Australia -- A Model Act for the Comprehensive Regulation of Gene Technology (2000)

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A Model Act for the Comprehensive Regulation of Gene Technology 2000

No. , 2000

A Bill for an Act to regulate all activities and dealings involving gene technology, and for related purposes

Prepared by
Donald K Anton,
Acting Director
Australian Centre for Environmental Law
The Australian National University
Canberra, ACT 0200 AUSTRALI
Tel: +61 2 6249 3516; Fax: +61 2 6249 4899
Email: don.anton@anu.edu.au;
Internet: law.anu.edu.au/centres/acel/

Contents
Part 1—Preliminary 1
^1 Short title 1
^2 Commencement 1
^3 Objects of Act 1
^3A Scope of the Act 2
^4 Regulatory framework to achieve objects 2
^5 Nationally consistent scheme 2
^6 Act to bind the Crown 2
^7 External Territories 3
^8 Offences 3
Part 2—Interpretation and operation of Act 4
Division 1—Simplified outline 4
^9 Simplified outline 4
Division 2—Definitions 5
^10 Definitions 5
Division 3—Operation of Act 13
^11 Operation of Act 13
^12 Wind-back of reach of Act 13
^12A Higher State Standards and Measures 13
Division 4—Provisions to facilitate a nationally consistent scheme 15
^13 State laws may operate concurrently 15
^14 Conferral of functions on Commonwealth authorities and officers 15
^15 No doubling﷓up of liabilities 15
^16 Review of certain decisions 15
Part 3—The Gene Technology Regulator 17
^17 Simplified outline 17
^18 The Gene Technology Regulator 17
^19 Functions of the Regulator 16
^20 Powers of the Regulator 19
^21 Commonwealth and States may issue policy guidelines and codes of practice 18
^22 Consultation on policy guidelines and codes of practices 19
^23 Delegation 20
^24 Independence of the Regulator 20
Part 4—Regulation of activities and dealings with gene technology 21
Division 1—Simplified outline 21
^25 Simplified outline 21
Division 2—Engaging in activities or dealings invloving gene technology must be licensed 22
^26 Person not to engage in activities or dealings involving gene technology without a licence 22
^27 Person must not breach conditions of a licence 23
^28 Aggravated offences—significant damage to health or safety or the environment 23
Part 5—Licensing system 24
Division 1—Simplified outline 24
^29 Simplified outline 24
Division 2—Licence applications 25
^30 Person must apply for a licence 265
^31 Regulator may require applicant to give further information 26
^32 Regulator must consider applications except in certain circumstances 26
Division 3—Consideration of applications for licences 27
^33 What the Regulator must do in relation to the application 27
^34 Risk assessment and risk management plan 28
^35 Public notification of risk assessment and risk management plan 30
^36 Person may request copies of certain documents 31
Division 4—Decision on licence etc. 31
^37 Regulator must make a decision on licence and licence conditions 31
^38 Regulator must not issue the licence unless satisfied as to risk 31
^39 Other circumstances in which Regulator must not issue the licence 33
^40 Ministerial Council must have regard to national interest 33
^41 Matters to be taken into account in deciding whether a person is suitable to hold a licence 34
^42 Notification of licence decision 35
^43 Period of licence 35
Division 5—Conditions of licences 36
^44 Licence is subject to conditions 36
^45 Conditions that may be prescribed or imposed 36
^46 Condition about informing people of obligations 37
^47 Condition about monitoring and audits 37
^48 Condition about additional information to be given to the Regulator 38
^49 Condition about the imposition of adequate financial assurances 38
^50 Condition about emergency measures 39
^51 Condition about animal welfare 39
Division 6—Suspension, cancellation and variation of licences 40
^52 Suspension and cancellation of licence 40
^53 Surrender of licence 4042
^54 Variation of licence 40
^55 Regulator to notify of proposed suspension, cancellation or variation 431
Division 7¾Review of licences 43
^56 Review of licences 43
Division 8—Register of licences 45
^57 Register of licences 46
^58 Inspection of Register 45
Part 5A¾Identification and labelling 46
^59 Requirement for identification and labelling 46
Part 5B¾Export of GMOs or products thereof
^60 Approval required for export 46
^61 Advance informed agreement 46
Part 6—The Gene Technology Advisory Committee and the Gene Technology Community Consultative Group 47
Division 1—Simplified outline 47
^62 Simplified outline 47
Division 2—The Gene Technology Advisory Committee 48
^63 The Gene Technology Advisory Committee 48
^64 Functions of the Gene Technology Advisory Committee 49
^65 Expert advisers 49
^66 Remuneration 50
^67 Members and procedures 50
^68 Subcommittees 51
Division 3—The Gene Technology Community Consultative Group 52
^69 The Gene Technology Community Consultative Group 52
^70 Functions 52
^71 Membership 52
^72 Expert advisers 53
^73 Remuneration 53
^74 Regulations 54
Part 7—Administration 55
Division 1—Simplified outline 55
^75 Simplified outline 55
Division 2—Appointment and conditions of Regulator 56
^76 Appointment of the Regulator 56
^77 Termination of appointment 56
^78 Acting appointment 57
^79 Terms and conditions 58
^80 Outside employment 58
^81 Remuneration 58
^82 Leave of absence 58
^83 Resignation 59
Division 3—Money 60
^84 Regulator may charge for services 60
^85 Notional payments by the Commonwealth 60
^86 Gene Technology Account 60
^87 Credits to Account 60
^88 Recovery of amounts 61
^89 Purposes of Account 61
Division 4—Establishment of Statutory Agency 62
^90 Statutory agency to assist the Regulator 62
^91 Constitution of statutory agency 62
^92 Seconded officers 65
Division 5—Reporting requirements 66
^93 Annual Report 66
^94 Reports to Parliament 66
Part 8—Enforcement 67
^95 Simplified outline 67
^96 Regulator may give directions 67
^97 Injunctions 68
^98 Forfeiture 69
Part 9—Powers of inspection 71
Division 1—Simplified outline 71
^99 Simplified outline 71
Division 2—Appointment of inspectors and identity cards 72
^100 Appointment of inspectors 72
^101 Identity card 72
Division 3—Monitoring powers 73
^102 Powers available to inspectors for monitoring compliance 73
^103 Monitoring powers 73
Division 4—Offence-related powers 75
^104 Searches and seizures related to offences 75
^105 Offence-related powers of inspectors in relation to premises 75
^106 Use of electronic equipment at premises 76
^107 Expert assistance to operate electronic equipment 77
Division 5—Emergency powers 78
^108 Powers available to inspectors for dealing with dangerous situations 78
Division 6—Obligations and incidental powers of inspectors 79
^109 Inspector must produce identity card on request 79
^110 Consent 79
^111 Details of warrant to be given to occupier etc. 79
^112 Announcement before entry 79
^113 Compensation for damage to electronic equipment 80
Division 7—Occupier’s rights and responsibilities 81
^114 Copies of seized things to be provided 81
^115 Occupier entitled to be present during search 81
^116 Receipts for things seized under warrant 82
^117 Retention of seized things 82
^118 Magistrate may permit a thing to be retained 83
Division 8—Warrants 84
^119 Monitoring warrants 84
^120 Offence-related warrants 84
^121 Offence-related warrants by telephone 85
^122 Offences relating to warrants 87
Division 9—Other matters 89
^123 Part not to abrogate privilege against self-incrimination 89
^124 Part does not limit power to impose licence conditions 89
Part 10—Miscellaneous 90
Division 1—Simplified outline 90
^125 Simplified outline 90
Division 1A¾Civil liability and redress
^126 Civil liability and redress 88
Division 2—Review of decisions 91
^127 Meaning of terms 91
^128 Notification of decisions and review rights 92
^129 Internal review 92
^130 Deadlines for making reviewable decisions 92
^131 Review of decisions by Administrative Appeals Tribunal 93
Division 3—Confidential commercial information 94
^132 Establishing confidential commercial information 94
^133 Application for protection of confidential commercial information 94
^134 Regulator may declare that information is to be treated as confidential commercial information 95
^135 Revocation of declaration 96
^136 Confidential commercial information must not be disclosed 96
Division 4—Conduct by directors, employees and agents 98
^137 Conduct by directors, employees and agents 99
^138 Meaning of terms 99
Division 5—Regulations 100
^139 Regulations 100

The Parliament of Australia enacts:
Part 1—Preliminary

^1 Short title
This Act may be cited as the Gene Technology Act 2000.
^2 Commencement
(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 six 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 Objects of Act
(1) The primary object of this Act is to protect the health and safety of people and animals, and to protect the environment, by identifying risks posed as a result of gene technology, and by preventing, reducing and eliminating those risks through regulating certain dealings with GMOs. This will outweigh any economic or trade advantages that might be derived from the gene technology to which this Act applies.
(2) It is also an object of this Act that dealings with GMOs be regulated in a way that is consistent with Australia’s national interests.
(3) It is also an object of this Act to protect, conserve and maintain biological diversity against threats posed by GMOs.
^3A Scope of the Act
This Act shall apply to all activities or dealings involving gene technology, including:
(a) deliberate release;
(b) contained use;
(c) marketing or placing on the market; and
(d) import and export
of GMOs, combinations of GMOs, and products thereof.
^4 Regulatory framework to achieve objects
The objects of this Act are to be achieved through a regulatory framework which:
(a) provides an effective, integrated and efficient system for the regulation of all activities or dealings involving gene technology, including the licensing, use, application, marketing and release of all GMOs and products derived from GMOs; and
(b) emphasises the primary place of the precautionary principle in decision-making regarding all activities or dealings involving gene technology, including the licensing, use, application, marketing and release of all GMOs and products derived from GMOs.
^5 Nationally consistent scheme
It is the intention of the Parliament that this Act a nationally consistent scheme, setting minimum standards, for the regulation of all activities and dealings involving gene technology.
^6 Act to bind the Crown
This Act binds the Crown in each of its capacities.
^7 External Territories
This Act extends to every external Territory.
^8 Offences
(1) Chapter 2 of the Criminal Code, including Division 6 where appropriate, 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 the offence referred to in the section or subsection is punishable, on conviction, by a penalty up to that maximum.

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 also contains provisions to enable the concurrent operation of State legislation in relation to GMOs, and give the capacity for this Act to have a more limited operation when corresponding State legislation is in force which provides equal or greater protection against risks posed by GMOs as provided by this Act.

Division 2—Definitions
^10 Definitions
In this Act, unless the contrary intention appears:
Account means the Gene Technology Account established by section 86.
activities or dealings involving gene technology include the following
(a) all applications and uses, including applications and uses on humans;
(b) all development, experimentation, breeding, propogation, production, manufacture;
(c) all deliberate releases into the environment;
(d) all marketing or the placing on the market;
(e) every import and export

of GMOs and products derived from GMOs. This definition includes the possession, supply, use, transport, or disposal of the GMO or products dervied from GMOs for the purposes of, or in the course of, a dealing mentioned in any of the paragraphs (a) to (e).
In cases of any doubt, the definition of activities and dealings involving gene technology is to be read in the most expansive manner that the context allows.
aggravated offence has the meaning given by section 28.
biological diversity means the natural variability among all living organisms and the ecological complexes of which they are part; this includes diversity within species, between species and of ecosystems
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 any of the above subparagraphs.
confidential commercial information means information declared by the Regulator to be confidential commercial information under section 134.
Consultative Group means the Gene Technology Community Consultative Group established by section 69.
contained use means any operation in which GMO(s) or products thereof are produced, grown, stored, destroyed or used in some other way in a closed system in which physical barriers are employed, either alone or together with chemical and/or biological barriers, to effectively limit their contact with, and their impact on, the general population, biological diversity and the external environment.
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 means a State law that provides equal or greater protection to public health and safety, the environment and biological diversity as this Act, and 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.
deliberate release or release means any intentional introduction into the environment, including any production or use that is not contained use, of GMO(s) or products thereof; this includes releases for: commercial purposes, remediation, research purposes in field experiments, use of GMO(s) or products thereof in greenhouses, aquaculture facilities, animal accommodation unless the facility is approved for contained use as part of an approved laboratory or other installation, disposal of waste containing GMO(s) or products thereof, and transport of GMO(s) or products thereof.
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 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.
export means the intentional transboundary movement from one country to another country.
exporter means any legal or natural person who arranges for GMO(s) or products thereof to be exported.
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, tank, pond or sea cage.
gene technology refers to techniques that involve the isolation, characterisation, modification of genes or other genetic material and the introduction of DNA into living cells or viruses; and includes cell technology, which refers to techniques for the production of living cells with new combinations of genetic material by the fusion of two or more cells.
Gene Technology Advisory Committee means the Gene Technology Advisory Committee established by section 63.
Gene Technology Agreement means the Gene Technology Intergovernmental Agreement made on [date] between the Commonwealth, New South Wales, Victoria, Queensland, Western Australia, South Australia, Tasmania, the Australian Capital Territory and the Northern Territory, as in force from time to time.
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 parent organism), being traits that occurred in the parent organism because of gene technology; or
(c) anything declared by the regulations to be a genetically modified organism;
(d) any biological entity capable of replication or transfer of genetic information, and includes plants, animals, bacteria and all other kinds of micro-organisms, cell cultures (prokaryotic or eukaryotic) created and propagated as such, viruses, and plasmids and other kinds of vectors, in which the genetic material has been altered in away that does not occur naturally, by means of cell or gene technology.
GMO means a genetically modified organism.
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.
human being means a whole human being (whether alive or dead), and for the avoidance of doubt, does not include any of the following:
(a) a human body part;
(b) human body tissue;
(c) human body fluid;
(e) human reproductive material.
import means the intentional transboundary movement into one country from another country.
importer means any legal or natural person who arranges for GMO(s) or products thereof to be imported.
Institutional Biosafety Committee means a committee established by an accredited organisation as an Institutional Biosafety Committee.
jurisdiction means the following:
(a) the Commonwealth;
(b) a State.
licence means a licence issued under section 37.
licence holder means the holder of a GMO licence.
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.
placing on the market or marketing means supplying or making available to third parties GMO(s) or products thereof.
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)).
principles of ecologically sustainable development are:
(a) decision-making processes should effectively integrate both long-term and short-term economic, environmental, social and equitable considerations;
(b) if there are threats of serious or irreversible environmental damage, lack of full scientific certainty should not be used as a reason for postponing measures to prevent environmental degradation;
(c) the principle of inter-generational equity—that the present generation should ensure that the health, diversity and productivity of the environment is maintained or enhanced for the benefit of future generations;
(d) the conservation of biological diversity and ecological integrity should be a fundamental consideration in decision-making;
(e) improved valuation, pricing and incentive mechanisms should be promoted.
products thereof means any material derived by processing, or in other way or by any other means derived, from any GMO(s).
Register means the Register mentioned in section 57.
Regulator means the Gene Technology Regulator appointed under section 76.
risk assessment means the evaluation of the direct and indirect risks to human and animal health, the environment, biological diversity and to the socio-economic conditions and ethical values of the country or its populace which may be posed by activities or dealings involving gene technology, including the import, contained use, deliberate release or the placing on the market of GMO(s) or products thereof. This includes the evaluation of secondary and long-term effects.
socio-economic impact means the direct or indirect effects to the economy, social or cultural practices, livelihoods, indigenous knowledge systems, or indigenous technologies as a result of activities or dealings involving gene technology, including the import, contained use, deliberate release or placing on the market of GMO(s) or products thereof.
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 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 body covered by paragraph (b) or (d);
(iii) a body covered by any of the above subparagraphs.

Division 3—Operation of Act
^11 Operation of Act
(1) This Act applies as follows:
(a) to things done by constitutional corporations;
(b) to things done in the course of constitutional trade or commerce;
(c) to things 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.
(g) to things authorised by the legislative power of the Commonwealth under paragraph 51(xxix) of the Constitution, so far as it relates to activities and dealings involving gene technology.
(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.
^12 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 12(1)(c) (which deals with the spread of pests and disease) had not been enacted; and
(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 terms of the Gene Technology Agreement, stating that this section is to apply to the State.
^12A Higher State Standards and Measures
Nothing in this Act shall prevent a State from adopting standards or measures that provide higher levels of protection for human health and safety, the environment or biological diversity, in relation to activities and dealings involving gene technology, than is provided for in this Act

Division 4—Provisions to facilitate a nationally consistent scheme
^13 State laws may operate concurrently
This Act is not intended to exclude the operation of any State law, to the extent that the State law falls within sections 12 or 12A.
^14 Conferral of functions on Commonwealth authorities and officers
(1) A corresponding State law may confer functions, powers and duties on authorities and officers of the Commonwealth.
(2) An authority or officer on whom a function, power or duty is conferred under subsection (1) may perform the function or duty or exercise the power, as the case requires.
^15 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.
^16 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 or by an officer of the Commonwealth 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.

Part 3—The Gene Technology Regulator

^17 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.
This Part also sets out consultation requirements in relation to policy guidelines and codes of practice.
^18 The Gene Technology Regulator
(1) There shall be a Gene Technology Regulator, who shall be a corporation with perpetual succession.
(2) The Commonwealth Authorities and Companies Act 1997 applies to the Gene Technology Regulator.
(3) The corporation shall have a seal, and may sue or be sued in its corporate name.
(4) All courts, judges and persons acting judicially shall take judicial notice of the seal of the corporation affixed to documents and shall presume that it was duly affixed.
(5) At all times after the first appointment of a person to the office of Director, the corporation continues in existence notwithstanding any vacancy in that office.
^19 Functions of the Regulator
The Regulator has the following functions:
(a) to determine all applications for licences under this Act;

(b) to periodically review any decision made in relation to a licence under this Act;

(c) to provide advice and make available any information to, and receive comments from, the public as is provided for under this Act;

(d) to carry out its functions in relation to the preparation of risk assessments and risk management plans as set out in sections 34 and 35;

(e) to impose measures for risk prevention and elimination under this Act;

(f) to enforce identification, labelling and packaging provisions required by this Act;

(g) to regulate the import and export of GMO(s) and products thereof;

(h) to establish mechanisms to facilitate the collection, storage and dissemination of data on local conditions, such as agronomic, epidemiological, logistic and environmental data;

(i) to establish mechanisms for exchange of information with other countries, particularly those in the region;

(j) to develop draft policy guidelines and codes of practice in relation to GMOs, as requested by the Commonwealth and the States under the terms of the Gene Technology Agreement;

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

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

(m) to provide advice to the Commonwealth and the States under the terms of the Gene Technology Agreement about:
(i) the operations of the Regulator and the Gene Technology Advisory Committee; and
(ii) the effectiveness of the legislative framework for the regulation of GMOs, including in relation to possible amendments of relevant legislation;

(n) to undertake research in relation to risk assessment and the biosafety of GMOs;

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

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

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

(r) to do all that may be deemed necessary to implement the policy and provisions of this Act."
^20 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.
^21 Commonwealth and States may issue policy guidelines and codes of practice
(1) The Commonwealth and the States may, in accordance with the Gene Technology Agreement, issue policy guidelines and codes of practice.
(2) Before issuing a policy guideline or a code of practice under this section, the Commonwealth and the States must, in accordance with the Gene Technology Agreement, request the Regulator to develop a draft of the policy guideline or the code of practice. The draft must be developed in accordance with any matters specified in the request.
(3) Policy guidelines and codes of practice are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901.
^22 Consultation on policy guidelines and codes of practices
(1) In developing a draft policy guideline or a code of practice as mentioned in paragraph 19(j), the Regulator must consult the following:
(a) the Gene Technology Advisory Committee;
(b) the Consultative Group;
(c) such Commonwealth and State agencies and such regulatory agencies as the Regulator considers appropriate;
(d) such environmental, consumer and industry groups as are interested;
(e) such members of the general public as are interested.

(2) The Regulator in consulting under subsection (1) must:

(a) cause to be published in a newspaper circulating in each State a notice:
(i ) stating that the Regulator is developing a draft policy guideline or a code of practice; and
(ii) stating that free copies of the draft will be made available to members of the public throughout the period specified in the notice; and
(iii) inviting interested persons to give written comments about the proposed policy guideline or code of practice to the Regulator within the period specified under subparagraph (ii); and
(b) make copies of the draft available in accordance with the notice.

(3) The period specified under subparagraph (2)(a)(ii) must run for at least 30 days after the publication of the notice.
(4) If interested persons have given comments in accordance with a notice under subsection (2), the Regulator must have due regard to those comments in determining the policy guideline or code of practice, as the case may be.
^23 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 to GMOs or GM products;
(c) an officer or employee of a State agency, if the functions of the State agency relate to GMOs or GM products.
(2) In exercising powers or functions under a delegation, the delegate must comply with any directions of the Regulator.
^24 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 activities and dealings involving gene technology
Division 1—Simplified outline
^25 Simplified outline
The following is a simplified outline of this Part:

This Part deals with the regulation of all activities and dealings involving gene technology, including the contained use, deliberate release, marketing or placing on the market, import and export of GMO(s) or products thereof.This part prohibits activities and dealings involving gene technology unless the person undertaking the activity or dealing is authorised to do so by a licence issued by the Regulator.

Division 2—Engaging in activities or dealings involving gene technology must be licensed
^26 Persons not to engage in activities or dealings involving gene technology without a licence
(1) A person is guilty of an offence if:
(a) the person engages in an activity or dealing involving gene technology knowing that it is an activity or dealing involving gene technology; and
(b) the activity or dealing involving gene technology is not authorised by a licence issued under Part 5 of this Act.
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 a fine of not more than whichever of the following amounts applies:
(a) in the case of an aggravated offence—2,000 penalty units; or
(b) in any other case—500 penalty units.
Note: Section ^28 defines aggravated offence.
^27 Person must not breach conditions of a licence
(1) The holder of a 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; and
Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.
(2) A person covered by a licence is guilty of an offence if the person:
(a) 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) 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—2,000 penalty units; or
(b) in any other case—500 penalty units.
Note: Section ^29 defines aggravated offence.
^28 Aggravated offences—significant damage to health or safety or 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
^29 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 activities and dealings involving gene technology.
This Part sets out the processes to be followed by the Regulator in relation to all applications.
A licence can cover activities and 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.
This Part requires the Regulator to maintain a public register of licences.

Division 2—Licence applications
^30 Person must apply for a licence
(1) Any person who intends to engage in an activity or dealing involving gene technology, including the contained use, deliberate release, marketing or placing on the market, import or export of GMO(s) or products thereof, must apply in writing for a licence authorising such activity or dealing.
(2) The application must include:
(a) the information set out in Schedule I of this Act, in particular
(i) general information, including the details of the location(s) at which the activities or dealings are to be carried out;
(ii) information relating to the GMO(s) or products thereof;
(iii) information relating to the conditions of release, contained use or placing on the market and, where appropriate, the receiving environment;
(iv) information on the interaction between the GMO(s) or products thereof and the environment;
(v) information on monitoring, control, waste treatment, and emergency response plans;
(vi) in case of an application for contained use, an impact assessment setting out the consequences of unintentional release of the GMO(s) or products thereof;
(vii) a report on the impacts and risks posed by the GMO(s) or products thereof to human and animal health, biological diversity and the environment in accordance with the guidelines set out in Schedule III of this Act;
(viii) information on results from deliberate releases in the country and other countries of the GMO(s) or products thereof previously or currently carried out by the applicant;
(iii) information on previous approvals or rejections of the GMO(s) or products thereof by any other country, where approval is sought;
(iv) information on where and for what purposes the GMO(s) or products thereof will be marketed, together with detailed instructions for use and the proposed labelling and packaging, fulfilling the requirements specifies in Schedule II, Part C; and
(b) such information as is prescribed by the regulations; and
(c) such further information as is specified in writing by the Regulator.
(3) If there is insufficient information for the person applying for a licence to meet the requirements of subsection (2), the application must indicate such lack of information.
(4) The applicant may apply for a licence authorising such activities or dealings by:
(a) a specified person or persons; or
(b) a specified class of persons; or
(c) all persons.
(5) The application must be accompanied by the application fee prescribed by the regulations.
^31 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.
^32 Regulator must consider applications except in certain circumstances
(1) The Regulator must consider an application under section 30 or a licence in accordance with this Part.
(2) However, the Regulator is not required to consider the application if:
(a) the application does not contain the information required by the Regulator; or
(c) the application is not accompanied by the application fee prescribed by the regulations; or
(d) the applicant did not provide further information required by the Regulator by notice under section 31 within the period specified in the notice; or
(e) the Regulator is satisfied that to issue the licence would be inconsistent with a policy guideline in force under section 21.
(3) The Regulator must issue the licence, or refuse to issue the licence, within the period (if any) specified in the regulations.
Division 3—Consideration of applications for licences
^33 What the Regulator must do in relation to the application
(1) The Regulator must publish a notice in respect of the application:
(a) in the Gazette; and
(b) in a newspaper circulating generally in all States.
(2) The notice must:
(a) state that the application has been made; and
(b) state that a person may request further information about the application under section 36; and
(c) invite written submissions on whether the licence should be issued, being submissions about matters that the Regulator is required to take into account:
(i) under paragraph 34(2)(a) in preparing a risk assessment in relation to the dealings proposed to be authorised by the licence; and
(ii) under paragraph 34(3)(a) in preparing a risk management plan in relation to those dealings; and
(d) specify the closing date for submissions, which must not be earlier than 30 days after the date on which the notice was published.
(3) The Regulator must also seek advice on whether the licence should be issued and matters relevant to the preparation of a risk management plan under s 34 from:
(a) the Gene Technology Advisory Committee; and
(b) the States; and
(c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this section; and
(d) the Minister for the Environment; and
(e) the Gene Technology Community Consultative Group.

(4) Before the Regulator publishes the notice required by Section 33(1), the Regulator must ensure at a minimum that the following items are all recorded on the public register established under section 57:
(a) the application for the licence;
(b) the information required from an applicant for a licence under section 30;
(c) the name of the person(s) seeking the licence; and
(d) the details of the location(s) at which the activities or dealings are proposed to be carried out.
^34 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.
(2) In preparing the risk assessment, the Regulator must take into account the matters set out in Schedule III to this Act, in particular:
(a) the impacts and risks posed by the proposed activities or dealings involving gene technology to human and animal health, the environment and biological diversity.
(b) any submission made under paragraph 30(2)(c) in relation to such risks;
(c) any advice in relation to the risk assessment provided by the Gene Technology Advisory Committee in response to a request under paragraph 30(3)(a);
(d) any advice in relation to the risk assessment provided by a State in response to a request under paragraph 30(3)(b);
(e) any advice in relation to the risk assessment provided by a Commonwealth authority or agency in response to a request under paragraph 30(3)(c);
(f) any advice in relation to the risk assessment provided by the Gene Technology Community Consultative group in response to a request under paragraph 30(3)(d);
(g) all socio-economic impacts;
(h) conformity with ethical and cultural values and norms as specified in a policy guideline in force under paragraph 21;
(i) whether the proposed activities or dealings involving gene technology will contribute to and further promote the principles of ecologically sustainable environment.
(3) In preparing the risk management plan, the Regulator must take into account the following:
(a) the means of preventing, reducing and eliminating any risks posed by the proposed activities or dealings involving gene technology in such a way as to protect:
(i) the health and safety of humans and animals; and
(ii) the environment; and
(iii) biological diversity.

(b) any submission made under paragraph 30(2)(c) in relation to the means of managing such risks;
(c) any advice in relation to the risk management plan provided by the Gene Technology Advisory Committee in response to a request under paragraph 30(3)(a);
(d) any advice in relation to the risk management plan provided by a State in response to a request under paragraph 30(3)(b);
(e) any advice in relation to the risk management plan provided by a Commonwealth authority or agency in response to a request under paragraph 30(3)(c).
(f) any advice in relation to the risk assessment provided by the Gene Technology Community Consultative Group in response to a request under paragraph 30(3)(d).
^35 Public notification of risk assessment and risk management plan
(1) After taking the steps referred to in sections 33 and 34, the Regulator must publish a notice:
(a) in the Gazette; and
(b) in a newspaper circulating generally in all States.
(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 36; and
(c) invite written submissions in relation to the risk assessment and the risk management plan, and in relation to matters of national interest arising from the application for the licence; and
(d) specify the closing date for submissions, which must not be earlier than 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 Gene Technology Advisory Committee; and
(b) the States; and
(c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this section; and
(d) the Gene Technology Community Consultative Group.
^36 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 34.
(2) If a person makes a request under subsection (1), the Regulator must provide to the person a copy of the documents, other than any confidential commercial information contained in the documents.
Division 4—Decision on licence etc.
^37 Regulator must make a decision on licence and licence conditions
After taking any steps required by Division 3 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.
^38 Regulator must not issue the licence unless satisfied as to risk
(1) The Regulator must not issue the licence unless there is clear, convincing and sufficient evidence that the activities or dealings involving gene technology that are sought to be licensed, pose no significant risk to:
(a) the health and safety of people and animals; and
(b) the environment;
(c) biological diversity.
(2) For the purposes of subsection (1), the Regulator must have regard to the following:
(a) if a risk assessment has been prepared under section 34 in relation to those dealings—the risk assessment;
(b) if a risk management plan has been prepared under section 34 in relation to those dealings—the risk management plan;
(c) any submissions received under section 35 in relation to the licence;
(d) any policy guidelines or codes of practice in force under section 21 that relate to:
(i) risks that may be posed by the activities or 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 and animals, to protect the environment, or to protect biological diversity.

(3) In making a decision whether to issue a licence the Regulator must have regard to the precautionary principle.
(4) As used in this Act, the "precautionary principle" requires that a lack of full scientific certainty about risks should not be used as a reason for not taking measures or making decisions to prevent risks to human and animal health, the environment or biological diversity where there are threats of serious or irreversible damage, including measures and decisions such as refusing an application for the licence or imposing any condition or limitation on a licence.
(5) For the purpose of subsection (1):
(a) the Regulator shall determine whether insurance in any form is available to cover the risks associated with the activities or dealings involving gene technology for which the licence has been applied for.
(b) The lack of insurance shall constitute prima facie evidence that the risks are too high or uncertain for the licence to issue.
(6) For the purpose of subsection (1):
(a) The Regulator must consider the advice provided by the Minister under the Environment Protection and Biodiversity Conservation Act 1999.
(b) If the Minister advises that the activities or dealings involving gene technology that are sought to be licensed pose any significant risks or threats to the environment, the regulator must refuse to issue the licence.
^39 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 guideline 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.
^40 Ministerial Council must have regard to national interest
(1) If the Regulator is satisfied:
(a) that there are no significant risks to:
(i) the health and safety of people and animals; and
(ii) the environment; and
(iii) biological diversity
posed by the activities or dealings proposed to be authorised by the licence; and
(b) that issuing the licence would not be inconsistent with a policy guideline as mentioned in subsection 39(1); and
(c) that the applicant is a suitable person to hold the licence;
the Regulator must then refer the application to the Gene technology Ministerial Council as established by the Gene Technology Agreement.
(2) The Ministerial Council shall advise the Regulator whether the issuance of the licence comports with Australia`s national interest and international obligations and whether the national interest or international obligations require any specific conditions to be attached to the licence.
(3) If the Ministerial Council advises that issuing the licence is not in Australia`s national interest or is against Australia`s international obligations, the Regulator must refuse to issue the licence.
(4) If the Ministerial Council advises that Australia`s national interest or international obligations requires specific condition to be attached to the licence, the regulator shall attach such conditions to the licence.
(5) For the purpose of this section, the national interest includes matters specified in a policy guideline in force under section 22 as being matters of national interest.
^41 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 or of a State relating to public health or the environment.
(2) Without limiting the matters to which the Regulator may have regard in deciding whether a body corporate is a suitable person to hold the 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 or of a State relating to public health or the environment.
(d) any information contained in a directors` report setting out the details of performance in relation to environmental regulation as required by s 299(1)(f) of the Corporations Law (Cth)."
(3) In this section:
relevant conviction means a conviction for a crime or offence against the laws of any jurisdiction, whether an Australian jurisdiction or foreign jurisdiction relating to public health, the environment or biological diversity, 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).
^42 Notification of licence decision
The Regulator must notify the applicant in writing of the Regulator’s decision.
^43 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) In no event shall a licence exceed a five year period of duration, measured from the date of issues, without being required by the Regulator to be renewed.

Division 5—Conditions of licences
^44 Licence is subject to conditions
A licence is subject to the following conditions:
(a) the conditions set out in sections ^53, ^54 and ^55;
(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 ^58 after the licence is issued.
^45 Conditions that may be prescribed or imposed
(1) 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 public health and safety 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) conditions requiring compliance with a policy guideline or a code of practice, or a technical or procedural guideline;
(m) conditions relating to supervision by, and monitoring by, Institutional Biosafety Committees.
^46 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 of the following:
(a) any condition of the licence imposed by the Regulator that applies to the person, including any variations;
(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 to be a condition of the licence; or
(b) specified by the Regulator to be a condition of the licence.
(3) Such requirements may include, but are not limited to, measures relating to labelling, packaging, conducting training and providing information.
^47 Condition about monitoring and audits
(1) It is a condition of a licence that any person authorised by the licence to deal with a GMO 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.
(3) It is a condition of a licence that a licence holder must monitor and evaluate, on a continuing basis after the licence is issued, any risks associated with the activities or dealings involving gene technology that are subject to the licence.
(4) It is a condition of a licence that all licence holders must submit complete and accurate annual reports to the Regulator in respect of monitoring carried out under subsection (3).
(5) All information gathered as a result of monitoring or audits shall be made available to the public and must be kept on the register of licences established by Part 5, Division 8.
^48 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 associated with the dealings authorised by the licence that may pose risks:
(i) to the health and safety of people; or
(ii) to the environment; or
(b) becomes aware of any contraventions of the licence by a person covered by the licence.
(2) For the purposes of subsection (1), the licence holder is taken to have become aware of additional information or a contravention if, having regard to:
(a) his or her abilities, experience, qualifications and other attributes; and
(b) the nature of the information or the contravention concerned;
he or she ought reasonably to have become aware of the information or contravention.
^49 Condition about the imposition of adequate financial assurances
(1) It is a condition of a licence that the licence holder be required to post an adequate financial assurance with the Regulator to protect against any harm that may result as a result of the activities or dealings involving gene technology authorised by the licence.

(2) Without limiting the power of the Regulator to require appropriate financial assurance, the financial assurances that the Regulator may require include:
(a) bonds;
(b) insurance;
(c) bank guarantees;
(d) certificates of title.

^50 Conditions about emergency measures
The Regulator shall ensure that before any release of GMOs is made or contained use carried out:
(1) that a licence holder for such uses prepare an emergency plan for the protection of human and animal health, biological diversity and the environment in the event of an accident and the appropriate emergency and other services are informed of this plan in writing; and
(2) that the licence holder for such uses supply persons liable to be affected by the accident information on safety measures and procedures to adopt in the case of an accident. This information shall also be made available to the general public.

^51 Condition about animal welfare
It is a condition of every licence that relates to any activity or dealing involving any live animal that no application of gene technology to the animal is permitted that results in a such a genetic modification so as to render the animal unrecognisable as a member of its species or incapable of living in a manner normal to the species being utilised.
Division 6—Suspension, cancellation and variation of licences
^52 Suspension and cancellation of licence
The Regulator may, by notice in writing given to the licence holder, suspend or cancel a 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 is not in a position to implement, adequate measures to deal with those risks.
^53 Surrender of licence
A licence holder may, with the consent of the Regulator, surrender the licence.
^54 Variation of licence
(1) The Reglator may, at any time, by notice in writing given to the licence holder, vary a licence.
(2) However, the Regulator must not vary a licence to authorise activities or dealings involving the deliberate release or release of a GMO into the environment if the original application for the licencedid not seek to licence deliberate release or release.
(3) Without limiting subsection (1), the Regulator may:
(a) impose 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) Before the Regulator may vary a licence in accordance with this section, the Regulator must notify the public in accordance with the procedures in section 33 and invite written submissions on whether the licence should be varied.
(5) Part 5, Division 4 of this Act applies mutatis mutandis to the decisions of the Regulator to vary licences.
(6) The Regulator must also seek advice on whether the licence should be varied from:
(a) The Gene Technology Advisory Committee; and
(b) the States;
(c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this section; and
(d) the Gene Technology Community Consultative Group.
^55 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 28 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 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.

Division 7¾Review of licences
^56 Review of licences
(1) The Regulator is required to review each licence at intervals not exceeding 5 years after the issue of the licence.
(2) The Regulator must give public notice of the licences that are to be reviewed as follows:
(a) a notice of the review of each licence is to be published in a newspaper circulating throughout the country,
(b) the notice is to be published not less than 1 month, and not more than 6 months, before the review of the licence is undertaken,
(c) the notice is to specify the activities or dealings to which the licence relates and the location of the premises (if any) at which the activities or dealings are carried out.
(3) Part 5, Division 4 of this Act applies mutatis mutandis to the Regulator`s review of licences.
(4) The Regulator must also seek advice in connection with the review from:
(a) the Gene Technology Advisory Committee; and
(b) the States; and
(c) each Commonwealth authority or agency prescribed by the regulations for the purposes of this section; and
(d) the Gene Technology Community Consultative Group.

Division 8—Register of licences
^57 Register of licences
(1) The Regulator must maintain a register of licences (the Register) issued under section 37.
(2) The Register must contain the following information, other than confidential commercial information as established under Part 10, Division 3, in relation to each licence:
(a) the application for the licence, and if the application is denied, the reasons why the Regulator decided to refuse the licence;
(b) all information submitted in support of an application for a licence in accordance with section 30 and Schedule I of the Act;
(c) the name of the licence holder;
(d) the persons covered by the licence;
(e) the activities or dealings involving gene technology authorised by the licence;
(f) licence conditions:
(g) the date on which the licence was issued, and the reasons why the Regulator decided to issue the licence;
(h) all information collected in the course of monitoring and/or auditing in accordance with section 47 and Part 9, Division 3 of the Act;
(i) any variations, suspensions or cancellations of the licence under Part 5, Division 6 of the Act.
(3) The Register may be kept in a computerised form.
(4) The Regulator must ensure that the information mentioned in subsection (2) is entered on the Register as soon as reasonably practicable.
^58 Inspection of Register
(1) The Regulator must permit any person to inspect any part of the Register.
(2) If a person applies to the Regulator for a copy of an extract from the Register, the Regulator must give the copy or extract to that person.

Part 5A—Identification and labelling
^59 Requirements for identification and labelling
(1) Any GMO(s) or products thereof shall be clearly identified and labelled as such, and such identification shall specify the relevant traits and characteristics in sufficient detail for purposes of traceability.
(2) Products containing, or consisting of, GMO(s) shall be clearly labelled and packaged in accordance with Annex II, Part C, to indicate that it is, or has been, derived from GMO(s); and, where applicable, whether it may cause reactions, allergies or other side-effects.
Part 5B¾Export of GMOs or products thereof
^60 Approval required for export
(1) Any person who intends to export GMO(s) or products thereof must apply for and obtain approval for such export from the Regulator.
(2) There shall be no authorization for the export of GMO(s) or products thereof that do not have licences under this Act or that are prohibited from use by the laws of Australia.
^61 Advance informed agreement
(1) Any person who intends to export GMO(s) or products thereof shall provide the Regulator a written advance informed agreement of the competent authority of the importing country.
(2) The presentation of the advance informed agreement by an exporter shall in no way absolve the exporter from complying with any other laws governing foreign trade.

Part 6—The Gene Technology Advisory Committee and the Gene Technology Community Consultative Group
Division 1—Simplified outline
^62 Simplified outline
The following is a simplified outline of this Part:
This Part provides for the establishment of the Gene Technology Advisory Committee and the Gene Technology Community Consultative Group.
The Part sets out the membership of these bodies, and their functions.
In exercising their functions under the Act every member of the Gene Technology Advisory Committee and the Gene Technology Community Consultative Group shall be provided all information required to be provided in connection with every application for a licence under section 30 and Schedule I, regardless of whether it has been declared confidential under section 134, of this Act

Division 2—The Gene Technology Advisory Committee
^63 The Gene Technology Advisory Committee
(1) The Gene Technology Advisory Committee is established.
(2) The Minister is to appoint up to 20 members of the Committee, and must appoint one of the members to chair the Committee.
(3) The members hold office on a part﷓time basis.
(4) Before appointing a member of the Committee, the Minister must consult the following:
(a) the Regulator;
(b) the States;
(c) such scientific, consumer, health, environmental and industry groups as the Minister considers appropriate;
(d) such other Ministers as the Minister considers appropriate.
(5) The Minister must not appoint a person as a member of the Committee unless the Minister is satisfied that the person has skills or experience in one or more of the following areas:
(a) molecular biology;
(b) ecology;
(c) plant, microbial, animal or human genetics;
(d) virology;
(e) entomology;
(f) agricultural or aquicultural systems;
(g) biosafety engineering;
(h) public health;
(i) occupational health and safety;
(j) risk assessment;
(k) clinical medicine;
(l) biochemistry;
(m) pharmacy;
(n) plant or animal pathology;
(o) ethics;
(p) an area prescribed by the regulations for the purposes of this paragraph.
(6) In appointing the members of the Committee, the Minister must ensure, as far as practicable, that among the members as a whole there is a broad range of skills and experience in the areas mentioned in subsection (5).
(7) The Minister must not appoint a member to chair the Committee unless a majority of jurisdictions agree to the appointment under the terms of the Gene Technology Agreement.
^64 Functions of the Gene Technology Advisory Committee
The functions of the Gene Technology Advisory Committee are as follows:
(a) to provide scientific advice to the Regulator about gene technology, GMOs and GM products;
(b) to evaluate and report to the Regulator on applications made under this Act;
(c) to maintain an overview of the biosafety aspects of gene technology;
(d) to advise the Regulator about:
(i) the need for policy guidelines, codes of practice and technical and procedural guidelines in relation to GMOs and GM products; and
(ii) the content of such guidelines and codes, if requested by the Regulator to give such advice;
(e) such other functions in relation to gene technology, GMOs and GM products as are specified by the Regulator in writing.
^65 Expert advisers
The Minister may appoint a person (an expert adviser) to give expert advice to the Gene Technology Advisory Committee to assist it in the performance of its functions. A person that has had any connection or interest (financial or otherwise) with a regulated entity under this Act at any time during the previous two years immediately prior to appointment, may not serve as an expert adviser to the Gene Technology Advisory Committee.
^66 Remuneration
(1) A person who is a member of the Gene Technology Advisory Committee or an expert adviser is to be paid the remuneration that is determined by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, the member is to be paid the remuneration that is prescribed.
(2) A person who is a member of the Gene Technology Advisory Committee or an expert adviser is to be paid the allowances that are prescribed.
(3) This section has effect subject to the Remuneration Tribunal Act 1973.
^67 Members and procedures
(1) A person that has had any connection or interest (financial or otherwise) with a regulated entity under this Act at any time during the previous two years immediately prior to the proposed appointment, may not serve as a member of Gene Technology Advisory Committee.
(2) The regulations may prescribe matters relating to the members of the Gene Technology Advisory Committee and expert advisers, including, but not limited to, the following:
(a) term of appointment;
(b) resignation;
(c) disclosure of interests;
(d) termination of appointment;
(e) leave of absence.
(2) The regulations may prescribe matters relating to the operation of the Gene Technology Advisory Committee, including, but not limited to:
(a) procedures for convening meetings of the Committee; and
(b) the constitution of a quorum for a meeting of the Committee; and
(c) the way in which matters are to be resolved by the Committee; and
(d) Committee records and reports.
(3) If no regulations are in force under subsection (2), the Committee may operate in the way it determines.
^68 Subcommittees
(1) The Gene Technology Advisory Committee may, with the Regulator’s consent, establish subcommittees to assist in the performance of its functions.
(2) The regulations may prescribe matters relating to the constitution and operation of subcommittees.

Division 3—The Gene Technology Community Consultative Group
^69 The Gene Technology Community Consultative Group
The Gene Technology Community Consultative Group (the Consultative Group) is established.
^70 Functions
The function of the Consultative Group is to provide advice to the Regulator and to the Commonwealth and the States under the terms of the Gene Technology Agreement on either of the following:
(a) matters of general concern in relation to GMOs;
(b) existing or proposed policy guidelines and codes of practice.
(c) To evaluate and make recommendations to the Regulator on all applications for licences made under this Act.
^71 Membership
(1) The Minister is to appoint up to 12 members of the Consultative Group, and must appoint one of the members to chair the Consultative Group.
(2) Before appointing a member of the Consultative Group, the Minister must consult the following:
(a) the Regulator;
(b) the States;
(c) such scientific, consumer, health, environmental and industry groups as the Minister considers appropriate;
(d) such other Ministers as the Minister considers appropriate.
(3) The Minister must ensure, to the extent reasonably practicable:
(a) that the members of the Consultative Group are drawn from various sectors of the community; and
(b) that each member is capable of articulating the views of members of his or her community sector.
(4) The members of the Consultative Group hold office on a part﷓time basis.
(5) The Minister must not appoint a member to chair the Consultative Group unless a majority of jurisdictions agree to the appointment under the terms of the Gene Technology Agreement.
(6) A person that has had any connection or interest (financial or otherwise) with a regulated entity under this Act at any time during the previous two years immediately prior to the proposed appointment, may not serve as a member of Gene Technology Community Consultative Group.
^72 Expert advisers
The Minister may appoint a person (an expert adviser) to give expert advice to the Consultative Group to assist it in the performance of its functions. A person that has had any connection or interest (financial or otherwise) with a regulated entity under this Act at any time during the previous two years immediately prior to appointment, may not serve as an expert adviser to the Gene Technology Community Consultative Group.
^73 Remuneration
(1) A person who is a member of the Consultative Group or an expert adviser is to be paid the remuneration that is determined by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, the person is to be paid the remuneration that is prescribed.
(2) A person who is a member of the Consultative Group or an expert adviser is to be paid the allowances that are prescribed.
(3) This section has effect subject to the Remuneration Tribunal Act 1973.
^74 Regulations
(1) The regulations may prescribe matters relating to the members of the Consultative Group and to expert advisers, including, but not limited to, the following:
(a) term of appointment;
(b) resignation;
(c) disclosure of interests;
(d) termination of appointment;
(e) leave of absence.
(2) The regulations may provide for matters relating to the operation of the Consultative Group, including:
(a) procedures for convening meetings of the Consultative Group; and
(b) the constitution of a quorum for a meeting of the Consultative Group; and
(c) the way in which matters are to be resolved by the Consultative Group.
(3) If no regulations are in force under subsection (2), the Consultative Group may operate in the way it determines.

Part 7—Administration
Division 1—Simplified outline
^75 Simplified outline
The following is a simplified outline of this Part:
This Part provides for various administrative matters.
Division 2 sets out matters relating to the appointment, conditions and remuneration of the Regulator.
Division 3 provides for financial matters, including the establishment of a Special Account, called the Gene Technology Account.
Division 4 provides for matters relating to staffing.
Division 5 sets out reporting requirements.

Division 2—Appointment and conditions of Regulator
^76 Appointment of the Regulator
(1) The Regulator is to be appointed by the Governor﷓General by written instrument.
(2) The Regulator holds office for the period specified in the instrument of appointment. The period specified must not be less than 3 years or more than 5 years.
(3) The Regulator holds office on a full﷓time basis.
(4) A person that has had any connection or interest (financial or otherwise) with a regulated entity under this Act at any time during the previous two years immediately prior to the proposed appointment as Regulator is disqualified from serving as the Regulator
^77 Termination of appointment
(1) The Governor﷓General may terminate the appointment of the Regulator for misbehaviour or physical or mental incapacity.
(2) If the Regulator:
(a) becomes bankrupt, applies to take the benefit of any law for the relief of bankrupt or insolvent debtors, compounds with his or her creditors or makes an assignment of his or her remuneration for their benefit; or
(b) without the consent of the Minister, engages in any paid employment outside the duties of his or her office; or
(c) is absent from duty, except on leave of absence, for 14 consecutive days or for 28 days in any 12 months;
the Governor﷓General must terminate his or her appointment.
(3) The Governor﷓General must not terminate the appointment of the Regulator under subsection (1) unless a majority of jurisdictions agree to the termination of the appointment under the terms of the Gene Technology Agreement.
(4) If the Regulator is:
(a) an eligible employee for the purposes of the Superannuation Act 1976; or
(b) a member of the superannuation scheme established by deed under the Superannuation Act 1990;
the Governor﷓General may, with the consent of the Regulator, retire the Regulator from office on the grounds of physical or mental incapacity.
(5) For the purposes of the Superannuation Act 1976, the Regulator is taken to have been retired from office on the grounds of invalidity if:
(a) the Regulator is removed or retired from office on the grounds of physical or mental incapacity; and
(b) the Commonwealth Superannuation Board of Trustees No. 2 gives a certificate under section 54C of the Superannuation Act 1976.
(6) For the purposes of the Superannuation Act 1990, the Regulator is taken to have been retired from office on the grounds of invalidity if:
(a) the Regulator is removed or retired from office on the grounds of physical or mental incapacity; and
(b) the Commonwealth Superannuation Board of Trustees No. 1 gives a certificate under section 13 of the Superannuation Act 1990.

^78 Acting appointment
(1) The Minister may appoint a person to act as the Regulator:
(a) during a vacancy in the office of Regulator, (whether or not an appointment has previously been made to the office); or
(b) during any period, or during all periods, when the Regulator is absent from duty or from Australia, or is, for any reason, unable to perform the duties of the office.
(2) Anything done by or in relation to a person purporting to act under an appointment is not invalid merely because:
(a) the occasion for the appointment had not arisen; or
(b) there was a defect or irregularity in connection with the appointment; or
(c) the appointment had ceased to have effect; or
(d) the occasion to act had not arisen or had ceased.
^79 Terms and conditions
The Regulator holds office on the terms and conditions (if any) in relation to matters not covered by this Act that are determined by the Governor﷓General.
^80 Outside employment
The Regulator must not engage in paid employment outside the duties of the Regulator’s office.
^81 Remuneration
(1) The Regulator is to be paid the remuneration that is determined by the Remuneration Tribunal. If no determination of that remuneration by the Tribunal is in operation, the Regulator is to be paid the remuneration that is prescribed by the regulations.
(2) The Regulator is to be paid the allowances that are prescribed by the regulations.
(3) This section has effect subject to the Remuneration Tribunal Act 1973.
^82 Leave of absence
(1) The Regulator has the recreation leave entitlements that are determined by the Remuneration Tribunal.
(2) The Minister may grant the Regulator leave of absence, other than recreation leave, on the terms and conditions as to remuneration or otherwise that the Minister determines.
(3) During a leave of absence the Regulator may not take up employment with or receive remuneration from a regulated entity under this Act
^83 Resignation
The Regulator may resign his or her appointment by giving the Governor﷓General a written resignation.

Division 3—Money
^84 Regulator may charge for services
The Regulator may charge for services provided by the Regulator in the performance of the Regulator’s functions.
^85 Notional payments by the Commonwealth
(1) The purpose of this section is to ensure that fees and charges under this Act and the regulations, and charges under the Gene Technology (Licence Charges) Act 2000, are notionally payable by the Commonwealth (or parts of the Commonwealth).
(2) The Minister for Finance and Administration may give written directions for the purpose of this section, including directions relating to the transfer of amounts within, or between, accounts operated by the Commonwealth.
^86 Gene Technology Account
(1) The Gene Technology Account is established.
(2) The Account is a Special Account for the purposes of the Financial Management and Accountability Act 1997.
^87 Credits to Account
(1) There must be credited to the Account the following:
(a) all money appropriated by the Parliament for the purposes of the Account;
(b) amounts equal to money from time to time received by the Commonwealth under the Gene Technology (Licence Charges) Act 2000;
(c) amounts equal to fees received by the Commonwealth under subsection 30(5);
(d) amounts equal to amounts received by the Commonwealth in connection with the performance of the Regulator’s functions under this Act or the regulations;
(e) amounts equal to interest received by the Commonwealth from the investment of money from the Account;
(f) amounts equal to money received by the Commonwealth in relation to property paid for with money from the Account;
(g) amounts recovered by the Commonwealth under subsection 96(5), to the extent that they are referrable to costs paid out of the Account;
(h) amounts equal to amounts of any gifts given or bequests made for the purposes of the Account.
(2) The purposes of the Account are to make payments:
(a) to further the objects of this Act (as set out in section 3); and
(b) otherwise in connection with the performance of the Regulator’s functions under this Act or the regulations.
^88 Recovery of amounts
The following amounts may be recovered in a court of competent jurisdiction as debts due to the Commonwealth:
(a) amounts payable to the Commonwealth under the Gene Technology (Licence Charges) Act 2000;
(b) fees payable to the Commonwealth under this Act or the regulations;
(c) amounts payable to the Commonwealth in connection with the performance of the Regulator’s functions.
^89 Purposes of Account
Amounts standing to the credit of the Account may be expended:
(a) in payment or discharge of the costs, expenses and other obligations incurred by the Regulator in the performance of the Regulator’s functions or in the exercise of the Regulator’s powers under this Act or the regulations; and
(b) in payment of any remuneration and allowances payable to any person under this Act or the regulations.

Division 4—Establishment of Statutory Agency
^90 Statutory agency to assist the Regulator
There is established by this Act, for the purpose of assisting the Regulator in the performance of his or her functions, an independent statutory agency per s 7 of the Public Service Act 1999 by the name of the Australian Gene Technology Regulatory Agency.
^91 Constitution of statutory agency
(1) The persons who constitute the statutory agency established by the Act shall be persons appointed or employed under the Public Service Act 1999 and having duties for the purposes of the Agency.
(2) The Regulator has all the powers of, or exercisable by, an Agency Head under the Public Service Act 1999, so far as those powers relate to the branch of the Australian Public Service comprising the persons referred to in sub-section (1), as if that branch were a separate Department of the Australian Public Service.
^92 Seconded officers
The Regulator may be assisted by the following:
(a) officers and employees of Departments of the Australian Public Service;
(b) officers and employees of Commonwealth authorities;
(c) officers and employees of State agencies;
whose services are made available to the Regulator in connection with the performance or exercise of any of the Regulator’s functions or powers.

Division 5—Reporting requirements
^93 Annual Report
(1) As soon as practicable after the end of each financial year, the Regulator must prepare and give to the Minister a report on the operations of the Regulator during that year.
(2) The report must include details of directions given by the Minister during the financial year under paragraph 96(2)(a).
(3) The Minister must cause a copy of the report to be laid before each House of Parliament within 15 sitting days of the day on which the report was given to the Minister.
^94 Reports to Parliament
(1) The Regulator may at any time cause a report about matters relating to the Regulator’s functions to be tabled in either House of the Parliament.
(2) The Regulator must give a copy of the report to the Minister and to each State.

Part 8—Enforcement

^95 Simplified outline
The following is a simplified outline of this Part:
This Part enables the Regulator to give directions to a licence holder or to a person covered by a licence, if:
(a) the Regulator believes that the person is not complying with the Act or the regulations; and
(b) the Regulator believes that it is necessary to do so in order to protect the health and safety of people or to protect the environment.
The Part also empowers the Federal Court to issue injunctions, and contains a forfeiture provision.
^96 Regulator may give directions
(1) This section applies if:
(a) the Regulator believes, on reasonable grounds, that a licence holder, or a person covered by a GMO licence, is not complying with the Act or regulations in respect of a thing; and
(b) the Regulator believes that it is necessary to exercise powers under this section in order to protect the health and safety of people or to protect the environment.
(2) The Regulator may:
(a) give written directions to the licence holder, or to the person covered by the licence, requiring the licence holder or the person to take such steps in relation to the thing as the Regulator considers necessary for the person to comply with the Act or the regulations; or
(b) if the Regulator considers it necessary in order to avoid an imminent risk of death, serious illness, serious injury or to protect the environment from serious damage—take such steps in relation to the thing as the Regulator considers appropriate.
(3) A person commits an offence if he or she does not take the steps specified in a notice under paragraph (2)(a) within the time specified in the notice.
Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.
Maximum penalty:
(a) in the case of an aggravated offence—2,000 penalty units;
(b) in any other case—500 penalty units.
Note: Aggravated offence is defined in section 28.
(4) If the licence holder or the person does not take the steps specified in the notice within the time specified in the notice, the Regulator may arrange for those steps to be taken.
(5) If the Regulator incurs costs because of:
(a) steps taken by the Regulator under paragraph (2)(b); or
(b) arrangements made by the Regulator under subsection (4);
the licence holder or the person is liable to pay to the Commonwealth an amount equal to the cost, and the amount may be recovered by the Commonwealth as a debt due to the Commonwealth in a court of competent jurisdiction.
(6) Section 4K of the Crimes Act 1914 does not apply to an offence against subsection (3).
^97 Injunctions
(1) If a person has engaged, is engaging, or is about to engage in any conduct that is or would be an offence against this Act or the regulations, the Federal Court of Australia (the Court) may, on the application of the Regulator, or any other person, grant an injunction restraining the person from engaging in the conduct.
(2) If:
(a) a person has refused or failed, is refusing or failing, or is about to refuse or fail, to do a thing; and
(b) the refusal or failure is, or would be, an offence against this Act;
the Court may, on the application of the Regulator, or any other person, grant an injunction requiring the person to do the thing.
(3) The power of the Court to grant an injunction may be exercised:
(a) whether or not it appears to the Court that the person intends to engage, or to continue to engage, in conduct of that kind; and
(b) whether or not the person has previously engaged in conduct of that kind.
(4) The Court may discharge or vary an injunction granted under this section.
(5) The Court may grant an interim injunction pending a determination of an application under subsection (1).
(6) The powers granted by this section are in addition to, and not in derogation of, any other powers of the Court.
^98 Forfeiture
(1) If a court:
(a) convicts a person of an offence against this Act or the regulations; or
(b) makes an order under section 19B of the Crimes Act 1914 in respect of a person charged with an offence against this Act;
the court may order forfeiture to the Commonwealth of any substance or thing used or otherwise involved in the commission of the offence.
(2) A substance or thing ordered by a court to be forfeited under this section becomes the property of the Commonwealth and may be sold or otherwise dealt with in accordance with the directions of the Minister.
(3) Until the Minister gives a direction, the substance or thing must be kept in such custody as the Minister directs.

Part 9—Powers of inspection
Division 1—Simplified outline
^99 Simplified outline
The following is a simplified outline of this Part:
This Part provides for powers of inspection in relation to monitoring and offences.
Division 2 provides for the appointment of inspectors.
Divisions 3 to 6 deal with the powers and obligations of inspectors.
Division 7 deals with the rights and responsibilities of an occupier of premises when an inspector seeks to exercise powers.
Division 8 sets out procedures relating to monitoring warrants and offence-related warrants.
This Part does not limit the conditions to which a licence can be subject, and section 47 imposes a condition in relation to monitoring dealings with GMOs.

Division 2—Appointment of inspectors and identity cards
^100 Appointment of inspectors
(1) The Regulator may, by instrument in writing, appoint either of the following persons as an inspector:
(a) a person who is appointed or employed by the Commonwealth;
(b) a person who is appointed or employed by a State.
(2) In exercising powers or performing functions as an inspector, an inspector must comply with any directions of the Regulator.
^101 Identity card
(1) The Regulator must issue an identity card to an inspector.
(2) The identity card:
(a) must be in the form prescribed by the regulations; and
(b) must contain a recent photograph of the inspector.
(3) If a person to whom an identity card has been issued ceases to be an inspector, the person must return the identity card to the Regulator as soon as practicable.
Maximum penalty: 1 penalty unit.
(4) An inspector must carry his or her identity card at all times when exercising powers or performing functions as an inspector.

Division 3—Monitoring powers
^102 Powers available to inspectors for monitoring compliance
(1) For the purpose of finding out whether this Act or the regulations have been complied with, an inspector may:
(a) enter any premises; and
(b) exercise the monitoring powers set out in section 103.
(2) An inspector is not authorised to enter premises under subsection (1) unless:
(a) the occupier of the premises has consented to the entry; or
(b) the entry is made under a warrant under section 119; or
(c) the occupier of the premises is a licence holder, or a person covered by a licence, and the entry is at a reasonable time.
(d) exigent circumstances warrant the immediate entry.

^103 Monitoring powers
(1) The monitoring powers that an inspector may exercise under paragraph 102(1)(b) are as follows:
(a) to search the premises and any thing on the premises;
(b) to inspect, examine, take measurements of, conduct tests on, or take samples of, any thing on the premises that relates to a GMO;
(c) to take photographs, make video or audio recordings or make sketches of the premises or any thing on the premises;
(d) if the inspector was authorised to enter the premises by a warrant under section 119—to require any person in or on the premises to:
(i) answer any questions put by the inspector; and
(ii) produce any book, record or document requested by the inspector;
(e) to inspect any book, record or document on the premises;
(f) to take extracts from or make copies of any such book, record or document;
(g) to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises;
(h) to secure a thing:
(i) that the inspector finds during the exercise of monitoring powers on the premises; and
(ii) that the inspector believes on reasonable grounds is evidential material;
until a warrant is obtained to seize the thing.
(2) For the purposes of this Part, monitoring powers include the power to operate equipment at premises to see whether:
(a) the equipment; or
(b) a disk, tape or other storage device that:
(i) is at the premises; and
(ii) can be used with the equipment or is associated with it;
contains information that is relevant to determining whether there has been compliance with the Act.
(3) If the inspector, after operating equipment at the premises, finds that the equipment, or that a tape, disk or other storage device at the premises, contains information of that kind, the inspector may:
(a) operate facilities at the premises to put the information in documentary form and copy the document so produced; or
(b) if the information can be transferred to a tape, disk or other storage device that:
(i) is brought to the premises; or
(ii) is at the premises and the use of which for the purpose has been agreed to in writing by the occupier of the premises;
operate the equipment or other facilities to copy the information to the storage device, and remove the storage device from the premises.

Division 4—Offence-related powers
^104 Searches and seizures related to offences
(1) This section applies if an inspector has reasonable grounds for suspecting that there may be evidential material on any premises.
(2) The inspector may:
(a) enter the premises, with the consent of the occupier or under a warrant issued under section 120; and
(b) exercise the powers set out in subsection (3) and section 105; and
(c) if the entry is under a warrant—seize the evidential material, if the inspector finds it on the premises.
(3) If:
(a) in the course of searching, in accordance with a warrant, for a particular thing, an inspector finds another thing that the inspector believes on reasonable grounds to be evidential material; and
(b) the inspector believes, on reasonable grounds, that it is necessary to seize that other thing in order to prevent its concealment, loss or destruction, or its use in committing, continuing or repeating an offence against this Act or the regulations;
the warrant is taken to authorise the inspector to seize that other thing.
^105 Offence-related powers of inspectors in relation to premises
The powers an inspector may exercise under paragraph 104(2)(b) are as follows:
(a) to search the premises and any thing on the premises for the evidential material;
(b) to inspect, examine, take measurements of, conduct tests on, or take samples of the evidential material;
(c) to take photographs, make video or audio recordings or make sketches of the premises or the evidential material;
(d) to take onto the premises such equipment and materials as the inspector requires for the purpose of exercising powers in relation to the premises.
^106 Use of electronic equipment at premises
(1) The inspector may operate electronic equipment at the premises to see whether evidential material is accessible by doing so if the inspector believes on reasonable grounds that the operation of the equipment can be carried out without damage to the equipment.
(2) If the inspector, after operating the equipment, finds that evidential material is accessible by doing so, the inspector may:
(a) seize the equipment and any disk, tape or other associated device; or
(b) if the material can, by using facilities at the premises, be put in documentary form—operate the facilities to put the material in that form and seize the documents so produced; or
(c) if the material can be transferred to a disk, tape or other storage device that:
(i) is brought to the premises; or
(ii) is at the premises and the use of which for the purpose has been agreed to in writing by the occupier of the premises;
operate the equipment or other facilities to copy the material to the storage device and take the storage device from the premises.
(3) An inspector may seize equipment under paragraph (2)(a) only if:
(a) it is not practicable to put the material in documentary form as mentioned in paragraph (2)(b) or to copy the material as mentioned in paragraph (2)(c); or
(b) possession by the occupier of the equipment could constitute an offence.
(4) An inspector may seize equipment under paragraph (2)(a) or documents under paragraph (2)(b) only if the inspector entered the premises under a warrant.
^107 Expert assistance to operate electronic equipment
(1) If the inspector believes on reasonable grounds that:
(a) evidential material may be accessible by operating electronic equipment at the premises; and
(b) expert assistance is required to operate the equipment; and
(c) if he or she does not take action under this subsection, the material may be destroyed, altered or otherwise interfered with;
he or she may do whatever is necessary to secure the equipment, whether by locking it up, placing a guard or otherwise.
(2) The inspector must give notice to the occupier of the premises of his or her intention to secure equipment and of the fact that the equipment may be secured for up to 24 hours.
(3) The equipment may be secured:
(a) for a period not exceeding 24 hours; or
(b) until the equipment has been operated by the expert;
whichever happens first.
(4) If the inspector believes on reasonable grounds that the expert assistance will not be available within 24 hours, he or she may apply to the magistrate for an extension of that period.
(5) The inspector must give notice to the occupier of the premises of his or her intention to apply for an extension, and the occupier is entitled to be heard in relation to the application.

Division 5—Emergency powers
^108 Powers available to inspectors for dealing with dangerous situations
(1) This section applies if:
(a) an inspector has reasonable grounds for suspecting that there may be on any premises a particular thing in respect of which this Act or the regulations have not been complied with; and
(b) the inspector considers that it is necessary in the interests of public health to exercise powers under this section in order to avoid an imminent risk of death, serious illness, serious injury, or to protect the environment.
(2) The inspector may do any of the following:
(a) enter the premises;
(b) search the premises for the thing;
(c) secure the thing, if the inspector finds it on the premises, until a warrant is obtained to seize the thing;
(d) if the inspector has reasonable grounds for suspecting that a person has not complied with this Act or the regulations in respect of the thing—require the person to take such steps that the inspector considers necessary for the person to comply with this Act or the regulations.
(3) The inspector may exercise the powers in subsection (2) only to the extent that it is necessary for the purpose of avoiding an imminent risk of death, serious illness, serious injury or serious damage to the environment.

Division 6—Obligations and incidental powers of inspectors
^109 Inspector must produce identity card on request
An inspector is not entitled to exercise any powers under this Part in relation to premises if:
(a) the occupier of the premises has required the inspector to produce his or her identity card for inspection by the occupier; and
(b) the inspector fails to comply with the requirement.
^110 Consent
(1) Before obtaining the consent of a person for the purposes of paragraph 102(2)(a) or 104(2)(a), the inspector must inform the person that he or she may refuse consent.
(2) An entry of an inspector by virtue of the consent of a person is not lawful unless the person voluntarily consented to the entry.
^111 Details of warrant to be given to occupier etc.
(1) If a warrant in relation to premises is being executed and the occupier of the premises or another person who apparently represents the occupier is present at the premises, the inspector must make available to that person a copy of the warrant.
(2) The inspector must identify himself or herself to that person.
(3) The copy of the warrant referred to in subsection (1) need not include the signature of the magistrate who issued the warrant.
^112 Announcement before entry
(1) An inspector must, before entering premises under a warrant:
(a) announce that he or she is authorised to enter the premises; and
(b) give any person at the premises an opportunity to allow entry to the premises.
(2) An inspector is not required to comply with subsection (1) if he or she believes on reasonable grounds that immediate entry to the premises is required:
(a) to ensure the safety of a person; or
(b) to prevent serious damage to the environment; or
(c) to ensure that the effective execution of the warrant is not frustrated.
^113 Compensation for damage to electronic equipment
(1) The owner of equipment is entitled to compensation for damage to the equipment if:
(a) the damage was caused to the equipment as a result of it being operated as mentioned in section 103 or 106; and
(b) the damage was caused as a result of:
(i) insufficient care being exercised in selecting the person who was to operate the equipment; or
(ii) insufficient care being exercised by the person operating the equipment.
(2) Compensation is payable out of money appropriated by the Parliament for the purpose.
(3) In determining the amount of compensation payable, regard is to be had to whether the occupier of the premises and his or her employees and agents, if they were available at the time, had provided any warning or guidance as to the operation of the equipment that was appropriate in the circumstances.

Division 7—Occupier’s rights and responsibilities
^114 Copies of seized things to be provided
(1) Subject to subsection (2), if an inspector seizes, under a warrant relating to premises:
(a) a document, film, computer file or other thing that can be readily copied; or
(b) a storage device the information in which can be readily copied;
the inspector must, if requested to do so by the occupier of the premises, or another person who apparently represents the occupier and who is present when the warrant is executed, give a copy of the thing or the information to that person as soon as practicable after the seizure.
(2) Subsection (1) does not apply if:
(a) the thing that has been seized was seized under paragraph 106(2)(b) or (c); or
(b) possession by the occupier of the document, film, computer file, thing or information could constitute an offence.
^115 Occupier entitled to be present during search
(1) If a warrant in relation to premises is being executed and the occupier of the premises, or another person who apparently represents the occupier is present at the premises, the person is entitled to observe the search being conducted.
(2) The right to observe the search being conducted ceases if the person impedes the search.
(3) This section does not prevent 2 or more areas of the premises being searched at the same time.
^116 Receipts for things seized under warrant
(1) If a thing is seized under this Part, the inspector must provide a receipt for the thing.
(2) If 2 or more things are seized, they may be covered in the one receipt.
^117 Retention of seized things
(1) Subject to any contrary order of a court, if an inspector seizes a thing under this Part, the inspector must return it if:
(a) the reason for its seizure no longer exists or it is decided that it is not to be used in evidence; or
(b) the period of 60 days after its seizure ends;
whichever first occurs, unless the thing is forfeited or forfeitable to the Commonwealth.
(2) At the end of the 60 days specified in subsection (1), an inspector must take reasonable steps to return the thing to the person from whom it was seized, unless:
(a) proceedings in respect of which the thing may afford evidence were instituted before the end of the 60 days and have not been completed (including an appeal to a court in relation to those proceedings); or
(b) an inspector may retain the thing because of an order under section 118; or
(c) to return the thing could cause an imminent risk of death, serious illness, serious injury or serious damage to the environment; or
(d) an inspector is otherwise authorised (by a law, or an order of a court, of the Commonwealth or of a State) to retain, destroy or dispose of the thing.
(3) The thing may be returned under subsection (2) either unconditionally or on such terms and conditions as the Regulator sees fit.
^118 Magistrate may permit a thing to be retained
(1) An inspector may apply to a magistrate for an order that he or she may retain the thing for a further period if:
(a) before the end of 60 days after the seizure; or
(b) before the end of a period previously specified in an order of a magistrate under this section;
proceedings in respect of which the thing may afford evidence have not commenced.
(2) If the magistrate is satisfied that it is necessary for an inspector to continue to retain the thing:
(a) for the purposes of an investigation as to whether an offence against this Act has been committed; or
(b) to enable evidence of an offence against this Act to be secured for the purposes of a prosecution;
the magistrate may order that an inspector may retain the thing for a period (not being a period exceeding 3 years) specified in the order.
(3) Before making the application, the inspector must:
(a) take reasonable steps to discover who has an interest in the retention of the thing; and
(b) if it is practicable to do so, notify each person whom the inspector believes to have such an interest of the proposed application.

Division 8—Warrants
^119 Monitoring warrants
(1) An inspector may apply to a magistrate for a warrant under this section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant if the magistrate is satisfied, by information on oath, that it is reasonably necessary that one or more inspectors should have access to the premises for the purposes of finding out whether this Act or the regulations have been complied with.
(3) The magistrate must not issue the warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought.
(4) The warrant must:
(a) authorise one or more inspectors (whether or not named in the warrant), with such assistance and by such force as is necessary and reasonable:
(i) to enter the premises; and
(ii) to exercise the powers set out in section 103 in relation to the premises; and
(b) state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and
(c) specify the day (not more than 6 months after the issue of the warrant) on which the warrant ceases to have effect; and
(d) state the purpose for which the warrant is issued.
^120 Offence-related warrants
(1) An inspector may apply to a magistrate for a warrant under this section in relation to premises.
(2) Subject to subsection (3), the magistrate may issue the warrant if the magistrate is satisfied, by information on oath, that there are reasonable grounds for suspecting that there is, or there may be within the next 72 hours, evidential material in or on the premises.
(3) The magistrate must not issue the warrant unless the inspector or some other person has given to the magistrate, either orally or by affidavit, such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought.
(4) The warrant must:
(a) name one or more inspectors; and
(b) authorise the inspectors so named, with such assistance and by such force as is necessary and reasonable:
(i) to enter the premises; and
(ii) to exercise the powers set out in subsection 104(3) and section 105; and
(iii) to seize the evidential material; and
(c) state whether the entry is authorised to be made at any time of the day or night or during specified hours of the day or night; and
(d) specify the day (not more than one week after the issue of the warrant) on which the warrant ceases to have effect; and
(e) state the purpose for which the warrant is issued.
^121 Offence-related warrants by telephone
(1) If, in an urgent case, an inspector considers it necessary to do so, the inspector may apply to a magistrate by telephone for a warrant under section 120 in relation to premises.
(2) Before applying for the warrant, the inspector must prepare an information of the kind mentioned in subsection 120(2) in relation to the premises that sets out the grounds on which the warrant is sought.
(3) If it is necessary to do so, the inspector may apply for the warrant before the information is sworn.
(4) If the magistrate is satisfied:
(a) after having considered the terms of the information; and
(b) after having received such further information (if any) as the magistrate requires concerning the grounds on which the issue of the warrant is being sought;
that there are reasonable grounds for issuing the warrant, the magistrate may complete and sign the same warrant that the magistrate would issue under section 120 if the application had been made under that section.
(5) If the magistrate completes and signs the warrant:
(a) the magistrate must:
(i) tell the inspector what the terms of the warrant are; and
(ii) tell the inspector the day on which and the time at which the warrant was signed; and
(iii) tell the inspector the day (not more than one week after the magistrate completes and signs the warrant) on which the warrant ceases to have effect; and
(iv) record on the warrant the reasons for granting the warrant; and
(b) the inspector must:
(i) complete a form of warrant in the same terms as the warrant completed and signed by the magistrate; and
(ii) write on the form the name of the magistrate and the day on which and the time at which the warrant was signed.
(6) The inspector must also, not later than the day after the day of expiry or execution of the warrant, whichever is the earlier, send to the magistrate:
(a) the form of warrant completed by the person; and
(b) the information referred to in subsection (2), which must have been duly sworn.
(7) When the magistrate receives those documents, the magistrate must:
(a) attach them to the warrant that the magistrate completed and signed; and
(b) deal with them in the way in which the magistrate would have dealt with the information if the application had been made under section 120.
(8) A form of warrant duly completed under subsection (5) is authority for any entry, search, seizure or other exercise of a power that the warrant signed by the magistrate authorises.
(9) If:
(a) it is material, in any proceedings, for a court to be satisfied that an exercise of a power was authorised by this section; and
(b) the warrant signed by the magistrate authorising the exercise of the power is not produced in evidence;
the court must assume, unless the contrary is proved, that the exercise of the power was not authorised by such a warrant.
(10) A reference in this Part to a warrant under section ^136 includes a reference to a warrant signed by a magistrate under this section.
^122 Offences relating to warrants
(1) An inspector must not make, in an application for a warrant, a statement that the inspector knows to be false or misleading in a material particular.
Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.
Maximum penalty: Imprisonment for 2 years.
(2) An inspector must not:
(a) state in a document that purports to be a form of warrant under section 121 the name of a magistrate unless that magistrate issued the warrant; or
(b) state on a form of warrant under that section a matter that, to the inspector’s knowledge, departs in a material particular from the form authorised by the magistrate; or
(c) purport to execute, or present to another person, a document that purports to be a form of warrant under that section that the inspector knows:
(i) has not been approved by a magistrate under that section; or
(ii) to depart in a material particular from the terms authorised by a magistrate under that section; or
(d) give to a magistrate a form of warrant under that section that is not the form of warrant that the inspector purported to execute.
Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.
Maximum penalty: Imprisonment for 2 years.

Division 9—Other matters
^123 Part not to abrogate privilege against self-incrimination
Nothing in this Part affects the right of a person to refuse to answer a question, give information, or produce a document, on the ground that the answer to the question, the information, or the production of the document, might tend to incriminate him or her or make him or her liable to a penalty.
^124 Part does not limit power to impose licence conditions
This Part is not to be taken to limit the Regulator’s power to impose licence conditions.

Part 10—Miscellaneous
Division 1—Simplified outline
^125 Simplified outline
The following is a simplified outline of this Part:
This Part provides for the following:
(a) review of decisions;
(b) provisions relating to confidential commercial information;
(c) the making of regulations.

26
Division 1A¾Civil liability and redress
^126 Civil liability and redress
(1) Any person who carries out any activity in relation to GMO(s) or products thereof shall be strictly liable for any harm, injury or loss caused directly or indirectly by such GMO(s) or products thereof or any activity in relation to them. The harm, injury or loss includes personal injury, damage to property, financial loss and damage to the environment or to biological diversity .
(2) Liability shall attach to the licence holder, the person responsible for the activity which results in the damage, injury or loss, as well as to the provider, supplier or developer of the GMO(s) or products thereof.
(3) Where liability under this section is incurred by a body corporate, any director, manager, secretary or similar officer of the body corporate shall be similarly liable unless he/she can show that he/she did everything in his/her power to prevent the import, deliberate release, placing on the market or contained use which caused the damage in question.
(4) If there is more than one person responsible for the damage, injury or loss, then the liability shall be joint and several.
(5) Where proceedings are brought against more than one person it shall not be a requirement for the person bringing the proceedings to identify the person who caused the damage in question, provided that he/she can prove that one or more of the persons so proceeded against could have caused the damage.
(6) In the case of harm to the environment or to biological diversity, redress shall include the costs of reinstatement, rehabilitation or clean-up measures actually incurred or to be incurred and, where applicable, the costs of preventive measures and any loss or damage caused by the taking of the preventive measures; provided that the person responsible may be required to carry out the reinstatement or rehabilitation at its own cost and to the satisfaction of the competent authority.
(7) Liability shall also extend to harm or damage caused directly or indirectly by the GMO(s) or products thereof to the economy, social or cultural practices, livelihoods, indigenous knowledge systems, or indigenous technologies. Such harm includes the following: disruption or damage to production systems, agricultural systems, reduction in yields, and damage to the economy of an area or community.
(8) A licence holder shall indemnify:
(a) any other person who deliberately releases or markets GMO(s) or products thereof; and
(b) any person who manufactures, processes or markets food, food ingredients or animal feed containing or derived from GMO(s) against any civil liability where the GMO(s) or products thereof in question was first imported, deliberately released, used in contained conditions, or placed on the market by the applicant.
(9) A licence holder shall indemnify against any civil liability any person who fails to label seeds, food, a food ingredient or animal feed containing or derived from GMO(s), but where the licence holder can show that he took all reasonable steps to prevent such failure the indemnity shall not apply.
(10) The right to bring any action to redress the harm caused by the GMO(s) or products thereof shall lapse only after a reasonable period from the date on which the affected person or community could reasonably be expected to have learned of the harm, taking due account of:
(a) the time the harm may take to manifest itself; and
(b) the time that it may reasonably take to co-relate the harm with the GMO(s) or products thereof, having regard to the situation or circumstance of the person or community affected.

(11) Any person or group of persons is entitled to bring a claim and seek relief in respect of the breach or threatened breach of any provision of this Act, including any provision relating to damage to the environment and biological diversity:
(a) in that person`s or group of person`s interest;
(b) in the interest of, or on behalf of, a person who is, for practical reasons, unable to institute such proceedings;
(c) in the interest of, or on behalf of, a group or class of persons whose interests are affected;
(d) in the public interest; and
(e) in the interest of protecting the environment or biological diversity.

(12) No costs shall be awarded against any of the above persons who fail in any action as aforesaid if the action was instituted reasonably out of concern for the public interest or in the interest of protecting the environment or biological diversity.
(13) It shall not be a defence to any claim for compensation or damage that the activity had been consented to by the competent authority.

Division 2—Review of decisions
^127 Meaning of terms
The following table sets out:
(a) decisions that are reviewable decisions; and
(b) each eligible person in relation to a reviewable decision:

Reviewable decisions and eligible persons
Item Decision Provision under which decision made Eligible person in relation to decision
1 To grant of refuse to issue a licence section 37 The applicant for a licence or any person who has made a submission in accordance with the Act
2 To impose a licence condition section 37 The applicant for a licence or any person who has made a submission in accordance with the Act
3 To cancel or suspend a licence section 52 the licence holder
4 To vary a licence section 54 The licence holder or any person who has made a submission in accordance with the Act
5 To refuse to declare information to be confidential commercial information section 134 the person who made an application under section 133 in relation to the information
6 To revoke a declaration that information is confidential commercial information section 135 the person who made an application under section 133 in relation to the information
7 To declare information is confidential commercial information Section 134 Any person objecting to the declaration
^128 Notification of decisions and review rights
(1) The Regulator must, as soon as practicable after making a reviewable decision, cause a notice in writing to be given to each eligible person in relation to the decision, containing:
(a) the terms of the decision; and
(b) the reasons for the decision; and
(c) a statement setting out particulars of the person’s review rights.
(2) A failure to comply with the requirements of subsection (1) in relation to a decision does not affect the validity of the decision.
^129 Internal review
(1) An eligible person in relation to a reviewable decision (other than a decision made by the Regulator personally) may apply in writing to the Regulator for review (internal review) of the decision.
(2) An application for internal review must be made within 30 days after the day on which the decision first came to the notice of the applicant, or within such period (if any) as the Regulator, either before or after the end of that period, allows.
(3) The Regulator must, on receiving an application, review the reviewable decision personally.
(4) The Regulator may:
(a) make a decision affirming, varying or revoking the reviewable decision; and
(b) if the Regulator revokes the decision, make such other decision as the Regulator thinks appropriate.
^130 Deadlines for making reviewable decisions
If:
(a) this Act provides for a person to apply to the Regulator to make a reviewable decision; and
(b) a period is specified under this Act or the regulations for giving notice of the decision to the applicant; and
(c) the Regulator has not notified the applicant of the Regulator’s decision within that period;
the Regulator is taken, for the purposes of this Act, to have made a decision to reject the application.
^131 Review of decisions by Administrative Appeals Tribunal
(1) Subject to the Administrative Appeals Tribunal Act 1975, an application may be made by an eligible person in relation to:
(a) a reviewable decision made by the Regulator personally; or
(b) a decision made by the Regulator under section 129 (which provides for internal review).
(2) In this section:
decision has the same meaning as in the Administrative Appeals Tribunal Act 1975.

Division 3—Confidential commercial information
^132 Application for protection of confidential commercial information
(1) A person may apply to the Regulator for a declaration that specified information is confidential commercial information for the purposes of this Act.
(3) An application under subsection (1) must be in writing in the approved form.
^133 Establishing confidential commercial
(1) All information collected under the Act shall be presumed to be publicly available.
(2) The person applying for a declaration under section 147 must establish beyond reasonable doubt the following matters to the satisfaction of the Regulator before the Regulator can make a declaration that information is confidential commercial information for the purposes of this Act:
(a) that the information has not already been disclosed anywhere in the world;
(b) that another law, in Australia or in any other country, does not require disclosure of the information;
(c) that keeping the information confidential would not create a significant risk to human or animal safety, the environment or biological diversity;
(d) that disclosure would cause significant financial harm to the person seeking the declaration; and
(e) that the information claimed to be confidential is not readily discoverable through reverse engineering or other scientific means.
^134 Regulator may declare that information is to be treated as confidential commercial information
(1) If the Regulator is satisfied that the information specified in the application is:
(a) a trade secret; or
(b) any other information that has a commercial or other value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or
(c) other information that:
(i) concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and
(ii) if it were disclosed, could unreasonably affect the person, organisation or undertaking;
the Regulator may declare that the information is confidential commercial information for the purposes of this Act, unless the Regulator is satisfied that the public interest in disclosure of the information outweighs the prejudice that the disclosure would cause to any person.
(2) The Regulator must notify the general public of the Regulator`s decision about the application by notice in the Gazette, and must give the person seeking the declaration written notice of the decision.
(3) If the Regulator refuses an application under subsection (1) in relation to information, the information is to be treated as confidential commercial information until any review rights under section 129 or 131 in relation to the application are exhausted.
(4) In no case may the following information be kept confidential:
(a) description of the GMO(s) or products thereof, names and addresses of the applicant, purpose and location of the import, deliberate release (including the location and scale of the release), contained use or placing on the market of the GMO(s) or products thereof;
(b) methods and plans for monitoring of the GMO(s) or products thereof and for emergency response;
(c) the evaluation of foreseeable effects, in particular any pathogenic and/or ecologically disruptive effects;
(d) the fact that the GMO(s) or products thereof have been banned or subject to stringent conditions in any other jurisdiction.
(5) The Regulator may make available any information collected under the Act to the public or to a class of individuals or group of individuals notwithstanding that the information may be commercially confidential, if the Regulator decides that it is in the public interest to do so.
(6) The Regulator must make available any information collected under the Act to the public or to a class of individuals or group of individuals notwithstanding that the information may be commercially confidential, if the information is necessary to protect for serious harm, human or animal health or safety, the environment or biological diversity.
^135 Revocation of declaration
(1) The Regulator may, by written notice given to the applicant, revoke a declaration under section 134 if the Regulator is satisfied:
(a) that the information concerned no longer satisfies paragraph 134(1)(a), (b) or (c); or
(b) that the public interest in disclosure of the information outweighs the prejudice that disclosure would cause to any person.
(2) A revocation by the Regulator under subsection (1) does not take effect until any review rights under section 129 or 131 in relation to the revocation are exhausted.
^136 Confidential commercial information must not be disclosed
(1) A person who:
(a) has confidential commercial information; and
(b) has it only because of performing duties or functions under this Act; and
(c) knows that the information is confidential commercial information;
must not disclose the information except:
(d) in the course of carrying out duties or functions under this Act; or
(e) by order of a court; or
(f) with the consent of the person who applied to have the information treated as confidential commercial information.
Note: Chapter 2 of the Criminal Code sets out the general principles of criminal responsibility.
Maximum penalty: Imprisonment for one year.
(2) For the avoidance of doubt, subsection (1) does not prohibit the disclosure by the Regulator, or by a person authorised by the Regulator, of confidential commercial information to:
(a) the Commonwealth or a Commonwealth authority; or
(b) a State agency; or
(c) the Gene Technology Advisory Committee;
for the purpose of facilitating the giving of advice mentioned in section 33(3) or 35(3) in relation to an application.

Division 4—Conduct by directors, employees and agents
^137 Conduct by directors, employees and agents
(1) If, in proceedings for an offence against this Act or the regulations, or an ancillary offence in relation to this Act or the regulations, it is necessary to establish the state of mind of a body corporate in relation to particular conduct, it is sufficient to show:
(a) that the conduct was engaged in by a director, employee or agent of the body corporate within the scope of his or her actual or apparent authority; and
(b) that the director, employee or agent had the state of mind.
(2) Any conduct engaged in on behalf of a body corporate by a director, employee or agent of the body corporate within the scope of his or her actual or apparent authority is taken, for the purposes of a prosecution for:
(a) an offence against this Act or the regulations; or
(b) an ancillary offence relating to this Act or the regulations;
to have been engaged in also by the body corporate, unless the body corporate establishes that the body corporate took reasonable precautions and exercised due diligence to avoid the conduct.
(3) If, in proceedings for an ancillary offence relating to this Act or the regulations, it is necessary to establish the state of mind of a person other than a body corporate in relation to particular conduct, it is sufficient to show:
(a) that the conduct was engaged in by an employee or agent of the person within the scope of his or her actual or apparent authority; and
(b) that the employee or agent had the state of mind.
(4) Any conduct engaged in on behalf of a person (the first person), other than a body corporate, by an employee or agent of the first person, within the scope of the actual or apparent authority of the employee or agent is taken, for the purposes of a prosecution for:
(a) an offence against this Act or the regulations; or
(b) an ancillary offence relating to this Act or the regulations;
to have been engaged in also by the first person unless the first person establishes that he or she took reasonable precautions and exercised due diligence to avoid the conduct.
(5) If:
(a) a person other than a body corporate is convicted of an offence; and
(b) the person would not have been convicted of the offence if subsections (3) and (4) had not been enacted;
the person is not liable to be punished by imprisonment for that offence.
^138 Meaning of terms
(1) A reference in subsection 137(1) or (3) to the state of mind of a person includes a reference to:
(a) the knowledge, intention, opinion, belief or purpose of the person; and
(b) the person’s reasons for the intention, opinion, belief or purpose.
(2) A reference in section 137 to a director of a body corporate includes a reference to a constituent member of a body corporate incorporated for a public purpose by a law of the Commonwealth or a State.
(3) A reference in section 137 to engaging in conduct includes a reference to failing or refusing to engage in conduct.
(4) A reference in section 137 to an ancillary offence relating to this Act or the regulations is a reference to an offence created by section 5, 6, 7 or 7A or subsection 86(1) of the Crimes Act 1914 that relates to this Act or the regulations.

Division 5—Regulations
^139 Regulations
(1) The Governor﷓General may make regulations prescribing matters:
(a) required or permitted by this Act to be prescribed; or
(b) necessary or convenient to be prescribed for carrying out or giving effect to this Act.
(2) Without limiting subsection (1), the regulations may require a person to comply with codes of practice or guidelines as in force at a particular time or from time to time.

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Schedule I

Information Required for the Application
------------------------------------------------------------------------

I. General information

A. Name and address of applicant

B. Information on personnel and training

1 Name of person(s) responsible for planning and carrying out the release, including those responsible for supervision, monitoring and safety, in particular, name and qualification(s) of the responsible scientist(s)

2. Information on training and qualification(s) of personnel involved in carrying out the release

II. Information relating to the GMO(s) or products thereof

A. Characteristics of a) the donor, b) the recipient or c) (where appropriate) parental organism(s)

1. Scientific name
2. Taxonomy
3. Other names (usual name, strain name, cultivar name etc.).
4. Phenotypic and genetic markers
5. Degree of relatedness between donor and recipient or between parental organisms
6. Description of identification and detection techniques
7. Sensitivity, reliability (in quantitative terms) and specificity of detention and identification techniques
8. Description of the geographic distribution and of the natural habitat of the organisms including information on natural predators, preys, parasites and competitors, symbionts and hosts
9. Potential for genetic transfer and exchange with other organisms
10. Verification of the genetic stability of the organisms and factors affecting it, taking into account the relevance of the laboratory experiments undertaken for the authentic ecological conditions under which the organisms live or are used
11. Pathological, ecological and physiological traits:

(a) Classification of hazard according to existing national rules concerning the protection of human health and/or environment
(b) Generation time in natural ecosystems, sexual and asexual reproductive cycle
(c) Information on survival, including seasonability and the ability to form survival structures e.g.: seeds, spores or sclerotia
(d) Pathogenicity: infectivity, toxigenicity, virulence, allergenicity, carrier (vector) of pathogen, possible vectors, host range including non-target organisms. Possible activation of latent viruses (proviruses).

Ability to colonize other organisms

(e) Antibiotic resistance, and potential use of these antibiotics in humans and domestic organisms for prophylaxis and therapy
(f) Involvement in environmental processes: primary production, nutrient turnover, decomposition of organic matter, respiration, etc.

12. Nature of indigenous vectors:

(a) Sequence
(b) Frequency of mobilization
(c) Specificity
(d) Presence of genes which confer resistance

13. History of previous genetic modifications

B. Characteristics of the vector

1. Nature and source of the vector
2. Sequence of transposons, vectors and other non-coding genetic segments used to construct the GMO(s) or products thereof and to make the introduced vector and insert function in the GMO(s) or products thereof
3. Frequency of mobilization of inserted vector and/or genetic transfer capabilities and methods of determination
4. Information on the degree to which the vector is limited to the DNA required to perform the intended function
5. Factors (chemical, biological, climatic, etc.) influencing the functional level of the promoter/enhancer, and how the functional level is changed

C. Characteristics of the GMO(s) or products thereof

1. Information relating to the genetic modification:

(a) Methods used for the modification
(b) Methods used to construct and introduce the insert(s) into the recipient or to delete a sequence
(c) Description of the insert and/or vector construction
(d) Purity of the insert from any unknown sequence and information on the degree to which the inserted sequence is limited to the DNA required to perform the intended function
(e) Number of intact and truncated vector inserts. Sequence, functional identity and location of the altered/inserted/deleted nucleic acid segment(s) in question with particular reference to any known harmful sequence
(f) Sequence and methylation pattern of the recipient DNA as far as 100 kbp
up and down stream from all DNA inserts

2. Information on the final GMO(s) or products thereof:

(a) Description of genetic trait(s) of phenotypic characteristics and in particular any new traits and characteristics which may be expressed or nolonger expressed
(b) Structure and amount of any vector and/or donor nucleic acis remaining in the final construction of the GMO(s) or product thereof
(c) Stability of the organism in terms of genetic traits
(d) Rate and level of expression of the new genetic material. Method and sensitivity of measurement
(e) Activity of the expressed protein(s)
(f) Expression levels for the recipient`s genes situated as far as 100 kbp up and down stream from all DNA inserts
(g) Sensitivity, reliability (in quantitative terms) and specificity of detection and identification techniques
(h) History of previous releases or uses of the GMO(s) or products thereof
(i) Health considerations:

(i) Toxic or allergenic effects of the non-viable GMO(s) or products thereof and/or their metabolic products
(ii) Product hazards
(iii) Comparison of the GMO(s) or products thereof to the donor, recipient or (where appropriate) parental organism regarding pathogenicity
(iv) Capacity for colonization
(v) If the organism is pathogenic to humans who are immunocompetent diseases caused and mechanism of pathogenicity including:
- invasiveness and virulence
- communicability
- infective dose
- host range, possibility of alteration
- possibility of survival outside of human
- presence of vectors or means of dissemination
- biological stability
- antibiotic-resistance patterns
- allergenicity
- availability of appropriate therapies

III. Information relating to the conditions of release and the receiving
environment

A. Information on the release

1. Description of the proposed deliberate release, including the purpose(s) and foreseen products
2. Foreseen dates of the release and time planning of the experiment including frequency and duration of releases
3. Preparation of the site previous to the release
4. Size of the site
5. Method(s) to be used for the release
6. Quantities of GMO(s) or products thereof to be released
7. Disturbance on the site (type and method of cultivation, mining, irrigation, or other activities) 8. Worker protection measures taken during the release
9. Post-release treatment of the site
10. Techniques foreseen for elimination or inactivation of the GMO(s) or products thereof at the end of the experiment
11. Information on, and results of, previous releases of the GMO(s) or products thereof, especially at different scales and in different ecosystems

B. Information of the environment (both on the site and in the wider
environment)

1. Geographical location and grid reference of the site(s) (in case of notifications the site(s) of release will be the foreseen areas of use of the product)
2. Physical or biological proximity to humans and other significant biota
3. Proximity to significant biotopes or protected areas
4. Size of local population
5. Economic activities of local populations which are based on the natural resources of the area 6. Distance to closest areas protected for drinking water and/or environmental purpose
7. Climatic characteristics of the region(s) likely to be affected
8. Geographical, geological and pedological characteristics
9. Flora and fauna, including crops, livestock and migratory species
10. Description of target and non-target ecosystems likely to be affected
11. A comparison of the natural habitat of the recipient organism with the proposed site(s) of release
12. Any known planned developments or changes in land use in the region
which could influence the environmental impact of the release

IV. Information relating to the interactions between the GMO(s) or products
thereof and the environment

A. Characteristics and factors affecting survival, multiplication, gene
expression and dissemination

1. Biological features which affect survival, multiplication and dispersal
2. Known or predicted environmental conditions which may affect survival,
multiplication and dissemination (wind, water, soil, temperature, pH,
pollutants such as pesticides, heavy metals and others, etc.)
3. Sensitivity to specific agents

B. Interactions with the environment

1. Predicted habitat of the GMO(s) or products thereof
2. Studies of the behaviour and characteristics of the GMO(s) or products
thereof and their ecological impact carried out in simulated natural
environments, such as microcosms, growth rooms, greenhouses
3. Genetic transfer capability:

(a) post-release transfer of genetic material from GMO(s) or products thereof into organisms in affected ecosystems
(b) post-release transfer of genetic material from indigenous organisms to
the GMO(s) or products thereof

4. Likelihood of post-release selection leading to the expression of unexpected and/or undesirable traits in the GMO(s) or products thereof
5. Measures employed to ensure and to verify genetic stability. Description of genetic traits which may prevent or minimize dispersal or genetic material. Methods to verify stability
6. Routes of biological dispersal, known or potential modes of interaction with the disseminating agent, including inhalation, ingestion, surface contact, burrowing, etc.
7. Description of ecosystems to which the GMO(s) or products thereof could
be disseminated

C. Potential environmental impact

1. Potential for excessive population increase in the environment
2. Competitive advantage of the GMO(s) or products thereof in relation to the unmodified recipient or parental organism(s)
3. Identification and description of the target organisms
4. Anticipated mechanism and result of interaction between the released GMO(s) or products thereof and the target organism
5. Identification and description of non-target organisms which may be affected unwittingly
6. Likelihood of post-release shifts in biological, or in host range
7. Known or predicted effects on non-target organisms in the environment, impact on population levels of competitors, preys, hosts, symbionts, predators, parasites and pathogens
8. Known or predicted involvement in biogeochemical processes
9. Other potentially significant interactions with the environment

V. Information on monitoring, control, waste treatment and emergency
response plans

A. Monitoring techniques

1. Methods for tracing the GMO(s) or products thereof, and for monitoring their effects
2. Specificity (to identify the GMO(s) or products thereof, and to distinguish them from the donor, recipient or, where appropriate, the parental organisms), sensitivity and reliability of the monitoring techniques
3. Techniques for detecting transfer of the donated genetic material to other organisms
4. Methods to detect aberrant gene expression

B. Control of the release

1. Methods and procedures to avoid and/or minimize the spread of the GMO(s) or products thereof beyond the site of release or the designated area for use
2. Methods and procedures to protect the site from intrusion by unauthorized individuals
3. Methods and procedures to prevent other organisms from entering the site

C. Waste treatment

1. Type of waste generated
2. Expected amount of waste
3. Possible risks
4. Description of treatment envisaged

D. Emergency response plan

1. Methods and procedures for controlling the GMO(s) or products thereof in case of unexpected spread
2. Methods for decontamination of the areas affected, e.g. eradication of the GMO(s) or products thereof
3. Methods for disposal or sanitation of plants, animals, soils, etc. that were exposed during or after the spread
4. Methods for the isolation of the area affected by the spread
5. Plans for protecting human health and the environment in case of the occurrence of an undesirable effect

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Schedule II

Additional Information Required in the Case of Notification for Placing on
the Market
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A. The following information shall be provided in the notification for
placing on the market products, in addition to that of Annex I:

1. Name of the product and name(s) of GMO(s) contained therein
2. Name of the manufacturer or distributor and his address, including address in the country
3. Specificity of the product, exact conditions of use including, when appropriate, the type of environment and/or the geographical area(s) of the country for which the product is suited
4. Type of expected use: industry, agriculture and skilled trades, consumer use by public at large

B. The following additional information shall be provided when
required/relevant:

1. Measures to take in case of unintended release or misuse
2. Specific instructions or recommendations for storage and handling
3. Estimated production in and/or imports to the country
4. Proposed packaging. This must be appropriate so as to avoid unintended release of the GMO(s) during storage, or at a later stage
5. Proposed labelling. This must include, at least in summarized form, the information referred to in points A.1, A.2, A.3, B.1 and B.2

C. The following information concerning labellingof products thereof shall
be provided on a label and/or in accompanying documents:

1. The words "This product contains GMO(s)" whenever there is evidence of the presence of GMO(s) in the product
2. The words "This product may contain GMO(s)" where the presence of GMO(s) in a product cannot be excluded but there is no evidence of any presence of GMO(s)
3. The words "This product may cause....[specify the particular reactions, allergies or other side-effects]" where it is known that a particular reaction, allergy or other side-effect may be caused by the product
4. Where applicable, further or as a qualification to C.1 or C.2, the words "This product contains genetic material (nucleic acids) from GMO(s)" or "This product is based on raw materials from GMO(s)"

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Schedule III

Risk Assessment

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The risk assessment shall take the following parameters into consideration:

A. General principles

1. The guiding principle of risk assessment is the precautionary approach. Where activities or dealings involving the use or handling of GMO(s) or products thereof may cause, or has a proven or theoretical potential (or based on reasonable scientific theory of hazards based on deductive, circumstantial as well as inductive evidence) to cause harm to biodiversity, ecosystems, human or animal health, the lack of full scientific certainty or consensus regarding the level of risk should not be interpreted as the lack of risk, or as acceptable risk.

2. The risk assessment should take into account, inter alia, all relevant scientific theory, evidence and experience, including previous risk assessments. This enables the risk assessment to evolve in the light of new evidence and knowledge; a GMO or product thereof previously considered acceptable may no longer be acceptable, and vice versa.

3. It shall be accepted as a principle underlying the risk assessment that every transgenic line is different because of random insertion, even if they are made with the same vector system, the same gene constructs and the same variety, and that it has to be well characterised to be stable for at least five generations under a reasonable range of environmental conditions that it may encounter.

4. The risk assessment should take into account, inter alia:

(a) All relevant scientific theory, evidence and experience;
(b) The general characteristics of both the GMO or product thereof and the parent organisms, the vector(s) used, the genetic modifications and the novel trait(s), including marker trait(s) and other sequences even when not expressed;
(c) The native environments or host range of the recipient organism and donor organisms;
(d) The intended use(s) of the GMO or product thereof and the nature of the receiving and surrounding environments;
(e) Potential impact of the GMO or product thereof on the environment, including long-term direct and indirect ecological impacts, particularly on centers of origin and areas with high genetic diversity of taxa related to the GMO or product thereof;
(f) Effects, long-term and direct or indirect, of the GMO or product thereof on human, plant and animal health;
(g) Socio-economic impacts;
(h) Conformity with ethical norms;
(i) Details of risk assessments completed elsewhere.

B. Specific information requirements

The information required for risk assessment should include the following:

1. Characteristics of donor and recipient organisms or parental organisms:

(a) Scientific name and taxonomy
(b) Strain, cultivar or other name
(c) Species it is related to and degree of relatedness
(d) The degree of relatedness between the donor and recipient organisms, or between the parental organisms
(e) All sites from where the donor and recipient organisms or parental organisms were collected, if known
(f) Information on the type of reproduction (sexual/asexual) and the length of reproductive cycle or generation time, as appropriate, as well as the formation of resting and survival stages
(g) History of prior genetic manipulation, whether the donor or recipient organisms are already genetically modified
(h) Phenotypic and genetic markers of interest
(i) Description of identification and detection techniques for the organisms, and the sensitivities of these techniques
(j) Geographic distribution and natural habitats of the organisms including information on natural predators, prey, parasites, competitors, symbionts and hosts
(k) Climatic characteristics of original habitats
(l) Ability of the organisms to survive and colonize the environment to which release is intended or otherwise
(m) Genetic stability of the organisms, and factors affecting the stability
(n) The presence of endogenous mobile genetic elements of viruses likely to affect the genetic stability
(o) The potential of the organisms to transfer or exchange genes with other organisms, either vertically or horizontally
(p) Pathogenicity to humans or animals, if any
(q) If pathogenic, their virulence, infectivity, toxicity and modes of transmission
(r) Known allergenicity and/or toxicity of biochemical and metabolic products
(s) Availability of appropriate therapies for pathogenicity, allergenicity and toxicity

2. Characteristics of the vector(s):

(a) Nature and source of the vector(s)
(b) Genetic map of the vector(s), position of the gene(s) inserted for the transfer, other coding and non-coding sequences affecting the expression of the introduced gene(s), and marker gene(s)
(c) Ability of the vector(s) to mobilize and transfer genes by integration and methods for determining the presence of the vector(s)
(d) Complete nucleotide sequence of the vector(s)
(e) History of prior genetic manipulation, whether the donor or recipient organisms are already genetically modified
(f) Potential for pathogenicity and virulence
(g) Natural and host range of vectors
(h) Natural habitat and geographic distribution of natural and potential hosts
(i) Potential impacts on human and animal health and the environment
(j) Measures for counteracting adverse impacts
(k) Potential to survive and multiply in the environment, or to form genetic recombinants
(l) Genetic stability of vector(s), such as hypermutability

3. Characteristics of the GMO or product thereof:

(a) The description of the modifications made using gene technology
(b) The function of the genetic modifications and/or the new insert, including any marker gene(s) (c) Purpose of the modification and intended use in relation to need or benefit
(d) Method of modification and, in case of transgenic organisms, the methods for constructing inserts and to introduce them into the recipient organism
(e) Whether introduced gene(s) are integrated or extrachromosomal
(f) Number of insert(s) and its/their structure(s), for example, the copy number, the number of truncated or fragmented inserts, whether in tandem or other types of repeats and the position of each insert
(g) Nucleotide sequence of each insert, including at least 100 kbp up and down stream from the insert
(h) Product(s) of the transferred gene(s), levels of expression and methods for measuring expression
(i) Stability of the introduced gene(s) in terms of expression and integration
(j) Biochemical and metabolic differences of the GMO or product thereof compared with the unmodified organism
(k) Probability of vertical or horizontal gene transfer to other species
(l) Probability of inserts or transferred gene(s) to generate pathogenic recombinants with endogenous viruses, plasmids and bacteria
(m) Allergenicities, toxicities, pathogenicities and unintended effects
(n) Autecology of the GMO or product thereof compared with that of the unmodified organism (o) Susceptibility of the GMO or product thereof to diseases and pests compared with the unmodified organism
(p) Detailed information on past uses including results on all experiments leading to previous releases

4. Characteristics of resuscitated organisms and gene(s) and fossil DNA
sequences:

Resuscitated organism

(a) Scientific name and taxonomy
(b) Identity of nearest species and their characteristics which are of
relevance to the intended use (c) Site at which it was found
(d) Method used for resuscitation
(e) Purpose of introducing the organism and benefits, if any
(f) Impacts on human and animal health and the environment
(g) Measures for counteracting adverse impacts
(h) Length of time the organism has been in use
(i) Genetic stability
(j) Likelihood of gene transfer to other organisms
(k) Fossil and living nearest relative species
(l) Biological and biochemical differences from related living species
(m) Information on previous uses since resuscitation

DNA sequences from fossils or from resuscitated organism

(a) Scientific name and taxonomy of the species whether resuscitated or a
fossil
(b) Site of origin of the fossil
(c) Site of the gene in the resuscitated genome, if known
(d) Base sequence of the extracted gene
(e) Method used in extracting the gene
(f) Function of gene, if known
(g) Purpose of use and benefits, if any
(h) Environment in which it lived before fossilization
(i) Fossil species related to the species from which the gene was taken
(j) Living species related to the species from which the gene was taken

5. Safety considerations for human and animal health:

Information on the GMO or product thereof and information on the donor and
recipient organisms as well as the vector before it was disarmed or
disabled in cases where it has been disarmed or disabled, regarding:

(a) Capacity for colonization
(b) If the GMO or product thereof is pathogenic to humans or animals the following information is required:

(i) Diseases caused and mechanism of pathogenicity, including invasiveness and virulence, and property of virulence
(ii) Communicability
(iii) Infective dose
(iv) Host range and possibilities of alteration
(v) Ability to survive outside of the human or animal host
(vi) The existence of vectors or other means of transmission
(vii) Biological stability
(viii) Allergenicity
(ix) Availability of appropriate therapies

6. Environmental considerations:

Information on the GMO or product thereof and information on the donor and recipient organisms as well as the vector before it was disarmed or disabled in cases where it has been disarmed or disabled, regarding:

(a) Factors affecting the survival, reproduction and spread of the GMO or product thereof in the environment
(b) Available techniques for detection, identification and monitoring of the GMO or product thereof
(c) Available techniques for detecting transmission of genes from the GMO or product thereof to other organisms
(d) Known and predicted habitats of the GMO or product thereof
(e) Description of the ecosystems which could be affected by accidental release of the GMO or product thereof
(f) Possible interactions between the GMO or product thereof and other organisms in the ecosystem which might be affected by accidental release
(g) Known or predicted effects on plants and animals such as pathogenicity, infectivity, toxicity, virulence, being a vector of pathogens, allergenicity, and colonization
(h) Possible involvement in biogeochemical processes
(i) Availability of methods for decontamination of the area in case of accidental releases
(j) Effects on agricultural practices with possible undesirable impacts on the environment

7. Socio-economic considerations:

(a) Anticipated changes in the existing social and economic patterns resulting from the introduction of the GMO or product thereof
(b) Possible threats to biological diversity, traditional crops or other products and, in particular, farmers` varieties and sustainable agriculture
(c) Impacts likely to be posed by the possibility of substituting traditional crops, products and indigenous technologies through modern biotechnology outside of their agro-climatic zones
(d) Anticipated social and economic costs due to loss of genetic diversity, employment, market opportunities and, in general, means of livelihood of the communities likely to be affected by the introduction of the GMO or product thereof
(e) Possible countries and/or communities to be affected in terms of disruptions to their social and economic welfare
(f) Possible effects which are contrary to the social, cultural, ethical and religious values of communities arising from the use or release of the GMO or product thereof