Act No. 169 of 2000 as amended

187........ Confidential commercial information must not be disclosed........... 133

185........ Regulator may declare that information is confidential commercial information 131

177........ Part does not limit power to impose conditions............................... 125

176........ Part not to abrogate privilege against self‑incrimination.................. 125

171........ Disposal of goods if there is no owner or owner cannot be located 119

170........ Magistrate may permit a thing to be retained................................... 119

167........ Occupier entitled to be present during search.................................. 117

166........ Copies of seized things to be provided............................................ 117

161........ Details of warrant to be given to occupier etc.................................. 114

158........ Powers available to inspectors for dealing with dangerous situations 113

156........ Use of equipment at premises......................................................... 111

155........ Offence‑related powers of inspectors in relation to premises.......... 110

152........ Powers available to inspectors for monitoring compliance.............. 108

143........ What Regulator may do after consideration....................................... 99

Part 8—The Gene Technology Technical Advisory Committee and the Gene Technology Ethics and Community Consultative Committee 76

97.......... Regulator to notify of proposed suspension, cancellation or variation 74

93.......... Regulator may require applicant to give further information............. 73

89.......... Regulator to notify of proposed suspension, cancellation or variation 69

85.......... Regulator may require applicant to give further information............. 68

84.......... When the Regulator may certify the facility....................................... 68

79.......... Regulator not to make determination unless risks can be managed... 65

78.......... Regulator may include dealings with GMOs on GMO Register....... 64

Part 6—Regulation of notifiable low risk dealings and dealings on the GMO Register 61

72.......... Regulator to notify of proposed suspension, cancellation or variation 51

65.......... Condition about additional information to be given to the Regulator. 46

62.......... Conditions that may be prescribed or imposed.................................. 44

58.......... Matters to be taken into account in deciding whether a person is suitable to hold a licence 41

57.......... Other circumstances in which Regulator must not issue the licence.. 41

56.......... Regulator must not issue the licence unless satisfied as to risk management 40

55.......... Regulator must make a decision on licence and licence conditions.... 40

54.......... Person may request copies of certain documents.............................. 39

53.......... Regulator may take other actions....................................................... 38

51.......... Matters Regulator must take into account in preparing risk assessment and risk management plan 36

49.......... Division does not apply to an application relating to inadvertent dealings 34

48.......... Applications to which this Division applies...................................... 34

Division 4—Initial consideration of licences for dealings involving intentional release of a GMO into the environment 34

47.......... What the Regulator must do in relation to application....................... 32

46A....... Division does not apply to an application relating to inadvertent dealings 32

46.......... Applications to which this Division applies...................................... 32

Division 3—Initial consideration of licences for dealings not involving intentional release of a GMO into the environment 32

45.......... Regulator must not use certain information in considering licence application 31

43.......... Regulator must consider applications except in certain circumstances 30

42.......... Regulator may require applicant to give further information............. 30

38.......... Aggravated offences—significant damage to health or safety of people or to the environment 27

36.......... Person must not breach conditions on GMO Register...................... 26

35B....... Person must not breach conditions of emergency dealing determination—strict liability offence 25

35A....... Person must not breach conditions of emergency dealing determination 25

35.......... Person must not breach conditions of a GMO licence—strict liability offence 24

34.......... Person must not breach conditions of a GMO licence...................... 23

33.......... Person not to deal with a GMO without a licence—strict liability offence 23

32.......... Person not to deal with a GMO without a licence............................. 22

Division 2—Dealings with GMOs must be licensed 22

17.......... Conferral of functions on Commonwealth officers and bodies......... 13

11.......... Meaning of intentional release of a GMO into the environment ......... 9

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

Part 1—Preliminary

1 Short title [see Note 1]

This Act may be cited as the Gene Technology Act 2000.

2 Commencement [see Note 1]

(1) Sections 1 and 2 of this Act commence on the day on which this Act receives the Royal Assent.

(2) Subject to subsection (3), the other provisions of this Act commence on a day or days to be fixed by Proclamation.

(3) If a provision of this Act does not commence under subsection (2) within 6 months after the day on which this Act receives the Royal Assent, it commences on the first day after the end of that period.

3 Object of Act

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

4 Regulatory 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 GM products.

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

5 Nationally 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.

6 Act to bind the Crown

(1) This Act binds the Crown in each of its capacities.

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

7 External Territories

This Act extends to every external Territory other than Norfolk Island.

8 Offences

(1) Chapter 2 of the Criminal Code applies to all offences against this Act.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

(2) If a maximum penalty is specified:

(a) at the foot of a section of this Act (other than a section that is divided into subsections); or

(b) at the foot of a subsection of this Act;

then:

(c) a person who contravenes the section or subsection is guilty of an offence punishable, on conviction, by a penalty not exceeding the specified penalty; or

(d) the offence referred to in the section or subsection is punishable, on conviction, by a penalty not exceeding the specified penalty.





Part 2—Interpretation and operation of Act

Division 1—Simplified outline

9 Simplified outline

The following is a simplified outline of this Part:

This Part contains the definitions used in this Act. This Part contains provisions to facilitate the conferral of functions and powers on the Regulator under State legislation, in order to facilitate a nationally consistent regulatory scheme. This Part contains provisions to enable the concurrent operation of certain State legislation in relation to GMOs, and gives the capacity for this Act to have a more limited operation when corresponding State legislation is in force. This Part also enables the Ministerial Council to issue policy principles, policy guidelines and codes of practice.





Division 2—Definitions

10 Definitions

(1) In this Act, unless the contrary intention appears:

Account means the Gene Technology Account established by section 129.

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

aggravated offence has the meaning given by section 38.

Australian Health Ethics Committee means the Australian Health Ethics Committee established under the National Health and Medical Research Council Act 1992.

Commonwealth authority means the following:

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

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

(i) the Commonwealth;

(ii) a body covered by paragraph (a);

(iii) a body covered by either of the above subparagraphs.

confidential commercial information means information declared by the Regulator to be confidential commercial information under section 185.

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

corresponding State law has the meaning given by section 12.

CSC (short for Commonwealth Superannuation Corporation) has the same meaning as in the Governance of Australian Government Superannuation Schemes Act 2011.

deal with, in relation to a GMO, means the following:

(a) conduct experiments with the GMO;

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

(c) breed the GMO;

(d) propagate the GMO;

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

(f) grow, raise or culture the GMO;

(g) import the GMO;

(h) transport the GMO;

(i) dispose of the GMO;

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

eligible person, in relation to a reviewable decision, has the meaning given by section 179.

emergency dealing determination means a determination in force under section 72B.

environment includes:

(a) ecosystems and their constituent parts; and

(b) natural and physical resources; and

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

Environment Minister means the Minister responsible for environment and conservation.

Ethics and Community Committee means the Gene Technology Ethics and Community Consultative Committee established by section 106.

evidential material means any of the following:

(a) a thing with respect to which an offence against this Act or the regulations has been committed or is suspected, on reasonable grounds, to have been committed;

(b) a thing that there are reasonable grounds for suspecting will afford evidence as to the commission of any such offence;

(c) a thing that there are reasonable grounds for suspecting is intended to be used for the purpose of committing any such offence.

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

(a) a building or part of a building;

(b) a laboratory;

(c) an aviary;

(d) a glasshouse;

(e) an insectary;

(f) an animal house;

(g) an aquarium or tank.

gene technology means any technique for the modification of genes or other genetic material, but does not include:

(a) sexual reproduction; or

(b) homologous recombination; or

(c) any other technique specified in the regulations for the purposes of this paragraph.

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

Gene Technology Technical Advisory Committee means the Gene Technology Technical Advisory Committee established by section 100.

genetically modified organism means:

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

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

(c) anything declared by the regulations to be a genetically modified organism, or that belongs to a class of things declared by the regulations to be genetically modified organisms;

but does not include:

(d) a human being, if the human being is covered by paragraph (a) only because the human being has undergone somatic cell gene therapy; or

(e) an organism declared by the regulations not to be a genetically modified organism, or that belongs to a class of organisms declared by the regulations not to be genetically modified organisms.

GMO means a genetically modified organism.

GMO licence means a licence issued under section 55.

GMO Register means the GMO Register established by section 76.

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

higher education institution means an institution within the meaning of section 4 of the Higher Education Funding Act 1988, but does not include the Australian National University.

inadvertent dealings application means an application for a GMO licence to which Division 3 or 4 of Part 5 does not apply because of the operation of section 46A or 49.

Institutional Biosafety Committee means a committee established as an Institutional Biosafety Committee in accordance with written guidelines issued by the Regulator under section 98.

jurisdiction means the following:

(a) the Commonwealth;

(b) a State.

licence holder means the holder of a GMO licence.

Ministerial Council means the Ministerial Council within the meaning of the Gene Technology Agreement.

notifiable low risk dealing has the meaning given by section 74.

officer, in relation to the Commonwealth, includes the following:

(a) a Minister;

(b) a person who holds:

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

(ii) an appointment made under an Act; or

(iii) an appointment made by the Governor‑General or a Minister but not under an Act;

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

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

organism means any biological entity that is:

(a) viable; or

(b) capable of reproduction; or

(c) capable of transferring genetic material.

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

premises includes the following:

(a) a building;

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

(c) a vehicle;

(d) a vessel;

(e) an aircraft;

(f) a facility;

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

Record means the Record of GMO and GM Product Dealings mentioned in section 138.

Regulator means the Gene Technology Regulator appointed under section 118.

reviewable decision has the meaning given by section 179.

State includes the Australian Capital Territory and the Northern Territory.

State agency means the following:

(a) the Crown in right of a State;

(b) a Minister of a State;

(c) a State Government Department;

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

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

(i) the Crown in right of a State;

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

(iii) a person or body covered by either of the above subparagraphs.

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

(2) If this Act requires or permits the Ministerial Council to do a thing, the Ministerial Council must do the thing in accordance with any requirements specified in the Gene Technology Agreement.

11 Meaning of intentional release of a GMO into the environment

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

12 Meaning of corresponding State law

(1) For the purposes of this Act, corresponding State law means a State law that is declared by the Minister, by notice in the Gazette, to correspond to this Act and the regulations, including such a law as amended from time to time.

(2) The Minister may revoke a Gazette notice under subsection (1) in relation to a State law only if:

(a) the Minister is requested by the State concerned to revoke the notice; or

(b) the State law has been amended otherwise than as agreed by a majority of the members of the Ministerial Council (being a majority that includes the Commonwealth) under the Gene Technology Agreement; or

(c) amendments of the State law have been agreed by a majority of the members of the Ministerial Council (being a majority that includes the Commonwealth) under the Gene Technology Agreement, and the State law has not been amended in accordance with that agreement within a reasonable period after the agreement.





Division 3—Operation of Act

13 Operation of Act

(1) This Act applies as follows:

(a) to things done, or omitted to be done, by constitutional corporations;

(b) to things done, or omitted to be done, in the course of constitutional trade or commerce;

(c) to things done, or omitted to be done, by a person that may cause the spread of diseases or pests;

(d) for purposes relating to the collection, compilation, analysis and dissemination of statistics;

(e) to the Commonwealth and Commonwealth authorities;

(f) to things authorised by the legislative power of the Commonwealth under paragraph 51(xxxix) of the Constitution, so far as it relates to the matters mentioned in paragraphs (a) to (e) of this subsection.

(2) In this section:

constitutional corporation means a trading, foreign or financial corporation within the meaning of paragraph 51(xx) of the Constitution.

constitutional trade or commerce means trade or commerce:

(a) between Australia and places outside Australia; or

(b) among the States; or

(c) by way of the supply of services to the Commonwealth or to a Commonwealth authority.

14 Wind‑back of reach of Act

(1) This section applies to a State (the notifying State) at a particular time if:

(a) a corresponding State law is in force in the notifying State at that time; and

(b) a wind‑back notice in relation to that State is in force at that time.

(2) This Act applies as a law of the Commonwealth in the notifying State with the following modifications:

(a) this Act applies as if paragraph 13(1)(c) (which deals with the spread of pests and diseases) had not been enacted;

(b) this Act does not apply to a dealing with a GMO undertaken:

(i) by a higher education institution or a State agency; or

(ii) by a person authorised to undertake the dealing by a licence held under the corresponding State law by a higher education institution or a State agency.

(3) In this section:

wind‑back notice, in relation to a State, means a notice given by the State to the Minister, under the Gene Technology Agreement, stating that this section is to apply to the State.

15 Relationship to other Commonwealth laws

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





Division 4—Provisions to facilitate a nationally consistent scheme

Subdivision A—General provisions

16 State laws may operate concurrently

(1) This Act is not intended to exclude the operation of any State law, to the extent that the State law is capable of operating concurrently with this Act, other than a State law prescribed by the regulations for the purposes of this section.

(2) The Governor‑General may prescribe a State law under subsection (1) only if:

(a) there is no corresponding State law in effect in relation to that State; and

(b) either:

(i) the State law relates specifically to dealings with GMOs; or

(ii) for the purposes of a decision under the State law as to whether or not a licence, authority or approval (however described) is granted under the State law, the State law distinguishes between dealings with GMOs and dealings with other things.

17 Conferral of functions on Commonwealth officers and bodies

(1) A corresponding State law may confer functions, powers and duties on the following:

(a) the Regulator or another officer of the Commonwealth;

(b) a Commonwealth authority;

(c) the Ethics and Community Committee;

(e) the Gene Technology Technical Advisory Committee.

(2) If a function, power or duty is conferred on a person or body under subsection (1), the person or body may perform the function or duty or exercise the power, as the case requires.

(3) If a corresponding State law is expressed to confer on the Regulator the power to determine that dealings be included on the GMO Register, the Regulator may include the dealings on the GMO Register in accordance with the corresponding State law.

(4) If a corresponding State law is expressed to confer on the Regulator the power to vary the GMO Register, the Regulator may vary the GMO Register in accordance with the corresponding State law.

(5) If a corresponding State law is expressed to confer on the Regulator the power to enter information on the Record of GMO and GM Product Dealings, the Regulator may enter the information on the Record in accordance with the corresponding State law.

(6) The Regulator may:

(a) make any notations in the GMO Register that the Regulator considers necessary to identify entries that relate to dealings included on the Register as mentioned in subsection (3) or (4); and

(b) make any notations in the Record of GMO and GM Product Dealings that the Regulator considers necessary to identify entries that relate to information entered on the Record as mentioned in subsection (5).

18 No doubling‑up of liabilities

(1) If:

(a) an act or omission is an offence against this Act and is also an offence against a corresponding State law; and

(b) the offender has been punished for the offence under the corresponding State law;

the offender is not liable to be punished for the offence under this Act.

(2) If a person has been ordered to pay a pecuniary penalty under a corresponding State law, the person is not liable to a pecuniary penalty under this Act in respect of the same conduct.

19 Review of certain decisions

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

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

(a) the law under which the decision was made provides for review by the Administrative Appeals Tribunal; and

(b) the decision is declared by the regulations to be a reviewable State decision for the purposes of this section.

(3) For the purposes of this section, the Administrative Appeals Tribunal Act 1975 has effect as if a corresponding State law were an enactment.

20 Things done for multiple purposes

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

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

21 Ministerial Council may issue policy principles

(1) The Ministerial Council may issue policy principles in relation to the following:

(a) ethical issues relating to dealings with GMOs;

(aa) recognising areas, if any, designated under State law for the purpose of preserving the identity of one or both of the following:

(i) GM crops;

(ii) non‑GM crops;

for marketing purposes;

(b) matters relating to dealings with GMOs prescribed by the regulations for the purposes of this paragraph.

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

Note 2: Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act.

(2) Before issuing a policy principle, the Ministerial Council must be satisfied that the policy principle was developed in accordance with section 22.

(3) Regulations for the purposes of paragraph (1)(b) may relate to matters other than the health and safety of people or the environment, but must not derogate from the health and safety of people or the environment.

(4) Policy principles are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901.

22 Consultation on policy principles

(1) Policy principles are to be developed in consultation with the following:

(a) the Gene Technology Technical Advisory Committee;

(b) the Regulator;

(c) the Ethics and Community Committee;

(e) such Commonwealth and State agencies and such regulatory agencies as the Ministerial Council considers appropriate;

(f) such industry groups as the Ministerial Council considers appropriate;

(g) such environmental, consumer and other groups as the Ministerial Council considers appropriate.

(2) Consultation under subsection (1) must be in accordance with guidelines (if any) issued by the Ministerial Council for the purposes of this section.

23 Ministerial Council may issue policy guidelines

The Ministerial Council may issue policy guidelines in relation to matters relevant to the functions of the Regulator.

Note 1: Section 56 requires the Regulator to have regard to policy guidelines when deciding an application for a GMO licence. Section 30 provides that the Regulator is not subject to direction in relation to individual decisions.

Note 2: Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act.

24 Ministerial Council may issue codes of practice

(1) The Ministerial Council may issue codes of practice in relation to gene technology.

Note: Subsection 33(3) of the Acts Interpretation Act 1901 confers power to revoke or amend an instrument issued under an Act.

(2) The Ministerial Council must not issue a code of practice unless the code of practice was developed by the Regulator in consultation with the following:

(a) the Gene Technology Technical Advisory Committee;

(b) the Ethics and Community Committee;

(d) such Commonwealth and State agencies and such regulatory agencies as the Ministerial Council considers appropriate;

(e) such industry groups as the Ministerial Council considers appropriate;

(f) such environmental, consumer and other groups as the Ministerial Council considers appropriate.

(3) Codes of practice are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901.





Part 3—The Gene Technology Regulator

25 Simplified outline

The following is a simplified outline of this Part:

This Part establishes the office of the Gene Technology Regulator (the Regulator), and specifies the Regulator’s functions and powers.

26 The Gene Technology Regulator

There is to be a Gene Technology Regulator.

27 Functions of the Regulator

The Regulator has the following functions:

(a) to perform functions in relation to GMO licences as set out in Part 5;

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

(c) to develop codes of practice;

(d) to issue technical and procedural guidelines in relation to GMOs;

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

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

(g) to provide advice to the Ministerial Council about:

(i) the operations of the Regulator and the Gene Technology Technical Advisory Committee; and

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

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

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

(j) to monitor international practice in relation to the regulation of GMOs;

(k) to maintain links with international organisations that deal with the regulation of gene technology and with agencies that regulate GMOs in countries outside Australia;

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

28 Powers of the Regulator

Subject to this Act, the Regulator has power to do all things necessary or convenient to be done for or in connection with the performance of the Regulator’s functions.

29 Delegation

(1) The Regulator may, by instrument in writing, delegate any of the Regulator’s powers or functions to any of the following:

(a) an employee of the Department;

(b) an employee of another Department or of a Commonwealth authority, if the functions of the other Department or Commonwealth authority relate, whether directly or indirectly, to GMOs or GM products;

(c) an officer or employee of a State agency, if the functions of the State agency relate, whether directly or indirectly, to GMOs or GM products.

(2) In exercising powers or functions under a delegation, the delegate must comply with any directions of the Regulator.

30 Independence of the Regulator

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

(a) whether or not a particular application for a GMO licence is issued or refused; or

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





Part 4—Regulation of dealings with GMOs

Division 1—Simplified outline

31 Simplified outline

The following is a simplified outline of this Part:

This Part deals with the regulation of dealings with GMOs. This Part prohibits dealings with GMOs unless: (a) the person undertaking the dealing is authorised to do so by a GMO licence; or (aa) the dealing is specified in an emergency dealing determination; or (b) the dealing is a notifiable low risk dealing (see Division 2 of Part 6); or (c) the dealing is an exempt dealing; or (d) the dealing is included in the GMO Register (see Division 3 of Part 6). This Part imposes heavier penalties on unlawful dealings that cause, or are likely to cause, significant damage to the health and safety of people or to the environment.





Division 2—Dealings with GMOs must be licensed

32 Person not to deal with a GMO without a licence

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

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

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

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

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

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

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

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

(2) An offence under subsection (1) is punishable on conviction by whichever of the following applies:

(a) in the case of an aggravated offence— imprisonment for 5 years or 2,000 penalty units;

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

Note: Section 38 defines aggravated offence.

(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.

33 Person 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.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

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

Note: For strict liability, see section 6.1 of the Criminal Code.

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

(a) in the case of an aggravated offence—200 penalty units;

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

Note: Section 38 defines aggravated offence.

(4) In this section:

exempt dealing has the same meaning as in section 32.

34 Person must not breach conditions of a GMO licence

(1) The holder of a GMO licence is guilty of an offence if:

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

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

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

(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.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

(3) 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 5 years or 2,000 penalty units;

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

Note: Section 38 defines aggravated offence.

(4) A person who is guilty of an offence under subsection (1) or (2) is guilty of a separate offence in respect of each day (including the day of a conviction for the offence or any later day) on which the person is guilty of the offence.

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

(1) The holder of a GMO licence is guilty of an offence if the holder:

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

(b) the action or omission contravenes the licence.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

(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.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

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

Note: For strict liability, see section 6.1 of the Criminal Code.

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

(a) in the case of an aggravated offence—200 penalty units;

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

Note: Section 38 defines aggravated offence.

35A Person 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.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

(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 5 years or 2,000 penalty units;

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

Note: Section 38 defines aggravated offence.

35B Person 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.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

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

Note: For strict liability, see section 6.1 of the Criminal Code.

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

(a) in the case of an aggravated offence—200 penalty units;

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

Note: Section 38 defines aggravated offence.

36 Person must not breach conditions on GMO Register

(1) A person is guilty of an offence if the person:

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

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

(c) the dealing contravenes a condition relating to the dealing that is specified in the GMO Register.

Maximum penalty: 50 penalty units.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

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

37 Offence 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.

Maximum penalty: 50 penalty units.

Note 1: Notifiable low risk dealings are specified in the regulations—see Part 6.

Note 2: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

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

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

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

(2) In order to prove an aggravated offence, the prosecution must prove that the person who committed the offence:

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

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





Part 5—Licensing system

Division 1—Simplified outline

39 Simplified outline

The following is a simplified outline of this Part:

This Part provides a licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs. This Part sets out the processes to be followed by the Regulator in relation to applications involving 2 kinds of dealings: (a) those that involve the intentional release of a GMO into the environment; and (b) those that do not involve the intentional release of a GMO into the environment. A licence can cover dealings by persons other than the licence holder. The licence holder is required to inform such persons of any conditions of the licence that apply to them.





Division 2—Licence applications

40 Person may apply for a licence

(1) A person may apply to the Regulator for a licence authorising specified dealings with one or more specified GMOs by a person or persons.

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

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

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

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

(4) The dealings in respect of which a person may apply for a licence may be:

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

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

(c) one or more specified dealings with a GMO, or with a specified class of GMOs.

(5) The applicant may apply for a licence authorising such dealings by:

(a) a specified person or persons; or

(b) a specified class of person; or

(c) all persons.

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

40A Licences relating to inadvertent dealings

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

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

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

41 Application may be withdrawn

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

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

42 Regulator may require applicant to give further information

(1) The Regulator may, by notice in writing, require an applicant for a licence to give the Regulator such further information in relation to the application as the Regulator requires.

(2) The notice may specify the period within which the information is to be provided.

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

43 Regulator must consider applications except in certain circumstances

(1) The Regulator must consider an application under section 40 for a licence in accordance with this Part.

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

(a) the application does not contain the information specified by the Regulator or prescribed by the regulations; or

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

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

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

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

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

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

44 Regulator may consult with applicant

Before considering an application in accordance with the requirements of this Part, the Regulator may consult the applicant, or another regulatory agency, on any aspect of the application.

45 Regulator must not use certain information in considering licence application

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

46 Applications to which this Division applies

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

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

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

(a) the dealings proposed to be authorised by the licence are limited to dealings to be undertaken for the purposes of, or for purposes relating to, disposing of a GMO; and

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

47 What the Regulator must do in relation to application

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

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

(3) In preparing the risk management plan, the Regulator must take into account the means of managing any risks posed by the dealings proposed to be authorised by the licence in such a way as to protect:

(a) the health and safety of people; and

(b) the environment.

(4) The Regulator may consult:

(a) the States; and

(b) the Gene Technology Technical Advisory Committee; and

(c) relevant Commonwealth authorities or agencies; and

(d) any local council that the Regulator considers appropriate; and

(e) any other person the Regulator considers appropriate;

on any aspect of the application.





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

48 Applications 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.

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

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

(a) the dealings proposed to be authorised by the licence are limited to dealings to be undertaken for the purposes of, or for purposes relating to, disposing of a GMO; and

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

50 Regulator must prepare risk assessment and risk management plan

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

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

(a) the States; and

(b) the Gene Technology Technical Advisory Committee; and

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

(d) the Environment Minister; and

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

50A Limited and controlled release applications

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

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

(b) the application proposes, in relation to any GMO in respect of which dealings are proposed to be authorised:

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

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

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

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

controls, in relation to a GMO and its genetic material, include the following:

(a) methods to restrict the dissemination or persistence of the GMO or its genetic material in the environment;

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

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

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

(e) compliance, in relation to dealings with the GMO or its genetic material, with:

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

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

(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.

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

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

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

(c) any advice in relation to the risk assessment provided by a State or a local council in response to a request under subsection 50(3);

(d) any advice in relation to the risk assessment provided by the Gene Technology Technical Advisory Committee in response to a request under subsection 50(3);

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

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

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

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

(a) the means of managing any risks posed by those dealings in such a way as to protect:

(i) the health and safety of people; and

(ii) the environment;

(c) any advice in relation to the risk management plan provided by a State or a local council in response to a request under subsection 50(3);

(d) any advice in relation to the risk management plan provided by the Gene Technology Technical Advisory Committee in response to a request under subsection 50(3);

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

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

(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 paragraph (2)(a), the Regulator:

(a) is not limited to considering submissions or advice mentioned in paragraphs (2)(b), (c), (d), (e) and (f); and

(b) subject to section 45, may take into account other information, including, but not limited to, relevant independent research.

52 Public notification of risk assessment and risk management plan

(1) After taking the steps referred to in sections 50 and 51, the Regulator must publish a notice:

(a) in the Gazette; and

(b) in a newspaper circulating generally in all States; and

(c) on the Regulator’s website (if any).

(2) The notice must:

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

(b) state that a person may request further information about the risk assessment and the risk management plan under section 54; and

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

(c) invite written submissions in relation to the risk assessment and the risk management plan; and

(d) specify the closing date for submissions, which must not be earlier than:

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

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

(3) The Regulator must also seek advice on the risk assessment and the risk management plan from:

(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 Environment Minister; and

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

53 Regulator may take other actions

(1) In addition to satisfying the requirements of this Division in relation to an application for a licence to which this Division applies, the Regulator may take any other action the Regulator considers appropriate for the purpose of deciding the application, including holding a public hearing.

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

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

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

Maximum penalty: 30 penalty units.

Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.

54 Person may request copies of certain documents

(1) A person may request that the Regulator provide the person with a copy of the following documents:

(a) an application to which this Division applies;

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

(2) If a person makes a request under subsection (1), the Regulator must provide to the person a copy of the documents, other than:

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

(b) any information contained in the documents about relevant convictions (within the meaning of section 58) of the applicant for the licence.

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

Note 2: The Privacy Act 1988 also contains provisions relevant to the disclosure of information.





Division 5—Decision on licence etc.

55 Regulator must make a decision on licence and licence conditions

After taking any steps required by Division 3 or 4 of this Part in relation to an application for a GMO licence, the Regulator:

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

(b) if the Regulator decides to issue the licence—may impose conditions to which the licence is subject.

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

(1) The Regulator must not issue the licence unless the Regulator is satisfied that any risks posed by the dealings proposed to be authorised by the licence are able to be managed in such a way as to protect:

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

57 Other circumstances in which Regulator must not issue the licence

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

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

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

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

(1) Without limiting the matters to which the Regulator may have regard in deciding whether a natural person is a suitable person to hold a licence, the Regulator must have regard to:

(a) any relevant conviction of the person; and

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

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

(2) Without limiting the matters to which the Regulator may have regard in deciding whether a body corporate is a suitable person to hold a licence, the Regulator must have regard to the following:

(a) any relevant conviction of the body corporate; and

(b) if there is a relevant conviction of the body corporate:

(i) whether the offence concerned was committed at a time when any person who is presently a director of the body corporate was a director; and

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

(c) any revocation or suspension of a licence or permit (however described) held by the body corporate under a law of the Commonwealth, a State or a foreign country, being a law relating to the health and safety of people or the environment; and

(d) the capacity of the body corporate to meet the conditions of the licence.

(3) In this section:

relevant conviction means a conviction for an offence against a law of the Commonwealth, a State or a foreign country, being a law relating to the health and safety of people or the environment, if:

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

(b) the offence was punishable on conviction by a fine of $5,000 or more, or by a term of imprisonment of one year or more.

(4) Nothing in this section affects the operation of Part VIIC of the Crimes Act 1914 (which includes provisions that, in certain circumstances, relieve persons from the requirement to disclose spent convictions and require persons aware of such convictions to disregard them).

59 Notification of licence decision

The Regulator must notify the applicant in writing of the Regulator’s decision (including any conditions imposed by the Regulator, if applicable).

60 Period of licence

(1) A licence continues in force:

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

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

(2) A licence is not in force throughout any period of suspension.

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





Division 6—Conditions of licences

61 Licence is subject to conditions

A GMO licence is subject to the following conditions:

(a) the conditions set out in sections 63, 64 and 65;

(b) any conditions prescribed by the regulations;

(c) any conditions imposed by the Regulator at the time of issuing the licence;

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

62 Conditions that may be prescribed or imposed

(1) Licence conditions may include conditions that impose obligations in relation to GM products that are derived from a GMO in respect of which particular dealings are licensed.

(2) Licence conditions may relate to, but are not limited to, the following:

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

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

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

(d) documentation and record‑keeping requirements;

(e) the required level of containment in respect of the dealings, including requirements relating to the certification of facilities to specified containment levels;

(f) waste disposal requirements;

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

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

(i) auditing and reporting;

(j) actions to be taken in case of the release of a GMO from a contained environment;

(k) the geographic area in which the dealings authorised by the licence may occur;

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

(m) supervision by, and monitoring by, Institutional Biosafety Committees;

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

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

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

63 Condition about informing people of obligations

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

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

(b) the cancellation or suspension of the licence;

(c) the surrender of the licence.

(2) Requirements in relation to the manner in which information is provided under subsection (1) may be:

(a) prescribed by the regulations; or

(b) specified by the Regulator.

(3) Such requirements may include, but are not limited to, measures relating to labelling, packaging, conducting training and providing information.

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

64 Condition about monitoring and audits

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

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

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

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

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

65 Condition about additional information to be given to the Regulator

(1) It is a condition of a licence that the licence holder inform the Regulator if he or she:

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

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

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

(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 he or she was reckless as to whether such information existed; and

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

66 Person may give information to Regulator

A person covered by a licence may inform the Regulator if he or she:

(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.

67 Protection of persons who give information

A person (the first person) does not incur any civil liability in respect of loss, damage or injury of any kind suffered by another person because the first person gave information to the Regulator under section 65, 66 or paragraph 72D(2)(h).





Division 7—Suspension, cancellation and variation of licences

68 Suspension and cancellation of licence

The Regulator may, by notice in writing given to the holder of a GMO licence, suspend or cancel the licence if:

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

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

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

(d) the licence was obtained improperly; or

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

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

69 Surrender of licence

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

70 Transfer of licences

(1) The licence holder and another person (the transferee) may jointly apply to the Regulator for the licence to be transferred from the licence holder to the transferee.

(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.

71 Variation of licence

(1) The Regulator may vary a licence, by notice in writing given to the licence holder:

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

(b) on application by the licence‑holder.

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

(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 subsection 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.

(2B) The Regulator must not vary a licence if the Regulator is satisfied that the risk assessment and the risk management plan in respect of the original application for the licence did not cover the risks posed by the dealings proposed to be authorised by the licence as varied.

(3) Without limiting subsection (1), the Regulator may:

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

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

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

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

(a) the health and safety of people; and

(b) the environment.

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

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

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

(8) For the purposes of subsection (2A):

controls has the same meaning as in subsection 50A(2).

limits has the same meaning as in subsection 50A(3).

72 Regulator to notify of proposed suspension, cancellation or variation

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

(2) The notice:

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

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

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

(3) The notice must specify a period within which the licence holder:

(a) must give the information referred to in paragraph (2)(b); and

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

The period must not end earlier than 30 days after the day on which the notice was given.

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

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

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

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





Part 5A—Emergency dealing determinations

Division 1—Simplified outline

72A Simplified outline

The following is a simplified outline of this Part:

This Part provides a system under which the Minister can make determinations relating to dealings with GMOs in emergencies.





Division 2—Making of emergency dealing determination

72B Minister may make emergency dealing determination

(1) The Minister may, by legislative instrument (an emergency dealing determination), specify dealings with a GMO for the purposes of this Part.

(2) The Minister may make an emergency dealing determination only if:

(a) the Minister has received advice from:

(i) the Commonwealth Chief Medical Officer; or

(ii) the Commonwealth Chief Veterinary Officer; or

(iii) the Commonwealth Chief Plant Protection Officer; or

(iv) a person prescribed by the regulations;

that there is an actual or imminent threat to the health and safety of people or to the environment, and that the dealings proposed to be specified in the emergency dealing determination would, or would be likely to, adequately address the threat; and

(b) the Minister is satisfied that there is an actual or imminent threat to the health and safety of people or to the environment, and that the dealings proposed to be specified in the emergency dealing determination would, or would be likely to, adequately address the threat; and

(c) the Minister has received advice from the Regulator that any risks posed by the dealings proposed to be specified in the emergency dealing determination are able to be managed in such a way as:

(i) to protect the health and safety of people; and

(ii) to protect the environment; and

(d) the Minister is satisfied that any risks posed by the dealings proposed to be specified in the emergency dealing determination are able to be managed in such a way as:

(i) to protect the health and safety of people; and

(ii) to protect the environment; and

(e) the States have been consulted in relation to the making of the proposed emergency dealing determination.

(3) An actual or imminent threat of a kind mentioned in paragraph (2)(a) or (b) may include, but is not limited to, any of the following:

(a) a threat from the outbreak of a plant, animal or human disease;

(b) a threat from a particular plant or animal, such as a pest or an alien invasive species;

(c) a threat from an industrial spillage.

(4) The dealings in respect of which the Minister may make an emergency dealing determination may be:

(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.

72C Period of effect of emergency dealing determination

(1) An emergency dealing determination takes effect:

(a) on the day on which the emergency dealing determination is made; or

(b) on a later day that is specified in the emergency dealing determination.

(2) An emergency dealing determination ceases to have effect:

(a) subject to subsection (3), at the end of the period of 6 months starting when the emergency dealing determination takes effect; or

(b) at the end of the period specified by the Minister in the emergency dealing determination; or

(c) when the emergency dealing determination is revoked;

whichever occurs first.

(3) The Minister may, by legislative instrument, extend the period of effect of an emergency dealing determination.

(4) The Minister may extend the period of effect of an emergency dealing determination under subsection (3) more than once, but each single such extension must not exceed 6 months.

(5) The Minister may extend the period of effect of an emergency dealing determination only if:

(a) the Minister has received advice from the original adviser in relation to the emergency dealing determination that the threat to which the determination relates still exists, and that the proposed extension would, or would be likely to, adequately address the threat; and

(b) the Minister is satisfied that the threat still exists, and that the proposed extension would, or would be likely to, adequately address that threat; and

(c) the Minister has received advice from the Regulator that any risks posed by the proposed extension are able to be managed in such a way as:

(i) to protect the health and safety of people; and

(ii) to protect the environment; and

(d) the Minister is satisfied that any risks posed by the proposed extension are able to be managed in such a way as:

(i) to protect the health and safety of people; and

(ii) to protect the environment; and

(e) a majority of jurisdictions agree to the extension.

(6) A legislative instrument extending the period of effect of an emergency dealing determination takes effect at the time when the determination would have ceased to have effect but for the extension.

(7) In subsection (5):

original adviser, in relation to an emergency dealing determination, means the person who gave the advice mentioned in paragraph 72B(2)(a) in relation to the determination.





Division 3—Effect and conditions of emergency dealing determination

72D Emergency dealing determination authorises dealings, subject to conditions

(1) If an emergency dealing determination is in force in respect of dealings with a GMO, those dealings are authorised, subject to the conditions (if any) specified in the emergency dealing determination.

(2) Conditions may relate to, but are not limited to, the following:

(a) the quantity of GMO in relation to which dealings are covered;

(b) the scope of the dealings covered;

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

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

(e) the source of the GMO;

(f) the persons who may deal with the GMO;

(g) the information that is required to be given by a person and the person to whom that information is to be given;

(h) obligations about informing the Regulator if:

(i) a person becomes aware of additional information as to any risks to the health and safety of people, or to the environment, associated with the dealings specified in the emergency dealing determination; or

(ii) a person becomes aware of any contraventions of the conditions to which the emergency dealing determination is subject by any person; or

(iii) a person becomes aware of any unintended effects of the dealings specified in the emergency dealing determination;

(i) the storage and security of the GMO;

(j) the required level of containment in respect of the dealings, including requirements relating to the certification of facilities to specified containment levels;

(k) waste disposal requirements;

(l) the manner in which any quantity of the GMO is to be dealt with if a condition of the emergency dealing determination is breached;

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

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

(o) auditing and reporting;

(p) the keeping and disclosure of, and access to, records about the GMO;

(q) actions to be taken in case of the release of a GMO from a contained environment;

(r) the geographic area in which the dealings specified in the emergency dealing determination may occur;

(s) requirements for compliance with a code of practice issued under section 24, or a technical or procedural guideline issued under section 27;

(t) supervision by, and monitoring by, Institutional Biosafety Committees;

(u) contingency planning in respect of unintended effects of the dealings specified in the emergency dealing determination;

(v) limiting the dissemination or persistence of the GMO or its genetic material in the environment;

(w) any other matters that the Minister thinks appropriate.

(3) A condition under paragraph (2)(f) may permit dealings with a GMO by, or may impose obligations upon:

(a) a specified person or persons; or

(b) a specified class of person.

(4) It is a condition of an emergency dealing determination that if:

(a) a dealing with a GMO is specified in the emergency dealing determination; and

(b) a particular condition of the emergency dealing determination applies to the dealing by a person;

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.

(5) Subsection (4) does not limit the conditions that may be specified in an emergency dealing determination.





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

72E Variation, suspension and revocation of emergency dealing determination

(1) The Minister may, by legislative instrument, vary the conditions to which an emergency dealing determination is subject, including by imposing new conditions.

(2) The Minister may, by legislative instrument, suspend or revoke an emergency dealing determination if:

(a) the Minister becomes aware of risks to the health and safety of people, or to the environment, associated with the continuation of the dealings authorised by the emergency dealing determination, and is satisfied that adequate measures to address those risks are not able to be implemented; or

(b) the Minister is satisfied that the threat to which the emergency dealing determination relates:

(i) no longer exists; or

(ii) is no longer sufficiently actual or imminent as to require the determination to be in force to address that threat; or

(c) the Minister is no longer satisfied that the dealings specified in the emergency dealing determination adequately address the threat.

(3) The Minister must not:

(a) vary an emergency dealing determination (unless the variation is of a minor technical nature); or

(b) suspend or revoke an emergency dealing determination;

unless the States have been consulted in relation to the variation, suspension or revocation, as the case requires.

(4) A variation, suspension or revocation of an emergency dealing determination takes effect:

(a) if the Minister states in the variation, suspension or revocation that the variation, suspension or revocation is necessary to prevent imminent risk of death, serious illness, serious injury or serious environmental damage—on the day on which the variation, suspension or revocation is made; or

(b) in any other case—on the day specified by the Minister in the variation, suspension or revocation.

(5) The day specified as mentioned in paragraph (4)(b) must not be earlier than 30 days after the day on which the variation, suspension or revocation is made.





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

Division 1—Simplified outline

73 Simplified outline

The following is a simplified outline of this Part:

Division 2 of this Part establishes a mechanism for the regulations to regulate certain dealings with GMOs that do not involve the intentional release of GMOs into the environment (notifiable low risk dealings). The regulations may (among other things) require that the Regulator be notified of such dealings. Division 3 of this Part establishes the GMO Register. The Regulator may determine that certain dealings previously authorised by a licence be included on the GMO Register. If a dealing is included on the GMO Register, anyone may undertake the dealing, subject to any specified conditions.





Division 2—Notifiable low risk dealings

74 Notifiable low risk dealings

(1) The regulations may declare a dealing with a GMO to be a notifiable low risk dealing for the purposes of this Act.

(2) Before the Governor‑General makes regulations declaring a dealing with a GMO to be a notifiable low risk dealing, the Regulator must be satisfied that the dealing would not involve the intentional release of a GMO into the environment.

(3) Before the Governor‑General makes regulations declaring a dealing with a GMO to be a notifiable low risk dealing, the Regulator must consider the following matters:

(a) whether the GMO is biologically contained so that it is not able to survive or reproduce without human intervention;

(b) whether the dealing with the GMO would involve minimal risk to the health and safety of people and to the environment, taking into account the properties of the GMO as a pathogen or pest and the toxicity of any proteins produced by the GMO;

(c) whether no conditions, or minimal conditions, would be necessary to be prescribed to manage any risk referred to in paragraph (b).

(4) Regulations under subsection (1) may be expressed to apply to:

(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.

75 Regulation of notifiable low risk dealings

(1) The regulations may regulate:

(a) a specified notifiable low risk dealing; or

(b) a specified class of notifiable low risk dealings;

for the purpose of protecting the health and safety of people or the environment.

(2) The regulations may prescribe different requirements to be complied with in different situations or by different persons, including requirements in relation to the following:

(a) the class of persons who may undertake notifiable low risk dealings;

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

(c) supervision by Institutional Biosafety Committees of notifiable low risk dealings;

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





Division 3—The GMO Register

76 GMO Register

(1) There is to be a Register known as the GMO Register.

(2) The GMO Register is to be maintained by the Regulator.

(3) The GMO Register may be kept in a computerised form.

77 Contents of Register

If the Regulator determines under section 78 that a dealing with a GMO is to be included on the GMO Register, the Regulator must specify in the GMO Register:

(a) a description of the dealing with the GMO; and

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

78 Regulator may include dealings with GMOs on GMO Register

(1) The Regulator may, by writing, determine that a dealing with a GMO is to be included on the GMO Register if the Regulator is satisfied that:

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

(b) the GMO concerned:

(i) is a GM product; and

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

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

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

(b) on the initiative of the Regulator.

(3) A determination under subsection (1) comes into effect on the day specified in the determination.

(4) A determination under subsection (1) is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.

79 Regulator not to make determination unless risks can be managed

(1) The Regulator must not make a determination under subsection 78(1) in respect of a dealing with a GMO unless the Regulator is satisfied:

(a) that any risks posed by the dealing are minimal; and

(b) that it is not necessary for persons undertaking the dealing to hold, or be covered by a GMO licence, in order to protect the health and safety of people or to protect the environment.

(2) For the purposes of subsection (1), the Regulator must have regard to the following:

(a) any data available to the Regulator about adverse effects posed by the dealing;

(b) any other information as to risks associated with the dealing of which the Regulator is aware, including information provided to the Regulator by a licence holder under section 65 or by another person under section 66;

(c) whether there is a need for the dealing to be subject to conditions;

(d) any other information in relation to whether the dealing should be authorised by a GMO licence.

(3) The Regulator may have regard to such other matters as the Regulator considers relevant.

80 Variation of GMO Register

(1) The Regulator may vary the GMO Register by written determination.

(2) A variation may:

(a) remove a dealing from the GMO Register; or

(b) revoke or vary conditions to which a dealing on the GMO Register is subject; or

(c) impose additional conditions to which a dealing on the GMO Register is subject.

(3) A determination under subsection (1) is a disallowable instrument for the purposes of section 46A of the Acts Interpretation Act 1901.

81 Inspection of Register

The Regulator must permit any person to inspect any part of the GMO Register.





Part 7—Certification and accreditation

Division 1—Simplified outline

82 Simplified outline

The following is a simplified outline of this Part:

Division 2 of this Part establishes a system under which the Regulator may certify facilities to specified containment levels in accordance with guidelines issued by the Regulator. Licence conditions, or conditions to which an emergency dealing determination is subject, can require that facilities be certified to specified containment levels. Division 3 of this Part enables the Regulator to accredit organisations in accordance with accreditation guidelines issued by the Regulator. Licence conditions, or conditions to which an emergency dealing determination is subject, can specify that dealings must be supervised by an Institutional Biosafety Committee established by an accredited organisation.





Division 2—Certification

83 Application for certification

(1) A person may apply to the Regulator for certification of a facility to a particular containment level under this Division.

(2) The application must be in writing, and must contain such information as the Regulator requires.

Note: The conditions of a licence, or conditions to which an emergency dealing determination is subject, may require that a facility be certified under this Division.

(3) The application must be accompanied by the application fee (if any) prescribed by the regulations.

84 When the Regulator may certify the facility

The Regulator may, by written instrument, certify the facility to a specified containment level if the facility meets the containment requirements specified in guidelines issued by the Regulator under section 90.

85 Regulator may require applicant to give further information

(1) The Regulator may, by notice in writing, require an applicant for certification of a facility to give the Regulator such further information in relation to the application as the Regulator requires.

(2) The notice may specify the period within which the information is to be provided.

86 Conditions of certification

The certification of a facility is subject to the following conditions:

(a) any conditions imposed by the Regulator at the time of certification;

(b) any conditions imposed by the Regulator under section 87 after certification;

(c) any conditions prescribed by the regulations.

87 Variation of certification

(1) The Regulator may, at any time, by notice in writing given to the holder of the certification, vary the certification of a facility.

(2) Without limiting subsection (1), the Regulator may:

(a) impose additional conditions; or

(b) remove or vary conditions that were imposed by the Regulator.

88 Suspension or cancellation of certification

The Regulator may, by notice in writing, suspend or cancel the certification of a facility if the Regulator believes on reasonable grounds that a condition of the certification has been breached.

89 Regulator to notify of proposed suspension, cancellation or variation

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

(2) The notice:

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

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

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

(3) The notice must specify a period within which the holder of the certification:

(a) must give the information referred to in paragraph (2)(b); and

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

The period must not end earlier than 30 days after the day on which the notice was given.

(4) In considering whether to suspend, cancel or vary a certification, the Regulator must have regard to any submission made under paragraph (2)(c).

(5) This section does not apply to a suspension, cancellation or variation requested by the holder of the certification.

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

(7) This section does not apply to a variation of a certification if the Regulator is satisfied that the variation is of minor significance or complexity.

89A Transfer of certification

(1) The holder of a certification and another person (the transferee) may jointly apply to the Regulator for the certification to be transferred from the holder of the certification to the transferee.

(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 certification unless the Regulator is satisfied that, if the certification is transferred, any conditions to which the certification is subject will continue to be met.

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

(5) If the Regulator decides to transfer the certification:

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

(b) the certification continues in force; and

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

90 Guidelines

(1) The Regulator may, by written instrument, issue technical or procedural guidelines about the requirements for the certification of facilities to specified containment levels.

(2) The Regulator may, by written instrument, vary or revoke the guidelines.





Division 3—Accredited organisations

91 Application for accreditation

(1) A person may apply to the Regulator for accreditation of an organisation as an accredited organisation under this Division.

Note 1: The conditions of a licence may require supervision of dealings by an Institutional Biosafety Committee established by an accredited organisation (see paragraph 62(2)(m)), and the regulations may require such supervision of notifiable low risk dealings (see paragraph 75(2)(c)).

Note 2: The conditions to which an emergency dealing determination is subject may require supervision of dealings by an Institutional Biosafety Committee established by an accredited organisation (see paragraph 72D(2)(t)).

(2) The application must be in writing, and must contain such information as the Regulator requires.

92 Regulator may accredit organisations

(1) The Regulator may, by written instrument, accredit an organisation as an accredited organisation.

(2) In deciding whether to accredit an organisation, the Regulator must have regard to:

(a) whether the organisation has established an Institutional Biosafety Committee in accordance with written guidelines issued by the Regulator under section 98; and

(b) if the organisation has established an Institutional Biosafety Committee—whether the organisation will be able to maintain the Institutional Biosafety Committee in accordance with such guidelines; and

(c) if the organisation has established an Institutional Biosafety Committee—whether the organisation has appropriate indemnity arrangements for its Institutional Biosafety Committee members; and

(ca) if the organisation has not established an Institutional Biosafety Committee as mentioned in paragraph (a)—whether the organisation will be in a position to use an Institutio