Commonwealth Numbered Regulations - Explanatory Statements

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AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT REGULATIONS 2004 (NO. 2) 2004 NO. 225

EXPLANATORY STATEMENT

STATUTORY RULES 2004 No. 225

Subject -        Agricultural and Veterinary Chemicals Code Act 1994

Agricultural and Veterinary Chemicals Code Amendment Regulations 2004 (No. 2)

Section 6 of the Agricultural and Veterinary Chemicals Code Act 1994 (the Act) provides, in part, that the Governor-General may make regulations prescribing matters required or permitted by the Code to be prescribed by regulations within the meaning of the Code or necessary or convenient to be prescribed by such regulations for carrying out or giving effect to the Code.

Subsection 5(1) of the Act provides that the Agricultural and Veterinary Chemicals Code set out in the Schedule to the Act may be referred to as the "Agvet Code" of the participating Territories. Section 3 of the Act defines "the Code" as the Agvet Code of the participating Territories. The Agvet Code is enacted under a Commonwealth Act that applies in the Australian Capital Territory (subsection 7(1) of the Agricultural and Veterinary Chemicals Act 1994). The Agvet Code operates nationally because the State and Northern Territory Governments have each passed complementary legislation to apply the Agvet Code in each of the States and the Northern Territory. The National Registration Authority for Agricultural and Veterinary Chemicals (the NRA) established by the Agricultural and Veterinary Chemicals (Administration) Act 1992 administers the operation of the Agvet Code.

The Regulations implement necessary regulatory changes to give effect to the intent of the Agricultural and Veterinary Chemicals Legislation Amendment Act 2003 (No. 13 of 2003) (the Amending Act).

The Amending Act amended the Act to introduce a regime in the Agvet Code which:

•       provides for the management of agricultural and veterinary chemicals categorised as low regulatory activity;

•       permits greater flexibility to the NRA in dealing with an interested person or an approved person;

•       provides better administrative practice in terms of how a 'distinguishing number' for an active constituent, registered product and / or approved label is used;

•       enables the NRA to reject applications that are extremely deficient in the information they provide without formally considering them;

•       increases the NRA's capacity to vary or change any particulars and conditions 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, including, but not limited to, any condition of such approval or registration;

•       provides a mechanism to issue a deemed permit for the use of a product for a time after registration ends, is suspended or cancelled;

•       provides a requirement that the label contain instructions for the use of the product; and

•       provides for greater consistency in the use of certain language relating to the 'instructions for use' used in labels.

The Regulations give effect to the regulatory changes introduced by the Amending Act.

These reforms in the Agvet Code arose from the inter-governmental response to the review of agricultural and veterinary legislation initiated under the National Competition Policy.

Details of the Regulations are in the Attachment.

The Regulations commence on the date of notification in the Gazette.

Authority:        Section 6 of the Agricultural and Veterinary Chemicals Code Act 1994

Attachment

DETAILS OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT REGULATIONS 2004 (NO. 2)

Regulation 1

Regulation 1 provides for the regulations to be named the Agricultural and Veterinary Chemicals Code Amendment Regulations 2004 (No. 2).

Regulation 2 - Commencement

Regulation 2 provides that the regulations commence on the date of their notification in the Gazette.

Regulation 3 - Amendment of Agricultural and Veterinary Chemicals Code Regulations 1995

Regulation 3 provides that Schedule 1 amends the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Principal Regulations).

SCHEDULE 1 - Amendments

Item [1]       Paragraph 8(4)(b)

The term 'instruction' is an inclusively (but not exhaustively) defined word in the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code Act) that includes direction, caution, warning, or recommendation. Throughout the Agvet Code and the Principal Regulations the words 'recommendations', 'directions', and 'instructions' are used more or less interchangeably. Consistent with recent amendments to the Agvet Code (refer Agricultural and Veterinary Chemicals Legislation Amendment Act 2003 [No 13 of 2003] (the Amending Act), this item omits 'directions' and inserts 'instructions' to provide certainty within the regulatory framework as to whether a matter is advisory or mandatory.

Item [2]       Subregulations 9(1) and 10(1)

As a consequence of regulations 9 and 10, certain agricultural and veterinary chemical products must contain a dye or pigment. Subregulations 9(1) and 10(1) are amended to provide that the requirement to contain a dye or pigment in certain chemical products, as set out in regulation 9 and regulation 10, applies also as a matter about which the NRA must become satisfied (paragraph 14(3)(d) of the Agvet Code) in the circumstance when the NRA is considering an application for a variation under paragraph 29(1)(d) of the Agvet Code of relevant particulars, or of conditions, of registration of an agricultural or veterinary chemical product of the required kind.

Item [3]       Subregulation 11(1)

By paragraph 14(3)(d) of the Agvet Code, the NRA must be satisfied, amongst other things, that a label for a container for a chemical product contains certain information, including that required by the Principal Regulations when granting or refusing an application made under section 10 of the Agvet Code Act. Subregulation 11(2) sets out the information that a label must contain.

Subregulation 11(1) is amended to extend the circumstances of when the NRA must be satisfied that a label contains the information listed in subregulation 11(2) to the additional circumstances:

•       when the NRA is considering granting or refusing an application for a variation of the relevant particulars, or of conditions, of an approval of a label (paragraph 29(1)(d) of the Agvet Code); and

•       when the NRA is reconsidering the approval of a label without notice in certain circumstances (subsection 34A(1) of the Agvet Code).

Item [4]       Paragraph 11(2)(m)

Labels must contain certain information as prescribed, including but not limited to, a distinguishing number. Following from amendments to the Agvet Code by the Amending Act, this paragraph is amended to provide that the label must contain the distinguishing number of the label, not the distinguishing number of the product. The distinguishing number includes any such number, which may have been given to the label by the NRA, where approval of the label precedes the commencement of the Agvet Code.

Item [5]       Regulation 11A

The Agvet Code provides that the Minister may make Orders that are not inconsistent with the regulations. An Order has been made for the purpose of paragraph 14(3)(d) of the Agvet Code in relation to a label for containers for pool or spa hypochlorites.

Regulation 11A is amended to provide that Orders may be made in relation to a label for containers for pool or spa hypochlorites for the purpose of the additional circumstances:

•       when the NRA is considering granting or refusing an application for a variation of the relevant particulars, or of conditions of an approval of a label for containers for pool or spa hypochlorites (paragraph 29(1)(d) of the Agvet Code); and

•       when the NRA is reconsidering the approval of a label for pool or spa hypochlorites without notice in certain circumstances (subsection 34A(1) of the Agvet Code).

Item [6]       Regulation 12

Regulation 12 specifies additional matters about which the NRA must be satisfied prior to granting or approving an application made under section 10 of the Agvet Code in certain circumstances. Specifically, regulation 12 provides that a label of a veterinary chemical product must contain adequate instructions relating to the duration of any treatment. Additionally, regulation 12 provides that, for certain purposes, a label for a container of a chemical product must contain other additional instructions, which the NRA, in its opinion, requires.

Regulation 12 is amended to ensure that the matters specified in regulation 12 are matters about which the NRA must be satisfied in the following additional circumstances:

•       when the NRA is reconsidering the approval of a label without notice in certain circumstances (per subsection 34A(1)); and

•       when the NRA is considering submitting a standard for listable chemical products to the Minister for approval (subparagraph 56E(1)(f)(x) of the Agvet Code).

Item [7]       Paragraph 12(b)

Paragraph 12(b) is amended to provide that the particular purposes to which the NRA, in its opinion, may require a label to contain additional instructions also includes the circumstance when the NRA is considering submitting a standard for listable chemical products to the Minister for approval.

Item [8]       Regulation 14

Regulation 14 provides that the NRA must have regard to the method of analysis (if any) of the chemical composition and form of the constituents of the chemical product in certain circumstances. Regulation 14 is amended to extend the circumstances when the NRA must have regard to those matters to when the NRA is considering submitting a standard for listable chemical products to the Minister for approval.

Item [9]       Regulation 15

Section 14A of Agvet Code, which was inserted by the Amending Act, provides that the NRA may decide to approve an active constituent, whether or not an application has been made for the approval, in circumstances where all the information is not readily available or if the constituent or product containing the constituent is specified in pharmacopoeia or other publication considered by the NRA to be appropriate.

Regulation 15 is amended to provide that it is subject to the new provisions of subregulation 15(2) to ensure that only information which is readily available to the NRA is entered in the Record of Active Constituents.

Item [10]       Paragraph 15(j)

Paragraph 15(j) is amended to reflect the omission of paragraph 15(k) - see item [11] below.

Item [11]       Paragraph 15(k)

Section 19 of the Agvet Code, as amended by the Amending Act, now structurally separates the acts associated with the making of a decision by the NRA to approve an active constituent for a proposed or an existing chemical product from those other actions which constitute the act of approval, that is the act of including the required details (relevant particulars, any other particulars prescribed by regulations and any conditions of the approval) in the Record of Approved Active Constituents.

Paragraph 15(k) relating to the entering of conditions of approval under section 23 of the Agvet Code in the Record, is omitted as the requirement has become superfluous upon the amendments made to the Agvet Code by the Amending Act, which now includes the requirement to enter conditions of approval in the Record in paragraph 19(2)(b).

Item [12]       Regulation 15

The Record of Approved Active Constituents must record those items prescribed in regulation 15. Not all the items, which are required, by operation of subregulation 15(1) to be entered in the Record, are readily available to the NRA. This amendment recognises the possibility of certain information not being available and provides that only those particulars, which are readily available to the NRA, must be entered in the Record.

Item [13]       Paragraph 16(d)

This item amends paragraph 16(d) by inserting the words 'if possible'. This amendment properly recognises that it may not always be possible to identify the composition and purity of each constituent of the chemical product (for example, with some chemical products containing material of biological origin).

Item [14]       Paragraph 16(g)

In some circumstances a registrant may have a product manufactured by one or several manufacturers at any particular time. This item is amended to ensure that the name of each manufacturer of the chemical product is entered in the register of chemical products. This amendment therefore acknowledges that there may be more than one manufacturer of a chemical product.

Item [15]       Paragraph 16(k)

Paragraph 16(k) is amended to reflect the omission of paragraph 16(l) - see item [16] below.

Item [16]       Paragraph 16(l)

Section 20 of the Agvet Code now structurally separates the acts associated with the making of a decision by the NRA to register a chemical product from those other actions which constitute the act of registration, that is the act of including the required details (relevant particulars, any other particulars prescribed by regulations and any conditions of the approval) in the Register of Chemical Products.

Paragraph 16(l) relating to the entering of conditions of registration under section 23 of the Agvet Code in the Register is omitted as the requirement is now superfluous upon the amendments made to the Agvet Code by the Amending Act, which now includes the requirement to enter conditions of registration in the Register in paragraph 20(2)(b).

Item [17]       Regulation 17

Regulation 17 is omitted to reflect the amendments to the Agvet Code in the Amending Act and the new arrangements for how approval of a label takes place.

Item [18]       Regulation 19, heading

The heading to regulation 19 is amended to clarify who is the person to whom a notice is given. The information in the notice is to be given to the approved person.

Item [19]       Subregulation 19(1)

The definition of approved person was amended in the Amending Act. The new definition provides the NRA greater flexibility in dealing with an applicant 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. This flexibility allows for communication with additional parties authorised by the applicant. This item omits each mention of applicant and substitutes each mention with approved person to properly reflect the flexibility now afforded to the NRA in dealing with persons other than the original applicant.

Item [20]       Subregulation 19(2)

In line with the intent of item 19 above, this item omits each mention of applicant and substitutes each mention with 'approved person' to properly reflect the flexibility now afforded to the NRA in dealing with persons other than the original applicant.

Item [21]       Paragraph 19(2)(d)

This item amends the format of subregulation (2) to provide continuity for the insertion of new paragraphs.

Item [22]       After paragraph 19(2)(d)

Certain matters must be contained in a notice to an approved person about the registration of a chemical product. In addition to those matters already provided for in the Principal Regulations, particulars of any notice of the registration of a chemical product that is to be published and any other details about the chemical product that are entered in the Register of Chemical Products that the NRA thinks appropriate, must be contained in the notice.

Item [23]       Subregulation 19(3)

In line with the intent of item 19 above, this item omits each mention of applicant and substitutes each mention with 'approved person' to properly reflect the flexibility now afforded to the NRA in dealing with persons other than the original applicant.

Item [24]       After regulation 19

A new regulation, 19A, is inserted after regulation 19.

19A       Variation of relevant particulars or conditions of approval or registration

This new regulation extends the provisions of regulation 9 (Certain agricultural products must contain dye or pigment), regulation 10 (Certain veterinary chemical products must contain dye marker), regulation 11 (Labels to contain certain information) and regulation 11A (Orders about labels for containers for pool or spa hypochlorites), to an application for variation of the relevant particulars or of the conditions of approval or registration to be applied in the same way as they apply to the original application for approval or registration.

Item [25]       Regulation 20

The Agvet Code provides (in Division 4 of Part 2, sections 30 to 34A) that the NRA may reconsider an existing approval or registration.

The Amending Act deleted subsection 31(2) and inserted new paragraph 32(1)(aa) into the Agvet Code in relation to the notice the NRA may publish before a proposed reconsideration. The notice must set out the matters to be dealt with in any reconsideration and state the requirements prescribed by the Principal Regulations for continued approval or registration that form the basis of the reconsideration.

Regulation 20 prescribes these requirements for continued approval of an active constituent.

In reconsidering a continued approval or registration, however, the NRA if satisfied that the relevant particulars or conditions of approval or registration can be varied in such a way that the requirements prescribed by the Principal Regulations for continued approval or registration would be complied with, must so vary the relevant particulars or conditions. Although subsection 34(5) has been amended to revise the way in which variations to existing approvals or registrations (particularly variations to label approvals) must be made, regulation 20 corrects an oversight in the Agvet Code in that the reference in subsection 34(5) to the "requirements prescribed by the regulations for continued approval or registration" are the same as were provided for in subsection 31(2) and are now provided for in new paragraph 32(1)(aa).

Additionally, the Amending Act repealed and substituted the definition of relevant particulars to broaden those details that are required to be included in the Record of Approved Active Constituents, the Register of Chemical Products or recorded in the relevant NRA file.

In particular, it includes, in relation to the approval of a label for containers for a chemical product, the size and type of, and particulars contained on the label. The approved label must be recorded in the relevant NRA file. To ensure that the NRA is satisfied that its assessment criteria for health and safety, trade and efficacy are met, and continue to be met (as required by the Agvet Code), the NRA is provided with the capacity to establish or vary these relevant particulars in the Record of Approved Active Constituents, the Register of Chemical Products or recorded in the relevant NRA file.

Subsection 34(5) was therefore amended in the Amending Act to allow the NRA to vary the relevant particulars upon reconsideration, where the NRA is satisfied that the relevant particulars or conditions can be varied in such a way that the Regulations can be complied with.

Regulation 20 is therefore amended to be made for the purposes of paragraph 32(1)(aa) as well as subsection 34(5).

Item [26]       Regulation 20

The term 'instruction' is an inclusively (but not exhaustively) defined word in the Agvet Code Act that includes direction, caution, warning, or recommendation. Throughout the Agvet Code and the Principal Regulations the words recommendations, directions, and instructions are used more or less interchangeably. Consistent with recent amendments to the Amending Act, this item omits 'directions' and inserts 'instructions' to provide certainty within the regulatory framework as to whether a matter is advisory or mandatory.

Item [27]       Regulation 21

The Amending Act inserted new paragraph 32(1)(aa) into the Agvet Code and amended subsection 34(5) (refer to item 25 above). Similar to regulation 20 (item 25 above), regulation 21, which prescribes the continued requirements for registration of a chemical product, is amended to be made for the purposes of paragraph 32(1)(aa) as well as subsection 34(5).

Item [28]       Paragraphs 21(a) and (b)

The term 'instruction' is an inclusively (but not exhaustively) defined word in the Agvet Code Act that includes direction, caution, warning, or recommendation. Throughout the Agvet Code and the Principal Regulations the words recommendations, directions, and instructions are used more or less interchangeably. Consistent with recent amendments to the Amending Act, this item omits 'recommendations' and inserts 'instructions' to provide certainty within the regulatory framework as to whether a matter is advisory or mandatory.

Item [29]       Regulation 22

Regulation 22 is substituted with new regulation 22 below.

22       Continued approval of a label

In the context of the reforms introduced by the Amending Act, in terms of more clearly identifying the requirements for labels, this substituted regulation specifies the requirements for continued approval of a label for containers or chemical products, when the NRA is considering if it is appropriate for it to issue a notice of proposed reconsideration (subsection 32(1) of the Agvet Code), or variation of relevant particulars or conditions of the approval of a label or registration of a product (subsection 34(5) of the Agvet Code).

Consistent with the amendments to regulation 20 (item 25 above) and to regulation 21 (item 27 above), this substituted regulation is made for the purposes of paragraph 32(1)(aa) as well as subsection 34(5).

This regulation provides that the requirements for continued approval of a label for containers of chemical products are as follows:

•       that the label contains adequate instructions about the matters the NRA thinks are appropriate which are prescribed by the Principal Regulations (subparagraph 14(3)(g)(x)), including (to avoid any doubt), additional label instructions prescribed by regulation 12 for the purposes of subparagraph 14(3)(g)(x) of the Agvet Code;

•       the label complies with regulation 11 and any orders made under regulation 11A; and

•       the approval is subject to appropriate conditions (section 23 of the Agvet Code).

Item [30]       After Part 2

New Part 2A Listable chemical products is inserted after Part 2.

Part 2A        Listable chemical products

Regulation 23A       Listing Schedule

To maintain continuity and the intent of these Regulations, regulation 23A is reserved for future use. At a future time, this regulation will, for the purposes of subsection 56C(1) of the Agvet Code, specify, in a new schedule to the Principal Regulations, those chemical products, or classes of chemical products, that can be granted listed registration under new Part 2A of the Agvet Code.

Regulation 23B       Particulars of registered listed chemical products to be recorded

Listed registration of a chemical product takes place by entering in the Register of Chemical Products certain matters and any other particulars that are prescribed by the regulations (paragraph 56M(2)(a) of the Agvet Code). The particulars, which must be entered in the Register, are listed at paragraphs 23B(1)(a) to (j) inclusive. The particulars correspond to the particulars, prescribed by regulation 16, that must be entered in the Register of Chemical Products, in relation to the registration of a chemical product.

The requirement to list certain prescribed particulars in the Register does not apply to particulars that are already contained in the established standard. The established standard must be published in the Gazette and will be available on the NRA's website so there is no need for any particulars in the established standard to be also entered in the Register.

Regulation 23C       Containers for the supply of registered listed chemical products

Listed registration of a chemical product may be granted subject to such conditions that the NRA thinks appropriate. A container for the supply of a registered listed chemical product must comply with prescribed standards to ensure that the contents cannot harm any person or have an unintended effect that is harmful to the environment (paragraph 23C(1)(e)). Additional conditions are identified in paragraphs 23C(1)(a) to (d) inclusive. These conditions in respect of a container for the supply of a registered listed chemical product correspond to the conditions prescribed by regulation 18 in respect of a container for the supply of a registered chemical product.

The conditions which are prescribed in paragraphs 23C(1)(a) to (e) do not apply if the established standard for the registered listed chemical product specifies a standard for the container for the registered listed chemical product and requires the product to be kept in a container that complies with the requirements specified in the standard.

The operation of any other law that applies in relation to containers for chemical products is not affected by the provisions of subregulations (1) and (2).

Regulation 23D       Information to be given in notice to approved person

When the NRA grants an application for listed registration of a chemical product, it must give a written notice to the approved person advising of the listed registration. The notice which is given to the approved person must contain that information which is prescribed by operation of regulation 23D.

The matters prescribed by regulation 23D broadly correspond to the matters prescribed in subregulation 19(2) - see also item 22 above - in relation to matters to be contained in a notice to the approved person of the registration of a chemical product. Additionally, however, regulation 23D requires a notice of the listed registration of a chemical product to give a copy of the established standard that applies to the registered listed chemical product or details of publication of that standard in the Gazette.

Regulation 23E       Continued listed registration of chemical product

The Agvet Code provides (in Division 6 of Part 2A, sections 56V to 56Z) that the NRA may propose a reconsideration of the listed registration of a chemical product. In such circumstances, the NRA may, if appropriate, publish a notice advising of the proposal and setting out the matters to be dealt with in any reconsideration and state the requirements prescribed by the Principal Regulations for continued listed registration that form the basis of the reconsideration.

This regulation prescribes the requirements for continued listed registration that form the basis of the reconsideration. The requirements correspond to those requirements prescribed by regulation 21 for the continued registration of a chemical product (see also item 27 above) - that is, that the continued use of, or other dealing with, the product in accordance with the instructions for its use or for such a dealing that the NRA has approved would not be an undue hazard to the safety of people exposed to it or from anything containing its residues; the product would not be likely to have an effect that is harmful to human beings; the product would not be likely to have an unintended effect which is harmful to animals, plants, or the environment; and the product would not unduly prejudice Australia's international trade. The product must also be effective according to the criteria determined by the NRA.

Regulation 23F       Late applications for renewal of listed registration of chemical product

As for the registration of chemical products, the listed registration of a chemical product also ends on 30 June each year and has to be renewed each year. Applications for renewal of listed registration of a chemical product must be made to the NRA no later than one month, or shorter period that the NRA permits, before the listed registration ends. However, the NRA may accept a late application for renewal of listed registration of a chemical product, in the circumstances that are prescribed by the Principal Regulations and upon payment of the prescribed fee (if any) provided that the late application is made on or before a date that the NRA determines.

This regulation prescribes the circumstances in which the NRA may accept such late applications for renewal of listed registration of a chemical product. The first circumstance in which the NRA may accept a late application is if the late application is made more than one month before the listed registration is due to end, and the applicant asks the NRA in writing to accept a late application and the NRA agrees to that request. No late fee is payable in these circumstances. In any other circumstance the NRA may accept a late application provided that it is made on or before a date that the NRA determines, if the NRA thinks it would be unreasonable not to accept the application. In this case a late fee of $30 is payable.

Part 2B       Reserved chemical products

To maintain continuity and the intent of these Regulations, Part 2B is reserved for future use. At a future time, this regulation will, for the purposes of subsection 56ZU(1) of the Agvet Code, specify, in a new schedule to the Principal Regulations, those chemical products, or classes of chemical products, that are reserved chemical products under new Part 2B of the Agvet Code.

Item [31]       Subregulations 41(1) and (2)

Subregulations 41(1) and (2) are amended to reflect the introduction in the Amending Act of a new offence provision (section 83A) prohibiting the supply of substance or mixture in a container with a label bearing the name of a registered listed chemical product in particular circumstances. The first circumstance prescribed in paragraph 83A(1)(a) is if the constituents of the substance or mixture, differ by more than the prescribed extent from the constituents of the named registered listed chemical product that were shown in the Register of Chemical Products. This amendment provides that the prescribed extent for registered listed chemical products, as with registered chemical products, is nil.

Item [32]       Subregulation 41(3)

This item is amended to include a second circumstance as prescribed in paragraph 83A(1)(b) prohibiting the supply of a substance or mixture in a container with a label bearing the name of a registered listed chemical product if the concentration of the constituents of the substance or mixture, differ by more than the prescribed extent from the concentration of the constituents of the named registered listed chemical product as shown in the particulars of the Register of Chemical Products.

This item also is amended to include a third circumstance as prescribed in paragraph 102(1)(ca) allowing the NRA to give written notice to any person recalling or regulating the stocks of a registered listed chemical product if the concentration of the constituents of the stocks, differ by more than the prescribed extent from the concentration of the constituents of the named registered listed chemical product as shown in the particulars of the Register of Chemical Products.

These amendments provide that the prescribed extent of variation for the active constituents of registered listed chemical products, as with the active constituents of registered chemical products, in respect of which a standard is prescribed under section 87 (by regulation 42) is the extent, if any, of variation of concentration permitted by the standard.

Item [33]       Subregulation 41(3)

The concept of a registered listed chemical product was introduced by new Part 2A of the Amending Act. This item is amended to provide that the intent of the regulation relates to both registered chemical products and registered listed chemical products.

Item [34]       Paragraphs 65(a) and (b)

Since the Principal Regulations were first made in 1995, some Australian Government Departments have changed their names. To ensure that the Principal Regulations are now correct, this item substitutes the up-to-date name for two Australian Government Departments: the Department of Health and Ageing; and the Department of the Environment and Heritage.

Item [35]       Subregulation 70(2)

This subregulation, which prescribes application fees as specified in Schedule 6 to the Principal Regulations, is subject to subregulation (6), which prescribes fees for applications for permits; and new subregulation (4), which prescribes a component of the fee for the preliminary assessment of an application (see item 36 below).

Item [36]       After Subregulation 70(3)

Regulation 70 prescribes the fees payable in respect of applications made under the Agvet Code to be those specified in Schedule 6 to the Principal Regulations. This item inserts new subregulation (4) which defines the component of the total application fee payable under the provisions of subsection 11A(4) of the Agvet Code for the preliminary assessment of an application specified in Column 2 of Schedule 6 to the Regulations. The prescribed fee is nil where the application fee is $620 or less; and is $620 where the application fee is $1030 or more.

Item [37]       Subregulation 71A(2)

This item omits reference to a pool or spa hypochlorite in prescribing the fee payable for an application for renewal of the registration of a chemical product. The fee for an application for renewal of the registration of a pool or spa hypochlorite is now provided for in new subparagraph 71A(2)(a)(ii) in lieu of subregulation 71A(7). This fee remains unchanged at $200.

Item [38]       Paragraph 71A(2)(a)

The fee payable in respect of the renewal of the registration of a chemical product for a financial year is provided for in subsection 71A(2). Paragraph (a) is expanded to include circumstances where the product is a pool or spa hypochlorite or a listed chemical product. The fee for such products is $200.

Item [39]       Subregulation 71A(7)

This item omits subregulation 71A(7) which is picked up in the amendment in paragraph 71A (see item 38, above).

Item [40]       Subregulation 78(4)

The Amending Act inserted a new provision, section 11A, allowing for the preliminary assessment of an application by the NRA and specified certain acts which must occur within stated time frames.

This item substitutes subregulation (4) to support the intent of new section 11A and section 14 of the Agvet Code. The NRA must notify the applicant in writing within 1 month of receiving an application, if it appears to the NRA that the application complies with its requirements (subsection 11A(2) of the Agvet Code), that it will proceed with the technical evaluation and assessment of the application.

However, the application may be treated as withdrawn if, any further information which is sought by the NRA under section 159 of the Agvet Code, has not been provided as required.

These provisions do not apply if the NRA has already given notice to the applicant that the application has passed preliminary assessment and will be given full evaluation in due course (subsection 11A(2) of the Agvet Code), or if the NRA has rejected the application (subsection 11A(5) of the Agvet Code).

Item [41]       Schedule 6, after item 23A

Schedule 6 to the Principal Regulations is amended by inserting new item 23B. This item provides for the fee and assessment period relevant to an application for listed registration of a listable chemical product for which there is an established standard. The fee is $310 and the assessment period is the modular assessment period.


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