Commonwealth: Agricultural and Veterinary Chemicals Legislation Amendment Act 2003 (Cth)

Agricultural and Veterinary Chemicals Legislation Amendment Act 2003 Act No. 13 of 2003 as amended This compilation was prepared on 18 July 2005 [This Act was amended by Act No. 100 of 2005] Amendment from Act No. 100 of 2005 [Schedule 2 (item 3) amended heading to item 22 of Schedule 1 Schedule 2 (item 3) commenced immediately after 8 October 2003] Prepared by the Office of Legislative Drafting and Publishing, Attorney‑General's Department, Canberra Contents 1 Short title 2 Commencement 3 Schedule(s) 4 Saving of regulations Schedule 1—Amendment of the Agricultural and Veterinary Chemicals Code Act 1994 Schedule 2—Amendment of the Agricultural and Veterinary Chemicals (Administration) Act 1992 Schedule 3—Amendment of the Agricultural and Veterinary Chemical Products (Collection of Levy) Act 1994 An Act to amend legislation relating to agricultural and veterinary chemicals, and for related purposes [Assented to 8 April 2003] The Parliament of Australia enacts: 1 Short title This Act may be cited as the Agricultural and Veterinary Chemicals Legislation Amendment Act 2003. 2 Commencement (1) Each provision of this Act specified in column 1 of the table commences, or is taken to have commenced, on the day or at the time specified in column 2 of the table. Commencement information Column 1 Column 2 Column 3 Provision(s) Commencement Date/Details 1. Sections 1 to 3 and anything in this Act not elsewhere covered by this table The day on which this Act receives the Royal Assent 8 April 2003 2. Section 4 A single day to be fixed by Proclamation, subject to subsection (3) 8 October 2003 3. Schedules 1, 2 and 3 At the same time as the provision covered by item 2 of this table 8 October 2003 Note: This table relates only to the provisions of this Act as originally passed by the Parliament and assented to. It will not be expanded to deal with provisions inserted in this Act after assent. (2) Column 3 of the table is for additional information that is not part of this Act. This information may be included in any published version of this Act. (3) If the provision covered by item 2 of the table does not commence within the period of 6 months beginning on the day on which this Act receives the Royal Assent, it commences on the first day after the end of that period. 3 Schedule(s) Each Act that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms. 4 Saving of regulations (1) This section applies to regulations made for the purposes of a provision of the Agvet Code if: (a) the regulations were in force immediately before the commencement of this section; and (b) the provision is repealed by this Act and a new provision substituted for it. (2) The regulations have effect, after the commencement of this section, as if they had been made under the substituted provision. Schedule 1—Amendment of the Agricultural and Veterinary Chemicals Code Act 1994 1 After section 8 Insert: 9 Certain matter not to form part of this Act Despite subsection 13(2) of the Acts Interpretation Act 1901, the following provisions that are included in the Schedule do not form part of this Act: (a) the Table of contents that appears at the beginning of the Schedule; (b) the list of terms defined by section 3 of the Schedule that appears immediately after the Table of contents. 2 The Schedule (section 3 of the Agvet Code, definition of approved person) Repeal the definition, substitute: approved person means: (a) in relation to the making of an application or request, or the giving of a notice, consent, information, report, sample or any other thing, by a person: (i) if that person is an individual residing, or a body corporate incorporated, in Australia—that person; or (ii) in any case—an individual residing in Australia who, or a body corporate incorporated in Australia which, that person has notified the NRA in writing is authorised to make the application or request or to give the notice, consent, information, report, sample or other thing on that person's behalf; or (b) in relation to the giving of a notice by the NRA that affects a person who is the interested person in relation to an approved active constituent for a chemical product, a registered chemical product, a registered listed chemical product or an approved label for containers for a chemical product or is the holder of a permit or a licence—an individual residing in Australia who, or a body corporate incorporated in Australia which, that person has notified the NRA in writing is authorised by that person to receive the notice on that person's behalf. 3 The Schedule (section 3 of the Agvet Code) Insert: continued use of an active constituent for a proposed or existing chemical product, or of a chemical product, includes any dealing with the constituent or product. 4 The Schedule (section 3 of the Agvet Code, definition of deal with) After "includes", insert "supply or otherwise". 5 The Schedule (section 3 of the Agvet Code, definition of eligible law) Omit "the definition of permit in section 109", substitute "this Code". 6 The Schedule (section 3 of the Agvet Code) Insert: established standard for a listable chemical product means a standard established for the product under Division 3 of Part 2A. 7 The Schedule (section 3 of the Agvet Code) Insert: instructions for use of an active constituent for a proposed or existing chemical product, or of a chemical product, includes instructions for any dealing with the constituent or product. 8 The Schedule (section 3 of the Agvet Code, definition of interested person) Repeal the definition, substitute: interested person, in relation to an approved active constituent for a chemical product, a registered chemical product, a registered listed chemical product or an approved label for containers for a chemical product, means: (a) subject to paragraphs (b), (c) and (d), the person (the original applicant) who applied for the approval, registration or listed registration or, in the case of a chemical product whose registration or listed registration has been renewed, applied for the renewal, or the last renewal, as the case may be; or (b) subject to paragraphs (c) and (d), if: (i) the original applicant has entered into a contract with another person in relation to the constituent or product under which, or as a result of which, the other person will or may apply to the NRA to have the other person's name entered in the relevant particulars in relation to the constituent or product, or to have a label approved in relation to containers for the product; and (ii) the other person's name is entered in those relevant particulars, or such a label is approved, on the application of the other person; the other person; or (c) if the person who, apart from this paragraph, would be the interested person because of paragraph (a) or (b) 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, as the case may be; or (d) if the person who, apart from this paragraph, would be the interested person because of paragraph (a) or (b) was a body corporate—a successor in law of the body corporate. 9 The Schedule (section 3 of the Agvet Code) Insert: listable chemical product means a chemical product that is, or is included in a class of chemical products that is, included in the Listing Schedule. 10 The Schedule (section 3 of the Agvet Code) Insert: listed registration means listed registration of a listable chemical product that is in force under Part 2A of the Agvet Code of this jurisdiction. 11 The Schedule (section 3 of the Agvet Code) Insert: Listing Schedule means the schedule contained in the regulations under section 56C. 12 The Schedule (section 3 of the Agvet Code, definition of penalty unit) Repeal the definition, substitute: penalty unit has the same meaning as in section 4AA of the Crimes Act 1914. 13 The Schedule (section 3 of the Agvet Code) Insert: 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. 14 The Schedule (section 3 of the Agvet Code) Insert: registered listed chemical product means a listable chemical product that has been granted listed registration. 15 The Schedule (section 3 of the Agvet Code, definition of relevant particulars) Repeal the definition, substitute: relevant particulars means: (a) in relation to the approval of an active constituent for a proposed or existing chemical product—the distinguishing number, instructions for use and other particulars that are required by paragraph 19(2)(a) to be entered in the Record of Approved Active Constituents; and (b) in relation to the registration of a chemical product—the distinguishing number and other particulars that are required by paragraph 20(2)(a) to be entered in the Register of Chemical Products; and (c) in relation to the listed registration of a chemical product—the notation, distinguishing number and other particulars that are required by paragraph 56M(2)(a) to be entered in the Register of Chemical Products; and (d) in relation to the approval of a label for containers for a chemical product—the distinguishing number, and the size and type of, and particulars contained on, the label kept in the relevant NRA file as required by paragraph 21(2)(d); and includes, in relation to the approval of an active constituent or of a label or in relation to the registration or listed registration of a chemical product, particulars of a variation of relevant particulars that is made under paragraph 29(1)(h), subsection 34(5), section 34A, paragraph 56U(1)(e) or subsection 56Z(5). 16 The Schedule (section 3 of the Agvet Code) Insert: 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. 17 The Schedule (section 3 of the Agvet Code) Insert: 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. 18 The Schedule (section 3 of the Agvet Code) Insert: Reserved Schedule means the schedule contained in the regulations under section 56ZU. 19 The Schedule (section 3 of the Agvet Code, definition of residues) Repeal the definition, substitute: 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 NRA 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. 20 The Schedule (at the end of section 6 of the Agvet Code) Add: (2) The NRA may at any time vary or revoke a determination made, approval or exemption given, or other thing done, by it under subsection (1). 21 The Schedule (subsection 9(2) of the Agvet Code) Repeal the subsection, substitute: (2) Division 2 deals with the giving of approvals and the granting of registrations. 22 The Schedule (heading to Division 2 of Part 2 of the Agvet Code) Repeal the heading, substitute: Division 2—Granting or refusing approvals and registrations 23 The Schedule (after paragraph 11(1)(b) of the Agvet Code) Insert: (ba) if the application is covered by paragraph 10(a) or (b)—contain proposed instructions for the use of or other dealing with the constituent or product; and 24 The Schedule (at the end of subsection 11(1) of the Agvet Code) Add: ; and (e) be lodged with the NRA. 25 The Schedule (subsections 11(2) and (3) of the Agvet Code) Omit "the applicant", substitute "an approved person". 26 The Schedule (section 12 of the Agvet Code) Repeal the section, substitute: 11A Preliminary assessment of application (1) The NRA must, within one month after an application is lodged under section 11, make a preliminary assessment as to whether the application complies with subsection 11(1). (2) If it appears to the NRA from the preliminary assessment that the application complies with subsection 11(1), the NRA must, as soon as practicable, give notice in writing to an approved person stating that the application has passed a preliminary assessment and will be given a full evaluation in due course. (3) If it appears to the NRA from the preliminary assessment that the application does not comply with subsection 11(1) but the defects in the application can reasonably be rectified: (a) the NRA must, as soon as practicable, give to an approved person notice in writing: (i) stating that the application does not comply with subsection 11(1); and (ii) giving particulars of the defects in the application; and (iii) requiring the defects to be rectified within one month or within such further period as the NRA allows; and (b) if the defects are not rectified to the satisfaction of the NRA within the period referred to in subparagraph (a)(iii), the NRA may: (i) defer consideration of the application; or (ii) treat the application as having been withdrawn; and, if it does either of those things, it must immediately give to the approved person notice in writing of its decision. (4) If it appears to the NRA from the preliminary assessment that the application does not comply with subsection 11(1) and that the defects in the application cannot reasonably be rectified, it may reject the application on the ground that the application has not been properly made and, if it does so, any fee paid in respect of the application (other than a component of the fee identified by the regulations as being in respect of the preliminary assessment) is repayable. (5) If the NRA rejects the application under subsection (4): (a) it must, as soon as practicable, give notice in writing to an approved person: (i) stating that the application has been rejected on the ground that it has not been properly made; and (ii) setting out the defects in the application; and (iii) giving brief particulars of the reasons why it considers that the application cannot reasonably be rectified; and (iv) telling the approved person that any fee paid in respect of the application (other than a component of the fee identified by the regulations as being in respect of the preliminary assessment) is repayable; and (b) it may return the application with the notice. (6) Section 168 provides for additional matters to be included in a notice under paragraph (3)(b) or (5)(a). (7) An application that is rejected by the NRA on the ground that it was not properly made is taken for the purposes of this Code other than this section, and for the purposes of Part 7B of the Agricultural and Veterinary Chemicals (Administration) Act 1992, not to have been validly made. 12 NRA to publish notice before deciding whether to approve new active constituent (1) Before deciding whether to approve 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, the NRA must cause to be published in the Gazette, and in any other manner that it thinks appropriate, a notice: (a) stating that it has to decide whether to approve the constituent and setting out the following: (i) the name of the constituent; (ii) particulars of the constituent other than confidential commercial information; (iii) a summary of the NRA's evaluation of the constituent with regard to the matters mentioned in paragraph 14(3)(e); (iv) any other matters that the NRA thinks appropriate; and (b) inviting any person who wishes to do so to make, within a period stated in the notice that ends not earlier than 28 days after the day on which the notice is published in the Gazette, a written submission to the NRA 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 matters that the NRA is required to take into account in deciding whether to approve the constituent. (2) The NRA must take into account any submissions made in accordance with an invitation contained in the notice published under subsection (1). 27 The Schedule (section 13 of the Agvet Code) Repeal the section, substitute: 13 NRA to publish notice before deciding whether to register chemical product containing new active constituent (1) Before deciding whether to register 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, the NRA must cause to be published in the Gazette, and in any other manner that it thinks appropriate, a notice: (a) stating that it has to decide whether to register the product and setting out the following: (i) the name that the applicant for registration intends to use to describe the product; (ii) particulars of the product and its active constituents other than confidential commercial information; (iii) a summary of the NRA's evaluation of the product with regard to the matters mentioned in paragraphs 14(3)(e) and (f); (iv) any other matters that the NRA thinks appropriate; and (b) inviting any person who wishes to do so to make, within a period stated in the notice that ends not earlier than 28 days after the day on which the notice is published in the Gazette, a written submission to the NRA 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 matters that the NRA is required to take into account in deciding whether to register the product. (2) The NRA must take into account any submissions made in accordance with an invitation contained in the notice published under subsection (1). 28 The Schedule (paragraphs 14(3)(e) and (f) of the Agvet Code) Omit "recommendations for its use that the NRA proposes to approve", substitute "instructions for its use that the NRA has approved or approves". 29 The Schedule (subsections 14(4) and (5) of the Agvet Code) Omit "recommendations for its use that the NRA proposes to approve", substitute "instructions for its use that the NRA has approved or approves". 30 The Schedule (at the end of paragraph 14(5)(f) of the Agvet Code) Add "or approves". 31 The Schedule (subsection 14(6) of the Agvet Code) Omit "recommendations for its use that the NRA proposes to approve", substitute "instructions for its use that the NRA has approved or approves". 32 The Schedule (subsection 14(7) of the Agvet Code) Omit "section 15", substitute "sections 14A and 15". 33 The Schedule (after section 14 of the Agvet Code) Insert: 14A Approval of active constituents for which information is not readily available Despite section 14, if: (a) either of the following applies in relation to an active constituent for a proposed or existing chemical product: (i) the NRA considers that the information referred to in paragraph 11(1)(b) is not readily available in respect of the constituent; (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 NRA to be appropriate; and (b) the NRA is satisfied of all the matters mentioned in paragraph 14(3)(e) having regard to matters (relevant matters) mentioned in subsection 14(4) where information about the relevant matters is readily available; the NRA may decide to approve the constituent, whether or not an application has been made for the approval. 34 The Schedule (subsection 17(3) of the Agvet Code) Repeal the subsection, substitute: (3) The Record is to be kept in 3 parts as follows: (a) one part is to consist of confidential commercial information relating to constituents approved under section 14; (b) one part is to consist of other information relating to constituents approved under section 14; (c) one part is to consist of information relating to constituents approved under section 14A. 35 The Schedule (section 19 of the Agvet Code) Repeal the section, substitute: 19 How approval of active constituent is effected (1) If the NRA decides to approve an active constituent for a proposed or existing chemical product, it must give a distinguishing number to, and approve, the constituent in accordance with subsection (2), either unconditionally or subject to conditions as mentioned in section 23. (2) Approval of an active constituent takes place by entering in the Record of Approved Active Constituents: (a) the relevant particulars, which are the distinguishing number, the instructions for the use of the constituent and any other particulars that are prescribed by the regulations; and (b) any conditions of the approval. 36 The Schedule (section 20 of the Agvet Code) Repeal the section, substitute: 20 How registration of chemical product is effected (1) If the NRA decides to register a chemical product, it must give a distinguishing number to, and register, the product in accordance with subsection (2), either unconditionally or subject to conditions as mentioned in section 23. (2) Registration of a chemical product takes place by entering in the Register of Chemical Products: (a) the relevant particulars, which are the distinguishing number and any other particulars that are prescribed by the regulations; and (b) any conditions of the registration. 37 The Schedule (section 21 of the Agvet Code) Repeal the section, substitute: (1) If the NRA decides to approve a label for containers for a chemical product, the NRA must give a distinguishing number to, and approve, the label in accordance with subsection (2), either unconditionally or subject to conditions as mentioned in section 23. (2) Approval of a label takes place by: (a) determining (if appropriate) the size and type of the label; and (b) giving a distinguishing number to the label; and (c) determining the particulars that are to be contained on the label (which must include the distinguishing number, the instructions for the use of the product and any particulars that are prescribed by the regulations); and (d) placing a label of the determined size and type, and containing the particulars mentioned in paragraph (c), in the relevant NRA file; and (e) recording in that file any conditions of the approval. 38 The Schedule (section 22 of the Agvet Code) Omit "the relevant distinguishing number and". 39 The Schedule (at the end of section 22 of the Agvet Code) Add: (2) If: (a) any of the relevant particulars of: (i) an approval of an active constituent for a proposed or existing chemical product; or (ii) a registration of a chemical product; or (iii) an approval of a label for containers for a chemical product; or (b) any of the conditions of such an approval or registration; are varied pursuant to an application or request made under this Part, then, the date of the approval of the constituent, of the registration of the product, or of the approval of the label, as varied, or as subject to the varied conditions, is the date on which particulars of the variations are entered in the Record of Approved Active Constituents or in the Register of Chemical Products or are recorded in the relevant NRA file, as the case may be. 40 The Schedule (paragraphs 24(1)(a) and 25(1)(a) of the Agvet Code) Omit "the applicant", substitute "an approved person". 41 The Schedule (paragraph 26(1)(b) of the Agvet Code) Omit "a particular", substitute "a relevant particular or a condition". 42 The Schedule (paragraph 26(1)(b) of the Agvet Code) Omit ", in the Register of Chemical Products or", substitute "or in the Register of Chemical Products or recorded". 43 The Schedule (subsection 26(1) of the Agvet Code) Omit "the incorrect particular and informing the NRA of the correct particular", substitute "the incorrect particular or condition and informing the NRA of the correct particular or condition". 44 The Schedule (subsection 26(2) of the Agvet Code) Repeal the subsection, substitute: (2) If the NRA is satisfied that the particular or condition entered in the Record or Register, or recorded in the NRA file, in relation to the constituent, product or label is not correct, the NRA must change the entry or record accordingly. 45 The Schedule (heading to Division 3 of Part 2 of the Agvet Code) Repeal the heading, substitute: Division 3—Application for variation of relevant particulars, or of conditions, of approval or registration 46 The Schedule (after paragraph 28(1)(b) of the Agvet Code) Insert: (ba) if the application relates to a label—be accompanied by a proposed new label; and 47 The Schedule (at the end of subsection 28(1) of the Agvet Code) Add: ; and (e) be lodged with the NRA. 48 The Schedule (subsections 28(2) and (3) of the Agvet Code) Omit "the applicant", substitute "an approved person". 49 The Schedule (paragraph 29(1)(a) of the Agvet Code) Repeal the paragraph, substitute: (a) that subsection 28(1) has been complied with; 50 The Schedule (paragraph 29(1)(e) of the Agvet Code) After "the application, the", insert "continued". 51 The Schedule (paragraph 29(1)(e) of the Agvet Code) Omit "recommendations", substitute "instructions". 52 The Schedule (paragraph 29(1)(f) of the Agvet Code) Omit "recommendations", substitute "instructions". 53 The Schedule (paragraph 29(1)(h) of the Agvet Code) Repeal the paragraph, substitute: (h) grant the application and vary those particulars or conditions: (i) if the application was for a variation of the relevant particulars or the conditions of the approval of a constituent or the registration of a product—by entering in the relevant Record or Register particulars of the variation and the date on which the entry is made; or (ii) if the application was for a variation of the relevant particulars of the approval of a label—by placing in the relevant NRA file a new label containing the relevant particulars as varied and recording in the file the date on which the new label is placed in the file; or (iii) if the application was for a variation of the conditions of approval of a label—by recording in the file the conditions as varied; or 54 The Schedule (paragraph 29(1)(i) of the Agvet Code) Omit "the interested person", substitute "an approved person". 55 The Schedule (paragraph 29(4)(a) of the Agvet Code) Omit "the applicant", substitute "an approved person". 56 The Schedule (subsection 31(2) of the Agvet Code) Repeal the subsection. 57 The Schedule (subsection 32(1) of the Agvet Code) Omit "or the registration of a chemical product", substitute ", the registration of a chemical product or the approval of a label for containers for a chemical product". 58 The Schedule (paragraph 32(1)(a) of the Agvet Code) Omit "constituent or product", substitute "approval of the constituent or label or of the registration of the product". 59 The Schedule (after paragraph 32(1)(a) of the Agvet Code) Insert: (aa) setting out the matters to be dealt with in the reconsideration and stating the requirement or requirements prescribed by the regulations for continued approval or registration that form the basis for the reconsideration; and 60 The Schedule (paragraph 32(1)(b) of the Agvet Code) Omit "should be continued", substitute "complies with the prescribed requirements for continued approval or registration". 61 The Schedule (subsection 32(2) of the Agvet Code) Omit "the constituent or product", substitute "the constituent, product or label or an approved person". 62 The Schedule (subparagraphs 32(2)(b)(i) and (ii) of the Agvet Code) Omit "the person", substitute "either the interested person or the approved person". 63 The Schedule (subsection 32(4) of the Agvet Code) Repeal the subsection, substitute: (4) Subsection (3) does not apply if, before the end of the period stated in the notice, the interested person or an approved person requests the NRA under section 42 to cancel the approval of the constituent, the registration of the product or the approval of the label, as the case may be, and the NRA complies with the request. 64 The Schedule (subsection 33(1) of the Agvet Code) Omit ", require the person", substitute ", or given to an approved person, require the interested person". 65 The Schedule (subsection 33(3) of the Agvet Code) Omit "the person", substitute "the interested person or an approved person". 66 The Schedule (paragraph 34(1)(a) of the Agvet Code) Omit "recommendations", substitute "instructions". 67 The Schedule (paragraph 34(1)(b) of the Agvet Code) Omit "recommendations", substitute "instructions". 68 The Schedule (paragraph 34(1)(c) of the Agvet Code) Repeal the paragraph, substitute: (c) if the reconsideration relates to an approval of a label: (i) the label would comply with any prescribed requirements under paragraph 14(3)(d); and (ii) the label would contain adequate instructions relating to the matters referred to in paragraph 14(3)(g); and 69 The Schedule (paragraph 34(1)(e) of the Agvet Code) After "interested person", insert "or to an approved person". 70 The Schedule (subsection 34(4) of the Agvet Code) After "interested person", insert "or to an approved person". 71 The Schedule (subsection 34(5) of the Agvet Code) Repeal the subsection, substitute: (5) If the NRA is satisfied that the relevant particulars or the conditions of the approval or registration can be varied in such a way that the requirements prescribed by the regulations for continued approval or registration will be complied with: (a) the NRA must vary the relevant particulars or conditions: (i) if the variation relates to the relevant particulars or the conditions of the approval of a constituent or the registration of a product—by entering in the relevant Record or Register particulars of the variation and the date on which the entry is made; or (ii) if the variation relates to the relevant particulars of the approval of a label—by placing in the relevant NRA file a new label containing the relevant particulars as varied and recording in that file the date on which the new label is placed in the file; or (iii) if the variation relates to the conditions of the approval of a label—by recording in the relevant NRA file particulars of the variation and the date on which the record is made; and (b) the NRA must: (i) state in the notice referred to in subsection (4) that, although it is not satisfied as mentioned in subsection (1), it is satisfied that the relevant particulars or the conditions can be so varied and has varied them accordingly; and (ii) set out in the notice details of the variation. (5A) The NRA may only vary the relevant particulars of the approval of a label if the interested person gives to the NRA a new label containing the particulars as proposed to be varied. Note: Subsection 40(2) provides for the suspension or cancellation of the approval of the label if the interested person does not give the NRA a new label in accordance with a request by the NRA. (5B) If a variation of any relevant particulars or conditions under subsection (5) would affect any instructions for the use of an active constituent for an existing or proposed chemical product or for the use of a chemical product or any instructions on a label for containers for a chemical product, the NRA must not make the variation until it has consulted each co‑ordinator designated for a jurisdiction and taken into account any recommendations made by the co‑ordinators. 72 The Schedule (at the end of Division 4 of Part 2 of the Agvet Code) Add: 34A Reconsideration of approval of label without notice in certain circumstances (1) The NRA may, at any time, reconsider the approval of a label for containers for a chemical product for the purpose of deciding whether the particulars on the label contain adequate instructions relating to matters prescribed by the regulations for the purposes of this section. (2) The matters that may be prescribed must be matters that are also prescribed by the regulations in relation to such a label for the purposes of paragraph 14(3)(d) or subparagraph 14(3)(g)(x). (3) If the NRA considers that the particulars do not contain adequate instructions in relation to a matter, the NRA must: (a) vary the relevant particulars by placing in the relevant NRA file a new label containing the relevant particulars as varied and recording in that file the date on which the new label is placed in the file; and (b) give written notice to the interested person in relation to the product, or to an approved person, setting out particulars of the variation. (4) The NRA may only vary the relevant particulars of the approval of a label if the interested person gives to the NRA a new label containing the particulars as proposed to be varied. Note: Subsection 41(4) provides for the suspension or cancellation of the approval of the label if the interested person does not give the NRA a new label in accordance with a request by the NRA. (5) Sections 30 to 34 do not apply to a reconsideration under this section. 73 The Schedule (paragraph 37(1)(a) of the Agvet Code) Repeal the paragraph, substitute: (a) at the end of the period stated in a notice given to a person under subsection 32(2), the NRA is satisfied that the interested person or an approved person is aware of information relevant to the reconsideration but the information has not been given to the NRA; or 74 The Schedule (paragraph 37(1)(b) of the Agvet Code) Omit "the person", substitute "the interested person". 75 The Schedule (subsection 38(1) of the Agvet Code) Before "fails", insert "or an approved person". 76 The Schedule (subsection 38(1) of the Agvet Code) Before "161", insert "160A or". 77 The Schedule (section 40 of the Agvet Code) Before "conditions", insert "relevant particulars or the". 78 The Schedule (at the end of section 40 of the Agvet Code) Add: (2) If, in the course of reconsidering the approval of a label for containers for a chemical product: (a) the NRA is satisfied that the relevant particulars of the approval of the label can be varied in such a way that the requirements prescribed by the regulations for continued approval will be complied with (see subsection 34(5)); and (b) the interested person does not give the NRA a label containing the particulars as proposed to be varied in accordance with a request by the NRA; the NRA may suspend or cancel the approval. 79 The Schedule (subsection 41(1) of the Agvet Code) Omit "recommendations", substitute "instructions". 80 The Schedule (subsection 41(2) of the Agvet Code) Omit "recommendations", substitute "instructions". 81 The Schedule (subsection 41(3) of the Agvet Code) Omit "a direction", substitute "any of the instructions". 82 The Schedule (at the end of section 41 of the Agvet Code) Add: (4) If: (a) the NRA considers that the particulars on a label for containers for a chemical product do not contain adequate instructions relating to matters prescribed by the regulations for the purposes of subsection 34A(1); and (b) the interested person does not give the NRA a label containing the particulars as proposed to be varied in accordance with a request by the NRA; the NRA may suspend or cancel the approval of the label. 83 The Schedule (paragraph 42(1)(a) of the Agvet Code) After "registration", insert "or an approved person". 84 The Schedule (subsections 45(2), (3), (4) and (5) of the Agvet Code) Repeal the subsections, substitute: 45A Notice of suspension or cancellation (1) Subject to subsection (3), if the NRA suspends or cancels an approval or registration, it must, as soon as practicable, give written notice of the suspension or cancellation to the interested person, or an approved person, and to any other person to whom, in its opinion, such a notice should be given. (2) A notice given to a person under subsection (1): (a) must tell the person of the suspension or cancellation; and (b) in respect of a suspension or cancellation of the approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product—must contain the following matters: (i) brief reasons for the suspension or cancellation; and (ii) instructions for possessing, having custody of, using or otherwise dealing with the constituent or product; and (iii) a warning of the consequences if the person fails to comply with the instructions, including a statement of any period after which it will be an offence against this Code to possess or have custody of the constituent or product with the intention of supply, or to supply the constituent or product; and (iv) any other warnings or explanations in relation to the constituent or product that the NRA thinks desirable; excluding any matters that the NRA thinks it unnecessary for the notice to contain. (3) Subsection (1) does not require notice of the cancellation under section 42 of an approval or registration to be given to the person who requested the cancellation. (4) Section 168 provides for additional matters to be included in a notice given under subsection (1). (5) After a notice of the suspension or cancellation of the approval or registration is given to a person under this section, that person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with the constituent or product, or the product containing the label, as the case may be, in accordance with the instructions contained in the notice until: (a) 2 years after the day of the suspension or cancellation; or (b) the NRA revokes the suspension or cancellation; or (c) the NRA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the constituent or product; whichever first occurs. (6) Subject to subsection (8), if: (a) a notice of the suspension or cancellation of the approval of an active constituent for a proposed or existing chemical product or the registration of a chemical product is given to a person under this section; and (b) the person has possession or custody of the constituent or product with the intention of supply; the person may only possess, have custody of or otherwise deal with the constituent or product if the possession, custody or dealing is in accordance with the instructions contained in the notice. Penalty: 300 penalty units. (7) In paragraph (6)(a), strict liability applies to the physical element of circumstance, that the notice is a notice given to the person under this section. Note: For strict liability, see section 6.1 of the Criminal Code. (8) Subsection (6) does not apply to a possession, custody or dealing with a constituent or product if the constituent was an approved active constituent or the product was a registered chemical product or a reserved chemical product when the possession, custody or dealing took place because of its having been approved or registered or having become reserved after its previous approval or registration had been cancelled. 85 The Schedule (subsection 46(2) of the Agvet Code) After "interested person", insert "or an approved person". 86 The Schedule (after subsection 47(4) of the Agvet Code) Insert: (4A) If: (a) the registration of a chemical product ends; but (b) a person is taken under subsection 54(2) to have been issued with a permit to possess, have custody of, use or otherwise deal with the product; the approval of a label for containers for the product continues in force until the permit ceases to have effect. 87 The Schedule (at the end of subsection 49(1) of the Agvet Code) Add: ; and (e) be lodged with the NRA. 88 The Schedule (subsections 49(2), (4) and (6) of the Agvet Code) Omit "the applicant", substitute "an approved person". 89 The Schedule (subsection 53(1) of the Agvet Code) Before "particulars", insert "of the relevant". 90 The Schedule (subsection 53(1) of the Agvet Code) Before "conditions", insert "of the". 91 The Schedule (paragraph 53(2)(a) of the Agvet Code) Before "particulars", insert "relevant". 92 The Schedule (after paragraph 54(b) of the Agvet Code) Insert: (ba) containing instructions for possessing, having custody of, using or otherwise dealing with the product; and (bb) containing a warning of the consequences if a person fails to comply with the instructions, including a statement of any period after which it will be an offence against this Code to possess or have custody of the product with the intention of supply, or to supply the product; and (bc) containing any other warnings or explanations in relation to the product that the NRA thinks desirable; and 93 The Schedule (at the end of section 54 of the Agvet Code) Add: (2) If, after the publication under this section of a notice stating that the registration of a chemical product has ended, a person possesses, has custody of, uses or otherwise deals with the product in accordance with the instructions contained in the notice, the person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with the product in accordance with those instructions until: (a) 2 years after the day on which the registration ended; or (b) the NRA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the product; whichever first occurs. (3) Subject to subsection (5), if: (a) a notice stating that the registration of a chemical product has ended has been published under this section; and (b) a person has possession or custody of the product for the purpose of supply; the person may only possess, have custody of or otherwise deal with the product if the possession, custody or dealing is in accordance with the instructions contained in the notice. Penalty: 300 penalty units. (4) In paragraph (3)(a), strict liability applies to the physical element of circumstance, that the publishing of the notice was under this section. Note: For strict liability, see section 6.1 of the Criminal Code. (5) Subsection (3) does not apply to a possession, custody or dealing with a product if the product was a registered chemical product or a reserved chemical product when the possession, custody or dealing took place because of its having been registered or having become reserved after the previous registration had ended. (6) If a notice stating that the registration of a chemical product has ended is published under this section, the NRA must: (a) as soon as practicable cause a copy of the notice to be given to the interested person in relation to the product or to an approved person; and (b) cause a copy of the notice to be given to any other person who, in the opinion of the NRA, should be given notice of the ending of the registration and of the instructions, warnings and explanations contained in the notice. 94 The Schedule (paragraph 55(2)(c) of the Agvet Code) Omit "a direction", substitute "an instruction". 95 The Schedule (paragraph 55(2)(e) of the Agvet Code) Omit "using or otherwise dealing with", substitute "possessing, having custody of, using or otherwise dealing with". 96 The Schedule (at the end of paragraph 55(2)(f) of the Agvet Code) Add "with the intention of supply, or to supply the constituent or product". 97 The Schedule (subsection 55(3) of the Agvet Code) Repeal the subsection, substitute: (3) If, after the publication under this section of a notice of the suspension or cancellation of an approval or registration, a person possesses, has custody of, uses or otherwise deals with the constituent or product, or a product containing a label, as the case may be, in accordance with the instructions contained in the notice, the person is taken to have been issued with a permit to possess, have custody of, use or otherwise deal with the constituent or product, or a product containing the label, in accordance with those instructions until: (a) 2 years after the day of the suspension or cancellation; or (b) the NRA revokes the suspension or cancellation; or (c) the NRA, by notice published in the Gazette, declares that this subsection ceases to apply in respect of the constituent or product, as the case may be; whichever first occurs. 98 The Schedule (subsection 55(4) of the Agvet Code) After "the person must not", insert "possess, have custody of or otherwise". 99 The Schedule (subsection 55(5) of the Agvet Code) Omit "a dealing", substitute "a possession, custody or dealing". 100 The Schedule (subsection 55(5) of the Agvet Code) Omit "when the dealing", insert "when the possession, custody or dealing". 101 The Schedule (subsection 55(6) of the Agvet Code) After "when the person", insert "possessed, had custody of or". 102 The Schedule (subsection 55(6) of the Agvet Code) Omit "the dealing", substitute "the possession, custody or dealing". 103 The Schedule (paragraph 55(7)(a) of the Agvet Code) Omit "in relation to an approved label for a container". 104 The Schedule (at the end of paragraph 55(7)(a) of the Agvet Code) Add "or an approved person". 105 The Schedule (at the end of paragraph 55(8)(a) of the Agvet Code) Add "or an approved person". 106 The Schedule (after Part 2 of the Agvet Code) Insert: Part 2A—Listable chemical products Division 1—Preliminary 56A Explanation of Part (1) This Part contains provisions relating to: (a) the listing of, and the establishment of standards for, certain chemical products; and (b) the listed registration of those chemical products. (2) Division 2 provides for the regulations to list certain chemical products that can be granted listed registration. (3) Division 3 provides for the establishment of standards for the listable chemical products. (4) Division 4 provides how applications for listed registration are to be dealt with. (5) Division 5 deals with applications to vary listed registrations or to vary the conditions of any listed registrations. (6) Division 6 provides for the NRA to reconsider listed registrations for the purpose of deciding whether they should remain in force. (7) Division 7 sets out the circumstances in which the NRA may suspend or cancel listed registrations. (8) Division 8 specifies the period for which listed registrations are to continue in force and makes provision for their renewal. (9) Division 9 provides for the NRA to publish notices telling the public of actions that it has taken under this Part. 56B Exclusion of restricted chemical products This Part does not apply to chemical products that are restricted chemical products. Division 2—Schedule of listable chemical products 56C Regulations may contain schedule of listable chemical products (1) The regulations may contain a schedule listing chemical products, or classes of chemical products, that can be granted listed registration under this Part. (2) Before the Governor‑General makes a regulation listing a chemical product, or a class of chemical products: (a) the listing of the product, or class of products, must have been recommended to the Minister by the NRA; and (b) the NRA must have given to the Minister: (i) written particulars of the product or class of products; and (ii) a draft of the standard that the NRA proposes to submit for approval by the Minister for the product, or for products in the class, if the product or class is granted listed registration; and (iii) a written explanation as to why the NRA is satisfied that use of the product, or use of products in the class, in accordance with instructions contained in the established standard for the product would satisfy the NRA of all the matters mentioned in paragraphs 56E(1)(a) to (e) having regard to matters (relevant matters) mentioned in subsection 56E(2) where information about the relevant matters is readily available; and (iv) a written statement identifying the consultations held by, and setting out the advice given to, the NRA in relation to the proposed listing of the products or class of products. (3) The Minister may, before the Governor‑General makes a regulation listing a chemical product or class of chemical products, require the NRA to cause to be published in the Gazette, and to be published in any other manner that the Minister thinks appropriate, a notice: (a) stating that it has recommended the listing of the product or class of products; and (b) setting out particulars of the product or of products in the class; and (c) giving the reasons for the recommendation; and (d) inviting any person who wishes to do so to make, within a period stated in the notice that ends not earlier than 28 days after the day on which the notice appears in the Gazette, a written submission to the NRA as to whether the recommendation should be confirmed or withdrawn and stating the grounds on which the submission is based, which must be grounds relating to the matters mentioned in paragraphs 56E(1)(a) to (e). (4) If the Minister requires the NRA to publish a notice under subsection (3), the NRA must take into account any submissions made in accordance with the invitation contained in the notice and must inform the Minister whether it confirms or withdraws its recommendation. Division 3—Establishing standards for listable chemical products 56D NRA to prepare standards (1) This section applies in respect of each listable 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 NRA must prepare in writing a standard for each listable chemical product and must submit the standard to the Minister for his or her approval of the standard. 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 listable 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) Without limiting the generality of subsection (3), the NRA 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) Without limiting the generality of the preceding provisions of this section, a standard for a listable 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 NRA 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 International Limited; (ix) such other matters as the NRA thinks fit; and (b) may require that a matter relating to the standard be determined in accordance with a particular test. (6) If the Minister decides not to approve a standard for a listable chemical product: (a) the Minister must inform the NRA of the reasons for the decision; and (b) the NRA must prepare in writing such revised standard or standards for the product as may be required until the Minister endorses his or her approval on the instrument containing the standard concerned. (7) If the Minister decides to approve a standard for a listable chemical product: (a) the approval is effected by the Minister endorsing his or her approval on an instrument containing the standard; and (b) that standard becomes the standard established for the product from the time of endorsement. (8) The NRA must cause a copy of the standard established for a listable chemical product to be published in the Gazette. 56E Matters to be taken into account in preparing a standard (1) The NRA must not submit a standard for a chemical product to the Minister for approval unless the NRA is satisfied that use of the product in accordance with the standard: (a) would ensure that the product 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) would ensure that the product would not be likely to have an effect that is harmful to human beings; and (c) would ensure that the product would not be likely to have an unintended effect that is harmful to animals, plants or things or to the environment; and (d) would not unduly prejudice trade or commerce between Australia and places outside Australia; and (e) would be effective according to criteria determined by the NRA for the product; and (f) would contain, or would require a label for containers for the product to contain, adequate instructions relating to such of the following as are appropriate: (i) the circumstances in which the product should be used; (ii) how the product should be used; (iii) the times when the product should be used; (iv) the frequency of the use of the product; (v) the withholding period after the use of the product; (vi) the re‑entry period after the use of the product; (vii) the disposal of the product when it is no longer required; (viii) the disposal of containers of the product; (ix) the safe handling of the product and first aid in the event of an accident caused by the handling of the product; (x) any other matters prescribed by the regulations. (2) In satisfying itself for the purposes of subsection (1) whether a standard would ensure that a chemical product would not be an undue hazard as mentioned in paragraph (1)(a), would not be likely to have an effect that is harmful as mentioned in paragraph (1)(b) or would not be likely to have an unintended effect that is harmful as mentioned in paragraph (1)(c), the NRA may have regard to such matters as it thinks relevant but must have regard to the following: (a) the toxicity of the product and its residues in relation to relevant organisms and ecosystems, including human beings; (b) the relevant poison classification of the product under the law in force under this jurisdiction; (c) how the product is formulated; (d) the composition and form of the constituents of the product; (e) the acceptable daily intake of each active constituent contained in the product; (f) 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 NRA has approved or approves; (g) the stability of the product; (h) the specifications for containers for the product; (i) any other matters prescribed by the regulations. (3) In satisfying itself for the purposes of paragraph (1)(e) whether the use of a product in accordance with a standard would be effective, the NRA must have regard to: (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; and (b) any other matters prescribed by the regulations. 56F Variation or revocation of standards (1) The NRA may at any time prepare, in writing, a variation of the standard established for a listable chemical product and submit the variation to the Minister for his or her approval. (2) If the Minister decides to approves the variation: (a) the approval is effected by the Minister endorsing his or her approval on an instrument varying the standard; and (b) the standard as varied becomes the established standard for the product from the time of endorsement. (3) The NRA may, by writing, with the approval of the Minister, revoke the standard established for a listable chemical product. (4) The NRA must cause a copy of an instrument of variation or revocation of the standard established for a listable chemical product to be published in the Gazette. 56G Date of effect of standards (1) A standard established for a listable chemical product takes effect on the day on which a copy of the instrument containing the standard is published in the Gazette or on such later day as is specified in that instrument. (2) An instrument varying or revoking a standard established for a listable chemical product takes effect on the day on which a copy of the instrument of variation or revocation is published in the Gazette or on such later day as is specified in that instrument. 56H Standards to be disallowable Instruments containing standards, and instruments varying or revoking standards, established for listable chemical products are disallowable instruments for the purposes of section 46A of the Acts Interpretation Act 1901. Division 4—Application for registration of listable chemical products 56I Application A person may apply to the NRA for a chemical product: (a) that is a listable chemical product; and (b) for which there is an established standard; to be granted listed registration. 56J How application is to be made (1) The application must: (a) be in writing in or to the effect of the approved form; and (b) contain, or be accompanied by, any information that the NRA requires; and (c) be signed by an approved person; and (d) be accompanied by the prescribed fee (if any); and (e) be lodged with the NRA. (2) The NRA may, with the written consent of an approved person, alter the application. (3) At any time after an application has been made and before it has been determined, an approved person: (a) may give to the NRA information additional to or varying information previously given to the NRA; and (b) may withdraw the application by giving to the NRA a written notice of the withdrawal signed by an approved person. 56K Grant or refusal of application (1) The NRA must grant an application under section 56I if it is satisfied: (a) that the applicant has complied with subsection 56J(1); and (b) that any requirement made under section 157 or 159 has been complied with; and (c) that, if necessary, paragraph 8A(2)(a) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 has been complied with; and (d) that the chemical product complies with the relevant established standard and with such other requirements as are prescribed by the regulations; and (e) that the fee (if any) prescribed in respect of the listed registration, and any other amount (including an amount in respect of a tax or penalty) that is payable (whether by the applicant or by any other person) to the NRA in respect of the product under this Code or any other law in force in this or any other jurisdiction, have been paid. (2) In satisfying itself for the purposes of subsection (1), the NRA may: (a) have regard to the results of its own inquiries; or (b) rely on a written declaration produced to it by an approved person; as it thinks appropriate. (3) If the NRA is not satisfied as mentioned in subsection (1) it must refuse the application. 56L Multiple listed registrations The listed registration of a chemical product on the application of a person does not preclude the listed registration of the same chemical product on the application of another person. 56M How listed registration of chemical product is effected (1) If the NRA grants an application for a listable chemical product to be granted listed registration, it must give a distinguishing number to the product and grant listed registration in respect of the product in accordance with this section, either unconditionally or subject to conditions as mentioned in section 56O. (2) Listed registration of a chemical product takes place by entering in the Register of Chemical Products: (a) the relevant particulars, which are a notation that the product is a listable chemical product, the distinguishing number and any other particulars that are prescribed by the regulations; and (b) any conditions of the listed registration. 56N Date of listed registration (1) The date of listed registration of a chemical product is the date on which the relevant particulars are entered in the Register of Chemical Products. (2) If: (a) any of the relevant particulars of the listed registration of a chemical product; or (b) any of the conditions of such a listed registration; are varied pursuant to an application or request made under this Part, then, the date of the listed registration of the product, as varied, or as subject to the varied conditions, is the date on which particulars of the variations are entered in the Register of Chemical Products. 56O Conditions of listed registration (1) The conditions of the listed registration of a chemical product are the conditions that the NRA thinks appropriate. (2) Without limiting subsection (1), listed registration of a chemical product may be granted: (a) on the condition that the product is supplied only in a container of a kind referred to in the condition or prescribed by the regulations; or (b) on the condition that the product is not supplied in a container of a kind referred to in the condition or prescribed by the regulations. (3) Listed registration of a chemical product may be granted on the condition that the listed registration remains in force only for a stated period that is not more than one year. (4) If the listed registration is subject to a condition referred to in subsection (3) and the conditions of listed 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 NRA may vary the condition so as to extend the period for a further period of not more than one year or for further periods each of which is not more than one year. 56P Notice of listed registration (1) If an application for listed registration of a chemical product is granted, the NRA: (a) must give to an approved person written notice of the listed registration; and (b) may cause to be made publicly available, in an appropriate manner, a material safety data sheet in respect of the product.