EXPLANATORY STATEMENT

Agricultural and Veterinary Chemicals Code

Instrument No 2 (Modular Assessment 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.

Subsection 165(1A) of the Agvet Code provides that the APVMA may also make a legislative instrument setting out criteria for working out which period stated in, or determined in accordance with, the regulations applies in a particular case.  This period is the period within which the APVMA must determine an application which has been made to it.

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.  The periods within which the APVMA must determine particular applications were also revised.  This fee and timeframes structure for applications is set out in Part 2 of Schedule 6 to the Agvet Code Regulations. 

Part 2 of Schedule 6 provides for 25 separate categories of applications, as described in Column 2 of Schedule 6.  For six of these categories, the fee prescribed is the “modular assessment fee” to be determined in accordance with Regulation 71 and Schedule 7 of the Agvet Code Regulations.

Schedule 7 provides for twelve broad modules to be applied to each application.  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.  For eight of the twelve modules, one of several levels or types will apply with varying levels of fees for each level.  The total modular assessment fee to be paid for the application shall be the total of all the particular levels for all twelve modules which are relevant.  This will then determine a fee for the application that is directly related to the actual amount of assessment that is necessary to determine it.

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, in circumstances when the modular assessment fee as provided by regulation 71 of the Agvet Regulations is to apply to a particular application made under the Agvet Code, describes which levels and types of modules, as set out in Schedule 7 of the Agvet Regulations, are to apply to the application.

This Instrument repeals the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment 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.  This Instrument also corrects a minor typographical error in section 15.  Apart from this correction, this remade Instrument is exactly the same as the 2005 Instrument, as amended.  Consequently, consultation was not considered to be necessary. 

This Legislative Instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

NOTES ON 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 2 (Modular Assessment 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, in circumstances when the modular assessment fee as provided by regulation 71 of the Agvet Regulations is to apply to a particular application made under the Agvet Code, describes which levels and types of modules, as set out in Schedule 7 of the Agvet Regulations, are to apply to the 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.  Definitions are also provided for several technical terms.

Part 2 – Repeal

Item 4A Repeal of Instrument

5. This item repeals the earlier Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2010.  

Part 2 – Criteria for working out which Application Module applies

Item 5 Module 1 – Screening

6. This item sets out that Module 1 (Screening) applies to all applications, the fee for which are to be determined by the modular assessment fee.  These are Categories 2, 10, 14, 23, 24 and 25 of Schedule 6.  For ease of reference, all the types of applications of these Categories received by the APVMA are listed.

Item 6 Module 2 – Chemistry

7. This item deals with Module 2 of Schedule 7 relating to the Chemistry assessment of an application.  There are four levels of Chemistry assessment in Schedule 7.  The highest level of Chemistry assessment – Level 1 Comprehensive assessment – is to be given to applications for new products containing various new active constituents.

8. The next level of Chemistry assessment – Level 2 Reduced assessment – is to be given to certain applications for chemical products containing active constituents for which some knowledge is already held by the APVMA (for example, active constituents which, while new to an agricultural chemical, are already being used in household or industrial chemicals).

9. Level 3 Chemistry assessment – is reserved for an assessment of new products containing existing active constituents so that the assessment of chemistry and manufacture data is limited to the product only.

10. Level 4 Limited Chemistry assessment – is to be given to those applications for chemical products where the details of chemistry and manufacture of the product (and its active constituent) is significantly well-known to the APVMA (for example, applications for variations to registered chemical products involving minor formulation changes).

Item 7 Module 3 – Toxicology (not requiring poison schedule classification)

11. This item deals with Module 3 of Schedule 7 relating o the Toxicology assessment of an application.  There are three levels of Toxicology assessment.  The highest level of Toxicology assessment – Comprehensive assessment – is to apply to applications for new chemical products, or for permits in relation to chemical products, containing new active constituents and where the product is to be used for food production.

12. Reduced Toxicology assessment – is to be given to those applications for chemical products where a significant toxicological assessment is still required, but which is less than the Level 1 Comprehensive assessment (for example, for new chemical products containing new active constituents but where the product is not to be used for food production).

13. Limited Toxicology assessment – is to apply to other applications requiring only certain aspects of toxicological assessment (for example, applications for newly formulated agricultural chemical products containing an existing active constituent).  The toxicology of such products would be relatively well-known.

Item 8 Module 4 – Toxicology (requiring poison schedule classification)

14. This item deals with Module 4 of Schedule 7.  This module applies only to applications for chemical products which require poisons scheduling.

Item 9 Module 5 – Residues

15. This item deals with Module 5 of Schedule 7 relating to the Residues assessment of an application.  There are five levels of Residues assessment, although two levels are reserved for permit applications only.  The highest level of Residues assessment –  Comprehensive Residues assessment – is to apply to most applications for new and existing chemical products that are for food-producing use.

16. Reduced Residues assessment for products – is to apply to applications for chemical products involving an extension of use to major food production.  There is also to be a Reduced Residues assessment for similar applications for a permit.

17. Limited Residues assessment for products – is to be given to applications involving non-major food production.  There is also a Limited Residues assessment for similar applications for a permit and for trial protocols.

Item 10 Module 6 – Occupational Health and Safety (OH&S)

18. This item deals with Module 6 of Schedule 7 relating to Occupational Health and Safety (OH&S) assessment.  There are three levels of OH&S assessment.  The highest level of OH&S assessment – Comprehensive OH&S assessment – is to apply to applications for new chemical products containing new active constituents.

19. A Reduced OH&S assessment – is to apply to applications for agricultural chemical products involving a major formulation change and certain other applications.

20. A Limited OH&S assessment – is to be given to applications for veterinary chemical products involving a major formulation change and certain other applications.  Some applications do not require OH&S assessment as set out in sub-item 10(4).

Item 11 Module 7 – Environment

21. This item deals with Module 7 of Schedule 7 relating to the Environment assessment.  There are three levels of Environment assessment.

22. Most veterinary chemical products will only require environmental impact assessment and will not be assessed under the modular assessment fee structure of Schedule 7.

23. Comprehensive Environment assessment – is to be given to applications for new chemical products containing new active constituents and applications for new agricultural chemical products involving an extension of use to a new crop.

24. Reduced Environment assessment – is to apply to applications for agricultural chemical products containing existing active constituents and involving extension of use to a new crop or new herd animal, as well as some other applications.

25. Limited Environment assessment – is to be given to applications for agricultural chemical products for use in the home garden and certain other applications.

Item 12 Module 8 – Efficacy and Safety

26. This item deals with Module 8 of Schedule 7 relating to Efficacy and Safety assessment.  There are three levels of Efficacy and Safety assessment.

27. Comprehensive Efficacy and Safety assessment – is to apply to applications for new agricultural chemical products containing a new active constituent and certain other applications.

28. Reduced Efficacy and Safety assessment – is to be given to most applications for existing agricultural chemical products and certain other applications.

29. Limited Efficacy and Safety assessment – is to apply to applications for chemical products where efficacy and safety data are required to demonstrate similarly to an existing registered product and certain other applications that are expected to have a minor impact on efficacy or crop/animal safety.

Item 13 Module 9 – Non-food trade (fee of $1,070)

30. This item deals with Module 9 of Schedule 7 relating to Non-food trade.  There is only one fee for this module.  The module applies to applications for chemical products involving trade risks not related to food residues.

Item 14 Module 10 – Special Data

31. This item deals with Module 10 of Schedule 7 relating to Special data.  All modular assessment fee applications for the registration of products which contain active constituents that are new antibiotic substances or which contain genetically-modified organisms (GMOs) require the submission of Special data.  There are three levels of Special data, although no fees are payable in respect of Special data assessments.

32. Comprehensive Special data assessment is required for applications for new veterinary chemical products containing a new antibiotic active constituent or for a permit for such a product.

33. Reduced Special data assessment is required for applications for new veterinary chemical products (or for variations to the particulars or conditions of veterinary chemical products) containing an existing antibiotic active constituent in certain circumstances expected to result in an increased risk to public health.

34. A Limited Special data is required for any application for chemical products containing GMOs or for any application not included in the Comprehensive or Reduced Special data assessment requirements but which requires a Special data assessment.

Item 15 Module 11 – Finalisation

35. This item deals with Module 11 of Schedule 7 relating to Finalisation assessment.  This module encompasses administrative and technical steps in public consultation on and the finalisation of applications.  There are four types of Finalisation assessment.

36. Type 1 Finalisation – is to apply to applications of three or more modular assessments from amongst modules 2.1 through to 10.3, but excluding 2.4.

37. Type 2 Finalisation – is to apply to applications for the registration of chemical products (or for a variation to the particulars or conditions of registration) that require one or two modular assessments only from amongst the modules 2.1 through to 10.3.

38. Type 3 Finalisation – is to apply to applications for a permit requiring one or two modular assessments only.

39.              Type 4 Finalisation – is to apply to any application involving no technical assessment; an assessment under module 2.4 (Limited Chemistry assessment); or any other application requiring finalisation that is not otherwise provided for, including applications for a permit or trial protocol in relation to chemical products[1]. 

40.              The reference to several section numbers in paragraph 15(5)(b) has been corrected in this Instrument.

Item 16 Module 12 – Data Protection (Fee of $155)

41. This item deals with Module 12 of Schedule 7 relating to Data Protection.  There are no levels for this module.  The module is to apply to any application attracting data protection.

Part 4 Fees and Assessment Periods

Item 17 Modular Assessment Fees

42. This item provides that, if a module, level or type of assessment is appropriate for a particular application then the fee payable for that module, level or type is the fee set out in column 4 of Schedule 7 of the Agvet Code Regulations.  The method of working out the total modular assessment fee for a particular application assessed by modular assessment is set out in regulation 71 of the Agvet Code Regulations.

43. Subsection 17(2) of this item also confirms that multiple applications are included in Category 14 and sets out how the fee for multiple applications, where no data of a technical nature is required, is to be calculated.

44. Paragraph 17(2)(b) of this item sets out the method of calculating the fee for multiple applications involving variations of more than five products.  The method effectively ‘bundles’ multiple applications into five product applications and after charging the module 11.4 finalisation fee for each of the first five product applications then only charges that fee once for each additional ‘bundle’ of up to five product applications. 

45. Subsection 17(3) of this item provides for the method of calculating the fee for multiple applications where data of a technical nature is required.  Essentially the method of calculating the fee for such multiple applications is the same as for multiple applications where no data of a technical nature is required except that the calculated fee additionally includes any technical assessment required by the APVMA (other than the screening or finalisation modules) multiplied by the effective rate of that technical assessment  ‑ that is, the actual number of each of the technical assessments required for all of the products in the multiple application.

Item 18 Modular Assessment Periods

46. This item provides that, if a module, level or type is appropriate for a particular application then the period within which the APVMA must complete that module, level or type is the period set out in column 3 of Schedule 7.  The method of working out the total modular assessment period within which the APVMA’s assessment of any particular application must be completed is set out in regulation 77 of the Agvet Code Regulations.

47. This item also specifies the timeframe within which the APVMA must complete multiple applications.

Legal Program

APVMA

July 2010

O:\LEGAL\LEGISLATION\EMs & ESs\ES Agvet Code LI 2 ModAss Fees July 2010.doc

[1]     It is to be noted that throughout the Principal Instrument the words “application for chemical products” is a general shortened expression that means “application for registration of chemical products”.  Where it is appropriate in its context, such as in paragraph 6(2)(d), subsection 6(3), paragraphs 6(4)(e) and 7(3)(c), section 8, paragraphs 10(3)(b) and 11 (4)9b), subparagraph12(5)(a)(ix), section 13 and subsection 14(4) the expression may also be taken to mean “application for a permit in relation to chemical products” or “application for a trial protocol in relation to chemical products”.