by a fine of not more than whichever of the following amounts applies:
(a) in the case of an aggravated offence—200 penalty units;
(b) in any other case—50 penalty units.
exempt dealing has the same meaning as in section 32.
34 Person must not breach conditions of a GMO licence
(1) The holder of a GMO licence is guilty of 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 as to that fact.
(2) A person covered by a GMO licence is guilty of 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 of the licence; and
(c) the action or omission contravenes a condition of the licence, and the person knows or is reckless as to that fact.
(3) An offence under this section is punishable on conviction by whichever of the following applies:
(4) A person who is guilty of an offence under subsection (1) or (2) is guilty of a separate offence in respect of each day (including the day of a conviction for the offence or any later day) on which the person is guilty of the offence.
35 Person must not breach conditions of a GMO licence—strict liability offence
(1) The holder of a GMO licence is guilty of an offence if the holder:
(a) takes an action or omits to take an action; and
(b) the action or omission contravenes the licence.
(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.
(3) Strict liability applies to paragraphs (1)(a) and (b) and (2)(a) and (b).
35A Person must not breach conditions of emergency dealing determination
(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 as to that fact.
(a) in the case of an aggravated offence—imprisonment for 5 years or 2,000 penalty units;
(b) in any other case—imprisonment for 2 years or 500 penalty units.
35B Person must not breach conditions of emergency dealing determination—strict liability offence
(c) the action or omission by the person contravenes such a condition.
(2) Strict liability applies to paragraphs (1)(a) and (c).
36 Person must not breach conditions on GMO Register
(1) A person is guilty of 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 relating to the dealing that is specified in the GMO Register.
Maximum penalty: 50 penalty units.
(2) Strict liability applies to paragraphs (1)(b) and (c).
37 Offence relating to notifiable low risk dealings
(b) the dealing is a notifiable low risk dealing; and
(c) the dealing by the person was not undertaken in accordance with the regulations.
Note 1: Notifiable low risk dealings are specified in the regulations—see Part 6.
Note 2: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.
38 Aggravated offences—significant damage to health or safety of people or to the 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) In order 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 as to whether that conduct would cause significant damage to the health and safety of people or to the environment.
This Part provides a licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs.
This Part sets out the processes to be followed by the Regulator in relation to applications involving 2 kinds of dealings:
(a) those that involve the intentional release of a GMO into the environment; and
(b) those that do not involve the intentional release of a GMO into the environment.
A licence can cover dealings by persons other than the licence holder. The licence holder is required to inform such persons of any conditions of the licence that apply to them.
Division 2—Licence applications
40 Person may apply for a licence
(1) A person may apply to the Regulator for a licence authorising specified dealings with one or more specified GMOs by a person or persons.
(2) The application must be in writing, and must contain:
(a) such information as is prescribed by the regulations (if any); and
(b) such information as is specified in writing by the Regulator.
(3) The application must specify 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 in respect of which a person may apply for a licence may be:
(a) all dealings with a GMO, or with a specified class of GMOs; or
(b) a specified class of dealings with a GMO, or with a specified class of GMOs; or
(c) one or more specified dealings with a GMO, or with a specified class of GMOs.
(5) The applicant may apply for a licence authorising such dealings by:
(a) a specified person or persons; or
(b) a specified class of person; or
(c) all persons.
(6) The application must be accompanied by the application fee (if any) prescribed by the regulations.
40A Licences 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 avoid doubt, subsection (1) does not prevent a person from making an application under section 40 in respect of a GMO that has inadvertently come into the person's possession.
Note: Sections 46A and 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 section 40, or is taken to have been made under this section.
41 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.
42 Regulator may require applicant to give further information
(1) The Regulator may, by notice in writing, require an applicant for a licence to give the Regulator such further information in relation to the application as the Regulator requires.
(2) The notice may specify the period within which the information is to be provided.
(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.
43 Regulator must consider applications except in certain circumstances
(1) The Regulator must consider an application under section 40 for a licence 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 the regulations; or
(b) the application does not satisfy subsection 40(3); or
(c) the application is not accompanied by the application fee (if any) prescribed by the regulations; or
(d) the applicant did not provide further information required by the Regulator by notice under section 42 within the period specified 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; or
(f) the Regulator is satisfied (having regard to the matters specified 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 the regulations.
44 Regulator may consult with applicant
Before considering an application in accordance with the requirements of this Part, the Regulator may consult the applicant, or another regulatory agency, on any aspect of the application.
45 Regulator must not use certain information in considering licence application
(a) a person (the first person) applies for a GMO licence; and
(b) the first person provides information to the Regulator for the purposes of the Regulator's consideration of the application; and
(c) the information is confidential commercial information;
the Regulator must not take that information into account for the purposes of considering an application by another person for a GMO licence, unless the first person has given written consent for the information to be so taken into account.
Division 3—Initial consideration of licences for dealings not involving intentional release of a GMO into the environment
46 Applications to which this Division 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.
46A Division 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 dealings to be undertaken for the purposes of, or for purposes relating to, disposing of a GMO; and
(b) the applicant for the licence came into possession of the GMO inadvertently.
47 What the 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.
(2) In preparing the risk assessment, the Regulator must take into account the risks posed by the dealings proposed to be authorised by the licence, including any risks to the health and safety of people or risks to the environment.
(3) In preparing the risk management plan, the Regulator must take into account the means of managing any risks posed by the dealings proposed to be authorised by the licence in such a way as to protect:
(a) the health and safety of people; and
(b) the environment.
(4) The Regulator may consult:
(a) the States; and
(b) the Gene Technology Technical Advisory Committee; and
(c) relevant Commonwealth authorities or agencies; and
(d) any local council that the Regulator considers appropriate; and
(e) any other person the Regulator considers appropriate;
on any aspect of the application.
Division 4—Initial consideration of licences for dealings involving intentional release of a GMO into the environment
This Division applies to an application for a GMO licence if the Regulator is satisfied that at least one of the dealings proposed to be authorised by the licence would involve the intentional release of a GMO into the environment.
49 Division does not apply to an application relating to inadvertent dealings
50 Regulator must prepare risk assessment and risk management plan
(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:
(c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph; and
(d) the Environment Minister; and
(e) any local council that the Regulator considers appropriate.
50A Limited 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 persons covered by the licence, to conduct experiments; and
(b) the application proposes, in relation to any GMO in respect of 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 referred to in subsection 50(3).
(2) For the purposes of subsection (1):
controls, in relation to a GMO and its genetic material, include the following:
(a) methods to restrict the dissemination or persistence of the GMO or its genetic material in the environment;
(b) methods for disposal of the GMO or its genetic material;
(c) data collection, including studies to be conducted about the GMO or its genetic material;
(d) the geographic area in which the proposed dealings with the GMO or its genetic material may occur;
(e) 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 persons who are to be permitted to conduct the dealings with the GMO.
(4) In deciding whether the principal purpose of an application is to enable the licence holder, and persons 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 any other matter that the Regulator considers to be relevant.
51 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 Regulator must take into account the following:
(a) the risks posed by those dealings, including any risks to the health and safety of people or risks to the environment, having regard to the matters prescribed by the regulations;
(c) any advice in relation to the risk assessment provided by a State or a local council in response to a request under subsection 50(3);
(d) any advice in relation to the risk assessment provided by the Gene Technology Technical Advisory Committee in response to a request under subsection 50(3);
(e) any advice in relation to the risk assessment provided by a Commonwealth authority or agency in response to a request under subsection 50(3);
(f) any advice in relation to the risk assessment provided by the Environment Minister in response to a request under subsection 50(3);
(g) any other matter prescribed by the regulations for the purposes of this paragraph.
(2) In preparing the risk management plan, the Regulator must take into account the following:
(a) the means of managing any risks posed by those dealings in such a way as to protect:
(i) the health and safety of people; and
(ii) the environment;
(c) any advice in relation to the risk management plan provided by a State or a local council in response to a request under subsection 50(3);
(d) any advice in relation to the risk management plan provided by the Gene Technology Technical Advisory Committee in response to a request under subsection 50(3);
(e) any advice in relation to the risk management plan provided by a Commonwealth authority or agency in response to a request under subsection 50(3);
(f) any advice in relation to the risk management plan provided by the Environment Minister in response to a request under subsection 50(3);
(3) For the avoidance of doubt, in taking into account the means of managing risks as mentioned in paragraph (2)(a), the Regulator:
(a) is not limited to considering submissions or advice mentioned in paragraphs (2)(b), (c), (d), (e) and (f); and
(b) subject to section 45, may take into account other information, including, but not limited to, relevant independent research.
52 Public notification of risk assessment and risk management plan
(1) After taking the steps referred to in sections 50 and 51, the Regulator must publish a notice:
(a) in the Gazette; and
(b) in a newspaper circulating generally in all States; and
(c) on the Regulator's website (if any).
(2) The notice must:
(a) state that a risk assessment and a risk management plan have been prepared in respect of dealings proposed to be authorised by the licence; and
(b) state that a person may request further information about the risk assessment and the risk management plan under section 54; and
(ba) if the Regulator is satisfied that one 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 in relation to the risk assessment and the risk management plan; and
(d) specify 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 Regulator must also seek advice on the risk assessment and the risk management plan from:
53 Regulator may take other actions
(1) In addition to satisfying the requirements of this Division in relation to an application for a licence to which this Division applies, the Regulator may take any other action the Regulator considers appropriate for the purpose of 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 in relation to confidential commercial information, direct that any part of the hearing be held in private, and may determine 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 given under subsection (3).
54 Person may request copies of certain documents
(1) A person may request that the Regulator provide the person with 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 provide to 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 (within the meaning of section 58) of the applicant for the licence.
Note 1: In order for information to be confidential commercial information, it must be covered by a declaration under section 185.
Note 2: The Privacy Act 1988 also contains provisions relevant to the disclosure of information.
Division 5—Decision on licence etc.
55 Regulator must make a decision on licence and licence conditions
After taking any steps required by Division 3 or 4 of this Part in relation to 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 to which the licence is subject.
56 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 such a way as to protect:
(2) For the purposes of subsection (1), the Regulator must have regard to the following:
(a) the risk assessment prepared under section 47 or 50 in relation to the dealings;
(b) the risk management plan prepared under section 47 or 50 in relation to the dealings;
(c) any submissions received under section 52 in relation to the licence;
(d) any policy guidelines in force under section 23 that relate to:
(i) risks that may be posed by the dealings proposed to be authorised by the licence; or
(ii) ways of managing such risks so as to protect the health and safety of people or to protect the environment.
Note: Paragraphs (2)(a), (b) and (c) do not apply to an inadvertent dealings application.
57 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.
58 Matters to be taken into account in deciding whether a person is suitable to hold a licence
(1) Without limiting the matters to which the Regulator may have regard in deciding whether a natural person is a suitable person to hold a licence, the Regulator must have regard to:
(a) any relevant conviction of the person; and
(b) any revocation or suspension of a licence or permit (however described) held by the person under a law of the Commonwealth, a State or a foreign country, being a law relating to the health and safety of people or the environment; and
(c) the capacity of the person to meet the conditions of the licence.
(2) Without limiting the matters to which the Regulator may have regard in deciding whether a body corporate is a suitable person to hold a licence, the Regulator must have regard to the following:
(a) any relevant conviction of the body corporate; and
(b) if there is a relevant conviction of the body corporate:
(i) whether the offence concerned was committed at a time when any person who is presently a director of the body corporate was a director; and
(ii) whether that offence was committed at a time when any officer or shareholder of the body corporate who is presently in a position to influence the management of the body corporate was such an officer or shareholder; and
(c) any revocation or suspension of a licence or permit (however described) held by the body corporate under a law of the Commonwealth, a State or a foreign country, being a law relating to the health and safety of people or the environment; and
(d) the capacity of the body corporate to meet the conditions of the licence.
relevant conviction means a conviction for an offence against a law of the Commonwealth, a State or a foreign country, being a law relating to the health and safety of people or the environment, if:
(a) the offence was committed within the period of 10 years immediately before the making of the application for the licence; and
(b) the offence was punishable on conviction by a fine of $5,000 or more, or by a term of imprisonment of one year or more.
(4) Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).
59 Notification of licence decision
The Regulator must notify the applicant in writing of the Regulator's decision (including any conditions imposed by the Regulator, if applicable).
60 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 that period; or
(b) otherwise—until it is cancelled or surrendered.
(2) A licence is not in force throughout any 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 6—Conditions of licences
61 Licence is subject to conditions
A GMO licence is subject to the following conditions:
(a) the conditions set out in sections 63, 64 and 65;
(b) any conditions prescribed by the regulations;
(c) any conditions imposed by the Regulator at the time of issuing the licence;
(d) any conditions imposed by the Regulator under section 71 after the licence is issued.
62 Conditions that may be prescribed or imposed
(1) Licence conditions may include conditions that impose obligations in relation to GM products that are derived from a GMO in respect of which particular dealings are licensed.
(2) Licence conditions may relate to, but are not limited to, 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 in respect of the dealings, including requirements relating to the certification of facilities to specified 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 in case of the release of a GMO from a contained environment;
(k) the geographic area in which the dealings authorised by the licence may occur;
(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 in respect of 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 licensed dealing.
63 Condition about informing people of obligations
(1) It is a condition of a licence that the licence holder inform any person 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 in relation to the manner in which information is provided under subsection (1) may be:
(a) prescribed by the regulations; or
(b) specified by the Regulator.
(3) Such requirements may include, but are not limited to, measures relating to labelling, packaging, conducting training and providing information.
(4) If such requirements are prescribed or specified, it is a condition of a licence that the licence holder comply with the requirements.
64 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 the purposes of auditing or monitoring the dealing.
(2) Subsection (1) does not limit the conditions that may be imposed by the Regulator or prescribed by the regulations.
65 Condition about additional information to be given to the Regulator
(1) It is a condition of a licence that the licence holder inform the Regulator if he or she:
(a) becomes aware of additional information as to any risks to the health and safety of people, or to the environment, associated with the dealings authorised by the licence; or
(b) becomes aware of any contraventions of the licence by a person covered by the licence; or
(c) becomes aware of any unintended effects of the dealings authorised by the licence.
(a) the licence holder is taken to have become aware of additional information of a kind mentioned in subsection (1) if he or she was reckless as to whether such 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 he or she was reckless as to whether such contraventions had occurred, or such unintended effects existed.
66 Person may give information to Regulator
A person covered by a licence may inform the Regulator if he or she:
67 Protection of persons who give information
A person (the first person) does not incur any civil liability in respect of loss, damage or injury of any kind suffered by another person because the first person gave information to the Regulator under section 65, 66 or paragraph 72D(2)(h).
Division 7—Suspension, cancellation and variation of licences
68 Suspension and cancellation of licence
The Regulator may, by notice in writing 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 by 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 the regulations; or
(c) any annual charge payable in respect of 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 those risks; or
(f) the Regulator is satisfied that the licence holder is no longer a suitable person to hold the licence.
69 Surrender of licence
The licence holder may, with the consent of the Regulator, surrender the licence.
70 Transfer of licences
(1) The licence holder and another person (the transferee) may jointly apply to the Regulator for the licence to be transferred from the licence holder to the transferee.
(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 such a way as to protect:
(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 specified 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 those in force immediately before the transfer.
71 Variation of licence
(1) The Regulator may vary a licence, by notice in writing 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:
(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 3 of this Part.
Note: Applications can only be considered under Division 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 persons covered by the licence, to conduct experiments; and
(b) the application for variation proposes, in relation to any GMO in respect of which dealings are proposed to be authorised as a result of the variation:
Note: Section 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) The Regulator must not vary a licence if the Regulator is satisfied that the risk assessment and the risk management plan in respect of the original application for the licence did not cover the risks posed by the dealings proposed to be authorised by the licence as varied.
(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 such a way as to protect:
(5) The Regulator must not vary a licence unless any local council that the Regulator considers appropriate has been consulted on the proposed variation.
(6) The Regulator must not vary a licence in the circumstances (if any) prescribed by the regulations.
(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 the regulations.
(8) For the purposes of subsection (2A):
controls has the same meaning as in subsection 50A(2).
limits has the same meaning as in subsection 50A(3).
72 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 specified 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 specify a period within which the licence holder:
(a) must give the information referred to in paragraph (2)(b); and
(b) may make a submission under paragraph (2)(c).
The period must not end earlier than 30 days after the day on which the notice was given.
(4) In considering whether to suspend, cancel or vary a licence, the Regulator must have regard to any submission made under paragraph (2)(c).
(5) This section does not apply to a suspension, cancellation or variation requested by the licence holder.
(6) 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 in order to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment.
(7) 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.
72A Simplified outline
This Part provides a system under which the Minister can make determinations relating to dealings with GMOs in emergencies.
Division 2—Making of emergency dealing determination
72B Minister may make emergency dealing determination
(1) The Minister may, by legislative instrument (an emergency dealing determination), specify dealings with a GMO for the purposes of this Part.
(2) The Minister may make an emergency dealing determination only if:
(a) the Minister has received advice from:
(i) the Commonwealth Chief Medical Officer; or
(ii) the Commonwealth Chief Veterinary Officer; or
(iii) the Commonwealth Chief Plant Protection Officer; or
(iv) a person prescribed by the regulations;
that there is an actual or imminent threat to the health and safety of people or to the environment, and that the dealings proposed to be specified in the emergency dealing determination would, or would be likely to, adequately address the threat; and
(b) the Minister is satisfied that there is an actual or imminent threat to the health and safety of people or to the environment, and that the dealings proposed to be specified in the emergency dealing determination would, or would be likely to, adequately address the threat; and
(c) the Minister has received advice from the Regulator that any risks posed by the dealings proposed to be specified in the emergency dealing determination are able to be managed in such a way as:
(i) to protect the health and safety of people; and
(ii) to protect the environment; and
(d) the Minister is satisfied that any risks posed by the dealings proposed to be specified in the emergency dealing determination are able to be managed in such a way as:
(e) the States have been consulted in relation to the making of the proposed emergency dealing determination.
(3) An actual or imminent threat of a kind mentioned in paragraph (2)(a) or (b) may include, but is not limited to, any of the following:
(a) a threat from the outbreak of a plant, animal or human disease;
(b) a threat from a particular plant or animal, such as a pest or an alien invasive species;
(c) a threat from an industrial spillage.
(4) The dealings in respect of which the Minister may make an emergency dealing determination may be:
72C Period of effect of emergency dealing determination
(1) An emergency dealing determination takes effect:
(a) on the day on which the emergency dealing determination is made; or
(b) on a later day that is specified in the emergency dealing determination.
(2) An emergency dealing determination ceases to have effect:
(a) subject to subsection (3), at the end of the period of 6 months starting when the emergency dealing determination takes effect; or
(b) at the end of the period specified by the Minister in the emergency dealing determination; or
(c) when the emergency dealing determination is revoked;
whichever occurs first.
(3) The Minister may, by legislative instrument, extend the period of effect of an emergency dealing determination.
(4) The Minister may extend the period of effect of an emergency dealing determination under subsection (3) more than once, but each single such extension must not exceed 6 months.
(5) The Minister may extend the period of effect of an emergency dealing determination only if:
(a) the Minister has received advice from the original adviser in relation to the emergency dealing determination that the threat to which the determination relates still exists, and that the proposed extension would, or would be likely to, adequately address the threat; and
(b) the Minister is satisfied that the threat still exists, and that the proposed extension would, or would be likely to, adequately address that threat; and
(c) the Minister has received advice from the Regulator that any risks posed by the proposed extension are able to be managed in such a way as:
(d) the Minister is satisfied that any risks posed by the proposed extension are able to be managed in such a way as:
(e) a majority of jurisdictions agree to the extension.
(6) A legislative instrument extending the period of effect of an emergency dealing determination takes effect at the time when the determination would have ceased to have effect but for the extension.
(7) In subsection (5):
original adviser, in relation to an emergency dealing determination, means the person who gave the advice mentioned in paragraph 72B(2)(a) in relation to the determination.
Division 3—Effect and conditions of emergency dealing determination
72D Emergency dealing determination authorises dealings, subject to conditions
(1) If an emergency dealing determination is in force in respect of dealings with a GMO, those dealings are authorised, subject to the conditions (if any) specified in the emergency dealing determination.
(2) Conditions may relate to, but are not limited to, the following:
(a) the quantity of GMO in relation to which dealings are covered;
(b) the scope of the dealings covered;
(c) the purposes for which the dealings may be undertaken;
(d) variations to the scope or purposes of the dealings;
(e) the source of the GMO;
(f) the persons who may deal with the GMO;
(g) the information that is required to be given by a person and the person to whom that information is to be given;
(h) obligations about informing the Regulator if:
(i) a person becomes aware of additional information as to any risks to the health and safety of people, or to the environment, associated with the dealings specified in the emergency dealing determination; or
(ii) a person becomes aware of any contraventions of the conditions to which the emergency dealing determination is subject by any person; or
(iii) a person becomes aware of any unintended effects of the dealings specified in the emergency dealing determination;
(i) the storage and security of the GMO;
(j) the required level of containment in respect of the dealings, including requirements relating to the certification of facilities to specified containment levels;
(k) waste disposal requirements;
(l) the manner in which any quantity of the GMO is to be dealt with if a condition of the emergency dealing determination is breached;
(m) measures to manage risks posed to the health and safety of people, or to the environment;
(n) data collection, including studies to be conducted;
(o) auditing and reporting;
(p) the keeping and disclosure of, and access to, records about the GMO;
(q) actions to be taken in case of the release of a GMO from a contained environment;
(r) the geographic area in which the dealings specified in the emergency dealing determination may occur;
(s) requirements for compliance with a code of practice issued under section 24, or a technical or procedural guideline issued under section 27;
(t) supervision by, and monitoring by, Institutional Biosafety Committees;
(u) contingency planning in respect of unintended effects of the dealings specified in the emergency dealing determination;
(v) limiting the dissemination or persistence of the GMO or its genetic material in the environment;
(w) any other matters that the Minister thinks appropriate.
(3) A condition under paragraph (2)(f) may permit dealings with a GMO by, or may impose obligations upon:
(b) a specified class of person.
(4) It is a condition of an emergency dealing determination that if:
(a) a dealing with a GMO is specified in the emergency dealing determination; and
(b) a particular condition of the emergency dealing determination applies to the dealing by a person;
(5) Subsection (4) does not limit the conditions that may be specified in an emergency dealing determination.
Division 4—Variation, suspension and revocation of emergency dealing determination
72E Variation, suspension and revocation of emergency dealing determination
(1) The Minister may, by legislative instrument, vary the conditions to which an emergency dealing determination is subject, including by imposing new conditions.
(2) The Minister may, by legislative instrument, suspend or revoke an emergency dealing determination if:
(a) the Minister becomes aware of risks to the health and safety of people, or to the environment, associated with the continuation of the dealings authorised by the emergency dealing determination, and is satisfied that adequate measures to address those risks are not able to be implemented; or
(b) the Minister is satisfied that the threat to which the emergency dealing determination relates:
(i) no longer exists; or
(ii) is no longer sufficiently actual or imminent as to require the determination to be in force to address that threat; or
(c) the Minister is no longer satisfied that the dealings specified in the emergency dealing determination adequately address the threat.
(3) The Minister must not:
(a) vary an emergency dealing determination (unless the variation is of a minor technical nature); or
(b) suspend or revoke an emergency dealing determination;
unless the States have been consulted in relation to the variation, suspension or revocation, as the case requires.
(4) A variation, suspension or revocation of an emergency dealing determination takes effect:
(a) if the Minister states in the variation, suspension or revocation that the variation, suspension or revocation is necessary to prevent imminent risk of death, serious illness, serious injury or serious environmental damage—on the day on which the variation, suspension or revocation is made; or
(b) in any other case—on the day specified by the Minister in the variation, suspension or revocation.
(5) The day specified as mentioned in paragraph (4)(b) must not be earlier than 30 days after the day on which the variation, suspension or revocation is made.
Division 2 of this Part establishes a mechanism for the regulations to regulate certain dealings with GMOs that do not involve the intentional release of GMOs into the environment (notifiable low risk dealings).
The regulations may (among other things) require that the Regulator be notified of such dealings.
Division 3 of this Part establishes the GMO Register.
The Regulator may determine that certain dealings previously authorised by a licence be included on the GMO Register.
If a dealing is included on the GMO Register, anyone may undertake the dealing, subject to any specified conditions.
Division 2—Notifiable low risk dealings
74 Notifiable low risk dealings
(1) The regulations may declare a dealing with a GMO to be a notifiable low risk dealing for the purposes of this Act.
(2) Before the Governor‑General makes regulations 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) Before the Governor‑General makes regulations declaring a dealing with a GMO to be a notifiable low risk dealing, the Regulator must consider the following matters:
(a) whether the GMO is biologically contained so that it is not able to survive or reproduce without human intervention;
(b) whether the dealing with the GMO would involve minimal risk to the health and safety of people and to the environment, taking into account the properties of the GMO as a pathogen or pest and the toxicity of any proteins produced by the GMO;
(c) whether no conditions, or minimal conditions, would be necessary to be prescribed to manage any risk referred to in paragraph (b).
(4) Regulations under subsection (1) may be expressed to apply to:
75 Regulation of notifiable low risk dealings
(1) The regulations may regulate:
(a) a specified notifiable low risk dealing; or
(b) a specified class of notifiable low risk dealings;
for the purpose of protecting the health and safety of people or the environment.
(2) The regulations may prescribe different requirements to be complied with in different situations or by different persons, including requirements in relation to the following:
(a) the class of persons 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.
Division 3—The GMO Register
76 GMO Register
(1) There is to be a Register known as the GMO Register.
(2) The GMO Register is to be maintained by the Regulator.
(3) The GMO Register may be kept in a computerised form.
77 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 specify in the GMO Register:
(a) a description of the dealing with the GMO; and
(b) any condition to which the dealing is subject.
78 Regulator may include dealings with GMOs on GMO Register
(1) The Regulator may, by 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 concerned:
(i) is a GM product; and
(ii) is a genetically modified organism only because of regulations made under paragraph (c) of the definition of genetically modified organism.
(2) A determination under subsection (1) may be made:
(a) on application by the holder of a licence that authorises the dealing; or
(b) on the initiative of the Regulator.
(3) A determination under subsection (1) comes into effect on the day specified in the determination.
(4) A determination under subsection (1) is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.
79 Regulator not to make determination unless risks can be managed
(1) The Regulator must not make a determination under subsection 78(1) in respect of a dealing with a GMO unless the Regulator is satisfied:
(a) that any risks posed by the dealing are minimal; and
(b) that it is not necessary for persons undertaking the dealing to hold, or be covered by a GMO licence, in order to protect the health and safety of people or to protect the environment.
(a) any data available to the Regulator about adverse effects posed by the dealing;
(b) any other information as to risks associated with the dealing of which the Regulator is aware, including information provided to the Regulator by a licence holder under section 65 or by another person under section 66;
(c) whether there is a need for the dealing to be subject to conditions;
(d) any other information in relation to whether the dealing should be authorised by a GMO licence.
(3) The Regulator may have regard to such other matters as the Regulator considers relevant.
80 Variation of GMO Register
(1) The Regulator may vary the GMO Register by written determination.
(2) A variation may:
(a) remove a dealing from the GMO Register; or
(b) revoke or vary conditions to which a dealing on the GMO Register is subject; or
(c) impose additional conditions to which a dealing on the GMO Register is subject.
81 Inspection of Register
The Regulator must permit any person to inspect any part of the GMO Register.
Division 2 of this Part establishes a system under which the Regulator may certify facilities to specified containment levels in accordance with guidelines issued by the Regulator. Licence conditions, or conditions to which an emergency dealing determination is subject, can require that facilities be certified to specified containment levels.
Division 3 of this Part enables the Regulator to accredit organisations in accordance with accreditation guidelines issued by the Regulator. Licence conditions, or conditions to which an emergency dealing determination is subject, can specify that dealings must be supervised by an Institutional Biosafety Committee established by an accredited organisation.
Division 2—Certification
83 Application for certification
(1) A person may apply to the Regulator for certification of a facility to a particular containment level under this Division.
(2) The application must be in writing, and must contain such information as the Regulator requires.
Note: The conditions of a licence, or conditions to which an emergency dealing determination is subject, may require that a facility be certified under this Division.
84 When the Regulator may certify the facility
The Regulator may, by written instrument, certify the facility to a specified containment level if the facility meets the containment requirements specified in guidelines issued by the Regulator under section 90.
(1) The Regulator may, by notice in writing, require an applicant for certification of a facility to give the Regulator such further information in relation to the application as the Regulator requires.
86 Conditions of certification
The certification of a facility is subject to the following conditions:
(a) any conditions imposed by the Regulator at the time of certification;
(b) any conditions imposed by the Regulator under section 87 after certification;
(c) any conditions prescribed by the regulations.
87 Variation of certification
(1) The Regulator may, at any time, by notice in writing given to the holder of the certification, vary the certification of a facility.
(a) impose additional conditions; or
(b) remove or vary conditions that were imposed by the Regulator.
88 Suspension or cancellation of certification
The Regulator may, by notice in writing, suspend or cancel the certification of a facility if the Regulator believes on reasonable grounds that a condition of the certification has been breached.
(1) Before suspending, cancelling or varying a certification under this Division, the Regulator must give written notice of the proposed suspension, cancellation or variation to the holder of the certification.
(a) must state that the Regulator proposes to suspend, cancel or vary the certification; and
(b) may require the holder of the certification to give to the Regulator any information of a kind specified in the notice that is relevant to the proposed suspension, cancellation or variation; and
(c) may invite the holder of the certification to make a written submission to the Regulator about the proposed suspension, cancellation or variation.
(3) The notice must specify a period within which the holder of the certification:
(4) In considering whether to suspend, cancel or vary a certification, the Regulator must have regard to any submission made under paragraph (2)(c).
(5) This section does not apply to a suspension, cancellation or variation requested by the holder of the certification.
(6) This section does not apply to a suspension, cancellation or variation of a certification if the Regulator considers that the suspension, cancellation or variation is necessary in order to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment.
(7) This section does not apply to a variation of a certification if the Regulator is satisfied that the variation is of minor significance or complexity.
89A Transfer of certification
(1) The holder of a certification and another person (the transferee) may jointly apply to the Regulator for the certification to be transferred from the holder of the certification to the transferee.
(3) The Regulator must not transfer the certification unless the Regulator is satisfied that, if the certification is transferred, any conditions to which the certification is subject will continue to be met.
(4) The Regulator must give written notice of his or her decision on the application to the holder of the certification and the transferee.
(5) If the Regulator decides to transfer the certification:
(b) the certification continues in force; and
(c) the certification is subject to the same conditions as those in force immediately before the transfer.
90 Guidelines
(1) The Regulator may, by written instrument, issue technical or procedural guidelines about the requirements for the certification of facilities to specified containment levels.
(2) The Regulator may, by written instrument, vary or revoke the guidelines.
Division 3—Accredited organisations
91 Application for accreditation
(1) A person may apply to the Regulator for accreditation of an organisation as an accredited organisation under this Division.
Note 1: The conditions of a licence may require supervision of dealings by an Institutional Biosafety Committee established by an accredited organisation (see paragraph 62(2)(m)), and the regulations may require such supervision of notifiable low risk dealings (see paragraph 75(2)(c)).
Note 2: The conditions to which an emergency dealing determination is subject may require supervision of dealings by an Institutional Biosafety Committee established by an accredited organisation (see paragraph 72D(2)(t)).
92 Regulator may accredit organisations
(1) The Regulator may, by written instrument, accredit an organisation as an accredited organisation.
(2) In deciding whether to accredit an organisation, the Regulator must have regard to:
(a) whether the organisation has established an Institutional Biosafety Committee in accordance with written guidelines issued by the Regulator under section 98; and
(b) if the organisation has established an Institutional Biosafety Committee—whether the organisation will be able to maintain the Institutional Biosafety Committee in accordance with such guidelines; and
(c) if the organisation has established an Institutional Biosafety Committee—whether the organisation has appropriate indemnity arrangements for its Institutional Biosafety Committee members; and
(ca) if the organisation has not established an Institutional Biosafety Committee as mentioned in paragraph (a)—whether the organisation will be in a position to use an Institutional Biosafety Committee established by an accredited organisation; and
(d) any other matters specified in such guidelines.
(1) The Regulator may, by notice in writing, require an applicant for accreditation of an organisation to give the Regulator such further information in relation to the application as the Regulator requires.
94 Conditions of accreditation
The accreditation of an accredited organisation is subject to the following conditions:
(a) any conditions imposed by the Regulator at the time of accreditation;
(b) any conditions imposed by the Regulator under section 95 after accreditation;
95 Variation of accreditation
(1) The Regulator may, at any time, by notice in writing given to an accredited organisation, vary the organisation's accreditation.
96 Suspension or cancellation of accreditation
The Regulator may, by notice in writing, suspend or cancel the accreditation of an organisation if the Regulator believes on reasonable grounds that a condition of the accreditation has been breached.
(1) Before suspending, cancelling or varying an accreditation under this Division, the Regulator must give written notice of the proposed suspension, cancellation or variation to the holder of the accreditation.
(a) must state that the Regulator proposes to suspend, cancel or vary the accreditation; and
(b) may require the holder of the accreditation to give to the Regulator any information of a kind specified in the notice that is relevant to the proposed suspension, cancellation or variation; and
(c) may invite the holder of the accreditation to make a written submission to the Regulator about the proposed suspension, cancellation or variation.
(3) The notice must specify a period within which the holder of the accreditation:
(4) In considering whether to suspend, cancel or vary an accreditation, the Regulator must have regard to any submission made under paragraph (2)(c).
(5) This section does not apply to a suspension, cancellation or variation requested by the holder of the accreditation.
(6) This section does not apply to a suspension, cancellation or variation of an accreditation if the Regulator considers that the suspension, cancellation or variation is necessary in order to avoid an imminent risk of death, serious illness, serious injury or serious damage to the environment.
(7) This section does not apply to a variation of an accreditation if the Regulator is satisfied that the variation is of minor significance or complexity.
(1) The Regulator may, by written instrument, issue technical or procedural guidelines in relation to requirements that must be met in order for an organisation to be accredited under this Division.
(2) The guidelines may relate to, but are not limited to, matters concerning the establishment and maintenance of Institutional Biosafety Committees.
This Part provides for the establishment of the Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee.
The Part sets out the membership of these bodies, and their functions.
Division 2—The Gene Technology Technical Advisory Committee
100 The Gene Technology Technical Advisory Committee
(1) The Gene Technology Technical Advisory Committee is established.
(2) The Minister is to appoint up to 20 members of the Committee, and must appoint one of the members to chair the Committee.
(3) The members hold office on a part‑time basis.
(4) Before appointing a member of the Committee, the Minister must consult the following:
(a) the States;
(c) such scientific, consumer, health, environmental and industry groups as the Minister considers appropriate;
(d) such other Ministers as the Minister considers appropriate.
(5) Subject to subsections (6) and (7A), the Minister must not appoint a person as a member of the Committee unless the Minister is satisfied that the person has skills or experience in one or more of the following areas:
(a) molecular biology;
(b) ecology;
(c) plant, microbial, animal or human genetics;
(d) virology;
(e) entomology;
(f) agricultural or aquacultural systems;
(g) biosafety engineering;
(h) public health;
(i) occupational health and safety;
(j) risk assessment;
(k) clinical medicine;
(l) biochemistry;
(m) pharmacology;
(n) plant or animal pathology;
(o) botany;
(p) microbiology;
(q) animal biology;
(r) immunology;
(s) toxicology;
(t) an area specified by the regulations for the purposes of this paragraph.
(6) The Minister must appoint a layperson as a member of the Committee. The Minister is not required to be satisfied that the person has skills or experience in an area mentioned in subsection (5).
(7) In appointing the members of the Committee, the Minister must ensure, as far as practicable, that among the members as a whole there is a broad range of skills and experience in the areas mentioned in subsection (5).
(7A) The Minister must ensure that the Committee includes at least one person who is a member of the Ethics and Community Committee. The Minister is not required to be satisfied that this person has skills or experience in an area mentioned in subsection (5).
(8) The Minister must not appoint a member to chair the Committee unless a majority of jurisdictions agree to the appointment.
101 Function of the Gene Technology Technical Advisory Committee
The function of the Gene Technology Technical Advisory Committee is to provide scientific and technical advice, on the request of the Regulator or the Ministerial Council, on the following:
(a) gene technology, GMOs and GM products;
(b) applications made under this Act;
(c) the biosafety aspects of gene technology;
(d) the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products, and the content of such principles, guidelines and codes.
102 Expert advisers
(1) The Minister may appoint one or more persons (expert advisers) to give expert advice to the Gene Technology Technical Advisory Committee to assist it in the performance of its functions. Expert advisers may be appointed on a continuing or an ad hoc basis.
(2) For the avoidance of doubt, expert advisers are not Committee members.
103 Remuneration
(1) A person who is a member of the Gene Technology Technical Advisory Committee or an expert adviser is to be paid the remuneration that is determined by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, the member is to be paid the remuneration that is prescribed by the regulations.
(2) A person who is a member of the Gene Technology Technical Advisory Committee or an expert adviser is to be paid the allowances that are prescribed by the regulations.
(3) This section has effect subject to the Remuneration Tribunal Act 1973.
104 Members and procedures
(1) The regulations may prescribe matters relating to the members of the Gene Technology Technical Advisory Committee and expert advisers, including, but not limited to, the following:
(a) term of appointment;
(b) resignation;
(c) disclosure of interests;
(d) termination of appointment;
(e) leave of absence.
(2) The regulations may prescribe matters relating to the operation of the Gene Technology Technical Advisory Committee, including, but not limited to:
(a) procedures for convening meetings of the Committee; and
(b) the constitution of a quorum for a meeting of the Committee; and
(c) the way in which matters are to be resolved by the Committee; and
(d) Committee records; and
(e) reporting requirements, including, but not limited to, reports to the Regulator and to the public.
(3) If no regulations are in force under subsection (2), the Committee must operate in the way determined by the Regulator in writing.
(4) If no regulations are in force under subsection (2) and no determination is in force under subsection (3), the Committee may operate in the way it determines.
105 Subcommittees
(1) The Gene Technology Technical Advisory Committee may, with the Regulator's consent, establish subcommittees to assist in the performance of its functions.
(2) The regulations may prescribe matters relating to the constitution and operation of subcommittees.
Division 3—The Gene Technology Ethics and Community Consultative Committee
106 The Gene Technology Ethics and Community Consultative Committee
The Gene Technology Ethics and Community Consultative Committee (the Ethics and Community Committee) is established.
107 Function of Ethics and Community Committee
The function of the Ethics and Community Committee is to provide advice, on the request of the Regulator or the Ministerial Council, on the following:
(a) ethical issues relating to gene technology;
(b) the need for, and content of, codes of practice in relation to ethics in respect of conducting dealings with GMOs;
(c) the need for, and content of, policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons;
(d) the need for policy principles, policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products and the content of such principles, guidelines and codes;
(e) community consultation in respect of the process for applications for licences covering dealings that involve the intentional release of a GMO into the environment;
(f) risk communication matters in relation to dealings that involve the intentional release of a GMO into the environment;
(g) matters of general concern identified by the Regulator in relation to applications made under this Act;
(h) matters of general concern in relation to GMOs.
108 Membership
(1) The Minister is to appoint up to 12 members of the Ethics and Community Committee, and must appoint one of the members to chair the Ethics and Community Committee.
(2) Before appointing a member of the Ethics and Community Committee, the Minister must consult the following:
(3) The Minister must not appoint a person as a member of the Ethics and Community Committee (other than as a member mentioned in subsection (4)) unless the Minister is satisfied that the person has skills or experience of relevance to gene technology in relation to one or more of the following:
(a) community consultation;
(b) risk communication;
(c) the impact of gene technology on the community;
(d) issues relevant to businesses developing or using biotechnology;
(e) issues relevant to gene technology research;
(f) issues relevant to local government;
(g) issues of concern to consumers;
(h) law;
(i) religious practices;
(j) human health;
(k) animal health and welfare;
(l) primary production;
(m) ethics;
(n) environmental issues;
(o) issues specified by the regulations for the purposes of this paragraph.
(4) The Minister must ensure that the Ethics and Community Committee includes the following members:
(a) a person who is a member of the Gene Technology Technical Advisory Committee;
(b) a person who is a member of the Australian Health Ethics Committee.
(5) The members of the Ethics and Community Committee hold office on a part‑time basis.
(6) The Minister must not appoint a member to chair the Ethics and Community Committee unless a majority of jurisdictions agree to the appointment.
(1) A person who is a member of the Ethics and Community Committee or an expert adviser is to be paid the remuneration that is determined by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, the member is to be paid the remuneration that is prescribed by the regulations.
(2) A person who is a member of the Ethics and Community Committee or an expert adviser is to be paid the allowances that are prescribed by the regulations.
110 Membership and Procedures
(1) The regulations may prescribe matters relating to the members of the Ethics and Community Committee, including, but not limited to, the following:
(2) The regulations may prescribe matters relating to the operation of the Ethics and Community Committee, including, but not limited to, the following:
(a) procedures for convening meetings of the Ethics and Community Committee;
(b) the constitution of a quorum for a meeting of the Ethics and Community Committee;
(c) the way in which matters are to be resolved by the Ethics and Community Committee;
(d) Ethics and Community Committee records;
(3) If no regulations are in force under subsection (2), the Ethics and Community Committee must operate in the way determined in writing by the Regulator.
(4) If no regulations are in force under subsection (2) and no determination is in force under subsection (3), the Ethics and Community Committee may operate in the way determined in writing by the Ethics and Community Committee.
(5) A determination made under subsection (3) or (4) is not a legislative instrument.
(1) The Ethics and Community Committee may, with the Regulator's consent, establish subcommittees to assist in the performance of its functions.
(1) The Minister may appoint one or more persons (expert advisers) to give expert advice to the Ethics and Community Committee to assist it in the performance of its functions. Expert advisers may be appointed on a continuing or an ad hoc basis.
(2) Expert advisers are not members of the Ethics and Community Committee.
117 Simplified outline
This Part provides for various administrative matters.
Division 2 sets out matters relating to the appointment, conditions and remuneration of the Regulator.
Division 3 provides for financial matters, including the establishment of a Special Account, called the Gene Technology Account.
Division 4 provides for matters relating to staffing.
Division 5 sets out reporting requirements.
Division 6 requires the Regulator to maintain a record of GMOs and GM products.
Division 7 permits the Regulator to review notifiable low risk dealings and exemptions.
Division 2—Appointment and conditions of Regulator
118 Appointment of the Regulator
(1) The Regulator is to be appointed by the Governor‑General by written instrument.
(2) The Regulator holds office for the period specified in the instrument of appointment. The period specified must not be less than 3 years or more than 5 years.
(3) The Regulator holds office on a full‑time basis.
(4) The Governor‑General must not appoint a person as the Regulator unless a majority of jurisdictions agree to the appointment.
(5) The Governor‑General must not appoint a person as the Regulator if, at any time during the period of 2 years immediately before the proposed period of appointment, the person was employed by a body corporate whose primary commercial activity relates directly to the development and implementation of gene technologies.
(6) The Governor‑General must not appoint a person as the Regulator if the person has a pecuniary interest in a body corporate whose primary commercial activity relates directly to the development and implementation of gene technologies.
119 Termination of appointment
(1) The Governor‑General may terminate the appointment of the Regulator for misbehaviour or physical or mental incapacity.
(2) If the Regulator:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) fails to comply with his or her obligations under section 120; or
(c) without the consent of the Minister, engages in any paid employment outside the duties of his or her office; or
(d) is absent from duty, except on leave of absence, for 14 consecutive days or for 28 days in any 12 months;
the Governor‑General must terminate his or her appointment.
(3) The Governor‑General must not terminate the appointment of the Regulator under subsection (1) unless a majority of jurisdictions agree to the termination of the appointment.
(4) If the Regulator is:
(a) an eligible employee for the purposes of the Superannuation Act 1976; or
(b) a member of the superannuation scheme established by deed under the Superannuation Act 1990; or
(c) an ordinary employer‑sponsored member of PSSAP, within the meaning of the Superannuation Act 2005;
the Governor‑General may, with the consent of the Regulator, retire the Regulator from office on the grounds of physical or mental incapacity.
(5) For the purposes of the Superannuation Act 1976, the Regulator is taken to have been retired from office on the grounds of invalidity if:
(a) the Regulator is removed or retired from office on the grounds of physical or mental incapacity; and
(b) CSC gives a certificate under section 54C of that Act.
(b) CSC gives a certificate under section 13 of that Act.
(b) CSC gives an approval and certificate under section 43 of that Act.
120 Disclosure of interests
The Regulator must give written notice to the Minister of all interests, pecuniary or otherwise, that the Regulator has or acquires and that could conflict with the proper performance of the Regulator's functions.
121 Acting appointment
(1) The Minister may appoint a person to act as the Regulator:
(a) during a vacancy in the office of Regulator, (whether or not an appointment has previously been made to the office); or
(b) during any period, or during all periods, when the Regulator is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.
(2) Anything done by or in relation to a person purporting to act under an appointment is not invalid merely because:
(a) the occasion for the appointment had not arisen; or
(b) there was a defect or irregularity in connection with the appointment; or
(c) the appointment had ceased to have effect; or
(d) the occasion to act had not arisen or had ceased.
122 Terms and conditions
The Regulator holds office on the terms and conditions (if any) in relation to matters not covered by this Act that are determined by the Governor‑General.
123 Outside employment
The Regulator must not engage in paid employment outside the duties of the Regulator's office without the approval of the Minister.
(1) The Regulator is to be paid the remuneration that is determined by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, the Regulator is to be paid the remuneration that is prescribed by the regulations.
(2) The Regulator is to be paid the allowances that are prescribed by the regulations.
125 Leave of absence
(1) The Regulator has the recreation leave entitlements that are determined by the Remuneration Tribunal.
(2) The Minister may grant the Regulator leave of absence, other than recreation leave, on the terms and conditions as to remuneration or otherwise that the Minister determines.
126 Resignation
The Regulator may resign his or her appointment by giving the Governor‑General a written resignation.
Division 3—Money
127 Regulator may charge for services
The Regulator may charge for services provided by, or on behalf of, the Regulator in the performance of the Regulator's functions.
128 Notional payments by the Commonwealth
(1) The purpose of this section is to ensure that fees and charges under this Act and the regulations, and charges under the Gene Technology (Licence Charges) Act 2000, are notionally payable by the Commonwealth (or parts of the Commonwealth).
(2) The Minister responsible for administering the Financial Management and Accountability Act 1997 may give written directions for the purpose of this section, including directions relating to the transfer of amounts within, or between, accounts operated by the Commonwealth.
129 Gene Technology Account
(1) The Gene Technology Account is established.
(2) The Account is a Special Account for the purposes of the Financial Management and Accountability Act 1997.
130 Credits to Account
(1) There must be credited to the Account the following:
(b) amounts equal to money from time to time received by the Commonwealth under the Gene Technology (Licence Charges) Act 2000;
(c) amounts equal to fees received by the Commonwealth under subsections 40(6) and 83(3);
(d) amounts equal to amounts received by the Commonwealth in connection with the performance of the Regulator's functions under this Act, the regulations or a corresponding State law;
(e) amounts equal to interest received by the Commonwealth from the investment of amounts standing to the credit of the Account;
(f) amounts equal to money received by the Commonwealth in relation to property paid for with amounts standing to the credit of the Account;
(g) amounts equal to amounts recovered by the Commonwealth under subsection 146(5) or 158(4), to the extent that they are referable to amounts debited from the Account;
(h) amounts equal to amounts of any gifts given or bequests made for the purposes of the Account.
Note: An Appropriation Act provides for amounts to be credited to a Special Account if any of the purposes of the Account is a purpose that is covered by an item in the Appropriation Act.
(2) The purposes of the Account are to make payments:
(a) to further the object of this Act (as set out in section 3); and
(b) otherwise in connection with the performance of the Regulator's functions under this Act, the regulations or a corresponding State law.
131 Recovery of amounts
The following amounts may be recovered in a court of competent jurisdiction as debts due to the Commonwealth:
(a) amounts payable to the Commonwealth under the Gene Technology (Licence Charges) Act 2000;
(b) fees payable to the Commonwealth under this Act, the regulations or a corresponding State law;
(c) amounts payable to the Commonwealth in connection with the performance of the Regulator's functions.
132 Purposes of Account
Amounts standing to the credit of the Account may be expended:
(a) in payment or discharge of the costs, expenses and other obligations incurred:
(i) by the Regulator in the performance of the Regulator's functions or in the exercise of the Regulator's powers under this Act, the regulations or a corresponding State law; or
(ii) by an inspector under paragraph 158(2)(e) or under a corresponding State law; and
(b) in payment of any remuneration and allowances payable to any person under this Act or the regulations.
Division 4—Staffing
133 Staff assisting the Regulator
The staff assisting the Regulator are to be persons engaged under the Public Service Act 1999 and made available for the purpose by the Secretary of the Department.
134 Consultants
(1) The Regulator may engage persons with suitable qualifications and experience as consultants to the Regulator.
(2) The terms and conditions of engagement of consultants are such as the Regulator determines.
135 Seconded officers
The Regulator may be assisted by the following:
(a) persons engaged under the Public Service Act 1999;
(b) officers and employees of Commonwealth authorities;
(c) officers and employees of State agencies;
whose services are made available to the Regulator in connection with the performance or exercise of any of the Regulator's functions or powers.
Division 5—Reporting requirements
136 Annual Report
(1) As soon as practicable after the end of each financial year, the Regulator must prepare and give to the Minister a report on the operations of the Regulator during that year.
(2) The Minister must cause a copy of the report to be laid before each House of the Parliament within 15 sitting days of the day on which the report was given to the Minister.
(3) The Regulator must give a copy of the report to each State.
136A Quarterly reports
(1) As soon as practicable after the end of each quarter, the Regulator must prepare and give to the Minister a report on the operations of the Regulator during that quarter.
(2) The report must include information about the following:
(a) GMO licences issued during the quarter;
(b) any breaches of conditions of a GMO licence that have come to the Regulator's attention during the quarter;
(ba) emergency dealing determinations made by the Minister during the quarter;
(bb) any breaches of conditions of an emergency dealing determination that have come to the Regulator's attention during the quarter;
(c) auditing and monitoring of dealings with GMOs under this Act by the Regulator or an inspector during the quarter.
Note: Auditing and monitoring may include spot checks.
quarter means a period of 3 months beginning on 1 January, 1 April, 1 July or 1 October of any year.
137 Reports to Parliament
(1) The Regulator may at any time cause a report about matters relating to the Regulator's functions to be tabled in either House of the Parliament.
(2) The Regulator must give a copy of the report to the Minister and to each State.
Division 6—Record of GMO and GM Product Dealings
138 Record of GMO and GM Product Dealings
(1) The Regulator must maintain a Record of GMO and GM Product Dealings (the Record).
(2) The purpose of the Record is to maintain a comprehensive record of all dealings in Australia that involve GMOs or GM products.
(3) The Record must contain the following information, other than confidential commercial information, in relation to each licence issued under section 55:
(a) the name of the licence holder;
(b) the persons covered by the licence;
(c) the dealings authorised by the licence and the GMO to which those dealings relate;
(d) any licence conditions;
(e) the date on which the licence was issued, and its expiry date (if any).
(3A) The Record must contain the following information, other than confidential commercial information, in relation to each emergency dealing determination made under section 72B:
(a) the dealings specified in the emergency dealing determination and the GMO to which those dealings relate;
(b) any conditions to which the emergency dealing determination is subject;
(c) the date on which the emergency dealing determination takes effect;
(d) the date on which the emergency dealing determination will cease to have effect.
(4) The Record must contain the following information, other than confidential commercial information, in relation to each notifiable low risk dealing that is notified to the Regulator in accordance with regulations under section 75:
(a) the name of the person who notified the dealing;
(b) such particulars of the dealing as are prescribed by the regulations for the purposes of this paragraph.
(5) The Record must contain such information as is prescribed by the regulations, other than confidential commercial information, in relation to GM products mentioned in designated notifications given to the Regulator under the following Acts:
(a) the Agricultural and Veterinary Chemicals (Administration) Act 1992;
(b) the Food Standards Australia New Zealand Act 1991;
(c) the Industrial Chemicals (Notification and Assessment) Act 1989;
(d) the Therapeutic Goods Act 1989.
(6) The Record must also contain:
(a) a description of each dealing on the GMO Register; and
(7) The Record may be kept in a computerised form.
(8) The Regulator must ensure that information mentioned in subsection (3), (4), (5) or (6) is entered on the Record as soon as reasonably practicable.
designated notification means a notification required because of the amendments made by the Gene Technology (Consequential Amendments) Act 2000.
139 Inspection of Record
The Regulator must permit any person to inspect any part of the Record.
Division 7—Reviews of notifiable low risk dealings and exemptions
140 Regulator may review notifiable low risk dealings
(1) The Regulator may, at any time, in accordance with this Division, consider the following matters:
(a) whether a dealing with a GMO should be a notifiable low risk dealing;
(b) whether an existing notifiable low risk dealing should no longer be a notifiable low risk dealing.
(2) The basis of the Regulator's consideration must relate to:
(a) the matters of which the Regulator must be satisfied under subsection 74(2); or
(b) the matters the Regulator must consider under subsection 74(3).
141 Regulator may review exemptions
The Regulator may, at any time, in accordance with this Division, consider the following matters:
(a) whether a dealing that is an exempt dealing within the meaning of subsection 32(3) should not be an exempt dealing;
(b) whether a dealing should be an exempt dealing within the meaning of that subsection.
142 Regulator may give notice of consideration
(1) The Regulator may publish a notice inviting written submissions in relation to any matter that the Regulator may consider under section 140 or 141. The notice must:
(a) specify the matters to which submissions are to relate; and
(b) specify the closing date for submissions, which must not be earlier than 30 days after the date on which the notice was published.
(2) If the Regulator publishes a notice under subsection (1), the Regulator must also give written notice, stating the matters mentioned in subsection (1), to:
(c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph.
(3) A notice under this section may relate to a single matter or to a class of matters.
143 What Regulator may do after consideration
(a) the matter relates to whether a dealing should be a notifiable low risk dealing; and
(b) the Regulator is satisfied as mentioned in subsection 74(2); and
(c) the Regulator has considered the matters mentioned in subsection 74(3);
the Regulator may recommend to the Ministerial Council that the dealing be declared to be a notifiable low risk dealing.
(a) the matter relates to whether an existing notifiable low risk dealing be reconsidered; and
(b) after having had regard to the matters mentioned in section 74, the Regulator considers that the dealing should not be a notifiable low risk dealing;
the Regulator may recommend to the Ministerial Council that the regulations be amended accordingly.
(3) If the matter relates to whether a dealing:
(a) should be an exempt dealing; or
(b) should cease to be an exempt dealing;
144 Regulator not required to review matters
Nothing in this Division requires the Regulator to consider a matter under section 140 or 141.
This Part enables the Regulator to give directions to a licence holder or to a person covered by a licence, if:
(a) the Regulator believes that the person is not complying with this Act or the regulations; and
(b) the Regulator believes that it is necessary to do so in order to protect the health and safety of people or to protect the environment, or for certain other reasons.
This Part enables the Regulator to give directions to a person permitted by an emergency dealing determination to deal with a GMO, if:
(b) the Regulator believes that it is necessary to do so in order to protect the health and safety of people or to protect the environment or for certain other reasons.
The Part also empowers the Federal Court to issue injunctions, and contains a forfeiture provision.
146 Regulator may give directions
(1) If the Regulator believes, on reasonable grounds, that:
(a) a licence holder is not complying with this Act or the regulations in respect of a thing; and
(b) either of the following applies:
(i) it is necessary to exercise powers under this section in order to protect the health and safety of people or to protect the environment;
(ii) it is desirable in the public interest, having regard to the matters specified in subsection (2A), for the Regulator to exercise powers under this section;
the Regulator may give directions to the licence holder, by written notice, requiring the licence holder, within the time specified in the notice, to take such steps in relation to the thing as are reasonable in the circumstances for the licence holder to comply with this Act or the regulations.
(2) If the Regulator believes on reasonable grounds that:
(a) one of the following kinds of persons is not complying with this Act or the regulations in respect of a thing:
(i) a person covered by a GMO licence;
(ii) a person dealing with, or who has dealt with, a GMO specified in an emergency dealing determination; and
the Regulator may give directions to the person, by written notice, requiring the person, within the time specified in the notice, to take such steps in relation to the thing as are reasonable in the circumstances for the person to comply with this Act or the regulations.
(2A) For the purposes of deciding under subparagraph (1)(b)(ii) or (2)(b)(ii) whether it is desirable to exercise powers under this section to give directions to a licence holder or another person, the Regulator must have regard to the following:
(a) the types of dealings with GMOs authorised by the licence or specified in the emergency dealing determination concerned, and, in particular, whether the dealings are ongoing;
(b) whether measures have been, or are being, taken to address the non‑compliance with this Act or the regulations that the Regulator believes is occurring (the suspected non‑compliance);
(c) the likelihood of the licence holder or other person not complying with this Act or the regulations at a future time;
(d) the severity of the suspected non‑compliance;
(e) whether, on one or more occasions, the licence holder or the other person:
(i) has been charged with or convicted of an offence against this Act; or
(ii) has been given a direction under this section;
(f) other means available to the Regulator to address the suspected non‑compliance (including, but not limited to, by cancelling, varying or suspending a licence, accreditation or certification);
(g) whether, in the Regulator's opinion, the suspected non‑compliance was deliberate;
(h) the desirability of deterring future non‑compliance with this Act or the regulations.
(3) A person commits an offence if he or she does not take the steps specified in a notice under subsection (1) or (2) within the time specified in the notice.
Maximum penalty:
(a) in the case of an aggravated offence—2,000 penalty units;
(b) in any other case—500 penalty units.
Note 2: Aggravated offence is defined in section 38.
(4) If the licence holder or the person, as the case requires, does not take the steps specified in the notice within the time specified in the notice, the Regulator may arrange for those steps to be taken.
(5) If the Regulator incurs costs because of arrangements made by the Regulator under subsection (4), the licence holder or the person, as the case requires, is liable to pay to the Commonwealth an amount equal to the cost, and the amount may be recovered by the Commonwealth as a debt due to the Commonwealth in a court of competent jurisdiction.
(6) Section 4K of the Crimes Act 1914 does not apply to an offence against subsection (3).
(7) A time specified in a notice under subsection (1) or (2) must be reasonable having regard to the circumstances.
147 Injunctions
(1) If a person has engaged, is engaging, or is about to engage in any conduct that is or would be an offence against this Act or the regulations, the Federal Court of Australia (the Court) may, on the application of the Regulator or any other aggrieved person, grant an injunction restraining the person from engaging in the conduct.
(a) a person has refused or failed, is refusing or failing, or is about to refuse or fail, to do a thing; and
(b) the refusal or failure is, or would be, an offence against this Act or the regulations;
the Court may, on the application of the Regulator or any other aggrieved person, grant an injunction requiring the person to do the thing.
(3) The power of the Court to grant an injunction may be exercised:
(a) whether or not it appears to the Court that the person intends to engage, or to continue to engage, in conduct of that kind; and
(b) whether or not the person has previously engaged in conduct of that kind.
(4) The Court may discharge or vary an injunction granted under this section.
(5) The Court may grant an interim injunction pending a determination of an application under subsection (1).
(6) The powers granted by this section are in addition to, and not in derogation of, any other powers of the Court.
148 Forfeiture
(1) If a court:
(a) convicts a person of an offence against this Act or the regulations; or
(b) makes an order under section 19B of the Crimes Act 1914 in respect of a person charged with an offence against this Act or the regulations;
the court may order forfeiture to the Commonwealth of any thing used or otherwise involved in the commission of the offence.
(2) A thing ordered by a court to be forfeited under this section becomes the property of the Commonwealth and may be sold or otherwise dealt with in accordance with the directions of the Regulator.
(3) Until the Regulator gives a direction, the thing must be kept in such custody as the Regulator directs.
This Part provides for powers of inspection in relation to monitoring and offences.
Division 2 provides for the appointment of inspectors.
Divisions 3 to 9 deal with the powers and obligations of inspectors, and the rights and responsibilities of an occupier of premises when an inspector seeks to exercise powers.
Division 10 sets out procedures relating to monitoring warrants and offence‑related warrants.
This Part does not limit the conditions to which a licence or an emergency dealing determination can be subject, and section 64 imposes a condition in relation to monitoring dealings with GMOs.
Division 2—Appointment of inspectors and identity cards
150 Appointment of inspectors
(1) The Regulator may, by instrument in writing, appoint any of the following persons as inspectors:
(a) a person who is appointed or employed by the Commonwealth;
(b) a person who is appointed or employed by a State.
(2) In exercising powers or performing functions as an inspector, an inspector must comply with any directions of the Regulator.
151 Identity card
(1) The Regulator must issue an identity card to an inspector.
(2) The identity card:
(a) must be in the form prescribed by the regulations; and
(b) must contain a recent photograph of the inspector.
(3) If a person to whom an identity card has been issued ceases to be an inspector, the person must return the identity card to the Regulator as soon as practicable.
Maximum penalty: 1 penalty unit.
(4) An inspector must carry his or her identity card at all times when exercising powers or performing functions as an inspector.
Division 3—Monitoring powers
152 Powers available to inspectors for monitoring compliance
(1) For the purpose of finding out whether this Act or the regulations have been complied with, an inspector may:
(a) enter any premises; and
(b) exercise the monitoring powers set out in section 153.
(2) An inspector is not authorised to enter premises under subsection (1) unless:
(a) the occupier of the premises has consented to the entry; or
(b) the entry is made under a warrant under section 172; or
(c) the occupier of the premises is a licence holder, or a person covered by a licence, and the entry is at a reasonable time; or
(d) the occupier of the premises is a person dealing with, or who has dealt with, a GMO specified in an emergency dealing determination, and the entry is at a reasonable time.
153 Monitoring powers
(1) The monitoring powers that an inspector may exercise under paragraph 152(1)(b) are as follows:
(a) to search the premises and any thing on the premises;
(b) to inspect, examine, take measurements of, conduct tests on, or take samples of, any thing on the premises that relates to a GMO;
(c) to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises;
(d) if the inspector was authorised to enter the premises by a warrant under section 172—to require any person in or on the premises to:
(i) answer any questions put by the inspector; and
(ii) produce any book, record or document requested by the inspector;
(e) to inspect any book, record or document on the premises;
(f) to take extracts from or make copies of any such book, record or document;
(g) to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises;
(h) to secure a thing, until a warrant is obtained to seize it, being a thing:
(i) that the inspector finds during the exercise of monitoring powers on the premises; and
(ii) that the inspector believes on reasonable grounds is evidential material; and
(iii) that the inspector believes on reasonable grounds would be lost, destroyed or tampered with before the warrant can be obtained.
(2) For the purposes of this Part, monitoring powers include the power to operate equipment at premises to see whether:
(a) the equipment; or
(b) a disk, tape or other storage device that:
(i) is at the premises; and
(ii) can be used with the equipment or is associated with it;
contains information that is relevant to determining whether there has been compliance with the Act or the regulations.
(3) If the inspector, after operating equipment at the premises, finds that the equipment, or that a tape, disk or other storage device at the premises, contains information mentioned in subsection (2), the inspector may:
(a) operate facilities at the premises to put the information in documentary form and copy the document so produced; or
(b) if the information can be transferred to a tape, disk or other storage device that:
(i) is brought to the premises; or
(ii) is at the premises and the use of which for the purpose has been agreed to in writing by the occupier of the premises;
operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises.
Division 4—Offence‑related powers
154 Searches and seizures related to offences
(1) This section applies if an inspector has reasonable grounds for suspecting that there may be evidential material on any premises.
(2) The inspector may:
(a) enter the premises, with the consent of the occupier or under a warrant issued under section 173; and
(b) exercise the powers set out in subsection (3) and section 155; and
(c) if the entry is under a warrant—seize the evidential material, if the inspector finds it on the premises.
(a) in the course of searching, in accordance with a warrant, for a particular thing, an inspector finds another thing that the inspector believes on reasonable grounds to be evidential material; and
(b) the inspector believes, on reasonable grounds, that it is necessary to seize that other thing in order to prevent its concealment, loss or destruction, or its use in committing, continuing or repeating an offence against this Act or the regulations;
the warrant is taken to authorise the inspector to seize that other thing.
155 Offence‑related powers of inspectors in relation to premises
The powers an inspector may exercise under paragraph 154(2)(b) are as follows:
(a) to search the premises and any thing on the premises for the evidential material;
(b) to inspect, examine, take measurements of, conduct tests on, or take samples of the evidential material;
(c) to take photographs, make video or audio recordings or make sketches of the premises or the evidential material;
(d) to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises.
156 Use of equipment at premises
(1) The inspector may operate equipment at the premises to see whether evidential material is accessible by doing so, if the inspector believes on reasonable grounds that the operation of the equipment can be carried out without damage to the equipment.
(2) If the inspector, after operating the equipment, finds that evidential material is accessible by doing so, the inspector may:
(a) seize the equipment and any disk, tape or other associated device; or
(b) if the material can, by using facilities at the premises, be put in documentary form—operate the facilities to put the material in that form and seize the documents so produced; or
(c) if the material can be transferred to a disk, tape or other storage device that:
operate the equipment or other facilities to copy the material to the storage device and take the storage device from the premises.
(3) An inspector may seize equipment under paragraph (2)(a) only if:
(a) it is not practicable to put the material in documentary form as mentioned in paragraph (2)(b) or to copy the material as mentioned in paragraph (2)(c); or
(b) possession by the occupier of the equipment could constitute an offence.
(4) An inspector may seize equipment under paragraph (2)(a) or documents under paragraph (2)(b) only if the inspector entered the premises under a warrant.
Division 5—Expert assistance
157 Expert assistance to operate a thing
(1) If an inspector believes on reasonable grounds that:
(a) information relevant to determining whether there has been compliance with this Act or the regulations, or evidential material, may be accessible by operating a thing at particular premises; and
(b) expert assistance is required to operate the thing; and
(c) if he or she does not take action under this subsection, the information or material may be destroyed, altered or otherwise interfered with;
he or she may do whatever is necessary to secure the thing, whether by locking it up, placing a guard or otherwise.
(2) The inspector must give notice to the occupier of the premises of his or her intention to secure the thing and of the fact that the thing may be secured for up to 24 hours.
(3) The thing may be secured:
(a) for a period not exceeding 24 hours; or
(b) until the thing has been operated by the expert;
whichever happens first.
(4) If the inspector believes on reasonable grounds that the expert assistance will not be available within 24 hours, he or she may apply to the magistrate for an extension of that period.
(5) The inspector must give notice to the occupier of the premises of his or her intention to apply for an extension, and the occupier is entitled to be heard in relation to the application.
Division 6—Emergency powers
158 Powers available to inspectors for dealing with dangerous situations
(1) This section applies if:
(a) an inspector has reasonable grounds for suspecting that there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied with; and
(b) the inspector considers that it is necessary to exercise powers under this section in order to avoid an imminent risk of death, serious illness, serious injury, or to protect the environment.
(2) The inspector may do any of the following:
(a) enter the premises;
(b) search the premises for the thing;
(c) secure the thing, if the inspector finds it on the premises, until a warrant is obtained to seize the thing;
(d) if the inspector has reasonable grounds for suspecting that a person has not complied with this Act or the regulations in respect of the thing—require the person to take such steps as the inspector considers necessary for the person to comply with this Act or the regulations;
(e) take such steps, or arrange for such steps to be taken, in relation to the thing as the inspector considers appropriate.
(3) The inspector may exercise the powers in subsection (2) only to the extent that it is necessary for the purpose of avoiding an imminent risk of death, serious illness, serious injury or serious damage to the environment.
(4) If the Regulator incurs costs because of steps reasonably taken or arranged to be taken by an inspector under paragraph (2)(e), the person is liable to pay to the Commonwealth an amount equal to the costs, and the amount may be recovered by the Commonwealth as a debt due to the Commonwealth in a court of competent jurisdiction.
Division 7—Obligations and incidental powers of inspectors
159 Inspector must produce identity card on request
An inspector is not entitled to exercise any powers under this Part in relation to premises if:
(a) the occupier of the premises has required the inspector to produce his or her identity card for inspection by the occupier; and
(b) the inspector fails to comply with the requirement.
160 Consent
(1) Before obtaining the consent of a person for the purposes of paragraph 152(2)(a) or 154(2)(a), the inspector must inform the person that he or she may refuse consent.
(2) An entry of an inspector by virtue of the consent of a person is not lawful unless the person voluntarily consented to the entry.
161 Details of warrant to be given to occupier etc.
(1) If a warrant in relation to premises is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the inspector must make available to that person a copy of the warrant.
(2) The inspector must identify himself or herself to that person.
(3) The copy of the warrant referred to in subsection (1) need not include the signature of the magistrate who issued the warrant.
162 Announcement before entry
(1) An inspector must, before entering premises under a warrant:
(a) announce that he or she is authorised to enter the premises; and
(b) give any person at the premises an opportunity to allow entry to the premises.
(2) An inspector is not required to comply with subsection (1) if he or she believes on reasonable grounds that immediate entry to the premises is required:
(a) to ensure the safety of a person; or
(b) to prevent serious damage to the environment; or
(c) to ensure that the effective execution of the warrant is not frustrated.
163 Compensation for damage
(1) The owner of a thing is entitled to compensation for damage to the thing if:
(a) the damage was caused to the thing as a result of it being operated as mentioned in this Part; and
(b) the damage was caused as a result of:
(i) insufficient care being exercised in selecting the person who was to operate the thing; or
(ii) insufficient care being exercised by the person operating the thing.
(2) Compensation is payable out of money appropriated by the Parliament.
(3) In determining the amount of compensation payable, regard is to be had to whether the occupier of the premises and his or her employees and agents, if they were available at the time, had provided any warning or guidance as to the operation of the thing that was appropriate in the circumstances.
Division 8—Power to search goods, baggage etc.
164 Power to search goods, baggage etc.
(1) This section applies to any goods that are to be, are being, or have been, taken off a ship that voyages, or an aircraft that flies, between:
(a) a place outside Australia and a place in Australia; or
(b) a place outside an external territory and a place in that territory.
(2) If an inspector believes, on reasonable grounds, that goods are goods to which this section applies, and that the goods may be, or may contain, evidential material, the inspector may:
(a) examine the goods; or
(b) if the goods are baggage—open and search the baggage; or
(c) if the goods are in a container—open and search the container.
(3) An inspector may ask a person who owns, is carrying or is otherwise associated with, or appears to the inspector to be associated with, goods to which this section applies, any question in respect of the goods.
(4) A person must not refuse or fail to answer a question put to the person under subsection (3).
165 Seizure of goods
An inspector may seize goods mentioned in section 164 if the inspector has reasonable grounds to suspect that the goods are evidential material.
Division 9—General provisions relating to search and seizure
166 Copies of seized things to be provided
(1) Subject to subsection (2), if an inspector seizes, under a warrant relating to premises:
(a) a document, film, computer file or other thing that can be readily copied; or
(b) a storage device, the information in which can be readily copied;
the inspector must, if requested to do so by the occupier of the premises, or another person who apparently represents the occupier and who is present when the warrant is executed, give a copy of the thing or the information to that person as soon as practicable after the seizure.
(2) Subsection (1) does not apply if:
(a) the thing that has been seized was seized under paragraph 156(2)(b) or (c); or
(b) possession by the occupier of the document, film, computer file, thing or information could constitute an offence.
167 Occupier entitled to be present during search
(1) If a warrant in relation to premises is being executed and the occupier of the premises, or another person who apparently represents the occupier is present at the premises, the person is entitled to observe the search being conducted.
(2) The right to observe the search being conducted ceases if the person impedes the search.
(3) This section does not prevent 2 or more areas of the premises being searched at the same time.
168 Receipts for things seized
(1) If a thing is seized under this Part, the inspector must provide a receipt for the thing.
(2) If 2 or more things are seized, they may be covered in the one receipt.
169 Retention of seized things
(1) Subject to any contrary order of a court, if an inspector seizes a thing under this Part, the inspector must return it if:
(a) the reason for its seizure no longer exists or it is decided that it is not to be used in evidence; or
(b) the period of 60 days after its seizure ends;
whichever first occurs, unless the thing is forfeited or forfeitable to the Commonwealth.
(2) At the end of the 60 days specified in subsection (1), an inspector must take reasonable steps to return the thing to the person from whom it was seized, unless:
(a) proceedings in respect of which the thing may afford evidence were instituted before the end of the 60 days and have not been completed (including an appeal to a court in relation to those proceedings); or
(b) an inspector may retain the thing because of an order under section 170; or
(c) to return the thing could cause an imminent risk of death, serious illness, serious injury or serious damage to the environment; or
(d) an inspector is otherwise authorised (by a law, or an order of a court, of the Commonwealth or of a State) to retain, destroy or dispose of the thing.
(3) The thing may be returned under subsection (2) either unconditionally or on such terms and conditions as the Regulator sees fit.
170 Magistrate may permit a thing to be retained
(1) An inspector may apply to a magistrate for an order that he or she may retain the thing for a further period if:
(a) before the end of 60 days after the seizure; or
(b) before the end of a period previously specified in an order of a magistrate under this section;
proceedings in respect of which the thing may afford evidence have not commenced.
(2) If the magistrate is satisfied that it is necessary for an inspector to continue to retain the thing:
(a) for the purposes of an investigation as to whether an offence against this Act has been committed; or
(b) to enable evidence of an offence against this Act to be secured for the purposes of a prosecution;
the magistrate may order that an inspector may retain the thing for a period (not being a period exceeding 3 years) specified in the order.
(3) Before making the application, the inspector must:
(a) take reasonable steps to discover who has an interest in the retention of the thing; and
(b) if it is practicable to do so, notify each person whom the inspector believes to have such an interest of the proposed application.
171 Disposal of goods if there is no owner or owner cannot be located
(a) a thing is seized under this Part; and
(b) apart from this section, the Commonwealth is required to return the thing to the owner; and
(c) there is no owner or the Regulator cannot, despite making reasonable efforts, locate the owner;
the Regulator may dispose of the thing in such manner as the Regulator thinks appropriate.
Division 10—Warrants
172 Monitoring warrants
(1) An inspector may apply to a magistrate for a warrant under this section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant if the magistrate is satisfied, by information on oath, that it is reasonably necessary that one or more inspectors should have access to the premises for the purposes of finding out whether this Act or the regulations have been complied with.
(3) The magistrate must not issue the warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought.
(4) The warrant must:
(a) authorise one or more inspectors (whether or not named in the warrant), with such assistance and by such force as is necessary and reasonable:
(i) to enter the premises; and
(ii) to exercise the powers set out in section 153 in relation to the premises; and
(b) state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and
(c) specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect; and
(d) state the purpose for which the warrant is issued.
173 Offence‑related warrants
(2) Subject to subsection (3), the magistrate may issue the warrant if the magistrate is satisfied, by information on oath, that there are reasonable grounds for suspecting that there is, or there may be within the next 72 hours, evidential material in or on the premises.
(a) name one or more inspectors; and
(b) authorise the inspectors so named, with such assistance and by such force as is necessary and reasonable:
(ii) to exercise the powers set out in subsection 154(3) and section 155; and
(iii) to seize the evidential material; and
(c) state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and
(d) specify the day (not more than one week after the issue of the warrant) on which the warrant ceases to have effect; and
(e) state the purpose for which the warrant is issued.
174 Offence‑related warrants by telephone, telex, fax etc.
(1) If, in an urgent case, an inspector considers it necessary to do so, the inspector may apply to a magistrate by telephone, telex, fax or other electronic means for a warrant under section 173 in relation to premises.
(2) The magistrate may require communication by voice to the extent that it is practicable in the circumstances.
(3) Before applying for the warrant, the inspector must prepare an information of the kind mentioned in subsection 173(2) in relation to the premises that sets out the grounds on which the warrant is sought.
(4) If it is necessary to do so, the inspector may apply for the warrant before the information is sworn.
(5) If the magistrate is satisfied:
(a) after having considered the terms of the information; and
(b) after having received such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought;
that there are reasonable grounds for issuing the warrant, the magistrate may complete and sign the same warrant that the magistrate would issue under section 173 if the application had been made under that section.
(6) If the magistrate completes and signs the warrant:
(a) the magistrate must:
(i) tell the inspector what the terms of the warrant are; and
(ii) tell the inspector the day on which and the time at which the warrant was signed; and
(iii) tell the inspector the day (not more than one week after the magistrate completes and signs the warrant) on which the warrant ceases to have effect; and
(iv) record on the warrant the reasons for issuing the warrant; and
(b) the inspector must:
(i) complete a form of warrant in the same terms as the warrant completed and signed by the magistrate; and
(ii) write on the form the name of the magistrate and the day on which and the time at which the warrant was signed.
(7) The inspector must also, not later than the day after the day of expiry or execution of the warrant, whichever is the earlier, send to the magistrate:
(a) the form of warrant completed by the inspector; and
(b) the information referred to in subsection (3), which must have been duly sworn.
(8) When the magistrate receives those documents, the magistrate must:
(a) attach them to the warrant that the magistrate completed and signed; and
(b) deal with them in the way in which the magistrate would have dealt with the information if the application had been made under section 173.
(9) A form of warrant duly completed under subsection (6) is authority for any entry, search, seizure or other exercise of a power that the warrant signed by the magistrate authorises.
(10) If:
(a) it is material, in any proceedings, for a court to be satisfied that an exercise of a power was authorised by this section; and
(b) the warrant signed by the magistrate authorising the exercise of the power is not produced in evidence;
the court must assume, unless the contrary is proved, that the exercise of the power was not authorised by such a warrant.
(11) A reference in this Part to a warrant under section 173 includes a reference to a warrant signed by a magistrate under this section.
175 Offences relating to warrants
(1) An inspector must not make, in an application for a warrant, a statement that the inspector knows to be false or misleading in a material particular.
Maximum penalty: Imprisonment for 2 years or 120 penalty units.
(2) An inspector must not:
(a) state in a document that purports to be a form of warrant under section 174 the name of a magistrate unless that magistrate issued the warrant; or
(b) state on a form of warrant under that section a matter that, to the inspector's knowledge, departs in a material particular from the form authorised by the magistrate; or
(c) purport to execute, or present to another person, a document that purports to be a form of warrant under that section that the inspector knows:
(i) has not been approved by a magistrate under that section; or
(ii) departs in a material particular from the terms authorised by a magistrate under that section; or
(d) give to a magistrate a form of warrant under that section that is not the form of warrant that the inspector purported to execute.
Division 11—Other matters
176 Part not to abrogate privilege against self‑incrimination
Nothing in this Part affects the right of a person to refuse to answer a question, give information, or produce a document, on the ground that the answer to the question, the information, or the production of the document, might tend to incriminate him or her or make him or her liable to a penalty.
177 Part does not limit power to impose conditions
This Part is not to be taken to limit the Regulator's power to impose licence conditions or the Minister's power to impose conditions on an emergency dealing determination.
This Part provides for miscellaneous matters, including the following:
(a) review of decisions;
(b) provisions relating to confidential commercial information;
(c) the making of regulations;
(d) transitional provisions;
(e) review of the operation of the Act.
Division 2—Review of decisions
179 Meaning of terms
The following table sets out:
(a) decisions that are reviewable decisions; and
(b) each eligible person in relation to a reviewable decision:
Reviewable decisions and eligible persons
Provision under which decision made
Eligible person in relation to decision
To refuse to consider an application on the basis that the applicant is not a suitable person to hold a licence
paragraph 43(2)(f)
the applicant
To refuse to issue a licence
the applicant for the licence
To impose a licence condition
the licence holder
To suspend or cancel a licence
To refuse to transfer a licence
an applicant for the transfer
To vary a licence
To refuse to vary a licence
To refuse to certify a facility
the applicant for certification
To specify a condition of a certification
the holder of the certification
To vary a certification
To refuse to transfer a certification
section 89A
To suspend or cancel a certification
To refuse to accredit an organisation
the applicant for accreditation
To specify a condition of an accreditation
the holder of the accreditation
To vary an accreditation
To suspend or cancel an accreditation
To refuse to declare information to be confidential commercial information
the person who made an application under section 184 in relation to the information
To revoke a declaration that information is confidential commercial information
180 Notification of decisions and review rights
(1) The Regulator must, as soon as practicable after making a reviewable decision, cause a notice in writing to be given to each eligible person in relation to the decision, containing:
(a) the terms of the decision; and
(b) the reasons for the decision; and
(c) a statement setting out particulars of the person's review rights.
(2) A failure to comply with the requirements of subsection (1) in relation to a decision does not affect the validity of the decision.
181 Internal review
(1) An eligible person in relation to a reviewable decision (other than a decision made by the Regulator personally) may apply in writing to the Regulator for review (internal review) of the decision.
(2) An application for internal review must be made within 30 days after the day on which the decision first came to the notice of the applicant, or within such period (if any) as the Regulator, either before or after the end of that period, allows.
(3) The Regulator must, on receiving an application, review the reviewable decision personally.
(a) make a decision affirming, varying or revoking the reviewable decision; and
(b) if the Regulator revokes the decision, make such other decision as the Regulator thinks appropriate.
182 Deadlines for making reviewable decisions
(a) this Act provides for a person to make an application of any kind to the Regulator; and
(b) a period is specified under this Act or the regulations for giving notice of the decision to the applicant; and
(c) the Regulator has not notified the applicant of the Regulator's decision within that period;
the Regulator is taken, for the purposes of this Act, to have made a reviewable decision to reject the application, and the person may seek internal review of the reviewable decision under section 181.
183 Review of decisions by Administrative Appeals Tribunal
(1) Subject to the Administrative Appeals Tribunal Act 1975, an application may be made by an eligible person in relation to:
(a) a reviewable decision made by the Regulator personally; or
(b) a decision made by the Regulator under section 181 (which provides for internal review).
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.
183A Extended standing for judicial review
(1) This section extends (and does not limit) the meaning of the term person aggrieved in the Administrative Decisions (Judicial Review) Act 1977 for the purposes of the application of that Act in relation to:
(a) a decision made under this Act or the regulations; or
(b) a failure to make a decision under this Act or the regulations; or
(c) conduct engaged in for the purpose of making a decision under this Act or the regulations.
(2) A State is taken to be a person aggrieved by the decision, failure or conduct.
(3) A term (except person aggrieved) used in this section and in the Administrative Decisions (Judicial Review) Act 1977 has the same meaning in this section as it has in that Act.
Division 3—Confidential commercial information
184 Application for protection of confidential commercial information
(1) A person may apply to the Regulator for a declaration that specified information to which this Act relates is confidential commercial information for the purposes of this Act.
(2) An application under subsection (1) must be in writing in the form approved by the Regulator.
185 Regulator may declare that information is confidential commercial information
(1) Subject to subsection (2), if the person satisfies the Regulator that the information specified in the application is:
(a) a trade secret; or
(b) any other information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or
(c) other information that:
(i) concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and
(ii) if it were disclosed, could unreasonably affect the person, organisation or undertaking;
the Regulator must declare that the information is confidential commercial information for the purposes of this Act.
(2) The Regulator may refuse to declare that the information is confidential commercial information if the Regulator is satisfied that the public interest in disclosure outweighs the prejudice that the disclosure would cause to any person.
(2A) The Regulator must refuse to declare that information is confidential commercial information if the information relates to one or more locations at which field trials involving GMOs are occurring, or are proposed to occur, unless the Regulator is satisfied that significant damage to the health and safety of people, the environment or property would be likely to occur if the locations were disclosed.
Note: This means that, in general, information about sites where dealings with GMOs are occurring will be required to be disclosed under sections 54 and 138, unless the Regulator is satisfied that disclosure would involve significant risks to health and safety.
(3) The Regulator must give the applicant written notice of the Regulator's decision about the application.
(3A) If:
(a) the Regulator declares that particular information is confidential commercial information; and
(b) the information relates to one or more locations at which field trials involving GMOs are occurring, or are proposed to occur;
the Regulator must make publicly available a statement of reasons for the making of the declaration, including, but not limited to:
(c) the reasons why the Regulator was satisfied as mentioned in subsection (1); and
(d) the reasons why the Regulator was not satisfied under subsection (2) that the public interest in disclosure of the information outweighed the prejudice that the disclosure would cause; and
(e) the reasons why the Regulator was satisfied under subsection (2A) that significant damage to the health and safety of people, the environment or property would be likely to occur if the locations were disclosed.
(3B) If:
(a) a person has made an application under section 184 for a declaration that specified information is confidential commercial information; and
(b) the Regulator has not yet made a decision on the application;
the information is to be treated as confidential commercial information until the Regulator makes a decision on the application.
(4) If the Regulator refuses an application under subsection 184(1) in relation to information, the information is to be treated as confidential commercial information until any review rights under section 181 or 183 in relation to the application are exhausted.
186 Revocation of declaration
(1) The Regulator may, by written notice given to the applicant, revoke a declaration under section 185 if the Regulator is satisfied:
(a) that the information concerned no longer satisfies paragraph 185(1)(a), (b) or (c); or
(b) that the public interest in disclosure of the information outweighs the prejudice that disclosure would cause to any person.
(2) A revocation by the Regulator under subsection (1) does not take effect until any review rights under section 181 or 183 in relation to the revocation are exhausted.
187 Confidential commercial information must not be disclosed
(1) A person who:
(a) has confidential commercial information; and
(b) has it only because of performing duties or functions under this Act or under a corresponding State law; and
(c) knows that the information is confidential commercial information;
must not disclose the information except:
(d) to any of the following in the course of carrying out duties or functions under this Act or under a corresponding State law:
(i) the Commonwealth or a Commonwealth authority;
(ii) a State agency;
(iii) the Gene Technology Technical Advisory Committee; or
(e) by order of a court; or
(f) with the consent of the person who applied to have the information treated as confidential commercial information.
Note 2: Information to which subsection (1) applies is information to which section 38 of the Freedom of Information Act 1982 applies, because subsection (1) is listed in Schedule 3 to that Act.
(b) has it because of a disclosure under subsection (1) or under this subsection; and
court includes a tribunal, authority or person having power to require the production of documents or the answering of questions.
disclose, in relation to information, means give or communicate in any way.
Division 4—Conduct by directors, employees and agents
188 Conduct by directors, employees and agents
(1) If, in proceedings for an offence against this Act or the regulations, or an ancillary offence in relation to this Act or the regulations, it is necessary to establish the state of mind of a body corporate in relation to particular conduct, it is sufficient to show:
(a) that the conduct was engaged in by a director, employee or agent of the body corporate within the scope of his or her actual or apparent authority; and
(b) that the director, employee or agent had the state of mind.
(2) Any conduct engaged in on behalf of a body corporate by a director, employee or agent of the body corporate within the scope of his or her actual or apparent authority is taken, for the purposes of a prosecution for:
(a) an offence against this Act or the regulations; or
(b) an ancillary offence relating to this Act or the regulations;
to have been engaged in also by the body corporate, unless the body corporate establishes that the body corporate took reasonable precautions and exercised due diligence to avoid the conduct.
(3) If, in proceedings for an ancillary offence relating to this Act or the regulations, it is necessary to establish the state of mind of a person other than a body corporate in relation to particular conduct, it is sufficient to show:
(a) that the conduct was engaged in by an employee or agent of the person within the scope of his or her actual or apparent authority; and
(b) that the employee or agent had the state of mind.
(4) Any conduct engaged in on behalf of a person (the first person), other than a body corporate, by an employee or agent of the first person, within the scope of the actual or apparent authority of the employee or agent is taken, for the purposes of a prosecution for:
to have been engaged in also by the first person unless the first person establishes that he or she took reasonable precautions and exercised due diligence to avoid the conduct.
(a) a person other than a body corporate is convicted of an offence; and
(b) the person would not have been convicted of the offence if subsections (3) and (4) had not been enacted;
the person is not liable to be punished by imprisonment for that offence.
(1) A reference in subsection 188(1) or (3) to the state of mind of a person includes a reference to:
(a) the knowledge, intention, opinion, belief or purpose of the person; and
(b) the person's reasons for the intention, opinion, belief or purpose.
(2) A reference in section 188 to a director of a body corporate includes a reference to a constituent member of a body corporate incorporated for a public purpose by a law of the Commonwealth or a State.
(3) A reference in section 188 to engaging in conduct includes a reference to failing or refusing to engage in conduct.
(4) A reference in section 188 to an ancillary offence relating to this Act or the regulations is a reference to an offence:
(a) against section 6 of the Crimes Act 1914; or
(b) that is taken to have been committed because of section 11.2 or 11.2A of the Criminal Code; or
(c) against section 11.1, 11.4 or 11.5 of the Criminal Code;
that relates to this Act or the regulations.
Division 5—Transitional provisions
190 Transitional provision—dealings covered by Genetic Manipulation Advisory Committee advice to proceed
(1) The prohibitions in this Act apply to a dealing with a GMO by a person at a particular time during the transition period (the dealing time) with the modifications set out in subsection (2), if:
(a) immediately before the commencement of Part 4 of this Act, an advice to proceed was in force in relation to the dealing with the GMO by the person; and
(b) the advice to proceed is in force at the dealing time; and
(c) the dealing is in accordance with the advice to proceed.
(2) Unless the dealing is a notifiable low risk dealing, an exempt dealing or a dealing on the GMO Register:
(a) the advice to proceed is taken for the purposes of this Act to be a GMO licence; and
(b) the holder of the advice to proceed is taken to be the licence holder; and
(c) the licence is taken to be subject to any conditions to which the advice to proceed is subject; and
(d) the licence is taken to remain in force for the period ending at the earliest of the following times:
(i) the time when the advice to proceed expires;
(ii) the end of the transition period;
(iii) when the licence is cancelled under section 68 or surrendered under section 69.
advice to proceed means an advice to proceed issued by the Genetic Manipulation Advisory Committee, in accordance with Guidelines issued by that Committee.
transition period means the period of 2 years beginning at the commencement of Part 4 of this Act.
191 Regulations may relate to transitional matters
Regulations may be made in relation to transitional matters arising from the enactment of this Act.
Division 6—Other
192 False or misleading information or document
A person must not:
(a) in connection with an application made to the Regulator under this Act or the regulations; or
(b) in compliance or purported compliance with this Act or the regulations;
do either of the following:
(c) give information (whether orally or in writing) that the person knows to be false or misleading in a material particular;
(d) produce a document that the person knows to be false or misleading in a material particular without:
(i) indicating to the person to whom the document is produced that it is false or misleading, and the respect in which it is false or misleading; and
(ii) providing correct information to that person, if the person producing the document is in possession of, or can reasonably acquire, the correct information.
Maximum penalty: Imprisonment for 1 year or 60 penalty units.
192A Interference with dealings with GMOs
(a) the person engages in conduct; and
(b) the conduct:
(i) results in damage to, destruction of, or interference with, premises at which dealings with GMOs are being undertaken; or
(ii) involves damaging, destroying, or interfering with, a thing at, or removing a thing from, such premises; and
(c) the owner or occupier of the premises, or the owner of the thing (as the case requires), has not consented to the conduct; and
(d) in engaging in the conduct, the person intends to prevent or hinder authorised GMO dealings that are being undertaken at the premises or facility; and
(e) the person knows, or is reckless as to, the matters mentioned in paragraphs (b) and (c).
authorised GMO dealings, in relation to premises or a facility, means dealings with GMOs being undertaken at the premises or facility:
(a) that are authorised to be undertaken at the premises or facility by a GMO licence; or
(aa) that are specified in an emergency dealing determination and are not prohibited from being undertaken at the premises or facility by a condition of the determination; or
(b) that are notifiable low risk dealings; or
(c) that are exempt dealings; or
(d) that are dealings included on the GMO Register.
193 Regulations
(1) The Governor‑General may make regulations prescribing matters:
(a) required or permitted by this Act to be prescribed; or
(b) necessary or convenient to be prescribed for carrying out or giving effect to this Act.
(2) Without limiting subsection (1), the regulations may require a person to comply with codes of practice or guidelines issued under this Act as in force at a particular time or from time to time.
194 Review of operation of Act
(1) The Ministerial Council must cause an independent review of the operation of this Act, including the structure of the Office of the Gene Technology Regulator, to be undertaken as soon as possible after the fourth anniversary of the commencement of this Act.
(2) A person who undertakes such a review must give the Ministerial Council a written report of the review.
(3) The Minister, on behalf of the Ministerial Council, must cause a copy of the report of the review to be tabled in each House of the Parliament within 12 months after the fourth anniversary of the commencement of this Act.
independent review means a review undertaken by persons who:
(a) in the opinion of a majority of the Ministerial Council possess appropriate qualifications to undertake the review; and
(b) include one or more persons who are not employed by the Commonwealth or a Commonwealth authority.
Notes to the Gene Technology Act 2000
The Gene Technology Act 2000 as shown in this compilation comprises Act No. 169, 2000 amended as indicated in the Tables below.
For all relevant information pertaining to application, saving or transitional provisions see Table A.
Table of Acts
and year
of Assent
Date of commencement
Application, saving or transitional provisions
Ss. 1 and 2: Royal Assent
Ss. 10, 26,
27(b)–(l), 28–30, 120, 121, 129, 130 and 132–135: 20 Apr 2001 (see Gazette 2001, No. S140)
Remainder: 22 June 2001
Australia New Zealand Food Authority Amendment Act 2001
Schedule 3 (item 2): 1 July 2002 (see Gazette 2002, No. GN30) (a)
Prohibition of Human Cloning Act 2002
Ss. 3–26 and Schedule 1: 16 Jan 2003
Remainder: Royal Assent
Financial Framework Legislation Amendment Act (No. 1) 2006
Schedule 1 (items 25–28): 7 Apr 2006
Gene Technology Amendment Act 2007
Schedule 1 (items 1–23, 36–61) and Schedule 2: 1 July 2007
Schedule 1 (items 24–35): 1 Jan 2008
Sch. 1 (item 35)
Superannuation Legislation Amendment (Trustee Board and Other Measures) (Consequential Amendments) Act 2008
Schedule 1 (items 73–76): Royal Assent
Crimes Legislation Amendment (Serious and Organised Crime) Act (No. 2) 2010
Schedule 11 (item 11): 20 Feb 2010
Acts Interpretation Amendment Act 2011
Schedule 2 (items 650–652) and Schedule 3 (items 10, 11): [see Note 2 and Table A]
Sch. 3 (items 10, 11)
Superannuation Legislation (Consequential Amendments and Transitional Provisions) Act 2011
Schedule 1 (items 90–93): (b)
(a) The Gene Technology Act 2000 was amended by Schedule 3 (item 2) only of the Australia New Zealand Food Authority Amendment Act 2001, subsections 2(2) and (5) of which provide as follows:
(2) Part 1 of Schedule 1 (other than item 120A), and Schedule 3, commence on the first day after the commencement of this section on which an amendment of the Australia New Zealand Joint Food Standards Agreement comes into force in accordance with Article 10 of that Agreement.
(5) As soon as practicable after the commencement of the following provisions:
(a) Part 1 of Schedule 1 (other than item 120A);
(b) Schedule 3;
the Minister must cause to be published in the Gazette a notice specifying the day on which those provisions commenced.
(b) Subsection 2(1) (item 2) of the Superannuation Legislation (Consequential Amendments and Transitional Provisions) Act 2011 provides as follows:
2. Schedules 1 and 2
Immediately after the commencement of section 2 of the Governance of Australian Government Superannuation Schemes Act 2011.
Table of Amendments
ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected
How affected
S. 10....................................
am. No. 99, 2007; No. 58, 2011
Subdivision A
am. No. 99, 2007
Subdivision B
Ss. 32–34............................
Ss. 35A, 35B.......................
ad. No. 99, 2007
S. 40A.................................
Ss. 42, 43............................
rs. No. 99, 2007
Note to s. 56.......................
Part 5A
Part 5A................................
Ss. 72B, 72C.......................
S. 72D.................................
S. 72E.................................
Note to s. 83(2)..................
rep. No. 99, 2007
Notes 1, 2 to s. 91(1).........
Heading to Part 8..............
S. 100..................................
Div. 3 of Part 8...................
Ss. 106–110........................
S. 110A...............................
Ss. 111, 112........................
Note to s. 130(1)................
Heading to s. 177..............
am. No. 4, 2010
Ss. 192B–192D...................
rep. No. 144, 2002
Acts Interpretation Amendment Act 2011 (No. 46, 2011)
The following amendments commence on 27 December 2011 unless proclaimed earlier:
650 Subsection 121(1)
Omit "(1)".
651 At the end of subsection 121(1)
Note: For rules that apply to acting appointments, see section 33A of the Acts Interpretation Act 1901.
As at 15 July 2011 the amendments are not incorporated in this compilation.
Gene Technology Amendment Act 2007 (No. 99, 2007)
35 Transitional provision
(1) This item applies if functions are conferred by a corresponding State law upon the Ethics Committee or the Consultative Committee.
(2) Despite the repeals and amendments made by this Part:
(a) the Ethics Committee and the Consultative Committee that were in existence immediately before the commencement of this item:
(i) continue in existence after the commencement of this item; and
(ii) the members of the Ethics and Community Committee are taken to constitute the Ethics Committee and the Consultative Committee, respectively; and
(b) if, after the commencement of this item, the Ethics and Community Committee performs a function corresponding to a function conferred on the Ethics Committee or the Consultative Committee by a corresponding State law, the Ethics Committee or the Consultative Committee, as continued in existence by this item, is taken to have performed the function.
(3) Despite the repeals and amendments made by this Part, the authority:
(a) given by section 17 of the Gene Technology Act 2000 (as in force immediately before the commencement of this item); and
(b) that permits a corresponding State law to confer functions, powers and duties on the Ethics Committee or the Consultative Committee;
continues in effect as if those repeals and amendments had not happened.
(4) In this item:
Consultative Committee has the meaning given by the Gene Technology Act 2000, as in force immediately before the commencement of this item.
Ethics Committee has the meaning given by the Gene Technology Act 2000, as in force immediately before the commencement of this item.
The following provisions commence on 27 December 2011 unless proclaimed earlier:
10 Saving—appointments
The amendments made by Schedule 2 do not affect the validity of an appointment that was made under an Act before the commencement of this item and that was in force immediately before that commencement.
11 Transitional regulations
The Governor‑General may make regulations prescribing matters of a transitional nature (including prescribing any saving or application provisions) relating to the amendments and repeals made by Schedules 1 and 2.