EXPLANATORY STATEMENT

Agricultural and Veterinary Chemicals Code

Amendment Instrument No. 2 (Multiple Applications) 2008

The Australian Pesticides and Veterinary Medicines Authority (APVMA) is a statutory authority of the Commonwealth operating on a fully cost-recovery basis.  The APVMA is responsible for ensuring that agricultural and veterinary chemicals entering into the Australian market pose no hazard to humans, target animals and plants and the environment, are effective for their approved use and pose no threat to Australian trade.

Subsection 32(1) of the Agricultural and Veterinary Chemicals (Administration) Act 1992 provides that the Chief Executive Officer of the APVMA is to manage the affairs of the APVMA and in doing so, may exercise any of the powers and perform any of the functions of the APVMA.

Subsection 164(1A) of the Agricultural and Veterinary Chemicals Code (the Agvet Code) scheduled to the Agricultural and Veterinary Chemicals Code Act 1994 (the Agvet Code Act) 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.

Amendments to the Agvet Code and the Agricultural and Veterinary Chemicals Code Regulations 1995 (the Agvet Code Regulations) in 2005 provided for new cost recovery arrangements for the APVMA, including a revised fee structure for applications made to the APVMA.  This revised structure for applications commenced on 1 July 2005 and is set out in an amended Part 2 of Schedule 6 of the Agvet Code Regulations.  The revised Part 2 of Schedule 6 provides for 25 separate categories of applications.

Categories 11 to 14 are all various forms of applications to vary a registration or label approval.  Category 12 is for an application to vary the particulars or conditions of registration or label approval if the variation is to allow a minor change and no data of a technical nature is required.  The fee for a Category 12 application is $560.  Category 14 is a general “catch-all” category for applications to vary a registration or label approval – that is, for categories 11 to 14.  In particular, Category 14 is for an application to vary the particulars or conditions of registration or listed registration or label approval if the application is not of a kind described in any of items 11 to 13.  The fee for a Category 14 application is the modular assessment fee. 

Schedule 7 provides for twelve broad modules to be applied to any application to be assessed by the modular assessment fee.  The modules cover the initial examination of an application by the APVMA (Screening), the assessment of its Chemistry, Toxicology, Poison Scheduling, Residues, Occupational Health and Safety (OH&S), Environment, Efficacy and Safety, Trade and other certain administrative matters.  The total modular assessment fee to be paid for the application is the total of all the particular levels for all twelve modules which are relevant (for certain applications some of the modules will not apply).  This will then determine a fee for the application that is directly related to the actual amount of assessment by the APVMA that is necessary to determine it.

Pursuant to sections 164(1A) of the Agvet Code, the APVMA enacted the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005 (the Principal Instrument).  The Principal Instrument sets out criteria which more fully describe some of the 25 items in Part 2 of Schedule 6 of the Agvet Code Regulations.  A more detailed description of the items allows applicants and the APVMA to work out which fee applies to a particular application.

The purpose of the Agricultural and Veterinary Chemicals Code Amendment Instrument No. 2 (Multiple Applications) 2008 (the Amendment Instrument) is to amend the Principal Instrument to provide for multiple applications.  Multiple applications are applications to vary the particulars or conditions of registration or label approval involving a minor label change and the same applicant seeks the same variation in respect of two or more chemical products.

The amendments to the Principal Instrument are to clarify that Category 12 is not to apply to multiple applications (even where the Category may be otherwise appropriate for the particular type of application).  The amendments to the Principal Instrument provide that Category 14 is to apply to all multiple applications and the modular assessment fee provisions are to be modified by corresponding changes to the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005 in a way to allow a form of ‘bundling’ of multiple applications.

This will allow multiple applications to have significantly reduced fees than they otherwise would have if assessed, either as a Category 12 or Category 14, as a number of single applications.

The APVMA has discussed the proposal with the agvet chemicals industry and it strongly supports the proposal.  While there will be a fee reduction for individual applicants, the overall revenue loss to the APVMA is not expected to be significant.

These amendments are to be made in conjunction with the Agricultural and Veterinary Chemicals Code Amendment Instrument No. 3 (Multiple Applications) 2008 which, by amending the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005, provides details of the bundling arrangements that are to apply to multiple applications.

The Agricultural and Veterinary Chemicals Code Amendment Instrument No. 2 (Multiple Applications) 2008 is a legislative instrument for the purposes of the Legislative Instruments Act 2003. 

NOTES ON ITEMS

Item 1 Name of Instrument

1. This item states that the full name of the Amendment Instrument is the Agricultural and Veterinary Chemicals Code Amendment Instrument No. 2 (Multiple Applications) 2008.

Item 2 Commencement

2. This item provides that the Amendment Instrument will commence on the day after it is registered on the Federal Register of Legislative Instruments (FRLI).

Item 3 Amendment of the Agricultural and Veterinary Chemicals Code
Instrument No. 1 (Application Fees) 2005

3. This item provides that Schedule 1 amends the Principal Instrument.

Schedule 1 Amendments

Item 1 Subsection 4(2)

4. This item adds a new definition of “multiple application”.  The definition provides that “multiple application” means an application to vary the particulars or conditions of registration or label approval where the variation is to allow a minor label change (whether or not data of a technical nature is required) and the same type of variation is requested by the same applicant in respect of more than one chemical product.

Item 2 After section 8

5. This items inserts new sections 8A and 8B after section 8. 

6. Section 8A provides that a Category 12 application (that has a fee of $560) does not include multiple applications.  This is necessary to enable multiple applications to be included within Category 14 as some multiple application may otherwise come within Category 12.

7. Section 8B provides that Category 14 (for which the modular assessment fee applies) includes multiple applications.  The section also provides that the modular assessment fee for multiple applications is to apply in the manner set out in subsections 17(2) and 17(3) of the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005.  Section 17 of the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005 is being amended by the Agricultural and Veterinary Chemicals Code Amendment Instrument No. 3 (Multiple Applications) 2008 which will insert new subsections 17(2) and 17(3) that provides the details of how the modular assessment fee will apply bundling arrangements for multiple applications so as to reduce their overall fee.  The amendments to section 17 of the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005 are being made in conjunction with these amendments.