Commonwealth: Agricultural and Veterinary Chemicals Code Act 1994 (Cth)

Agricultural and Veterinary Chemicals Code Act 1994 No. 47, 1994 Compilation No. 34 Compilation date: 14 October 2024 Includes amendments: Act No. 39, 2024 About this compilation This compilation This is a compilation of the Agricultural and Veterinary Chemicals Code Act 1994 that shows the text of the law as amended and in force on 14 October 2024 (the compilation date). The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law. Uncommenced amendments The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the Register for the compiled law. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Editorial changes For more information about any editorial changes made in this compilation, see the endnotes. Modifications If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the Register for the compiled law. Self‑repealing provisions If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes. Contents 1 Short title 2 Commencement 3 Definitions 4 The Schedule 5 Citation and interpretation of Agvet Code and Agvet Regulations 6 Regulations 7 Orders 8 Compensation Schedule—Agricultural and Veterinary Chemicals Code Part 1—Preliminary Division 1—Object, definitions etc. 1 Object of Code 1A Implementing the Code 2 Relationship of Code to other laws 3 Definitions 4 Definition of agricultural chemical product 5 Definition of veterinary chemical product 5AA Definition of registered chemical product 5A Definition of meets the safety criteria 5B Definition of meets the efficacy criteria 5C Definition of meets the trade criteria 5D Definition of meets the labelling criteria 5E Overseas trials and experiments 5F APVMA may arrange for use of computer programs to make decisions 6 Determinations, approvals, exemptions etc. by APVMA 6A APVMA may make guidelines etc. 6B Varying relevant particulars and conditions 6C Right of APVMA to use information 6D Failure to comply with time limit does not affect validity 6E APVMA may make standards 6F Specification by class 7 Possession or custody of constituent or product 8 Labels attached to containers 8AA Application of the Criminal Code Division 2—General provisions about applications 8A Definition of meets the application requirements 8B Information to be provided with applications 8C Information to be taken into account in determining applications 8D Applications may be withdrawn Division 3—General provisions about notices 8E Notice to Food Standards Australia New Zealand 8F Notice to holder of approval, registration or variation 8G Notice to applicant of refusal of application 8H Published notice of approvals and registrations 8J Published notice of variations of approvals and registrations Division 4—Holders of approvals and registrations and nominated agents 8L Changing the holder 8M Nominated agent 8N Overseas holder must have nominated agent 8P Changing the nominated agent 8Q Nominated agent may withdraw 8R Role of nominated agent Division 5—Notice of certain proposed decisions 8S Notice of certain proposed decisions Division 6—Listed chemical products and established standards 8T Regulations may include schedule of listed chemical products 8U APVMA to prepare standards 8V Matters to be taken into account in preparing a standard Division 7—Access to certain documents and information 8W Access to certain documents in the possession or custody of the APVMA 8X Confidential commercial information must not be disclosed under certain provisions Part 2—Approvals and registration Division 1—Preliminary 9 Explanation of Part Division 2—Approving and registering Subdivision A—Explanation of Division 9A Explanation of Division Subdivision B—Approval and registration for active constituents, chemical products or labels after assessment 10 Applications 11 Preliminary assessment 12 APVMA to publish notice before deciding whether to approve new active constituent 13 APVMA to publish notice before deciding whether to register chemical product containing new active constituent 14 Approval and registration 14A Approval of active constituents for which information is not readily available 14B APVMA not to use information for registration of new chemical product to register a similar product after disclosure Subdivision C—Approval and registration for prescribed active constituents, chemical products or labels 14C Applications for approval of prescribed active constituents 14D Applications for registration of prescribed chemical products 14E Applications for approval of prescribed labels for containers for chemical products Subdivision D—Common provisions 15 Restriction on power of APVMA to register products and approve labels 16 Multiple approvals or registrations 17 APVMA must keep a Record of Approved Active Constituents for Chemical Products 18 APVMA must keep a Register of Agricultural and Veterinary Chemical Products 19 How approval of active constituent takes place 20 How registration of chemical product takes place 21 How approval of label takes place 22 Date of approval or registration 23 Conditions of approval or registration 26 Incorrect particulars and conditions Division 2AA—Notified variations of relevant particulars 26AA Explanation of Division 26AB Notice of notifiable variations 26AC Variation of relevant particulars 26AD Notice requirements Division 2A—Prescribed variations of relevant particulars 26A Explanation of Division 26B Applications for prescribed variations 26C Decision on prescribed variations 26D How prescribed variation takes place Division 3—Varying relevant particulars and conditions 26E Explanation of Division 27 Applications 28 Preliminary assessment 29 Varying relevant particulars and conditions 29A APVMA may vary on its own initiative with holder's consent 29B How variation takes place Division 4—Reconsidering approvals and registrations 29L Explanation of Division 30 Inviting the public to propose reconsiderations 31 APVMA may reconsider approval or registration 32 Notice of reconsideration 33 APVMA may require information, reports, results or samples 34 Reconsideration by APVMA 34A Varying relevant particulars or conditions to allow affirmation 34AA Suspension or cancellation 34AB Notice of proposed decision 34AC Notice of decision on reconsideration 34AF Reconsideration of approval of label without notice in certain circumstances Division 4A—Limits on use of information Subdivision A—Preliminary 34F Explanation of Division Subdivision B—General rules 34G General rules 34H Contraventions of general rules Subdivision C—Exceptions 34J Consent, public interest etc. 34K Further rules about public interest exception 34KA Extension of protection periods 34L Information with limitation periods 34M Limitation periods 34MA Extension of limitation periods Division 5—Suspending and cancelling approvals and registrations 34N Explanation of Division 34P Notice of proposed suspension or cancellation to be given to holder 35 Notice of proposed suspension or cancellation to be given to co‑ordinators 35A Suspension or cancellation of registration if imminent risk to persons of death, serious injury or serious illness 36 Suspension or cancellation of approval or registration for breach of condition 38 Suspension of approval or registration for failing to give information, results, report or sample to APVMA 38A Suspension or cancellation of approval or registration for provision of false or misleading information 39 Suspension of approval or registration if compensation for use of protected information cannot be arbitrated 41 Suspension or cancellation of approval or registration for non‑compliance with criteria for approval or registration or prescribed requirements 42 Suspension or cancellation of approval or registration at request of holder 43 Effect of suspension of approval or registration 44 Inter‑related suspensions and cancellations 45 How approval or registration is suspended or cancelled 45A Notice of suspension or cancellation 45B Permit taken to have been issued 45C Possession or custody with intention of supply 46 How suspension or cancellation is revoked Division 6—Duration of approvals and registrations and renewal of registrations Subdivision A—Preliminary 46A Explanation of Division Subdivision B—Period of approval or registration 47 Period of approval or registration Subdivision C—Notifying the end of registrations 47C Notice of end of registration 47D Permit taken to have been issued 47E Possession or custody with intention of supply Subdivision D—Renewing registrations 48 Applications 49 Renewal of registration 50 How renewal takes place 51 Renewal of approval of label Part 2B—Reserved chemical products 56ZU Regulations may contain schedule of reserved chemical products Part 3—Compensation for provider of certain information in respect of continued registration of certain chemical products Division 1—Preliminary 57 Explanation of Part Division 2—Right to compensation 59 Right of originator of protected information to compensation for its use in relation to other applications 60 APVMA to notify holders 61 Primary holder to notify secondary holder Division 3—Mediation or arbitration as to terms of compensation 62 Application of Division 63 Mediation 64 Appointment of arbitrator 65 Determination of compensation on the basis of proposals made during negotiations 66 Arbitrator may require fresh proposals 67 Determination on basis of fresh proposals 68 What happens if fresh proposals are not made or are inadequate 69 What constitutes a reasonable proposal for compensation 70 Effect and enforcement of determination by arbitrator 71 Regulations to govern conduct of arbitration Part 4—Control of chemical products Division 1—Preliminary 72 Explanation of Part 73 Part not to apply to veterinary surgeons acting under other laws Division 2—Control generally 74 Possession or custody of unapproved active constituents with the intention of supply 75 Possession or custody of chemical products, other than registered or reserved products, with the intention of supply 76 Supply of unapproved active constituents 77 Supply of approved active constituents in contravention of conditions of approval 78 Supply of chemical products that are not registered products or reserved products 79 Supply of registered chemical products in contravention of conditions of registration 79B Supply of reserved chemical products contrary to conditions specified in the regulations 80 Supply of chemical products without a label 81 Supply of registered chemical products with unapproved label 83 Supply of substances whose constituents differ from constituents of registered chemical product 84 Claims inconsistent with labels 85 Modification of warning prohibited 86 Labels not to be detached etc. 87 Chemical product to conform to standard 88 Certain notices not to be published 89 Certain statements prohibited Division 3—Date‑controlled chemical products 89A Exclusion of certain chemical products 90 Manufacture or import of date‑controlled chemical product 91 Supply of date‑controlled chemical product 92 Abuse of warning on label prohibited Division 4—Restricted chemical products 93 Restricted chemical product 94 Restricted chemical products may be supplied only to authorised persons 95 Labels for restricted chemical products Part 5—Analysis 96 Explanation of Part 97 Analysis by approved analysts 98 Evidence of results of analysis 99 Information and documents about, and analysis of, substances supplied as active constituents or chemical products Part 6—Recall notices 100 Explanation of Part 101 Recall of products that are not registered or whose registration is being reconsidered 102 Recall of products in certain circumstances 103 Recall of products with labels that are not approved or are not authorised by an established standard 104 Notice of recall to be published 105 Non‑compliance with recall notice 106 Notification to APVMA of voluntary recalls 107 Inconsistent requirements Part 7—Permits 108 Explanation of Part 109 Definition of permit 110 Applications 110A Preliminary assessment 111 Functions of co‑ordinators 112 Issuing permits 112A APVMA may issue permit on its own initiative 113 Record of Permits 114 How permits are issued 115 Duration of permit 116 Effect of permit and compliance with conditions of permit 117 Surrender of permit 117A Notice of proposed suspension or cancellation to be given to permit holder 118 Suspension of permit—general grounds 119 Cancellation of permit—general grounds 119A Suspension or cancellation of permit—imminent risk to persons of death, serious injury or serious illness 119B Suspension or cancellation of permit—providing false or misleading information Part 8—Manufacture of chemical products 120 Explanation of Part 120A Exclusion of certain chemical products 121 Offences relating to manufacture and licences 122 Application for licence 123 Issue of licence 125 Period of licence 126 Conditions of licences 127 Suspension and cancellation of licences 128 Publication of list of manufacturers etc. Part 9—Investigative powers Division 1—Preliminary 129 Explanation of Part Division 2—Requiring people to attend, give information and produce documents or things Subdivision A—Notices by the APVMA 130 Notice to produce or attend 130A APVMA may retain documents and things Subdivision B—Offence and related provisions 130B Failure to comply with notice etc. 130C Self‑incrimination etc. Division 3—Monitoring Subdivision A—Monitoring powers etc. 131 Powers available to inspectors for monitoring compliance 131AA Monitoring powers to prevent imminent risk to persons of death, serious injury or serious illness 131A Monitoring powers—with consent or with warrant 131B Operating electronic equipment 131C Securing evidence of the contravention of a related provision 131D Persons assisting inspectors 131E Use of force in executing a monitoring warrant Subdivision B—Powers of inspectors to ask questions and seek production of documents 131F Inspector may ask questions and seek production of documents 131G Copying of documents Division 4—Investigation Subdivision A—Investigation powers 132 Powers available to inspectors to investigate potential breaches of an agvet law 132A Investigation powers 132B Operating electronic equipment 132C Seizing evidence of related offences and civil penalty provisions 132D Supervisory powers of seized things 132E Persons assisting inspectors 132F Use of force in executing an investigation warrant Subdivision B—Powers of inspectors to ask questions and seek production of documents 132G Inspector may ask questions and seek production of documents 132H Copying of documents Division 5—Obligations and incidental powers of inspectors 133 Consent 134 Announcement before entry 135 Inspector to be in possession of warrant 136 Details of warrant etc. to be given to occupier 137 Expert assistance to operate electronic equipment 138 Compensation for damage to electronic equipment Division 6—Execution of an investigation warrant interrupted 138A Completing execution of an investigation warrant after temporary cessation 138B Completing execution of an investigation warrant stopped by court order Division 7—Occupier's rights and responsibilities 138C Occupier entitled to observe execution of warrant 138D Occupier to provide inspector with facilities and assistance Division 8—General provisions relating to seizure 139 Copies of seized things to be given 139A Receipts for seized things 140 Return of things that are seized 141 Magistrate may permit a thing to be kept 141A Disposal of things 142 Certain expenses to be recoverable by APVMA Division 9—Applying for warrants etc. 143 Monitoring warrants 143A Investigation warrants 143B Warrants by telephone, fax etc. 143C Authority of warrant 143D Offence relating to warrants by telephone, fax etc. 143E Effect of warrant Division 10—Powers of magistrates 143F Powers of magistrates Part 9A—Enforcement Division 1—Preliminary 145 Explanation of Part Division 2—Civil penalty orders Subdivision A—Obtaining a civil penalty order 145A Civil penalty orders 145AA Maximum penalties for contravention of civil penalty provisions 145AB Civil enforcement of penalty 145AC Conduct contravening more than one civil penalty provision 145AD Multiple contraventions 145AE Proceedings may be heard together 145AF Civil evidence and procedure rules for civil penalty orders 145AG Contravening a civil penalty provision is not an offence Subdivision B—Civil proceedings and criminal proceedings 145B Civil proceedings after criminal proceedings 145BA Criminal proceedings during civil proceedings 145BB Criminal proceedings after civil proceedings 145BC Evidence given in civil proceedings not admissible in criminal proceedings Subdivision C—Miscellaneous 145C Continuing contraventions of civil penalty provisions 145CA Ancillary contravention of civil penalty provisions 145CB Mistake of fact 145CC State of mind 145CD Evidential burden for exceptions 145CE Liability of body corporate for actions by employees, agents or officers 145CF Liability of executive officers 145CG Establishing whether an executive officer took reasonable steps to prevent the contravention of a civil penalty provision Division 3—Infringement notices 145DA When an infringement notice may be given 145DB Matters to be included in an infringement notice 145DC Extension of time to pay amount 145DD Withdrawal of an infringement notice 145DE Effect of payment of amount 145DF Effect of this Division Division 4—Enforceable undertakings 145E Acceptance of undertakings 145EA Enforcement of undertakings Division 5—Injunctions 145F Grant of injunctions 145FA Discharging or varying injunctions 145FB Certain limits on granting injunctions not to apply 145FC Other powers of a court unaffected Division 6—Substantiation notices 145G APVMA may require claims to be substantiated etc. 145GA Compliance with substantiation notices 145GB Failure to comply with substantiation notice Division 7—Enforceable directions 145H APVMA may give directions Division 8—Formal warnings 145J APVMA may issue a formal warning Division 9—Miscellaneous 146 False or misleading information or document 146A Self‑incrimination to be a reasonable excuse for non‑compliance with requirement 147 Time for bringing proceedings 149 Evidential certificates 149A Recovery of costs of investigations 150 Forfeiture 151 Conduct by directors, employees and agents 152 Liability of persons acting on behalf of non‑residents Part 10—Miscellaneous 153 Explanation of Part 154 Recognition of things done under corresponding laws 155 Discharge of obligations under this Code 156 The making of single applications or the giving of single notices under the Agvet Codes of all jurisdictions 156A Giving information electronically 157 Samples to be given for analysis 159 APVMA or other authority may require, or require additional, information, report or sample in certain circumstances 160 Overseas trials and experiments etc. 160A Notification of new information to APVMA in respect of pending application 161 Notification of new information to APVMA 162 Disclosure of confidential commercial information 163 Notice to the applicant or holder of proposed disclosure of information that is claimed to be confidential commercial information 163A Legislative instruments to be disallowable 163B Certain provisions to have effect as part of this Code 164 Fees 165 Period within which APVMA is to determine applications 165A Period within which APVMA is to conclude reconsiderations under Division 4 of Part 2 166 Internal review of decisions 167 Review of decisions by Administrative Review Tribunal 168 Statement to be included in certain notices of decisions 169 Documents and samples become property of APVMA 170 Provisions relating to offences 170A Person not to use protected name or protected symbol Part 11—Transitional provisions 171 Explanation of Part 172 Existing clearance for registration of chemical product 174 Existing registration of chemical product 176 Existing registration or approval of label 178 Provisions that apply in respect of existing registrations or approvals 181 Existing permit Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history An Act to make provision for the evaluation, registration and control of agricultural and veterinary chemical products, and for related matters, for the purposes of the Agricultural and Veterinary Chemicals Act 1994 RECOGNISING: (a) that the protection of the health and safety of human beings, animals and the environment is essential to the well‑being of society and can be enhanced by putting in place a system to regulate agricultural chemical products and veterinary chemical products; and (b) that the principle of ecologically sustainable development requires a regulatory system that is designed to ensure that the use of such products at the present time will not impair the prospects of future generations; and (c) that the furthering of trade and commerce between Australia and places outside Australia, and the present and future economic viability and competitiveness of primary industry and of a domestic industry for manufacturing and formulating such products, are essential for the well being of the economy and require a system for regulating such products that is cost effective, efficient, predictable, adaptive and responsive; and (d) that it is desirable to establish a regulatory system that is open and accountable and gives opportunity for public input with respect to the regulation of such products; and (e) that the system should, so far as practicable, be uniform throughout Australia; and (f) that uniformity could best be achieved by the enactment of legislation by the Parliament of the Commonwealth as a law for the government of the Australian Capital Territory and the adoption of that legislation by the Parliaments and legislatures of the States and the Northern Territory: The Parliament of Australia enacts: 1 Short title This Act may be cited as the Agricultural and Veterinary Chemicals Code Act 1994. 2 Commencement This Act commences on the same day as the Agricultural and Veterinary Chemicals Act 1994. 3 Definitions In this Act, unless the contrary intention appears: APVMA means the Australian Pesticides and Veterinary Medicines Authority continued in existence by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992. participating Territory has the same meaning as in the Agricultural and Veterinary Chemicals Act 1994. prescribed means prescribed by the regulations. the Code means the Agvet Code of the participating Territories. the regulations means the regulations in force for the time being under section 6. 4 The Schedule The Schedule has effect for the purposes of the Agricultural and Veterinary Chemicals Act 1994. 5 Citation and interpretation of Agvet Code and Agvet Regulations (1) The Agricultural and Veterinary Chemicals Code set out in the Schedule, as it applies as a law for the government of the participating Territories, may be referred to as the Agvet Code of the participating Territories. (2) The regulations, as they apply for the purposes of the Agvet Code of the participating Territories, may be referred to as the Agvet Regulations of the participating Territories. (3) In the Agvet Code, and the Agvet Regulations, of the participating Territories: Act of this jurisdiction means an Act of the Parliament or an Act or Ordinance of a participating Territory. the Minister for this jurisdiction means the Minister. this jurisdiction means the participating Territories. (4) In the Agvet Code, or the Agvet Regulations, of the participating Territories, a reference to an offence against that Code, or those Regulations, includes a reference to an offence against: (a) section 6 of the Crimes Act 1914; or (b) section 11.1, 11.4 or 11.5 of the Criminal Code; that relates to an offence against that Code or those Regulations, as the case may be. 6 Regulations (1) The Governor‑General may make regulations prescribing matters: (a) required or permitted by the Code to be prescribed by regulations within the meaning of the Code; or (b) necessary or convenient to be prescribed by such regulations for carrying out or giving effect to the Code. (2) In particular, the regulations may include provision for the purposes of the Code for or in relation to: (a) the development and approval of standards for: (i) constituents for chemical products; and (ii) chemical products; and (iii) labels for containers for chemical products; or (b) prescribing and regulating all matters and things with respect to inspection and investigation and with respect to samples, including the method of taking samples, the quantity or weight of samples, the labelling of samples, the delivery of samples to the APVMA and the analysis of samples; or (c) authorising any matter or thing to be from time to time determined, applied or regulated by a particular person; or (d) the records to be made and kept and the persons by whom they are to be made and kept; or (e) requiring records so kept to be produced at stated times to the APVMA; or (f) the particulars to be included in labels for containers for chemical products, the way to write those particulars on those labels and the way to attach those labels to containers; or (g) the size and type of labels to be attached to containers for chemical products; or (h) the giving of notices by or to the APVMA; or (i) prescribing penalties of not more than 50 penalty units for offences against the regulations; or (j) declaring provisions of the regulations to be civil penalty provisions. (3) The regulations may: (a) adopt wholly or partly, and specifically or by reference, and with any modifications, any of the standards, rules, codes, specifications or methods of any association, body or institution whether as in force at the time of adoption or as changed from time to time; and (b) provide for the approval of the APVMA to be the standard that applies in respect of a particular matter or thing; and (c) exempt particular substances or chemical products from the operation of any provision of the Code, either unconditionally or subject to conditions; and (d) exempt persons identified in the regulations from the operation of any provision of the Code, either unconditionally or subject to conditions. (4) Except as otherwise expressly provided in this Act or the Code, the regulations may be of general or specially limited application or may differ according to differences in time, locality, place or circumstance. (5) Subject to subsection (6), in the regulations, unless the contrary intention appears, an expression has the same meaning as it has in the Agvet Code of the participating Territories. (6) In a provision of the regulations that has effect for the purposes of a particular provision of the Agvet Code of the participating Territories, unless the contrary intention appears, an expression has the same meaning as it has in that provision of that Code. (7) The regulations are to be interpreted subject to the Agvet Code of the participating Territories and it is intended that if, apart from this subsection, a provision of the regulations would have been interpreted as being inconsistent with that Code, the provision is nevertheless to be valid in so far as it is not so inconsistent. (8) An expression has, in this section, the meaning it would have if this section were included in the Code. 7 Orders (1) Subject to subsection (2), if: (a) provision may be made by the regulations for or in relation to a matter; and (b) the regulations declare that this section applies to that matter; the Minister may, by legislative instrument, make orders with respect to that matter that are consistent with the regulations. (2) An order must not be made prescribing a penalty. (3) Despite subsection 44(1) of the Legislation Act 2003, section 42 (disallowance) of that Act applies to a legislative instrument made under subsection (1) of this section. (6) In considering whether to make an order under subsection (1), the Minister must have regard to: (a) the effect that the order would have for the purposes of the Agvet Code of each jurisdiction other than the participating Territories because of a law of that jurisdiction that corresponds to the Agricultural and Veterinary Chemicals Act 1994; and (b) the fact that section 42 of the Legislation Act 2003 would apply in relation to the order because of subsection (3) of this section. (7) Subject to subsection (8), in an order, unless the contrary intention appears, an expression has the same meaning as it has in the Agvet Code of the participating Territories. (8) In a provision of an order that has effect for the purposes of a particular provision of the Agvet Code of the participating Territories, unless the contrary intention appears, an expression has the same meaning as it has in that provision of that Code. (9) An order is to be interpreted subject to the Agvet Code of the participating Territories and it is intended that if, apart from this subsection, a provision of an order would have been interpreted as being inconsistent with that Code, the provision is nevertheless to be valid in so far as it is not so inconsistent. 8 Compensation (1) In this section: acquisition of property has the same meaning as in paragraph 51(xxxi) of the Constitution. (2) If the operation of, or the doing of any act by the APVMA under, the Agvet Code of the participating Territories results in the acquisition of property from a person, the Commonwealth is liable to pay to the person such compensation as is agreed upon between them or, in the absence of agreement, as is determined by the Supreme Court of a participating Territory in an action brought in that Court by the person against the Commonwealth. Schedule—Agricultural and Veterinary Chemicals Code Section 4 Part 1—Preliminary Division 1—Object, definitions etc. 1 Object of Code The object of this Code is to make provision for and in relation to: (a) the evaluation, approval, and control of the supply, of active constituents for proposed or existing agricultural chemical products or veterinary chemical products; and (b) the evaluation, registration, and control of the manufacture and supply, of agricultural chemical products and veterinary chemical products. 1A Implementing the Code (1) This Code recognises that: (a) the furthering of trade and commerce between Australia and places outside Australia; and (b) the present and future economic viability and competitiveness of primary industry which relies on access to chemical products and their constituents; and (c) a domestic industry for manufacturing and formulating chemical products and their constituents; are essential for the well‑being of the economy and require a system for regulating chemical products and their constituents that is cost effective, efficient, predictable, adaptive and responsive. (2) This Code is to be implemented in a manner that: (a) recognises that the health and safety of human beings, animals and the environment is the first priority of the system for regulating chemical products and their constituents, in part to ensure that the use of chemical products at the present time will not impair the prospects of future generations; and (b) reflects established best‑practice principles for the assessment and management of risk, based on science; and (c) balances regulatory effort and any burden imposed by the system of regulation on: (i) holders of approvals, registrations, permits and licences; and (ii) the domestic industry for manufacturing and formulating chemical products and their constituents; and (iii) the users of chemical products; with the risk of the use of the products and constituents to the health and safety of human beings, animals and the environment; and (d) recognises that the use of chemical products that pose unmanageable risks to the health and safety of human beings, animals and the environment is not appropriate in Australia; and (e) promotes community confidence in the regulation of chemical products and their constituents, is open and accountable, and gives opportunity for public involvement and participation; and (f) secures compliance with this Code through appropriate, proportionate, consistent and effective compliance and enforcement measures. 2 Relationship of Code to other laws (1) This Code excludes the operation of any other laws of this jurisdiction that are inconsistent with this Code. (2) A law of this jurisdiction is not taken to be inconsistent with this Code if it can operate concurrently with this Code. (3) A law of this jurisdiction enacted, or an instrument made under a law of this jurisdiction, after the commencement of this Code is not to be interpreted as amending or repealing, or otherwise altering the effect of, this Code unless that law, or the law under which that instrument was made, as the case may be, so provides expressly. 3 Definitions In this Code, unless the contrary intention appears: active constituent, in relation to a proposed or existing agricultural chemical product or veterinary chemical product, means the substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the product as an agricultural chemical product or a veterinary chemical product, as the case may be. adequate, in relation to instructions on a label for containers for a chemical product, means adequate to ensure, as far as reasonably practicable, that the product meets the safety criteria and the trade criteria. agricultural chemical product has the meaning given by section 4. agvet law means: (a) the Agvet Code or the Agvet Regulations of this, or another, jurisdiction; or (b) the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994; or (c) the Agricultural and Veterinary Chemicals (Administration) Act 1992. agvet penalty provision means: (a) a civil penalty provision of the Agvet Code or the Agvet Regulations of this, or another, jurisdiction; or (b) a civil penalty provision of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994; or (c) a civil penalty provision of the Agricultural and Veterinary Chemicals (Administration) Act 1992. animal means any animal (other than a human being), whether vertebrate or not, and whether a food‑producing species or not, and includes: (a) mammals, birds, bees, reptiles, amphibians, fish, crustaceans and molluscs; and (b) the semen, ova or embryo of an animal (other than a human being) or any other substance or thing directly relevant to the reproduction of an animal (other than a human being); and (c) any other prescribed form of animal life, whether prescribed by reference to a species or in any other way. application means an application under this Code. approval means approval under Part 2 of: (a) an active constituent for a proposed or existing chemical product; or (b) a label for containers for a chemical product. approved active constituent means an active constituent that is approved and complies with the relevant particulars entered in the Record for the constituent. approved analyst means a person appointed under subsection 69G(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 to be an approved analyst for the purposes of this Code. approved form means a form approved by the APVMA or prescribed by the regulations. approved label means a label that is approved and complies with the relevant particulars recorded in the relevant APVMA file for the label. APVMA means the Australian Pesticides and Veterinary Medicines Authority continued in existence by section 6 of the Agricultural and Veterinary Chemicals (Administration) Act 1992. Australia includes any external Territories that are participating Territories. authorising party for information means a person who would be entitled to bring an action for breach of an obligation of confidence if the information were disclosed by someone else to the APVMA for the purposes of this Code without the person's permission. chemical product means an agricultural chemical product or a veterinary chemical product, or both. Chief Executive Officer, in relation to the APVMA, includes a person acting as the Chief Executive Officer of the APVMA. civil penalty order has the meaning given by section 145A. civil penalty provision means a provision declared by this Code to be a civil penalty provision. claim includes any statement. confidential commercial information, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product or a constituent of a chemical product, means: (a) a trade secret relating to the constituent or product; or (b) any other information relating to the constituent or product that has a commercial value that would be, or could reasonably be expected to be, destroyed or diminished if the information were disclosed; or (c) information (other than trade secrets to which paragraph (a) applies or information to which paragraph (b) applies) that: (i) concerns the lawful commercial or financial affairs of a person, organisation or undertaking; and (ii) relates to the manufacture, distribution or supply of the constituent or product; and (iii) if it were disclosed, could unreasonably affect the person, organisation or undertaking in an adverse manner; but does not include: (d) the making of an application for a permit for the use of an active constituent for a proposed or existing chemical product or for the use of a chemical product, if the use of the product proposed in the application is: (i) a minor use; or (ii) an emergency use; or (e) any prescribed information relating to the making of an application for a permit, as mentioned in paragraph (d). constituent, in relation to a chemical product, means any constituent of the product, whether an active constituent or not. container includes anything by which or in which a chemical product is, or is to be, covered, enclosed, contained or packaged, but does not include a container (such as a shipping container) in which other containers of chemical products are, or are to be, placed for the purpose of being transported. continue, in relation to an approval or registration, has, for the purposes of Part 3, the meaning given by subsection 59(6). co‑ordinator, in relation to a jurisdiction, means a person designated: (a) if the jurisdiction is a State—by a Minister of the State; or (b) if the jurisdiction is the participating Territories: (i) if the Australian Capital Territory is the only participating Territory—by a Minister of the Australian Capital Territory; or (ii) if there is more than one participating Territory—jointly by a Minister of the Commonwealth and a Minister of the Australian Capital Territory; to perform the functions of a co‑ordinator under this Code. copy, in relation to a warrant issued under section 143 or 143A (or a form of warrant completed under subsection 143B(6)), includes: (a) a copy sent by fax or other electronic means; or (b) a copy of a copy so sent. corresponding previous law means a previous law of this jurisdiction that corresponds wholly or partly to this Code, to the extent that it so corresponds. criteria includes standards. damage, in relation to data, includes damage by erasure of data or addition of other data. data includes: (a) information in any form; and (b) any program (or part of a program). date‑controlled chemical product means a chemical product declared by the regulations to be a date‑controlled chemical product. date of manufacture, in relation to a chemical product, means the date on which formulation of the product was completed. deal with, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, includes supply or otherwise dispose of the constituent or product. determine, in relation to an application, means: (a) approve, register, renew, vary or issue upon the application; or (b) refuse the application. director, in relation to a body corporate incorporated for a public purpose by a law of the Commonwealth, of a State or of a Territory, means: (a) a constituent member of the body; or (b) if the body does not have any members—a member of the board or other group of persons responsible for the administration or management of the affairs of the body. distinguishing number includes a distinguishing number together with one or more letters or symbols, or both. electronic signature of a person means the unique identification of the person in an electronic form approved by the APVMA. eligible law, in relation to a jurisdiction, means a law, or a provision of a law, of that jurisdiction that is declared by a law of that jurisdiction to be an eligible law for the purposes of this Code. emergency use has the same meaning as in the regulations. environment includes all aspects of the surroundings of human beings, whether affecting them as individuals or in their social groupings. established standard has the meaning given by subsection 8U(7). evidential burden, in relation to a matter, means the burden of adducing or pointing to evidence that suggests a reasonable possibility that the matter exists or does not exist. evidential material means any of the following: (a) a thing with respect to which an offence against an agvet law has been committed or is suspected, on reasonable grounds, to have been committed; (b) a thing with respect to which an agvet penalty provision has been contravened or is suspected, on reasonable grounds, to have been contravened; (c) a thing that there are reasonable grounds for suspecting will afford evidence as to the commission of such an offence or contravention of such an agvet penalty provision; (d) a thing that there are reasonable grounds for suspecting is intended to be used for the purpose of committing such an offence or contravening such an agvet penalty provision. excluded organism means an organism that is declared by the regulations to be an excluded organism. executive officer of a body corporate means a person, by whatever name called and whether or not a director of the body, who is concerned in, or takes part in, the management of the body. expiry date, in relation to the contents of a container, means the month and year after which the contents must not be used. fee includes a fee that is a tax. file includes a file of information stored or recorded by means of a computer. food‑producing species means an animal that produces food for human consumption or is used as food for human beings, and includes: (a) any buffalo, cattle, deer, fish (other than ornamental fish), goat, kangaroo, pig, poultry, rabbit, sheep, bee, crustacean or mollusc; or (b) any animal declared by the regulations to be a food‑producing species. give information includes make a statement. handling includes transportation, storage, processing, use or disposal. holder: (a) in relation to an approval or registration, means: (i) the person entered in the Record, Register or relevant APVMA file as the holder of the approval or registration; or (ii) if the holder was an individual who has died or is an individual whose affairs are being lawfully administered by another person—the legal personal representative of the individual or the person administering the individual's affairs; or (iii) if the holder was a body corporate—a successor in law of the body corporate; or (b) in relation to a permit or licence, means the person to whom the permit or licence was issued. inspector means: (a) a person appointed as an inspector for the purposes of this Code under subsection 69F(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992; or (b) a person to whom an authorisation referred to in subsection 69F(2) of that Act applies for the purposes of this Code. instruction includes direction, caution, warning or recommendation. instructions approved by the APVMA includes authorisations and requirements (however described) set out in a permit. investigation powers has the meaning given by sections 132A, 132B and 132C. investigation warrant means: (a) a warrant issued under section 143A; or (b) a warrant signed by a magistrate under section 143B, being a warrant of the same kind as would have been issued under section 143A. jurisdiction means: (a) a State; or (b) the participating Territories. label includes tag, leaflet, brand, stamp, mark, stencil or written statement. licence means a licence under Part 8. limitation period has the meanings given by section 34M. Note: See also section 34MA (which deals with extensions of limitation periods). listed chemical product means a chemical product that: (a) is, or is included in a class of chemical products that is, listed by regulations under section 8T; and (b) complies with the established standard for the product. lodged, in relation to an application under this Code or a notice under Division 2AA of Part 2, has the meaning prescribed by the regulations. manufacture, in relation to a chemical product, means: (a) to produce the chemical product; or (b) to engage in any part of the process of producing the chemical product, or any component or ingredient of the chemical product as part of that process, or of bringing the chemical product to its final state, including by formulating, processing, assembling, packaging, labelling, storing, sterilising, testing, supplying or releasing for supply. manufacturing principles means principles that the APVMA has determined under section 23 of the Agricultural and Veterinary Chemicals Act 1994 to be principles to be observed in the manufacture of chemical products. Maximum Residue Limits Standard means the Maximum Residue Limits Standard, made under the Food Standards Australia New Zealand Act 1991, as in force from time to time, or any standard in force in substitution for that standard. meets the application requirements has the meaning given by section 8A. meets the efficacy criteria has the meaning given by subsection 5B(1). meets the labelling criteria has the meaning given by subsection 5D(1). meets the notice requirements has the meaning given by subsection 26AD(1). meets the safety criteria has the meaning given by subsection 5A(1). meets the trade criteria has the meaning given by subsection 5C(1). member of the staff, in relation to the APVMA, has the same meaning as in the Agricultural and Veterinary Chemicals (Administration) Act 1992. minor use has the same meaning as in the regulations. monitoring powers has the meaning given by sections 131A, 131B and 131C. monitoring warrant means: (a) a warrant issued under section 143; or (b) a warrant signed by a magistrate under section 143B, being a warrant of the same kind as would have been issued under section 143. nominated agent, for an approval or registration, means the person entered in the Record, Register or relevant APVMA file as the nominated agent for the approval or registration. notifiable variation, of the relevant particulars of an approval or registration, has the meaning given by subsection 26AB(3). occupier, in relation to any premises or a part of any premises, means the person in occupation, charge or control of the premises or of that part of the premises, as the case may be. ordinary office hours means the hours when the office of the APVMA is open to members of the public. participating Territory has the same meaning as in the Agricultural and Veterinary Chemicals Act 1994. penalty unit has the same meaning as in section 4AA of the Crimes Act 1914. permit means a permit under Part 7. person assisting an inspector: (a) in relation to the exercise of monitoring powers—has the meaning given by section 131D; and (b) in relation to the exercise of investigation powers—has the meaning given by section 132E. pest means: (a) in relation to an animal, plant or thing—any animal, plant or other biological entity that injuriously affects the physical condition, worth or utility of the first‑mentioned animal or plant or of that thing; or (b) in relation to a place—an animal, plant or other biological entity that injuriously affects the use or enjoyment of that place. place of residence, in relation to a body corporate that is incorporated in Australia, means its registered office in Australia. plant means any vegetation or fungus and includes a seed or cutting of a plant, or any other part or product of a plant. premises includes any place (whether enclosed or built on or not), including a place situated under ground or under water, and, in particular, includes: (a) a building, aircraft, vehicle or vessel; and (b) any structure, whether a fixed structure, or a moveable structure such as a tent, and whether on land or the bed of any waters or floating on any waters; and (c) a part of premises (including a part of premises of a kind referred to in paragraph (a) or (b)). prescribed means prescribed by the Agvet Code of this jurisdiction or by the regulations. prescribed active constituent has the meaning given by subsection 14C(4). prescribed chemical product has the meaning given by subsection 14D(4). prescribed civil penalty provision means a civil penalty provision that is prescribed by the regulations. prescribed label for containers for a chemical product has the meaning given by subsection 14E(4). prescribed variation, of the relevant particulars of an approval or registration, has the meaning given by subsection 26B(4). previous registering authority means a registering authority under a corresponding previous law. previously endorsed active constituent for a chemical product at a particular time means a substance that: (a) before that time, had been approved or registered (however described) under a law of the Commonwealth or a State or Territory as an active constituent for a chemical product; or (b) was an active constituent for a chemical product that, before that time, had been approved or registered (however described) under a law of the Commonwealth or a State or Territory as a chemical product; whether or not the approval or registration was a result of an application by a particular person. primary active constituent has the meaning given in section 59. primary chemical product has the meaning given in section 59. primary holder means: (a) in relation to a primary active constituent—the holder by whom, or on whose behalf, protected information was given to the APVMA in respect of the constituent; or (b) in relation to a primary chemical product—the holder by whom, or on whose behalf, protected information was given to the APVMA in respect of the product. prohibited chemical product means a chemical product that is declared by the regulations to be a prohibited chemical product. protected active constituent means an active constituent for a proposed or existing chemical product, being an active constituent to which each of the following paragraphs apply: (a) the constituent is or includes an invention in respect of which letters patent were granted under the Patents Act 1952 or the Patents Act 1990; (b) the term of the letters patent (including any extension of that term): (i) has ended; or (ii) will end during the protection period (including that period as extended) that applies to protected information about that constituent; (c) the constituent is approved under Part 2. protected chemical product means a chemical product to which each of the following paragraphs apply: (a) the product is or includes an invention in respect of which letters patent were granted under the Patents Act 1952 or the Patents Act 1990; (b) the term of the letters patent (including any extension of that term): (i) has ended; or (ii) will end during the protection period (including that period as extended) that applies to protected information about that product; (c) the product is registered under Part 2. protected commodity means: (a) any substance or thing of a kind used, or capable of being used, as food or drink by human beings; or (b) any substance or thing of a kind used, or capable of being used, as an ingredient or additive in, or any substance used in the preparation of, a substance or thing referred to in paragraph (a); or (c) any plant or animal; or (d) any soil, water or other environmental component; or (e) any other agricultural commodity; or (f) any animal feed; or (g) any other prescribed substance or thing; or (h) any substance or thing that is capable of being made into anything referred to in any of the above paragraphs; but does not include a therapeutic good within the meaning of the Therapeutic Goods Act 1989. protected information means information or results given to the APVMA as required under paragraph 32(1)(b) or 33(1)(a) or (c), or subparagraph 159(1)(d)(i), (ii) or (iii), that: (a) have been obtained because of a trial or laboratory experiment; and (b) relate to: (i) an active constituent that has been approved; or (ii) a chemical product that has been registered. protection period, in relation to protected information, means the period that: (a) begins when the information is first given to the APVMA in relation to a reconsideration; and (b) ends 8 years after the APVMA makes its decision on the reconsideration. Note: See also section 34KA (which deals with extensions of the protection period). published literature, in relation to a particular matter, means all documents that relate to that matter and are accessible to the public. recall notice means a notice issued under section 101, 102 or 103. Record means the Record of Approved Active Constituents for Chemical Products kept under section 17. Record of Permits means the Record of Permits kept under section 113. re‑entry period, in relation to the use of a chemical product in a particular place (including a use of the product in relation to a crop or pasture in that place), means the period after that use during which it is unsafe for a person to enter the place without wearing appropriate protective clothing or equipment, or both. Register means the Register of Agricultural and Veterinary Chemical Products kept under section 18. registered chemical product has the meaning given by section 5AA. registration means registration under Part 2 of a chemical product. regulations means the Agvet Regulations of this jurisdiction. relevant APVMA file means the file in which information about approved labels is recorded as mentioned in paragraph 21(c). relevant data means information relevant to determining whether: (a) an agvet law has been, or is being, complied with; or (b) information provided under an agvet law is correct. relevant particulars means: (a) in relation to the approval of an active constituent—the distinguishing number, any instructions for use and any other particulars required by paragraph 19(c) to be entered in the Record; and (b) in relation to the registration of a chemical product—the distinguishing number, any instructions for use and any other particulars required by paragraph 20(1)(c) to be entered in the Register; and (c) in relation to the approval of a label—the information required to be recorded in the relevant APVMA file by subparagraphs 21(c)(i) to (iva); and includes particulars of variations of relevant particulars made under section 26, 26AC, 26C, 29, 29A, 34A or 34AF. repealed Act means the Agricultural and Veterinary Chemicals Act 1988. reserved means reserved by being a chemical product that is, or is included in a class of chemical products that is, specified in the Reserved Schedule. reserved chemical product means a chemical product that is, or is included in a class of chemical products that is, specified in the Reserved Schedule. Reserved Schedule means the schedule contained in the regulations under section 56ZU. residues, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, means: (a) subject to paragraph (b), any remains, persisting in or on a protected commodity, of: (i) the active constituent, or the active constituents in the chemical product; or (ii) any derivatives, metabolites, or degradation products, of the active constituent or of the active constituents in the chemical product; or (b) if the APVMA has published a notice in the Gazette for the purposes of this paragraph that applies to the active constituent or chemical product—only such of the remains referred to in paragraph (a) as are specified in the notice to be remains that constitute residues of the active constituent or of the chemical product for the purposes of this Code. restricted chemical product means a chemical product declared by regulations made for the purposes of section 93 to be a restricted chemical product. sample includes specimen. secondary active constituent has the meaning given in section 59. secondary chemical product has the meaning given in section 59. secondary holder, in relation to a secondary active constituent for a proposed or existing chemical product, means: (a) if the APVMA is considering an application for the approval of that constituent—the person who made the application; or (b) if the APVMA has reconsidered or is reconsidering the approval of that constituent: (i) the person entered in the Record as the holder of the approval; or (ii) if the holder was an individual who has died or is an individual whose affairs are being lawfully administered by another person—the legal personal representative of the individual or the person administering the individual's affairs; or (iii) if the holder was a body corporate—a successor in law of the body corporate. secondary holder, in relation to a secondary chemical product, means: (a) if the APVMA is considering an application for the registration of that product—the person who made the application; or (b) if the APVMA has reconsidered or is reconsidering the registration of that product: (i) the person entered in the Register as the holder of the registration; or (ii) if the holder was an individual who has died or is an individual whose affairs are being lawfully administered by another person—the legal personal representative of the individual or the person administering the individual's affairs; or (iii) if the holder was a body corporate—a successor in law of the body corporate. State includes the Northern Territory. substance includes: (a) any gas, liquid, mixture or compound of gases, or mixture or compound of liquids; and (b) an organism or part of an organism, including a genetically manipulated organism or part of a genetically manipulated organism; and (c) material that is produced from an organism; and (d) matter whose production involves the use of an organism; but does not include an excluded organism or part of an excluded organism, or material that is produced from, or matter whose production involves the use of, an excluded organism. supply includes do, or cause or permit the doing of, any of the following: (a) sell; (b) expose for sale; (c) send or deliver for sale or on sale; (d) dispose of under a hire purchase agreement; (e) exchange; (f) give; (g) offer to do an act that would be a supply (including an act referred to in any of the above paragraphs); and, for example, includes supply under a contract for work or labour that also involves the supply of any thing. Territory does not include the Northern Territory; thing, except where used as an object of the verb "to do", includes: (a) an animal; and (b) information; and (c) a document; and (d) a substance. this Code means the Agvet Code of this jurisdiction and includes the Agvet Regulations of this jurisdiction. use, in relation to an active constituent for a proposed or existing chemical product, or in relation to a chemical product, includes deal with the constituent or product. variations includes additions, omissions, substitutions and modifications. veterinary chemical product has the meaning given by section 5. veterinary surgeon means a person who is registered as a veterinary surgeon under the law of a State or Territory. warrant means a monitoring warrant or an investigation warrant. withholding period, in relation to the use of a chemical product, means the minimum period that needs to elapse between: (a) the last use of the product in relation to a crop, pasture or animal; and (b) the harvesting or cutting of, or the grazing of animals on, the crop or pasture, the shearing or slaughtering of the animal, or the collection of milk or eggs from the animal for human consumption, as the case may be; in order to ensure that the product's residues fall to or below the maximum limit that the APVMA permits. working day means a day other than a Saturday, a Sunday or a day that is a public holiday in the place where the office of the APVMA is situated. 4 Definition of agricultural chemical product (1) This section defines what is meant by an agricultural chemical product for the purposes of this Code. (2) Subject to subsections (3) and (4), an agricultural chemical product is a substance or mixture of substances that is represented, imported, manufactured, supplied or used as a means of directly or indirectly: (a) destroying, stupefying, repelling, inhibiting the feeding of, or preventing infestation by or attacks of, any pest in relation to a plant, a place or a thing; or (b) destroying a plant; or (c) modifying the physiology of a plant or pest so as to alter its natural development, productivity, quality or reproductive capacity; or (d) modifying an effect of another agricultural chemical product; or (e) attracting a pest for the purpose of destroying it. (3) An agricultural chemical product includes a substance or mixture of substances declared by the regulations to be an agricultural chemical product. (4) An agricultural chemical product does not include: (a) a veterinary chemical product; or (b) a substance or mixture of substances declared by the regulations not to be an agricultural chemical product. 5 Definition of veterinary chemical product (1) This section defines what is meant by a veterinary chemical product for the purposes of this Code. (2) Subject to subsections (3) and (4), a veterinary chemical product is a substance or mixture of substances that is represented as being suitable for, or is manufactured, supplied or used for, administration or application to an animal by any means, or consumption by an animal, as a way of directly or indirectly: (a) preventing, diagnosing, curing or alleviating a disease or condition in the animal or an infestation of the animal by a pest; or (b) curing or alleviating an injury suffered by the animal; or (c) modifying the physiology of the animal: (i) so as to alter its natural development, productivity, quality or reproductive capacity; or (ii) so as to make it more manageable; or (d) modifying the effect of another veterinary chemical product. (3) A veterinary chemical product includes: (a) a vitamin, a mineral substance, or an additive, if, and only if, the vitamin, substance or additive is used for a purpose mentioned in paragraph (2)(a), (b), (c) or (d); and (b) a substance or mixture of substances declared by the regulations to be a veterinary chemical product. (4) A veterinary chemical product does not include: (a) a substance or mixture of substances that is: (i) prepared by a pharmacist in accordance with the instructions of a veterinary surgeon; or (ii) prepared by a veterinary surgeon; in the course of the practice, by the person preparing the substance or mixture of substances, of his or her profession as permitt