Agricultural and Veterinary Chemicals Code Amendment Instrument No. 1 (Trial Protocols) 2008

Administered by Department of Agriculture

Legislation au F2008L00021 Not in force Legislative Instrument

Legislation content

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”.

 

Overview

The Agricultural and Veterinary Chemicals Code Amendment Instrument No. 1 (Trial Protocols) 2008 was enacted to address a specific gap in the application fee structure for trial protocols under the Agricultural and Veterinary Chemicals Code (Agvet Code) as administered by the Australian Pesticides and Veterinary Medicines Authority (APVMA). The primary objective of the instrument is to ensure that the fee structure for trial protocol applications aligns with the existing modular assessment fees, thereby providing clarity and consistency in fee determination. This amendment was introduced by the APVMA to accurately reflect the resources required for assessing trial protocols, which are critical for the registration of agricultural and veterinary chemical products. The instrument aims to avoid the current scenario where the appropriate fee for certain residues assessments in trial protocols is not explicitly defined, thereby ensuring a fair and transparent fee structure. The instrument amends the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005 by including trial protocols within the scope of the limited residues assessment module, thereby specifying the fee structure for such assessments. This legislative change ensures that the fee for trial protocol applications requiring residues assessment is clearly defined and directly related to the assessment workload, promoting both administrative efficiency and financial transparency. The instrument also clarifies the application of the finalisation module to all relevant applications, including permits and trial protocols, thereby ensuring consistency across the board.

Scope and Application

The Agricultural and Veterinary Chemicals Code Amendment Instrument No. 1 (Trial Protocols) 2008 amends the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005, which sets out the modular assessment fee structure for applications to the Australian Pesticides and Veterinary Medicines Authority (APVMA). This amendment applies to applications for trial protocols, specifically Category 25 applications for the assessment of safety and efficacy, residue, and other trials conducted on a particular crop or animal group with a chemical product. The amendment clarifies that a level 5 limited residues assessment, currently applicable only to permit applications, is also required for trial protocol applications, with a fee of $1,070. The total fee for a trial protocol application requiring both safety/efficacy and residues assessments is thus $2,130. Additionally, the amendment clarifies that Finalisation module 11.4 applies to any application for chemical products, including permits or trial protocols, that requires finalisation not included in other modules, with a fee of $145. This amendment ensures that the fee structure for trial protocol applications is accurately reflected in the modular assessment fee structure, aligning with the intended use of Category 25 for such assessments. The Amendment Instrument operates within the Commonwealth jurisdiction and applies to entities and individuals seeking to conduct trials for agricultural and veterinary chemicals in Australia. The instrument does not specify exclusions, exemptions, or thresholds beyond the outlined fee structure. The APVMA may extend or restrict the application of the amendment through subordinate instruments, as per the provisions of the Agricultural and Veterinary Chemicals Code Act 1994 and the Agricultural and Veterinary Chemicals (Administration) Act 1992.

Key Provisions

The Agricultural and Veterinary Chemicals Code Amendment Instrument No. 1 (Trial Protocols) 2008 amends the Agricultural and Veterinary Chemicals Code Instrument No. 2 (Modular Assessment Fees) 2005. The main changes introduced by this Amendment Instrument are detailed in Schedule 1, which modifies the existing modular assessment fees structure to include fees for trial protocol applications. Specifically, subsection 9(6) of the Principal Instrument is updated to require a level 5 limited residues assessment (with a fee of $1,070) for trial protocol applications. This means that trial protocols that require residues assessment will now also incur this fee, bringing the total fee for such applications to $2,130, combining the screening (module 1), limited safety and residues assessment (module 8.3), and type 4 finalisation (module 11.4) fees. Additionally, subsection 15(5) is amended to include a new paragraph (b) that specifies that finalisation module 11.4 (with a fee of $145) applies to any application for chemical products, including permits or trial protocols, that requires finalisation not included in modules 11.1, 11.2, 11.3, or elsewhere in 11.4. Under the amended legislation, entities and individuals responsible for submitting applications for trial protocols must ensure they adhere to the new fee structure. This includes being aware of the specific modules applicable to their trial protocol applications and the corresponding fees. The APVMA will now assess trial protocol applications under the revised fee structure, which includes a modular assessment approach. Applicants must correctly identify the relevant modules for their specific trial protocol and calculate the total fee accordingly. Failure to correctly identify and pay the required fees may result in delays or rejections of the application. Failure to comply with the new fee structure and requirements may lead to administrative consequences. The APVMA is empowered to enforce compliance with the new fee structure. If an applicant fails to pay the correct fee or provides incomplete or incorrect information, the APVMA may reject the application or require additional information before proceeding with the assessment. There are no specific criminal penalties outlined for non-compliance with the fee structure; however, the APVMA can impose civil penalties for incorrect or incomplete submissions. These penalties are intended to ensure that applications meet the necessary standards and that the APVMA can efficiently manage its resources.

Legal classification tags

Area of Law
Regulatory Standards
Instrument
Legislative Instrument
Concepts
Definitions & Interpretation
Regulatory Standards
Licensing & Registration
Enforcement Powers

Interactions

Authorises

All Versions

Sourced from the Federal Register of Legislation at 26 August 2026. For the latest information on Australian Government law please go to https://www.legislation.gov.au.