Agricultural and Veterinary Chemicals (Administration) Amendment Regulations 2010 (No. 2)

Administered by Department of Agriculture

Legislation au F2010L01802 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Select Legislative Instrument 2010 No. 143

 

Issued by Authority of the Minister for Agriculture, Fisheries and Forestry

 

 

Agricultural and Veterinary Chemicals (Administration) Act 1992

Agricultural and Veterinary Chemicals (Administration) Amendment Regulations 2010 (No. 2)

 

 

Agricultural and Veterinary Chemicals Code Act 1994

Agricultural and Veterinary Chemicals Code Amendment

Regulations 2010 (No. 3)

 

 

 

Section 73 of the Agricultural and Veterinary Chemicals (Administration) Act 1992 (the Administration Act) provides that the Governor-General may make regulations prescribing all matters required or permitted by the Act to be prescribed or necessary or convenient to be prescribed for carrying out or giving effect to the Act.

 

Subsection 6(1) 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 Agricultural and Veterinary Chemicals Code (the Code) to be prescribed by regulations within the meaning of the Code.

 

The Regulations amend the Agricultural and Veterinary Chemicals (Administration) Regulations 1995 and the Agricultural and Veterinary Chemicals Code Regulations 1995 is to provide for a 10 per cent increase across all annual and applications fees charged by the Australian Pesticides and Veterinary Medicines Authority (APVMA).

 

The increases commence from 1 July 2010 and apply to the following range of fees charged by the APVMA:

  • annual fees for continued registration of chemical product;
  • fees for applications to register chemical product according to application type;
  • fee for applications to supply hormonal growth promotant;
  • fees for applications to issue licences under the Good Manufacturing Practices (GMP) scheme for veterinary chemical products; and
  • fees for applications for export certificates of chemical products.

 

In early 2008 the APVMA commenced a review of its cost recovery arrangements. The APVMA sought stakeholder input into this process and released a draft Cost Recovery Impact Statement (CRIS) in December 2008. A final CRIS was produced in August 2009 which outlined a number of revised cost recovery strategies.

 

Following consideration of the CRIS, the Minister for Agriculture, Fisheries and Forestry (the Minister), advised that he has decided to increase all annual and application fees charged by the APVMA by 10 per cent effective from 1 July 2010. The Minister further advised that the increase is an interim measure and that further changes to the APVMA’s cost recovery arrangements will be considered within twelve months in line with expected reforms to the operation of the APVMA. In the meantime, in addition to these Regulations, this change will be given effect by a variation to an earlier CRIS developed for the APVMA by the Department of Agriculture, Fisheries and Forestry (DAFF) in 2005.

 

Details of the Regulations are in the Attachment.

 

The Act specifies no other conditions that need to be met before the power to make the Regulations may be exercised.

 

The Regulations are a legislative instrument for the purposes of the Legislative Instruments Act 2003.

 

The Regulations commenced on 1 July 2010.

 

 1011242A-100611Z

 1011242B-100611Z

 


ATTACHMENT

 

Details of the Agricultural and Veterinary Chemicals (Administration) Amendment Regulations 2010 (No. 2)

 

Regulation 1 – Name of Regulations

 

This regulation provides that the title of the Regulations is the Agricultural and Veterinary Chemicals (Administration) Amendment Regulations 2010 (No. 2).

 

Regulation 2 – Commencement

 

This regulation provides that the Regulations commence on 1 July 2010.

 

Regulation 3 – Schedule 1

 

This regulation provides that the Agricultural and Veterinary Chemicals (Administration) Regulations 1995 (the Principal Regulations) are amended as set out in Schedule 1.

 

Schedule 1 – Amendments

 

Item [1]

 

This item amends subregulation 3.550(1) of the Principal Regulations to prescribe the increased fees for applications for export certificates of chemical products.

 

Details of the Agricultural and Veterinary Chemicals Code Amendment Regulations 2010 (No. 3)

 

Regulation 1 – Name of Regulations

 

This regulation provides that the title of the Regulations is the Agricultural and Veterinary Chemicals Code Amendment Regulations 2010 (No. 3).

 

Regulation 2 – Commencement

 

This regulation provides that the Regulations commence on 1 July 2010.

 

Regulation 3 – Schedule 1

 

This regulation provides that the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Principal Regulations) are amended as set out in Schedule 1.

 

Schedule 1 – Amendments

 

Item [1]

 

This item amends subregulation 47(2) of the Principal Regulations to prescribe the increased fee for applications to supply hormonal growth promotant.

 

 

 

Item [2]

 

This item amends paragraphs 70(4)(a) and 70(5)(a) to (c) of the Principal Regulations to prescribe the increased fee to be paid for applications for modular assessments and to prescribe increased not repayable preliminary assessment fees.

 

Item [3]

 

This item amends subregulation 71(4), note 1 of the Principal Regulations to reflect that the legislative instrument, Agricultural and Veterinary Chemicals Code Instrument No.2 (Modular Assessment Fees) 2005 exists.

 

Item [4]

 

This item amends subregulation 71(4), note 2 of the Principal Regulations to prescribe the increased not repayable amount in respect of the fee paid for applications for modular assessments.

 

Item [5]

 

This item amends subregulations 71A(1) and (2)of the Principal Regulations to prescribe the increased the annual fees for continued registration of chemical product.

 

Items [6] to [11]

 

These items amend subregulation 72A(1), subparagraphs 72A(2)(a)(i) to (iii) and paragraphs 72A(2)(d) to (g) of the Principal Regulations to prescribe the increased fees to be paid for applications to issue licences under the GMP scheme for veterinary chemical products.

 

Item [12]

 

This item amends subregulation 78(3), note of the Principal Regulations to prescribe the increased balance payable for applications where a modular assessment fee is payable.

 

Item [13]

 

This item amends subregulation 78A(2), note 1 of the Principal Regulations to prescribe the increased balance payable for applications where a modular assessment fee is payable.

 

Item [14]

 

This item amends Schedule 6, Part 2, table, column 4 of the Principal Regulations to prescribe the increased fees for applications to register chemical product according to application type.

 

Item [15]

 

This item amends Schedule 7, table, column 4 of the Principal Regulations to prescribe the increased fees for applications to register chemical product by modular assessment.

Overview

The Agricultural and Veterinary Chemicals (Administration) Amendment Regulations 2010 (No. 2) and Agricultural and Veterinary Chemicals Code Amendment Regulations 2010 (No. 3) were enacted to address the need for increased cost recovery measures by the Australian Pesticides and Veterinary Medicines Authority (APVMA). The regulations were issued by the Minister for Agriculture, Fisheries and Forestry in accordance with the powers provided under the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code Act 1994, respectively. The policy objective of these regulations is to implement a 10 per cent increase across all annual and application fees charged by the APVMA, effective from 1 July 2010. This increase was deemed necessary following a review of the APVMA’s cost recovery arrangements, which sought stakeholder input and resulted in a final Cost Recovery Impact Statement released in August 2009. The amendments apply to various fees, including those for the continued registration of chemical products, applications to register chemical products, applications to supply hormonal growth promotants, applications to issue licences under the Good Manufacturing Practices scheme for veterinary chemical products, and applications for export certificates of chemical products. The enactment of these regulations aims to ensure that the APVMA can adequately recover costs while maintaining its regulatory functions.

Scope and Application

The Agricultural and Veterinary Chemicals (Administration) Amendment Regulations 2010 (No. 2) and the Agricultural and Veterinary Chemicals Code Amendment Regulations 2010 (No. 3) amend the Agricultural and Veterinary Chemicals (Administration) Regulations 1995 and the Agricultural and Veterinary Chemicals Code Regulations 1995, respectively. These regulations apply to entities involved in the registration, supply, and export of agricultural and veterinary chemicals in Australia, including chemical manufacturers, distributors, and exporters. The amendments primarily pertain to a 10% increase in annual and application fees for various services provided by the Australian Pesticides and Veterinary Medicines Authority (APVMA), effective from 1 July 2010. This encompasses fees for continued registration of chemical products, applications to register chemical products by type, applications to supply hormonal growth promotants, applications for Good Manufacturing Practices (GMP) licences for veterinary chemical products, and applications for export certificates of chemical products. The regulations extend across Australia, impacting all entities subject to the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code Act 1994. The specified fee increases are the primary amendments, with no stated exclusions or exemptions.

Key Provisions

The main operative sections of the Agricultural and Veterinary Chemicals (Administration) Amendment Regulations 2010 (No. 2) and the Agricultural and Veterinary Chemicals Code Amendment Regulations 2010 (No. 3) prescribe a 10 per cent increase in fees charged by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Regulation 1 of each set of Regulations specifies the title and commencement date of 1 July 2010, while Regulation 3 directs that the relevant Principal Regulations are amended as set out in Schedule 1. The amendments, detailed in the Schedules, affect a range of fees, including those for continued registration of chemical products, applications to register chemical products, applications to supply hormonal growth promotants, applications to issue licences under the Good Manufacturing Practices (GMP) scheme for veterinary chemical products, and applications for export certificates of chemical products. The obligations and requirements imposed by the Regulations on parties or entities governed by the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code Act 1994 include the payment of increased fees for various applications and registrations. Specifically, entities must pay the revised fees for applications to register chemical products, supply hormonal growth promotants, issue GMP licences, and obtain export certificates. These fees are adjusted to reflect the 10 per cent increase mandated by the Regulations. Entities must ensure compliance with these fee structures when submitting applications or seeking registrations and licences from the APVMA. The Regulations do not explicitly state any offences or penalties for breach; however, failure to comply with the fee requirements could result in administrative consequences. The APVMA may refuse to process applications or renew registrations if the required fees are not paid. This administrative action could significantly impact the ability of entities to legally use or supply agricultural and veterinary chemicals in Australia. It is important for entities to stay informed about these fee adjustments to avoid any disruptions in their operations.

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