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

Administered by Department of Agriculture

Legislation au F2010L01805 Regulations Not in force Legislative Instrument

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EXPLANATORY STATEMENT

Select Legislative Instrument 2010 No. 144

 

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 the Agricultural and Veterinary Chemicals Code Amendment Regulations 2010 (No. 3) were enacted to implement a 10% increase in fees charged by the Australian Pesticides and Veterinary Medicines Authority (APVMA) starting from 1 July 2010. These Regulations were made under the authority of the Minister for Agriculture, Fisheries and Forestry pursuant to the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code Act 1994, respectively. The increases were deemed necessary following a review of the APVMA's cost recovery arrangements, which included stakeholder consultation and the publication of a Cost Recovery Impact Statement. The policy objective was to adjust the fees to better reflect the costs associated with administering the regulatory framework for agricultural and veterinary chemicals, while also ensuring that the APVMA could effectively carry out its functions. Further changes to the cost recovery arrangements were to be considered within twelve months of the implementation of these Regulations.

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) apply to entities involved in the registration, supply, and export of agricultural and veterinary chemicals in Australia. These regulations are amendments to the Agricultural and Veterinary Chemicals (Administration) Regulations 1995 and the Agricultural and Veterinary Chemicals Code Regulations 1995, respectively, and are made under the authority of the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code Act 1994. The regulations increase various fees associated with the administration of chemical products, including annual fees for continued registration, fees for applications to register chemical products, and fees for applications to supply hormonal growth promotants, among others. These changes came into effect from 1 July 2010, as an interim measure following a review of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) cost recovery arrangements. The regulations do not explicitly state any exclusions or exemptions, but their application is limited to the fees outlined in the schedules of the regulations. Further adjustments to the APVMA's cost recovery strategies may be considered within twelve months of the regulations' commencement.

Key Provisions

The Agricultural and Veterinary Chemicals (Administration) Amendment Regulations 2010 (No. 2) and the Agricultural and Veterinary Chemicals Code Amendment Regulations 2010 (No. 3) implement a 10% increase across all annual and application fees charged by the Australian Pesticides and Veterinary Medicines Authority (APVMA), which commenced from 1 July 2010. These regulations amend the Agricultural and Veterinary Chemicals (Administration) Regulations 1995 and the Agricultural and Veterinary Chemicals Code Regulations 1995 respectively. The fees affected by this increase include annual fees for continued registration of chemical products, fees for applications to register chemical products according to application type, fees 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. The Regulations impose several obligations on parties and entities governed by the Agricultural and Veterinary Chemicals (Administration) Act 1992 and the Agricultural and Veterinary Chemicals Code Act 1994. Firstly, they mandate the APVMA to charge the increased fees as specified in the Regulations from 1 July 2010. Secondly, they require applicants to pay the new fees when submitting applications for registration, licences, or export certificates, or when renewing annual registrations. Furthermore, entities responsible for supplying hormonal growth promotants must also adhere to the increased fees for such applications. These obligations ensure compliance with the updated fee structure as prescribed by the Regulations. Breach of the obligations set out in the Regulations may result in various consequences. For instance, failure to pay the prescribed fees could lead to delays in processing applications or renewals, potentially disrupting business operations for those involved. While the Regulations themselves do not explicitly outline penalties for non-compliance, the underlying Acts provide for penalties in cases of non-compliance. Under the Agricultural and Veterinary Chemicals (Administration) Act 1992, penalties for non-compliance can include fines up to $22,200 for individuals and $111,000 for bodies corporate, as stipulated by section 75 of the Act. Additionally, under the Agricultural and Veterinary Chemicals Code Act 1994, penalties for contravening the Act can include fines up to $22,200 for individuals and $111,000 for bodies corporate, as outlined in section 88 of the Act. These penalties underscore the importance of adhering to the fee requirements specified in the Regulations.

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