EXPLANATORY STATEMENT
Agricultural and Veterinary Chemicals Code
Instrument No. 1 (Application Fees) 2010
The Australian Pesticides and Veterinary Medicines Authority (APVMA) is an independent statutory authority of the Commonwealth operating on a full 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 ), which is a Schedule 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 fee structure for applications is set out in Part 2 of Schedule 6 to the Agvet Code Regulations. The Schedule provides for 25 separate categories of applications, as described in Column 2 of Schedule 6.
Further amendments to the Agvet Code Regulations have increased application fees by 10% with effect from 1 July 2010.
The purpose of this Instrument is to set out criteria which more fully describe some of the 25 items in Part 2 of Schedule 6 to the Agvet Code Regulations. A more detailed description of the items will allow applicants to work out which fee applies to a particular application.
This Instrument repeals the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005 (the 2005 Instrument), as amended, and remakes it. The 2005 Instrument contained for reference purposes only, the fee payable in respect of those categories of applications that were referred to in the Instrument. This reference to the fee payable is not actually necessary and has been removed in this remade Instrument as a consequence of the 10% increase in fees. As this remade Instrument is otherwise exactly the same as the 2005 Instrument, as amended, consultation was not considered to be necessary.
This Legislative Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.
NOTES TO ITEMS
Part 1 Preliminary
Item 1 Name of Instrument
1. This item states that the full name of the Instrument is the Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2010.
Item 2 Commencement
2. This item provides that the Instrument will commence on the day after it is registered.
Item 3 Object
3. This item outlines that the purpose of the Instrument is to set out criteria which more fully describe some of the 25 items in Part 2 of Schedule 6 to the Agvet Code Regulations. A more detailed description of the items allows applicants to work out which fee applies to a particular application.
Item 4 Interpretation
4. This item clarifies, consistent with section 13 of the Legislative Instruments Act 2003, that expressions used in the Instrument have the same meaning as in the Agvet Code Act or the Agvet Code Regulations.
5. A definition is provided for “multiple application”. Basically, a “multiple application” is an application for a minor label change and the same change is requested by the same applicant for more than one chemical product.
6. Definitions are also provided for “new active constituent” and “new chemical product” to clarify that they are ‘new’ if they have not been previously approved or registered by the APVMA.
Part 2 Repeal
Item 5 Repeal of Instrument
7. This item repeals the earlier Agricultural and Veterinary Chemicals Code Instrument No. 1 (Application Fees) 2005.
Part 3 Criteria for working out which Application Category Applies
Item 6 Category 1
8. A Category 1 application is described in Schedule 6 of the Agvet Code Regulations as being an application for approval of an active constituent contained in a chemical product, registration of the associated chemical product and approval of the product label requiring full assessment of the active constituent and chemical product. This item provides that this Category includes only applications for agricultural chemical products for use on food-crops where the new active constituent in the agricultural chemical product is synthetic or semi-synthetic or is highly purified or is produced by genetic engineering.
9. This item also provides that, for a Category 1 application, a “full assessment” means that, in order to be satisfied that the product would pose no hazard, the APVMA would have to undertake an assessment of the application that is equivalent to the following modules in Schedule 7 of the Agvet Code Regulations: Screening (Module 1), comprehensive Chemistry assessment (Module 2.1), comprehensive Toxicology assessment (Module 3.1), Poison Scheduling (Module 4), comprehensive Residues assessment (Module 5.1), comprehensive Occupational Health and Safety assessment (Module 6.1), comprehensive Environment assessment (Module 7.1), comprehensive Efficacy and Safety assessment (Module 8.1), Type 1 Finalisation (Module 11.1) and Data Protection (Module 12).
Item 7 Category 2
10. This item provides that, as a corollary to item 6, a Category 2 application includes applications for agricultural chemical products where the active constituent is commonly used with a history of safe use (requiring a lower Toxicology and OH&S assessment); or for veterinary products (requiring lower Environmental and OH&S assessments).
Item 8 Category 3
11. This item provides that, for a Category 3 application ‑ which is an application for registration of a chemical product containing an approved active constituent, and approval of the product label, if there is no registered chemical product containing the active constituent and full assessment of the chemical product is required – a “full assessment” has the same meaning as in item 6 except that only limited Chemistry (Module 2.3) and Toxicology (Module 3.3) assessments are required.
Item 9 Category 11
12. This item provides that, a Category 11 application – which is an application to vary the particulars or conditions of registration or label approval where the variation is to extend the use of the chemical product to a new major food crop – does not include applications to vary the particulars or conditions of registration for a product where it is the first time that the use of any product containing the active constituent in this product is being extended from a non-food producing use to a food-producing use.
Item 10 Category 12
13. This item provides that a Category 12 application – which is an application to vary the particulars or conditions of registration or label approval where the variation is to allow a minor change and no data of a technical nature is required – does not include multiple applications. This is necessary to enable multiple applications to be included within Category 14 as some multiple applications may otherwise come within Category 12.
Item 11 Category 14
14. This item provides that a Category 14 application – which is an application to vary the particulars or conditions of registration (or listed registration) and the application is not of a kind described in earlier categories – includes multiple applications. Part 2 of Schedule 6 of the Agvet Code Regulations provides that the modular assessment fee applies for Category 14 applications. The item 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) 2010. These subsections provide details of how the modular assessment fee will apply bundling arrangements for multiple applications so as to reduce their overall fee.
Item 12 Category 15
15. This item provides that, for a Category 15 application – which is an application for approval of an active constituent requiring full assessment – a “full assessment” means that the APVMA would have to undertake an assessment of the application that is equivalent to either a comprehensive chemistry assessment (Module 2.1) and a comprehensive Toxicology assessment (Module 3.1) or a comprehensive chemistry assessment (Module 2.1) and a limited Toxicology assessment (Module 3.2).
Item 13 Category 17
16. This item clarifies that a Category 17 application – which is an application for approval of an active constituent requiring less than full assessment but not requiring a toxicological assessment – includes an application for a new source of manufacture for the active constituent being applied for.
Item 14 Category 18
17. This item explains that a Category 18 application – which is an application to vary particulars or conditions of an approved active constituent – applies to applications to vary the particulars or conditions of an approved active constituent where a chemistry assessment is the only assessment that is required. Variations to the particulars or conditions of approval of biological active constituents or other active constituents that involve other assessments such as efficacy and safety assessment are not included in this Category.
Item 15 Category 20
18. This item explains that, for a Category 20 application – which is an application for a permit where a previous assessment remains valid but no data of a technical nature is required – a ‘previous assessment’ would remain valid where the application is for the purposes of extending or renewing the duration of a permit.
Item 16 Category 25
19. This item clarifies that a Category 25 application – which is any other application requiring assessment of a technical nature that is neither made under section 10 of the Agvet Code nor is of a kind listed in an item of Schedule 6 – includes an application for assessment of a trial protocol.
Part 4 Fees
Item 17 Fees
20. The purpose of this Instrument is to allow the fee for a particular type of application to be determined. By more precisely and more fully describing a Category of application, or by clarifying what may be or may not be included in that Category, allows the fee for that particular application to be more readily determined. This item notes that the fee payable for application described in Column 2 of an item or category of Part 2 of Schedule 6 of the Agvet Code Regulations is the fee (if any) specified for the item in Column 4 of that Schedule.
Legal Program, APVMA July 2010