AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT REGULATIONS 2005 (NO. 1) (SLI NO 105 OF 2005)

Attachment

DETAILS OF THE AGRICULTURAL AND VETERINARY CHEMICALS CODE AMENDMENT REGULATIONS 2005 (No. 1)

Regulation 1

Regulation 1 provides for the name of the regulations to be the Agricultural and Veterinary Chemicals Code Amendment Regulations 2005 (No. 1).

Regulation 2

Regulation 2 provides for regulations 1 to 3 and Schedule 1 to commence on the day after the regulations are registered and for Schedule 2 to commence on 1 July 2005.

Regulation 3

Regulation 3 provides that Schedules 1 and 2 amend the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Principal Regulations).

SCHEDULE 1 – Amendments

Item [1] Regulation 3, definition of total leviable value

In the definition of “total leviable value” the words “total leviable value” have not been italicised consistent with the other definitions in regulation 3 of the Principal Regulations. This item corrects this error.

Item [2] Regulations 22A (first occurring), 22B and 22A (second occurring)

Regulation 22A occurs twice in the Principal Regulations. This item corrects this error by clarifying that the second occurrence of regulation 22A is to be regulation 22A and that the first occurrence of regulation 22A is numbered as regulation 22B. As a consequence, existing regulation 22B becomes regulation 22C. The contents of these provisions have not changed.

Item [3] Subregulation 70(1), note

The note to subregulation 70(1) of the Principal Regulations previously noted that regulation 71A makes further provisions regarding fees payable in respect of applications under the Code. However, regulations 70A, 71, 71A, 72 and 72A also contain provisions regarding fees payable in respect of application under the Code. This item replaces the note with a new note referencing all regulations that make provisions regarding fees payable in respect of applications under the Code.

Item [4] Regulations 71A and 71B

Regulation 71A of the Principal Regulations prescribes the fee payable for the renewal of a chemical product. The fee is prescribed by reference to the value of leviable disposals of the chemical product. From 1 July 2005 the fee payable for an application for the renewal of the registration of a chemical product and for the renewal of the listed registration of a chemical product will be a fixed fee of $390. This item prescribes this amount for the purposes of paragraph 49(1)(d) (for registration of a chemical product) and 56ZM(1)(d) (for listed registration of a chemical product) of the Code.

Regulation 71B of the Principal Regulations is no longer needed, as it relates to applications made under the Agvet Code’s transitional provisions for implementation of the National Registration Scheme for Agricultural and Veterinary Chemicals (NRS). These provisions relate to products or labels registered or approved under previous State and Territory registration schemes before the establishment of the NRS. Regulation 71B provides that no fee is payable in respect of an application for the renewal of the registration of a chemical product if the registration is one to which subsection 47(3) of the Code applies. Subsection 47(3) of the Code provides that the registration of a chemical product that is taken to have been effected by subsection 172(2) or paragraph 174(1)(a) or 176(1)(c) ends at the end of 3 months after the commencement of the Code unless the registration is renewed. Subsection 172(2), paragraph 174(1) (a) and paragraph 176(1)(c) of the Code are transitional provisions which provide that if, immediately before the commencement of the Agvet Code, there was an existing clearance for registration of chemical product, an existing registration of chemical product, or and existing registration or approval of label, then the product was taken to be registered by the Australian Pesticides and Veterinary Medicines Authority (APVMA) under section 20 of the Code (subject to any existing conditions). Section 71B effectively was only relevant until 3 months after the commencement of the Code, after which time either registration would have been renewed or the registration would have ended (under section 47(3) of the Code). Accordingly, this item removes this regulation, as it is no longer needed.

Item [5] After Subregulation 72(1)

Paragraph 164(8)(b) of the Code provides that the APVMA may waive or remit the whole or part of a fee that has been paid under the Code in circumstances that are prescribed by the regulations. This item prescribes, for the purposes of paragraph 164(8)(b) of the Code, a circumstance in which the APVMA may waive or remit the whole or part of a fee up to an amount of $100.

Item [6] Subregulations 72A(6) and (7)

From 1 July 2005 the levy on leviable products will be calculated on a financial rather than a calendar year basis. Regulation 72A of the Principal Regulations prescribes the fee to be paid for manufacturing licences. Whilst the fees for these licences are not to change, subregulation 72A(6) previously provided that the fee payable for a manufacturing licence was one-half of what it would otherwise be if the “notional wholesale value” (defined in subregulation 72A(7)) of the veterinary chemical product manufactured at the premises during a calendar year were less than $50,000. This item amends subregulation 72A(6) to continue the effect of the provision at the same levels with the exception that the relevant period is converted to a financial year basis, consistent with the way levies are to be derived. To do this, there needs to be a six-month conversion period which is provided for in new paragraph 72A(6)(b).

Item [7] Paragraph 73(1)(a)

This item corrects a typographical error in the reference to the “Code” in paragraph 73(1)(a) of the Principal Regulations.

Item [8] Paragraph 73(1)(c)

The APVMA no longer charges a fee for the provision of the copy of a label. This item omits paragraph 73(1)(c), which currently prescribes the fee for the provision of a copy of a label, as it is no longer required.

Item [9] Paragraph 73(1)(f)

As previously drafted, paragraph 73(1)(f) of the Principal Regulations suggested that the fees prescribed by that paragraph are authorised by section 162 of the Code, which relates to the disclosure of information. Those fees are actually authorised by section 164 of the Code. This item amends paragraph 73(1)(f) to make it clear that it is only the disclosure of the confidential information that is authorised by section 162 of the Code.

SCHEDULE 2 – Amendments commencing on 1 July 2005

Item [1] Subregulations 23(2) and (3)

The Principal Regulations provide for the payment of a fee for the late application for the renewal of the registration of a chemical product. The fee payable is linked to the amount of the fee payable for the application under regulation 70. Under the new cost recovery framework a flat fee of $50 would be payable for the acceptance of a late application. This item makes provision for payment of this late fee. This item also merges the existing subregulation 23(3) into subregulation 23(2) so that no late fee is payable where the applicant requests that the APVMA accept a late application before registration ends.

Item [2] Subregulations 23F(2) and (3)

This item retains the existing flat fee of $30 as the fee payable for the acceptance of a late application for the renewal of the listed registration of a chemical product. However, this item merges the existing subregulation 23F(3) into subregulation 23F(2) so that no late fee is payable where the applicant requests that the APVMA accept a late application before listed registration ends.

Item [3] Subregulation 47(2)

Under regulation 47 of the Principal Regulations, the APVMA must assign, on payment of the prescribed fee, a notification number for premises from which hormonal growth product is to be supplied. This item increases the existing fee from $200 to $275.

Item [4] Subregulation 70(2)

Schedule 6 is amended to comprise two parts, Part 1 and Part 2. Part 1 contains definitions required for the purposes of Schedule 6. This item consequentially replaces subregulation 70(2) with a new subregulation 70(2) which refers to Part 2 of Schedule 6 as being that part of Schedule 6 that specifies the fees.

Item [5] Subregulation 70(3)

Schedule 6 is amended to comprise two parts, Part 1 and Part 2. Part 1 contains definitions required for the purposes of Schedule 6. This item consequentially amends subregulation 70(3) to refer to Part 2 of Schedule 6 rather than Schedule 6.

Item [6] Subregulation 70(4)

If only part of the prescribed fee payable for an application is required to be paid at the time of making the application then, for applications made under section 10 of the Code, subparagraph 11(1)(d)(i) of the Code provides that the application must be accompanied by the amount required to be paid. Otherwise, by virtue of subparagraph 11(1)(d)(ii), the application must be accompanied by the whole of the prescribed fee. For applications made under the Code, other than under section 10 of the Code, subsection 164(2) of the Code provides that the fees to be paid in respect of the making of an application are due and payable in the manner prescribed.

Subregulation 70(4) provides that at the time of making an application the fee to be paid is:

(a) $460, if the an item in Part 2 of Schedule 6 specifies that the fee for the application is the modular assessment fee;

(b) the fee specified in Column 4 of the relevant item in Part, 2 of the Schedule 6, if the fee is so specified.

Section 11A of the Code provides for the APVMA to undertake a preliminary assessment of an application to determine whether the application complies with subsection 11(1) of the Code. Subsection 11A(4) of the Code provides that if the APVMA rejects the application on the grounds that it does not meet the requirements of subsection 11(1), then the fee payable for that application is repayable except that part of the fee identified by the regulations as being in respect of the preliminary assessment. This item identifies the amounts as being the amounts to be paid for the purposes of a preliminary assessment under subsection 11A(4) of the Code. The amounts are:

(a) in the case of an item in Schedule 6 for which the fee specified in column 4 is nil or less than $460 – the amount specified; and

(b) in the case of an item in Schedule 6 for which the fee specified in column 4 is $460 or more or is the modular assessment fee – $460.

Item [7] Paragraph 70(6)(a)

Subregulation 70(6) of the Principal Regulations sets out circumstances in which no fee is payable in respect of an application for a permit. This item amends that subregulation to:

(a) remove the exemption for a person primarily engaged in the growing of an agricultural or horticultural product; and

(b) limit the current exemption to the Commonwealth, a State or a Territory; or of an authority or agency of the Commonwealth, a State or Territory; or an officer or employee of the Commonwealth, a State or Territory or an authority or agency to circumstances in which the permit is in support of the core activities of the Commonwealth, the State or Territory and the permit must not be for a use that has a commercial benefit.

Item [8] Regulation 71

Regulation 71 relates to modular assessment fees. Under the new cost recovery framework there will be 25 categories of applications for which fees will be payable. These fees will be specified in Part 2 of the new Schedule 6. The fee payable will be either a fixed fee or the modular assessment fee. The fee payable will be indicated in Column 4 of Part 2 of Schedule 6. If a fee is specified in Column 4 of Part 2 of Schedule 6 then that is the fee that will be prescribed for that application. If the modular assessment fee is payable for an application then that will be calculated in accordance with Schedule 7. Schedule 7 will specify the modular assessment fees that are to apply for the different types/levels of assessment that are required for a particular application.

This item substitutes new provisions into regulation 71 that prescribe how the modular assessment fee is to be calculated. The modular assessment fee will be the sum of the fees payable for each module/level of assessment that an application is required to undergo. All applications will be subject to screening assessment module and a finalisation module. The APVMA will determine which other modules and which levels of assessment are required in accordance with the Legislative Instrument, the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005, that it intends to make for the purposes of subsection 164(1A) of the Code.

Subregulation 70(4) specifies that a fee of $460 is payable at the time of making an application if the application requires a modular assessment fee. This item makes provision for the payment of the remainder of the fee by specifying that any balance of the modular assessment fee is due and payable on the date specified by the APVMA in a notice under paragraph 78(3)(b) or subregulation 78A(2).

Item [9] Paragraphs 73(2)(a) and (b)

This item amends paragraphs 73(2)(a) and (b) of the Principal Regulations to increase the fees prescribed for providing certain copies or extracts from the Register of Agricultural and Veterinary Chemical Products; the Record of Approved Active Constituents for Chemical Products; or certain other documents or information from $20 to $90.

Item [10] Paragraph 73(2)(c)

Under the new cost recovery framework the new fee per page of photocopying is to be 20 cents per page in excess of the first 100 pages. There is no per page charge for the first 100 pages. This item amends paragraph 73(2)(c) to give effect to these charges.

Item [11] Paragraph 73(3)(a)

Item 11 of Schedule 1 above omits paragraph 73(1)(c). Paragraph 73(3)(a) contains a reference to paragraph 73(1)(c), which has been deleted (see item 8 in Schedule 1). This item omits that reference.

Item [12] Subregulations 76(1) and (2)

Schedule 6 is amended to comprise two parts, Part 1 and Part 2. Part 1 contains definitions required for the purposes of Schedule 6. This item consequentially amends subregulations 76(1) and (2) to refer to Part 2 of Schedule 6 rather than Schedule 6.

Item [13] Subregulation 76(3)

This item omits subregulation 76(3) which previously referred to primary and secondary applications in Schedule 6. As Schedule 6 is replaced with a new Schedule 6 which no longer refers to primary and secondary applications, this regulation is no longer required.

Item [14] Regulation 77

This item replaces the previous regulation 77 with a new regulation 77 setting out the modular assessment period that will apply to those applications that would be shown in Schedule 6 as being subject to modular assessment.

If an application is subject to modular assessment then Column 3 of Schedule 7 will set out the period – referred to as the “modular assessment period” – within which the modules, levels and types of assessment must be completed. Subregulation 77(2) will describe how the modular assessment period for a particular application is calculated. The modular assessment period is the sum of the period for the type of finalisation module that the application is required to undergo and the longest of the periods for such of the other modules or levels of assessment that the application is required to undergo.

Item [15] Regulation 78

This item replaces regulation 78 with a new regulation 78 that prescribes when the assessment period for assessing an application made under section 10 of the Code commences.

Subregulation 78(1) provides for those applications made under section 10 of the Code and, in respect of which a specified fee is prescribed, that the assessment period commences on the later of:

(a) the day on which the APVMA notifies the applicant that the application has passed preliminary assessment; and

(b) the day on which the correct fee specified in respect of the application is made.

Subregulation 78(2) provides for those applications made under section 10 of the Code and, in respect of which the prescribed fee is the modular assessment fee, that the assessment period (being the modular assessment period) commences immediately after the day on which the balance of the modular assessment fee is paid.

Subregulation 78(3) requires the APVMA if it gives a notice under subsection 11A(2) of the Code to also give the applicant notice of:

(a) the fact that, if any further information is required to be provided by the applicant under section 159 of the Code, then the application may be suspended or may be treated as withdrawn, if the applicant fails to comply with the requirement; and

(b) if the fee payable in respect of the application is the modular assessment fee, the modules that the application must undergo, the balance of the modular assessment fee and when the balance must be paid.

This item also inserts a new regulation, regulation 78A, which would specify the assessment period when applications made under the Code are made otherwise than under section 10 of the Code.

Subregulation 78A(1) provides that for applications that are not made under section 10 of the Code, the assessment period commences on the later of:

(a) the day on which the APVMA gives notice to the applicant that the APVMA will proceed with the technical evaluation and assessment of the application; and

(b) the day on which the correct fee specified in respect of the application is made.

Subregulation 78A(2) provides that within one month after receiving an application under the Code, being an application that is not made under section 10 of the Code, the APVMA must notify the applicant in writing whether or not the APVMA will proceed with the technical evaluation and assessment of the Code together with:

(b) if the fee payable in respect of the application is a modular assessment fee, the modules that the application must undergo, the balance of the modular assessment fee and when the balance must be paid.

Item [16] Schedule 3A, note following heading

The note to Schedule 3A of the Principal Regulations explains that the text of Parts 1 and 2 is derived from the Codex Alimentarius. It explains that the columns headed 'Codex number' and 'Major Uses' are included for the assistance of Codex users.

The note further provides that food crops listed in the 'Major uses' column are also used for the purposes of the definition of major food crop in Schedule 6.

Item [17] Schedules 6 and 7

This item replaces Schedules 6 and 7 to the Principal Regulations with new Schedules 6 and 7 that are consistent with the new cost recovery framework proposed in the CRIS. Schedule 6 comprises two parts, Part 1 and Part 2. Part 1 contains definitions required for the purposes of Schedule 6. The definitions set out in Part 1 of Schedule 6 are relevant to the fees prescribed and the assessment periods for the different kinds of applications set out in Part 2 of Schedule 6.

Section 1.1 provides a list of general definitions.

Section 1.2 provides a definition of' closely similar' ;

being - two chemical products are closely similar if they satisfy the criteria specified in the definition. The criteria varies depending on whether the two chemical products being compared are agricultural chemical products and reference chemical products or veterinary chemical products and reference chemical products. In both situations, the chemical products are not taken to be closely similar if the information about either the reference chemical product or the veterinary chemical product is protected information.

Section 1.3 provides a definition of 'similar'

being - an agricultural and a reference chemical product are similar if the conditions specified in the definition are satisfied. The conditions which must be satisfied for two chemical products to be similar are different where a veterinary and reference chemical product are being compared. In both situations, the chemical products are not taken to be similar if the information about the reference chemical product is protected information.

Section 1.4 provides a definition of 'same'

being - a proposed chemical product and a reference chemical product are the same if they are the same in all respects except their names, their distinguishing numbers and the name and business address of the applicant. However, the chemical product and the reference product are not taken to be the same if the information about the reference chemical product is protected information.

Section 1.5 provides a definition of 'protected information'

This definition has two parts. The fee payable for an application otherwise relying on or utilising protected information is affected.

Section 1.6 specifies that the fee for an application that would otherwise rely on or utilise protected information is to be determined as if the active constituent or label were not approved or the product was not registered, as the case may be.

Section 1.7 specifies that, where an application for registration of a chemical product is preceded by an application for a permit for that product, the fee for such a registration application only includes any additional assessment modules that are undertaken for the registration.

Both Part 2 of Schedule 6 and Schedule 7 set out tables prescribing fees. Schedule 7 prescribes the fees and periods for completion of modules, levels and types of assessments for modular assessments.

Note that subsection 164(1A) of the Agricultural and Veterinary Chemicals Code (a Schedule to the Agricultural and Veterinary Chemicals Code Act 1994 (Code)) provides that the APVMA may make a legislative instrument setting out criteria for working out which fee applies under the regulations in a particular case. Subsection165 (1) provides that when an application is made under the Code to the APVMA, the APVMA must determine the application within a period of time stated in, or determined in accordance with, the regulations. Subsection 165(1A) provides that the APVMA may make a legislative instrument setting out criteria for working out the period of time referred to in subsection 165(1) within which an application must be determined.

Reference is therefore made to the relevant legislative instrument to be made by the APVMA to assist in working out the which fee applies and the relevant time frame.

An explanation of the revised cost recovery arrangements for the APVMA in Schedules 6 and 7 is set out in the CRIS. A copy of the CRIS is available on the Department of Agriculture, Fisheries and Forestry website.

Commonwealth Numbered Regulations - Explanatory Statements

Attachment

Regulation 1

Regulation 2

Regulation 3

SCHEDULE 1 – Amendments