EXPLANATORY STATEMENT
Agricultural and Veterinary Chemicals Code
Amendment Instrument No. 1 (Trial Protocols) 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.
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 made for the purposes of subsection 165(1) 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. 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 Schedule provides for 25 separate categories of applications. 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.
Category 25 of Schedule 6 is a ‘catch all’ category for the technical assessments of certain applications not provided for elsewhere. It had always been intended that a major use of Category 25 would be the assessment of trial protocols – that is, safety and efficacy, residue, and other trials conducted on a particular crop or animal group with a chemical product for the purpose of obtaining registration of that chemical product. APVMA documentation states that applications for trial protocols are to be assessed under Category 25. Schedule 6 provides that the fee for the assessment by the APVMA of a Category 25 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. 2 (Modular Assessment Fees) 2005 (the Principal Instrument). The Principal Instrument details which modular levels, as set out in Schedule 7 of the Agvet Regulations, are to apply to a particular application. Section 9 of the Principal Instrument sets out the types of applications for which module 5 residues assessment is required. Subsection 9(6) describes the types of permit applications for which a module 5.5 limited residue assessment (for permits only) is necessary. The fee for this assessment is $1,070.
The purpose of the Agricultural and Veterinary Chemicals Code Amendment Instrument No. 1 (Trial Protocols) 2008 (the Amendment Instrument) is to add to subsection 9(6) assessments for applications for trial protocols. Applications for trial protocols are Category 25 applications for which the modular assessment fee applies. Mostly, trial protocols require only a screening (module 1 – fee of $460), limited safety and residues assessment (module 8.3 – fee of $455) and type 4 finalisation (module 11.4 – fee of $145) and for which the total fee is thus $1,060. Occasionally, however, they also require a residues assessment but there is currently no residues module that applies to trial protocols. The residues module that would be appropriate for the assessment of trial protocol applications would be module 5.5 (limited assessment) that currently applies only to permit applications. The intention is for limited residues assessment (module 5.5 – fee of $1,070) to also apply to residues assessments of trial protocols. The total fee for an application for a trial protocol requiring residues as well as safety/efficacy assessment would thus be $2,130.
The Amending Instrument also clarifies that Finalisation module 11.4 (Type 4 Finalisation) also applies to any other application for chemical products, including applications for a permit or a trial protocol in relation to chemical products, which requires finalisation that is not included in modules 11.1, 11.2, 11.3, or elsewhere in 11.4. The fee for a Finalisation module 11.4 is $145.
Column 3 of Schedule 7 to the Agvet Code Regulations is also used to determine the period within which the assessment of a particular application must be completed. However, by the operation of regulation 77 of the Agvet Code Regulations, the three month timeframe for module 5.5 limited residues assessments would not be added to the total timeframe for trial protocols as the total timeframe is the longest of the periods for any of the Schedule 7 modules that applies to the application plus the finalisation assessment module.
The Agricultural and Veterinary Chemicals Code Amendment Instrument No. 1 (Trial Protocols) 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. 1 (Trial Protocols) 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. 2 (Modular Assessment Fees) 2005
3. This item provides that Schedule 1 amends the Principal Instrument.
Schedule 1 Amendments
Item 1 Subsection 9(6)
4. This item omits subsection (6) and substitutes a new subsection. The new subsection (6) includes “or Trial Protocols” in the heading and also inserts paragraph (b) providing that a level 5 limited residues assessment (with a fee of $1,070) is also required for applications for assessment of a trial protocol for agricultural and veterinary chemical products.
Item 2 Subsection 15(5)
5. This items adds paragraph (b) at the end of subsection 15(5). The new paragraph provides that finalisation module 11.4 (with a fee of $145) applies to any other application for chemical products, including applications for a permit or a trial protocol in relation to chemical products1, which requires finalisation that is not included in modules 11.1, 11.2, 11.3, or elsewhere in 11.4.
Footnote
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)(b), subparagraph 12(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”.