Gene Technology Act 2001 (Vic)

Version No. 023

Gene Technology Act 2001

No. 67 of 2001

Version incorporating amendments as at

22 October 2025

TABLE OF PROVISIONS

Section  Page

Part 1—Preliminary

1Purpose and citation

2Commencement

3Object of Act

4Regulatory framework to achieve object

5Nationally consistent scheme

6Act to bind the Crown

7External Territories

8Offences

8ANumbering

8COutlines

Part 2—Interpretation and operation of Act

Division 1—Simplified outline

9Simplified outline

Division 2—Definitions

10Definitions

11Meaning of intentional release of a GMO into the environment

12Meaning of corresponding State law

Division 3—Operation of Act

13Operation of Act

14Wind-back of reach of Act

15Relationship to other State laws

Division 4—Provisions to facilitate a nationally consistent scheme

Subdivision A—General provisions

16State laws may operate concurrently

17Conferral of functions on Commonwealth officers and bodies

18No doubling-up of liabilities

19Review of certain decisions

20Things done for multiple purposes

Subdivision B—Policy principles, policy guidelines and codes of practice

21Ministerial Council may issue policy principles

22Consultation on policy principles

23Ministerial Council may issue policy guidelines

24Ministerial Council may issue codes of practice

Part 3—The Gene Technology Regulator

25Simplified outline

26The Gene Technology Regulator

27Functions of the Regulator

28Powers of the Regulator

29Delegation

30Independence of the Regulator

Part 4—Regulation of dealings with GMOs

Division 1—Simplified outline

31Simplified outline

Division 2—Dealings with GMOs must be licensed

32Person not to deal with a GMO without a licence

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

34Person must not breach conditions of a GMO licence

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

35APerson must not breach conditions of emergency dealing determination

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

36Person must not breach conditions on GMO Register

37Offence relating to notifiable low risk dealings

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

Part 5—Licensing system

Division 1—Simplified outline

39Simplified outline

Division 2—Licence applications

40Person may apply for a licence

40ALicences relating to inadvertent dealings

41Application may be withdrawn

42Regulator may require applicant to give further information

43Regulator must consider applications except in certain circumstances

44Regulator may consult with applicant

45Regulator must not use certain information in considering licence application

Division 3—Initial consideration of licences for dealings not involving intentional release of a GMO into the environment

46Applications to which this Division applies

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

47What the Regulator must do in relation to application

Division 4—Initial consideration of licences for dealings involving intentional release of a GMO into the environment

48Applications to which this Division applies

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

50Regulator must prepare risk assessment and risk management plan

50ALimited and controlled release applications

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

52Public notification of risk assessment and risk management plan

53Regulator may take other actions

54Person may request copies of certain documents

Division 5—Decision on licence etc.

55Regulator must make a decision on licence and licence conditions

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

57Other circumstances in which Regulator must not issue the licence

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

59Notification of licence decision

60Period of licence

Division 6—Conditions of licences

61Licence is subject to conditions

62Conditions that may be prescribed or imposed

63Condition about informing people of obligations

64Condition about monitoring and audits

65Condition about additional information to be given to the Regulator

66Person may give information to Regulator

67Protection of persons who give information

Division 7—Suspension, cancellation and variation of licences

68Suspension and cancellation of licence

69Surrender of licence

70Transfer of licences

71Variation of licence

72Regulator to notify of proposed suspension, cancellation or variation

Division 8—Annual charge

72AAGMO licence—annual charge

Part 5A—Emergency dealing determinations

Division 1—Simplified outline

72ASimplified outline

Division 2—Making of emergency dealing determination

72BMinister may make emergency dealing determination

72CPeriod of effect of emergency dealing determination

Division 3—Effect and conditions of emergency dealing determination

72DEmergency dealing determination authorises dealings, subject to conditions

Division 4—Variation, suspension and revocation of emergency dealing determination

72EVariation, suspension and revocation of emergency dealing determination

Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register

Division 1—Simplified outline

73Simplified outline

Division 2—Notifiable low risk dealings

74Notifiable low risk dealings

75Regulation of notifiable low risk dealings

Division 3—The GMO Register

76GMO Register

77Contents of Register

78Regulator may include dealings with GMOs on GMO Register

79Regulator not to make determination unless risks can be managed

80Variation of GMO Register

81Inspection of Register

Part 7—Certification and accreditation

Division 1—Simplified outline

82Simplified outline

Division 2—Certification

83Application for certification

84When the Regulator may certify the facility

85Regulator may require applicant to give further information

86Conditions of certification

87Variation of certification

88Suspension or cancellation of certification

89Regulator to notify of proposed suspension, cancellation or variation

89ATransfer of certification

90Guidelines

Division 3—Accredited organisations

91Application for accreditation

92Regulator may accredit organisations

93Regulator may require applicant to give further information

94Conditions of accreditation

95Variation of accreditation

96Suspension or cancellation of accreditation

97Regulator to notify of proposed suspension, cancellation or variation

98Guidelines

Part 8—The Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee

Division 1—Simplified outline

99Simplified outline

Division 2—The Gene Technology Technical Advisory Committee

100The Gene Technology Technical Advisory Committee

101Function of the Gene Technology Technical Advisory Committee

102Expert advisers

103Remuneration

104Members and procedures

105Subcommittees

Division 3—The Gene Technology Ethics and Community Consultative Committee

106The Gene Technology Ethics and Community Consultative Committee

107Function of Ethics and Community Committee

108Membership

109Remuneration

110Regulations

111Subcommittees

112Expert advisers

Part 9—Administration

Division 1—Simplified outline

117Simplified outline

Division 2—Appointment and conditions of Regulator

118Appointment of the Regulator

119Termination of appointment

120Disclosure of interests

121Acting appointment

122Terms and conditions

123Outside employment

124Remuneration

125Leave of absence

126Resignation

Division 3—Money

127Regulator may charge for services

128Notional payments by the State

129Gene Technology Account

130Credits to Gene Technology Account

131Recovery of amounts

132Purposes of Account

Division 4—Staffing

133Staff assisting the Regulator

134Consultants

135Seconded officers

Division 5—Reporting requirements

136Annual report

137Reports to Parliament

Division 6—Record of GMO Dealings

138Record of GMO Dealings

139Inspection of Record

Division 7—Reviews of notifiable low risk dealings and exemptions

140Regulator may review notifiable low risk dealings

141Regulator may review exemptions

142Regulator may give notice of consideration

143What Regulator may do after consideration

144Regulator not required to review matters

Part 10—Enforcement

145Simplified outline

146Regulator may give directions

147Injunctions

148Forfeiture

Part 11—Powers of inspection

Division 1—Simplified outline

149Simplified outline

Division 2—Appointment of inspectors and identity cards

150Appointment of inspectors

151Identity card

Division 3—Monitoring powers

152Powers available to inspectors for monitoring compliance

153Monitoring powers

Division 4—Offence-related powers

154Searches and seizures related to offences

155Offence-related powers of inspectors in relation to premises

156Use of equipment at premises

Division 5—Expert assistance

157Expert assistance to operate a thing

Division 6—Emergency powers

158Powers available to inspectors for dealing with dangerous situations

Division 7—Obligations and incidental powers of inspectors

159Inspector must produce identity card on request

160Consent

161Details of warrant to be given to occupier etc.

162Announcement before entry

163Compensation for damage

Division 8—Power to search goods, baggage etc.

164Power to search goods, baggage etc.

165Seizure of goods

Division 9—General provisions relating to search and seizure

166Copies of seized things to be provided

167Occupier entitled to be present during search

168Receipts for things seized

169Retention of seized things

170Magistrates' Court may permit a thing to be retained

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

Division 10—Warrants

172Monitoring warrants

173Offence-related warrants

174Offence-related warrants by telephone, telex, fax etc.

175Offences relating to warrants

Division 11—Other matters

176Part not to abrogate privilege against self-incrimination

177Part does not limit power to impose conditions

Part 12—Miscellaneous

Division 1—Simplified outline

178Simplified outline

Division 2—Review of decisions

179Meaning of terms

180Notification of decisions and review rights

181Internal review

182Deadlines for making reviewable decisions

183Review of decisions by Administrative Review Tribunal

183AExtended standing for judicial review

Division 3—Confidential commercial information

184Application for protection of confidential commercial information

185Regulator may declare that information is confidential commercial information

186Revocation of declaration

187Confidential commercial information must not be disclosed

Division 4—Conduct by directors, employees and agents

188Conduct by directors, employees and agents

189Meaning of terms

Division 5—Transitional provisions

190Transitional provision—dealings covered by Genetic Manipulation Advisory Committee advice to proceed

190ATransitional provision—Gene Technology Amendment Act 2016

191Regulations may relate to transitional matters

Division 6—Other

192False or misleading information or document

192AInterference with dealings with GMOs

192EAttempts to commit offences against Act

193Regulations

194Review of operation of Act

═══════════════

Endnotes

1     General information

2     Table of Amendments

3     Explanatory details

Version No. 023

Gene Technology Act 2001

No. 67 of 2001

Version incorporating amendments as at

22 October 2025

The Parliament of Victoria enacts as follows:

PART 1—PRELIMINARY

1Purpose and citation

(1)The purpose of this Act is to regulate activities involving gene technology.

(2)Without limiting section 10(1) of the Interpretation of Legislation Act 1984, this Act may be referred to as the Gene Technology Law of Victoria or simply as the Gene Technology Law.

Note

This section differs from section 1 of the Commonwealth Act.

2Commencement

(1)Subject to subsection (2), this Act comes into operation on a day or days to be proclaimed.

(2)If a provision of this Act does not come into operation before 1 December 2001, it comes into operation on that day.

Note

This section differs from section 2 of the Commonwealth Act.

3Object of Act

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

4Regulatory framework to achieve object

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 GMO products.

Note

Examples of the schemes mentioned in paragraph (b) are those that regulate food, agricultural and veterinary chemicals, industrial chemicals and therapeutic goods.

5Nationally consistent scheme

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.

6Act to bind the Crown

(1)This Act binds the Crown in right of Victoria and, so far as the legislative power of the Parliament permits, the Crown in all its other capacities.

(2)Nothing in this Act renders the Crown liable to be prosecuted for an offence.

7External Territories

Note

The Commonwealth Act includes a provision extending that Act to every external Territory other than Norfolk Island.

8Offences[1]

Note

The Commonwealth Act includes a provision applying Chapter 2 of the Criminal Code to offences against that Act and construing penalty provisions in that Act.

8ANumbering[2]

(1)In order to maintain consistent numbering between this Act and the Gene Technology Act 2000 of the Commonwealth—

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

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

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

Notes

1     A note appears under each heading of a kind referred to in subsection (1)(a) describing the omitted section of the Commonwealth Act.

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

3     This section does not appear in the Commonwealth Act.

*                *                *                *                *

8COutlines[3]

The provisions appearing at the beginning of Parts 2 to 12 outlining the Part (simplified outlines) are intended only as a guide to readers as to the general scheme and effect of that Part.

Note

This section does not appear in the Commonwealth Act.

PART 2—INTERPRETATION AND OPERATION OF ACT

Division 1—Simplified outline

9Simplified outline

In outline, this Part—

·   contains the definitions used in this Act;

·   contains provisions to facilitate a nationally consistent regulatory scheme;

·   enables the Ministerial Council to issue policy principles, policy guidelines and codes of practice.

Note

This section differs from section 9 of the Commonwealth Act.

Division 2—Definitions

10Definitions

(1)In this Act—

accredited organisation means an organisation accredited under Division 3 of Part 7;

*                *                *                *                *

Administrative Review Tribunal means the Administrative Review Tribunal established by the Administrative Review Tribunal Act 2024 of the Commonwealth;

aggravated offence has the meaning given by section 38;

Commonwealth Act means the Gene Technology Act 2000 of the Commonwealth;

Commonwealth authority means the following—

(a)a body corporate established for a public purpose by or under a Commonwealth 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;

Commonwealth Environment Minister means the Minister of State for the Commonwealth responsible for environment and conservation;

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 Commonwealth emergency dealing determination, in relation to an emergency dealing determination under this Act, means a determination under section 72B of the Commonwealth Act that specifies the same kind of dealings as those proposed to be specified in, or specified in, the emergency dealing determination under this Act;

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;

*                *                *                *                *

Ethics and Community Committee means the Gene Technology Ethics and Community Consultative Committee established by section 106 of the Commonwealth Act;

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 Account means the GeneTechnology Account established by section 129 of the Commonwealth Act;

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 of the Commonwealth Act;

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 of the Commonwealth Act;

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

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)a State; or

(b)the Commonwealth;

licence holder means the holder of a GMO licence;

local council means a Council within the meaning of the Local Government Act 2020;

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 of the Crown in right of the Commonwealth;

(b)a person who holds—

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

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

(iii)an appointment made by the Governor-General or a Minister of the Crown in right of the Commonwealth but not under a Commonwealth Act;

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

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

organism means any biological entity that is—

(a)viable; or

(b)capable of reproduction; or

(c)capable of transferring genetic material;

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

premises includes the following—

(a)a building;

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

(c)a vehicle;

(d)a vessel;

(e)an aircraft;

(f)a facility;

(g)any part of premises (including premises referred to in paragraphs (a) to (f));

Record means the Record of GMO Dealings mentioned in section 138 of the Commonwealth Act;

Regulator means the Gene Technology Regulator appointed under section 118 of the Commonwealth Act;

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 Victoria;

(b)a Minister of the Crown in right of Victoria;

(c)a public service body within the meaning of the Public Administration Act 2004;

(d)an instrumentality of the State of Victoria, including a body corporate established for a public purpose by or under a law of the State of Victoria;

(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 Victoria;

(ii)a person or body covered by paragraph (b) or (d);

(iii)a 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.

Note

This section differs from section 10 of the Commonwealth Act.

11Meaning 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.

12Meaning of corresponding State law

Note

The Commonwealth Act includes a provision defining corresponding State law for the purposes of that Act.

Division 3—Operation of Act

13Operation of Act

Note

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

14Wind-back of reach of Act

Note

The Commonwealth Act includes a provision about the giving of wind-back notices by a State.

15Relationship to other State laws

The provisions of this Act are in addition to, and not in substitution for, the requirements of any other law of the State of Victoria (whether passed or made before or after the commencement of this section).

Note

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

Division 4—Provisions to facilitate a nationally consistent scheme

Subdivision A—General provisions

16State laws may operate concurrently

Note

The Commonwealth Act includes a provision allowing State laws (apart from State laws prescribed for the purposes of the provision) to operate concurrently with that Act.

17Conferral of functions on Commonwealth officers and bodies

Note

The Commonwealth Act includes a provision allowing corresponding State laws to confer functions, powers and duties on certain Commonwealth officers and bodies.

18No doubling-up of liabilities

(1)If—

(a)an act or omission is an offence against this Act and is also an offence against the Commonwealth Act; and

(b)the offender has been punished for the offence under the Commonwealth Act—

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 the Commonwealth Act, the person is not liable to a pecuniary penalty under this Act in respect of the same conduct.

19Review of certain decisions

(1)Application may be made to the Administrative Review Tribunal for review of a reviewable decision.

(2)A decision made by the Regulator in the performance of a function or the exercise of a power conferred by this Act is a reviewable decision for the purposes of this section if—

(a)this Act provides for review by the Administrative Review Tribunal; and

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

(3)The Administrative Review Tribunal Act 2024 of the Commonwealth (excluding Part 7) and the regulations in force for the time being under that Act apply as laws of Victoria in relation to reviewable decisions.

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

Note

This section differs from section 19 of the Commonwealth Act.

20Things 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 the Commonwealth Act.

Subdivision B—Policy principles, policy guidelines and codes of practice

21Ministerial 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 a law of Victoria 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.

Notes

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

2 Section 27 of the Interpretation of Legislation Act 1984 confers power to revoke or amend an instrument of a legislative character made 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 of the Commonwealth Act.

(3)Regulations for the purposes of subsection (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.

Note

This section differs from section 21 of the Commonwealth Act.

22Consultation on policy principles

Note

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

23Ministerial Council may issue policy guidelines

The Ministerial Council may issue policy guidelines in relation to matters relevant to the functions of the Regulator under this Act or the regulations.

Notes

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.

2 Section 27 of the Interpretation of Legislation Act 1984 confers power to revoke or amend an instrument of a legislative character made under an Act.

24Ministerial Council may issue codes of practice

The Ministerial Council may issue codes of practice, developed in accordance with section 24(2) of the Commonwealth Act, in relation to gene technology.

Notes

1 Section 27 of the Interpretation of Legislation Act 1984 confers power to revoke or amend an instrument of a legislative character made under an Act.

2 Section 24 of the Commonwealth Act includes provisions about how codes of practice are to be developed and making them disallowable instruments.

PART 3—THE GENE TECHNOLOGY REGULATOR

25Simplified outline

In outline, this Part specifies the functions and powers of the Gene Technology Regulator under this Act or the regulations.

Note

This section differs from section 25 of the Commonwealth Act.

26The Gene Technology Regulator

Note

Section 26 of the Commonwealth Act creates the office of Gene Technology Regulator.

27Functions 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 places outside Victoria;

(l)such other functions as are conferred on the Regulator by this Act, the regulations or any other law.

28Powers 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 under this Act or the regulations.

29Delegation

(1)The Regulator may, by instrument in writing, delegate any of the Regulator's powers or functions under this Act or the regulations to any of the following—

(a)an employee within the meaning of the Public Administration Act 2004;

(b)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;

(c)an employee of a Commonwealth authority, if the functions of the Commonwealth authority 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.

Note

This section differs from section 29 of the Commonwealth Act.

30Independence of the Regulator

Subject to this Act and to other laws of the State of Victoria, the Regulator has discretion in the performance or exercise of his or her functions or powers under this Act or the regulations. In particular, the Regulator is not subject to direction from anyone in relation to—

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

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

PART 4—REGULATION OF DEALINGS WITH GMOS

Division 1—Simplified outline

31Simplified outline

In outline, this Part—

·   deals with the regulation of dealings with GMOs;

·   prohibits dealings with GMOs unless—

–the person undertaking the dealing is authorised to do so by a GMO licence; or

–the dealing is specified in an emergency dealing determination; or

–the dealing is a notifiable low risk dealing (see Division 2 of Part 6); or

–the dealing is an exempt dealing; or

–the dealing is included in the GMO Register (see Division 3 of Part 6);

· 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

32Person 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 by whichever of the following applies—

(a)in the case of an aggravated offence—imprisonment for a term not exceeding 5 years or a fine not exceeding $220 000; or

(b)in any other case—imprisonment for a term not exceeding 2 years or a fine not exceeding $55 000.

Note

Section 38 defines aggravated offence.

(3)In this section—

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.

Note

This section differs from section 32 of the Commonwealth Act.

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

(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

(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 subsection (1)(b), (ba), (c), (d) and (e).

(3)An offence under this section is punishable by a fine of not more than whichever of the following amounts applies—

(a)in the case of an aggravated offence—$22 000; or

(b)in any other case—$5500.

Note

Section 38 defines aggravated offence.

(4)In this section—

exempt dealing has the same meaning as in section 32.

Note

This section differs from section 33 of the Commonwealth Act.

34Person 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 subsection (1) or (2) is punishable by whichever of the following applies—

(a)in the case of an aggravated offence—imprisonment for a term not exceeding 5 years or a fine not exceeding $220 000 plus an additional fine not exceeding $22 000 for every day during which the offence continues;

(b)in any other case—imprisonment for a term not exceeding 2 years or a fine not exceeding $55 000 plus an additional fine not exceeding $5500 for every day during which the offence continues.

Notes

1     Section 38 defines aggravated offence.

2 This section differs from section 34 of the Commonwealth Act.

35Person 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.

(2)A person covered by a GMO licence is guilty of an offence if—

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

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

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

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

(4)An offence under this section is punishable by a fine of not more than whichever of the following amounts applies—

(a)in the case of an aggravated offence—$22 000; or

(b)in any other case—$5500.

Note

Section 38 defines aggravated offence.

35APerson must not breach conditions of emergency dealing determination

(1)A person 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 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.

(2)An offence under this section is punishable on conviction by whichever of the following applies—

(a)in the case of an aggravated offence—imprisonment for a term not exceeding 5 years or a fine not exceeding $220 000;

(b)in any other case—imprisonment for a term not exceeding 2 years or a fine not exceeding $55 000.

Notes

1     Section 38 defines aggravated offence.

2 This section differs from section 35A of the Commonwealth Act.

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

(1)A person is guilty of an offence if—

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

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

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

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

(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—$22 000;

(b)in any other case—$5500.

Notes

1     Section 38 defines aggravated offence.

2 This section differs from section 35B of the Commonwealth Act.

36Person 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.

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

(3)An offence against subsection (1) is punishable by a fine of not more than $5500.

37Offence relating to notifiable low risk dealings

(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 is a notifiable low risk dealing; and

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

Note

Notifiable low risk dealings are specified in the regulations—see Part 6.

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

(3)An offence against subsection (1) is punishable by a fine of not more than $5500.

38Aggravated 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 their 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.

PART 5—LICENSING SYSTEM

Division 1—Simplified outline

39Simplified outline

In outline, this Part—

· provides a licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs;

· sets out the processes to be followed by the Regulator in relation to applications involving 2 kinds of dealings—

–those that involve the intentional release of a GMO into the environment; and

–those that do not involve the intentional release of a GMO into the environment;

· provides that a licence can cover dealings by persons other than the licence holder and requires the licence holder to inform such persons of any conditions of the licence that apply to them.

Division 2—Licence applications

40Person 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.

40ALicences relating to inadvertent dealings

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

(2)To 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.

41Application 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.

42Regulator 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.

43Regulator 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 section 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.

44Regulator 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.

45Regulator must not use certain information in considering licence application

If—

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

(b)the first person 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

46Applications 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.

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

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

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

(i)conducting experiments with the GMO;

(ii)propagating the GMO;

(iii)growing, raising or culturing the GMO;

(iv)transporting the GMO;

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

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

47What 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

48Applications to which this Division applies

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.

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

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

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

(i)conducting experiments with the GMO;

(ii)propagating the GMO;

(iii)growing, raising or culturing the GMO;

(iv)transporting the GMO;

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

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

50Regulator must prepare risk assessment and risk management plan

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

*                *                *                *                *

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

(a)the States; and

(b)the Gene Technology Technical Advisory Committee; and

(c)each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph; and

(d)the Commonwealth Environment Minister; and

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

50ALimited and controlled release applications

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

(a)the principal purpose of the application is to enable the licence holder, and 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 section 50(3).

(2)For the purposes of subsection (1)—

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

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

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

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

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

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

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

(3)For the purposes of subsection (1)—

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.

Note

This section differs from section 50A of the Commonwealth Act.

51Matters 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 section 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 section 50(3);

(e)any advice in relation to the risk assessment provided by a Commonwealth authority or agency in response to a request under section 50(3);

(f)any advice in relation to the risk assessment provided by the Commonwealth Environment Minister in response to a request under section 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 section 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 section 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 section 50(3);

(f)any advice in relation to the risk management plan provided by the Commonwealth Environment Minister in response to a request under section 50(3);

(g)any other matter prescribed by the regulations for the purposes of this paragraph.

(3)For the avoidance of doubt, in taking into account the means of managing risks as mentioned in subsection (2)(a), the Regulator—

(a)is not limited to considering submissions or advice mentioned in subsection (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.

52Public 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 Government Gazette; and

(b)in one or more newspapers that the Regulator considers appropriate, having regard to the geographic area in which the dealings proposed to be authorised by the licence may occur; and

(c)on the Regulator's website.

(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—

(a)the States; and

(b)the Gene Technology Technical Advisory Committee; and

(c)each Commonwealth authority or agency prescribed by the regulations for the purposes of this paragraph; and

(d)the Commonwealth Environment Minister; and

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

53Regulator 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).

Penalty:$3300.

54Person 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.

Notes

1     In order for information to be confidential commercial information, it must be covered by a declaration under section 185.

2     The Privacy and Data Protection Act 2014 and the Health Records Act 2001 also contain provisions relevant to the disclosure of information.

Division 5—Decision on licence etc.

55Regulator 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.

56Regulator 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—

(a)the health and safety of people; and

(b)the environment.

(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

Subsections (2)(a), (2)(b) and (2)(c) do not apply to an inadvertent dealings application.

57Other 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.

58Matters 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 Victoria, the Commonwealth, another 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 Victoria, the Commonwealth, another 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.

(3)In this section—

relevant conviction means a conviction for an offence against a law of Victoria, the Commonwealth, another 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 by a fine of $5000 or more, or by a term of imprisonment of one year or more.

Note

This section differs from section 58 of the Commonwealth Act.

59Notification 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).

60Period 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

61Licence 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.

62Conditions 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.

63Condition 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.

64Condition 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.

65Condition 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 the licence holder—

(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.

(2)For the purposes of subsection (1)—

(a)the licence holder is taken to have become aware of additional information of a kind mentioned in subsection (1) if the licence holder was reckless 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 the licence holder was reckless as to whether such contraventions had occurred, or such unintended effects existed.

66Person may give information to Regulator

A person covered by a licence may inform the Regulator if the person—

(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.

67Protection 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 72D(2)(h).

Division 7—Suspension, cancellation and variation of licences

68Suspension 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.

69Surrender of licence

A licence holder may, with the consent of the Regulator, surrender the licence.

70Transfer 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.

(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 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—

(a)the health and safety of people; and

(b)the environment.

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

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

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

(a)the transfer takes effect on the date 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.

71Variation 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—

(a)such information as is prescribed by the regulations (if any); and

(b)such information as is specified in writing by the Regulator.

(2)The Regulator must not vary a licence to authorise dealings involving the intentional release of a GMO into the environment if the application for the licence was originally considered under Division 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—

(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 section 50(3).

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.

(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 affidavit referred to in subsection (3), which must have been duly sworn or affirmed.

(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 affidavit 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.

175Offences 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.

Penalty:Imprisonment for 2 years or $13 200.

(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.

Penalty:Imprisonment for 2 years or $13 200.

Division 11—Other matters

176Part 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.

177Part 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.

PART 12—MISCELLANEOUS

Division 1—Simplified outline

178Simplified outline

In outline this Part provides for miscellaneous matters, including the following—

·   review of decisions;

· provisions relating to confidential commercial information;

·   the making of regulations;

·   transitional provisions;

·   review of the operation of the Act.

Division 2—Review of decisions

179Meaning 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
Item	Decision	Provision under which decision made	Eligible person in relation to decision
1A		To refuse to consider an application on the basis that the applicant is not a suitable person to hold a licence	section 43(2)(f)	the applicant
1		To refuse to issue a licence	section 55	the applicant for the licence
2	To impose a licence condition	section 55	the licence holder
3	To suspend or cancel a licence	section 68	the licence holder
3A		To refuse to transfer a licence	section 70	an applicant for the transfer
4	To vary a licence	section 71	the licence holder
4A	To refuse to vary a licence	section 71	the licence holder
5	To refuse to certify a facility	section 84	the applicant for certification
6	To specify a condition of a certification	section 86	the holder of the certification
7	To vary a certification	section 87	the holder of the certification
7A		To refuse to transfer a certification	section 89A	an applicant for the transfer
8	To suspend or cancel a certification	section 88	the holder of the certification
9	To refuse to accredit an organisation	section 92	the applicant for accreditation
10	To specify a condition of an accreditation	section 94	the holder of the accreditation

Reviewable decisions and eligible persons
Item		Decision		Provision under which decision made	Eligible person in relation to decision
11		To vary an accreditation		section 95	the holder of the accreditation
12		To suspend or cancel an accreditation		section 96	the holder of the accreditation
13		To refuse to declare information to be confidential commercial information	section 185	the person who made an application under section 184 in relation to the information
14		To revoke a declaration that information is confidential commercial information	section 186	the person who made an application under section 184 in relation to the information

180Notification 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.

181Internal 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.

(4)The Regulator may—

(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.

182Deadlines for making reviewable decisions

If—

(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.

183Review of decisions by Administrative Review Tribunal[8]

(1)Subject to the Administrative Review Tribunal Act 2024 of the Commonwealth, 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).

(2)In this section—

decision has the same meaning as in the Administrative Review Tribunal Act 2024 of the Commonwealth.

183AExtended standing for judicial review[9]

Note

Section 183A of the Commonwealth Act requires that a State be taken to be a person aggrieved for the purpose of the application of the Administrative Decisions (Judicial Review) Act 1977 of the Commonwealth in relation to certain decisions, failures or conduct under the Commonwealth Act or regulations.

Division 3—Confidential commercial information

184Application 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.

185Regulator 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 section 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.

186Revocation 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 section 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.

187Confidential 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 the regulations or under the Commonwealth Act or a corresponding State law within the meaning of the Commonwealth Act; 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 the regulations or under the Commonwealth Act or a corresponding State law within the meaning of the Commonwealth Act—

(i)a State agency;

(ii)the Commonwealth or a Commonwealth authority;

(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.

Penalty:Imprisonment for 2 years or $13 200.

(2)A person who—

(a)has confidential commercial information; and

(b)has it because of a disclosure under subsection (1) or under this subsection; 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 the regulations or under the Commonwealth Act or a corresponding State law within the meaning of the Commonwealth Act—

(i)a State agency;

(ii)the Commonwealth or a Commonwealth authority;

(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.

Penalty:Imprisonment for 2 years or $13 200.

(3)For the purposes of the Freedom of Information Act 1982, information to which subsection (1) or (2) applies is information of a kind to which section 38 of that Act applies.

(4)Section 50(4) of the Freedom of Information Act 1982 does not apply to a document containing information to which subsection (1) or (2) of this section applies.

(5)In this section—

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.

(6)This section has effect despite anything to the contrary in the Freedom of Information Act 1982.

Note

This section differs from section 187 of the Commonwealth Act.

Division 4—Conduct by directors, employees and agents

188Conduct 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—

(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 first person unless the first person establishes that he or she took reasonable precautions and exercised due diligence to avoid the conduct.

(5)If—

(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.

189Meaning of terms

(1)A reference in section 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 State of Victoria, the Commonwealth or another 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 created by Division 10 or 11 of Part I of the Crimes Act 1958 that relates to this Act or the regulations.

Note

A person who is involved in the commission of an offence referred to in section 188 is taken to have committed the offence. See Subdivision (1) of Division 1 of Part II of the Crimes Act 1958 which deals with complicity in the commission of offences.

Division 5—Transitional provisions

190Transitional 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.

(3)In this section—

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, not exceeding 2 years, prescribed for the purposes of this section.

Note

Section 190(3) of the Commonwealth Act defines the transition period as being 2 years from the commencement of Part 4 of that Act.

190ATransitional provision—Gene Technology Amendment Act 2016

(1)Sections 46A(a) and 49(a) as in force on or after the commencement of sections 6 and 7 of the Gene Technology Amendment Act 2016 apply to an inadvertent dealings application that is in existence but not decided immediately before that commencement.

(2)Section 71 as in force on or after the commencement of section 9 of the Gene Technology Amendment Act 2016 applies to an application to vary a licence under section 71 that is in existence but not decided immediately before that commencement.

(3)Despite the repeal of section 136A, section 136A(3) continues to have effect, in relation to a report given to the Minister under section 136A(1) as in force before its repeal, that has not been laid before each House of the Parliament immediately before the commencement of section 13 of the Gene Technology Amendment Act 2016.

191Regulations may relate to transitional matters

Regulations may be made in relation to transitional matters arising from the enactment of this Act.

Division 6—Other

192False or misleading information or document[10]

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.

Penalty:Imprisonment for 1 year or $6600.

192AInterference with dealings with GMOs[11]

(1)A person is guilty of an offence if—

(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).

Penalty:Imprisonment for 2 years or $13 200.

(2)In this section—

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.

Note

This section differs from section 192A of the Commonwealth Act.

*                *                *                *                *

192EAttempts to commit offences against Act[12]

(1)A person who attempts to commit an offence against this Act is guilty of the offence of attempting to commit that offence and is liable to the same penalty as is provided by this Act for committing the offence attempted.

(2)Sections 321N and 321Q of the Crimes Act 1958 apply to and in respect of an offence against subsection (1) to the same extent as they apply to and in respect of offences against section 321M of that Act.

Note

This section is not required in the Commonwealth Act.

193Regulations

(1)The Governor in Council 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.

194Review of operation of Act

(1)The Minister must cause an independent review of the operation of this Act 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 Minister a written report of the review.

(3)The Minister must cause a copy of the report of the review to be laid before each House of the Parliament within 12 months after the fourth anniversary of the commencement of this Act.

(4)In this section—

independent review means a review undertaken by persons who—

(a)in the opinion of the Minister possess appropriate qualifications to undertake the review; and

(b)include one or more persons who are not employed by the State of Victoria, a State agency, the Commonwealth or a Commonwealth authority.

Note

This section differs from section 194 of the Commonwealth Act.

*                *                *                *                *

═══════════════

ENDNOTES

1   General information

See for Victorian Bills, Acts and current Versions of legislation and up-to-date legislative information.

Minister's second reading speech—

Legislative Assembly: 23 August 2001

Legislative Council: 9 October 2001

The long title for the Bill for this Act was "A Bill to regulate activities involving gene technology, to amend the Agricultural and Veterinary Chemicals (Victoria) Act 1994 and the Therapeutic Goods (Victoria) Act 1994 and for other purposes."

The Gene Technology Act 2001 was assented to on 30 October 2001 and came into operation on 1 December 2001: section 2(2).

INTERPRETATION OF LEGISLATION ACT 1984 (ILA)

Style changes

Section 54A of the ILA authorises the making of the style changes set out in Schedule 1 to that Act.

References to ILA s. 39B

Sidenotes which cite ILA s. 39B refer to section 39B of the ILA which provides that where an undivided section or clause of a Schedule is amended by the insertion of one or more subsections or subclauses, the original section or clause becomes subsection or subclause (1) and is amended by the insertion of the expression "(1)" at the beginning of the original section or clause.

Interpretation

As from 1 January 2001, amendments to section 36 of the ILA have the following effects:

•     Headings

All headings included in an Act which is passed on or after 1 January 2001 form part of that Act.  Any heading inserted in an Act which was passed before 1 January 2001, by an Act passed on or after 1 January 2001, forms part of that Act.  This includes headings to Parts, Divisions or Subdivisions in a Schedule; sections; clauses; items; tables; columns; examples; diagrams; notes or forms.  See section 36(1A)(2A).

•     Examples, diagrams or notes

All examples, diagrams or notes included in an Act which is passed on or after 1 January 2001 form part of that Act.  Any examples, diagrams or notes inserted in an Act which was passed before 1 January 2001, by an Act passed on or after 1 January 2001, form part of that Act.  See section 36(3A).

•     Punctuation

All punctuation included in an Act which is passed on or after 1 January 2001 forms part of that Act.  Any punctuation inserted in an Act which was passed before 1 January 2001, by an Act passed on or after 1 January 2001, forms part of that Act.  See section 36(3B).

•     Provision numbers

All provision numbers included in an Act form part of that Act, whether inserted in the Act before, on or after 1 January 2001.  Provision numbers include section numbers, subsection numbers, paragraphs and subparagraphs.  See section 36(3C).

•     Location of "legislative items"

A "legislative item" is a penalty, an example or a note.  As from 13 October 2004, a legislative item relating to a provision of an Act is taken to be at the foot of that provision even if it is preceded or followed by another legislative item that relates to that provision.  For example, if a penalty at the foot of a provision is followed by a note, both of these legislative items will be regarded as being at the foot of that provision.  See section 36B.

•     Other material

Any explanatory memorandum, table of provisions, endnotes, index and other material printed after the Endnotes does not form part of an Act. 
See section 36(3)(3D)(3E).

2   Table of Amendments

This publication incorporates amendments made to the Gene Technology Act 2001 by Acts and subordinate instruments.

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Health Legislation (Research Involving Human Embryos and Prohibition of Human Cloning) Act 2003, No. 11/2003

Assent Date:	6.5.03
Commencement Date:	S. 24 on 16.10.03: Government Gazette 16.10.03 p. 2624
CurrentState:	This information relates only to the provision/s amending the Gene Technology Act 2001

Public Administration Act 2004, No. 108/2004

Assent Date:	21.12.04
Commencement Date:	S. 117(1)(Sch. 3 item 90) on 5.4.05: Government Gazette 31.3.05 p. 602
CurrentState:	This information relates only to the provision/s amending the Gene Technology Act 2001

Statute Law Revision Act 2007, No. 28/2007

Assent Date:	26.6.07
Commencement Date:	S. 3(Sch. item 28) on 27.6.07: s. 2(1)
CurrentState:	This information relates only to the provision/s amending the Gene Technology Act 2001

Gene Technology Amendment Act 2007, No. 43/2007

Assent Date:	25.9.07
Commencement Date:	Ss 4–24, 31–42 on 1.11.07: Government Gazette 25.10.07 p. 2458; s. 43 immediately after s. 31 on 1.11.07: s. 2(2); ss 25–30 on 1.1.08: s. 2(3)
CurrentState:	All of Act in operation

Privacy and Data Protection Act 2014, No. 60/2014

Assent Date:	2.9.14
Commencement Date:	S. 140(Sch. 3 item 21) on 17.9.14: Special Gazette (No. 317) 16.9.14 p. 1
CurrentState:	This information relates only to the provision/s amending the Gene Technology Act 2001

Justice Legislation Amendment Act 2015, No. 20/2015

Assent Date:	16.6.15
Commencement Date:	S. 56(Sch. 1 item 8) on 17.6.15: s. 2(3)
CurrentState:	This information relates only to the provision/s amending the Gene Technology Act 2001

Gene Technology Amendment Act 2016, No. 43/2016

Assent Date:	23.8.16
Commencement Date:	Ss 4–17 on 1.11.16: Special Gazette (No. 319) 18.10.16 p. 1
CurrentState:	This information relates only to the provision/s amending the Gene Technology Act 2001

Oaths and Affirmations Act 2018, No. 6/2018

Assent Date:	27.2.18
Commencement Date:	S. 68(Sch. 2 item 62) on 1.3.19: s. 2(2)
Current State:	This information relates only to the provision/s amending the Gene Technology Act 2001

Local Government Act 2020, No. 9/2020

Assent Date:	24.3.20
Commencement Date:	S. 390(Sch. 1 item 48) on 6.4.20: Special Gazette (No. 150) 24.3.20 p. 1
CurrentState:	This information relates only to the provision/s amending the Gene Technology Act 2001

Statute Law Revision Act 2025, No. 41/2025

Assent Date:	21.10.25
Commencement Date:	S. 3(Sch. 1 item 20) on 22.10.25: s. 2
CurrentState:	This information relates only to the provision/s amending the Gene Technology Act 2001

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3   Explanatory details

[1] S. 8: The next section is section 8A.

[2] S. 8A: The next section is section 8C.

[3] S. 8C: The next section is section 9.

[4] S. 72: The next section is section 72AA.

[5] S. 72AA: The next section is section 72A.

[6] S. 110: The next section is section 111.

[7] S. 136: The next section is section 137.

[8] S. 183: The next section is section 183A.

[9] S. 183A: The next section is section 184.

[10] S. 192: The next section is section 192A.

[11] S. 192A: The next section is section 192E.

[12] S. 192E: The next section is section 193.