Commonwealth: Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 (Cth)

Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 No. 125, 2013 as amended Compilation start date: 21 July 2014 Includes amendments up to: Act No. 91, 2014 About this compilation This compilation This is a compilation of the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013 as in force on 21 July 2014. It includes any commenced amendment affecting the legislation to that date. This compilation was prepared on 4 August 2014. The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of each amended provision. Uncommenced amendments The effect of uncommenced amendments is not reflected in the text of the compiled law but the text of the amendments is included in the endnotes. Application, saving and transitional provisions for provisions and amendments If the operation of a provision or amendment is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes. Modifications If a provision of the compiled law is affected by a modification that is in force, details are included in the endnotes. Provisions ceasing to have effect If a provision of the compiled law has expired or otherwise ceased to have effect in accordance with a provision of the law, details are included in the endnotes. Contents 1 Short title 2 Commencement 3 Schedule(s) 4 Review of operation of amendments 5 Review of prescribed matters 6 Regulations for section 5 Schedule 1—Approvals, registrations, permits and licences Agricultural and Veterinary Chemicals Code Act 1994 Schedule 2—Re‑approvals and re‑registrations Agricultural and Veterinary Chemicals Code Act 1994 Schedule 3—Enforcement Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 Agricultural and Veterinary Chemicals (Administration) Act 1992 Agricultural and Veterinary Chemicals Code Act 1994 Schedule 4—Data protection Agricultural and Veterinary Chemicals Code Act 1994 Schedule 5—Arrangements for collecting levy Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 Schedule 6—Miscellaneous Part 1—Miscellaneous amendments Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 Agricultural and Veterinary Chemicals Act 1994 Agricultural and Veterinary Chemicals (Administration) Act 1992 Agricultural and Veterinary Chemicals Code Act 1994 Part 2—Transitional, application and savings provisions Endnotes Endnote 1—About the endnotes Endnote 2—Abbreviation key Endnote 3—Legislation history Endnote 4—Amendment history Endnote 5—Uncommenced amendments [none] Endnote 6—Modifications [none] Endnote 7—Misdescribed amendments [none] Endnote 8—Miscellaneous [none] An Act to amend laws relating to agricultural and veterinary chemicals, and for related purposes 1 Short title This Act may be cited as the Agricultural and Veterinary Chemicals Legislation Amendment Act 2013. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms. Commencement information Column 1 Column 2 Column 3 Provision(s) Commencement Date/Details 1. Sections 1 to 4 and anything in this Act not elsewhere covered by this table The day this Act receives the Royal Assent. 29 June 2013 2. Schedules 1 to 6 1 July 2014. 1 July 2014 Note: This table relates only to the provisions of this Act as originally enacted. It will not be amended to deal with any later amendments of this Act. (2) Any information in column 3 of the table is not part of this Act. Information may be inserted in this column, or information in it may be edited, in any published version of this Act. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. 4 Review of operation of amendments (1) The Minister must cause a review to be conducted of: (a) the operation of the amendments made by this Act; and (b) any other related matter that the Minister specifies. (2) At least one of the persons conducting the review must be a person who is not otherwise appointed, employed or engaged by the Commonwealth. (3) The review must include a request for, and consideration of, submissions from members of the public. (4) The Minister must cause a written report of the review to be laid before each House of the Parliament within 15 sitting days of that House after 1 July 2019. 5 Review of prescribed matters (1) The Minister must cause a review to be conducted of matters relating to the powers and functions of the APVMA that are prescribed by the regulations. (2) The person conducting the review must give the Minister a report of the review in accordance with the regulations. (3) This section, and any regulations made for the purposes of this section, cease to have effect 5 years after the day this Act receives the Royal Assent. 6 Regulations for section 5 (1) The Governor‑General may make regulations prescribing matters: (a) required or permitted by section 5 to be prescribed; or (b) necessary or convenient to be prescribed for carrying out or giving effect to section 5. (2) Without limiting subsection (1), regulations may deal with any or all of the following: (a) the terms of reference for the review; (b) when the review is to be conducted; (c) how the review is to be conducted; (d) the publication of the report of the review. (3) This section ceases to have effect 5 years after the day this Act receives the Royal Assent. Schedule 1—Approvals, registrations, permits and licences Agricultural and Veterinary Chemicals Code Act 1994 1 Before section 1 of the Code set out in the Schedule Insert: Division 1—Object, definitions etc. 2 After section 1 of the Code set out in the Schedule Insert: 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. 3 Subsection 3(1) of the Code set out in the Schedule (definition of acknowledge) Repeal the definition. 4 Subsection 3(1) of the Code set out in the Schedule (definition of adequate) Omit all the words after "practicable, that the", substitute "product meets the safety criteria and the trade criteria". 5 Subsection 3(1) of the Code set out in the Schedule Insert: application means an application under this Code. 6 Subsection 3(1) of the Code set out in the Schedule (definition of approved person) Repeal the definition. 7 Subsection 3(1) of the Code set out in the Schedule Insert: determine, in relation to an application, means: (a) approve, re‑approve, register, re‑register, vary or issue on the application; or (b) refuse the application; or (c) if the application resulted in the reconsideration of an approval or registration as required by section 29H—cancel the approval or registration under section 34AA. 8 Subsection 3(1) of the Code set out in the Schedule Insert: electronic signature of a person means the unique identification of the person in an electronic form approved by the APVMA. 9 Subsection 3(1) of the Code set out in the Schedule (definition of established standard) Repeal the definition, substitute: established standard has the meaning given by subsection 8U(7). 10 Subsection 3(1) of the Code set out in the Schedule (definition of holder) Repeal the definition, substitute: 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. 10A Subsection 3(1) of the Code set out in the Schedule Insert: instructions approved by the APVMA includes authorisations and requirements (however described) set out in a permit. 11 Subsection 3(1) of the Code set out in the Schedule (definition of instructions for use) Repeal the definition. 12 Subsection 3(1) of the Code set out in the Schedule (definition of interested person) Repeal the definition. 13 Subsection 3(1) of the Code set out in the Schedule Insert: limitation period has the meanings given by section 34M. 14 Subsection 3(1) of the Code set out in the Schedule (definition of listable chemical product) Repeal the definition. 15 Subsection 3(1) of the Code set out in the Schedule Insert: listed chemical product means a chemical product that is, or is included in a class of chemical products that is, listed by regulations under section 8T. 16 Subsection 3(1) of the Code set out in the Schedule (definition of listed registration) Repeal the definition. 17 Subsection 3(1) of the Code set out in the Schedule (definition of Listing Schedule) Repeal the definition. 17A Subsection 3(1) of the Code set out in the Schedule Insert: lodged, in relation to an application under this Code, has the meaning prescribed by the regulations. 18 Subsection 3(1) of the Code set out in the Schedule Insert: 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 safety criteria has the meaning given by subsection 5A(1). meets the trade criteria has the meaning given by subsection 5C(1). 19 Subsection 3(1) of the Code set out in the Schedule Insert: 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. 20 Subsection 3(1) of the Code set out in the Schedule Insert: Record means the Record of Approved Active Constituents for Chemical Products kept under section 17. 21 Subsection 3(1) of the Code set out in the Schedule (definition of Record of Approved Active Constituents) Repeal the definition. 22 Subsection 3(1) of the Code set out in the Schedule Insert: Register means the Register of Agricultural and Veterinary Chemical Products kept under section 18. 23 Subsection 3(1) of the Code set out in the Schedule (definition of Register of Chemical Products) Repeal the definition. 24 Subsection 3(1) of the Code set out in the Schedule (definition of registered listed chemical product) Repeal the definition. 25 Subsection 3(1) of the Code set out in the Schedule Insert: relevant APVMA file means the file in which information about approved labels is recorded as mentioned in paragraph 21(c). 26 Subsection 3(1) of the Code set out in the Schedule (definition of relevant particulars) Repeal the definition, substitute: 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(1)(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, 26C, 29, 29A, 29G, 34A or 34AF. 27 After section 5 of the Code set out in the Schedule Insert: 5A Definition of meets the safety criteria (1) An active constituent or chemical product meets the safety criteria if use of the constituent or product, in accordance with any instructions approved, or to be approved, by the APVMA for the constituent or product or contained in an established standard: (a) is not, or would not be, an undue hazard to the safety of people exposed to it during its handling or people using anything containing its residues; and (b) is not, or would not be, likely to have an effect that is harmful to human beings; and (c) is not, or would not be, likely to have an unintended effect that is harmful to animals, plants or things or to the environment. (2) For the purposes of being satisfied as to whether an active constituent meets the safety criteria, the APVMA: (a) must have regard to the following: (i) the toxicity of the constituent and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings; (ii) the method by which the constituent is, or is proposed to be, manufactured; (iii) the extent to which the constituent will contain impurities; (iv) whether an analysis of the chemical composition of the constituent has been carried out and, if so, the results of the analysis; (v) any conditions to which its approval is, or would be, subject; (vi) any relevant particulars that are, or would be, entered in the Record for the constituent; (via) whether the constituent conforms, or would conform, to any standard made for the constituent under section 6E to the extent that the standard relates to matters covered by subsection (1); (vii) any matters prescribed by the regulations; and (b) may have regard to such other matters as it thinks relevant. (3) For the purposes of being satisfied as to whether a chemical product meets the safety criteria, the APVMA: (a) must have regard to the following: (i) the toxicity of the product and its residues, including metabolites and degradation products, in relation to relevant organisms and ecosystems, including human beings; (ii) the relevant poison classification of the product under the law in force in this jurisdiction; (iii) how the product is formulated; (iv) the composition and form of the constituents of the product; (v) any conditions to which its registration is, or would be, subject; (vi) any relevant particulars that are, or would be, entered in the Register for the product; (via) whether the product conforms, or would conform, to any standard made for the product under section 6E to the extent that the standard relates to matters covered by subsection (1); (vii) any matters prescribed by the regulations; and (b) may have regard to one or more of the following: (i) the acceptable daily intake of each constituent contained in the product; (ii) any dietary exposure assessment prepared under subsection 82(4) of the Food Standards Australia New Zealand Act 1991 as a result of any proposed variation notified under subsection 82(3) of that Act in relation to the product, and any comments on the assessment given to the APVMA under subsection 82(4) of that Act; (iii) whether any trials or laboratory experiments have been carried out to determine the residues of the product and, if so, the results of those trials or experiments and whether those results show that the residues of the product will not be greater than limits that the APVMA has approved or approves; (iv) the stability of the product; (v) the specifications for containers for the product; (vi) such other matters as it thinks relevant. 5B Definition of meets the efficacy criteria (1) A chemical product meets the efficacy criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA for the product or contained in an established standard, is, or would be, effective according to criteria determined by the APVMA by legislative instrument. (2) For the purposes of being satisfied as to whether a chemical product meets the efficacy criteria, the APVMA must have regard to the following: (a) whether any trials or laboratory experiments have been carried out to determine the efficacy of the product and, if so, the results of those trials or experiments; (b) any conditions to which its registration is, or would be, subject; (c) any relevant particulars that are, or would be, entered in the Register for the product; (ca) whether the product conforms, or would conform, to any standard made for the product under section 6E to the extent that the standard relates to matters covered by subsection (1); (d) any matters prescribed by the regulations. (3) For the purposes of the operation of this Code in relation to a particular chemical product, the APVMA is required to have regard to the matters set out in subsections (1) and (2) only: (a) to the extent prescribed by the regulations; or (b) if there are no such regulations—to the extent that the APVMA thinks the matters are relevant. 5C Definition of meets the trade criteria (1) A chemical product meets the trade criteria if use of the product, in accordance with instructions approved, or to be approved, by the APVMA or contained in an established standard, does not, or would not, unduly prejudice trade or commerce between Australia and places outside Australia. (2) For the purposes of being satisfied as to whether a chemical product meets the trade criteria, the APVMA must have regard to the following: (a) any conditions to which its registration is, or would be, subject; (b) any relevant particulars that are, or would be, entered in the Register for the product; (ba) whether the product conforms, or would conform, to any standard made for the product under section 6E to the extent that the standard relates to matters covered by subsection (1); (c) any matters prescribed by the regulations. (3) For the purposes of the operation of this Code in relation to a particular chemical product, the APVMA is required to have regard to the matters set out in subsections (1) and (2) only: (a) to the extent prescribed by the regulations; or (b) if there are no such regulations—to the extent that the APVMA thinks the matters are relevant. 5D Definition of meets the labelling criteria (1) A label for containers for a chemical product meets the labelling criteria if the label contains adequate instructions relating to such of the following as are appropriate: (a) the circumstances in which the product should be used; (b) how the product should be used; (c) the times when the product should be used; (d) the frequency of the use of the product; (e) the withholding period after the use of the product; (f) the re‑entry period after the use of the product; (g) the disposal of the product when it is no longer required; (h) the disposal of containers of the product; (i) the safe handling of the product and first aid in the event of an accident caused by the handling of the product; (j) any matters prescribed by the regulations. (2) For the purposes of being satisfied as to whether a label meets the labelling criteria, the APVMA must have regard to the following: (a) any conditions to which its approval is, or would be, subject; (b) any relevant particulars and instructions that are, or would be, entered in the relevant APVMA file for the label; (c) whether the label conforms, or would conform, to any standard made for the label under section 6E to the extent that the standard relates to matters covered by subsection (1). 28 After section 6 of the Code set out in the Schedule Insert: 6A APVMA may make guidelines etc. (1) The APVMA may make written guidelines for performing its functions and exercising its powers under this Code. (2) The APVMA must have regard to the guidelines. (3) The guidelines must include: (a) principles and processes for effective and efficient regulation of chemical products and their constituents; and (b) principles and processes relating to: (i) the approval of active constituents for proposed or existing chemical products; and (ii) the registration of chemical products; and (iii) the approval of labels for containers for chemical products; and (iv) the variation of relevant particulars and conditions; and (v) the issue of permits and licences; and (vi) the reconsideration of approvals and registrations. (4) The guidelines must not be inconsistent with an agvet law. (5) The APVMA must publish the guidelines on its website. (6) The guidelines are not a legislative instrument. 6B Varying relevant particulars and conditions To avoid doubt, a power under this Code to vary a relevant particular or condition does not authorise the APVMA to vary a relevant particular or condition that was not imposed by the APVMA. 6C Right of APVMA to use information (1) The APVMA may use information obtained by it from any source for the purpose of performing any of its functions or exercising any of its powers under this Code. (2) Subsection (1) has effect subject to this Code. 6D Failure to comply with time limit does not affect validity Failure by the APVMA to comply with a time limit set out in this Code does not affect the validity of anything done by the APVMA. 6E APVMA may make standards (1) The APVMA may, by legislative instrument, make standards for the following: (a) constituents for chemical products; (b) chemical products; (c) labels for containers for chemical products. (2) A standard made under subsection (1) may apply, adopt or incorporate, with or without modification, any matter contained in any instrument or other writing as in force at a particular time or as in force from time to time. 29 After section 8A of the Code set out in the Schedule Insert: Division 2—General provisions about applications 8A Definition of meets the application requirements An application meets the application requirements if: (a) the application: (i) is in writing in the approved form; and (ii) is signed by the applicant; and (iii) is accompanied by so much of the prescribed fee as is required to be paid when the application is made; and (iv) is lodged with the APVMA; and (v) contains, or is accompanied by, any information specified for the application under section 8B; and (b) the constituent, product or label in relation to which the application is made complies, or will comply, with any requirement prescribed by the regulations; and (c) any requirement made under section 157 or 159 in relation to the application has been complied with; and (d) any requirement prescribed by another provision of this Code in relation to the application has been complied with; and (e) any amount (including an amount in respect of a tax or penalty) that is payable by the applicant to the APVMA (including under a law of another jurisdiction or the agvet law), has been paid. Note: For giving information electronically, see section 156A. 8B Information to be provided with applications (1) The APVMA may, by legislative instrument, specify the information that must be contained in, or accompany, the application. (2) The APVMA may specify information under subsection (1) only if: (a) the inclusion of the information would enable the APVMA to determine the application; and (b) in relation to an application under section 29D (applications for re‑approval or re‑registration)—the information is information that the applicant could be reasonably expected to have, or to have access to. 8C Information to be taken into account in determining applications (1) In determining the application, the APVMA: (a) must have regard to: (i) the information in, or accompanying, the application as required under section 8B or any other provision of this Code; and (ii) any information or thing given to the APVMA as required under section 157 or 159 or by section 160A in relation to the application; and (iii) any submission made in response to an invitation given by the APVMA in relation to the application; and (b) may have regard to any other matter that it thinks relevant. (2) However, the APVMA must not take into account any information that: (a) is given by or on behalf of the applicant in connection with the application; but (b) is not covered by paragraph (1)(a). (3) This section does not apply in relation to an application under section 122 for a licence. 8D Applications may be withdrawn At any time after the application is made and before it is determined, the applicant may withdraw it by giving the APVMA written notice of the withdrawal signed by the applicant. Division 3—General provisions about notices 8E Notice to Food Standards Australia New Zealand (1) The APVMA must notify Food Standards Australia New Zealand if an approval, registration, variation or permit proposed under this Code (whether by application or on the initiative of the APVMA) would, if it were given, made or issued, be likely to require a variation to the Maximum Residue Limits Standard. (2) The notice must: (a) be in writing; and (b) set out: (i) the relevant particulars, or proposed relevant particulars, of the active constituents and products concerned, other than confidential commercial information; and (ii) any other matters that the APVMA thinks appropriate; and (c) be given to Food Standards Australia New Zealand: (i) for an application, other than an application under section 29D—within 28 days after the APVMA completes a preliminary assessment of the application; or (ii) for a variation under section 26C, 29, 29A, 29G, 34A or 34AF—before the variation is made. (3) This section does not apply in relation to an approval, registration, variation or permit proposed by an application that is subject to preliminary assessment before the application has passed preliminary assessment. 8F Notice to holder of approval, registration or variation (1) The APVMA must give written notice to the holder within 14 days if the APVMA: (a) approves (or re‑approves) an active constituent; or (b) registers (or re‑registers) a chemical product; or (c) renews the registration of a chemical product; or (d) approves a label; or (e) varies relevant particulars or conditions (whether on application or on the initiative of the APVMA), other than under section 34A (varying relevant particulars or conditions to allow affirmation). Note: For notices in relation to reconsiderations, see Division 4 of Part 2. (2) The notice must: (a) for an approval or registration: (i) state that the constituent, product or label has been approved or registered; and (ii) set out the relevant particulars and conditions of the approval or registration; and (iii) state the date the approval or registration ends; and (b) for a registration—state the date (if any) after which the registration cannot be renewed under Division 6 of Part 2; and (c) for the renewal of a registration—state that the registration of the chemical product has been renewed; and (d) for the variation of relevant particulars or conditions: (i) state that the relevant particulars or conditions have been varied; and (ii) set out the relevant particulars or conditions as varied; and (iii) state the date the approval or registration ends; and (iv) of a registration—state the date (if any) after which the registration cannot be renewed under Division 6 of Part 2; and (e) include any information prescribed by the regulations. 8G Notice to applicant of refusal of application (1) The APVMA must give written notice to the applicant within 14 days if the APVMA refuses an application. Note: For notices in relation to reconsiderations, see Division 4 of Part 2. (2) The notice must: (a) state that the application has been refused; and (b) set out the reasons for the refusal; and (c) include any information prescribed by the regulations; and (d) specify any amount of fee that is repayable because of the refusal. Note: Other provisions of this Code specify additional requirements for certain notices of refusal. 8H Published notice of approvals and registrations (1) If the APVMA approves an active constituent or registers a chemical product, it must, unless it thinks that in the circumstances it is unnecessary to do so, publish notice of the approval or registration. (2) The notice must: (a) be published in the Gazette, as soon as practicable, and in any other manner that the APVMA thinks appropriate; and (b) state that the constituent has been approved or the product has been registered and the date of the approval or registration as mentioned in section 22; and (c) if the approval or registration is a re‑approval or re‑registration—state that fact; and (d) contain a brief statement of the conditions of the approval or registration that directly regulate the use of the constituent or product; and (e) include any information prescribed by the regulations. 8J Published notice of variations of approvals and registrations (1) If the APVMA varies any of the relevant particulars or conditions of the approval of an active constituent or the registration of a chemical product, it must, unless it thinks that in the circumstances it is unnecessary to do so, publish notice of the variation. (2) The notice must: (a) be published in the Gazette, as soon as practicable, and in any other manner that the APVMA thinks appropriate; and (b) state that the relevant particulars or conditions have been varied and the date on which the variation took place; and (c) contain a brief statement of the nature of, and reasons for, the variation; and (d) include any information prescribed by the regulations. 8K Confidential commercial information must not be disclosed under certain provisions (1) Engaging in conduct in the performance of functions or duties, or the exercise of powers, under any of the following provisions does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: (a) subsection 8F(2); (b) subsection 8S(2); (c) subsection 17(4) or (5); (d) subsection 18(4) or (5); (e) subsection 34AB(2); (f) subsection 34AC(2); (g) subsection 47B(4). (2) Subsection (1) has effect despite subsection 162(1A). Division 4—Holders of approvals and registrations and nominated agents 8L Changing the holder (1) The holder of an approval or registration may apply to the APVMA to change the holder. (2) The APVMA must record the change in the Record, Register or relevant APVMA file, as required, if the APVMA is satisfied that: (a) the application meets the application requirements; and (b) the proposed holder has consented, by signed writing, to being the holder; and (c) if the proposed holder is not a resident of, and does not carry on business in, Australia—there will be a nominated agent for the approval or registration; and (d) any requirements prescribed by the regulations have been met. (3) Otherwise, the APVMA must refuse the application. Note: For notice of refusal, see section 8G. 8M Nominated agent (1) The holder may, at any time, apply to the APVMA for the person nominated in the application to be the nominated agent for the approval or registration. (2) The APVMA must record the person as the nominated agent in the Record, Register or relevant APVMA file, as required, if the APVMA is satisfied that: (a) the application meets the application requirements; and (b) the nominated person has consented, by signed writing, to being the nominated agent; and (c) any requirements prescribed by the regulations have been met. (3) Otherwise, the APVMA must refuse the application. Note: For notice of refusal, see section 8G. (4) It is a condition of the approval or registration that the nominated agent is a resident of, or carries on business in, Australia. 8N Overseas holder must have nominated agent If the holder is not a resident of, and does not carry on business in, Australia, it is a condition of the approval or registration that there is a nominated agent for the approval or registration. 8P Changing the nominated agent (1) The holder may apply to the APVMA to change the nominated agent. (2) The APVMA must record the change in the Record, Register or relevant APVMA file, as required, if the APVMA is satisfied that: (a) the application meets the application requirements; and (b) the person to be the nominated agent has consented, by signed writing, to being the nominated agent; and (c) any requirements prescribed by the regulations have been met. (3) Otherwise, the APVMA must refuse the application. Note: For notice of refusal, see section 8G. 8Q Nominated agent may withdraw (1) The nominated agent may, by signed writing given to the APVMA, request to withdraw from being the nominated agent. (2) The APVMA must record the withdrawal in the Record, Register or relevant APVMA file, as required, if the APVMA is satisfied that: (a) the nominated agent has notified the holder of the withdrawal; and (b) any requirements prescribed by the regulations have been met. 8R Role of nominated agent Anything that may, or must, be done under this Code by, or in relation to, the holder, as the holder of the approval or registration, may be done by, or in relation to, either the holder or the nominated agent. Note: For liabilities imposed on the nominated agent, see section 152. Division 5—Notice of certain proposed decisions 8S Notice of certain proposed decisions (1) The APVMA must give the applicant written notice of what it proposes to do before it: (a) refuses an application, other than on preliminary assessment; or (b) approves (or re‑approves) or registers (or re‑registers) an active constituent, chemical product or label with instructions or relevant particulars other than those set out in the application; or (c) if the application is to vary relevant particulars or conditions—varies the relevant particulars or conditions other than in accordance with the application. Note: For notices in relation to reconsiderations, see Division 4 of Part 2. (2) The notice must: (a) for notice under paragraph (1)(b)—set out the proposed instructions and relevant particulars; and (b) for notice under paragraph (1)(c)—set out the proposed variation; and (c) include a draft statement of reasons for the proposed course of action; and (d) set out the information on which the reasons are based (including information not given to the APVMA by the applicant); and (e) invite written submissions from the applicant within 28 days, or within such further period as is specified in the notice. (3) The APVMA is not required to take account of anything given in response to the invitation under paragraph (2)(e) that is not related to information: (a) already given to the APVMA by, or on behalf of, the applicant; or (b) set out in the notice under paragraph (2)(d). (4) The APVMA is not required to comply with this section more than once in relation to a particular application. Division 6—Listed chemical products and established standards 8T Regulations may include schedule of listed chemical products (1) The regulations may include a schedule specifying chemical products, or classes of chemical products, that are listed chemical products for the purposes of this Code. (2) Before the Governor‑General makes a regulation that includes, or amends, the schedule referred to in subsection (1), the APVMA must publish in the Gazette, and in any other manner that the APVMA thinks appropriate, a notice: (a) stating that it proposes to recommend to the Minister that the regulation be made; and (b) setting out particulars of the chemical products, or class of chemical products, that would be covered, or otherwise affected, by the regulation; and (c) setting out a draft standard the APVMA proposes to make under section 8U in relation to each chemical product that would be covered by the regulation; and (d) giving the reasons for the proposed recommendation; and (e) inviting any person, within a period of at least 28 days specified in the notice, to make a written submission to the APVMA as to whether the proposed regulation should be made and stating the grounds on which the submission is based, which must be grounds relating to the matters mentioned in paragraph 8V(a). (3) In making a recommendation to the Minister, the APVMA must take into account any submissions made in accordance with the invitation. (4) Before the Governor‑General makes a regulation that includes, or amends, the schedule referred to in subsection (1): (a) the APVMA must have recommended to the Minister that the regulation be made; and (b) the APVMA must have given to the Minister: (i) its reasons for the recommendation; and (ii) written particulars of the product or class of products that would be covered, or otherwise affected, by the regulation; and (iii) a draft of the standard that the APVMA proposes to make under section 8U for the product, or for products in the class, if the product or class is specified in the schedule; and (iv) a written explanation as to why the APVMA is satisfied that the product, or class of products, meets the safety criteria, the trade criteria and the efficacy criteria (see section 8V); and (v) a written statement identifying the consultations held by, and setting out the advice given to, the APVMA in relation to the proposed regulation. 8U APVMA to prepare standards (1) This section applies in respect of each listed chemical product, whether or not the product is the subject of a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary) or in a similar publication. (2) The APVMA must, by legislative instrument, make a standard for each listed chemical product. A particular standard may relate to a specified chemical product or specified chemical products or to each chemical product in a specified class of chemical products. (3) The standard for a listed chemical product must require that the product be labelled in a manner, or kept in containers that comply with requirements, specified in the standard. (4) The APVMA may, in a standard, direct that the particulars required by the standard be set out, in a manner specified in the standard, on: (a) chemical products, or a class of chemical products, identified in the standard; or (b) a container containing chemical products, or a class of chemical products, identified in the standard; or (c) a label for containers for chemical products, or a class of chemical products, identified in the standard. (5) A standard for a listed chemical product: (a) may be specified by reference to any one or more of the following: (i) the composition and form of the constituents of the product; (ii) the physical and chemical properties of the chemical product; (iii) the quantity of the chemical product when contained in specified containers; (iv) procedures to be carried out in the manufacture of the chemical product; (v) a monograph in the British Pharmacopoeia or the British Pharmacopoeia (Veterinary); (vi) a monograph in another publication approved by the APVMA for the purposes of this subparagraph; (vii) a monograph referred to in subparagraph (v) or (vi) as modified in a manner specified in the standard; (viii) a standard published by Standards Australia; (ix) such other matters as the APVMA thinks fit; and (b) may require that a matter relating to the standard be determined in accordance with a particular test. (6) Subsections (4) and (5) do not limit subsection (3). (7) The standard made by the APVMA in relation to a listed chemical product is the established standard for the product. Note: The APVMA may revoke or amend a standard. See subsection 33(3) of the Acts Interpretation Act 1901. 8V Matters to be taken into account in preparing a standard The APVMA must not make a standard for a listed chemical product unless the APVMA is satisfied that compliance with the standard would result in: (a) the product meeting the safety criteria, the trade criteria and the efficacy criteria; and (b) any label for containers for the product meeting the labelling criteria. 30 Section 9 of the Code set out in the Schedule Repeal the section, substitute: 9 Explanation of Part (1) This Part contains provisions relating to: (a) approval of active constituents for proposed or existing chemical products; and (b) registration of chemical products; and (c) approval of labels for containers for chemical products. (2) Division 2 provides for approvals and registrations. (3) Division 2A provides for variation of relevant particulars of approvals and registrations if the relevant particulars are of a kind set out in a legislative instrument made under section 26B. Only holders of approvals or registrations may apply under Division 2A. (4) Division 3 provides generally for variation of relevant particulars or conditions of approvals and registrations. Holders and other persons may apply under Division 3. (5) Division 3A provides for re‑approval and re‑registration of active constituents and chemical products. (6) Division 4 provides for the APVMA to reconsider approvals and registrations in order to decide whether they should remain in force. (7) Division 4A limits the use the APVMA can make of certain information given to it in connection with certain applications. (8) Division 5 sets out the circumstances in which the APVMA may suspend or cancel approvals and registrations. (9) Division 6 states how long approvals and registrations are to continue in force and makes provision for the renewal of registrations. 31 Division 2 of Part 2 of the Code set out in the Schedule (heading) Repeal the heading, substitute: Division 2—Approving and registering 32 Sections 10 to 14A of the Code set out in the Schedule Repeal the sections, substitute: 9A Explanation of Division (1) This Division provides for: (a) approval of active constituents for proposed or existing chemical products; and (b) registration of chemical products; and (c) approval of labels for containers for chemical products. (2) Section 10 provides for applications to be made. Applications must meet the application requirements specified in section 8A. (3) The APVMA must complete a preliminary assessment of an application. If the application passes preliminary assessment, the APVMA must notify the applicant and publish a summary of the application (section 11). (4) Before determining certain applications that have passed preliminary assessment, the APVMA must publish a notice inviting public submissions (sections 12 and 13). (5) The APVMA must approve an active constituent or label, or register a chemical product, if specified criteria are met (section 14). Sections 14A to 16 set out special rules about approvals and registrations. (6) The APVMA must keep a Record of Approved Active Constituents for Chemical Products and a Register of Agricultural and Veterinary Chemical Products (sections 17 and 18). (7) Sections 19 to 21 set out how approvals and registrations take place, and section 22 deals with dates of approval and registration. (8) Approvals and registrations may be subject to conditions (section 23). (9) Section 26 provides for incorrect relevant particulars and conditions of a kind prescribed by the regulations to be corrected. 10 Applications (1) A person may apply to the APVMA: (a) for approval of an active constituent for a proposed or existing chemical product; or (b) for registration of a chemical product; or (c) for approval of a label for containers for a chemical product. (2) The application: (a) must meet the application requirements; and (b) for an active constituent or chemical product—must include proposed instructions for use of the constituent or product. Note: For meets the application requirements, see section 8A. 11 Preliminary assessment (1) The APVMA must complete a preliminary assessment of the application within 1 month after it is lodged. (2) If it appears from the preliminary assessment that the application meets the application requirements, the APVMA must, within 14 days: (a) give written notice to the applicant: (i) stating that the application has passed preliminary assessment and that it will be determined under section 14; and (ii) setting out any matters prescribed by the regulations; and (b) publish a summary of the application that includes any details prescribed by the regulations. (3) Otherwise, the APVMA must refuse the application. Note: For notice of refusal, see section 8G. (4) The APVMA may alter the application, after it has passed preliminary assessment, with the written consent of the applicant. 12 APVMA to publish notice before deciding whether to approve new active constituent (1) This section applies if the application: (a) has passed preliminary assessment; and (b) is for approval of an active constituent not previously contained in a chemical product registered in this or another jurisdiction under the Agvet Code, or a corresponding previous law, of the jurisdiction concerned. (2) The APVMA must publish a notice in the Gazette and in any other manner that it thinks appropriate. (3) The notice must state that the APVMA has to decide whether to approve the constituent and must: (a) set out the following: (i) the name of the constituent; (ii) particulars of the constituent; (iii) a summary of the APVMA's assessment of whether the constituent meets the safety criteria; (iv) any other matters that the APVMA thinks appropriate; and (b) invite any person to make, within a specified period of at least 28 days, a written submission as to whether the constituent should be approved and stating the grounds on which the submission is based, which must be grounds that relate to the safety criteria. 13 APVMA to publish notice before deciding whether to register chemical product containing new active constituent (1) This section applies if the application: (a) has passed preliminary assessment; and (b) is for registration of a chemical product containing an active constituent not previously contained in a chemical product registered in this or another jurisdiction under the Agvet Code, or a corresponding previous law, of the jurisdiction concerned. (2) The APVMA must publish a notice in the Gazette and in any other manner that it thinks appropriate. (3) The notice must state that the APVMA has to decide whether to register the product and must: (a) set out the following: (i) the name that the applicant intends to use to describe the product; (ii) particulars of the product and its active constituents; (iii) a summary of the APVMA's assessment of whether the product meets the safety criteria, the trade criteria and the efficacy criteria; (iv) any other matters that the APVMA thinks appropriate; and (b) invite any person to make, within a specified period of at least 28 days, a written submission to the APVMA as to whether the product should be registered and stating the grounds on which the submission is based, which must be grounds that relate to the safety criteria, the trade criteria or the efficacy criteria. 14 Approval and registration (1) The APVMA must approve the active constituent or label, or register the chemical product, if it is satisfied: (a) that the application meets the application requirements; and (b) for an active constituent—that the constituent meets the safety criteria; and (c) for a chemical product—that the product: (i) meets the safety criteria, the trade criteria and the efficacy criteria; or (ii) complies with the established standard for the product; and (d) for a label for a chemical product—that the label: (i) meets the labelling criteria; or (ii) complies with the established standard for the product. Note: For notice of approval or registration, see section 8F. (2) Otherwise, the APVMA must refuse the application. Note: For notice of refusal, see section 8G. 14A Approval of active constituents for which information is not readily available (1) The APVMA may approve an active constituent for a proposed or existing chemical product if: (a) either of the following applies: (i) the APVMA considers that information it requires in respect of the constituent is not readily available; (ii) the constituent is, or is part of, a product in respect of which a standard is specified in the European Pharmacopoeia, the British Pharmacopoeia (Veterinary), the United States Pharmacopoeia or any other publication considered by the APVMA to be appropriate; and (b) having regard to information that is readily available, the APVMA is satisfied that the constituent would meet the safety criteria. (2) Subsection (1) applies: (a) despite subsection 14(2); and (b) whether or not an application has been made for approval of the constituent. (3) If the APVMA approves an active constituent under this section without an application having been made for the approval, the APVMA must, under paragraph 19(1)(a), be entered in the Record as the holder of the approval. 33 Section 14B of the Code set out in the Schedule (heading) Repeal the heading, substitute: 14B APVMA not to use information for registration of new chemical product to register a similar product after disclosure 34 Paragraph 14B(1)(a) of the Code set out in the Schedule Omit "an agricultural", substitute "a". 35 Paragraph 14B(1)(b) of the Code set out in the Schedule Repeal the paragraph, substitute: (b) the information related to the first product or the active constituent and: (i) the safety criteria; or (ii) a matter that is prescribed by the regulations; and 36 Paragraph 14B(1)(e) of the Code set out in the Schedule Repeal the paragraph, substitute: (e) as a result of the disclosure, the applicant for an application for registration of a chemical product (the second product) that is the same as, or similar to, the first product, seeks to have the APVMA use the information in determining the application. 37 Subsection 14B(2) of the Code set out in the Schedule Omit "grant the application for registration of", substitute "register". 38 Subsection 14B(3) of the Code set out in the Schedule Omit "granting", substitute "determining". 39 Subsection 14B(3) of the Code set out in the Schedule Omit "of the grant or". 40 Section 15 of the Code set out in the Schedule (heading) Repeal the heading, substitute: 15 Restriction on power of APVMA to register products and approve labels 41 Paragraphs 15(1)(a) and (b) of the Code set out in the Schedule Repeal the paragraphs, substitute: (a) register a chemical product unless: (i) the APVMA also approves each active constituent for the product; and (ii) the APVMA also approves a label for containers for the product; or (b) approve a label for containers for a chemical product unless it also registers the product. 41A Subsection 15(2) of the Code set out in the Schedule Omit all the words after "in relation", substitute: to: (a) an active constituent that is exempted by the APVMA from the operation of that subparagraph; or (b) an active constituent for a listed chemical product if the product complies with the established standard for the product. 42 Subsection 16(1) of the Code set out in the Schedule Omit "for a proposed or existing chemical product". 42A Subsection 17(4) of the Code set out in the Schedule Omit "that does not contain confidential commercial information". 42B At the end of subsection 17(4) of the Code set out in the Schedule Add: Note: This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8K. 42C Subsection 17(5) of the Code set out in the Schedule Omit "that does not contain confidential commercial information". 42D At the end of subsection 17(5) of the Code set out in the Schedule Add: Note: This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8K. 42E Subsection 18(4) of the Code set out in the Schedule Omit "that does not contain confidential commercial information". 42F At the end of subsection 18(4) of the Code set out in the Schedule Add: Note: This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8K. 42G Subsection 18(5) of the Code set out in the Schedule Omit "that does not contain confidential commercial information". 42H At the end of subsection 18(5) of the Code set out in the Schedule Add: Note: This subsection does not authorise the disclosure of confidential commercial information whose disclosure would otherwise be prohibited by section 162: see section 8K. 43 Sections 19 to 26 of the Code set out in the Schedule Repeal the sections, substitute: 19 How approval of active constituent takes place (1) Approval of an active constituent takes place when the APVMA enters the following in the Record: (a) the name of the person who applied for the approval as the holder of the approval; (b) the name of any nominated agent for the approval; (c) the relevant particulars, which are the distinguishing number, any instructions for the use of the constituent and any other particulars prescribed by the regulations; (d) any conditions of the approval imposed by the APVMA; (e) the date the approval ends. (2) The date the approval ends must: (a) be worked out in accordance with the method prescribed by the regulations; and (b) be the last day of a calendar month at least 7 years but not more than 15 years after the approval takes place. (3) Despite subsection (2), the APVMA may approve the active constituent for a period of less than 7 years to provide for its approval to end at the same time as another approval of the active constituent. (4) Paragraph (2)(b) does not apply if the approval is subject to the condition that it remains in force only for a stated period of not more than 1 year (see subsection 23(2)). 20 How registration of chemical product takes place (1) Registration of a chemical product takes place when the APVMA enters the following in the Register: (a) the name of the person who applied for the registration as the holder of the registration; (b) the name of any nominated agent for the registration; (c) the relevant particulars, which are the distinguishing number, any instructions for the use of the product and any other particulars prescribed by the regulations; (d) if the product is a listed chemical product—a notation to that effect; (e) any conditions of the registration imposed by the APVMA; (f) the date the registration ends, which must be the last day of a calendar month not more than 12 months after the registration takes place; (g) unless the product is a listed chemical product, and the product and each label for the product comply with the established standard for the product—the date (the last renewal date) after which the registration cannot be renewed under Division 6. Rules about last renewal dates (2) The last renewal date must: (a) be worked out in accordance with the method prescribed by the regulations; and (b) if the last renewal date is entered in the Register when the product is registered—be the last day of a calendar month at least 7 years but not more than 15 years after the registration takes place; and (c) if the last renewal date is entered in the Register when the relevant particulars or conditions of the registration are varied—be the last day of a calendar month at least 7 years but not more than 15 years after the variation takes place. Note: For entering last renewal dates when relevant particulars or conditions are varied, see sections 26D, 29B and 34A. (3) However, the last renewal date may be less than 7 years after the registration or variation takes place to provide for the last renewal date to be the same as the last renewal date for another chemical product that contains one or more of the same active constituents. (4) Paragraphs (2)(b) and (c) do not apply if the registration is subject to the condition that it remains in force only for a stated period of not more than 1 year (see subsection 23(2)). 21 How approval of label takes place Approval of a label takes place when the APVMA: (a) determines the particulars prescribed by the regulations that are appropriate to be contained on the label; and (b) gives a distinguishing number to the label; and (c) records the following information in the relevant APVMA file: (i) the name of the person who applied for the approval as the holder of the approval; (ii) the name of any nominated agent for the approval; (iii) the distinguishing number; (iv) the instructions and any particulars that are to be contained on the label; (iva) any other particulars prescribed by the regulations; (v) any conditions of the approval imposed by the APVMA. 22 Date of approval or registration (1) The date of approval of an active constituent, of registration of a chemical product or of approval of a label is the date on which the relevant particulars are entered in the Record, Register or relevant APVMA file. (2) If: (a) any of the relevant particulars of: (i) an approval of an active constituent; or (ii) a registration of a chemical product; or (iii) an approval of a label; or (b) any of the conditions of such an approval or registration imposed by the APVMA; are varied, then, the date of approval of the constituent, registration of the product, or approval of the label, as varied, or as subject to the varied conditions, is the date on which particulars of the variation are entered in the Record, Register or relevant APVMA file. 23 Conditions of approval or registration (1) The approval of an active constituent, the registration of a chemical product or the approval of a label for containers for a chemical product is subject to: (a) the conditions prescribed by the regulations (whether or not the conditions are prescribed at the time the constituent, product or label is approved or registered); and (b) any conditions imposed on the approval or registration as the APVMA thinks appropriate. (2) An active constituent, chemical product or a label may be approved or registered on the condition that the approval or registration remains in force only for a stated period of not more than 1 year. (3) If: (a) the approval or registration is subject to a condition referred to in subsection (2); and (b) the conditions of approval or registration have not been varied before the end of the period referred to in the condition, or the end of that period as previously extended under this subsection, so as to remove the condition; the APVMA may vary the condition so as to extend the period for a further period of not more than 1 year. 26 Incorrect particulars and conditions (1) If: (a) the APVMA is satisfied that a relevant particular or condition entered in the Record or Register, or recorded in the relevant APVMA file, is incorrect in a material respect; and (b) the relevant particular or condition is of a kind prescribed by the regulations; the APVMA must vary the entry or record accordingly. Note: For notice of variation, see section 8F. (2) If the APVMA is satisfied that a relevant particular or condition entered in the Record or Register, or recorded in the relevant APVMA file, is incorrect in a material respect because of inaccurate recording, the APVMA must vary the entry or record accordingly. Note: For notice of variation, see section 8F. (3) If the holder of the approval of an active constituent, the registration of a chemical product or the approval of a label for containers for a chemical product has reasonable cause to believe that: (a) a relevant particular or condition entered in the Record or Register, or recorded in the relevant APVMA file, in relation to the constituent, product or label is incorrect in a material respect; and (b) the relevant particular or condition is incorrect because of inaccurate recording; the holder must, within 28 days, give to the APVMA a written notice, signed by the holder, identifying the incorrect particular or condition and informing the APVMA of the correct particular or condition. (4) The holder commits an offence of strict liability if the holder contravenes subsection (3). Penalty: 30 penalty units. Note: For strict liability, see section 6.1 of the Criminal Code. (5) Subsection (3) is a civil penalty provision. Note: Division 2 of Part 9A provides for pecuniary penalties for contraventions of civil penalty provisions. 44 Divisions 2A and 3 of Part 2 of the Code set out in the Schedule Repeal the Divisions, substitute: Division 2A—Varying prescribed relevant particulars 26A Explanation of Division (1) This Division provides for the variation of a relevant particular of an approval or registration if the relevant particular is set out in a legislative instrument made under section 26B. (2) Only the holder of the approval or registration may apply under this Division (section 26B). The application must meet the application requirements specified in section 8A. (3) The APVMA must vary the relevant particular if specified criteria are met, otherwise it must refuse the application (section 26C). (4) Section 26D sets out how a variation takes place. 26B Applications (1) The holder may apply to the APVMA for variation of a relevant particular of an approval or registration if the relevant particular is of a kind set out in a legislative instrument made by the APVMA for the purposes of this section. (2) The application must meet the application requirements. Note: For meets the application requirements, see section 8A. (3) The APVMA may alter the application with the written consent of the applicant. 26C Varying prescribed relevant particulars (1) The APVMA must vary the relevant particular if it is satisfied: (a) that the application meets the application requirements; and (b) for an active constituent—that, if the particular were varied in accordance with the application, the constituent would meet the safety criteria; and (c) for a chemical product—that, if the particular were varied in accordance with the application, the product would: (i) meet the safety criteria, the trade criteria and the efficacy criteria; or (ii) comply with the established standard for the product; and (d) for a label for a chemical product—that, if the particular were varied in accor